20.9.2016   

EN

Official Journal of the European Union

L 254/22

(1)

On 9 February 2009, Syngenta France SAS submitted to the competent authority of Germany 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 Bt11 × MIR162 × MIR604 × GA21 maize (‘the application’).

(2)

The application also covers the placing on the market of genetically modified maize Bt11 × MIR162 × MIR604 × GA21 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 5 July 2013, Syngenta extended the scope of the application to all sub-combinations of the single genetic modification events constituting Bt11 × MIR162 × MIR604 × GA21 maize (‘sub-combinations’), including Bt11 × GA21 maize, MIR604 × GA21 maize, Bt11 × MIR604 maize, and Bt11 × MIR604 × GA21 which are already authorised respectively by Commission Decisions 2010/426/EU (3), 2011/892/EU (4), 2011/893/EU (5) and 2011/894/EU (6). Syngenta asked the Commission to repeal those four Decisions once authorisation is given to Bt11 × MIR162 × MIR604 × GA21 maize and all sub-combinations.

(5)

On 7 December 2015, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (7). It concluded that genetically modified maize Bt11 × MIR162 × MIR604 × GA21, as described in the application, is as safe and as nutritious as its conventional counterpart and no safety concerns are identified for any of the sub-combinations.

(6)

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.

(7)

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.

(8)

In its opinion, EFSA recommends the collection of relevant information on expression levels of the newly expressed proteins, if the sub-combinations Bt11 × MIR162 × MIR604, MIR162 × MIR604 × GA21, Bt11 × MIR162, MIR162 × MIR604 and/or MIR162 × GA21 were to be created via targeted breeding approaches and commercialised. In line with this recommendation, specific conditions should be laid down to that effect.

(9)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified maizes Bt11 × MIR162 × MIR604 × GA21, Bt11 × MIR162 × MIR604, Bt11 × MIR162 × GA21, Bt11 × MIR604 × GA21, MIR162 × MIR604 × GA21, Bt11 × MIR162, Bt11 × MIR604, Bt11 × GA21, MIR162 × MIR604, MIR162 × GA21 and MIR604 × GA21.

(10)

Decisions 2010/426/EU, 2011/892/EU, 2011/893/EU and 2011/894/EU authorising Bt11 × GA21 maize, MIR604 × GA21 maize, Bt11 × MIR604 maize, and Bt11 × GA21 × MIR604 maize should be repealed.

(11)

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

(12)

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 Bt11 × MIR162 × MIR604 × GA21 including all possible combinations of the single genetic modification events. 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 maize Bt11 × MIR162 × MIR604 × GA21 and the sub-combinations, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(13)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (9) 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.

(14)

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 (10). The EFSA opinion does not justify the imposition of specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in point (e) of Article 6(5) and Article 18(5) of Regulation (EC) No 1829/2003.

(15)

The authorisation holder should also submit annual reports on the results of the activities set out in the specific conditions of this authorisation.

(16)

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.

(17)

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 (11).

(18)

The Standing Committee on the Food Chain and Animal Health 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,

(a)

the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × MIR604 × GA21;

(b)

the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × MIR604;

(c)

the unique identifier SYN-BTØ11-1 × SYN-IR162-4 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR162 × GA21;

(d)

the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × MIR604 × GA21;

(e)

the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR162 × MIR604 × GA21;

(f)

the unique identifier SYN-BTØ11-1 × SYN-IR162-4 for genetically modified maize (Zea mays L.) Bt11 × MIR162;

(g)

the unique identifier SYN-BTØ11-1 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) Bt11 × MIR604;

(h)

the unique identifier SYN-BTØ11-1 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) Bt11 × GA21;

(i)

the unique identifier SYN-IR162-4 × SYN-IR6Ø4-5 for genetically modified maize (Zea mays L.) MIR162 × MIR604;

(j)

the unique identifier SYN-IR162-4 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR162 × GA21;

(k)

the unique identifier SYN-IR6Ø4-5 × MON-ØØØ21-9 for genetically modified maize (Zea mays L.) MIR604 × GA21.

(a)

foods and food ingredients containing, consisting of, or produced from the GMOs referred to in Article 1;

(b)

feed containing, consisting of, or produced from the GMOs referred to in Article 1;

(c)

GMOs referred to in Article 1 in products containing them or consisting of them for any other use than those provided in points (a) and (b), with the exception of cultivation.