Date: 2021-06-25Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2021/1035 of 23 June 2021 amending Implementing Decisions 2013/648/EU and 2013/650/EU 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 maize (notified under document C(2021) 4317) (Text with EEA relevance) (Only the Dutch text is authentic)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision EU 2021/1035 amends Implementing Decisions 2013/648/EU and 2013/650/EU, updating 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 maize. The changes reflect name and legal form updates for Monsanto Company (now Bayer CropScience LP) and Dow AgroSciences LLC (now Corteva Agriscience LLC), along with their respective representatives. The decision was adopted on 23 June 2021.
Key Points / Main Content:
Authorisation Holder and Representative Changes:
* Monsanto Company has changed its legal form and name to Bayer CropScience LP, effective 1 August 2020.
* Bayer Agriculture BVBA has changed its name to Bayer Agriculture BV, effective 1 August 2020.
* Dow AgroSciences LLC has changed its name to Corteva Agriscience LLC, effective 1 January 2021.
* Corteva Agriscience LLC's representative in the Union is now Corteva Agriscience Belgium B.V., effective 22 March 2021.
Amendments to Implementing Decision 2013/648/EU:
* Article 6(1) is replaced, designating Corteva Agriscience LLC (represented by Corteva Agriscience Belgium B.V.) and Bayer CropScience LP (represented by Bayer Agriculture BV) as the authorisation holders.
* Article 8 is replaced, addressing the decision to Corteva Agriscience LLC and Bayer CropScience LP, including their respective addresses and representatives.
* The Annex is amended, updating the names and addresses of the applicants and authorisation holders to reflect the changes.
Amendments to Implementing Decision 2013/650/EU:
* Article 6(1) is replaced, designating Corteva Agriscience LLC (represented by Corteva Agriscience Belgium B.V.) and Bayer CropScience LP (represented by Bayer Agriculture BV) as the authorisation holders.
* Article 8 is replaced, addressing the decision to Corteva Agriscience LLC and Bayer CropScience LP, including their respective addresses and representatives.
* The Annex is amended, updating the names and addresses of the applicants and authorisation holders to reflect the changes.
Addressees:
* The decision is addressed to Corteva Agriscience LLC and Bayer CropScience LP, including their respective addresses and representatives.
Impact Analysis:
Corteva Agriscience LLC:
Impact: Officially recognised as the new name for Dow AgroSciences LLC, with Corteva Agriscience Belgium B.V. as their representative in the EU for the specified genetically modified maize products.
Action Required: Ensure compliance with the updated authorisation details in all relevant documentation and processes.
Corteva Agriscience Belgium B.V.:
Impact: Officially recognised as the representative of Corteva Agriscience LLC in the EU for the specified genetically modified maize products.
Action Required: Act as the official point of contact for Corteva Agriscience LLC regarding the authorisation of the specified genetically modified maize products in the EU.
Bayer CropScience LP:
Impact: Officially recognised as the new name for Monsanto Company, with Bayer Agriculture BV as their representative in the EU for the specified genetically modified maize products.
Action Required: Ensure compliance with the updated authorisation details in all relevant documentation and processes.
Bayer Agriculture BV:
Impact: Officially recognised as the representative of Bayer CropScience LP in the EU for the specified genetically modified maize products.
Action Required: Act as the official point of contact for Bayer CropScience LP regarding the authorisation of the specified genetically modified maize products in the EU.
European Commission:
Impact: Updates the official records and legal framework related to the authorisation of genetically modified maize products.
Action Required: Ensure that all relevant databases and documentation are updated to reflect the changes in authorisation holders and their representatives.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An executive branch of the European Union responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
Bayer Agriculture BV: A company based in Belgium, representing Bayer CropScience LP in the European Union.
Bayer CropScience LP: Formerly known as Monsanto Company, based in the United States of America and an authorisation holder for genetically modified maize.
Corteva Agriscience LLC: Formerly known as Dow AgroSciences LLC, based in the United States of America and an authorisation holder for genetically modified maize.
Corteva Agriscience Belgium B.V.: Representative of Corteva Agriscience LLC in the European Union, based in Belgium.
Regulation EC No 1829/2003: Regulation of the European Parliament and of the Council on genetically modified food and feed.
Commission Implementing Decision 2013/648/EU: A European Commission Implementing Decision authorising the placing on the market of products containing, consisting of, or produced from certain genetically modified maize.
25.6.2021 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 226/31
COMMISSION IMPLEMENTING DECISION (EU) 2021/1035
of 23 June 2021
amending Implementing Decisions 2013/648/EU and 2013/650/EU 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 maize
(notified under document C(2021) 4317)
(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 Articles 9(2) and 21(2) thereof,
Whereas:
(1) Bayer Agriculture BVBA, based in Belgium, is the representative in the Union of Monsanto Company, based in the
United States of America, concerning the authorisations for the placing on the market of products containing,
consisting of, or produced from genetically modified maize authorised by Commission Implementing Decisions
2013/648/EU(2)and 2013/650/EU(3). Dow AgroSciences LLC, based in the United States of America, is the other
authorisation holder for the genetically modified maize authorised by these Implementing Decisions. Dow
AgroSciences LLC is represented by Dow AgroSciences Distribution S.A.S., based in France.
