# L_2017173EN.01002301.xml

| 6.7.2017 | EN | Official Journal of the European Union | L 173/23 |
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6.7.2017

EN

Official Journal of the European Union

L 173/23

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COMMISSION IMPLEMENTING DECISION (EU) 2017/1208

of 4 July 2017

authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton GHB119 (BCS-GHØØ5-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed

(notified under document C(2017) 4457)

(Only the Dutch and French texts are authentic)

(Text with EEA relevance)

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,

Whereas:

| (1) | On 25 March 2011, Bayer 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 GHB119 cotton (‘the application’). The application also covered the placing on the market of genetically modified cotton GHB119 in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation. |
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(1)

On 25 March 2011, Bayer 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 GHB119 cotton (‘the application’). The application also covered the placing on the market of genetically modified cotton GHB119 in products consisting of it or containing it for other uses than food and feed as any other cotton, with the exception of cultivation.

| (2) | In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included 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 included a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC. |
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(2)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included 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 included a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

| (3) | On 21 October 2016, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that genetically modified cotton GHB119, as described in the application, is as safe and as nutritious as its conventional counterpart as regards the potential effects on human and animal health and the environment in the context of the scope of the application. |
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(3)

On 21 October 2016, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). It concluded that genetically modified cotton GHB119, as described in the application, is as safe and as nutritious as its conventional counterpart as regards the potential effects on human and animal health and the environment in the context of the scope of the application.

| (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 Article 18(4) of Regulation (EC) No 1829/2003. |
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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 Article 18(4) of Regulation (EC) No 1829/2003.

| (5) | 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. |
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(5)

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.

| (6) | Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton GHB119. |
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(6)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified cotton GHB119.

| (7) | A unique identifier should be assigned to cotton GHB119, in accordance with Commission Regulation (EC) No 65/2004 (4). |
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(7)

A unique identifier should be assigned to cotton GHB119, in accordance with Commission Regulation (EC) No 65/2004 (4).

| (8) | 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 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear to be necessary for the products covered by this Decision. 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 or consisting of cotton GHB119, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation. |
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(8)

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 and in Article 4(6) of Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5), appear to be necessary for the products covered by this Decision. 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 or consisting of cotton GHB119, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

| (9) | 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 the standard reporting format set out in 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. |
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(9)

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 the standard reporting format set out in 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.

| (10) | All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Regulation (EC) No 1829/2003. |
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(10)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Regulation (EC) No 1829/2003.

| (11) | 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 Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7). |
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(11)

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 Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

| (12) | The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion, |
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(12)

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

HAS ADOPTED THIS DECISION:

Article 1

Genetically modified organism and unique identifier

Genetically modified cotton (Gossypium hirsutum L.) GHB119, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier BCS-GHØØ5-8, in accordance with Regulation (EC) No 65/2004.

Gossypium hirsutum

Article 2

Authorisation

The following products are authorised for the purposes of Articles 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 cotton GHB119; |
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(a)

foods and food ingredients containing, consisting of, or produced from cotton GHB119;

| (b) | feed containing, consisting of, or produced from cotton GHB119; |
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(b)

feed containing, consisting of, or produced from cotton GHB119;

| (c) | Cotton GHB119 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. |
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(c)

Cotton GHB119 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.

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 ‘cotton’.

2.   The words ‘not for cultivation’ shall appear on the label of and in the documents accompanying products containing or consisting of cotton GHB119, with the exception of products referred to in point (a) 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 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 NV, Belgium, representing Bayer CropScience LP, United States of America.

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 NV, J.E. Mommaertslaan 14, 1831, Diegem, Belgium.

Done at Brussels, 4 July 2017.

For the Commission

Vytenis ANDRIUKAITIS

Member of the Commission

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

1

(2)  Directive 2001/18/EC of the European Parliament and of the Council of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC (OJ L 106, 17.4.2001, p. 1).

2

(3)  EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2016. Scientific opinion on application (EFSA-GMO-NL-2011-96) for the placing on the market of genetically modified insect-resistant and herbicide-tolerant cotton GHB119, for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Bayer CropScience AG. EFSA Journal 2016;14(10):4586, 27 pp. doi:10.2903/j.efsa.2016.4586.

3

EFSA Journal

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

4

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

5

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

6

(7)  Regulation (EC) No 1946/2003 of the European Parliament and of the Council of 15 July 2003 on transboundary movements of genetically modified organisms (OJ L 287, 5.11.2003, p. 1).

7

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ANNEX

(a)   Authorisation holder:

| Name | : | Bayer CropScience NV. |
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| Address | : | J.E. Mommaertslaan 14, 1831, Diegem, Belgium. |

Name

:

Bayer CropScience NV.

Address

:

J.E. Mommaertslaan 14, 1831, Diegem, Belgium.

On behalf of Bayer CropScience LP — 2 T.W. Alexander Drive — P.O. Box 12014 — Research Triangle Park — RTP, North Carolina 27709 — United States of America.

(b)   Designation and specification of the products:

| (1) | foods and food ingredients containing, consisting of, or produced from genetically modified cotton BCS-GHØØ5-8; |
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(1)

foods and food ingredients containing, consisting of, or produced from genetically modified cotton BCS-GHØØ5-8;

| (2) | feed containing, consisting of, or produced from genetically modified cotton BCS-GHØØ5-8; |
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(2)

feed containing, consisting of, or produced from genetically modified cotton BCS-GHØØ5-8;

| (3) | genetically modified cotton BCS-GHØØ5-8 in products containing them or consisting of them for any other use than those provided in points (1) and (2), with the exception of cultivation. |
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(3)

genetically modified cotton BCS-GHØØ5-8 in products containing them or consisting of them for any other use than those provided in points (1) and (2), with the exception of cultivation.

BCS-GHØØ5-8 as described in the application, expresses the PAT protein which confers tolerance to glufosinate ammonium-based herbicides and Cry2Ae protein which confers resistance to certain lepidopteran pests.

(c)   Labelling:

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

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

| (2) | The words ‘not for cultivation’ shall appear on the label of and in the accompanying documents of the products containing or consisting of the cotton covered by this Decision, with the exception of products referred to in point (a) of Article 2. |
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(2)

The words ‘not for cultivation’ shall appear on the label of and in the accompanying documents of the products containing or consisting of the cotton covered by this Decision, 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 BCS-GHØØ5-8 cotton. |
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(1)

Event-specific real-time PCR based method for the quantification of BCS-GHØØ5-8 cotton.

| (2) | Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from seeds of BCS-GHØØ5-8 cotton, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx |
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(2)

Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003 on genomic DNA extracted from seeds of BCS-GHØØ5-8 cotton, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx

| (3) | Reference Material: ERM-BF428 accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.irmm.jrc.ec.europa.eu/jrc/en/reference-materials/catalogue |
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(3)

Reference Material: ERM-BF428 accessible via the Joint Research Centre (JRC) of the European Commission, at https://crm.irmm.jrc.ec.europa.eu/jrc/en/reference-materials/catalogue

(e)   Unique identifier:

BCS-GHØØ5-8

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

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

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

Not required.

(h)   Monitoring plan for environmental effects:

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

(Link: plan published in the Community register of genetically modified food and feed)

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

Not required.

Note: Links to relevant documents may need to be modified over 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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