Pending: 32012D0739

                                January 16, 2026                            

30.11.2012
EN
Official Journal of the European Union
L 330/21



(1)
On 1 December 2011, the Council adopted Decision 2011/782/CFSP concerning restrictive measures against Syria(1).



(2)
On the basis of a review of Decision 2011/782/CFSP, the Council has concluded that the restrictive measures should be renewed until 1 March 2013.



(3)
Furthermore, it is necessary to update the list of persons and entities subject to restrictive measures as set out in Annex I to Decision 2011/782/CFSP.



(4)
For the sake of clarity, the measures imposed under Decision 2011/273/CFSP should be integrated into a single legal instrument.



(5)
Decision 2011/782/CFSP should therefore be repealed.



(6)
Further action by the Union is needed in order to implement certain measures,



(a)
provide, directly or indirectly, technical assistance, brokering services or other services related to the items referred to in paragraphs 1 and 2 or related to the provision, manufacture, maintenance and use of such items, to any natural or legal person, entity or body in, or for use in, Syria;



(b)
provide, directly or indirectly, financing or financial assistance related to the items referred to in paragraphs 1 and 2, including in particular grants, loans and export credit insurance, as well as insurance and reinsurance, for any sale, supply, transfer or export of such items, or for the provision of related technical assistance, brokering services or other services to any natural or legal person, entity or body in, or for use in, Syria.



(a)
technical assistance, brokering services or other services related to the items referred to in paragraph 1 or related to the provision, manufacture, maintenance and use of such items, to any natural or legal person, entity or body in, or for use in, Syria;



(b)
financing or financial assistance related to the items referred to in paragraph 1, including in particular grants, loans and export credit insurance, as well as insurance and reinsurance, for any sale, supply, transfer or export of such items, or for the provision of related technical assistance, brokering services or other services to any natural or legal person, entity or body in, or for use in, Syria,



(a)
supplies and technical assistance intended solely for the support of or use by the United Nations Disengagement Observer Force (UNDOF);



(b)
the sale, supply, transfer or export of non-lethal military equipment or of equipment which might be used for internal repression, intended solely for humanitarian or protective use, or for institution building programmes of the United Nations (UN) and the European Union, or for European Union and UN crisis management operations;



(c)
the sale, supply, transfer or export of non-combat vehicles which have been manufactured or fitted with materials to provide ballistic protection, intended solely for the protective use of personnel of the European Union and its Member States in Syria;



(d)
the provision of technical assistance, brokering services and other services related to such equipment or to such programmes and operations;



(e)
the provision of financing and financial assistance related to such equipment or to such programmes and operations,



(a)
refining;



(b)
liquefied natural gas;



(c)
exploration;



(d)
production.



(a)
technical assistance or training and other services related to key equipment and technology as referred to in paragraph 1;



(b)
financing or financial assistance for any sale, supply, transfer or export of key equipment and technology as set out in paragraph 1 or for the provision of related technical assistance or training.



(a)
the granting of any financial loan or credit to enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining, or to Syrian or Syrian-owned enterprises engaged in those sectors outside Syria;



(b)
the granting of any financial loan or credit to enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria;



(c)
the acquisition or extension of a participation in enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining, or in Syrian or Syrian-owned enterprises engaged in those sectors outside Syria, including the acquisition in full of such enterprises and the acquisition of shares or securities of a participating nature;



(d)
the acquisition or extension of a participation in enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria, including the acquisition in full of such enterprises and the acquisition of shares or securities of a participating nature;



(e)
the creation of any joint venture with enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining and with any subsidiary or affiliate under their control;



(f)
the creation of any joint venture with enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria and with any subsidiary or affiliate under their control.



(i)
shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 23 September 2011;



(ii)
shall not prevent the extension of a participation, if such extension is an obligation under an agreement concluded before 23 September 2011.



(i)
shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 1 December 2011;



(ii)
shall not prevent the extension of a participation, if such extension is an obligation under an agreement concluded before 1 December 2011.



(a)
any disbursement or payment by the European Investment Bank (EIB) under or in connection with any existing loan agreements entered into between Syria and the EIB;



(b)
the continuation by the EIB of any existing Technical Assistance Service Contracts for sovereign projects located in Syria.



(a)
health or travel insurance to natural persons;



(b)
compulsory or third party insurance to Syrian persons, entities or bodies based in the Union;



(c)
insurance or re-insurance to the owner of a vessel, aircraft or vehicle chartered by a Syrian person, entity or body and which person, entity or body is not listed in Annex I or II.



(a)
as a host country to an international intergovernmental organisation;



(b)
as a host country to an international conference convened by, or under the auspices of, the UN;



(c)
under a multilateral agreement conferring privileges and immunities; or



(d)
under the 1929 Treaty of Conciliation (Lateran pact) concluded by the Holy See (State of the Vatican City) and Italy.



(a)
necessary to satisfy the basic needs of the persons listed in Annexes I and II and their dependent family members, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges;



(b)
intended exclusively for the payment of reasonable professional fees and the reimbursement of incurred expenses associated with the provision of legal services;



(c)
intended exclusively for the payment of fees or service charges for the routine holding or maintenance of frozen funds or economic resources; or



(d)
necessary for extraordinary expenses, provided that the competent authority has notified the competent authority of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least two weeks prior to the authorisation;



(e)
necessary for humanitarian purposes, such as delivering or facilitating the delivery of assistance, including medical supplies, food, humanitarian workers and related assistance, or evacuations from Syria;



(f)
to be paid into or from an account of a diplomatic or consular mission or an international organisation enjoying immunities in accordance with international law, in so far as such payments are intended to be used for official purposes of the diplomatic or consular mission or international organisation.



(a)
the funds or economic resources are subject of an arbitral decision rendered prior to the date on which the person or entity referred to in Paragraph 1 was listed in Annex I or II or of a judicial or administrative decision rendered in the EU, or a judicial decision enforceable in the Member State concerned, prior to or after that date;



(b)
the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims;



(c)
the decision is not for the benefit of a person or entity listed in Annex I or II; and



(d)
recognising the decision is not contrary to public policy in the Member State concerned.



(a)
interest or other earnings on those accounts; or



(b)
payments due under contracts, agreements or obligations that were concluded or arose prior to the date on which those accounts became subject to this Decision,




Name
Identifying information
Reasons
Date of listing

1.
Bashar Al-Assad
Date of birth: 11 September 1965;Place of birth: Damascus;diplomatic passport No D1903
President of the Republic; person authorising and supervising the crackdown on demonstrators.
23.5.2011

2.
Maher (a.k.a. Mahir) Al-Assad
Date of birth: 8 December 1967;diplomatic passport No 4138
Commander of the Army's 4th Armoured Division, member of Ba'ath Party Central Command, strongman of the Republican Guard; brother of President Bashar Al-Assad; principal overseer of violence against demonstrators.
9.5.2011

3.
Ali Mamluk (a.k.a. Mamlouk)
Date of birth: 19 February 1946;Place of birth: Damascus;diplomatic passport No 983
Head of Syrian General Intelligence Directorate (GID); involved in violence against demonstrators.
9.5.2011

4.
Atej (a.k.a. Atef, Atif) Najib

Former Head of the Political Security Directorate in Dara'a; cousin of President Bashar Al-Assad; involved in violence against demonstrators.
9.5.2011

5.
Hafiz Makhluf (a.k.a. Hafez Makhlouf)
Date of birth: 2 April 1971;Place of birth: Damascus;diplomatic passport No 2246
Colonel and Head of Unit in General Intelligence Directorate, Damascus Branch; cousin of President Bashar Al-Assad; close to Maher Al-Assad; involved in violence against demonstrators.
9.5.2011

6.
Muhammad Dib Zaytun (a.k.a. Mohammed Dib Zeitoun)
Date of birth: 20 May 1951;Place of birth: Damascus;diplomatic passport No D000001300
Head of Political Security Directorate; involved in violence against demonstrators.
9.5.2011

7.
Amjad Al-Abbas

Head of Political Security in Banyas, involved in violence against demonstrators in Baida.
9.5.2011

8.
Rami Makhlouf
Date of birth: 10 July 1969;Place of birth: Damascus;passport No 454224
Syrian businessman; cousin of President Bashar Al-Assad, controls the investment funds Al Mahreq, Bena Properties, Cham Holding Syriatel, Souruh Company thereby furnishing financing and support to the regime.
9.5.2011

9.
Abd Al-Fatah Qudsiyah
Born: 1953;Place of birth: Hama;diplomatic passport No D0005788
Head of Syrian Military Intelligence (SMI); involved in violence against the civilian population.
9.5.2011

10.
Jamil Hassan

Head of Syrian Air Force Intelligence; involved in violence against the civilian population.
9.5.2011

11.
Rustum Ghazali
Date of birth: 3 May 1953;Place of birth: Dara'a;diplomatic passport No D000000887
Head of Syrian Military Intelligence, Damascus Countryside Branch; involved in violence against the civilian population.
9.5.2011

12.
Fawwaz Al-Assad
Date of birth: 18 June 1962;Place of birth: Kerdala;passport No 88238
Involved in violence against the civilian population as part of the Shabiha militia.
9.5.2011

13.
Munzir Al-Assad
Date of birth: 1 March 1961;Place of birth: Latakia;passports No 86449 and No 842781
Involved in violence against the civilian population as part of the Shabiha militia.
9.5.2011

14.
Asif Shawkat
Date of birth: 15 January 1950;Place of birth: Al-Madehleh, Tartous
Deputy Chief of Staff for Security and Reconnaissance; involved in violence against the civilian population.
23.5.2011

15.
Hisham Ikhtiyar
Born: 1941
Head of Syrian National Security Bureau; involved in violence against the civilian population.
23.5.2011

16.
Faruq Al Shar'
Date of birth: 10 December 1938
Vice-President of Syria; involved in violence against the civilian population.
23.5.2011

17.
Muhammad Nasif Khayrbik
Date of birth: 10 April 1937 (or 20 May 1937);Place of birth: Hama;diplomatic passport No 0002250
Deputy Vice-President of Syria for National Security Affairs; involved in violence against the civilian population.
23.5.2011

18.
Mohamed Hamcho
Date of birth: 20 May 1966;passport No 002954347
Syrian businessman and local agent for several foreign companies; associate of Maher al-Assad, managing a part of his financial and economic interests and as such provides funding to the regime.
23.5.2011

19.
Iyad (a.k.a. Eyad) Makhlouf
Date of birth: 21 January 1973;Place of birth: Damascus;passport No N001820740
Brother of Rami Makhlouf and GID Officer involved in violence against the civilian population.
23.5.2011

20.
Bassam Al Hassan

Presidential Advisor for Strategic Affairs; involved in violence against the civilian population.
23.5.2011

21.
Dawud Rajiha

Chief of Staff of the Armed Forces responsible for the military involvement in violence against peaceful protesters.
23.5.2011

22.
Ihab (a.k.a. Ehab, Iehab) Makhlouf
Date of birth: 21 January 1973;Place of birth: Damascus;passport No N002848852
President of Syriatel, which transfers 50 % of its profits to the Syrian government by way of its licencing contract.
23.5.2011

23.
Zoulhima Chaliche (Dhu al-Himma Shalish)
Born: 1951 or 1946;Place of birth: Kerdaha
Head of presidential security; involved in violence against demonstrators; first cousin of President Bashar Al-Assad.
23.6.2011

24.
Riyad Chaliche (Riyad Shalish)

Director of Military Housing Establishment; provides funding to the regime; first cousin of President Bashar Al-Assad.
23.6.2011

25.
Brigadier Commander Mohammad Ali Jafari (a.k.a. Ja'fari, Aziz; a.k.a. Jafari, Ali; a.k.a. Jafari, Mohammad Ali; a.k.a. Ja'fari, Mohammad Ali; a.k.a. Jafari-Naja-fabadi, Mohammad Ali)
Date of birth: 1 September 1957;Place of birth: Yazd, Iran
General Commander of Iranian Revolutionary Guard Corps, involved in providing equipment and support to help the Syrian regime suppress protests in Syria.
23.6.2011

26.
Major General Qasem Soleimani (a.k.a. Qasim Soleimany)

Commander of Iranian Revolutionary Guard Corps, IRGC – Qods, involved in providing equipment and support to help the Syrian regime suppress protests in Syria.
23.6.2011

27.
Hossein Taeb (a.k.a. Taeb, Hassan; a.k.a. Taeb, Hosein; a.k.a. Taeb, Hossein; a.k.a. Taeb, Hussayn; a.k.a. Hojjatoleslam Hossein Ta'eb)
Born: 1963;Place of birth: Tehran, Iran
Deputy Commander for Intelligence of Iranian Revolutionary Guard Corps, involved in providing equipment and support to help the Syrian regime suppress protests in Syria.
23.6.2011

28.
Khalid Qaddur

Business associate of Maher Al-Assad; provides funding to the regime.
23.6.2011

29.
Ra'if Al-Quwatly (a.k.a. Ri'af Al-Quwatli a.k.a. Raeef Al-Kouatly)

Business associate of Maher Al-Assad and responsible for managing some of his business interests; provides funding to the regime.
23.6.2011

30.
Mohammad Mufleh

Head of Syrian Military Intelligence in the town of Hama, involved in the crackdown on demonstrators.
1.8.2011

31.
Major General Tawfiq Younes

Head of the Department for Internal Security of the General Intelligence Directorate; involved in violence against the civilian population.
1.8.2011

32.
Mr Mohammed Makhlouf (a.k.a. Abu Rami)
Date of birth: 19.10.1932;Place of birth: Latakia, Syria
Close associate and maternal uncle of Bashar and Mahir al-Assad. Business associate and father of Rami, Ihab and Iyad Makhlouf.
1.8.2011

33.
Ayman Jabir
Place of birth: Latakia
Associate of Mahir al-Assad for the Shabiha militia. Directly involved in repression and violence against the civilian population and coordination of Shabiha militia groups
1.8.2011

34.
Hayel Al-Assad

Assistant to Maher Al-Assad, Head of the military police unit of the army's 4th Division, involved in repression.
23.8.2011

35.
Ali Al-Salim

Director of the supplies office of the Syrian Ministry of Defence, entry point for all arms acquisitions by the Syrian army.
23.8.2011

36.
Nizar Al-Assad ()
Cousin of Bashar Al-Assad; previously head of the ‧Nizar Oilfield Supplies‧ company
Very close to key government officials. Financing Shabiha in the region of Latakia.
23.8.2011

37.
Brigadier-General Rafiq Shahadah

Head of Syrian Military Intelligence (SMI) Branch 293 (Internal Affairs) in Damascus. Directly involved in repression and violence against the civilian population in Damascus. Advisor to President Bashar Al-Assad for strategic questions and military intelligence.
23.8.2011

38.
Brigadier-General Jamea Jamea (Jami Jami)

Branch Chief for Syrian Military Intelligence (SMI) in Dayr az-Zor. Directly involved in repression and violence against the civilian population in Dayr az-Zor and Alboukamal.
23.8.2011

39.
Hassan Bin-Ali Al-Turkmani
Born: 1935;Place of birth: Aleppo
Deputy Vice Minister, former Minister for Defence, Special Envoy of President Bashar Al-Assad.
23.8.2011

40.
Muhammad Said Bukhaytan

Assistant Regional Secretary of Ba'ath Arab Socialist Party since 2005, 2000-2005 Director for the national security of the regional Ba'ath party. Former Governor of Hama (1998-2000). Close associate of President Bashar Al-Assad and Maher Al-Assad. Senior decision-maker in the regime on repression of civilian population.
23.8.2011

41.
Ali Douba

Responsible for killings in Hama in 1980, has been called back to Damascus as special advisor to President Bashar Al-Assad.
23.8.2011

42.
Brigadier-General Nawful Al-Husayn

Idlib Syrian Military Intelligence (SMI) Branch Chief. Directly involved in repression and violence against the civilian population in Idlib province.
23.8.2011

43.
Brigadier Husam Sukkar

Presidential Adviser on Security Affairs. Presidential Adviser for security agencies' repression and violence against the civilian population.
23.8.2011

44.
Brigadier-General Muhammed Zamrini

Branch Chief for Syrian Military Intelligence (SMI) in Homs. Directly involved in repression and violence against the civilian population in Homs.
23.8.2011

45.
Lieutenant-General Munir Adanov (Adnuf)

Deputy Chief of General Staff, Operations and Training for Syrian Army. Directly involved in repression and violence against the civilian population in Syria.
23.8.2011

46.
Brigadier-General Ghassan Khalil

Head of General Intelligence Directorate's (GID) Information Branch. Directly involved in repression and violence against the civilian population in Syria.
23.8.2011

47.
Mohammed Jabir
Place of birth: Latakia
Shabiha militia. Associate of Maher Al-Assad for the Shabiha militia. Directly involved in repression and violence against the civilian population and coordination of Shabiha militia groups.
23.8.2011

48.
Samir Hassan

Close business associate of Maher Al-Assad. Known for supporting the Syrian regime financially.
23.8.2011

49.
Fares Chehabi (a.k.a. Fares Shihabi; Fares Chihabi)
Son of Ahmad Chehabi;Date of birth: 7 May 1972
President of Aleppo Chamber of Industry. Vice-chairman of Cham Holding. Provides economic support to the Syrian regime.
2.9.2011

50.
Tarif Akhras
Date of birth: 2 June 1951;Place of birth: Homs, Syria;Syrian passport nr. 0000092405
Prominent businessman benefiting from and supporting the regime. Founder of the Akhras Group (commodities, trading, processing and logistics) and former Chairman of the Homs Chamber of Commerce. Close business relations with President Al-Assad's family. Member of the Board of the Federation of Syrian Chambers of Commerce. Provided industrial and residential premises for improvised detention camps, as well as logistical support for the regime (buses and tank loaders).
2.9.2011

51.
Issam Anbouba
President of Anbouba for Agricultural Industries Co.;Born: 1952;Place of birth: Homs, Syria
Providing financial support for the repressive apparatus and the paramilitary groups exerting violence against the civil population in Syria. Providing property (premises, warehouses) for improvised detention centers. Financial relations with high Syrian officials.
2.9.2011

52.
Mazen al-Tabba
Date of birth: 01.01.1958;Place of birth: Damascus;Passport nr. 004415063 expires 06.05.2015 (Syrian)
Business partner of Ihab Makhlour and Nizar al-Assad (became subject to sanctions on 23.8.2011); co-owner, with Rami Makhlour, of the al-diyar lil-Saraafa (a.k.a. Diar Electronic Services) currency exchange company, which supports the policy of the Central Bank of Syria.
23.3.2012

53.
Adib Mayaleh
Born: 1955;Place of birth: Daraa
Adib Mayaleh is responsible for providing economic and financial support to the Syrian regime through his functions as the Governor of the Central Bank of Syria.
15.5.2012

54.
Major General Jumah Al-Ahmad

Commander Special Forces. Responsible for the use of violence against protestors across Syria.
14.11.2011

55.
Colonel Lu'ai al-Ali

Head of Syrian Military Intelligence, Dara'a Branch. Responsible for the violence against protesters in Dara'a.
14.11.2011

56.
Lt. General Ali Abdullah Ayyub

Deputy Chief of General Staff (Personnel and Manpower). Responsible for the use of violence against protestors across Syria.
14.11.2011

57.
Lt. General Jasim al-Furayj

Chief of General staff. Responsible for the use of violence against protestors across Syria.
14.11.2011

58.
General Aous (Aws) Aslan
Born: 1958
Head of Battalion in the Republican Guard. Close to Maher al-Assad and President al-Assad. Involved in the crackdown on the civilian population across Syria.
14.11.2011

59.
General Ghassan Belal

General in command of the 4th Division reserve bureau. Adviser to Maher al-Assad and coordinator of security operations. Responsible for the crackdown on the civilian population across Syria.
14.11.2011

60.
Abdullah Berri

Head of Berri family militia. In charge of pro-government militia involved in the crackdown on the civilian population in Aleppo.
14.11.2011

61.
George Chaoui

Member of Syrian electronic army. Involved in the violent crackdown and call for violence against the civilian population across Syria.
14.11.2011

62.
Major General Zuhair Hamad

Deputy Head of General Intelligence Directorate. Responsible for the use of violence across Syria and for intimidation and torture of protestors.
14.11.2011

63.
Amar Ismael

Civilian – Head of Syrian electronic army (territorial army intelligence service). Involved in the violent crackdown and call for violence against the civilian population across Syria.
14.11.2011

64.
Mujahed Ismail

Member of Syrian electronic army. Involved in the violent crackdown and call for violence against the civilian population across Syria.
14.11.2011

65.
Major General Nazih

Deputy Director of General Intelligence Directorate. Responsible for the use of violence across Syria and intimidation and torture of protestors.
14.11.2011

66.
Kifah Moulhem

Batallion Commander in the 4th Division. Responsible for the crackdown on the civilian population in Deir el-Zor.
14.11.2011

67.
Major General Wajih Mahmud

Commander 18th Armoured Division. Responsible for the violence against protestors in Homs.
14.11.2011

68.
Bassam Sabbagh
Date of birth: 24 August 1959;Place of birth: Damascus.Address: Kasaa, Anwar al Attar Street, al Midani building, Damascus;Syrian passport no 004326765 issued 2 November 2008, valid until November 2014.
Legal and financial adviser and manages affairs of Rami Makhlouf and Khaldoun Makhlouf. Involved with Bashar al-Assad in funding a real estate project in Latakia. Provides financial support for the regime.
14.11.2011

69.
Lt. General Mustafa Tlass

Deputy Chief of General Staff (Logistics and supplies). Responsible for the use of violence against protestors across Syria.
14.11.2011

70.
Major General Fu'ad Tawil

Deputy head Syrian Air Force Intelligence. Responsible for the use of violence across Syria and intimidation and torture of protestors.
14.11.2011

71.
Bushra Al-Assad (a.k.a. Bushra Shawkat)
Date of birth: 24.10.1960
Sister of Bashar Al-Assad and wife of Asif Shawkat, Deputy Chief of Staff for Security and Reconnaissance. Given the close personal relationship and intrinsic financial relationship to the Syrian President Bashar Al-Assad and other core Syrian regime figures, she benefits from and is associated with the Syrian regime.
23.3.2012

72.
Asma Al-Assad (a.k.a. Asma Fawaz Al Akhras)
Date of birth: 11.08.1975;Place of birth: London, UK;Passport nr. 707512830, expires 22.09.2020;Maiden name: Al Akhras
Wife of Bashar Al-Assad. Given the close personal relationship and intrinsic financial relationship to the Syrian President, Bashar Al-Assad, she benefits from and is associated with the Syrian regime.
23.3.2012

73.
Manal Al-Assad (a.k.a. Manal Al Ahmad)
Date of birth: 02.02.1970;Place of Birth: Damascus;Passport number (Syrian): 0000000914;Maiden name: Al Jadaan
Spouse of Maher Al-Assad, and as such benefiting from and closely associated with the regime.
23.3.2012

74.
Anisa Al-Assad (a.k.a. Anisah Al-Assad)
Born: 1934;Maiden name: Makhlouf
Mother of President Al-Assad. Given the close personal relationship and intrinsic financial relationship to the Syrian President, Bashar Al-Assad, she benefits from and is associated with the Syrian regime.
23.3.2012

75.
Lt. General Fahid Al-Jassim

Chief of Staff. Military official involved in the violence in Homs.
1.12.2011

76.
Major General Ibrahim Al-Hassan

Deputy Chief of Staff. Military official involved in the violence in Homs.
1.12.2011

77.
Brigadier Khalil Zghraybih

14th Division. Military official involved in the violence in Homs.
1.12.2011

78.
Brigadier Ali Barakat

103rd Brigade of the Republican Guard Division. Military official involved in the violence in Homs.
1.12.2011

79.
Brigadier Talal Makhluf

103rd Brigade of the Republican Guard Division. Military official involved in the violence in Homs.
1.12.2011

80.
Brigadier Nazih Hassun

Syrian Air Force Intelligence. Military official involved in the violence in Homs.
1.12.2011

81.
Captain Maan Jdiid

Presidential Guard. Military official involved in the violence in Homs.
1.12.2011

82.
Muahmamd Al-Shaar

Political Security Division. Military official involved in the violence in Homs.
1.12.2011

83.
Khald Al-Taweel

Political Security Division. Military official involved in the violence in Homs.
1.12.2011

84.
Ghiath Fayad

Political Security Division. Military official involved in the violence in Homs.
1.12.2011

85.
Brigadier General Jawdat Ibrahim Safi
Commander of 154th Regiment
Ordered troops to shoot at protestors in and around Damascus, including Mo'adamiyeh, Douma, Abasiyeh, Duma.
23.1.2012

86.
Major General Muhammad Ali Durgham
Commander in 4th Division
Ordered troops to shoot at protestors in and around Damascus, including Mo'adamiyeh, Douma, Abasiyeh, Duma.
23.1.2012

87.
Major General Ramadan Mahmoud Ramadan
Commander of 35th Special Forces Regiment
Ordered troops to shoot protestors in Baniyas and Deraa.
23.1.2012

88.
Brigadier General Ahmed Yousef Jarad
Commander of 132nd Brigade
Ordered troops to shoot at protestors in Deraa, including the use of machine guns and anti-aircraft guns.
23.1.2012

89.
Major General Naim Jasem Suleiman
Commander of the 3rd Division
Gave orders to troops to shoot protestors in Douma.
23.1.2012

90.
Brigadier General Jihad Mohamed Sultan
Commander of 65th Brigade
Gave orders to troops to shoot protestors in Douma.
23.1.2012

91.
Major General Fo'ad Hamoudeh
Commander of the military operations in Idlib
Gave orders to troops to shoot protestors in Idlib at the beginning of September 2011.
23.1.2012

92.
Major General Bader Aqel
Special Forces Commander
Gave the soldiers orders to pick up the bodies and hand them over to the mukhabarat and responsible for the violence in Bukamal.
23.1.2012

93.
Brigadier General Ghassan Afif
Commander from the 45th Regiment
Commander of military operations in Homs, Baniyas and Idlib.
23.1.2012

94.
Brigadier General Mohamed Maaruf
Commander from the 45th Regiment
Commander of military operations in Homs. Gave orders to shoot protestors in Homs.
23.1.2012

95.
Brigadier General Yousef Ismail
Commander of the 134th Brigade
Gave orders to troops to shoot at houses and people on roofs during a funeral in Talbiseh for protesters killed the previous day.
23.1.2012

96.
Brigadier General Jamal Yunes
Commander of the 555th Regiment
Gave orders to troops to shoot at protestors in Mo'adamiyeh.
23.1.2012

97.
Brigadier General Mohsin Makhlouf

Gave orders to troops to shoot at protestors in Al-Herak.
23.1.2012

98.
Brigadier General Ali Dawwa

Gave orders to troops to shoot protestors in Al-Herak.
23.1.2012

99.
Brigadier General Mohamed Khaddor
Commander of the 106th Brigade, Presidential Guard
Gave orders to troops to beat the protesters with sticks and then arrest them. Responsible for repression of peaceful protestors in Douma.
23.1.2012

100.
Major General Suheil Salman Hassan
Commander of 5th Division
Gave orders to troops to shoot at the protesters in Deraa Governorate.
23.1.2012

101.
Wafiq Nasser
Head of Suwayda Regional Branch (Department of Military Intelligence)
As Head of the Suwayda branch of the Department for Military Intelligence, responsible for arbitrary detention and torture of detainees in Suwayda.
23.1.2012

102.
Ahmed Dibe
Head of Deraa Regional Branch (General Security Directorate)
As Head of the Deraa Regional Branch of the General Security Directorate, responsible for arbitrary detention and torture of detainees in Deraa.
23.1.2012

103.
Makhmoud al-Khattib
Head of Investigative Branch (Political Security Directorate)
As Head of the Investigative Branch of the Political Security Directorate, responsible for detention and torture of detainees.
23.1.2012

104.
Mohamed Heikmat Ibrahim
Head of Operations Branch (Political Security Directorate)
As Head of the Operations Branch of the Political Security Directorate, responsible for detention and torture of detainees.
23.1.2012

105.
Nasser Al-Ali (a.k.a. Brigadier General Nasr al-Ali)
Head of Deraa Regional Branch (Political Security Directorate)
As Head of the Deraa Regional Branch of the Political Security Directorate, responsible for detention and torture of detainees. Since April 2012 Head of the Deraa site of the Political Security Directorate (ex-head of the Homs branch).
23.1.2012

106.
Mehran (or Mahran) Khwanda
Owner of transport company Qadmous Transport Co.;Date of birth 11.05.1938;Passports: No 3298 858, expired 09.05.2004;No 001452904, expired 29.11.2011;No 006283523, expires 28.06.2017
Provides logistical support to violent repression of civilian population in areas of operation of pro-government militias involved in violence (shabihas).
23.1.2012

107.
Dr. Wael Nader Al –Halqi
Born: 1964;Place of birth: Daraa Province
Prime Minister and former Minister of Health. As Prime Minister, shares responsibility for the regime's violent repression against the civilian population.
27.2.2012

108.
Muhammad Ibrahim Al-Sha'ar (a.k.a. Mohammad Ibrahim Al-Chaar)
Born: 1956;Place of birth: Aleppo
Minister of the Interior. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
1.12.2011

109.
Dr. Mohammad Al-Jleilati
Born: 1945;Place of birth: Damascus
Minister of Finance. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
1.12.2011

110.
Imad Mohammad Deeb Khamis (a.k.a.: Imad Mohammad Dib Khamees)
Date of birth: 1 August 1961;Place of Birth: near Damascus
Minister of Electricity. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
23.3.2012

111.
Omar Ibrahim Ghalawanji
Born: 1954;Place of Birth: Tartous
Vice Prime Minister for Services Affairs, Minister of Local Administration. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
23.3.2012

112.
Joseph Suwaid (a.k.a. Joseph Jergi Sweid)
Born: 1958;Place of Birth: Damascus
Minister of State. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
23.3.2012

113.
Eng Hussein Mahmoud Farzat (a.k.a.: Hussein Mahmud Farzat)
Born: 1957;Place of Birth: Hama
Minister of State. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
23.3.2012

114.
Mansour Fadlallah Azzam (a.k.a.: Mansur Fadl Allah Azzam)
Born: 1960;Place of birth: Sweida Province
Minister for Presidency Affairs. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
27.2.2012

115.
Dr. Emad Abdul-Ghani Sabouni (a.k.a.: Imad Abdul Ghani Al Sabuni)
Born: 1964;Place of birth: Damascus
Minister of Telecommunications and Technology. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
27.2.2012

116.
General Ali Habib Mahmoud
Born: 1939;Place of birth: Tartous
Former Minister of Defence. Associated with the Syrian regime and the Syrian military, and its violent repression against the civilian population.
1.8.2011

117.
Tayseer Qala Awwad
Born: 1943;Place of birth: Damascus
Former Minister of Justice. Associated with the Syrian regime and its violent repression against the civilian population.
23.9.2011

118.
Dr Adnan Hassan Mahmoud
Born: 1966;Place of birth: Tartous
Former Minister of Information. Associated with the Syrian regime and its violent repression against the civilian population.
23.9.2011

119.
Dr. Mohammad Nidal Al-Shaar
Born: 1956;Place of birth: Aleppo
Former Minister of Economy and Trade. Associated with the Syrian regime and its violent repression against the civilian population.
1.12.2011

120.
Sufian Allaw
Born: 1944;Place of birth: al-Bukamal, Deir Ezzor
Former Minister of Oil and Mineral Resources. Associated with the regime and its violent repression against the civilian population.
27.2.2012

121.
Dr Adnan Slakho
Born: 1955;Place of birth: Damascus
Former Minister of Industry. Associated with the regime and its violent repression against the civilian population.
27.2.2012

122.
Dr. Saleh Al-Rashed
Born: 1964;Place of birth: Aleppo Province
Former Minister of Education. Associated with the regime and its violent repression against the civilian population.
27.2.2012

123.
Dr. Fayssal Abbas
Born: 1955;Place of birth: Hama Province
Former Minister of Transport. Associated with the regime and its violent repression against the civilian population.
27.2.2012

124.
Ghiath Jeraatli
Born: 1950;Place of Birth: Salamiya
Former Minister of State. Associated with the regime and its violent repression against the civilian population.
23.3.2012

125.
Yousef Suleiman Al-Ahmad
Born: 1956;Place of Birth: Hasaka
Former Minister of State. Associated with the regime and its violent repression against the civilian population.
23.3.2012

126.
Hassan al-Sari
Born: 1953;Place of Birth: Hama
Former Minister of State. Associated with the regime and its violent repression against the civilian population.
23.3.2012

127.
Bouthaina Shaaban (a.k.a. Buthaina Shaaban)
Born: 1953;Place of birth: Homs, Syria
Political and Media Advisor to the President since July 2008 and as such associated with the violent crackdown on the population.
26.6.2012

128.
Brigadier General Sha'afiq Masa

Head of Branch 215 (Damascus) of the army's intelligence service. Responsible for the torture of detained opponents. Involved in repressive actions against civilians.
24.7.2012

129.
Brigadier General Burhan Qadour

Head of Branch 291 (Damascus) of the army's intelligence service. Responsible for the torture of opponents in custody.
24.7.2012

130.
Brigadier General Salah Hamad

Deputy Head of Branch 291 of the army's intelligence service. Responsible for the torture of opponents in custody.
24.7.2012

131.
Brigadier General Muhammad (or: Mohammed) Khallouf (a.k.a. Abou Ezzat)

Head of Branch 235, a.k.a. "Palestine" (Damascus) of the army's intelligence service, which is at the centre of the army's apparatus of repression. Directly involved in repression of opponents. Responsible for the torture of opponents in custody.
24.7.2012

132.
Major General Riad al-Ahmed

Deputy Head of Latakia Branch of the army's intelligence service. Responsible for the torture and murder of opponents in custody.
24.7.2012

133.
Brigadier General Abdul Salam Fajr Mahmoud

Head of the Bab Tuma (Damascus) Branch of the air force's intelligence service. Responsible for the torture of opponents in custody.
24.7.2012

134.
Brigadier General Jawdat al-Ahmed

Head of the Homs Branch of the air force's intelligence service. Responsible for the torture of opponents in custody.
24.7.2012

135.
Colonel Qusay Mihoub

Head of the Deraa branch of the air force's intelligence service (sent from Damascus to Deraa at the start of demonstrations there). Responsible for the torture of opponents in custody.
24.7.2012

136.
Colonel Suhail Al-Abdullah

Head of the Latakia Branch of the air force's intelligence service. Responsible for the torture of opponents in custody.
24.7.2012

137
Brigadier General Khudr Khudr

Head of the Latakia branch of the General Intelligence Directorate. Responsible for the torture of opponents in custody.
24.7.2012

138.
Brigadier General Ibrahim Ma'ala

Head of branch 285 (Damascus) of the General Intelligence Directorate (replaced Brig. Gen. Hussam Fendi at end 2011). Responsible for the torture of opponents in custody.
24.7.2012

139.
Brigadier General Firas Al-Hamed

Head of branch 318 (Homs) of the General Intelligence Directorate. Responsible for the torture of opponents in custody.
24.7.2012

140.
Brigadier General Hussam Luqa

Since April 2012, head of the Homs branch of the Political Security Directorate (succeeded Brig. Gen. Nasr al-Ali). Responsible for the torture of opponents in custody.
24.7.2012

141.
Brigadier General Taha Taha

Site manager of the Latakia branch of the Political Security Directorate. Responsible for the torture of opponents in custody
24.7.2012

142.
Bassel Bilal

Police officer at Idlib central prison; has taken part directly in acts of torture of opponents held in Idlib central prison.
24.7.2012

143.
Ahmad Kafan

Police officer at Idlib central prison; has taken part directly in acts of torture of opponents held in Idlib central prison.
24.7.2012

144.
Bassam al-Misri

Police officer at Idlib central prison; has taken part directly in acts of torture of opponents held in Idlib central prison.
24.7.2012

145.
Ahmed al-Jarroucheh
Born: 1957
Head of the foreign branch of General Intelligence (branch 279). As such, responsible for General Intelligence arrangements in Syrian embassies. He participates directly in the repression implemented by the Syrian authorities against opponents and in particular has responsibility for repression of the Syrian opposition abroad.
24.7.2012

146.
Michel Kassouha (a.k.a. Ahmed Salem; a.k.a. Ahmed Salem Hassan)
Date of birth: 1 February 1948
Member of the Syrian security services since the early 1970s, he is involved in combating opposition in France and Germany. Since March 2006, has been responsible for public relations of branch 273 of the Syrian General Intelligence Directorate. A longstanding member of the managerial staff, he is close to General Intelligence Directorate head Ali Mamlouk, one of the top security officials of the regime who has been subject to EU restrictive measures since 9 May 2011. He directly supports the regime's repression of opponents and is responsible inter alia for repression of the Syrian opposition abroad.
24.7.2012

147.
General Ghassan Jaoudat Ismail
Born: 1960;Place of origin: Drekish, Tartous region
Responsible for the missions branch of the air force intelligence service, which, in cooperation with the special operations branch, manages the elite troops of the air force intelligence service, who play an important role in the repression conducted by the regime. As such, Ghassan Jaoudat Ismail is one of the military leaders directly implementing the repression of opponents conducted by the regime.
24.7.2012

148.
General Amer al-Achi (a.k.a. Amis al Ashi; a.k.a. Ammar Aachi; a.k.a. Amer Ashi)

Graduate of the military school of Aleppo, head of the intelligence branch of the air force intelligence service (since 2012), close to Daoud Rajah, Syrian Minister for Defence. Through his role in the air force intelligence service, Amer al-Achi is implicated in the repression of the Syrian opposition.
24.7.2012

149.
General Mohammed Ali Nasr (or: Mohammed Ali Naser)
Born: around 1960.
Close to Maher Al-Assad, younger brother of the President. Most of his career has been spent in the Republican Guard. In 2010 he joined the internal branch (or branch 251) of the General Intelligence Directorate which is responsible for combating the political opposition. As one of its senior officers, General Mohammed Ali is directly involved in the repression of opponents.
24.7.2012

150.
General Issam Hallaq

Air Force Chief of Staff since 2010. Commands air operations against opponents.
24.7.2012

151.
Ezzedine Ismael
Born: middle of the 1940s (probably 1947);Place of birth: Bastir. Jableh region
Retired general, longstanding member of the managerial staff of the air force intelligence service, of which he became the head in the early 2000s. Was appointed political and security adviser to the President in 2006. As political and security adviser to the Syrian president, Ezzedine Ismael is implicated in the political repression conducted by the regime against the opposition.
24.7.2012

152.
Samir Joumaa (a.k.a. Abou Sami)
Born: around 1962
For almost 20 years he has been head of the office of Mohammad Nassif Kheir Bek, one of the main security advisers of Bashar al-Assad (and officially deputy to the Vice- President, Farouk al-Sharaa). Samir Joumaa's closeness to Bashar al-Assad and Mohammed Nassif Kheir Bek means that he is implicated in the policy of repression conducted by the regime against its opponents.
24.7.2012

153.
Dr. Qadri Jameel

Vice Prime Minister for Economic Affairs, Minister of Domestic Trade and Consumer's Protection. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

154.
Waleed Al Mo'allem

Vice Prime Minister, Minister of Foreign Affairs and Expatriates. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

155.
Major general Fahd Jassem Al Freij

Minister of Defence and military commander. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

156.
Dr. Mohammad Abdul Sattar Al Sayed

Minister of Religious Endowments. As Government Minister, shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

157.
Eng. Hala Mohammad Al Nasser

Minister of Tourism. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

158.
Eng. Bassam Hanna

Minister of Water Resources. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

159.
Eng. Subhi Ahmad Al Abdallah

Minister of Agriculture and Agrarian Reform. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

160.
Dr. Mohammad Yahiya Mo'alla

Minister of Higher Education. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

161.
Dr. Hazwan Al Wez

Minister of Education. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

162.
Dr. Mohamad Zafer Mohabak

Minister of Economy and Foreign Trade. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

163.
Dr. Mahmud Ibraheem Sa'iid

Minister of Transport. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

164.
Dr. Safwan Al Assaf

Minister of Housing and Urban Development. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

165.
Eng. Yasser Al Siba'ii

Minister of Public Works. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

166.
Eng Sa'iid Ma'thi Hneidi

Minister of Oil and Mineral Resources. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

167.
Dr. Lubana Mushaweh

Minister of Culture. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

168.
Dr. Jassem Mohammad Zakaria

Minister of Labour and Social Affairs. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

169.
Omran Ahed Al Zu'bi

Minister of Information. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

170.
Dr. Adnan Abdo Al Sikhny

Minister of Industry. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

171.
Najm Hamad Al Ahmad

Minister of Justice. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

172.
Dr. Abdul Salam Al Nayef

Minister of Health. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

173.
Dr. Ali Heidar

State Minister for National Reconciliation Affairs. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

174.
Dr. Nazeera Farah Sarkees

State Minister for Environmental Affairs. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

175.
Mohammad Turki Al Sayed

State Minister. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

176.
Najm-eddin Khreit

State Minister. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

177.
Abdullah Khaleel Hussein

State Minister. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

178.
Jamal Sha'ban Shaheen

State Minister. As Government Minister shares responsibility for the regime's violent repression against the civilian population.
16.10.2012

179.
Sulieman Maarouf (a.k.a. Suleiman Maarouf, Sulayman Mahmud Ma'ruf, Sleiman Maarouf, Mahmoud Soleiman Maarouf; Sulaiman Maarouf)
Passport: in possession of a UK passport
Businessman close to President Al-Assad's family. Owns shares in the listed TV station Dounya TV. Close to Muhammad Nasif Khayrbik, who has been designated. Supports the Syrian regime.
16.10.2012

180.
Razan Othman
Wife of Rami Makhlouf, daughter of Walif Othman;Date of birth: 31 January 1977;Place of birth: governorate of Latakia;ID nr.: 06090034007
She has close personal and financial relations with Rami Makhlouf, cousin of president Bashar Al-Assad and principal financer of the regime, who has been designated. As such, associated with the Syrian regime, and benefiting from it.
16.10.2012




Name
Identifying information
Reasons
Date of listing

1.
Bena Properties

Controlled by Rami Makhlouf; provides funding to the regime.
23.6.2011

2.
Al Mashreq Investment Fund (AMIF) (alias Sunduq Al Mashrek Al Istithmari)
P.O. Box 108, Damascus;Tel.: 963 112110059 / 963 112110043Fax: 963 933333149
P.O. Box 108, Damascus;
Tel.: 963 112110059 / 963 112110043
Fax: 963 933333149
Controlled by Rami Makhlouf; provides funding to the regime.
23.6.2011

P.O. Box 108, Damascus;

Tel.: 963 112110059 / 963 112110043

Fax: 963 933333149

3.
Hamcho International (Hamsho International Group)
Baghdad Street, P.O. Box 8254, Damascus;Tel.: 963 112316675Fax: 963 112318875;Website: www.hamshointl.comE-mail: [email protected] and [email protected]
Baghdad Street, P.O. Box 8254, Damascus;
Tel.: 963 112316675
Fax: 963 112318875;
Website: www.hamshointl.com
E-mail: [email protected] and [email protected]
Controlled by Mohammad Hamcho or Hamsho; provides funding to the regime.
23.6.2011

Baghdad Street, P.O. Box 8254, Damascus;

Tel.: 963 112316675

Fax: 963 112318875;

Website: www.hamshointl.com

E-mail: [email protected] and [email protected]

4.
Military Housing Establishment (alias MILIHOUSE)

Public works company controlled by Riyad Shalish and Ministry of Defence; provides funding to the regime.
23.6.2011

5.
Political Security Directorate

Syrian government agency directly involved in repression.
23.8.2011

6.
General Intelligence Directorate

Syrian government agency directly involved in repression.
23.8.2011

7.
Military Intelligence Directorate

Syrian government agency directly involved in repression.
23.8.2011

8.
Air Force Intelligence Agency

Syrian government agency directly involved in repression.
23.8.2011

9.
IRGC Qods Force (Quds Force)
Teheran, Iran
The Qods (or Quds) Force is a specialist arm of the Iranian Islamic Revolutionary Guard Corps (IRGC). The Qods Force is involved in providing equipment and support to help the Syria regime suppress protests in Syria. IRGC Qods Force has provided technical assistance, equipment and support to the Syrian security services to repress civilian protest movements.
23.8.2011

10.
Mada Transport
Subsidiary of Cham Holding (Sehanya Dara'a Highway, PO Box 9525, Tel: 00 963 11 99 62)
Economic entity financing the regime.
2.9.2011

11.
Cham Investment Group
Subsidiary of Cham Holding (Sehanya Dara'a Highway, PO Box 9525, Tel: 00 963 11 99 62)
Economic entity financing the regime.
2.9.2011

12.
Real Estate Bank
Insurance Bldg- Yousef Al-Azmeh Square, Damascus P.O. Box: 2337 Damascus Syrian Arab Republic;Tel: (+963) 11 2456777 and 2218602;Fax: (+963) 11 2237938 and 2211186;Bank's e-mail: [email protected]: www.reb.sy
Insurance Bldg- Yousef Al-Azmeh Square, Damascus P.O. Box: 2337 Damascus Syrian Arab Republic;
Tel: (+963) 11 2456777 and 2218602;
Fax: (+963) 11 2237938 and 2211186;
Bank's e-mail: [email protected]
Website: www.reb.sy
State-owned bank providing financial support for the regime.
2.9.2011

Insurance Bldg- Yousef Al-Azmeh Square, Damascus P.O. Box: 2337 Damascus Syrian Arab Republic;

Tel: (+963) 11 2456777 and 2218602;

Fax: (+963) 11 2237938 and 2211186;

Bank's e-mail: [email protected]

Website: www.reb.sy

13.
Addounia TV (a.k.a. Dounia TV)
Tel: +963-11-5667274; +963-11-5667271;Fax: +963-11-5667272;Website: http://www.addounia.tv
Addounia TV has incited violence against the civilian population in Syria.
23.9.2011

14.
Cham Holding
Cham Holding Building Daraa Highway – Ashrafiyat Sahnaya Rif Dimashq – Syria P.O. Box 9525;Tel +963 (11) 9962; +963 (11) 668 14000; +963 (11) 673 1044;Fax +963 (11) 673 1274;E-mail: [email protected]: www.chamholding.sy
Cham Holding Building Daraa Highway – Ashrafiyat Sahnaya Rif Dimashq – Syria P.O. Box 9525;
Tel +963 (11) 9962; +963 (11) 668 14000; +963 (11) 673 1044;
Fax +963 (11) 673 1274;
E-mail: [email protected]
Website: www.chamholding.sy
Controlled by Rami Makhlouf; largest holding company in Syria, benefiting from and supporting the regime.
23.9.2011

Cham Holding Building Daraa Highway – Ashrafiyat Sahnaya Rif Dimashq – Syria P.O. Box 9525;

Tel +963 (11) 9962; +963 (11) 668 14000; +963 (11) 673 1044;

Fax +963 (11) 673 1274;

E-mail: [email protected]

Website: www.chamholding.sy

15.
El-Tel. Co. (El-Tel. Middle East Company)
Address: Dair Ali Jordan Highway, P.O. Box 13052, Damascus, Syria;Tel. +963-11-2212345;Fax +963-11-44694450E-mail: [email protected]: www.eltelme.com
Address: Dair Ali Jordan Highway, P.O. Box 13052, Damascus, Syria;
Tel. +963-11-2212345;
Fax +963-11-44694450
E-mail: [email protected]
Website: www.eltelme.com
Manufacturing and supplying communication and transmission towers and other equipment for the Syrian army.
23.9.2011

Address: Dair Ali Jordan Highway, P.O. Box 13052, Damascus, Syria;

Tel. +963-11-2212345;

Fax +963-11-44694450

E-mail: [email protected]

Website: www.eltelme.com

16.
Ramak Constructions Co.
Address: Dara'a Highway, Damascus, Syria;Tel: +963-11-6858111;Mobile: +963-933-240231
Address: Dara'a Highway, Damascus, Syria;
Tel: +963-11-6858111;
Mobile: +963-933-240231
Construction of military barracks, border post barracks and other buildings for Army needs.
23.9.2011

Address: Dara'a Highway, Damascus, Syria;

Tel: +963-11-6858111;

Mobile: +963-933-240231

17.
Souruh Company (a.k.a. SOROH Al Cham Company)
Address: Adra Free Zone Area Damascus – Syria;Tel: +963-11-5327266;Mobile: +963-933-526812; +963-932-878282;Fax: +963-11-5316396E-mail: [email protected]: http://sites.google.com/site/sorohco
Address: Adra Free Zone Area Damascus – Syria;
Tel: +963-11-5327266;
Mobile: +963-933-526812; +963-932-878282;
Fax: +963-11-5316396
E-mail: [email protected]
Website: http://sites.google.com/site/sorohco
Investment in local military industrial projects, manufacturing weapons parts and related items. 100 % of the company is owned by Rami Makhlouf.
23.9.2011

Address: Adra Free Zone Area Damascus – Syria;

Tel: +963-11-5327266;

Mobile: +963-933-526812; +963-932-878282;

Fax: +963-11-5316396

E-mail: [email protected]

Website: http://sites.google.com/site/sorohco

18.
Syriatel
Thawra Street, Ste Building 6th Floor, BP 2900;Tel: +963 11 61 26 270;Fax: +963 11 23 73 97 19;E-mail: [email protected];Website: http://syriatel.sy/
Thawra Street, Ste Building 6th Floor, BP 2900;
Tel: +963 11 61 26 270;
Fax: +963 11 23 73 97 19;
E-mail: [email protected];
Website: http://syriatel.sy/
Controlled by Rami Makhlouf; provides financial support to the regime: through its licensing contract it pays 50 % of its profits to the Government.
23.9.2011

Thawra Street, Ste Building 6th Floor, BP 2900;

Tel: +963 11 61 26 270;

Fax: +963 11 23 73 97 19;

E-mail: [email protected];

Website: http://syriatel.sy/

19.
Cham Press TV
Al Qudsi building, 2nd Floor – Baramkeh – Damas;Tel: +963-11-2260805;Fax: +963-11-2260806E-mail: [email protected]: www.champress.net
Al Qudsi building, 2nd Floor – Baramkeh – Damas;
Tel: +963-11-2260805;
Fax: +963-11-2260806
E-mail: [email protected]
Website: www.champress.net
Television channel which participates in campaigns to spread disinformation and incite violence against demonstrators.
1.12.2011

Al Qudsi building, 2nd Floor – Baramkeh – Damas;

Tel: +963-11-2260805;

Fax: +963-11-2260806

E-mail: [email protected]

Website: www.champress.net

20.
Al Watan
Al Watan Newspaper -Damascus – Duty Free Zone;Tel: 00963 11 2137400;Fax: 00963 11 2139928
Al Watan Newspaper -Damascus – Duty Free Zone;
Tel: 00963 11 2137400;
Fax: 00963 11 2139928
Daily newspaper which participates in campaigns to spread disinformation and incite violence against demonstrators.
1.12.2011

Al Watan Newspaper -Damascus – Duty Free Zone;

Tel: 00963 11 2137400;

Fax: 00963 11 2139928

21.
Centre d'études et de recherches syrien (CERS) (a.k.a.; Centre d'Etude et de Recherche Scientifique (CERS); Scientific Studies and Research Center (SSRC); Centre de Recherche de Kaboun)
Barzeh Street, PO Box 4470, Damas
Provides support to the Syrian army for the acquisition of equipment used directly for the surveillance and repression of demonstrators.
1.12.2011

22.
Business Lab
Maysat Square, Al Rasafi Street Bldg. 9, PO Box 7155, Damascus;Tel: 963112725499;Fax: 963112725399
Maysat Square, Al Rasafi Street Bldg. 9, PO Box 7155, Damascus;
Tel: 963112725499;
Fax: 963112725399
Front company for the acquisition of sensitive equipment by the CERS.
1.12.2011

Maysat Square, Al Rasafi Street Bldg. 9, PO Box 7155, Damascus;

Tel: 963112725499;

Fax: 963112725399

23.
Industrial Solutions
Baghdad Street 5, PO Box 6394, Damascus;Tel /fax: 63114471080
Baghdad Street 5, PO Box 6394, Damascus;
Tel /fax: 63114471080
Front company for the acquisition of sensitive equipment by the CERS.
1.12.2011

Baghdad Street 5, PO Box 6394, Damascus;

Tel /fax: 63114471080

24.
Mechanical Construction Factory (MCF)
P.O. Box 35202, Industrial Zone, Al-Qadam Road, Damas
Front company for the acquisition of sensitive equipment by the CERS.
1.12.2011

25.
Syronics – Syrian Arab Co. for Electronic Industries
Kaboon Street, P.O.Box 5966, Damascus;Tel.: +963-11-5111352;Fax: +963-11-5110117
Kaboon Street, P.O.Box 5966, Damascus;
Tel.: +963-11-5111352;
Fax: +963-11-5110117
Front company for the acquisition of sensitive equipment by the CERS.
1.12.2011

Kaboon Street, P.O.Box 5966, Damascus;

Tel.: +963-11-5111352;

Fax: +963-11-5110117

26.
Handasieh – Organization for Engineering Industries
P.O. Box 5966, Abou Bakr Al-Seddeq St., Damascus and PO BOX 2849 Al-Moutanabi Street, Damascus and PO BOX 21120 Baramkeh, Damascus;Tel: 963112121816; 963112121834; 963112214650; 963112212743; 963115110117
Front company for the acquisition of sensitive equipment by the CERS.
1.12.2011

27.
Syria Trading Oil Company (Sytrol)
Prime Minister Building, 17 Street Nissan, Damascus, Syria
State-owned company responsible for all oil exports from Syria. Provides financial support to the regime.
1.12.2011

28.
General Petroleum Corporation (GPC)
New Sham – Building of Syrian Oil Company, PO Box 60694, Damascus, Syria BOX: 60694;Tel: 963113141635;Fax: 963113141634;E-mail: [email protected]
New Sham – Building of Syrian Oil Company, PO Box 60694, Damascus, Syria BOX: 60694;
Tel: 963113141635;
Fax: 963113141634;
E-mail: [email protected]
State-owned oil company. Provides financial support to the regime.
1.12.2011

New Sham – Building of Syrian Oil Company, PO Box 60694, Damascus, Syria BOX: 60694;

Tel: 963113141635;

Fax: 963113141634;

E-mail: [email protected]

29.
Al Furat Petroleum Company
Dummar – New Sham -Western Dummer 1st. Island -Property 2299- AFPC Building P.O. Box 7660 Damascus, Syria;Tel: 00963-11- (6183333); 00963-11- (31913333);Fax: 00963-11- (6184444); 00963-11- (31914444);[email protected]
Dummar – New Sham -Western Dummer 1st. Island -Property 2299- AFPC Building P.O. Box 7660 Damascus, Syria;
Tel: 00963-11- (6183333); 00963-11- (31913333);
Fax: 00963-11- (6184444); 00963-11- (31914444);
[email protected]
Joint venture 50 % owned by GPC. Provides financial support to the regime.
1.12.2011

Dummar – New Sham -Western Dummer 1st. Island -Property 2299- AFPC Building P.O. Box 7660 Damascus, Syria;

Tel: 00963-11- (6183333); 00963-11- (31913333);

Fax: 00963-11- (6184444); 00963-11- (31914444);

[email protected]

30.
Industrial Bank
Dar Al Muhanisen Building, 7th Floor, Maysaloun Street, P.O. Box 7572 Damascus, Syria;Tel: +963 11-222-8200; +963 11-222-7910;Fax: +963 11-222-8412
Dar Al Muhanisen Building, 7th Floor, Maysaloun Street, P.O. Box 7572 Damascus, Syria;
Tel: +963 11-222-8200; +963 11-222-7910;
Fax: +963 11-222-8412
State-owned bank. Provides financial support to the regime.
23.1.2012

Dar Al Muhanisen Building, 7th Floor, Maysaloun Street, P.O. Box 7572 Damascus, Syria;

Tel: +963 11-222-8200; +963 11-222-7910;

Fax: +963 11-222-8412

31.
Popular Credit Bank
Dar Al Muhanisen Building, 6th Floor, Maysaloun Street, Damascus, Syria;Tel: +963 11-222-7604; +963 11-221-8376;Fax: +963 11-221-0124
Dar Al Muhanisen Building, 6th Floor, Maysaloun Street, Damascus, Syria;
Tel: +963 11-222-7604; +963 11-221-8376;
Fax: +963 11-221-0124
State-owned bank. Provides financial support to the regime.
23.1.2012

Dar Al Muhanisen Building, 6th Floor, Maysaloun Street, Damascus, Syria;

Tel: +963 11-222-7604; +963 11-221-8376;

Fax: +963 11-221-0124

32.
Saving Bank
Syria-Damascus – Merjah – Al-Furat St. P.O. Box: 5467;Fax: 224 4909; 245 3471;Tel: 222 8403;e-mail: [email protected], [email protected]
Syria-Damascus – Merjah – Al-Furat St. P.O. Box: 5467;
Fax: 224 4909; 245 3471;
Tel: 222 8403;
e-mail: [email protected], [email protected]
State-owned bank. Provides financial support to the regime.
23.1.2012

Syria-Damascus – Merjah – Al-Furat St. P.O. Box: 5467;

Fax: 224 4909; 245 3471;

Tel: 222 8403;

e-mail: [email protected], [email protected]

33.
Agricultural Cooperative Bank
Agricultural Cooperative Bank Building, Damascus Tajhez, P.O. Box 4325, Damascus, Syria;Tel: +963 11-221-3462; +963 11-222-1393;Fax: +963 11-224-1261;Website: www.agrobank.org
Agricultural Cooperative Bank Building, Damascus Tajhez, P.O. Box 4325, Damascus, Syria;
Tel: +963 11-221-3462; +963 11-222-1393;
Fax: +963 11-224-1261;
Website: www.agrobank.org
State-owned bank. Provides financial support to the regime.
23.1.2012

Agricultural Cooperative Bank Building, Damascus Tajhez, P.O. Box 4325, Damascus, Syria;

Tel: +963 11-221-3462; +963 11-222-1393;

Fax: +963 11-224-1261;

Website: www.agrobank.org

34.
Syrian Lebanese Commercial Bank
Syrian Lebanese Commercial Bank Building, 6th Floor, Makdessi Street, Hamra, P.O. Box 11-8701, Beirut, Lebanon;Tel: +961 1-741666;Fax: +961 1-738228; +961 1-753215; +961 1-736629;Website: www.slcb.com.lb
Syrian Lebanese Commercial Bank Building, 6th Floor, Makdessi Street, Hamra, P.O. Box 11-8701, Beirut, Lebanon;
Tel: +961 1-741666;
Fax: +961 1-738228; +961 1-753215; +961 1-736629;
Website: www.slcb.com.lb
Subsidiary of the Commercial Bank of Syria already listed. Provides financial support to the regime.
23.1.2012

Syrian Lebanese Commercial Bank Building, 6th Floor, Makdessi Street, Hamra, P.O. Box 11-8701, Beirut, Lebanon;

Tel: +961 1-741666;

Fax: +961 1-738228; +961 1-753215; +961 1-736629;

Website: www.slcb.com.lb

35.
Deir ez-Zur Petroleum Company
Dar Al Saadi Building 1st, 5th, and 6th Floor Zillat Street Mazza Area P.O. Box 9120 Damascus, Syria;Tel: +963 11-662-1175; +963 11-662-1400;Fax: +963 11-662-1848
Dar Al Saadi Building 1st, 5th, and 6th Floor Zillat Street Mazza Area P.O. Box 9120 Damascus, Syria;
Tel: +963 11-662-1175; +963 11-662-1400;
Fax: +963 11-662-1848
Joint venture of GPC. Provides financial support to the regime.
23.1.2012

Dar Al Saadi Building 1st, 5th, and 6th Floor Zillat Street Mazza Area P.O. Box 9120 Damascus, Syria;

Tel: +963 11-662-1175; +963 11-662-1400;

Fax: +963 11-662-1848

36.
Ebla Petroleum Company
Head Office Mazzeh Villat Ghabia Dar Es Saada 16, P.O. Box 9120, Damascus, Syria;Tel: +963 116691100
Head Office Mazzeh Villat Ghabia Dar Es Saada 16, P.O. Box 9120, Damascus, Syria;
Tel: +963 116691100
Joint venture of GPC. Provides financial support to the regime.
23.1.2012

Head Office Mazzeh Villat Ghabia Dar Es Saada 16, P.O. Box 9120, Damascus, Syria;

Tel: +963 116691100

37.
Dijla Petroleum Company
Building No. 653 – 1st Floor, Daraa Highway, P.O. Box 81, Damascus, Syria
Joint venture of GPC. Provides financial support to the regime.
23.1.2012

38.
Central Bank of Syria
Syria, Damascus, Sabah Bahrat Square Postal address: Altjreda al Maghrebeh square, Damascus, Syrian Arab Republic, P.O. Box: 2254
Providing financial support to the regime.
27.2.2012

39.
Syrian Petroleum company
Address: Dummar Province, Expansion Square, Island 19-Building 32 P.O. BOX: 2849 or 3378;Phone: 00963-11-3137935 or 3137913;Fax: 00963-11-3137979 or 3137977;E-mail: [email protected] or [email protected];Websites: www.spc.com.sy www.spc-sy.com
Address: Dummar Province, Expansion Square, Island 19-Building 32 P.O. BOX: 2849 or 3378;
Phone: 00963-11-3137935 or 3137913;
Fax: 00963-11-3137979 or 3137977;
E-mail: [email protected] or [email protected];
Websites: www.spc.com.sy www.spc-sy.com
State-owned oil company. Provides financial support to the Syrian regime.
23.3.2012

Address: Dummar Province, Expansion Square, Island 19-Building 32 P.O. BOX: 2849 or 3378;

Phone: 00963-11-3137935 or 3137913;

Fax: 00963-11-3137979 or 3137977;

E-mail: [email protected] or [email protected];

Websites: www.spc.com.sy www.spc-sy.com

40.
Mahrukat Company (The Syrian Company for the Storage and Distribution of Petroleum Products)
Headquarters: Damascus – Al Adawi st., Petroleum building;Fax: 00963-11/4445796;Phone: 00963-11/44451348 – 4451349;E-mail: [email protected];Website: http://www.mahrukat.gov.sy/indexeng.php
Headquarters: Damascus – Al Adawi st., Petroleum building;
Fax: 00963-11/4445796;
Phone: 00963-11/44451348 – 4451349;
E-mail: [email protected];
Website: http://www.mahrukat.gov.sy/indexeng.php
State-owned oil company. Provides financial support to the Syrian regime.
23.3.2012

Headquarters: Damascus – Al Adawi st., Petroleum building;

Fax: 00963-11/4445796;

Phone: 00963-11/44451348 – 4451349;

E-mail: [email protected];

Website: http://www.mahrukat.gov.sy/indexeng.php

41.
General Organisation of Tobacco
Salhieh Street 616, Damascus, Syria
Provides financial support to the Syrian regime. The General Organisation of Tobacco is wholly owned by the Syrian state. The profits that the organisation makes, including through the sale of licenses to market foreign brands of tobacco and taxes levied on imports of foreign brands of tobacco are transferred to the Syrian state.
15.5.2012

42.
Ministry of Defence
Address: Umayyad Square, Damascus;Telephone: +963-11-7770700
Address: Umayyad Square, Damascus;
Telephone: +963-11-7770700
Syrian government branch directly involved in repression.
26.6.2012

Address: Umayyad Square, Damascus;

Telephone: +963-11-7770700

43.
Ministry of Interior
Address: Merjeh Square, Damascus;Telephone: +963-11-2219400; +963-11-2219401; +963-11-2220220; +963-11-2210404
Address: Merjeh Square, Damascus;
Telephone: +963-11-2219400; +963-11-2219401; +963-11-2220220; +963-11-2210404
Syrian government branch directly involved in repression.
26.6.2012

Address: Merjeh Square, Damascus;

Telephone: +963-11-2219400; +963-11-2219401; +963-11-2220220; +963-11-2210404

44.
Syrian National Security Bureau

Syrian government branch and element of the Syrian Ba'ath Party. Directly involved in repression. It directed Syrian security forces to use extreme force against demonstrators.
26.6.2012

45.
Syria International Islamic Bank (SIIB) (a.k.a.: Syrian International Islamic Bank; a.k.a. SIIB)
Location: Syria International Islamic Bank Building, Main Highway Road, Al Mazzeh Area, P.O. Box 35494, Damascus, Syria; Alt. Location: P.O. Box 35494, Mezza'h Vellat Sharqia'h, beside the Consulate of Saudi Arabia, Damascus, Syria
SIIB has acted as a front for the Commercial Bank of Syria, which has allowed that bank to circumvent sanctions imposed on it by the EU. From 2011 to 2012, SIIB surreptitiously facilitated financing worth almost $150 million on behalf of the Commercial Bank of Syria. Financial arrangements that were purportedly made by SIIB were actually made by the Commercial Bank of Syria. In addition to working with the Commercial Bank of Syria to circumvent sanctions, in 2012, SIIB facilitated several substantial payments for the Syrian Lebanese Commercial Bank, another bank already designated by the EU. In these ways, SIIB has contributed to providing financial support to the Syrian regime.
26.6.2012

46.
General Organisation of Radio and TV (a.k.a. Syrian Directorate General of Radio & Television Est; a.k.a. General Radio and Television Corporation; a.k.a. Radio and Television Corporation; a.k.a. GORT)
Address: Al Oumaween Square, P.O. Box 250, Damascus, Syria;Telephone (963 11) 223 4930
Address: Al Oumaween Square, P.O. Box 250, Damascus, Syria;
Telephone (963 11) 223 4930
State-run agency subordinate to Syria's Ministry of Information and as such supports and promotes its information policy. It is responsible for operating Syria's state-owned television channels, two terrestrial and one satellite, as well as government radio stations. The GORT has incited violence against the civilian population in Syria, serving as a propaganda instrument for the Assad regime and spreading disinformation.
26.6.2012

Address: Al Oumaween Square, P.O. Box 250, Damascus, Syria;

Telephone (963 11) 223 4930

47.
Syrian Company for Oil Transport (a.k.a. Syrian Crude Oil Transportation Company; a.k.a. ‧SCOT‧; a.k.a. ‧SCOTRACO‧)
Banias Industrial Area, Latakia Entrance Way, P.O. Box 13, Banias, Syria;Website www.scot-syria.com;E-mail: [email protected]
Banias Industrial Area, Latakia Entrance Way, P.O. Box 13, Banias, Syria;
Website www.scot-syria.com;
E-mail: [email protected]
Syrian state owned oil company. Provides financial support to the regime.
26.6.2012

Banias Industrial Area, Latakia Entrance Way, P.O. Box 13, Banias, Syria;

Website www.scot-syria.com;

E-mail: [email protected]

48.
Drex Technologies S.A.
Incorporation date: 4 July 2000; Incorporation number: 394678;Director: Rami Makhlouf;Registered agent: Mossack Fonseca & Co (BVI) Ltd
Drex Technologies is wholly owned by Rami Makhlouf, who is listed under EU sanctions for providing financial support to the Syrian regime. Rami Makhlouf uses Drex Technologies to facilitate and manage his international financial holdings, including a majority share in SyriaTel, which the EU has previously listed on the grounds that it also provides financial support to the Syrian regime.
24.7.2012

49.
Cotton Marketing Organisation
Address: Bab Al-Faraj P.O. Box 729, Aleppo;Tel.: +96321 2239495/6/7/8;[email protected],www.cmo.gov.sy
Address: Bab Al-Faraj P.O. Box 729, Aleppo;
Tel.: +96321 2239495/6/7/8;
[email protected],
www.cmo.gov.sy
State-owned company. Provides financial support to the Syrian regime.
24.7.2012

Address: Bab Al-Faraj P.O. Box 729, Aleppo;

Tel.: +96321 2239495/6/7/8;

[email protected],

www.cmo.gov.sy

50.
Syrian Arab Airlines (a.k.a. SAA, a.k.a. Syrian Air)
Al-Mohafazeh Square, P.O. Box 417, Damascus, Syria;Tel: +963112240774
Al-Mohafazeh Square, P.O. Box 417, Damascus, Syria;
Tel: +963112240774
Public company controlled by the regime. Provides financial support for the regime.
24.7.2012

Al-Mohafazeh Square, P.O. Box 417, Damascus, Syria;

Tel: +963112240774

51.
Drex Technologies Holding S.A.
Registered in Luxembourg under number B77616, formerly established at the following address: 17, rue Beaumont L-1219 Luxembourg
The beneficial owner of Drex Technologies Holding S.A. is Rami Makhlouf, who is listed under EU sanctions for providing financial support to the Syrian regime.
17.8.2012

52.
Megatrade
Address: Aleppo Street, P.O. Box 5966, Damascus, Syria;Fax: 963114471081
Address: Aleppo Street, P.O. Box 5966, Damascus, Syria;
Fax: 963114471081
Acts as a proxy for the Scientific Studies and Research Centre (SSRC), which is listed. Involved in trade in dual use goods prohibited by EU sanctions for the Syrian government.
16.10.2012

Address: Aleppo Street, P.O. Box 5966, Damascus, Syria;

Fax: 963114471081

53.
Expert Partners
Address: Rukn Addin, Saladin Street, Building 5, PO Box: 7006, Damascus, Syria
Acts as a proxy for the Scientific Studies and Research Centre (SSRC), which is listed. Involved in trade in dual use goods prohibited by EU sanctions for the Syrian government.
16.10.2012



P.O. Box 108, Damascus;

Tel.: 963 112110059 / 963 112110043

Fax: 963 933333149



Baghdad Street, P.O. Box 8254, Damascus;

Tel.: 963 112316675

Fax: 963 112318875;

Website: www.hamshointl.com

E-mail: [email protected] and [email protected]



Insurance Bldg- Yousef Al-Azmeh Square, Damascus P.O. Box: 2337 Damascus Syrian Arab Republic;

Tel: (+963) 11 2456777 and 2218602;

Fax: (+963) 11 2237938 and 2211186;

Bank's e-mail: [email protected]

Website: www.reb.sy



Cham Holding Building Daraa Highway – Ashrafiyat Sahnaya Rif Dimashq – Syria P.O. Box 9525;

Tel +963 (11) 9962; +963 (11) 668 14000; +963 (11) 673 1044;

Fax +963 (11) 673 1274;

E-mail: [email protected]

Website: www.chamholding.sy



Address: Dair Ali Jordan Highway, P.O. Box 13052, Damascus, Syria;

Tel. +963-11-2212345;

Fax +963-11-44694450

E-mail: [email protected]

Website: www.eltelme.com



Address: Dara'a Highway, Damascus, Syria;

Tel: +963-11-6858111;

Mobile: +963-933-240231



Address: Adra Free Zone Area Damascus – Syria;

Tel: +963-11-5327266;

Mobile: +963-933-526812; +963-932-878282;

Fax: +963-11-5316396

E-mail: [email protected]

Website: http://sites.google.com/site/sorohco



Thawra Street, Ste Building 6th Floor, BP 2900;

Tel: +963 11 61 26 270;

Fax: +963 11 23 73 97 19;

E-mail: [email protected];

Website: http://syriatel.sy/



Al Qudsi building, 2nd Floor – Baramkeh – Damas;

Tel: +963-11-2260805;

Fax: +963-11-2260806

E-mail: [email protected]

Website: www.champress.net



Al Watan Newspaper -Damascus – Duty Free Zone;

Tel: 00963 11 2137400;

Fax: 00963 11 2139928



Maysat Square, Al Rasafi Street Bldg. 9, PO Box 7155, Damascus;

Tel: 963112725499;

Fax: 963112725399



Baghdad Street 5, PO Box 6394, Damascus;

Tel /fax: 63114471080



Kaboon Street, P.O.Box 5966, Damascus;

Tel.: +963-11-5111352;

Fax: +963-11-5110117



New Sham – Building of Syrian Oil Company, PO Box 60694, Damascus, Syria BOX: 60694;

Tel: 963113141635;

Fax: 963113141634;

E-mail: [email protected]



Dummar – New Sham -Western Dummer 1st. Island -Property 2299- AFPC Building P.O. Box 7660 Damascus, Syria;

Tel: 00963-11- (6183333); 00963-11- (31913333);

Fax: 00963-11- (6184444); 00963-11- (31914444);

[email protected]



Dar Al Muhanisen Building, 7th Floor, Maysaloun Street, P.O. Box 7572 Damascus, Syria;

Tel: +963 11-222-8200; +963 11-222-7910;

Fax: +963 11-222-8412



Dar Al Muhanisen Building, 6th Floor, Maysaloun Street, Damascus, Syria;

Tel: +963 11-222-7604; +963 11-221-8376;

Fax: +963 11-221-0124



Syria-Damascus – Merjah – Al-Furat St. P.O. Box: 5467;

Fax: 224 4909; 245 3471;

Tel: 222 8403;

e-mail: [email protected], [email protected]



Agricultural Cooperative Bank Building, Damascus Tajhez, P.O. Box 4325, Damascus, Syria;

Tel: +963 11-221-3462; +963 11-222-1393;

Fax: +963 11-224-1261;

Website: www.agrobank.org



Syrian Lebanese Commercial Bank Building, 6th Floor, Makdessi Street, Hamra, P.O. Box 11-8701, Beirut, Lebanon;

Tel: +961 1-741666;

Fax: +961 1-738228; +961 1-753215; +961 1-736629;

Website: www.slcb.com.lb



Dar Al Saadi Building 1st, 5th, and 6th Floor Zillat Street Mazza Area P.O. Box 9120 Damascus, Syria;

Tel: +963 11-662-1175; +963 11-662-1400;

Fax: +963 11-662-1848



Head Office Mazzeh Villat Ghabia Dar Es Saada 16, P.O. Box 9120, Damascus, Syria;

Tel: +963 116691100



Address: Dummar Province, Expansion Square, Island 19-Building 32 P.O. BOX: 2849 or 3378;

Phone: 00963-11-3137935 or 3137913;

Fax: 00963-11-3137979 or 3137977;

E-mail: [email protected] or [email protected];

Websites: www.spc.com.sy www.spc-sy.com



Headquarters: Damascus – Al Adawi st., Petroleum building;

Fax: 00963-11/4445796;

Phone: 00963-11/44451348 – 4451349;

E-mail: [email protected];

Website: http://www.mahrukat.gov.sy/indexeng.php



Address: Umayyad Square, Damascus;

Telephone: +963-11-7770700



Address: Merjeh Square, Damascus;

Telephone: +963-11-2219400; +963-11-2219401; +963-11-2220220; +963-11-2210404



Address: Al Oumaween Square, P.O. Box 250, Damascus, Syria;

Telephone (963 11) 223 4930



Banias Industrial Area, Latakia Entrance Way, P.O. Box 13, Banias, Syria;

Website www.scot-syria.com;

E-mail: [email protected]



Address: Bab Al-Faraj P.O. Box 729, Aleppo;

Tel.: +96321 2239495/6/7/8;

[email protected],

www.cmo.gov.sy



Al-Mohafazeh Square, P.O. Box 417, Damascus, Syria;

Tel: +963112240774



Address: Aleppo Street, P.O. Box 5966, Damascus, Syria;

Fax: 963114471081




Name
Identifying information
Reasons
Date of listing

1.
Commercial Bank of Syria
—Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;—P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;—Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];Website: http://cbs-bank.sy/En-index.phpTel: +963 11 2218890;Fax: +963 11 2216975;General management: [email protected]
—
Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;
—
P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;
—
Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];
State-owned bank providing financial support to the regime.
13.10.2011

—
Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;

—
P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;

—
Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];



—
Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;



—
P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;



—
Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

(1) On 1 December 2011, the Council adopted Decision 2011/782/CFSP concerning restrictive measures against Syria(1).

