(EU) 2015/2279：欧盟批准含有转基因玉米NK603× T25 (MON-ØØ6Ø3-6 × ACS-ZMØØ3-2)的产品上市销售（authorising the placing on t_中国食品网

【发布单位】欧盟委员会
【发布文号】 (EU) 2015/2279
【发布日期】 2015/12/8
【生效日期】 2015/12/8
【废止日期】
【替代法规】
【效　　力】
【食品伙伴网解读】

2015年12月4日，欧盟发布(EU) 2015/684号法规，根据（EC）1829/2003号法规内容，批准含有转基因玉米NK603×T25(MON-ØØ6Ø3-6×ACS-ZMØØ3-2)的食品和饲料上市销售。

欧盟收到1份申请，请求批准上述转基因产品上市销售，经欧盟食品安全委员会评估，这种转基因产品的安全性对动物、人体健康和环境无不利影响，因此，欧盟批准了这项申请。并对这种转基因产品的规格、名称、标签、检验方法和可追溯性做了相关规定，每种转基因生物都应标示特有的标识符。

本次批准的产品有以下几种：

1、含有或由MON-ØØ6Ø3-6 × ACS-ZMØØ3-2玉米构成或生产的食品和食品配料；

2、含有或由MON-ØØ6Ø3-6 × ACS-ZMØØ3-2玉米构成或生产的饲料；

3、1和2之外的其他含有或由MON-ØØ6Ø3-6 × ACS-ZMØØ3-2玉米构成的产品。

COMMISSION IMPLEMENTING DECISION (EU) 2015/2279

of 4 December 2015

authorising the placing on the market of products containing, co nsisting of, or produced from genetically modified maize NK603 × T25 (MON-??6?3-6 × ACS-ZM??3-2) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under docu ment C(2015) 8581)

(o nly the Dutch and French texts are authentic)

(Text with EEA relevance)

THE EUROPEAN COMMISSION,

Havin g regard to the Treaty on the Functio ning of the European Unio n,

Havin g 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,

Wher eas:

(1)

On 17 May 2010, Mo nsanto 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, co nsisting 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 co nsisting of it or co ntaining 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 co nclusions a bout the risk assessment carried out in accordance with the principles set out in Annex II to that Directive. It also includes a mo nitoring plan for enviro nmental effects co nforming 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 co ncluded 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 enviro nment in the co ntext of its scope (3).

(5)

In its opinion, EFSA co nsidered all the specific questions and co ncerns raised by the Member States in the co ntext of the co nsultation of the natio nal competent authorities as provided for by Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(6)

In its opinion, EFSA also co ncluded that the mo nitoring plan for enviro nmental effects, co nsisting 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, co nsisting 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, co nsisting 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 co ntaining or co nsisting 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 co ntaining or co nsisting 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 mo nitoring plan for enviro nmental 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 co nditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market mo nitoring requirements or specific co nditions for the protection of particular ecosystems/enviro nment 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 Co nvention 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 1

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-??6?3-6 × ACS-ZM??3-2, as provided for in Regulation (EC) No 65/2004.

Article 2

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 co nditions set out in this Decision:

(a)

foods and food ingredients containing, co nsisting of, or produced from MON-??6?3-6 × ACS-ZM??3-2 maize;

(b)

feed containing, co nsisting of, or produced from MON-??6?3-6 × ACS-ZM??3-2 maize;

(c)

MON-??6?3-6 × ACS-ZM??3-2 maize in products co ntaining it or co nsisting 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 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 docu ments accompanying products co ntaining or co nsisting of MON-??6?3-6 × ACS-ZM??3-2 maize, with the exception of products referred to in point (a) of Article 2.

Article 4

Mo nitoring for enviro nmental effects

1. The authorisation holder shall ensure that the mo nitoring plan for enviro nmental 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 mo nitoring 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 Mo nsanto Europe SA, Belgium, representing Mo nsanto Company, 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 Mo nsanto 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

(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 enviro nment 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, im port 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 co ncerning 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 mo nitoring results of the deliberate release into the enviro nment 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).

ANNEX

(a)

Applicant and authorisation holder:

Name

Mo nsanto Europe SA

Address

Avenue de Tervuren 270-272, 1150 Brussels, Belgium

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

(b)

Designation and specification of the products:

(1)

foods and food ingredients containing, co nsisting of, or produced from MON-??6?3-6 × ACS-ZM??3-2 maize;

(2)

feed containing, co nsisting of, or produced from MON-??6?3-6 × ACS-ZM??3-2 maize;

(3)

MON-??6?3-6 × ACS-ZM??3-2 maize in products co ntaining it or co nsisting of it for any other use than those provided in points (1) and (2), with the exception of cultivation.

The genetically modified MON-??6?3-6 × ACS-ZM??3-2 maize, as described in the application, expresses the CP4 EPSPS protein which co nfers tolerance to glyphosate herbicides and PAT protein which co nfers tolerance to glufosinate ammo nium herbicides.

(c)

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 accompanying docu ments of the products co ntaining or co nsisting of MON-??6?3-6 × ACS-ZM??3-2 maize with the exception of products referred to in point (a) of Article 2.

(d)

Method for detection:

(1)

Event-specific real-time quantitative PCR-ba sed methods for MON-??6?3-6 and ACS-ZM??3-2 maize; the detection methods are validated on the single-trait events and verified on genomic DNA extracted from seeds of MON-??6?3-6 × ACS-ZM??3-2 maize;

(2)

Validated by the EU Reference Laboratory established under Regulation (EC) No 1829/2003, published at http://gmo-crl.jrc.ec.europa.eu/statusofdossiers.aspx

(3)

Reference material: ERM?-BF415 (for MON-??6?3-6) 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-ZM??3-2) accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248

(e)

Unique identifier:

MON-??6?3-6 × ACS-ZM??3-2

(f)

Information required under Annex II to the Cartagena Protocol on Biosafety to the Co nvention on Biological Diversity:

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

(g)

Co nditions or restrictions on the placing on the market, use or handling of the products:

Not required.

(h)

Mo nitoring plan for enviro nmental effects:

Mo nitoring plan for enviro nmental effects co nforming with Annex VII to Directive 2001/18/EC.

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

(i)

Post-market mo nitoring requirements for the use of the food for human consumption:

Not required.

Note: l inks to relevant docu ments 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.