(1)

Commission Decision 2008/280/EC (2) authorised the placing on the market of food and feed containing, consisting of, or produced from genetically modified maize GA21 (hereinafter ‘maize GA21’). The scope of that authorisation also covered products other than food and feed containing or consisting of maize GA21, for the same uses as any other maize with the exception of cultivation.

(2)

On 6 October 2016, Syngenta France SAS submitted to the Commission, on behalf of Syngenta Crop Protection AG, Switzerland, an application, in accordance with Articles 11 and 23 of Regulation (EC) No 1829/2003, for the renewal of that authorisation.

(3)

On 24 October 2017, the European Food Safety Authority (‘EFSA’) issued a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. Based on the data provided, it concluded (3) that there was no evidence in the renewal application for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment (4) on maize GA21.

(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)

EFSA also concluded that the environmental monitoring plan submitted by the applicant, consisting of a general surveillance plan, was in line with the intended uses of the products.

(6)

By a letter dated 27 February 2018, Syngenta France SAS asked the transfer of its rights and obligations as authorisation holder of Decision 2008/280/EC to Syngenta Crop Protection NV/SA, Belgium. By a letter dated 27 February 2018, Syngenta Crop Protection NV/SA, Belgium, confirmed its agreement to this transfer and indicated that it acts as representative in the Union of Syngenta Crop Protection AG, Switzerland.

(7)

Taking into account those considerations, the authorisation for the placing on the market of food and feed containing, consisting of, or produced from maize GA21 and of products consisting of it or containing it for other uses than food or feed, with the exception of cultivation, should be renewed.

(8)

A unique identifier has been assigned to maize GA21 by Decision 2008/280/EC, in accordance with Commission Regulation (EC) No 65/2004 (5). That unique identifier should continue to be used.

(9)

On the basis of the EFSA opinion, no specific labelling requirements, other than those provided for 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 (6), appear to be necessary for the products covered by this Decision. However, in order to ensure that the use of products containing or consisting of maize GA21 remains within the limits of the authorisation granted by this Decision, the labelling of those products, with the exception of food products, should contain a clear indication that the products in question 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 environmental monitoring plan. These results should be presented in accordance with Commission Decision 2009/770/EC (7).

(11)

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 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 (8).

(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)

food and food ingredients containing, consisting of or produced from maize GA21;

(b)

feed containing, consisting of or produced from maize GA21;

(c)

maize GA21 in products containing it or consisting of it for any other use than those provided for in points (a) and (b), with the exception of cultivation.