(2) On the basis of a review of Decision 2011/782/CFSP, the Council has concluded that the restrictive measures should be renewed until 1 March 2013.

(3) Furthermore, it is necessary to update the list of persons and entities subject to restrictive measures as set out in Annex I to Decision 2011/782/CFSP.

(4) For the sake of clarity, the measures imposed under Decision 2011/273/CFSP should be integrated into a single legal instrument.

(5) Decision 2011/782/CFSP should therefore be repealed.

(6) Further action by the Union is needed in order to implement certain measures,

HAS ADOPTED THIS DECISION:
Article 1

1.   The sale, supply, transfer or export of arms and related matériel of all types, including weapons and ammunition, military vehicles and equipment, paramilitary equipment and spare parts for the aforementioned, as well as equipment which might be used for internal repression, to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be prohibited, whether originating or not in their territories.

2.   The sale, supply, transfer or export of certain other equipment, goods and technology which might be used for internal repression or for the manufacture and maintenance of products which could be used for internal repression, to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be prohibited, whether originating or not in their territories.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this paragraph.

3.   It shall be prohibited to:

(a)

provide, directly or indirectly, technical assistance, brokering services or other services related to the items referred to in paragraphs 1 and 2 or related to the provision, manufacture, maintenance and use of such items, to any natural or legal person, entity or body in, or for use in, Syria;

(b)

provide, directly or indirectly, financing or financial assistance related to the items referred to in paragraphs 1 and 2, including in particular grants, loans and export credit insurance, as well as insurance and reinsurance, for any sale, supply, transfer or export of such items, or for the provision of related technical assistance, brokering services or other services to any natural or legal person, entity or body in, or for use in, Syria.
Article 2

1.   The sale, supply, transfer or export of certain equipment, goods or technology other than those referred to in Article 1(2) which might be used for internal repression or for the manufacture and maintenance of products which could be used for internal repression, to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be subject to authorisation on a case-by-case basis by the competent authorities of the exporting Member State.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this paragraph.

2.   The provision of:

(a)

technical assistance, brokering services or other services related to the items referred to in paragraph 1 or related to the provision, manufacture, maintenance and use of such items, to any natural or legal person, entity or body in, or for use in, Syria;

(b)

financing or financial assistance related to the items referred to in paragraph 1, including in particular grants, loans and export credit insurance, as well as insurance and reinsurance, for any sale, supply, transfer or export of such items, or for the provision of related technical assistance, brokering services or other services to any natural or legal person, entity or body in, or for use in, Syria,

shall also be subject to an authorisation of the competent authority of the exporting Member State.
Article 3

1.   Article 1 shall not apply to:

(a)

supplies and technical assistance intended solely for the support of or use by the United Nations Disengagement Observer Force (UNDOF);

(b)

the sale, supply, transfer or export of non-lethal military equipment or of equipment which might be used for internal repression, intended solely for humanitarian or protective use, or for institution building programmes of the United Nations (UN) and the European Union, or for European Union and UN crisis management operations;

(c)

the sale, supply, transfer or export of non-combat vehicles which have been manufactured or fitted with materials to provide ballistic protection, intended solely for the protective use of personnel of the European Union and its Member States in Syria;

(d)

the provision of technical assistance, brokering services and other services related to such equipment or to such programmes and operations;

(e)

the provision of financing and financial assistance related to such equipment or to such programmes and operations,

on condition that such exports and assistance have been approved in advance by the relevant competent authority.

2.   Article 1 shall not apply to protective clothing, including flak jackets and military helmets, temporarily exported to Syria by UN personnel, personnel of the European Union or its Member States, representatives of the media and humanitarian and development workers and associated personnel for their personal use only.
Article 4

1.   The purchase, import or transport of arms and related material of all types, including weapons and ammunition, military vehicles and equipment, paramilitary equipment and spare parts for the aforementioned, from Syria or originating in Syria, shall be prohibited.

2.   It shall be prohibited to provide, directly or indirectly, financing or financial assistance, including financial derivatives, as well as insurance and reinsurance, and brokering services related to insurance and reinsurance, for any purchase, import or transport of the items referred to in paragraph 1, from Syria or originating in Syria.
Article 5

The sale, supply, transfer or export of equipment or software intended primarily for use in the monitoring or interception by the Syrian regime, or on its behalf, of the Internet and of telephone communications on mobile or fixed networks in Syria and the provision of assistance to install, operate or update such equipment or software shall be prohibited.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this Article.
Article 6

1.   The purchase, import or transport from Syria of crude oil and petroleum products shall be prohibited.

2.   It shall be prohibited to provide, directly or indirectly, financing or financial assistance, including financial derivatives, as well as insurance and reinsurance, related to the prohibitions referred to in paragraph 1.
Article 7

The prohibitions in Article 6 shall be without prejudice to the execution, until 15 November 2011, of obligations provided for in contracts concluded before 2 September 2011.
Article 8

1.   The sale, supply or transfer of key equipment and technology for the following key sectors of the oil and natural gas industry in Syria, or to Syrian or Syrian-owned enterprises engaged in those sectors outside Syria, by nationals of Member States, or from the territories of Member States, or using vessels or aircraft under the jurisdiction of Member States shall be prohibited whether or not originating in their territories:

(a)

refining;

(b)

liquefied natural gas;

(c)

exploration;

(d)

production.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this paragraph.

2.   It shall be prohibited to provide the following to enterprises in Syria that are engaged in the key sectors of the Syrian oil and gas industry referred to in paragraph 1 or to Syrian, or Syrian-owned enterprises engaged in those sectors outside Syria:

(a)

technical assistance or training and other services related to key equipment and technology as referred to in paragraph 1;

(b)

financing or financial assistance for any sale, supply, transfer or export of key equipment and technology as set out in paragraph 1 or for the provision of related technical assistance or training.
Article 9

1.   The prohibition in Article 8(1) shall be without prejudice to the execution of an obligation relating to the delivery of goods provided for in contracts awarded or concluded before 1 December 2011.

2.   The prohibitions in Article 8 shall be without prejudice to the execution of an obligation arising from contracts awarded or concluded before 1 December 2011 and relating to investments made in Syria before 23 September 2011 by enterprises established in Member States.
Article 10

The delivery of Syrian denominated banknotes and coinage to the Central Bank of Syria shall be prohibited.
Article 11

The direct or indirect sale, purchase, transportation or brokering of gold and precious metals, as well as of diamonds to, from or for the Government of Syria, its public bodies, corporations and agencies, the Central Bank of Syria, as well as to, from or for persons and entities acting on their behalf or at their direction, or entities owned or controlled by them, shall be prohibited.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this Article.
Article 12

The sale, supply, transfer or export of luxury goods to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be prohibited, whether originating or not in their territories.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this Article.
Article 13

The following shall be prohibited:

(a)

the granting of any financial loan or credit to enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining, or to Syrian or Syrian-owned enterprises engaged in those sectors outside Syria;

(b)

the granting of any financial loan or credit to enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria;

(c)

the acquisition or extension of a participation in enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining, or in Syrian or Syrian-owned enterprises engaged in those sectors outside Syria, including the acquisition in full of such enterprises and the acquisition of shares or securities of a participating nature;

(d)

the acquisition or extension of a participation in enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria, including the acquisition in full of such enterprises and the acquisition of shares or securities of a participating nature;

(e)

the creation of any joint venture with enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining and with any subsidiary or affiliate under their control;

(f)

the creation of any joint venture with enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria and with any subsidiary or affiliate under their control.
Article 14

1.   The prohibitions set out in points (a) and (c) of Article 13:

(i)

shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 23 September 2011;

(ii)

shall not prevent the extension of a participation, if such extension is an obligation under an agreement concluded before 23 September 2011.

2.   The prohibitions set out in points (b) and (d) of Article 13:

(i)

shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 1 December 2011;

(ii)

shall not prevent the extension of a participation, if such extension is an obligation under an agreement concluded before 1 December 2011.
Article 15

1.   Participation in the construction of new power plants for the production of electricity in Syria shall be prohibited.

2.   It shall be prohibited to provide technical assistance or financing or financial assistance to the construction of new power plants for the production of electricity in Syria.

3.   The prohibition in paragraphs 1 and 2 shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 1 December 2011.
Article 16

1.   Member States shall exercise restraint in entering into new short and medium-term commitments for public and private provided financial support for trade with Syria, including the granting of export credits, guarantees or insurance, to their nationals or entities involved in such trade, with a view to reducing their outstanding amounts, in particular to avoid any financial support contributing to the violent repression against the civilian population in Syria. In addition, Member States shall not enter into new long-term commitments for public and private provided financial support for trade with Syria.

2.   Paragraph 1 shall not affect commitments established prior to 1 December 2011.

3.   Paragraph 1 shall not concern trade for food, agricultural, medical or other humanitarian purposes.
Article 17

Member States shall not enter into new commitments for grants, financial assistance or concessional loans to the Government of Syria, including through their participation in international financial institutions, except for humanitarian and developmental purposes.
Article 18

The following shall be prohibited:

(a)

any disbursement or payment by the European Investment Bank (EIB) under or in connection with any existing loan agreements entered into between Syria and the EIB;

(b)

the continuation by the EIB of any existing Technical Assistance Service Contracts for sovereign projects located in Syria.
Article 19

The following shall be prohibited: the direct or indirect sale or purchase of, or brokering or assistance in the issuance of Syrian public or public-guaranteed bonds issued after 1 December 2011 to and from the Government of Syria, its public bodies, corporations and agencies, the Central Bank of Syria, or banks domiciled in Syria, or branches and subsidiaries within and outside the jurisdiction of Member States of banks domiciled in Syria, or financial entities that are neither domiciled in Syria nor within the jurisdiction of the Member States, but are controlled by persons and entities domiciled in Syria as well as any persons and entities acting on their behalf or at their direction, or entities owned or controlled by them.
Article 20

1.   The opening of new branches, subsidiaries, or representative offices of Syrian banks in the territories of Member States, and the establishment of new joint ventures, or the taking of an ownership interest, or the establishment of new correspondent banking relationships by Syrian banks, including the Central Bank of Syria, its branches and subsidiaries and financial entities that are not domiciled in Syria, but are controlled by persons or entities domiciled in Syria, with banks in the jurisdiction of Member States, shall be prohibited.

2.   Financial institutions within the territories of the Member States or under their jurisdiction shall be prohibited from opening representative offices, subsidiaries or banking accounts in Syria.
Article 21

1.   The provision of insurance and re-insurance to the Government of Syria, its public bodies, corporations and agencies or to any persons or entities acting on their behalf or at their direction, or to entities owned or controlled by them, including through illicit means, shall be prohibited.

2.   Paragraph 1 shall not apply to the provision of:

(a)

health or travel insurance to natural persons;

(b)

compulsory or third party insurance to Syrian persons, entities or bodies based in the Union;

(c)

insurance or re-insurance to the owner of a vessel, aircraft or vehicle chartered by a Syrian person, entity or body and which person, entity or body is not listed in Annex I or II.
Article 22

1.   Member States, in accordance with their national legislation and consistent with international law, in particular relevant international civil aviation agreements, shall take the necessary measures to prevent access to the airports under their jurisdiction of all exclusively cargo flights operated by Syrian carriers and all flights operated by Syrian Arab Airlines.

2.   Paragraph 1 shall not apply to the access to airports under the jurisdiction of Member States of flights operated by Syrian Arab Airlines, necessary for the sole purpose of evacuating citizens of the Union and their family members from Syria.
Article 23

1.   If Member States have information that provides reasonable grounds to believe that the cargo of vessels and aircraft bound for Syria contains items whose supply, sale, transfer or export is prohibited under Article 1 or subject to authorisation under Article 2, they shall inspect, in accordance with their national legislation and consistent with international law, in particular the law of the sea and relevant international civil aviation agreements and maritime transport agreements, such vessels and aircraft in their seaports and airports, as well as in their territorial sea, in accordance with decisions and capabilities of their competent authorities and with the consent, as necessary in accordance with international law for the territorial sea, of the flag State.

2.   Member States, in accordance with their national legislation and consistent with international law, shall, upon discovery, seize and dispose of items whose supply, sale, transfer or export is prohibited under Article 1 or 2.

3.   Member States shall cooperate, in accordance with their national legislation, with inspections and disposals undertaken pursuant to paragraphs 1 and 2.

4.   Aircraft and vessels transporting cargo to Syria shall be subject to the requirement of additional pre-arrival or pre-departure information for all goods brought into or out of a Member State.
Article 24

1.   Member States shall take the necessary measures to prevent the entry into, or transit through, their territories of the persons responsible for the violent repression against the civilian population in Syria, persons benefiting from or supporting the regime, and persons associated with them, as listed in Annex I.

2.   Paragraph 1 shall not oblige a Member State to refuse its own nationals entry into its territory.

3.   Paragraph 1 shall be without prejudice to the cases where a Member State is bound by an obligation of international law, namely:

(a)

as a host country to an international intergovernmental organisation;

(b)

as a host country to an international conference convened by, or under the auspices of, the UN;

(c)

under a multilateral agreement conferring privileges and immunities; or

(d)

under the 1929 Treaty of Conciliation (Lateran pact) concluded by the Holy See (State of the Vatican City) and Italy.

4.   Paragraph 3 shall be considered as also applying in cases where a Member State is host country to the Organisation for Security and Cooperation in Europe (OSCE).

5.   The Council shall be duly informed in all cases where a Member State grants an exemption pursuant to paragraph 3 or 4.

6.   Member States may grant exemptions from the measures imposed under paragraph 1 where travel is justified on the grounds of urgent humanitarian need, or on grounds of attending intergovernmental meetings, including those promoted by the Union, or hosted by a Member State holding the Chairmanship in office of the OSCE, where a political dialogue is conducted that directly promotes democracy, human rights and the rule of law in Syria.

7.   A Member State wishing to grant exemptions referred to in paragraph 6 shall notify the Council in writing. The exemption shall be deemed to be granted unless one or more of the Council members raises an objection in writing within two working days of receiving notification of the proposed exemption. Should one or more of the Council members raise an objection, the Council, acting by a qualified majority, may decide to grant the proposed exemption.

8.   Where, pursuant to paragraphs 3 to 7, a Member State authorises the entry into, or transit through, its territory of persons listed in Annex I, the authorisation shall be limited to the purpose for which it is given and to the person concerned therewith.
Article 25

1.   All funds and economic resources belonging to, or owned, held or controlled by persons responsible for the violent repression against the civilian population in Syria, persons and entities benefiting from or supporting the regime, and persons and entities associated with them, as listed in Annexes I and II, shall be frozen.

2.   No funds or economic resources shall be made available, directly or indirectly, to or for the benefit of, the natural or legal persons or entities listed in Annexes I and II.

3.   The competent authority of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as it deems appropriate, after having determined that the funds or economic resources concerned are:

(a)

necessary to satisfy the basic needs of the persons listed in Annexes I and II and their dependent family members, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges;

(b)

intended exclusively for the payment of reasonable professional fees and the reimbursement of incurred expenses associated with the provision of legal services;

(c)

intended exclusively for the payment of fees or service charges for the routine holding or maintenance of frozen funds or economic resources; or

(d)

necessary for extraordinary expenses, provided that the competent authority has notified the competent authority of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least two weeks prior to the authorisation;

(e)

necessary for humanitarian purposes, such as delivering or facilitating the delivery of assistance, including medical supplies, food, humanitarian workers and related assistance, or evacuations from Syria;

(f)

to be paid into or from an account of a diplomatic or consular mission or an international organisation enjoying immunities in accordance with international law, in so far as such payments are intended to be used for official purposes of the diplomatic or consular mission or international organisation.

A Member State shall inform the other Member States and the Commission of any authorisation it grants under this paragraph.

4.   By way of derogation from paragraph 1, the competent authorities of a Member State, may authorise the release of certain frozen funds or economic resources, provided that the following conditions are met:

(a)

the funds or economic resources are subject of an arbitral decision rendered prior to the date on which the person or entity referred to in Paragraph 1 was listed in Annex I or II or of a judicial or administrative decision rendered in the EU, or a judicial decision enforceable in the Member State concerned, prior to or after that date;

(b)

the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims;

(c)

the decision is not for the benefit of a person or entity listed in Annex I or II; and

(d)

recognising the decision is not contrary to public policy in the Member State concerned.

A Member State shall inform the other Member States and the Commission of any authorisation granted under this paragraph.

5.   Paragraph 1 shall not prevent a designated person or entity from making a payment due under a contract entered into before the listing of such a person or entity, provided that the relevant Member State has determined that the payment is not directly or indirectly received by a person or entity referred to in paragraph 1.

6.   Paragraph 1 shall not prevent a designated entity listed in Annex II, for a period of two months after the date of its designation, from making a payment from frozen funds or economic resources received by such entity after the date of its designation, where such payment is due under a contract in connection with the financing of trade, provided that the relevant Member State has determined that the payment is not directly or indirectly received by a person or entity referred to in paragraph 1.

7.   Paragraph 2 shall not apply to the addition to frozen accounts of:

(a)

interest or other earnings on those accounts; or

(b)

payments due under contracts, agreements or obligations that were concluded or arose prior to the date on which those accounts became subject to this Decision,

provided that any such interest, other earnings and payments remain subject to paragraph 1.

8.   Paragraphs 1 and 2 shall not apply to a transfer by or through the Central Bank of Syria of funds or economic resources received and frozen after the date of its designation or to a transfer of funds or economic resources to or through the Central Bank of Syria after the date of its designation where such transfer is related to a payment by a non-designated financial institution due in connection with a specific trade contract, provided that the relevant Member State has determined, on a case-by-case basis, that the payment is not directly or indirectly received by a person or entity referred to in paragraph 1.

9.   Paragraph 1 shall not apply to a transfer by or through the Central Bank of Syria of frozen funds or economic resources where such transfer is for the purpose of providing financial institutions under the jurisdiction of Member States with liquidity for the financing of trade, provided that the transfer has been authorised by the relevant Member State.

10.   Paragraphs 1 and 2 shall not apply to a transfer, by or through a financial entity listed in Annex I or II, of frozen funds or economic resources where the transfer is related to a payment by a person or entity not listed in Annex I or II in connection with the provision of financial support to Syrian nationals pursuing an education, professional training or engaged in academic research in the Union, provided that the relevant Member State has determined, on a case-by-case basis, that the payment is not directly or indirectly received by a person or entity referred to in paragraph 1.

11.   Paragraphs 1 and 2 shall not apply to acts or transactions carried out, with regard to Syrian Arab Airlines, for the sole purpose of evacuating citizens of the Union and their family members from Syria.
Article 26

No claims, including for compensation or indemnification or any other claim of this kind, such as a claim of set-off, fines or a claim under a guarantee, claims for extension or payment of a bond, financial guarantee, including claims arising from letters of credit and similar instruments in connection with any contract or transaction the performance of which was affected, directly or indirectly, wholly or in part, by reason of measures covered by this Decision, shall be granted to the designated persons or entities listed in Annexes I and II, or any other person or entity in Syria, including the Government of Syria, its public bodies, corporations and agencies, or any person or entity claiming through or for the benefit of any such person or entity.
Article 27

1.   The Council, acting upon a proposal by a Member State or the High Representative of the Union for Foreign Affairs and Security Policy, shall establish and amend the lists in Annexes I and II.

2.   The Council shall communicate its decision on listing, including the grounds therefor, to the person or entity concerned, either directly, if the address is known, or through the publication of a notice, providing such person or entity with an opportunity to present observations.

3.   Where observations are submitted, or where substantial new evidence is presented, the Council shall review its decision and inform the person or entity concerned accordingly.
Article 28

1.   Annexes I and II shall include the grounds for listing the persons and entities concerned.

2.   Annexes I and II shall also contain, where available, the information necessary to identify the persons or entities concerned. With regard to persons, such information may include names, including aliases, date and place of birth, nationality, passport and identity card numbers, gender, address if known, and function or profession. With regard to entities, such information may include names, place and date of registration, registration number and place of business.
Article 29

It shall be prohibited to participate, knowingly or intentionally, in activities the object or effect of which is to circumvent the prohibitions laid down in this Decision.
Article 30

In order to maximise the impact of the measures set out in this Decision, the Union shall encourage third States to adopt restrictive measures similar to those contained in this Decision.
Article 31

This Decision shall apply until 1 March 2013. It shall be kept under constant review. It shall be renewed, or amended as appropriate, if the Council deems that its objectives have not been met.
Article 32

Decision 2011/782/CFSP is hereby repealed.
Article 33

This Decision shall enter into force on the date of its publication in theOfficial Journal of the European Union.
THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 29 thereof,

(1) On 1 December 2011, the Council adopted Decision 2011/782/CFSP concerning restrictive measures against Syria(1).

(2) On the basis of a review of Decision 2011/782/CFSP, the Council has concluded that the restrictive measures should be renewed until 1 March 2013.

(3) Furthermore, it is necessary to update the list of persons and entities subject to restrictive measures as set out in Annex I to Decision 2011/782/CFSP.

(4) For the sake of clarity, the measures imposed under Decision 2011/273/CFSP should be integrated into a single legal instrument.

(5) Decision 2011/782/CFSP should therefore be repealed.

(6) Further action by the Union is needed in order to implement certain measures,

HAS ADOPTED THIS DECISION:
1.   The sale, supply, transfer or export of arms and related matériel of all types, including weapons and ammunition, military vehicles and equipment, paramilitary equipment and spare parts for the aforementioned, as well as equipment which might be used for internal repression, to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be prohibited, whether originating or not in their territories.

2.   The sale, supply, transfer or export of certain other equipment, goods and technology which might be used for internal repression or for the manufacture and maintenance of products which could be used for internal repression, to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be prohibited, whether originating or not in their territories.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this paragraph.

3.   It shall be prohibited to:

(a)

provide, directly or indirectly, technical assistance, brokering services or other services related to the items referred to in paragraphs 1 and 2 or related to the provision, manufacture, maintenance and use of such items, to any natural or legal person, entity or body in, or for use in, Syria;

(b)

provide, directly or indirectly, financing or financial assistance related to the items referred to in paragraphs 1 and 2, including in particular grants, loans and export credit insurance, as well as insurance and reinsurance, for any sale, supply, transfer or export of such items, or for the provision of related technical assistance, brokering services or other services to any natural or legal person, entity or body in, or for use in, Syria.
1.   The sale, supply, transfer or export of certain equipment, goods or technology other than those referred to in Article 1(2) which might be used for internal repression or for the manufacture and maintenance of products which could be used for internal repression, to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be subject to authorisation on a case-by-case basis by the competent authorities of the exporting Member State.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this paragraph.

2.   The provision of:

(a)

technical assistance, brokering services or other services related to the items referred to in paragraph 1 or related to the provision, manufacture, maintenance and use of such items, to any natural or legal person, entity or body in, or for use in, Syria;

(b)

financing or financial assistance related to the items referred to in paragraph 1, including in particular grants, loans and export credit insurance, as well as insurance and reinsurance, for any sale, supply, transfer or export of such items, or for the provision of related technical assistance, brokering services or other services to any natural or legal person, entity or body in, or for use in, Syria,

shall also be subject to an authorisation of the competent authority of the exporting Member State.
1.   Article 1 shall not apply to:

(a)

supplies and technical assistance intended solely for the support of or use by the United Nations Disengagement Observer Force (UNDOF);

(b)

the sale, supply, transfer or export of non-lethal military equipment or of equipment which might be used for internal repression, intended solely for humanitarian or protective use, or for institution building programmes of the United Nations (UN) and the European Union, or for European Union and UN crisis management operations;

(c)

the sale, supply, transfer or export of non-combat vehicles which have been manufactured or fitted with materials to provide ballistic protection, intended solely for the protective use of personnel of the European Union and its Member States in Syria;

(d)

the provision of technical assistance, brokering services and other services related to such equipment or to such programmes and operations;

(e)

the provision of financing and financial assistance related to such equipment or to such programmes and operations,

on condition that such exports and assistance have been approved in advance by the relevant competent authority.

2.   Article 1 shall not apply to protective clothing, including flak jackets and military helmets, temporarily exported to Syria by UN personnel, personnel of the European Union or its Member States, representatives of the media and humanitarian and development workers and associated personnel for their personal use only.
1.   The purchase, import or transport of arms and related material of all types, including weapons and ammunition, military vehicles and equipment, paramilitary equipment and spare parts for the aforementioned, from Syria or originating in Syria, shall be prohibited.

2.   It shall be prohibited to provide, directly or indirectly, financing or financial assistance, including financial derivatives, as well as insurance and reinsurance, and brokering services related to insurance and reinsurance, for any purchase, import or transport of the items referred to in paragraph 1, from Syria or originating in Syria.
The sale, supply, transfer or export of equipment or software intended primarily for use in the monitoring or interception by the Syrian regime, or on its behalf, of the Internet and of telephone communications on mobile or fixed networks in Syria and the provision of assistance to install, operate or update such equipment or software shall be prohibited.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this Article.
1.   The purchase, import or transport from Syria of crude oil and petroleum products shall be prohibited.

2.   It shall be prohibited to provide, directly or indirectly, financing or financial assistance, including financial derivatives, as well as insurance and reinsurance, related to the prohibitions referred to in paragraph 1.
The prohibitions in Article 6 shall be without prejudice to the execution, until 15 November 2011, of obligations provided for in contracts concluded before 2 September 2011.
1.   The sale, supply or transfer of key equipment and technology for the following key sectors of the oil and natural gas industry in Syria, or to Syrian or Syrian-owned enterprises engaged in those sectors outside Syria, by nationals of Member States, or from the territories of Member States, or using vessels or aircraft under the jurisdiction of Member States shall be prohibited whether or not originating in their territories:

(a)

refining;

(b)

liquefied natural gas;

(c)

exploration;

(d)

production.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this paragraph.

2.   It shall be prohibited to provide the following to enterprises in Syria that are engaged in the key sectors of the Syrian oil and gas industry referred to in paragraph 1 or to Syrian, or Syrian-owned enterprises engaged in those sectors outside Syria:

(a)

technical assistance or training and other services related to key equipment and technology as referred to in paragraph 1;

(b)

financing or financial assistance for any sale, supply, transfer or export of key equipment and technology as set out in paragraph 1 or for the provision of related technical assistance or training.
1.   The prohibition in Article 8(1) shall be without prejudice to the execution of an obligation relating to the delivery of goods provided for in contracts awarded or concluded before 1 December 2011.

2.   The prohibitions in Article 8 shall be without prejudice to the execution of an obligation arising from contracts awarded or concluded before 1 December 2011 and relating to investments made in Syria before 23 September 2011 by enterprises established in Member States.
The delivery of Syrian denominated banknotes and coinage to the Central Bank of Syria shall be prohibited.
The direct or indirect sale, purchase, transportation or brokering of gold and precious metals, as well as of diamonds to, from or for the Government of Syria, its public bodies, corporations and agencies, the Central Bank of Syria, as well as to, from or for persons and entities acting on their behalf or at their direction, or entities owned or controlled by them, shall be prohibited.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this Article.
The sale, supply, transfer or export of luxury goods to Syria by nationals of Member States or from the territories of Member States or using their flag vessels or aircraft, shall be prohibited, whether originating or not in their territories.

The Union shall take the necessary measures in order to determine the relevant items to be covered by this Article.
The following shall be prohibited:

(a)

the granting of any financial loan or credit to enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining, or to Syrian or Syrian-owned enterprises engaged in those sectors outside Syria;

(b)

the granting of any financial loan or credit to enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria;

(c)

the acquisition or extension of a participation in enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining, or in Syrian or Syrian-owned enterprises engaged in those sectors outside Syria, including the acquisition in full of such enterprises and the acquisition of shares or securities of a participating nature;

(d)

the acquisition or extension of a participation in enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria, including the acquisition in full of such enterprises and the acquisition of shares or securities of a participating nature;

(e)

the creation of any joint venture with enterprises in Syria that are engaged in the Syrian oil industry sectors of exploration, production or refining and with any subsidiary or affiliate under their control;

(f)

the creation of any joint venture with enterprises in Syria that are engaged in the construction of new power plants for the production of electricity in Syria and with any subsidiary or affiliate under their control.
1.   The prohibitions set out in points (a) and (c) of Article 13:

(i)

shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 23 September 2011;

(ii)

shall not prevent the extension of a participation, if such extension is an obligation under an agreement concluded before 23 September 2011.

2.   The prohibitions set out in points (b) and (d) of Article 13:

(i)

shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 1 December 2011;

(ii)

shall not prevent the extension of a participation, if such extension is an obligation under an agreement concluded before 1 December 2011.
1.   Participation in the construction of new power plants for the production of electricity in Syria shall be prohibited.

2.   It shall be prohibited to provide technical assistance or financing or financial assistance to the construction of new power plants for the production of electricity in Syria.

3.   The prohibition in paragraphs 1 and 2 shall be without prejudice to the execution of an obligation arising from contracts or agreements concluded before 1 December 2011.
1.   Member States shall exercise restraint in entering into new short and medium-term commitments for public and private provided financial support for trade with Syria, including the granting of export credits, guarantees or insurance, to their nationals or entities involved in such trade, with a view to reducing their outstanding amounts, in particular to avoid any financial support contributing to the violent repression against the civilian population in Syria. In addition, Member States shall not enter into new long-term commitments for public and private provided financial support for trade with Syria.

2.   Paragraph 1 shall not affect commitments established prior to 1 December 2011.

3.   Paragraph 1 shall not concern trade for food, agricultural, medical or other humanitarian purposes.
Member States shall not enter into new commitments for grants, financial assistance or concessional loans to the Government of Syria, including through their participation in international financial institutions, except for humanitarian and developmental purposes.
The following shall be prohibited:

(a)

any disbursement or payment by the European Investment Bank (EIB) under or in connection with any existing loan agreements entered into between Syria and the EIB;

(b)

the continuation by the EIB of any existing Technical Assistance Service Contracts for sovereign projects located in Syria.
The following shall be prohibited: the direct or indirect sale or purchase of, or brokering or assistance in the issuance of Syrian public or public-guaranteed bonds issued after 1 December 2011 to and from the Government of Syria, its public bodies, corporations and agencies, the Central Bank of Syria, or banks domiciled in Syria, or branches and subsidiaries within and outside the jurisdiction of Member States of banks domiciled in Syria, or financial entities that are neither domiciled in Syria nor within the jurisdiction of the Member States, but are controlled by persons and entities domiciled in Syria as well as any persons and entities acting on their behalf or at their direction, or entities owned or controlled by them.
1.   The opening of new branches, subsidiaries, or representative offices of Syrian banks in the territories of Member States, and the establishment of new joint ventures, or the taking of an ownership interest, or the establishment of new correspondent banking relationships by Syrian banks, including the Central Bank of Syria, its branches and subsidiaries and financial entities that are not domiciled in Syria, but are controlled by persons or entities domiciled in Syria, with banks in the jurisdiction of Member States, shall be prohibited.

2.   Financial institutions within the territories of the Member States or under their jurisdiction shall be prohibited from opening representative offices, subsidiaries or banking accounts in Syria.
1.   The provision of insurance and re-insurance to the Government of Syria, its public bodies, corporations and agencies or to any persons or entities acting on their behalf or at their direction, or to entities owned or controlled by them, including through illicit means, shall be prohibited.

2.   Paragraph 1 shall not apply to the provision of:

(a)

health or travel insurance to natural persons;

(b)

compulsory or third party insurance to Syrian persons, entities or bodies based in the Union;

(c)

insurance or re-insurance to the owner of a vessel, aircraft or vehicle chartered by a Syrian person, entity or body and which person, entity or body is not listed in Annex I or II.
1.   Member States, in accordance with their national legislation and consistent with international law, in particular relevant international civil aviation agreements, shall take the necessary measures to prevent access to the airports under their jurisdiction of all exclusively cargo flights operated by Syrian carriers and all flights operated by Syrian Arab Airlines.

2.   Paragraph 1 shall not apply to the access to airports under the jurisdiction of Member States of flights operated by Syrian Arab Airlines, necessary for the sole purpose of evacuating citizens of the Union and their family members from Syria.
1.   If Member States have information that provides reasonable grounds to believe that the cargo of vessels and aircraft bound for Syria contains items whose supply, sale, transfer or export is prohibited under Article 1 or subject to authorisation under Article 2, they shall inspect, in accordance with their national legislation and consistent with international law, in particular the law of the sea and relevant international civil aviation agreements and maritime transport agreements, such vessels and aircraft in their seaports and airports, as well as in their territorial sea, in accordance with decisions and capabilities of their competent authorities and with the consent, as necessary in accordance with international law for the territorial sea, of the flag State.

2.   Member States, in accordance with their national legislation and consistent with international law, shall, upon discovery, seize and dispose of items whose supply, sale, transfer or export is prohibited under Article 1 or 2.

3.   Member States shall cooperate, in accordance with their national legislation, with inspections and disposals undertaken pursuant to paragraphs 1 and 2.

4.   Aircraft and vessels transporting cargo to Syria shall be subject to the requirement of additional pre-arrival or pre-departure information for all goods brought into or out of a Member State.
1.   Member States shall take the necessary measures to prevent the entry into, or transit through, their territories of the persons responsible for the violent repression against the civilian population in Syria, persons benefiting from or supporting the regime, and persons associated with them, as listed in Annex I.

2.   Paragraph 1 shall not oblige a Member State to refuse its own nationals entry into its territory.

3.   Paragraph 1 shall be without prejudice to the cases where a Member State is bound by an obligation of international law, namely:

(a)

as a host country to an international intergovernmental organisation;

(b)

as a host country to an international conference convened by, or under the auspices of, the UN;

(c)

under a multilateral agreement conferring privileges and immunities; or

(d)

under the 1929 Treaty of Conciliation (Lateran pact) concluded by the Holy See (State of the Vatican City) and Italy.

4.   Paragraph 3 shall be considered as also applying in cases where a Member State is host country to the Organisation for Security and Cooperation in Europe (OSCE).

5.   The Council shall be duly informed in all cases where a Member State grants an exemption pursuant to paragraph 3 or 4.

6.   Member States may grant exemptions from the measures imposed under paragraph 1 where travel is justified on the grounds of urgent humanitarian need, or on grounds of attending intergovernmental meetings, including those promoted by the Union, or hosted by a Member State holding the Chairmanship in office of the OSCE, where a political dialogue is conducted that directly promotes democracy, human rights and the rule of law in Syria.

7.   A Member State wishing to grant exemptions referred to in paragraph 6 shall notify the Council in writing. The exemption shall be deemed to be granted unless one or more of the Council members raises an objection in writing within two working days of receiving notification of the proposed exemption. Should one or more of the Council members raise an objection, the Council, acting by a qualified majority, may decide to grant the proposed exemption.

8.   Where, pursuant to paragraphs 3 to 7, a Member State authorises the entry into, or transit through, its territory of persons listed in Annex I, the authorisation shall be limited to the purpose for which it is given and to the person concerned therewith.
1.   All funds and economic resources belonging to, or owned, held or controlled by persons responsible for the violent repression against the civilian population in Syria, persons and entities benefiting from or supporting the regime, and persons and entities associated with them, as listed in Annexes I and II, shall be frozen.

2.   No funds or economic resources shall be made available, directly or indirectly, to or for the benefit of, the natural or legal persons or entities listed in Annexes I and II.

3.   The competent authority of a Member State may authorise the release of certain frozen funds or economic resources, or the making available of certain funds or economic resources, under such conditions as it deems appropriate, after having determined that the funds or economic resources concerned are:

(a)

necessary to satisfy the basic needs of the persons listed in Annexes I and II and their dependent family members, including payments for foodstuffs, rent or mortgage, medicines and medical treatment, taxes, insurance premiums, and public utility charges;

(b)

intended exclusively for the payment of reasonable professional fees and the reimbursement of incurred expenses associated with the provision of legal services;

(c)

intended exclusively for the payment of fees or service charges for the routine holding or maintenance of frozen funds or economic resources; or

(d)

necessary for extraordinary expenses, provided that the competent authority has notified the competent authority of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least two weeks prior to the authorisation;

(e)

necessary for humanitarian purposes, such as delivering or facilitating the delivery of assistance, including medical supplies, food, humanitarian workers and related assistance, or evacuations from Syria;

(f)

to be paid into or from an account of a diplomatic or consular mission or an international organisation enjoying immunities in accordance with international law, in so far as such payments are intended to be used for official purposes of the diplomatic or consular mission or international organisation.

A Member State shall inform the other Member States and the Commission of any authorisation it grants under this paragraph.

4.   By way of derogation from paragraph 1, the competent authorities of a Member State, may authorise the release of certain frozen funds or economic resources, provided that the following conditions are met:

(a)

the funds or economic resources are subject of an arbitral decision rendered prior to the date on which the person or entity referred to in Paragraph 1 was listed in Annex I or II or of a judicial or administrative decision rendered in the EU, or a judicial decision enforceable in the Member State concerned, prior to or after that date;

(b)

the funds or economic resources will be used exclusively to satisfy claims secured by such a decision or recognised as valid in such a decision, within the limits set by applicable laws and regulations governing the rights of persons having such claims;

(c)

the decision is not for the benefit of a person or entity listed in Annex I or II; and

(d)

recognising the decision is not contrary to public policy in the Member State concerned.

A Member State shall inform the other Member States and the Commission of any authorisation granted under this paragraph.

5.   Paragraph 1 shall not prevent a designated person or entity from making a payment due under a contract entered into before the listing of such a person or entity, provided that the relevant Member State has determined that the payment is not directly or indirectly received by a person or entity referred to in paragraph 1.

6.   Paragraph 1 shall not prevent a designated entity listed in Annex II, for a period of two months after the date of its designation, from making a payment from frozen funds or economic resources received by such entity after the date of its designation, where such payment is due under a contract in connection with the financing of trade, provided that the relevant Member State has determined that the payment is not directly or indirectly received by a person or entity referred to in paragraph 1.

7.   Paragraph 2 shall not apply to the addition to frozen accounts of:

(a)

interest or other earnings on those accounts; or

(b)

payments due under contracts, agreements or obligations that were concluded or arose prior to the date on which those accounts became subject to this Decision,

provided that any such interest, other earnings and payments remain subject to paragraph 1.

8.   Paragraphs 1 and 2 shall not apply to a transfer by or through the Central Bank of Syria of funds or economic resources received and frozen after the date of its designation or to a transfer of funds or economic resources to or through the Central Bank of Syria after the date of its designation where such transfer is related to a payment by a non-designated financial institution due in connection with a specific trade contract, provided that the relevant Member State has determined, on a case-by-case basis, that the payment is not directly or indirectly received by a person or entity referred to in paragraph 1.

9.   Paragraph 1 shall not apply to a transfer by or through the Central Bank of Syria of frozen funds or economic resources where such transfer is for the purpose of providing financial institutions under the jurisdiction of Member States with liquidity for the financing of trade, provided that the transfer has been authorised by the relevant Member State.

10.   Paragraphs 1 and 2 shall not apply to a transfer, by or through a financial entity listed in Annex I or II, of frozen funds or economic resources where the transfer is related to a payment by a person or entity not listed in Annex I or II in connection with the provision of financial support to Syrian nationals pursuing an education, professional training or engaged in academic research in the Union, provided that the relevant Member State has determined, on a case-by-case basis, that the payment is not directly or indirectly received by a person or entity referred to in paragraph 1.

11.   Paragraphs 1 and 2 shall not apply to acts or transactions carried out, with regard to Syrian Arab Airlines, for the sole purpose of evacuating citizens of the Union and their family members from Syria.
No claims, including for compensation or indemnification or any other claim of this kind, such as a claim of set-off, fines or a claim under a guarantee, claims for extension or payment of a bond, financial guarantee, including claims arising from letters of credit and similar instruments in connection with any contract or transaction the performance of which was affected, directly or indirectly, wholly or in part, by reason of measures covered by this Decision, shall be granted to the designated persons or entities listed in Annexes I and II, or any other person or entity in Syria, including the Government of Syria, its public bodies, corporations and agencies, or any person or entity claiming through or for the benefit of any such person or entity.
1.   The Council, acting upon a proposal by a Member State or the High Representative of the Union for Foreign Affairs and Security Policy, shall establish and amend the lists in Annexes I and II.

2.   The Council shall communicate its decision on listing, including the grounds therefor, to the person or entity concerned, either directly, if the address is known, or through the publication of a notice, providing such person or entity with an opportunity to present observations.

3.   Where observations are submitted, or where substantial new evidence is presented, the Council shall review its decision and inform the person or entity concerned accordingly.
1.   Annexes I and II shall include the grounds for listing the persons and entities concerned.

2.   Annexes I and II shall also contain, where available, the information necessary to identify the persons or entities concerned. With regard to persons, such information may include names, including aliases, date and place of birth, nationality, passport and identity card numbers, gender, address if known, and function or profession. With regard to entities, such information may include names, place and date of registration, registration number and place of business.
It shall be prohibited to participate, knowingly or intentionally, in activities the object or effect of which is to circumvent the prohibitions laid down in this Decision.
In order to maximise the impact of the measures set out in this Decision, the Union shall encourage third States to adopt restrictive measures similar to those contained in this Decision.
This Decision shall apply until 1 March 2013. It shall be kept under constant review. It shall be renewed, or amended as appropriate, if the Council deems that its objectives have not been met.
Decision 2011/782/CFSP is hereby repealed.
This Decision shall enter into force on the date of its publication in theOfficial Journal of the European Union.
List of persons and entities referred to in Articles 24 and 25ANNEX IA.   Persons
 | Name | Identifying information | Reasons | Date of listing

1. | Bashar Al-Assad | Date of birth: 11 September 1965;Place of birth: Damascus;diplomatic passport No D1903 | President of the Republic; person authorising and supervising the crackdown on demonstrators. | 23.5.2011

2. | Maher (a.k.a. Mahir) Al-Assad | Date of birth: 8 December 1967;diplomatic passport No 4138 | Commander of the Army’s 4th Armoured Division, member of Ba’ath Party Central Command, strongman of the Republican Guard; brother of President Bashar Al-Assad; principal overseer of violence against demonstrators. | 9.5.2011

3. | Ali Mamluk (a.k.a. Mamlouk) | Date of birth: 19 February 1946;Place of birth: Damascus;diplomatic passport No 983 | Head of Syrian General Intelligence Directorate (GID); involved in violence against demonstrators. | 9.5.2011

4. | Atej (a.k.a. Atef, Atif) Najib |  | Former Head of the Political Security Directorate in Dara’a; cousin of President Bashar Al-Assad; involved in violence against demonstrators. | 9.5.2011

5. | Hafiz Makhluf (a.k.a. Hafez Makhlouf) | Date of birth: 2 April 1971;Place of birth: Damascus;diplomatic passport No 2246 | Colonel and Head of Unit in General Intelligence Directorate, Damascus Branch; cousin of President Bashar Al-Assad; close to Maher Al-Assad; involved in violence against demonstrators. | 9.5.2011

6. | Muhammad Dib Zaytun (a.k.a. Mohammed Dib Zeitoun) | Date of birth: 20 May 1951;Place of birth: Damascus;diplomatic passport No D000001300 | Head of Political Security Directorate; involved in violence against demonstrators. | 9.5.2011

7. | Amjad Al-Abbas |  | Head of Political Security in Banyas, involved in violence against demonstrators in Baida. | 9.5.2011

8. | Rami Makhlouf | Date of birth: 10 July 1969;Place of birth: Damascus;passport No 454224 | Syrian businessman; cousin of President Bashar Al-Assad, controls the investment funds Al Mahreq, Bena Properties, Cham Holding Syriatel, Souruh Company thereby furnishing financing and support to the regime. | 9.5.2011

9. | Abd Al-Fatah Qudsiyah | Born: 1953;Place of birth: Hama;diplomatic passport No D0005788 | Head of Syrian Military Intelligence (SMI); involved in violence against the civilian population. | 9.5.2011

10. | Jamil Hassan |  | Head of Syrian Air Force Intelligence; involved in violence against the civilian population. | 9.5.2011

11. | Rustum Ghazali | Date of birth: 3 May 1953;Place of birth: Dara’a;diplomatic passport No D000000887 | Head of Syrian Military Intelligence, Damascus Countryside Branch; involved in violence against the civilian population. | 9.5.2011

12. | Fawwaz Al-Assad | Date of birth: 18 June 1962;Place of birth: Kerdala;passport No 88238 | Involved in violence against the civilian population as part of the Shabiha militia. | 9.5.2011

13. | Munzir Al-Assad | Date of birth: 1 March 1961;Place of birth: Latakia;passports No 86449 and No 842781 | Involved in violence against the civilian population as part of the Shabiha militia. | 9.5.2011

14. | Asif Shawkat | Date of birth: 15 January 1950;Place of birth: Al-Madehleh, Tartous | Deputy Chief of Staff for Security and Reconnaissance; involved in violence against the civilian population. | 23.5.2011

15. | Hisham Ikhtiyar | Born: 1941 | Head of Syrian National Security Bureau; involved in violence against the civilian population. | 23.5.2011

16. | Faruq Al Shar’ | Date of birth: 10 December 1938 | Vice-President of Syria; involved in violence against the civilian population. | 23.5.2011

17. | Muhammad Nasif Khayrbik | Date of birth: 10 April 1937 (or 20 May 1937);Place of birth: Hama;diplomatic passport No 0002250 | Deputy Vice-President of Syria for National Security Affairs; involved in violence against the civilian population. | 23.5.2011

18. | Mohamed Hamcho | Date of birth: 20 May 1966;passport No 002954347 | Syrian businessman and local agent for several foreign companies; associate of Maher al-Assad, managing a part of his financial and economic interests and as such provides funding to the regime. | 23.5.2011

19. | Iyad (a.k.a. Eyad) Makhlouf | Date of birth: 21 January 1973;Place of birth: Damascus;passport No N001820740 | Brother of Rami Makhlouf and GID Officer involved in violence against the civilian population. | 23.5.2011

20. | Bassam Al Hassan |  | Presidential Advisor for Strategic Affairs; involved in violence against the civilian population. | 23.5.2011

21. | Dawud Rajiha |  | Chief of Staff of the Armed Forces responsible for the military involvement in violence against peaceful protesters. | 23.5.2011

22. | Ihab (a.k.a. Ehab, Iehab) Makhlouf | Date of birth: 21 January 1973;Place of birth: Damascus;passport No N002848852 | President of Syriatel, which transfers 50 % of its profits to the Syrian government by way of its licencing contract. | 23.5.2011

23. | Zoulhima Chaliche (Dhu al-Himma Shalish) | Born: 1951 or 1946;Place of birth: Kerdaha | Head of presidential security; involved in violence against demonstrators; first cousin of President Bashar Al-Assad. | 23.6.2011

24. | Riyad Chaliche (Riyad Shalish) |  | Director of Military Housing Establishment; provides funding to the regime; first cousin of President Bashar Al-Assad. | 23.6.2011

25. | Brigadier Commander Mohammad Ali Jafari (a.k.a. Ja’fari, Aziz; a.k.a. Jafari, Ali; a.k.a. Jafari, Mohammad Ali; a.k.a. Ja’fari, Mohammad Ali; a.k.a. Jafari-Naja-fabadi, Mohammad Ali) | Date of birth: 1 September 1957;Place of birth: Yazd, Iran | General Commander of Iranian Revolutionary Guard Corps, involved in providing equipment and support to help the Syrian regime suppress protests in Syria. | 23.6.2011

26. | Major General Qasem Soleimani (a.k.a. Qasim Soleimany) |  | Commander of Iranian Revolutionary Guard Corps, IRGC – Qods, involved in providing equipment and support to help the Syrian regime suppress protests in Syria. | 23.6.2011

27. | Hossein Taeb (a.k.a. Taeb, Hassan; a.k.a. Taeb, Hosein; a.k.a. Taeb, Hossein; a.k.a. Taeb, Hussayn; a.k.a. Hojjatoleslam Hossein Ta’eb) | Born: 1963;Place of birth: Tehran, Iran | Deputy Commander for Intelligence of Iranian Revolutionary Guard Corps, involved in providing equipment and support to help the Syrian regime suppress protests in Syria. | 23.6.2011

28. | Khalid Qaddur |  | Business associate of Maher Al-Assad; provides funding to the regime. | 23.6.2011

29. | Ra’if Al-Quwatly (a.k.a. Ri’af Al-Quwatli a.k.a. Raeef Al-Kouatly) |  | Business associate of Maher Al-Assad and responsible for managing some of his business interests; provides funding to the regime. | 23.6.2011

30. | Mohammad Mufleh |  | Head of Syrian Military Intelligence in the town of Hama, involved in the crackdown on demonstrators. | 1.8.2011

31. | Major General Tawfiq Younes |  | Head of the Department for Internal Security of the General Intelligence Directorate; involved in violence against the civilian population. | 1.8.2011

32. | Mr Mohammed Makhlouf (a.k.a. Abu Rami) | Date of birth: 19.10.1932;Place of birth: Latakia, Syria | Close associate and maternal uncle of Bashar and Mahir al-Assad. Business associate and father of Rami, Ihab and Iyad Makhlouf. | 1.8.2011

33. | Ayman Jabir | Place of birth: Latakia | Associate of Mahir al-Assad for the Shabiha militia. Directly involved in repression and violence against the civilian population and coordination of Shabiha militia groups | 1.8.2011

34. | Hayel Al-Assad |  | Assistant to Maher Al-Assad, Head of the military police unit of the army’s 4th Division, involved in repression. | 23.8.2011

35. | Ali Al-Salim |  | Director of the supplies office of the Syrian Ministry of Defence, entry point for all arms acquisitions by the Syrian army. | 23.8.2011

36. | Nizar Al-Assad () | Cousin of Bashar Al-Assad; previously head of the ‧Nizar Oilfield Supplies‧ company | Very close to key government officials. Financing Shabiha in the region of Latakia. | 23.8.2011

37. | Brigadier-General Rafiq Shahadah |  | Head of Syrian Military Intelligence (SMI) Branch 293 (Internal Affairs) in Damascus. Directly involved in repression and violence against the civilian population in Damascus. Advisor to President Bashar Al-Assad for strategic questions and military intelligence. | 23.8.2011

38. | Brigadier-General Jamea Jamea (Jami Jami) |  | Branch Chief for Syrian Military Intelligence (SMI) in Dayr az-Zor. Directly involved in repression and violence against the civilian population in Dayr az-Zor and Alboukamal. | 23.8.2011

39. | Hassan Bin-Ali Al-Turkmani | Born: 1935;Place of birth: Aleppo | Deputy Vice Minister, former Minister for Defence, Special Envoy of President Bashar Al-Assad. | 23.8.2011

40. | Muhammad Said Bukhaytan |  | Assistant Regional Secretary of Ba’ath Arab Socialist Party since 2005, 2000-2005 Director for the national security of the regional Ba’ath party. Former Governor of Hama (1998-2000). Close associate of President Bashar Al-Assad and Maher Al-Assad. Senior decision-maker in the regime on repression of civilian population. | 23.8.2011

41. | Ali Douba |  | Responsible for killings in Hama in 1980, has been called back to Damascus as special advisor to President Bashar Al-Assad. | 23.8.2011

42. | Brigadier-General Nawful Al-Husayn |  | Idlib Syrian Military Intelligence (SMI) Branch Chief. Directly involved in repression and violence against the civilian population in Idlib province. | 23.8.2011

43. | Brigadier Husam Sukkar |  | Presidential Adviser on Security Affairs. Presidential Adviser for security agencies’ repression and violence against the civilian population. | 23.8.2011

44. | Brigadier-General Muhammed Zamrini |  | Branch Chief for Syrian Military Intelligence (SMI) in Homs. Directly involved in repression and violence against the civilian population in Homs. | 23.8.2011

45. | Lieutenant-General Munir Adanov (Adnuf) |  | Deputy Chief of General Staff, Operations and Training for Syrian Army. Directly involved in repression and violence against the civilian population in Syria. | 23.8.2011

46. | Brigadier-General Ghassan Khalil |  | Head of General Intelligence Directorate’s (GID) Information Branch. Directly involved in repression and violence against the civilian population in Syria. | 23.8.2011

47. | Mohammed Jabir | Place of birth: Latakia | Shabiha militia. Associate of Maher Al-Assad for the Shabiha militia. Directly involved in repression and violence against the civilian population and coordination of Shabiha militia groups. | 23.8.2011

48. | Samir Hassan |  | Close business associate of Maher Al-Assad. Known for supporting the Syrian regime financially. | 23.8.2011

49. | Fares Chehabi (a.k.a. Fares Shihabi; Fares Chihabi) | Son of Ahmad Chehabi;Date of birth: 7 May 1972 | President of Aleppo Chamber of Industry. Vice-chairman of Cham Holding. Provides economic support to the Syrian regime. | 2.9.2011

50. | Tarif Akhras | Date of birth: 2 June 1951;Place of birth: Homs, Syria;Syrian passport nr. 0000092405 | Prominent businessman benefiting from and supporting the regime. Founder of the Akhras Group (commodities, trading, processing and logistics) and former Chairman of the Homs Chamber of Commerce. Close business relations with President Al-Assad’s family. Member of the Board of the Federation of Syrian Chambers of Commerce. Provided industrial and residential premises for improvised detention camps, as well as logistical support for the regime (buses and tank loaders). | 2.9.2011

51. | Issam Anbouba | President of Anbouba for Agricultural Industries Co.;Born: 1952;Place of birth: Homs, Syria | Providing financial support for the repressive apparatus and the paramilitary groups exerting violence against the civil population in Syria. Providing property (premises, warehouses) for improvised detention centers. Financial relations with high Syrian officials. | 2.9.2011

52. | Mazen al-Tabba | Date of birth: 01.01.1958;Place of birth: Damascus;Passport nr. 004415063 expires 06.05.2015 (Syrian) | Business partner of Ihab Makhlour and Nizar al-Assad (became subject to sanctions on 23.8.2011); co-owner, with Rami Makhlour, of the al-diyar lil-Saraafa (a.k.a. Diar Electronic Services) currency exchange company, which supports the policy of the Central Bank of Syria. | 23.3.2012

53. | Adib Mayaleh | Born: 1955;Place of birth: Daraa | Adib Mayaleh is responsible for providing economic and financial support to the Syrian regime through his functions as the Governor of the Central Bank of Syria. | 15.5.2012

54. | Major General Jumah Al-Ahmad |  | Commander Special Forces. Responsible for the use of violence against protestors across Syria. | 14.11.2011

55. | Colonel Lu’ai al-Ali |  | Head of Syrian Military Intelligence, Dara’a Branch. Responsible for the violence against protesters in Dara’a. | 14.11.2011

56. | Lt. General Ali Abdullah Ayyub |  | Deputy Chief of General Staff (Personnel and Manpower). Responsible for the use of violence against protestors across Syria. | 14.11.2011

57. | Lt. General Jasim al-Furayj |  | Chief of General staff. Responsible for the use of violence against protestors across Syria. | 14.11.2011

58. | General Aous (Aws) Aslan | Born: 1958 | Head of Battalion in the Republican Guard. Close to Maher al-Assad and President al-Assad. Involved in the crackdown on the civilian population across Syria. | 14.11.2011

59. | General Ghassan Belal |  | General in command of the 4th Division reserve bureau. Adviser to Maher al-Assad and coordinator of security operations. Responsible for the crackdown on the civilian population across Syria. | 14.11.2011

60. | Abdullah Berri |  | Head of Berri family militia. In charge of pro-government militia involved in the crackdown on the civilian population in Aleppo. | 14.11.2011

61. | George Chaoui |  | Member of Syrian electronic army. Involved in the violent crackdown and call for violence against the civilian population across Syria. | 14.11.2011

62. | Major General Zuhair Hamad |  | Deputy Head of General Intelligence Directorate. Responsible for the use of violence across Syria and for intimidation and torture of protestors. | 14.11.2011

63. | Amar Ismael |  | Civilian – Head of Syrian electronic army (territorial army intelligence service). Involved in the violent crackdown and call for violence against the civilian population across Syria. | 14.11.2011

64. | Mujahed Ismail |  | Member of Syrian electronic army. Involved in the violent crackdown and call for violence against the civilian population across Syria. | 14.11.2011

65. | Major General Nazih |  | Deputy Director of General Intelligence Directorate. Responsible for the use of violence across Syria and intimidation and torture of protestors. | 14.11.2011

66. | Kifah Moulhem |  | Batallion Commander in the 4th Division. Responsible for the crackdown on the civilian population in Deir el-Zor. | 14.11.2011

67. | Major General Wajih Mahmud |  | Commander 18th Armoured Division. Responsible for the violence against protestors in Homs. | 14.11.2011

68. | Bassam Sabbagh | Date of birth: 24 August 1959;Place of birth: Damascus.Address: Kasaa, Anwar al Attar Street, al Midani building, Damascus;Syrian passport no 004326765 issued 2 November 2008, valid until November 2014. | Legal and financial adviser and manages affairs of Rami Makhlouf and Khaldoun Makhlouf. Involved with Bashar al-Assad in funding a real estate project in Latakia. Provides financial support for the regime. | 14.11.2011

69. | Lt. General Mustafa Tlass |  | Deputy Chief of General Staff (Logistics and supplies). Responsible for the use of violence against protestors across Syria. | 14.11.2011

70. | Major General Fu’ad Tawil |  | Deputy head Syrian Air Force Intelligence. Responsible for the use of violence across Syria and intimidation and torture of protestors. | 14.11.2011

71. | Bushra Al-Assad (a.k.a. Bushra Shawkat) | Date of birth: 24.10.1960 | Sister of Bashar Al-Assad and wife of Asif Shawkat, Deputy Chief of Staff for Security and Reconnaissance. Given the close personal relationship and intrinsic financial relationship to the Syrian President Bashar Al-Assad and other core Syrian regime figures, she benefits from and is associated with the Syrian regime. | 23.3.2012

72. | Asma Al-Assad (a.k.a. Asma Fawaz Al Akhras) | Date of birth: 11.08.1975;Place of birth: London, UK;Passport nr. 707512830, expires 22.09.2020;Maiden name: Al Akhras | Wife of Bashar Al-Assad. Given the close personal relationship and intrinsic financial relationship to the Syrian President, Bashar Al-Assad, she benefits from and is associated with the Syrian regime. | 23.3.2012

73. | Manal Al-Assad (a.k.a. Manal Al Ahmad) | Date of birth: 02.02.1970;Place of Birth: Damascus;Passport number (Syrian): 0000000914;Maiden name: Al Jadaan | Spouse of Maher Al-Assad, and as such benefiting from and closely associated with the regime. | 23.3.2012

74. | Anisa Al-Assad (a.k.a. Anisah Al-Assad) | Born: 1934;Maiden name: Makhlouf | Mother of President Al-Assad. Given the close personal relationship and intrinsic financial relationship to the Syrian President, Bashar Al-Assad, she benefits from and is associated with the Syrian regime. | 23.3.2012

75. | Lt. General Fahid Al-Jassim |  | Chief of Staff. Military official involved in the violence in Homs. | 1.12.2011

76. | Major General Ibrahim Al-Hassan |  | Deputy Chief of Staff. Military official involved in the violence in Homs. | 1.12.2011

77. | Brigadier Khalil Zghraybih |  | 14th Division. Military official involved in the violence in Homs. | 1.12.2011

78. | Brigadier Ali Barakat |  | 103rd Brigade of the Republican Guard Division. Military official involved in the violence in Homs. | 1.12.2011

79. | Brigadier Talal Makhluf |  | 103rd Brigade of the Republican Guard Division. Military official involved in the violence in Homs. | 1.12.2011

80. | Brigadier Nazih Hassun |  | Syrian Air Force Intelligence. Military official involved in the violence in Homs. | 1.12.2011

81. | Captain Maan Jdiid |  | Presidential Guard. Military official involved in the violence in Homs. | 1.12.2011

82. | Muahmamd Al-Shaar |  | Political Security Division. Military official involved in the violence in Homs. | 1.12.2011

