Date: 2021-06-25Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2021/1036 of 22 June 2021 amending Implementing Decision (EU) 2018/1113 as regards the authorisation holder and its representative in the Union for the placing on the market of products produced from genetically modified sugar beet H7-1 (notified under document C(2021) 4325) (Only the Dutch and German texts are authentic) (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision EU 2021/1036 amends Implementing Decision EU 2018/1113 regarding the authorisation holder and its representative in the Union for the placing on the market of products produced from genetically modified sugar beet H71. The changes are due to Bayer Agriculture BVBA and Monsanto Company converting their legal forms and changing their names. The decision was made on 22 June 2021.
Key Points / Main Content:
Amendments to Implementing Decision EU 2018/1113:
* Article 6, paragraph 1, point b is replaced, updating the name of the Union representative to Bayer Agriculture BV representing Bayer CropScience LP.
* Article 8, point b is replaced, updating the name and address of Bayer CropScience LP and its Union representative Bayer Agriculture BV.
* The Annex, point a is replaced, updating the applicants and authorisation holders to include KWS SAAT SE and Bayer CropScience LP, represented in the Union by Bayer Agriculture BV.
Addressees:
* The decision is addressed to KWS SAAT SE (Germany) and Bayer CropScience LP (USA), represented in the Union by Bayer Agriculture BV (Belgium).
Impact Analysis:
KWS SAAT SE:
* Impact: Officially recognised as the authorisation holder with updated contact information in the Annex.
* Action Required: Ensure compliance with the updated decision.
Bayer CropScience LP:
* Impact: Officially recognised as an applicant and authorisation holder with updated contact information in the Annex; name change from Monsanto Company acknowledged.
* Action Required: Ensure compliance with the updated decision.
Bayer Agriculture BV:
* Impact: Officially recognised as the Union representative for Bayer CropScience LP, reflecting the name change from Bayer Agriculture BVBA.
* Action Required: Ensure all representative activities align with the updated decision and reflect the new company name.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Decision EU 2021/1036: A European Commission decision amending Implementing Decision EU 2018/1113 regarding the authorisation holder for genetically modified sugar beet H71.
Commission Implementing Decision EU 2018/1113: A European Commission decision renewing the authorisation for placing on the market of food and feed produced from genetically modified sugar beet H71.
Regulation EC No 1829/2003: Regulation of the European Parliament and of the Council on genetically modified food and feed.
Bayer CropScience LP: Company resulting from a name change of Monsanto Company. Located in St. Louis, Missouri, United States of America.
Bayer Agriculture BV: The representative in the Union of Bayer CropScience LP, formerly Monsanto Company. Located in Antwerp, Belgium.
KWS SAAT SE: The authorisation holder for the genetically modified sugar beet H71, located in Einbeck, Germany.
Stella KYRIAKIDES: Member of the European Commission.
L 226/34 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
COMMISSION IMPLEMENTING DECISION (EU) 2021/1036
of 22 June 2021
amending Implementing Decision (EU) 2018/1113 as regards the authorisation holder and its
representative in the Union for the placing on the market of products produced from genetically
modified sugar beet H7-1
(notified under document C(2021) 4325)
(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 2003on
genetically modified food and feed(1), and in particular to Article 9(2) and Article 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, concerning the authorisation for the placing on the market of products produced from genetically
modified sugar beet H7-1 pursuant to Commission Implementing Decision (EU) 2018/1113(2). KWS SAAT SE,
based in Germany, is the authorisation holder for the genetically modified sugar beet H7-1, authorised by that
Implementing Decision.
(2) By letter dated 28 July 2020, Bayer Agriculture BVBA informed the Commission that it converts its legal form and
changes its name to Bayer Agriculture BV as of 1 August 2020.
(3) By letter dated 28 July 2020, Bayer Agriculture BVBA informed the Commission that Monsanto Company converts
its legal form and changes its name to Bayer CropScience LP as of 1 August 2020.
(4) The requested changes are purely administrative in nature and therefore do not entail a new assessment of the
products concerned.
(5) By letter dated 10 August 2020, the Commission informed KWS SAAT SE about the requested changes. By letter of
9 December 2020, KWS SAAT SE informed the Commission that it agrees with the proposed modifications.
(6) Implementing Decision (EU) 2018/1113 should therefore be amended accordingly.
(7) 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 (EU) 2018/1113
Implementing Decision (EU) 2018/1113 is amended as follows:
(1) OJ L 268, 18.10.2003, p. 1.
(2) Commission Implementing Decision (EU) 2018/1113 of 3 August 2018 renewing the authorisation for the placing on the market of
food and feed produced from genetically modified sugar beet H7-1 (KM-ØØØH71-4) pursuant to Regulation (EC) No 1829/2003 of
the European Parliament and of the Council (OJ L 203, 10.8.2018, p. 32).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 226/35
(1) in Article 6, paragraph 1, point (b) is replaced by the following:
‘(b) Bayer CropScience LP, represented in the Union by Bayer Agriculture BV,’;
(2) in Article 8, point (b) is replaced by the following:
‘(b) Bayer CropScience LP, 800 N, Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America,
represented in the Union 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: KWS SAAT SE
Address: Grimsehlstrasse 31, 37574 Einbeck, Germany
and
Name: Bayer CropScience LP
Address: 800 N, Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America
Represented in the Union by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.’
Article 2
Addressees
This Decision is addressed to:
(a) KWS SAAT SE, Grimsehlstrasse 31, 37574 Einbeck, Germany, and
(b) Bayer CropScience LP, 800 N, Lindbergh Boulevard, St. Louis, Missouri 63167, United States of America, represented in
the Union by Bayer Agriculture BV, Scheldelaan 460, 2040 Antwerp, Belgium.
Done at Brussels, 22 June 2021.
For the Commission
Stella KYRIAKIDES
Member of the Commission