Date: 2021-11-17Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2021/1999 of 15 November 2021 amending Implementing Decision (EU) 2016/1215 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 genetically modified soybean FG72 (notified under document C(2021) 8000) (Only the French and Dutch 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 2021/1999 amends Implementing Decision EU 2016/1215, transferring the authorisation for placing genetically modified soybean FG72 on the market from BASF Agricultural Solutions Seeds US LLC to Syngenta Crop Protection AG, effective June 2, 2020. The changes are administrative and do not require a new assessment. The decision was adopted on November 15, 2021.
Key Points / Main Content:
* **Authorisation Transfer:**
* The authorisation holder for placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 is now Syngenta Crop Protection AG, based in Switzerland.
* Syngenta Crop Protection NVSA, based in Belgium, represents Syngenta Crop Protection AG in the Union.
* **Amendment of Implementing Decision EU 2016/1215:**
* Article 6 of Implementing Decision EU 2016/1215 is replaced, designating Syngenta Crop Protection AG as the authorisation holder.
* Article 8 of Implementing Decision EU 2016/1215 is replaced, designating Syngenta Crop Protection AG as the addressee.
* Point a in the Annex of Implementing Decision EU 2016/1215 is replaced, updating the applicant and authorisation holder information to Syngenta Crop Protection AG.
Impact Analysis:
Syngenta Crop Protection AG:
* Impact: Assumes the rights and obligations of the authorisation holder for placing genetically modified soybean FG72 on the market.
* Action Required: Ensure compliance with the terms of the authorisation as the new holder.
Syngenta Crop Protection NVSA:
* Impact: Represents Syngenta Crop Protection AG in the Union regarding the authorisation.
* Action Required: Act as the representative for Syngenta Crop Protection AG in all matters related to the authorisation.
BASF Agricultural Solutions Seeds US LLC:
* Impact: Relinquishes its rights and obligations as the authorisation holder for genetically modified soybean FG72.
* Action Required: Ensure the transfer of all relevant information and documentation to Syngenta Crop Protection AG.
European Commission:
* Impact: Oversees the administrative transfer of the authorisation.
* Action Required: Ensure the updated information regarding the authorisation holder is accurately reflected in relevant records and communications.
Key Entities Referenced
Commission Implementing Decision EU 2016/1215: A European Union Commission Implementing Decision authorizing the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72 MSTFG722 pursuant to Regulation EC No 1829/2003.
Syngenta Crop Protection AG: A Swiss-based company that is the new authorization holder for the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72.
Syngenta Crop Protection NVSA: The Union representative, based in Belgium, for Syngenta Crop Protection AG.
Regulation EC No 1829/2003: A Regulation of the European Parliament and of the Council on genetically modified food and feed.
BASF Agricultural Solutions Seeds US LLC: The previous authorization holder for the placing on the market of products containing, consisting of, or produced from genetically modified soybean FG72, based in the United States.
BASF SE: The Union representative, based in Germany, for BASF Agricultural Solutions Seeds US LLC.
genetically modified soybean FG72: The specific genetically modified soybean that is the subject of the authorization transfer.
Brussels, Belgium: Location where the Commission Implementing Decision was adopted.
L 408/6 EN Official Journal of the European Union 17.11.2021
COMMISSION IMPLEMENTING DECISION (EU) 2021/1999
of 15 November 2021
amending Implementing Decision (EU) 2016/1215 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 genetically modified soybean FG72
(notified under document C(2021) 8000)
(Only the French and Dutch 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) BASF Agricultural Solutions Seeds US LLC, based in the United States, is the authorisation holder for the placing on
the market of products containing, consisting of, or produced from genetically modified soybean FG72 authorised
by Commission Implementing Decision (EU) 2016/1215(2). BASF Agricultural Solutions Seeds US LLC is
represented in the Union by BASF SE, based in Germany. BASF Belgium Coordination Center CommV, based in
Belgium, is a branch of BASF SE.
(2) By letter dated 26 April 2021, BASF Belgium Coordination Center CommV informed the Commission that BASF
Agricultural Solutions Seeds US LLC had transferred its right and obligations related the authorisation for placing
on the market of the FG72 soybean event to Syngenta Crop Protection AG, based in Switzerland, represented in the
Union by Syngenta Crop Protection NV/SA, based in Belgium, as of 2 June 2020.
(3) By letter dated 27 April 2021, Syngenta Crop Protection NV/SA informed the Commission that Syngenta Crop
Protection AG had consented to this transfer.
(4) The requested changes are purely administrative in nature and therefore do not entail a new assessment of the
products concerned.
(5) Implementing Decision (EU) 2016/1215 should therefore be amended accordingly.
(6) 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) 2016/1215
Implementing Decision (EU) 2016/1215 is amended as follows:
(1) Article 6 is replaced by the following:
‘Article 6
Authorisation holder
The authorisation holder shall be Syngenta Crop Protection AG, Switzerland, represented in the Union by Syngenta
Crop Protection NV/SA, Belgium.’
(1) OJ L 268, 18.10.2003, p. 1.
(2) Commission Implementing Decision (EU) 2016/1215 of 22 July 2016 authorising the placing on the market of products containing,
consisting of, or produced from genetically modified soybean FG72 (MST-FGØ72-2) pursuant to Regulation (EC) No 1829/2003 of
the European Parliament and of the Council (OJ L 199 26.7.2016, p. 16).17.11.2021 EN Official Journal of the European Union L 408/7
(2) Article 8 is replaced by the following:
‘Article 8
Addressee
This Decision is addressed to Syngenta Crop Protection AG, Rosentalstrasse 67, CH 4058 Basel, Switzerland,
represented in the Union by Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.’;
(3) in the Annex, point (a) is replaced by the following:
‘(a) Applicant and authorisation holder
Name: Syngenta Crop Protection AG
Address: Rosentalstrasse 67, CH 4058 Basel, Switzerland,
represented in the Union by Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.’
Article 2
Addressee
This Decision is addressed to Syngenta Crop Protection AG, Rosentalstrasse 67, CH-4058 Basel, Switzerland, represented in
the Union by Syngenta Crop Protection NV/SA, Avenue Louise 489, 1050 Brussels, Belgium.
Done at Brussels, 15 November 2021.
For the Commission
Stella KYRIAKIDES
Member of the Commission