83. | Khald Al-Taweel |  | Political Security Division. Military official involved in the violence in Homs. | 1.12.2011

84. | Ghiath Fayad |  | Political Security Division. Military official involved in the violence in Homs. | 1.12.2011

85. | Brigadier General Jawdat Ibrahim Safi | Commander of 154th Regiment | Ordered troops to shoot at protestors in and around Damascus, including Mo’adamiyeh, Douma, Abasiyeh, Duma. | 23.1.2012

86. | Major General Muhammad Ali Durgham | Commander in 4th Division | Ordered troops to shoot at protestors in and around Damascus, including Mo’adamiyeh, Douma, Abasiyeh, Duma. | 23.1.2012

87. | Major General Ramadan Mahmoud Ramadan | Commander of 35th Special Forces Regiment | Ordered troops to shoot protestors in Baniyas and Deraa. | 23.1.2012

88. | Brigadier General Ahmed Yousef Jarad | Commander of 132nd Brigade | Ordered troops to shoot at protestors in Deraa, including the use of machine guns and anti-aircraft guns. | 23.1.2012

89. | Major General Naim Jasem Suleiman | Commander of the 3rd Division | Gave orders to troops to shoot protestors in Douma. | 23.1.2012

90. | Brigadier General Jihad Mohamed Sultan | Commander of 65th Brigade | Gave orders to troops to shoot protestors in Douma. | 23.1.2012

91. | Major General Fo’ad Hamoudeh | Commander of the military operations in Idlib | Gave orders to troops to shoot protestors in Idlib at the beginning of September 2011. | 23.1.2012

92. | Major General Bader Aqel | Special Forces Commander | Gave the soldiers orders to pick up the bodies and hand them over to the mukhabarat and responsible for the violence in Bukamal. | 23.1.2012

93. | Brigadier General Ghassan Afif | Commander from the 45th Regiment | Commander of military operations in Homs, Baniyas and Idlib. | 23.1.2012

94. | Brigadier General Mohamed Maaruf | Commander from the 45th Regiment | Commander of military operations in Homs. Gave orders to shoot protestors in Homs. | 23.1.2012

95. | Brigadier General Yousef Ismail | Commander of the 134th Brigade | Gave orders to troops to shoot at houses and people on roofs during a funeral in Talbiseh for protesters killed the previous day. | 23.1.2012

96. | Brigadier General Jamal Yunes | Commander of the 555th Regiment | Gave orders to troops to shoot at protestors in Mo’adamiyeh. | 23.1.2012

97. | Brigadier General Mohsin Makhlouf |  | Gave orders to troops to shoot at protestors in Al-Herak. | 23.1.2012

98. | Brigadier General Ali Dawwa |  | Gave orders to troops to shoot protestors in Al-Herak. | 23.1.2012

99. | Brigadier General Mohamed Khaddor | Commander of the 106th Brigade, Presidential Guard | Gave orders to troops to beat the protesters with sticks and then arrest them. Responsible for repression of peaceful protestors in Douma. | 23.1.2012

100. | Major General Suheil Salman Hassan | Commander of 5th Division | Gave orders to troops to shoot at the protesters in Deraa Governorate. | 23.1.2012

101. | Wafiq Nasser | Head of Suwayda Regional Branch (Department of Military Intelligence) | As Head of the Suwayda branch of the Department for Military Intelligence, responsible for arbitrary detention and torture of detainees in Suwayda. | 23.1.2012

102. | Ahmed Dibe | Head of Deraa Regional Branch (General Security Directorate) | As Head of the Deraa Regional Branch of the General Security Directorate, responsible for arbitrary detention and torture of detainees in Deraa. | 23.1.2012

103. | Makhmoud al-Khattib | Head of Investigative Branch (Political Security Directorate) | As Head of the Investigative Branch of the Political Security Directorate, responsible for detention and torture of detainees. | 23.1.2012

104. | Mohamed Heikmat Ibrahim | Head of Operations Branch (Political Security Directorate) | As Head of the Operations Branch of the Political Security Directorate, responsible for detention and torture of detainees. | 23.1.2012

105. | Nasser Al-Ali (a.k.a. Brigadier General Nasr al-Ali) | Head of Deraa Regional Branch (Political Security Directorate) | As Head of the Deraa Regional Branch of the Political Security Directorate, responsible for detention and torture of detainees. Since April 2012 Head of the Deraa site of the Political Security Directorate (ex-head of the Homs branch). | 23.1.2012

106. | Mehran (or Mahran) Khwanda | Owner of transport company Qadmous Transport Co.;Date of birth 11.05.1938;Passports: No 3298 858, expired 09.05.2004;No 001452904, expired 29.11.2011;No 006283523, expires 28.06.2017 | Provides logistical support to violent repression of civilian population in areas of operation of pro-government militias involved in violence (shabihas). | 23.1.2012

107. | Dr. Wael Nader Al –Halqi | Born: 1964;Place of birth: Daraa Province | Prime Minister and former Minister of Health. As Prime Minister, shares responsibility for the regime’s violent repression against the civilian population. | 27.2.2012

108. | Muhammad Ibrahim Al-Sha’ar (a.k.a. Mohammad Ibrahim Al-Chaar) | Born: 1956;Place of birth: Aleppo | Minister of the Interior. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 1.12.2011

109. | Dr. Mohammad Al-Jleilati | Born: 1945;Place of birth: Damascus | Minister of Finance. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 1.12.2011

110. | Imad Mohammad Deeb Khamis (a.k.a.: Imad Mohammad Dib Khamees) | Date of birth: 1 August 1961;Place of Birth: near Damascus | Minister of Electricity. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 23.3.2012

111. | Omar Ibrahim Ghalawanji | Born: 1954;Place of Birth: Tartous | Vice Prime Minister for Services Affairs, Minister of Local Administration. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 23.3.2012

112. | Joseph Suwaid (a.k.a. Joseph Jergi Sweid) | Born: 1958;Place of Birth: Damascus | Minister of State. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 23.3.2012

113. | Eng Hussein Mahmoud Farzat (a.k.a.: Hussein Mahmud Farzat) | Born: 1957;Place of Birth: Hama | Minister of State. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 23.3.2012

114. | Mansour Fadlallah Azzam (a.k.a.: Mansur Fadl Allah Azzam) | Born: 1960;Place of birth: Sweida Province | Minister for Presidency Affairs. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 27.2.2012

115. | Dr. Emad Abdul-Ghani Sabouni (a.k.a.: Imad Abdul Ghani Al Sabuni) | Born: 1964;Place of birth: Damascus | Minister of Telecommunications and Technology. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 27.2.2012

116. | General Ali Habib Mahmoud | Born: 1939;Place of birth: Tartous | Former Minister of Defence. Associated with the Syrian regime and the Syrian military, and its violent repression against the civilian population. | 1.8.2011

117. | Tayseer Qala Awwad | Born: 1943;Place of birth: Damascus | Former Minister of Justice. Associated with the Syrian regime and its violent repression against the civilian population. | 23.9.2011

118. | Dr Adnan Hassan Mahmoud | Born: 1966;Place of birth: Tartous | Former Minister of Information. Associated with the Syrian regime and its violent repression against the civilian population. | 23.9.2011

119. | Dr. Mohammad Nidal Al-Shaar | Born: 1956;Place of birth: Aleppo | Former Minister of Economy and Trade. Associated with the Syrian regime and its violent repression against the civilian population. | 1.12.2011

120. | Sufian Allaw | Born: 1944;Place of birth: al-Bukamal, Deir Ezzor | Former Minister of Oil and Mineral Resources. Associated with the regime and its violent repression against the civilian population. | 27.2.2012

121. | Dr Adnan Slakho | Born: 1955;Place of birth: Damascus | Former Minister of Industry. Associated with the regime and its violent repression against the civilian population. | 27.2.2012

122. | Dr. Saleh Al-Rashed | Born: 1964;Place of birth: Aleppo Province | Former Minister of Education. Associated with the regime and its violent repression against the civilian population. | 27.2.2012

123. | Dr. Fayssal Abbas | Born: 1955;Place of birth: Hama Province | Former Minister of Transport. Associated with the regime and its violent repression against the civilian population. | 27.2.2012

124. | Ghiath Jeraatli | Born: 1950;Place of Birth: Salamiya | Former Minister of State. Associated with the regime and its violent repression against the civilian population. | 23.3.2012

125. | Yousef Suleiman Al-Ahmad | Born: 1956;Place of Birth: Hasaka | Former Minister of State. Associated with the regime and its violent repression against the civilian population. | 23.3.2012

126. | Hassan al-Sari | Born: 1953;Place of Birth: Hama | Former Minister of State. Associated with the regime and its violent repression against the civilian population. | 23.3.2012

127. | Bouthaina Shaaban (a.k.a. Buthaina Shaaban) | Born: 1953;Place of birth: Homs, Syria | Political and Media Advisor to the President since July 2008 and as such associated with the violent crackdown on the population. | 26.6.2012

128. | Brigadier General Sha’afiq Masa |  | Head of Branch 215 (Damascus) of the army’s intelligence service. Responsible for the torture of detained opponents. Involved in repressive actions against civilians. | 24.7.2012

129. | Brigadier General Burhan Qadour |  | Head of Branch 291 (Damascus) of the army’s intelligence service. Responsible for the torture of opponents in custody. | 24.7.2012

130. | Brigadier General Salah Hamad |  | Deputy Head of Branch 291 of the army’s intelligence service. Responsible for the torture of opponents in custody. | 24.7.2012

131. | Brigadier General Muhammad (or: Mohammed) Khallouf (a.k.a. Abou Ezzat) |  | Head of Branch 235, a.k.a. “Palestine” (Damascus) of the army’s intelligence service, which is at the centre of the army’s apparatus of repression. Directly involved in repression of opponents. Responsible for the torture of opponents in custody. | 24.7.2012

132. | Major General Riad al-Ahmed |  | Deputy Head of Latakia Branch of the army’s intelligence service. Responsible for the torture and murder of opponents in custody. | 24.7.2012

133. | Brigadier General Abdul Salam Fajr Mahmoud |  | Head of the Bab Tuma (Damascus) Branch of the air force’s intelligence service. Responsible for the torture of opponents in custody. | 24.7.2012

134. | Brigadier General Jawdat al-Ahmed |  | Head of the Homs Branch of the air force’s intelligence service. Responsible for the torture of opponents in custody. | 24.7.2012

135. | Colonel Qusay Mihoub |  | Head of the Deraa branch of the air force’s intelligence service (sent from Damascus to Deraa at the start of demonstrations there). Responsible for the torture of opponents in custody. | 24.7.2012

136. | Colonel Suhail Al-Abdullah |  | Head of the Latakia Branch of the air force’s intelligence service. Responsible for the torture of opponents in custody. | 24.7.2012

137 | Brigadier General Khudr Khudr |  | Head of the Latakia branch of the General Intelligence Directorate. Responsible for the torture of opponents in custody. | 24.7.2012

138. | Brigadier General Ibrahim Ma’ala |  | Head of branch 285 (Damascus) of the General Intelligence Directorate (replaced Brig. Gen. Hussam Fendi at end 2011). Responsible for the torture of opponents in custody. | 24.7.2012

139. | Brigadier General Firas Al-Hamed |  | Head of branch 318 (Homs) of the General Intelligence Directorate. Responsible for the torture of opponents in custody. | 24.7.2012

140. | Brigadier General Hussam Luqa |  | Since April 2012, head of the Homs branch of the Political Security Directorate (succeeded Brig. Gen. Nasr al-Ali). Responsible for the torture of opponents in custody. | 24.7.2012

141. | Brigadier General Taha Taha |  | Site manager of the Latakia branch of the Political Security Directorate. Responsible for the torture of opponents in custody | 24.7.2012

142. | Bassel Bilal |  | Police officer at Idlib central prison; has taken part directly in acts of torture of opponents held in Idlib central prison. | 24.7.2012

143. | Ahmad Kafan |  | Police officer at Idlib central prison; has taken part directly in acts of torture of opponents held in Idlib central prison. | 24.7.2012

144. | Bassam al-Misri |  | Police officer at Idlib central prison; has taken part directly in acts of torture of opponents held in Idlib central prison. | 24.7.2012

145. | Ahmed al-Jarroucheh | Born: 1957 | Head of the foreign branch of General Intelligence (branch 279). As such, responsible for General Intelligence arrangements in Syrian embassies. He participates directly in the repression implemented by the Syrian authorities against opponents and in particular has responsibility for repression of the Syrian opposition abroad. | 24.7.2012

146. | Michel Kassouha (a.k.a. Ahmed Salem; a.k.a. Ahmed Salem Hassan) | Date of birth: 1 February 1948 | Member of the Syrian security services since the early 1970s, he is involved in combating opposition in France and Germany. Since March 2006, has been responsible for public relations of branch 273 of the Syrian General Intelligence Directorate. A longstanding member of the managerial staff, he is close to General Intelligence Directorate head Ali Mamlouk, one of the top security officials of the regime who has been subject to EU restrictive measures since 9 May 2011. He directly supports the regime’s repression of opponents and is responsible inter alia for repression of the Syrian opposition abroad. | 24.7.2012

147. | General Ghassan Jaoudat Ismail | Born: 1960;Place of origin: Drekish, Tartous region | Responsible for the missions branch of the air force intelligence service, which, in cooperation with the special operations branch, manages the elite troops of the air force intelligence service, who play an important role in the repression conducted by the regime. As such, Ghassan Jaoudat Ismail is one of the military leaders directly implementing the repression of opponents conducted by the regime. | 24.7.2012

148. | General Amer al-Achi (a.k.a. Amis al Ashi; a.k.a. Ammar Aachi; a.k.a. Amer Ashi) |  | Graduate of the military school of Aleppo, head of the intelligence branch of the air force intelligence service (since 2012), close to Daoud Rajah, Syrian Minister for Defence. Through his role in the air force intelligence service, Amer al-Achi is implicated in the repression of the Syrian opposition. | 24.7.2012

149. | General Mohammed Ali Nasr (or: Mohammed Ali Naser) | Born: around 1960. | Close to Maher Al-Assad, younger brother of the President. Most of his career has been spent in the Republican Guard. In 2010 he joined the internal branch (or branch 251) of the General Intelligence Directorate which is responsible for combating the political opposition. As one of its senior officers, General Mohammed Ali is directly involved in the repression of opponents. | 24.7.2012

150. | General Issam Hallaq |  | Air Force Chief of Staff since 2010. Commands air operations against opponents. | 24.7.2012

151. | Ezzedine Ismael | Born: middle of the 1940s (probably 1947);Place of birth: Bastir. Jableh region | Retired general, longstanding member of the managerial staff of the air force intelligence service, of which he became the head in the early 2000s. Was appointed political and security adviser to the President in 2006. As political and security adviser to the Syrian president, Ezzedine Ismael is implicated in the political repression conducted by the regime against the opposition. | 24.7.2012

152. | Samir Joumaa (a.k.a. Abou Sami) | Born: around 1962 | For almost 20 years he has been head of the office of Mohammad Nassif Kheir Bek, one of the main security advisers of Bashar al-Assad (and officially deputy to the Vice- President, Farouk al-Sharaa). Samir Joumaa’s closeness to Bashar al-Assad and Mohammed Nassif Kheir Bek means that he is implicated in the policy of repression conducted by the regime against its opponents. | 24.7.2012

153. | Dr. Qadri Jameel |  | Vice Prime Minister for Economic Affairs, Minister of Domestic Trade and Consumer’s Protection. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

154. | Waleed Al Mo’allem |  | Vice Prime Minister, Minister of Foreign Affairs and Expatriates. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

155. | Major general Fahd Jassem Al Freij |  | Minister of Defence and military commander. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

156. | Dr. Mohammad Abdul Sattar Al Sayed |  | Minister of Religious Endowments. As Government Minister, shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

157. | Eng. Hala Mohammad Al Nasser |  | Minister of Tourism. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

158. | Eng. Bassam Hanna |  | Minister of Water Resources. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

159. | Eng. Subhi Ahmad Al Abdallah |  | Minister of Agriculture and Agrarian Reform. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

160. | Dr. Mohammad Yahiya Mo’alla |  | Minister of Higher Education. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

161. | Dr. Hazwan Al Wez |  | Minister of Education. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

162. | Dr. Mohamad Zafer Mohabak |  | Minister of Economy and Foreign Trade. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

163. | Dr. Mahmud Ibraheem Sa’iid |  | Minister of Transport. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

164. | Dr. Safwan Al Assaf |  | Minister of Housing and Urban Development. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

165. | Eng. Yasser Al Siba’ii |  | Minister of Public Works. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

166. | Eng Sa’iid Ma’thi Hneidi |  | Minister of Oil and Mineral Resources. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

167. | Dr. Lubana Mushaweh |  | Minister of Culture. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

168. | Dr. Jassem Mohammad Zakaria |  | Minister of Labour and Social Affairs. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

169. | Omran Ahed Al Zu’bi |  | Minister of Information. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

170. | Dr. Adnan Abdo Al Sikhny |  | Minister of Industry. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

171. | Najm Hamad Al Ahmad |  | Minister of Justice. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

172. | Dr. Abdul Salam Al Nayef |  | Minister of Health. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

173. | Dr. Ali Heidar |  | State Minister for National Reconciliation Affairs. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

174. | Dr. Nazeera Farah Sarkees |  | State Minister for Environmental Affairs. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

175. | Mohammad Turki Al Sayed |  | State Minister. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

176. | Najm-eddin Khreit |  | State Minister. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

177. | Abdullah Khaleel Hussein |  | State Minister. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

178. | Jamal Sha’ban Shaheen |  | State Minister. As Government Minister shares responsibility for the regime’s violent repression against the civilian population. | 16.10.2012

179. | Sulieman Maarouf (a.k.a. Suleiman Maarouf, Sulayman Mahmud Ma’ruf, Sleiman Maarouf, Mahmoud Soleiman Maarouf; Sulaiman Maarouf) | Passport: in possession of a UK passport | Businessman close to President Al-Assad’s family. Owns shares in the listed TV station Dounya TV. Close to Muhammad Nasif Khayrbik, who has been designated. Supports the Syrian regime. | 16.10.2012

180. | Razan Othman | Wife of Rami Makhlouf, daughter of Walif Othman;Date of birth: 31 January 1977;Place of birth: governorate of Latakia;ID nr.: 06090034007 | She has close personal and financial relations with Rami Makhlouf, cousin of president Bashar Al-Assad and principal financer of the regime, who has been designated. As such, associated with the Syrian regime, and benefiting from it. | 16.10.2012

B.   Entities
 | Name | Identifying information | Reasons | Date of listing

1. | Bena Properties |  | Controlled by Rami Makhlouf; provides funding to the regime. | 23.6.2011

2. | Al Mashreq Investment Fund (AMIF) (alias Sunduq Al Mashrek Al Istithmari) | P.O. Box 108, Damascus;Tel.: 963 112110059 / 963 112110043Fax: 963 933333149 | P.O. Box 108, Damascus; | Tel.: 963 112110059 / 963 112110043 | Fax: 963 933333149 | Controlled by Rami Makhlouf; provides funding to the regime. | 23.6.2011

P.O. Box 108, Damascus;

Tel.: 963 112110059 / 963 112110043

Fax: 963 933333149

3. | Hamcho International (Hamsho International Group) | Baghdad Street, P.O. Box 8254, Damascus;Tel.: 963 112316675Fax: 963 112318875;Website: www.hamshointl.comE-mail: [email protected] and [email protected] | Baghdad Street, P.O. Box 8254, Damascus; | Tel.: 963 112316675 | Fax: 963 112318875; | Website: www.hamshointl.com | E-mail: [email protected] and [email protected] | Controlled by Mohammad Hamcho or Hamsho; provides funding to the regime. | 23.6.2011

Baghdad Street, P.O. Box 8254, Damascus;

Tel.: 963 112316675

Fax: 963 112318875;

Website: www.hamshointl.com

E-mail: [email protected] and [email protected]

4. | Military Housing Establishment (alias MILIHOUSE) |  | Public works company controlled by Riyad Shalish and Ministry of Defence; provides funding to the regime. | 23.6.2011

5. | Political Security Directorate |  | Syrian government agency directly involved in repression. | 23.8.2011

6. | General Intelligence Directorate |  | Syrian government agency directly involved in repression. | 23.8.2011

7. | Military Intelligence Directorate |  | Syrian government agency directly involved in repression. | 23.8.2011

8. | Air Force Intelligence Agency |  | Syrian government agency directly involved in repression. | 23.8.2011

9. | IRGC Qods Force (Quds Force) | Teheran, Iran | The Qods (or Quds) Force is a specialist arm of the Iranian Islamic Revolutionary Guard Corps (IRGC). The Qods Force is involved in providing equipment and support to help the Syria regime suppress protests in Syria. IRGC Qods Force has provided technical assistance, equipment and support to the Syrian security services to repress civilian protest movements. | 23.8.2011

10. | Mada Transport | Subsidiary of Cham Holding (Sehanya Dara’a Highway, PO Box 9525, Tel: 00 963 11 99 62) | Economic entity financing the regime. | 2.9.2011

11. | Cham Investment Group | Subsidiary of Cham Holding (Sehanya Dara’a Highway, PO Box 9525, Tel: 00 963 11 99 62) | Economic entity financing the regime. | 2.9.2011

12. | Real Estate Bank | Insurance Bldg- Yousef Al-Azmeh Square, Damascus P.O. Box: 2337 Damascus Syrian Arab Republic;Tel: (+963) 11 2456777 and 2218602;Fax: (+963) 11 2237938 and 2211186;Bank’s e-mail: [email protected]: www.reb.sy | Insurance Bldg- Yousef Al-Azmeh Square, Damascus P.O. Box: 2337 Damascus Syrian Arab Republic; | Tel: (+963) 11 2456777 and 2218602; | Fax: (+963) 11 2237938 and 2211186; | Bank’s e-mail: [email protected] | Website: www.reb.sy | State-owned bank providing financial support for the regime. | 2.9.2011

Insurance Bldg- Yousef Al-Azmeh Square, Damascus P.O. Box: 2337 Damascus Syrian Arab Republic;

Tel: (+963) 11 2456777 and 2218602;

Fax: (+963) 11 2237938 and 2211186;

Bank’s e-mail: [email protected]

Website: www.reb.sy

13. | Addounia TV (a.k.a. Dounia TV) | Tel: +963-11-5667274; +963-11-5667271;Fax: +963-11-5667272;Website: http://www.addounia.tv | Addounia TV has incited violence against the civilian population in Syria. | 23.9.2011

14. | Cham Holding | Cham Holding Building Daraa Highway – Ashrafiyat Sahnaya Rif Dimashq – Syria P.O. Box 9525;Tel +963 (11) 9962; +963 (11) 668 14000; +963 (11) 673 1044;Fax +963 (11) 673 1274;E-mail: [email protected]: www.chamholding.sy | Cham Holding Building Daraa Highway – Ashrafiyat Sahnaya Rif Dimashq – Syria P.O. Box 9525; | Tel +963 (11) 9962; +963 (11) 668 14000; +963 (11) 673 1044; | Fax +963 (11) 673 1274; | E-mail: [email protected] | Website: www.chamholding.sy | Controlled by Rami Makhlouf; largest holding company in Syria, benefiting from and supporting the regime. | 23.9.2011

Cham Holding Building Daraa Highway – Ashrafiyat Sahnaya Rif Dimashq – Syria P.O. Box 9525;

Tel +963 (11) 9962; +963 (11) 668 14000; +963 (11) 673 1044;

Fax +963 (11) 673 1274;

E-mail: [email protected]

Website: www.chamholding.sy

15. | El-Tel. Co. (El-Tel. Middle East Company) | Address: Dair Ali Jordan Highway, P.O. Box 13052, Damascus, Syria;Tel. +963-11-2212345;Fax +963-11-44694450E-mail: [email protected]: www.eltelme.com | Address: Dair Ali Jordan Highway, P.O. Box 13052, Damascus, Syria; | Tel. +963-11-2212345; | Fax +963-11-44694450 | E-mail: [email protected] | Website: www.eltelme.com | Manufacturing and supplying communication and transmission towers and other equipment for the Syrian army. | 23.9.2011

Address: Dair Ali Jordan Highway, P.O. Box 13052, Damascus, Syria;

Tel. +963-11-2212345;

Fax +963-11-44694450

E-mail: [email protected]

Website: www.eltelme.com

16. | Ramak Constructions Co. | Address: Dara’a Highway, Damascus, Syria;Tel: +963-11-6858111;Mobile: +963-933-240231 | Address: Dara’a Highway, Damascus, Syria; | Tel: +963-11-6858111; | Mobile: +963-933-240231 | Construction of military barracks, border post barracks and other buildings for Army needs. | 23.9.2011

Address: Dara’a Highway, Damascus, Syria;

Tel: +963-11-6858111;

Mobile: +963-933-240231

17. | Souruh Company (a.k.a. SOROH Al Cham Company) | Address: Adra Free Zone Area Damascus – Syria;Tel: +963-11-5327266;Mobile: +963-933-526812; +963-932-878282;Fax: +963-11-5316396E-mail: [email protected]: http://sites.google.com/site/sorohco | Address: Adra Free Zone Area Damascus – Syria; | Tel: +963-11-5327266; | Mobile: +963-933-526812; +963-932-878282; | Fax: +963-11-5316396 | E-mail: [email protected] | Website: http://sites.google.com/site/sorohco | Investment in local military industrial projects, manufacturing weapons parts and related items. 100 % of the company is owned by Rami Makhlouf. | 23.9.2011

Address: Adra Free Zone Area Damascus – Syria;

Tel: +963-11-5327266;

Mobile: +963-933-526812; +963-932-878282;

Fax: +963-11-5316396

E-mail: [email protected]

Website: http://sites.google.com/site/sorohco

18. | Syriatel | Thawra Street, Ste Building 6th Floor, BP 2900;Tel: +963 11 61 26 270;Fax: +963 11 23 73 97 19;E-mail: [email protected];Website: http://syriatel.sy/ | Thawra Street, Ste Building 6th Floor, BP 2900; | Tel: +963 11 61 26 270; | Fax: +963 11 23 73 97 19; | E-mail: [email protected]; | Website: http://syriatel.sy/ | Controlled by Rami Makhlouf; provides financial support to the regime: through its licensing contract it pays 50 % of its profits to the Government. | 23.9.2011

Thawra Street, Ste Building 6th Floor, BP 2900;

Tel: +963 11 61 26 270;

Fax: +963 11 23 73 97 19;

E-mail: [email protected];

Website: http://syriatel.sy/

19. | Cham Press TV | Al Qudsi building, 2nd Floor – Baramkeh – Damas;Tel: +963-11-2260805;Fax: +963-11-2260806E-mail: [email protected]: www.champress.net | Al Qudsi building, 2nd Floor – Baramkeh – Damas; | Tel: +963-11-2260805; | Fax: +963-11-2260806 | E-mail: [email protected] | Website: www.champress.net | Television channel which participates in campaigns to spread disinformation and incite violence against demonstrators. | 1.12.2011

Al Qudsi building, 2nd Floor – Baramkeh – Damas;

Tel: +963-11-2260805;

Fax: +963-11-2260806

E-mail: [email protected]

Website: www.champress.net

20. | Al Watan | Al Watan Newspaper -Damascus – Duty Free Zone;Tel: 00963 11 2137400;Fax: 00963 11 2139928 | Al Watan Newspaper -Damascus – Duty Free Zone; | Tel: 00963 11 2137400; | Fax: 00963 11 2139928 | Daily newspaper which participates in campaigns to spread disinformation and incite violence against demonstrators. | 1.12.2011

Al Watan Newspaper -Damascus – Duty Free Zone;

Tel: 00963 11 2137400;

Fax: 00963 11 2139928

21. | Centre d’études et de recherches syrien (CERS) (a.k.a.; Centre d’Etude et de Recherche Scientifique (CERS); Scientific Studies and Research Center (SSRC); Centre de Recherche de Kaboun) | Barzeh Street, PO Box 4470, Damas | Provides support to the Syrian army for the acquisition of equipment used directly for the surveillance and repression of demonstrators. | 1.12.2011

22. | Business Lab | Maysat Square, Al Rasafi Street Bldg. 9, PO Box 7155, Damascus;Tel: 963112725499;Fax: 963112725399 | Maysat Square, Al Rasafi Street Bldg. 9, PO Box 7155, Damascus; | Tel: 963112725499; | Fax: 963112725399 | Front company for the acquisition of sensitive equipment by the CERS. | 1.12.2011

Maysat Square, Al Rasafi Street Bldg. 9, PO Box 7155, Damascus;

Tel: 963112725499;

Fax: 963112725399

23. | Industrial Solutions | Baghdad Street 5, PO Box 6394, Damascus;Tel /fax: 63114471080 | Baghdad Street 5, PO Box 6394, Damascus; | Tel /fax: 63114471080 | Front company for the acquisition of sensitive equipment by the CERS. | 1.12.2011

Baghdad Street 5, PO Box 6394, Damascus;

Tel /fax: 63114471080

24. | Mechanical Construction Factory (MCF) | P.O. Box 35202, Industrial Zone, Al-Qadam Road, Damas | Front company for the acquisition of sensitive equipment by the CERS. | 1.12.2011

25. | Syronics – Syrian Arab Co. for Electronic Industries | Kaboon Street, P.O.Box 5966, Damascus;Tel.: +963-11-5111352;Fax: +963-11-5110117 | Kaboon Street, P.O.Box 5966, Damascus; | Tel.: +963-11-5111352; | Fax: +963-11-5110117 | Front company for the acquisition of sensitive equipment by the CERS. | 1.12.2011

Kaboon Street, P.O.Box 5966, Damascus;

Tel.: +963-11-5111352;

Fax: +963-11-5110117

26. | Handasieh – Organization for Engineering Industries | P.O. Box 5966, Abou Bakr Al-Seddeq St., Damascus and PO BOX 2849 Al-Moutanabi Street, Damascus and PO BOX 21120 Baramkeh, Damascus;Tel: 963112121816; 963112121834; 963112214650; 963112212743; 963115110117 | Front company for the acquisition of sensitive equipment by the CERS. | 1.12.2011

27. | Syria Trading Oil Company (Sytrol) | Prime Minister Building, 17 Street Nissan, Damascus, Syria | State-owned company responsible for all oil exports from Syria. Provides financial support to the regime. | 1.12.2011

28. | General Petroleum Corporation (GPC) | New Sham – Building of Syrian Oil Company, PO Box 60694, Damascus, Syria BOX: 60694;Tel: 963113141635;Fax: 963113141634;E-mail: [email protected] | New Sham – Building of Syrian Oil Company, PO Box 60694, Damascus, Syria BOX: 60694; | Tel: 963113141635; | Fax: 963113141634; | E-mail: [email protected] | State-owned oil company. Provides financial support to the regime. | 1.12.2011

New Sham – Building of Syrian Oil Company, PO Box 60694, Damascus, Syria BOX: 60694;

Tel: 963113141635;

Fax: 963113141634;

E-mail: [email protected]

29. | Al Furat Petroleum Company | Dummar – New Sham -Western Dummer 1st. Island -Property 2299- AFPC Building P.O. Box 7660 Damascus, Syria;Tel: 00963-11- (6183333); 00963-11- (31913333);Fax: 00963-11- (6184444); 00963-11- (31914444);[email protected] | Dummar – New Sham -Western Dummer 1st. Island -Property 2299- AFPC Building P.O. Box 7660 Damascus, Syria; | Tel: 00963-11- (6183333); 00963-11- (31913333); | Fax: 00963-11- (6184444); 00963-11- (31914444); | [email protected] | Joint venture 50 % owned by GPC. Provides financial support to the regime. | 1.12.2011

Dummar – New Sham -Western Dummer 1st. Island -Property 2299- AFPC Building P.O. Box 7660 Damascus, Syria;

Tel: 00963-11- (6183333); 00963-11- (31913333);

Fax: 00963-11- (6184444); 00963-11- (31914444);

[email protected]

30. | Industrial Bank | Dar Al Muhanisen Building, 7th Floor, Maysaloun Street, P.O. Box 7572 Damascus, Syria;Tel: +963 11-222-8200; +963 11-222-7910;Fax: +963 11-222-8412 | Dar Al Muhanisen Building, 7th Floor, Maysaloun Street, P.O. Box 7572 Damascus, Syria; | Tel: +963 11-222-8200; +963 11-222-7910; | Fax: +963 11-222-8412 | State-owned bank. Provides financial support to the regime. | 23.1.2012

Dar Al Muhanisen Building, 7th Floor, Maysaloun Street, P.O. Box 7572 Damascus, Syria;

Tel: +963 11-222-8200; +963 11-222-7910;

Fax: +963 11-222-8412

31. | Popular Credit Bank | Dar Al Muhanisen Building, 6th Floor, Maysaloun Street, Damascus, Syria;Tel: +963 11-222-7604; +963 11-221-8376;Fax: +963 11-221-0124 | Dar Al Muhanisen Building, 6th Floor, Maysaloun Street, Damascus, Syria; | Tel: +963 11-222-7604; +963 11-221-8376; | Fax: +963 11-221-0124 | State-owned bank. Provides financial support to the regime. | 23.1.2012

Dar Al Muhanisen Building, 6th Floor, Maysaloun Street, Damascus, Syria;

Tel: +963 11-222-7604; +963 11-221-8376;

Fax: +963 11-221-0124

32. | Saving Bank | Syria-Damascus – Merjah – Al-Furat St. P.O. Box: 5467;Fax: 224 4909; 245 3471;Tel: 222 8403;e-mail: [email protected], [email protected] | Syria-Damascus – Merjah – Al-Furat St. P.O. Box: 5467; | Fax: 224 4909; 245 3471; | Tel: 222 8403; | e-mail: [email protected], [email protected] | State-owned bank. Provides financial support to the regime. | 23.1.2012

Syria-Damascus – Merjah – Al-Furat St. P.O. Box: 5467;

Fax: 224 4909; 245 3471;

Tel: 222 8403;

e-mail: [email protected], [email protected]

33. | Agricultural Cooperative Bank | Agricultural Cooperative Bank Building, Damascus Tajhez, P.O. Box 4325, Damascus, Syria;Tel: +963 11-221-3462; +963 11-222-1393;Fax: +963 11-224-1261;Website: www.agrobank.org | Agricultural Cooperative Bank Building, Damascus Tajhez, P.O. Box 4325, Damascus, Syria; | Tel: +963 11-221-3462; +963 11-222-1393; | Fax: +963 11-224-1261; | Website: www.agrobank.org | State-owned bank. Provides financial support to the regime. | 23.1.2012

Agricultural Cooperative Bank Building, Damascus Tajhez, P.O. Box 4325, Damascus, Syria;

Tel: +963 11-221-3462; +963 11-222-1393;

Fax: +963 11-224-1261;

Website: www.agrobank.org

34. | Syrian Lebanese Commercial Bank | Syrian Lebanese Commercial Bank Building, 6th Floor, Makdessi Street, Hamra, P.O. Box 11-8701, Beirut, Lebanon;Tel: +961 1-741666;Fax: +961 1-738228; +961 1-753215; +961 1-736629;Website: www.slcb.com.lb | Syrian Lebanese Commercial Bank Building, 6th Floor, Makdessi Street, Hamra, P.O. Box 11-8701, Beirut, Lebanon; | Tel: +961 1-741666; | Fax: +961 1-738228; +961 1-753215; +961 1-736629; | Website: www.slcb.com.lb | Subsidiary of the Commercial Bank of Syria already listed. Provides financial support to the regime. | 23.1.2012

Syrian Lebanese Commercial Bank Building, 6th Floor, Makdessi Street, Hamra, P.O. Box 11-8701, Beirut, Lebanon;

Tel: +961 1-741666;

Fax: +961 1-738228; +961 1-753215; +961 1-736629;

Website: www.slcb.com.lb

35. | Deir ez-Zur Petroleum Company | Dar Al Saadi Building 1st, 5th, and 6th Floor Zillat Street Mazza Area P.O. Box 9120 Damascus, Syria;Tel: +963 11-662-1175; +963 11-662-1400;Fax: +963 11-662-1848 | Dar Al Saadi Building 1st, 5th, and 6th Floor Zillat Street Mazza Area P.O. Box 9120 Damascus, Syria; | Tel: +963 11-662-1175; +963 11-662-1400; | Fax: +963 11-662-1848 | Joint venture of GPC. Provides financial support to the regime. | 23.1.2012

Dar Al Saadi Building 1st, 5th, and 6th Floor Zillat Street Mazza Area P.O. Box 9120 Damascus, Syria;

Tel: +963 11-662-1175; +963 11-662-1400;

Fax: +963 11-662-1848

36. | Ebla Petroleum Company | Head Office Mazzeh Villat Ghabia Dar Es Saada 16, P.O. Box 9120, Damascus, Syria;Tel: +963 116691100 | Head Office Mazzeh Villat Ghabia Dar Es Saada 16, P.O. Box 9120, Damascus, Syria; | Tel: +963 116691100 | Joint venture of GPC. Provides financial support to the regime. | 23.1.2012

Head Office Mazzeh Villat Ghabia Dar Es Saada 16, P.O. Box 9120, Damascus, Syria;

Tel: +963 116691100

37. | Dijla Petroleum Company | Building No. 653 – 1st Floor, Daraa Highway, P.O. Box 81, Damascus, Syria | Joint venture of GPC. Provides financial support to the regime. | 23.1.2012

38. | Central Bank of Syria | Syria, Damascus, Sabah Bahrat Square Postal address: Altjreda al Maghrebeh square, Damascus, Syrian Arab Republic, P.O. Box: 2254 | Providing financial support to the regime. | 27.2.2012

39. | Syrian Petroleum company | Address: Dummar Province, Expansion Square, Island 19-Building 32 P.O. BOX: 2849 or 3378;Phone: 00963-11-3137935 or 3137913;Fax: 00963-11-3137979 or 3137977;E-mail: [email protected] or [email protected];Websites: www.spc.com.sy www.spc-sy.com | Address: Dummar Province, Expansion Square, Island 19-Building 32 P.O. BOX: 2849 or 3378; | Phone: 00963-11-3137935 or 3137913; | Fax: 00963-11-3137979 or 3137977; | E-mail: [email protected] or [email protected]; | Websites: www.spc.com.sy www.spc-sy.com | State-owned oil company. Provides financial support to the Syrian regime. | 23.3.2012

Address: Dummar Province, Expansion Square, Island 19-Building 32 P.O. BOX: 2849 or 3378;

Phone: 00963-11-3137935 or 3137913;

Fax: 00963-11-3137979 or 3137977;

E-mail: [email protected] or [email protected];

Websites: www.spc.com.sy www.spc-sy.com

40. | Mahrukat Company (The Syrian Company for the Storage and Distribution of Petroleum Products) | Headquarters: Damascus – Al Adawi st., Petroleum building;Fax: 00963-11/4445796;Phone: 00963-11/44451348 – 4451349;E-mail: [email protected];Website: http://www.mahrukat.gov.sy/indexeng.php | Headquarters: Damascus – Al Adawi st., Petroleum building; | Fax: 00963-11/4445796; | Phone: 00963-11/44451348 – 4451349; | E-mail: [email protected]; | Website: http://www.mahrukat.gov.sy/indexeng.php | State-owned oil company. Provides financial support to the Syrian regime. | 23.3.2012

Headquarters: Damascus – Al Adawi st., Petroleum building;

Fax: 00963-11/4445796;

Phone: 00963-11/44451348 – 4451349;

E-mail: [email protected];

Website: http://www.mahrukat.gov.sy/indexeng.php

41. | General Organisation of Tobacco | Salhieh Street 616, Damascus, Syria | Provides financial support to the Syrian regime. The General Organisation of Tobacco is wholly owned by the Syrian state. The profits that the organisation makes, including through the sale of licenses to market foreign brands of tobacco and taxes levied on imports of foreign brands of tobacco are transferred to the Syrian state. | 15.5.2012

42. | Ministry of Defence | Address: Umayyad Square, Damascus;Telephone: +963-11-7770700 | Address: Umayyad Square, Damascus; | Telephone: +963-11-7770700 | Syrian government branch directly involved in repression. | 26.6.2012

Address: Umayyad Square, Damascus;

Telephone: +963-11-7770700

43. | Ministry of Interior | Address: Merjeh Square, Damascus;Telephone: +963-11-2219400; +963-11-2219401; +963-11-2220220; +963-11-2210404 | Address: Merjeh Square, Damascus; | Telephone: +963-11-2219400; +963-11-2219401; +963-11-2220220; +963-11-2210404 | Syrian government branch directly involved in repression. | 26.6.2012

Address: Merjeh Square, Damascus;

Telephone: +963-11-2219400; +963-11-2219401; +963-11-2220220; +963-11-2210404

44. | Syrian National Security Bureau |  | Syrian government branch and element of the Syrian Ba’ath Party. Directly involved in repression. It directed Syrian security forces to use extreme force against demonstrators. | 26.6.2012

45. | Syria International Islamic Bank (SIIB) (a.k.a.: Syrian International Islamic Bank; a.k.a. SIIB) | Location: Syria International Islamic Bank Building, Main Highway Road, Al Mazzeh Area, P.O. Box 35494, Damascus, Syria; Alt. Location: P.O. Box 35494, Mezza’h Vellat Sharqia’h, beside the Consulate of Saudi Arabia, Damascus, Syria | SIIB has acted as a front for the Commercial Bank of Syria, which has allowed that bank to circumvent sanctions imposed on it by the EU. From 2011 to 2012, SIIB surreptitiously facilitated financing worth almost $150 million on behalf of the Commercial Bank of Syria. Financial arrangements that were purportedly made by SIIB were actually made by the Commercial Bank of Syria. In addition to working with the Commercial Bank of Syria to circumvent sanctions, in 2012, SIIB facilitated several substantial payments for the Syrian Lebanese Commercial Bank, another bank already designated by the EU. In these ways, SIIB has contributed to providing financial support to the Syrian regime. | 26.6.2012

46. | General Organisation of Radio and TV (a.k.a. Syrian Directorate General of Radio & Television Est; a.k.a. General Radio and Television Corporation; a.k.a. Radio and Television Corporation; a.k.a. GORT) | Address: Al Oumaween Square, P.O. Box 250, Damascus, Syria;Telephone (963 11) 223 4930 | Address: Al Oumaween Square, P.O. Box 250, Damascus, Syria; | Telephone (963 11) 223 4930 | State-run agency subordinate to Syria’s Ministry of Information and as such supports and promotes its information policy. It is responsible for operating Syria’s state-owned television channels, two terrestrial and one satellite, as well as government radio stations. The GORT has incited violence against the civilian population in Syria, serving as a propaganda instrument for the Assad regime and spreading disinformation. | 26.6.2012

Address: Al Oumaween Square, P.O. Box 250, Damascus, Syria;

Telephone (963 11) 223 4930

47. | Syrian Company for Oil Transport (a.k.a. Syrian Crude Oil Transportation Company; a.k.a. ‧SCOT‧; a.k.a. ‧SCOTRACO‧) | Banias Industrial Area, Latakia Entrance Way, P.O. Box 13, Banias, Syria;Website www.scot-syria.com;E-mail: [email protected] | Banias Industrial Area, Latakia Entrance Way, P.O. Box 13, Banias, Syria; | Website www.scot-syria.com; | E-mail: [email protected] | Syrian state owned oil company. Provides financial support to the regime. | 26.6.2012

Banias Industrial Area, Latakia Entrance Way, P.O. Box 13, Banias, Syria;

Website www.scot-syria.com;

E-mail: [email protected]

48. | Drex Technologies S.A. | Incorporation date: 4 July 2000; Incorporation number: 394678;Director: Rami Makhlouf;Registered agent: Mossack Fonseca & Co (BVI) Ltd | Drex Technologies is wholly owned by Rami Makhlouf, who is listed under EU sanctions for providing financial support to the Syrian regime. Rami Makhlouf uses Drex Technologies to facilitate and manage his international financial holdings, including a majority share in SyriaTel, which the EU has previously listed on the grounds that it also provides financial support to the Syrian regime. | 24.7.2012

49. | Cotton Marketing Organisation | Address: Bab Al-Faraj P.O. Box 729, Aleppo;Tel.: +96321 2239495/6/7/8;[email protected],www.cmo.gov.sy | Address: Bab Al-Faraj P.O. Box 729, Aleppo; | Tel.: +96321 2239495/6/7/8; | [email protected], | www.cmo.gov.sy | State-owned company. Provides financial support to the Syrian regime. | 24.7.2012

Address: Bab Al-Faraj P.O. Box 729, Aleppo;

Tel.: +96321 2239495/6/7/8;

[email protected],

www.cmo.gov.sy

50. | Syrian Arab Airlines (a.k.a. SAA, a.k.a. Syrian Air) | Al-Mohafazeh Square, P.O. Box 417, Damascus, Syria;Tel: +963112240774 | Al-Mohafazeh Square, P.O. Box 417, Damascus, Syria; | Tel: +963112240774 | Public company controlled by the regime. Provides financial support for the regime. | 24.7.2012

Al-Mohafazeh Square, P.O. Box 417, Damascus, Syria;

Tel: +963112240774

51. | Drex Technologies Holding S.A. | Registered in Luxembourg under number B77616, formerly established at the following address: 17, rue Beaumont L-1219 Luxembourg | The beneficial owner of Drex Technologies Holding S.A. is Rami Makhlouf, who is listed under EU sanctions for providing financial support to the Syrian regime. | 17.8.2012

52. | Megatrade | Address: Aleppo Street, P.O. Box 5966, Damascus, Syria;Fax: 963114471081 | Address: Aleppo Street, P.O. Box 5966, Damascus, Syria; | Fax: 963114471081 | Acts as a proxy for the Scientific Studies and Research Centre (SSRC), which is listed. Involved in trade in dual use goods prohibited by EU sanctions for the Syrian government. | 16.10.2012

Address: Aleppo Street, P.O. Box 5966, Damascus, Syria;

Fax: 963114471081

53. | Expert Partners | Address: Rukn Addin, Saladin Street, Building 5, PO Box: 7006, Damascus, Syria | Acts as a proxy for the Scientific Studies and Research Centre (SSRC), which is listed. Involved in trade in dual use goods prohibited by EU sanctions for the Syrian government. | 16.10.2012
List of entities referred to in Article 25ANNEX II

Entities
 | Name | Identifying information | Reasons | Date of listing

1. | Commercial Bank of Syria | —Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;—P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;—Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];Website: http://cbs-bank.sy/En-index.phpTel: +963 11 2218890;Fax: +963 11 2216975;General management: [email protected] | — | Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria; | — | P.O. Box 933, Yousef Azmeh Square, Damascus, Syria; | — | Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD]; | State-owned bank providing financial support to the regime. | 13.10.2011

— | Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;

— | P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;

— | Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];
			

Pending: 32012D0721

                                January 16, 2026                            

24.11.2012
EN
Official Journal of the European Union
L 326/38

(1)
Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2)
Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3)
The criteria, as well as the related assessment and verification requirements, should be valid for four years from the date of adoption of this Decision.

(4)
The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

1.
Product and dosage information

2.
Toxicity to aquatic organisms: Critical Dilution Volume (CDV)

3.
Biodegradability

4.
Excluded or limited substances and mixtures

5.
Packaging requirements

6.
Washing performance (fitness for use)

7.
Automatic dosing systems

8.
User information — Information appearing on the EU Ecolabel

The full formulation indicating trade name, chemical name, CAS No, DID No(*1), the ingoing quantity including and excluding water, the function and the form of all the ingoing substances (regardless of concentration) in the product shall be submitted to the competent body. A sample of the artwork including dosage recommendations must be submitted to the competent body.

Safety data sheets for each ingoing substance shall be submitted to the competent body in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council(1).

http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_a_en.pdf

http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_b_en.pdf

Light
Medium
Heavy

Hotel: bed-linen, bedclothes and towels, etc. (towels may be considered heavily soiled)Cloth hand towel rolls
Work clothes: institutions/retail/service, etc.Restaurants: table-cloths, napkins, etc.Mops and mats
Work clothes: industry/kitchen/butchering, etc.Kitchen textiles: clothes, dish towels, etc.Institutions as hospitals: bed-linen, bedclothes, contour sheets, patient clothing, doctor’s coat or coatdress, etc.

Soft water (0-6 °dH)
CDVchronic(L/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
30 000
40 000
50 000

Liquid
50 000
60 000
70 000

Multi-component-system
50 000
70 000
90 000

Medium water (7-13 °dH)
CDVchronic(L/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
40 000
60 000
80 000

Liquid
60 000
75 000
90 000

Multi-component-system
60 000
80 000
100 000

Hard water (> 14 °dH)
CDVchronic(L/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
50 000
75 000
90 000

Liquid
75 000
90 000
120 000

Multi-component-system
75 000
100 000
120 000

weight
=
the weight of the ingoing substance per recommended dose

DF
=
the degradation factor

TF
=
the chronic toxicity factor of the substance as stated in the DID list.

—
Hydrogen Peroxide (H2O2) — not to be included in calculation of CDV

—
Peracetic acid — to be included in the calculation as acetic acid.

Soft water (0-6 °dH)
aNBO (g/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
0,70
1,10
1,40

Liquid
0,50
0,60
0,70

Multi-component-system
1,25
1,75
2,50

Medium water (7-13 °dH)
aNBO (g/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
1,10
1,40
1,75

Liquid
0,60
0,70
0,90

Multi-component-system
1,75
2,50
3,75

Hard water (> 14 °dH)
aNBO (g/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
1,40
1,75
2,20

Liquid
0,70
0,90
1,20

Multi-component-system
2,50
3,75
4,80

Soft water (0-6 °dH)
anNBO (g/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
0,70
1,10
1,40

Liquid
0,50
0,60
0,70

Multi-component-system
1,25
1,75
2,50

Medium water (7-13 °dH)
anNBO (g/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
1,10
1,40
1,75

Liquid
0,60
0,70
0,90

Multi-component-system
1,75
2,50
3,75

Hard water (> 14 °dH)
anNBO (g/kg laundry)

Product type/Degree of soiling
Light
Medium
Heavy

Powder
1,40
1,75
2,20

Liquid
0,70
0,90
1,20

Multi-component-system
2,50
3,75
4,80

1.
Readily degradable and has low adsorption (A < 25 %) or

2.
Readily degradable and has high desorption (D > 75 %) or

3.
Readily degradable and non-bioaccumulating.

—
Phosphates (phosphonates are not excluded but limited by criterion 3)

—
APEO (Alkyl phenol ethoxylates) and ADP (Alkylphenols and derivatives thereof)

—
EDTA (ethylene-diamine-tetra-acetic-acid) and its salts

Hazard statement(4)
Risk phrase(5)

H300 Fatal if swallowed
R28

H301 Toxic if swallowed
R25

H304 May be fatal if swallowed and enters airways
R65

H310 Fatal in contact with skin
R27

H311 Toxic in contact with skin
R24

H330 Fatal if inhaled
R23/26

H331 Toxic if inhaled
R23

H340 May cause genetic defects
R46

H341 Suspected of causing genetic defects
R68

H350 May cause cancer
R45

H350i May cause cancer by inhalation
R49

H351 Suspected of causing cancer
R40

H360F May damage fertility
R60

H360D May damage the unborn child
R61

H360FD May damage fertility. May damage the unborn child
R60/61/60-61

H360Fd May damage fertility. Suspected of damaging the unborn child
R60/63

H360Df May damage the unborn child. Suspected of damaging fertility
R61/62

H361f Suspected of damaging fertility
R62

H361d Suspected of damaging the unborn child
R63

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.
R62-63

H362 May cause harm to breast fed children
R64

H370 Causes damage to organs
R39/23/24/25/26/27/28

H371 May cause damage to organs
R68/20/21/22

H372 Causes damage to organs through prolonged or repeated exposure
R48/25/24/23

H373 May cause damage to organs through prolonged or repeated exposure
R48/20/21/22

H400 Very toxic to aquatic life
R50

H410 Very toxic to aquatic life with long-lasting effects
R50-53

H411 Toxic to aquatic life with long-lasting effects
R51-53

H412 Harmful to aquatic life with long-lasting effects
R52-53

H413 May cause long-lasting harmful effects to aquatic life
R53

EUH059 Hazardous to the ozone layer
R59

EUH029 Contact with water liberates toxic gas
R29

EUH031 Contact with acids liberates toxic gas
R31

EUH032 Contact with acids liberates very toxic gas
R32

EUH070 Toxic by eye contact
R39-41

Sensitising substances

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
R42

H317: May cause allergic skin reaction
R43

Surfactants< 20 % in the final product
H400 Very toxic to aquatic life
R50

Biocides for preservations purposes(*2)(only for liquids with pH between 2 and 12 and maximum 0,10 % w/w of active material)
H331: Toxic if inhaled
R23

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
R42

H317: May cause allergic skin reaction
R43

H400: Very toxic to aquatic life
R50

Enzymes(*3)
H400: Very toxic to aquatic life
R50

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
R42

H317: May cause allergic skin reaction
R43

Bleach catalysts(*3)
H400: Very toxic to aquatic life
R50

NTA as an impurity in MGDA and GLDA(*4)
H351: Suspected of causing cancer
R40

(i)
The product may only include biocides in order to preserve the product, and in the appropriate dosage for this purpose alone. This does not refer to surfactants, which may also have biocidal properties.Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocides added, together with information on their exact concentration in the product. The manufacturer or supplier of the biocides shall provide information on the dosage necessary to preserve the product.

(ii)
It is prohibited to claim or suggest on the packaging or by any other communication that the product has an antimicrobial or disinfecting effect.Assessment and verification: the applicant shall provide the texts and layouts used on each type of packaging and/or an example of each different type of packaging to the competent body.

(iii)
The product may contain biocides provided that they are not bioaccumulating. A biocide is not considered bioaccumulating if BCF < 100 or logKow < 3,0. If both BCF and logKow values are available, the highest measured BCF value shall be used.Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocide added, together with information on their BCF and/or logKow values.

Product type/water hardness
WUR (g/kg laundry)

Soft water
Medium water
Hard water

Powders
1,5
2,0
2,5

Liquids
2,0
2,5
3,0

Wi
=
the weight (g) of the packaging component (i) including the label if applicable.

Ui
=
the weight (g) of non-recycled (virgin) material in the packaging component (i). If the proportion of recycled material in the packaging component is 0 % then Ui= Wi.

Di
=
the number of functional units contained in the packaging component (i). The functional unit = dosage in g/kg laundry. Note that the highest recommended dosage for each water hardness must be used in the WUR calculation.

ri
=
recycling figure, i.e. the number of times the packaging component (i) is used for the same purpose through a return or refill system. r = 1 if the packaging is not re-used for the same purpose. If the packaging is reused r is set to 1 unless the applicant can document a higher number.

—
WFK-PCMS-55 for industrial laundering processes, consisting of 13 different small dirt patches (WFK-Cleaning Technology Research Institute, Germany)

—
EMPA 102, consisting of 15 different fresh spots (Swiss EMPA-Testmaterials)

—
wash clothes of DTI (Danish Technology Institute) for industrial washing processes or equivalent

—
Wash at the lowest recommended temperature

—
Always wash with the highest possible load, the textiles allow

—
Dose according to the dosing instructions and use the dosage according to water hardness and degree of soiling

—
Using this EU Ecolabelled product according to the dosage instructions will contribute to the reduction of water pollution, waste production and energy consumption.

—
E.g. if a product claims efficiency at 20 °C, the performance test must be performed at ≤ 20 °C (and correspondingly for other temperature claims below 40 °C).

—
E.g. if a product claims to be efficient on certain stain types, this must be documented with performance test.

—
Reduced impact on aquatic ecosystems

—
Limited hazardous substances

—
Performance tested.

Acute toxicity
Chronic toxicity
Degradation

Ingoing substance
LC50/EC50
SF(acute)
TF(acute)
NOEC(*1)
SF(chronic)(*1)
TF(chronic)
DF
Aerobic
Anaerobic

‘Name’
1  mg/l
10 000
0,0001

0,0001
1
P
N

(1)
Until 1 December 2010 and during transition period from 1 December 2010 to 1 December 2015:The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

(2)
After 1 December 2015 and during transition period from 1 December 2010 to 1 December 2015:The test methods provided for in Regulation (EC) No 1272/2008.

(1)
Apply reasonable extrapolation. Use test results obtained with one raw material to extrapolate the ultimate anaerobic degradability of structurally related surfactants. Where anaerobic biodegradability has been confirmed for a surfactant (or a group of homologues) according to the DID-list, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. C12-15 A 1-3 EO sulphate [DID No 8] is anaerobically biodegradable, and a similar anaerobic biodegradability may also be assumed for C12-15 A 6 EO sulphate). Where anaerobic biodegradability has been confirmed for a surfactant by use of an appropriate test method, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. literature data confirming the anaerobic biodegradability of surfactants belonging to the group alkyl ester ammonium salts may be used as documentation for a similar anaerobic biodegradability of other quaternary ammonium salts containing ester-linkages in the alkyl chain(s)).

(2)
Perform screening test for anaerobic degradability. If new testing is necessary, perform a screening test by use of EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent method.

(3)
Perform low-dosage degradability test. If new testing is necessary, and in the case of experimental problems in the screening test (e.g. inhibition due to toxicity of test substance), repeat testing by using a low dosage of surfactant and monitor degradation by14C measurements or chemical analyses. Testing at low dosages may be performed by use of OECD 308 (August 2000) or an equivalent method.

—
the authorities monitor the sampling and analysis process, or

—
the manufacturer has a quality system incorporating testing and analyses and which is certified in accordance with ISO 9001, or

—
the manufacturer can show that there is conformity between a first-time test conducted as a parallel test between an impartial test institution and the manufacturer’s own laboratory and that the manufacturer takes samples in accordance with a prescribed sampling plan.

—
It must be possible for ecolabelling organisations to monitor the performance of testing

—
The ecolabelling organisation must have access to all data on the product

—
The samples must be made anonymous for the test laboratory

—
Performance of the effectiveness test must be described in the quality control system.

1.
Responses must be obtained from at least five test centres representing a selection of customers.

2.
The procedure and dosage must conform to the manufacturer’s recommendations.

3.
The test period must continue for at least four weeks.

4.
Every test centre must assess the serviceability of the product or multi-component system, dosability, compressibility, rinsing and solubility.

5.
Every test centre must assess the effectiveness of the product or multi-component system by answering questions relating to the following aspects (or similar formulations):(a)ability to launder lightly, moderately or heavily soiled articles to be washed;(b)an assessment of primary laundering effects such as dirt removal, stain removal capacity and bleaching effect must be rated;(c)assessment of secondary laundering effects such as greying of white washing and colour-fastness and staining of coloured washing;(d)assessment of the effect of the rinsing agent on drying, ironing or mangling of the articles to be washed;(e)how satisfied the test subject is with customer visiting arrangements.
(a)
ability to launder lightly, moderately or heavily soiled articles to be washed;
(b)
an assessment of primary laundering effects such as dirt removal, stain removal capacity and bleaching effect must be rated;
(c)
assessment of secondary laundering effects such as greying of white washing and colour-fastness and staining of coloured washing;
(d)
assessment of the effect of the rinsing agent on drying, ironing or mangling of the articles to be washed;
(e)
how satisfied the test subject is with customer visiting arrangements.

(a)
ability to launder lightly, moderately or heavily soiled articles to be washed;

(b)
an assessment of primary laundering effects such as dirt removal, stain removal capacity and bleaching effect must be rated;

(c)
assessment of secondary laundering effects such as greying of white washing and colour-fastness and staining of coloured washing;

(d)
assessment of the effect of the rinsing agent on drying, ironing or mangling of the articles to be washed;

(e)
how satisfied the test subject is with customer visiting arrangements.

(a)
ability to launder lightly, moderately or heavily soiled articles to be washed;

(b)
an assessment of primary laundering effects such as dirt removal, stain removal capacity and bleaching effect must be rated;

(c)
assessment of secondary laundering effects such as greying of white washing and colour-fastness and staining of coloured washing;

(d)
assessment of the effect of the rinsing agent on drying, ironing or mangling of the articles to be washed;

(e)
how satisfied the test subject is with customer visiting arrangements.

6.
The response must be rated on a scale comprising at least three levels, for example, ‘insufficiently effective’, ‘sufficiently effective’ or ‘very effective’. With regard to how satisfied the test centre is with visit reporting arrangements, the categories must be ‘not satisfied’, ‘satisfied’ and ‘very satisfied’.

7.
At least five test centres must submit responses. At least 80 % must rate the product as sufficiently effective or very effective on all points (see point 4 and be satisfied or very satisfied with customer visiting arrangements.

8.
All raw data from the test must be specified.

9.
The test procedure must be described in detail.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,

After consulting the European Union Eco-labelling Board,

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3) The criteria, as well as the related assessment and verification requirements, should be valid for four years from the date of adoption of this Decision.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:
Article 1

The product group ‘Industrial and Institutional Laundry Detergents’ shall comprise: laundry detergent products performed by professional users in the industrial and institutional sector.

Included in the product group are multi-component-systems constituting of more than one component used to build up a complete detergent or a laundering program for automatic dosing system.

This product group shall not comprise products for obtaining textile attributes such as water-repellent, waterproof or fireproof, etc. Furthermore, the product group shall not comprise products that are dosed by carriers such as sheets, cloths or other materials, as well as washing auxiliaries used without subsequent washing, such as stain removers for carpets and furniture upholstery.

Consumer laundry detergents are excluded from the scope of this product group.
Article 2

In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of laundry detergent shall fall within the product group ‘Industrial and Institutional Laundry Detergents’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.
Article 3

The criteria for the product group ‘Industrial and Institutional Laundry Detergents’, as well as the related assessment and verification requirements, shall be valid for four years from the date of adoption of this Decision.
Article 4

For administrative purposes the code number assigned to the product group ‘Industrial and Institutional Laundry Detergents’ shall be ‘039’.
Article 5

This Decision is addressed to the Member States.
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,

After consulting the European Union Eco-labelling Board,

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3) The criteria, as well as the related assessment and verification requirements, should be valid for four years from the date of adoption of this Decision.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:
The product group ‘Industrial and Institutional Laundry Detergents’ shall comprise: laundry detergent products performed by professional users in the industrial and institutional sector.

Included in the product group are multi-component-systems constituting of more than one component used to build up a complete detergent or a laundering program for automatic dosing system.

This product group shall not comprise products for obtaining textile attributes such as water-repellent, waterproof or fireproof, etc. Furthermore, the product group shall not comprise products that are dosed by carriers such as sheets, cloths or other materials, as well as washing auxiliaries used without subsequent washing, such as stain removers for carpets and furniture upholstery.

Consumer laundry detergents are excluded from the scope of this product group.
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of laundry detergent shall fall within the product group ‘Industrial and Institutional Laundry Detergents’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.
The criteria for the product group ‘Industrial and Institutional Laundry Detergents’, as well as the related assessment and verification requirements, shall be valid for four years from the date of adoption of this Decision.
For administrative purposes the code number assigned to the product group ‘Industrial and Institutional Laundry Detergents’ shall be ‘039’.
This Decision is addressed to the Member States.
FRAMEWORKANNEX

The aims of the criteria

The criteria aim, in particular, at promoting products that have a reduced impact on aquatic ecosystems, contain a limited amount of hazardous substances and whose performance has been tested. The criteria furthermore aim at reducing the energy consumption from laundering by promoting products that are efficient at lower temperatures.
CRITERIA

Criteria are set for each of the following aspects:
1. | Product and dosage information

2. | Toxicity to aquatic organisms: Critical Dilution Volume (CDV)

3. | Biodegradability

4. | Excluded or limited substances and mixtures

5. | Packaging requirements

6. | Washing performance (fitness for use)

7. | Automatic dosing systems

8. | User information — Information appearing on the EU Ecolabel(1)   Assessment and verification

(a)   RequirementsThe specific assessment and verification requirements are indicated within each criterion.

Where the applicant is required to provide declarations, documentation, analyses test reports, or other evidence to show compliance with the criteria, it is understood that these may originate from the applicant and/or his supplier(s) and/or their supplier(s), et cetera, as appropriate.

Where possible, the testing should be performed by laboratories that meet the general requirements of EN ISO 17025 or equivalent.

Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.

Appendix I makes reference to the detergent ingredient database (DID list) which contains the most widely used ingoing substances used in detergent formulations. It shall be used for deriving the data for the calculations of the Critical Dilution Volume (CDV) and for the assessment of the biodegradability of the ingoing substances. For substances not present on the DID list, guidance is given on how to calculate or extrapolate the relevant data. The latest version of the DID list is available from the EU Ecolabel website or via the websites of the individual competent bodies.

Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.

(b)   Measurement thresholdsCompliance with the ecological criteria is required for substances intentionally added, as well as for by-products and impurities from raw materials, the concentration of which equals or exceeds 0,010 % by weight of final formulation.

For biocides, colouring agents and fragrance compliance with the criteria is required regardless of their concentration.

Substances meeting the threshold limit as listed above are hereby referred to as ‘Ingoing substances’.

For all products: it is the highest total dosage recommended for the individual degree of soiling which must comply with the ecological criteria. If the dosage is stated in intervals the worst case dosage must be used when the criterions are assessed.

(2)   Functional unit

The functional unit for this product group shall be expressed in g/kg laundry (grams per kilo laundry).

Requirements relating to assessment and verification of the functional unit:
 | The full formulation indicating trade name, chemical name, CAS No, DID No(*1), the ingoing quantity including and excluding water, the function and the form of all the ingoing substances (regardless of concentration) in the product shall be submitted to the competent body. A sample of the artwork including dosage recommendations must be submitted to the competent body.

 | Safety data sheets for each ingoing substance shall be submitted to the competent body in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council(1).Part A and Part B of the DID list can be found on the EU Ecolabel website:
 | http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_a_en.pdf

 | http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_b_en.pdf

EU ECOLABEL CRITERIA
Criterion 1 —   Product and dosage information

The recommended total dosage for 1 kg of laundry according to the degree of soiling and water hardness shall be given in g/kg laundry or ml/kg laundry. All products in a multi-component system have to be included with the worst case dosage when assessments of the criteria are made.

Examples of degree of soiling:
Light | Medium | Heavy

Hotel: bed-linen, bedclothes and towels, etc. (towels may be considered heavily soiled)Cloth hand towel rolls | Work clothes: institutions/retail/service, etc.Restaurants: table-cloths, napkins, etc.Mops and mats | Work clothes: industry/kitchen/butchering, etc.Kitchen textiles: clothes, dish towels, etc.Institutions as hospitals: bed-linen, bedclothes, contour sheets, patient clothing, doctor’s coat or coatdress, etc.The product name, or in case of a multi-component system, a list of all products part of that system, together with the recommended water hardness (soft, medium or hard) and the intended degree of soiling shall be provided.

The applicant must document compliance with criteria 2, 3 and 6 for all product names.

Assessment and verification: the applicant shall provide the product name, or in case of a multi-component system, a list of all products part of that system, together with exact formulation of the product(s) and the label or artwork including dosage instructions according to the three degrees of soiling and water hardness. The density (g/ml) shall be stated for all products (either on the packaging or in a Safety Data Sheet).
Criterion 2 —   Toxicity to aquatic organisms: Critical Dilution Volume (CDV) The Critical Dilution Volume (CDVchronic) of the product shall not exceed the following limits:
Soft water (0-6 °dH) | CDVchronic(L/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 30 000 | 40 000 | 50 000

Liquid | 50 000 | 60 000 | 70 000

Multi-component-system | 50 000 | 70 000 | 90 000
Medium water (7-13 °dH) | CDVchronic(L/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 40 000 | 60 000 | 80 000

Liquid | 60 000 | 75 000 | 90 000

Multi-component-system | 60 000 | 80 000 | 100 000
Hard water (> 14 °dH) | CDVchronic(L/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 50 000 | 75 000 | 90 000

Liquid | 75 000 | 90 000 | 120 000

Multi-component-system | 75 000 | 100 000 | 120 000The Critical Dilution Volume (CDVchronic) is calculated for all ingoing substances (i) in the product using the following equation:
Where:
weight | = | the weight of the ingoing substance per recommended dose

DF | = | the degradation factor

TF | = | the chronic toxicity factor of the substance as stated in the DID list.Biocides, colouring agents and fragrances present in the product must also be included in the CDV calculation even if the concentration is lower than 0,010 % (100 ppm).

Because of the degradation of the substances in the wash process, separate rules apply to the following substances:
— | Hydrogen Peroxide (H2O2) — not to be included in calculation of CDV

— | Peracetic acid — to be included in the calculation as acetic acid.Assessment and verification: the applicant shall provide calculation of the CDVchronicof the product. A spreadsheet for calculation of the CDV value is available on the EU Ecolabel website.

The values of the DF and TF parameters shall be as given in the Detergent Ingredient Database list (DID list). If the substance is not found on the DID list, the parameters shall be calculated using the guidelines in part B of the DID list and attaching the associated documentation.
Criterion 3 —   Biodegradability

(a)   Biodegradability of surfactantsAll surfactants must be biodegradable under aerobic conditions.

All non-ionic and cationic surfactants must also be biodegradable under anaerobic conditions.

(b)   Biodegradability of organic substancesThe content of all organic substances in the product that are aerobically non-biodegradable (not readily biodegradable) (aNBO) and anaerobically non-biodegradable (anNBO) shall not exceed the following limits:
aNBO
Soft water (0-6 °dH) | aNBO (g/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 0,70 | 1,10 | 1,40

Liquid | 0,50 | 0,60 | 0,70

Multi-component-system | 1,25 | 1,75 | 2,50
Medium water (7-13 °dH) | aNBO (g/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 1,10 | 1,40 | 1,75

Liquid | 0,60 | 0,70 | 0,90

Multi-component-system | 1,75 | 2,50 | 3,75
Hard water (> 14 °dH) | aNBO (g/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 1,40 | 1,75 | 2,20

Liquid | 0,70 | 0,90 | 1,20

Multi-component-system | 2,50 | 3,75 | 4,80

anNBO
Soft water (0-6 °dH) | anNBO (g/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 0,70 | 1,10 | 1,40

Liquid | 0,50 | 0,60 | 0,70

Multi-component-system | 1,25 | 1,75 | 2,50
Medium water (7-13 °dH) | anNBO (g/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 1,10 | 1,40 | 1,75

Liquid | 0,60 | 0,70 | 0,90

Multi-component-system | 1,75 | 2,50 | 3,75
Hard water (> 14 °dH) | anNBO (g/kg laundry)

Product type/Degree of soiling | Light | Medium | Heavy

Powder | 1,40 | 1,75 | 2,20

Liquid | 0,70 | 0,90 | 1,20

Multi-component-system | 2,50 | 3,75 | 4,80Assessment and verification: the applicant shall provide documentation for the degradability of surfactants as well as the calculation of aNBO and anNBO for the product. A spreadsheet for use in calculating aNBO and anNBO values is available on the EU Ecolabel website.

For both surfactants and aNBO and anNBO values reference should be done to the DID List. For ingoing substances which are not included in the DID list, the relevant information from literature or other sources, or appropriate test results, showing that they are aerobically and anaerobically biodegradable shall be provided as described in Appendix I.

Note that TAED should be considered as anaerobically biodegradable.

In the absence of documentation in accordance with the above requirements, a substance other than a surfactant may be exempted from the requirement for anaerobic degradability if one of the following three alternatives is fulfilled:
1. | Readily degradable and has low adsorption (A < 25 %) or

2. | Readily degradable and has high desorption (D > 75 %) or

3. | Readily degradable and non-bioaccumulating.Testing for adsorption/desorption may be conducted in accordance with OECD guidelines 106.
Criterion 4 —   Excluded or limited substances and mixtures

(a)   Specified excluded substancesThe following substances shall not be included in the product, either as part of the formulation nor as part of any mixture included in the formulation:
— | Phosphates (phosphonates are not excluded but limited by criterion 3)

— | APEO (Alkyl phenol ethoxylates) and ADP (Alkylphenols and derivatives thereof)

— | EDTA (ethylene-diamine-tetra-acetic-acid) and its saltsAssessment and verification: the applicant shall provide a declaration supported by declarations from manufacturers of substances, as appropriate, confirming that the listed substances have not been included in the product.

(b)   Hazardous substances and mixturesAccording to the Article 6(6) of Regulation (EC) No 66/2010 on the EU Ecolabel, the product or any component of it shall not contain substances meeting criteria for classification with the hazard statements or risk phrases specified below in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council(2)or Council Directive 67/548/EEC(3)nor shall it contain substances referred to in Article 57 of Regulation (EC) No 1907/2006. The risk phrases below generally refer to substances. However, if information on substances cannot be obtained, the classification rules for mixtures apply.

List of hazard statements:
Hazard statement(4) | Risk phrase(5)

H300 Fatal if swallowed | R28

H301 Toxic if swallowed | R25

H304 May be fatal if swallowed and enters airways | R65

H310 Fatal in contact with skin | R27

H311 Toxic in contact with skin | R24

H330 Fatal if inhaled | R23/26

H331 Toxic if inhaled | R23

H340 May cause genetic defects | R46

H341 Suspected of causing genetic defects | R68

H350 May cause cancer | R45

H350i May cause cancer by inhalation | R49

H351 Suspected of causing cancer | R40

H360F May damage fertility | R60

H360D May damage the unborn child | R61

H360FD May damage fertility. May damage the unborn child | R60/61/60-61

H360Fd May damage fertility. Suspected of damaging the unborn child | R60/63

H360Df May damage the unborn child. Suspected of damaging fertility | R61/62

H361f Suspected of damaging fertility | R62

H361d Suspected of damaging the unborn child | R63

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. | R62-63

H362 May cause harm to breast fed children | R64

H370 Causes damage to organs | R39/23/24/25/26/27/28

H371 May cause damage to organs | R68/20/21/22

H372 Causes damage to organs through prolonged or repeated exposure | R48/25/24/23

H373 May cause damage to organs through prolonged or repeated exposure | R48/20/21/22

H400 Very toxic to aquatic life | R50

H410 Very toxic to aquatic life with long-lasting effects | R50-53

H411 Toxic to aquatic life with long-lasting effects | R51-53

H412 Harmful to aquatic life with long-lasting effects | R52-53

H413 May cause long-lasting harmful effects to aquatic life | R53

EUH059 Hazardous to the ozone layer | R59

EUH029 Contact with water liberates toxic gas | R29

EUH031 Contact with acids liberates toxic gas | R31

EUH032 Contact with acids liberates very toxic gas | R32

EUH070 Toxic by eye contact | R39-41

Sensitising substances

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42

H317: May cause allergic skin reaction | R43Note that this criterion also applies to known degradation products such as formaldehyde from formaldehyde releasers.

Substances or mixtures which change their properties upon processing (e.g. become no longer bioavailable, undergo chemical modification) so that the identified hazard no longer applies are exempted from the above requirement.

The final product must not be labelled according to the hazard statements above.
Derogations

The following substances are specifically exempted from this requirement:
Surfactants< 20 % in the final product | H400 Very toxic to aquatic life | R50

Biocides for preservations purposes(*2)(only for liquids with pH between 2 and 12 and maximum 0,10 % w/w of active material) | H331: Toxic if inhaled | R23

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42

H317: May cause allergic skin reaction | R43

H400: Very toxic to aquatic life | R50

Enzymes(*3) | H400: Very toxic to aquatic life | R50

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42

H317: May cause allergic skin reaction | R43

Bleach catalysts(*3) | H400: Very toxic to aquatic life | R50

NTA as an impurity in MGDA and GLDA(*4) | H351: Suspected of causing cancer | R40Assessment and verification: the applicant shall demonstrate compliance with this criterion by providing a declaration on the non-classification of each ingoing substance into any of the hazard classes associated to the hazard statements referred to in the above list in accordance with Regulation (EC) No 1272/2008, as far as this can be determined, as a minimum, from the information meeting the requirements listed in Annex VII to Regulation (EC) No 1907/2006. This declaration shall be supported by summarised information on the relevant characteristics associated to the hazard statements referred to in the above list, to the level of detail specified in sections 10, 11 and 12 of Annex II to Regulation (EC) No 1907/2006 (Requirements for the Compilation of Safety Data Sheets).

Information on intrinsic properties of substances may be generated by means other than tests, for instance through the use of alternative methods such asin vitromethods, by quantitative structure activity models or by the use of grouping or read-across in accordance with Annex XI to Regulation (EC) No 1907/2006. The sharing of relevant data is strongly encouraged.

The information provided shall relate to the forms or physical states of the substance or mixtures as used in the final product.

For substances listed in Annexes IV and V to REACH, exempted from registration obligations under Article 2(7)(a) and (b) of Regulation (EC) No 1907/2006 REACH, a declaration to this effect will suffice to comply with the requirements set out above.

(c)   Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006No derogation from the exclusion in Article 6(6) of the Regulation (EC) No 66/2010 shall be given concerning substances identified as substances of very high concern and included in the list foreseen in Article 59 of Regulation (EC) No 1907/2006, present in mixtures in concentrations > 0,010 %.

Assessment and verification: the list of substances identified as substances of very high concern and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 can be found at: http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

Reference to the list shall be made on the date of application. The applicant shall provide the exact formulation of the product to the competent body. The applicant shall also provide a declaration of compliance with this criterion, together with related documentation, such as declarations of compliance signed by the material suppliers and copies of relevant Safety Data Sheets for substances or mixtures.

(d)   Specified limited ingoing substances — fragrancesThe product shall not contain perfumes containing nitro-musk or polycyclic musk

Any ingoing substance added to the product as a fragrance shall be manufactured and handled following the code of practice of the International Fragrance Association (IFRA). The code can be found on IFRA website: http://www.ifraorg.org. The recommendations of the IFRA Standards concerning prohibition, restricted use and specified purity criteria for materials shall be followed by the manufacturer.

Fragrance substances subject to the declaration requirement provided for in Regulation (EC) No 648/2004 of the European Parliament and of the Council(6)on detergents (Annex VII) and which are not already excluded by criterion 4(b) shall not be present in quantities ≥ 0,010 % (≥ 100 ppm) per substance in the final product.

Assessment and verification: the applicant shall provide a signed declaration of compliance indicating the amount of fragrances in the product. The applicant shall also provide a declaration from the fragrance manufacturer specifying the content of each of the substances in the fragrances which are listed in Annex III, Part I to Council Directive 76/768/EEC(7).

(e)   Biocides

 | (i) | The product may only include biocides in order to preserve the product, and in the appropriate dosage for this purpose alone. This does not refer to surfactants, which may also have biocidal properties.Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocides added, together with information on their exact concentration in the product. The manufacturer or supplier of the biocides shall provide information on the dosage necessary to preserve the product.

 | (ii) | It is prohibited to claim or suggest on the packaging or by any other communication that the product has an antimicrobial or disinfecting effect.Assessment and verification: the applicant shall provide the texts and layouts used on each type of packaging and/or an example of each different type of packaging to the competent body.

 | (iii) | The product may contain biocides provided that they are not bioaccumulating. A biocide is not considered bioaccumulating if BCF < 100 or logKow < 3,0. If both BCF and logKow values are available, the highest measured BCF value shall be used.Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocide added, together with information on their BCF and/or logKow values.(f)   EnzymesEnzymes must be in liquid form or dust-free granulate. Enzymes must be free from micro-organism remnants from manufacture.

Assessment and verification:the applicant shall provide copies of the material safety data sheets of any enzyme added, together with documentation to ensure that the enzyme is free from micro-organism remnants.
Criterion 5 —   Packaging requirements

(a)   Weight/utility ratio (WUR)The weight/utility ratio (WUR) of the product shall not exceed the following values:
Product type/water hardness | WUR (g/kg laundry)

Soft water | Medium water | Hard water

Powders | 1,5 | 2,0 | 2,5

Liquids | 2,0 | 2,5 | 3,0WUR shall be calculated only for primary packaging and a calculation shall be made for every product within a multi-component system (including caps, stoppers and hand pumps/spraying devices) using the formula below:
Where:
Wi | = | the weight (g) of the packaging component (i) including the label if applicable.

Ui | = | the weight (g) of non-recycled (virgin) material in the packaging component (i). If the proportion of recycled material in the packaging component is 0 % then Ui= Wi.

Di | = | the number of functional units contained in the packaging component (i). The functional unit = dosage in g/kg laundry. Note that the highest recommended dosage for each water hardness must be used in the WUR calculation.

ri | = | recycling figure, i.e. the number of times the packaging component (i) is used for the same purpose through a return or refill system. r = 1 if the packaging is not re-used for the same purpose. If the packaging is reused r is set to 1 unless the applicant can document a higher number.

Exceptions

Plastic/paper/cardboard packaging containing more than 80 % recycled material or more than 80 % plastic from renewable origin is exempted from this requirement.

Packaging is regarded as recycled if the raw material used to make the packaging has been collected from packaging manufacturers at the distribution stage or at the consumer stage. Where the raw material is industrial waste from the material manufacturer’s own production process, then the material will not be regarded as recycled.

Assessment and verification: the applicant shall provide the calculation of the WUR for every product. A spreadsheet for this calculation is available on the EU Ecolabel website. The applicant shall provide a completed and signed declaration for the content of recycled or material from renewable origin in the packaging. For approval of refill packaging, the applicant and/or retailer shall document that the refills will be/are available for purchase on the market.

(b)   Plastic packagingOnly phthalates that at the time of application have been risk assessed and have not been classified according to criterion 4(b) (and combinations hereof) may be used in the plastic packaging.

In order to allow for identification of different parts of the packaging for recycling, plastic parts in the primary packaging must be marked in accordance with DIN 6120, Part 2 or the equivalent. Caps and pumps are exempted from this requirement.

Assessment and verification: the applicant shall provide completed and signed declaration of compliance.
Criterion 6 —   Washing performance (fitness for use)

The primary laundering effects of the detergent such as dirt removal and stain removal capacity must be documented by the producer/applicant with the aid of artificially soiled test clothes which are washed in the process.

The test may be conducted by an external or internal laboratory fulfilling the requirements in Appendix II(a). The test must be conducted with the recommended dosage and at the corresponding water hardness and the degree of soiling at the lowest recommended wash temperature. The measurements must be performed on unlaundered and laundered test clothes. Evaluation of the test results shall be made by the laboratory and it shall be clearly stated in the report.

The measurements of secondary effects such as bleaching effect, bleaching/damage factor, ash content, greying and fluidity increase can for instance be made with multi wash test clothes and analysed according to standard ISO 4312.

Examples of what may be used as wash test clothes included the following:
— | WFK-PCMS-55 for industrial laundering processes, consisting of 13 different small dirt patches (WFK-Cleaning Technology Research Institute, Germany)

— | EMPA 102, consisting of 15 different fresh spots (Swiss EMPA-Testmaterials)

— | wash clothes of DTI (Danish Technology Institute) for industrial washing processes or equivalentAs an alternative to the above mentioned laboratory test, a user test may be used to document efficiency. The user test should then meet the requirements stated in Appendix II(b).

For both laboratory test and user test the following apply:

The test product must be tested against a reference product. The reference product may be a well-established product on the market or — in the case of a user test — the product normally used by the user. The test product must show efficiency equal to or better than the reference product.

Assessment and verification: the applicant shall provide a test report stating that the product fulfils the minimum requirements defined in the chosen test; also see Appendix II(a) and II(b) respectively.
Criterion 7 —   Automatic dosing systems

Multi-component systems shall be offered to the customer together with an automatic and controlled dosing system.

In order to ensure correct dosage in the automatic dosing systems, customer visits must be incorporated as a normal routine for manufacturers/suppliers. These customer visits are performed at all premises at least once a year during the license period; as a minimum they must include calibration of the dosage equipment. A third party can perform customer visits as well.

Assessment and verification: the applicant shall provide a written description of responsibility for, frequency and content of customer visits.
Criterion 8 —   User information — Information appearing on the EU Ecolabel

(a)   Information on the packaging/product information sheetThe following washing recommendations (or equivalent) must appear on the packaging, and/or on a product information sheet. The washing recommendations must include examples of the classification of the textiles soiling degree and shall include the following text:
— | Wash at the lowest recommended temperature

— | Always wash with the highest possible load, the textiles allow

— | Dose according to the dosing instructions and use the dosage according to water hardness and degree of soiling

— | Using this EU Ecolabelled product according to the dosage instructions will contribute to the reduction of water pollution, waste production and energy consumption.(b)   Claims on the packagingIn general, claims on the packaging shall be documented through performance testing (e.g. claims of efficiency at low temperatures, claims of removal of certain stain types, claims of benefits for certain types or colours of textile or other claims of specific properties/benefits of the product).
— | E.g. if a product claims efficiency at 20 °C, the performance test must be performed at ≤ 20 °C (and correspondingly for other temperature claims below 40 °C).

— | E.g. if a product claims to be efficient on certain stain types, this must be documented with performance test.(c)   Information appearing on the EU EcolabelThe logo should be visible and legible. The use of the EU Ecolabel logo is protected in primary EU law. The EU Ecolabel registration/license number must appear on the product, it must be legible and clearly visible.

The optional label with text box shall contain the following text:
— | Reduced impact on aquatic ecosystems

— | Limited hazardous substances

— | Performance tested.The guidelines for the use of the optional label with text box can be found in the ‘Guidelines for use of the Ecolabel logo’ on the website: http://ec.europa.eu/environment/ecolabel/documents/logo_guidelines.pdf

Assessment and verification (a-c): the applicant shall provide a sample of the product label and/or product sheet, together with a declaration of compliance with this criterion. Product claims shall be documented through appropriate test reports.
(*1)  DID No is the number of the ingoing substance on the DID list (‘Detergent Ingredient Database’ list), and is used in determining compliance with criteria 2 and 3. See Appendix I.

(1)  

            OJ L 396, 30.12.2006, p. 1.

(2)  

            OJ L 353, 31.12.2008, p. 1.

(3)  

            OJ 196, 16.8.1967, p. 1.

(4)  Regulation (EC) No 1272/2008.

(5)  Directive 67/548/EEC with adjustment to REACH according to Directive 2006/121/EC and Directive 1999/45/EC as amended.

(*2)  Derogation is only for criterion 4(b). Biocides shall comply with criterion 4(e).

(*3)  Including stabilisers and other auxiliary substances in the preparations.

(*4)  In concentrations lower than 1,0 % in the raw material as long as the total concentration in the final product is lower than 0,10 %.

(6)  

            OJ L 104, 8.4.2004, p. 1.

(7)  

            OJ L 262, 27.9.1976, p. 169.
Detergents Ingredients Database (DID) listAppendix IThe DID list (part A) is a list containing information of the aquatic toxicity and biodegradability of ingoing substances typically used in detergent formulations. The list includes information on the toxicity and biodegradability of a range of substances used in washing and cleaning products. The list is not comprehensive, but guidance is given in part B of the DID list concerning the determination of the relevant calculation parameters for substances not present on the DID list (e.g. the Toxicity Factor (TF) and degradation factor (DF), which are used for calculation of the critical dilution volume). The list is a generic source of information and substances present on the DID list are not automatically approved for use in EU Ecolabelled products. The DID list (part A and B) can be found on the EU Ecolabel website.

For substances with no data regarding aquatic toxicity and degradability, structure analogies with similar substances may be used to assess the TF and DF. Such structure analogies shall be approved by the competent body granting the EU Ecolabel license. Alternatively, a worst case approach shall be applied, using the parameters below:

Worst case approach:
 | Acute toxicity | Chronic toxicity | Degradation

Ingoing substance | LC50/EC50 | SF(acute) | TF(acute) | NOEC(*1) | SF(chronic)(*1) | TF(chronic) | DF | Aerobic | Anaerobic

‘Name’ | 1  mg/l | 10 000 | 0,0001 |  |  | 0,0001 | 1 | P | N

Documentation of ready biodegradability

The following test methods for ready biodegradability shall be used:
(1) | Until 1 December 2010 and during transition period from 1 December 2010 to 1 December 2015:The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents). |  | The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests. |  | The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

 | The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

 | The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

(2) | After 1 December 2015 and during transition period from 1 December 2010 to 1 December 2015:The test methods provided for in Regulation (EC) No 1272/2008.

Documentation of anaerobic biodegradability

The reference test for anaerobic degradability shall be EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent test method, with the requirement of 60 % ultimate degradability under anaerobic conditions. Test methods simulating the conditions in a relevant anaerobic environment may also be used to document that 60 % ultimate degradability has been attained under anaerobic conditions.
Extrapolation for substances not listed in the DID-list

Where the ingoing substances are not listed in the DID-list the following approach may be used to provide the necessary documentation of anaerobic biodegradability:
(1) | Apply reasonable extrapolation. Use test results obtained with one raw material to extrapolate the ultimate anaerobic degradability of structurally related surfactants. Where anaerobic biodegradability has been confirmed for a surfactant (or a group of homologues) according to the DID-list, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. C12-15 A 1-3 EO sulphate [DID No 8] is anaerobically biodegradable, and a similar anaerobic biodegradability may also be assumed for C12-15 A 6 EO sulphate). Where anaerobic biodegradability has been confirmed for a surfactant by use of an appropriate test method, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. literature data confirming the anaerobic biodegradability of surfactants belonging to the group alkyl ester ammonium salts may be used as documentation for a similar anaerobic biodegradability of other quaternary ammonium salts containing ester-linkages in the alkyl chain(s)).

(2) | Perform screening test for anaerobic degradability. If new testing is necessary, perform a screening test by use of EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent method.

(3) | Perform low-dosage degradability test. If new testing is necessary, and in the case of experimental problems in the screening test (e.g. inhibition due to toxicity of test substance), repeat testing by using a low dosage of surfactant and monitor degradation by14C measurements or chemical analyses. Testing at low dosages may be performed by use of OECD 308 (August 2000) or an equivalent method.

(*1)  If no acceptable chronic toxicity data are found, these columns are empty. In that case TF(chronic) is defined as equal to TF(acute).
(a)   Laboratory testAppendix IIThe analysis laboratory must meet the general requirements pursuant to standard EN ISO 17025 or be an officially GLP-approved analysis laboratory.

The applicant’s analysis laboratory/measurement may be approved to conduct analyses and measurements if:
— | the authorities monitor the sampling and analysis process, or

— | the manufacturer has a quality system incorporating testing and analyses and which is certified in accordance with ISO 9001, or

— | the manufacturer can show that there is conformity between a first-time test conducted as a parallel test between an impartial test institution and the manufacturer’s own laboratory and that the manufacturer takes samples in accordance with a prescribed sampling plan.The manufacturer’s test laboratory can be approved to conduct testing to document effectiveness if the following additional requirements are met.
— | It must be possible for ecolabelling organisations to monitor the performance of testing

— | The ecolabelling organisation must have access to all data on the product

— | The samples must be made anonymous for the test laboratory

— | Performance of the effectiveness test must be described in the quality control system.(b)   User test

 | 1. | Responses must be obtained from at least five test centres representing a selection of customers.

 | 2. | The procedure and dosage must conform to the manufacturer’s recommendations.

 | 3. | The test period must continue for at least four weeks.

 | 4. | Every test centre must assess the serviceability of the product or multi-component system, dosability, compressibility, rinsing and solubility.

 | 5. | Every test centre must assess the effectiveness of the product or multi-component system by answering questions relating to the following aspects (or similar formulations):(a)ability to launder lightly, moderately or heavily soiled articles to be washed;(b)an assessment of primary laundering effects such as dirt removal, stain removal capacity and bleaching effect must be rated;(c)assessment of secondary laundering effects such as greying of white washing and colour-fastness and staining of coloured washing;(d)assessment of the effect of the rinsing agent on drying, ironing or mangling of the articles to be washed;(e)how satisfied the test subject is with customer visiting arrangements. | (a) | ability to launder lightly, moderately or heavily soiled articles to be washed; | (b) | an assessment of primary laundering effects such as dirt removal, stain removal capacity and bleaching effect must be rated; | (c) | assessment of secondary laundering effects such as greying of white washing and colour-fastness and staining of coloured washing; | (d) | assessment of the effect of the rinsing agent on drying, ironing or mangling of the articles to be washed; | (e) | how satisfied the test subject is with customer visiting arrangements.

(a) | ability to launder lightly, moderately or heavily soiled articles to be washed;

(b) | an assessment of primary laundering effects such as dirt removal, stain removal capacity and bleaching effect must be rated;

(c) | assessment of secondary laundering effects such as greying of white washing and colour-fastness and staining of coloured washing;

(d) | assessment of the effect of the rinsing agent on drying, ironing or mangling of the articles to be washed;

(e) | how satisfied the test subject is with customer visiting arrangements.

 | 6. | The response must be rated on a scale comprising at least three levels, for example, ‘insufficiently effective’, ‘sufficiently effective’ or ‘very effective’. With regard to how satisfied the test centre is with visit reporting arrangements, the categories must be ‘not satisfied’, ‘satisfied’ and ‘very satisfied’.

 | 7. | At least five test centres must submit responses. At least 80 % must rate the product as sufficiently effective or very effective on all points (see point 4 and be satisfied or very satisfied with customer visiting arrangements.

 | 8. | All raw data from the test must be specified.

 | 9. | The test procedure must be described in detail.

Pending: 32012D0720

                                January 16, 2026                            

24.11.2012
EN
Official Journal of the European Union
L 326/25

(1)
Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2)
Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3)
The new criteria, as well as the related assessment and verification requirements, should be valid for four years from the date of adoption of this Decision.

(4)
The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

1.
Toxicity to aquatic organisms: Critical Dilution Volume (CDV)

2.
Biodegradability

3.
Excluded or limited substances and mixtures

4.
Packaging requirements

5.
Washing performance (fitness for use)

6.
Automatic dosing systems

7.
User information — Information appearing on the EU Ecolabel

The full formulation indicating trade name, chemical name, CAS No, DID No(*1), the ingoing quantity including and excluding water, the function and the form of all the ingoing substances (regardless of concentration) in the product must be submitted to the competent body. A sample of the artwork including dosage recommendations must be submitted to the competent body.

Safety data sheets for each ingoing substance shall be submitted to the competent body in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council(1).

http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_a_en.pdf

http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_b_en.pdf

CDV at the highest recommended dosage
Soft
Medium
Hard

Product type
0-6 °dH
7-13 °dH
> 14 °dH

Pre-soaks
2 000
2 000
2 000

Dishwasher detergents
3 000
5 000
10 000

Multi-component system
3 000
4 000
7 000

Rinse aids
3 000
3 000
3 000

weight
=
the weight of the ingoing substance per recommended dose

DF
=
the degradation factor

TF
=
the chronic toxicity factor of the substance as stated in the DID list.

—
Hydrogen Peroxide (H2O2) — not to be included in calculation of CDV,

—
Peracetic acid — to be included in the calculation as acetic acid.

Product type(g/l washing solution)
Soft
Medium
Hard

0-6 °dH
7-13 °dH
> 14 °dH

Pre-soaks
0,4
0,4
0,4

Dishwasher detergents/Multi-component system
0,4
0,4
0,4

Rinse aids
0,04
0,04
0,04

Product type(g/l washing solution)
Soft
Medium
Hard

0-6 °dH
7-13 °dH
> 14 °dH

Pre-soaks
0,4
0,4
0,4

Dishwasher detergents/Multi-component system
0,6
1,0
1,5

Rinse aids
0,04
0,04
0,04

1.
Readily degradable and has low adsorption (A < 25 %); or

2.
Readily degradable and has high desorption (D > 75 %); or

3.
Readily degradable and non-bioaccumulating.

—
EDTA (ethylenediamine tetraacetate),

—
Fragrances,

—
Reactive chlorine compounds,

—
APEO (Alkyl phenol ethoxylates) and APD (Alkylphenols and derivatives thereof).

Hazard Statement(4)
Risk Phrase(5)

H300 Fatal if swallowed
R28

H301 Toxic if swallowed
R25

H304 May be fatal if swallowed and enters airways
R65

H310 Fatal in contact with skin
R27

H311 Toxic in contact with skin
R24

H330 Fatal if inhaled
R23/26

H331 Toxic if inhaled
R23

H340 May cause genetic defects
R46

H341 Suspected of causing genetic defects
R68

H350 May cause cancer
R45

H350i May cause cancer by inhalation
R49

H351 Suspected of causing cancer
R40

H360F May damage fertility
R60

H360D May damage the unborn child
R61

H360FD May damage fertility. May damage the unborn child
R60/61/60-61

H360Fd May damage fertility. Suspected of damaging the unborn child
R60/63

H360Df May damage the unborn child. Suspected of damaging fertility
R61/62

H361f Suspected of damaging fertility
R62

H361d Suspected of damaging the unborn child
R63

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child
R62-63

H362 May cause harm to breast fed children
R64

H370 Causes damage to organs
R39/23/24/25/26/27/28

H371 May cause damage to organs
R68/20/21/22

H372 Causes damage to organs through prolonged or repeated exposure
R48/25/24/23

H373 May cause damage to organs through prolonged or repeated exposure
R48/20/21/22

H400 Very toxic to aquatic life
R50

H410 Very toxic to aquatic life with long-lasting effects
R50-53

H411 Toxic to aquatic life with long-lasting effects
R51-53

H412 Harmful to aquatic life with long-lasting effects
R52-53

H413 May cause long-lasting harmful effects to aquatic life
R53

EUH059 Hazardous to the ozone layer
R59

EUH029 Contact with water liberates toxic gas
R29

EUH031 Contact with acids liberates toxic gas
R31

EUH032 Contact with acids liberates very toxic gas
R32

EUH070 Toxic by eye contact
R39-41

Sensitising substances

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
R42

H317: May cause allergic skin reaction
R43

Surfactants< 15 % in the final product
H400: Very toxic to aquatic life
R50

Biocides for preservation purpose(*2)(only for liquids with pH between 2 and 12 and maximum 0,10 % w/w of active material)
H331: Toxic if inhaled
R23

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
R42

H317: May cause allergic skin reaction
R43

H400: Very toxic to aquatic life
R50

Enzymes(*3)
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled
R42

H317: May cause allergic skin reaction
R43

H400: Very toxic to aquatic life
R50

NTA as in impurity in MGDA and GLDA(*4)
H351: Suspected of causing cancer
R40

(i)
The product may only include biocides in order to preserve the product, and in the appropriate dosage for this purpose alone. This does not refer to surfactants, which may also have biocidal properties.Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocides added, together with information on their exact concentration in the product. The manufacturer or supplier of the biocides shall provide information on the dosage necessary to preserve the product.

(ii)
It is prohibited to claim or suggest on the packaging or by any other communication that the product has an antimicrobial or disinfecting effect.Assessment and verification: the applicant shall provide the texts and layouts used on each type of packaging and/or an example of each different type of packaging to the competent body.

(iii)
The product may contain biocides provided that they are not bioaccumulating. A biocide is not considered bioaccumulating if BCF < 100 or logKow < 3,0. If both BCF and logKow values are available, the highest measured BCF value shall be used.Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocide added, together with information on their BCF and/or logKow values.

Product typePhosphorous (g P/l water)
Soft
Medium
Hard

0-6 °dH
7-13 °dH
> 14 °dH

Pre-soaks
0,08
0,08
0,08

Detergents
0,15
0,30
0,50

Rinse aids
0,02
0,02
0,02

Multi-component systems
0,17
0,32
0,52

Product type
WUR

0-6 °dH
7-13 °dH
> 14 °dH

Powders [g/l washing solution]
0,8
1,4
2,0

Liquids [g/l washing solution]
1,0
1,8
2,5

Wi
=
the weight (g) of the packaging component (i) including the label if applicable.

Ui
=
the weight (g) of non-recycled (virgin) material in the packaging component (i). If the proportion of recycled material in the packaging component is 0 % then Ui= Wi.

Di
=
the number of functional units contained in the packaging component (i). The functional unit = dosage in g/l washing solution.

ri
=
recycling figure, i.e. the number of times the packaging component (i) is used for the same purpose through a return or refill system. r = 1, if the packaging is not reused for the same purpose. If the packaging is reused r is set to 1 unless the applicant can document a higher number.

—
Dose according to the degree of soil, and the water hardness. Follow the dosing instructions.

—
Using this EU Ecolabelled product according to the dosage instructions will contribute to the reduction of water pollution and waste production.

—
reduced impact on aquatic ecosystems,

—
limited hazardous substances,

—
performance tested.

Acute toxicity
Chronic toxicity
Degradation

Ingoing substance
LC50/EC50
SF(acute)
TF(acute)
NOEC(*1)
SF(chronic)(*1)
TF(chronic)
DF
Aerobic
Anaerobic

‘Name’
1  mg/l
10 000
0,0001

0,0001
1
P
N

(1)
Until 1 December 2010 and during transition period from 1 December 2010 to 1 December 2015:The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

(2)
After 1 December 2015 and during transition period from 1 December 2010 to 1 December 2015:The test methods provided for in Regulation (EC) No 1272/2008.

(1)
Apply reasonable extrapolation. Use test results obtained with one raw material to extrapolate the ultimate anaerobic degradability of structurally related surfactants. Where anaerobic biodegradability has been confirmed for a surfactant (or a group of homologues) according to the DID-list, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. C12-15 A 1-3 EO sulphate [DID No 8] is anaerobically biodegradable, and a similar anaerobic biodegradability may also be assumed for C12-15 A 6 EO sulphate). Where anaerobic biodegradability has been confirmed for a surfactant by use of an appropriate test method, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. literature data confirming the anaerobic biodegradability of surfactants belonging to the group alkyl ester ammonium salts may be used as documentation for a similar anaerobic biodegradability of other quaternary ammonium salts containing ester-linkages in the alkyl chain(s)).

(2)
Perform screening test for anaerobic degradability. If new testing is necessary, perform a screening test by use of EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent method.

(3)
Perform low-dosage degradability test. If new testing is necessary, and in the case of experimental problems in the screening test (e.g. inhibition due to toxicity of test substance), repeat testing by using a low dosage of surfactant and monitor degradation by14C measurements or chemical analyses. Testing at low dosages may be performed by use of OECD 308 (August 2000) or an equivalent method.

—
it must be possible for ecolabelling organisations to monitor the performance of testing,

—
the ecolabelling organisation must have access to all data on the product,

—
performance of the effectiveness test must be described in the quality control system.

(a)
Dishes soiled with spots that are representative for the kind of soiled expected in the areas where the products will be marketed.

(b)
Recommended dosage and at the corresponding water hardness at the lowest recommended wash temperature

—
the product’s ability to remove soiling from the dishes,

—
the product’s ability to dry the dishes.

1.
Responses must be obtained from at least five test centres representing a random selection of customers.

2.
The procedure and dosage must conform to the manufacturer’s recommendations.

3.
The test period must continue for at least four weeks with at least 400 test cycles.

4.
Every test centre must assess the effectiveness of the product or multi-component system by answering questions relating to the following aspects (or similar formulations):—the product’s ability to remove soiling from the dishes,—the product’s ability to dry the dishes,—the respondent’s satisfaction with the agreement on customer visits.
—
the product’s ability to remove soiling from the dishes,
—
the product’s ability to dry the dishes,
—
the respondent’s satisfaction with the agreement on customer visits.

—
the product’s ability to remove soiling from the dishes,

—
the product’s ability to dry the dishes,

—
the respondent’s satisfaction with the agreement on customer visits.

—
the product’s ability to remove soiling from the dishes,

—
the product’s ability to dry the dishes,

—
the respondent’s satisfaction with the agreement on customer visits.

5.
The response must be rated on a scale comprising at least three levels, for example, ‘insufficiently effective’, ‘sufficiently effective’ or ‘very effective’. With regard to how satisfied the test centre is with visit reporting arrangements, the categories must be ‘not satisfied’, ‘satisfied’ and ‘very satisfied’.

6.
At least 80 % must rate the product as sufficiently effective or very effective on all points (see point 4) and be satisfied or very satisfied with customer visiting arrangements.

7.
All raw data from the test must be specified.

8.
The test procedure must be described in detail.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,

After consulting the European Union Eco-labelling Board,

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3) The new criteria, as well as the related assessment and verification requirements, should be valid for four years from the date of adoption of this Decision.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:
Article 1

The product group ‘Industrial and Institutional Automatic Dishwasher Detergents’ shall comprise single and multi-component dishwasher detergents, rinse and pre-soaks, designed for use in professional dishwashers.

The following products are excluded from the scope of this product group: consumer automatic dishwasher detergents, detergents intended to be used in washers of medical devices or in special machines for cleaning industrial equipment, including in special machines for the food industry.

Sprays not dosed via automatic pumps are excluded from this product group.
Article 2

In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of automatic dishwasher detergent shall fall within the product group ‘Industrial and Institutional Automatic Dishwasher Detergents’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.
Article 3

The criteria for the product group ‘Industrial and Institutional Automatic Dishwasher Detergents’, as well as the related assessment and verification requirements, shall be valid for four years from the date of adoption of this Decision.
Article 4

For administrative purposes the code number assigned to the product group ‘Industrial and Institutional Automatic Dishwasher Detergents’ shall be ‘038’.
Article 5

This Decision is addressed to the Member States.
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,

After consulting the European Union Eco-labelling Board,

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3) The new criteria, as well as the related assessment and verification requirements, should be valid for four years from the date of adoption of this Decision.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:
The product group ‘Industrial and Institutional Automatic Dishwasher Detergents’ shall comprise single and multi-component dishwasher detergents, rinse and pre-soaks, designed for use in professional dishwashers.

The following products are excluded from the scope of this product group: consumer automatic dishwasher detergents, detergents intended to be used in washers of medical devices or in special machines for cleaning industrial equipment, including in special machines for the food industry.

Sprays not dosed via automatic pumps are excluded from this product group.
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of automatic dishwasher detergent shall fall within the product group ‘Industrial and Institutional Automatic Dishwasher Detergents’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.
The criteria for the product group ‘Industrial and Institutional Automatic Dishwasher Detergents’, as well as the related assessment and verification requirements, shall be valid for four years from the date of adoption of this Decision.
For administrative purposes the code number assigned to the product group ‘Industrial and Institutional Automatic Dishwasher Detergents’ shall be ‘038’.
This Decision is addressed to the Member States.
FRAMEWORKANNEX

The aims of the criteria

The criteria aim, in particular, at promoting products that have a reduced impact on aquatic ecosystems, contain a limited amount of hazardous substances and whose performance has been tested.
CRITERIA

Criteria are set for each of the following aspects:
1. | Toxicity to aquatic organisms: Critical Dilution Volume (CDV)

2. | Biodegradability

3. | Excluded or limited substances and mixtures

4. | Packaging requirements

5. | Washing performance (fitness for use)

6. | Automatic dosing systems

7. | User information — Information appearing on the EU Ecolabel(1)   Assessment and verification

(a)   RequirementsThe specific assessment and verification requirements are indicated within each criterion.

Where the applicant is required to provide declarations, documentation, analyses test reports or other evidence to show compliance with the criteria, it is understood that these may originate from the applicant and/or his supplier(s) and/or their supplier(s) etc., as appropriate.

Where possible, the testing should be performed by laboratories that meet the general requirements of EN ISO 17025 or equivalent.

Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.

Appendix I makes reference to the detergent ingredient database (DID list) which contains the most widely used ingoing substances used in detergent formulations. It shall be used for deriving the data for the calculations of the Critical Dilution Volume (CDV) and for the assessment of the biodegradability of the ingoing substances. For substances not present on the DID list, guidance is given on how to calculate or extrapolate the relevant data. The latest version of the DID list is available from the EU Ecolabel website or via the websites of the individual competent bodies.

Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.

(b)   Measurement thresholdsCompliance with the ecological criteria is required for substances intentionally added, as well as for by-products and impurities from raw materials, the concentration of which equals or exceeds 0,010 % by weight of final formulation.

For biocides and colouring agents compliance with the criteria is required regardless of their concentration.

Substances meeting the threshold limit as listed above are hereby referred to as ‘Ingoing substances’.

(2)   Functional unit

The functional unit for this product group shall be expressed in g/l washing solution (grams per litre washing solution).

Requirements relating to assessment and verification of the functional unit:
 | The full formulation indicating trade name, chemical name, CAS No, DID No(*1), the ingoing quantity including and excluding water, the function and the form of all the ingoing substances (regardless of concentration) in the product must be submitted to the competent body. A sample of the artwork including dosage recommendations must be submitted to the competent body.

 | Safety data sheets for each ingoing substance shall be submitted to the competent body in accordance with Regulation (EC) No 1907/2006 of the European Parliament and of the Council(1).Parts A and B of the DID list can be found on the EU Ecolabel website:
 | http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_a_en.pdf

 | http://ec.europa.eu/environment/ecolabel/documents/did_list/didlist_part_b_en.pdf

EU ECOLABEL CRITERIA
Criterion 1 —   Toxicity to aquatic organisms: Critical Dilution Volume (CDV) The Critical Dilution Volume (CDVchronic) of a single or multi-component system must not exceed the following limits (at the highest recommended dose):
CDV at the highest recommended dosage | Soft | Medium | Hard

Product type | 0-6 °dH | 7-13 °dH | > 14 °dH

Pre-soaks | 2 000 | 2 000 | 2 000

Dishwasher detergents | 3 000 | 5 000 | 10 000

Multi-component system | 3 000 | 4 000 | 7 000

Rinse aids | 3 000 | 3 000 | 3 000The Critical Dilution Volume (CDVchronic) is calculated for all ingoing substances (i) in the product using the following equation:
Where:
weight | = | the weight of the ingoing substance per recommended dose

DF | = | the degradation factor

TF | = | the chronic toxicity factor of the substance as stated in the DID list.Biocides and colouring agents present in the product shall also be included in the CDV calculation even if the concentration is lower than 0,010 % (100 ppm).

Because of the degradation of the substances in the wash process, separate rules apply to the following substances:
— | Hydrogen Peroxide (H2O2) — not to be included in calculation of CDV,

— | Peracetic acid — to be included in the calculation as acetic acid.Assessment and verification: the applicant shall provide the calculation of the CDVchronicof the product. A spreadsheet for calculation of the CDV value is available on the EU Ecolabel website.

The values of the DF and TF parameters shall be as given in the Detergent Ingredient Database list (DID list). If the substance is not found on the DID list, the parameters shall be calculated using the guidelines in Part B of the DID list and attaching the associated documentation.
Criterion 2 —   Biodegradability

(a)   Biodegradability of surfactantsAll surfactants must be biodegradable under aerobic and anaerobic conditions.

(b)   Biodegradability of organic substancesThe content of all organic substances in the product that are aerobically non-biodegradable (not readily biodegradable) (aNBO) and anaerobically non-biodegradable (anNBO) shall not exceed the following limits:
aNBO
Product type(g/l washing solution) | Soft | Medium | Hard

0-6 °dH | 7-13 °dH | > 14 °dH

Pre-soaks | 0,4 | 0,4 | 0,4

Dishwasher detergents/Multi-component system | 0,4 | 0,4 | 0,4

Rinse aids | 0,04 | 0,04 | 0,04
anNBO
Product type(g/l washing solution) | Soft | Medium | Hard

0-6 °dH | 7-13 °dH | > 14 °dH

Pre-soaks | 0,4 | 0,4 | 0,4

Dishwasher detergents/Multi-component system | 0,6 | 1,0 | 1,5

Rinse aids | 0,04 | 0,04 | 0,04Assessment and verification: the applicant shall provide documentation for the degradability of surfactants as well as the calculation of aNBO and anNBO for the product. A spreadsheet for use in calculating aNBO and anNBO values is available on the EU Ecolabel website.

For both surfactants and aNBO and anNBO values reference should be done to the DID List. For ingoing substances which are not included in the DID list, the relevant information from literature or other sources, or appropriate test results, showing that they are aerobically and anaerobically biodegradable shall be provided as described in Appendix I.

Note that TAED should be considered anaerobically biodegradable.

In the absence of documentation in accordance with the above requirements, a substance other than a surfactant may be exempted from the requirement for anaerobic degradability if one of the following three alternatives is fulfilled:
1. | Readily degradable and has low adsorption (A < 25 %); or

2. | Readily degradable and has high desorption (D > 75 %); or

3. | Readily degradable and non-bioaccumulating.Testing for adsorption/desorption may be conducted in accordance with OECD guidelines 106.
Criterion 3 —   Excluded or limited substances and mixtures

(a)   Specified excluded ingoing substancesThe following ingoing substances must not be included in the product, neither as part of the formulation nor as part of any mixture included in the formulation:
— | EDTA (ethylenediamine tetraacetate),

— | Fragrances,

— | Reactive chlorine compounds,

— | APEO (Alkyl phenol ethoxylates) and APD (Alkylphenols and derivatives thereof).Assessment and verification: the applicant shall provide a completed and signed declaration of compliance.

(b)   Hazardous substances and mixturesAccording to the Article 6(6) of Regulation (EC) No 66/2010 on the EU Ecolabel, the product or any component of it shall not contain substances meeting criteria for classification with the hazard statements or risk phrases specified below in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council(2)or Council Directive 67/548/EEC(3)nor shall it contain substances referred to in Article 57 of Regulation (EC) No 1907/2006. The risk phrases below generally refer to substances. However, if information on substances cannot be obtained, the classification rules for mixtures apply.

List of hazard statements:
Hazard Statement(4) | Risk Phrase(5)

H300 Fatal if swallowed | R28

H301 Toxic if swallowed | R25

H304 May be fatal if swallowed and enters airways | R65

H310 Fatal in contact with skin | R27

H311 Toxic in contact with skin | R24

H330 Fatal if inhaled | R23/26

H331 Toxic if inhaled | R23

H340 May cause genetic defects | R46

H341 Suspected of causing genetic defects | R68

H350 May cause cancer | R45

H350i May cause cancer by inhalation | R49

H351 Suspected of causing cancer | R40

H360F May damage fertility | R60

H360D May damage the unborn child | R61

H360FD May damage fertility. May damage the unborn child | R60/61/60-61

H360Fd May damage fertility. Suspected of damaging the unborn child | R60/63

H360Df May damage the unborn child. Suspected of damaging fertility | R61/62

H361f Suspected of damaging fertility | R62

H361d Suspected of damaging the unborn child | R63

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child | R62-63

H362 May cause harm to breast fed children | R64

H370 Causes damage to organs | R39/23/24/25/26/27/28

H371 May cause damage to organs | R68/20/21/22

H372 Causes damage to organs through prolonged or repeated exposure | R48/25/24/23

H373 May cause damage to organs through prolonged or repeated exposure | R48/20/21/22

H400 Very toxic to aquatic life | R50

H410 Very toxic to aquatic life with long-lasting effects | R50-53

H411 Toxic to aquatic life with long-lasting effects | R51-53

H412 Harmful to aquatic life with long-lasting effects | R52-53

H413 May cause long-lasting harmful effects to aquatic life | R53

EUH059 Hazardous to the ozone layer | R59

EUH029 Contact with water liberates toxic gas | R29

EUH031 Contact with acids liberates toxic gas | R31

EUH032 Contact with acids liberates very toxic gas | R32

EUH070 Toxic by eye contact | R39-41

Sensitising substances

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42

H317: May cause allergic skin reaction | R43Note that this criterion also applies to known degradation products such as formaldehyde from formaldehyde releasers.

Substances or mixtures which change their properties through processing (e.g. become no longer bioavailable, or undergo chemical modification in a way that removes the previously identified hazard) are exempted from the above requirement.

The final product must not be labelled according to the hazard statements above.
Derogations

The following substances are specifically exempted from this requirement:
Surfactants< 15 % in the final product | H400: Very toxic to aquatic life | R50

Biocides for preservation purpose(*2)(only for liquids with pH between 2 and 12 and maximum 0,10 % w/w of active material) | H331: Toxic if inhaled | R23

H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42

H317: May cause allergic skin reaction | R43

H400: Very toxic to aquatic life | R50

Enzymes(*3) | H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42

H317: May cause allergic skin reaction | R43

H400: Very toxic to aquatic life | R50

NTA as in impurity in MGDA and GLDA(*4) | H351: Suspected of causing cancer | R40Assessment and verification: the applicant shall demonstrate compliance with this criterion by providing a declaration on the non-classification of each ingoing substance into any of the hazard classes associated to the hazard statements referred to in the above list in accordance with Regulation (EC) No 1272/2008, as far as this can be determined, as a minimum, from the information meeting the requirements listed in Annex VII to Regulation (EC) No 1907/2006. This declaration shall be supported by summarised information on the relevant characteristics associated to the hazard statements referred to in the above list, to the level of detail specified in Sections 10, 11 and 12 of Annex II to Regulation (EC) No 1907/2006 (Requirements for the Compilation of Safety Data Sheets).

Information on intrinsic properties of substances may be generated by means other than tests, for instance through the use of alternative methods such asin vitromethods, by quantitative structure activity models or by the use of grouping or read-across in accordance with Annex XI to Regulation (EC) No 1907/2006. The sharing of relevant data is strongly encouraged.

The information provided shall relate to the forms or physical states of the substance or mixtures as used in the final product.

For substances listed in Annexes IV and V to REACH, exempted from registration obligations under Article 2(7)(a) and (b) of Regulation (EC) No 1907/2006 REACH, a declaration to this effect will suffice to comply with the requirements set out above.

(c)   Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006No derogation from the exclusion in Article 6(6) of the Regulation (EC) No 66/2010 shall be given concerning substances identified as substances of very high concern and included in the list foreseen in Article 59 of Regulation (EC) No 1907/2006, present in mixtures in concentrations > 0,010 %.

Assessment and verification: the list of substances identified as substances of very high concern and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 can be found here: http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

Reference to the list shall be made on the date of application. The applicant shall provide the exact formulation of the product to the competent body. The applicant shall also provide a declaration of compliance with this criterion, together with related documentation, such as declarations of compliance signed by the material suppliers and copies of relevant Safety Data Sheets for substances or mixtures.

(d)   Specified limited ingoing substances — Biocides

(i) | The product may only include biocides in order to preserve the product, and in the appropriate dosage for this purpose alone. This does not refer to surfactants, which may also have biocidal properties.Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocides added, together with information on their exact concentration in the product. The manufacturer or supplier of the biocides shall provide information on the dosage necessary to preserve the product.

(ii) | It is prohibited to claim or suggest on the packaging or by any other communication that the product has an antimicrobial or disinfecting effect.Assessment and verification: the applicant shall provide the texts and layouts used on each type of packaging and/or an example of each different type of packaging to the competent body.

(iii) | The product may contain biocides provided that they are not bioaccumulating. A biocide is not considered bioaccumulating if BCF < 100 or logKow < 3,0. If both BCF and logKow values are available, the highest measured BCF value shall be used.Assessment and verification: the applicant shall provide copies of the material safety data sheets of any biocide added, together with information on their BCF and/or logKow values.(e)   Colouring agentsColouring agents allowed in the product must not be bioaccumulating. In the case of colouring agents approved for use in foodstuffs it is not necessary to submit documentation of bioaccumulation potential. A colouring agent is considered not bioaccumulating if BCF < 100 or logKow < 3,0. If both BCF and logKow values are available, the highest measured BCF value shall be used.

Assessment and verification: the applicant shall provide copies of the material safety data sheets of any colouring agents added, or documentation to ensure that the colouring agent is approved for use in foodstuff.

(f)   EnzymesEnzymes must be in liquid form or dust-free granulate. Enzymes must be free from micro-organism remnants from manufacture.

Assessment and verification: the applicant shall provide copies of the material safety data sheets of any enzyme added, together with documentation to ensure that the enzyme is free from micro-organism remnants.

(g)   PhosphorousThe total quantity of phosphates and other phosphorous compounds must not exceed the limit values specified in table, calculated in grams of phosphorous per litre water.

The highest recommended dosage shall be used for the phosphorous calculations.
Product typePhosphorous (g P/l water) | Soft | Medium | Hard

0-6 °dH | 7-13 °dH | > 14 °dH

Pre-soaks | 0,08 | 0,08 | 0,08

Detergents | 0,15 | 0,30 | 0,50

Rinse aids | 0,02 | 0,02 | 0,02

Multi-component systems | 0,17 | 0,32 | 0,52Assessment and verification: the applicant shall provide documentation to ensure that the limit in the above table is fulfilled.
Criterion 4 —   Packaging requirements

(a)   Weight/utility ratio (WUR)The weight/utility ratio (WUR) of the product shall not exceed the following values:
Product type | WUR

0-6 °dH | 7-13 °dH | > 14 °dH

Powders [g/l washing solution] | 0,8 | 1,4 | 2,0

Liquids [g/l washing solution] | 1,0 | 1,8 | 2,5WUR shall be calculated only for primary packaging (including caps, stoppers and hand pumps/spraying devices) using the formula below:
Where:
Wi | = | the weight (g) of the packaging component (i) including the label if applicable.

Ui | = | the weight (g) of non-recycled (virgin) material in the packaging component (i). If the proportion of recycled material in the packaging component is 0 % then Ui= Wi.

Di | = | the number of functional units contained in the packaging component (i). The functional unit = dosage in g/l washing solution.

ri | = | recycling figure, i.e. the number of times the packaging component (i) is used for the same purpose through a return or refill system. r = 1, if the packaging is not reused for the same purpose. If the packaging is reused r is set to 1 unless the applicant can document a higher number.

Exceptions

Plastic/paper/cardboard packaging containing more than 80 % recycled material or more than 80 % plastic from renewable origin is exempted from this requirement.

Packaging is regarded as recycled if the raw material used to make the packaging has been collected from packaging manufacturers at the distribution stage or at the consumer stage. Where the raw material is industrial waste from the material manufacturer’s own production process, then the material will not be regarded as recycled.

Assessment and verification:the applicant shall provide the calculation of the WUR of the product. A spreadsheet for this calculation is available on the EU Ecolabel website. The applicant shall provide a completed and signed declaration for the content of recycled or material from renewable origin in the packaging. For approval of refill packaging, the applicant and/or retailer shall document that the refills will be/are available for purchase on the market.

(b)   Plastic packagingOnly phthalates that at the time of application have been risk assessed and have not been classified according to criterion 3(b) (and combinations hereof) may be used in the plastic packaging.

In order to allow for identification of different parts of the packaging for recycling, plastic parts in the primary packaging must be marked in accordance with DIN 6120, Part 2 or the equivalent. Caps and pumps are exempted from this requirement.

Assessment and verification: the applicant shall provide completed and signed declaration of compliance.
Criterion 5 —   Washing performance (fitness for use)

The performance and efficiency of the product must be satisfactory. The product must satisfy the requirements for the user test or internal testing in accordance with Appendix II.

Assessment and verification:the applicant shall submit a detailed test report to the Competent Body, including information/documentation. See Appendix II.
Criterion 6 —   Automatic dosing systems

Multi-component systems shall be offered together with an automatic and controlled dosing system.

In order to ensure correct dosage in the automatic dosing systems, customer visits must be incorporated as a normal routine for manufacturers/suppliers. These customer visits are performed at all premises at least once a year during the license period; they must include calibration of the dosage equipment. Also, a third party can perform customer visits.

In exceptional cases, customer visits may be dispensed with if the distance and method of delivery makes the visit impracticable.

Assessment and verification:the applicant shall provide a written description of responsibility for, frequency and content of customer visits.
Criterion 7 —   User information — Information appearing on the EU Ecolabel

(a)   Information on the packaging/product information sheetThe following recommendations must appear on the packaging, and/or on product information sheet or equivalent:
— | Dose according to the degree of soil, and the water hardness. Follow the dosing instructions.

— | Using this EU Ecolabelled product according to the dosage instructions will contribute to the reduction of water pollution and waste production.(b)   Information appearing on the EU EcolabelThe logo should be visible and legible. The use of the EU Ecolabel logo is protected in primary EU law. The EU Ecolabel registration/licence number must appear on the product, it must be legible and clearly visible.

The optional label with text box shall contain the following text:
— | reduced impact on aquatic ecosystems,

— | limited hazardous substances,

— | performance tested.The guidelines for the use of the optional label with text box can be found in the ‘Guidelines for use of the Ecolabel logo’ on the website: http://ec.europa.eu/environment/ecolabel/documents/logo_guidelines.pdf

Assessment and verification (a-b): the applicant shall provide a sample of the product label and/or product sheet, together with a declaration of compliance with this criterion. Product claims shall be documented through appropriate test reports.
(*1)  DID No is the number of the ingoing substance on the DID list (‘Detergent Ingredient Database’ list), and is used in determining compliance with criteria 1 and 2.

(1)  

            OJ L 396, 30.12.2006, p. 1.

(2)  

            OJ L 353, 31.12.2008, p. 1.

(3)  

            OJ 196, 16.8.1967, p. 1.

(4)  Regulation (EC) No 1272/2008.

(5)  Directive 67/548/EEC with adjustment to REACH according to Directive 2006/121/EC and Directive 1999/45/EC as amended.

(*2)  Derogation is only for criterion 3(b). Biocides shall comply with criterion 3(d).

(*3)  Including stabilisers and other auxiliary substances in the preparations.

(*4)  In concentrations lower than 1,0 % in the raw material as long as the total concentration in the final product is lower than 0,10 %.
Detergents Ingredients Database (DID) listAppendix IThe DID list (Part A) is a list containing information of the aquatic toxicity and biodegradability of ingoing substances typically used in detergent formulations. The list includes information on the toxicity and biodegradability of a range of substances used in washing and cleaning products. The list is not comprehensive, but guidance is given in Part B of the DID list concerning the determination of the relevant calculation parameters for substances not present on the DID list (e.g. the Toxicity Factor (TF) and degradation factor (DF), which are used for calculation of the critical dilution volume). The list is a generic source of information and substances present on the DID list are not automatically approved for use in EU Ecolabelled products. The DID list (Parts A and B) can be found on the EU Ecolabel website.

For substances with no data regarding aquatic toxicity and degradability, structure analogies with similar substances may be used to assess the TF and DF. Such structure analogies shall be approved by the competent body granting the EU Ecolabel license. Alternatively, a worst-case approach shall be applied, using the parameters below:

Worst-case approach:
 | Acute toxicity | Chronic toxicity | Degradation

Ingoing substance | LC50/EC50 | SF(acute) | TF(acute) | NOEC(*1) | SF(chronic)(*1) | TF(chronic) | DF | Aerobic | Anaerobic

‘Name’ | 1  mg/l | 10 000 | 0,0001 |  |  | 0,0001 | 1 | P | N

Documentation of ready biodegradability

The following test methods for ready biodegradability shall be used:
(1) | Until 1 December 2010 and during transition period from 1 December 2010 to 1 December 2015:The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents). |  | The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests. |  | The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

 | The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.

 | The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

(2) | After 1 December 2015 and during transition period from 1 December 2010 to 1 December 2015:The test methods provided for in Regulation (EC) No 1272/2008.

Documentation of anaerobic biodegradability

The reference test for anaerobic degradability shall be EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent test method, with the requirement of 60 % ultimate degradability under anaerobic conditions. Test methods simulating the conditions in a relevant anaerobic environment may also be used to document that 60 % ultimate degradability has been attained under anaerobic conditions.
Extrapolation for substances not listed in the DID-list

Where the ingoing substances are not listed in the DID-list the following approach may be used to provide the necessary documentation of anaerobic biodegradability:
(1) | Apply reasonable extrapolation. Use test results obtained with one raw material to extrapolate the ultimate anaerobic degradability of structurally related surfactants. Where anaerobic biodegradability has been confirmed for a surfactant (or a group of homologues) according to the DID-list, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. C12-15 A 1-3 EO sulphate [DID No 8] is anaerobically biodegradable, and a similar anaerobic biodegradability may also be assumed for C12-15 A 6 EO sulphate). Where anaerobic biodegradability has been confirmed for a surfactant by use of an appropriate test method, it can be assumed that a similar type of surfactant is also anaerobically biodegradable (e.g. literature data confirming the anaerobic biodegradability of surfactants belonging to the group alkyl ester ammonium salts may be used as documentation for a similar anaerobic biodegradability of other quaternary ammonium salts containing ester-linkages in the alkyl chain(s)).

(2) | Perform screening test for anaerobic degradability. If new testing is necessary, perform a screening test by use of EN ISO 11734, ECETOC No 28 (June 1988), OECD 311 or an equivalent method.

(3) | Perform low-dosage degradability test. If new testing is necessary, and in the case of experimental problems in the screening test (e.g. inhibition due to toxicity of test substance), repeat testing by using a low dosage of surfactant and monitor degradation by14C measurements or chemical analyses. Testing at low dosages may be performed by use of OECD 308 (August 2000) or an equivalent method.

(*1)  If no acceptable chronic toxicity data are found, these columns are empty. In that case TF(chronic) is defined as equal to TF(acute).
Washing performance (fitness for use)Appendix II(a)   Internal testingThe manufacturer’s test laboratory can be approved to conduct testing to document effectiveness if the following additional requirements are met:
— | it must be possible for ecolabelling organisations to monitor the performance of testing,

— | the ecolabelling organisation must have access to all data on the product,

— | performance of the effectiveness test must be described in the quality control system.The applicant must submit documentation proving that the product has been tested under realistic conditions:
(a) | Dishes soiled with spots that are representative for the kind of soiled expected in the areas where the products will be marketed.

(b) | Recommended dosage and at the corresponding water hardness at the lowest recommended wash temperatureThe applicant must submit documentation proving:
— | the product’s ability to remove soiling from the dishes,

— | the product’s ability to dry the dishes.The test product must be tested against a reference product. The reference product may be a well-established product on the market and the tested product must be at least as effective as the reference.

(b)   User test

 | 1. | Responses must be obtained from at least five test centres representing a random selection of customers.

 | 2. | The procedure and dosage must conform to the manufacturer’s recommendations.

 | 3. | The test period must continue for at least four weeks with at least 400 test cycles.

 | 4. | Every test centre must assess the effectiveness of the product or multi-component system by answering questions relating to the following aspects (or similar formulations):—the product’s ability to remove soiling from the dishes,—the product’s ability to dry the dishes,—the respondent’s satisfaction with the agreement on customer visits. | — | the product’s ability to remove soiling from the dishes, | — | the product’s ability to dry the dishes, | — | the respondent’s satisfaction with the agreement on customer visits.

— | the product’s ability to remove soiling from the dishes,

— | the product’s ability to dry the dishes,

— | the respondent’s satisfaction with the agreement on customer visits.

 | 5. | The response must be rated on a scale comprising at least three levels, for example, ‘insufficiently effective’, ‘sufficiently effective’ or ‘very effective’. With regard to how satisfied the test centre is with visit reporting arrangements, the categories must be ‘not satisfied’, ‘satisfied’ and ‘very satisfied’.

 | 6. | At least 80 % must rate the product as sufficiently effective or very effective on all points (see point 4) and be satisfied or very satisfied with customer visiting arrangements.

 | 7. | All raw data from the test must be specified.

 | 8. | The test procedure must be described in detail.

Pending: 32012D0707

                                January 16, 2026                            

17.11.2012
EN
Official Journal of the European Union
L 320/33

(1)
Directive 2010/63/EU provides for the harmonisation of national provisions required to improve the welfare of animals used for scientific purposes and aims at the replacement, reduction and refinement of the use of animals for such purposes.

(2)
Article 54(1) of Directive 2010/63/EU requires Member States to send information on the implementation of that Directive to the Commission by 10 November 2018, and every 5 years thereafter.

(3)
Article 54(2) of Directive 2010/63/EU requires Member States to collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures. Member States are to submit that statistical information to the Commission by 10 November 2015 and every year thereafter.

(4)
In accordance with Article 54(3) of Directive 2010/63/EU, Member States are to submit to the Commission annually detailed information on exemptions granted under Article 6(4)(a) of that Directive.

(5)
A common format for submitting the information referred to in paragraphs 1, 2, and 3 of Article 54 of Directive 2010/63/EU should be established in order to ensure consistency in the implementation of that Directive.

(6)
In order to have comparable information on the implementation of Directive 2010/63/EU and to enable the Commission to assess the effectiveness of the implementation of that Directive at Union level, data submissions from the Member States on implementation, annual statistics on the use of animals in procedures and exemptions granted under Article 6(4)(a) should be accurate and consistent, and therefore the reporting requirements should be harmonised across Member States by establishing a common format for the submission of that information.

(7)
On the basis of the statistical information submitted by Member States under Article 54(2) of Directive 2010/63/EU, the Commission is required in accordance with Article 57(2) of that Directive to submit to the European Parliament and the Council a summary report on that information. In order for the data to be meaningful, accurate and comparable, it is essential to have a common format to ensure uniform reporting by all Member States.

(8)
To allow the list of methods for killing animals contained in Annex IV to Directive 2010/63/EU to be kept up to date with the latest scientific development, it is necessary to receive detailed information on methods granted exceptionally under Article 6(4)(a) of that Directive.

(9)
The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 56(3) of Directive 2010/63/EU,

i.
granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU)information on the annual number of projects authorised, and on the number and type authorised as "multiple generic projects";information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.

information on the annual number of projects authorised, and on the number and type authorised as "multiple generic projects";

information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.

information on the annual number of projects authorised, and on the number and type authorised as "multiple generic projects";

information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.

information on the annual number of projects authorised, and on the number and type authorised as "multiple generic projects";

information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.

ii.
retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of Directive 2010/63/EU)information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.

information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);

information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.

information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);

information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.

information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);

information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.

i.
animals bred, killed and not used in procedures including genetically altered animals not covered in the annual statistics, covering the calendar year prior to that in which the 5-year report is submitted; the global figure shall differentiate those animals involved in GA creation and maintenance of established GA-lines (including wild-type offspring);

ii.
the sourcing of non-human primates and how the requirements of Articles 10 and 28 of Directive 2010/63/EU are met.

1.
The data should be entered on each use of an animal.

2.
When entering data for an animal, only one optionwithina category can be selected.

3.
Animals killed for organs and tissues, as well as sentinels, are excluded from the provision of statistical data, unless the killing is performed under a project authorisation using a method not included in Annex IV or where the animal has gone through a previous intervention, prior to being killed, and which has been above the threshold of minimum pain, suffering, distress and lasting harm.

4.
Surplus animals that are killed are not included in the statistical data apart from genetically altered animals with intended and exhibited harmful phenotype.

5.
Larval forms of animals are to be counted once they become capable of independent feeding.

6.
Foetal and embryonic forms of mammalian species are not counted; only animals that are born, including by Caesarean section, and live, are to be counted.

7.
Whenever the ‧severe‧ classification is exceeded, whether pre-authorised or not, these animals and their use are to be reported normally like any other use, and under the ‧severe‧ category. Commentary should be added in the "Member State" narrative section covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‧severe‧ classification was exceeded.

8.
The data are to be reported for the year that the procedure ends. In case of studies running across two calendar years, all of the animals may be accounted for together in the year in which the last procedure endsif this exemption to annual reporting is authorised by the competent authority. For projects running longer than two calendar years, animals are reported on the year they are killed or die.

9.
The use of "other" category requires a compulsory entry in the narratives to provide further details.

1.
For the purposes of statistical reporting, "genetically altered animals" include genetically modified (transgenic, knock-out and other forms of genetic alteration) and naturally occurring or induced mutant animals.

2.
Genetically altered animals are reported eithera)when used for the creation of a new line;b)when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; orc)when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).
a)
when used for the creation of a new line;
b)
when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; or
c)
when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).

a)
when used for the creation of a new line;

b)
when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; or

c)
when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).

a)
when used for the creation of a new line;

b)
when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; or

c)
when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).

3.
All animalscarrying the genetic alterationshould be reported during the creation of a new line. In addition, those used for superovulation, vasectomy, embryo implantation should equally be reported (these may or may not be genetically altered themselves). Genetically normal animals (wild type offspring) produced as a result of creation of a new genetically altered line should not be reported.

4.
In the category ‧Purposes‧, the animals used for thecreationof a new genetically altered line should be reported under ‧basic research‧ or ‧translational and applied research‧ in therespective category the line is being created for.

5.
A new strain or line of genetically altered animals is considered to be "established"when transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.

6.
The welfare assessment will determine if the newly created line is expected to have anintended harmful phenotypeand, if this is the case, the animals from this point onwards shall be reported under category ‧Maintenance of colonies of established genetically altered animals, not used in other procedures‧ – or, if appropriate, in the other procedures they are being used for. If the welfare assessment concludes that the line isnotexpected to have a harmful phenotype, itsbreedingfalls outside the scope of a procedure and no longer needs to be reported.

7.
‧Maintenance of colonies of established genetically altered animals, not used in other procedures‧ contains the animals required for themaintenanceof colonies of genetically altered animals of established lineswith an intended harmful phenotypeandwhich have exhibitedpain, suffering, distress or lasting harm as a consequence of the harmful genotype. The intended purpose for which the line is being maintained for is not recorded.

8.
All genetically altered animals which are used in other procedures(not for the creation or maintenance of a genetically altered line) should be reported under their respective purposes (the same way as any non-genetically altered animal). These animals may or may not exhibit a harmful phenotype.

9.
Genetically altered animals, expressing a harmful phenotype, and killed for their organs and tissue, should be reported under the respective primary purposes for which the organs/tissue were used.

i.
All cephalopod species are to be reported under heading cephalopod from the stage at which the animal becomes capable of independent feeding i.e. immediately post-hatching for octopus and squid; and around seven days after hatching for cuttlefish.

ii.
Fish should be counted from the stage of being capable of independent feeding onward. Zebrafish kept in optimal breeding conditions (approximately + 28C) should be counted 5 days post fertilisation.

iii.
Due to the small size of some fish and cephalopod species, the count may be done on the basis of estimation.

i.
Each use of the animal should be reported at the end of each procedure.

ii.
The statistics will present thenumber of naïve animals only in connection with their species and place of birth. For reused animals, their ‧place of birth‧ is therefore not recorded.

iii.
Anysubsequent categorieswill show thenumber of uses of animals in procedures. Thus these numbers cannot be cross referenced with the total numbers of naïve animals.

iv.
The number of animals that are reused cannot be deduced from the data due to the fact that some animals may be reused more than once.

v.
The actual suffering of the animal in the procedure should be reported. In some cases this could be influenced by a previous use. However, the severity will not always increase in a subsequent use and in some cases even decrease as a result (habituation). Therefore there should be no attempt to automatically add up the severities from its previous uses. This should always be judged on a case-by-case basis.

i.
Origin is based on the place of birth i.e. "born in" and not according to where the animal is supplied from.

ii.
Animals born in the EU at a registered breeder covers animals born at breeders as authorised and registered under Article 20 of Directive 2010/63/EU.

iii.
Animals born in the EU but not at a registered breeder includes animals born outside a registered breeder such as wild animals, farm animals (unless the breeder is authorised and registered), as well as any exemptions granted under Article 10(3) of Directive 2010/63/EU.

iv.
Animals born in rest of Europe and Animals born in rest of world groups together all animals regardless of whether they have been bred in registered breeding establishments, other establishments and includes animals that have been captured in the wild.

i.
Animals born in rest of Europe is to include animals born in Turkey, Russia and Israel.

ii.
Animals born in Asia is to include animals born in China.

iii.
Animals born in America is to include animals born in the North, Central and South America.

iv.
Animals born in Africa is to include animals born in Mauritius.

v.
Animals born elsewhere is to include animals born in Australasia.

i.
As long as the colony is not self-sustained, animals born in that colony should be reported under F0, F1, F2 or greater according to their generation derived from the maternal line.

ii.
Once the whole colony is self-sustained, all animals born in that colony should be reported under Self-sustaining colony regardless of their generation derived from the maternal line.

i.
Not genetically altered covers all animals that have not been genetically altered, including genetically normal parent animals used for the creation of a new genetically altered animal line/strain.

ii.
Genetically altered without a harmful phenotype includes animals used for thecreation of a new line, carrying the genetic alteration but exhibiting no harmful phenotype and genetically altered animalsusedin other procedures (not for creation or maintenance) but exhibiting no harmful phenotype.

iii.
Genetically altered with a harmful phenotype includes:a)animals used for thecreation of a new lineand exhibiting a harmful phenotype;b)those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; andc)genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.
a)
animals used for thecreation of a new lineand exhibiting a harmful phenotype;
b)
those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; and
c)
genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.

a)
animals used for thecreation of a new lineand exhibiting a harmful phenotype;

b)
those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; and

c)
genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.

a)
animals used for thecreation of a new lineand exhibiting a harmful phenotype;

b)
those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; and

c)
genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.

i.
Non-recovery– Animals which have undergone a procedure that has been performed entirely under general anaesthesia from which the animal has not recovered consciousness shall be reported as non-recovery.

ii.
Mild (up to and including)- Animals which have undergone a procedure as a result of which the animals have experienced up to, and including, short-term mild pain, suffering or distress, as well as when there has been no significant impairment of the well-being or general condition of the animals shall be reported as Mild. N.B. This should also include any animals used in an authorised project, but which have ultimately not been observed to have experienced a level of pain, suffering, distress or lasting harm equivalent to that caused by the introduction of a needle in accordance with good veterinary practice, with the exception of animals required for themaintenanceof colonies of genetically altered animals of established lineswith an intended harmful phenotypeandwhich have not exhibitedpain, suffering, distress or lasting harm as a consequence of the harmful genotype.

iii.
Moderate- Animals which have undergone a procedure as a result of which the animals have experienced short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that have caused moderate impairment of the well-being or general condition of the animals shall be reported as Moderate.

iv.
Severe- Animals which have undergone a procedure as a result of which the animals have experienced severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that have caused severe impairment of the well-being or general condition of the animals shall be reported as Severe.

v.
If the ‧severe‧ classification is exceeded, whether pre-authorised or not, these animals and their use are to be reported under Severe. Commentary should be added in the "Member State" narrative section covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‧severe‧ classification was exceeded.

i.
Use of animals in procedures carried out with a view to satisfying legal requirements for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed.

ii.
This includes tests carried out on products/substances for which no regulatory submission is made (i.e. tests performed on those products/substances (for which a regulatory submission was foreseen) that are ultimately deemed unsuitable for the market by the developer, and thus fail to reach the end of the development process).

iii.
This category also includes animals used in the manufacturing process of products if that manufacturing process requires regulatory approval (e.g. animals used in the manufacturing of serum-based medicinal products should be included within this category).

i.
Efficacy testing during the development of new medicinal product is excluded and should be reported under category "Translational and Applied research".

ii.
Quality control includes animals used in the testing of purity, stability, efficacy, potency and other quality control parameters of the final product and its constituents and any controls carried out during the manufacturing process for registration purposes, to satisfy any other national or international regulatory requirements or to satisfy the in-house policy of the manufacturer. This includes pyrogenicity testing.

iii.
Other efficacy and tolerance testing Efficacy testing of biocides and pesticides is covered under this category as well as the tolerance testing of additives in animal nutrition.

iv.
Routine production covers the production of monoclonal antibodies (by ascites) and blood products including polyclonal antisera by established methods. This excludes immunisation of animals for hybridoma production which should be captured under basic or applied research under the appropriate category.

v.
Toxicity and other safety testing (including safety evaluation of products and devices for human medicine and dentistry and veterinary medicine) covers studies carried out on any product or substance to determine its potential to cause any dangerous or undesirable effects in humans or animals as a result of its intended or abnormal use, manufacture or as a potential or actual contaminant in the environment.

i.
The legislative requirement should be entered as per theintended primaryuse.

ii.
Water quality; if concerning e.g. tap water to be reported under food legislation

i.
This category allows identification of the level of harmonisation between different legislative requirements. The determining factor is notwhorequests the test to be carried out but which legislation is satisfied, giving priority to the widest level of harmonisation.

ii.
Where national legislation is derived from EU legislation, only Legislation satisfying EU requirements is to be chosen.

iii.
Legislation satisfying EU requirements also includes any international requirement which at the same time satisfies EU requirements (such as testing to ICH, VICH, OECD guidelines, European Pharmacopoeia monographs).

iv.
Legislation satisfying national requirements only (within EU) is to be chosen only when the test is carried out to satisfy the requirements of one or more Member State; not necessarily the one in which the work is being carried out. However, there is no equivalent requirement in the EU.

v.
Legislation satisfying Non-EU requirements only is to be chosen when there is no equivalent requirement to carry out the test to satisfy EU requirements.

i.
Immunotoxicology studies should be covered under Repeated dose toxicity.

ii.
Kinetics (pharmacokinetics, toxicokinetics, residue depletion) if toxicokinetics is performed as part of the regulatory repeat dose toxicity study, it should be reported under repeated dose toxicity.

iii.
Safety testing in the food and feed area includes testing of drinking water (including target animal safety testing).

iv.
Target animal safety this is testing to ensure a product for a specific animal can be used safely on that species (excluding batch safety testing which is covered under quality control).

1.
General information on any changes in trends observed since the previous reporting period.

2.
Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

3.
Information on any changes in trends in actual severities and analysis of the reasons thereof.

4.
Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

5.
Further breakdown on the use of "other" categories if a significant proportion of animal use is reported under this category.

6.
Details on cases where the ‧severe‧ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‧severe‧ classification was exceeded.

Type of method
Species
Justification

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes(1), and in particular Article 54(4) thereof,

(1) Directive 2010/63/EU provides for the harmonisation of national provisions required to improve the welfare of animals used for scientific purposes and aims at the replacement, reduction and refinement of the use of animals for such purposes.

(2) Article 54(1) of Directive 2010/63/EU requires Member States to send information on the implementation of that Directive to the Commission by 10 November 2018, and every 5 years thereafter.

(3) Article 54(2) of Directive 2010/63/EU requires Member States to collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures. Member States are to submit that statistical information to the Commission by 10 November 2015 and every year thereafter.

(4) In accordance with Article 54(3) of Directive 2010/63/EU, Member States are to submit to the Commission annually detailed information on exemptions granted under Article 6(4)(a) of that Directive.

(5) A common format for submitting the information referred to in paragraphs 1, 2, and 3 of Article 54 of Directive 2010/63/EU should be established in order to ensure consistency in the implementation of that Directive.

(6) In order to have comparable information on the implementation of Directive 2010/63/EU and to enable the Commission to assess the effectiveness of the implementation of that Directive at Union level, data submissions from the Member States on implementation, annual statistics on the use of animals in procedures and exemptions granted under Article 6(4)(a) should be accurate and consistent, and therefore the reporting requirements should be harmonised across Member States by establishing a common format for the submission of that information.

(7) On the basis of the statistical information submitted by Member States under Article 54(2) of Directive 2010/63/EU, the Commission is required in accordance with Article 57(2) of that Directive to submit to the European Parliament and the Council a summary report on that information. In order for the data to be meaningful, accurate and comparable, it is essential to have a common format to ensure uniform reporting by all Member States.

(8) To allow the list of methods for killing animals contained in Annex IV to Directive 2010/63/EU to be kept up to date with the latest scientific development, it is necessary to receive detailed information on methods granted exceptionally under Article 6(4)(a) of that Directive.

(9) The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 56(3) of Directive 2010/63/EU,

HAS ADOPTED THIS DECISION:
Article 1

Member States shall use the common reporting format set out in Annex I to this Decision for the submission of the information referred to in Article 54(1) of Directive 2010/63/EU.
Article 2

Member States shall use the common reporting format and the detailed instructions set out in Annex II to this Decision for the submission of the statistical information referred to in Article 54(2) of Directive 2010/63/EU.
Article 3

Member States shall use the common reporting format set out in Annex III to this Decision for the submission of the information on the exemptions granted under Article 6(4)(a) of Directive 2010/63/EU referred to in Article 54(3) of that Directive.
Article 4

This Decision is addressed to the Member States.
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive 2010/63/EU of the European Parliament and of the Council of 22 September 2010 on the protection of animals used for scientific purposes(1), and in particular Article 54(4) thereof,

(1) Directive 2010/63/EU provides for the harmonisation of national provisions required to improve the welfare of animals used for scientific purposes and aims at the replacement, reduction and refinement of the use of animals for such purposes.

(2) Article 54(1) of Directive 2010/63/EU requires Member States to send information on the implementation of that Directive to the Commission by 10 November 2018, and every 5 years thereafter.

(3) Article 54(2) of Directive 2010/63/EU requires Member States to collect and make publicly available, on an annual basis, statistical information on the use of animals in procedures. Member States are to submit that statistical information to the Commission by 10 November 2015 and every year thereafter.

(4) In accordance with Article 54(3) of Directive 2010/63/EU, Member States are to submit to the Commission annually detailed information on exemptions granted under Article 6(4)(a) of that Directive.

(5) A common format for submitting the information referred to in paragraphs 1, 2, and 3 of Article 54 of Directive 2010/63/EU should be established in order to ensure consistency in the implementation of that Directive.

(6) In order to have comparable information on the implementation of Directive 2010/63/EU and to enable the Commission to assess the effectiveness of the implementation of that Directive at Union level, data submissions from the Member States on implementation, annual statistics on the use of animals in procedures and exemptions granted under Article 6(4)(a) should be accurate and consistent, and therefore the reporting requirements should be harmonised across Member States by establishing a common format for the submission of that information.

(7) On the basis of the statistical information submitted by Member States under Article 54(2) of Directive 2010/63/EU, the Commission is required in accordance with Article 57(2) of that Directive to submit to the European Parliament and the Council a summary report on that information. In order for the data to be meaningful, accurate and comparable, it is essential to have a common format to ensure uniform reporting by all Member States.

(8) To allow the list of methods for killing animals contained in Annex IV to Directive 2010/63/EU to be kept up to date with the latest scientific development, it is necessary to receive detailed information on methods granted exceptionally under Article 6(4)(a) of that Directive.

(9) The measures provided for in this Decision are in accordance with the opinion of the Committee established under Article 56(3) of Directive 2010/63/EU,

HAS ADOPTED THIS DECISION:
Member States shall use the common reporting format set out in Annex I to this Decision for the submission of the information referred to in Article 54(1) of Directive 2010/63/EU.
Member States shall use the common reporting format and the detailed instructions set out in Annex II to this Decision for the submission of the statistical information referred to in Article 54(2) of Directive 2010/63/EU.
Member States shall use the common reporting format set out in Annex III to this Decision for the submission of the information on the exemptions granted under Article 6(4)(a) of Directive 2010/63/EU referred to in Article 54(3) of that Directive.
This Decision is addressed to the Member States.
REPORTING FORMAT FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(1) OF DIRECTIVE 2010/63/EUANNEX IDetails on specific events (such as numbers) are either to be collected as a snapshot covering the last year of the five-year cycle or exceptionally for the full five-year period broken down by year.

A.   GENERAL INFORMATION

Changes made to national measures regarding the implementation of Directive 2010/63/EU since the previous report.

B.   STRUCTURES AND FRAMEWORK

1.   Competent authorities (Article 59 of Directive 2010/63/EU)information on the framework for competent authorities, including the numbers and types of authorities.

2.   National committee (Article 49 of Directive 2010/63/EU)information on the structure and operation of the national committee.

3.   Education and training of personnel (Article 23 of Directive 2010/63/EU)information on the minimum requirements referred to in Article 23(3) of Directive 2010/63/EU including any additional educational and training requirements for staff coming from another Member State.

4.   Project evaluation and authorisation (Articles 38 and 40 of Directive 2010/63/EU)description of the processes of project evaluation and authorisation and how the requirements of Articles 38 and 40 of Directive 2010/63/EU are met.

C.   OPERATION

1.   Projects

i. | granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU)information on the annual number of projects authorised, and on the number and type authorised as “multiple generic projects”;information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU. |  | information on the annual number of projects authorised, and on the number and type authorised as “multiple generic projects”; |  | information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.

 | information on the annual number of projects authorised, and on the number and type authorised as “multiple generic projects”;

 | information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.

ii. | retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of Directive 2010/63/EU)information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive. |  | information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU); |  | information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.

 | information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);

 | information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.2.   Animals bred for use in procedures (Articles 10, 28 and 30 of Directive 2010/63/EU)

i. | animals bred, killed and not used in procedures including genetically altered animals not covered in the annual statistics, covering the calendar year prior to that in which the 5-year report is submitted; the global figure shall differentiate those animals involved in GA creation and maintenance of established GA-lines (including wild-type offspring);

ii. | the sourcing of non-human primates and how the requirements of Articles 10 and 28 of Directive 2010/63/EU are met.3.   Exemptionsinformation on circumstances under which exemptions were granted in accordance with Articles 10(3), 12(1), 33(3) of Directive 2010/63/EU and in particular on the exceptional circumstances referred to in Article 16(2) of that Directive where a reuse of an animal after a procedure in which the actual suffering was assessed as severe was authorised during the reporting period.

4.   Animal welfare body (Articles 26 and 27 of Directive 2010/63/EU)information on the structure and functioning of animal welfare bodies.

D.   PRINCIPLES OF REPLACEMENT, REDUCTION AND REFINEMENT

1.   Principle of replacement, reduction and refinement (Articles 4 and 13 and Annex VI of Directive 2010/63/EU)the general measures taken to ensure that the principle of replacement, reduction and refinement is satisfactorily addressed within authorised projects as well as during housing and care also in breeding and supplying establishments.

2.   Avoidance of duplication (Article 46 of Directive 2010/63/EU)general description of measures taken to ensure that there is no duplication of procedures.

3.   Tissue sampling of genetically altered animals (Articles 4, 30 and 38 of Directive 2010/63/EU)representative information on approximate numbers, species, types of methods and their related severities of tissue sampling for the purposes of genetic characterisation carried out with and without project authorisation covering the calendar year prior to that in which the 5-year report is submitted, and on efforts made to refine those methods.

E.   ENFORCEMENT

1.   Authorisation of breeders, suppliers and users (Articles 20 and 21 of Directive 2010/63/EU)number of active authorised breeders, suppliers and users; information on suspensions or withdrawals of authorisations of breeders, suppliers and users and the reasons therefore.

2.   Inspections (Article 34 of Directive 2010/63/EU)quantitative and qualitative operational information including criteria applied under Article 34(2) of Directive 2010/63/EU and proportion of unannounced inspections broken down by year.

3.   Withdrawals of project authorisation (Article 44 of Directive 2010/63/EU)information and reasons for the withdrawals of project authorisation during the reporting period.

4.   Penalties (Article 60 of Directive 2010/63/EU)information on the nature of infringements as well as legal and administrative actions resulting from those infringements during the reporting period.
REPORTING FORMAT FOR THE SUBMISSION OF THE INFORMATION REFERRED TO IN ARTICLE 54(2) OF DIRECTIVE 2010/63/EUANNEX IIType of animal

Mice (Mus musculus)

Rats (Rattus norvegicus)

Guinea-Pigs (Cavia porcellus)

Hamsters (Syrian) (Mesocricetus auratus)

Hamsters (chinese) (Cricetulus griseus)

Mongolian gerbil (Meriones unguiculatus)

Other Rodents (other Rodentia)

Rabbits (Oryctolagus cuniculus)

Cats (Felis catus)

Dogs (Canis familiaris)

Ferrets (Mustela putorius furo)

Other carnivores (other Carnivora)

Horses, donkeys & cross-breeds (Equidae)

Pigs (Sus scrofa domesticus)

Goats (Capra aegagrus hircus)

Sheep (Ovis aries)

Cattle (Bos primigenius)

Prosimians (Prosimia)

Marmoset and tamarins (eg. Callithrix jacchus)

Cynomolgus monkey (Macaca fascicularis)

Rhesus monkey (Macaca mulatta)

Vervets Chlorocebus spp. (usually either pygerythrus or sabaeus)

Baboons (Papio spp.)

Squirrel monkey (eg. Saimiri sciureus)

Other species of non-human primates (other species of Ceboidea and Cercopithecoidea)

Apes (Hominoidea)

Other Mammals (other Mammalia)

Domestic fowl (Gallus gallus domesticus)

Other birds (other Aves)

Reptiles (Reptilia)

Rana (Rana temporaria and Rana pipiens)

Xenopus (Xenopus laevis and Xenopus tropicalis)

Other Amphibians (other Amphibia)

Zebra fish (Danio rerio)

Other Fish (other Pisces)

Cephalopods (Cephalopoda)

Basic research studies

Oncology

Cardiovascular Blood and Lymphatic System

Nervous System

Respiratory System

Gastrointestinal System including Liver

Musculoskeletal System

Immune System

Urogenital/Reproductive System

Sensory Organs (skin, eyes and ears)

Endocrine System/Metabolism

Multisystemic

Ethology / Animal Behaviour /Animal Biology

Other

END

Translational and applied research

Human Cancer

Human Infectious Disorders

Human Cardiovascular Disorders

Human Nervous and Mental Disorders

Human Respiratory Disorders

Human Gastrointestinal Disorders including Liver

Human Musculoskeletal Disorders

Human Immune Disorders

Human Urogenital/Reproductive Disorders

Human Sensory Organ Disorders (skin, eyes and ears)

Human Endocrine/Metabolism Disorders

Other Human Disorders

Animal Diseases and Disorders

Animal Welfare

Diagnosis of diseases

Plant diseases

Non-regulatory toxicology and ecotoxicology

END

Ecotoxicity

Acute toxicity

Chronic toxicity

Reproductive toxicity

Endocrine activity

Bioaccumulation

Other

END

Re-use

Re-use

Place of birth

Animals born in the EU at a registered breeder

Animals born in the EU but not at a registered breeder

Animals born in rest of Europe

Animals born in rest of world

NHP (excl.apes) ?

YES

Non-human primate – source

Animals born at a registered breeder within EU

Animals born in rest of Europe

Animals born in Asia

Animals born in America

Animals born in Africa

Animals born elsewhere

Non-human primate – generation

F0

F1

F2 or greater

Self-sustaining colony

NO

Genetic status

Not genetically altered

Genetically altered without a harmful phenotype

Genetically altered with a harmful phenotype

Creation of a new genetically altered line

Animals used for the creation of a new genetically altered line/strain

Severity

Non-recovery

Mild (up to and including)

Moderate

Severe

Purposes

Basic research

Translational and applied research

Regulatory use and routine production

Protection of the natural environment in the interests of the health or welfare of human beings or animals

Preservation of species

Higher education or training for the acquisition, maintenance or improvement of vocational skills

Forensic enquiries

Maintenance of colonies of established genetically altered animals, not used in other procedures

END

END

END

END

END

Regulatory use and routine production by type

Quality control (incl batch safety and potency testing)

Other efficacy and tolerance testing

Toxicity and other safety testing including pharmacology

Routine production

END

Use of animals for regulated production by product type

Blood based products

Monoclonal antibodies

Other

END

Quality control (incl batch safety and potency testing)

Batch safety testing

Pyrogenicity testing

Batch potency testing

Other quality controls

END

Toxicity and other safety testing required by legislation

Legislation on medicinal products for human use

Legislation on medicinal products for veterinary use and their residues

Medical devices legislation

Industrial chemicals legislation

Plant protection product legislation

Biocides legislation

Food legislation including food contact material

Feed legislation including legislation for the safety of target animals, workers and environment

Cosmetics legislation

Other

Legislative requirements

Legislation satisfying EU requirements

Legislation satisfying national requirements only (within EU)

Legislation satisfying Non-EU requirements only

Toxicity and other safety testing by test type

Acute (single dose) toxicity testing methods (including limit test)

Skin irritation/corrosion

Skin sensitisation

Eye irritation/corrosion

Repeated dose toxicity

Carcinogenicity

Genotoxicity

Reproductive toxicity

Developmental toxicity

Neurotoxicity

Kinetics (pharmacokinetics, toxicokinetics, residue depletion)

Pharmaco-dynamics (including safety pharmacology)

Phototoxicity

Ecotoxicity

Safety testing in food and feed area

Target animal safety

Other

END

END

END

END

END

END

END

END

END

END

END

END

END

END

Acute and sub-acute toxicity testing methods

LD50, LC50

Other lethal methods

Non lethal methods

END

Repeated dose toxicity

up to 28 days

29 – 90 days

> 90 days

END
 | 1. | The data should be entered on each use of an animal.

 | 2. | When entering data for an animal, only one optionwithina category can be selected.

 | 3. | Animals killed for organs and tissues, as well as sentinels, are excluded from the provision of statistical data, unless the killing is performed under a project authorisation using a method not included in Annex IV or where the animal has gone through a previous intervention, prior to being killed, and which has been above the threshold of minimum pain, suffering, distress and lasting harm.

 | 4. | Surplus animals that are killed are not included in the statistical data apart from genetically altered animals with intended and exhibited harmful phenotype.

 | 5. | Larval forms of animals are to be counted once they become capable of independent feeding.

 | 6. | Foetal and embryonic forms of mammalian species are not counted; only animals that are born, including by Caesarean section, and live, are to be counted.

 | 7. | Whenever the ‧severe‧ classification is exceeded, whether pre-authorised or not, these animals and their use are to be reported normally like any other use, and under the ‧severe‧ category. Commentary should be added in the “Member State” narrative section covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‧severe‧ classification was exceeded.

 | 8. | The data are to be reported for the year that the procedure ends. In case of studies running across two calendar years, all of the animals may be accounted for together in the year in which the last procedure endsif this exemption to annual reporting is authorised by the competent authority. For projects running longer than two calendar years, animals are reported on the year they are killed or die.

 | 9. | The use of “other” category requires a compulsory entry in the narratives to provide further details.A.   GENETICALLY ALTERED ANIMALS
 | 1. | For the purposes of statistical reporting, “genetically altered animals” include genetically modified (transgenic, knock-out and other forms of genetic alteration) and naturally occurring or induced mutant animals.

 | 2. | Genetically altered animals are reported eithera)when used for the creation of a new line;b)when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; orc)when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line). | a) | when used for the creation of a new line; | b) | when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; or | c) | when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).

a) | when used for the creation of a new line;

b) | when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; or

c) | when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).

 | 3. | All animalscarrying the genetic alterationshould be reported during the creation of a new line. In addition, those used for superovulation, vasectomy, embryo implantation should equally be reported (these may or may not be genetically altered themselves). Genetically normal animals (wild type offspring) produced as a result of creation of a new genetically altered line should not be reported.

 | 4. | In the category ‧Purposes‧, the animals used for thecreationof a new genetically altered line should be reported under ‧basic research‧ or ‧translational and applied research‧ in therespective category the line is being created for.

 | 5. | A new strain or line of genetically altered animals is considered to be “established”when transmission of the genetic alteration is stable, which will be a minimum of two generations, and a welfare assessment has been completed.

 | 6. | The welfare assessment will determine if the newly created line is expected to have anintended harmful phenotypeand, if this is the case, the animals from this point onwards shall be reported under category ‧Maintenance of colonies of established genetically altered animals, not used in other procedures‧ – or, if appropriate, in the other procedures they are being used for. If the welfare assessment concludes that the line isnotexpected to have a harmful phenotype, itsbreedingfalls outside the scope of a procedure and no longer needs to be reported.

 | 7. | ‧Maintenance of colonies of established genetically altered animals, not used in other procedures‧ contains the animals required for themaintenanceof colonies of genetically altered animals of established lineswith an intended harmful phenotypeandwhich have exhibitedpain, suffering, distress or lasting harm as a consequence of the harmful genotype. The intended purpose for which the line is being maintained for is not recorded.

 | 8. | All genetically altered animals which are used in other procedures(not for the creation or maintenance of a genetically altered line) should be reported under their respective purposes (the same way as any non-genetically altered animal). These animals may or may not exhibit a harmful phenotype.

 | 9. | Genetically altered animals, expressing a harmful phenotype, and killed for their organs and tissue, should be reported under the respective primary purposes for which the organs/tissue were used.B.   DATA CATEGORIES

The sections below follow the order of the categories and related headings in the flow chart.

1.   Type of animal
 | i. | All cephalopod species are to be reported under heading cephalopod from the stage at which the animal becomes capable of independent feeding i.e. immediately post-hatching for octopus and squid; and around seven days after hatching for cuttlefish.

 | ii. | Fish should be counted from the stage of being capable of independent feeding onward. Zebrafish kept in optimal breeding conditions (approximately + 28C) should be counted 5 days post fertilisation.

 | iii. | Due to the small size of some fish and cephalopod species, the count may be done on the basis of estimation.2.   Reuse
 | i. | Each use of the animal should be reported at the end of each procedure.

 | ii. | The statistics will present thenumber of naïve animals only in connection with their species and place of birth. For reused animals, their ‧place of birth‧ is therefore not recorded.

 | iii. | Anysubsequent categorieswill show thenumber of uses of animals in procedures. Thus these numbers cannot be cross referenced with the total numbers of naïve animals.

 | iv. | The number of animals that are reused cannot be deduced from the data due to the fact that some animals may be reused more than once.

 | v. | The actual suffering of the animal in the procedure should be reported. In some cases this could be influenced by a previous use. However, the severity will not always increase in a subsequent use and in some cases even decrease as a result (habituation). Therefore there should be no attempt to automatically add up the severities from its previous uses. This should always be judged on a case-by-case basis.

Reuse versus continued use

A procedure means a use of one animal for a single scientific/experimental/educational/ training purpose. A single use extends from the time when the first technique is applied to the animal until the completion of data collection, observations or achievement of educational objective. This is usually a single experiment, test or training of a technique.

A single procedure may contain a number of steps (techniques) all necessarily related to achieve a single outcome and which require the use of the same animal.

The end user will reportthe entire procedureincluding any preparation (regardless of the location this has taken place) and take into account the severity associated with the preparation.

Examples of preparation include surgical procedures (such as cannulation, implantation of telemetry, ovariectomy, castration, hypophysectomy etc), non-surgical (such as feeding modified diets, induction of diabetes etc). The same applies to the breeding of genetically altered animals i.e. when the animal is used in its intended procedure, the end user will report the entire procedure taking into account the severity associated with the phenotype. See section on genetically altered animals for more details.

Should, for exceptional reasons, a prepared animal not be used for a scientific purpose, the establishment having prepared the animal, should report the details of the preparation as an independent procedure in the statistics as per the intended purpose, provided the preparation of the animal has been above the threshold of minimum pain, suffering, distress and lasting harm.

3.   Place of birth

Animals born in the EU at a registered breederAnimals born in the EU but not at a registered breederAnimals born in rest of EuropeAnimals born in rest of world

 | i. | Origin is based on the place of birth i.e. “born in” and not according to where the animal is supplied from.

 | ii. | Animals born in the EU at a registered breeder covers animals born at breeders as authorised and registered under Article 20 of Directive 2010/63/EU.

 | iii. | Animals born in the EU but not at a registered breeder includes animals born outside a registered breeder such as wild animals, farm animals (unless the breeder is authorised and registered), as well as any exemptions granted under Article 10(3) of Directive 2010/63/EU.

 | iv. | Animals born in rest of Europe and Animals born in rest of world groups together all animals regardless of whether they have been bred in registered breeding establishments, other establishments and includes animals that have been captured in the wild.4.   Non-human primate – source

Animals born at a registered breeder within EUAnimals born in rest of EuropeAnimals born in AsiaAnimals born in AmericaAnimals born in AfricaAnimals born elsewhereFor the purposes of this reporting:
i. | Animals born in rest of Europe is to include animals born in Turkey, Russia and Israel.

ii. | Animals born in Asia is to include animals born in China.

iii. | Animals born in America is to include animals born in the North, Central and South America.

iv. | Animals born in Africa is to include animals born in Mauritius.

v. | Animals born elsewhere is to include animals born in Australasia.The origins of animals recorded under Animals born elsewhere are to be detailed to the competent authority with the data submission.

5.   Non-human primate – generation

F0F1F2 or greaterSelf-sustaining colony

 | i. | As long as the colony is not self-sustained, animals born in that colony should be reported under F0, F1, F2 or greater according to their generation derived from the maternal line.

 | ii. | Once the whole colony is self-sustained, all animals born in that colony should be reported under Self-sustaining colony regardless of their generation derived from the maternal line.6.   Genetic status

Not genetically alteredGenetically altered without a harmful phenotypeGenetically altered with a harmful phenotype

 | i. | Not genetically altered covers all animals that have not been genetically altered, including genetically normal parent animals used for the creation of a new genetically altered animal line/strain.

 | ii. | Genetically altered without a harmful phenotype includes animals used for thecreation of a new line, carrying the genetic alteration but exhibiting no harmful phenotype and genetically altered animalsusedin other procedures (not for creation or maintenance) but exhibiting no harmful phenotype.

 | iii. | Genetically altered with a harmful phenotype includes:a)animals used for thecreation of a new lineand exhibiting a harmful phenotype;b)those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; andc)genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype. | a) | animals used for thecreation of a new lineand exhibiting a harmful phenotype; | b) | those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; and | c) | genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.

a) | animals used for thecreation of a new lineand exhibiting a harmful phenotype;

b) | those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; and

c) | genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.7.   Creation of a new genetically altered line

Animals used for the creation of a new genetically altered line/strainAnimals used for the creation of a new genetically altered line/strain identifies animals which areused for the creationof a new genetically altered line/strain, separating from other animals used for the purposes of ‧basic research‧ or ‧translational and applied research‧.

8.   Severity
 | i. | Non-recovery– Animals which have undergone a procedure that has been performed entirely under general anaesthesia from which the animal has not recovered consciousness shall be reported as non-recovery.

 | ii. | Mild (up to and including)- Animals which have undergone a procedure as a result of which the animals have experienced up to, and including, short-term mild pain, suffering or distress, as well as when there has been no significant impairment of the well-being or general condition of the animals shall be reported as Mild. N.B. This should also include any animals used in an authorised project, but which have ultimately not been observed to have experienced a level of pain, suffering, distress or lasting harm equivalent to that caused by the introduction of a needle in accordance with good veterinary practice, with the exception of animals required for themaintenanceof colonies of genetically altered animals of established lineswith an intended harmful phenotypeandwhich have not exhibitedpain, suffering, distress or lasting harm as a consequence of the harmful genotype.

 | iii. | Moderate- Animals which have undergone a procedure as a result of which the animals have experienced short-term moderate pain, suffering or distress, or long-lasting mild pain, suffering or distress as well as procedures that have caused moderate impairment of the well-being or general condition of the animals shall be reported as Moderate.

 | iv. | Severe- Animals which have undergone a procedure as a result of which the animals have experienced severe pain, suffering or distress, or long-lasting moderate pain, suffering or distress as well as procedures, that have caused severe impairment of the well-being or general condition of the animals shall be reported as Severe.

 | v. | If the ‧severe‧ classification is exceeded, whether pre-authorised or not, these animals and their use are to be reported under Severe. Commentary should be added in the “Member State” narrative section covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‧severe‧ classification was exceeded.9.   Purposes

Basic researchTranslational and applied researchRegulatory use and routine productionProtection of the natural environment in the interests of the health or welfare of human beings or animalsPreservation of speciesHigher education or training for the acquisition, maintenance or improvement of vocational skillsForensic enquiriesMaintenance of colonies of established genetically altered animals, not used in other proceduresi.   Basic researchBasic research includes studies of a fundamental nature including physiology. Studies that are designed to add knowledge about normal and abnormal structure, functioning and behaviour of living organisms and environment, this includes fundamental studies in toxicology. Investigation and analysis focused on a better or fuller understanding of a subject, phenomenon, or a basic law of nature instead of on a specific practical application of the results.

The animals used for the creation of a new genetically altered animal line (including crossing of two lines)intended to be used for thepurposes of basic research(e.g. developmental biology, immunology) should be recordedaccording to the purposethey are being created for. In addition they should be reported in “Creation of a new genetic line – Animals used for the creation of a new genetically altered line/strain”.

All animals carrying the genetic alteration should be reported during the creation of a new line. Also animals used in creation, such as for superovulation, vasectomy and embryo implantation, are reported here. The reporting should exclude non-genetically altered (wild type) offspring.

A new strain or line of genetically altered animals is considered to be “established” when transmission of the genetic alteration is stable, which will be aminimumof two generations, and a welfare assessment has been completed.

ii.   Translational and applied researchTranslational and applied research includes animals used for purposes as described in Article 5(b) and (c) excluding any regulatory use of animals.

This also includes discovery toxicology and investigations to prepare for the regulatory submission and method development. This does not include studies required for regulatory submissions.

The animals used for thecreationof a new genetically altered animal line (including crossing of two lines)intended to be used for thepurposes of translational or applied research(e.g. cancer research, vaccine development) should be recordedaccording to the purposethey are being created for. In addition, they should be reported in “Creation of a new genetic line – Animals used for the creation of a new genetically altered line/strain”.

All animals carrying the genetic alteration should be reported during the creation of a new line. Also animals used in creation, such as for superovulation, vasectomy and embryo implantation, are reported here. The reporting should exclude non-genetically altered (wild type) offspring.

A new strain or line of genetically altered animals is considered to be “established” when transmission of the genetic alteration is stable, which will be aminimumof two generations, and a welfare assessment has been completed.

iii.   Regulatory use and routine production by typeUse of animals in procedures carried out with a view to satisfying legal requirements for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed. This includes tests carried out on products/substances for which no regulatory submission is ultimately made if those tests would have been included in a regulatory submission had a regulatory submission occurred (i.e. tests performed on those products/substances that fail to reach the end of the development process).

This also includes animals used in the manufacturing process of products if that manufacturing process requires regulatory approval (e.g. animals used in the manufacturing serum-based medicinal products should be included within this category).

The efficacy testing during the development of new medicinal products is excluded and should be reported under category “Translational and applied research”.

iv.   Protection of the natural environment in the interests of the health or welfare of human beings or animalsThis includes studies aimed at investigating and understanding phenomena such as environmental pollution, loss of biodiversity, and epidemiology studies in wild animals.

This excludes any regulatory use of animals for ecotoxicology purposes.

v.   Higher education or training for the acquisition, maintenance or improvement of vocational skillsThis includes training to acquire and maintain practical competence in techniques as required under Article 23(2).

vi.   Maintenance of colonies of established genetically altered animals, not used in other proceduresThis contains the number of animals required for themaintenanceof colonies of genetically altered animals of established lineswith an intended harmful phenotypeand which have exhibited pain, suffering, distress or lasting harm as a consequence of the harmful genotype. The intended purpose for which the line is being bred for is not recorded.

This excludes all animals needed for thecreationof a new genetically altered line and those usedin other procedures(other than creation/breeding).

10.   Basic research studies

OncologyCardiovascular Blood and Lymphatic SystemNervous SystemRespiratory SystemGastrointestinal System including LiverMusculoskeletal SystemImmune SystemUrogenital/Reproductive SystemSensory Organs (skin, eyes and ears)Endocrine System/MetabolismMultisystemicEthology / Animal Behaviour /Animal BiologyOtheri.   OncologyAny research studying oncology should be included here regardless of the target system.

ii.   Nervous systemThis category includes neuroscience, peripheral or central nervous system, psychology.

iii.   Sensory Organs (skin eyes and ears)Studies on nose should be reported under ‧Respiratory System‧ and those on tongue should be reported under ‧Gastrointestinal System including Liver‧

iv.   MultisystemicThis should only include research where more than one system is the primary interest, such as on some infectious diseases, and excluding oncology.

v.   Ethology / Animal Behaviour /Animal Biology category covers both animals in the wild and in captivity with the primary goal of learning more about that specific species.

vi.   OtherResearch that is not related to an organ/system listed above or is not organ/system specific.

vii.   RemarksAnimals used for the production and maintenance of infectious agents, vectors and neoplasms, animals used for other biological material and animals used for the production of polyclonal antibodies for the purposes of translational/applied research, but excluding production of monoclonal antibodies by ascites method (which is covered under category “Regulatory use and routine production by type”) should be reported in the respective fields of categories “Basic research studies” or “Translational and applied research”. The purpose of studies needs to be carefully established, because any listings under the two categories could apply and only the main purpose shall be reported.

11.   Translational and applied research

Human CancerHuman Infectious DisordersHuman Cardiovascular DisordersHuman Nervous and Mental DisordersHuman Respiratory DisordersHuman Gastrointestinal Disorders including LiverHuman Musculoskeletal DisordersHuman Immune DisordersHuman Urogenital/Reproductive DisordersHuman Sensory Organ Disorders (skin, eyes and ears)Human Endocrine/Metabolism DisordersOther Human DisordersAnimal Diseases and DisordersAnimal WelfareDiagnosis of diseasesPlant diseasesNon-regulatory toxicology and ecotoxicologyi.   Any applied research studyinghuman cancerandhuman infectious disordersshould be included regardless of the target system.

ii.   Any regulatory use of animals is to be excluded such as regulatory carcinogenicity studies.

iii.   Studies on disorders of the nose should be reported under ‧Human Respiratory Disorders‧ and those of the tongue should be reported under ‧Human Gastrointestinal Disorders including Liver‧.

iv.   Diagnosis of diseases includes animals used in direct diagnosis of diseases such as rabies, botulism, but excluding those covered under regulatory use.

v.   Non-regulatory toxicology covers discovery toxicology and investigations to prepare for the regulatory submission and method development. This category does not include studies required for regulatory submissions (preliminary studies, MTD (Maximum Tolerated Dose)).

vi.   Animal welfare should include studies as per Article 5(b)(iii) of Directive 2010/63/EU.

vii.   RemarksAnimals used for the production and maintenance of infectious agents, vectors and neoplasms, animals used for other biological material and animals used for the production of polyclonal antibodies for the purposes of translational/applied research, but excluding production of monoclonal antibodies by ascites method (which is covered under category “Regulatory use and routine production by type”) should be reported in the respective fields of categories “Basic research studies” or “Translational and applied research”. The purpose of studies needs to be carefully established, because any listings under the two categories could apply and only the main purpose shall be reported.

12.   Regulatory use and routine production
 | i. | Use of animals in procedures carried out with a view to satisfying legal requirements for producing, placing and maintaining products/substances on the market, including safety and risk assessment for food and feed.

 | ii. | This includes tests carried out on products/substances for which no regulatory submission is made (i.e. tests performed on those products/substances (for which a regulatory submission was foreseen) that are ultimately deemed unsuitable for the market by the developer, and thus fail to reach the end of the development process).

 | iii. | This category also includes animals used in the manufacturing process of products if that manufacturing process requires regulatory approval (e.g. animals used in the manufacturing of serum-based medicinal products should be included within this category).13.   Regulatory use and routine production by type

Quality control (incl. batch safety and potency testing)Other efficacy and tolerance testingToxicity and other safety testing including pharmacologyRoutine production

 | i. | Efficacy testing during the development of new medicinal product is excluded and should be reported under category “Translational and Applied research”.

 | ii. | Quality control includes animals used in the testing of purity, stability, efficacy, potency and other quality control parameters of the final product and its constituents and any controls carried out during the manufacturing process for registration purposes, to satisfy any other national or international regulatory requirements or to satisfy the in-house policy of the manufacturer. This includes pyrogenicity testing.

 | iii. | Other efficacy and tolerance testing Efficacy testing of biocides and pesticides is covered under this category as well as the tolerance testing of additives in animal nutrition.

 | iv. | Routine production covers the production of monoclonal antibodies (by ascites) and blood products including polyclonal antisera by established methods. This excludes immunisation of animals for hybridoma production which should be captured under basic or applied research under the appropriate category.

 | v. | Toxicity and other safety testing (including safety evaluation of products and devices for human medicine and dentistry and veterinary medicine) covers studies carried out on any product or substance to determine its potential to cause any dangerous or undesirable effects in humans or animals as a result of its intended or abnormal use, manufacture or as a potential or actual contaminant in the environment.14.   Quality control (incl. batch safety and potency testing)

Batch safety testingPyrogenicity testingBatch potency testingOther quality controlsBatch safety testing excludes pyrogenicity testing. These are reported under a separate category Pyrogenicity testing.

15.   Toxicity and other safety testing required by legislation

Legislation on medicinal products for human useLegislation on medicinal products for veterinary use and their residuesMedical devices legislationIndustrial chemicals legislationPlant protection product legislationBiocides legislationFood legislation including food contact materialFeed legislation including legislation for the safety of target animals, workers and environmentCosmetics legislationOther

 | i. | The legislative requirement should be entered as per theintended primaryuse.

 | ii. | Water quality; if concerning e.g. tap water to be reported under food legislation16.   Legislative requirements

Legislation satisfying EU requirementsLegislation satisfying national requirements only (within EU)Legislation satisfying Non-EU requirements only

 | i. | This category allows identification of the level of harmonisation between different legislative requirements. The determining factor is notwhorequests the test to be carried out but which legislation is satisfied, giving priority to the widest level of harmonisation.

 | ii. | Where national legislation is derived from EU legislation, only Legislation satisfying EU requirements is to be chosen.

 | iii. | Legislation satisfying EU requirements also includes any international requirement which at the same time satisfies EU requirements (such as testing to ICH, VICH, OECD guidelines, European Pharmacopoeia monographs).

 | iv. | Legislation satisfying national requirements only (within EU) is to be chosen only when the test is carried out to satisfy the requirements of one or more Member State; not necessarily the one in which the work is being carried out. However, there is no equivalent requirement in the EU.

 | v. | Legislation satisfying Non-EU requirements only is to be chosen when there is no equivalent requirement to carry out the test to satisfy EU requirements.17.   Toxicity and other safety testing by test type

Acute (single dose) toxicity testing methods (including limit test)Skin irritation/corrosionSkin sensitisationEye irritation/corrosionRepeated dose toxicityCarcinogenicityGenotoxicityReproductive toxicityDevelopmental toxicityNeurotoxicityKinetics (pharmacokinetics, toxicokinetics, residue depletion)Pharmaco-dynamics (including safety pharmacology)PhototoxicityEcotoxicitySafety testing in food and feed areaTarget animal safetyOther

 | i. | Immunotoxicology studies should be covered under Repeated dose toxicity.

 | ii. | Kinetics (pharmacokinetics, toxicokinetics, residue depletion) if toxicokinetics is performed as part of the regulatory repeat dose toxicity study, it should be reported under repeated dose toxicity.

 | iii. | Safety testing in the food and feed area includes testing of drinking water (including target animal safety testing).

 | iv. | Target animal safety this is testing to ensure a product for a specific animal can be used safely on that species (excluding batch safety testing which is covered under quality control).18.   Acute and sub-acute toxicity testing methods

LD50, LC50Other lethal methodsNon lethal methods19.   Repeated dose toxicity

Up to 28 days29 – 90 days> 90 days20.   Use of animals for regulated production by product type

Blood based productsMonoclonal antibodiesOther21.   Ecotoxicity

Acute toxicityChronic toxicityReproductive toxicityEndocrine activityBioaccumulationOtherC.   MEMBER STATE NARRATIVE
 | 1. | General information on any changes in trends observed since the previous reporting period.

 | 2. | Information on significant increase or decrease in use animals in any of the specific areas and analysis of the reasons thereof.

 | 3. | Information on any changes in trends in actual severities and analysis of the reasons thereof.

 | 4. | Particular efforts to promote the principle of replacement, reduction and refinement and its impacts on statistics if any.

 | 5. | Further breakdown on the use of “other” categories if a significant proportion of animal use is reported under this category.

 | 6. | Details on cases where the ‧severe‧ classification is exceeded, whether pre-authorised or not, covering the species, numbers, whether prior exemption was authorised, the details of the use and the reasons why ‧severe‧ classification was exceeded.
ANNEX III

REPORTING FORMAT FOR THE SUBMISSION OF THE INFORMATION ON THE EXEMPTIONS GRANTED UNDER ARTICLE 6(4)(a) OF DIRECTIVE 2010/63/EU REFERRED TO IN ARTICLE 54(3) OF THAT DIRECTIVE
Type of method | Species | Justification

 |  | 

 |  | 

 |  | 

 |  | 

 |  |

Pending: 32012D0481

                                January 16, 2026                            

21.8.2012
EN
Official Journal of the European Union
L 223/55

(1)
Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2)
Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3)
Since the chemicals used in the printed paper products may hinder recyclability of printed paper products, and may be hazardous for the environment and for human health, it is appropriate to establish EU Ecolabel criteria for the product group ‘printed paper’.

(4)
The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

(a)
printed tissue papers;

(b)
printed paper products used for packaging and wrapping;

(c)
folders, envelopes, ring binders.

(1)
‘Books’ means yarn-bound and/or glue-bound printed paper products with hard or soft covers, such as school books, fiction or non-fiction books, notebooks, exercise books, spiral-bound notebook, reports, calendars with covers, handbooks and paperbacks. ‘Books’ do not include journals, brochures, magazines, catalogues published on a regular basis and annual reports.

(2)
‘Consumables’ means chemical products used during the printing, coating and finishing processes and capable of being consumed, destroyed, dissipated, wasted, or spent. Consumables include products such as printing inks and dyes, toners, overprinting varnishes, varnishes, adhesives, washing agents and damping solutions.

(3)
‘Folder’ means a folding case or cover for loose papers. Folders include products such as indices dividers, document wallets, square cut folders, suspension files, cardboard boxes and 3-flap folders.

(4)
‘Halogenated organic solvent’ means an organic solvent which contains at least one atom of bromine, chlorine, fluorine or iodine per molecule.

(5)
An ‘insert’ means an extra leaf or section, printed independently from the printed paper product which is either placed within the pages of a printed paper product and may be removed (loose insert) or bound into the pages of the printed paper product and thus form an integral part thereof (fixed insert). Inserts include multipage advertisements, booklets, brochures, reply cards, or other promotional materials.

(6)
‘Newspapers’ means a publication issued daily or weekly containing news and printed on newsprint paper grade that is made from pulp and/or recovered paper, the weight of which ranges between 40 and 65 g/m2.

(7)
‘Non-paper components’ means all the parts of a printed paper product that do not consist of paper, paperboard or paper based substrates.

(8)
‘Packaging’ means all products made of any materials of any nature to be used for the containment, protection, handling, delivery and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer.

(9)
A ‘printed paper product’ means the product resulting from the processing of a printing material. The processing consists of printing onto paper. In addition to printing, the processing may include finishing, for example folding, stamping and cutting or assembling, using glue, binding, yarn-binding. Printed paper products include newspapers, advertising materials and newssheets, journals, catalogues, books, leaflets, brochures, pads, posters, loose-leafs, business cards, and labels.

(10)
‘Printing’ (or printing process) means a process whereby a printing material is processed into a printed paper product. Printing includes pre-press, press, and post-press operations.

(11)
‘Recycling’ means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original purpose or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.

(12)
‘VOC’ (Volatile Organic Compounds) means any organic compound as well as the fraction of creosote, having at 293,15 K a vapour pressure of 0,01 kPa or more, or having a corresponding volatility under the particular conditions of use.

(13)
‘Washing agents’ (also sometimes known as cleaning agents or cleaners) means the following: (a) liquid chemicals used to wash printing forms, both separate (off-press) and integrated (in-press), and printing presses to remove printing inks, paper dust and similar products; (b) cleaners for finishing machines and printing machines, such as cleaners to remove adhesive and varnish residues; (c) printing inks removers used in washing off dried printing inks. Washing agents do not include cleaning agents for cleaning other parts of the printing machine or for cleaning other machines than printing machines and finishing machines.

(14)
‘Waste paper’ means paper generated during printing and finishing processes, or while shaving or cutting paper or during starting runs in the print workshop and the bindery, which does not form part of the finished printed paper product.

1.
Substrate

2.
Excluded or limited substances and mixtures

3.
Recyclability

4.
Emissions

5.
Waste

6.
Energy

7.
Training

8.
Fitness for use

9.
Information on the product

10.
Information appearing on the EU Ecolabel

(a)
The printed paper product shall be printed only on paper bearing the EU Ecolabel as established in Commission Decision 2011/333/EU(2).

(b)
Where newsprint paper is used, the printed paper product shall be printed only on paper bearing the EU Ecolabel as established in Commission Decision 2012/448/EU(3).

Hazard Statement(7)
Risk Phrase(8)

H300 Fatal if swallowed
R28

H301 Toxic if swallowed
R25

H304 May be fatal if swallowed and enters airways
R65

H310 Fatal in contact with skin
R27

H311 Toxic in contact with skin
R24

H330 Fatal if inhaled
R26

H331 Toxic if inhaled
R23

H340 May cause genetic defects
R46

H341 Suspected of causing genetic defects
R68

H350 May cause cancer
R45

H350i May cause cancer by inhalation
R49

H351 Suspected of causing cancer
R40

H360F May damage fertility
R60

H360D May damage the unborn child
R61

H360FD May damage fertility. May damage the unborn child
R60; R61; R60-61

H360Fd May damage fertility. Suspected of damaging the unborn child
R60-R63

H360Df May damage the unborn child. Suspected of damaging fertility
R61-R62

H361f Suspected of damaging fertility
R62

H361d Suspected of damaging the unborn child
R63

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child
R62-63

H362 May cause harm to breast fed children
R64

H370 Causes damage to organs
R39/23; R39/24; R39/25; R39/26; R39/27; R39/28

H371 May cause damage to organs
R68/20; R68/21; R68/22

H372 Causes damage to organs through prolonged or repeated exposure
R48/25; R48/24; R48/23

H373 May cause damage to organs through prolonged or repeated exposure
R48/20; R48/21; R48/22

H400 Very toxic to aquatic life
R50

H410 Very toxic to aquatic life with long-lasting effects
R50-53

H411 Toxic to aquatic life with long-lasting effects
R51-53

H412 Harmful to aquatic life with long-lasting effects
R52-53

H413 May cause long-lasting harmful effects to aquatic life
R53

EUH059 Hazardous to the ozone layer
R59

EUH029 Contact with water liberates toxic gas
R29

EUH031 Contact with acids liberates toxic gas
R31

EUH032 Contact with acids liberates very toxic gas
R32

EUH070 Toxic by eye contact
R39-41

(i)
The amount of aromatic hydrocarbons in the washing agent products used does not exceed 0,1 % (w/w);

(ii)
The amount of aromatic hydrocarbon-based washing agent used annually does not exceed 5 % of the total amount of washing agent used in one calendar year.

—
Alkyl phenol ethoxylates and their derivatives that may produce alkyl phenols by degradation.

—
Halogenated solvents that at the time of application are classified in the hazard or risk categories listed in point 2(a).

—
Phthalates that at the time of application are classified with risk phrases H360F, H360D, H361f in accordance with Regulation (EC) No 1272/2008.

(a)
Wet strength agents may be used only if the recyclability of the finished product can be proved.

(b)
Adhesives may be used only if their removability can be proved.

(c)
Coating varnishes and lamination, including polyethene and/or polyethene/polypropylene, may be used only for covers of books, pads, magazines and catalogues, exercise books.

(d)
The de-inkability shall be proved.

PVOC
=
the annual total kilograms of VOC contained in the purchased chemical products used for the annual total production of printed products

RVOC
=
the annual total kilograms of VOC destroyed by abatement, recovered from printing processes and sold, or reused

Ppaper
=
the annual total tonnes of paper purchased and used for the production of printed products.

(i)
For heat-set offset printing with an integrated after-burner unit in place for the drying unit, the following calculation method shall apply:PVOC=90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.
PVOC
=
90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.

PVOC
=
90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.

PVOC
=
90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.

(ii)
For heat-set offset printing, without an integrated after-burner unit in place for the drying unit, the following calculation method shall apply:PVOC=90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.
PVOC
=
90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.

PVOC
=
90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.

PVOC
=
90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.

(i)
Publication rotogravure printing emissions of VOC to air shall not exceed 50 mg C/Nm3.Assessment and verification: the applicant shall provide appropriate documentation showing compliance with this criterion.

(ii)
Equipment for reduction of emission to air of Cr6 +shall be installed.

(iii)
Emissions of Cr6 +to air shall not exceed 15 mg/tonne paper.Assessment and verification: the applicant shall provide a description of the system in place, together with a documentation related to the control and the monitoring of Cr6 +emissions. The documentation shall include the test results related to the reduction of Cr6 +emissions to the air.

(i)
handling, collection, separation and use of recyclable materials from the waste stream,

(ii)
precovery of materials for other uses, such as incineration for raising process steam or heating, or agricultural use,

(iii)
handling, collection, separation and disposal of hazardous waste, as defined by the relevant local and national regulatory authorities.

Printing method
Maximum Waste paper (%)

Sheet offset
23

Coldset, newspaper
10

Coldset, form printing
18

Coldset rotation (except newspapers and forms)
19

Heatset rotation
21

Gravure printing
15

Flexography (except corrugated fibreboard)
11

Digital printing
10

Offset
4

Flexography, corrugated fibreboard
17

Screen printing
23

X
=
annual tonnes of waste paper produced during the printing (including finishing processes) of the ecolabelled printed paper product, divided by annual tonnes of paper purchased and used for the production of ecolabelled printed paper product.

—
This printed product is recyclable

—
It is printed using paper with low environmental impact

—
Emissions of chemicals to air and water of paper production and printing process have been limited

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,

After consulting the European Union Eco-labelling Board,

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3) Since the chemicals used in the printed paper products may hinder recyclability of printed paper products, and may be hazardous for the environment and for human health, it is appropriate to establish EU Ecolabel criteria for the product group ‘printed paper’.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:
Article 1

1.   The product group ‘printed paper’ shall comprise any printed paper product that consist of at least 90 % by weight of paper, paperboard or paper-based substrates, except for books, catalogues, pads, booklets or forms that shall consist of at least 80 % by weight of paper or paperboard or paper-based substrates. Inserts, covers and any printed paper part of the final printed paper shall be considered to form part of the printed paper product.

2.   Fixed inserts to the printed paper product (not intended to be removed) shall fulfil the requirements of the Annex to this Decision. Inserts that are not fixed to the printed paper (such as flyers, removable stickers) but sold or provided with it, shall fulfil the requirements of the Annex to this Decision only if the EU Ecolabel is intended to be placed on them.

3.   The product group ‘printed paper’ shall not include the following:

(a)

printed tissue papers;

(b)

printed paper products used for packaging and wrapping;

(c)

folders, envelopes, ring binders.
Article 2

For the purpose of this Decision, the following definitions shall apply:

(1)

‘Books’ means yarn-bound and/or glue-bound printed paper products with hard or soft covers, such as school books, fiction or non-fiction books, notebooks, exercise books, spiral-bound notebook, reports, calendars with covers, handbooks and paperbacks. ‘Books’ do not include journals, brochures, magazines, catalogues published on a regular basis and annual reports.

(2)

‘Consumables’ means chemical products used during the printing, coating and finishing processes and capable of being consumed, destroyed, dissipated, wasted, or spent. Consumables include products such as printing inks and dyes, toners, overprinting varnishes, varnishes, adhesives, washing agents and damping solutions.

(3)

‘Folder’ means a folding case or cover for loose papers. Folders include products such as indices dividers, document wallets, square cut folders, suspension files, cardboard boxes and 3-flap folders.

(4)

‘Halogenated organic solvent’ means an organic solvent which contains at least one atom of bromine, chlorine, fluorine or iodine per molecule.

(5)

An ‘insert’ means an extra leaf or section, printed independently from the printed paper product which is either placed within the pages of a printed paper product and may be removed (loose insert) or bound into the pages of the printed paper product and thus form an integral part thereof (fixed insert). Inserts include multipage advertisements, booklets, brochures, reply cards, or other promotional materials.

(6)

‘Newspapers’ means a publication issued daily or weekly containing news and printed on newsprint paper grade that is made from pulp and/or recovered paper, the weight of which ranges between 40 and 65 g/m2.

(7)

‘Non-paper components’ means all the parts of a printed paper product that do not consist of paper, paperboard or paper based substrates.

(8)

‘Packaging’ means all products made of any materials of any nature to be used for the containment, protection, handling, delivery and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer.

(9)

A ‘printed paper product’ means the product resulting from the processing of a printing material. The processing consists of printing onto paper. In addition to printing, the processing may include finishing, for example folding, stamping and cutting or assembling, using glue, binding, yarn-binding. Printed paper products include newspapers, advertising materials and newssheets, journals, catalogues, books, leaflets, brochures, pads, posters, loose-leafs, business cards, and labels.

(10)

‘Printing’ (or printing process) means a process whereby a printing material is processed into a printed paper product. Printing includes pre-press, press, and post-press operations.

(11)

‘Recycling’ means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original purpose or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.

(12)

‘VOC’ (Volatile Organic Compounds) means any organic compound as well as the fraction of creosote, having at 293,15 K a vapour pressure of 0,01 kPa or more, or having a corresponding volatility under the particular conditions of use.

(13)

‘Washing agents’ (also sometimes known as cleaning agents or cleaners) means the following: (a) liquid chemicals used to wash printing forms, both separate (off-press) and integrated (in-press), and printing presses to remove printing inks, paper dust and similar products; (b) cleaners for finishing machines and printing machines, such as cleaners to remove adhesive and varnish residues; (c) printing inks removers used in washing off dried printing inks. Washing agents do not include cleaning agents for cleaning other parts of the printing machine or for cleaning other machines than printing machines and finishing machines.

(14)

‘Waste paper’ means paper generated during printing and finishing processes, or while shaving or cutting paper or during starting runs in the print workshop and the bindery, which does not form part of the finished printed paper product.
Article 3

In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of printed paper shall fall within the product group ‘Printed paper’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.
Article 4

The criteria for the product group ‘Printed paper’, as well as the related assessment and verification requirements, shall be valid for three years from the date of adoption of this Decision.
Article 5

For administrative purposes the code number assigned to ‘printed paper’ shall be ‘028’.
Article 6

This Decision is addressed to the Member States.
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,

After consulting the European Union Eco-labelling Board,

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3) Since the chemicals used in the printed paper products may hinder recyclability of printed paper products, and may be hazardous for the environment and for human health, it is appropriate to establish EU Ecolabel criteria for the product group ‘printed paper’.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:
1.   The product group ‘printed paper’ shall comprise any printed paper product that consist of at least 90 % by weight of paper, paperboard or paper-based substrates, except for books, catalogues, pads, booklets or forms that shall consist of at least 80 % by weight of paper or paperboard or paper-based substrates. Inserts, covers and any printed paper part of the final printed paper shall be considered to form part of the printed paper product.

2.   Fixed inserts to the printed paper product (not intended to be removed) shall fulfil the requirements of the Annex to this Decision. Inserts that are not fixed to the printed paper (such as flyers, removable stickers) but sold or provided with it, shall fulfil the requirements of the Annex to this Decision only if the EU Ecolabel is intended to be placed on them.

3.   The product group ‘printed paper’ shall not include the following:

(a)

printed tissue papers;

(b)

printed paper products used for packaging and wrapping;

(c)

folders, envelopes, ring binders.
For the purpose of this Decision, the following definitions shall apply:

(1)

‘Books’ means yarn-bound and/or glue-bound printed paper products with hard or soft covers, such as school books, fiction or non-fiction books, notebooks, exercise books, spiral-bound notebook, reports, calendars with covers, handbooks and paperbacks. ‘Books’ do not include journals, brochures, magazines, catalogues published on a regular basis and annual reports.

(2)

‘Consumables’ means chemical products used during the printing, coating and finishing processes and capable of being consumed, destroyed, dissipated, wasted, or spent. Consumables include products such as printing inks and dyes, toners, overprinting varnishes, varnishes, adhesives, washing agents and damping solutions.

(3)

‘Folder’ means a folding case or cover for loose papers. Folders include products such as indices dividers, document wallets, square cut folders, suspension files, cardboard boxes and 3-flap folders.

(4)

‘Halogenated organic solvent’ means an organic solvent which contains at least one atom of bromine, chlorine, fluorine or iodine per molecule.

(5)

An ‘insert’ means an extra leaf or section, printed independently from the printed paper product which is either placed within the pages of a printed paper product and may be removed (loose insert) or bound into the pages of the printed paper product and thus form an integral part thereof (fixed insert). Inserts include multipage advertisements, booklets, brochures, reply cards, or other promotional materials.

(6)

‘Newspapers’ means a publication issued daily or weekly containing news and printed on newsprint paper grade that is made from pulp and/or recovered paper, the weight of which ranges between 40 and 65 g/m2.

(7)

‘Non-paper components’ means all the parts of a printed paper product that do not consist of paper, paperboard or paper based substrates.

(8)

‘Packaging’ means all products made of any materials of any nature to be used for the containment, protection, handling, delivery and presentation of goods, from raw materials to processed goods, from the producer to the user or the consumer.

(9)

A ‘printed paper product’ means the product resulting from the processing of a printing material. The processing consists of printing onto paper. In addition to printing, the processing may include finishing, for example folding, stamping and cutting or assembling, using glue, binding, yarn-binding. Printed paper products include newspapers, advertising materials and newssheets, journals, catalogues, books, leaflets, brochures, pads, posters, loose-leafs, business cards, and labels.

(10)

‘Printing’ (or printing process) means a process whereby a printing material is processed into a printed paper product. Printing includes pre-press, press, and post-press operations.

(11)

‘Recycling’ means any recovery operation by which waste materials are reprocessed into products, materials or substances whether for the original purpose or other purposes. It includes the reprocessing of organic material but does not include energy recovery and the reprocessing into materials that are to be used as fuels or for backfilling operations.

(12)

‘VOC’ (Volatile Organic Compounds) means any organic compound as well as the fraction of creosote, having at 293,15 K a vapour pressure of 0,01 kPa or more, or having a corresponding volatility under the particular conditions of use.

(13)

‘Washing agents’ (also sometimes known as cleaning agents or cleaners) means the following: (a) liquid chemicals used to wash printing forms, both separate (off-press) and integrated (in-press), and printing presses to remove printing inks, paper dust and similar products; (b) cleaners for finishing machines and printing machines, such as cleaners to remove adhesive and varnish residues; (c) printing inks removers used in washing off dried printing inks. Washing agents do not include cleaning agents for cleaning other parts of the printing machine or for cleaning other machines than printing machines and finishing machines.

(14)

‘Waste paper’ means paper generated during printing and finishing processes, or while shaving or cutting paper or during starting runs in the print workshop and the bindery, which does not form part of the finished printed paper product.
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of printed paper shall fall within the product group ‘Printed paper’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.
The criteria for the product group ‘Printed paper’, as well as the related assessment and verification requirements, shall be valid for three years from the date of adoption of this Decision.
For administrative purposes the code number assigned to ‘printed paper’ shall be ‘028’.
This Decision is addressed to the Member States.
FRAMEWORKANNEX

The aims of the criteria

The criteria aim, in particular, at promoting the environmental efficiency of de-inkability and recyclability for printed paper products, the reduction of VOC emissions, the reduction or prevention of risks for the environment and for human health related to the use of hazardous substances. The criteria are set at levels that promote the labelling of printed paper products that have a low environmental impact.
CRITERIA

These criteria are set for each of the following aspects:
1. | Substrate

2. | Excluded or limited substances and mixtures

3. | Recyclability

4. | Emissions

5. | Waste

6. | Energy

7. | Training

8. | Fitness for use

9. | Information on the product

10. | Information appearing on the EU EcolabelCriteria 1, 3, 8, 9 and 10 apply to the final printed paper product.

Criterion 2 applies both to the non-paper components of the printed paper product and to the printing, coating and finishing processes of the paper components.

Criteria 4, 5, 6 and 7 apply to the printing, coating and finishing processes of the paper components only.

These criteria apply to all such processes undertaken at the site or sites where the printed paper product is manufactured. If there are printing, coatings and finishing processes exclusively used for ecolabelled products, criteria 2, 4, 5, 6 and 7 shall apply only to those processes.

The ecological criteria do not cover the transport of raw materials, consumables and final products.
Assessment and verification requirements

The specific assessment and verification requirements are indicated within each criterion.

All printing on the printed paper product shall fulfil the criteria. Parts of the product that are printed by a sub-contractor shall therefore also fulfil the printing requirements. The application shall include a list of all the printing houses and subcontractors involved in the production of the printed paper, and their geographic locations.

The applicant shall provide a list of chemical products used in the printing house for the production of the printed paper products. This requirement applies to all consumables used during the printing, coating and finishing processes. The list provided by the applicant shall include the amount, function and supplier of any chemical product used, together with the Safety Data Sheet, designed in accordance with Commission Directive 2001/58/EC(1).

Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, it is understood that those may originate from the applicant and/or his supplier(s) and/or their supplier(s), as appropriate.

Where appropriate, test methods other than those indicated for each criterion may be used if their equivalence is accepted by the competent body assessing the application.

Where possible, the testing should be performed by laboratories that meet the general requirements of EN ISO 17025 or equivalent.

Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.
EU ECOLABEL CRITERIA
Criterion 1 —   Substrate
 | (a) | The printed paper product shall be printed only on paper bearing the EU Ecolabel as established in Commission Decision 2011/333/EU(2).

 | (b) | Where newsprint paper is used, the printed paper product shall be printed only on paper bearing the EU Ecolabel as established in Commission Decision 2012/448/EU(3).Assessment and verification: the applicant shall provide the specifications of the printed paper products concerned, including the trade names, amounts and weight/m2of the paper used. The list shall also include the names of the suppliers of the papers used. The applicant shall provide a copy of a valid EU Ecolabel certificate for the paper used.
Criterion 2 —   Excluded or limited substances and mixtures

(a)   Hazardous substances and mixturesConsumables that could end up in the final printed paper product, and that contain substances and/or mixtures meeting the criteria for classification with the hazard statements or risk phrases specified below in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council(4)or Council Directive 67/548/EEC(5)or substances referred to in Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(6)shall not be used for printing, coating, and finishing operations of the final printed paper product.

This requirement shall not apply to toluene for use in rotogravure printing processes where a closed or encapsulated installation or recovery system, or any equivalent system, is in place to control and monitor fugitive emissions and where the recovery efficiency is at least 92 %. UV varnishes and UV inks classified H412/R52-53 are also exempted from this requirement.

The non-paper components (up to 20 % in weight, as specified in Article 1) that are part of the final paper product shall not contain the substances referred to above.

List of hazard statements and risk phrases:

Hazard Statement(7) | Risk Phrase(8)

H300 Fatal if swallowed | R28

H301 Toxic if swallowed | R25

H304 May be fatal if swallowed and enters airways | R65

H310 Fatal in contact with skin | R27

H311 Toxic in contact with skin | R24

H330 Fatal if inhaled | R26

H331 Toxic if inhaled | R23

H340 May cause genetic defects | R46

H341 Suspected of causing genetic defects | R68

H350 May cause cancer | R45

H350i May cause cancer by inhalation | R49

H351 Suspected of causing cancer | R40

H360F May damage fertility | R60

H360D May damage the unborn child | R61

H360FD May damage fertility. May damage the unborn child | R60; R61; R60-61

H360Fd May damage fertility. Suspected of damaging the unborn child | R60-R63

H360Df May damage the unborn child. Suspected of damaging fertility | R61-R62

H361f Suspected of damaging fertility | R62

H361d Suspected of damaging the unborn child | R63

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child | R62-63

H362 May cause harm to breast fed children | R64

H370 Causes damage to organs | R39/23; R39/24; R39/25; R39/26; R39/27; R39/28

H371 May cause damage to organs | R68/20; R68/21; R68/22

H372 Causes damage to organs through prolonged or repeated exposure | R48/25; R48/24; R48/23

H373 May cause damage to organs through prolonged or repeated exposure | R48/20; R48/21; R48/22

H400 Very toxic to aquatic life | R50

H410 Very toxic to aquatic life with long-lasting effects | R50-53

H411 Toxic to aquatic life with long-lasting effects | R51-53

H412 Harmful to aquatic life with long-lasting effects | R52-53

H413 May cause long-lasting harmful effects to aquatic life | R53

EUH059 Hazardous to the ozone layer | R59

EUH029 Contact with water liberates toxic gas | R29

EUH031 Contact with acids liberates toxic gas | R31

EUH032 Contact with acids liberates very toxic gas | R32

EUH070 Toxic by eye contact | R39-41Substances or mixtures which change their properties upon processing (e.g. become no longer bioavailable, undergo chemical modification) so that the identified hazard no longer applies are exempted from the above requirement.

Concentration limits for substances and mixtures which may be, or have been, assigned the hazard statements or risk phrase listed above or which meet the criteria for classification in the hazard classes or categories, and concentration limits for substances meeting the criteria of Article 57(a), (b) or (c) of Regulation (EC) No 1907/2006, shall not exceed the generic or specific concentration limits determined in accordance with Article 10 of Regulation (EC) No 1272/2008. Where specific concentration limits are determined they shall prevail over the generic ones.

Concentration limits for substances meeting criteria set out in Article 57(d), (e) or (f) of Regulation (EC) No 1907/2006 shall not exceed 0,1 % weight by weight.

Assessment and verification: For substances not already classified in accordance with Regulation (EC) No 1272/2008, the applicant shall prove compliance with these criteria by providing: (i) a declaration that the non-paper components that are part of the final product do not contain the substances referred to in these criteria in concentration above the authorised limits; (ii) a declaration that consumables that could end up in the final printed paper product and used for printing, coating, and finishing operations do not contain the substances referred to in these criteria in concentration above the authorised limits; (iii) a list of all consumables used for the printing, finishing and coating of the printed paper products. This list shall include the quantity, function and suppliers of all the consumables used in the production process.

The applicant shall demonstrate compliance with this criterion by providing a declaration on the non-classification of each substance into any of the hazard classes associated to the hazard statements referred to in the above list in accordance with Regulation (EC) No 1272/2008, as far as this can be determined, as a minimum, from the information meeting the requirements listed in Annex VII to Regulation (EC) No 1907/2006. This declaration shall be supported by summarised information on the relevant characteristics associated to the hazard statements referred to in the above list, to the level of detail specified in Sections 10, 11 and 12 of Annex II to Regulation (EC) No 1907/2006 (Requirements for the Compilation of Safety Data Sheets).

Information on intrinsic properties of substances may be generated by means other than tests, for instance through the use of alternative methods such asin vitromethods, by quantitative structure activity models or by the use of grouping or read-across in accordance with Annex XI to Regulation (EC) No 1907/2006. The sharing of relevant data is strongly encouraged.

The information provided shall relate to the forms or physical states of the substance or mixtures as used in the final product.

For substances listed in Annexes IV and V to REACH, exempted from registration obligations under Article 2(7)(a) and (b) of Regulation (EC) No 1907/2006 REACH, a declaration to this effect will suffice to comply with the requirements set out above.

The applicant shall provide appropriate documentation on the recovery efficiency of the closed/encapsulated installation/recovery system, or any equivalent system, that has been put in place to deal with the use of toluene in rotogravure printing processes.

(b)   Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006No derogation from the prohibition set out in Article 6(6)(a) of Regulation (EC) No 66/2010 shall be granted concerning substances identified as substances of very high concern and included in the list provided for in Article 59 of Regulation (EC) No 1907/2006, present in mixtures in concentrations higher than 0,1 %. Specific concentration limits determined in accordance with Article 10 of Regulation (EC) No 1272/2008 shall apply where the concentration is lower than 0,1 %.

Assessment and verification: the list of substances identified as substances of very high concern and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 can be found here:

http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

Reference to the list shall be made on the date of application.

The applicant shall prove compliance with the criterion providing data on the amount of substances used for the printing of the printed paper products and a declaration stating that the substances referred to in this criterion are not retained in the final product above the concentration limits specified. The concentration shall be specified in the safety data sheets in accordance with Article 31 of Regulation (EC) No 1907/2006.

(c)   BiocidesBiocides, either as part of the formulation or as part of any mixture included in the formulation, that are used to preserve the product and that are classified H410/R50-53 or H411/R51-53 in accordance with Directive 67/548/EEC, Council Directive 1999/45/EC(9)or Regulation (EC) No 1272/2008, are permitted only if their bioaccumulation potentials are characterised by log Pow (log octanol/water partition coefficient) < 3,0 or an experimentally determined bioconcentration factor (BCF) ≤ 100.

Assessment and verification: the applicant shall provide copies of the material safety data sheets for all biocides used during the different production stages, together with a documentation of the concentrations of the biocides in the final product.

(d)   Washing agentsWashing agents used for cleaning in printing processes and/or sub-processes that contain aromatic hydrocarbon shall only be allowed if they are in compliance with point 2(b) and if one of the following conditions is fulfilled:
(i) | The amount of aromatic hydrocarbons in the washing agent products used does not exceed 0,1 % (w/w);

(ii) | The amount of aromatic hydrocarbon-based washing agent used annually does not exceed 5 % of the total amount of washing agent used in one calendar year.This criterion shall not apply to toluene used as washing agent in rotogravure printing.

Assessment and verification: the applicant shall provide the Safety Data Sheet for each washing agent used in a printing house during the year to which the annual consumption refers. The washing agent suppliers shall provide declarations of the aromatic hydrocarbon contents in the washing agents.

(e)   Alkyl phenol ethoxylates — Halogenated solvents — PhthalatesThe following substances or preparations shall not be added to inks, dyes, toners, adhesives, or washing agents or other cleaning chemicals used for the printing of the printed paper product:
— | Alkyl phenol ethoxylates and their derivatives that may produce alkyl phenols by degradation.

— | Halogenated solvents that at the time of application are classified in the hazard or risk categories listed in point 2(a).

— | Phthalates that at the time of application are classified with risk phrases H360F, H360D, H361f in accordance with Regulation (EC) No 1272/2008.Assessment and verification: the applicant shall provide a declaration of compliance with this criterion.

(f)   Printing inks, toners, inks, varnishes, foils and laminatesThe following heavy metals or their compounds shall not be used in printing inks, toners, inks, varnishes, foils and laminates (whether as a substance or as part of any preparation used): cadmium, copper (excluding copper-phthalocyanine), lead, nickel, chromium VI, mercury, arsenic, soluble barium, selenium, antimony. Cobalt can only be used up to 0,1 % (w/w).

Ingredients may contain traces of those metals up to 0,01 % (w/w) deriving from impurities in the raw materials.

Assessment and verification: the applicant shall provide a declaration of compliance with this criterion as well as declarations from ingredient suppliers.
Criterion 3 —   Recyclability

The printed paper product shall be recyclable. The printed paper shall be de-inkable and the non-paper components of the printed paper product shall be easily removable to ensure that those components will not hinder the recycling process.
 | (a) | Wet strength agents may be used only if the recyclability of the finished product can be proved.

 | (b) | Adhesives may be used only if their removability can be proved.

 | (c) | Coating varnishes and lamination, including polyethene and/or polyethene/polypropylene, may be used only for covers of books, pads, magazines and catalogues, exercise books.

 | (d) | The de-inkability shall be proved.Assessment and verification: the applicant shall provide the test result of the recyclability for wet strength agents and removability for adhesives. The reference test methods are PTS method PTS-RH 021/97 (for wet strength agents), INGEDE Method 12 (for non-soluble adhesive removability), or equivalent test methods. The de-inkability shall be proven by using the ‘Deinking Scorecard’(10)of the European Recovered Paper Council or equivalent test methods. Testing must be performed on three types of paper: uncoated, coated and surface-sized paper. If a type of printing ink is only sold for one or two specific types of paper, it is sufficient to test the paper type(s) in question. The applicant shall provide a declaration that coated and laminated printed paper products are in compliance with point 3(b). Where a part of a printed paper product is easily removable (for instance a plastic cover or a reusable exercise book cover), the recyclability test may be made without this component. The easiness of removal of the non-paper components shall be proven via a declaration of the paper collecting company, the recycling company or an equivalent organisation. Test methods shown by a competent and independent third party as giving equivalent results may also be used.
Criterion 4 —   Emissions

(a)   Emissions to waterRinsing water containing silver from film processing, as well as from plate production, and photo-chemicals shall not be discharged to a sewage treatment plant.

Assessment and verification: the applicant shall provide a declaration of compliance with this criterion, together with a description of the management of photo-chemicals and silver containing rinsing water on site. Where the film processing and/or the plate production are outsourced, the sub-contractor shall provide a declaration of compliance with this criterion, together with a description of the management of photo-chemicals and silver containing rinsing water at the subcontractors.

The amount of Cr and Cu discharged into a sewage treatment plant must not exceed, respectively, 45 mg per m2and 400 mg per m2of printing cylinder surface area used in the press.

Assessment and verification: discharges of Cr and Cu into the sewage shall be checked at rotogravure printing plants after treatment and before their release. A representative sample of Cr and Cu discharges shall be collected each month. At least one annual analytical test shall be carried out by an accredited laboratory to determine the content of Cr and Cu in a representative sub-sample of these samples. Compliance with this criterion shall be assessed by dividing the content of Cr and Cu, as determined by the annual analytical test, by the cylinder surface used in the press during the printing. The cylinder surface used in the press during printing is calculated by multiplying the cylinder surface (= 2πrL, where r is the radius and L the length of the cylinder) by the number of printing productions during a year (= number of different printing jobs).

(b)   Emissions to airVolatile Organic Compounds (VOC)

The following criterion must be met:

(PVOC– RVOC)/Ppaper< 5 [kg/tonnes]

Where:
PVOC | = | the annual total kilograms of VOC contained in the purchased chemical products used for the annual total production of printed products

RVOC | = | the annual total kilograms of VOC destroyed by abatement, recovered from printing processes and sold, or reused

Ppaper | = | the annual total tonnes of paper purchased and used for the production of printed products.Where a printing house uses different printing technologies, this criterion shall be fulfilled for each one separately.

The PVOCterm shall be calculated from SDS information related to VOC content or from an equivalent declaration provided by the supplier of chemical products.

The RVOCterm shall be calculated from the declaration on the content of VOC contained in the chemical products sold or from the internal counting register (or any other equivalent document) reporting the annual amount of VOC recovered and reused on site.

Specific conditions for heat-set printing:
(i) | For heat-set offset printing with an integrated after-burner unit in place for the drying unit, the following calculation method shall apply:PVOC=90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products. | PVOC | = | 90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.

PVOC | = | 90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.

(ii) | For heat-set offset printing, without an integrated after-burner unit in place for the drying unit, the following calculation method shall apply:PVOC=90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products. | PVOC | = | 90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.

PVOC | = | 90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.For (i) and (ii), proportionately lower percentages than 90 % and 85 % may be used in this calculation if more than 10 % or 15 % respectively of annual total kilograms of VOC contained in the damping solutions or washing agents used for the annual production of printed products are shown to be abated in the treatment system for combusting gases from the drying process.

Assessment and verification: a declaration of the VOC content in alcohols, washing agents, inks, damping solutions or other corresponding chemical products shall be provided by the chemical supplier. The applicant shall provide evidence of the calculation according to the criteria laid down above. The period for the calculations shall be based on the production during 12 months. In case of a new or a rebuilt production plant, the calculations shall be based on at least three months of representative running of the plant.

(c)   Emissions from publication rotogravure printing

 | (i) | Publication rotogravure printing emissions of VOC to air shall not exceed 50 mg C/Nm3.Assessment and verification: the applicant shall provide appropriate documentation showing compliance with this criterion.

 | (ii) | Equipment for reduction of emission to air of Cr6 +shall be installed.

 | (iii) | Emissions of Cr6 +to air shall not exceed 15 mg/tonne paper.Assessment and verification: the applicant shall provide a description of the system in place, together with a documentation related to the control and the monitoring of Cr6 +emissions. The documentation shall include the test results related to the reduction of Cr6 +emissions to the air.(d)   Printing processes to which no legislative measures applyVolatile solvents from the drying process of heat-set offset and flexography printing shall be managed by means of recovery or combustion or any equivalent system. In all cases where no legislative measures apply, the emissions of VOC to air must not exceed 20 mg C/Nm3.

This requirement does not apply to screen printing and digital printing. Moreover it does not apply to heat-set and flexography installations with solvent consumption lower than 15 tonnes per year.

Assessment and verification: the applicant shall provide a description of the system in place together with documentation and test results related to the control and the monitoring of emissions to air.
Criterion 5 —   Waste

(a)   Waste managementThe facility where the printed paper products are produced shall have in place a system for handling waste, including residual products derived from the production of the printed paper products, as defined by local and national relevant regulatory authorities.

The system shall be documented or explained and shall include information on at least the following procedures:
(i) | handling, collection, separation and use of recyclable materials from the waste stream,

(ii) | precovery of materials for other uses, such as incineration for raising process steam or heating, or agricultural use,

(iii) | handling, collection, separation and disposal of hazardous waste, as defined by the relevant local and national regulatory authorities.Assessment and verification: the applicant shall provide a declaration of compliance with this criterion, together with a description of the procedures adopted for waste management. Where appropriate, the applicant shall provide the corresponding declaration to the local authority every year. Where the waste management is outsourced, the sub-contractor shall provide a declaration of compliance with this criterion as well.

(b)   Waste paperThe amount of waste paper ‘X’ produced shall be:
Printing method | Maximum Waste paper (%)

Sheet offset | 23

Coldset, newspaper | 10

Coldset, form printing | 18

Coldset rotation (except newspapers and forms) | 19

Heatset rotation | 21

Gravure printing | 15

Flexography (except corrugated fibreboard) | 11

Digital printing | 10

Offset | 4

Flexography, corrugated fibreboard | 17

Screen printing | 23where:
X | = | annual tonnes of waste paper produced during the printing (including finishing processes) of the ecolabelled printed paper product, divided by annual tonnes of paper purchased and used for the production of ecolabelled printed paper product.Where the printing house carries out finishing processes on behalf of another printing house, the amount of waste paper produced in those processes shall not be included in the calculation of ‘X’.

Where the finishing processes are outsourced to another company, the amount of waste paper resulting from the outsourced work shall be calculated and declared in the calculation of ‘X’.

Assessment and verification: the applicant shall provide a description of the calculation of the amount of waste paper, together with a declaration from the contractor collecting the waste paper from the printing house. The outsourcing terms and calculations on the amount of paper waste involved in the finishing processes shall be provided. The period for the calculations shall be based on the production during 12 months. In case of a new or a rebuilt production plant, the calculations shall be based on at least three months of representative running of the plant.
Criterion 6 —   Energy use

The printing house shall establish a register of all energy consuming devices (including machinery, lightning, air conditioning, cooling) and a programme consisting of measures for improvement of energy efficiency.

Assessment and verification: the applicant shall provide the register of energy consuming devices together with the improvement programme.
Criterion 7 —   Training

All members of staff participating in day-to-day operation shall be given the knowledge necessary to ensure that the Ecolabel requirements are fulfilled and continuously improved.

Assessment and verification: the applicant shall provide a declaration of compliance with this criterion, together with details of the training programme, its content, and an indication of which staff have received what training and when. The applicant shall provide to the Competent Body also a sample of training material.
Criterion 8 —   Fitness for use

The product shall be suitable for its purpose.

Assessment and verification: the applicant shall provide appropriate documentation in compliance with this criterion. National or commercial standards, where relevant, may be used by the applicant to prove the fitness for use of the printed paper products.
Criterion 9 —   Information on the product

The following information shall appear on the product:
                  ‘Please collect used paper for recycling’.

Assessment and verification: the applicant shall provide a sample of the product packaging bearing the information required.
Criterion 10 —   Information appearing on the EU Ecolabel

The optional label with text box shall contain the following text:
— | This printed product is recyclable

— | It is printed using paper with low environmental impact

— | Emissions of chemicals to air and water of paper production and printing process have been limitedThe guidelines for the use of the optional label with the text box can be found in the ‘Guidelines for the use of the EU Ecolabel logo’ on the website:

http://ec.europa.eu/environment/ecolabel/promo/pdf/logo%20guidelines.pdf

Assessment and verification: the applicant shall provide a sample of the printed paper product showing the label, together with a declaration of compliance with this criterion.
(1)  

            OJ L 212, 7.8.2001, p. 24.

(2)  Decision of 7 June 2011 on establishing the ecological criteria for the award of the EU Ecolabel for copying and graphic paper (OJ L 149, 8.6.2011, p. 12).

(3)  Decision of 12 July 2012 establishing the ecological criteria for the award of the EU Ecolabel for newsprint paper (OJ L 202, 28.7.2012, p. 26).

(4)  

            OJ L 353, 31.12.2008, p. 1.

(5)  

            OJ 196, 16.8.1967, p. 1.

(6)  

            OJ L 396, 30.12.2006, p. 1.

(7)  As provided for in Regulation (EC) No 1272/2008.

(8)  As provided for in Directive 67/548/EEC.

(9)  

            OJ L 200, 30.7.1999, p. 1.

(10)  Assessment of Print Product Recyclability — Deinkability Score — User’s Manual, www.paperrecovery.org, ‘Publications’.

Pending: 32012D0448

                                January 16, 2026                            

28.7.2012
EN
Official Journal of the European Union
L 202/26

(1)
Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2)
Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3)
Since the production of newsprint paper consumes significant amounts of energy, wood and chemicals, and may lead to environmental damage or risks related to the use of the natural resources, it is appropriate to establish EU Ecolabel criteria for the product group ‘newsprint paper’.

(4)
The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

(1)
‘newsprint paper’ means paper mainly used for printing newspapers and made from pulp and/or recovered paper the weight of which ranges between 40 and 65 g/m2;

(2)
‘recovered fibres’ means fibres diverted from the waste stream during a manufacturing process or generated by households or by commercial, industrial and institutional facilities in their role as end-users of the product which can no longer be used for their intended purpose.

1.
Emissions to water and air

2.
Energy use

3.
Fibres: sustainable forest management

4.
Hazardous chemical substances

5.
Waste management

6.
Fitness for use

7.
Information appearing on the Ecolabel

1.
Transport and packaging of the pulp, paper or raw materials

2.
Conversion of paper

Pulp Grade/Paper
Emissions (kg/ADT)

CODreference
Sreference
NOx,reference
Preference

Bleached Chemical pulp (others than sulphite)
18,0
0,6
1,6
0,045

Bleached Chemical pulp (sulphite)
25,0
0,6
1,6
0,045

Unbleached chemical pulp
10,0
0,6
1,6
0,04

CTMP
15,0
0,2
0,3
0,01

TMP/groundwood pulp
3,0
0,2
0,3
0,01

Recovered fibre pulp
2,0
0,2
0,3
0,01

Paper (non-integrated mills where all pulps used are purchased market pulps)
1
0,3
0,8
0,01

Paper (Other mills)
1
0,3
0,7
0,01

—
Until 31 March 2013, the AOX emissions from the production of each pulp used shall not exceed 0,20 kg/ADT.

—
From 1 April 2013 until the expiry of the period of validity of the criteria set out in this Decision, the AOX emissions from the production of each pulp used shall not exceed 0,17 kg/ADT.

Fuel
CO2 fossilemission
Unit

Coal
96
g CO2 fossil/MJ

Crude oil
73
g CO2 fossil/MJ

Fuel oil 1
74
g CO2 fossil/MJ

Fuel oil 2-5
81
g CO2 fossil/MJ

LPG
66
g CO2 fossil/MJ

Natural Gas
56
g CO2 fossil/MJ

Grid Electricity
400
g CO2 fossil/kWh

1.
Fpulp,i(and its contribution to PF,pulp) need not be calculated for mechanical pulp unless it is market air dried mechanical pulp containing at least 90 % dry matter.

2.
The amount of fuel used to produce the sold heat shall be added to the term sold fuel in the equation above.

Pulp grade
Fuel kWh/ADTFreference
Electricity kWh/ADTEreference

Non-admp
admp
Non-admp
admp

Chemical pulp
4 000
5 000
800
800

Thermomechanical pulp (TMP)
0
900
2 200
2 200

Groundwood pulp (including Pressurised Groundwood)
0
900
2 000
2 000

Chemithermomechanical pulp (CTMP)
0
1 000
2 000
2 000

Recovered fibre pulp
300
1 300
450
550

Paper grade
Fuel
kWh/tonne

ElectricitykWh/tonne

Newsprint paper grade

1 800

700

Admp=air dried market pulp.
Admp
=
air dried market pulp.

Admp
=
air dried market pulp.

Admp
=
air dried market pulp.

Hazard statement(6)
Risk phrase(7)

H300 Fatal if swallowed
R28

H301 Toxic if swallowed
R25

H304 May be fatal if swallowed and enters airways
R65

H310 Fatal in contact with skin
R27

H311 Toxic in contact with skin
R24

H330 Fatal if inhaled
R23/26

H331 Toxic if inhaled
R23

H340 May cause genetic defects
R46

H341 Suspected of causing genetic defects
R68

H350 May cause cancer
R45

H350i May cause cancer by inhalation
R49

H351 Suspected of causing cancer
R40

H360F May damage fertility
R60

H360D May damage the unborn child
R61

H360FD May damage fertility. May damage the unborn child
R60/61/60-61

H360Fd May damage fertility. Suspected of damaging the unborn child
R60/63

H360Df May damage the unborn child. Suspected of damaging fertility
R61/62

H361f Suspected of damaging fertility
R62

H361d Suspected of damaging the unborn child
R63

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.
R62-63

H362 May cause harm to breast fed children
R64

H370 Causes damage to organs
R39/23/24/25/26/27/28

H371 May cause damage to organs
R68/20/21/22

H372 Causes damage to organs through prolonged or repeated exposure
R48/25/24/23

H373 May cause damage to organs through prolonged or repeated exposure
R48/20/21/22

H400 Very toxic to aquatic life
R50

H410 Very toxic to aquatic life with long-lasting effects
R50-53

H411 Toxic to aquatic life with long-lasting effects
R51-53

H412 Harmful to aquatic life with long-lasting effects
R52-53

H413 May cause long-lasting harmful effects to aquatic life
R53

EUH059 Hazardous to the ozone layer
R59

EUH029 Contact with water liberates toxic gas
R29

EUH031 Contact with acids liberates toxic gas
R31

EUH032 Contact with acids liberates very toxic gas
R32

EUH070 Toxic by eye contact
R39-41

No commercial dye formulation, colourants, surface-finishing agents, auxiliaries and coating materials shall be used on either pulp or paper that has been assigned or may be assigned at the time of application the hazard statement H317: May cause allergic skin reaction.
R43

Hazard statement(8)
Risk phrase(9)

H340 May cause genetic defects
R46

H350 May cause cancer
R45

H350i May cause cancer by inhalation
R49

H351 Suspected of causing cancer
R40

H360F May damage fertility
R60

H360D May damage the unborn child
R61

H360FD May damage fertility. May damage the unborn child
R60/61/60-61

H360Fd May damage fertility. Suspected of damaging the unborn child
R60/63

H360Df May damage the unborn child. Suspected of damaging fertility
R61/62

H400 Very toxic to aquatic life
R50/50-53

H410 Very toxic to aquatic life with long-lasting effects
R50-53

H411 Toxic to aquatic life with long-lasting effects
R51-53

H412 Harmful to aquatic life with long-lasting effects
R52-53

H413 May cause long-lasting effects to aquatic life
R53

1.4-aminobiphenyl
1.
4-aminobiphenyl
(92-67-1),

1.
4-aminobiphenyl

2.benzidine
2.
benzidine
(92-87-5),

2.
benzidine

3.4-chloro-o-toluidine
3.
4-chloro-o-toluidine
(95-69-2),

3.
4-chloro-o-toluidine

4.2-naphthylamine
4.
2-naphthylamine
(91-59-8),

4.
2-naphthylamine

5.o-aminoazotoluene
5.
o-aminoazotoluene
(97-56-3),

5.
o-aminoazotoluene

6.2-amino-4-nitrotoluene
6.
2-amino-4-nitrotoluene
(99-55-8),

6.
2-amino-4-nitrotoluene

7.p-chloroaniline
7.
p-chloroaniline
(106-47-8),

7.
p-chloroaniline

8.2,4-diaminoanisole
8.
2,4-diaminoanisole
(615-05-4),

8.
2,4-diaminoanisole

9.4,4'-diaminodiphenylmethane
9.
4,4'-diaminodiphenylmethane
(101-77-9),

9.
4,4'-diaminodiphenylmethane

10.3,3'-dichlorobenzidine
10.
3,3'-dichlorobenzidine
(91-94-1),

10.
3,3'-dichlorobenzidine

11.3,3'-dimethoxybenzidine
11.
3,3'-dimethoxybenzidine
(119-90-4),

11.
3,3'-dimethoxybenzidine

12.3,3'-dimethylbenzidine
12.
3,3'-dimethylbenzidine
(119-93-7),

12.
3,3'-dimethylbenzidine

13.3,3'-dimethyl-4,4'-diaminodiphenylmethane
13.
3,3'-dimethyl-4,4'-diaminodiphenylmethane
(838-88-0),

13.
3,3'-dimethyl-4,4'-diaminodiphenylmethane

14.p-cresidine
14.
p-cresidine
(120-71-8),

14.
p-cresidine

15.4,4'-methylene-bis-(2-chloroaniline)
15.
4,4'-methylene-bis-(2-chloroaniline)
(101-14-4),

15.
4,4'-methylene-bis-(2-chloroaniline)

16.4,4'-oxydianiline
16.
4,4'-oxydianiline
(101-80-4),

16.
4,4'-oxydianiline

17.4,4'-thiodianiline
17.
4,4'-thiodianiline
(139-65-1),

17.
4,4'-thiodianiline

18.o-toluidine
18.
o-toluidine
(95-53-4),

18.
o-toluidine

19.2,4-diaminotoluene
19.
2,4-diaminotoluene
(95-80-7),

19.
2,4-diaminotoluene

20.2,4,5-trimethylaniline
20.
2,4,5-trimethylaniline
(137-17-7),

20.
2,4,5-trimethylaniline

21.4-aminoazobenzene
21.
4-aminoazobenzene
(60-09-3),

21.
4-aminoazobenzene

22.o-anisidine
22.
o-anisidine
(90-04-0).

22.
o-anisidine

1.
4-aminobiphenyl

2.
benzidine

3.
4-chloro-o-toluidine

4.
2-naphthylamine

5.
o-aminoazotoluene

6.
2-amino-4-nitrotoluene

7.
p-chloroaniline

8.
2,4-diaminoanisole

9.
4,4'-diaminodiphenylmethane

10.
3,3'-dichlorobenzidine

11.
3,3'-dimethoxybenzidine

12.
3,3'-dimethylbenzidine

13.
3,3'-dimethyl-4,4'-diaminodiphenylmethane

14.
p-cresidine

15.
4,4'-methylene-bis-(2-chloroaniline)

16.
4,4'-oxydianiline

17.
4,4'-thiodianiline

18.
o-toluidine

19.
2,4-diaminotoluene

20.
2,4,5-trimethylaniline

21.
4-aminoazobenzene

22.
o-anisidine

—
procedures for separating and using recyclable materials from the waste stream,

—
procedures for recovering materials for other uses, such as incineration for raising process steam or heating, or agricultural use,

—
procedures for handling hazardous waste (as defined by the relevant regulatory authorities of the pulp and paper production sites in question).

‘—
low air and water pollution

—
use of certified fibres AND/OR use of recovered fibres [case-by-case]

—
hazardous substances restricted’

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,

After consulting the European Union Eco-labelling Board,

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3) Since the production of newsprint paper consumes significant amounts of energy, wood and chemicals, and may lead to environmental damage or risks related to the use of the natural resources, it is appropriate to establish EU Ecolabel criteria for the product group ‘newsprint paper’.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:
Article 1

1.   The product group ‘newsprint paper’ shall comprise paper made from pulp and used for printing newspapers and other printed products.

2.   The product group ‘Newsprint paper’ shall not include copying and graphic paper, thermally sensitive paper, photographic and carbonless paper, packaging and wrapping paper as well as fragranced paper.
Article 2

For the purpose of this Decision, the following definitions shall apply:

(1)

‘newsprint paper’ means paper mainly used for printing newspapers and made from pulp and/or recovered paper the weight of which ranges between 40 and 65 g/m2;

(2)

‘recovered fibres’ means fibres diverted from the waste stream during a manufacturing process or generated by households or by commercial, industrial and institutional facilities in their role as end-users of the product which can no longer be used for their intended purpose.
Article 3

In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of newsprint paper shall fall within the product group ‘Newsprint paper’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.
Article 4

The criteria for the product group ‘Newsprint paper’, as well as the related assessment and verification requirements, shall be valid for three years from the date of adoption of this Decision.
Article 5

For administrative purposes the code number assigned to ‘Newsprint paper’ shall be ‘037’.
Article 6

This Decision is addressed to the Member States.
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,

After consulting the European Union Eco-labelling Board,

(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to those products with a reduced environmental impact during their entire life cycle.

(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.

(3) Since the production of newsprint paper consumes significant amounts of energy, wood and chemicals, and may lead to environmental damage or risks related to the use of the natural resources, it is appropriate to establish EU Ecolabel criteria for the product group ‘newsprint paper’.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,

HAS ADOPTED THIS DECISION:
1.   The product group ‘newsprint paper’ shall comprise paper made from pulp and used for printing newspapers and other printed products.

2.   The product group ‘Newsprint paper’ shall not include copying and graphic paper, thermally sensitive paper, photographic and carbonless paper, packaging and wrapping paper as well as fragranced paper.
For the purpose of this Decision, the following definitions shall apply:

(1)

‘newsprint paper’ means paper mainly used for printing newspapers and made from pulp and/or recovered paper the weight of which ranges between 40 and 65 g/m2;

(2)

‘recovered fibres’ means fibres diverted from the waste stream during a manufacturing process or generated by households or by commercial, industrial and institutional facilities in their role as end-users of the product which can no longer be used for their intended purpose.
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, an item of newsprint paper shall fall within the product group ‘Newsprint paper’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex to this Decision.
The criteria for the product group ‘Newsprint paper’, as well as the related assessment and verification requirements, shall be valid for three years from the date of adoption of this Decision.
For administrative purposes the code number assigned to ‘Newsprint paper’ shall be ‘037’.
This Decision is addressed to the Member States.
FRAMEWORKANNEX

The aims of the criteria

The criteria aim, in particular, at promoting resource efficiency by fostering recycling of paper, by reducing discharges of toxic or eutrophic substances into waters, by reducing environmental damage or risks related to the use of energy (global warming, acidification, ozone depletion, depletion of non-renewable resources) through the reduction of energy consumption and related emissions to air and at reducing environmental damage or risks related to the use of hazardous chemicals and applying sustainable management principles in order to safeguard forests.
CRITERIA

These criteria are set for each of the following aspects:
1. | Emissions to water and air

2. | Energy use

3. | Fibres: sustainable forest management

4. | Hazardous chemical substances

5. | Waste management

6. | Fitness for use

7. | Information appearing on the EcolabelThe ecological criteria cover the production of pulp including all constituent sub-processes from the point at which the virgin fibre/recovered raw-material enters the production site, to the point at which the pulp leaves the pulp mill. For the paper production processes, the ecological criteria cover all sub-processes from the beating of the pulp (disintegration of the recovered paper) to winding the paper onto rolls.

The following activities are not covered by these criteria:
1. | Transport and packaging of the pulp, paper or raw materials

2. | Conversion of paper

Assessment and verification requirements

The specific assessment and verification requirements are indicated within each criterion.

Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, it is understood that those may originate from the applicant and/or his supplier(s) and/or their supplier(s), as appropriate.

Where appropriate, test methods other than those indicated for each criterion may be used if their equivalence is accepted by the competent body assessing the application.

Where possible, the testing shall be performed by laboratories that meet the general requirements of EN ISO 17025 or equivalent.

Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.
EU ECOLABEL CRITERIA
Criterion 1 —   Emissions to water and air

(a)   COD, Sulphur (S), NOx, Phosphorous (P)For each of these parameters, the emissions to air and/or water from the pulp and the paper production shall be expressed in terms of points (PCOD, PS, PNOx, PP) as detailed below.

None of the individual points PCOD, PS, PNOx, PPshall exceed 1,5.

The total number of points (Ptotal= PCOD+ PS+ PNOx+ PP) shall not exceed 4,0.

The calculation of PCODshall be made as follows (the calculations of PS, PNOx, PPshall be made in exactly the same manner).

For each pulp ‘i’ used, the related measured COD emissions (CODpulp,iexpressed in kg/air dried tonne — ADT), shall be weighted according to the proportion of each pulp used (pulp ‘i’ with respect to air dried tonne of pulp), and summed together. The weighted COD emission for the pulps is then added to the measured COD emission from the paper production to give a total COD emission, CODtotal.

The weighted COD reference value for the pulp production shall be calculated in the same manner, as the sum of the weighted reference values for each pulp used and added to the reference value for the paper production to give a total CODreferencevalue CODreftotal. The reference values for each pulp type used and for the paper production are indicated in Table 1.

Finally, the total COD emission shall be divided by the total COD reference value as follows:

Table 1
Reference values for emissions from different pulp types and from paper production
Pulp Grade/Paper | Emissions (kg/ADT)

CODreference | Sreference | NOx,reference | Preference

Bleached Chemical pulp (others than sulphite) | 18,0 | 0,6 | 1,6 | 0,045

Bleached Chemical pulp (sulphite) | 25,0 | 0,6 | 1,6 | 0,045

Unbleached chemical pulp | 10,0 | 0,6 | 1,6 | 0,04

CTMP | 15,0 | 0,2 | 0,3 | 0,01

TMP/groundwood pulp | 3,0 | 0,2 | 0,3 | 0,01

Recovered fibre pulp | 2,0 | 0,2 | 0,3 | 0,01

Paper (non-integrated mills where all pulps used are purchased market pulps) | 1 | 0,3 | 0,8 | 0,01

Paper (Other mills) | 1 | 0,3 | 0,7 | 0,01An exemption for the Preference-value of bleached chemical pulp (others than sulphite) indicated in Table 1, up to a level of 0,1 shall be granted where it is demonstrated that the higher level of P is due to P naturally occurring in the wood pulp.

In case of co-generation of heat and electricity at the same plant, the emissions of S and NOxresulting from electricity generation can be subtracted from the total amount. The following equation can be used to calculate the proportion of the emissions resulting from electricity generation:

2 × (MWh(electricity)) / [2 × MWh(electricity) + MWh(heat)]

The electricity in this calculation is the electricity produced at the co-generation plant.

The heat in this calculation is the net heat delivered from the power plant to the pulp/paper production.

Assessment and verification:the applicant shall provide detailed calculations showing compliance with this criterion, together with related supporting documentation which shall include test reports using the following test methods: COD: ISO 6060; NOx: ISO 11564; S(oxid.): EPA No 8; S(red.): EPA No 16A; S content in oil: ISO 8754; S content in coal: ISO 351; P: EN ISO 6878, APAT IRSA CNR 4110 or Dr Lange LCK 349.

The supporting documentation shall include an indication of the measurement frequency and the calculation of the points for COD, S and NOx. It shall include all emissions of S and NOxwhich occur during the production of pulp and paper, including steam generated outside the production site, except those emissions related to the production of electricity. Measurements shall include recovery boilers, lime kilns, steam boilers and destructor furnaces for strong smelling gases. Diffuse emissions shall be taken into account. Reported emission values for S to air shall include both oxidised and reduced S emissions (dimethyl sulphide, methyl mercaptan, hydrogen sulphide and similar emissions). The S emissions related to the heat energy generation from oil, coal and other external fuels with known S content may be calculated instead of measured, and shall be taken into account.

Measurements of emissions to water shall be taken on unfiltered and unsettled samples either after treatment at the plant or after treatment by a public treatment plant. The period for the measurements shall be based on the production during 12 months. In case of a new or a rebuilt production plant, the measurements shall be based on at least 45 subsequent days of stable running of the plant. The measurement shall be representative of the respective campaign.

In case of integrated mills, due to the difficulties in getting separate emission figures for pulp and paper, if only a combined figure for pulp and paper production is available, the emission values for pulp(s) shall be set to zero and the figure for the paper mill shall include both pulp and paper production.

(b)   AOX (Adsorbable Organic Halogen)

— | Until 31 March 2013, the AOX emissions from the production of each pulp used shall not exceed 0,20 kg/ADT.

— | From 1 April 2013 until the expiry of the period of validity of the criteria set out in this Decision, the AOX emissions from the production of each pulp used shall not exceed 0,17 kg/ADT.Assessment and verification:the applicant shall provide test reports using the following test method: AOX ISO 9562 accompanied by detailed calculations showing compliance with this criterion, together with related supporting documentation.

The supporting documentation shall include an indication of the measurement frequency. AOX shall only be measured in processes where chlorine compounds are used for the bleaching of the pulp. AOX need not be measured in the effluent from non-integrated paper production or in the effluents from pulp production without bleaching or where the bleaching is performed with chlorine-free substances.

Measurements shall be taken on unfiltered and unsettled samples either after treatment at the plant or after treatment by a public treatment plant. The period for the measurements shall be based on the production during 12 months. In case of a new or a re-built production plant, the measurements shall be based on at least 45 subsequent days of stable running of the plant. The measurement shall be representative of the respective campaign.

(c)   CO2

The emissions of carbon dioxide from non-renewable sources shall not exceed 1 000 kg per tonne of paper produced, including emissions from the production of electricity (whether on-site or off-site). For non-integrated mills (where all pulps used are purchased market pulps) the emissions shall not exceed 1 100 kg per tonne. The emissions shall be calculated as the sum of the emissions from the pulp and paper production.

Assessment and verification:the applicant shall provide detailed calculations showing compliance with this criterion, together with related supporting documentation.

The applicant shall provide data on the air emissions of carbon dioxide. This shall include all sources of non-renewable fuels during the production of pulp and paper, including the emissions from the production of electricity (whether on-site or off-site).

The following emission factors shall be used in the calculation of the CO2emissions from fuels:
Table 2
Fuel | CO2 fossilemission | Unit

Coal | 96 | g CO2 fossil/MJ

Crude oil | 73 | g CO2 fossil/MJ

Fuel oil 1 | 74 | g CO2 fossil/MJ

Fuel oil 2-5 | 81 | g CO2 fossil/MJ

LPG | 66 | g CO2 fossil/MJ

Natural Gas | 56 | g CO2 fossil/MJ

Grid Electricity | 400 | g CO2 fossil/kWhThe period for the calculations or mass balances shall be based on the production during 12 months. In case of a new or a rebuilt production plant, the calculations shall be based on at least 45 subsequent days of stable running of the plant. The calculations shall be representative of the respective campaign.

For grid electricity, the value quoted in the table above (the European average) shall be used unless the applicant presents documentation establishing the average value for their suppliers of electricity (contracting supplier or national average), in which case the applicant may use this value instead of the value quoted in the table.

The amount of energy from renewable sources(1)purchased and used for the production processes will not be considered in the calculation of the CO2emissions. Appropriate documentation that this kind of energy is actually used at the mill or is externally purchased shall be provided by the applicant.
Criterion 2 —   Energy use

(a)   ElectricityThe electricity consumption related to the pulp and the paper production shall be expressed in terms of points (PE) as detailed below.

The number of points, PE, shall be less than or equal to 1,5.

The calculation of PEshall be made as follows.

Calculation for pulp production: For each pulp i used, the related electricity consumption (Epulp,iexpressed in kWh/ADT) shall be calculated as follows:

Epulp,i= Internally produced electricity + purchased electricity – sold electricity

Calculation for paper production: Similarly, the electricity consumption related to the paper production (Epaper) shall be calculated as follows:

Epaper= Internally produced electricity + purchased electricity – sold electricity

Finally, the points for pulp and paper production shall be combined to give the overall number of points (PE) as follows:
In case of integrated mills, due to the difficulties in getting separate electricity figures for pulp and paper, if only a combined figure for pulp and paper production is available, the electricity values for pulp(s) shall be set to zero and the figure for the paper mill shall include both pulp and paper production.

(b)   Fuel (heat)The fuel consumption related to the pulp and the paper production shall be expressed in terms of points (PF) as detailed below.

The number of points, PF, shall be less than or equal to 1,5.

The calculation of PFshall be made as follows.

Calculation for pulp production: For each pulp i used, the related fuel consumption (Fpulp,iexpressed in kWh/ADT) shall be calculated as follows:

Fpulp,i= Internally produced fuel + purchased fuel – sold fuel – 1,25 × internally produced electricity
Note:
1. | Fpulp,i(and its contribution to PF,pulp) need not be calculated for mechanical pulp unless it is market air dried mechanical pulp containing at least 90 % dry matter.

2. | The amount of fuel used to produce the sold heat shall be added to the term sold fuel in the equation above.Calculation for paper production: similarly, the fuel consumption related to the paper production (Fpaper, expressed in kWh/ADT), shall be calculated as follows:

Fpaper= Internally produced fuel + purchased fuel – sold fuel – 1,25 × internally produced electricity

Finally, the points for pulp and paper production shall be combined to give the overall number of points (PF) as follows:

Table 3
Reference values for electricity and fuel
Pulp grade | Fuel kWh/ADTFreference | Electricity kWh/ADTEreference

Non-admp | admp | Non-admp | admp

Chemical pulp | 4 000 | 5 000 | 800 | 800

Thermomechanical pulp (TMP) | 0 | 900 | 2 200 | 2 200

Groundwood pulp (including Pressurised Groundwood) | 0 | 900 | 2 000 | 2 000

Chemithermomechanical pulp (CTMP) | 0 | 1 000 | 2 000 | 2 000

Recovered fibre pulp | 300 | 1 300 | 450 | 550

Paper grade | Fuel | kWh/tonne |  | ElectricitykWh/tonne

Newsprint paper grade |  | 1 800 |  | 700

Admp=air dried market pulp. | Admp | = | air dried market pulp.

Admp | = | air dried market pulp.Assessment and verification (for both (a) and (b)):the applicant shall provide detailed calculations showing compliance with this criterion, together with all related supporting documentation. Reported details shall therefore include the total electricity and fuel consumption.

The applicant shall calculate all energy inputs, divided into heat/fuels and electricity used during the production of pulp and paper, including the energy used in the de-inking of waste papers for the production of recovered paper. Energy used in the transport of raw materials, as well as conversion and packaging, is not included in the energy consumption calculations.

Total heat energy includes all purchased fuels. It also includes heat energy recovered by incinerating liquors and wastes from on-site processes (e.g. wood waste, sawdust, liquors, waste paper, paper broke), as well as heat recovered from the internal generation of electricity — however, the applicant need only count 80 % of the heat energy from such sources when calculating the total heat energy.

Electric energy means net imported electricity coming from the grid and internal generation of electricity measured as electric power. Electricity used for wastewater treatment need not be included.

Where steam is generated using electricity as the heat source, the heat value of the steam shall be calculated, then divided by 0, 8 and added to the total fuel consumption.

In case of integrated mills, due to the difficulties in getting separate fuel (heat) figures for pulp and paper, if only a combined figure for pulp and paper production is available, the fuel (heat) values for pulp(s) shall be set to zero and the figure for the paper mill shall include both pulp and paper production.
Criterion 3 —   Fibres

At least the 70 % (w/w) on the total amount of fibres used for newsprint paper shall be recovered fibres.

All fibres used that are not recovered shall be virgin fibres covered by valid sustainable forest management and chain of custody certificates issued by an independent third party certification scheme such as FSC, PEFC or equivalent.

However, where certification schemes allow mixing certified material and uncertified material in a product or product line, the proportion of uncertified material shall not exceed 50 % of the overall amount of virgin fibres used. Such uncertified material shall be covered by a verification system which ensures that it is legally sourced and meets any other requirement of the certification scheme with respect to uncertified material.

The certification bodies issuing forest and/or chain of custody certificates shall be accredited/recognised by that certification scheme.

Excluded from the calculation of recovered fibres content is the reutilisation of materials generated in a process and capable of being reclaimed within the same process that generated it (mill broke — own produced or purchased).

Assessment and verification:the applicant shall provide appropriate documentation indicating the types, quantities and origins of fibres used in the pulp and the paper production.

Where virgin fibres are used, the product shall be covered by valid forest management and chain of custody certificates issued by an independent third party certification scheme, such as PEFC, FSC or equivalent. If the product or product line includes uncertified material, proof should be provided that the uncertified material is less than 50 per cent and is covered by a verification system which ensures that it is legally sourced and meets any other requirement of the certification scheme with respect to uncertified material.

The percentage of recovered fibres shall be calculated as ratio between the inputs of recovered fibres compared to the final paper production. Where recovered fibres are used, the applicant shall provide a declaration stating the average amount of grades of recovered paper used for the product in accordance with the standard EN 643(2)or an equivalent standard. The applicant shall also provide a declaration that no mill broke (own or purchased) was used for the calculation of the recovered percentage.
Criterion 4 —   Excluded or limited substances and mixtures

Assessment and verification:the applicant shall supply a list of the chemical products used in the pulp and paper production, together with appropriate documentation (such as Safety Data Sheets). This list shall include the quantity, function and suppliers of all the substances used in the production process.

(a)   Hazardous substances and mixturesIn accordance with Article 6(6) of Regulation (EC) No 66/2010, the product shall not contain substances referred to in Article 57 of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(3)nor substances or mixtures meeting the criteria for classification with the hazard statements or risk phrases in accordance with Regulation (EC) No 1272/2008 of the European Parliament and of the Council(4)or Council Directive 67/548/EEC(5)specified in the table below.

List of hazard statements and risk phrases:

Hazard statement(6) | Risk phrase(7)

H300 Fatal if swallowed | R28

H301 Toxic if swallowed | R25

H304 May be fatal if swallowed and enters airways | R65

H310 Fatal in contact with skin | R27

H311 Toxic in contact with skin | R24

H330 Fatal if inhaled | R23/26

H331 Toxic if inhaled | R23

H340 May cause genetic defects | R46

H341 Suspected of causing genetic defects | R68

H350 May cause cancer | R45

H350i May cause cancer by inhalation | R49

H351 Suspected of causing cancer | R40

H360F May damage fertility | R60

H360D May damage the unborn child | R61

H360FD May damage fertility. May damage the unborn child | R60/61/60-61

H360Fd May damage fertility. Suspected of damaging the unborn child | R60/63

H360Df May damage the unborn child. Suspected of damaging fertility | R61/62

H361f Suspected of damaging fertility | R62

H361d Suspected of damaging the unborn child | R63

H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. | R62-63

H362 May cause harm to breast fed children | R64

H370 Causes damage to organs | R39/23/24/25/26/27/28

H371 May cause damage to organs | R68/20/21/22

H372 Causes damage to organs through prolonged or repeated exposure | R48/25/24/23

H373 May cause damage to organs through prolonged or repeated exposure | R48/20/21/22

H400 Very toxic to aquatic life | R50

H410 Very toxic to aquatic life with long-lasting effects | R50-53

H411 Toxic to aquatic life with long-lasting effects | R51-53

H412 Harmful to aquatic life with long-lasting effects | R52-53

H413 May cause long-lasting harmful effects to aquatic life | R53

EUH059 Hazardous to the ozone layer | R59

EUH029 Contact with water liberates toxic gas | R29

EUH031 Contact with acids liberates toxic gas | R31

EUH032 Contact with acids liberates very toxic gas | R32

EUH070 Toxic by eye contact | R39-41

No commercial dye formulation, colourants, surface-finishing agents, auxiliaries and coating materials shall be used on either pulp or paper that has been assigned or may be assigned at the time of application the hazard statement H317: May cause allergic skin reaction. | R43Substances or mixtures which change their properties upon processing (e.g., become no longer bioavailable, undergo chemical modification) so that the identified hazard no longer applies are exempted from the above requirement.

Concentration limits for substances or mixtures which may be or have been assigned the hazard statements or risk phrase listed above, or which meet the criteria for classification in the hazard classes or categories listed in the table above, and concentration limits for substances meeting the criteria set out in Article 57(a), (b) or (c) of Regulation (EC) No 1907/2006, shall not exceed the generic or specific concentration limits determined in accordance with the Article 10 of Regulation (EC) No 1272/2008. Where specific concentration limits are determined, they shall prevail over the generic ones.

Concentration limits for substances meeting the criteria set out in Article 57(d), (e) or (f) of Regulation (EC) No 1907/2006 shall not exceed 0,1 % weight by weight.

Assessment and verification:the applicant shall prove compliance with these criteria by providing data on the amount (kg/ADT paper produced) of substances used in the process and by demonstrating that the substances referred to in these criteria are not retained in the final product above the concentration limits specified. The concentration for substances and mixtures shall be specified in the Safety Data Sheets in accordance with Article 31 of Regulation (EC) No 1907/2006.

(b)   Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006No derogation from the prohibition set out in Article 6(6) of Regulation (EC) No 66/2010 shall be granted concerning substances identified as substances of very high concern and included in the list provided in Article 59 of Regulation (EC) No 1907/2006, present in mixtures, in an article or in any homogenous part of a complex article in concentrations higher than 0,1 %. Specific concentration limits determined in accordance with Article 10 of Regulation (EC) No 1272/2008 shall apply where the concentration is lower than 0,1 %.

Assessment and verification:the list of substances identified as substances of very high concern and included in the candidate list in accordance with Article 59 of Regulation (EC) No 1907/2006 can be found here:

http://echa.europa.eu/chem_data/authorisation_process/candidate_list_table_en.asp

Reference to the list shall be made on the date of application.

The applicant shall prove compliance with this criterion by providing data on the amount (kg/ADT paper produced) of substances used in the process and by demonstrating that the substances referred to in this criterion are not retained in the final product above the concentration limits specified. The concentration shall be specified in the safety data sheets in accordance with Article 31 of Regulation (EC) No 1907/2006.

(c)   ChlorineChlorine gas or other chlorinated compounds shall not be used as a bleaching agent. This requirement does not apply to chlorine gas related to the production and use of chlorine dioxide.

Assessment and verification:the applicant shall provide a declaration from the pulp producer(s) that chlorine gas or other chlorinated compounds have not been used as a bleaching agent.Note:while this requirement also applies to the bleaching of recovered fibres, it is accepted that the fibres in their previous life-cycle may have been bleached with chlorine gas or other chlorinated compounds.

(d)   APEOsAlkylphenol ethoxylates or other alkylphenol derivatives shall not be added to cleaning substances, de-inking substances, foam inhibitors, or dispersants. Alkylphenol derivatives are defined as substances that upon degradation produce alkyl phenols.

Assessment and verification:the applicant shall provide a declaration(s) from their chemical supplier(s) that alkylphenol ethoxylates or other alkylphenol derivatives have not been added to those products.

(e)   Residual monomersThe total quantity of residual monomers (excluding acrylamide) that may be or have been assigned any of the following risk phrases (or combinations thereof) and are present in coatings, retention aids, strengtheners, water repellents or chemicals used in internal and external water treatment shall not exceed 100 ppm (calculated on the basis of their solid content).
Hazard statement(8) | Risk phrase(9)

H340 May cause genetic defects | R46

H350 May cause cancer | R45

H350i May cause cancer by inhalation | R49

H351 Suspected of causing cancer | R40

H360F May damage fertility | R60

H360D May damage the unborn child | R61

H360FD May damage fertility. May damage the unborn child | R60/61/60-61

H360Fd May damage fertility. Suspected of damaging the unborn child | R60/63

H360Df May damage the unborn child. Suspected of damaging fertility | R61/62

H400 Very toxic to aquatic life | R50/50-53

H410 Very toxic to aquatic life with long-lasting effects | R50-53

H411 Toxic to aquatic life with long-lasting effects | R51-53

H412 Harmful to aquatic life with long-lasting effects | R52-53

H413 May cause long-lasting effects to aquatic life | R53Acrylamide shall not be present in coatings, retention aids, strengtheners, water repellents or chemicals used in internal and external water treatment in concentrations higher than 700 ppm (calculated on the basis of their solid content).

The competent body may exempt the applicant from those requirements in relation to chemicals used in external water treatment.

Assessment and verification:the applicant shall provide a declaration of compliance with this criterion, together with appropriate documentation (such as Safety Data Sheets).

(f)   Surfactants in de-inkingAll surfactants used in de-inking shall be ultimately biodegradable (see test methods and pass levels below).

Assessment and verification:the applicant shall provide a declaration of compliance with this criterion together with the relevant safety data sheets or test reports for each surfactant which shall indicate the test method, threshold and conclusion stated, using one of the following test method and pass levels: OECD 302 A-C (or equivalent ISO standards), with a percentage degradation (including adsorption) within 28 days of at least 70 % for 302 A and B, and of at least 60 % for 302 C.

(g)   BiocidesThe active components in biocides or biostatic agents used to counter slime-forming organisms in circulation water systems containing fibres shall not be potentially bio-accumulative. Biocides’ bioaccumulation potentials are characterised by log Pow (log octanol/water partition coefficient) < 3,0 or an experimentally determined bioconcentration factor (BCF) ≤ 100.

Assessment and verification:the applicant shall provide a declaration of compliance with this criterion together with the relevant material safety data sheet or test report which shall indicate the test method, threshold and conclusion stated, using the following test methods: OECD 107, 117 or 305 A-E.

(h)   Azo dyesAzo dyes that may cleave to any of the following aromatic amines shall not be used, in accordance with Annex XVII to Regulation (EC) No 1907/2006:
1.4-aminobiphenyl | 1. | 4-aminobiphenyl | (92-67-1),

1. | 4-aminobiphenyl

2.benzidine | 2. | benzidine | (92-87-5),

2. | benzidine

3.4-chloro-o-toluidine | 3. | 4-chloro-o-toluidine | (95-69-2),

3. | 4-chloro-o-toluidine

4.2-naphthylamine | 4. | 2-naphthylamine | (91-59-8),

4. | 2-naphthylamine

5.o-aminoazotoluene | 5. | o-aminoazotoluene | (97-56-3),

5. | o-aminoazotoluene

6.2-amino-4-nitrotoluene | 6. | 2-amino-4-nitrotoluene | (99-55-8),

6. | 2-amino-4-nitrotoluene

7.p-chloroaniline | 7. | p-chloroaniline | (106-47-8),

7. | p-chloroaniline

8.2,4-diaminoanisole | 8. | 2,4-diaminoanisole | (615-05-4),

8. | 2,4-diaminoanisole

9.4,4′-diaminodiphenylmethane | 9. | 4,4′-diaminodiphenylmethane | (101-77-9),

9. | 4,4′-diaminodiphenylmethane

10.3,3′-dichlorobenzidine | 10. | 3,3′-dichlorobenzidine | (91-94-1),

10. | 3,3′-dichlorobenzidine

11.3,3′-dimethoxybenzidine | 11. | 3,3′-dimethoxybenzidine | (119-90-4),

11. | 3,3′-dimethoxybenzidine

12.3,3′-dimethylbenzidine | 12. | 3,3′-dimethylbenzidine | (119-93-7),

12. | 3,3′-dimethylbenzidine

13.3,3′-dimethyl-4,4′-diaminodiphenylmethane | 13. | 3,3′-dimethyl-4,4′-diaminodiphenylmethane | (838-88-0),

13. | 3,3′-dimethyl-4,4′-diaminodiphenylmethane

14.p-cresidine | 14. | p-cresidine | (120-71-8),

14. | p-cresidine

15.4,4′-methylene-bis-(2-chloroaniline) | 15. | 4,4′-methylene-bis-(2-chloroaniline) | (101-14-4),

15. | 4,4′-methylene-bis-(2-chloroaniline)

16.4,4′-oxydianiline | 16. | 4,4′-oxydianiline | (101-80-4),

16. | 4,4′-oxydianiline

17.4,4′-thiodianiline | 17. | 4,4′-thiodianiline | (139-65-1),

17. | 4,4′-thiodianiline

18.o-toluidine | 18. | o-toluidine | (95-53-4),

18. | o-toluidine

19.2,4-diaminotoluene | 19. | 2,4-diaminotoluene | (95-80-7),

19. | 2,4-diaminotoluene

20.2,4,5-trimethylaniline | 20. | 2,4,5-trimethylaniline | (137-17-7),

20. | 2,4,5-trimethylaniline

21.4-aminoazobenzene | 21. | 4-aminoazobenzene | (60-09-3),

21. | 4-aminoazobenzene

22.o-anisidine | 22. | o-anisidine | (90-04-0).

22. | o-anisidineAssessment and verification:the applicant shall provide a declaration of compliance with this criterion.

(i)   Metal complex dye stuffs or pigmentsDyes or pigments based on lead, copper, chromium, nickel or aluminium shall not be used. Copper phthalocyanine dyes or pigments may, however, be used.

Assessment and verification:the applicant shall provide a declaration of compliance.

(j)   Ionic impurities in dye stuffsThe levels of ionic impurities in the dye stuffs used shall not exceed the following: Ag 100 ppm; As 50 ppm; Ba 100 ppm; Cd 20 ppm; Co 500 ppm; Cr 100 ppm; Cu 250 ppm; Fe 2 500 ppm; Hg 4 ppm; Mn 1 000 ppm; Ni 200 ppm; Pb 100 ppm; Se 20 ppm; Sb 50 ppm; Sn 250 ppm; Zn 1 500 ppm.

Assessment and verification:the applicant shall provide a declaration of compliance.
Criterion 5 —   Waste management

All pulp and paper production sites shall have a system for handling waste (as defined by the relevant regulatory authorities of the pulp and paper production sites in question) and residual products arising from the production of the ecolabelled product. The system shall be documented or explained in the application and include information on at least the following points:
— | procedures for separating and using recyclable materials from the waste stream,

— | procedures for recovering materials for other uses, such as incineration for raising process steam or heating, or agricultural use,

— | procedures for handling hazardous waste (as defined by the relevant regulatory authorities of the pulp and paper production sites in question).Assessment and verification:the applicant shall provide a detailed description of the procedures adopted for the waste management of each of the sites concerned and a declaration of compliance with the criterion.
Criterion 6 —   Fitness for use

The product shall be suitable for its purpose.

Assessment and verification:the applicant shall provide appropriate documentation demonstrating compliance with the scope of the criteria. The product shall fulfil the requirements for permanence in accordance with applicable standards. The user manual will provide the list of norms and standards which shall be used for the permanence assessment.

As alternative to the use of the above methods, the producers shall guarantee the fitness for use of their products providing appropriate documentation demonstrating the paper quality, in accordance with the standard EN ISO/IEC 17050-1:2004, which provides general criteria for suppliers’ declaration of conformity with normative documents.
Criterion 7 —   Information appearing on the EU Ecolabel

The optional label with text box shall contain the following text:
‘— | low air and water pollution

— | use of certified fibres AND/OR use of recovered fibres [case-by-case]

— | hazardous substances restricted’The guidelines for the use of the optional label with the text box can be found in the ‘Guidelines for the use of the EU Ecolabel logo’ on the website:

http://ec.europa.eu/environment/ecolabel/promo/pdf/logo%20guidelines.pdf

Assessment and verification:the applicant shall provide a sample of the product packaging showing the label, together with a declaration of compliance with this criterion.
(1)  As defined in Directive 2009/28/EC of the European Parliament and of the Council (OJ L 140, 5.6.2009, p. 16).

(2)  European List of Standard Grades of Recovered Paper and Board, June 2002.

(3)  

            OJ L 396, 30.12.2006, p. 1.

(4)  

            OJ L 353, 31.12.2008, p. 1.

(5)  

            OJ 196, 16.8.1967, p. 1.

(6)  As provided for in Regulation (EC) No 1272/2008.

(7)  As provided for in Directive 67/548/EEC.

(8)  As provided for in Regulation (EC) No 1272/2008.

(9)  As provided for in Directive 67/548/EEC.

Pending: 32012D0440

                                January 16, 2026                            

27.7.2012
EN
Official Journal of the European Union
L 200/21

(1)
On 12 December 2011, the High Representative of the European Union for Foreign Affairs and Security Policy (HR) presented, also on behalf of the Commission, a joint communication to the European Parliament and the Council entitled ‘Human Rights and Democracy at the heart of EU external action — towards a more effective approach’.

(2)
On 25 June 2012, the Council adopted the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy.

(3)
A European Union Special Representative (EUSR) for Human Rights should therefore be appointed to strengthen the effectiveness and the visibility of the Union’s human rights policy and contribute to the implementation of its objectives, in support of and without prejudice to the role of the HR under the Treaty in representing the Union for matters relating to the Common Foreign and Security Policy,

(a)
enhancing the Union’s effectiveness, presence and visibility in protecting and promoting human rights, notably by deepening Union cooperation and political dialogue with third countries, relevant partners, business, civil society and international and regional organisations and through action in relevant international fora;

(b)
enhancing the Union’s contribution to the strengthening of democracy and institution building, the rule of law, good governance, respect for human rights and fundamental freedoms worldwide;

(c)
improving the coherence of Union action on human rights and the integration of human rights in all areas of the Union’s external action.

(a)
contribute to the implementation of the Union’s human rights policy, in particular the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy, including by formulating recommendations in this regard;

(b)
contribute to the implementation of Union guidelines, toolkits and action plans on human rights and international humanitarian law;

(c)
enhance dialogue with governments in third countries and international and regional organisations on human rights as well as with civil society organisations and other relevant actors in order to ensure the effectiveness and the visibility of the Union’s human rights policy;

(d)
contribute to better coherence and consistency of the Union policies and actions in the area of protection and promotion of human rights notably by providing input to the formulation of relevant policies of the Union.

(a)
establishing a mission-specific security plan based on guidance from the EEAS, providing for mission-specific physical, organisational and procedural security measures governing the management of the secure movement of personnel to, and within, the mission area and the management of security incidents, and providing for a contingency plan and a mission evacuation plan;

(b)
ensuring that all personnel deployed outside the Union are covered by high risk insurance, as required by the conditions in the mission area;

(c)
ensuring that all members of the EUSR’s team to be deployed outside the Union, including locally contracted personnel, have received appropriate security training before or upon arriving in the mission area, based on the risk ratings assigned to the mission area by the EEAS;

(d)
ensuring that all agreed recommendations made following regular security assessments are implemented, and providing the HR, the Council and the Commission with written reports on their implementation and on other security issues within the framework of the mid-term and mandate implementation reports.

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 28, Article 31(2) and Article 33 thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

(1) On 12 December 2011, the High Representative of the European Union for Foreign Affairs and Security Policy (HR) presented, also on behalf of the Commission, a joint communication to the European Parliament and the Council entitled ‘Human Rights and Democracy at the heart of EU external action — towards a more effective approach’.

(2) On 25 June 2012, the Council adopted the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy.

(3) A European Union Special Representative (EUSR) for Human Rights should therefore be appointed to strengthen the effectiveness and the visibility of the Union’s human rights policy and contribute to the implementation of its objectives, in support of and without prejudice to the role of the HR under the Treaty in representing the Union for matters relating to the Common Foreign and Security Policy,

HAS ADOPTED THIS DECISION:
Appointment

Article 1

Mr Stavros LAMBRINIDIS is hereby appointed as the EUSR for Human Rights until 30 June 2014. The mandate of the EUSR may be terminated earlier, if the Council so decides, on a proposal from the HR.
Policy objectives

Article 2

The mandate of the EUSR shall be based on the policy objectives of the Union regarding human rights as set out in the Treaty, the Charter of Fundamental Rights of the European Union as well as the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy:

(a)

enhancing the Union’s effectiveness, presence and visibility in protecting and promoting human rights, notably by deepening Union cooperation and political dialogue with third countries, relevant partners, business, civil society and international and regional organisations and through action in relevant international fora;

(b)

enhancing the Union’s contribution to the strengthening of democracy and institution building, the rule of law, good governance, respect for human rights and fundamental freedoms worldwide;

(c)

improving the coherence of Union action on human rights and the integration of human rights in all areas of the Union’s external action.
Mandate

Article 3

In order to achieve the policy objectives, the mandate of the EUSR shall be to:

(a)

contribute to the implementation of the Union’s human rights policy, in particular the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy, including by formulating recommendations in this regard;

(b)

contribute to the implementation of Union guidelines, toolkits and action plans on human rights and international humanitarian law;

(c)

enhance dialogue with governments in third countries and international and regional organisations on human rights as well as with civil society organisations and other relevant actors in order to ensure the effectiveness and the visibility of the Union’s human rights policy;

(d)

contribute to better coherence and consistency of the Union policies and actions in the area of protection and promotion of human rights notably by providing input to the formulation of relevant policies of the Union.
Implementation of the mandate

Article 4

1.   The EUSR shall be responsible for the implementation of the mandate, acting under the authority of the HR.

2.   The Political and Security Committee (PSC) shall maintain a privileged link with the EUSR and shall be the EUSR’s primary point of contact with the Council. The PSC shall provide the EUSR with strategic guidance and political direction within the framework of the mandate, without prejudice to the powers of the HR.

