Prováděcí rozhodnutí Komise (EU) 2015/2281 ze dne 4. prosince 2015 o povolení uvedení produktů, které obsahují geneticky modifikovanou kukuřici MON 87427 (MON-87427-7), sestávají z ní nebo jsou z ní vyrobeny, na trh podle nařízení Evropského parlamentu a Rady (ES) č. 1829/2003 (oznámeno pod číslem (C2015) 8587) (Pouze francouzské a nizozemské znění je závazné) (Text s významem pro EHP)

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 feedOJ L 268, 18.10.2003, p. 1 . , and in particular Articles 7(3) and 19(3) thereof,

Genetically modified maize (Zea mays L.) MON 87427, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-87427-7, as provided for in Regulation (EC) No 65/2004.

OJ L 268, 18.10.2003, p. 1 .

(1) On 11 June 2012 , 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 87427 maize (the application).

(2) The application also covers the placing on the market of genetically modified maize MON 87427 in products consisting of it or containing it for other uses than food and feed as any other maize, 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 CouncilDirective 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 ). 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.

(4) On 19 June 2015 , 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 genetically modified maize MON 87427, as described in the application, is as safe as its conventional counterpart and other non-genetically modified maize varieties and is unlikely to have adverse effects on human and animal health and the environment in the context of the scope of the applicationEFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2015. Scientific Opinion on application (EFSA-GMO-BE-2012-110) for the placing on the market of tissue-selective herbicide tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal: 2015;13(6):4130, 25 pp. doi:10.2903/j.efsa.2015.4130. .

(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 Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(6) In its opinion, 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.

(7) Taking into account these considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified maize MON 87427.

(8) A unique identifier should be assigned to each genetically modified organism (hereinafter GMO) as provided for in Commission Regulation (EC) No 65/2004Commission 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 ). .

(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 genetically modified maize MON 87427. 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 MON 87427 maize, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(10) Regulation (EC) No 1830/2003 of the European Parliament and of the CouncilRegulation (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 ). lays down labelling requirements in Article 4(6) 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.

(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/ECCommission 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 ). . The EFSA opinion does not justify either the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements or 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.

(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 CouncilRegulation (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 ). .

(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,

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-87427-7 maize;

(b) feed containing, consisting of, or produced from MON-87427-7 maize;

(c) MON-87427-7 maize 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.

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 ).

Article 1 Article 1 Genetically modified organism and unique identifier

Article 2 Article 2 Authorisation

Article 3 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 the documents accompanying products containing or consisting of MON-87427-7 maize, with the exception of products referred to in point (a) of Article 2.

Article 4 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 Article 5 Community register

Article 6 Article 6 Authorisation holder

Article 7 Article 7 Validity

Article 8 Article 8 Addressee

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.

The words not for cultivation shall appear on the label of and in the documents accompanying products containing or consisting of MON-87427-7 maize, with the exception of products referred to in point (a) of Article 2.

EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2015. Scientific Opinion on application (EFSA-GMO-BE-2012-110) for the placing on the market of tissue-selective herbicide tolerant genetically modified maize MON 87427 for food and feed uses, import and processing under Regulation (EC) No 1829/2003 from Monsanto. EFSA Journal: 2015;13(6):4130, 25 pp. doi:10.2903/j.efsa.2015.4130.

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.

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.

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 ).

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.

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 ).

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

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 ).

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

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 ).

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

HAS ADOPTED THIS DECISION: