Council Decision (CFSP) 2024/2643 of 8 October 2024 concerning restrictive measures in view of Russia’s destabilising activities

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2024/2643
9.10.2024

(1)
In 2013, the Chief of the General Staff of the Russian Federation Armed Forces, Valery Gerasimov, advocated for a change in the types of warfare used by the Russian Federation and for the use of political, diplomatic and other non-military measures in combination with the use of military force. Gerasimov stated that the information space opens wide asymmetrical possibilities for reducing the fighting potential of the enemy.

(2)
On 21 September 2021, in its judgment in the case of Carter v Russia (20914/07), the European Court of Human Rights concluded that Alexander Litvinenko was poisoned by two individuals acting under the direction or control of the Russian authorities.

(3)
On 9 March 2022, the European Parliament, in its resolution on foreign interference in all democratic processes in the European Union, including disinformation, stated that Russia has been engaging in disinformation of an unparalleled malice and magnitude across both traditional media outlets and social media platforms, in order to deceive its citizens at home and the international community on the eve of and during its war of aggression against Ukraine. The European Parliament underlined that Russia is one of the countries which have targeted journalists and opponents in the Union.

(4)
On 10 May 2022, the Union and its international partners strongly condemned the malicious cyber activity conducted by the Russian Federation against Ukraine, which targeted the satellite KA-SAT network, owned by Viasat. That cyberattack took place one hour before Russia’s unprovoked and unjustified invasion of Ukraine on 24 February 2022, thus facilitating the military aggression, and was another example of Russia’s continued pattern of irresponsible behaviour in cyberspace.

(5)
On 19 July 2022, the High Representative of the Union for Foreign Affairs and Security Policy (the ‘High Representative’) condemned malicious cyber activities conducted in the context of Russia’s war of aggression against Ukraine, and the distributed denial-of-service attacks against several Member States and partners claimed by pro-Russian hacker groups.

(6)
In its conclusions of 21 June 2022, the Council of the European Union noted that while definitions of hybrid threats and campaigns may vary, they need to remain flexible in order to allow for proper responses to the evolving nature of those threats. In that context, the Council took note of the conceptualisation of ‘hybrid threat’ and ‘hybrid campaign’ provided by the Commission and the European Centre of Excellence for Countering Hybrid Threats in ‘The landscape of Hybrid Threats: A Conceptual Model’.

(7)
In its conclusions of 21 June 2022, as well as those of 18 July 2022, the Council reiterated the call for the High Representative and the Commission to present options, fully respecting human rights and fundamental freedoms, for well-defined measures that could be taken against actors engaged in Foreign Information Manipulation and Interference (‘FIMI’) where necessary to protect public order and security in the Union.

(8)
In February 2023, the European External Action Service published a report on FIMI threats, in which it defined FIMI as a mostly non-illegal pattern of behaviour that threatens or has the potential to negatively impact values, procedures and political processes. Such activity is manipulative in character and conducted in an intentional and coordinated manner by state or non-state actors, including their proxies inside and outside of their own territory.

(9)
On 3 February 2023, in a statement following the 24th EU-Ukraine summit, the Union reconfirmed its solidarity with Ukraine in countering hybrid threats and cyberattacks and its commitment to continue its support in this regard. The Union and Ukraine acknowledged the importance of strengthening cooperation in tackling Russian state-controlled information manipulation and interference, including disinformation, as well as building resilience in Ukraine’s digital transformation.

(10)
On 1 June 2023, the European Parliament in a resolution on foreign interference in all democratic processes in the Union, including disinformation, stressed that Russia uses an array of different methods of interference, embedded within a larger strategy, to harm, confuse, frighten, weaken and divide the Member States and its neighbourhood.

(11)
In its conclusions of 14 and 15 December 2023, the European Council condemned all hybrid attacks, including the instrumentalisation of migrants by third countries for political purposes, and stated that it remained determined to ensure effective control of the Union’s external borders. The European Council underlined that the Union is determined to counter at its external borders the ongoing hybrid attacks launched by the Russian Federation.

(12)
In its conclusions of 17 and 18 April 2024, the European Council underlined, in the context of the European elections, the Union and its Member States’ determination to contain any risks stemming from FIMI in electoral processes.

(13)
The instrumentalisation of migrants, as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359 of the European Parliament and of the Council(1), is liable to put at risk the essential functions of a Member State, including the maintenance of law and order or the safeguard of its national security.

(14)
In its conclusions of 21 May 2024, the Council acknowledged that state and non-state actors are increasingly using hybrid tactics, posing a growing threat to the security of the Union, its Member States and its partners and called on Union institutions and the Member States to step up action to monitor attempts by foreign actors to interfere in the Union’s democratic process.

(15)
In its conclusions of 27 June 2024, the European Council strongly condemned all types of hybrid activities, which are on the rise and target the Union, its Member States and its partners, including intimidation, sabotage, subversion, foreign information manipulation and interference, disinformation, malicious cyber activities and the instrumentalisation of migrants by third countries, and stressed that Russia has intensified its campaign with new active operations on European soil. The European Council called, inter alia, for work to be taken forward in the Council to establish a new sanctions regime in view of hybrid threats.

(16)
In the view of the gravity of the situation, restrictive measures should be imposed against persons, entities or bodies responsible for, implementing, or supporting actions or policies by the Government of the Russian Federation which undermine or threaten the fundamental values of the Union and its security, independence and integrity, as well as the stability, security or independence of its Member States, of international organisations or of third countries, or the sovereignty of Member States or third countries. Such targeted restrictive measures will pursue common foreign and security policy objectives as set out in Article 21 of the Treaty on European Union (TEU) and contribute to the Union’s actions to safeguard its values, fundamental interests, security, independence and integrity, to consolidate and support democracy, the rule of law, human rights and the principles of international law, and to prevent conflicts and strengthen international security in accordance with points (a) to (c) of Article 21(2) TEU.

(17)
Such measures are consistent with the fundamental rights and freedoms recognised in the Charter of Fundamental Rights of the European Union, in particular with the right to freedom of expression and information, the freedom to conduct a business and the right to property, as recognised in Articles 11, 16 and 17 thereof. In particular, such measures do not modify the obligation to respect the rights, freedoms and principles referred to in Article 6 TEU, in the Charter of Fundamental Rights, and in Member States’ constitutions, within their respective fields of application.

(18)
In order to increase consistency across the Union’s restrictive measures regimes and with those measures adopted by the UNSC or its Sanctions Committees, and to ensure the timely delivery of humanitarian assistance or to support other activities supporting basic human needs, it is appropriate to introduce an exemption from the asset-freeze measures applicable, and the restrictions on making funds and economic resources available, to natural or legal persons, entities or bodies designated under this Decision, for the benefit of actors referred to in UNSCR 2664 (2022), organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate, organisations and agencies which are certified or recognised by a Member State, and the Member States’ specialised agencies. Furthermore, the Council considers that a derogation mechanism should be introduced for those organisations and actors involved in humanitarian activities that cannot benefit from that exemption. The Council also considers that a derogation mechanism should apply, in place of the exemption, in cases where the Council has determined that scrutiny by national competent authorities is required due to a higher risk that the funds or economic resources provided would be misused for purposes other than humanitarian assistance.

(19)
Further action by the Union is needed in order to implement certain measures,

(a)
responsible for, implementing, supporting, or benefitting from actions or policies by the Government of the Russian Federation which undermine or threaten democracy, the rule of law, stability or security in the Union or in one or several of its Member States, in an international organisation or in a third country, or which undermine or threaten the sovereignty or independence of one or several of its Member States, or of a third country, through any of the following actions:(i)planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;(ii)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;(iii)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;(iv)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;(v)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorised entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;(vi)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;(vii)exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;(viii)instigating or facilitating an armed conflict in a third country;
(i)
planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;
(ii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;
(iii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;
(iv)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;
(v)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorised entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;
(vi)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;
(vii)
exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;
(viii)
instigating or facilitating an armed conflict in a third country;

(i)
planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;

(ii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;

(iii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;

(iv)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;

(v)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorised entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;

(vi)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;

(vii)
exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;

(viii)
instigating or facilitating an armed conflict in a third country;

(i)
planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;

(ii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;

(iii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;

(iv)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;

(v)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorised entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;

(vi)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;

(vii)
exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;

(viii)
instigating or facilitating an armed conflict in a third country;

(b)
associated with the natural persons listed under point (a);

(c)
supporting the natural persons engaged in activities referred to in point (a).

(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 United Nations (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)
responsible for, implementing, supporting, or benefitting from actions or policies by the Government of the Russian Federation which undermine or threaten democracy, the rule of law, stability or security in the Union, or in one or more of its Member States, in an international organisation or in a third country, or which undermine or threaten the sovereignty or independence of one or several of its Member States, or of a third country, through any of the following actions:(i)planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;(ii)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;(iii)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;(iv)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;(v)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorized entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;(vi)planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;(vii)exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;(viii)instigating or facilitating an armed conflict in a third country;
(i)
planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;
(ii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;
(iii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;
(iv)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;
(v)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorized entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;
(vi)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;
(vii)
exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;
(viii)
instigating or facilitating an armed conflict in a third country;

(i)
planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;

(ii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;

(iii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;

(iv)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;

(v)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorized entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;

(vi)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;

(vii)
exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;

(viii)
instigating or facilitating an armed conflict in a third country;

(i)
planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;

(ii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;

(iii)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;

(iv)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;

(v)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorized entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;

(vi)
planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;

(vii)
exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;

(viii)
instigating or facilitating an armed conflict in a third country;

(b)
associated with the natural or legal persons, entities or bodies listed under point (a);

(c)
supporting the natural or legal persons, entities or bodies engaged in activities referred to point (a);

(a)
necessary to satisfy the basic needs of the persons listed in the Annex 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;

(d)
necessary for extraordinary expenses, provided that the competent authority has notified the competent authorities of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least 2 weeks prior to the authorisation;

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

(f)
necessary for the functioning of diplomatic and consular representations of the Union and of the Member States or partner countries in Russia, including delegations, embassies and missions, or international organisations in Russia enjoying immunities in accordance with international law; or

(g)
necessary for the provision of electronic communication services by Union telecommunication operators, and for the provision of associated facilities and services necessary for the operation, maintenance and security of such electronic communication services.

(a)
the funds or economic resources are the subject of an arbitral decision rendered prior to the date on which the person, entity or body referred to in paragraph 1 was listed in the Annex, or of a judicial or administrative decision rendered in the Union, 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 natural or legal person, entity or body listed in the Annex; and

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

(a)
interest or other earnings on those accounts;

(b)
payments due under contracts, agreements or obligations that were concluded or arose prior to the date on which those accounts became subject to the measures provided for in paragraphs 1 and 2; or

(c)
payments due under judicial, administrative or arbitral decisions rendered in the Union or enforceable in the Member State concerned;

(a)
the UN, including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;

(b)
international organisations;

(c)
humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;

(d)
bilaterally or multilaterally funded non-governmental organisations participating in UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;

(e)
organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;

(f)
Member States’ specialised agencies; or

(g)
employees, grantees, subsidiaries, or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.

(a)
as regards the Council, for preparing and making amendments to the Annex;

(b)
as regards the High Representative, for preparing amendments to the Annex.

(a)
natural or legal persons, entities or bodies listed in the Annex;

(b)
any natural or legal person, entity or body acting through or on behalf of one of the natural or legal persons, entities or bodies referred to in point (a).

THE COUNCIL OF THE EUROPEAN UNION,

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

Having regard to the proposal from the High Representative of the Union for Foreign Affairs and Security Policy,

Whereas:

(1) In 2013, the Chief of the General Staff of the Russian Federation Armed Forces, Valery Gerasimov, advocated for a change in the types of warfare used by the Russian Federation and for the use of political, diplomatic and other non-military measures in combination with the use of military force. Gerasimov stated that the information space opens wide asymmetrical possibilities for reducing the fighting potential of the enemy.

(2) On 21 September 2021, in its judgment in the case of Carter v Russia (20914/07), the European Court of Human Rights concluded that Alexander Litvinenko was poisoned by two individuals acting under the direction or control of the Russian authorities.

(3) On 9 March 2022, the European Parliament, in its resolution on foreign interference in all democratic processes in the European Union, including disinformation, stated that Russia has been engaging in disinformation of an unparalleled malice and magnitude across both traditional media outlets and social media platforms, in order to deceive its citizens at home and the international community on the eve of and during its war of aggression against Ukraine. The European Parliament underlined that Russia is one of the countries which have targeted journalists and opponents in the Union.