3.   The EUSR shall work in full coordination with the European External Action Service (EEAS) and its relevant departments in order to ensure coherence and consistency in their respective work in the area of human rights.
Financing

Article 5

1.   The financial reference amount intended to cover the expenditure related to the mandate of the EUSR until 30 June 2013 shall be EUR 712 500.

2.   The financial reference amount for the subsequent period of the EUSR’s mandate shall be decided by the Council.

3.   The expenditure shall be managed in accordance with the procedures and rules applicable to the general budget of the Union.

4.   The management of the expenditure shall be subject to a contract between the EUSR and the Commission. The EUSR shall be accountable to the Commission for all expenditure.
Constitution and composition of the team

Article 6

1.   Within the limits of the EUSR’s mandate and the corresponding financial means made available, the EUSR shall be responsible for constituting a team. The team shall include the expertise on specific policy issues as required by the mandate. The EUSR shall keep the Council and the Commission promptly informed of the composition of the team.

2.   Member States, the institutions of the Union and the EEAS may propose the secondment of staff to work with the EUSR. The salary of such seconded personnel shall be covered by the Member State, the institution of the Union concerned or the EEAS, respectively. Experts seconded by Member States to the institutions of the Union or the EEAS may also be posted to the EUSR. International contracted staff shall have the nationality of a Member State.

3.   All seconded personnel shall remain under the administrative authority of the sending Member State, the sending institution of the Union or the EEAS and shall carry out their duties and act in the interest of the mandate of the EUSR.
Security of EU classified information

Article 7

The EUSR and the members of the EUSR’s team shall respect the security principles and minimum standards established by Council Decision 2011/292/EU of 31 March 2011 on the security rules for protecting EU classified information(1).
Access to information and logistical support

Article 8

1.   Member States, the Commission, the EEAS and the General Secretariat of the Council shall ensure that the EUSR is given access to any relevant information.

2.   The Union delegations and the diplomatic representations of Member States, as appropriate, shall provide logistical support to the EUSR.
Security

Article 9

In accordance with the Union’s policy on the security of personnel deployed outside the Union in an operational capacity under Title V of the Treaty, the EUSR shall take all reasonably practicable measures, in conformity with the mandate and on the basis of the security situation in the relevant country, for the security of all personnel under the EUSR’s direct authority, in particular by:

(a)

establishing a mission-specific security plan based on guidance from the EEAS, providing for mission-specific physical, organisational and procedural security measures governing the management of the secure movement of personnel to, and within, the mission area and the management of security incidents, and providing for a contingency plan and a mission evacuation plan;

(b)

ensuring that all personnel deployed outside the Union are covered by high risk insurance, as required by the conditions in the mission area;

(c)

ensuring that all members of the EUSR’s team to be deployed outside the Union, including locally contracted personnel, have received appropriate security training before or upon arriving in the mission area, based on the risk ratings assigned to the mission area by the EEAS;

(d)

ensuring that all agreed recommendations made following regular security assessments are implemented, and providing the HR, the Council and the Commission with written reports on their implementation and on other security issues within the framework of the mid-term and mandate implementation reports.
Reporting

Article 10

The EUSR shall regularly provide the HR and the PSC with oral and written reports. The EUSR shall also report to the competent Council working parties, in particular the Working Party on Human Rights, as necessary. Regular written reports shall be circulated through the COREU network. Upon recommendation of the HR or the PSC, the EUSR may provide the Foreign Affairs Council with reports. In accordance with Article 36 of the Treaty, the EUSR may be involved in briefing the European Parliament.
Coordination

Article 11

1.   The EUSR shall contribute to the unity, consistency and effectiveness of the Union’s action and shall help ensure that all Union instruments and Member States’ actions are engaged consistently, to attain the Union’s policy objectives. The EUSR shall work in coordination with the Member States and the Commission, as well as other European Union Special Representatives, as appropriate. The EUSR shall provide regular briefings to Member States’ missions and Union delegations.

2.   In the field, close liaison shall be maintained with the Heads of Union delegations, Member States’ Heads of Mission, as well as with Heads or Commanders of Common Security and Defence Policy missions and operations and other European Union Special Representatives as appropriate, who shall make every effort to assist the EUSR in the implementation of the mandate.

3.   The EUSR shall also liaise and seek complementarity and synergies with other international and regional actors at Headquarters level and in the field. The EUSR shall seek regular contacts with civil society organisations both at Headquarters and in the field.
Review

Article 12

The implementation of this Decision and its consistency with other contributions from the Union in this domain shall be kept under regular review. The EUSR shall present the HR, the Council and the Commission with a six-monthly progress report and with a comprehensive implementation report on the mandate at the end thereof.
Entry into force

Article 13

This Decision shall enter into force on the day of its adoption.
THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty on European Union, and in particular Article 28, Article 31(2) and Article 33 thereof,

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

(1) On 12 December 2011, the High Representative of the European Union for Foreign Affairs and Security Policy (HR) presented, also on behalf of the Commission, a joint communication to the European Parliament and the Council entitled ‘Human Rights and Democracy at the heart of EU external action — towards a more effective approach’.

(2) On 25 June 2012, the Council adopted the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy.

(3) A European Union Special Representative (EUSR) for Human Rights should therefore be appointed to strengthen the effectiveness and the visibility of the Union’s human rights policy and contribute to the implementation of its objectives, in support of and without prejudice to the role of the HR under the Treaty in representing the Union for matters relating to the Common Foreign and Security Policy,

HAS ADOPTED THIS DECISION:
AppointmentMr Stavros LAMBRINIDIS is hereby appointed as the EUSR for Human Rights until 30 June 2014. The mandate of the EUSR may be terminated earlier, if the Council so decides, on a proposal from the HR.
Policy objectivesThe mandate of the EUSR shall be based on the policy objectives of the Union regarding human rights as set out in the Treaty, the Charter of Fundamental Rights of the European Union as well as the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy:

(a)

enhancing the Union’s effectiveness, presence and visibility in protecting and promoting human rights, notably by deepening Union cooperation and political dialogue with third countries, relevant partners, business, civil society and international and regional organisations and through action in relevant international fora;

(b)

enhancing the Union’s contribution to the strengthening of democracy and institution building, the rule of law, good governance, respect for human rights and fundamental freedoms worldwide;

(c)

improving the coherence of Union action on human rights and the integration of human rights in all areas of the Union’s external action.
MandateIn order to achieve the policy objectives, the mandate of the EUSR shall be to:

(a)

contribute to the implementation of the Union’s human rights policy, in particular the EU Strategic Framework on Human Rights and Democracy and the EU Action Plan on Human Rights and Democracy, including by formulating recommendations in this regard;

(b)

contribute to the implementation of Union guidelines, toolkits and action plans on human rights and international humanitarian law;

(c)

enhance dialogue with governments in third countries and international and regional organisations on human rights as well as with civil society organisations and other relevant actors in order to ensure the effectiveness and the visibility of the Union’s human rights policy;

(d)

contribute to better coherence and consistency of the Union policies and actions in the area of protection and promotion of human rights notably by providing input to the formulation of relevant policies of the Union.
Implementation of the mandate1.   The EUSR shall be responsible for the implementation of the mandate, acting under the authority of the HR.

2.   The Political and Security Committee (PSC) shall maintain a privileged link with the EUSR and shall be the EUSR’s primary point of contact with the Council. The PSC shall provide the EUSR with strategic guidance and political direction within the framework of the mandate, without prejudice to the powers of the HR.

3.   The EUSR shall work in full coordination with the European External Action Service (EEAS) and its relevant departments in order to ensure coherence and consistency in their respective work in the area of human rights.
Financing1.   The financial reference amount intended to cover the expenditure related to the mandate of the EUSR until 30 June 2013 shall be EUR 712 500.

2.   The financial reference amount for the subsequent period of the EUSR’s mandate shall be decided by the Council.

3.   The expenditure shall be managed in accordance with the procedures and rules applicable to the general budget of the Union.

4.   The management of the expenditure shall be subject to a contract between the EUSR and the Commission. The EUSR shall be accountable to the Commission for all expenditure.
Constitution and composition of the team1.   Within the limits of the EUSR’s mandate and the corresponding financial means made available, the EUSR shall be responsible for constituting a team. The team shall include the expertise on specific policy issues as required by the mandate. The EUSR shall keep the Council and the Commission promptly informed of the composition of the team.

2.   Member States, the institutions of the Union and the EEAS may propose the secondment of staff to work with the EUSR. The salary of such seconded personnel shall be covered by the Member State, the institution of the Union concerned or the EEAS, respectively. Experts seconded by Member States to the institutions of the Union or the EEAS may also be posted to the EUSR. International contracted staff shall have the nationality of a Member State.

3.   All seconded personnel shall remain under the administrative authority of the sending Member State, the sending institution of the Union or the EEAS and shall carry out their duties and act in the interest of the mandate of the EUSR.
Security of EU classified informationThe EUSR and the members of the EUSR’s team shall respect the security principles and minimum standards established by Council Decision 2011/292/EU of 31 March 2011 on the security rules for protecting EU classified information(1).
Access to information and logistical support1.   Member States, the Commission, the EEAS and the General Secretariat of the Council shall ensure that the EUSR is given access to any relevant information.

2.   The Union delegations and the diplomatic representations of Member States, as appropriate, shall provide logistical support to the EUSR.
SecurityIn accordance with the Union’s policy on the security of personnel deployed outside the Union in an operational capacity under Title V of the Treaty, the EUSR shall take all reasonably practicable measures, in conformity with the mandate and on the basis of the security situation in the relevant country, for the security of all personnel under the EUSR’s direct authority, in particular by:

(a)

establishing a mission-specific security plan based on guidance from the EEAS, providing for mission-specific physical, organisational and procedural security measures governing the management of the secure movement of personnel to, and within, the mission area and the management of security incidents, and providing for a contingency plan and a mission evacuation plan;

(b)

ensuring that all personnel deployed outside the Union are covered by high risk insurance, as required by the conditions in the mission area;

(c)

ensuring that all members of the EUSR’s team to be deployed outside the Union, including locally contracted personnel, have received appropriate security training before or upon arriving in the mission area, based on the risk ratings assigned to the mission area by the EEAS;

(d)

ensuring that all agreed recommendations made following regular security assessments are implemented, and providing the HR, the Council and the Commission with written reports on their implementation and on other security issues within the framework of the mid-term and mandate implementation reports.
ReportingThe EUSR shall regularly provide the HR and the PSC with oral and written reports. The EUSR shall also report to the competent Council working parties, in particular the Working Party on Human Rights, as necessary. Regular written reports shall be circulated through the COREU network. Upon recommendation of the HR or the PSC, the EUSR may provide the Foreign Affairs Council with reports. In accordance with Article 36 of the Treaty, the EUSR may be involved in briefing the European Parliament.
Coordination1.   The EUSR shall contribute to the unity, consistency and effectiveness of the Union’s action and shall help ensure that all Union instruments and Member States’ actions are engaged consistently, to attain the Union’s policy objectives. The EUSR shall work in coordination with the Member States and the Commission, as well as other European Union Special Representatives, as appropriate. The EUSR shall provide regular briefings to Member States’ missions and Union delegations.

2.   In the field, close liaison shall be maintained with the Heads of Union delegations, Member States’ Heads of Mission, as well as with Heads or Commanders of Common Security and Defence Policy missions and operations and other European Union Special Representatives as appropriate, who shall make every effort to assist the EUSR in the implementation of the mandate.

3.   The EUSR shall also liaise and seek complementarity and synergies with other international and regional actors at Headquarters level and in the field. The EUSR shall seek regular contacts with civil society organisations both at Headquarters and in the field.
ReviewThe implementation of this Decision and its consistency with other contributions from the Union in this domain shall be kept under regular review. The EUSR shall present the HR, the Council and the Commission with a six-monthly progress report and with a comprehensive implementation report on the mandate at the end thereof.
Entry into forceThis Decision shall enter into force on the day of its adoption.

Pending: 32012D0414

                                January 16, 2026                            

21.7.2012
EN
Official Journal of the European Union
L 194/12

(1)
Commission Decision 2006/168/EC of 4 January 2006 establishing the animal health and veterinary certification requirements for imports into the Community of bovine embryos and repealing Decision 2005/217/EC(2)establishes in Annex I thereto the list of third countries from which Member States are to authorise imports of embryos of domestic animals of the bovine species (‘the embryos’). It also lays down additional guarantees as regards specific animal diseases to be provided by certain third countries listed in that Annex.

(2)
Decision 2006/168/EC also provides that Member States are to authorise imports of embryos that comply with the animal health requirements set out in the model veterinary certificates in Annexes II, III and IV to that Decision.

(3)
The animal health requirements relating to bluetongue in the model veterinary certificates in Annexes II, III and IV to Decision 2006/168/EC are based on the recommendations of Chapter 8.3 of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE) which deals with bluetongue. That Chapter recommends a whole range of risk mitigating measures aiming at either protecting the mammalian host from exposure to the infectious vector or at inactivating the virus by antibodies.

(4)
In addition, the OIE has laid down a chapter on Surveillance for arthropod vectors of animal diseases in the Terrestrial Animal Health Code. Those recommendations do not include the monitoring of ruminants for antibodies to Simbu viruses, such as the Akabane and Aino viruses of theBunyaviridaefamily, which in the past was considered an economical method for determining the distribution of bluetongue competent vectors until more information on the spread of those diseases became available.

(5)
Also, the OIE does not list Akabane and Aino diseases in the Terrestrial Animal Health Code. Consequently, the requirement for annual testing for those diseases to prove the absence of the vector should be deleted from Annex I to Decision 2006/168/EC and from the model veterinary certificates in Annexes II, III and IV thereto.

(6)
In addition, bilateral agreements have been concluded between the Union and certain third countries containing specific conditions for the imports of embryos into the Union. Therefore, in the interests of consistency where those bilateral agreements contain specific conditions and model veterinary certificates for imports, those conditions and models should apply instead of the conditions and models set out in Decision 2006/168/EC.

(7)
The animal health status of Switzerland is equivalent to that of the Member States. It is therefore appropriate thatin vivoderived andin vitroproduced embryos imported into the Union from that third country are accompanied by a veterinary certificate drawn up in accordance with the model intra-trade certificate used for trade within the Union in embryos of domestic animals of the bovine species set out in Annex C to Directive 89/556/EEC. That certificate should take account of the adaptations set out in point 2 of Chapter VI(B) of Appendix 2 of Annex 11 to the Agreement between the European Community and the Swiss Confederation on Trade in Agricultural Products, as approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation, of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation(3).

(8)
On the basis of Directive 89/556/EEC, New Zealand was also recognised as a third country with an animal health status equivalent to that of Member States for imports ofin vivoderived embryos.

(9)
It is therefore appropriate thatin vivoderived embryos collected in New Zealand and imported into the Union from that third country are accompanied by a simplified certificate drawn up in accordance with the appropriate model health certificate set out in Annex IV to Commission Decision 2003/56/EC of 24 January 2003 on health certificates for the importation of live animals and animal products from New Zealand(4)laid down in accordance with the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products(5), as approved by Council Decision 97/132/EC(6).

(10)
Commission Decision 2007/240/EC(7)provides that the various veterinary, public and animal health certificates required for the imports into the Union of live animals, semen, embryo, ova and products of animal origin are to be based on the standard models for veterinary certificates set out in Annex I thereto. In the interests of consistency and simplification of Union legislation, the model veterinary certificates set out in Annexes II, III and IV to Decision 2006/168/EC should take account of Decision 2007/240/EC.

(11)
Annexes I to IV to Decision 2006/168/EC should therefore be amended accordingly.

(12)
To avoid any disruption of trade, the use of veterinary certificates issued in accordance with Decision 2006/168/EC in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions.

(13)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

ISO code
Third country
Applicable veterinary certificate

AR
Argentina
ANNEX II
ANNEX III
ANNEX IV

AU
Australia
ANNEX II
ANNEX III
ANNEX IV

CA
Canada
ANNEX II
ANNEX III
ANNEX IV

CH
Switzerland(*1)
ANNEX II
ANNEX III
ANNEX IV

HR
Croatia
ANNEX II
ANNEX III
ANNEX IV

IL
Israel
ANNEX II
ANNEX III
ANNEX IV

MK
the former Yugoslav Republic of Macedonia(*2)
ANNEX II
ANNEX III
ANNEX IV

NZ
New Zealand(*3)
ANNEX II
ANNEX III
ANNEX IV

US
United States
ANNEX II
ANNEX III
ANNEX IV

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species(1), and in particular Article 7(1) and point (b) of the first subparagraph of Article 9(1) thereof,

(1) Commission Decision 2006/168/EC of 4 January 2006 establishing the animal health and veterinary certification requirements for imports into the Community of bovine embryos and repealing Decision 2005/217/EC(2)establishes in Annex I thereto the list of third countries from which Member States are to authorise imports of embryos of domestic animals of the bovine species (‘the embryos’). It also lays down additional guarantees as regards specific animal diseases to be provided by certain third countries listed in that Annex.

(2) Decision 2006/168/EC also provides that Member States are to authorise imports of embryos that comply with the animal health requirements set out in the model veterinary certificates in Annexes II, III and IV to that Decision.

(3) The animal health requirements relating to bluetongue in the model veterinary certificates in Annexes II, III and IV to Decision 2006/168/EC are based on the recommendations of Chapter 8.3 of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE) which deals with bluetongue. That Chapter recommends a whole range of risk mitigating measures aiming at either protecting the mammalian host from exposure to the infectious vector or at inactivating the virus by antibodies.

(4) In addition, the OIE has laid down a chapter on Surveillance for arthropod vectors of animal diseases in the Terrestrial Animal Health Code. Those recommendations do not include the monitoring of ruminants for antibodies to Simbu viruses, such as the Akabane and Aino viruses of theBunyaviridaefamily, which in the past was considered an economical method for determining the distribution of bluetongue competent vectors until more information on the spread of those diseases became available.

(5) Also, the OIE does not list Akabane and Aino diseases in the Terrestrial Animal Health Code. Consequently, the requirement for annual testing for those diseases to prove the absence of the vector should be deleted from Annex I to Decision 2006/168/EC and from the model veterinary certificates in Annexes II, III and IV thereto.

(6) In addition, bilateral agreements have been concluded between the Union and certain third countries containing specific conditions for the imports of embryos into the Union. Therefore, in the interests of consistency where those bilateral agreements contain specific conditions and model veterinary certificates for imports, those conditions and models should apply instead of the conditions and models set out in Decision 2006/168/EC.

(7) The animal health status of Switzerland is equivalent to that of the Member States. It is therefore appropriate thatin vivoderived andin vitroproduced embryos imported into the Union from that third country are accompanied by a veterinary certificate drawn up in accordance with the model intra-trade certificate used for trade within the Union in embryos of domestic animals of the bovine species set out in Annex C to Directive 89/556/EEC. That certificate should take account of the adaptations set out in point 2 of Chapter VI(B) of Appendix 2 of Annex 11 to the Agreement between the European Community and the Swiss Confederation on Trade in Agricultural Products, as approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation, of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation(3).

(8) On the basis of Directive 89/556/EEC, New Zealand was also recognised as a third country with an animal health status equivalent to that of Member States for imports ofin vivoderived embryos.

(9) It is therefore appropriate thatin vivoderived embryos collected in New Zealand and imported into the Union from that third country are accompanied by a simplified certificate drawn up in accordance with the appropriate model health certificate set out in Annex IV to Commission Decision 2003/56/EC of 24 January 2003 on health certificates for the importation of live animals and animal products from New Zealand(4)laid down in accordance with the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products(5), as approved by Council Decision 97/132/EC(6).

(10) Commission Decision 2007/240/EC(7)provides that the various veterinary, public and animal health certificates required for the imports into the Union of live animals, semen, embryo, ova and products of animal origin are to be based on the standard models for veterinary certificates set out in Annex I thereto. In the interests of consistency and simplification of Union legislation, the model veterinary certificates set out in Annexes II, III and IV to Decision 2006/168/EC should take account of Decision 2007/240/EC.

(11) Annexes I to IV to Decision 2006/168/EC should therefore be amended accordingly.

(12) To avoid any disruption of trade, the use of veterinary certificates issued in accordance with Decision 2006/168/EC in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions.

(13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Article 1

Annexes I to IV to Decision 2006/168/EC are amended in accordance with the Annex to this Decision.
Article 2

For a transitional period until 30 June 2013, Member States shall continue to authorise imports of consignments of embryos of domestic animals of the bovine species from third countries which are accompanied by a veterinary certificate issued not later than 31 May 2013 in accordance with the models set out in Annexes II, III and IV to Decision 2006/168/EC in its version prior to the amendments introduced by this Decision.
Article 3

This Decision shall apply from 1 January 2013.
Article 4

This Decision is addressed to the Member States.
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 89/556/EEC of 25 September 1989 on animal health conditions governing intra-Community trade in and importation from third countries of embryos of domestic animals of the bovine species(1), and in particular Article 7(1) and point (b) of the first subparagraph of Article 9(1) thereof,

(1) Commission Decision 2006/168/EC of 4 January 2006 establishing the animal health and veterinary certification requirements for imports into the Community of bovine embryos and repealing Decision 2005/217/EC(2)establishes in Annex I thereto the list of third countries from which Member States are to authorise imports of embryos of domestic animals of the bovine species (‘the embryos’). It also lays down additional guarantees as regards specific animal diseases to be provided by certain third countries listed in that Annex.

(2) Decision 2006/168/EC also provides that Member States are to authorise imports of embryos that comply with the animal health requirements set out in the model veterinary certificates in Annexes II, III and IV to that Decision.

(3) The animal health requirements relating to bluetongue in the model veterinary certificates in Annexes II, III and IV to Decision 2006/168/EC are based on the recommendations of Chapter 8.3 of the Terrestrial Animal Health Code of the World Organisation for Animal Health (OIE) which deals with bluetongue. That Chapter recommends a whole range of risk mitigating measures aiming at either protecting the mammalian host from exposure to the infectious vector or at inactivating the virus by antibodies.

(4) In addition, the OIE has laid down a chapter on Surveillance for arthropod vectors of animal diseases in the Terrestrial Animal Health Code. Those recommendations do not include the monitoring of ruminants for antibodies to Simbu viruses, such as the Akabane and Aino viruses of theBunyaviridaefamily, which in the past was considered an economical method for determining the distribution of bluetongue competent vectors until more information on the spread of those diseases became available.

(5) Also, the OIE does not list Akabane and Aino diseases in the Terrestrial Animal Health Code. Consequently, the requirement for annual testing for those diseases to prove the absence of the vector should be deleted from Annex I to Decision 2006/168/EC and from the model veterinary certificates in Annexes II, III and IV thereto.

(6) In addition, bilateral agreements have been concluded between the Union and certain third countries containing specific conditions for the imports of embryos into the Union. Therefore, in the interests of consistency where those bilateral agreements contain specific conditions and model veterinary certificates for imports, those conditions and models should apply instead of the conditions and models set out in Decision 2006/168/EC.

(7) The animal health status of Switzerland is equivalent to that of the Member States. It is therefore appropriate thatin vivoderived andin vitroproduced embryos imported into the Union from that third country are accompanied by a veterinary certificate drawn up in accordance with the model intra-trade certificate used for trade within the Union in embryos of domestic animals of the bovine species set out in Annex C to Directive 89/556/EEC. That certificate should take account of the adaptations set out in point 2 of Chapter VI(B) of Appendix 2 of Annex 11 to the Agreement between the European Community and the Swiss Confederation on Trade in Agricultural Products, as approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation, of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation(3).

(8) On the basis of Directive 89/556/EEC, New Zealand was also recognised as a third country with an animal health status equivalent to that of Member States for imports ofin vivoderived embryos.

(9) It is therefore appropriate thatin vivoderived embryos collected in New Zealand and imported into the Union from that third country are accompanied by a simplified certificate drawn up in accordance with the appropriate model health certificate set out in Annex IV to Commission Decision 2003/56/EC of 24 January 2003 on health certificates for the importation of live animals and animal products from New Zealand(4)laid down in accordance with the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products(5), as approved by Council Decision 97/132/EC(6).

(10) Commission Decision 2007/240/EC(7)provides that the various veterinary, public and animal health certificates required for the imports into the Union of live animals, semen, embryo, ova and products of animal origin are to be based on the standard models for veterinary certificates set out in Annex I thereto. In the interests of consistency and simplification of Union legislation, the model veterinary certificates set out in Annexes II, III and IV to Decision 2006/168/EC should take account of Decision 2007/240/EC.

(11) Annexes I to IV to Decision 2006/168/EC should therefore be amended accordingly.

(12) To avoid any disruption of trade, the use of veterinary certificates issued in accordance with Decision 2006/168/EC in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions.

(13) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Annexes I to IV to Decision 2006/168/EC are amended in accordance with the Annex to this Decision.
For a transitional period until 30 June 2013, Member States shall continue to authorise imports of consignments of embryos of domestic animals of the bovine species from third countries which are accompanied by a veterinary certificate issued not later than 31 May 2013 in accordance with the models set out in Annexes II, III and IV to Decision 2006/168/EC in its version prior to the amendments introduced by this Decision.
This Decision shall apply from 1 January 2013.
This Decision is addressed to the Member States.
ANNEXAnnexes I to IV to Decision 2006/168/EC are replaced by the following:
‘ANNEX I

ISO code

Third country

Applicable veterinary certificate

AR

Argentina

ANNEX II

ANNEX III

ANNEX IV

AU

Australia

ANNEX II

ANNEX III

ANNEX IV

CA

Canada

ANNEX II

ANNEX III

ANNEX IV

CH

Switzerland (*1)

ANNEX II

ANNEX III

ANNEX IV

HR

Croatia

ANNEX II

ANNEX III

ANNEX IV

IL

Israel

ANNEX II

ANNEX III

ANNEX IV

MK

the former Yugoslav Republic of Macedonia (*2)

ANNEX II

ANNEX III

ANNEX IV

NZ

New Zealand (*3)

ANNEX II

ANNEX III

ANNEX IV

US

United States

ANNEX II

ANNEX III

ANNEX IV

‘ANNEX II

Model veterinary certificate for imports of in vivo derived embryos of domestic animals of the bovine species collected in accordance with Council Directive 89/556/EEC

Text of image

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of destination

Name

Address

Postal cod

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

Documentary references

I.16. Entry BIP in EU

I.17. I.18. Description of commodity

I.19. Commodity code (HS code)

05 11 99 85

I.20. Quantity

I.21. I.22. Number of packages

I.23. Seal/Container No

I.24. I.25. Commodities certified for:

Artificial reproduction

I.26. For transit through EU to third country

Third country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(Scientific name)

Breed

Category

Donor identity

Date of collection

Date of freezing

Approval number of the team

Quantity

Text of image

Part II: Certification

COUNTRY

In vivo derived bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

I, the undersigned, official veterinarian of the … certify that:

(exporting country) (2) II.1. The embryos to be exported:

II.1.1. were collected in the exporting country, which according to official findings:

II.1.1.1. was free from rinderpest during the 12 months immediately prior to their collection;

(1) either [II.1.1.2. was free from foot-and-mouth disease during the 12 months immediately prior to their collection and did not carry out vaccination against foot-and-mouth disease during that period.]

(1) or [II.1.1.2. was not free from foot-and-mouth disease during the 12 months immediately prior to their collection and/or carried out vaccination against foot-and-mouth disease during that period, and:

the embryos were not subjected to penetration of the zona pellucida,

the embryos were stored under approved conditions for at least 30 days immediately after their collection,

the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease during the 30 days prior to, and at least the 30 days after, the embryos were collected.]

II.1.2. were collected by the embryo collection team (3):

approved in accordance with Chapter I of Annex A to Directive 89/556/EEC;

which carried out the collection, processing, storing and transport of the embryos in accordance with Chapter II of Annex A to Directive 89/556/EEC;

subject to inspection by an official veterinarian at least twice a year.

II.1.3. were collected and processed on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no incidence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia in the 30 days immediately prior to their collection and until dispatch to the Union, in the case of fresh embryos, or during the 30 days after collection, in the case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.1.1.2. II.1.4. from the time of collection until 30 days thereafter or, in the case of fresh embryos until the day of their dispatch to the Union, they were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no incidence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia.

II.1.5. were collected from the donor females, which:

II.1.5.1. were located, during the 30 days immediately prior to collection, on premises situated in an area of at least 10 km radius centred on them, on which, according to official findings, there was no incidence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia;

II.1.5.2. showed no clinical signs of disease on the day of collection;

II.1.5.3. spent the six months immediately prior to collection within the territory of the exporting country in no more than two herds:

which, according to official findings, were free from tuberculosis during that time,

which, according to official findings, were free from brucellosis during that time,

which were free from enzootic bovine leukosis or in which no bovine animal showed clinical signs of enzootic bovine leukosis during the previous three years,

in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months.

II.1.6. The embryos to be exported were conceived by artificial insemination using semen coming from semen collection or storage centres approved for the collection, processing and/or storage of semen by the competent authority of a third country or part thereof listed in Annex I to Commission Implementing Decision 2011/630/EU (4) or by the competent authority of a Member State.

Text of image

COUNTRY

In vivo derived bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

Notes

Part I:

Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.

Box I.11: Place of origin shall correspond to the embryo collection team from which the embryos are dispatched to the Union and which is listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm.

Box I.22: Number of packages shall correspond to the number of containers.

Box I.23: identification of container and seal number shall be indicated.

Box I.26: fill in according to whether it is a transit or an import certificate.

Box I.27: fill in according to whether it is a transit or an import certificate.

Box I.28: Species: select amongst ‘Bos taurus’, ‘Bison bison’ or ‘Bubalus bubalis’ as appropriate.

Category: select ‘in vivo derived embryos’.

Donor identity shall correspond to the official identification of the animal.

Date of collection shall be indicated in the following format: dd.mm.yyyy.

Approval number of the team: shall correspond to the embryo collection team by which the embryos were collected, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm.

Part II:

(1) Delete as appropriate.

(2) Only third countries listed in Annex I to Decision 2006/168/EC.

(3) Only embryo collection teams listed in accordance with Article 8(2) of Directive 89/556/EEC on Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm.

(4) OJ L 247, 24.9.2011, p. 32. The signature and the stamp must be in a different colour to that of the printing.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp:

‘ANNEX III

Model veterinary certificate for imports of in vitro produced embryos of domestic animals of the bovine species conceived using semen complying with Council Directive 88/407/EEC

Text of image

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of origin

Name

Address

Postal code

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

Documentary references

I.16. Entry BIP in EU

I.17. I.18. Description of commodity

I.19. Commodity code (HS code)

05 11 99 85

I.20. Quantity

I.21. I.22. Number of packages

I.23. Seal/Container No

I.24. I.25. Commodities certified for:

Artificial reproduction

I.26. For transit through EU to third country

Third country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(scientific name)

Breed

Category

Dam identity

Sire identity

Date of freezing

Approval number of the team

Quantity

Text of image

Part II: Certification

COUNTRY

In vitro produced bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

I, the undersigned, official veterinarian of …certify that:

(exporting country) (2) II.1. The embryos to be exported:

II.1.1. were produced in the exporting country, which according to official findings:

II.1.1.1. was free from rinderpest during the 12 months immediately prior to their production;

(1) either [II.1.1.2. was free from foot-and-mouth disease during the 12 months immediately prior to their production and did not carry out vaccination against foot-and-mouth disease during that period.]

(1) or [II.1.1.2. was not free from foot-and-mouth disease during the 12 months immediately prior to their production and/or carried out vaccination against foot-and-mouth disease during that period, and

the embryos were produced without penetration of the zona pellucida,

the embryos were stored under approved conditions for at least 30 days immediately after their production,

the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease during the 30 days prior to, and at least the 30 days after, the oocytes were collected.]

II.1.2. were produced by the embryo production team (3) which:

has been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC,

carried out the production, processing, storing and transport in accordance with Chapter II of Annex A to Directive 89/556/EEC,

is subject to inspection by an official veterinarian at least twice a year.

II.2. The oocytes used in the production of the embryos to be exported were collected on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no incidence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia in the 30 days immediately prior to their collection and until their dispatch to the Union, in the case of fresh embryos, or during the 30 days after collection, in the case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.1.1.2. II.3. From the time of collection until 30 days thereafter or, in the case of fresh embryos until the day of dispatch, the embryos to be exported were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no incidence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia.

II.4. The donors of oocytes used in the production of the embryos to be exported:

II.4.1. were located, during the 30 days immediately prior to collection of the oocytes, on premises situated in an area of at least 10-km radius on which, according to official findings, there was no incidence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia;

II.4.2. showed no clinical signs of disease on the day of collection;

II.4.3. spent the six months immediately prior to collection within the territory of the exporting country in no more than two herds:

which, according to official findings, were free from tuberculosis during that time,

which, according to official findings, were free from brucellosis during that time,

which were free from enzootic bovine leukosis or in which no bovine animal showed clinical signs of enzootic bovine leukosis during the previous three years,

in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months;

(1) either [II.4.4. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the oocytes.]

Text of image

COUNTRY

In vitro produced bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

(1) or [II.4.4. were kept during a seasonally free period or protected from the vector for at least 60 days prior to, and during, the collection of the oocytes, and the embryos were produced without penetration of the zona pellucida, except if the donors underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results and the embryos were stored for at least 30 days.]

(1) or [II.4.4. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results, and the embryos were stored for at least 30 days.]

(1) or [II.4.4. underwent an agent identification test, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of collection or the day of slaughtering and giving negative results – the embryos having been produced, in the latter case, without penetration of the zona pellucida.]

II.5. The embryos to be exported were conceived by in vitro fertilisation using semen coming from semen collection or storage centres (4):

(1) either [II.5.1. approved in accordance with Article 5(1) of Directive 88/407/EEC and located in a Member State of the European Union, and the semen complies with the requirements of Directive 88/407/EEC.]

(1) or [II.5.1. approved in accordance with Article 9(1) of Directive 88/407/EEC and located in a third country or part thereof listed in Annex I to Commission Implementing Decision 2011/630/EU, and the semen complies with the requirements set out in Section A of Part 1 of Annex II to that Decision.]

Notes

Part I:

Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.

Box I.11: Place of origin shall correspond to the embryo collection team from which the embryos are dispatch to the Union and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website:

http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm.

Box I.22: Number of packages shall correspond to the number of containers.

Box I.23: identification of container and seal number shall be indicated.

Box I.26: fill in according to whether it is a transit or an import certificate.

Box I.27: fill in according to whether it is a transit or an import certificate.

Box I.28: Species: select amongst “Bos taurus”, “Bison bison” or “Bubalus bubalis” as appropriate.

Category: select “in vivo derived embryos”.

Dam identity shall correspond to the official identification of the animal.

Sire identity shall correspond to the official identification of the animal.

Date of freezing shall be indicated in the following format: dd.mm.yyyy

Approval number of the team: shall correspond to the embryo collection team by which the embryos were collected, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

Part II:

(1) Delete as appropriate.

(2) Only third countries listed in Annex I to Decision 2006/168/EC.

(3) Only embryo production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm

(4) Only semen collection centres listed in accordance with Article 5(2) and Article 9(2) of Directive 88/407/EEC on the Commission websites:

http://ec.europa.eu/food/animal/approved_establishments/establishments_vet_field_en.htm;

http://ec.europa.eu/food/animal/semen_ova/bovine/index_en.htm.

The signature and the stamp must be in a different colour to that of the printing.

Text of image

COUNTRY

In vitro produced bovine embryos

II. Health information

II.a. Certificate reference No

II.b.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp:

‘ANNEX IV

Model veterinary certificate for imports of in vitro-produced embryos of domestic animals of the bovine species conceived using semen coming from semen collection or storage centres approved by the competent authority of the exporting country

Text of image

Part I: Details of dispatched consignment

COUNTRY

Veterinary certificate to EU

I.1. Consignor

Name

Address

Tel.

I.2. Certificate reference No

I.2.a.

I.3. Central competent authority

I.4. Local competent authority

I.5. Consignee

Name

Address

Postal code

Tel.

I.6. Person responsible for the load in EU

Name

Address

Postal code

Tel.

I.7. Country of origin

ISO code

I.8. Region of origin

Code

I.9. Country of destination

ISO code

I.10. Region of destination

Code

I.11. Place of origin

Name

Approval number

Address

Name

Approval number

Address

Name

Approval number

Address

I.12. Place of destination

Name

Address

Postal code

I.13. Place of loading

I.14. Date of departure

I.15. Means of transport

Aeroplane

Ship

Railway wagon

Road vehicle

Other

Identification

Documentary references

I.16. Entry BIP in EU

I.17. I.18. Description of commodity

I.19. Commodity code (HS code)

05 11 99 85

I.20. Quantity

I.21. I.22. Number of packages

I.23. Seal/Container No

I.24. I.25. Commodities certified for:

Artificial reproduction

I.26. For transit through EU to third country

Third country

ISO code

I.27. For import or admission into EU

I.28. Identification of the commodities

Species

(Scientific name)

Breed

Category

Dam identity

Sire identity

Date of freezing

Approval number of the team

Quantity

Text of image

Part II: Certification

COUNTRY

In vitro produced bovine embryos using semen from semen centres approved by the exporting country

II. Health information

II.a. Certificate reference No

II.b.

I, the undersigned, official veterinarian of … certify that:

(exporting country) (2) II.1. The embryos to be exported

II.1.1. were produced in the exporting country, which according to official findings:

II.1.1.1. was free from rinderpest during the 12 months immediately prior to their production;

(1) either [II.1.1.2. was free from foot-and-mouth disease during the 12 months immediately prior to their production and did not carry out vaccination against foot-and-mouth disease during that period.]

(1) or [II.1.1.2. was not free from foot-and-mouth disease during the 12 months immediately prior to their production and/or carried out vaccination against foot-and-mouth disease during that period, and

the embryos were produced without penetration of the zona pellucida,

the embryos were stored under approved conditions for at least 30 days immediately after their production,

the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease during the 30 days prior to collection and no animal of a susceptible species showed clinical signs of foot-and-mouth disease during the 30 days prior to, and at least the 30 days after, the oocytes were collected.]

II.1.2. were produced by the embryo production team (3) which:

has been approved in accordance with Chapter I of Annex A to Directive 89/556/EEC;

carried out the production, processing, storing and transport of the embryos in accordance with Chapter II of Annex A to Directive 89/556/EEC;

is subject to inspection by an official veterinarian at least twice a year.

II.2. The oocytes used in the production of the embryos to be exported were collected on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no incidence of foot-and-mouth disease, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia in the 30 days immediately prior to their collection and until their dispatch to the Union, in case of fresh embryos, or during the 30 days after collection, in case of embryos subject to a mandatory storage for at least 30 days in accordance with point II.2.2. II.3. From the time of collection until 30 days thereafter or, in the case of fresh embryos until the day of dispatch, the embryos to be exported were stored on premises situated in an area of at least 10 km radius centred on them, on which according to official findings there was no incidence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia.

II.4. The donors of oocytes used in the production of the embryos to be exported:

II.4.1. were located, during the 30 days immediately prior to collection of the oocytes, on premises within a 10-km radius of which, according to official findings, there was no incidence of foot-and-mouth disease, bluetongue, epizootic haemorrhagic disease, vesicular stomatitis, Rift Valley fever or contagious bovine pleuropneumonia;

II.4.2. showed no clinical signs of disease on the day of collection;

II.4.3. spent the six months immediately prior to collection within the territory of the exporting country in no more than two herds:

which, according to official findings, were free from tuberculosis during that time,

which, according to official findings, were free from brucellosis during that time,

which were free from enzootic bovine leukosis or in which no animal showed clinical signs of enzootic bovine leukosis during the previous three years,

in which no bovine animal showed clinical signs of infectious bovine rhinotracheitis/infectious pustular vulvo-vaginitis during the previous 12 months.

(1) either [II.4.4. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the oocytes.]

Text of image

COUNTRY

In vitro produced bovine embryos using semen from semen centres approved by the exporting country

II. Health information

II.a. Certificate reference No

II.b.

(1) or [II.4.4. were kept during a seasonally free period or protected from the vector for at least 60 days prior to, and during, the collection of the oocytes, and the embryos were produced without penetration of the zona pellucida, except if the donors underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results and the embryos were stored for at least 30 days.]

(1) or [II.4.4. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection and giving negative results, and the embryos were stored for at least 30 days.]

(1) or [II.4.4. underwent an agent identification test, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of collection or the day of slaughtering and giving negative results – the embryos having been produced, in the latter case, without penetration of the zona pellucida.]

II.5. The embryos to be exported were conceived by in vitro fertilisation using semen coming from semen collection or storage centres approved for the collection, processing and/or storage of semen by the competent authority of a third country or a part thereof listed in Annex I to Commission Implementing Decision 2011/630/EU (4) or by the competent authority of a Member State.

Notes

In accordance with Article 3(a) of Directive 89/556/EEC, the in vitro produced bovine embryos using semen from semen centres approved by the exporting country, imported under the conditions laid down in this certificate are excluded from intra-Union trade.

Part I:

Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.

Box I.11: Place of origin shall correspond to the embryo collection team from which the embryos are dispatch to the Union and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website:

http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm.

Box I.22: number of packages shall correspond to the number of containers.

Box I.23: identification of container and seal number shall be indicated.

Box I.26: fill in according to whether it is a transit or an import certificate.

Box I.27: fill in according to whether it is a transit or an import certificate.

Box I.28: Species: select amongst “Bos taurus”, “Bison bison” or “Bubalus bubalis” as appropriate.

Category: select “in vivo produced embryos”.

Dam identity shall correspond to the official identification of the animal.

Sire identity shall correspond to the official identification of the animal.

Date of freezing shall be indicated in the following format: dd.mm.yyyy

Approval number of the team: shall correspond to the embryo production team by which the embryos were produced, processed and stored; and listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm.

Part II:

(1) Delete as appropriate.

(2) Only third countries listed in Annex I to Decision 2006/168/EC.

(3) Only embryo production teams listed in accordance with Article 8(2) of Directive 89/556/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/bovine/ova_embryos_en.htm.

(4) Only third countries listed in Annex I to Implementing Decision 2011/630/EU.

The signature and the stamp must be in a different colour to that of the printing.

Text of image

COUNTRY

In vitro produced bovine embryos using semen from semen centres approved by the exporting country

II. Health information

II.a. Certificate reference No

II.b.

Official veterinarian

Name (in capital letters):

Qualification and title:

Date:

Signature:

Stamp:

’

(*1)  For in vivo derived and in vitro produced embryos, the certificates to be used for imports from Switzerland are set out in Annex C to Directive 89/556/EEC, with the adaptations set out in point 2 of Chapter VI(B) of Appendix 2 of Annex 11 to the Agreement between the European Community and the Swiss Confederation on Trade in Agricultural Products as approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation of 4 April 2002 on the conclusion of seven Agreements with the Swiss Confederation.

(*2)  Provisional code that does not affect the definitive denomination of the country to be attributed after the conclusion of the negotiations currently taking place in the United Nations.

(*3)  For in vivo derived embryos, the certificate to be used for imports from New Zealand is set out in Annex IV to Commission Decision 2003/56/EC of 24 January 2003 on health certificates for the importation of live animals and animal products from New Zealand (only for the embryos collected in New Zealand), laid down in accordance with the Agreement between the European Community and New Zealand on sanitary measures applicable to trade in live animals and animal products, as approved by Council Decision 97/132/EC.

Pending: 32012D0411

                                January 16, 2026                            

20.7.2012
EN
Official Journal of the European Union
L 192/16

(1)
Commission Decision 2010/472/EU of 26 August 2010 on imports of semen, ova and embryos of animals of the ovine and caprine species into the Union(2)sets out a list of third countries or parts thereof from which Member States are to authorise the importation into the Union of consignments of semen, ova and embryos of animals of the ovine and caprine species. It also lays down additional guarantees as regards specific animal diseases to be provided by certain third countries or parts thereof listed in Annexes I and III thereto and establishes the model health certificates for such imports in Part 2 of Annexes II and IV thereto.

(2)
The animal health requirements relating to bluetongue in the model health certificates set out in Part 2 of Annexes II and IV to Decision 2010/472/EU are based on the recommendations of Chapter 8.3 of the Terrestrial Animal Health Code of the World Organisation for animal Health (OIE) which deals with that disease. That Chapter recommends a whole range of risk mitigating measures aiming at either protecting the mammalian host from exposure to the infectious vector or at inactivating the virus by antibodies.

(3)
In addition, the OIE has laid down a Chapter on Surveillance for arthropod vectors of animal diseases in the Terrestrial Animal Health Code. Those recommendations do not include the monitoring of ruminants for antibodies to Simbu viruses, such as the Akabane and Aino viruses of theBunyaviridaefamily, which in the past was considered an economical method for determining the distribution of bluetongue competent vectors until more information on the spread of those diseases became available.

(4)
Also, the OIE does not list Akabane and Aino diseases in the Terrestrial Animal Health Code. Consequently, the requirement for annual testing for those diseases to prove the absence of the vector should be deleted from Annexes I and III to Decision 2010/472/EU and from the model health certificates set out in Part 2 of Annexes II and IV thereto.

(5)
In addition, the animal health requirements for epizootic haemorrhagic disease in the model health certificates in Part 2 of Annexes II and IV to Decision 2010/472/EU are not entirely consistent with the requirements laid down in Commission Implementing Decision 2011/630/EU of 20 September 2011 on imports into the Union of semen of domestic animals of the bovine species(3)and the recommendations of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE. Those model health certificates should therefore be amended to take account of the requirements laid down in Implementing Decision 2011/630/EU and the recommendations of that Manual.

(6)
The Annexes to Decision 2010/472/EU should therefore be amended accordingly.

(7)
To avoid any disruption of trade, the use of health certificates issued in accordance with Decision 2010/472/EU in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions.

(8)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

(a)
semen of animals of the ovine and caprine species which are accompanied by a health certificate issued not later than 31 May 2013 in accordance with the model health certificate set out in Section A of Part 2 of Annex II to Decision 2010/472/EU in its version prior to the amendments introduced by this Decision.

(b)
ova and embryos of animals of the ovine and caprine species accompanied by a health certificate issued not later than 31 May 2013 in accordance with the model health certificate set out in Part 2 of Annex IV to Decision 2010/472/EU in its version prior to the amendments introduced by this Decision.

(1)
Annex I is replaced by the following:‘ANNEX IList of third countries or parts thereof from which Member States are to authorise imports of consignments of semen of animals of the ovine and caprine speciesISO CodeName of the third countryRemarksDescription of the territory(if appropriate)Additional guaranteesAUAustraliaThe additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.CACanadaThe additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.CHSwitzerland(*1)CLChileGLGreenlandHRCroatiaISIcelandNZNew ZealandPMSaint Pierre and MiquelonUSUnited StatesThe additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.
ISO Code
Name of the third country
Remarks
Description of the territory(if appropriate)
Additional guarantees
AU
Australia

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.
CA
Canada

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.
CH
Switzerland(*1)

CL
Chile

GL
Greenland

HR
Croatia

IS
Iceland

NZ
New Zealand

PM
Saint Pierre and Miquelon

US
United States

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

ISO Code
Name of the third country
Remarks

Description of the territory(if appropriate)
Additional guarantees

AU
Australia

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

CA
Canada

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

CH
Switzerland(*1)

CL
Chile

GL
Greenland

HR
Croatia

IS
Iceland

NZ
New Zealand

PM
Saint Pierre and Miquelon

US
United States

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

ISO Code
Name of the third country
Remarks

Description of the territory(if appropriate)
Additional guarantees

AU
Australia

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

CA
Canada

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

CH
Switzerland(*1)

CL
Chile

GL
Greenland

HR
Croatia

IS
Iceland

NZ
New Zealand

PM
Saint Pierre and Miquelon

US
United States

The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

(2)
in Part 2 of Annex II, Section A is replaced by the following:‘Section AModel 1 — Health certificate for semen dispatched from an approved semen collection centre of origin of the semenText of imagePart I: Details of dispatched consignmentCOUNTRYVeterinary certificate to EUI.1. ConsignorNameAddressTel.I.2. Certificate reference NoI.2.a.I.3. Central competent authorityI.4. Local competent authorityI.5. ConsigneeNameAddressPostal codeTel.I.6. Person responsible for the load in EUNameAddressPostal codeTel.I.7. Country of originISO codeI.8. Region of originCodeI.9. Country of destinationISO codeI.10. Region of destinationCodeI.11. Place of originNameApproval numberAddressNameApproval numberAddressNameApproval numberAddressI.12. Place of destinationNameAddressPostal codeI.13. Place of loadingI.14. Date of departureI.15. Means of transportAeroplaneShipRailway wagonRoad vehicleOtherIdentificationDocumentary referencesI.16. Entry BIP in EUI.17.I.18. Description of commodityI.19. Commodity code (HS code)05 11 99 85I.20. QuantityI.21.I.22. Number of packagesI.23. Seal/container NoI.24.I.25. Commodities certified for:Artificial reproductionI.26. For transit through EU to third countryThird countryISO codeI.27. For import or admission into EUI.28. Identification of the commoditiesSpecies(scientific name)BreedDondor identityDate of collectionApproval number of the centreQuantityText of imagePart II: CertificationCOUNTRYOvine and caprine semen — Section AII. Health informationII.a. Certificate reference NoII.b.I, the undersigned, official veterinarian, hereby certify that:II.1. The exporting country …(name of exporting country) (2)II.1.1. has been free from rinderpest, peste des petits ruminants, sheep and goat pox, contagious caprine pleuropneumonia and Rift Valley fever during the 12 months immediately prior to collection of the semen to be exported and until its date of dispatch to the Union and no vaccination against these diseases took place during that period;II.1.2. has been free from foot-and-mouth disease during the 12 months immediately prior to collection of the semen to be exported and until its date of dispatch to the Union and no vaccination against this disease took place during that period.II.2. The semen collection centre described in Box I.11 and at which the semen to be exported was collected and stored:II.2.1. meets the conditions for the approval of semen collection centres laid down in Chapter I(I)(1) of Annex D to Directive 92/65/EEC;II.2.2. is operated and supervised in accordance with the conditions applicable to semen collection centres and storage centres laid down in Chapter I(II)(1) of Annex D to Directive 92/65/EEC.II.3. The ovine/caprine (1) animals standing at the semen collection centre:II.3.1. prior to their stay in the quarantine accommodation described in point II.3.3,(1)(4) either [II.3.1.1. originate from the territory described in Box I.8, which has been recognised as officially brucellosis (B. melitensis)-free,](1)or [II.3.1.1. have belonged to a holding which has obtained and maintained its officially brucellosis (B. melitensis)-free status in accordance with Directive 91/68/EEC,](1)or [II.3.1.1. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from clinical or any signs of this disease for the last 12 months, none of the ovine and caprine animals have been vaccinated against this disease, save those vaccinated with Rev. 1 vaccine more than two years ago, and all ovine and caprine animals over six months of age have been subjected to at least two tests (3), carried out with negative results on samples taken on … (date) and on … (date) at least six months apart, the latter being within 30 days of entry into the quarantine accommodation,]and have not been kept previously in a holding of a lower status;II.3.1.2. have been kept continuously for at least 60 days on a holding where no case of contagious epididymitis (Brucella ovis) has been diagnosed in the last 12 months,(1) and [they are animals of the ovine species and have undergone during the 60 days prior to their stay in the quarantine accommodation described in point II.3.3 a complement fixation test, or any other test with an equivalent documented sensitivity and specificity, to detect contagious epididymitis with result of less than 50 ICFTU/ml;]II.3.1.3. to the best of my knowledge do not come from holdings and have not been in contact with animals of a holding, in which, based on the official notification system and according to the written declaration made by the owner, any of the following diseases has been clinically detected within the periods referred to in (a) to (d) prior to their stay in the quarantine accommodation described in point II.3.3:(a) contagious agalactia of sheep or goats (Mycoplasma agalactiae, Mycoplasma capricolum, Mycoplasma mycoides var. mycoides “large colony”), within the last six months;(b) paratuberculosis and caseous lymphadenitis, within the last 12 months;(c) pulmonary adenomatosis, within the last three years;(1) either [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last three years;](1) or [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last 12 months, and all the infected animals were slaughtered and remaining animals subsequently reacted negatively to two tests carried out at least six months apart;]II.3.2. have undergone the following tests carried out on a blood sample collected within the 28 days preceding the commencement of the period of quarantine specified in point II.3.3 for:Text of imageCOUNTRYOvine and caprine semen — Section AII. Health informationII.a. Certificate reference NoII.b.brucellosis (B. melitensis), with negative results in each case in accordance with Annex C to Directive 91/68/EEC,contagious epididymitis (Brucella. ovis), in the case of sheep only, with negative results in each case in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity,border disease in accordance with point 1.4 (c) of Chapter II(II) of Annex D to Directive 92/65/EEC;II.3.3. have satisfied the quarantine isolation period of at least 28 days in a quarantine accommodation specifically approved for the purpose by the competent authority and during that periodII.3.3.1. only animals of at least the same health status were present in the quarantine accommodation;II.3.3.2. the animals have undergone the following tests, carried out by the laboratory approved by the competent authority of the exporting country on samples taken not earlier than 21 days after the animals were admitted to the quarantine accommodation, for:brucellosis (B. melitensis) with negative results in accordance with Annex C to Directive 91/68/EEC,contagious epididymitis (Brucella ovis), in the case of sheep only, with negative results in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity,border disease in accordance with point 1.6 of Chapter II(II) of Annex D to Directive 92/65/EEC;II.3.4. have undergone at least once a year the routine tests with negative results for:brucellosis (B. melitensis) in accordance with Annex C to Directive 91/68/EEC,contagious epididymitis (Brucella ovis) in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity; in the case of sheep only,border disease in accordance with point 5(c) of Chapter II(II) of Annex D to Directive 92/65/EEC.II.4. The semen to be exported was obtained from donor rams/bucks (1) which:II.4.1. were admitted to the approved semen collection centre with the express permission of the centre veterinarian;II.4.2. show no clinical signs of disease on the day of admission to the approved semen collection centre and on the day the semen was collected;(1) either [II.4.3. have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection of the semen;](1) or [II.4.3. have been vaccinated against foot-and-mouth disease at least 30 days prior to the collection, and 5 % (with a minimum of five straws) of each collection have been submitted to a virus isolation test for foot-and-mouth disease with negative results;]II.4.4. have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately prior to collection of the semen, in the case of collections of fresh semen;II.4.5. have not served naturally after their entry to the quarantine accommodation described in point II.3.3 and up to and including the day of semen collection;II.4.6. have been kept at the approved semen collection centres:II.4.6.1. which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection or, in the case of fresh semen, until the date of dispatch, and which are situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days prior to collection of the semen;II.4.6.2. which have been free, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, from brucellosis (B. melitensis), contagious epididymitis (Brucella. ovis), anthrax and rabies;Text of imageCOUNTRYOvine and caprine semen — Section AII. Health informationII.a. Certificate reference NoII.b.(1) either [II.4.7. have remained in the exporting country for at least the past six months prior to collection of the semen to be exported;](1) or [II.4.7. during the past six months prior to collection of the semen they satisfied the animal health conditions applying to donors of the semen which is intended for export to the Union and they have been imported into the exporting country at least 30 days prior to collection of the semen from … (2);](1) either [II.4.8. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the semen;](1) or [II.4.8. were kept during a bluetongue virus seasonally free period in a seasonally free zone for at least 60 days prior to, and during collection of the semen;](1) or [II.4.8. were kept in a vector-protected establishment for at least 60 days prior to, and during collection of the semen;](1) or [II.4.8. were subjected to a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, with negative results, at least every 60 days throughout the collection period and between 21 and 60 days after the final collection for this consignment of semen;](1) or [II.4.8. were subjected to an agent identification test for bluetongue virus, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals with negative results on blood samples taken at commencement and final collection for this consignment of semen and at least every seven days (virus isolation test) or at least every 28 days (PCR test) during collection for this consignment of semen;]II.4.9. were resident in the exporting country,(1)(5) either [II.4.9.1. which according to official findings is free from epizootic haemorrhagic disease (EHD);](1) or [II.4.9.1. in which according to official findings the following serotypes of epizootic haemorrhagic disease (EHD) exist: … and were subjected with negative results in each case to:(1) either [on two occasions not more than 12 months apart in a serological test (6) carried out in an approved laboratory on samples of blood taken prior to and not less than 21 days following collection for this consignment of semen.](1) or [a serological test (6) for the detection of antibody to the EHDV group, carried out on samples taken at intervals of not more than 60 days throughout the collection period and between 21 and 60 days after the final collection for this consignment of semen.](1) or [an agent identification test (6) carried out in approved laboratories on blood samples collected at commencement and conclusion of, and at least every seven days (virus isolation test) or at least every 28 days (PCR test) during collection for this consignment of semen.]]II.5. The semen to be exported:II.5.1. was collected after the date on which the semen collection centre was approved by the competent authority of the exporting country;II.5.2. was collected, processed, preserved, stored and transported in accordance with the requirements applicable to semen laid down in Chapter III(I) of Annex D to Directive 92/65/EEC;(1) either [II.5.3. meets the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001;](1) or [II.5.3. meets the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and is destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and the donor animals comply regarding scrapie with the guarantees provided for by the national scrapie control program referred to in those points and with the guarantees (7) requested by the Member State of destination;]II.5.4. was sent to the place of loading in a sealed container in accordance with the requirements for semen to be subject to trade laid down in point 1.4 of Chapter III(I) of Annex D to Directive 92/65/EEC and bearing the number indicated in Box I.23.(1) either [II.6. No antibiotics were added to the semen.]Text of imageCOUNTRYOvine and caprine semen — Section AII. Health informationII.a. Certificate reference NoII.b.(1) or [II.6. The following antibiotic or combination of antibiotics was added to produce a concentration in the final diluted semen of not less than (8):… ]NotesPart I:Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodityBox I.11: Place of origin shall correspond to the approved semen collection centre in which the semen was collected and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htmBox I.22: number of packages shall correspond to the number of containers.Box I.23: identification of container and seal number shall be indicated.Box I.26: fill in according to whether it is a transit or an import certificate.Box I.27: fill in according to whether it is a transit or an import certificate.Box I.28: Species: select amongst “Ovis aries” or “Capra hircus” as appropriate.Donor identity shall correspond to the official identification of the animal.Date of collection shall be indicated in the following format: dd.mm.yyyy.Approval number of the centre shall correspond to the approval number of the semen collection centre indicated in Box I.11.Part II:(1) Delete as necessary.(2) Only third countries listed in Annex I to Decision 2010/472/EU.(3) Tests shall be carried out in accordance with Annex C to Directive 91/68/EEC.(4) Only for the territory appearing with the entry “V” in column 6 of Part 1 of Annex I to Commission Regulation (EU) No 206/2010 (OJ L 73, 20.3.2010, p. 1).(5) See remarks for exporting country concerned in Annex I to Decision 2010/472/EU.(6) Standards for EHD virus diagnostic tests are described in Chapter 2.1.3 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.(7) Additional guarantees as laid down in Article 2 of Regulation (EC) No 546/2006 (OJ L 94, 1.4.2006, p. 28).(8) Insert names and concentrations.Official veterinarian (*)Name (in capital letters):Qualification and title:Date:Signature:Stamp:(*) The signature and the stamp must be in a different colour to that of the printing.’

(3)
Annex III is replaced by the following:‘ANNEX IIIList of third countries or parts thereof from which Member States are to authorise imports of consignments of ova and embryos of animals of the ovine and caprine speciesISO CodeName of the third countryRemarksDescription of the territory(if appropriate)Additional guaranteesAUAustraliaThe additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.CACanadaThe additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.CHSwitzerland(*2)CLChileGLGreenlandHRCroatiaISIcelandNZNew ZealandPMSaint Pierre and MiquelonUSUnited StatesThe additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.
ISO Code
Name of the third country
Remarks
Description of the territory(if appropriate)
Additional guarantees
AU
Australia

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.
CA
Canada

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.
CH
Switzerland(*2)

CL
Chile

GL
Greenland

HR
Croatia

IS
Iceland

NZ
New Zealand

PM
Saint Pierre and Miquelon

US
United States

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

ISO Code
Name of the third country
Remarks

Description of the territory(if appropriate)
Additional guarantees

AU
Australia

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

CA
Canada

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

CH
Switzerland(*2)

CL
Chile

GL
Greenland

HR
Croatia

IS
Iceland

NZ
New Zealand

PM
Saint Pierre and Miquelon

US
United States

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

ISO Code
Name of the third country
Remarks

Description of the territory(if appropriate)
Additional guarantees

AU
Australia

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

CA
Canada

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

CH
Switzerland(*2)

CL
Chile

GL
Greenland

HR
Croatia

IS
Iceland

NZ
New Zealand

PM
Saint Pierre and Miquelon

US
United States

The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

(4)
Part 2 of Annex IV is replaced by the following:‘PART 2Model health certificate for imports of consignments of ova and embryos of animals of the ovine and caprine speciesText of imagePart I: Details of dispatched consignmentCOUNTRYVeterinary certificate to EUI.1. ConsignorNameAddressTel.I.2. Certificate reference NoI.2.a.I.3. Central competent authorityI.4. Local competent authorityI.5. ConsigneeNameAddressPostal codeTel.I.6. Person responsible for the load in EUNameAddressPostal codeTel.I.7. Country of originISO codeI.8. Region of originCodeI.9. Country of destinationISO codeI.10. Region of destinationCodeI.11. Place of originNameApproval numberAddressNameApproval numberAddressNameApproval numberAddressI.12. Place of destinationNameAddressPostal codeI.13. Place of loadingI.14. Date of departureI.15. Means of transportAeroplaneShipRailway wagonRoad vehicleOtherIdentificationDocumentary referencesI.16. Entry BIP in EUI.17.I.18. Description of commodityI.19. Commodity code (HS code)05 11 99 85I.20. QuantityI.21.I.22. Number of packagesI.23. Seal/container NoI.24.I.25. Commodities certified for:Artificial reproductionI.26. For transit through EU to third countryThird countryISO codeI.27. For import or admission into EUI.28. Identification of the commoditiesSpecies(scientific name)BreedCategoryDonor identityDate of collectionDate of freezingApproval number of the teamQuantityText of imagePart II: CertificationCOUNTRYOvine and caprine ova/embryosII. Health informationII.a. Certificate reference NoII.b.I, the undersigned, official veterinarian, hereby certify that:II.1. The exporting country …(name of exporting country) (2)II.1.1. has been free from rinderpest, peste des petits ruminants, sheep and goat pox, contagious caprine pleuropneumonia, and Rift Valley fever during the 12 months immediately prior to collection of the ova/embryos (1) to be exported and until their date of dispatch to the Union and no vaccination against these diseases took place during that period;(1) either [II.1.2. has been free from foot-and-mouth disease during the 12 months immediately prior to collection of the ova/embryos (1) and did not carry out vaccination against foot-and-mouth disease during that period;](1) or [II.1.2. has not been free from foot-and-mouth disease during the 12 months immediately prior to collection of the ova/embryos (1) and/or carried out vaccination against foot-and-mouth disease during that period and the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease during 30 days prior to collection and no animal of susceptible species showed clinical signs of foot-and-mouth disease during the 30 days prior to, and at least 30 days after, the ova/embryos (1) were collected and the ova/embryos (1) were not subjected to penetration of zona pellucida;]II.2. The ova/embryos (1) to be exported:II.2.1. were collected/produced (1) and processed on premises within a 10-km radius of which there was no incidence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever in the 30 days immediately prior to their collection;II.2.2. were stored at all times on approved premises within a 10-km radius of which there was no incidence of foot-and-mouth disease, vesicular stomatitis or Rift Valley fever from the time of their collection until 30 days thereafter;II.2.3. were collected/produced (1) by the team described in Box I.11, which has been approved and supervised in accordance with the conditions for the approval and supervision of embryo collection teams and embryo production teams laid down in Chapter I(III) of Annex D to Directive 92/65/EEC;II.2.4. meet the conditions for ova and embryos laid down in Chapter III(II) of Annex D to Directive 92/65/EEC;II.2.5. come from the donor females of ovine/caprine (1) species which:(1) either [II.2.5.1. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during collection of the ova/embryos (1);](1) or [II.2.5.1. were kept during a bluetongue virus seasonally free period in a seasonally free zone;](1) or [II.2.5.1. were kept protected from the vector for at least 60 days prior to, and during the collection of the ova/embryos (1);](1) or [II.2.5.1. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection of the ova/embryos (1) and giving negative results;](1) or [II.2.5.1. underwent an agent identification test for bluetongue virus, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of the ova/embryos (1) collection or the day of slaughtering and giving negative results;]II.2.5.2. to the best of my knowledge do not come from holdings and have not been in contact with animals of a holding, in which, based on the official notification system and according to the written declaration made by the owner, any of the following diseases has been clinically detected within the periods referred to in (a) to (d) prior to collection of the ova/embryos (1) to be exported:(a) contagious agalactia of sheep or goats (Mycoplasma agalactiae, Mycoplasma capricolum, Mycoplasma mycoides var. mycoides “large colony”), within the last six months;(b) paratuberculosis and caseous lymphadenitis, within the last 12 months;(c) pulmonary adenomatosis, within the last three years;(1) either [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last three years;](1) or [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last 12 months, and all the infected animals were slaughtered and remaining animals subsequently reacted negatively to two tests carried out at least six months apart;]Text of imageCOUNTRYOvine and caprine ova/embryosII. Health informationII.a. Certificate reference NoII.b.II.2.5.3. showed no clinical signs of disease on the day of the ova/embryos (1) collection;(1)(4) either [II.2.5.4 originate from the region described in Box I.8., which has been recognised as officially brucellosis (B. melitensis)-free, and](1) or [II.2.5.4. have belonged to a holding which has obtained and maintained its officially brucellosis (B. melitensis)-free status in accordance with Directive 91/68/EEC, and](1) or [II.2.5.4. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from any clinical or any signs of this disease for the last 12 months, none of the ovine and caprine animals have been vaccinated against this disease, save those vaccinated with Rev. 1 vaccine more than two years ago, and all ovine and caprine animals over six months of age have been subjected to at least two tests (3) , carried out with negative results on samples taken on … (date) and on … (date) at least six months apart, the latter being within 30 days prior to collection of the ova/embryos (1),]and have not been kept previously in a holding of a lower status;(1) either [II.2.5.5. have remained in the exporting country for at least the past six months prior to collection of the ova/embryos (1) to be exported;](1) or [II.2.5.5 during the past six months prior to collection of the ova/embryos (1) they satisfied the animal health conditions applying to donors of the ova/embryos (1) which are intended for export to the Union and they have been imported into the exporting country at least 30 days prior to collection of the ova/embryos (1) from … (2);][II.2.6. were collected/produced (1) in the exporting country,(1) either [II.2.6.1. which according to official findings is free from epizootic haemorrhagic disease (EHD);](1)(5) or [II.2.6.1. in which according to official findings the following serotypes of epizootic haemorrhagic disease (EHD) exist: … and were subjected with negative results in each case to:(1) either [on two occasions not more than 12 months apart in a serological test (6) carried out in an approved laboratory on samples of blood taken prior to and not less than 21 days following collection for this consignment of ova/embryos (1);](1) or [a serological test (6) for the detection of antibody to the EHDV group, carried out on samples taken at intervals of not more than 60 days throughout the collection period and between 21 and 60 days after the final collection for this consignment of ova/embryos (1);](1) or [an agent identification test (6) carried out in approved laboratories on blood samples collected at commencement and conclusion of, and at least every seven days (virus isolation test) or at least every 28 days (PCR test) during collection for this consignment of ova/embryos (1);]](1) either [II.2.8. meet the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001;](1) or [II.2.8. meet the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and the donor animals comply regarding scrapie with the guarantees provided for by the national scrapie control program referred to in that point and with the guarantees (7) requested by the Member State of destination;]II.2.9. were collected/produced (1) after the date on which the embryo collection team was approved by the competent authority of the exporting country;II.2.10. were processed and stored under approved conditions for at least 30 days immediately after their collection/production (1) and transported under conditions for ova and embryos laid down in Chapter III(II) of Annex D to Directive 92/65/EEC;II.2.11. were sent to the place of loading in a sealed container in accordance with the requirements for the transport of embryos laid down in point 6 of Chapter III(II) of Annex D to Directive 92/65/EEC and bearing the number detailed in Box I.23;(9) II.2.12. were conceived by artificial insemination/as a result of in vitro fertilisation (1) using semen coming from semen collection centres.(1) either [II.2.12.1. approved in accordance with Article 11(2) of Directive 92/65/EEC and located in a Member State of the European Union; and the semen complies with the requirements of Directive 92/65/EEC.](1) or [II.2.12.1. approved in accordance with Article 17(3)(b) of Directive 92/65/EEC and located in a third country or part thereof listed in Annex I to Decision 2010/472/EU, and the semen complies with the requirements set out in Part 2 of Annex II to that Decision.]Text of imageCOUNTRYOvine and caprine ova/embryosII. Health informationII.a. Certificate reference NoII.b.NotesPart I:Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.Box I.11: Place of origin shall correspond to the approved embryo collection team or embryo production team by which the ova/embryos were collected/produced, processed and stored; and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htmBox I.22: number of packages shall correspond to the number of containers.Box I.23: identification of container and seal number shall be indicated.Box I.26: fill in according to whether it is a transit or an import certificate.Box I.27: fill in according to whether it is a transit or an import certificate.Box I.28: Species: select amongst “Ovis aries” or “Capra hircus” as appropriate.Category: specify if in vivo derived embryos, in vivo derived ova, in vitro produced embryos or micromanipulated embryos.Donor identity shall correspond to the official identification of the animal.Date of collection shall be indicated for in vivo derived embryos and in the following format: dd.mm.yyyy.Date of freezing shall be indicated in the following format: dd.mm.yyyy.Approval number of the team: shall correspond to the approved embryo collection team or embryo production team by which the ova/embryos were collected/produced, processed and stored; and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htmPart II:(1) Delete as appropriate.(2) Only third countries or parts thereof listed in Annex I to Decision 2010/472/EU.(3) Tests shall be carried out in accordance with Annex C to Directive 91/68/EEC.(4) Only for the territory appearing with the entry “V” in column 6 of Part 1 of Annex I to Commission Regulation (EU) No 206/2010 (OJ L 73, 20.3.2010).(5) See remarks for exporting country or part thereof concerned in Annex III to Decision 2010/472/EU.(6) Standards for EHD virus diagnostic tests are described in Chapter 2.1.3 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.(7) Additional guarantees as laid down in Article 2 of Regulation (EC) No 546/2006 (OJ L 94, 1.4.2006, p. 28).(8) Only approved semen collection centres listed in accordance with Article 11(4) and Article 17(3)(b) of Directive 92/65/EEC on the Commission websites:http://ec.europa.eu/food/animal/approved_establishments/establishments_vet_field_en.htm;http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htm(9) Does not apply to ova.Official veterinarian (*)Name (in capital letters):Qualification and title:Date:Signature:Stamp:(*) The signature and the stamp must be in a different colour to that of the printing.’

