(1)

Commission Decision 2008/730/EC (2) authorised the placing on the market of food and feed containing, consisting of or produced from genetically modified soybean A2704-12 (‘soybean A2704-12’). The scope of that authorisation also covers the placing on the market of products, other than food and feed, containing or consisting of soybean A2704-12 for the same uses as any other soybean, with the exception of cultivation.

(2)

On 29 August 2017, the authorisation holder, Bayer CropScience AG submitted to the Commission an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation.

(3)

On 14 January 2019, the European Food Safety Authority (‘the Authority’) published a favourable opinion (3) in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. It concluded that the renewal application did not contain evidence for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on soybean A2704-12, adopted by the Authority in 2007 (4).

(4)

In its opinion of 14 January 2019, the Authority considered all the questions and concerns raised by the Member States in the context of the consultation of the national competent authorities as provided for in Articles 6(4) and 18(4) of Regulation (EC) No 1829/2003.

(5)

The Authority also concluded that the monitoring plan for the environmental effects, consisting of a general surveillance plan, submitted by Bayer CropScience AG, is in line with the intended uses of the products.

(6)

Taking into account those conclusions, the authorisation for the placing on the market of food and feed containing, consisting of, or produced from soybean A2704-12 and of products consisting of it or containing it for other uses than food or feed, with the exception of cultivation, should be renewed.

(7)

By letter dated 1 August 2018, Bayer CropScience AG requested the Commission to transfer their rights and obligations pertaining to all authorisations and pending applications for genetically modified products, to BASF Agricultural Solutions Seed US LLC. By letter dated 19 October 2018, BASF Agricultural Solutions Seed US LLC confirmed this transfer and authorised BASF SE, Germany, to act as its representative in the Union.

(8)

A unique identifier has been assigned to soybean A2704-12, in accordance with Commission Regulation (EC) No 65/2004 (5), in the context of its initial authorisation by Decision 2008/730/EC. That unique identifier should continue to be used.

(9)

For the products covered by this Decision, no specific labelling requirements, other than those provided for 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 (6), appear to be necessary. However, in order to ensure that the use of products containing or consisting of soybean A2704-12 remains within the limits of the authorisation granted by this Decision, the labelling of such products, with the exception of food products, should contain a clear indication that they are not intended for cultivation.

(10)

The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (7).

(11)

The opinion of the Authority does not justify the imposition of specific conditions or restrictions for the placing on the market, for the use and handling, including post-market monitoring requirements regarding the consumption of the food and feed containing, consisting of, or produced from genetically modified soybean A2704-12, or 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.

(12)

All relevant information on the authorisation of the products should be entered in the Community register of genetically modified food and feed referred to in Article 28(1) of 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 15(2)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (8).

(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)

foods and food ingredients containing, consisting of, or produced from genetically modified soybean ACS-GMØØ5-3;

(b)

feed containing, consisting of, or produced from genetically modified soybean ACS-GMØØ5-3;

(c)

products containing or consisting of genetically modified soybean ACS-GMØØ5-3 for uses other than those provided for in points (a) and (b), with the exception of cultivation.