28.12.2017   

EN

Official Journal of the European Union

L 346/31

(1)

On 3 December 2013, Monsanto Europe S.A. and Bayer CropScience N.V. submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified oilseed rape MON 88302 × Ms8 × Rf3 to the national competent authority of the Netherlands in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of genetically modified oilseed rape MON 88302 × Ms8 × Rf3 in products consisting of it or containing it for other uses than food and feed as any other oilseed rape, with the exception of cultivation. The application covered, for those uses, all sub-combinations of the single genetic modification events constituting oilseed rape MON 88302 × Ms8 × Rf3.

(2)

In accordance with Articles 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the environmental risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council (2) and the data and information required by Annexes III and IV to that Directive. It also included a monitoring plan for environmental effects conforming with Annex VII to Directive 2001/18/EC.

(3)

On 10 April 2017, the European Food Safety Authority (‘EFSA’) gave a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). EFSA concluded that genetically modified oilseed rape MON 88302 × Ms8 × Rf3, as described in the application, is as safe and nutritious as its conventional counterpart and non-genetically modified reference varieties as respect to potential effects on human and animal health and the environment, and no safety concerns were identified for the sub-combinations covered by the scope of the application.

(4)

On 23 May 2017, Monsanto Europe S.A. and Bayer CropScience N.V. updated the scope of the application by excluding the sub-combination Ms8 × Rf3, which is already authorised by Commission Decision 2007/232/EC (4) and Commission Implementing Decision 2013/327/EU (5).

(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 Article 18(4) of Regulation (EC) No 1829/2003.

(6)

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 those considerations, the placing on the market of products containing, consisting of, or produced from genetically modified oilseed rapes MON 88302 × Ms8 × Rf3, MON 88302 × Ms8 and MON 88302 × Rf3, for the uses listed in the application should be authorised.

(8)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) in accordance with Commission Regulation (EC) No 65/2004 (6).

(9)

On the basis of the EFSA opinion, no specific labelling requirements, other than those 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 of the European Parliament and of the Council (7), appear to be necessary for the products covered by this Decision. 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 genetically modified oilseed rapes MON 88302 × Ms8 × Rf3, MON 88302 × Ms8 and MON 88302 × Rf3, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(10)

The authorisation holders 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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC (8).

(11)

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.

(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 Articles 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (9).

(14)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chairman. This implementing act was deemed to be necessary and the chair submitted it to the appeal committee for further deliberation. The appeal committee did not deliver an opinion,

(a)

the unique identifier MON-883Ø2-9 × ACS-BNØØ5-8 × ACS-BNØØ3-6 for genetically modified oilseed rape (Brassica napus L.) MON 88302 × Ms8 × Rf3;

(b)

the unique identifier MON-883Ø2-9 × ACS-BNØØ5-8, for genetically modified oilseed rape (Brassica napus L.) MON 88302 × Ms8;

(c)

the unique identifier MON-883Ø2-9 × ACS-BNØØ3-6 for genetically modified oilseed rape (Brassica napus L.) MON 88302 × Rf3.

(a)

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

(b)

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

(c)

GMOs referred to in Article 1(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.

(a)

Monsanto Europe S.A., Belgium, representing Monsanto Company, United States;

and

(b)

Bayer CropScience N.V., Belgium, representing Bayer CropScience LP, United States.

(a)

Monsanto Europe S.A., Avenue de Tervuren 270-272, B-1150 Brussels, Belgium;

and

(b)

Bayer CropScience N.V., J.E. Mommaertslaan 14, 1831, Diegem, Belgium.