(1)

Commission Implementing Decision 2013/649/EU (2) authorised the placing on the market of pollen produced from genetically maize MON 810, as or in foods and food ingredients.

(2)

Commission Implementing Decision (EU) 2017/1207 (3) renewed the authorisation for placing on the market of existing foods and food ingredients produced from genetically modified maize MON 810, with the exception of pollen, of feed containing, consisting of or produced from genetically modified maize MON 810 and of products containing or consisting of genetically modified maize MON 810 for any other use than food or feed, with the exception of cultivation.

(3)

On 6 October 2022, Bayer Agriculture BV, based in Belgium, submitted on behalf of Bayer CropScience LP, based in the United States, an application to the Commission for the renewal of Implementing Decision 2013/649/EU and of Implementing Decision (EU) 2017/1207. In accordance with Article 11(4) of Regulation (EC) No 1829/2003, the period of authorisation of genetically modified pollen produced from genetically modified maize MON 810 for food uses covered by Implementing Decision 2013/649/EU has been automatically extended until a decision is taken on the renewal application.

(4)

On 19 January 2024, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion (4). It concluded that the renewal application did not contain evidence for any new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessments on genetically modified maize MON 810, adopted by the Authority in 2009 (5) and in 2012 (6).

(5)

In its scientific opinion, 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 Article 6(4) and Article 18(4) of Regulation (EC) No 1829/2003.

(6)

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

(7)

Taking into account those conclusions, the authorisation for the placing on the market of feed containing, consisting of or produced from genetically modified maize MON 810, of foods and food ingredients produced from genetically modified maize MON 810, including pollen produced from genetically modified maize MON 810, as or in foods and food ingredients, and of products containing or consisting of genetically modified maize MON 810 for uses other than food and feed, with the exception of cultivation, should be renewed.

(8)

Unique identifiers have been assigned to genetically modified maize MON 810, in accordance with Commission Regulation (EC) No 65/2004 (7), in the context of the initial authorisation by Implementing Decision 2013/649/EU.

(9)

For the products covered by this Decision, 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 (8), appear to be necessary.

(10)

The authorisation holder should submit annual reports on the implementation and on the results of the activities set out in the monitoring plan for environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (9).

(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 feed containing, consisting of or produced from genetically modified maize MON 810 and of foods and food ingredients produced from genetically modified maize MON 810, or for the protection of particular ecosystems/environment and/or geographical areas, as provided for in Article 6(5), point (e), and Article 18(5), point (e) of Regulation (EC) No 1829/2003.

(12)

All relevant information on the authorisation of the products covered by this Decision 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)

As the provisions of this Decision overlap with the provisions of Implementing Decision (EU) 2017/1207 and for reasons of legal certainty, Implementing Decision (EU) 2017/1207 should be repealed.

(14)

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), point (c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (10).

(15)

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 produced from genetically modified maize MON-ØØ81Ø-6;

(b)

feed containing, consisting of or produced from genetically modified maize MON-ØØ81Ø-6;

(c)

products containing or consisting of genetically modified maize MON-ØØ81Ø-6, for uses other than those provided for in points (a) and (b), with the exception of cultivation.