Commission Implementing Decision (EU) 2024/391

Contents

THE EUROPEAN COMMISSION,Having regard to the Treaty on the Functioning of the European Union,Having regard to Regulation (EC) No 1829/2003 of the European Parliament and of the Council of 22 September 2003 on genetically modified food and feed^note, and in particular Article 7(3) and 19(3) thereof,Whereas:

(1)On 13 April 2018, Syngenta Crop Protection NV/SA, based in Belgium, submitted, on behalf of Syngenta Crop Protection AG, based in Switzerland, an application to the competent authority of Germany (‘the application’) for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21, in accordance with Article 5 and Article 17 of Regulation (EC) No 1829/2003. The application also concerned the placing on the market of products containing or consisting of genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 for uses other than food and feed, with the exception of cultivation.

(2)In addition, the application concerned the placing on the market of products containing, consisting of or produced from thirty sub-combinations, out of the possible fifty-six, of the single transformation events constituting genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21.

(3)This Decision covers the thirty sub-combinations in the scope of the application: MIR162 × MON 89034, 5307 × MON 89034, Bt11 × MON 89034, GA21 × MON 89034, MIR604 × MON 89034, 5307 × Bt11 × MON 89034, 5307 × GA21 × MON 89034, 5307 × MIR162 × MON 89034, 5307 × MIR604 × MON 89034, Bt11 × GA21 × MON 89034, Bt11 × MIR162 × MON 89034, Bt11 × MIR604 × MON 89034, GA21 × MIR162 × MON 89034, GA21 × MIR604 × MON 89034, MIR162 × MIR604 × MON 89034, 5307 × Bt11 × GA21 × MON 89034, 5307 × Bt11 × MIR162 × MON 89034, 5307 × Bt11 × MIR604 × MON 89034, 5307 × GA21 × MIR162 × MON 89034, 5307 × GA21 × MIR604 × MON 89034, 5307 × MIR162 × MIR604 × MON 89034, Bt11 × GA21 × MIR162 × MON 89034, Bt11 × GA21 × MIR604 × MON 89034, Bt11 × MIR162 × MIR604 × MON 89034, GA21 × MIR162 × MIR604 × MON 89034, 5307 × Bt11 × GA21 × MIR162 × MON 89034, 5307 × Bt11 × GA21 × MIR604 × MON 89034, 5307 × Bt11 × MIR162 × MIR604 × MON 89034, 5307 × GA21 × MIR162 × MIR604 × MON 89034, Bt11 × GA21 × MIR162 × MIR604 × MON 89034 (‘the thirty sub-combinations concerned’).

(4)The twenty-six sub-combinations not covered by the scope of the application were already authorised as follows: Bt11 × MIR162 × MIR604 × GA21, Bt11 × MIR162 × MIR604, Bt11 × MIR162 × GA21, Bt11 × MIR604 × GA21, MIR162 × MIR604 × GA21, Bt11 × MIR162, Bt11 × MIR604, Bt11 × GA21, MIR162 × MIR604, MIR162 × GA21, MIR604 × GA21, authorised by Commission Implementing Decision (EU) 2016/1685^note; 5307 × Bt11, 5307 × GA21, 5307 × MIR162, 5307 × MIR604, 5307 × Bt11 × GA21, 5307 × Bt11 × MIR162, 5307 × Bt11 × MIR604, 5307 × GA21 × MIR162, 5307 × GA21 × MIR604, 5307 × MIR162 × MIR604, 5307 × Bt11 × GA21 × MIR162, 5307 × Bt11 × GA21 × MIR604, 5307 × Bt11 × MIR162 × MIR604, 5307 × GA21 × MIR162 × MIR604, 5307 × Bt11 × GA21 × MIR162 × MIR604, authorised by Commission Implementing Decision (EU) 2019/2087^note; MIR162 × MON 89034, authorised by Commission Implementing Decision (EU) 2021/60^note.

(5)In accordance with Article 5(5) and Article 17(5) of Regulation (EC) No 1829/2003, the application included information and conclusions about the risk assessment carried out in accordance with the principles set out in Annex II to Directive 2001/18/EC of the European Parliament and of the Council^note. It also included the information required pursuant to Annexes III and IV to that Directive and a monitoring plan for environmental effects in accordance with Annex VII to that Directive.

(6)On 5 June 2023, the European Food Safety Authority (‘the Authority’) issued a favourable scientific opinion^note in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003. The Authority concluded that genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 as described in the application, is as safe as its non-genetically modified comparator and the selected non-genetically modified reference varieties with respect to the potential effects on human and animal health and the environment.

(7)As regards the thirty sub-combinations covered in the application, the Authority concluded that they are expected to be as safe as the previously assessed single transformation events Bt11, MIR162, MIR604, MON 89034, 5307 and GA21, the previously assessed sub-combinations and the genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21.

(8)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.

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

(10)Taking into account those conclusions, the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21, and of the thirty sub-combinations concerned, should be authorised for the uses listed in the application.

(11)A unique identifier should be assigned to genetically modified maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21, and to the thirty sub-combinations concerned, in accordance with Commission Regulation (EC) No 65/2004^note.

(12)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^note, appear to be necessary. However, in order to ensure that the use of those products remains within the limits of the authorisation granted by this Decision, the labelling of the products covered, with the exception of food products, should contain a clear indication that they are not intended for cultivation.

(13)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^note.

(14)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 maize Bt11 × MIR162 × MIR604 × MON 89034 × 5307 × GA21 and all sub-combinations thereof, or for the protection of particular ecosystems/environment or geographical areas, as provided for in Article 6(5), point (e) and Article 18(5), point (e) of Regulation (EC) No 1829/2003.

(15)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.

(16)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^note.

(17)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,

HAS ADOPTED THIS DECISION: