Home Europe European Commission Commission Implementing Decision (EU) 2021/1161 of 13 July 2...
Date: 2021-07-15 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Decision (EU) 2021/1161 of 13 July 2021 amending Decision 2011/891/EU and Implementing Decisions (EU) 2017/1211, (EU) 2017/1212, (EU) 2017/2449, (EU) 2019/2085 and (EU) 2019/2086 as regards the authorisation holder and its representative in the Union for the placing on the market of products containing, consisting of, or produced from certain genetically modified organisms (notified under document C(2021) 5148) (Text with EEA relevance) (Only the Dutch text is authentic)

Issued by European Commission · Directorate-General for Health and Food Safety

Research with AI Agent Chat with Document Generate Summary Translate Helpful Share Add to Project Create Task

Executive Summary & Key Takeaways

Executive Summary: This Commission Implementing Decision EU/2021/1161 amends Decisions 2011/891/EU and Implementing Decisions EU/2017/1211, EU/2017/1212, EU/2017/2449, EU/2019/2085 and EU/2019/2086, regarding the authorisation holder and its representative in the Union for the placing on the market of products containing, consisting of, or produced from certain genetically modified organisms. It reflects a change of name from Dow AgroSciences LLC to Corteva Agriscience LLC, and the transfer of authorisations from Mycogen LLC to Corteva Agriscience LLC. The effective date is July 13, 2021. Key Points / Main Content: * **Change of Authorisation Holder:** * Dow AgroSciences LLC changed its name to Corteva Agriscience LLC, effective January 1, 2021. * Corteva Agriscience LLC is now the authorisation holder for genetically modified organisms previously held by Dow AgroSciences LLC. * Authorisations held by Mycogen LLC are transferred to Corteva Agriscience LLC. * **Union Representative:** * Corteva Agriscience Belgium BV is the representative in the Union for Corteva Agriscience LLC, effective March 22, 2021. * **Amendments to Existing Decisions:** * Decision 2011/891/EU is amended to reflect the new authorisation holder and Union representative (Articles 1, 6, 8 and Annex point a). * Implementing Decision EU/2017/1211 is amended to reflect the new authorisation holder and Union representative (Articles 6, 8 and Annex point a). * Implementing Decision EU/2017/1212 is amended to reflect the new authorisation holder and Union representative (Articles 6, 8 and Annex point a). * Implementing Decision EU/2017/2449 is amended to reflect the new authorisation holder and Union representative (Articles 7, 9 and Annex point a). * Implementing Decision EU/2019/2085 is amended to reflect the new authorisation holder and Union representative (Articles 7, 9 and Annex point a). * Implementing Decision EU/2019/2086 is amended to reflect the new authorisation holder and Union representative (Articles 7, 9 and Annex point a). Impact Analysis: Corteva Agriscience LLC: * Impact: Assumes responsibility as the authorisation holder for the specified genetically modified organisms. Must ensure compliance with all relevant regulations. * Action Required: Acknowledge the change in authorisation and ensure all activities align with the updated terms, including correct labeling and documentation with the new company name and Union representative. Corteva Agriscience Belgium BV: * Impact: Serves as the Union representative for Corteva Agriscience LLC. * Action Required: Fulfill all representative duties as defined by the relevant regulations, including communication with the Commission and other relevant bodies. European Commission: * Impact: Maintains oversight and ensures compliance with regulations regarding genetically modified organisms. * Action Required: Update records and databases to reflect the changes in authorisation holder and Union representative. Stakeholders dealing with products containing, consisting of, or produced from the specified GMOs: * Impact: Need to be aware of the change of authorisation holder. * Action Required: Update records to reflect the new authorisation holder (Corteva Agriscience LLC) and its representative in the Union (Corteva Agriscience Belgium BV).

Key Entities Referenced

European Union: The political and economic union of member states located primarily in Europe; the context indicates the policy is being implemented within the EU. Commission Implementing Decision EU 2021/1161: A decision of the European Commission amending several previous implementing decisions related to genetically modified organisms. Regulation EC No 1829/2003: Regulation of the European Parliament and of the Council on genetically modified food and feed. Corteva Agriscience LLC: A company based in Indianapolis, Indiana, United States, that is the authorization holder for the placing on the market of products containing genetically modified organisms. Corteva Agriscience Belgium BV: The representative in the Union of Corteva Agriscience LLC, based in Belgium. Mycogen Seeds LLC: A company based in the United States; the authorisations held by Mycogen LLC were requested to be transferred to Corteva Agriscience LLC Dow AgroSciences Distribution SAS: A company based in France, previously the representative in the Union of Mycogen Seeds LLC and Dow AgroSciences LLC. Indianapolis, Indiana, United States: Location of Corteva Agriscience LLC headquarters
Official Source Record View Original Source →
See Full Document Text
15.7.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 252/1 II (Non-legislative acts) DECISIONS COMMISSION IMPLEMENTING DECISION (EU) 2021/1161 of 13 July 2021 amending Decision 2011/891/EU and Implementing Decisions (EU) 2017/1211, (EU) 2017/1212, (EU) 2017/2449, (EU) 2019/2085 and (EU) 2019/2086 as regards the authorisation holder and its representative in the Union for the placing on the market of products containing, consisting of, or produced from certain genetically modified organisms (notified under document C(2021) 5148) (Text with EEA relevance) (Only the Dutch text is authentic) 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 2003on genetically modified food and feed(1), and in particular to Article 9(2) and Article 21(2) thereof, Whereas: (1) Dow AgroSciences Distribution SAS based in France is the representative in the Union of Mycogen Seeds LLC, based in the United States, concerning the authorisations for the placing on the market of products containing, consisting of, or produced from genetically modified organisms granted by Commission Decision 2011/891/EU(2) and Commission Implementing Decision (EU) 2017/1211(3). (1) OJ L 268, 18.10.2003, p. 1. (2) Commission Decision 2011/891/EU of 22 December 2011 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236x3006-210-23 (DAS-24236-5xDAS-21Ø23-5) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 344, 28.12.2011, p. 51). (3) Commission Implementing Decision (EU) 2017/1211 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified cotton 281-24-236 × 3006-210-23 × MON 88913 (DAS-24236-5 × DAS- 21Ø23-5 × MON-88913-8) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 173, 6.7.2017, p. 38).L 252/2 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 15.7.2021 (2) Dow AgroSciences Distribution SAS, based in France, is the representative in the Union of Dow AgroSciences LLC, based in the United States, as regards the authorisations for the placing on the market of products containing, consisting of, or produced from certain genetically modified organisms, granted by Commission Implementing Decisions (EU) 2017/1212(4), (EU) 2017/2449(5), (EU) 2019/2085(6)and (EU) 2019/2086(7). (3) By the letter of 22 March 2021, Corteva Agriscience LLC, based in the United States informed the Commission that Dow AgroSciences LLC changed the name to Corteva Agriscience LLC as of 1 January 2021. (4) In a joint letter of 22 March 2021, Corteva Agriscience LLC and Mycogen LLC requested the transfer of the authorisations held by Mycogen LLC to Corteva Agriscience LLC. (5) By letter dated 22 March 2021, Corteva Agriscience LLC informed the Commission that its representative in the Union was Corteva Agriscience Belgium BV, based in Belgium, as of 22 March 2021. (6) The requested changes are purely administrative in nature and therefore do not entail a new assessment of the products concerned. (7) Decision 2011/891/EU and Implementing Decisions (EU) 2017/1211, (EU) 2017/1212, (EU) 2017/2449, (EU) 2019/2085 and (EU) 2019/2086 should therefore be amended accordingly. (8) The measures provided for in this Decision are in accordance with the opinion of the Standing Committee on Plants, Animals, Food and Feed, HAS ADOPTED THIS DECISION: Article 1 Amendments to Decision 2011/891/EU Decision 2011/891/EU is amended as follows: (1) Article 6 is replaced by the following: ‘Article 6 Authorisation holder The authorisation holder shall be Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience Belgium BV.’ (4) Commission Implementing Decision (EU) 2017/1212 of 4 July 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize DAS-40278-9, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ L 173, 6.7.2017, p. 43). (5) Commission Implementing Decision (EU) 2017/2449 of 21 December 2017 authorising the placing on the market of products containing, consisting of, or produced from genetically modified soybean DAS-68416-4, pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council on genetically modified food and feed (OJ L 346, 28.12.2017, p. 12). (6) Commission Implementing Decision (EU) 2019/2085 of 28 November 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × NK603 × DAS-40278-9 and sub- combinations MON 89034 × NK603 × DAS-40278-9, 1507 × NK603 × DAS-40278-9 and NK603 × DAS-40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 316, 6.12.2019, p. 80). (7) Commission Implementing Decision (EU) 2019/2086 of 28 November 2019 authorising the placing on the market of products containing, consisting of or produced from genetically modified maize MON 89034 × 1507 × MON 88017 × 59122 × DAS-40278-9 and genetically modified maize combining two, three or four of the single events MON 89034, 1507, MON 88017, 59122 and DAS- 40278-9 pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 316, 6.12.2019, p. 87).15.7.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 252/3 (2) Article 8 is replaced by the following: ‘Article 8 Addressee This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ (3) in the Annex, point (a) is replaced by the following: ‘(a) Applicant and authorisation holder Name: Corteva Agriscience LLC Address: 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ Article 2 Amendments to Implementing Decision (EU) 2017/1211 Implementing Decision (EU) 2017/1211 is amended as follows: (1) Article 6 is replaced by the following: ‘Article 6 Authorisation holder The authorisation holder shall be Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience Belgium BV.’ (2) Article 8 is replaced by the following: ‘Article 8 Addressee This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ (3) in the Annex, point (a) is replaced by the following: ‘(a) Applicant and authorisation holder Name: Corteva Agriscience LLC Address: 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ Article 3 Amendments to Implementing Decision (EU) 2017/1212 Implementing Decision (EU) 2017/1212 is amended as follows:L 252/4 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 15.7.2021 (1) Article 6 is replaced by the following: ‘Article 6 Authorisation holder The authorisation holder shall be Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience Belgium BV.’ (2) Article 8 is replaced by the following: ‘Article 8 Addressee This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ (3) in the Annex, point (a) is replaced by the following: ‘(a) Authorisation holder Name: Corteva Agriscience LLC Address: 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ Article 4 Amendments to Implementing Decision (EU) 2017/2449 Implementing Decision (EU) 2017/2449 is amended as follows: (1) Article 7 is replaced by the following: ‘Article 7 Authorisation holder The authorisation holder shall be Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience Belgium BV.’ (2) Article 9 is replaced by the following: ‘Article 9 Addressee This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ (3) in the Annex, point (a) is replaced by the following: ‘(a) Authorisation holder Name: Corteva Agriscience LLC Address: 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’15.7.2021 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union L 252/5 Article 5 Amendments to Implementing Decision (EU) 2019/2085 Implementing Decision (EU) 2019/2085 is amended as follows: (1) Article 7 is replaced by the following: ‘Article 7 Authorisation holder The authorisation holder shall be Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience Belgium BV.’ (2) Article 9 is replaced by the following: ‘Article 9 Addressee This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ (3) in the Annex, point (a) is replaced by the following: ‘(a) Applicant and authorisation holder Name: Corteva Agriscience LLC Address: 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ Article 6 Amendments to Implementing Decision (EU) 2019/2086 Implementing Decision (EU) 2019/2086 is amended as follows: (1) Article 7 is replaced by the following: ‘Article 7 Authorisation holder The authorisation holder shall be Corteva Agriscience LLC, United States, represented in the Union by Corteva Agriscience Belgium BV.’ (2) Article 9 is replaced by the following: ‘Article 9 Addressee This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’L 252/6 E N O f f i c i a l J o u r n a l o f t h e E u r o p e a n Union 15.7.2021 (3) in the Annex, point (a) is replaced by the following: ‘(a) Applicant and authorisation holder Name: Corteva Agriscience LLC Address: 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium.’ Article 7 Addressee This Decision is addressed to Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States, represented in the Union by Corteva Agriscience Belgium BV, Bedrijvenlaan 9, 2800 Mechelen, Belgium. Done at Brussels, 13 July 2021. For the Commission Stella KYRIAKIDES Member of the Commission

Continue your research