(1)

Commission Implementing Decision 2013/327/EU (2) authorised the placing on the market of food containing or consisting of genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3, or food and feed produced from genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3.

(2)

Commission Implementing Decision (EU) 2019/1301 (3) amended Implementing Decision 2013/327/EU as regards the renewal of the authorisation to place on the market feed containing or consisting of genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3. The scope of that authorisation also covered the renewal of the placing on the market of products containing or consisting of genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3 for uses other than food and feed, with the exception of cultivation, previously authorised by Commission Decision 2007/232/EC (4).

(3)

On 8 February 2021, BASF SE, based in Germany, submitted on behalf of BASF Agricultural Solutions Seed US LLC, based in the United States, an application to the Commission for the renewal of that authorisation.

(4)

On 26 April 2023, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion (5). It concluded that the renewal application did not contain evidence for any new hazards, modified exposure or scientific uncertainties that would change the original risk assessment on genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3, adopted by the Authority 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 food and feed containing, consisting of or produced from genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3 and of products containing or consisting of them for uses other than food and feed, with the exception of cultivation, should be renewed.

(8)

Unique identifiers have been assigned to genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3, in accordance with Commission Regulation (EC) No 65/2004 (7), in in the context of the initial authorisation by Implementing Decision 2013/327/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. However, in order to ensure that the use of products containing or consisting of genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3 remain within the limits of the authorisation granted by this Decision, the labelling of such products, with the exception of food and food ingredients, 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 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 use and handling, including post-market monitoring requirements regarding the consumption of food and feed containing, consisting of or produced from genetically modified oilseed rapes Ms8, Rf3 and Ms8 × Rf3, 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)

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).

(14)

The Standing Committee on Plants, Animals, Food and Feed has not delivered an opinion within the time limit laid down by its Chair. 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 oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6;

(b)

feed containing, consisting of or produced from genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6;

(c)

products containing or consisting of genetically modified oilseed rapes ACS-BNØØ5-8, ACS-BNØØ3-6 and ACS-BNØØ5-8 × ACS-BNØØ3-6, for uses other than those provided for in points (a) and (b), with the exception of cultivation.