(2) By letter dated 28 July 2020, Bayer Agriculture BVBA, based in Belgium, informed the Commission that Monsanto
Company, based in the United States, converts its legal form and changes its name to Bayer CropScience LP, based in
the United States of America, as of 1 August 2020.
(3) By letter dated 28 July 2020, Bayer Agriculture BVBA, informed the Commission that it changes its name to Bayer
Agriculture BV, based in Belgium, as of 1 August 2020.
(4) By the letter dated 17 March 2021, the Commission was informed that Dow AgroSciences LLC changed the name to
Corteva Agriscience LLC, based in the United States of America, as of 1 January 2021.
(5) By the letter dated 22 March 2021, Corteva Agriscience LLC informed the Commission that its representative in the
Union is Corteva Agriscience Belgium B.V., 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.
(1) OJ L 268, 18.10.2003, p. 1.
(2) Commission Implementing Decision 2013/648/EU of 6 November 2013 authorising the placing on the market of products
containing, consisting of, or produced from genetically modified maize MON89034 × 1507 × NK603 (MON-89Ø34-3 × DAS-
Ø15Ø7-1 × MON-ØØ6Ø3-6) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 302,
13.11.2013, p. 38).
(3) Commission Implementing Decision 2013/650/EU of 6 November 2013 authorising the placing on the market of products
containing, consisting of, or produced from genetically modified (GM) maize MON 89034 × 1507 × MON88017 × 59122 (MON-
89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7), four related GM maizes combining three different single GM events
(MON89034 × 1507 × MON88017 (MON-89Ø34-3 × DAS-Ø15Ø7-1 × MON-88Ø17-3), MON89034 × 1507 × 59122 (MON-
89Ø34-3 × DAS-Ø15Ø7-1 × DAS-59122-7), MON89034 × MON88017 × 59122 (MON-89Ø34-3 × MON-88Ø17-3 × DAS-
59122-7), 1507 × MON 88017 × 59122 (DAS-Ø15Ø7-1 × MON-88Ø17-3 × DAS-59122-7)) and four related GM maizes
combining two different single GM events (MON89034 × 1507 (MON-89Ø34-3 × DAS-Ø15Ø7-1), MON89034 × 59122 (MON-
89Ø34-3 × DAS-59122-7), 1507 × MON88017 (DAS-Ø15Ø7-1 × MON-88Ø17-3), MON 88017 × 59122 (MON-88Ø17-3 × DAS-
59122-7)) pursuant to Regulation (EC) No 1829/2003 of the European Parliament and of the Council (OJ L 302, 13.11.2013, p. 47).L 226/32 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 25.6.2021
(7) Implementing Decisions 2013/648/EU and 2013/650/EU 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 Implementing Decision 2013/648/EU
Implementing Decision 2013/648/EU is amended as follows:
(1) in Article 6, paragraph 1 is replaced by the following:
‘1. The authorisation holders shall be:
(a) Corteva Agriscience LLC, United States of America, represented by Corteva Agriscience Belgium B.V.; and
(b) Bayer CropScience LP, United States of America, represented by Bayer Agriculture BV, Belgium.’;
(2) Article 8 is replaced by the following:
‘This Decision is addressed to:
(a) Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States of America,
represented by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium; and
(b) Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States of America,
represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.’;
(3) in the Annex, point (a) is replaced by the following:
‘(a) Applicants and Authorisation holders
Name: Corteva Agriscience LLC
Address: 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States of America
represented by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium,
and
Name: Bayer CropScience LP
Address: 800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States of America
represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium’.
Article 2
Amendments to Implementing Decision 2013/650/EU
Implementing Decision 2013/650/EU is amended as follows:
(1) in Article 6, paragraph 1 is replaced by the following:
‘1. The authorisation holders shall be:
(a) Corteva Agriscience LLC, United States of America, represented by Corteva Agriscience Belgium B.V.; and
(b) Bayer CropScience LP, United States of America, represented by Bayer Agriculture BV, Belgium.’;25.6.2021 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 226/33
(2) Article 8 is replaced by the following:
‘This Decision is addressed to:
(a) Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States of America,
represented by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium; and
(b) Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States of America,
represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.’;
(3) in the Annex, point (a) is replaced by the following:
‘(a) Applicants and Authorisation holders
Name: Corteva Agriscience LLC
Address: 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States of America
represented by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium
and
Name: Bayer CropScience LP
Address: 800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States of America
represented by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.’
Article 3
Addressees
This Decision is addressed to:
(a) Corteva Agriscience LLC, 9330 Zionsville Road Indianapolis, Indiana 46268-1054, United States of America,
represented by Corteva Agriscience Belgium B.V., Bedrijvenlaan 9, 2800 Mechelen, Belgium; and
(b) Bayer CropScience LP, 800 N. Lindbergh Boulevard, St Louis, Missouri, 63167, United States of America, represented
by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.
Done at Brussels, 23 June 2021.
For the Commission
Stella KYRIAKIDES
Member of the Commission