Pending: 32015D0693

January 15, 2026
30.4.2015 EN Official Journal of the European Union L 112/48
(1) Food additives, feed materials and feed additives produced from genetically modified cotton MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(2) On 17 April 2007, Monsanto Europe SA submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 1445 (‘the application’).
(3) On 16 June 2011, Monsanto Europe SA requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 1445, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.
(4) The scope of the application as extended covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 16 December 2011, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 1445, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 1445.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be renewed for the products produced from genetically modified cotton MON 1445.
(9) A unique identifier should be assigned to each genetically modified organism as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 1445.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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 Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
(a) food produced from MON-Ø1445-2 cotton;
(b) feed produced from MON-Ø1445-2 cotton.
Name : Monsanto Europe SA
Address : Avenue de Tervuren 270-272, 1150 Brussels, Belgium
1. Food produced from MON-Ø1445-2 cotton.
2. Feed produced from MON-Ø1445-2 cotton.
1. Event-specific real-time PCR based method for the quantification of MON-Ø1445-2 cotton.
2. Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
3. Reference Material: AOCS 0804-B and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
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,
(1) Food additives, feed materials and feed additives produced from genetically modified cotton MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(2) On 17 April 2007, Monsanto Europe SA submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 1445 (‘the application’).
(3) On 16 June 2011, Monsanto Europe SA requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 1445, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.
(4) The scope of the application as extended covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 16 December 2011, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 1445, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 1445.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be renewed for the products produced from genetically modified cotton MON 1445.
(9) A unique identifier should be assigned to each genetically modified organism as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 1445.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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 Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 1445, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-Ø1445-2, as provided for in Regulation (EC) No 65/2004.

Renewal of authorisation
Article 2
The authorisation for the placing on the market of the following products is renewed for the purposes of Articles 11 and 23 of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
food produced from MON-Ø1445-2 cotton;
(b)
feed produced from MON-Ø1445-2 cotton.

Labelling
Article 3
For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘cotton’.

Community register
Article 4
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 5
The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States of America.

Validity
Article 6
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 7
This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

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,
(1) Food additives, feed materials and feed additives produced from genetically modified cotton MON 1445 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(2) On 17 April 2007, Monsanto Europe SA submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 1445 (‘the application’).
(3) On 16 June 2011, Monsanto Europe SA requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 1445, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.
(4) The scope of the application as extended covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 16 December 2011, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 1445, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 1445 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 1445.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be renewed for the products produced from genetically modified cotton MON 1445.
(9) A unique identifier should be assigned to each genetically modified organism as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 1445.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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 Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 1445, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-Ø1445-2, as provided for in Regulation (EC) No 65/2004.

Renewal of authorisation

The authorisation for the placing on the market of the following products is renewed for the purposes of Articles 11 and 23 of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
food produced from MON-Ø1445-2 cotton;
(b)
feed produced from MON-Ø1445-2 cotton.

Labelling

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

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States of America.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

(a)   Applicant and authorisation holder

ANNEX
Name | : | Monsanto Europe SA
Address | : | Avenue de Tervuren 270-272, 1150 Brussels, BelgiumOn behalf of Monsanto Company, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America.
(b) Designation and specification of the products

1. | Food produced from MON-Ø1445-2 cotton.
2. | Feed produced from MON-Ø1445-2 cotton.The genetically modified MON-Ø1445-2 cotton, as described in the application, expresses the CP4 EPSPS protein which confers tolerance to glyphosate-containing herbicides. AnnptII gene, conferring kanamycin and neomycin resistance, andaadA gene, conferring spectinomycin and streptomycin resistance, were used as selective markers in the genetic modification process.
(c) Labelling
For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘cotton’.
(d) Method for detection

1. | Event-specific real-time PCR based method for the quantification of MON-Ø1445-2 cotton.
2. | Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
3. | Reference Material: AOCS 0804-B and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier
MON-Ø1445-2
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Not applicable.
(g) Conditions or restrictions on the placing on the market, use or handling of the products
Not required.
(h) Monitoring plan for environmental effects
Not required.
(i) Post-market monitoring requirements for the use of the food for human consumption
Not required.

Pending: 32015D0689

January 15, 2026
30.4.2015 EN Official Journal of the European Union L 112/31
(1) Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(2) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 (‘the application’).
(3) On 16 June 2011, Monsanto Europe S.A. requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 531, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.
(4) The scope of the application as extended covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 16 September 2011, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be renewed for the products produced from genetically modified cotton MON 531.
(9) A unique identifier should be assigned to each genetically modified organism as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
(a) food produced from MON-ØØ531-6 cotton;
(b) feed produced from MON-ØØ531-6 cotton.
Name : Monsanto Europe S.A.
Address : Avenue de Tervuren 270-272, 1150 Brussels — Belgium
1. Food produced from MON-ØØ531-6 cotton.
2. Feed produced from MON-ØØ531-6 cotton.
1. Event specific real-time PCR based method for the quantification of MON-ØØ531-6 cotton.
2. Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
3. Reference Material: AOCS 0804-C and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
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,
(1) Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(2) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 (‘the application’).
(3) On 16 June 2011, Monsanto Europe S.A. requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 531, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.
(4) The scope of the application as extended covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 16 September 2011, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be renewed for the products produced from genetically modified cotton MON 531.
(9) A unique identifier should be assigned to each genetically modified organism as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 531, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ531-6, as provided for in Regulation (EC) No 65/2004.

Renewal of authorisation
Article 2
The authorisation for the placing on the market of the following products is renewed for the purposes of Articles 11 and 23 of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
food produced from MON-ØØ531-6 cotton;
(b)
feed produced from MON-ØØ531-6 cotton.

Labelling
Article 3
For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘cotton’.

Community register
Article 4
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 5
The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity
Article 6
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 7
This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

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,
(1) Food additives, feed materials and feed additives produced from genetically modified cotton MON 531 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(2) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 531 (‘the application’).
(3) On 16 June 2011, Monsanto Europe S.A. requested an extension of the scope of the application to include food cottonseed oil produced from genetically modified cotton MON 531, which was previously notified as an existing product in accordance with Article 8(1)(a) of Regulation (EC) No 1829/2003.
(4) The scope of the application as extended covers the full range of current commercial uses of food and feed produced from cotton as defined in Articles 3(1)(c) and 15(1)(c) of Regulation (EC) No 1829/2003.
(5) On 16 September 2011, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(2)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that products derived from genetically modified cotton MON 531, as described in the application, are as safe as products derived from its conventional counterpart, in the context of their intended uses.
(6) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 531 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 531.
(7) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) Consequently, authorisation should be renewed for the products produced from genetically modified cotton MON 531.
(9) A unique identifier should be assigned to each genetically modified organism as provided for in Commission Regulation (EC) No 65/2004(3).
(10) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed produced from genetically modified cotton MON 531.
(11) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(4).
(13) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 531, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ531-6, as provided for in Regulation (EC) No 65/2004.

Renewal of authorisation

The authorisation for the placing on the market of the following products is renewed for the purposes of Articles 11 and 23 of Regulation (EC) No 1829/2003 in accordance with the conditions set out in this Decision:
(a)
food produced from MON-ØØ531-6 cotton;
(b)
feed produced from MON-ØØ531-6 cotton.

Labelling

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

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

(a)   Applicant and authorisation holder

ANNEX
Name | : | Monsanto Europe S.A.
Address | : | Avenue de Tervuren 270-272, 1150 Brussels — BelgiumOn behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.
(b) Designation and specification of the products

1. | Food produced from MON-ØØ531-6 cotton.
2. | Feed produced from MON-ØØ531-6 cotton.The genetically modified MON-ØØ531-6 cotton, as described in the application, expresses the Cry1Ac protein which confers resistance to lepidopteran pests. AnnptII gene, conferring kanamycin and neomycin resistance, andaadA gene, conferring spectinomycin and streptomycin resistance, were used as selective markers in the genetic modification process.
(c) Labelling
For the purposes of the labelling requirements laid down in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, the ‘name of the organism’ shall be ‘cotton’.
(d) Method for detection

1. | Event specific real-time PCR based method for the quantification of MON-ØØ531-6 cotton.
2. | Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
3. | Reference Material: AOCS 0804-C and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier
MON-ØØ531-6
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Not applicable.
(g) Conditions or restrictions on the placing on the market, use or handling of the products
Not required.
(h) Monitoring plan for environmental effects
Not required.
(i) Post-market monitoring requirements for the use of the food for human consumption
Not required.

Pending: 32015D0688

January 15, 2026
30.4.2015 EN Official Journal of the European Union L 112/26
(1) On 28 February 2007, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 88913 cotton (‘the application’).
(2) The application also covers the placing on the market of MON 88913 cotton in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.
(3) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 29 July 2013, the European Food Safety Authority (‘EFSA’) gave an opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It could not reach an overall conclusion on the MON 88913 cotton due to the use by the applicant of an outdated toxin database for the bioinformatic analyses.
(5) On 18 October 2013, the applicant provided new bioinformatic analyses using updated databases.
(6) On 13 March 2014, EFSA published a statement complementing its scientific opinion(4), taking into account those updated bioinformatic analyses, and concluded that MON 88913 cotton assessed in the initial scientific opinion and in the supplementary bioinformatic dataset is as safe and nutritious as its conventional counterpart and commercial cotton varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.
(7) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(9) Taking into account those considerations, authorisation should be granted to the products.
(10) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(5).
(11) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 88913 cotton. However, in order to ensure the use of the products containing or consisting of MON 88913 cotton within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(12) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(6)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(13) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(7). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.
(14) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(15) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(8).
(16) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act 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 MON-88913-8 cotton;
(b) feed containing, consisting of, or produced from MON-88913-8 cotton;
(c) MON-88913-8 cotton in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.
Name : Monsanto Europe S.A.
Address : Avenue de Tervuren 270-272, 1150 Brussels — Belgium
(1) foods and food ingredients containing, consisting of, or produced from MON-88913-8 cotton;
(2) feed containing, consisting of, or produced from MON-88913-8 cotton;
(3) MON-88913-8 cotton in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
(1) For the purposes of the labelling requirements laid down in Articles 13(1) and 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 products containing or consisting of MON-88913-8 cotton with the exception of products referred to in point (a) of Article 2.
(1) Event specific real-time PCR based method for the quantification of MON-88913-8 cotton;
(2) Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from cotton leaves, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
(3) Reference Material: AOCS 0906-D and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
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 7(3) and 19(3) thereof,
(1) On 28 February 2007, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 88913 cotton (‘the application’).
(2) The application also covers the placing on the market of MON 88913 cotton in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.
(3) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 29 July 2013, the European Food Safety Authority (‘EFSA’) gave an opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It could not reach an overall conclusion on the MON 88913 cotton due to the use by the applicant of an outdated toxin database for the bioinformatic analyses.
(5) On 18 October 2013, the applicant provided new bioinformatic analyses using updated databases.
(6) On 13 March 2014, EFSA published a statement complementing its scientific opinion(4), taking into account those updated bioinformatic analyses, and concluded that MON 88913 cotton assessed in the initial scientific opinion and in the supplementary bioinformatic dataset is as safe and nutritious as its conventional counterpart and commercial cotton varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.
(7) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(9) Taking into account those considerations, authorisation should be granted to the products.
(10) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(5).
(11) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 88913 cotton. However, in order to ensure the use of the products containing or consisting of MON 88913 cotton within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(12) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(6)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(13) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(7). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.
(14) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(15) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(8).
(16) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 88913, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-88913-8, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The following products are authorised for the purposes of Articles 4(2) and 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 MON-88913-8 cotton;
(b)
feed containing, consisting of, or produced from MON-88913-8 cotton;
(c)
MON-88913-8 cotton in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling
Article 3
1. For the purposes of the labelling requirements laid down in Articles 13(1) and 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 and in the documents accompanying the products containing or consisting of MON-88913-8 cotton with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects
Article 4
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 Decision 2009/770/EC.

Community register
Article 5
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 6
The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States.

Validity
Article 7
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 8
This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

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 7(3) and 19(3) thereof,
(1) On 28 February 2007, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 88913 cotton (‘the application’).
(2) The application also covers the placing on the market of MON 88913 cotton in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.
(3) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 29 July 2013, the European Food Safety Authority (‘EFSA’) gave an opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It could not reach an overall conclusion on the MON 88913 cotton due to the use by the applicant of an outdated toxin database for the bioinformatic analyses.
(5) On 18 October 2013, the applicant provided new bioinformatic analyses using updated databases.
(6) On 13 March 2014, EFSA published a statement complementing its scientific opinion(4), taking into account those updated bioinformatic analyses, and concluded that MON 88913 cotton assessed in the initial scientific opinion and in the supplementary bioinformatic dataset is as safe and nutritious as its conventional counterpart and commercial cotton varieties with respect to potential effects on human and animal health and the environment in the context of its intended uses.
(7) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(8) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(9) Taking into account those considerations, authorisation should be granted to the products.
(10) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(5).
(11) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 88913 cotton. However, in order to ensure the use of the products containing or consisting of MON 88913 cotton within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(12) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(6)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(13) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(7). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.
(14) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(15) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(8).
(16) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 88913, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-88913-8, as provided for in Regulation (EC) No 65/2004.

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 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 MON-88913-8 cotton;
(b)
feed containing, consisting of, or produced from MON-88913-8 cotton;
(c)
MON-88913-8 cotton in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling

1. For the purposes of the labelling requirements laid down in Articles 13(1) and 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 and in the documents accompanying the products containing or consisting of MON-88913-8 cotton with the exception of products referred to in point (a) of Article 2.

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 Decision 2009/770/EC.

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

(a)   Applicant and Authorisation holder:

ANNEX
Name | : | Monsanto Europe S.A.
Address | : | Avenue de Tervuren 270-272, 1150 Brussels — BelgiumOn behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States.
(b) Designation and specification of the products:

(1) | foods and food ingredients containing, consisting of, or produced from MON-88913-8 cotton;
(2) | feed containing, consisting of, or produced from MON-88913-8 cotton;
(3) | MON-88913-8 cotton in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.The genetically modified MON-88913-8 cotton, as described in the application, expresses the CP4 5-enolpyruvylshikimate-3-phosphate synthase (CP4 EPSPS) which confers tolerance to glyphosate-based herbicides.
(c) Labelling:

(1) | For the purposes of the labelling requirements laid down in Articles 13(1) and 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 products containing or consisting of MON-88913-8 cotton with the exception of products referred to in point (a) of Article 2.(d) Method for detection:

(1) | Event specific real-time PCR based method for the quantification of MON-88913-8 cotton;
(2) | Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from cotton leaves, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
(3) | Reference Material: AOCS 0906-D and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier:
MON-88913-8
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
Biosafety Clearing-House, Record ID: see [to be completed 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 conforming with Annex VII to Directive 2001/18/EC.
[Link:plan published on the internet]
(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.

Pending: 32015D0687

January 15, 2026
30.4.2015 EN Official Journal of the European Union L 112/22
(1) On 31 August 2011, Monsanto Europe S.A. submitted to the competent authority of Belgium an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 88302 oilseed rape (‘the application’).
(2) The application also covers the placing on the market of MON 88302 oilseed rape in products consisting of it or containing it for any other uses than food and feed as any other oilseed rape, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 17 June 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 88302 oilseed rape is as safe as its conventional counterpart and non-GM oilseed rape commercial varieties and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the application.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Taking into account those considerations, authorisation should be granted to the products.
(8) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(9) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 88302 oilseed rape. However, in order to ensure the use of the products containing or consisting of MON 88302 oilseed rape within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(10) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(11) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.
(12) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(14) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act 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 MON-883Ø2-9 oilseed rape;
(b) feed containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;
(c) MON-883Ø2-9 oilseed rape in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.
Name : Monsanto Europe S.A.
Address : Avenue de Tervuren 270-272, B-1150 Brussels — Belgium
1. foods and food ingredients containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;
2. feed containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;
3. MON-883Ø2-9 oilseed rape in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
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 ‘oilseed rape’;
2. The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-883Ø2-9 oilseed rape with the exception of products referred to in point (a) of Article 2.
1. Event specific real-time PCR based method for the quantification of MON-883Ø2-9 oilseed rape;
2. Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from oilseed rape seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx;
3. Reference Material: AOCS 1011-A and AOCS 0304-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm.
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,
(1) On 31 August 2011, Monsanto Europe S.A. submitted to the competent authority of Belgium an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 88302 oilseed rape (‘the application’).
(2) The application also covers the placing on the market of MON 88302 oilseed rape in products consisting of it or containing it for any other uses than food and feed as any other oilseed rape, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 17 June 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 88302 oilseed rape is as safe as its conventional counterpart and non-GM oilseed rape commercial varieties and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the application.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Taking into account those considerations, authorisation should be granted to the products.
(8) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(9) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 88302 oilseed rape. However, in order to ensure the use of the products containing or consisting of MON 88302 oilseed rape within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(10) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(11) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.
(12) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(14) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified oilseed rape (Brassica napusL.) MON 88302, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-883Ø2-9, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The 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 MON-883Ø2-9 oilseed rape;
(b)
feed containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;
(c)
MON-883Ø2-9 oilseed rape in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling
Article 3
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 ‘oilseed rape’.
2. The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-883Ø2-9 oilseed rape with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects
Article 4
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 Decision 2009/770/EC.

Community register
Article 5
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 6
The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States.

Validity
Article 7
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 8
This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels, Belgium.

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,
(1) On 31 August 2011, Monsanto Europe S.A. submitted to the competent authority of Belgium an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 88302 oilseed rape (‘the application’).
(2) The application also covers the placing on the market of MON 88302 oilseed rape in products consisting of it or containing it for any other uses than food and feed as any other oilseed rape, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 17 June 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 88302 oilseed rape is as safe as its conventional counterpart and non-GM oilseed rape commercial varieties and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the application.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) Taking into account those considerations, authorisation should be granted to the products.
(8) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(9) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003 appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 88302 oilseed rape. However, in order to ensure the use of the products containing or consisting of MON 88302 oilseed rape within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(10) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(11) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or of specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.
(12) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(14) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time-limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified oilseed rape (Brassica napusL.) MON 88302, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-883Ø2-9, as provided for in Regulation (EC) No 65/2004.

Authorisation

The 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 MON-883Ø2-9 oilseed rape;
(b)
feed containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;
(c)
MON-883Ø2-9 oilseed rape in products containing it or consisting of it for any other use than (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 ‘oilseed rape’.
2. The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-883Ø2-9 oilseed rape with the exception of products referred to in point (a) of Article 2.

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 Decision 2009/770/EC.

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels, Belgium.

(a)   Applicant and Authorisation holder:

ANNEX
Name | : | Monsanto Europe S.A.
Address | : | Avenue de Tervuren 270-272, B-1150 Brussels — BelgiumOn behalf of Monsanto Company, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167 — United States.
(b) Designation and specification of the products:

1. | foods and food ingredients containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;
2. | feed containing, consisting of, or produced from MON-883Ø2-9 oilseed rape;
3. | MON-883Ø2-9 oilseed rape in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.The genetically modified MON-883Ø2-9 oilseed rape, as described in the application, expresses the CP4 5-enolpyruvyl-shikimate-3-phosphate synthase (CP4 EPSPS) protein which confers 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 ‘oilseed rape’;
2. | The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of MON-883Ø2-9 oilseed rape with the exception of products referred to in point (a) of Article 2.(d) Method for detection:

1. | Event specific real-time PCR based method for the quantification of MON-883Ø2-9 oilseed rape;
2. | Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from oilseed rape seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx;
3. | Reference Material: AOCS 1011-A and AOCS 0304-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm.(e) Unique identifier:
MON-883Ø2-9
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
Biosafety Clearing-House, Record ID: see [to be completed 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 conforming with Annex VII to Directive 2001/18/EC.
[Link:plan published on the internet]
(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.

