(1)

On 8 December 2015, Pioneer Overseas Corporation based in Belgium submitted, on behalf of Pioneer Hi-Bred International Inc., based in United States of America, an application to the national competent authority of the Netherlands (‘the application’) for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified maize 1507 × MIR162 × MON810 × NK603 in accordance with Article 5 and Article 17 of Regulation (EC) No 1829/2003. The application also covered the placing on the market of products containing or consisting of genetically modified maize 1507 × MIR162 × MON810 × NK603 for uses other than food and feed, with the exception of cultivation.

(2)

In addition, the application covered the placing on the market of products containing, consisting of or produced from 10 sub-combinations of those single transformation events constituting maize 1507 × MIR162 × MON810 × NK603.

(3)

Six sub-combinations included in the application were authorised as follows: 1507 × MON810 × NK603 and 1507 × MON810, authorised by Commission Implementing Decision (EU) 2018/1110 (2); MON810 × NK603, authorised by Commission Implementing Decision (EU) 2018/2045 (3); MIR162 × NK603, authorised by Commission Implementing Decision (EU) 2021/60 (4); 1507 × NK603, authorised by Commission Implementing Decision (EU) 2019/1306 (5); and 1507 × MIR162, authorised by Commission Implementing Decision (EU) 2019/1305 (6).

(4)

This Decision covers the four remaining sub-combinations in the application: MIR162 × MON810, 1507 × MIR162 × MON810, 1507 × MIR162 × NK603 and MIR162 × MON810 × NK603.

(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 (7). 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 13 January 2021, the European Food Safety Authority (‘the Authority’) issued a favourable opinion in accordance with Article 6 and Article 18 of Regulation (EC) No 1829/2003 (8). The Authority concluded that genetically modified maize 1507 × MIR162 × MON810 × NK603, as described in the application, is as safe as and nutritionally equivalent to their non-genetically modified comparator and the tested non-genetically modified reference varieties with respect to the potential effects on human and animal health and the environment.

(7)

No new safety concerns were identified for the previously assessed sub-combinations and therefore previous conclusions on those sub-combinations remain valid. As regards the remaining sub-combinations, the Authority concluded that they are expected to be as safe as and nutritionally equivalent to the single transformation events 1507, MON810, MIR162 and NK603, the previously assessed sub-combinations and the four-event stack maize 1507 × MIR162 x MON810 × NK603.

(8)

In its 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 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 1507 × MIR162 × MON810 × NK603, and of the four sub-combinations referred to above and listed in the application, should be authorised for the uses listed in the application.

(11)

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

(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 (10), 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 by it, 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 environment effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (11).

(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 food and feed containing, consisting of or produced from genetically modified 1507 × MIR162 × MON810 × NK603, 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.

(15)

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.

(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)(c) of Regulation (EC) No 1946/2003 of the European Parliament and of the Council (12).

(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,

(a)

the unique identifier DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 for genetically modified maize 1507 × MIR162 × MON810 × NK603;

(b)

the unique identifier DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ81Ø-6 for genetically modified maize 1507 × MIR162 × MON810;

(c)

the unique identifier DAS-Ø15Ø7-1 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize 1507 × MIR162 × NK603;

(d)

the unique identifier SYN-IR162-4 × MON-ØØ81Ø-6 × MON-ØØ6Ø3-6 for genetically modified maize MIR162 × MON810 × NK603;

(e)

the unique identifier SYN-IR162-4 × MON-ØØ81Ø-6 for genetically modified maize MIR162 × MON810.

(a)

foods and food ingredients containing, consisting of or produced from genetically modified maize as referred to in Article 1;

(b)

feed containing, consisting of or produced from genetically modified maize as referred to in Article 1;

(c)

products containing or consisting of genetically modified maize as referred to in Article 1 for uses other than those provided for in points (a) and (b), with the exception of cultivation.