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC(1), and in particular Article 17(2)(b), the first indent of Article 18(1), and the introductory phrase and point (b) of Article 19 thereof,

(1) Commission Decision 2010/472/EU of 26 August 2010 on imports of semen, ova and embryos of animals of the ovine and caprine species into the Union(2)sets out a list of third countries or parts thereof from which Member States are to authorise the importation into the Union of consignments of semen, ova and embryos of animals of the ovine and caprine species. It also lays down additional guarantees as regards specific animal diseases to be provided by certain third countries or parts thereof listed in Annexes I and III thereto and establishes the model health certificates for such imports in Part 2 of Annexes II and IV thereto.

(2) The animal health requirements relating to bluetongue in the model health certificates set out in Part 2 of Annexes II and IV to Decision 2010/472/EU are based on the recommendations of Chapter 8.3 of the Terrestrial Animal Health Code of the World Organisation for animal Health (OIE) which deals with that disease. That Chapter recommends a whole range of risk mitigating measures aiming at either protecting the mammalian host from exposure to the infectious vector or at inactivating the virus by antibodies.

(3) In addition, the OIE has laid down a Chapter on Surveillance for arthropod vectors of animal diseases in the Terrestrial Animal Health Code. Those recommendations do not include the monitoring of ruminants for antibodies to Simbu viruses, such as the Akabane and Aino viruses of theBunyaviridaefamily, which in the past was considered an economical method for determining the distribution of bluetongue competent vectors until more information on the spread of those diseases became available.

(4) Also, the OIE does not list Akabane and Aino diseases in the Terrestrial Animal Health Code. Consequently, the requirement for annual testing for those diseases to prove the absence of the vector should be deleted from Annexes I and III to Decision 2010/472/EU and from the model health certificates set out in Part 2 of Annexes II and IV thereto.

(5) In addition, the animal health requirements for epizootic haemorrhagic disease in the model health certificates in Part 2 of Annexes II and IV to Decision 2010/472/EU are not entirely consistent with the requirements laid down in Commission Implementing Decision 2011/630/EU of 20 September 2011 on imports into the Union of semen of domestic animals of the bovine species(3)and the recommendations of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE. Those model health certificates should therefore be amended to take account of the requirements laid down in Implementing Decision 2011/630/EU and the recommendations of that Manual.

(6) The Annexes to Decision 2010/472/EU should therefore be amended accordingly.

(7) To avoid any disruption of trade, the use of health certificates issued in accordance with Decision 2010/472/EU in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions.

(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
Article 1

The Annexes to Decision 2010/472/EU are amended in accordance with the Annex to this Decision.
Article 2

For a transitional period until 30 June 2013, Member States shall authorise imports from third countries of consignments of:

(a)

semen of animals of the ovine and caprine species which are accompanied by a health certificate issued not later than 31 May 2013 in accordance with the model health certificate set out in Section A of Part 2 of Annex II to Decision 2010/472/EU in its version prior to the amendments introduced by this Decision.

(b)

ova and embryos of animals of the ovine and caprine species accompanied by a health certificate issued not later than 31 May 2013 in accordance with the model health certificate set out in Part 2 of Annex IV to Decision 2010/472/EU in its version prior to the amendments introduced by this Decision.
Article 3

This Decision shall apply from 1 January 2013.
Article 4

This Decision is addressed to the Member States.
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 92/65/EEC of 13 July 1992 laying down animal health requirements governing trade in and imports into the Community of animals, semen, ova and embryos not subject to animal health requirements laid down in specific Community rules referred to in Annex A(I) to Directive 90/425/EEC(1), and in particular Article 17(2)(b), the first indent of Article 18(1), and the introductory phrase and point (b) of Article 19 thereof,

(1) Commission Decision 2010/472/EU of 26 August 2010 on imports of semen, ova and embryos of animals of the ovine and caprine species into the Union(2)sets out a list of third countries or parts thereof from which Member States are to authorise the importation into the Union of consignments of semen, ova and embryos of animals of the ovine and caprine species. It also lays down additional guarantees as regards specific animal diseases to be provided by certain third countries or parts thereof listed in Annexes I and III thereto and establishes the model health certificates for such imports in Part 2 of Annexes II and IV thereto.

(2) The animal health requirements relating to bluetongue in the model health certificates set out in Part 2 of Annexes II and IV to Decision 2010/472/EU are based on the recommendations of Chapter 8.3 of the Terrestrial Animal Health Code of the World Organisation for animal Health (OIE) which deals with that disease. That Chapter recommends a whole range of risk mitigating measures aiming at either protecting the mammalian host from exposure to the infectious vector or at inactivating the virus by antibodies.

(3) In addition, the OIE has laid down a Chapter on Surveillance for arthropod vectors of animal diseases in the Terrestrial Animal Health Code. Those recommendations do not include the monitoring of ruminants for antibodies to Simbu viruses, such as the Akabane and Aino viruses of theBunyaviridaefamily, which in the past was considered an economical method for determining the distribution of bluetongue competent vectors until more information on the spread of those diseases became available.

(4) Also, the OIE does not list Akabane and Aino diseases in the Terrestrial Animal Health Code. Consequently, the requirement for annual testing for those diseases to prove the absence of the vector should be deleted from Annexes I and III to Decision 2010/472/EU and from the model health certificates set out in Part 2 of Annexes II and IV thereto.

(5) In addition, the animal health requirements for epizootic haemorrhagic disease in the model health certificates in Part 2 of Annexes II and IV to Decision 2010/472/EU are not entirely consistent with the requirements laid down in Commission Implementing Decision 2011/630/EU of 20 September 2011 on imports into the Union of semen of domestic animals of the bovine species(3)and the recommendations of the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals of the OIE. Those model health certificates should therefore be amended to take account of the requirements laid down in Implementing Decision 2011/630/EU and the recommendations of that Manual.

(6) The Annexes to Decision 2010/472/EU should therefore be amended accordingly.

(7) To avoid any disruption of trade, the use of health certificates issued in accordance with Decision 2010/472/EU in its version prior to the amendments introduced by this Decision should be authorised during a transitional period subject to certain conditions.

(8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health,

HAS ADOPTED THIS DECISION:
The Annexes to Decision 2010/472/EU are amended in accordance with the Annex to this Decision.
For a transitional period until 30 June 2013, Member States shall authorise imports from third countries of consignments of:

(a)

semen of animals of the ovine and caprine species which are accompanied by a health certificate issued not later than 31 May 2013 in accordance with the model health certificate set out in Section A of Part 2 of Annex II to Decision 2010/472/EU in its version prior to the amendments introduced by this Decision.

(b)

ova and embryos of animals of the ovine and caprine species accompanied by a health certificate issued not later than 31 May 2013 in accordance with the model health certificate set out in Part 2 of Annex IV to Decision 2010/472/EU in its version prior to the amendments introduced by this Decision.
This Decision shall apply from 1 January 2013.
This Decision is addressed to the Member States.
ANNEXThe Annexes to Decision 2010/472/EU are amended as follows:
(1) | Annex I is replaced by the following:‘ANNEX IList of third countries or parts thereof from which Member States are to authorise imports of consignments of semen of animals of the ovine and caprine speciesISO CodeName of the third countryRemarksDescription of the territory(if appropriate)Additional guaranteesAUAustraliaThe additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.CACanadaThe additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.CHSwitzerland(*1)CLChileGLGreenlandHRCroatiaISIcelandNZNew ZealandPMSaint Pierre and MiquelonUSUnited StatesThe additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory. | ISO Code | Name of the third country | Remarks | Description of the territory(if appropriate) | Additional guarantees | AU | Australia |  | The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory. | CA | Canada |  | The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory. | CH | Switzerland(*1) |  |  | CL | Chile |  |  | GL | Greenland |  |  | HR | Croatia |  |  | IS | Iceland |  |  | NZ | New Zealand |  |  | PM | Saint Pierre and Miquelon |  |  | US | United States |  | The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

ISO Code | Name of the third country | Remarks

Description of the territory(if appropriate) | Additional guarantees

AU | Australia |  | The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

CA | Canada |  | The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

CH | Switzerland(*1) |  | 

CL | Chile |  | 

GL | Greenland |  | 

HR | Croatia |  | 

IS | Iceland |  | 

NZ | New Zealand |  | 

PM | Saint Pierre and Miquelon |  | 

US | United States |  | The additional guarantee as regards testing set out in point II.4.9.1 of the model health certificate set out in Section A of Part 2 of Annex II is compulsory.

(2) | in Part 2 of Annex II, Section A is replaced by the following:‘Section AModel 1 — Health certificate for semen dispatched from an approved semen collection centre of origin of the semenText of imagePart I: Details of dispatched consignmentCOUNTRYVeterinary certificate to EUI.1. ConsignorNameAddressTel.I.2. Certificate reference NoI.2.a.I.3. Central competent authorityI.4. Local competent authorityI.5. ConsigneeNameAddressPostal codeTel.I.6. Person responsible for the load in EUNameAddressPostal codeTel.I.7. Country of originISO codeI.8. Region of originCodeI.9. Country of destinationISO codeI.10. Region of destinationCodeI.11. Place of originNameApproval numberAddressNameApproval numberAddressNameApproval numberAddressI.12. Place of destinationNameAddressPostal codeI.13. Place of loadingI.14. Date of departureI.15. Means of transportAeroplaneShipRailway wagonRoad vehicleOtherIdentificationDocumentary referencesI.16. Entry BIP in EUI.17.I.18. Description of commodityI.19. Commodity code (HS code)05 11 99 85I.20. QuantityI.21.I.22. Number of packagesI.23. Seal/container NoI.24.I.25. Commodities certified for:Artificial reproductionI.26. For transit through EU to third countryThird countryISO codeI.27. For import or admission into EUI.28. Identification of the commoditiesSpecies(scientific name)BreedDondor identityDate of collectionApproval number of the centreQuantityText of imagePart II: CertificationCOUNTRYOvine and caprine semen — Section AII. Health informationII.a. Certificate reference NoII.b.I, the undersigned, official veterinarian, hereby certify that:II.1. The exporting country …(name of exporting country) (2)II.1.1. has been free from rinderpest, peste des petits ruminants, sheep and goat pox, contagious caprine pleuropneumonia and Rift Valley fever during the 12 months immediately prior to collection of the semen to be exported and until its date of dispatch to the Union and no vaccination against these diseases took place during that period;II.1.2. has been free from foot-and-mouth disease during the 12 months immediately prior to collection of the semen to be exported and until its date of dispatch to the Union and no vaccination against this disease took place during that period.II.2. The semen collection centre described in Box I.11 and at which the semen to be exported was collected and stored:II.2.1. meets the conditions for the approval of semen collection centres laid down in Chapter I(I)(1) of Annex D to Directive 92/65/EEC;II.2.2. is operated and supervised in accordance with the conditions applicable to semen collection centres and storage centres laid down in Chapter I(II)(1) of Annex D to Directive 92/65/EEC.II.3. The ovine/caprine (1) animals standing at the semen collection centre:II.3.1. prior to their stay in the quarantine accommodation described in point II.3.3,(1)(4) either [II.3.1.1. originate from the territory described in Box I.8, which has been recognised as officially brucellosis (B. melitensis)-free,](1)or [II.3.1.1. have belonged to a holding which has obtained and maintained its officially brucellosis (B. melitensis)-free status in accordance with Directive 91/68/EEC,](1)or [II.3.1.1. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from clinical or any signs of this disease for the last 12 months, none of the ovine and caprine animals have been vaccinated against this disease, save those vaccinated with Rev. 1 vaccine more than two years ago, and all ovine and caprine animals over six months of age have been subjected to at least two tests (3), carried out with negative results on samples taken on … (date) and on … (date) at least six months apart, the latter being within 30 days of entry into the quarantine accommodation,]and have not been kept previously in a holding of a lower status;II.3.1.2. have been kept continuously for at least 60 days on a holding where no case of contagious epididymitis (Brucella ovis) has been diagnosed in the last 12 months,(1) and [they are animals of the ovine species and have undergone during the 60 days prior to their stay in the quarantine accommodation described in point II.3.3 a complement fixation test, or any other test with an equivalent documented sensitivity and specificity, to detect contagious epididymitis with result of less than 50 ICFTU/ml;]II.3.1.3. to the best of my knowledge do not come from holdings and have not been in contact with animals of a holding, in which, based on the official notification system and according to the written declaration made by the owner, any of the following diseases has been clinically detected within the periods referred to in (a) to (d) prior to their stay in the quarantine accommodation described in point II.3.3:(a) contagious agalactia of sheep or goats (Mycoplasma agalactiae, Mycoplasma capricolum, Mycoplasma mycoides var. mycoides “large colony”), within the last six months;(b) paratuberculosis and caseous lymphadenitis, within the last 12 months;(c) pulmonary adenomatosis, within the last three years;(1) either [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last three years;](1) or [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last 12 months, and all the infected animals were slaughtered and remaining animals subsequently reacted negatively to two tests carried out at least six months apart;]II.3.2. have undergone the following tests carried out on a blood sample collected within the 28 days preceding the commencement of the period of quarantine specified in point II.3.3 for:Text of imageCOUNTRYOvine and caprine semen — Section AII. Health informationII.a. Certificate reference NoII.b.brucellosis (B. melitensis), with negative results in each case in accordance with Annex C to Directive 91/68/EEC,contagious epididymitis (Brucella. ovis), in the case of sheep only, with negative results in each case in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity,border disease in accordance with point 1.4 (c) of Chapter II(II) of Annex D to Directive 92/65/EEC;II.3.3. have satisfied the quarantine isolation period of at least 28 days in a quarantine accommodation specifically approved for the purpose by the competent authority and during that periodII.3.3.1. only animals of at least the same health status were present in the quarantine accommodation;II.3.3.2. the animals have undergone the following tests, carried out by the laboratory approved by the competent authority of the exporting country on samples taken not earlier than 21 days after the animals were admitted to the quarantine accommodation, for:brucellosis (B. melitensis) with negative results in accordance with Annex C to Directive 91/68/EEC,contagious epididymitis (Brucella ovis), in the case of sheep only, with negative results in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity,border disease in accordance with point 1.6 of Chapter II(II) of Annex D to Directive 92/65/EEC;II.3.4. have undergone at least once a year the routine tests with negative results for:brucellosis (B. melitensis) in accordance with Annex C to Directive 91/68/EEC,contagious epididymitis (Brucella ovis) in accordance with Annex D to Directive 91/68/EEC, or any other test with an equivalent documented sensitivity and specificity; in the case of sheep only,border disease in accordance with point 5(c) of Chapter II(II) of Annex D to Directive 92/65/EEC.II.4. The semen to be exported was obtained from donor rams/bucks (1) which:II.4.1. were admitted to the approved semen collection centre with the express permission of the centre veterinarian;II.4.2. show no clinical signs of disease on the day of admission to the approved semen collection centre and on the day the semen was collected;(1) either [II.4.3. have not been vaccinated against foot-and-mouth disease during the 12 months prior to collection of the semen;](1) or [II.4.3. have been vaccinated against foot-and-mouth disease at least 30 days prior to the collection, and 5 % (with a minimum of five straws) of each collection have been submitted to a virus isolation test for foot-and-mouth disease with negative results;]II.4.4. have been kept at an approved semen collection centre for a continuous period of at least 30 days immediately prior to collection of the semen, in the case of collections of fresh semen;II.4.5. have not served naturally after their entry to the quarantine accommodation described in point II.3.3 and up to and including the day of semen collection;II.4.6. have been kept at the approved semen collection centres:II.4.6.1. which have been free from foot-and-mouth disease for at least three months prior to collection of the semen and 30 days after collection or, in the case of fresh semen, until the date of dispatch, and which are situated in the centre of an area of 10 kilometres radius in which there has been no case of foot-and-mouth disease for at least 30 days prior to collection of the semen;II.4.6.2. which have been free, during the period commencing 30 days prior to collection and ending 30 days after collection of the semen or, in the case of fresh semen, until the date of dispatch, from brucellosis (B. melitensis), contagious epididymitis (Brucella. ovis), anthrax and rabies;Text of imageCOUNTRYOvine and caprine semen — Section AII. Health informationII.a. Certificate reference NoII.b.(1) either [II.4.7. have remained in the exporting country for at least the past six months prior to collection of the semen to be exported;](1) or [II.4.7. during the past six months prior to collection of the semen they satisfied the animal health conditions applying to donors of the semen which is intended for export to the Union and they have been imported into the exporting country at least 30 days prior to collection of the semen from … (2);](1) either [II.4.8. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during, collection of the semen;](1) or [II.4.8. were kept during a bluetongue virus seasonally free period in a seasonally free zone for at least 60 days prior to, and during collection of the semen;](1) or [II.4.8. were kept in a vector-protected establishment for at least 60 days prior to, and during collection of the semen;](1) or [II.4.8. were subjected to a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals, with negative results, at least every 60 days throughout the collection period and between 21 and 60 days after the final collection for this consignment of semen;](1) or [II.4.8. were subjected to an agent identification test for bluetongue virus, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals with negative results on blood samples taken at commencement and final collection for this consignment of semen and at least every seven days (virus isolation test) or at least every 28 days (PCR test) during collection for this consignment of semen;]II.4.9. were resident in the exporting country,(1)(5) either [II.4.9.1. which according to official findings is free from epizootic haemorrhagic disease (EHD);](1) or [II.4.9.1. in which according to official findings the following serotypes of epizootic haemorrhagic disease (EHD) exist: … and were subjected with negative results in each case to:(1) either [on two occasions not more than 12 months apart in a serological test (6) carried out in an approved laboratory on samples of blood taken prior to and not less than 21 days following collection for this consignment of semen.](1) or [a serological test (6) for the detection of antibody to the EHDV group, carried out on samples taken at intervals of not more than 60 days throughout the collection period and between 21 and 60 days after the final collection for this consignment of semen.](1) or [an agent identification test (6) carried out in approved laboratories on blood samples collected at commencement and conclusion of, and at least every seven days (virus isolation test) or at least every 28 days (PCR test) during collection for this consignment of semen.]]II.5. The semen to be exported:II.5.1. was collected after the date on which the semen collection centre was approved by the competent authority of the exporting country;II.5.2. was collected, processed, preserved, stored and transported in accordance with the requirements applicable to semen laid down in Chapter III(I) of Annex D to Directive 92/65/EEC;(1) either [II.5.3. meets the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001;](1) or [II.5.3. meets the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and is destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and the donor animals comply regarding scrapie with the guarantees provided for by the national scrapie control program referred to in those points and with the guarantees (7) requested by the Member State of destination;]II.5.4. was sent to the place of loading in a sealed container in accordance with the requirements for semen to be subject to trade laid down in point 1.4 of Chapter III(I) of Annex D to Directive 92/65/EEC and bearing the number indicated in Box I.23.(1) either [II.6. No antibiotics were added to the semen.]Text of imageCOUNTRYOvine and caprine semen — Section AII. Health informationII.a. Certificate reference NoII.b.(1) or [II.6. The following antibiotic or combination of antibiotics was added to produce a concentration in the final diluted semen of not less than (8):… ]NotesPart I:Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodityBox I.11: Place of origin shall correspond to the approved semen collection centre in which the semen was collected and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htmBox I.22: number of packages shall correspond to the number of containers.Box I.23: identification of container and seal number shall be indicated.Box I.26: fill in according to whether it is a transit or an import certificate.Box I.27: fill in according to whether it is a transit or an import certificate.Box I.28: Species: select amongst “Ovis aries” or “Capra hircus” as appropriate.Donor identity shall correspond to the official identification of the animal.Date of collection shall be indicated in the following format: dd.mm.yyyy.Approval number of the centre shall correspond to the approval number of the semen collection centre indicated in Box I.11.Part II:(1) Delete as necessary.(2) Only third countries listed in Annex I to Decision 2010/472/EU.(3) Tests shall be carried out in accordance with Annex C to Directive 91/68/EEC.(4) Only for the territory appearing with the entry “V” in column 6 of Part 1 of Annex I to Commission Regulation (EU) No 206/2010 (OJ L 73, 20.3.2010, p. 1).(5) See remarks for exporting country concerned in Annex I to Decision 2010/472/EU.(6) Standards for EHD virus diagnostic tests are described in Chapter 2.1.3 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.(7) Additional guarantees as laid down in Article 2 of Regulation (EC) No 546/2006 (OJ L 94, 1.4.2006, p. 28).(8) Insert names and concentrations.Official veterinarian (*)Name (in capital letters):Qualification and title:Date:Signature:Stamp:(*) The signature and the stamp must be in a different colour to that of the printing.’

(3) | Annex III is replaced by the following:‘ANNEX IIIList of third countries or parts thereof from which Member States are to authorise imports of consignments of ova and embryos of animals of the ovine and caprine speciesISO CodeName of the third countryRemarksDescription of the territory(if appropriate)Additional guaranteesAUAustraliaThe additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.CACanadaThe additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.CHSwitzerland(*2)CLChileGLGreenlandHRCroatiaISIcelandNZNew ZealandPMSaint Pierre and MiquelonUSUnited StatesThe additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory. | ISO Code | Name of the third country | Remarks | Description of the territory(if appropriate) | Additional guarantees | AU | Australia |  | The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory. | CA | Canada |  | The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory. | CH | Switzerland(*2) |  |  | CL | Chile |  |  | GL | Greenland |  |  | HR | Croatia |  |  | IS | Iceland |  |  | NZ | New Zealand |  |  | PM | Saint Pierre and Miquelon |  |  | US | United States |  | The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

ISO Code | Name of the third country | Remarks

Description of the territory(if appropriate) | Additional guarantees

AU | Australia |  | The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

CA | Canada |  | The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

CH | Switzerland(*2) |  | 

CL | Chile |  | 

GL | Greenland |  | 

HR | Croatia |  | 

IS | Iceland |  | 

NZ | New Zealand |  | 

PM | Saint Pierre and Miquelon |  | 

US | United States |  | The additional guarantee as regards testing set out in point II.2.6.1 of the model health certificate set out in Part 2 of Annex IV is compulsory.

(4) | Part 2 of Annex IV is replaced by the following:‘PART 2Model health certificate for imports of consignments of ova and embryos of animals of the ovine and caprine speciesText of imagePart I: Details of dispatched consignmentCOUNTRYVeterinary certificate to EUI.1. ConsignorNameAddressTel.I.2. Certificate reference NoI.2.a.I.3. Central competent authorityI.4. Local competent authorityI.5. ConsigneeNameAddressPostal codeTel.I.6. Person responsible for the load in EUNameAddressPostal codeTel.I.7. Country of originISO codeI.8. Region of originCodeI.9. Country of destinationISO codeI.10. Region of destinationCodeI.11. Place of originNameApproval numberAddressNameApproval numberAddressNameApproval numberAddressI.12. Place of destinationNameAddressPostal codeI.13. Place of loadingI.14. Date of departureI.15. Means of transportAeroplaneShipRailway wagonRoad vehicleOtherIdentificationDocumentary referencesI.16. Entry BIP in EUI.17.I.18. Description of commodityI.19. Commodity code (HS code)05 11 99 85I.20. QuantityI.21.I.22. Number of packagesI.23. Seal/container NoI.24.I.25. Commodities certified for:Artificial reproductionI.26. For transit through EU to third countryThird countryISO codeI.27. For import or admission into EUI.28. Identification of the commoditiesSpecies(scientific name)BreedCategoryDonor identityDate of collectionDate of freezingApproval number of the teamQuantityText of imagePart II: CertificationCOUNTRYOvine and caprine ova/embryosII. Health informationII.a. Certificate reference NoII.b.I, the undersigned, official veterinarian, hereby certify that:II.1. The exporting country …(name of exporting country) (2)II.1.1. has been free from rinderpest, peste des petits ruminants, sheep and goat pox, contagious caprine pleuropneumonia, and Rift Valley fever during the 12 months immediately prior to collection of the ova/embryos (1) to be exported and until their date of dispatch to the Union and no vaccination against these diseases took place during that period;(1) either [II.1.2. has been free from foot-and-mouth disease during the 12 months immediately prior to collection of the ova/embryos (1) and did not carry out vaccination against foot-and-mouth disease during that period;](1) or [II.1.2. has not been free from foot-and-mouth disease during the 12 months immediately prior to collection of the ova/embryos (1) and/or carried out vaccination against foot-and-mouth disease during that period and the donor females come from holdings on which no animal was vaccinated against foot-and-mouth disease during 30 days prior to collection and no animal of susceptible species showed clinical signs of foot-and-mouth disease during the 30 days prior to, and at least 30 days after, the ova/embryos (1) were collected and the ova/embryos (1) were not subjected to penetration of zona pellucida;]II.2. The ova/embryos (1) to be exported:II.2.1. were collected/produced (1) and processed on premises within a 10-km radius of which there was no incidence of foot-and-mouth disease, vesicular stomatitis, Rift Valley fever in the 30 days immediately prior to their collection;II.2.2. were stored at all times on approved premises within a 10-km radius of which there was no incidence of foot-and-mouth disease, vesicular stomatitis or Rift Valley fever from the time of their collection until 30 days thereafter;II.2.3. were collected/produced (1) by the team described in Box I.11, which has been approved and supervised in accordance with the conditions for the approval and supervision of embryo collection teams and embryo production teams laid down in Chapter I(III) of Annex D to Directive 92/65/EEC;II.2.4. meet the conditions for ova and embryos laid down in Chapter III(II) of Annex D to Directive 92/65/EEC;II.2.5. come from the donor females of ovine/caprine (1) species which:(1) either [II.2.5.1. were kept in a bluetongue virus-free country or zone for at least 60 days prior to, and during collection of the ova/embryos (1);](1) or [II.2.5.1. were kept during a bluetongue virus seasonally free period in a seasonally free zone;](1) or [II.2.5.1. were kept protected from the vector for at least 60 days prior to, and during the collection of the ova/embryos (1);](1) or [II.2.5.1. underwent a serological test to detect antibodies to the bluetongue virus group, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals between 21 and 60 days after collection of the ova/embryos (1) and giving negative results;](1) or [II.2.5.1. underwent an agent identification test for bluetongue virus, carried out in accordance with the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals on a blood sample taken on the day of the ova/embryos (1) collection or the day of slaughtering and giving negative results;]II.2.5.2. to the best of my knowledge do not come from holdings and have not been in contact with animals of a holding, in which, based on the official notification system and according to the written declaration made by the owner, any of the following diseases has been clinically detected within the periods referred to in (a) to (d) prior to collection of the ova/embryos (1) to be exported:(a) contagious agalactia of sheep or goats (Mycoplasma agalactiae, Mycoplasma capricolum, Mycoplasma mycoides var. mycoides “large colony”), within the last six months;(b) paratuberculosis and caseous lymphadenitis, within the last 12 months;(c) pulmonary adenomatosis, within the last three years;(1) either [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last three years;](1) or [(d) Maedi/Visna for sheep or caprine viral arthritis/encephalitis for goats, within the last 12 months, and all the infected animals were slaughtered and remaining animals subsequently reacted negatively to two tests carried out at least six months apart;]Text of imageCOUNTRYOvine and caprine ova/embryosII. Health informationII.a. Certificate reference NoII.b.II.2.5.3. showed no clinical signs of disease on the day of the ova/embryos (1) collection;(1)(4) either [II.2.5.4 originate from the region described in Box I.8., which has been recognised as officially brucellosis (B. melitensis)-free, and](1) or [II.2.5.4. have belonged to a holding which has obtained and maintained its officially brucellosis (B. melitensis)-free status in accordance with Directive 91/68/EEC, and](1) or [II.2.5.4. originate from a holding, where in respect of brucellosis (B. melitensis) all susceptible animals have been free from any clinical or any signs of this disease for the last 12 months, none of the ovine and caprine animals have been vaccinated against this disease, save those vaccinated with Rev. 1 vaccine more than two years ago, and all ovine and caprine animals over six months of age have been subjected to at least two tests (3) , carried out with negative results on samples taken on … (date) and on … (date) at least six months apart, the latter being within 30 days prior to collection of the ova/embryos (1),]and have not been kept previously in a holding of a lower status;(1) either [II.2.5.5. have remained in the exporting country for at least the past six months prior to collection of the ova/embryos (1) to be exported;](1) or [II.2.5.5 during the past six months prior to collection of the ova/embryos (1) they satisfied the animal health conditions applying to donors of the ova/embryos (1) which are intended for export to the Union and they have been imported into the exporting country at least 30 days prior to collection of the ova/embryos (1) from … (2);][II.2.6. were collected/produced (1) in the exporting country,(1) either [II.2.6.1. which according to official findings is free from epizootic haemorrhagic disease (EHD);](1)(5) or [II.2.6.1. in which according to official findings the following serotypes of epizootic haemorrhagic disease (EHD) exist: … and were subjected with negative results in each case to:(1) either [on two occasions not more than 12 months apart in a serological test (6) carried out in an approved laboratory on samples of blood taken prior to and not less than 21 days following collection for this consignment of ova/embryos (1);](1) or [a serological test (6) for the detection of antibody to the EHDV group, carried out on samples taken at intervals of not more than 60 days throughout the collection period and between 21 and 60 days after the final collection for this consignment of ova/embryos (1);](1) or [an agent identification test (6) carried out in approved laboratories on blood samples collected at commencement and conclusion of, and at least every seven days (virus isolation test) or at least every 28 days (PCR test) during collection for this consignment of ova/embryos (1);]](1) either [II.2.8. meet the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001;](1) or [II.2.8. meet the requirements of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and are destined for a Member State which benefits, for all or part of its territory, from the provisions laid down in point (b) or (c) of Chapter A(I) of Annex VIII to Regulation (EC) No 999/2001 and the donor animals comply regarding scrapie with the guarantees provided for by the national scrapie control program referred to in that point and with the guarantees (7) requested by the Member State of destination;]II.2.9. were collected/produced (1) after the date on which the embryo collection team was approved by the competent authority of the exporting country;II.2.10. were processed and stored under approved conditions for at least 30 days immediately after their collection/production (1) and transported under conditions for ova and embryos laid down in Chapter III(II) of Annex D to Directive 92/65/EEC;II.2.11. were sent to the place of loading in a sealed container in accordance with the requirements for the transport of embryos laid down in point 6 of Chapter III(II) of Annex D to Directive 92/65/EEC and bearing the number detailed in Box I.23;(9) II.2.12. were conceived by artificial insemination/as a result of in vitro fertilisation (1) using semen coming from semen collection centres.(1) either [II.2.12.1. approved in accordance with Article 11(2) of Directive 92/65/EEC and located in a Member State of the European Union; and the semen complies with the requirements of Directive 92/65/EEC.](1) or [II.2.12.1. approved in accordance with Article 17(3)(b) of Directive 92/65/EEC and located in a third country or part thereof listed in Annex I to Decision 2010/472/EU, and the semen complies with the requirements set out in Part 2 of Annex II to that Decision.]Text of imageCOUNTRYOvine and caprine ova/embryosII. Health informationII.a. Certificate reference NoII.b.NotesPart I:Box I.6: Person responsible for the load in EU: this box is to be filled in only if it is a certificate for transit commodity.Box I.11: Place of origin shall correspond to the approved embryo collection team or embryo production team by which the ova/embryos were collected/produced, processed and stored; and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htmBox I.22: number of packages shall correspond to the number of containers.Box I.23: identification of container and seal number shall be indicated.Box I.26: fill in according to whether it is a transit or an import certificate.Box I.27: fill in according to whether it is a transit or an import certificate.Box I.28: Species: select amongst “Ovis aries” or “Capra hircus” as appropriate.Category: specify if in vivo derived embryos, in vivo derived ova, in vitro produced embryos or micromanipulated embryos.Donor identity shall correspond to the official identification of the animal.Date of collection shall be indicated for in vivo derived embryos and in the following format: dd.mm.yyyy.Date of freezing shall be indicated in the following format: dd.mm.yyyy.Approval number of the team: shall correspond to the approved embryo collection team or embryo production team by which the ova/embryos were collected/produced, processed and stored; and listed in accordance with Article 17(3)(b) of Directive 92/65/EEC on the Commission website: http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htmPart II:(1) Delete as appropriate.(2) Only third countries or parts thereof listed in Annex I to Decision 2010/472/EU.(3) Tests shall be carried out in accordance with Annex C to Directive 91/68/EEC.(4) Only for the territory appearing with the entry “V” in column 6 of Part 1 of Annex I to Commission Regulation (EU) No 206/2010 (OJ L 73, 20.3.2010).(5) See remarks for exporting country or part thereof concerned in Annex III to Decision 2010/472/EU.(6) Standards for EHD virus diagnostic tests are described in Chapter 2.1.3 of the OIE Manual of Diagnostic Tests and Vaccines for Terrestrial Animals.(7) Additional guarantees as laid down in Article 2 of Regulation (EC) No 546/2006 (OJ L 94, 1.4.2006, p. 28).(8) Only approved semen collection centres listed in accordance with Article 11(4) and Article 17(3)(b) of Directive 92/65/EEC on the Commission websites:http://ec.europa.eu/food/animal/approved_establishments/establishments_vet_field_en.htm;http://ec.europa.eu/food/animal/semen_ova/ovine/index_en.htm(9) Does not apply to ova.Official veterinarian (*)Name (in capital letters):Qualification and title:Date:Signature:Stamp:(*) The signature and the stamp must be in a different colour to that of the printing.’

(*1)  Certificates in accordance with the Agreement between the European Community and the Swiss Confederation on Trade in Agricultural Products as approved by Decision 2002/309/EC, Euratom of the Council, and of the Commission as regards the Agreement on Scientific and Technological Cooperation of 4 April 2002 on the conclusion of seven Agreements with the Swiss Federation (OJ L 114, 30.4.2002, p. 1).’
(*2)  Certificates in accordance with the Agreement between the European Community and the Swiss Confederation on Trade in Agricultural Products as approved by Decision 2002/309/EC.’

Pending: 32012D0340

                                January 16, 2026                            

27.6.2012
EN
Official Journal of the European Union
L 166/90

(1)
Official field inspections of the crop are a condition for the certification of basic seed and bred seed of generations prior to basic seed. As regards certified seed, however, the possibility has been introduced some time ago, to choose between official field inspections and field inspections under official supervision.

(2)
Providing for the possibility to choose between official field inspections and field inspections under official supervision may also constitute an improved alternative to requiring official field inspection as far as basic seed and bred seed of generations prior to basic seed are concerned. A temporary experiment should therefore be organised to assess this alternative.

(3)
Taking into account the experience gained, as regards certified seed, with field inspections under official supervision, it is appropriate to carry out the experiment applying the same provisions as apply to certified seed in order to assess whether those provisions are suitable for basic seed and bred seed of generations prior to basic seed.

(4)
It is necessary to release Member States participating in the experiment from the obligations with respect to official field inspections provided for in Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC.

(5)
Member States participating in the experiment should report annually.

(6)
The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

(a)
Article 2(1)(B)(1)(d) of Directive 66/401/EEC and Article 14a(a) thereof and point (6) of Annex I thereto;

(b)
Article 2(1)(C)(d) of Directive 66/402/EEC, Article 2(1)(Ca)(c) thereof, Article 2(1)(D)(1)(d) thereof, Article 2(1)(D)(2)(b) thereof, Article 2(1)(D)(3)(c) thereof and Article 14a(a) thereof and point (7) of Annex I thereto;

(c)
Article 2(1)(c)(iv) of Directive 2002/54/EC and Article 21(a) thereof and point (4) of Part A of Annex I thereto;

(d)
Article 2(1)(c)(iv) of Directive 2002/55/EC and Article 35(a) thereof and point (2) of Annex I thereto;

(e)
Article 2(1)(c)(iv) of Directive 2002/57/EC, Article 2(1)(d)(1)(ii) thereof, Article 2(1)(d)(2)(iii) thereof and Article 18(a) thereof and point (5) of Annex I thereto.

(a)
They have the necessary technical qualifications.

(b)
They derive no private gain in connection with the inspections.

(c)
They have been officially licensed by the seed certification authority of the Member State concerned to carry out inspections under official supervision; licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official inspections.

(d)
They carry out inspections under the supervision of the competent seed certification authority.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed(1), and in particular Article 13a thereof,

Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed(2), and in particular Article 13a thereof,

Having regard to Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed(3), and in particular Article 19 thereof,

Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed(4), and in particular Article 33 thereof,

Having regard to Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants(5), and in particular Article 16 thereof,

(1) Official field inspections of the crop are a condition for the certification of basic seed and bred seed of generations prior to basic seed. As regards certified seed, however, the possibility has been introduced some time ago, to choose between official field inspections and field inspections under official supervision.

(2) Providing for the possibility to choose between official field inspections and field inspections under official supervision may also constitute an improved alternative to requiring official field inspection as far as basic seed and bred seed of generations prior to basic seed are concerned. A temporary experiment should therefore be organised to assess this alternative.

(3) Taking into account the experience gained, as regards certified seed, with field inspections under official supervision, it is appropriate to carry out the experiment applying the same provisions as apply to certified seed in order to assess whether those provisions are suitable for basic seed and bred seed of generations prior to basic seed.

(4) It is necessary to release Member States participating in the experiment from the obligations with respect to official field inspections provided for in Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC.

(5) Member States participating in the experiment should report annually.

(6) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

HAS ADOPTED THIS DECISION:
Subject matter

Article 1

A temporary experiment is organised at Union level assessing, as regards certification of basic seed and bred seed of generations prior to basic seed, whether the possibility to choose between official field inspections and field inspections under official supervision, carried out in accordance with Articles 2 and 3, may constitute an improved alternative to official field inspections and whether the same provisions as apply to the certification of certified seed are to be applied to basic seed and bred seed of generations prior to basic seed.

The purpose of that experiment is to decide whether, as regards basic seed and bred seed of generations prior to basic seed, the requirement of official field inspections may be replaced by a requirement of either official field inspections or field inspections under official supervision as regards the following provisions:

(a)

Article 2(1)(B)(1)(d) of Directive 66/401/EEC and Article 14a(a) thereof and point (6) of Annex I thereto;

(b)

Article 2(1)(C)(d) of Directive 66/402/EEC, Article 2(1)(Ca)(c) thereof, Article 2(1)(D)(1)(d) thereof, Article 2(1)(D)(2)(b) thereof, Article 2(1)(D)(3)(c) thereof and Article 14a(a) thereof and point (7) of Annex I thereto;

(c)

Article 2(1)(c)(iv) of Directive 2002/54/EC and Article 21(a) thereof and point (4) of Part A of Annex I thereto;

(d)

Article 2(1)(c)(iv) of Directive 2002/55/EC and Article 35(a) thereof and point (2) of Annex I thereto;

(e)

Article 2(1)(c)(iv) of Directive 2002/57/EC, Article 2(1)(d)(1)(ii) thereof, Article 2(1)(d)(2)(iii) thereof and Article 18(a) thereof and point (5) of Annex I thereto.
Inspectors carrying out inspections under official supervision

Article 2

Participating Member States shall ensure that inspectors carrying out inspections under official supervision fulfil the following conditions:

(a)

They have the necessary technical qualifications.

(b)

They derive no private gain in connection with the inspections.

(c)

They have been officially licensed by the seed certification authority of the Member State concerned to carry out inspections under official supervision; licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official inspections.

(d)

They carry out inspections under the supervision of the competent seed certification authority.
Inspections of crops and harvested seeds

Article 3

1.   Participating Member States shall ensure that inspections of crops and harvested seed fulfil the requirements provided for in paragraphs 2 to 5.

2.   The crop to be inspected shall be grown from seed which has undergone official post-control, the results of which satisfy the requirements laid down in Annexes I to Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC.

3.   A proportion of at least 20 % of the crops shall be checked by the competent authority, as regards vegetable crops covered by Directive 2002/55/EC. For all other crops the proportion shall be at least 5 %. The following different proportions shall be used to allow to establish an appropriate level of check testing for the categories of basic seed and bred seed of generations prior to basic seed: 5, 10, 15 and 20 %.

4.   A proportion of samples from the seed lots harvested from the crops shall be drawn for official post-control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity. Member States shall identify seed lots for which field inspection has been carried out under official supervision.

5.   The Member States which participate in the experiment shall compare the official field inspections with those of the same field inspected under official supervision.
Participation of Member States

Article 4

Any Member State may participate in the experiment.

Member States which decide to participate in the experiment (‘the participating Member States’) shall inform the Commission and the other Member States indicating the species, categories and regions covered by their participation and any restrictions.

Member States may terminate their participation at any time by informing the Commission accordingly.
Release

Article 5

For the purposes of the experiment, participating Member States are released, in respect of official field inspections of basic seed and bred seed of generations prior to basic seed, from the obligations provided for in Article 2(1)(B)(1)(d) of Directive 66/401/EEC and Article 14a(a) thereof and point (6) of Annex I thereto, Article 2(1)(C)(d) of Directive 66/402/EEC, Article 2(1)(Ca)(c) thereof, Article 2(1)(D)(1)(d) thereof, Article 2(1)(D)(2)(b) thereof, Article 2(1)(D)(3)(c) thereof and Article 14a(a) thereof and point (7) of Annex I thereto, Article 2(1)(c)(iv) of Directive 2002/54/EC and Article 21(a) thereof and point (4) of Part A of Annex I thereto, Article 2(1)(c)(iv) of Directive 2002/55/EC and Article 35(a) thereof and point (2) of Annex I thereto and Article 2(1)(c)(iv) of Directive 2002/57/EC, Article 2(1)(d)(1)(ii) thereof, Article 2(1)(d)(2)(iii) thereof and Article 18(a) thereof and point (5) of Annex I thereto.
Reporting obligations

Article 6

1.   Participating Member States shall for each year, by 31 March of the following year, present to the Commission and to the other Member States a report on the results of the experiment carried out in accordance with Articles 2 and 3.

2.   At the end of the experiment and in any case at the end of their participation, participating Member States shall by 31 March of the following year, present to the Commission and the other Member States a report on the results of the experiment carried out in accordance with Articles 2 and 3.

This report may include other information they consider relevant in view of the purpose of the experiment.
Time period

Article 7

The experiment shall start on 1 January 2013 and end on 31 December 2017.
Addressees

Article 8

This Decision is addressed to the Member States.
THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Council Directive 66/401/EEC of 14 June 1966 on the marketing of fodder plant seed(1), and in particular Article 13a thereof,

Having regard to Council Directive 66/402/EEC of 14 June 1966 on the marketing of cereal seed(2), and in particular Article 13a thereof,

Having regard to Council Directive 2002/54/EC of 13 June 2002 on the marketing of beet seed(3), and in particular Article 19 thereof,

Having regard to Council Directive 2002/55/EC of 13 June 2002 on the marketing of vegetable seed(4), and in particular Article 33 thereof,

Having regard to Council Directive 2002/57/EC of 13 June 2002 on the marketing of seed of oil and fibre plants(5), and in particular Article 16 thereof,

(1) Official field inspections of the crop are a condition for the certification of basic seed and bred seed of generations prior to basic seed. As regards certified seed, however, the possibility has been introduced some time ago, to choose between official field inspections and field inspections under official supervision.

(2) Providing for the possibility to choose between official field inspections and field inspections under official supervision may also constitute an improved alternative to requiring official field inspection as far as basic seed and bred seed of generations prior to basic seed are concerned. A temporary experiment should therefore be organised to assess this alternative.

(3) Taking into account the experience gained, as regards certified seed, with field inspections under official supervision, it is appropriate to carry out the experiment applying the same provisions as apply to certified seed in order to assess whether those provisions are suitable for basic seed and bred seed of generations prior to basic seed.

(4) It is necessary to release Member States participating in the experiment from the obligations with respect to official field inspections provided for in Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC.

(5) Member States participating in the experiment should report annually.

(6) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Seeds and Propagating Material for Agriculture, Horticulture and Forestry,

HAS ADOPTED THIS DECISION:
Subject matterA temporary experiment is organised at Union level assessing, as regards certification of basic seed and bred seed of generations prior to basic seed, whether the possibility to choose between official field inspections and field inspections under official supervision, carried out in accordance with Articles 2 and 3, may constitute an improved alternative to official field inspections and whether the same provisions as apply to the certification of certified seed are to be applied to basic seed and bred seed of generations prior to basic seed.

The purpose of that experiment is to decide whether, as regards basic seed and bred seed of generations prior to basic seed, the requirement of official field inspections may be replaced by a requirement of either official field inspections or field inspections under official supervision as regards the following provisions:

(a)

Article 2(1)(B)(1)(d) of Directive 66/401/EEC and Article 14a(a) thereof and point (6) of Annex I thereto;

(b)

Article 2(1)(C)(d) of Directive 66/402/EEC, Article 2(1)(Ca)(c) thereof, Article 2(1)(D)(1)(d) thereof, Article 2(1)(D)(2)(b) thereof, Article 2(1)(D)(3)(c) thereof and Article 14a(a) thereof and point (7) of Annex I thereto;

(c)

Article 2(1)(c)(iv) of Directive 2002/54/EC and Article 21(a) thereof and point (4) of Part A of Annex I thereto;

(d)

Article 2(1)(c)(iv) of Directive 2002/55/EC and Article 35(a) thereof and point (2) of Annex I thereto;

(e)

Article 2(1)(c)(iv) of Directive 2002/57/EC, Article 2(1)(d)(1)(ii) thereof, Article 2(1)(d)(2)(iii) thereof and Article 18(a) thereof and point (5) of Annex I thereto.
Inspectors carrying out inspections under official supervisionParticipating Member States shall ensure that inspectors carrying out inspections under official supervision fulfil the following conditions:

(a)

They have the necessary technical qualifications.

(b)

They derive no private gain in connection with the inspections.

(c)

They have been officially licensed by the seed certification authority of the Member State concerned to carry out inspections under official supervision; licensing shall include either the swearing-in of inspectors or the signature by inspectors of a written statement of commitment to the rules governing official inspections.

(d)

They carry out inspections under the supervision of the competent seed certification authority.
Inspections of crops and harvested seeds1.   Participating Member States shall ensure that inspections of crops and harvested seed fulfil the requirements provided for in paragraphs 2 to 5.

2.   The crop to be inspected shall be grown from seed which has undergone official post-control, the results of which satisfy the requirements laid down in Annexes I to Directives 66/401/EEC, 66/402/EEC, 2002/54/EC, 2002/55/EC and 2002/57/EC.

3.   A proportion of at least 20 % of the crops shall be checked by the competent authority, as regards vegetable crops covered by Directive 2002/55/EC. For all other crops the proportion shall be at least 5 %. The following different proportions shall be used to allow to establish an appropriate level of check testing for the categories of basic seed and bred seed of generations prior to basic seed: 5, 10, 15 and 20 %.

4.   A proportion of samples from the seed lots harvested from the crops shall be drawn for official post-control and, where appropriate, for official laboratory seed testing in respect of varietal identity and purity. Member States shall identify seed lots for which field inspection has been carried out under official supervision.

5.   The Member States which participate in the experiment shall compare the official field inspections with those of the same field inspected under official supervision.
Participation of Member StatesAny Member State may participate in the experiment.

Member States which decide to participate in the experiment (‘the participating Member States’) shall inform the Commission and the other Member States indicating the species, categories and regions covered by their participation and any restrictions.

Member States may terminate their participation at any time by informing the Commission accordingly.
ReleaseFor the purposes of the experiment, participating Member States are released, in respect of official field inspections of basic seed and bred seed of generations prior to basic seed, from the obligations provided for in Article 2(1)(B)(1)(d) of Directive 66/401/EEC and Article 14a(a) thereof and point (6) of Annex I thereto, Article 2(1)(C)(d) of Directive 66/402/EEC, Article 2(1)(Ca)(c) thereof, Article 2(1)(D)(1)(d) thereof, Article 2(1)(D)(2)(b) thereof, Article 2(1)(D)(3)(c) thereof and Article 14a(a) thereof and point (7) of Annex I thereto, Article 2(1)(c)(iv) of Directive 2002/54/EC and Article 21(a) thereof and point (4) of Part A of Annex I thereto, Article 2(1)(c)(iv) of Directive 2002/55/EC and Article 35(a) thereof and point (2) of Annex I thereto and Article 2(1)(c)(iv) of Directive 2002/57/EC, Article 2(1)(d)(1)(ii) thereof, Article 2(1)(d)(2)(iii) thereof and Article 18(a) thereof and point (5) of Annex I thereto.
Reporting obligations1.   Participating Member States shall for each year, by 31 March of the following year, present to the Commission and to the other Member States a report on the results of the experiment carried out in accordance with Articles 2 and 3.

2.   At the end of the experiment and in any case at the end of their participation, participating Member States shall by 31 March of the following year, present to the Commission and the other Member States a report on the results of the experiment carried out in accordance with Articles 2 and 3.

This report may include other information they consider relevant in view of the purpose of the experiment.
Time periodThe experiment shall start on 1 January 2013 and end on 31 December 2017.
AddresseesThis Decision is addressed to the Member States.

	Name	Identifying information	Reasons	Date of listing
1.	Commercial Bank of Syria	—Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;—P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;—Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];Website: http://cbs-bank.sy/En-index.phpTel: +963 11 2218890;Fax: +963 11 2216975;General management: [email protected]	—	Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;	—	P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;	—	Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];	State-owned bank providing financial support to the regime.	13.10.2011
—	Damascus Branch, P.O. Box 2231, Moawiya St., Damascus, Syria;
—	P.O. Box 933, Yousef Azmeh Square, Damascus, Syria;
—	Aleppo Branch, P.O. Box 2, Kastel Hajjarin St., Aleppo, Syria; SWIFT/BIC CMSY SY DA; all offices worldwide [NPWMD];

Light	Medium	Heavy
Hotel: bed-linen, bedclothes and towels, etc. (towels may be considered heavily soiled)Cloth hand towel rolls	Work clothes: institutions/retail/service, etc.Restaurants: table-cloths, napkins, etc.Mops and mats	Work clothes: industry/kitchen/butchering, etc.Kitchen textiles: clothes, dish towels, etc.Institutions as hospitals: bed-linen, bedclothes, contour sheets, patient clothing, doctor’s coat or coatdress, etc.

Soft water (0-6 °dH)	CDVchronic(L/kg laundry)
Product type/Degree of soiling	Light	Medium	Heavy
Powder	30 000	40 000	50 000
Liquid	50 000	60 000	70 000
Multi-component-system	50 000	70 000	90 000

Medium water (7-13 °dH)	CDVchronic(L/kg laundry)
Product type/Degree of soiling	Light	Medium	Heavy
Powder	40 000	60 000	80 000
Liquid	60 000	75 000	90 000
Multi-component-system	60 000	80 000	100 000

Hard water (> 14 °dH)	CDVchronic(L/kg laundry)
Product type/Degree of soiling	Light	Medium	Heavy
Powder	50 000	75 000	90 000
Liquid	75 000	90 000	120 000
Multi-component-system	75 000	100 000	120 000

weight	=	the weight of the ingoing substance per recommended dose
DF	=	the degradation factor
TF	=	the chronic toxicity factor of the substance as stated in the DID list.

Soft water (0-6 °dH)	aNBO (g/kg laundry)
Product type/Degree of soiling	Light	Medium	Heavy
Powder	0,70	1,10	1,40
Liquid	0,50	0,60	0,70
Multi-component-system	1,25	1,75	2,50

Soft water (0-6 °dH)	anNBO (g/kg laundry)
Product type/Degree of soiling	Light	Medium	Heavy
Powder	0,70	1,10	1,40
Liquid	0,50	0,60	0,70
Multi-component-system	1,25	1,75	2,50

Hazard statement(4)	Risk phrase(5)
H300 Fatal if swallowed	R28
H301 Toxic if swallowed	R25
H304 May be fatal if swallowed and enters airways	R65
H310 Fatal in contact with skin	R27
H311 Toxic in contact with skin	R24
H330 Fatal if inhaled	R23/26
H331 Toxic if inhaled	R23
H340 May cause genetic defects	R46
H341 Suspected of causing genetic defects	R68
H350 May cause cancer	R45
H350i May cause cancer by inhalation	R49
H351 Suspected of causing cancer	R40
H360F May damage fertility	R60
H360D May damage the unborn child	R61
H360FD May damage fertility. May damage the unborn child	R60/61/60-61
H360Fd May damage fertility. Suspected of damaging the unborn child	R60/63
H360Df May damage the unborn child. Suspected of damaging fertility	R61/62
H361f Suspected of damaging fertility	R62
H361d Suspected of damaging the unborn child	R63
H361fd Suspected of damaging fertility. Suspected of damaging the unborn child.	R62-63
H362 May cause harm to breast fed children	R64
H370 Causes damage to organs	R39/23/24/25/26/27/28
H371 May cause damage to organs	R68/20/21/22
H372 Causes damage to organs through prolonged or repeated exposure	R48/25/24/23
H373 May cause damage to organs through prolonged or repeated exposure	R48/20/21/22
H400 Very toxic to aquatic life	R50
H410 Very toxic to aquatic life with long-lasting effects	R50-53
H411 Toxic to aquatic life with long-lasting effects	R51-53
H412 Harmful to aquatic life with long-lasting effects	R52-53
H413 May cause long-lasting harmful effects to aquatic life	R53
EUH059 Hazardous to the ozone layer	R59
EUH029 Contact with water liberates toxic gas	R29
EUH031 Contact with acids liberates toxic gas	R31
EUH032 Contact with acids liberates very toxic gas	R32
EUH070 Toxic by eye contact	R39-41
Sensitising substances
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled	R42
H317: May cause allergic skin reaction	R43

Surfactants< 20 % in the final product	H400 Very toxic to aquatic life	R50
Biocides for preservations purposes(*2)(only for liquids with pH between 2 and 12 and maximum 0,10 % w/w of active material)	H331: Toxic if inhaled	R23
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled	R42
H317: May cause allergic skin reaction	R43
H400: Very toxic to aquatic life	R50
Enzymes(*3)	H400: Very toxic to aquatic life	R50
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled	R42
H317: May cause allergic skin reaction	R43
Bleach catalysts(*3)	H400: Very toxic to aquatic life	R50
NTA as an impurity in MGDA and GLDA(*4)	H351: Suspected of causing cancer	R40

Product type/water hardness	WUR (g/kg laundry)
Soft water	Medium water	Hard water
Powders	1,5	2,0	2,5
Liquids	2,0	2,5	3,0

Wi	=	the weight (g) of the packaging component (i) including the label if applicable.
Ui	=	the weight (g) of non-recycled (virgin) material in the packaging component (i). If the proportion of recycled material in the packaging component is 0 % then Ui= Wi.
Di	=	the number of functional units contained in the packaging component (i). The functional unit = dosage in g/kg laundry. Note that the highest recommended dosage for each water hardness must be used in the WUR calculation.
ri	=	recycling figure, i.e. the number of times the packaging component (i) is used for the same purpose through a return or refill system. r = 1 if the packaging is not re-used for the same purpose. If the packaging is reused r is set to 1 unless the applicant can document a higher number.

	Acute toxicity	Chronic toxicity	Degradation
Ingoing substance	LC50/EC50	SF(acute)	TF(acute)	NOEC(*1)	SF(chronic)(*1)	TF(chronic)	DF	Aerobic	Anaerobic
‘Name’	1 mg/l	10 000	0,0001			0,0001	1	P	N

(1)	Until 1 December 2010 and during transition period from 1 December 2010 to 1 December 2015:The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).	The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.	The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).
	The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.
	The 10 days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

CDV at the highest recommended dosage	Soft	Medium	Hard
Product type	0-6 °dH	7-13 °dH	> 14 °dH
Pre-soaks	2 000	2 000	2 000
Dishwasher detergents	3 000	5 000	10 000
Multi-component system	3 000	4 000	7 000
Rinse aids	3 000	3 000	3 000

Product type(g/l washing solution)	Soft	Medium	Hard
0-6 °dH	7-13 °dH	> 14 °dH
Pre-soaks	0,4	0,4	0,4
Dishwasher detergents/Multi-component system	0,4	0,4	0,4
Rinse aids	0,04	0,04	0,04

Surfactants< 15 % in the final product	H400: Very toxic to aquatic life	R50
Biocides for preservation purpose(*2)(only for liquids with pH between 2 and 12 and maximum 0,10 % w/w of active material)	H331: Toxic if inhaled	R23
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled	R42
H317: May cause allergic skin reaction	R43
H400: Very toxic to aquatic life	R50
Enzymes(*3)	H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled	R42
H317: May cause allergic skin reaction	R43
H400: Very toxic to aquatic life	R50
NTA as in impurity in MGDA and GLDA(*4)	H351: Suspected of causing cancer	R40

Product typePhosphorous (g P/l water)	Soft	Medium	Hard
0-6 °dH	7-13 °dH	> 14 °dH
Pre-soaks	0,08	0,08	0,08
Detergents	0,15	0,30	0,50
Rinse aids	0,02	0,02	0,02
Multi-component systems	0,17	0,32	0,52

(1)	Until 1 December 2010 and during transition period from 1 December 2010 to 1 December 2015:The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).	The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.	The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).
	The test methods for ready biodegradability provided for in Directive 67/548/EEC, in particular the methods detailed in Annex V.C4 to that Directive, or their equivalent OECD 301 A-F test methods, or their equivalent ISO tests.
	The 10-days window principle shall not apply for surfactants. The pass levels shall be 70 % for the tests referred to in Annex V.C4-A and C4-B to Directive 67/548/EEC (and their equivalent OECD 301 A and E tests and ISO equivalents), and shall be 60 % for tests C4-C, D, E and F (and their equivalent OECD 301 B, C, D and F tests and ISO equivalents).

	4.	Every test centre must assess the effectiveness of the product or multi-component system by answering questions relating to the following aspects (or similar formulations):—the product’s ability to remove soiling from the dishes,—the product’s ability to dry the dishes,—the respondent’s satisfaction with the agreement on customer visits.	—	the product’s ability to remove soiling from the dishes,	—	the product’s ability to dry the dishes,	—	the respondent’s satisfaction with the agreement on customer visits.
—	the product’s ability to remove soiling from the dishes,
—	the product’s ability to dry the dishes,
—	the respondent’s satisfaction with the agreement on customer visits.

i.	granting of project authorisation (Articles 40 and 41 of Directive 2010/63/EU)information on the annual number of projects authorised, and on the number and type authorised as "multiple generic projects";information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.	information on the annual number of projects authorised, and on the number and type authorised as "multiple generic projects";	information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.
	information on the annual number of projects authorised, and on the number and type authorised as "multiple generic projects";
	information on the circumstances and proportion of total authorisations where the deadline of 40 days has been extended as permitted by Article 41(2) of Directive 2010/63/EU.

ii.	retrospective assessment, non-technical project summaries (Articles 38, 39 and 43 of Directive 2010/63/EU)information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.	information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);	information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.
	information on the operation of non-technical project summaries; how it is assured that the requirements under Article 43(1) of Directive 2010/63/EU are met and whether the non-technical project summaries will indicate projects chosen for retrospective review (Article 43 (2) of Directive 2010/63/EU);
	information on the proportion and types of projects submitted for retrospective assessment under Article 38(2)(f) of Directive 2010/63/EU beyond those compulsory under Article 39(2) of that Directive.

	2.	Genetically altered animals are reported eithera)when used for the creation of a new line;b)when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; orc)when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).	a)	when used for the creation of a new line;	b)	when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; or	c)	when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).
a)	when used for the creation of a new line;
b)	when used for the maintenance of an established line with an intendedandexhibited harmful phenotype; or
c)	when used in other (scientific) procedures (i.e. not for creation or for the maintenance of a line).

	iii.	Genetically altered with a harmful phenotype includes:a)animals used for thecreation of a new lineand exhibiting a harmful phenotype;b)those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; andc)genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.	a)	animals used for thecreation of a new lineand exhibiting a harmful phenotype;	b)	those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; and	c)	genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.
a)	animals used for thecreation of a new lineand exhibiting a harmful phenotype;
b)	those used formaintaining an established linewith an intended harmful phenotype and exhibiting a harmful phenotype; and
c)	genetically altered animalsusedin other procedures (not for creation or maintenance) and exhibiting a harmful phenotype.

Hazard Statement(7)	Risk Phrase(8)
H300 Fatal if swallowed	R28
H301 Toxic if swallowed	R25
H304 May be fatal if swallowed and enters airways	R65
H310 Fatal in contact with skin	R27
H311 Toxic in contact with skin	R24
H330 Fatal if inhaled	R26
H331 Toxic if inhaled	R23
H340 May cause genetic defects	R46
H341 Suspected of causing genetic defects	R68
H350 May cause cancer	R45
H350i May cause cancer by inhalation	R49
H351 Suspected of causing cancer	R40
H360F May damage fertility	R60
H360D May damage the unborn child	R61
H360FD May damage fertility. May damage the unborn child	R60; R61; R60-61
H360Fd May damage fertility. Suspected of damaging the unborn child	R60-R63
H360Df May damage the unborn child. Suspected of damaging fertility	R61-R62
H361f Suspected of damaging fertility	R62
H361d Suspected of damaging the unborn child	R63
H361fd Suspected of damaging fertility. Suspected of damaging the unborn child	R62-63
H362 May cause harm to breast fed children	R64
H370 Causes damage to organs	R39/23; R39/24; R39/25; R39/26; R39/27; R39/28
H371 May cause damage to organs	R68/20; R68/21; R68/22
H372 Causes damage to organs through prolonged or repeated exposure	R48/25; R48/24; R48/23
H373 May cause damage to organs through prolonged or repeated exposure	R48/20; R48/21; R48/22
H400 Very toxic to aquatic life	R50
H410 Very toxic to aquatic life with long-lasting effects	R50-53
H411 Toxic to aquatic life with long-lasting effects	R51-53
H412 Harmful to aquatic life with long-lasting effects	R52-53
H413 May cause long-lasting harmful effects to aquatic life	R53
EUH059 Hazardous to the ozone layer	R59
EUH029 Contact with water liberates toxic gas	R29
EUH031 Contact with acids liberates toxic gas	R31
EUH032 Contact with acids liberates very toxic gas	R32
EUH070 Toxic by eye contact	R39-41

PVOC	=	the annual total kilograms of VOC contained in the purchased chemical products used for the annual total production of printed products
RVOC	=	the annual total kilograms of VOC destroyed by abatement, recovered from printing processes and sold, or reused
Ppaper	=	the annual total tonnes of paper purchased and used for the production of printed products.

(i)	For heat-set offset printing with an integrated after-burner unit in place for the drying unit, the following calculation method shall apply:PVOC=90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.	PVOC	=	90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.
PVOC	=	90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products.

(ii)	For heat-set offset printing, without an integrated after-burner unit in place for the drying unit, the following calculation method shall apply:PVOC=90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.	PVOC	=	90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.
PVOC	=	90 % of the annual total kilograms of VOC contained in damping solutions used for the annual production of printed products + 85 % of the annual total kilograms of VOC contained in washing agents used for the annual production of printed products + 10 % of annual total kilograms of VOC contained in the printing inks used for the annual production of printed products.

Printing method	Maximum Waste paper (%)
Sheet offset	23
Coldset, newspaper	10
Coldset, form printing	18
Coldset rotation (except newspapers and forms)	19
Heatset rotation	21
Gravure printing	15
Flexography (except corrugated fibreboard)	11
Digital printing	10
Offset	4
Flexography, corrugated fibreboard	17
Screen printing	23

Pulp Grade/Paper	Emissions (kg/ADT)
CODreference	Sreference	NOx,reference	Preference
Bleached Chemical pulp (others than sulphite)	18,0	0,6	1,6	0,045
Bleached Chemical pulp (sulphite)	25,0	0,6	1,6	0,045
Unbleached chemical pulp	10,0	0,6	1,6	0,04
CTMP	15,0	0,2	0,3	0,01
TMP/groundwood pulp	3,0	0,2	0,3	0,01
Recovered fibre pulp	2,0	0,2	0,3	0,01
Paper (non-integrated mills where all pulps used are purchased market pulps)	1	0,3	0,8	0,01
Paper (Other mills)	1	0,3	0,7	0,01