Pending: 32015D0686

January 15, 2026
30.4.2015 EN Official Journal of the European Union L 112/16
(1) On 14 September 2009, Monsanto Europe SA submitted to the competent authority of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87769 soybean (‘the application’).
(2) The application also covers the placing on the market of MON 87769 soybean in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 16 May 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 87769 soybean, as described in the application, is as safe as its conventional counterpart and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the application.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
(8) Taking into account those considerations, authorisation should be granted to the products.
(9) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(10) Food, food ingredients and feed containing, consisting of, or produced from soybean MON 87769 should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2)(a) and (b) of Regulation (EC) No 1829/2003.
(11) On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87769 soybean and derived oil has been changed in relation to the conventional counterpart, specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c). This specific labelling should ensure informed choice without misleading the consumers.
(12) In order to ensure the use of the products containing or consisting of MON 87769 soybean within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(13) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(14) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.
(15) The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(18) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act 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 MON-87769-7 soybean;
(b) feed containing, consisting of, or produced from MON-87769-7 soybean;
(c) MON-87769-7 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.
Name : Monsanto Europe SA
Address : Avenue de Tervuren 270-272, 1150 Brussels, Belgium
1. foods and food ingredients containing, consisting of, or produced from MON-87769-7 soybean;
2. feed containing, consisting of, or produced from MON-87769-7 soybean;
3. MON-87769-7 soybean in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
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 ‘soybean’.
2. For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with stearidonic acid’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
3. The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-87769-7 soybean with the exception of products referred to in point (a) of Article 2.
1. Event-specific real-time PCR based method for the quantification of MON-87769-7 soybean.
2. Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from soybean seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
3. Reference Material: AOCS 0809-B and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
1. The authorisation holder shall collect the following information:(i)quantities of MON-87769-7 soybean oil and MON-87769-7 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)in case of import of products referred to in point (i), results of searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed;(iii)in case of import of products referred to in point (i), data on the different categories of food and feed uses of MON-87769-7 oil in the EU. (i) quantities of MON-87769-7 soybean oil and MON-87769-7 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food; (ii) in case of import of products referred to in point (i), results of searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed; (iii) in case of import of products referred to in point (i), data on the different categories of food and feed uses of MON-87769-7 oil in the EU.
(i) quantities of MON-87769-7 soybean oil and MON-87769-7 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii) in case of import of products referred to in point (i), results of searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed;
(iii) in case of import of products referred to in point (i), data on the different categories of food and feed uses of MON-87769-7 oil in the EU.
(i) quantities of MON-87769-7 soybean oil and MON-87769-7 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii) in case of import of products referred to in point (i), results of searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed;
(iii) in case of import of products referred to in point (i), data on the different categories of food and feed uses of MON-87769-7 oil in the EU.
2. The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.
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,
(1) On 14 September 2009, Monsanto Europe SA submitted to the competent authority of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87769 soybean (‘the application’).
(2) The application also covers the placing on the market of MON 87769 soybean in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 16 May 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 87769 soybean, as described in the application, is as safe as its conventional counterpart and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the application.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
(8) Taking into account those considerations, authorisation should be granted to the products.
(9) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(10) Food, food ingredients and feed containing, consisting of, or produced from soybean MON 87769 should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2)(a) and (b) of Regulation (EC) No 1829/2003.
(11) On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87769 soybean and derived oil has been changed in relation to the conventional counterpart, specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c). This specific labelling should ensure informed choice without misleading the consumers.
(12) In order to ensure the use of the products containing or consisting of MON 87769 soybean within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(13) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(14) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.
(15) The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(18) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified soybean (Glycine max(L.) Merr.) MON 87769, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-87769-7, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The 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 MON-87769-7 soybean;
(b)
feed containing, consisting of, or produced from MON-87769-7 soybean;
(c)
MON-87769-7 soybean in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling
Article 3
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 ‘soybean’.
2. For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with stearidonic acid’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
3. The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-87769-7 soybean with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects
Article 4
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 Decision 2009/770/EC.

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003
Article 5
1. The authorisation holder shall ensure that the post-market monitoring plan of the MON-87769-7 soybean oil, as set out in point (g) 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 post-market monitoring plan for the duration of the authorisation.

Community register
Article 6
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 7
The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States.

Validity
Article 8
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 9
This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

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,
(1) On 14 September 2009, Monsanto Europe SA submitted to the competent authority of the United Kingdom an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87769 soybean (‘the application’).
(2) The application also covers the placing on the market of MON 87769 soybean in products consisting of it or containing it for any other uses than food and feed as any other soybean, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 16 May 2014, the European Food Safety Authority (‘EFSA’) gave a favourable opinion(3)in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 87769 soybean, as described in the application, is as safe as its conventional counterpart and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the application.
(5) In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.
(6) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(7) In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.
(8) Taking into account those considerations, authorisation should be granted to the products.
(9) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(10) Food, food ingredients and feed containing, consisting of, or produced from soybean MON 87769 should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2)(a) and (b) of Regulation (EC) No 1829/2003.
(11) On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87769 soybean and derived oil has been changed in relation to the conventional counterpart, specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c). This specific labelling should ensure informed choice without misleading the consumers.
(12) In order to ensure the use of the products containing or consisting of MON 87769 soybean within the limits of the authorisation provided for by this Decision, the labelling of these products, with the exception of food products, should be complemented by a clear indication that the products in question must not be used for cultivation.
(13) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(14) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.
(15) The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(18) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified soybean (Glycine max(L.) Merr.) MON 87769, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-87769-7, as provided for in Regulation (EC) No 65/2004.

Authorisation

The 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 MON-87769-7 soybean;
(b)
feed containing, consisting of, or produced from MON-87769-7 soybean;
(c)
MON-87769-7 soybean in products containing it or consisting of it for any other use than (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 ‘soybean’.
2. For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with stearidonic acid’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
3. The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-87769-7 soybean with the exception of products referred to in point (a) of Article 2.

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 Decision 2009/770/EC.

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1. The authorisation holder shall ensure that the post-market monitoring plan of the MON-87769-7 soybean oil, as set out in point (g) 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 post-market monitoring plan for the duration of the authorisation.

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

(a)   Applicant and authorisation holder:

ANNEX
Name | : | Monsanto Europe SA
Address | : | Avenue de Tervuren 270-272, 1150 Brussels, BelgiumOn behalf of Monsanto Company, 800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States.
(b) Designation and specification of the products:

1. | foods and food ingredients containing, consisting of, or produced from MON-87769-7 soybean;
2. | feed containing, consisting of, or produced from MON-87769-7 soybean;
3. | MON-87769-7 soybean in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.The genetically modified MON-87769-7 soybean, as described in the application, expresses Δ15 desaturase which results in conversion of linoleic acid to α-linolenic acid and Δ6 desaturase which results in conversion of α-linolenic acid to stearidonic acid (SDA). SDA is a normal intermediate in the formation of the long-chain omega-3 polyunsaturated fatty acids.
(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 ‘soybean’.
2. | For the purposes of the labelling requirements laid down in Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003, the words ‘with stearidonic acid’ shall appear after the name of the organism on the label or, where appropriate, in the documents accompanying the products.
3. | The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of MON-87769-7 soybean with the exception of products referred to in point (a) of Article 2.(d) Method for detection:

1. | Event-specific real-time PCR based method for the quantification of MON-87769-7 soybean.
2. | Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from soybean seeds, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
3. | Reference Material: AOCS 0809-B and AOCS 0906-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier:
MON-87769-7
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity:
Biosafety Clearing-House, Record ID: see (to be completed when notified).
(g) Conditions or restrictions on the placing on the market, use or handling of the products:

Post-market monitoring in accordance with Article 6(5)(e) of Regulation (EC) No 1829/2003

1. | The authorisation holder shall collect the following information:(i)quantities of MON-87769-7 soybean oil and MON-87769-7 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;(ii)in case of import of products referred to in point (i), results of searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed;(iii)in case of import of products referred to in point (i), data on the different categories of food and feed uses of MON-87769-7 oil in the EU. | (i) | quantities of MON-87769-7 soybean oil and MON-87769-7 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food; | (ii) | in case of import of products referred to in point (i), results of searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed; | (iii) | in case of import of products referred to in point (i), data on the different categories of food and feed uses of MON-87769-7 oil in the EU.
(i) | quantities of MON-87769-7 soybean oil and MON-87769-7 soybeans for oil extraction, imported into the European Union for the placing on the market as or in products for food;
(ii) | in case of import of products referred to in point (i), results of searches in the FAOSTAT database on the quantities of vegetable oil consumption by Member State, including shifts in quantities between the different types of oils consumed;
(iii) | in case of import of products referred to in point (i), data on the different categories of food and feed uses of MON-87769-7 oil in the EU.
2. | The authorisation holder shall, based on the information collected and reported, review the nutritional assessment conducted as part of the risk assessment.(h) Monitoring plan for environmental effects:
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(Link:plan published on the internet)
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.

Pending: 32015D0685

January 15, 2026
30.4.2015 EN Official Journal of the European Union L 112/11
(1) On 9 December 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed produced from genetically modified cotton MON 15985.
(2) Food additives, feed materials and feed additives produced from genetically modified cotton MON 15985 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(3) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 15985.
(4) On 22 April 2008, Monsanto Europe S.A. submitted a new broader application for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified cotton MON 15985, including the existing products (‘the application’) and on 2 July 2008 withdrew its application submitted on 9 December 2004.
(5) The application also covers the placing on the market of genetically modified cotton MON 15985 in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.
(6) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003 the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(7) On 29 July 2014, the European Food Safety Authority (‘EFSA’) gave an opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3). It concluded that genetically modified cotton MON 15985, as described in the application, is as safe as its conventional counterpart and non-genetically modified cotton commercial varieties and is unlikely to have adverse effects on human and animal health and the environment, notwithstanding the incompleteness in the agronomic and phenotypic dataset. Considering the scope of these applications and the poor ability of cotton to survive outside cultivated fields, EFSA concluded that the likelihood of any adverse environmental impacts due to the accidental release into the environment of viable seeds from cotton MON 15985 is very low.
(8) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 15985 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 15985.
(9) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(10) EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(11) Consequently, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton MON 15985.
(12) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(13) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from genetically modified cotton MON 15985. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing, consisting of, or produced from MON 15985 cotton, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.
(14) Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(15) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) 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 Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(18) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act 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 MON-15985-7 cotton;
(b) feed containing, consisting of, or produced from MON-15985-7 cotton;
(c) MON-15985-7 cotton in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.
Name : Monsanto Europe S.A.
Address : Avenue de Tervuren 270-272, 1150 Brussels — Belgium
1. Foods and food ingredients containing, consisting of, or produced from MON-15985-7 cotton.
2. Feed containing, consisting of, or produced from MON-15985-7 cotton.
3. MON-15985-7 cotton in products containing it or consisting of it for any other use than those provided in points 1 and 2, with the exception of cultivation.
1. For the purposes of the labelling requirements laid down in Articles 13(1) and 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 products containing or consisting of MON-15985-7 cotton with the exception of products referred to in point (a) of Article 2.
1. Event specific real-time PCR based method for the quantification of MON-15985-7.
2. Validated on genomic DNA, extracted from seeds 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 0804-D and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
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 7(3), 11(3), 19(3) and 23(3) thereof,
(1) On 9 December 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed produced from genetically modified cotton MON 15985.
(2) Food additives, feed materials and feed additives produced from genetically modified cotton MON 15985 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(3) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 15985.
(4) On 22 April 2008, Monsanto Europe S.A. submitted a new broader application for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified cotton MON 15985, including the existing products (‘the application’) and on 2 July 2008 withdrew its application submitted on 9 December 2004.
(5) The application also covers the placing on the market of genetically modified cotton MON 15985 in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.
(6) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003 the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(7) On 29 July 2014, the European Food Safety Authority (‘EFSA’) gave an opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3). It concluded that genetically modified cotton MON 15985, as described in the application, is as safe as its conventional counterpart and non-genetically modified cotton commercial varieties and is unlikely to have adverse effects on human and animal health and the environment, notwithstanding the incompleteness in the agronomic and phenotypic dataset. Considering the scope of these applications and the poor ability of cotton to survive outside cultivated fields, EFSA concluded that the likelihood of any adverse environmental impacts due to the accidental release into the environment of viable seeds from cotton MON 15985 is very low.
(8) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 15985 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 15985.
(9) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(10) EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(11) Consequently, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton MON 15985.
(12) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(13) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from genetically modified cotton MON 15985. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing, consisting of, or produced from MON 15985 cotton, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.
(14) Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(15) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) 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 Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(18) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 15985, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-15985-7, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The following products are authorised for the purposes of Articles 4(2) and 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 MON-15985-7 cotton;
(b)
feed containing, consisting of, or produced from MON-15985-7 cotton;
(c)
MON-15985-7 cotton in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.

Labelling
Article 3
1. For the purposes of the labelling requirements laid down in Articles 13(1) and 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 products containing or consisting of MON-15985-7 cotton, with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects
Article 4
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 Decision 2009/770/EC.

Community register
Article 5
The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 6
The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity
Article 7
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 8
This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

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 7(3), 11(3), 19(3) and 23(3) thereof,
(1) On 9 December 2004, Monsanto Europe S.A. submitted to the competent authority of the United Kingdom an application in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 for the placing on the market of food and feed produced from genetically modified cotton MON 15985.
(2) Food additives, feed materials and feed additives produced from genetically modified cotton MON 15985 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(3) On 17 April 2007, Monsanto Europe S.A. submitted to the Commission an application in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003 for the renewal of the authorisation for existing food additives, feed materials and feed additives produced from genetically modified cotton MON 15985.
(4) On 22 April 2008, Monsanto Europe S.A. submitted a new broader application for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from genetically modified cotton MON 15985, including the existing products (‘the application’) and on 2 July 2008 withdrew its application submitted on 9 December 2004.
(5) The application also covers the placing on the market of genetically modified cotton MON 15985 in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.
(6) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003 the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(7) On 29 July 2014, the European Food Safety Authority (‘EFSA’) gave an opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003(3). It concluded that genetically modified cotton MON 15985, as described in the application, is as safe as its conventional counterpart and non-genetically modified cotton commercial varieties and is unlikely to have adverse effects on human and animal health and the environment, notwithstanding the incompleteness in the agronomic and phenotypic dataset. Considering the scope of these applications and the poor ability of cotton to survive outside cultivated fields, EFSA concluded that the likelihood of any adverse environmental impacts due to the accidental release into the environment of viable seeds from cotton MON 15985 is very low.
(8) EFSA concluded that the analysis of horizontal gene transfer from genetically modified cotton MON 15985 to bacteria did not indicate a risk to human or animal health or to the environment in the context of its intended uses, considering the expected low frequency of gene transfer from plant to bacteria compared with that between bacteria, and the very low exposure to DNA from genetically modified cotton MON 15985.
(9) EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.
(10) EFSA also concluded that the monitoring plan for environmental effects, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(11) Consequently, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton MON 15985.
(12) A unique identifier should be assigned to each genetically modified organism (‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(4).
(13) On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from genetically modified cotton MON 15985. However, in order to ensure the use of those products within the limits of the authorisation granted by this Decision, the labelling of the products containing, consisting of, or produced from MON 15985 cotton, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.
(14) Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council(5)lays down labelling requirements for products containing or consisting of GMOs. Traceability requirements for those products are laid down in paragraphs 1 to 5 of Article 4 and traceability requirements for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(15) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(6). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.
(16) All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(17) 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 Articles 9(1) and 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(7).
(18) The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutumL. andGossypium barbadenseL.) MON 15985, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-15985-7, as provided for in Regulation (EC) No 65/2004.

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 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 MON-15985-7 cotton;
(b)
feed containing, consisting of, or produced from MON-15985-7 cotton;
(c)
MON-15985-7 cotton in products containing it or consisting of it for any other use than those provided in points (a) and (b), with the exception of cultivation.

Labelling

1. For the purposes of the labelling requirements laid down in Articles 13(1) and 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 products containing or consisting of MON-15985-7 cotton, with the exception of products referred to in point (a) of Article 2.

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 Decision 2009/770/EC.

Community register

The information set out in the Annex to this Decision shall be entered in the Community register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

(a)   Applicant and authorisation holder

ANNEX
Name | : | Monsanto Europe S.A.
Address | : | Avenue de Tervuren 270-272, 1150 Brussels — BelgiumOn behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.
(b) Designation and specification of the products

1. | Foods and food ingredients containing, consisting of, or produced from MON-15985-7 cotton.
2. | Feed containing, consisting of, or produced from MON-15985-7 cotton.
3. | MON-15985-7 cotton in products containing it or consisting of it for any other use than those provided in points 1 and 2, with the exception of cultivation.The genetically modified MON-15985-7 cotton, as described in the application, expresses the Cry2Ab2 and Cry1Ac proteins which confer protection against certain lepidopteran pests and GUS protein which acts as selection marker. In addition, annptII gene, conferring kanamycin and neomycin resistance, andaadA gene, conferring spectinomycin and streptomycin resistance, were used as selective markers in the genetic modification process.
(c) Labelling

1. | For the purposes of the labelling requirements laid down in Articles 13(1) and 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 products containing or consisting of MON-15985-7 cotton with the exception of products referred to in point (a) of Article 2.(d) Method for detection

1. | Event specific real-time PCR based method for the quantification of MON-15985-7.
2. | Validated on genomic DNA, extracted from seeds 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 0804-D and AOCS 0804-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier
MON-15985-7
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Biosafety Clearing-House, Record ID: see [to be completed 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 conforming with Annex VII to Directive 2001/18/EC.
[Link:plan published on the internet]
(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.

