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Brussels, 3.9.2009

COM(2009) 443 final

Proposal for a

COUNCIL DECISION

authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122xNK603 (DAS-59122-7xMON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(Only the French and Dutch texts are authentic) (Text with EEA relevance)

EXPLANATORY MEMORANDUM

The attached proposal for a Council Decision concerns food and feed containing, consisting of or produced from genetically modified maize 59122xNK603, for which a request for placing on the market was submitted by Pioneer Overseas Corporation to the competent authority of the United Kingdom on 26 August 2005, under Regulation (EC) No 1829/2003 on genetically modified food and feed.

The attached proposal also concerns the placing on the market of other products containing and consisting of 59122xNK603 maize for the same uses as any other maize with the exception of cultivation.

On 25 November 2008, the European Food Safety Authority ('EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from 59122xNK603 maize as described in the application will have any adverse effects on human or animal health or the environment in the context of their intended uses.

Against this background, a draft Commission Decision authorising the placing on the Community market of products containing, consisting of or produced from genetically modified maize 59122xNK603 was submitted to the Standing Committee on the Food Chain and Animal Health, on 22 July 2009, for vote. The Committee delivered no opinion: 12 Member States (152 votes) voted in favour, 10 Member States (112 votes) voted against, 4 Member States (77 votes) abstained and one Member State was not represented (4 votes).

Consequently, pursuant to Article 35, paragraph 2 of Regulation (EC) No 1829/2003 and in accordance with Article 5 of Council Decision 1999/468/EC modified by Council Decision 2006/512/EC, the Commission is required to submit to the Council a proposal relating to the measures to be taken, the Council having three months in which to act by a qualified majority, and inform the Parliament.

Proposal for a

COUNCIL DECISION

authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize 59122xNK603 (DAS-59122-7xMON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(Only the French and Dutch texts are authentic) (Text with EEA relevance)

THE COUNCIL OF THE EUROPEAN UNION,

Having regard to the Treaty establishing the European Community,

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,

Having regard to the proposal from the Commission,

Whereas:

1. On 26 August 2005, Pioneer Overseas Corporation 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 59122xNK603 maize ('the application').

2. The application also covers the placing on the market of other products containing or consisting of 59122xNK603 maize for the same uses as any other maize 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 25 November 2008, the European Food Safety Authority ('EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 and concluded that it is unlikely that the placing on the market of the products containing, consisting of, or produced from 59122xNK603 maize as described in the application ('the products') will have any adverse effects on human or animal health or the environment in the context of their intended uses[3]. 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.

4. 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.

5. Taking into account those considerations, authorisation should be granted for the products.

6. 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].

7. 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 59122xNK603 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 feed containing or consisting of the GMO and other products 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.

8. Similarly, 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 Articles 6(5) and 18(5) of Regulation (EC) No 1829/2003.

9. 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.

10. Article 4(6) of 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 labelling requirements for products consisting of, or containing GMOs.

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 15(2)(c) 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[6].

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

13. The Standing Committee on the Food Chain and Animal Health has not delivered an opinion within the time-limit laid down by its Chairman,

HAS ADOPTED THIS DECISION:

Article 1 Genetically modified organism and unique identifier

Genetically modified maize ( Zea mays L.) 59122xNK603, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier DAS-59122-7xMON-ØØ6Ø3-6, as provided for in Regulation (EC) No 65/2004.

Article 2Authorisation

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 DAS-59122-7xMON-ØØ6Ø3-6 maize;

(b) feed containing, consisting of, or produced from DAS-59122-7xMON-ØØ6Ø3-6 maize;

(c) products other than food and feed containing or consisting of DAS-59122-7xMON-ØØ6Ø3-6 maize for the same uses as any other maize with the exception of cultivation.

Article 3 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 of and in documents accompanying products containing or consisting of DAS-59122-7xMON-ØØ6Ø3-6 maize referred to in Article 2(b) and (c).

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.

Article 5Community 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 6Authorisation holder

The authorisation holder shall be Pioneer Overseas Corporation, Belgium, representing Pioneer Hi-Bred International, Inc., United States of America.

Article 7 Validity

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

Article 8Addressee

This Decision is addressed to Pioneer Overseas Corporation, Avenue des Arts 44, B-1040 Brussels – Belgium.

Done at Brussels,

For the Council

The President

ANNEX

(a) Applicant and Authorisation holder:

Name: Pioneer Overseas Corporation

Address: Avenue des Arts 44, B-1040 Brussels - Belgium

On behalf of Pioneer Hi-Bred International, Inc. - 7100 NW 62nd Avenue – P.O. Box 1014 – Johnston, IA 50131-1014 - United States of America.

(b) Designation and specification of the products:

(1) Foods and food ingredients containing, consisting of, or produced from DAS-59122-7xMON-ØØ6Ø3-6 maize;

(2) Feed containing, consisting of, or produced from DAS-59122-7xMON-ØØ6Ø3-6 maize;

(3) Products other than food and feed containing or consisting of DAS-59122-7xMON-ØØ6Ø3-6 maize for the same uses as any other maize with the exception of cultivation.

The genetically modified DAS-59122-7xMON-ØØ6Ø3-6 maize, as described in the application, is produced by crosses between maize containing DAS-59122-7 and MON-ØØ6Ø3-6 events and expresses the Cry34Ab1 and Cry35Ab1 proteins which confer tolerance to certain coleopteran pests, the PAT protein, used as a selectable marker, which confers tolerance to the glufosinate-ammonium herbicide and the CP4 EPSPS protein which confers tolerance to glyphosate herbicide.

(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 DAS-59122-7xMON-ØØ6Ø3-6 maize referred to in Article 2(b) and (c) of this Decision.

(d) Method for detection:

- Event specific real-time quantitative PCR based methods for genetically modified maize DAS-59122-7 and MONØØ6Ø3-6 maize validated on DAS-59122-7xMON-ØØ6Ø3-6 maize;

- Validated on seeds by the Community reference laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdoss.htm;

- Reference Material: ERM®-BF424 (for DAS-59122-7) and ERM®-BF415 (for MON-ØØ6Ø3-6) accessible via the Joint Research Centre (JRC) of the European Commission, the Institute of Reference Materials and Measurements (IRMM) at http://www.irmm.jrc.be/html/reference_materials_catalogue/index.htm.

(e) Unique identifier:

DAS-59122-7xMON-ØØ6Ø3-6

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

Biosafety Clearing-House, Record ID: 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 the time. Those modifications will be made available to the public via the updating of the Community register of genetically modified food and feed.

[1] OJ L 268, 18.10.2003, p. 1.

[2] OJ L 106, 17.4.2001, p. 1.

[3] http://registerofquestions.efsa.europa.eu/roqFrontend/questionLoader?question=EFSA-Q-2005-247

[4] OJ L 10, 16.1.2004, p. 5.

[5] OJ L 268, 18.10.2003, p. 24.

[6] OJ L 287, 5.11.2003, p. 1.