(4) On 10 May 2022, the Union and its international partners strongly condemned the malicious cyber activity conducted by the Russian Federation against Ukraine, which targeted the satellite KA-SAT network, owned by Viasat. That cyberattack took place one hour before Russia’s unprovoked and unjustified invasion of Ukraine on 24 February 2022, thus facilitating the military aggression, and was another example of Russia’s continued pattern of irresponsible behaviour in cyberspace.

(5) On 19 July 2022, the High Representative of the Union for Foreign Affairs and Security Policy (the ‘High Representative’) condemned malicious cyber activities conducted in the context of Russia’s war of aggression against Ukraine, and the distributed denial-of-service attacks against several Member States and partners claimed by pro-Russian hacker groups.

(6) In its conclusions of 21 June 2022, the Council of the European Union noted that while definitions of hybrid threats and campaigns may vary, they need to remain flexible in order to allow for proper responses to the evolving nature of those threats. In that context, the Council took note of the conceptualisation of ‘hybrid threat’ and ‘hybrid campaign’ provided by the Commission and the European Centre of Excellence for Countering Hybrid Threats in ‘The landscape of Hybrid Threats: A Conceptual Model’.

(7) In its conclusions of 21 June 2022, as well as those of 18 July 2022, the Council reiterated the call for the High Representative and the Commission to present options, fully respecting human rights and fundamental freedoms, for well-defined measures that could be taken against actors engaged in Foreign Information Manipulation and Interference (‘FIMI’) where necessary to protect public order and security in the Union.

(8) In February 2023, the European External Action Service published a report on FIMI threats, in which it defined FIMI as a mostly non-illegal pattern of behaviour that threatens or has the potential to negatively impact values, procedures and political processes. Such activity is manipulative in character and conducted in an intentional and coordinated manner by state or non-state actors, including their proxies inside and outside of their own territory.

(9) On 3 February 2023, in a statement following the 24th EU-Ukraine summit, the Union reconfirmed its solidarity with Ukraine in countering hybrid threats and cyberattacks and its commitment to continue its support in this regard. The Union and Ukraine acknowledged the importance of strengthening cooperation in tackling Russian state-controlled information manipulation and interference, including disinformation, as well as building resilience in Ukraine’s digital transformation.

(10) On 1 June 2023, the European Parliament in a resolution on foreign interference in all democratic processes in the Union, including disinformation, stressed that Russia uses an array of different methods of interference, embedded within a larger strategy, to harm, confuse, frighten, weaken and divide the Member States and its neighbourhood.

(11) In its conclusions of 14 and 15 December 2023, the European Council condemned all hybrid attacks, including the instrumentalisation of migrants by third countries for political purposes, and stated that it remained determined to ensure effective control of the Union’s external borders. The European Council underlined that the Union is determined to counter at its external borders the ongoing hybrid attacks launched by the Russian Federation.

(12) In its conclusions of 17 and 18 April 2024, the European Council underlined, in the context of the European elections, the Union and its Member States’ determination to contain any risks stemming from FIMI in electoral processes.

(13) The instrumentalisation of migrants, as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359 of the European Parliament and of the Council (1), is liable to put at risk the essential functions of a Member State, including the maintenance of law and order or the safeguard of its national security.

(14) In its conclusions of 21 May 2024, the Council acknowledged that state and non-state actors are increasingly using hybrid tactics, posing a growing threat to the security of the Union, its Member States and its partners and called on Union institutions and the Member States to step up action to monitor attempts by foreign actors to interfere in the Union’s democratic process.

(15) In its conclusions of 27 June 2024, the European Council strongly condemned all types of hybrid activities, which are on the rise and target the Union, its Member States and its partners, including intimidation, sabotage, subversion, foreign information manipulation and interference, disinformation, malicious cyber activities and the instrumentalisation of migrants by third countries, and stressed that Russia has intensified its campaign with new active operations on European soil. The European Council called, inter alia, for work to be taken forward in the Council to establish a new sanctions regime in view of hybrid threats.

(16) In the view of the gravity of the situation, restrictive measures should be imposed against persons, entities or bodies responsible for, implementing, or supporting actions or policies by the Government of the Russian Federation which undermine or threaten the fundamental values of the Union and its security, independence and integrity, as well as the stability, security or independence of its Member States, of international organisations or of third countries, or the sovereignty of Member States or third countries. Such targeted restrictive measures will pursue common foreign and security policy objectives as set out in Article 21 of the Treaty on European Union (TEU) and contribute to the Union’s actions to safeguard its values, fundamental interests, security, independence and integrity, to consolidate and support democracy, the rule of law, human rights and the principles of international law, and to prevent conflicts and strengthen international security in accordance with points (a) to (c) of Article 21(2) TEU.

(17) Such measures are consistent with the fundamental rights and freedoms recognised in the Charter of Fundamental Rights of the European Union, in particular with the right to freedom of expression and information, the freedom to conduct a business and the right to property, as recognised in Articles 11, 16 and 17 thereof. In particular, such measures do not modify the obligation to respect the rights, freedoms and principles referred to in Article 6 TEU, in the Charter of Fundamental Rights, and in Member States’ constitutions, within their respective fields of application.

(18) In order to increase consistency across the Union’s restrictive measures regimes and with those measures adopted by the UNSC or its Sanctions Committees, and to ensure the timely delivery of humanitarian assistance or to support other activities supporting basic human needs, it is appropriate to introduce an exemption from the asset-freeze measures applicable, and the restrictions on making funds and economic resources available, to natural or legal persons, entities or bodies designated under this Decision, for the benefit of actors referred to in UNSCR 2664 (2022), organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate, organisations and agencies which are certified or recognised by a Member State, and the Member States’ specialised agencies. Furthermore, the Council considers that a derogation mechanism should be introduced for those organisations and actors involved in humanitarian activities that cannot benefit from that exemption. The Council also considers that a derogation mechanism should apply, in place of the exemption, in cases where the Council has determined that scrutiny by national competent authorities is required due to a higher risk that the funds or economic resources provided would be misused for purposes other than humanitarian assistance.

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

HAS ADOPTED THIS DECISION:
 1.   Member States shall take the necessary measures to prevent the entry into, or transit through, their territories of natural persons, as listed in the Annex, who are:

(a) responsible for, implementing, supporting, or benefitting from actions or policies by the Government of the Russian Federation which undermine or threaten democracy, the rule of law, stability or security in the Union or in one or several of its Member States, in an international organisation or in a third country, or which undermine or threaten the sovereignty or independence of one or several of its Member States, or of a third country, through any of the following actions:

(i) planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;

(ii) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;

(iii) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;

(iv) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;

(v) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorised entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;

(vi) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;

(vii) exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;

(viii) instigating or facilitating an armed conflict in a third country;

(b) associated with the natural persons listed under point (a);

(c) supporting the natural persons engaged in activities referred to in point (a).
 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 cases in which 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 United Nations (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 also apply 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, or those promoted or hosted 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 the policy objectives of those measures.
 7.   Member States may also grant exemptions from the measures imposed under paragraph 1 where entry or transit is necessary for the fulfilment of a judicial process, including surrender and extradition procedures.
 8.   A Member State wishing to grant the exemptions referred to in paragraph 6 or 7 shall notify the Council in writing. An exemption shall be deemed to be granted unless one or more of the Council members raises an objection in writing within 2 working days of receiving notification of the proposed exemption. Should one or more of the Council members raise an objection, the Council, acting by qualified majority, may decide to grant the proposed exemption.
 9.   Where, pursuant to paragraph 3, 4, 6, 7 or 8, a Member State authorises the entry into, or transit through its territory of a person listed in the Annex, that authorisation shall be limited to the purpose for which it is given to the person concerned therewith.
 1.   All funds and economic resources belonging to, owned, held or controlled by natural or legal persons, entities or bodies that are:

(a) responsible for, implementing, supporting, or benefitting from actions or policies by the Government of the Russian Federation which undermine or threaten democracy, the rule of law, stability or security in the Union, or in one or more of its Member States, in an international organisation or in a third country, or which undermine or threaten the sovereignty or independence of one or several of its Member States, or of a third country, through any of the following actions:

(i) planning, directing, engaging in, directly or indirectly, or otherwise facilitating the obstruction or undermining of the democratic political process, including by obstructing or undermining the holding of elections or attempting to destabilise or overthrow the constitutional order;

(ii) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating violent demonstrations;

(iii) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating acts of violence, including activities to silence, intimidate, coerce, or exact reprisals against persons critical of the actions or policies of the Russian Federation;

(iv) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the use of coordinated information manipulation and interference;

(v) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating any actions targeted at the functioning of democratic institutions, economic activities or services of public interest, including by unauthorized entry into the territory of a Member State, including its airspace, or aimed at interfering with, damaging or destroying, including through sabotage or malicious cyber activities as part of hybrid activities, critical infrastructure, including submarine infrastructure;

(vi) planning, directing, engaging in, directly or indirectly, supporting or otherwise facilitating the instrumentalisation of migrants as referred to in Article 1(4), point (b), of Regulation (EU) 2024/1359;

(vii) exploiting an armed conflict, instability or insecurity, including through the illicit exploitation or trade of natural resources and wildlife in a third country;

(viii) instigating or facilitating an armed conflict in a third country;

(b) associated with the natural or legal persons, entities or bodies listed under point (a);

(c) supporting the natural or legal persons, entities or bodies engaged in activities referred to point (a);

as listed in the Annex, shall be frozen.
 2.   No funds or economic resources shall be made available, directly or indirectly, to or for the benefit of natural or legal persons, entities or bodies listed in the Annex.
 3.   By way of derogation from paragraphs 1 and 2, the competent authorities of the Member States 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 they deem appropriate, after having determined that the funds or economic resources concerned are:

(a) necessary to satisfy the basic needs of the persons listed in the Annex 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;

(d) necessary for extraordinary expenses, provided that the competent authority has notified the competent authorities of the other Member States and the Commission of the grounds on which it considers that a specific authorisation should be granted, at least 2 weeks prior to the authorisation;

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

(f) necessary for the functioning of diplomatic and consular representations of the Union and of the Member States or partner countries in Russia, including delegations, embassies and missions, or international organisations in Russia enjoying immunities in accordance with international law; or

(g) necessary for the provision of electronic communication services by Union telecommunication operators, and for the provision of associated facilities and services necessary for the operation, maintenance and security of such electronic communication services.
 4.   The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under paragraph 3 within 2 weeks of that authorisation.
 5.   By way of derogation from paragraph 1, the competent authorities of the Member States 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 the subject of an arbitral decision rendered prior to the date on which the person, entity or body referred to in paragraph 1 was listed in the Annex, or of a judicial or administrative decision rendered in the Union, 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 natural or legal person, entity or body listed in the Annex; and

(d) recognition of the decision is not contrary to public policy in the Member State concerned.
 6.   The Member State concerned shall inform the other Member States and the Commission of any authorisations granted under paragraph 5 within 2 weeks of that authorisation.
 7.   Paragraph 1 shall not prevent a listed natural or legal person, entity or body from making a payment due under a contract entered into prior to the date on which such natural or legal person, entity or body was listed in the Annex, provided that the Member State concerned has determined that the payment is not, directly or indirectly, received by a natural or legal person, entity or body referred to in paragraph 1. 

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

(a) interest or other earnings on those accounts;

(b) payments due under contracts, agreements or obligations that were concluded or arose prior to the date on which those accounts became subject to the measures provided for in paragraphs 1 and 2; or

(c) payments due under judicial, administrative or arbitral decisions rendered in the Union or enforceable in the Member State concerned;

provided that any such interest, other earnings and payments remain subject to the measures provided for in paragraph 1. 
 1.   Article 2(1) and (2) shall not apply to the provision, processing or payment of funds, other financial assets or economic resources or to the provision of goods and services which are necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs where such assistance and other activities are carried out by:

(a) the UN, including its programmes, funds and other entities and bodies, as well as its specialised agencies and related organisations;

(b) international organisations;

(c) humanitarian organisations having observer status with the UN General Assembly and members of those humanitarian organisations;

(d) bilaterally or multilaterally funded non-governmental organisations participating in UN Humanitarian Response Plans, UN Refugee Response Plans, other UN appeals or humanitarian clusters coordinated by the UN Office for the Coordination of Humanitarian Affairs;

(e) organisations and agencies to which the Union has granted the Humanitarian Partnership Certificate or which are certified or recognised by a Member State in accordance with national procedures;

(f) Member States’ specialised agencies; or

(g) employees, grantees, subsidiaries, or implementing partners of the entities referred to in points (a) to (f) while and to the extent that they are acting in those capacities.
 2.   The exemption set out in paragraph 1 shall not apply to the natural or legal persons, entities or bodies identified with an asterisk in the Annex.
 3.   Without prejudice to paragraph 1, and by way of derogation from Article 2(1) and (2), the competent authorities 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 they deem appropriate, after having determined that the provision of such funds or economic resources is necessary to ensure the timely delivery of humanitarian assistance or to support other activities that support basic human needs.
 4.   In the absence of a negative decision, a request for information or a notification for additional time from the relevant competent authority within 5 working days of the date of receipt of a request for authorisation under paragraph 1, that authorisation shall be considered granted.
 5.   The Member State concerned shall inform the other Member States and the Commission of any authorisation granted under this Article within 4 weeks of such authorisation.
 1.   The Council, acting by unanimity upon a proposal from a Member State or the High Representative of the Union for Foreign Affairs and Security Policy (the ‘High Representative’), shall decide to establish and amend the list in the Annex.
 2.   The Council shall communicate a decision pursuant to paragraph 1, including the grounds for the listing, to the natural or legal person, entity or body concerned, either directly, if the address is known, or through the publication of a notice in the Official Journal of the European Union, providing such natural or legal person, entity or body with an opportunity to present observations.
 3.   Where observations are submitted, or where substantial new evidence is presented, the Council shall review the decision pursuant to paragraph 1 and inform the natural or legal person, entity or body concerned accordingly.
 1.   The Annex shall include the grounds for listing the natural and legal persons, entities and bodies referred to in Articles 1 and 2. 

 2.   The Annex shall contain, where available, the information necessary to identify the natural or legal persons, entities or bodies concerned. With regard to natural persons, such information may include: names and aliases; date and place of birth; nationality; passport and identity card numbers; gender; address, if known; and function or profession. With regard to legal persons, entities or bodies, such information may include: names; place and date of registration; registration number; and place of business.
 1.   The Council and the High Representative may process personal data in order to carry out their tasks under this Decision, in particular:

(a) as regards the Council, for preparing and making amendments to the Annex;

(b) as regards the High Representative, for preparing amendments to the Annex.
 2.   The Council and the High Representative may process, where applicable, relevant data relating to criminal offences committed by listed natural persons, to criminal convictions of such persons or to security measures concerning such persons, only to the extent that such processing is necessary for the preparation of the Annex.
 3.   For the purposes of this Decision, the Council and the High Representative are designated as ‘controllers’ within the meaning of Article 3, point (8), of Regulation (EU) 2018/1725 of the European Parliament and of the Council (2), in order to ensure that the natural persons concerned can exercise their rights under that Regulation.
 1.   No claims in connection with any contract or transaction the performance of which has been affected, directly or indirectly, in whole or in part, by the measures imposed under this Decision, including claims for indemnity or any other claim of this type, such as a claim for compensation or a claim under a guarantee, in particular a claim for extension or payment of a bond, guarantee or indemnity, in particular a financial guarantee or financial indemnity, of whatever form, shall be satisfied, if they are made by:

(a) natural or legal persons, entities or bodies listed in the Annex;

(b) any natural or legal person, entity or body acting through or on behalf of one of the natural or legal persons, entities or bodies referred to in point (a).
 2.   In any proceedings for the enforcement of a claim, the onus of proving that satisfying the claim is not prohibited by paragraph 1 shall be on the natural or legal person, group, entity or body seeking the enforcement of that claim.
 3.   This Article is without prejudice to the right of the natural or legal persons, groups, entities and bodies referred to in paragraph 1 to judicial review of the legality of the non-performance of contractual obligations in accordance with this Decision.
It shall be prohibited to participate, knowingly or intentionally, in activities the object or effect of which is to circumvent the prohibitions set out in this Decision, including by participating in such activities without deliberately seeking that object or effect but being aware that the participation may have that object or effect and accepting that possibility.
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 provided for in this Decision.
This Decision shall apply until 9 October 2025.

This Decision 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.

The exceptions referred to in Article 3, as regards Article 2(1) and (2), shall be reviewed at regular intervals and at least every 12 months or at the urgent request of any Member State, of the High Representative or of the Commission following a fundamental change in circumstances.
This Decision shall enter into force on the day following that of its publication in the Official Journal of the European Union.

[…]

Commission Implementing Decision (EU) 2024/2638 of 9 October 2024 on the harmonised standards drafted in support of Regulation (EU) 2016/2281 laying down ecodesign requirements for air heating products, cooling products, high temperature process chillers and fan coil units

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2024/2638
11.10.2024

(1)
In accordance with Article 9(2) of Directive 2009/125/EC of the European Parliament and of the Council(2), fan coil units that conform to harmonised standards or parts of them, the references of which have been published in theOfficial Journal of the European Union, are to be presumed to conform to the relevant requirements of the applicable implementing measure to which such standards relate. These standards are referred to in Article 9(2) of Directive 2009/125/EC and set out in Annex VII to the Directive, and covered by the harmonised standards or parts of them.

(2)
By means of Implementing Decision C(2019) 1725 final(3)the Commission made a request to the European Committee for Standardisation (CEN) for the drafting of harmonised standards in support of the implementation of Commission Regulation (EU) 2016/2281(4).

(3)
On the basis of the request set out in Implementing Decision C(2019) 1725 final, the CEN published adapted standards(5), in particular standard EN 1397:2021 on fan coil units.

(4)
The Commission, together with the CEN, has assessed whether standard EN 1397:2021 drafted by the CEN complies with request M/560 of 11.3.2019.

(5)
The standard satisfies the requirements which it aims to cover and which are set out in Regulation (EU) 2016/2281. It is therefore appropriate to publish the standard’s references in theOfficial Journal of the European Union.

(6)
Compliance with a harmonised standard confers a presumption of conformity to the corresponding essential requirements, including the safety objectives, set out in Union harmonisation legislation from the date of publication of the standard’s reference in theOfficial Journal of the European Union. This Decision should therefore enter into force on the day of its publication,

No
Reference of the standard

1.
EN 1397:2021Heat exchangers – Hydronic room fan coil units – Test procedures for establishing the performance

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (1), and in particular Article 10(6) thereof,

Whereas:

(1) In accordance with Article 9(2) of Directive 2009/125/EC of the European Parliament and of the Council (2), fan coil units that conform to harmonised standards or parts of them, the references of which have been published in the Official Journal of the European Union, are to be presumed to conform to the relevant requirements of the applicable implementing measure to which such standards relate. These standards are referred to in Article 9(2) of Directive 2009/125/EC and set out in Annex VII to the Directive, and covered by the harmonised standards or parts of them.

(2) By means of Implementing Decision C(2019) 1725 final (3) the Commission made a request to the European Committee for Standardisation (CEN) for the drafting of harmonised standards in support of the implementation of Commission Regulation (EU) 2016/2281 (4).

(3) On the basis of the request set out in Implementing Decision C(2019) 1725 final, the CEN published adapted standards (5), in particular standard EN 1397:2021 on fan coil units.

(4) The Commission, together with the CEN, has assessed whether standard EN 1397:2021 drafted by the CEN complies with request M/560 of 11.3.2019.

(5) The standard satisfies the requirements which it aims to cover and which are set out in Regulation (EU) 2016/2281. It is therefore appropriate to publish the standard’s references in the Official Journal of the European Union.

(6) Compliance with a harmonised standard confers a presumption of conformity to the corresponding essential requirements, including the safety objectives, set out in Union harmonisation legislation from the date of publication of the standard’s reference in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its publication,

HAS ADOPTED THIS DECISION:
The references of harmonised standard for fan coil units drafted in support of Regulation (EU) 2016/2281 listed in the Annex to this Decision, are hereby published in the Official Journal of the European Union.
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.

No

Reference of the standard 1. EN 1397:2021

Heat exchangers – Hydronic room fan coil units – Test procedures for establishing the performance

Commission Implementing Decision (EU) 2024/2631 of 8 October 2024 amending Implementing Decision (EU) 2021/1182 as regards the harmonised standard for aseptic processing of health care products

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2024/2631
9.10.2024

(1)
In accordance with Article 8(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council(2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in theOfficial Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.

(2)
Regulation (EU) 2017/745 replaced Council Directives 90/385/EEC(3)and 93/42/EEC(4)with effect from 26 May 2021.

(3)
By Implementing Decision C(2021) 2406(5), the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) for the revision of existing harmonised standards on medical devices developed in support of Directives 90/385/EEC and 93/42/EEC and for the drafting of new harmonised standards in support of Regulation (EU) 2017/745 (‘the request’).

(4)
On the basis of the request, CEN and CENELEC revised the harmonised standard EN ISO 13408-1:2015 for aseptic processing of health care products, the reference of which is not published in theOfficial Journal of the European Union, in order to take into account the latest technical and scientific progress and the need to support the requirements of Regulation (EU) 2017/745.

(5)
This resulted in the adoption of the harmonised standard EN ISO 13408-1:2024 (‘the standard’).

(6)
The Commission together with CEN and CENELEC has assessed whether the standard complies with the request.

(7)
The standard satisfies the requirements which it aims to cover, and which are set out in Regulation (EU) 2017/745. It is therefore appropriate to publish the reference of the standard in theOfficial Journal of the European Union.

(8)
The Annex to Commission Implementing Decision (EU) 2021/1182(6)lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745.

(9)
In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/745 are listed in one act, the reference of the standard should be included in Implementing Decision (EU) 2021/1182.

(10)
Implementing Decision (EU) 2021/1182 should therefore be amended accordingly.

(11)
Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in theOfficial Journal of the European Union. This Decision should therefore enter into force on the day of its publication.

(12)
The harmonised standards adopted in response to standardisation requests may be subject to access to documents requests in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council(7). In its judgment of 5 March 2024Public.Resource.Org and Right to Know v. Commission and Others(8), the Court of Justice of the European Union recognised that there is an overriding public interest, within the meaning of Article 4(2) of Regulation (EC) No 1049/2001, justifying the disclosure of harmonised standards,

No
Reference of the standard

‘26.
EN ISO 13408-1:2024Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)’.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (1), and in particular Article 10(6) thereof,

Whereas:

(1) In accordance with Article 8(1) of Regulation (EU) 2017/745 of the European Parliament and of the Council (2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.

(2) Regulation (EU) 2017/745 replaced Council Directives 90/385/EEC (3) and 93/42/EEC (4) with effect from 26 May 2021.

(3) By Implementing Decision C(2021) 2406 (5), the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (CENELEC) for the revision of existing harmonised standards on medical devices developed in support of Directives 90/385/EEC and 93/42/EEC and for the drafting of new harmonised standards in support of Regulation (EU) 2017/745 (‘the request’).

(4) On the basis of the request, CEN and CENELEC revised the harmonised standard EN ISO 13408-1:2015 for aseptic processing of health care products, the reference of which is not published in the Official Journal of the European Union, in order to take into account the latest technical and scientific progress and the need to support the requirements of Regulation (EU) 2017/745.

(5) This resulted in the adoption of the harmonised standard EN ISO 13408-1:2024 (‘the standard’).

(6) The Commission together with CEN and CENELEC has assessed whether the standard complies with the request.

(7) The standard satisfies the requirements which it aims to cover, and which are set out in Regulation (EU) 2017/745. It is therefore appropriate to publish the reference of the standard in the Official Journal of the European Union.

(8) The Annex to Commission Implementing Decision (EU) 2021/1182 (6) lists the references of harmonised standards drafted in support of Regulation (EU) 2017/745.

(9) In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/745 are listed in one act, the reference of the standard should be included in Implementing Decision (EU) 2021/1182.

(10) Implementing Decision (EU) 2021/1182 should therefore be amended accordingly.

(11) Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its publication.

(12) The harmonised standards adopted in response to standardisation requests may be subject to access to documents requests in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council (7). In its judgment of 5 March 2024Public.Resource.Org and Right to Know v. Commission and Others (8), the Court of Justice of the European Union recognised that there is an overriding public interest, within the meaning of Article 4(2) of Regulation (EC) No 1049/2001, justifying the disclosure of harmonised standards,

HAS ADOPTED THIS DECISION:
The Annex to Implementing Decision (EU) 2021/1182 is amended in accordance with the Annex to this Decision.
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
In the Annex to Implementing Decision (EU) 2021/1182, the following entry is added:
No

Reference of the standard

‘26. EN ISO 13408-1:2024

Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)’.

Commission Implementing Decision (EU) 2024/2630 of 8 October 2024 recognising under Article 31(2) and (4) of Directive (EU) 2018/2001 that the report contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed in Denmark

                                January 13, 2026                            

Official Journalof the European Union
ENL series




2024/2630
9.10.2024



(1)
Directive (EU) 2018/2001 requires biofuels, bioliquids, and biomass fuels to save significant greenhouse gas emissions compared to fossil fuels so that they can be counted towards the targets set in that Directive. For this purpose, Article 29(10) sets specific emission savings thresholds for those fuels, and Article 31 regulates how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from the cultivation of agricultural raw materials, it is possible to use typical values under some conditions. These typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.



(2)
On 2 June 2024, Denmark submitted to the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed typically produced in areas on its territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS) in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council(2). Denmark asked for the data to be recognised as accurate in line with Article 31(4) of Directive (EU) 2018/2001.



