# Commission Implementing Decision (EU) 2015/2279Show full title

Commission Implementing Decision (EU) 2015/2279 of 4 December 2015 authorising the placing on the market of products containing,            consisting of, or produced from genetically modified maize NK603 × T25 (MON-ØØ6Ø3-6 × ACS-ZMØØ3-2) pursuant to Regulation            (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2015) 8581) (Only the Dutch and            French texts are authentic) (Text with EEA relevance)         

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U.K.

# Commission Implementing Decision (EU) 2015/2279                     

# of 4 December 2015

# authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize NK603                        × T25 (MON-ØØ6Ø3-6 × ACS-ZMØØ3-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council                     

# *(notified under document C(2015) 8581)*

# (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 17 May 2010, 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 NK603 × T25 maize (‘the application’).

(2)The application also covers the placing on the market of genetically modified maize NK603 × T25 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 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.

(4)On 15 July 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 NK603 × T25, as described in the application,                              is as safe as its non-genetically modified comparator and other non-genetically modified maize varieties with respect to potential                              effects on human and animal health and the environment in the context of its scope(3).

(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 NK603 × T25.

(8)A unique identifier should be assigned to each genetically modified organism (hereinafter ‘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 Articles 13(1) and                              25(2) of Regulation (EC) No 1829/2003, appear to be necessary for food, food ingredients and feed containing, consisting of,                              or produced from genetically modified maize NK603 × T25. 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 NK603 × T25                              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 Council(5) 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/EC(6). 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 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 Articles 9(1) and 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:

## Article 1U.K.Genetically modified organism and unique identifier

Genetically modified maize (*Zea mays* L.) NK603 × T25, as specified in point (b) of the Annex to this Decision, is assigned the unique identifier MON-ØØ6Ø3-6 ×                     ACS-ZMØØ3-2, as provided for in Regulation (EC) No 65/2004.                  

## Article 2U.K.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:                  

foods and food ingredients containing, consisting of, or produced from MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize;

feed containing, consisting of, or produced from MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize;

MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 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.                           

## Article 3U.K.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-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize, with the exception of products referred to in point (a) of Article 2.                  

## Article 4U.K.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 5U.K.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 6U.K.Authorisation holder

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

## Article 7U.K.Validity

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

## Article 8U.K.Addressee

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

Done at Brussels, 4 December 2015.

*For the Commission*                            

Vytenis Andriukaitis                            

*Member of the Commission*                            

## ANNEXU.K.

**Applicant and authorisation holder:**                            

:

Monsanto Europe SA

:

Avenue de Tervuren 270-272, 1150 Brussels, Belgium

On behalf of Monsanto Company — 800 N. Lindbergh Boulevard — St. Louis, Missouri 63167 — United States of America.

**Designation and specification of the products:**                            

foods and food ingredients containing, consisting of, or produced from MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize;

feed containing, consisting of, or produced from MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize;

MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize 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-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize, as described in the application, expresses the CP4 EPSPS protein                              which confers tolerance to glyphosate herbicides and PAT protein which confers tolerance to glufosinate ammonium herbicides.                           

**Labelling:**                            

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 accompanying documents of the products containing                                       or consisting of MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize with the exception of products referred to in point (a) of Article 2.                                    

**Method for detection:**                            

Event-specific real-time quantitative PCR-based methods for MON-ØØ6Ø3-6 and ACS-ZMØØ3-2 maize; the detection methods are validated                                       on the single-trait events and verified on genomic DNA extracted from seeds of MON-ØØ6Ø3-6 × ACS-ZMØØ3-2 maize;                                    

Validated 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: ERM®-BF415 (for MON-ØØ6Ø3-6) 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 and AOCS 0306-H6 and                                       AOCS 0306-C2 (for ACS-ZMØØ3-2) accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248                                    

**Unique identifier:**                            

MON-ØØ6Ø3-6 × ACS-ZMØØ3-2

**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*).                           

**Conditions or restrictions on the placing on the market, use or handling of the products:**                            

Not required.

**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*)                           

**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.U.K.                  

1

OJ L 268, 18.10.2003, p. 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).                           

3

EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), 2015. Scientific Opinion on application (EFSA-GMO-NL-2010-80)                              for the placing on the market of herbicide tolerant genetically modified maize NK603 × T25 for food and feed uses, import                              and processing under Regulation (EC) No 1829/2003 from Monsanto. *EFSA Journal*: 2015; 13(7):4165, 23 pp. doi:10.2903/j.efsa.2015.4165.                           

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).                           

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).                           

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).                           

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).