Commission Implementing Decision (EU) 2019/1305 of 26 July 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × 1507 × GA21 and sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (notified under document C(2019) 5502) (Text with EEA relevance.)

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⁽¹⁾, and in particular Article 7(3) and Article 19(3) thereof,

Whereas:

1. On 10 August 2010, Syngenta Crop Protection AG submitted, through its affiliated company Syngenta Crop Protection NV/SA, an application, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003, for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × 1507 × GA21 (‘the application’) to the national competent authority of Germany. The application also covered the placing on the market of products containing or consisting of genetically modified maize Bt11 × MIR162 × 1507 × GA21 for uses other than food and feed, with the exception of cultivation.

2. 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⁽²⁾ and the information required by Annexes III and IV to that Directive. It also included a monitoring plan for environmental effects in accordance with Annex VII to Directive 2001/18/EC.

3. On 30 July 2013, Syngenta extended the scope of the application to all ten sub-combinations of the single transformation events constituting maize Bt11 × MIR162 × 1507 × GA21.

4. On 31 March 2016, Syngenta updated the scope of the application by excluding the sub-combinations that were in the scope of other applications: Bt11 × MIR162 × GA21, Bt11 × MIR162, Bt11 × GA21 and MIR162 × GA21, authorised by Commission Implementing Decision (EU) 2016/1685⁽³⁾ and sub-combinations Bt11 × 1507 × GA21, Bt11 × 1507 and 1507 × GA21, authorised by Commission Implementing Decision (EU) 2017/1209⁽⁴⁾. The scope of the application therefore covers sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507.

5. On 11 July 2018, the European Food Safety Authority (‘the Authority’) issued a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003⁽⁵⁾. The Authority concluded that genetically modified maize Bt11 × MIR162 × 1507 × GA21, as described in the application, is as safe as and nutritionally equivalent to its non-genetically modified comparator in the context of the scope of the application. As regards the three sub-combinations in the scope of the application, the Authority concluded that they are expected to be as safe as the single events Bt11, MIR162, 1507 and GA21, the previously assessed sub-combinations and the four-event stack maize Bt11 × MIR162 × 1507 × GA21.

6. In its opinion, the Authority considered 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.

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

8. Taking into account those conclusions, the placing on the market of products containing, consisting of or produced from genetically modified maize Bt11 × MIR162 × 1507 × GA21 and of the three maize sub-combinations Bt11 × MIR162 × 1507, MIR162 × 1507 × GA21 and MIR162 × 1507 should be authorised for the uses listed in the application.

9. A unique identifier should be assigned to each genetically modified organism covered by this Decision, in accordance with Commission Regulation (EC) No 65/2004⁽⁶⁾.

10. On the basis of the Authority's 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⁽⁷⁾, appear to be necessary for the products covered by this Decision. However, in order to ensure the use of those products 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.

11. In order to account for the implementation and the results of the activities set out in the monitoring plan for environmental effects, the authorisation holder should submit annual reports, presented in accordance with the standard reporting format requirements laid down in Commission Decision 2009/770/EC⁽⁸⁾.

12. 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, or for the protection of particular ecosystems/environment or geographical areas, as provided for in Article 6(5)(e) and Article 18(5)(e) of Regulation (EC) No 1829/2003.

13. 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.

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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council⁽⁹⁾.

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,

HAS ADOPTED THIS DECISION: