(1)

On 11 August 2011, Monsanto Europe S.A. 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, consisting of, or produced from MON 87705 × MON 89788 soybean (‘the application’).

(2)

The application also covers the placing on the market of genetically modified soybean MON 87705 × MON 89788 in products consisting of it or containing it for other uses than food and feed as any other soybean, 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 16 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 (3). It concluded that genetically modified soybean MON 87705 × MON 89788, as described in the application, is as safe as its non-genetically modified counterpart and other non-genetically modified soybean reference varieties with respect to potential adverse effects on human and animal health and the environment in the context of the scope of the application.

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

(6)

In its opinion, 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)

In addition, EFSA recommended a post-market monitoring plan to be implemented, focusing on the collection of consumption data for the European population.

(8)

Taking into account those considerations, authorisation should be granted to the products containing, consisting of, or produced from genetically modified soybean MON 87705 × MON 89788.

(9)

A unique identifier should be assigned to each genetically modified organism (hereinafter ‘GMO’) as provided for in Commission Regulation (EC) No 65/2004 (4).

(10)

Food, food ingredients and feed containing, consisting of, or produced from MON 87705 × MON 89788 soybean should be labelled in accordance with the requirements provided for in Article 13(1) and Article 25(2) of Regulation (EC) No 1829/2003.

(11)

On the basis of the EFSA opinion, confirming that fatty acid composition of the seeds of MON 87705 × MON 89788 soybean and derived oil has been changed in relation to the conventional counterpart, a specific labelling appears to be necessary in accordance with Articles 13(2)(a) and 25(2)(c) of Regulation (EC) No 1829/2003.

(12)

Regulation (EC) No 1830/2003 of the European Parliament and of the Council (5) 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.

(13)

In order to ensure the use of the products within the limits of the authorisation provided for by this Decision, the labelling of products containing or consisting of the GMO for which authorisation is requested, with the exception of food products should be complemented by a clear indication that the products in question must not be used for cultivation.

(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 (6). The EFSA opinion does not justify either the imposition of specific conditions or restrictions for the placing on the market and/or the use and handling of the food and feed, including post-market monitoring requirements or specific conditions for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Articles 6(5)(e) and 18(5)(e) of Regulation (EC) No 1829/2003.

(15)

The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(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 (7).

(18)

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,

(a)

foods and food ingredients containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean;

(b)

feed containing, consisting of, or produced from MON-877Ø5-6 × MON-89788-1 soybean;

(c)

MON-877Ø5-6 × MON-89788-1 soybean 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.