# L_2012040EN.01001001.xml

| 14.2.2012 | EN | Official Journal of the European Union | L 40/10 |
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14.2.2012

EN

Official Journal of the European Union

L 40/10

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COMMISSION IMPLEMENTING DECISION

of 10 February 2012

authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean A5547-127 (ACS-GMØØ6-4) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under document C(2012) 691)

(Only the German text is authentic)

(Text with EEA relevance)

(2012/81/EU)

THE EUROPEAN COMMISSION,

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

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

Whereas:

| (1) | On 31 March 2008, Bayer CropScience AG 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 A5547-127 soybean (‘the application’). |
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(1)

On 31 March 2008, Bayer CropScience AG 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 A5547-127 soybean (‘the application’).

| (2) | The application also covers the placing on the market of products other than food and feed containing or consisting of A5547-127 soybean for the same uses as any other soybean with the exception of cultivation. Therefore, in accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (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. |
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(2)

The application also covers the placing on the market of products other than food and feed containing or consisting of A5547-127 soybean for the same uses as any other soybean with the exception of cultivation. Therefore, in accordance with Articles 5(5) and 17(5) of Regulation (EC) No 1829/2003, it includes the data and information required by Annexes III and IV to Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (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.

| (3) | On 10 May 2011, 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 soybean A5547-127, as described in the application, is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment (3). |
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(3)

On 10 May 2011, 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 soybean A5547-127, as described in the application, is as safe as its non-genetically modified counterpart with respect to potential effects on human and animal health or the environment (3).

| (4) | 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. |
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(4)

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.

| (5) | In particular, EFSA concluded that soybean A5547-127 is compositionally and agronomically not different from its non-genetically modified counterpart and equivalent to commercial varieties, except for the introduced trait and as a consequence, that animal safety studies with the whole food/feed (e.g. a 90-day toxicity study in rats) are not needed. |
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(5)

In particular, EFSA concluded that soybean A5547-127 is compositionally and agronomically not different from its non-genetically modified counterpart and equivalent to commercial varieties, except for the introduced trait and as a consequence, that animal safety studies with the whole food/feed (e.g. a 90-day toxicity study in rats) are not needed.

| (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 use of the products. |
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(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 use of the products.

| (7) | Taking into account those considerations, authorisation should be granted for the products containing, consisting of, or produced from A5547-127 soybean as described in the application (‘the products’). |
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(7)

Taking into account those considerations, authorisation should be granted for the products containing, consisting of, or produced from A5547-127 soybean as described in the application (‘the products’).

| (8) | A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4). |
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(8)

A unique identifier should be assigned to each GMO as provided for in Commission Regulation (EC) No 65/2004 of 14 January 2004 establishing a system for the development and assignment of unique identifiers for genetically modified organisms (4).

| (9) | 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 A5547-127 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of feed containing or consisting of the GMO and products other than food and feed containing or consisting of the GMO for which authorisation is requested should be complemented by a clear indication that the products in question must not be used for cultivation. |
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(9)

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 A5547-127 soybean. However, in order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of feed containing or consisting of the GMO and products other than food and feed containing or consisting of the GMO for which authorisation is requested 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 of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (5), lays down in Article 4(6) labelling requirements 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 for food and feed produced from GMOs are laid down in Article 5 of that Regulation. |
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(10)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council of 22 September 2003 concerning the traceability and labelling of genetically modified organisms and the traceability of food and feed products produced from genetically modified organisms and amending Directive 2001/18/EC (5), lays down in Article 4(6) labelling requirements 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 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 of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (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 point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003. |
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(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 of 13 October 2009 establishing standard reporting formats for presenting the monitoring results of the deliberate release into the environment of genetically modified organisms, as or in products, for the purpose of placing on the market, pursuant to Directive 2001/18/EC of the European Parliament and of the Council (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 point (e) of Article 6(5) and Article 18(5) 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. |
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(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 point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (7). |
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(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 point (c) of Article 15(2) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (7).

| (14) | The applicant has been consulted on the measures provided for in this Decision. |
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(14)

The applicant has been consulted on the measures provided for in this Decision.

| (15) | 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, |
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(15)

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:

Article 1

Genetically modified organism and unique identifier

Genetically modified soybean A5547-127, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier ACS-GMØØ6-4, as provided for in Regulation (EC) No 65/2004.

