Commission Implementing Decision (EU) 2021/1391 of 17 August 2021 authorising the placing on the market of products containing, consisting of or produced from genetically modified oilseed rapes Ms8 × Rf3 × GT73, Ms8 × GT73 and Rf3 × GT73 pursuant to Regulation (EC) No 1829/2003 of the European parliament and of the Council (notified under document C(2021)5998) (Only the Dutch and German texts are authentic) (Text with EEA relevance)

• Published date: 24 August 2021
• Date of Signature: 17 August 2021
• Official Gazette Publication: Official Journal of the European Union, L 300, 24 August 2021

24.8.2021 EN Official Journal of the European Union L 300/41

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COMMISSION IMPLEMENTING DECISION (EU) 2021/1391

of 17 August 2021

authorising the placing on the market of products containing, consisting of or produced from genetically modified oilseed rapes Ms8 × Rf3 × GT73, Ms8 × GT73 and Rf3 × GT73 pursuant to Regulation (EC) No 1829/2003 of the European parliament and of the Council

(notified under document C(2021)5998)

(Only the Dutch and German texts are authentic)

(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 20 October 2009, Monsanto Europe S.A/N.V., based in Belgium, submitted, on behalf of Monsanto Company, based in the United States, and Bayer CropScience AG, based in Germany, an application to the national competent authority of the Netherlands for the placing on the market of foods, food ingredients and feed containing, consisting of or produced from genetically modified oilseed rape Ms8 × Rf3 × GT73, in accordance with Articles 5 and 17 of Regulation (EC) No 1829/2003 (‘the application’). The application also concerned the placing on the market of products containing or consisting of genetically modified oilseed rape Ms8 × Rf3 × GT73 for uses other than food and feed, with the exception of cultivation. In addition, the application concerned the placing on the market of products containing, consisting of or produced from all sub-combinations of the single transformation events constituting oilseed rape Ms8 × Rf3 × GT73.

(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 9 September 2013, Monsanto Europe S.A./N.V. and Bayer CropScience AG updated the contents of the application, in order to exclude from its scope the specific use of Ms8 × Rf3 × GT73 oilseed rape for the production of isolated seed protein for food.

(4) On 12 August 2015, Monsanto Europe S.A./N.V. and Bayer CropScience AG updated further the contents of the application, in order to exclude from its scope the sub-combination Ms8 × Rf3, which was already authorised by Commission Decision 2007/232/EC (3) and Commission Implementing Decision 2013/327/EU (4).

(5) This Decision concerns the remaining two sub-combinations, Ms8 × GT73 and Rf3 × GT73, and excludes the use, for food, of isolated seed protein products produced from oilseed rape Ms8 × Rf3 × GT73 and from the sub-combinations Ms8 × GT73 and Rf3 × GT73.

(6) On 20 May 2016, the European Food Safety Authority (‘the Authority’) issued an opinion, in accordance with Articles 6 and 18 of Regulation (EC) No 1829/2003 (5). The Authority was not able to reach a conclusion on the safety of Ms8 × Rf3 × GT73 oilseed rape products rich in protein, such as rapeseed protein isolates, in feed, because of a lack of a 28-day toxicity study with the GOXv247 protein. As the risk assessment of the three-event stack oilseed rape could not be completed for products rich in protein, the Authority was not in a position to complete the food and feed safety assessment of the sub-combinations Ms8 × GT73 and Rf3 × GT73 within the scope of the application.

(7) By a letter dated 1 August 2018, Bayer CropScience AG requested that the Commission transfer its rights and obligations pertaining to all authorisations and pending applications for genetically modified products to BASF Agricultural Solutions Seed US LLC. By a letter dated 19 October 2018, BASF Agricultural Solutions Seed US LLC confirmed its agreement with this transfer and authorised BASF SE, based in Germany, to act as its representative in the Union.

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

(9) On 23 October 2018, the co-applicants provided a new 28-day toxicity study on the GOXv247 protein.

(10) 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.

(11) 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.

(12) On 30 July 2020, the Authority published a statement complementing its scientific opinion (6), taking into consideration the supplementary toxicity study. The Authority concluded that oilseed rape Ms8 × Rf3 × GT73 and its sub-combinations Ms8 × GT73 and Rf3 × GT73, as defined in the application and as assessed in the initial opinion and in the supplementary toxicity study, are as safe as its conventional counterpart for the requested uses.

(13) In its opinion of 20 May 2016, 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.

(14) 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.

(15) Taking into account these conclusions, the placing on the market of products containing, consisting of or produced from genetically modified oilseed rapes Ms8 × Rf3 × GT73, Ms8 × GT73 and Rf3 × GT73 should be authorised for the uses listed in the application.

(16) A unique identifier should be assigned to each genetically modified organism covered by this Decision, in accordance with Commission Regulation (EC) No 65/2004 (7).

(17) 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 (8), 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.

(18) The authorisation holders 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 (9).

(19) 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 oilseed rapes Ms8 × Rf3 × GT73, Ms8 × GT73 and Rf3 × GT73, with the exception of isolated seed protein for food, 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.

(20) All relevant information on the authorisation of the products covered by this Decision should be entered in the

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