(3)
The Commission assessed the report and found that it contains accurate data for the purposes of measuring the greenhouse gas emissions associated with cultivating rapeseed typically produced in NUTS 2 regions in Denmark.



(4)
The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,




Soil N2O
Crop residue
Embedded
Fuel incl. drying
Fertiliser acidification
Seed
Total

Direct
Indirect
Fertiliser
Pesticide
Lime

DK1 Hovedstaden
244,3
28,6
50,5
147,7
2,1
2,4
48,4
45,9
0,5
570,5

DK2 Sjælland
235,0
28,7
48,6
129,5
2,0
2,3
48,5
44,2
0,5
539,4

DK3 Syddanmark
248,8
37,5
44,1
98,2
2,1
2,4
53,2
46,8
0,5
533,6

DK4 Midtjylland
243,7
35,2
45,4
103,5
2,0
2,4
52,1
45,8
0,5
530,6

DK5 Nordjylland
271,0
39,8
45,6
96,6
2,1
2,5
56,1
51,0
0,5
565,2

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (1), and in particular Article 31(4) thereof,

Whereas:

(1) Directive (EU) 2018/2001 requires biofuels, bioliquids, and biomass fuels to save significant greenhouse gas emissions compared to fossil fuels so that they can be counted towards the targets set in that Directive. For this purpose, Article 29(10) sets specific emission savings thresholds for those fuels, and Article 31 regulates how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from the cultivation of agricultural raw materials, it is possible to use typical values under some conditions. These typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.

(2) On 2 June 2024, Denmark submitted to the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed typically produced in areas on its territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS) in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council (2). Denmark asked for the data to be recognised as accurate in line with Article 31(4) of Directive (EU) 2018/2001.

(3) The Commission assessed the report and found that it contains accurate data for the purposes of measuring the greenhouse gas emissions associated with cultivating rapeseed typically produced in NUTS 2 regions in Denmark.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,

HAS ADOPTED THIS DECISION:
The report submitted for recognition to the Commission by Denmark on 2 June 2024 contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed typically produced in regions in NUTS 2 regions in Denmark, pursuant to Article 31(4) of Directive (EU) 2018/2001. The summary of the report’s data is set out in the Annex.
If the data contained in the report, as submitted for recognition to the Commission on 2 June 2024, changes in a way that might affect the accuracy of the data and thereby the basis for this Decision, Denmark shall notify the Commission of such changes immediately. The Commission shall assess the notified changes to determine whether the report still provides the accurate data for which it is recognised.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall cease to apply on 29 October 2029.
Greenhouse gas emissions arising from the cultivation of rapeseed in the Danish regions (g CO2eq/kg rapeseed dry matter)
Soil N2O

Crop residue

Embedded

Fuel incl. drying

Fertiliser acidification

Seed

Total

Direct

Indirect

Fertiliser

Pesticide

Lime

DK1 Hovedstaden

244,3 

28,6 

50,5 

147,7 

2,1 

2,4 

48,4 

45,9 

0,5 

570,5 

DK2 Sjælland

235,0 

28,7 

48,6 

129,5 

2,0 

2,3 

48,5 

44,2 

0,5 

539,4 

DK3 Syddanmark

248,8 

37,5 

44,1 

98,2 

2,1 

2,4 

53,2 

46,8 

0,5 

533,6 

DK4 Midtjylland

243,7 

35,2 

45,4 

103,5 

2,0 

2,4 

52,1 

45,8 

0,5 

530,6 

DK5 Nordjylland

271,0 

39,8 

45,6 

96,6 

2,1 

2,5 

56,1 

51,0 

0,5 

565,2 
			

Commission Implementing Decision (EU) 2024/2629 of 8 October 2024 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and eight of its sub-combinations pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2024) 6892)

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2024/2629
10.10.2024

(1)
Commission Implementing Decision 2013/650/EU(2)authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122. The scope of that authorisation also covered the placing on the market of products other than food and feed containing or consisting of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 for the same uses as any other maize, with the exception of cultivation.

(2)
In addition, Implementing Decision 2013/650/EU authorised the placing on the market of food and feed containing, consisting of or produced from eight sub-combinations of the single transformation events constituting genetically modified maize MON 89034 × 1507 × MON 88017 × 59122: MON 89034 × 1507 × MON 88017, MON 89034 × 1507 × 59122, MON 89034 × MON 88017 × 59122, 1507 × MON 88017 × 59122, MON 89034 × 1507, MON 89034 × 59122, 1507 × MON 88017 and MON 88017 × 59122.

(3)
On 7 October 2022, Corteva Agriscience Belgium B.V., based in Belgium, on behalf of Corteva Agriscience LLC, based in the United States, and Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP based in the United States, jointly submitted an application to the Commission for the renewal of the authorisation.

(4)
On 29 April 2024, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion on the assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and eight of its sub-combinations(3). It concluded that the renewal application did not contain evidence for any new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment adopted by the Authority in 2010(4)and complemented in 2011(5).

(5)
In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities, as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(6)
The Authority also concluded that the monitoring plan for the environmental effects, consisting of a general surveillance plan, submitted by the applicants, is in line with the intended uses of the products.

(7)
Taking into account those conclusions, the authorisation for the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and the sub-combinations MON 89034 × 1507 × MON 88017, MON 89034 × 1507 × 59122, MON 89034 × MON 88017 × 59122, 1507 × MON 88017 × 59122, MON 89034 × 1507, MON 89034 × 59122, 1507 × MON 88017 and MON 88017 × 59122 and of products containing or consisting of them for uses other than food and feed, with the exception of cultivation, should be renewed.

(8)
Unique identifiers have been assigned to genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and to the eight sub-combinations MON 89034 × 1507 × MON 88017, MON 89034 × 1507 × 59122, MON 89034 × MON 88017 × 59122, 1507 × MON 88017 × 59122, MON 89034 × 1507, MON 89034 × 59122, 1507 × MON 88017 and MON 88017 × 59122, in accordance with Commission Regulation (EC) No 65/2004(6), in the context of the initial authorisation by Implementing Decision 2013/650/EU. Those unique identifiers should continue to be used.

(9)
For the products covered by this Decision, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council(7), appear to be necessary. However, in order to ensure that the use of products remain within the limits of the authorisation granted by this Decision, the labelling of such products, with the exception of food and food ingredients, should contain a clear indication that they are not intended for cultivation.

(10)
The authorisation holders should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC(8).

(11)
The opinion of the Authority does not justify the imposition of specific conditions or restrictions for the placing on the market for use and handling, including post-market monitoring requirements regarding the consumption of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and from its eight sub-combinations, or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e) of Regulation (EC) No 1829/2003.

(12)
All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(13)
This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(9).

(14)
The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)
the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7 for genetically modified maize MON 89034 × 1507 × MON 88017 × 59122;

(b)
the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 for genetically modified maize MON 89034 × 1507 × MON 88017;

(c)
the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7 for genetically modified maize MON 89034 × 1507 × 59122;

(d)
the unique identifier MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7 for genetically modified maize MON 89034 × MON 88017 × 59122;

(e)
the unique identifier DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7 for genetically modified maize 1507 × MON 88017 × 59122;

(f)
the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 for genetically modified maize MON 89034 × 1507;

(g)
the unique identifier MON-89Ø34-3 × DAS-59122-7 for genetically modified maize MON 89034 × 59122;

(h)
the unique identifier DAS-Ø15Ø7-1 × MON-88Ø17-3 for genetically modified maize 1507 × MON 88017;

(i)
the unique identifier MON-88Ø17-3 × DAS-59122-7 for genetically modified maize MON 88017 × 59122.

(a)
foods and food ingredients containing, consisting of or produced from genetically modified maize and its sub-combinations referred to in Article 1;

(b)
feed containing, consisting of or produced from genetically modified maize and its sub-combinations referred to in Article 1;

(c)
products containing or consisting of genetically modified maize and its sub-combinations referred to in Article 1, for uses other than those provided for in points (a) and (b), with the exception of cultivation.

(a)
Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience BV, Belgium;

(b)
Bayer CropScience LP, United States, represented in the Union by Bayer Agriculture B.V., Belgium.

(a)
Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium;and

(b)
Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, MO 63167, United States, represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium.

(a)
Applicants and authorisation holders:(1)Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and(2)Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States;represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.
(1)
Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and
(2)
Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States;represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(1)
Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and

(2)
Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States;represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(1)
Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and

(2)
Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States;represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(b)
Designation and specification of the products:(1)foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);(2)feed containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);(3)products containing or consisting of genetically modified maize (Zea maysL.) referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.The genetically modified maize MON-89Ø34-3 expresses thecry1A.105andcry2Ab2genes, which confer protection against certain lepidopteran pests.The genetically modified maize DAS-Ø15Ø7-1 expresses thecry1Fgene, which confers protection against certain lepidopteran pests, and thepatgene, which confers tolerance to herbicides containing glufosinate-ammonium.The genetically modified maize MON-88Ø17-3 expresses thecry3Bb1gene, which confers protection against certain coleopteran pests, and the CP4epspsgene, which confers tolerance to glyphosate-based herbicides.The genetically modified maize DAS-59122-7 expresses thecry34Ab1andcry35Ab1genes, which confer resistance to certain coleopteran pests, and thepatgene, which confers tolerance to herbicides containing glufosinate-ammonium.
(1)
foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);
(2)
feed containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);
(3)
products containing or consisting of genetically modified maize (Zea maysL.) referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(1)
foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);

(2)
feed containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);

(3)
products containing or consisting of genetically modified maize (Zea maysL.) referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(1)
foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);

(2)
feed containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);

(3)
products containing or consisting of genetically modified maize (Zea maysL.) referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(c)
Labelling:(1)For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’;(2)The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize specified in point (e), with the exception of products referred to in point (b)(1).
(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’;
(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize specified in point (e), with the exception of products referred to in point (b)(1).

(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’;

(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize specified in point (e), with the exception of products referred to in point (b)(1).

(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’;

(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize specified in point (e), with the exception of products referred to in point (b)(1).

(d)
Method for detection:(1)The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;(2)Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;(3)Reference Material: AOCS 0906-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.
(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;
(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;
(3)
Reference Material: AOCS 0906-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.

(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;

(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;

(3)
Reference Material: AOCS 0906-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.

(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;

(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;

(3)
Reference Material: AOCS 0906-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.

(e)
Unique identifiers:MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7MON-89Ø34-3 × DAS-Ø15Ø7-1MON-89Ø34-3 × DAS-59122-7DAS-Ø15Ø7-1 × MON-88Ø17-3MON-88Ø17-3 × DAS-59122-7

(f)
Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:[Biosafety Clearing-House, Record ID number:published in the Community register of genetically modified food and feed when notified].

(g)
Conditions or restrictions on the placing on the market, use or handling of the products:Not required.

(h)
Monitoring plan for environmental effects:Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC of the European Parliament and of the Council(1).[Link:plan published in the Community register of genetically modified food and feed]

(i)
Post-market monitoring requirements for the use of the food for human consumption:Not required.Note:links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
Note:
links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

Note:
links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

Note:
links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 11(3) and 23(3) thereof,

Whereas:

(1) Commission Implementing Decision 2013/650/EU (2) authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122. The scope of that authorisation also covered the placing on the market of products other than food and feed containing or consisting of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 for the same uses as any other maize, with the exception of cultivation.

(2) In addition, Implementing Decision 2013/650/EU authorised the placing on the market of food and feed containing, consisting of or produced from eight sub-combinations of the single transformation events constituting genetically modified maize MON 89034 × 1507 × MON 88017 × 59122: MON 89034 × 1507 × MON 88017, MON 89034 × 1507 × 59122, MON 89034 × MON 88017 × 59122, 1507 × MON 88017 × 59122, MON 89034 × 1507, MON 89034 × 59122, 1507 × MON 88017 and MON 88017 × 59122.

(3) On 7 October 2022, Corteva Agriscience Belgium B.V., based in Belgium, on behalf of Corteva Agriscience LLC, based in the United States, and Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP based in the United States, jointly submitted an application to the Commission for the renewal of the authorisation.

(4) On 29 April 2024, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion on the assessment of genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and eight of its sub-combinations (3). It concluded that the renewal application did not contain evidence for any new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment adopted by the Authority in 2010 (4) and complemented in 2011 (5).

(5) In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities, as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(6) The Authority also concluded that the monitoring plan for the environmental effects, consisting of a general surveillance plan, submitted by the applicants, is in line with the intended uses of the products.