Pending: 32015D0684

January 15, 2026
30.4.2015 EN Official Journal of the European Union L 112/6
(1) By Commission Decision 2004/643/EC(2), the placing on the market of feed containing or consisting of NK603 maize and NK603 maize in products consisting of it or containing it for any other uses than food and feed, with the exception of cultivation, is authorised in accordance with Directive 2001/18/EC of the European Parliament and of the Council(3), until 17 October 2014.
(2) By Commission Decision 2005/448/EC(4), the placing on the market of foods and food ingredients containing, consisting of or produced from NK603 maize is authorised in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council(5), until 2 March 2015.
(3) Food and feed additives and feed materials produced from genetically modified maize NK603 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation when it came into force.
(4) On 2 August 2005, Monsanto Europe S.A. submitted to the European Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of food and feed additives and feed materials produced from NK603 maize which were previously notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(5) On 2 August 2005, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from NK603 maize.
(6) This application also covered the placing on the market of NK603 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, including the seeds for cultivation.
(7) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(8) On 25 March 2008, the Spanish Competent Authority and its Biosafety Commission provided to the European Food Safety Authority (‘EFSA’) its opinion on the environmental risk assessment in line with Articles 6(3)(c) and 18(3)(c) of Regulation (EC) No 1829/2003 and it concluded that according to the current state of scientific knowledge and after examining the existing information and data provided by the applicant, the Spanish Commission on Biosafety could give a favourable opinion to the commercialisation in the EU of maize NK603 if the proposals and conditions established in the Environmental Risk Assessment report are implemented.
(9) On 11 June 2009, EFSA gave a favourable opinion for both applications in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that NK603 maize, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment(6). In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.
(10) In its opinion, EFSA also concluded that the environmental monitoring plan submitted by the applicant is in line with the intended uses of the products.
(11) On 14 March 2014, Monsanto Europe S.A. informed the European Commission of its decision to amend the scope of the abovementioned new application to no longer include authorisation for cultivation of NK603 maize in the European Union.
(12) Taking into account those considerations, authorisation should be granted for the products, with the exception of cultivation, and the environmental monitoring plan should be adapted to the modified scope.
(13) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(7).
(14) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from NK603 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.
(15) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(8), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(16) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(9). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(17) All relevant information on the authorisation of the products should be entered in the EU register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(18) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(10).
(19) Commission Decisions 2004/643/EC and 2005/448/EC should be repealed.
(20) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act 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 MON-ØØ6Ø3-6 maize;
(b) feed containing, consisting of, or produced from MON-ØØ6Ø3-6 maize;
(c) MON-ØØ6Ø3-6 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.
Name : Monsanto Europe S.A.
Address : Avenue de Tervuren 270-272, 1150 Brussels — Belgium
1. Foods and food ingredients containing, consisting of, or produced from MON-ØØ6Ø3-6 maize.
2. Feed containing, consisting of, or produced from MON-ØØ6Ø3-6 maize.
3. MON-ØØ6Ø3-6 maize in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
1. For the purposes of the specific labelling requirements laid down in Articles 13(1) and 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 products containing or consisting of MON-ØØ6Ø3-6 maize with the exception of products referred to in point (a) of Article 2.
— Event specific real-time PCR based method for the quantification of MON-ØØ6Ø3-6 maize.
— Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, on genomic DNA extracted from Certified Reference Material, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
— Reference Material: ERM®-BF415 accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue
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 7(3), 11(3), 19(3) and 23(3) thereof,
(1) By Commission Decision 2004/643/EC(2), the placing on the market of feed containing or consisting of NK603 maize and NK603 maize in products consisting of it or containing it for any other uses than food and feed, with the exception of cultivation, is authorised in accordance with Directive 2001/18/EC of the European Parliament and of the Council(3), until 17 October 2014.
(2) By Commission Decision 2005/448/EC(4), the placing on the market of foods and food ingredients containing, consisting of or produced from NK603 maize is authorised in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council(5), until 2 March 2015.
(3) Food and feed additives and feed materials produced from genetically modified maize NK603 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation when it came into force.
(4) On 2 August 2005, Monsanto Europe S.A. submitted to the European Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of food and feed additives and feed materials produced from NK603 maize which were previously notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(5) On 2 August 2005, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from NK603 maize.
(6) This application also covered the placing on the market of NK603 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, including the seeds for cultivation.
(7) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(8) On 25 March 2008, the Spanish Competent Authority and its Biosafety Commission provided to the European Food Safety Authority (‘EFSA’) its opinion on the environmental risk assessment in line with Articles 6(3)(c) and 18(3)(c) of Regulation (EC) No 1829/2003 and it concluded that according to the current state of scientific knowledge and after examining the existing information and data provided by the applicant, the Spanish Commission on Biosafety could give a favourable opinion to the commercialisation in the EU of maize NK603 if the proposals and conditions established in the Environmental Risk Assessment report are implemented.
(9) On 11 June 2009, EFSA gave a favourable opinion for both applications in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that NK603 maize, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment(6). In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.
(10) In its opinion, EFSA also concluded that the environmental monitoring plan submitted by the applicant is in line with the intended uses of the products.
(11) On 14 March 2014, Monsanto Europe S.A. informed the European Commission of its decision to amend the scope of the abovementioned new application to no longer include authorisation for cultivation of NK603 maize in the European Union.
(12) Taking into account those considerations, authorisation should be granted for the products, with the exception of cultivation, and the environmental monitoring plan should be adapted to the modified scope.
(13) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(7).
(14) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from NK603 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.
(15) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(8), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(16) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(9). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(17) All relevant information on the authorisation of the products should be entered in the EU register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(18) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(10).
(19) Commission Decisions 2004/643/EC and 2005/448/EC should be repealed.
(20) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified maize (Zea maysL.) NK603, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ6Ø3-6, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The following products are authorised for the purposes of Articles 4(2) and 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 MON-ØØ6Ø3-6 maize;
(b)
feed containing, consisting of, or produced from MON-ØØ6Ø3-6 maize;
(c)
MON-ØØ6Ø3-6 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling
Article 3
1. For the purposes of the labelling requirements laid down in Articles 13(1) and 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 and in the documents accompanying the products containing or consisting of MON-ØØ6Ø3-6 maize with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects
Article 4
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 Decision 2009/770/EC.

EU register
Article 5
The information set out in the Annex to this Decision shall be entered in the EU register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 6
The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity
Article 7
This Decision shall apply for a period of 10 years from the date of its notification.

Repeal
Article 8
Decisions 2004/643/EC and 2005/448/EC are repealed.

Addressee
Article 9
This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

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 7(3), 11(3), 19(3) and 23(3) thereof,
(1) By Commission Decision 2004/643/EC(2), the placing on the market of feed containing or consisting of NK603 maize and NK603 maize in products consisting of it or containing it for any other uses than food and feed, with the exception of cultivation, is authorised in accordance with Directive 2001/18/EC of the European Parliament and of the Council(3), until 17 October 2014.
(2) By Commission Decision 2005/448/EC(4), the placing on the market of foods and food ingredients containing, consisting of or produced from NK603 maize is authorised in accordance with Regulation (EC) No 258/97 of the European Parliament and of the Council(5), until 2 March 2015.
(3) Food and feed additives and feed materials produced from genetically modified maize NK603 were placed on the market before the entry into force of Regulation (EC) No 1829/2003 and were notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation when it came into force.
(4) On 2 August 2005, Monsanto Europe S.A. submitted to the European Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of food and feed additives and feed materials produced from NK603 maize which were previously notified as existing products in accordance with Articles 8(1)(b) and 20(1)(b) of that Regulation.
(5) On 2 August 2005, Monsanto Europe S.A. submitted to the competent authority of the Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from NK603 maize.
(6) This application also covered the placing on the market of NK603 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, including the seeds for cultivation.
(7) In accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(8) On 25 March 2008, the Spanish Competent Authority and its Biosafety Commission provided to the European Food Safety Authority (‘EFSA’) its opinion on the environmental risk assessment in line with Articles 6(3)(c) and 18(3)(c) of Regulation (EC) No 1829/2003 and it concluded that according to the current state of scientific knowledge and after examining the existing information and data provided by the applicant, the Spanish Commission on Biosafety could give a favourable opinion to the commercialisation in the EU of maize NK603 if the proposals and conditions established in the Environmental Risk Assessment report are implemented.
(9) On 11 June 2009, EFSA gave a favourable opinion for both applications in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that NK603 maize, as described in the application, is as safe as its conventional counterpart with respect to potential effects on human and animal health and the environment(6). In its opinion, EFSA considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Articles 6(4) and 18(4) of that Regulation.
(10) In its opinion, EFSA also concluded that the environmental monitoring plan submitted by the applicant is in line with the intended uses of the products.
(11) On 14 March 2014, Monsanto Europe S.A. informed the European Commission of its decision to amend the scope of the abovementioned new application to no longer include authorisation for cultivation of NK603 maize in the European Union.
(12) Taking into account those considerations, authorisation should be granted for the products, with the exception of cultivation, and the environmental monitoring plan should be adapted to the modified scope.
(13) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(7).
(14) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Articles 13(1) and 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from NK603 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.
(15) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(8), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(16) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(9). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(17) All relevant information on the authorisation of the products should be entered in the EU register of genetically modified food and feed, as provided for in Regulation (EC) No 1829/2003.
(18) 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(10).
(19) Commission Decisions 2004/643/EC and 2005/448/EC should be repealed.
(20) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified maize (Zea maysL.) NK603, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ6Ø3-6, as provided for in Regulation (EC) No 65/2004.

Authorisation

The following products are authorised for the purposes of Articles 4(2) and 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 MON-ØØ6Ø3-6 maize;
(b)
feed containing, consisting of, or produced from MON-ØØ6Ø3-6 maize;
(c)
MON-ØØ6Ø3-6 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling

1. For the purposes of the labelling requirements laid down in Articles 13(1) and 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 and in the documents accompanying the products containing or consisting of MON-ØØ6Ø3-6 maize with the exception of products referred to in point (a) of Article 2.

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 Decision 2009/770/EC.

EU register

The information set out in the Annex to this Decision shall be entered in the EU register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe S.A., Belgium, representing Monsanto Company, United States of America.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Repeal

Decisions 2004/643/EC and 2005/448/EC are repealed.

Addressee

This Decision is addressed to Monsanto Europe S.A., Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

(a)   Applicant and authorisation holder

ANNEX
Name | : | Monsanto Europe S.A.
Address | : | Avenue de Tervuren 270-272, 1150 Brussels — BelgiumOn behalf ofMonsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.
(b) Designation and specification of the products

1. | Foods and food ingredients containing, consisting of, or produced from MON-ØØ6Ø3-6 maize.
2. | Feed containing, consisting of, or produced from MON-ØØ6Ø3-6 maize.
3. | MON-ØØ6Ø3-6 maize in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.The genetically modified MON-ØØ6Ø3-6 maize, as described in the applications, expresses the CP4 EPSPS protein which confers tolerance to the glyphosate herbicides.
(c) Labelling

1. | For the purposes of the specific labelling requirements laid down in Articles 13(1) and 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 products containing or consisting of MON-ØØ6Ø3-6 maize with the exception of products referred to in point (a) of Article 2.(d) Method for detection

— | Event specific real-time PCR based method for the quantification of MON-ØØ6Ø3-6 maize.
— | Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, on genomic DNA extracted from Certified Reference Material, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm
— | Reference Material: ERM®-BF415 accessible via the Joint Research Centre (JRC) of the European Commission, Institute for Reference Materials and Measurements (IRMM) at https://irmm.jrc.ec.europa.eu/rmcatalogue(e) Unique identifier
MON-ØØ6Ø3-6
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Biosafety Clearing-House [to be entered in the EU 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
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC [to be entered in the EU register of genetically modified food and feed when notified].
(i) Post market monitoring requirements for the use of the food for human consumption
Not required.

Pending: 32015D0683

January 15, 2026
30.4.2015 EN Official Journal of the European Union L 112/1
(1) On 29 May 2009, Monsanto Europe SA submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87460 maize (‘the application’).
(2) The application also covers the placing on the market of MON 87460 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 15 November 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 87460 maize, as described in the application, is as safe as its conventional counterpart and non-GM reference varieties with respect to potential effects on human and animal health and the environment, in the context of its intended use. EFSA performed a specific risk assessment linked to the presence of the antibiotic resistance markernptII genein MON 87460. The detailed analysis of risks associated with a theoretically possible horizontal gene transfer did not raise safety concerns to human or animal health or to the environment in the context of MON 87460 intended uses. In its opinion, EFSA also considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of that Regulation.
(5) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(6) Taking into account those considerations, authorisation should be granted for the products containing, consisting, or produced from MON 87460 maize, as described in the application, called (‘the products’).
(7) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(3).
(8) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 87460 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.
(9) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(4), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(10) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(5). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(11) All relevant information on the authorisation of the products should be entered in the EU register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(6).
(13) The applicant has been consulted on the measures provided for in this Decision.
(14) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act 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 MON 8746Ø-4 maize;
(b) feed containing, consisting of, or produced from MON 8746Ø-4 maize;
(c) MON 8746Ø-4 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.
Name : Monsanto Europe SA
Address : Avenue de Tervuren 270-272, 1150 Brussels, Belgium
1. foods and food ingredients containing, consisting of, or produced from MON 8746Ø-4 maize;
2. feed containing, consisting of, or produced from MON 8746Ø-4 maize;
3. MON 8746Ø-4 maize in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.
1. For the purposes of the specific 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 products containing or consisting of MON 8746Ø-4 maize with the exception of products referred to in point (a) of Article 2.
— Event-specific real-time PCR based method for the quantification of MON 8746Ø-4 maize.
— Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
— Reference Material: AOCS 0709-A and AOCS 0406-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm
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,
(1) On 29 May 2009, Monsanto Europe SA submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87460 maize (‘the application’).
(2) The application also covers the placing on the market of MON 87460 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 15 November 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 87460 maize, as described in the application, is as safe as its conventional counterpart and non-GM reference varieties with respect to potential effects on human and animal health and the environment, in the context of its intended use. EFSA performed a specific risk assessment linked to the presence of the antibiotic resistance markernptII genein MON 87460. The detailed analysis of risks associated with a theoretically possible horizontal gene transfer did not raise safety concerns to human or animal health or to the environment in the context of MON 87460 intended uses. In its opinion, EFSA also considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of that Regulation.
(5) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(6) Taking into account those considerations, authorisation should be granted for the products containing, consisting, or produced from MON 87460 maize, as described in the application, called (‘the products’).
(7) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(3).
(8) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 87460 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.
(9) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(4), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(10) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(5). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(11) All relevant information on the authorisation of the products should be entered in the EU register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(6).
(13) The applicant has been consulted on the measures provided for in this Decision.
(14) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier
Article 1
Genetically modified maize (Zea maysL.) MON 87460, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON 8746Ø-4, as provided for in Regulation (EC) No 65/2004.

Authorisation
Article 2
The 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 MON 8746Ø-4 maize;
(b)
feed containing, consisting of, or produced from MON 8746Ø-4 maize;
(c)
MON 8746Ø-4 maize in products containing it or consisting of it for any other use than (a) and (b), with the exception of cultivation.

Labelling
Article 3
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 products containing or consisting of MON 8746Ø-4 maize with the exception of products referred to in point (a) of Article 2.

Monitoring for environmental effects
Article 4
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 Decision 2009/770/EC.

EU register
Article 5
The information set out in the Annex to this Decision shall be entered in the EU register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder
Article 6
The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States of America.

Validity
Article 7
This Decision shall apply for a period of 10 years from the date of its notification.

Addressee
Article 8
This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

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,
(1) On 29 May 2009, Monsanto Europe SA submitted to the competent authority of The Netherlands an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients, and feed containing, consisting of, or produced from MON 87460 maize (‘the application’).
(2) The application also covers the placing on the market of MON 87460 maize in products consisting of it or containing it for any other uses than food and feed as any other maize, with the exception of cultivation.
(3) In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council(2)and information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC. It also includes a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.
(4) On 15 November 2012, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that MON 87460 maize, as described in the application, is as safe as its conventional counterpart and non-GM reference varieties with respect to potential effects on human and animal health and the environment, in the context of its intended use. EFSA performed a specific risk assessment linked to the presence of the antibiotic resistance markernptII genein MON 87460. The detailed analysis of risks associated with a theoretically possible horizontal gene transfer did not raise safety concerns to human or animal health or to the environment in the context of MON 87460 intended uses. In its opinion, EFSA also considered all the specific questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for by Article 6(4) and Article 18(4) of that Regulation.
(5) In its opinion, EFSA also concluded that the environmental monitoring plan, consisting of a general surveillance plan, submitted by the applicant is in line with the intended uses of the products.
(6) Taking into account those considerations, authorisation should be granted for the products containing, consisting, or produced from MON 87460 maize, as described in the application, called (‘the products’).
(7) A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004(3).
(8) On the basis of the EFSA opinion, no specific labelling requirements other than those provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003, appear to be necessary for foods, food ingredients and feed containing, consisting of, or produced from MON 87460 maize. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO with the exception of food products for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation.
(9) Regulation (EC) No 1830/2003 of the European Parliament and of the Council(4), lays down labelling requirements in Article 4(6) for products containing or consisting of GMOs. Traceability requirements for products containing or consisting of GMOs are laid down in paragraphs 1 to 5 of Article 4 and those for food and feed produced from GMOs are laid down in Article 5 of that Regulation.
(10) The authorisation holder should submit annual reports on the implementation and the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with Commission Decision 2009/770/EC(5). The EFSA opinion does not justify the imposition of specific conditions or restrictions for the placing on the market and/or specific conditions or restrictions for the use and handling, including post-market monitoring requirements for the use of the food and feed, or of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.
(11) All relevant information on the authorisation of the products should be entered in the EU register of genetically modified food and feed, as provided for in 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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council(6).
(13) The applicant has been consulted on the measures provided for in this Decision.
(14) The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time limit laid down by its Chairman. An implementing act was deemed to be necessary and the chair submitted the draft implementing act to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,
HAS ADOPTED THIS DECISION:

Genetically modified organism and unique identifier

Genetically modified maize (Zea maysL.) MON 87460, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON 8746Ø-4, as provided for in Regulation (EC) No 65/2004.

Authorisation

The 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 MON 8746Ø-4 maize;
(b)
feed containing, consisting of, or produced from MON 8746Ø-4 maize;
(c)
MON 8746Ø-4 maize in products containing it or consisting of it for any other use than (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 documents accompanying products containing or consisting of MON 8746Ø-4 maize with the exception of products referred to in point (a) of Article 2.

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 Decision 2009/770/EC.

EU register

The information set out in the Annex to this Decision shall be entered in the EU register of genetically modified food and feed, as provided for in Article 28 of Regulation (EC) No 1829/2003.

Authorisation holder

The authorisation holder shall be Monsanto Europe SA, Belgium, representing Monsanto Company, United States of America.

Validity

This Decision shall apply for a period of 10 years from the date of its notification.

Addressee

This Decision is addressed to Monsanto Europe SA, Avenue de Tervuren 270-272, 1150 Brussels, Belgium.

(a)   Applicant and authorisation holder

ANNEX
Name | : | Monsanto Europe SA
Address | : | Avenue de Tervuren 270-272, 1150 Brussels, BelgiumOn behalf ofMonsanto Company,800 N. Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America.
(b) Designation and specification of the products

1. | foods and food ingredients containing, consisting of, or produced from MON 8746Ø-4 maize;
2. | feed containing, consisting of, or produced from MON 8746Ø-4 maize;
3. | MON 8746Ø-4 maize in products containing it or consisting of it for any other use than 1 and 2, with the exception of cultivation.The genetically modified MON 8746Ø-4 maize, as described in the application, expresses the cold shock protein B (CspB) which aims to reduce yield loss caused by drought stress. AnnptIIgene, conferring kanamycine and neomycine resistance, was used as a selective marker in the genetic modification process.
(c) Labelling

1. | For the purposes of the specific 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 products containing or consisting of MON 8746Ø-4 maize with the exception of products referred to in point (a) of Article 2.(d) Method for detection

— | Event-specific real-time PCR based method for the quantification of MON 8746Ø-4 maize.
— | Validated on genomic DNA, extracted from seeds, by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx
— | Reference Material: AOCS 0709-A and AOCS 0406-A are accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm(e) Unique identifier
MON 8746Ø-4
(f) Information required under Annex II to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity
Biosafety Clearing-House (to be entered in the EU 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
Monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC [to be entered in the EU register of genetically modified food and feed when notified).
(i) Post-market monitoring requirements for the use of the food for human consumption
Not required.

Pending: 32014D0908

January 15, 2026
16.12.2014 EN Official Journal of the European Union L 359/155
(1) Institutions are to fulfil capital requirements which adequately reflect the risks undertaken by those institutions, including credit risk, having regard to the different geographical contexts in which they operate. The credit risk incurred by institutions attached to exposures to entities located outside the Union is determined, all other factors being equal, by the quality of the relevant regulatory framework and supervision implemented in the relevant third country.
(2) Article 107(3) of Regulation (EU) No 575/2013 allows institutions to treat exposures to third country investment firms, credit institutions and exchanges as exposures to institutions only if the third country applies prudential and supervisory requirements to the entity concerned which are at least equivalent to those applied in the Union.
(3) Articles 114(7), 115(4) and 116(5) of Regulation (EU) No 575/2013 set specific risk weights applicable to exposures to central governments, central banks, regional governments, local authorities, and public sector entities located in third countries that apply supervisory and regulatory arrangements at least equivalent to those applied in the Union.
(4) Article 153 of Regulation (EU) No 575/2013 lays down the formula for the calculation of the risk weighted exposures amounts for exposures to corporates, institutions, central governments and central banks under the internal-ratings based (IRB) approach and details the parameters to be used for the calculation, including the coefficient of correlation. Article 153(2) of Regulation (EU) No 575/2013 sets the coefficient of correlation applicable to large financial sector entities. According to Article 142(1)(4)(b) of that Regulation, in order to qualify for the definition of ‘large financial sector entity’, the financial sector entity or one of its subsidiaries must be subject to the laws of a third country applying prudential supervisory requirements at least equivalent to those applied in the Union.
(5) In order to determine the appropriate risk-weighted exposures for the calculation of capital requirements for the credit risk attached to exposures to certain categories of entities located in third countries, the Commission has assessed the equivalence of the supervisory and regulatory arrangements of third countries to the corresponding supervisory and regulatory arrangements in the Union.
(6) The equivalence has been determined by an outcome-based analysis of the third country's regulatory and supervisory arrangements which tests their ability to achieve the same general objectives as the Union's supervisory and regulatory arrangements. The objectives refer, in particular, to the stability and integrity of both the domestic and the global financial system in its entirety; the effectiveness and adequacy of protection of depositors and other consumers of financial services; the cooperation between different actors of the financial system, including regulators and supervisors; the independence and the effectiveness of supervision; and the effective implementation and enforcement of relevant internationally agreed standards. In order to achieve the same general objectives of the Union's supervisory and regulatory arrangements, the supervisory and regulatory arrangements of the third country should comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union's supervisory and regulatory requirements applicable to relevant categories of financial institutions. Taking into account independent assessments by the international organisations, such as those carried out by the Basel Committee on Banking Supervision, the International Monetary Fund and the International Organization of Securities Commissions, the Commission has assessed the supervisory and regulatory arrangements of certain third countries applicable to credit institutions, investment firms, and exchanges. This analysis has enabled the Commission to evaluate the equivalence of third country arrangements for the purposes of determining the treatment of the relevant categories of exposures mentioned in Articles 107, 114, 115, 116 and 142 of Regulation (EU) No 575/2013.
(7) For the purposes of Articles 114, 115, and 116 of Regulation (EU) No 575/2013 equivalence should be determined by reference to the supervisory and regulatory arrangements applicable to credit institutions since these arrangements usually set the risk weights for the calculation of capital requirements for credit risk.
(8) For the purposes of Article 142(1)(4)(b) of Regulation (EU) No 575/2013, the equivalence assessment is confined to the supervisory and regulatory arrangements applicable to third country undertakings with a main business comparable to that of a credit institution or investment firm, in accordance with the definition provided in Article 4(1)(27) of that Regulation.
(9) Following the assessment, it appears that Australia, Brazil, Canada, China, Guernsey, Hong Kong, India, Isle of Man, Japan, Jersey, Mexico, Monaco, Saudi Arabia, Singapore, South Africa, Switzerland and the USA have in place supervisory and regulatory arrangements which comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union's supervisory and regulatory arrangements applicable to credit institutions. Therefore, it is appropriate to consider the supervisory and regulatory requirements for credit institutions located in those third countries and territories as at least equivalent to those applied in the Union for the purposes of Article 107(4) and Article 142(1)(4)(b) of Regulation (EU) No 575/2013.
(10) Following the assessment, it appears that Australia, Brazil, Canada, China, Mexico, Saudi Arabia, Singapore, South Africa and the USA have in place supervisory and regulatory arrangements which comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union's supervisory and regulatory arrangements applicable to investment firms. Therefore, it is appropriate to consider the supervisory and regulatory requirements applying to investment firms located in those third countries as at least equivalent to those applied in the Union for the purposes of Article 107(4) and Article 142(1)(4)(b) of Regulation (EU) No 575/2013.
(11) Following the assessment, it appears that Brazil, Canada, China, India, Japan, Mexico, Saudi Arabia, Singapore, South Africa and the USA have in place supervisory and regulatory arrangements which comply with a series of operational standards reflecting the essential elements of the Union's supervisory and regulatory arrangements applicable to exchanges. Therefore, it is appropriate to consider the supervisory and regulatory requirements of those third countries applied to exchanges as at least equivalent to those applied in the Union for the purposes of Article 107(4) of Regulation (EU) No 575/2013 limited to exposures to exchanges located in those third countries.
(12) The sole purpose of this Decision is to determine equivalence for the purposes of assigning risk weights under Articles 107, 114, 115, 116 and 142 of Regulation (EU) No 575/2013.
(13) The list of third countries and territories considered to be equivalent for the purposes of this Decision is not definitive. The Commission, with the assistance of the European Banking Authority, will continue monitoring on a regular basis the evolution of the supervisory and regulatory arrangements of third countries and territories with a view to updating, as appropriate and at least every 5 years, the lists of third countries and territories set out in this Decision in light, in particular, of the constant development of supervisory and regulatory arrangements, in the Union and at global level, and taking into account new available sources of relevant information.
(14) The regular review of the prudential and supervisory requirements applicable in the third countries and territories listed in the Annexes should be without prejudice to the possibility of the Commission to undertake a specific review relating to an individual third country or territory at any time outside the general review, where relevant developments make it necessary for the Commission to re-assess the recognition granted by this Decision. Such re-assessment could lead to the withdrawal of the recognition of equivalence.
(15) The provisions in this Decision are closely linked, since they deal with the equivalence of the supervisory and regulatory requirements of certain third countries and territories for the purposes of the treatment of exposures according to Regulation (EU) No 575/2013. To ensure coherence between those provisions, which should enter into force at the same time, and to facilitate a comprehensive view and compact access to them by institutions subject to those obligations, it is desirable to include certain implementing acts required by Regulation (EU) No 575/2013 in a single Decision.
(16) The measures provided for in this Decision are in accordance with the opinion of the European Banking Committee.
(17) In order to avoid a sudden increase in capital requirements for credit institutions and investment firms in the Union, this Decision should enter into force on 1 January 2015,
(1) Australia
(2) Brazil
(3) Canada
(4) China
(5) Guernsey
(6) Hong Kong
(7) India
(8) Isle of Man
(9) Japan
(10) Jersey
(11) Mexico
(12) Monaco
(13) Saudi Arabia
(14) Singapore
(15) South Africa
(16) Switzerland
(17) USA
(1) Australia
(2) Brazil
(3) Canada
(4) China
(5) Mexico
(6) Saudi Arabia
(7) Singapore
(8) South Africa
(9) USA
(1) Brazil
(2) Canada
(3) China
(4) India
(5) Japan
(6) Mexico
(7) Saudi Arabia
(8) Singapore
(9) South Africa
(10) USA
(1) Australia
(2) Brazil
(3) Canada
(4) China
(5) Guernsey
(6) Hong Kong
(7) India
(8) Isle of Man
(9) Japan
(10) Jersey
(11) Mexico
(12) Monaco
(13) Saudi Arabia
(14) Singapore
(15) South Africa
(16) Switzerland
(17) USA
(1) Australia
(2) Brazil
(3) Canada
(4) China
(5) Guernsey
(6) Hong Kong
(7) India
(8) Isle of Man
(9) Japan
(10) Jersey
(11) Mexico
(12) Monaco
(13) Saudi Arabia
(14) Singapore
(15) South Africa
(16) Switzerland
(17) USA
(1) Australia
(2) Brazil
(3) Canada
(4) China
(5) Mexico
(6) Saudi Arabia
(7) Singapore
(8) South Africa
(9) USA
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012(1), and in particular Articles 107(4), 114(7), 115(4), 116(5) and 142(2) thereof,
(1) Institutions are to fulfil capital requirements which adequately reflect the risks undertaken by those institutions, including credit risk, having regard to the different geographical contexts in which they operate. The credit risk incurred by institutions attached to exposures to entities located outside the Union is determined, all other factors being equal, by the quality of the relevant regulatory framework and supervision implemented in the relevant third country.
(2) Article 107(3) of Regulation (EU) No 575/2013 allows institutions to treat exposures to third country investment firms, credit institutions and exchanges as exposures to institutions only if the third country applies prudential and supervisory requirements to the entity concerned which are at least equivalent to those applied in the Union.
(3) Articles 114(7), 115(4) and 116(5) of Regulation (EU) No 575/2013 set specific risk weights applicable to exposures to central governments, central banks, regional governments, local authorities, and public sector entities located in third countries that apply supervisory and regulatory arrangements at least equivalent to those applied in the Union.
(4) Article 153 of Regulation (EU) No 575/2013 lays down the formula for the calculation of the risk weighted exposures amounts for exposures to corporates, institutions, central governments and central banks under the internal-ratings based (IRB) approach and details the parameters to be used for the calculation, including the coefficient of correlation. Article 153(2) of Regulation (EU) No 575/2013 sets the coefficient of correlation applicable to large financial sector entities. According to Article 142(1)(4)(b) of that Regulation, in order to qualify for the definition of ‘large financial sector entity’, the financial sector entity or one of its subsidiaries must be subject to the laws of a third country applying prudential supervisory requirements at least equivalent to those applied in the Union.
(5) In order to determine the appropriate risk-weighted exposures for the calculation of capital requirements for the credit risk attached to exposures to certain categories of entities located in third countries, the Commission has assessed the equivalence of the supervisory and regulatory arrangements of third countries to the corresponding supervisory and regulatory arrangements in the Union.
(6) The equivalence has been determined by an outcome-based analysis of the third country’s regulatory and supervisory arrangements which tests their ability to achieve the same general objectives as the Union’s supervisory and regulatory arrangements. The objectives refer, in particular, to the stability and integrity of both the domestic and the global financial system in its entirety; the effectiveness and adequacy of protection of depositors and other consumers of financial services; the cooperation between different actors of the financial system, including regulators and supervisors; the independence and the effectiveness of supervision; and the effective implementation and enforcement of relevant internationally agreed standards. In order to achieve the same general objectives of the Union’s supervisory and regulatory arrangements, the supervisory and regulatory arrangements of the third country should comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union’s supervisory and regulatory requirements applicable to relevant categories of financial institutions. Taking into account independent assessments by the international organisations, such as those carried out by the Basel Committee on Banking Supervision, the International Monetary Fund and the International Organization of Securities Commissions, the Commission has assessed the supervisory and regulatory arrangements of certain third countries applicable to credit institutions, investment firms, and exchanges. This analysis has enabled the Commission to evaluate the equivalence of third country arrangements for the purposes of determining the treatment of the relevant categories of exposures mentioned in Articles 107, 114, 115, 116 and 142 of Regulation (EU) No 575/2013.
(7) For the purposes of Articles 114, 115, and 116 of Regulation (EU) No 575/2013 equivalence should be determined by reference to the supervisory and regulatory arrangements applicable to credit institutions since these arrangements usually set the risk weights for the calculation of capital requirements for credit risk.
(8) For the purposes of Article 142(1)(4)(b) of Regulation (EU) No 575/2013, the equivalence assessment is confined to the supervisory and regulatory arrangements applicable to third country undertakings with a main business comparable to that of a credit institution or investment firm, in accordance with the definition provided in Article 4(1)(27) of that Regulation.
(9) Following the assessment, it appears that Australia, Brazil, Canada, China, Guernsey, Hong Kong, India, Isle of Man, Japan, Jersey, Mexico, Monaco, Saudi Arabia, Singapore, South Africa, Switzerland and the USA have in place supervisory and regulatory arrangements which comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union’s supervisory and regulatory arrangements applicable to credit institutions. Therefore, it is appropriate to consider the supervisory and regulatory requirements for credit institutions located in those third countries and territories as at least equivalent to those applied in the Union for the purposes of Article 107(4) and Article 142(1)(4)(b) of Regulation (EU) No 575/2013.
(10) Following the assessment, it appears that Australia, Brazil, Canada, China, Mexico, Saudi Arabia, Singapore, South Africa and the USA have in place supervisory and regulatory arrangements which comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union’s supervisory and regulatory arrangements applicable to investment firms. Therefore, it is appropriate to consider the supervisory and regulatory requirements applying to investment firms located in those third countries as at least equivalent to those applied in the Union for the purposes of Article 107(4) and Article 142(1)(4)(b) of Regulation (EU) No 575/2013.
(11) Following the assessment, it appears that Brazil, Canada, China, India, Japan, Mexico, Saudi Arabia, Singapore, South Africa and the USA have in place supervisory and regulatory arrangements which comply with a series of operational standards reflecting the essential elements of the Union’s supervisory and regulatory arrangements applicable to exchanges. Therefore, it is appropriate to consider the supervisory and regulatory requirements of those third countries applied to exchanges as at least equivalent to those applied in the Union for the purposes of Article 107(4) of Regulation (EU) No 575/2013 limited to exposures to exchanges located in those third countries.
(12) The sole purpose of this Decision is to determine equivalence for the purposes of assigning risk weights under Articles 107, 114, 115, 116 and 142 of Regulation (EU) No 575/2013.
(13) The list of third countries and territories considered to be equivalent for the purposes of this Decision is not definitive. The Commission, with the assistance of the European Banking Authority, will continue monitoring on a regular basis the evolution of the supervisory and regulatory arrangements of third countries and territories with a view to updating, as appropriate and at least every 5 years, the lists of third countries and territories set out in this Decision in light, in particular, of the constant development of supervisory and regulatory arrangements, in the Union and at global level, and taking into account new available sources of relevant information.
(14) The regular review of the prudential and supervisory requirements applicable in the third countries and territories listed in the Annexes should be without prejudice to the possibility of the Commission to undertake a specific review relating to an individual third country or territory at any time outside the general review, where relevant developments make it necessary for the Commission to re-assess the recognition granted by this Decision. Such re-assessment could lead to the withdrawal of the recognition of equivalence.
(15) The provisions in this Decision are closely linked, since they deal with the equivalence of the supervisory and regulatory requirements of certain third countries and territories for the purposes of the treatment of exposures according to Regulation (EU) No 575/2013. To ensure coherence between those provisions, which should enter into force at the same time, and to facilitate a comprehensive view and compact access to them by institutions subject to those obligations, it is desirable to include certain implementing acts required by Regulation (EU) No 575/2013 in a single Decision.
(16) The measures provided for in this Decision are in accordance with the opinion of the European Banking Committee.
(17) In order to avoid a sudden increase in capital requirements for credit institutions and investment firms in the Union, this Decision should enter into force on 1 January 2015,
HAS ADOPTED THIS DECISION:

Equivalence of requirements applied to credit institutions for the purposes of Article 107(4) of Regulation (EU) No 575/2013
Article 1
For the purposes of Article 107(4) of Regulation (EU) No 575/2013, the third countries and territories listed in Annex I to this Decision shall be considered as applying supervisory and regulatory arrangements to credit institutions equivalent to those applied in the Union.

Equivalence of requirements applied to investment firms for the purposes of Article 107(4) of Regulation (EU) No 575/2013
Article 2
For the purposes of Article 107(4) of Regulation (EU) No 575/2013, the third countries listed in Annex II to this Decision shall be considered as applying supervisory and regulatory arrangements to investment firms equivalent to those applied in the Union.

Equivalence of requirements applied to exchanges for the purposes of Article 107(4) of Regulation (EU) No 575/2013
Article 3
For the purposes of Article 107(4) of Regulation (EU) No 575/2013, the third countries listed in Annex III to this Decision shall be considered as applying supervisory and regulatory arrangements to exchanges equivalent to those applied in the Union.

Equivalence of requirements applied to exposures to central governments, central banks, regional governments, local authorities and public sector entities for the purposes of Articles 114, 115, 116 of Regulation (EU) No 575/2013
Article 4
For the purposes of Articles 114(7), 115(4) and 116(5) of Regulation (EU) No 575/2013, the third countries and territories listed in Annex IV to this Decision shall be considered as applying supervisory and regulatory arrangements equivalent to those applied to credit institutions in the Union.

Equivalence of requirements to credit institutions and investment firms for the purposes Article 142 of Regulation (EU) No 575/2013
Article 5
For the purposes of Article 142(2) of Regulation (EU) No 575/2013, the third countries and territories listed in Annex V to this Decision shall be considered as applying supervisory and regulatory arrangements equivalent to those applied in the Union.

Entry into force
Article 6
This Decision shall enter into force on 1 January 2015.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 575/2013 of the European Parliament and of the Council of 26 June 2013 on prudential requirements for credit institutions and investment firms and amending Regulation (EU) No 648/2012(1), and in particular Articles 107(4), 114(7), 115(4), 116(5) and 142(2) thereof,
(1) Institutions are to fulfil capital requirements which adequately reflect the risks undertaken by those institutions, including credit risk, having regard to the different geographical contexts in which they operate. The credit risk incurred by institutions attached to exposures to entities located outside the Union is determined, all other factors being equal, by the quality of the relevant regulatory framework and supervision implemented in the relevant third country.
(2) Article 107(3) of Regulation (EU) No 575/2013 allows institutions to treat exposures to third country investment firms, credit institutions and exchanges as exposures to institutions only if the third country applies prudential and supervisory requirements to the entity concerned which are at least equivalent to those applied in the Union.
(3) Articles 114(7), 115(4) and 116(5) of Regulation (EU) No 575/2013 set specific risk weights applicable to exposures to central governments, central banks, regional governments, local authorities, and public sector entities located in third countries that apply supervisory and regulatory arrangements at least equivalent to those applied in the Union.
(4) Article 153 of Regulation (EU) No 575/2013 lays down the formula for the calculation of the risk weighted exposures amounts for exposures to corporates, institutions, central governments and central banks under the internal-ratings based (IRB) approach and details the parameters to be used for the calculation, including the coefficient of correlation. Article 153(2) of Regulation (EU) No 575/2013 sets the coefficient of correlation applicable to large financial sector entities. According to Article 142(1)(4)(b) of that Regulation, in order to qualify for the definition of ‘large financial sector entity’, the financial sector entity or one of its subsidiaries must be subject to the laws of a third country applying prudential supervisory requirements at least equivalent to those applied in the Union.
(5) In order to determine the appropriate risk-weighted exposures for the calculation of capital requirements for the credit risk attached to exposures to certain categories of entities located in third countries, the Commission has assessed the equivalence of the supervisory and regulatory arrangements of third countries to the corresponding supervisory and regulatory arrangements in the Union.
(6) The equivalence has been determined by an outcome-based analysis of the third country’s regulatory and supervisory arrangements which tests their ability to achieve the same general objectives as the Union’s supervisory and regulatory arrangements. The objectives refer, in particular, to the stability and integrity of both the domestic and the global financial system in its entirety; the effectiveness and adequacy of protection of depositors and other consumers of financial services; the cooperation between different actors of the financial system, including regulators and supervisors; the independence and the effectiveness of supervision; and the effective implementation and enforcement of relevant internationally agreed standards. In order to achieve the same general objectives of the Union’s supervisory and regulatory arrangements, the supervisory and regulatory arrangements of the third country should comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union’s supervisory and regulatory requirements applicable to relevant categories of financial institutions. Taking into account independent assessments by the international organisations, such as those carried out by the Basel Committee on Banking Supervision, the International Monetary Fund and the International Organization of Securities Commissions, the Commission has assessed the supervisory and regulatory arrangements of certain third countries applicable to credit institutions, investment firms, and exchanges. This analysis has enabled the Commission to evaluate the equivalence of third country arrangements for the purposes of determining the treatment of the relevant categories of exposures mentioned in Articles 107, 114, 115, 116 and 142 of Regulation (EU) No 575/2013.
(7) For the purposes of Articles 114, 115, and 116 of Regulation (EU) No 575/2013 equivalence should be determined by reference to the supervisory and regulatory arrangements applicable to credit institutions since these arrangements usually set the risk weights for the calculation of capital requirements for credit risk.
(8) For the purposes of Article 142(1)(4)(b) of Regulation (EU) No 575/2013, the equivalence assessment is confined to the supervisory and regulatory arrangements applicable to third country undertakings with a main business comparable to that of a credit institution or investment firm, in accordance with the definition provided in Article 4(1)(27) of that Regulation.
(9) Following the assessment, it appears that Australia, Brazil, Canada, China, Guernsey, Hong Kong, India, Isle of Man, Japan, Jersey, Mexico, Monaco, Saudi Arabia, Singapore, South Africa, Switzerland and the USA have in place supervisory and regulatory arrangements which comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union’s supervisory and regulatory arrangements applicable to credit institutions. Therefore, it is appropriate to consider the supervisory and regulatory requirements for credit institutions located in those third countries and territories as at least equivalent to those applied in the Union for the purposes of Article 107(4) and Article 142(1)(4)(b) of Regulation (EU) No 575/2013.
(10) Following the assessment, it appears that Australia, Brazil, Canada, China, Mexico, Saudi Arabia, Singapore, South Africa and the USA have in place supervisory and regulatory arrangements which comply with a series of operational, organisational and supervisory standards reflecting the essential elements of the Union’s supervisory and regulatory arrangements applicable to investment firms. Therefore, it is appropriate to consider the supervisory and regulatory requirements applying to investment firms located in those third countries as at least equivalent to those applied in the Union for the purposes of Article 107(4) and Article 142(1)(4)(b) of Regulation (EU) No 575/2013.
(11) Following the assessment, it appears that Brazil, Canada, China, India, Japan, Mexico, Saudi Arabia, Singapore, South Africa and the USA have in place supervisory and regulatory arrangements which comply with a series of operational standards reflecting the essential elements of the Union’s supervisory and regulatory arrangements applicable to exchanges. Therefore, it is appropriate to consider the supervisory and regulatory requirements of those third countries applied to exchanges as at least equivalent to those applied in the Union for the purposes of Article 107(4) of Regulation (EU) No 575/2013 limited to exposures to exchanges located in those third countries.
(12) The sole purpose of this Decision is to determine equivalence for the purposes of assigning risk weights under Articles 107, 114, 115, 116 and 142 of Regulation (EU) No 575/2013.
(13) The list of third countries and territories considered to be equivalent for the purposes of this Decision is not definitive. The Commission, with the assistance of the European Banking Authority, will continue monitoring on a regular basis the evolution of the supervisory and regulatory arrangements of third countries and territories with a view to updating, as appropriate and at least every 5 years, the lists of third countries and territories set out in this Decision in light, in particular, of the constant development of supervisory and regulatory arrangements, in the Union and at global level, and taking into account new available sources of relevant information.
(14) The regular review of the prudential and supervisory requirements applicable in the third countries and territories listed in the Annexes should be without prejudice to the possibility of the Commission to undertake a specific review relating to an individual third country or territory at any time outside the general review, where relevant developments make it necessary for the Commission to re-assess the recognition granted by this Decision. Such re-assessment could lead to the withdrawal of the recognition of equivalence.
(15) The provisions in this Decision are closely linked, since they deal with the equivalence of the supervisory and regulatory requirements of certain third countries and territories for the purposes of the treatment of exposures according to Regulation (EU) No 575/2013. To ensure coherence between those provisions, which should enter into force at the same time, and to facilitate a comprehensive view and compact access to them by institutions subject to those obligations, it is desirable to include certain implementing acts required by Regulation (EU) No 575/2013 in a single Decision.
(16) The measures provided for in this Decision are in accordance with the opinion of the European Banking Committee.
(17) In order to avoid a sudden increase in capital requirements for credit institutions and investment firms in the Union, this Decision should enter into force on 1 January 2015,
HAS ADOPTED THIS DECISION:

Equivalence of requirements applied to credit institutions for the purposes of Article 107(4) of Regulation (EU) No 575/2013

For the purposes of Article 107(4) of Regulation (EU) No 575/2013, the third countries and territories listed in Annex I to this Decision shall be considered as applying supervisory and regulatory arrangements to credit institutions equivalent to those applied in the Union.

Equivalence of requirements applied to investment firms for the purposes of Article 107(4) of Regulation (EU) No 575/2013

For the purposes of Article 107(4) of Regulation (EU) No 575/2013, the third countries listed in Annex II to this Decision shall be considered as applying supervisory and regulatory arrangements to investment firms equivalent to those applied in the Union.

Equivalence of requirements applied to exchanges for the purposes of Article 107(4) of Regulation (EU) No 575/2013

For the purposes of Article 107(4) of Regulation (EU) No 575/2013, the third countries listed in Annex III to this Decision shall be considered as applying supervisory and regulatory arrangements to exchanges equivalent to those applied in the Union.

Equivalence of requirements applied to exposures to central governments, central banks, regional governments, local authorities and public sector entities for the purposes of Articles 114, 115, 116 of Regulation (EU) No 575/2013

For the purposes of Articles 114(7), 115(4) and 116(5) of Regulation (EU) No 575/2013, the third countries and territories listed in Annex IV to this Decision shall be considered as applying supervisory and regulatory arrangements equivalent to those applied to credit institutions in the Union.

Equivalence of requirements to credit institutions and investment firms for the purposes Article 142 of Regulation (EU) No 575/2013

For the purposes of Article 142(2) of Regulation (EU) No 575/2013, the third countries and territories listed in Annex V to this Decision shall be considered as applying supervisory and regulatory arrangements equivalent to those applied in the Union.

Entry into force

This Decision shall enter into force on 1 January 2015.
ANNEX ILIST OF THIRD COUNTRIES AND TERRITORIES FOR THE PURPOSES OF ARTICLE 1 (CREDIT INSTITUTIONS)
(1) | Australia
(2) | Brazil
(3) | Canada
(4) | China
(5) | Guernsey
(6) | Hong Kong
(7) | India
(8) | Isle of Man
(9) | Japan
(10) | Jersey
(11) | Mexico
(12) | Monaco
(13) | Saudi Arabia
(14) | Singapore
(15) | South Africa
(16) | Switzerland
(17) | USA
ANNEX IILIST OF THIRD COUNTRIES FOR THE PURPOSES OF ARTICLE 2 (INVESTMENT FIRMS)
(1) | Australia
(2) | Brazil
(3) | Canada
(4) | China
(5) | Mexico
(6) | Saudi Arabia
(7) | Singapore
(8) | South Africa
(9) | USA
ANNEX IIILIST OF THIRD COUNTRIES FOR THE PURPOSES OF ARTICLE 3 (EXCHANGES)
(1) | Brazil
(2) | Canada
(3) | China
(4) | India
(5) | Japan
(6) | Mexico
(7) | Saudi Arabia
(8) | Singapore
(9) | South Africa
(10) | USA
ANNEX IVLIST OF THIRD COUNTRIES AND TERRITORIES FOR THE PURPOSES OF ARTICLE 4 (CREDIT INSTITUTIONS)
(1) | Australia
(2) | Brazil
(3) | Canada
(4) | China
(5) | Guernsey
(6) | Hong Kong
(7) | India
(8) | Isle of Man
(9) | Japan
(10) | Jersey
(11) | Mexico
(12) | Monaco
(13) | Saudi Arabia
(14) | Singapore
(15) | South Africa
(16) | Switzerland
(17) | USA
ANNEX VLIST OF THIRD COUNTRIES AND TERRITORIES FOR THE PURPOSES OF ARTICLE 5 (CREDIT INSTITUTIONS AND INVESTMENT FIRMS)Credit institutions:

(1) | Australia
(2) | Brazil
(3) | Canada
(4) | China
(5) | Guernsey
(6) | Hong Kong
(7) | India
(8) | Isle of Man
(9) | Japan
(10) | Jersey
(11) | Mexico
(12) | Monaco
(13) | Saudi Arabia
(14) | Singapore
(15) | South Africa
(16) | Switzerland
(17) | USAInvestment firms:

(1) | Australia
(2) | Brazil
(3) | Canada
(4) | China
(5) | Mexico
(6) | Saudi Arabia
(7) | Singapore
(8) | South Africa
(9) | USA