Article 2

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 ACS-GMØØ6-4 soybean; |
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(a)

foods and food ingredients containing, consisting of, or produced from ACS-GMØØ6-4 soybean;

| (b) | feed containing, consisting of, or produced from ACS-GMØØ6-4 soybean; |
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(b)

feed containing, consisting of, or produced from ACS-GMØØ6-4 soybean;

| (c) | products other than food and feed containing or consisting of ACS-GMØØ6-4 soybean for the same uses as any other soybean with the exception of cultivation. |
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(c)

products other than food and feed containing or consisting of ACS-GMØØ6-4 soybean for the same uses as any other soybean with the exception of cultivation.

Article 3

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.   The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of ACS-GMØØ6-4 soybean referred to in points (b) and (c) of Article 2.

Article 4

Monitoring for environmental effects

1.   The authorisation holder shall ensure that the monitoring plan for environmental effects, as set out in point (h) of the Annex, is put in place and implemented.

2.   The authorisation holder shall submit to the Commission annual reports on the implementation and the results of the activities set out in the monitoring plan in accordance with the Decision 2009/770/EC.

Article 5

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.

Article 6

Authorisation holder

The authorisation holder shall be Bayer CropScience AG.

Article 7

Validity

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

Article 8

Addressee

This Decision is addressed to Bayer CropScience AG, Alfred-Nobel-Strasse 50, 40789 Monheim am Rhein, GERMANY.

Done at Brussels, 10 February 2012.

For the Commission

John DALLI

Member of the Commission

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(1)  
  OJ L 268, 18.10.2003, p. 1.

1

(2)  
  OJ L 106, 17.4.2001, p. 1.

2

(3)  http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2011-00292

3

(4)  
  OJ L 10, 16.1.2004, p. 5.

4

(5)  
  OJ L 268, 18.10.2003, p. 24.

5

(6)  
  OJ L 275, 21.10.2009, p. 9.

6

(7)  
  OJ L 287, 5.11.2003, p. 1.

7

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ANNEX

(a)   Applicant and authorisation holder

| Name | : | Bayer CropScience AG |
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| Address | : | Alfred-Nobel-Strasse 50, 40789 Monheim am Rhein, GERMANY |

Name

:

Bayer CropScience AG

Address

:

Alfred-Nobel-Strasse 50, 40789 Monheim am Rhein, GERMANY

(b)   Designation and specification of the products

| (1) | Foods and food ingredients containing, consisting of, or produced from ACS-GMØØ6-4 soybean. |
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(1)

Foods and food ingredients containing, consisting of, or produced from ACS-GMØØ6-4 soybean.

| (2) | Feed containing, consisting of, or produced from ACS-GMØØ6-4 soybean. |
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(2)

Feed containing, consisting of, or produced from ACS-GMØØ6-4 soybean.

| (3) | Products other than food and feed containing or consisting of ACS-GMØØ6-4 soybean for the same uses as any other soybean with the exception of cultivation. |
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(3)

Products other than food and feed containing or consisting of ACS-GMØØ6-4 soybean for the same uses as any other soybean with the exception of cultivation.

The genetically modified ACS-GMØØ6-4 soybean, as described in the application, expresses the PAT protein which confers tolerance to the glufosinate-ammonium herbicide.

(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 ‘soybean’. |
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(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 ‘soybean’.

| (2) | The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of ACS-GMØØ6-4 soybean referred to in Article 2(b) and (c) of this Decision. |
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(2)

The words ‘not for cultivation’ shall appear on the label of and in documents accompanying products containing or consisting of ACS-GMØØ6-4 soybean referred to in Article 2(b) and (c) of this Decision.

(d)   Method for detection

| — | Event-specific real-time PCR-based method for the quantification of ACS-GMØØ6-4 soybean, |
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—

Event-specific real-time PCR-based method for the quantification of ACS-GMØØ6-4 soybean,

| — | validated by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm |
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—

validated by the European Union Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm

| — | reference material: AOCS 0707-C3 and 0707-A2 accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm |
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—

reference material: AOCS 0707-C3 and 0707-A2 accessible via the American Oil Chemists Society at http://www.aocs.org/tech/crm

(e)   Unique identifier

ACS-GMØØ6-4

(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

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.

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