(7) Taking into account those conclusions, the authorisation for the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and the sub-combinations MON 89034 × 1507 × MON 88017, MON 89034 × 1507 × 59122, MON 89034 × MON 88017 × 59122, 1507 × MON 88017 × 59122, MON 89034 × 1507, MON 89034 × 59122, 1507 × MON 88017 and MON 88017 × 59122 and of products containing or consisting of them for uses other than food and feed, with the exception of cultivation, should be renewed.

(8) Unique identifiers have been assigned to genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and to the eight sub-combinations MON 89034 × 1507 × MON 88017, MON 89034 × 1507 × 59122, MON 89034 × MON 88017 × 59122, 1507 × MON 88017 × 59122, MON 89034 × 1507, MON 89034 × 59122, 1507 × MON 88017 and MON 88017 × 59122, in accordance with Commission Regulation (EC) No 65/2004 (6), in the context of the initial authorisation by Implementing Decision 2013/650/EU. Those unique identifiers should continue to be used.

(9) For the products covered by this Decision, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (7), appear to be necessary. However, in order to ensure that the use of products remain within the limits of the authorisation granted by this Decision, the labelling of such products, with the exception of food and food ingredients, should contain a clear indication that they are not intended for cultivation.

(10) The authorisation holders should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (8).

(11) The opinion of the Authority does not justify the imposition of specific conditions or restrictions for the placing on the market for use and handling, including post-market monitoring requirements regarding the consumption of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 and from its eight sub-combinations, or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e) of Regulation (EC) No 1829/2003.

(12) All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(13) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (9).

(14) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:
Genetically modified organisms and unique identifierGenetically modified maizes (Zea mays L.), as specified in point (b) of the Annex to this Decision, are assigned the following unique identifiers, in accordance with Regulation (EC) No 65/2004:
(a) the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7 for genetically modified maize MON 89034 × 1507 × MON 88017 × 59122;

(b) the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 for genetically modified maize MON 89034 × 1507 × MON 88017;

(c) the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7 for genetically modified maize MON 89034 × 1507 × 59122;

(d) the unique identifier MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7 for genetically modified maize MON 89034 × MON 88017 × 59122;

(e) the unique identifier DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7 for genetically modified maize 1507 × MON 88017 × 59122;

(f) the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 for genetically modified maize MON 89034 × 1507;

(g) the unique identifier MON-89Ø34-3 × DAS-59122-7 for genetically modified maize MON 89034 × 59122;

(h) the unique identifier DAS-Ø15Ø7-1 × MON-88Ø17-3 for genetically modified maize 1507 × MON 88017;

(i) the unique identifier MON-88Ø17-3 × DAS-59122-7 for genetically modified maize MON 88017 × 59122. 
Renewal of the authorisationThe authorisation for placing on the market of the following products is renewed as regards:
(a) foods and food ingredients containing, consisting of or produced from genetically modified maize and its sub-combinations referred to in Article 1;

(b) feed containing, consisting of or produced from genetically modified maize and its sub-combinations referred to in Article 1;

(c) products containing or consisting of genetically modified maize and its sub-combinations referred to in Article 1, for uses other than those provided for in points (a) and (b), with the exception of cultivation.
Labelling 1.   For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’.
 2.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified maize referred to in Article 1, with the exception of products referred to in Article 2, point (a).
Method for detectionThe method set out in point (d) of the Annex shall apply for the detection of maize and its sub-combinations referred to in Article 1.
Monitoring for environmental effects 1.   The authorisation holders shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
 2.   The authorisation holders shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.
Community registerThe information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed referred to in Article 28 of Regulation (EC) No 1829/2003.
Authorisation holdersThe authorisation holders shall be:
(a) Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience BV, Belgium;

(b) Bayer CropScience LP, United States, represented in the Union by Bayer Agriculture B.V., Belgium.
ValidityThis Decision shall apply for a period of 10 years from the date of its notification.
AddresseeThis Decision is addressed to:
(a) Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium;

and

(b) Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, MO 63167, United States, represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium.

(a) Applicants and authorisation holders:

(1) Name: Bayer CropScience LP

Address: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;

represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;

and

(2) Name: Corteva Agriscience LLC

Address: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States;

represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(b) Designation and specification of the products:

(1) foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea mays L.) referred to in point (e);

(2) feed containing, consisting of or produced from genetically modified maize (Zea mays L.) referred to in point (e);

(3) products containing or consisting of genetically modified maize (Zea mays L.) referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified maize MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.

The genetically modified maize DAS-Ø15Ø7-1 expresses the cry1F gene, which confers protection against certain lepidopteran pests, and the pat gene, which confers tolerance to herbicides containing glufosinate-ammonium.

The genetically modified maize MON-88Ø17-3 expresses the cry3Bb1 gene, which confers protection against certain coleopteran pests, and the CP4 epsps gene, which confers tolerance to glyphosate-based herbicides.

The genetically modified maize DAS-59122-7 expresses the cry34Ab1 and cry35Ab1 genes, which confer resistance to certain coleopteran pests, and the pat gene, which confers tolerance to herbicides containing glufosinate-ammonium.

(c) Labelling:

(1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’;

(2) The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize specified in point (e), with the exception of products referred to in point (b)(1).

(d) Method for detection:

(1) The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;

(2) Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;

(3) Reference Material: AOCS 0906-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), at https://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/.

(e) Unique identifiers:

MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7

MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3

MON-89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7

MON-89Ø34-3 × MON-88Ø17-3 × DAS-59122-7

DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7

MON-89Ø34-3 × DAS-Ø15Ø7-1

MON-89Ø34-3 × DAS-59122-7

DAS-Ø15Ø7-1 × MON-88Ø17-3

MON-88Ø17-3 × DAS-59122-7

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].

(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h) Monitoring plan for environmental effects:

Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC of the European Parliament and of the Council (1).

[Link: plan published in the Community register of genetically modified food and feed]

(i) Post-market monitoring requirements for the use of the food for human consumption:

Not required.

Note:

links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
(1)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1, ELI: http://data.europa.eu/eli/dir/2001/18/oj).

Commission Implementing Decision (EU) 2024/2628 of 8 October 2024 renewing the authorisation for the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2024) 6915)

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2024/2628
10.10.2024

(1)
Commission Implementing Decision 2013/648/EU(2)authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603. The scope of that authorisation also covered the placing on the market of products other than food and feed containing or consisting of genetically modified maize MON 89034 × 1507 × NK603, for the same uses as any other maize, with the exception of cultivation.

(2)
On 21 October 2022, Corteva Agriscience Belgium B.V., based in Belgium, on behalf of Corteva Agriscience LLC, based in the United States, and Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP based in the United States, jointly submitted an application to the Commission for the renewal of that authorisation.

(3)
On 26 April 2024, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion on genetically modified maize MON 89034 × 1507 × NK603(3). It concluded that the renewal application did not contain evidence for any new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on genetically modified maize MON 89034 × 1507 × NK603, adopted by the Authority in 2010(4).

(4)
In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities, as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5)
The Authority also concluded that the monitoring plan for the environmental effects, consisting of a general surveillance plan, submitted by the applicants, is in line with the intended uses of the products.

(6)
Taking into account those conclusions, the authorisation for the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 and of products containing or consisting of genetically modified maize MON 89034 × 1507 × NK603, for uses other than food and feed, with the exception of cultivation, should be renewed.

(7)
A unique identifier has been assigned to genetically modified maize MON 89034 × 1507 × NK603 in accordance with Commission Regulation (EC) No 65/2004(5), in the context of the initial authorisation by Implementing Decision 2013/648/EU. That unique identifier should continue to be used.

(8)
For the products covered by this Decision, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council(6), appear to be necessary. However, in order to ensure that the use of products containing or consisting of genetically modified maize MON 89034 × 1507 × NK603 remains within the limits of the authorisation granted by this Decision, the labelling of such products, with the exception of food and food ingredients, should contain a clear indication that they are not intended for cultivation.

(9)
The authorisation holders should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC(7).

(10)
The opinion of the Authority does not justify the imposition of specific conditions or restrictions for the placing on the market, for the use and handling, including post-market monitoring requirements regarding the consumption of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e) of Regulation (EC) No 1829/2003.

(11)
All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(12)
This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(8).

(13)
The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)
foods and food ingredients containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(b)
feed containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(c)
products containing or consisting of genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, for uses other than those provided for in points (a) and (b), with the exception of cultivation.

(a)
Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience B.V., Belgium;

(b)
Bayer CropScience LP, United States, represented in the Union by Bayer Agriculture B.V., Belgium.

(a)
Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium B.V., Rue Montoyer 25, 1000 Brussels, Belgium;and

(b)
Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, MO 63167, United States, represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium.

(a)
Applicants and authorisation holders:(1)Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States,represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and(2)Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States,represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.
(1)
Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States,represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and
(2)
Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States,represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(1)
Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States,represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and

(2)
Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States,represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(1)
Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States,represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and

(2)
Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States,represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(b)
Designation and specification of the products:(1)foods and food ingredients containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;(2)feed containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;(3)products containing or consisting of genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation.The genetically modified maize MON-89Ø34-3 expresses thecry1A.105andcry2Ab2genes, which confer protection against certain lepidopteran pests.The genetically modified maize DAS-Ø15Ø7-1 expresses thecry1Fgene, which confers protection against certain lepidopteran pests, and thepatgene, which confers tolerance to herbicides containing glufosinate-ammonium.The genetically modified maize MON-ØØ6Ø3-6 expresses the CP4epspsand the CP4epspsL214P genes, which confer tolerance to glyphosate-based herbicides.
(1)
foods and food ingredients containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;
(2)
feed containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;
(3)
products containing or consisting of genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(1)
foods and food ingredients containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(2)
feed containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(3)
products containing or consisting of genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(1)
foods and food ingredients containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(2)
feed containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(3)
products containing or consisting of genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(c)
Labelling:(1)For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘maize’;(2)The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, with the exception of the products referred to in point (b)(1).
(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘maize’;
(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, with the exception of the products referred to in point (b)(1).

(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘maize’;

(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, with the exception of the products referred to in point (b)(1).

(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘maize’;

(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, with the exception of the products referred to in point (b)(1).

(d)
Method for detection:(1)The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1 and MON-ØØ6Ø3-6 and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;(2)Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;(3)Reference Material: AOCS 0906-E (for MON-89Ø34-3) and AOCS 0406-A (for the non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.
(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1 and MON-ØØ6Ø3-6 and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;
(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;
(3)
Reference Material: AOCS 0906-E (for MON-89Ø34-3) and AOCS 0406-A (for the non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.

(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1 and MON-ØØ6Ø3-6 and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;

(3)
Reference Material: AOCS 0906-E (for MON-89Ø34-3) and AOCS 0406-A (for the non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.

(1)
The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1 and MON-ØØ6Ø3-6 and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;

(3)
Reference Material: AOCS 0906-E (for MON-89Ø34-3) and AOCS 0406-A (for the non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.

(e)
Unique identifier:MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6

(f)
Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:[Biosafety Clearing-House, Record ID number:published in the Community register of genetically modified food and feed when notified].

(g)
Conditions or restrictions on the placing on the market, use or handling of the products:Not required.

(h)
Monitoring plan for environmental effects:Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC of the European Parliament and of the Council(*1).[Link:plan published in the Community register of genetically modified food and feed]

(i)
Post-market monitoring requirements for the use of the food for human consumption:Not required.

Note:
links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Articles 11(3) and 23(3) thereof,

Whereas:

(1) Commission Implementing Decision 2013/648/EU (2) authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603. The scope of that authorisation also covered the placing on the market of products other than food and feed containing or consisting of genetically modified maize MON 89034 × 1507 × NK603, for the same uses as any other maize, with the exception of cultivation.

(2) On 21 October 2022, Corteva Agriscience Belgium B.V., based in Belgium, on behalf of Corteva Agriscience LLC, based in the United States, and Bayer Agriculture B.V., based in Belgium, on behalf of Bayer CropScience LP based in the United States, jointly submitted an application to the Commission for the renewal of that authorisation.

(3) On 26 April 2024, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion on genetically modified maize MON 89034 × 1507 × NK603 (3). It concluded that the renewal application did not contain evidence for any new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on genetically modified maize MON 89034 × 1507 × NK603, adopted by the Authority in 2010 (4).

(4) In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities, as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5) The Authority also concluded that the monitoring plan for the environmental effects, consisting of a general surveillance plan, submitted by the applicants, is in line with the intended uses of the products.

(6) Taking into account those conclusions, the authorisation for the placing on the market of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 and of products containing or consisting of genetically modified maize MON 89034 × 1507 × NK603, for uses other than food and feed, with the exception of cultivation, should be renewed.

(7) A unique identifier has been assigned to genetically modified maize MON 89034 × 1507 × NK603 in accordance with Commission Regulation (EC) No 65/2004 (5), in the context of the initial authorisation by Implementing Decision 2013/648/EU. That unique identifier should continue to be used.

