(1)

On 15 February 2016, Monsanto Europe S.A/N.V. submitted, on behalf of Monsanto company, United States, 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 MON 87427 × MON 89034 × MIR162 × NK603 in accordance with Articles 5 and 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 MON 87427 × MON 89034 × MIR162 × 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 MON 87427 × MON 89034 × MIR162 × NK603.

(3)

Four of the sub-combinations MON 89034 × NK603, MON 87427 × MON 89034, MON 87427 × NK603 and MON 87427 × MON 89034 × NK603, included in the application, were already authorised by Commission Implementing Decision (EU) 2018/1111 (2).

(4)

By a letter dated 27 August 2018, Monsanto Europe S.A./N.V. informed the Commission that it has converted its legal form and changed its name to Bayer Agriculture BVBA, Belgium.

(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 (3). 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 8 July 2019, the European Food Safety Authority (‘the Authority’) issued a favourable opinion in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (4). The Authority concluded that genetically modified maize MON 87427 × MON 89034 × MIR162 × NK603 and its sub-combinations, as described in the application, are 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)

The Authority concluded that genetically modified maize MON 87427 × MON 89034 × MIR162 × NK603, as described in the application, is as safe as and nutritionally equivalent to the non-genetically modified comparator and the tested non-genetically modified reference varieties. 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 MON 87427, MON 89034, MIR162 and NK603, the previously assessed sub-combinations and the four-event stack maize MON 87427 × MON 89034 × MIR162 × 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 Articles 6(4) and 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 MON 87427 × MON 89034 × MIR162 × NK603, and of the 10 sub-combinations referred to above, should be authorised for the uses listed in the application.

(11)

By a letter dated 27 August 2019, Bayer Agriculture BVBA, Belgium representing Monsanto Company, United States, the authorisation holder for Implementing Decision (EU) 2018/1111, requested the Commission to repeal that Implementing Decision and to incorporate it in the scope of the present Implementing Decision.

(12)

Implementing Decision (EU)2018/1111 should be repealed.

(13)

By a letter dated 28 July 2020, Bayer Agriculture BVBA Belgium informed the Commission that, as of 1 August 2020, it converts its legal form and changes its name to Bayer Agriculture BV, Belgium.

(14)

By a letter dated 28 July 2020, Bayer Agriculture BVBA Belgium representing Monsanto Company, United States, informed the Commission that, as of 1 August 2020, Monsanto Company, United States, converts its legal form and changes its name to Bayer CropScience LP, United States.

(15)

A unique identifier should be assigned to each genetically modified organism covered by this Decision, in accordance with Commission Regulation (EC) No 65/2004 (5).

(16)

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 (6), 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.

(17)

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 (7).

(18)

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 maize MON 87427 × MON 89034 × MIR162 × NK603 and all sub-combinations thereof, 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.

(19)

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.

(20)

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 (8).

(21)

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 MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 87427 × MON 89034 × MIR162 × NK603;

(b)

the unique identifier MON-87427-7 × MON-89Ø34-3 × SYN-IR162-4 for genetically modified maize MON 87427 × MON 89034 × MIR162;

(c)

the unique identifier MON-87427-7 × MON-89Ø34-3 × MON-ØØ6Ø3-6 for genetically modified maize MON 87427 × MON 89034 × NK603;

(d)

the unique identifier MON-87427-7 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 87427 × MIR162 × NK603;

(e)

the unique identifier MON-89Ø34-3 × SYN-IR162-4 × MON-ØØ6Ø3-6 for genetically modified maize MON 89034 × MIR162 × NK603;

(f)

the unique identifier MON-87427-7 × MON-89Ø34-3 for genetically modified maize MON 87427 × MON 89034;

(g)

the unique identifier MON-87427-7 × MON-ØØ6Ø3-6 for genetically modified maize MON 87427 × NK603;

(h)

the unique identifier MON-87427-7 × SYN-IR162-4 for genetically modified maize MON 87427 × MIR162;

(i)

the unique identifier MON-89Ø34-3 × MON-ØØ6Ø3-6 for genetically modified maize MON 89034 × NK603;

(j)

the unique identifier MON-89Ø34-3 × SYN-IR162-4 for genetically modified maize MON 89034 × MIR162;

(k)

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

(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.