Pending: 32014D0763

January 15, 2026
6.11.2014 EN Official Journal of the European Union L 320/46
(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to products which have a reduced environmental impact during their entire life cycle.
(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.
(3) The criteria, as well as the related assessment and verification requirements should be valid for four years from the date of adoption of this Decision, taking into account the innovation cycle for this product group.
(4) Since consumption of materials can contribute significantly to the overall environmental impacts of absorbent hygiene products, it is appropriate to establish EU Ecolabel criteria for this product group. The criteria should, in particular, promote sustainable sourcing of materials, limited use of hazardous substances, high-quality and high-performance products which are fit-for-use and are designed to minimise waste production.
(5) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,
(1) ‘cellulose pulp’ means a fibrous material mainly composed of cellulose and obtained from the treatment of lignocellulosic materials with one or more aqueous solutions of pulping and/or bleaching chemicals;
(2) ‘optical brightener’ and ‘fluorescent whitening agent’ mean any additives used with the only purpose of ‘whitening’ or ‘brightening’ the material;
(3) ‘plastic materials’, also referred to as ‘plastics’, means synthetic polymers to which additives or other substances may have been added which can be moulded and used as main structural component of final materials and articles;
(4) ‘synthetic polymers’ means macromolecular substances, other than cellulose pulp, intentionally obtained either by a polymerisation process or chemical modification of natural or synthetic macromolecules or microbial fermentation;
(5) ‘super absorbent polymers’ means synthetic polymers designed for absorbing and retaining large amounts of liquid compared to their own mass.
1. Product description
2. Fluff pulp
3. Man-made cellulose fibres (including viscose, modal, lyocell, cupro, triacetate)
4. Cotton and other natural cellulosic seed fibres
5. Plastic materials and superabsorbent polymers
6. Other materials and components
7. Excluded or limited substances or mixtures
8. Material efficiency in the manufacturing
9. Guidance on the product disposal
10. Fitness for use and quality of the product
11. Social aspects
12. Information appearing on the EU Ecolabel
— the total weight of the product and packaging,
— the components, materials and additives used in the product with their respective weights and, whenever applicable, their respective CAS numbers.
— None of the individual points PCOD, PP, PS, PNOx, shall exceed 1,5.
— The total number of points (Ptotal= PCOD+ PP+ PS+ PNOx) shall not exceed 4,0.
Pulp grade Reference values (kg/ADT)
CODref Pref Sref NOxref
Bleached chemical pulp (others than sulphite) 18,0 0,045(*1) 0,6 1,6
Bleached chemical pulp (sulphite) 25,0 0,045 0,6 1,6
CTMP 15,0 0,01 0,2 0,3
— MWh(electricity) is the electricity produced at the co-generation plant,
— MWh(heat) is the useful heat produced in a cogeneration process,
— MWh(heat)soldis the useful heat that is used outside the pulp manufacturing plant.
— COD: ISO 6060, EPA SM 5220D or HACH 8000,
— P: ISO 6878, SM4500, APAT IRSA CNR 4110 or Dr Lange LCK 349,
— S(oxid.): EPA 8 or equivalent,
— S(red.): EPA 8, EPA 16A or equivalent,
— S content in oil: ISO 8754 or EPA 8,
— S content in coal: ISO 351 or EPA 8,
— NOx: ISO 11564 or EPA 7E.
Fuel CO2fossil emissions Unit
Coal 95 g CO2 fossil/MJ
Crude oil 73 g CO2 fossil/MJ
Fuel oil 1 74 g CO2 fossil/MJ
Fuel oil 2-5 77 g CO2 fossil/MJ
LPG 69 g CO2 fossil/MJ
Natural Gas 56 g CO2 fossil/MJ
Grid Electricity 400 g CO2 fossil/kWh
(a) All pulp fibres shall be covered by valid chain of custody certificates issued by an independent third party certification scheme such as FSC, PEFC or equivalent.A minimum of 25 % pulp fibres shall be covered by valid Sustainable Forestry Management certificates issued by an independent third party certification scheme such as FSC, PEFC or equivalent.The remaining proportion of pulp fibres shall be covered by a verification system which ensures that it is legally sourced and meets any other requirement of the certification scheme with respect to uncertified material.The certification bodies issuing forest and/or chain of custody certificates shall be accredited/recognised by that certification scheme.
(b) Dissolving pulp produced from cotton linters shall meet the criterion 4.1 for cotton (sourcing and traceability).
(a) The applicant shall obtain from the pulp manufacturer(s) valid, independently certified chain of custody certificates demonstrating that wood fibres have been grown according to Sustainable Forestry Management principles and/or are from legal and controlled sources. FSC, PEFC or equivalent schemes shall be accepted as independent third party certification.
(b) The application shall provide evidence of compliance according to criterion 4.1 for cotton (sourcing and traceability).
— 0,170 kg/ADT, if measured in the wastewater from pulp manufacturing (AOX), or
— 150 ppm, if measured in the finished fibres (OCl).
— ISO 9562 or the equivalent EPA 1650C for AOX,
— ISO 11480 for OCl.
(a) More than 50 % of pulp used to manufacture fibres shall be obtained from dissolving pulp mills that recover value from their spent process liquor either by:—generating on-site electricity and steam, or—manufacturing chemical co-products. — generating on-site electricity and steam, or — manufacturing chemical co-products.
— generating on-site electricity and steam, or
— manufacturing chemical co-products.
— generating on-site electricity and steam, or
— manufacturing chemical co-products.
(b) The following limit values for the emission of sulphur compounds to air shall be respected in the viscose and in the modal fibres production process:Table 3Viscose and modal fibres sulphur emission valuesFibre typeSulphur emissions to air — Limit value (g/kg)Staple fibre30Filament fibre—Batch washing40—Integrated washing170Note:Limit values expressed as annual average. Fibre type Sulphur emissions to air — Limit value (g/kg) Staple fibre 30 Filament fibre —Batch washing — Batch washing 40 —Integrated washing — Integrated washing 170 Note:Limit values expressed as annual average.
Fibre type Sulphur emissions to air — Limit value (g/kg)
Staple fibre 30
Filament fibre
—Batch washing — Batch washing 40
— Batch washing
—Integrated washing — Integrated washing 170
— Integrated washing
Note:Limit values expressed as annual average.
Fibre type Sulphur emissions to air — Limit value (g/kg)
Staple fibre 30
Filament fibre
—Batch washing — Batch washing 40
— Batch washing
—Integrated washing — Integrated washing 170
— Integrated washing
Note:Limit values expressed as annual average.
— Batch washing
— Integrated washing
(a) The applicant shall make the fibres manufacturers to provide a list of pulp suppliers used to produce the fibres and the proportion they supply. Supporting documentation and evidence shall be provided that the required proportion of suppliers has the appropriate energy generating equipment or co-product recovery and manufacturing systems installed at related production sites.
(b) The applicant shall provide detailed documentation and test reports showing compliance with this criterion, together with a declaration of compliance.
(a) Cotton shall be grown according to the requirements laid down in Council Regulation (EC) No 834/2007(2), the US National Organic Programme (NOP) or equivalent legal obligations set by trade partners of the Union. The organic cotton content may include organically grown cotton and transitional organic cotton.
(b) Cotton grown according to criterion 4.1(a) and used to manufacture absorbent hygiene product shall be traceable from the point of verification of the production standard.
(a) Organic cotton content shall be certified by an independent control body to have been produced in conformity with the production and inspection requirements laid down in Regulation (EC) No 834/2007, the US National Organic Programme (NOP) or those set by other trade partners. Verification shall be provided on an annual basis for each country of origin.
(b) The applicant shall demonstrate compliance with the cotton content requirement for the annual volume of cotton purchased to manufacture the final product(s) and according to each product line on an annualised basis: Transaction records or invoices shall be provided that document the quantity of cotton purchased on an annual basis from farmers or producer groups, and the total weight of certified bales.
— water-saving (e.g. monitoring of water flow in a facility and circulating the water in closed systems),
— integrated waste management plan to optimise prevention, reuse, recycling, recovery and final disposal of waste (e.g. separation of different waste fractions),
— optimisation of energy efficiency and energy management (e.g. reuse of the steam generated during the manufacture of SAPs).
(a) Contents of lead, cadmium, hexavalent chrome and related compounds shall be lower than 0,01 % (100 ppm) of the mass of each plastic material and synthetic polymer used in the product.
(b) Additives used in plastics in concentration above 0,10 % by weight shall not be classified with any of the below listed hazard statements, in accordance with the classification rules in Regulation (EC) No 1272/2008 of the European Parliament and of the Council(3):—carcinogenic, mutagenic or toxic for reproduction, categories 1a, 1b and 2 (H340, H350, H350i, H360F, H360D, H360FD, H360Fd, H360Df),—acutely toxic, categories 1 and 2 (H300, H310, H330, H304),—toxic to specific target organs (STOT), category 1: (H370, H372),—hazardous to the aquatic environment, categories 1 and 2 (H400, H410, H411). — carcinogenic, mutagenic or toxic for reproduction, categories 1a, 1b and 2 (H340, H350, H350i, H360F, H360D, H360FD, H360Fd, H360Df), — acutely toxic, categories 1 and 2 (H300, H310, H330, H304), — toxic to specific target organs (STOT), category 1: (H370, H372), — hazardous to the aquatic environment, categories 1 and 2 (H400, H410, H411).
— carcinogenic, mutagenic or toxic for reproduction, categories 1a, 1b and 2 (H340, H350, H350i, H360F, H360D, H360FD, H360Fd, H360Df),
— acutely toxic, categories 1 and 2 (H300, H310, H330, H304),
— toxic to specific target organs (STOT), category 1: (H370, H372),
— hazardous to the aquatic environment, categories 1 and 2 (H400, H410, H411).
— carcinogenic, mutagenic or toxic for reproduction, categories 1a, 1b and 2 (H340, H350, H350i, H360F, H360D, H360FD, H360Fd, H360Df),
— acutely toxic, categories 1 and 2 (H300, H310, H330, H304),
— toxic to specific target organs (STOT), category 1: (H370, H372),
— hazardous to the aquatic environment, categories 1 and 2 (H400, H410, H411).
(a) Acrylamide (CAS number: 79-06-1) shall not be intentionally added to the product.
(b) Superabsorbent polymers used in the product may contain a maximum of 1 000 ppm residual monomers that are classified with the H-statements reported in criterion 7 on excluded or limited substances or mixtures. For sodium polyacrilate these represent total of unreacted acrylic acid and cross linkers.
(c) Superabsorbent polymers used in the product may, as a maximum, contain 10 % (weight/weight) of water-soluble extracts and these shall comply with criterion 7 on excluded or limited substances or mixtures. For sodium polyacrilate these represent monomers and oligomers of acrylic acid with lower molecular weight than the superabsorbent polymer according to ISO 17190.
(a) The applicant shall provide a declaration of non-use of the substance.
(b) The applicant shall provide a declaration from the supplier documenting the composition of the super absorbent polymer(s) used in the product. This shall be done by means of product safety data sheets which specify the full name and CAS number and the residual monomers contained in the product classified in accordance with the requirement and the quantities thereof. Recommended test methods are ISO 17190 and WSP 210. The methods used for the analyses shall be described and the names of the laboratories used for analysis shall be stated.
(c) The applicant shall provide a declaration from the supplier specifying the quantity of water-soluble extracts in the superabsorbent polymer(s). Recommended test methods are ISO 17190 and WSP 270. The methods used for the analyses shall be described and the analysis laboratories shall be stated.
— Colophony resins (CAS numbers 8050-09-7, 8052-10-6, 73138-82-6),
— Diisobutyl phthalate (DIBP, CAS number 84-69-5),
— Diisononyl phthalate (DINP, CAS number 28553-12-0),
— Formaldehyde (CAS number 50-00-0).
— tampon strings, packaging materials and tapes,
— titanium dioxide in polymers and viscose,
— materials that are not directly in contact with the skin may be dyed if the dye fulfils specific functions (e.g. reducing visibility of the product through white or light coloured clothing, showing landing zones of tapes, indicating the wetness).
(a) Products marketed as designed and intended for children as well tampons and nursing pads shall be fragrance-free.
(b) Any ingoing substance or mixture added to the product as a fragrance shall be manufactured and handled following the code of practice of the International Fragrance Association (IFRA). The code can be found on IFRA website: http://www.ifraorg.org. The recommendations of the IFRA Standards concerning prohibition, restricted use and specified purity criteria for materials shall be followed by the manufacturer.
(c) Any fragrance used shall also comply with Criterion 7 on excluded or limited substances or mixtures regardless of the concentration in the final product.
(d) Fragrances and ingredients of the fragrance mixtures that are identified as established contact allergens of special concern by the Scientific Committee on Consumer Safety(4)as well as the fragrances whose presence, in accordance with Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council(5), is required to be indicated in the list of ingredients shall not be used. Further the use of nitromusks and polycyclic musks is not allowed.
(e) The use of fragrances shall be indicated on the product packaging. Further, fragrances and/or ingredients of the fragrance mixtures that are identified as established contact allergens in humans by the Scientific Committee on Consumer and are not restricted by Criterion 6.3 (c) and (d) shall additionally be named.
(a) Lotions shall not be used in feminine care pads, tampons and nursing pads. The use of lotions in other products shall be indicated on the packaging.
(b) Any lotion used in products other than feminine care pads, tampons and nursing pads shall comply with Criterion 6.3 on fragrances and Criterion 7 on excluded or limited substances or mixtures regardless of their concentration in the final product.
(c) The following substances shall not be used: triclosan, parabens, formaldehyde and formaldehyde releasers.
(a) Where components of the product are treated with silicone, the manufacturer shall ensure that employees are protected from the solvents.
(b) Neither octamethyl cyclotetrasiloxane D4 (CAS 556-67-2) nor decamethyl cyclopentasiloxane D5 (CAS 541-02-6) shall be present in chemical products used in the silicone treatment of components. This requirement shall not apply where D4 and D5 are not intentionally added to the material or to the final product, and where D4 and D5 are present in the silicone in concentrations below 100 ppm (0,01 % by weight).
(a) The applicant shall provide information on the method used for the treatment of silicone and documentation attesting that employees are protected.
(b) The applicant shall provide a declaration from the supplier that this requirement has been fulfilled.
Hazard Statement(1) Risk Phrase(2)
H300 Fatal if swallowed R28
H301 Toxic if swallowed R25
H304 May be fatal if swallowed and enters airways R65
H310 Fatal in contact with skin R27
H311 Toxic in contact with skin R24
H330 Fatal if inhaled R23/26
H331 Toxic if inhaled R23
H340 May cause genetic defects R46
H341 Suspected of causing genetic defects R68
H350 May cause cancer R45
H350i May cause cancer by inhalation R49
H351 Suspected of causing cancer R40
H360F May damage fertility R60
H360D May damage the unborn child R61
H360FD May damage fertility. May damage the unborn child R60/61/60-61
H360Fd May damage fertility. Suspected of damaging the unborn child R60/63
H360Df May damage the unborn child. Suspected of damaging fertility R61/62
H361f Suspected of damaging fertility R62
H361d Suspected of damaging the unborn child R63
H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. R62-63
H362 May cause harm to breast fed children R64
H370 Causes damage to organs R39/23/24/25/26/27/28
H371 May cause damage to organs R68/20/21/22
H372 Causes damage to organs through prolonged or repeated exposure R48/25/24/23
H373 May cause damage to organs through prolonged or repeated exposure R48/20/21/22
H400 Very toxic to aquatic life R50
H410 Very toxic to aquatic life with long-lasting effects R50-53
H411 Toxic to aquatic life with long-lasting effects R51-53
H412 Harmful to aquatic life with long-lasting effects R52-53
H413 May cause long-lasting effects to aquatic life R53
EUH059 Hazardous to the ozone layer R59
EUH029 Contact with water liberates toxic gas R29
EUH031 Contact with acids liberates toxic gas R31
EUH032 Contact with acids liberates very toxic gas R32
EUH070 Toxic by eye contact R39-41
H317 (Sub-category 1A): May cause allergic skin reaction (trigger concentration ≥ 0,1 % w/w)(3) R43
H317 (Sub-category 1B): May cause allergic skin reaction (trigger concentration ≥ 1,0 % w/w)(3)
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled R42
— homogenous parts and any associated treatments or impurities (e.g. superabsorbent polymer layer): safety data sheets shall be provided for the materials composing that part of product and for substances and mixtures used in the formulation and treatment of the materials remaining in the final part above a cut-off limit of 0,10 % w/w unless a lower generic or specific concentration limit applies in accordance with the Article 10 of Regulation (EC) No 1272/2008,
— chemical recipes used to impart a specific function to the product or to components of the product (e.g. glues and adhesives, dyes): safety data sheets shall be provided for substances and mixtures used in the assembly of the final product or substances and mixtures applied to components of the product and remaining in the components of the product.
(i) for substances that have not been registered under Regulation (EC) No 1907/2006 or which do not yet have a harmonised CLP classification: information meeting the requirements listed in Annex VII to that Regulation;
(ii) for substances that have been registered under Regulation (EC) No 1907/2006 and which do not meet the requirements for CLP classification: information based on the REACH registration dossier confirming the non-classified status of the substance;
(iii) for substances that have a harmonised classification or are self-classified: safety data sheets where available. If these are not available or the substance is self-classified then information shall be provided relevant to the substances hazard classification in accordance with Annex II to Regulation (EC) No 1907/2006;
(iv) in the case of mixtures: safety data sheets where available. If these are not available then calculation of the mixture classification shall be provided according to the rules under Regulation (EC) No 1272/2008 together with information relevant to the mixtures hazard classification in accordance with Annex II to Regulation (EC) No 1907/2006.
— 10 % by weight of the end products for tampons,
— 5 % by weight of the end products for all the other products.
— the weight of product and packaging,
— all the waste streams generated during the manufacture, and
— the respective treatment processing (e.g. recycling, incineration), including the fraction of recovered waste and that disposed of.
— that the product must not be flushed into toilets,
— how to dispose the product correctly.
Characteristic Testing practice required (performance threshold)
Baby diapers Feminine care pads Tampons Nursing pads
In-use tests U1.Absorption and leakage protection(*2) U1. Absorption and leakage protection(*2) Consumer panel test (Leakage occurs in less than 5 % of the product uses)
U1. Absorption and leakage protection(*2)
U2.Skin dryness U2. Skin dryness Consumer panel test (80 % of the consumers testing the product shall rate the performance as satisfactory) Not applicable As for baby diapers
U2. Skin dryness
U3.Fit and comfort U3. Fit and comfort Consumer panel test (80 % of the consumers testing the product shall rate the performance as satisfactory)
U3. Fit and comfort
U4.Overall performance U4. Overall performance Consumer panel test (80 % of the consumers testing the product shall rate the performance as satisfactory)
U4. Overall performance
Technical tests T1.Absorption and leakage protection T1. Absorption and leakage protection Absorption rate and absorption before leakage Syngina method No method recommended
T1. Absorption and leakage protection
T2.Skin dryness T2. Skin dryness TEWL, rewet method or corneometric testing Not applicable No method recommended
T2. Skin dryness
U1. Absorption and leakage protection(*2)
U2. Skin dryness
U3. Fit and comfort
U4. Overall performance
T1. Absorption and leakage protection
T2. Skin dryness
— Sampling, test design, panel recruitment and the analysis of test results shall comply with standard statistical practices (AFNOR Q 34-019, ASTM E1958-07e1 or equivalent).
— Each product shall be assessed on the basis of a questionnaire. The test is to last at least 72 hours, a full week when possible, and shall be realised in normal conditions of use of the product.
— The recommended number of testers shall be at least 30. All the individuals participating to the survey shall be current users of the specific type/size of product tested.
— When the product is not designed specifically for a single gender, the ratio of male to female individuals shall be 1:1.
— A mixture of individuals representing proportionally different groups of consumers available on the market shall take part to the survey. Age, countries and genders shall be clearly stated.
— Sick individuals and those with a chronic skin condition should not participate in the test. In cases where individuals become ill during the course of the user trial, this is to be indicated on the questionnaire and the answers shall not be taken into consideration for the assessment.
— For skin dryness, fit and comfort and overall performance, 80 % of the consumers testing the product shall rate the performance as satisfactory, which could for instance mean that a rate above 60 is assigned by the consumer (on a quantitative scale from 1 to 100) or that the product has been assessed as good or very good (among five qualitative options: very poor, poor, average, good, very good). For absorption and leakage protection, leakage shall occur in less than 5 % of the products tested.
— The results shall be statistically evaluated after the user trial has been completed.
— External factors such as branding, market shares and advertising that may have an impact on the perceived performance of the products shall be communicated.
— Test methods shall be based as much as possible on product-relevant, reproducible and rigorous methods.
— A minimum of five samples shall be tested. Average results shall be reported together with indication of the standard deviation.
029 Forced Labour
087 Freedom of Association and Protection of the Right to Organise
098 Right to Organise and Collective Bargaining
100 Equal remuneration
105 Abolition of Forced Labour
111 Discrimination (Employment and Occupation)
138 Minimum Age Convention
155 Occupational safety and health
182 Elimination of the Worst Forms of Child Labour
— ‘Reduced impacts from consumption of resources’,
— ‘Restricted use of hazardous substances’,
— ‘Performance and quality tests satisfied’.
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,
After consulting the European Union Eco-labelling Board,
(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to products which have a reduced environmental impact during their entire life cycle.
(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.
(3) The criteria, as well as the related assessment and verification requirements should be valid for four years from the date of adoption of this Decision, taking into account the innovation cycle for this product group.
(4) Since consumption of materials can contribute significantly to the overall environmental impacts of absorbent hygiene products, it is appropriate to establish EU Ecolabel criteria for this product group. The criteria should, in particular, promote sustainable sourcing of materials, limited use of hazardous substances, high-quality and high-performance products which are fit-for-use and are designed to minimise waste production.
(5) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,
HAS ADOPTED THIS DECISION:

Article 1
1. The product group ‘absorbent hygiene products’ shall comprise baby diapers, feminine care pads, tampons and nursing pads (also known as breast pads), which are disposable and composed of a mix of natural fibres and polymers, with the fibre content lower than 90 % by weight (except for tampons).
2. The product group shall not include incontinence products and any other type of products falling under the scope of Council Directive 93/42/EEC(2).

Article 2
For the purpose of this Decision, the following definitions shall apply:
(1)
‘cellulose pulp’ means a fibrous material mainly composed of cellulose and obtained from the treatment of lignocellulosic materials with one or more aqueous solutions of pulping and/or bleaching chemicals;
(2)
‘optical brightener’ and ‘fluorescent whitening agent’ mean any additives used with the only purpose of ‘whitening’ or ‘brightening’ the material;
(3)
‘plastic materials’, also referred to as ‘plastics’, means synthetic polymers to which additives or other substances may have been added which can be moulded and used as main structural component of final materials and articles;
(4)
‘synthetic polymers’ means macromolecular substances, other than cellulose pulp, intentionally obtained either by a polymerisation process or chemical modification of natural or synthetic macromolecules or microbial fermentation;
(5)
‘super absorbent polymers’ means synthetic polymers designed for absorbing and retaining large amounts of liquid compared to their own mass.

Article 3
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, a product shall fall within the product group ‘absorbent hygiene products’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex.

Article 4
The criteria for the product group ‘absorbent hygiene products’, as well as the related assessment and verification requirements, shall be valid for four years from the date of adoption of this Decision.

Article 5
For administrative purposes, the code number assigned to the product group ‘absorbent hygiene products’ shall be ‘047’.

Article 6
This Decision is addressed to the Member States.

THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EC) No 66/2010 of the European Parliament and of the Council of 25 November 2009 on the EU Ecolabel(1), and in particular Article 8(2) thereof,
After consulting the European Union Eco-labelling Board,
(1) Under Regulation (EC) No 66/2010, the EU Ecolabel may be awarded to products which have a reduced environmental impact during their entire life cycle.
(2) Regulation (EC) No 66/2010 provides that specific EU Ecolabel criteria are to be established according to product groups.
(3) The criteria, as well as the related assessment and verification requirements should be valid for four years from the date of adoption of this Decision, taking into account the innovation cycle for this product group.
(4) Since consumption of materials can contribute significantly to the overall environmental impacts of absorbent hygiene products, it is appropriate to establish EU Ecolabel criteria for this product group. The criteria should, in particular, promote sustainable sourcing of materials, limited use of hazardous substances, high-quality and high-performance products which are fit-for-use and are designed to minimise waste production.
(5) The measures provided for in this Decision are in accordance with the opinion of the Committee established by Article 16 of Regulation (EC) No 66/2010,
HAS ADOPTED THIS DECISION:
1. The product group ‘absorbent hygiene products’ shall comprise baby diapers, feminine care pads, tampons and nursing pads (also known as breast pads), which are disposable and composed of a mix of natural fibres and polymers, with the fibre content lower than 90 % by weight (except for tampons).
2. The product group shall not include incontinence products and any other type of products falling under the scope of Council Directive 93/42/EEC(2).
For the purpose of this Decision, the following definitions shall apply:
(1)
‘cellulose pulp’ means a fibrous material mainly composed of cellulose and obtained from the treatment of lignocellulosic materials with one or more aqueous solutions of pulping and/or bleaching chemicals;
(2)
‘optical brightener’ and ‘fluorescent whitening agent’ mean any additives used with the only purpose of ‘whitening’ or ‘brightening’ the material;
(3)
‘plastic materials’, also referred to as ‘plastics’, means synthetic polymers to which additives or other substances may have been added which can be moulded and used as main structural component of final materials and articles;
(4)
‘synthetic polymers’ means macromolecular substances, other than cellulose pulp, intentionally obtained either by a polymerisation process or chemical modification of natural or synthetic macromolecules or microbial fermentation;
(5)
‘super absorbent polymers’ means synthetic polymers designed for absorbing and retaining large amounts of liquid compared to their own mass.
In order to be awarded the EU Ecolabel under Regulation (EC) No 66/2010, a product shall fall within the product group ‘absorbent hygiene products’ as defined in Article 1 of this Decision and shall comply with the criteria as well as the related assessment and verification requirements set out in the Annex.
The criteria for the product group ‘absorbent hygiene products’, as well as the related assessment and verification requirements, shall be valid for four years from the date of adoption of this Decision.
For administrative purposes, the code number assigned to the product group ‘absorbent hygiene products’ shall be ‘047’.
This Decision is addressed to the Member States.

ASSESSMENT AND VERIFICATION REQUIREMENTS

ANNEXThe specific assessment and verification requirements are indicated within each criterion.
Where the applicant is required to provide declarations, documentation, analyses, test reports, or other evidence to show compliance with the criteria, these may originate from the applicant or his supplier or both.
Competent bodies shall preferentially recognise tests which are accredited according to ISO 17025 and verifications performed by bodies which are accredited under the EN 45011 standard or an equivalent international standard.
Where appropriate, test methods other than those indicated for each criterion may be used if the competent body assessing the application accepts their equivalence.
Where appropriate, competent bodies may require supporting documentation and may carry out independent verifications.
As pre-requisite, the product shall meet all respective legal requirements of the country (countries) in which the product is intended to be placed on the market. The applicant shall declare the product’s compliance with this requirement.
EU ECOLABEL CRITERIACriteria for awarding the EU Ecolabel to absorbent hygiene products:

1. | Product description
2. | Fluff pulp
3. | Man-made cellulose fibres (including viscose, modal, lyocell, cupro, triacetate)
4. | Cotton and other natural cellulosic seed fibres
5. | Plastic materials and superabsorbent polymers
6. | Other materials and components
7. | Excluded or limited substances or mixtures
8. | Material efficiency in the manufacturing
9. | Guidance on the product disposal
10. | Fitness for use and quality of the product
11. | Social aspects
12. | Information appearing on the EU EcolabelThe EU Ecolabel criteria shall reflect the best environmental performing products on the market of absorbent hygiene products.

Criterion 1. Product description
A description of the product and packaging shall be provided (product name, classification, functionalities) together with information on all of the following characteristics:

— | the total weight of the product and packaging,
— | the components, materials and additives used in the product with their respective weights and, whenever applicable, their respective CAS numbers.Information on the weight of the product shall be also displayed in the packaging.

Assessment and verification:
The applicant shall provide a sample of the product and a report including the technical description and the weight of the product and of each component, material and additive used.

Criterion 2. Fluff pulp
2.1. Sourcing
All pulp fibres shall be covered by valid chain of custody certificates issued by an independent third party certification scheme such as FSC, PEFC or equivalent.
A minimum of 25 % pulp fibres shall be covered by valid Sustainable Forestry Management certificates issued by an independent third party certification scheme such as FSC, PEFC or equivalent.
The remaining proportion of pulp fibres shall be covered by a verification system which ensures that it is legally sourced and meets any other requirement of the certification scheme with respect to uncertified material.
The certification bodies issuing forest and/or chain of custody certificates shall be accredited/recognised by that certification scheme.