(8) For the products covered by this Decision, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (6), appear to be necessary. However, in order to ensure that the use of products containing or consisting of genetically modified maize MON 89034 × 1507 × NK603 remains within the limits of the authorisation granted by this Decision, the labelling of such products, with the exception of food and food ingredients, should contain a clear indication that they are not intended for cultivation.

(9) The authorisation holders should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (7).

(10) The opinion of the Authority does not justify the imposition of specific conditions or restrictions for the placing on the market, for the use and handling, including post-market monitoring requirements regarding the consumption of food and feed containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e) of Regulation (EC) No 1829/2003.

(11) All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(12) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (8).

(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:
Genetically modified organism and unique identifierGenetically modified maize (Zea mays L.) MON 89034 × 1507 × NK603, as specified in the Annex, is assigned the unique identifier MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, in accordance with Regulation (EC) No 65/2004.
Renewal of the authorisationThe authorisation for the placing on the market of the following products is renewed as regards:
(a) foods and food ingredients containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(b) feed containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(c) products containing or consisting of genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, for uses other than those provided for in points (a) and (b), with the exception of cultivation.
Labelling 1.   For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘maize’.
 2.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified maize referred to in Article 1, with the exception of products referred to in Article 2, point (a).
Method for detectionThe method set out in point (d) of the Annex shall apply for the detection of MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6.
Monitoring for environmental effects 1.   The authorisation holders shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
 2.   The authorisation holders shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.
Community registerThe information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed referred to in Article 28 of Regulation (EC) No 1829/2003.
Authorisation holdersThe authorisation holders shall be:
(a) Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience B.V., Belgium;

(b) Bayer CropScience LP, United States, represented in the Union by Bayer Agriculture B.V., Belgium.
ValidityThis Decision shall apply for a period of 10 years from the date of its notification.
AddresseesThis Decision is addressed to:
(a) Corteva Agriscience LLC, 9330 Zionsville Road, Indianapolis, IN 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium B.V., Rue Montoyer 25, 1000 Brussels, Belgium;

and

(b) Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, MO 63167, United States, represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium.

(a) Applicants and authorisation holders:

(1) Name: Bayer CropScience LP

Address: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States,

represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;

and

(2) Name: Corteva Agriscience LLC

Address: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States,

represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(b) Designation and specification of the products:

(1) foods and food ingredients containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(2) feed containing, consisting of or produced from genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(3) products containing or consisting of genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified maize MON-89Ø34-3 expresses the cry1A.105 and cry2Ab2 genes, which confer protection against certain lepidopteran pests.

The genetically modified maize DAS-Ø15Ø7-1 expresses the cry1F gene, which confers protection against certain lepidopteran pests, and the pat gene, which confers tolerance to herbicides containing glufosinate-ammonium.

The genetically modified maize MON-ØØ6Ø3-6 expresses the CP4 epsps and the CP4 epsps L214P genes, which confer tolerance to glyphosate-based herbicides.

(c) Labelling:

(1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘maize’;

(2) The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6, with the exception of the products referred to in point (b)(1).

(d) Method for detection:

(1) The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1 and MON-ØØ6Ø3-6 and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6;

(2) Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;

(3) Reference Material: AOCS 0906-E (for MON-89Ø34-3) and AOCS 0406-A (for the non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), at https://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF415 (for MON-ØØ6Ø3-6) are accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.jrc.ec.europa.eu/.

(e) Unique identifier:

MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-ØØ6Ø3-6

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

[Biosafety Clearing-House, Record ID number: published in the Community register of genetically modified food and feed when notified].

(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h) Monitoring plan for environmental effects:

Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC of the European Parliament and of the Council (*1).

[Link: plan published in the Community register of genetically modified food and feed]

(i) Post-market monitoring requirements for the use of the food for human consumption:

Not required.

Note:

links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
(*1)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1, ELI: http://data.europa.eu/eli/dir/2001/18/oj).

Commission Implementing Decision (EU) 2024/2627 of 8 October 2024 authorising the placing on the market of products containing, consisting of or produced from genetically modified cotton COT102 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2024) 6938)

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2024/2627
10.10.2024

(1)
On 31 March 2017, Syngenta Crop Protection NV/SA, based in Belgium, submitted, on behalf of Syngenta Crop Protection AG, based in Switzerland, an application to the national competent authority of Germany for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified cotton COT102, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’). The application also covered the placing on the market of products containing or consisting of genetically modified cotton COT102 for uses other than food and feed, with the exception of cultivation.

(2)
In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council(2). It also included the information required pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with Annex VII to that Directive.

(3)
On 26 June 2023, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3). The Authority concluded that genetically modified cotton COT102, as described in the application, is as safe as the non-genetically modified comparator and the tested non-genetically modified cotton reference varieties with respect to the potential effects on human and animal health and the environment. The Authority also concluded that the consumption of food and feed from genetically modified cotton COT102 does not represent a nutritional concern in humans and animals.

(4)
In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5)
The Authority also concluded that the monitoring plan for the environmental effects, submitted by the applicant, consisting of a general surveillance plan, is in line with the intended uses of the products.

(6)
Taking into account those conclusions, the placing on the market of products containing, consisting of or produced from genetically modified cotton COT102 should be authorised for the uses listed in the application.

(7)
A unique identifier should be assigned to genetically modified cotton COT102 in accordance with Commission Regulation (EC) No 65/2004(4).

(8)
For the products covered by this Decision, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5), appear to be necessary. However, in order to ensure that the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of genetically modified cotton COT102, with the exception of foods and food ingredients, should contain a clear indication that they are not intended for cultivation.

(9)
The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC(6).

(10)
The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the placing on the market, for the use and handling or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e), of Regulation (EC) No 1829/2003.

(11)
All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(12)
This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c), of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).

(13)
The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)
foods and food ingredients containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(b)
feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(c)
products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 for uses other than those provided for in points (a) and (b), with the exception of cultivation.

(a)
Applicant and Authorisation holder:Name: Syngenta Crop Protection AGAddress: Rosentalstrasse 67, CH-4058 Basel, SwitzerlandRepresented in the Union by: Syngenta Crop Protection NV/SA, avenue Louise, 489, 1050 Brussels, Belgium.

(b)
Designation and specification of the products:(1)foods and food ingredients containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;(2)feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;(3)products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 for uses other than those provided for in points (1) and (2), with the exception of cultivation.The genetically modified cotton SYN-IR1Ø2–7 expresses theVip3Aa19gene, which confers resistance to certain lepidopteran pests. In addition, anaph4gene, conferring hygromycin B resistance, was used as a selection marker in the genetic modification process.
(1)
foods and food ingredients containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;
(2)
feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;
(3)
products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(1)
foods and food ingredients containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(2)
feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(3)
products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(1)
foods and food ingredients containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(2)
feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(3)
products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(c)
Labelling:(1)For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘cotton’.(2)The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of genetically modified cotton SYN-IR1Ø2–7, with the exception of products referred to in point (b)(1) of this Annex.
(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘cotton’.
(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of genetically modified cotton SYN-IR1Ø2–7, with the exception of products referred to in point (b)(1) of this Annex.

(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘cotton’.

(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of genetically modified cotton SYN-IR1Ø2–7, with the exception of products referred to in point (b)(1) of this Annex.

(1)
For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘cotton’.

(2)
The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of genetically modified cotton SYN-IR1Ø2–7, with the exception of products referred to in point (b)(1) of this Annex.

(d)
Method for detection:(1)Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7.(2)Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttps://gmo-crl.jrc.ec.europa.eu/method-validations.(3)Reference Material: AOCS 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.
(1)
Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7.
(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttps://gmo-crl.jrc.ec.europa.eu/method-validations.
(3)
Reference Material: AOCS 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.

(1)
Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7.

(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttps://gmo-crl.jrc.ec.europa.eu/method-validations.

(3)
Reference Material: AOCS 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.

(1)
Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7.

(2)
Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttps://gmo-crl.jrc.ec.europa.eu/method-validations.

(3)
Reference Material: AOCS 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.

(e)
Unique identifier:SYN-IR1Ø2–7

(f)
Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:[Biosafety Clearing-House, Record ID number:published in the register of genetically modified food and feed when notified].

(g)
Conditions or restrictions on the placing on the market, use or handling of the products:Not required.

(h)
Monitoring plan for environmental effects:Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC.[Link:plan published in the Community register of genetically modified food and feed]

(i)
Post-market monitoring requirements for the use of the food for human consumption:Not required.Note:links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
Note:
links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

Note:
links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

Note:
links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed (1), and in particular Article 7(3) and Article 19(3) thereof,

Whereas:

(1) On 31 March 2017, Syngenta Crop Protection NV/SA, based in Belgium, submitted, on behalf of Syngenta Crop Protection AG, based in Switzerland, an application to the national competent authority of Germany for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified cotton COT102, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’). The application also covered the placing on the market of products containing or consisting of genetically modified cotton COT102 for uses other than food and feed, with the exception of cultivation.

(2) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council (2). It also included the information required pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with Annex VII to that Directive.

(3) On 26 June 2023, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). The Authority concluded that genetically modified cotton COT102, as described in the application, is as safe as the non-genetically modified comparator and the tested non-genetically modified cotton reference varieties with respect to the potential effects on human and animal health and the environment. The Authority also concluded that the consumption of food and feed from genetically modified cotton COT102 does not represent a nutritional concern in humans and animals.

(4) In its scientific opinion, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for in Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5) The Authority also concluded that the monitoring plan for the environmental effects, submitted by the applicant, consisting of a general surveillance plan, is in line with the intended uses of the products.

(6) Taking into account those conclusions, the placing on the market of products containing, consisting of or produced from genetically modified cotton COT102 should be authorised for the uses listed in the application.

(7) A unique identifier should be assigned to genetically modified cotton COT102 in accordance with Commission Regulation (EC) No 65/2004 (4).

(8) For the products covered by this Decision, no specific labelling requirements, other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear to be necessary. However, in order to ensure that the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of the products containing or consisting of genetically modified cotton COT102, with the exception of foods and food ingredients, should contain a clear indication that they are not intended for cultivation.

(9) The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (6).

(10) The opinion of the Authority does not justify the imposition of other specific conditions or restrictions for the placing on the market, for the use and handling or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e), of Regulation (EC) No 1829/2003.

(11) All relevant information on the authorisation of the products covered by this Decision should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of Regulation (EC) No 1829/2003.

(12) This Decision is to be notified through the Biosafety Clearing-House to the Parties to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity, pursuant to Article 9(1) and Article 15(2), point (c), of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

HAS ADOPTED THIS DECISION:
Genetically modified organism and unique identifierGenetically modified cotton (Gossypium hirsutum L.) COT102, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier SYN-IR1Ø2–7, in accordance with Regulation (EC) No 65/2004.
AuthorisationThe following products are authorised for the purposes of Article 4(2) and Article 16(2) of Regulation (EC) No 1829/2003, in accordance with the conditions set out in this Decision:
(a) foods and food ingredients containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(b) feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(c) products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 for uses other than those provided for in points (a) and (b), with the exception of cultivation.
Labelling 1.   For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘cotton’.
 2.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying the products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 as referred to in Article 1, with the exception of products referred to in Article 2, point (a).
Method for detectionThe method set out in point (d) of the Annex shall apply for the detection of genetically modified cotton SYN-IR1Ø2–7.
Monitoring for environmental effects 1.   The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.
 2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the format set out in Decision 2009/770/EC.
Community registerThe information set out in the Annex shall be entered in the Community register of genetically modified food and feed, as referred to in Article 28(1) of Regulation (EC) No 1829/2003.
Authorisation holderThe authorisation holder shall be Syngenta Crop Protection AG, Switzerland, represented in the Union by Syngenta Crop Protection NV/SA, Belgium.
ValidityThis Decision shall apply for a period of 10 years from the date of its notification.
AddresseeThis Decision is addressed to Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland, represented in the Union by Syngenta Crop Protection NV/SA, avenue Louise, 489, 1050 Brussels, Belgium.

(a) Applicant and Authorisation holder:

Name: Syngenta Crop Protection AG

Address: Rosentalstrasse 67, CH-4058 Basel, Switzerland
Represented in the Union by: Syngenta Crop Protection NV/SA, avenue Louise, 489, 1050 Brussels, Belgium.

(b) Designation and specification of the products:

(1) foods and food ingredients containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(2) feed containing, consisting of or produced from genetically modified cotton SYN-IR1Ø2–7;

(3) products containing or consisting of genetically modified cotton SYN-IR1Ø2–7 for uses other than those provided for in points (1) and (2), with the exception of cultivation.

