(1)

On 27 July 2010, Monsanto Europe S.A./N.V., based in Belgium, submitted on behalf of Monsanto Company, based in the 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 soybean MON 87769 × MON 89788, 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 soybean MON 87769 × MON 89788 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). 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.

(3)

On 8 October 2015, the European Food Safety Authority (‘the Authority’) issued an opinion, in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (3). The Authority was not able to reach a conclusion on the safety of genetically modified soybean MON 87769 × MON 89788 because of the lack of data on dietary exposure to refined bleached deodorised oil produced from genetically modified soybean MON 87769 × MON 89788, leading to an incomplete nutritional assessment. The Authority concluded that genetically modified soybean MON 87769 × MON 89788 is unlikely to have adverse effects on the environment in the context of the application.

(4)

In its opinion of 8 October 2015, 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.

(5)

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.

(6)

By a letter dated 27 August 2018, Monsanto Europe S.A./N.V. informed the Commission that, as of 23 August 2018, it converted its legal form and changed its name to Bayer Agriculture BVBA.

(7)

On 8 May 2019, the applicant provided a revised dietary exposure assessment of the genetically modified soybean MON 87769 × MON 89788.

(8)

By a letter dated 28 July 2020, Bayer Agriculture BVBA informed the Commission that, as of 1 August 2020, it changed its name to Bayer Agriculture BV.

(9)

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

(10)

On 12 May 2021, the Authority published a statement complementing its scientific opinion (4), taking into account the revised dietary exposure assessment provided by the applicant for the human nutritional assessment of refined bleached deodorised oil produced from genetically modified soybean MON 87769 × MON 89788. The Authority concluded that the consumption of genetically modified soybean MON 87769 × MON 89788 and its derived products, in particular its refined bleached deodorised oil, does not represent a nutritional concern in humans.

(11)

In addition, the Authority recommended a post-market monitoring plan to be implemented, focusing on the collection of import data to Europe of genetically modified soybean MON 87769 × MON 89788 and/or its products, in particular its refined bleached deodorised oil.

(12)

Taking into account these conclusions, the placing on the market of products containing, consisting of or produced from genetically modified soybean MON 87769 × MON 89788 should be authorised for the uses listed in the application.

(13)

A unique identifier should be assigned to genetically modified soybean MON 87769 × MON 89788, in accordance with Commission Regulation (EC) No 65/2004 (5).

(14)

Products containing, consisting of or produced from soybean MON 87769 × MON 89788 should be labelled in accordance with the requirements 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).

(15)

The Authority’s statement complementing its scientific opinion confirmed that the nutritional composition of genetically modified soybean MON 87769 × MON 89788 is different from its conventional counterpart due to a different fatty acid profile. Specific labelling is therefore necessary in accordance with Article 13(2)(a) and Article 25(2)(c) of Regulation (EC) No 1829/2003.

(16)

In order to ensure that the use of the products containing or consisting of genetically modified soybean MON 87769 × MON 89788 remain within the limits of the authorisation granted by this Decision, the labelling of those products, with the exception of foods and food ingredients, 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 environmental effects. Those results should be presented in accordance with the requirements laid down in Commission Decision 2009/770/EC (7).

(18)

The authorisation holder should also submit annual reports on the implementation and the results of the activities set out in the post-market monitoring plan.

(19)

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.

(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 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 soybean MON-87769-7 × MON-89788-1;

(b)

feed containing, consisting of or produced from genetically modified soybean MON-87769-7 × MON-89788-1;

(c)

products containing or consisting of genetically modified soybean MON-87769-7 × MON-89788-1 for uses other than those provided for in points (a) and (b), with the exception of cultivation.