(EU) 2015/2281：欧盟批准含有转基因玉米MON 87427 (MON-87427-7)的产品上市销售（authorising the placing on the market of p_中国食品网

【发布单位】欧盟委员会
【发布文号】 (EU) 2015/2281
【发布日期】 2015/12/8
【生效日期】
【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)2015/2281号法规，根据（EC）1829/2003号法规的内容，批准含有转基因玉米MON 87427 (MON-87427-7)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等同于非转基因同类物质，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。

本次法规批准的产品有以下几种：

1、含有或由MON 87427玉米构成或生产的食品和食品配料；

2、含有或由MON 87427玉米构成或生产的饲料；

3、1和2之外的其他含有或由MON 87427玉米构成的产品。

COMMISSION IMPLEMENTING DECISION (EU) 2015/2281

of 4 December 2015

authorising the placing on the market of products containing, co nsisting of, or produced from genetically modified maize MON 87427 (MON-87427-7) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council

(notified under docu ment C(2015) 8587)

(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 11 June 2012, Mo nsanto 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, co nsisting 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 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 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 co ncluded that genetically modified maize MON 87427, as described in the application, is as safe as its co nventional counterpart and other non-genetically modified maize varieties and is unlikely to have adverse effects on human and animal health and the enviro nment in the co ntext of the scope of the application (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 MON 87427.

(8)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (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 foods, food ingredients and feed containing, co nsisting 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 co ntaining or co nsisting 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 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, 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 Co nvention 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 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.) 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.

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-87427-7 maize;

(b)

feed containing, co nsisting of, or produced from MON-87427-7 maize;

(c)

MON-87427-7 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-87427-7 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 S.A., 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-BE-2012-110) for the placing on the market of tissue-selec tive herbicide tolerant genetically modified maize MON 87427 for food and feed uses, im port 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.

(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 S.A.

Address

Avenue de Tervuren 270-272, B-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-87427-7 maize;

(2)

feed containing, co nsisting of, or produced from MON-87427-7 maize;

(3)

MON-87427-7 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-87427-7 maize, as described in the application, expresses the CP4 EPSPS protein which co nfers tissue-selec tive tolerance to glyphosate herbicides. The CP4 EPSPS ex pression is absent or limited in male reproductive tissues, which eliminates or reduces the need for detasseling when MON-87427-7 is used as female parent in hybrid maize seed production.

(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-87427-7 maize with the exception of products referred to in point (a) of Article 2.

(d) Method for detection:

(1)

Event specific real-time PCR ba sed method for the quantification of MON-87427-7;

(2)

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

(3)

Reference Material: AOCS 0512-A and AOCS 0406-A are accessible via the American Oil Chemists Society at http://www.aocs.org/LabServices/content.cfm?ItemNumber=19248

(e) Unique identifier:

MON-87427-7

(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.

(EU) 2015/2281： 欧盟批准含有转基因玉米MON 87427 (MON-87427-7)的产品上市销售（authorising the placing on the market of p

(EU) 2015/2281：欧盟批准含有转基因玉米MON 87427 (MON-87427-7)的产品上市销售（authorising the placing on the market of p