The genetically modified cotton SYN-IR1Ø2–7 expresses the Vip3Aa19 gene, which confers resistance to certain lepidopteran pests. In addition, an aph4 gene, conferring hygromycin B resistance, was used as a selection marker in the genetic modification process.

(c) Labelling:

(1) For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organism shall be ‘cotton’.

(2) The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of genetically modified cotton SYN-IR1Ø2–7, with the exception of products referred to in point (b)(1) of this Annex.

(d) Method for detection:

(1) Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7. (2) Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published at https://gmo-crl.jrc.ec.europa.eu/method-validations.

(3) Reference Material: AOCS 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society at https://www.aocs.org/crm.

(e) Unique identifier:

SYN-IR1Ø2–7

(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:

[Biosafety Clearing-House, Record ID number: published in the register of genetically modified food and feed when notified].

(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h) Monitoring plan for environmental effects:

Monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC.

[Link: plan published in the Community register of genetically modified food and feed]

(i) Post-market monitoring requirements for the use of the food for human consumption:

Not required.

Note:

links to relevant documents may need to be modified over the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

Commission Implementing Decision (EU) 2024/2626 of 8 October 2024 recognising under Article 31(2) and (4) of Directive (EU) 2018/2001 that the report contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of wheat, maize and rapeseed in Lithuania

                                January 13, 2026                            

Official Journalof the European Union
ENL series




2024/2626
9.10.2024



(1)
Directive (EU) 2018/2001 requires biofuels, bioliquids, and biomass fuels to save significant greenhouse gas emissions compared to fossil fuels so that they can be counted towards the targets set in that Directive. For this purpose, Article 29(10) sets specific emission savings thresholds for those fuels, and Article 31 regulates how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from the cultivation of agricultural raw materials, it is possible to use typical values under some conditions. These typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.



(2)
On 25 July 2024, Lithuania submitted to the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of wheat, maize and rapeseed typically produced in areas on its territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS), in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council(2). Lithuania asked for the data to be recognised as accurate in line with Article 31(4) of Directive (EU) 2018/2001.



(3)
The Commission assessed the report and found that it contains accurate data for the purposes of measuring the greenhouse gas emissions associated with cultivating wheat, maize and rapeseed typically produced in NUTS 2 regions in Lithuania.



(4)
The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,



NUTS 2 region according to Regulation (EC) No 1059/2003
Soil N2O
Embedded
Fuel Use
Seed
Total

Direct
Indirect
Fertilizer
Neutralization
Pesticide

Capital Region
0,252
0,044
0,151
0,032
0,007
0,096
0,002
0,584

Central and Western Lithuania Region
0,226
0,036
0,128
0,027
0,006
0,082
0,002
0,507



NUTS 2 region according to Regulation (EC) No 1059/2003
Soil N2O
Embedded
Fuel Use
Seed
Total

Direct
Indirect
Fertilizer
Neutralization
Pesticide

Capital Region
0,166
0,029
0,103
0,024
0,004
0,083
0,019
0,428

Central and Western Lithuania Region
0,126
0,022
0,075
0,017
0,003
0,062
0,013
0,318



NUTS 2 region according to Regulation (EC) No 1059/2003
Soil N2O
Embedded
Fuel Use
Seed
Total

Direct
Indirect
Fertilizer
Neutralization
Pesticide

Capital Region
0,192
0,036
0,154
0,027
0,001
0,051
0,002
0,462

Central and Western Lithuania Region
0,165
0,028
0,129
0,023
0,001
0,043
0,001
0,391

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (1), and in particular Article 31(4) thereof,

Whereas:

(1) Directive (EU) 2018/2001 requires biofuels, bioliquids, and biomass fuels to save significant greenhouse gas emissions compared to fossil fuels so that they can be counted towards the targets set in that Directive. For this purpose, Article 29(10) sets specific emission savings thresholds for those fuels, and Article 31 regulates how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from the cultivation of agricultural raw materials, it is possible to use typical values under some conditions. These typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.

(2) On 25 July 2024, Lithuania submitted to the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of wheat, maize and rapeseed typically produced in areas on its territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS), in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council (2). Lithuania asked for the data to be recognised as accurate in line with Article 31(4) of Directive (EU) 2018/2001.

(3) The Commission assessed the report and found that it contains accurate data for the purposes of measuring the greenhouse gas emissions associated with cultivating wheat, maize and rapeseed typically produced in NUTS 2 regions in Lithuania.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,

HAS ADOPTED THIS DECISION:
The report submitted for recognition to the Commission by Lithuania on 25 July 2024 contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of wheat, maize and rapeseed typically produced in regions in NUTS 2 regions in Lithuania, pursuant to Article 31(4) of Directive (EU) 2018/2001. The summary of the report’s data is set out in the Annex.
If the data contained in the report as submitted for recognition to the Commission on 25 July 2024, changes in a way that might affect the accuracy of the data and thereby the basis for this Decision, Lithuania shall notify the Commission of such changes immediately. The Commission shall assess the notified changes to determine whether the report still provides the accurate data for which it is recognised.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall cease to apply on 29 October 2029.
Greenhouse gas emissions arising from the cultivation of rapeseed in the Lithuanian NUTS2 regions (tonne CO2-eq/tonne rapeseed harvested on dry matter basis)NUTS 2 region according to Regulation (EC) No 1059/2003

Soil N2O

Embedded

Fuel Use

Seed

Total

Direct

Indirect

Fertilizer

Neutralization

Pesticide

Capital Region

0,252 

0,044 

0,151 

0,032 

0,007 

0,096 

0,002 

0,584 

Central and Western Lithuania Region

0,226 

0,036 

0,128 

0,027 

0,006 

0,082 

0,002 

0,507 

Greenhouse gas emissions arising from the cultivation of wheat in the Lithuanian NUTS2 regions (tonne CO2-eq/tonne wheat harvested on dry matter basis)

NUTS 2 region according to Regulation (EC) No 1059/2003

Soil N2O

Embedded

Fuel Use

Seed

Total

Direct

Indirect

Fertilizer

Neutralization

Pesticide

Capital Region

0,166 

0,029 

0,103 

0,024 

0,004 

0,083 

0,019 

0,428 

Central and Western Lithuania Region

0,126 

0,022 

0,075 

0,017 

0,003 

0,062 

0,013 

0,318 

Grenhouse gas emissions arising from the cultivation of maize in the Lithuanian NUTS2 regions (tonne CO2-eq/tonne maize harvested on dry matter basis)

NUTS 2 region according to Regulation (EC) No 1059/2003

Soil N2O

Embedded

Fuel Use

Seed

Total

Direct

Indirect

Fertilizer

Neutralization

Pesticide

Capital Region

0,192 

0,036 

0,154 

0,027 

0,001 

0,051 

0,002 

0,462 

Central and Western Lithuania Region

0,165 

0,028 

0,129 

0,023 

0,001 

0,043 

0,001 

0,391 
			

Commission Implementing Decision (EU) 2024/2625 of 8 October 2024 amending Implementing Decision (EU) 2021/1195 as regards harmonised standards for aseptic processing of health care products and clinical performance studies using specimens from human subjects

                                January 13, 2026                            

Official Journalof the European Union
ENL series

2024/2625
9.10.2024

(1)
In accordance with Article 8(1) of Regulation (EU) 2017/746 of the European Parliament and of the Council(2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in theOfficial Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.

(2)
Regulation (EU) 2017/746 replaced Directive 98/79/EC of the European Parliament and of the Council(3)with effect from 26 May 2022.

(3)
By Implementing Decision C(2021) 2406(4), the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for the revision of existing harmonised standards onin vitrodiagnostic medical devices developed in support of Directive 98/79/EC and for the drafting of new harmonised standards in support of Regulation (EU) 2017/746 (the ‘request’).

(4)
On the basis of the request, CEN and Cenelec revised the harmonised standards EN ISO 13408-1:2015 for aseptic processing of health care products, and drafted a new harmonised standard for clinical performance studies using specimens from human subjects, the reference of which are not published in theOfficial Journal of the European Union, in order to take into account the latest technical and scientific progress and the need to support the requirements of Regulation (EU) 2017/746.

(5)
This resulted in the adoption of the harmonised standards EN ISO 13408-1:2024 and EN ISO 20916:2024 (‘the standards’).

(6)
The Commission together with CEN and Cenelec has assessed whether the standards comply with the request.

(7)
The standards satisfy the requirements which they aim to cover, and which are set out in Regulation (EU) 2017/746. It is therefore appropriate to publish the references of the standards in theOfficial Journal of the European Union.

(8)
The Annex to Commission Implementing Decision (EU) 2021/1195(5)lists the references of harmonised standards drafted in support of Regulation (EU) 2017/746.

(9)
In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/746 are listed in one act, the references of the standards should be included in Implementing Decision (EU) 2021/1195.

(10)
Implementing Decision (EU) 2021/1195 should therefore be amended accordingly.

(11)
Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in theOfficial Journal of the European Union. This Decision should therefore enter into force on the day of its publication.

(12)
The harmonised standards adopted in response to standardisation requests may be subject to access to documents requests in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council(6). In its judgment of 5 March 2024Public.Resource.Org and Right to Know v. Commission and Others(7), the Court of Justice of the European Union recognised that there is an overriding public interest, within the meaning of Article 4(2) of Regulation (EC) No 1049/2001, justifying the disclosure of harmonised standards,

No
Reference of the standard

‘14.
EN ISO 13408-1:2024Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)

15.
EN ISO 20916:2024In vitrodiagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)’.

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Regulation (EU) No 1025/2012 of the European Parliament and of the Council of 25 October 2012 on European standardisation, amending Council Directives 89/686/EEC and 93/15/EEC and Directives 94/9/EC, 94/25/EC, 95/16/EC, 97/23/EC, 98/34/EC, 2004/22/EC, 2007/23/EC, 2009/23/EC and 2009/105/EC of the European Parliament and of the Council and repealing Council Decision 87/95/EEC and Decision No 1673/2006/EC of the European Parliament and of the Council (1), and in particular Article 10(6) thereof,

Whereas:

(1) In accordance with Article 8(1) of Regulation (EU) 2017/746 of the European Parliament and of the Council (2), devices that are in conformity with the relevant harmonised standards, or the relevant parts of those standards, the references of which have been published in the Official Journal of the European Union, are to be presumed to be in conformity with the requirements of that Regulation covered by those standards or parts thereof.

(2) Regulation (EU) 2017/746 replaced Directive 98/79/EC of the European Parliament and of the Council (3) with effect from 26 May 2022.

(3) By Implementing Decision C(2021) 2406 (4), the Commission made a request to the European Committee for Standardization (CEN) and the European Committee for Electrotechnical Standardization (Cenelec) for the revision of existing harmonised standards on in vitro diagnostic medical devices developed in support of Directive 98/79/EC and for the drafting of new harmonised standards in support of Regulation (EU) 2017/746 (the ‘request’).

(4) On the basis of the request, CEN and Cenelec revised the harmonised standards EN ISO 13408-1:2015 for aseptic processing of health care products, and drafted a new harmonised standard for clinical performance studies using specimens from human subjects, the reference of which are not published in the Official Journal of the European Union, in order to take into account the latest technical and scientific progress and the need to support the requirements of Regulation (EU) 2017/746.

(5) This resulted in the adoption of the harmonised standards EN ISO 13408-1:2024 and EN ISO 20916:2024 (‘the standards’).

(6) The Commission together with CEN and Cenelec has assessed whether the standards comply with the request.

(7) The standards satisfy the requirements which they aim to cover, and which are set out in Regulation (EU) 2017/746. It is therefore appropriate to publish the references of the standards in the Official Journal of the European Union.

(8) The Annex to Commission Implementing Decision (EU) 2021/1195 (5) lists the references of harmonised standards drafted in support of Regulation (EU) 2017/746.

(9) In order to ensure that the references of harmonised standards drafted in support of Regulation (EU) 2017/746 are listed in one act, the references of the standards should be included in Implementing Decision (EU) 2021/1195.

(10) Implementing Decision (EU) 2021/1195 should therefore be amended accordingly.

(11) Compliance with a harmonised standard confers a presumption of conformity with the corresponding essential requirements set out in Union harmonisation legislation from the date of publication of the reference of such standard in the Official Journal of the European Union. This Decision should therefore enter into force on the day of its publication.

(12) The harmonised standards adopted in response to standardisation requests may be subject to access to documents requests in accordance with Regulation (EC) No 1049/2001 of the European Parliament and of the Council (6). In its judgment of 5 March 2024Public.Resource.Org and Right to Know v. Commission and Others (7), the Court of Justice of the European Union recognised that there is an overriding public interest, within the meaning of Article 4(2) of Regulation (EC) No 1049/2001, justifying the disclosure of harmonised standards,

HAS ADOPTED THIS DECISION:
The Annex to Implementing Decision (EU) 2021/1195 is amended in accordance with the Annex to this Decision.
This Decision shall enter into force on the day of its publication in the Official Journal of the European Union.
In the Annex to Implementing Decision (EU) 2021/1195, the following entries are added:
No

Reference of the standard

‘14. EN ISO 13408-1:2024

Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023) 15. EN ISO 20916:2024

In vitro diagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)’.

Commission Implementing Decision (EU) 2024/2624 of 8 October 2024 recognising under Article 31(2) and (4) of Directive (EU) 2018/2001 that the report contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed in Czechia

                                January 13, 2026                            

Official Journalof the European Union
ENL series




2024/2624
9.10.2024



(1)
Directive (EU) 2018/2001 requires biofuels, bioliquids and biomass fuels to save significant greenhouse gas emissions compared to fossil fuels, so that they can be counted towards the targets set in that Directive. For this purpose, Article 29(10) sets specific emission savings thresholds for those fuels, and Article 31 regulates how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from the cultivation of agricultural raw materials, it is possible to use typical values under some conditions. These typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.



(2)
On 27 June 2024, Czechia submitted to the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed typically produced in areas on its territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS), in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council(2). Czechia asked for the data to be recognised as accurate in line with Article 31(4) of Directive (EU) 2018/2001.



(3)
The Commission assessed the report and found that it contains accurate data for the purposes of measuring the greenhouse gas emissions associated with cultivating rapeseed typically produced in NUTS 2 regions in Czechia.



(4)
The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,



NUTS 2 region according to Regulation (EC) No 1059/2003
Soil N2O
Embedded
Fuel Use
Seed
Total

Direct
Indirect
Fertiliser
Neutralisation
Pesticide




CZ 01 Hl. město Praha
0,1650
0,0114
0,1967
0,0063
0,0055
0,1102
0,0007
0,4958

CZ 02 Střední Čechy
0,1651
0,0128
0,1823
0,0065
0,0056
0,1095
0,0008
0,4826

CZ 03 Jihozápad
0,2537
0,0497
0,1766
0,0108
0,0055
0,1099
0,0008
0,6070

CZ 04 Severozápad
0,2043
0,0319
0,1688
0,0103
0,0049
0,1138
0,0008
0,5348

CZ 05 Severovýchod
0,2908
0,0623
0,1921
0,0116
0,0059
0,1094
0,0008
0,6728

CZ 06 Jihovýchod
0,1805
0,0149
0,1999
0,0138
0,0057
0,1125
0,0008
0,5281

CZ 07 Střední Morava
0,3036
0,0692
0,1821
0,0106
0,0055
0,1069
0,0008
0,6786

CZ 08 Moravskoslezsko
0,3741
0,0998
0,1758
0,0087
0,0046
0,1063
0,0008
0,7701

THE EUROPEAN COMMISSION,

Having regard to the Treaty on the Functioning of the European Union,

Having regard to Directive (EU) 2018/2001 of the European Parliament and of the Council of 11 December 2018 on the promotion of the use of energy from renewable sources (1), and in particular Article 31(4) thereof,

Whereas:

(1) Directive (EU) 2018/2001 requires biofuels, bioliquids and biomass fuels to save significant greenhouse gas emissions compared to fossil fuels, so that they can be counted towards the targets set in that Directive. For this purpose, Article 29(10) sets specific emission savings thresholds for those fuels, and Article 31 regulates how to calculate the greenhouse gas emission savings from their use. When making those calculations, it is possible to use the default values set out in Annexes V and VI to Directive (EU) 2018/2001. Instead of the default values of greenhouse gas emissions from the cultivation of agricultural raw materials, it is possible to use typical values under some conditions. These typical values, representing the average value in a specific area, may be reported to the Commission by Member States or third countries. The typical values may only be used if the Commission recognises them to be accurate.

(2) On 27 June 2024, Czechia submitted to the Commission the final report with data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed typically produced in areas on its territory classified as level 2 in the nomenclature of territorial units for statistics (NUTS), in accordance with Regulation (EC) No 1059/2003 of the European Parliament and of the Council (2). Czechia asked for the data to be recognised as accurate in line with Article 31(4) of Directive (EU) 2018/2001.

(3) The Commission assessed the report and found that it contains accurate data for the purposes of measuring the greenhouse gas emissions associated with cultivating rapeseed typically produced in NUTS 2 regions in Czechia.

(4) The measures provided for in this Decision are in accordance with the opinion of the Committee on the Sustainability of Biofuels, Bioliquids and Biomass Fuels,

HAS ADOPTED THIS DECISION:
The report submitted for recognition to the Commission by Czechia on 27 June 2024 contains accurate data for the purposes of measuring the greenhouse gas emissions associated with the cultivation of rapeseed typically produced in regions in NUTS 2 regions in Czechia, pursuant to Article 31(4) of Directive (EU) 2018/2001. The summary of the report’s data is set out in the Annex.
If the data contained in the report, as submitted for recognition to the Commission on 27 June 2024, changes in a way that might affect the accuracy of the data and thereby the basis for this Decision, Czechia shall notify the Commission of such changes immediately. The Commission shall assess the notified changes to determine whether the report still provides the accurate data for which it is recognised.
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

It shall cease to apply on 29 October 2029.
NUTS 2 region according to Regulation (EC) No 1059/2003

Soil N2O

Embedded

Fuel Use

Seed

Total

Direct

Indirect

Fertiliser

Neutralisation

Pesticide
CZ 01 Hl. město Praha

0,1650 

0,0114 

0,1967 

0,0063 

0,0055 

0,1102 

0,0007 

0,4958 

CZ 02 Střední Čechy

0,1651 

0,0128 

0,1823 

0,0065 

0,0056 

0,1095 

0,0008 

0,4826 

CZ 03 Jihozápad

0,2537 

0,0497 

0,1766 

0,0108 

0,0055 

0,1099 

0,0008 

0,6070 

CZ 04 Severozápad

0,2043 

0,0319 

0,1688 

0,0103 

0,0049 

0,1138 

0,0008 

0,5348 

CZ 05 Severovýchod

0,2908 

0,0623 

0,1921 

0,0116 

0,0059 

0,1094 

0,0008 

0,6728 

CZ 06 Jihovýchod

0,1805 

0,0149 

0,1999 

0,0138 

0,0057 

0,1125 

0,0008 

0,5281 

CZ 07 Střední Morava

0,3036 

0,0692 

0,1821 

0,0106 

0,0055 

0,1069 

0,0008 

0,6786 

CZ 08 Moravskoslezsko

0,3741 

0,0998 

0,1758 

0,0087 

0,0046 

0,1063 

0,0008 

0,7701 
			

No	Reference of the standard
1.	EN 1397:2021Heat exchangers – Hydronic room fan coil units – Test procedures for establishing the performance

No	Reference of the standard
‘26.	EN ISO 13408-1:2024Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)’.

	Soil N2O	Crop residue	Embedded	Fuel incl. drying	Fertiliser acidification	Seed	Total
Direct	Indirect	Fertiliser	Pesticide	Lime
DK1 Hovedstaden	244,3	28,6	50,5	147,7	2,1	2,4	48,4	45,9	0,5	570,5
DK2 Sjælland	235,0	28,7	48,6	129,5	2,0	2,3	48,5	44,2	0,5	539,4
DK3 Syddanmark	248,8	37,5	44,1	98,2	2,1	2,4	53,2	46,8	0,5	533,6
DK4 Midtjylland	243,7	35,2	45,4	103,5	2,0	2,4	52,1	45,8	0,5	530,6
DK5 Nordjylland	271,0	39,8	45,6	96,6	2,1	2,5	56,1	51,0	0,5	565,2

(a)	Applicants and authorisation holders:(1)Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and(2)Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States;represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.	(1)	Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and	(2)	Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States;represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.
(1)	Name: Bayer CropScience LPAddress: 800 N. Lindbergh Boulevard, St Louis, MO, 63167, United States;represented in the Union by Bayer Agriculture B.V., Scheldelaan 460, 2040, Antwerp, Belgium;and
(2)	Name: Corteva Agriscience LLCAddress: 9330 Zionsville Road, Indianapolis, IN, 46268-1054, United States;represented in the Union by Corteva Agriscience Belgium B.V., rue Montoyer 25, 1000 Brussels, Belgium.

(b)	Designation and specification of the products:(1)foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);(2)feed containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);(3)products containing or consisting of genetically modified maize (Zea maysL.) referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.The genetically modified maize MON-89Ø34-3 expresses thecry1A.105andcry2Ab2genes, which confer protection against certain lepidopteran pests.The genetically modified maize DAS-Ø15Ø7-1 expresses thecry1Fgene, which confers protection against certain lepidopteran pests, and thepatgene, which confers tolerance to herbicides containing glufosinate-ammonium.The genetically modified maize MON-88Ø17-3 expresses thecry3Bb1gene, which confers protection against certain coleopteran pests, and the CP4epspsgene, which confers tolerance to glyphosate-based herbicides.The genetically modified maize DAS-59122-7 expresses thecry34Ab1andcry35Ab1genes, which confer resistance to certain coleopteran pests, and thepatgene, which confers tolerance to herbicides containing glufosinate-ammonium.	(1)	foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);	(2)	feed containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);	(3)	products containing or consisting of genetically modified maize (Zea maysL.) referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.
(1)	foods and food ingredients containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);
(2)	feed containing, consisting of or produced from genetically modified maize (Zea maysL.) referred to in point (e);
(3)	products containing or consisting of genetically modified maize (Zea maysL.) referred to in point (e) for uses other than those provided for in points (1) and (2), with the exception of cultivation.

(c)	Labelling:(1)For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’;(2)The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize specified in point (e), with the exception of products referred to in point (b)(1).	(1)	For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’;	(2)	The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize specified in point (e), with the exception of products referred to in point (b)(1).
(1)	For the purposes of the labelling requirements laid down in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, and in Article 4(6) of Regulation (EC) No 1830/2003, the name of the organisms shall be ‘maize’;
(2)	The words ‘not for cultivation’ shall appear on the label of and in documents accompanying the products containing or consisting of the genetically modified maize specified in point (e), with the exception of products referred to in point (b)(1).

(d)	Method for detection:(1)The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;(2)Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;(3)Reference Material: AOCS 0906-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.	(1)	The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;	(2)	Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;	(3)	Reference Material: AOCS 0906-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.
(1)	The quantitative event-specific PCR detection methods are those individually validated for genetically modified maize events MON-89Ø34-3, DAS-Ø15Ø7-1, MON-88Ø17-3 and DAS-59122-7, and further verified on maize stack MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7;
(2)	Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttp://gmo-crl.jrc.ec.europa.eu/StatusOfDossiers.aspx;
(3)	Reference Material: AOCS 0906-E (for MON-89Ø34-3), AOCS 0406-D (for MON-88Ø17-3) and AOCS 0406-A (for their non-GM counterpart) are accessible via the American Oil Chemists Society (AOCS), athttps://www.aocs.org/crm?SSO=True. ERM®-BF418 (for DAS-Ø15Ø7-1) and ERM®-BF424 (for DAS-59122-7) are accessible via the Joint Research Centre (JRC) of the European Commission, athttps://crm.jrc.ec.europa.eu/.

(i)	Post-market monitoring requirements for the use of the food for human consumption:Not required.Note:links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.	Note:	links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.
Note:	links to relevant documents may need to be modified over time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

(d)	Method for detection:(1)Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7.(2)Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttps://gmo-crl.jrc.ec.europa.eu/method-validations.(3)Reference Material: AOCS 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.	(1)	Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7.	(2)	Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttps://gmo-crl.jrc.ec.europa.eu/method-validations.	(3)	Reference Material: AOCS 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.
(1)	Event specific real-time PCR based method for the quantification of genetically modified cotton SYN-IR1Ø2–7.
(2)	Validated by the EU reference laboratory established under Regulation (EC) No 1829/2003, published athttps://gmo-crl.jrc.ec.europa.eu/method-validations.
(3)	Reference Material: AOCS 1012-C2 and AOCS 1012-A2 (for the non-GM counterpart) are accessible via the American Oil Chemists Society athttps://www.aocs.org/crm.

NUTS 2 region according to Regulation (EC) No 1059/2003	Soil N2O	Embedded	Fuel Use	Seed	Total
Direct	Indirect	Fertilizer	Neutralization	Pesticide
Capital Region	0,252	0,044	0,151	0,032	0,007	0,096	0,002	0,584
Central and Western Lithuania Region	0,226	0,036	0,128	0,027	0,006	0,082	0,002	0,507

No	Reference of the standard
‘14.	EN ISO 13408-1:2024Aseptic processing of health care products – Part 1: General requirements (ISO 13408-1:2023)
15.	EN ISO 20916:2024In vitrodiagnostic medical devices – Clinical performance studies using specimens from human subjects – Good study practice (ISO 20916:2019)’.