Assessment and verification:
The applicant shall obtain from the pulp manufacturer(s) valid, independently certified chain of custody certificates demonstrating that wood fibres have been grown according to Sustainable Forestry Management principles and/or are from legal and controlled sources. FSC, PEFC or equivalent schemes shall be accepted as independent third party certification.
2.2. Bleaching
The pulp used in the product shall not be bleached with the use of chlorine gas. The total amount of AOX emissions from pulp manufacturing shall not exceed 0,170 kg/ADT.

Assessment and verification:
The applicant shall provide a declaration from the pulp manufacturer that chlorine gas was not used and a test report showing compliance with the AOX limit value. ISO 9562 or the equivalent EPA 1650C shall be accepted as test methods, accompanied by detailed calculations showing compliance with this requirement, together with related supporting documentation.
The supporting documentation shall include an indication of the measurement frequency. AOX shall only be measured in processes where chlorine compounds are used for the bleaching of the pulp.
Measurements shall be taken on unfiltered and unsettled samples either after treatment at the plant or after treatment by a public treatment plant.
The measurement period shall be 12 months of production. Measurements shall be taken on a monthly basis from representative composite samples (24 hours composite).
For a new or rebuilt plant or a change of process at the production plant, measurements shall be done on a weekly basis for a total of 8 consecutive weeks following steady running of the plant. The measurement shall be representative of the respective campaign.
2.3. Optical brighteners and colouring agents
Optical brighteners and colouring agents, including fluorescent whitening agents, shall not be intentionally added to the pulp.

Assessment and verification:
The applicant shall provide a declaration from the supplier that the requirements have been fulfilled.
2.4. Emission of COD and phosphorous (P) to water and sulphur (S) compounds and NOx to air from production
The emissions to air and water from the pulp production shall be expressed in terms of points (PCOD, PP, PS, PNOx). Points are calculated by dividing actual emission by the reference values reported in Table 1.

— | None of the individual points PCOD, PP, PS, PNOx, shall exceed 1,5.
— | The total number of points (Ptotal= PCOD+ PP+ PS+ PNOx) shall not exceed 4,0.For each pulp ‘i’ sourced, the related measured emissions (expressed in kg/air dried tonne — ADT) shall be weighted according to the proportion of pulp sourced (pulp ‘i’ with respect to air dried tonne of pulp) and summed together. The reference values for each pulp type used and for the paper production are given in the Table 1. Finally, the total emissions shall be divided by the total reference value as shown in the following formula for COD:

Table 1

Reference values for emissions from different pulp types

Pulp grade | Reference values (kg/ADT)
CODref | Pref | Sref | NOxref
Bleached chemical pulp (others than sulphite) | 18,0 | 0,045(*1) | 0,6 | 1,6
Bleached chemical pulp (sulphite) | 25,0 | 0,045 | 0,6 | 1,6
CTMP | 15,0 | 0,01 | 0,2 | 0,3In case of a co-generation of heat and electricity at the same plant, the emissions of S and NOx resulting from electricity generation shall be subtracted from the total amount. The following equation shall be used to calculate the proportion of the emissions resulting from heat generation: [MWh(heat) — MWh(heat)sold]/[MWh(heat) + 2 × MWh(electricity)]
Where,

— | MWh(electricity) is the electricity produced at the co-generation plant,
— | MWh(heat) is the useful heat produced in a cogeneration process,
— | MWh(heat)soldis the useful heat that is used outside the pulp manufacturing plant.
Assessment and verification:
The applicant shall provide detailed calculations showing compliance with this criterion, together with related supporting documentation which shall include test reports using the following test methods:

— | COD: ISO 6060, EPA SM 5220D or HACH 8000,
— | P: ISO 6878, SM4500, APAT IRSA CNR 4110 or Dr Lange LCK 349,
— | S(oxid.): EPA 8 or equivalent,
— | S(red.): EPA 8, EPA 16A or equivalent,
— | S content in oil: ISO 8754 or EPA 8,
— | S content in coal: ISO 351 or EPA 8,
— | NOx: ISO 11564 or EPA 7E.The supporting documentation shall include an indication of the measurement frequency and the calculation of the points for COD, P, S and NOx. It shall include all emissions of S and NOx which occur during the production of pulp, including steam generated outside the production site, except those emissions related to the production of electricity.
Measurements shall include recovery boilers, lime kilns, steam boilers and destructor furnaces for strong smelling gases. Diffuse emissions shall be taken into account.
Reported emission values for S to air shall include both oxidised and reduced S emissions (dimethyl sulphide, methyl mercaptan, hydrogen sulphide and similar emissions). The S emissions related to the heat energy generation from oil, coal and other external fuels with known S content may be calculated instead of measured, and shall be taken into account.
Measurements of emissions to water shall be taken on unfiltered and unsettled samples either after treatment at the plant or after treatment by a public treatment plant.
The measurement period shall be 12 months of production. Measurements for COD and P shall be taken on a monthly basis and measurements for S and NOxon a yearly basis. Alternatively, continuous measurements can be accepted if they are verified by a third party at least once per year.
For a new or rebuilt plant or a change of process at the production plant, measurements shall be done on a weekly basis for a total of 8 consecutive weeks following steady running of the plant. The measurement shall be representative of the respective campaign.
2.5. Emissions of CO2 from production
CO2emissions from non-renewable energy sources shall not exceed 450 kg per tonne of pulp produced, including emissions from the production of electricity (whether on-site or off-site). Reference emission values according to Table 2 shall be used in the calculation of CO2emission from fuels.

Table 2

Reference values for CO2 emissions from different energy sources

Fuel | CO2fossil emissions | Unit
Coal | 95 | g CO2 fossil/MJ
Crude oil | 73 | g CO2 fossil/MJ
Fuel oil 1 | 74 | g CO2 fossil/MJ
Fuel oil 2-5 | 77 | g CO2 fossil/MJ
LPG | 69 | g CO2 fossil/MJ
Natural Gas | 56 | g CO2 fossil/MJ
Grid Electricity | 400 | g CO2 fossil/kWh
Assessment and verification:
The applicant shall provide detailed calculations showing compliance with this requirement, together with related supporting documentation.
The applicant shall provide data on the air emissions of carbon dioxide. This shall include all sources of non-renewable fuels during the production of pulp, including the emissions from the production of electricity (whether on-site or off-site).
The measurement period shall be 12 months of production. Measurements shall be done on a yearly basis.
For a new or rebuilt plant or a change of process at the production plant, measurements shall be done on a weekly basis for a total of 8 consecutive weeks following steady running of the plant. Results have to be shown also after 12 months of production. The measurement shall be representative of the respective campaign.
The amount of energy from renewable sources(1)purchased and used for the production processes will not be considered in the calculation of the CO2emissions: appropriate documentation that this kind of energy are actually used at the mill or are externally purchased shall be provided by the applicant.

Criterion 3. Man-made cellulose fibres (including viscose, modal, lyocell, cupro, triacetate)
3.1. Sourcing

(a) | All pulp fibres shall be covered by valid chain of custody certificates issued by an independent third party certification scheme such as FSC, PEFC or equivalent.A minimum of 25 % pulp fibres shall be covered by valid Sustainable Forestry Management certificates issued by an independent third party certification scheme such as FSC, PEFC or equivalent.The remaining proportion of pulp fibres shall be covered by a verification system which ensures that it is legally sourced and meets any other requirement of the certification scheme with respect to uncertified material.The certification bodies issuing forest and/or chain of custody certificates shall be accredited/recognised by that certification scheme.
(b) | Dissolving pulp produced from cotton linters shall meet the criterion 4.1 for cotton (sourcing and traceability).
Assessment and verification:

(a) | The applicant shall obtain from the pulp manufacturer(s) valid, independently certified chain of custody certificates demonstrating that wood fibres have been grown according to Sustainable Forestry Management principles and/or are from legal and controlled sources. FSC, PEFC or equivalent schemes shall be accepted as independent third party certification.
(b) | The application shall provide evidence of compliance according to criterion 4.1 for cotton (sourcing and traceability).3.2. Bleaching
The pulp used to manufacture fibres shall not be bleached with the use of chlorine gas. The resulting total amount of adsorbable organically bound halogens (AOX) and organically bound chlorine (OCl) shall not exceed either of the following:

— | 0,170 kg/ADT, if measured in the wastewater from pulp manufacturing (AOX), or
— | 150 ppm, if measured in the finished fibres (OCl).
Assessment and verification:
The applicant shall provide a declaration from the pulp supplier that chlorine gas is not used and a test report showing compliance with either the AOX or the OCl requirement, using the appropriate test method:

— | ISO 9562 or the equivalent EPA 1650C for AOX,
— | ISO 11480 for OCl.Frequency of measurement for AOX shall be set in accordance with the criterion 2.2 for fluff pulp.
3.3. Optical brighteners and colouring agents
Optical brighteners and colouring agents, including fluorescent whitening agents, shall not be intentionally added to the fibres.

Assessment and verification:
The applicant shall provide a declaration from the supplier that the requirements have been fulfilled.
3.4. Production of fibres

(a) | More than 50 % of pulp used to manufacture fibres shall be obtained from dissolving pulp mills that recover value from their spent process liquor either by:—generating on-site electricity and steam, or—manufacturing chemical co-products. | — | generating on-site electricity and steam, or | — | manufacturing chemical co-products.
— | generating on-site electricity and steam, or
— | manufacturing chemical co-products.
(b) | The following limit values for the emission of sulphur compounds to air shall be respected in the viscose and in the modal fibres production process:Table 3Viscose and modal fibres sulphur emission valuesFibre typeSulphur emissions to air — Limit value (g/kg)Staple fibre30Filament fibre—Batch washing40—Integrated washing170Note:Limit values expressed as annual average. | Fibre type | Sulphur emissions to air — Limit value (g/kg) | Staple fibre | 30 | Filament fibre | | —Batch washing | — | Batch washing | 40 | —Integrated washing | — | Integrated washing | 170 | Note:Limit values expressed as annual average.
Fibre type | Sulphur emissions to air — Limit value (g/kg)
Staple fibre | 30
Filament fibre |
—Batch washing | — | Batch washing | 40
— | Batch washing
—Integrated washing | — | Integrated washing | 170
— | Integrated washing
Note:Limit values expressed as annual average.
Assessment and verification:

(a) | The applicant shall make the fibres manufacturers to provide a list of pulp suppliers used to produce the fibres and the proportion they supply. Supporting documentation and evidence shall be provided that the required proportion of suppliers has the appropriate energy generating equipment or co-product recovery and manufacturing systems installed at related production sites.
(b) | The applicant shall provide detailed documentation and test reports showing compliance with this criterion, together with a declaration of compliance.
Criterion 4. Cotton and other natural cellulosic seed fibres
4.1. Sourcing and traceability

(a) | Cotton shall be grown according to the requirements laid down in Council Regulation (EC) No 834/2007(2), the US National Organic Programme (NOP) or equivalent legal obligations set by trade partners of the Union. The organic cotton content may include organically grown cotton and transitional organic cotton.
(b) | Cotton grown according to criterion 4.1(a) and used to manufacture absorbent hygiene product shall be traceable from the point of verification of the production standard.
Assessment and verification:

(a) | Organic cotton content shall be certified by an independent control body to have been produced in conformity with the production and inspection requirements laid down in Regulation (EC) No 834/2007, the US National Organic Programme (NOP) or those set by other trade partners. Verification shall be provided on an annual basis for each country of origin.
(b) | The applicant shall demonstrate compliance with the cotton content requirement for the annual volume of cotton purchased to manufacture the final product(s) and according to each product line on an annualised basis: Transaction records or invoices shall be provided that document the quantity of cotton purchased on an annual basis from farmers or producer groups, and the total weight of certified bales.4.2. Bleaching
Cotton shall not be bleached with the use of chlorine gas.

Assessment and verification:
The applicant shall provide a declaration from the supplier that chlorine gas is not used.
4.3. Optical brighteners and colouring agents
Optical brighteners and colouring agents, including fluorescent whitening agents, shall not be intentionally added to the cotton.

Assessment and verification:
The applicant shall provide a declaration from the supplier that the requirements have been fulfilled.

Criterion 5. Plastic materials and superabsorbent polymers
5.1. Production of synthetic polymers and plastic materials
All plants producing synthetic polymers and plastic materials used in the product shall have implemented systems for:

— | water-saving (e.g. monitoring of water flow in a facility and circulating the water in closed systems),
— | integrated waste management plan to optimise prevention, reuse, recycling, recovery and final disposal of waste (e.g. separation of different waste fractions),
— | optimisation of energy efficiency and energy management (e.g. reuse of the steam generated during the manufacture of SAPs).
Assessment and verification:
The applicant shall provide a declaration of compliance with the requirement from the suppliers. The declaration shall be supported by a report describing in detail the procedures adopted by the suppliers in order to fulfil the requirement for each of the sites concerned.
5.2. Additives in plastic materials

(a) | Contents of lead, cadmium, hexavalent chrome and related compounds shall be lower than 0,01 % (100 ppm) of the mass of each plastic material and synthetic polymer used in the product.
(b) | Additives used in plastics in concentration above 0,10 % by weight shall not be classified with any of the below listed hazard statements, in accordance with the classification rules in Regulation (EC) No 1272/2008 of the European Parliament and of the Council(3):—carcinogenic, mutagenic or toxic for reproduction, categories 1a, 1b and 2 (H340, H350, H350i, H360F, H360D, H360FD, H360Fd, H360Df),—acutely toxic, categories 1 and 2 (H300, H310, H330, H304),—toxic to specific target organs (STOT), category 1: (H370, H372),—hazardous to the aquatic environment, categories 1 and 2 (H400, H410, H411). | — | carcinogenic, mutagenic or toxic for reproduction, categories 1a, 1b and 2 (H340, H350, H350i, H360F, H360D, H360FD, H360Fd, H360Df), | — | acutely toxic, categories 1 and 2 (H300, H310, H330, H304), | — | toxic to specific target organs (STOT), category 1: (H370, H372), | — | hazardous to the aquatic environment, categories 1 and 2 (H400, H410, H411).
— | carcinogenic, mutagenic or toxic for reproduction, categories 1a, 1b and 2 (H340, H350, H350i, H360F, H360D, H360FD, H360Fd, H360Df),
— | acutely toxic, categories 1 and 2 (H300, H310, H330, H304),
— | toxic to specific target organs (STOT), category 1: (H370, H372),
— | hazardous to the aquatic environment, categories 1 and 2 (H400, H410, H411).
Assessment and verification:
(a), (b) The applicant shall provide a declaration of compliance with the requirements from the suppliers. A list of added substances shall be also provided, including concentrations and related H statements/R phrases, supported by safety data sheets.
In order to facilitate follow-up and monitoring of the documentation provided, a random sample of suppliers may be examined. The supplier shall provide access to production facilities, warehouses and similar installations. Confidentiality applies to any documentation and information submitted and shared.
5.3. Superabsorbent polymers

(a) | Acrylamide (CAS number: 79-06-1) shall not be intentionally added to the product.
(b) | Superabsorbent polymers used in the product may contain a maximum of 1 000 ppm residual monomers that are classified with the H-statements reported in criterion 7 on excluded or limited substances or mixtures. For sodium polyacrilate these represent total of unreacted acrylic acid and cross linkers.
(c) | Superabsorbent polymers used in the product may, as a maximum, contain 10 % (weight/weight) of water-soluble extracts and these shall comply with criterion 7 on excluded or limited substances or mixtures. For sodium polyacrilate these represent monomers and oligomers of acrylic acid with lower molecular weight than the superabsorbent polymer according to ISO 17190.
Assessment and verification:

(a) | The applicant shall provide a declaration of non-use of the substance.
(b) | The applicant shall provide a declaration from the supplier documenting the composition of the super absorbent polymer(s) used in the product. This shall be done by means of product safety data sheets which specify the full name and CAS number and the residual monomers contained in the product classified in accordance with the requirement and the quantities thereof. Recommended test methods are ISO 17190 and WSP 210. The methods used for the analyses shall be described and the names of the laboratories used for analysis shall be stated.
(c) | The applicant shall provide a declaration from the supplier specifying the quantity of water-soluble extracts in the superabsorbent polymer(s). Recommended test methods are ISO 17190 and WSP 270. The methods used for the analyses shall be described and the analysis laboratories shall be stated.
Criterion 6. Other materials and components
6.1. Adhesive materials
Adhesive materials shall not contain any of the following substances:

— | Colophony resins (CAS numbers 8050-09-7, 8052-10-6, 73138-82-6),
— | Diisobutyl phthalate (DIBP, CAS number 84-69-5),
— | Diisononyl phthalate (DINP, CAS number 28553-12-0),
— | Formaldehyde (CAS number 50-00-0).This requirement shall not apply if those substances are not intentionally added to the material or to the final product, and are present in the adhesive materials in concentrations below 100 ppm (0,010 % by weight).
For formaldehyde, the maximum limit for the content of formaldehyde generated during adhesive production shall be 250 ppm, measured in newly produced polymer dispersion. Content of free formaldehyde in hardened adhesive (glue) shall not exceed 10 ppm. Hotmelt adhesives shall be exempted from this requirement.

Assessment and verification:
The applicant shall provide a declaration from the supplier that the requirements have been fulfilled. Safety data sheets may be used as proof. Test results for formaldehyde shall be provided, with the exception of hotmelt adhesives.
6.2. Inks and dyes
The product and any homogeneous part of it shall not be dyed. Derogations to this requirement shall apply to:

— | tampon strings, packaging materials and tapes,
— | titanium dioxide in polymers and viscose,
— | materials that are not directly in contact with the skin may be dyed if the dye fulfils specific functions (e.g. reducing visibility of the product through white or light coloured clothing, showing landing zones of tapes, indicating the wetness).Inks and dyes used shall also comply with Criterion 7 on excluded or limited substances or mixtures.

Assessment and verification:
The applicant shall provide and shall make suppliers to provide a declaration that the requirements have been fulfilled. In case dyes are used, their presence shall be justified by indicating the specific function provided.
6.3. Fragrances

(a) | Products marketed as designed and intended for children as well tampons and nursing pads shall be fragrance-free.
(b) | Any ingoing substance or mixture added to the product as a fragrance shall be manufactured and handled following the code of practice of the International Fragrance Association (IFRA). The code can be found on IFRA website: http://www.ifraorg.org. The recommendations of the IFRA Standards concerning prohibition, restricted use and specified purity criteria for materials shall be followed by the manufacturer.
(c) | Any fragrance used shall also comply with Criterion 7 on excluded or limited substances or mixtures regardless of the concentration in the final product.
(d) | Fragrances and ingredients of the fragrance mixtures that are identified as established contact allergens of special concern by the Scientific Committee on Consumer Safety(4)as well as the fragrances whose presence, in accordance with Annex III to Regulation (EC) No 1223/2009 of the European Parliament and of the Council(5), is required to be indicated in the list of ingredients shall not be used. Further the use of nitromusks and polycyclic musks is not allowed.
(e) | The use of fragrances shall be indicated on the product packaging. Further, fragrances and/or ingredients of the fragrance mixtures that are identified as established contact allergens in humans by the Scientific Committee on Consumer and are not restricted by Criterion 6.3 (c) and (d) shall additionally be named.
Assessment and verification:
The applicant shall provide a declaration of compliance for all the requirements laid down in points (a) to (e), supported by a declaration of the fragrance manufacturer, if appropriate. The list of fragrances used and visual evidence that information has been added to the packaging shall be also provided, when fragrances are used.
6.4. Lotions

(a) | Lotions shall not be used in feminine care pads, tampons and nursing pads. The use of lotions in other products shall be indicated on the packaging.
(b) | Any lotion used in products other than feminine care pads, tampons and nursing pads shall comply with Criterion 6.3 on fragrances and Criterion 7 on excluded or limited substances or mixtures regardless of their concentration in the final product.
(c) | The following substances shall not be used: triclosan, parabens, formaldehyde and formaldehyde releasers.
Assessment and verification:
The applicant shall provide a declaration of compliance supported by a declaration of the lotion manufacturer, if appropriate. Visual evidence that information has been added to the packaging shall be also provided, when lotions are used.
6.5. Silicone

(a) | Where components of the product are treated with silicone, the manufacturer shall ensure that employees are protected from the solvents.
(b) | Neither octamethyl cyclotetrasiloxane D4 (CAS 556-67-2) nor decamethyl cyclopentasiloxane D5 (CAS 541-02-6) shall be present in chemical products used in the silicone treatment of components. This requirement shall not apply where D4 and D5 are not intentionally added to the material or to the final product, and where D4 and D5 are present in the silicone in concentrations below 100 ppm (0,01 % by weight).
Assessment and verification:

(a) | The applicant shall provide information on the method used for the treatment of silicone and documentation attesting that employees are protected.
(b) | The applicant shall provide a declaration from the supplier that this requirement has been fulfilled.6.6. Nanosilver particles
Nanosilver particles shall not be intentionally added to the product or to any homogeneous part or material of it.

Assessment and verification
The applicant shall provide a declaration and shall make suppliers to provide a declaration that this requirement has been fulfilled.

Criterion 7. Excluded or limited substances or mixtures
7.1. Hazardous substances and mixtures
The EU Ecolabel may not be awarded if the product or any article of it, as defined in Article 3(3) of Regulation (EC) No 1907/2006 of the European Parliament and of the Council(6), or any homogenous part of it contain substances or mixtures meeting the criteria for classification with the hazard statements or risk phrases specified in table 4, in accordance with Regulation (EC) No 1272/2008 or Council Directive 67/548/EEC(7), nor they contain substances or mixtures referred to in Article 57 of Regulation (EC) No 1907/2006, unless they have been specifically derogated from.
The most recent classification rules adopted by the Union shall take precedence over the listed hazard classifications and risk phrases. Applicants shall therefore ensure that any classifications are based on the most recent classification rules.
The hazard statements and the risk phrases in table 4 generally refer to substances. However, if information on substances cannot be obtained, the classification rules for mixtures shall apply.
Substances or mixtures which change their properties through processing and thus become no longer bioavailable or undergo chemical modification in a way that removes the previously identified hazard are exempted from criterion 7.1. This shall include, for instance, modified polymers and monomers or additives, which become covalently bonded within plastics.
Concentration limits for substances or mixtures which may be or have been assigned the hazard statements or risk phrase listed in table 4, meeting the criteria for classification in the hazard classes or categories, and for substances meeting the criteria of Article 57 (a), (b) or (c) of Regulation (EC) No 1907/2006, shall not exceed the generic or specific concentration limits determined in accordance with Article 10 of Regulation (EC) No 1272/2008. Where specific concentration limits are determined they shall prevail over the generic ones.

Table 4

Hazard statements and respective risk phrases

Hazard Statement(1) | Risk Phrase(2)
H300 Fatal if swallowed | R28
H301 Toxic if swallowed | R25
H304 May be fatal if swallowed and enters airways | R65
H310 Fatal in contact with skin | R27
H311 Toxic in contact with skin | R24
H330 Fatal if inhaled | R23/26
H331 Toxic if inhaled | R23
H340 May cause genetic defects | R46
H341 Suspected of causing genetic defects | R68
H350 May cause cancer | R45
H350i May cause cancer by inhalation | R49
H351 Suspected of causing cancer | R40
H360F May damage fertility | R60
H360D May damage the unborn child | R61
H360FD May damage fertility. May damage the unborn child | R60/61/60-61
H360Fd May damage fertility. Suspected of damaging the unborn child | R60/63
H360Df May damage the unborn child. Suspected of damaging fertility | R61/62
H361f Suspected of damaging fertility | R62
H361d Suspected of damaging the unborn child | R63
H361fd Suspected of damaging fertility. Suspected of damaging the unborn child. | R62-63
H362 May cause harm to breast fed children | R64
H370 Causes damage to organs | R39/23/24/25/26/27/28
H371 May cause damage to organs | R68/20/21/22
H372 Causes damage to organs through prolonged or repeated exposure | R48/25/24/23
H373 May cause damage to organs through prolonged or repeated exposure | R48/20/21/22
H400 Very toxic to aquatic life | R50
H410 Very toxic to aquatic life with long-lasting effects | R50-53
H411 Toxic to aquatic life with long-lasting effects | R51-53
H412 Harmful to aquatic life with long-lasting effects | R52-53
H413 May cause long-lasting effects to aquatic life | R53
EUH059 Hazardous to the ozone layer | R59
EUH029 Contact with water liberates toxic gas | R29
EUH031 Contact with acids liberates toxic gas | R31
EUH032 Contact with acids liberates very toxic gas | R32
EUH070 Toxic by eye contact | R39-41
H317 (Sub-category 1A): May cause allergic skin reaction (trigger concentration ≥ 0,1 % w/w)(3) | R43
H317 (Sub-category 1B): May cause allergic skin reaction (trigger concentration ≥ 1,0 % w/w)(3)
H334: May cause allergy or asthma symptoms or breathing difficulties if inhaled | R42

Assessment and verification:
The applicant shall provide the bill of materials of the product, including a list with all articles and homogeneous part of it.
The applicant shall screen the presence of substances and mixtures that may be classified with the hazard statements or risk phrases reported in this criterion. The applicant shall provide a declaration of compliance with this criterion for the product, any article of it or any homogenous part of it.
Applicants shall select the appropriate forms of verification. The main forms of verification are set out as follows:

— | homogenous parts and any associated treatments or impurities (e.g. superabsorbent polymer layer): safety data sheets shall be provided for the materials composing that part of product and for substances and mixtures used in the formulation and treatment of the materials remaining in the final part above a cut-off limit of 0,10 % w/w unless a lower generic or specific concentration limit applies in accordance with the Article 10 of Regulation (EC) No 1272/2008,
— | chemical recipes used to impart a specific function to the product or to components of the product (e.g. glues and adhesives, dyes): safety data sheets shall be provided for substances and mixtures used in the assembly of the final product or substances and mixtures applied to components of the product and remaining in the components of the product.That declaration shall include related documentation, such as declarations of compliance signed by the suppliers, on the non-classification of the substances, mixtures or materials with any of the hazard classes associated to the hazard statements or risk phrases referred in table 4 in accordance with Regulation (EC) No 1272/2008, as far as this can be determined, as a minimum, from the information meeting the requirements listed in Annex VII to Regulation (EC) No 1907/2006.
The information provided shall relate to the forms or physical states of the substances or mixtures as used in the final product.
The following technical information shall be provided to support the declaration of classification or non-classification for each substance and mixture:

(i) | for substances that have not been registered under Regulation (EC) No 1907/2006 or which do not yet have a harmonised CLP classification: information meeting the requirements listed in Annex VII to that Regulation;
(ii) | for substances that have been registered under Regulation (EC) No 1907/2006 and which do not meet the requirements for CLP classification: information based on the REACH registration dossier confirming the non-classified status of the substance;
(iii) | for substances that have a harmonised classification or are self-classified: safety data sheets where available. If these are not available or the substance is self-classified then information shall be provided relevant to the substances hazard classification in accordance with Annex II to Regulation (EC) No 1907/2006;
(iv) | in the case of mixtures: safety data sheets where available. If these are not available then calculation of the mixture classification shall be provided according to the rules under Regulation (EC) No 1272/2008 together with information relevant to the mixtures hazard classification in accordance with Annex II to Regulation (EC) No 1907/2006.Safety data sheets (SDS) shall be completed in accordance with the guidance set out in Section 2, 3, 9, 10, 11 and 12 of Annex II to Regulation (EC) No 1907/2006 (requirements for the compilation of safety data sheets). Incomplete SDS shall require supplementing with information from declarations by chemical suppliers.
Information on intrinsic properties of substances may be generated by means other than tests, for instance through the use of alternative methods such as in vitro methods, by quantitative structure activity models or by the use of grouping or read-across in accordance with Annex XI to Regulation (EC) No 1907/2006. The sharing of relevant data across the supply chain is strongly encouraged.
7.2. Substances listed in accordance with Article 59(1) of Regulation (EC) No 1907/2006
No derogation from the exclusion in Article 6(6) of Regulation (EC) No 66/2010 shall be given concerning substances identified as substances of very high concern and included in the list provided for in Article 59(1) of Regulation (EC) No 1907/2006, present in mixtures, in an article or in any homogeneous part of the product in concentrations > 0,10 % by weight.

Assessment and verification
Reference to the latest list of substances of very high concern shall be made on the date of application. The applicant shall provide a declaration of compliance with criterion 7.2, together with related documentation, including declarations of compliance signed by the material suppliers and copies of relevant SDS for substances or mixtures in accordance with Annex II to Regulation (EC) No 1907/2006 for substances or mixtures. Concentration limits shall be specified in the safety data sheets in accordance with Article 31 of Regulation (EC) No 1907/2006 for substances and mixtures.

Criterion 8. Material efficiency in the manufacturing
The quantity of waste generated during the manufacture and packaging of the products, at the net of the fraction that is reused or converted into useful materials and/or energy, shall not exceed:

— | 10 % by weight of the end products for tampons,
— | 5 % by weight of the end products for all the other products.
Assessment and verification
The applicant shall provide evidence of the quantity of waste that has not been reused within the manufacturing process or that is not converted into materials and/or energy.
Calculations shall be shown in accordance with ISO 14025 and the applicant shall present all of the following parameters concerning:

— | the weight of product and packaging,
— | all the waste streams generated during the manufacture, and
— | the respective treatment processing (e.g. recycling, incineration), including the fraction of recovered waste and that disposed of.The net waste shall be calculated as the difference between the amount of waste produced and the amount of waste recovered.

Criterion 9. Guidance on the product disposal
The producers shall write or indicate through visual symbols on the packaging:

— | that the product must not be flushed into toilets,
— | how to dispose the product correctly.
Assessment and verification:
The applicant shall provide a sample of the packaging.

Criterion 10. Fitness for use and quality of the product
The efficiency/quality of the product shall be satisfactory and at the least equivalent of products already on the market. Fitness-for-use shall be tested with respect to the characteristics and parameters reported in Table 5. Performance thresholds shall be matched, where these have been identified.

Table 5

Characteristics and parameters describing the fitness for use of the product to be tested

Characteristic | Testing practice required (performance threshold)
Baby diapers | Feminine care pads | Tampons | Nursing pads
In-use tests | U1.Absorption and leakage protection(*2) | U1. | Absorption and leakage protection(*2) | Consumer panel test (Leakage occurs in less than 5 % of the product uses)
U1. | Absorption and leakage protection(*2)
U2.Skin dryness | U2. | Skin dryness | Consumer panel test (80 % of the consumers testing the product shall rate the performance as satisfactory) | Not applicable | As for baby diapers
U2. | Skin dryness
U3.Fit and comfort | U3. | Fit and comfort | Consumer panel test (80 % of the consumers testing the product shall rate the performance as satisfactory)
U3. | Fit and comfort
U4.Overall performance | U4. | Overall performance | Consumer panel test (80 % of the consumers testing the product shall rate the performance as satisfactory)
U4. | Overall performance
Technical tests | T1.Absorption and leakage protection | T1. | Absorption and leakage protection | Absorption rate and absorption before leakage | Syngina method | No method recommended
T1. | Absorption and leakage protection
T2.Skin dryness | T2. | Skin dryness | TEWL, rewet method or corneometric testing | Not applicable | No method recommended
T2. | Skin dryness
Assessment and verification:
A test report shall be provided for in-use and technical tests describing test methods, test results and data used. Tests shall be carried out by laboratories certified to implement quality management systems, no matter if internal or external.
Tests shall be conducted for the specific type and size of products applying for the EU Ecolabel. Nevertheless, if it can be demonstrated that products have the same performance, it can be enough to test only one size or a representative mix of sizes per each product design. Special care shall be taken regarding sampling, transport and storage of the products to guarantee reproducible results. It is recommended not to blind products or repack them in neutral packaging due to the risk of altering the performance of products and/or packaging.
Information on testing shall be made available to competent bodies under the respect of confidentiality issues. Test results shall be clearly explained and presented in language, units and symbols that are understandable to the data user. The following elements shall be specified: place and date of the tests; criteria used to select the products tested and their representativeness; selected testing characteristics and, if applicable, the reasons why some were not included; test methods used and their limitations if any. Clear guidelines on the use of test results shall be provided.
Additional guidelines for user tests.

— | Sampling, test design, panel recruitment and the analysis of test results shall comply with standard statistical practices (AFNOR Q 34-019, ASTM E1958-07e1 or equivalent).
— | Each product shall be assessed on the basis of a questionnaire. The test is to last at least 72 hours, a full week when possible, and shall be realised in normal conditions of use of the product.
— | The recommended number of testers shall be at least 30. All the individuals participating to the survey shall be current users of the specific type/size of product tested.
— | When the product is not designed specifically for a single gender, the ratio of male to female individuals shall be 1:1.
— | A mixture of individuals representing proportionally different groups of consumers available on the market shall take part to the survey. Age, countries and genders shall be clearly stated.
— | Sick individuals and those with a chronic skin condition should not participate in the test. In cases where individuals become ill during the course of the user trial, this is to be indicated on the questionnaire and the answers shall not be taken into consideration for the assessment.
— | For skin dryness, fit and comfort and overall performance, 80 % of the consumers testing the product shall rate the performance as satisfactory, which could for instance mean that a rate above 60 is assigned by the consumer (on a quantitative scale from 1 to 100) or that the product has been assessed as good or very good (among five qualitative options: very poor, poor, average, good, very good). For absorption and leakage protection, leakage shall occur in less than 5 % of the products tested.
— | The results shall be statistically evaluated after the user trial has been completed.
— | External factors such as branding, market shares and advertising that may have an impact on the perceived performance of the products shall be communicated.Additional requirements for technical tests.

— | Test methods shall be based as much as possible on product-relevant, reproducible and rigorous methods.
— | A minimum of five samples shall be tested. Average results shall be reported together with indication of the standard deviation.Weight, dimensions and design features of the product shall be described and provided in accordance with criterion 1.

Criterion 11. Social aspects
Applicants shall ensure that the fundamental principles and rights at work as described in the International Labour Organisation’s (ILO) Core Labour Standards, the UN Global Compact and the OECD Guidelines for Multi-National Enterprises shall be observed by production sites along the supply chain used to manufacture the licensed product(s). For the purpose of verification, the following ILO Core Labour Standards shall be referred to:

029 | Forced Labour
087 | Freedom of Association and Protection of the Right to Organise
098 | Right to Organise and Collective Bargaining
100 | Equal remuneration
105 | Abolition of Forced Labour
111 | Discrimination (Employment and Occupation)
138 | Minimum Age Convention
155 | Occupational safety and health
182 | Elimination of the Worst Forms of Child LabourThese standards shall be communicated to production sites along the supply chain used to manufacture the final product.

Assessment and verification
The applicant shall demonstrate third party verification of compliance, using independent verification or documentary evidence, including site visits by auditors during the Ecolabel verification process for production sites in the supply chain for the licensed products. This shall take place upon application and subsequently during the license period if new production sites are introduced.

Criterion 12. Information appearing on the EU Ecolabel
The EU Ecolabel logo shall be applied on the packaging of the product. Box 2 of the EU Ecolabel shall contain the following text:

— | ‘Reduced impacts from consumption of resources’,
— | ‘Restricted use of hazardous substances’,
— | ‘Performance and quality tests satisfied’.The following text should moreover appear on the packaging: ‘For more information on why this product has been awarded the EU Ecolabel, please visit http://ec.europa.eu/environment/ecolabel/’.

Assessment and verification
The applicant shall provide a declaration of compliance with the requirement and visual evidence.

(*1) Net emissions of P are considered in the calculation. The P naturally contained in wood raw materials and in water can be subtracted from the total emissions of P. Reductions up to 0,010 kg/ADT shall be accepted.
(1) As defined in Directive 2009/28/EC of the European Parliament and of the Council of 23 April 2009 on the promotion of the use of energy from renewable sources and amending and subsequently repealing Directives 2001/77/EC and 2003/30/EC (OJ L 140, 5.6.2009, p. 16).
(2) Council Regulation (EC) No 834/2007 of 28 June 2007 on organic production and labelling of organic products and repealing Regulation (EEC) No 2092/91 (OJ L 189, 20.7.2007, p. 1).
(3) Regulation (EC) No 1272/2008 of the European Parliament and of the Council of 16 December 2008 on classification, labelling and packaging of substances and mixtures, amending and repealing Directives 67/548/EEC and 1999/45/EC, and amending Regulation (EC) No 1907/2006 (OJ L 353, 31.12.2008, p. 1).
(4) SCCS Opinion on Fragrance allergens in cosmetic products adopted in June 2012 http://ec.europa.eu/health/scientific_committees/consumer_safety/docs/sccs_o_102.pdf
(5) Regulation (EC) No 1223/2009 of the European Parliament and of the Council of 30 November 2009 on cosmetic products (OJ L 342, 22.12.2009, p. 59).
(6) Regulation (EC) No 1907/2006 of the European Parliament and of the Council of 18 December 2006 concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), establishing a European Chemicals Agency, amending Directive 1999/45/EC and repealing Council Regulation (EEC) No 793/93 and Commission Regulation (EC) No 1488/94 as well as Council Directive 76/769/EEC and Commission Directives 91/155/EEC, 93/67/EEC, 93/105/EC and 2000/21/EC (OJ L 396, 30.12.2006, p. 1).
(7) Council Directive 67/548/EEC of 27 June 1967 on the approximation of laws, regulations and administrative provisions relating to the classification, packaging and labelling of dangerous substances (OJ 196, 16.8.1967, p. 1).
(1) In accordance with Regulation (EC) No 1272/2008.
(2) In accordance with Directive 67/548/EEC and Directive 1999/45/EC of the European Parliament and of the Council of 31 May 1999 concerning the approximation of the laws, regulations and administrative provisions of the Member States relating to the classification, packaging and labelling of dangerous preparations (OJ L 200, 30.7.1999, p. 1).
(3) In accordance with Commission Regulation (EU) No 286/2011 of 10 March 2011 amending, for the purposes of its adaptation to technical and scientific progress, Regulation (EC) No 1272/2008 of the European Parliament and of the Council on classification, labelling and packaging of substances and mixtures (OJ L 83, 30.3.2011, p. 1).
(*2) Panty liners without a core intended to protect the feminine lingerie (light panty liners) are derogated from this requirement.