(1)

Regulation (EC) No 1829/2003 lays down authorisation procedures for genetically modified food and feed. On 25 January 2011, Dow AgroSciences Europe submitted an application for the placing on the market of foods, food ingredients and feed containing, consisting of, or produced from genetically modified DAS-68416-4 soybean 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 soybean DAS-68416-4 in products consisting of it or containing it for other uses than food and feed as any other soybean, with the exception of cultivation.

(2)

In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the 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 17 March 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 soybean DAS-68416-4, as described in the application, is as safe and as nutritious as its conventional counterpart and non-genetically modified commercial varieties with regard to potential effects on human and animal health and the environment.

(4)

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 Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(5)

In addition, EFSA 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.

(6)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean DAS-68416-4.

(7)

A unique identifier should be assigned to genetically modified soybean DAS-68416-4 in accordance with Commission Regulation (EC) No 65/2004 (4).

(8)

On the basis of the EFSA opinion, no specific labelling requirements, other than those laid down in Article 13(1) and Article 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 (5), 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 soybean DAS-68416-4, with the exception of food products, should be complemented by a clear indication that the products in question are not intended for cultivation.

(9)

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 the standard reporting format requirements laid down in Commission Decision 2009/770/EC (6).

(10)

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

(11)

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.

(12)

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 Article 9(1) and Article 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (7).

(13)

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)

foods and food ingredients containing, consisting of, or produced from soybean DAS-68416-4;

(b)

feed containing, consisting of, or produced from soybean DAS-68416-4;

(c)

soybean DAS-68416-4 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.