Date: 2021-11-26Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Regulation (EU) 2021/2068 of 25 November 2021 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl and pyraclostrobin (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Regulation (EU) 2021/2068 amends Implementing Regulation (EU) No 540/2011, extending the approval periods for several active substances, including benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P, mepiquat, metiram, oxamyl, and pyraclostrobin. The extensions are due to delays in assessment and the need for endocrine-disrupting properties assessments. This regulation took effect twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
Extension of Approval Periods:
* The approval periods for the following active substances are extended until January 31, 2023: Mecoprop-P, Pyraclostrobin, Metiram, Oxamyl, and Dimoxystrobin.
* The approval periods for the following active substances are extended until February 28, 2023: Flutolanil, Benfluralin, Fluazinam, and Mepiquat.
Renewal Procedure:
* The procedure for renewal of approval for these active substances, as outlined in Commission Implementing Regulation (EU) No 844/2012, remains applicable.
Commission Actions:
* If the Commission decides not to renew approval due to unmet criteria, the expiry date will be the same as before this regulation or the date of entry into force of the non-renewal regulation, whichever is later.
* If the Commission decides to renew approval, it will aim to set the earliest possible application date.
Amendments:
* The Annex to Implementing Regulation (EU) No 540/2011 is amended as specified in the Annex to this regulation, reflecting the changes in expiration dates.
Impact Analysis:
European Commission:
* Impact: Responsible for setting expiry dates and application dates related to the approval or non-renewal of active substances.
* Action Required: Implement and enforce the amended regulation.
Member States:
* Impact: Directly affected as the regulation is binding and applicable in all member states.
* Action Required: Adjust national regulations and practices to align with the extended approval periods.
Plant Protection Product Manufacturers/Applicants:
* Impact: Benefit from the extended approval periods for the listed active substances, allowing continued marketing and use of related products.
* Action Required: Continue to cooperate with the renewal process and provide necessary data for assessment.
Users of Plant Protection Products:
* Impact: Can continue using products containing the listed active substances within the extended approval periods.
* Action Required: Ensure compliance with regulations regarding the use of these substances.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An institution of the European Union, responsible for proposing legislation, implementing decisions, and managing the day-to-day business of the EU.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union, outlining the scope of the EU's powers.
Regulation EC No 1107/2009: Regulation of the European Parliament and of the Council concerning the placing of plant protection products on the market.
Commission Implementing Regulation EU No 540/2011: Commission Implementing Regulation setting out the list of approved active substances under Regulation EC No 1107/2009.
Brussels: The capital of Belgium and a major administrative centre for the European Union, where the regulation was adopted.
Ursula VON DER LEYEN: The President of the European Commission.
Standing Committee on Plants, Animals, Food and Feed: A committee that provides opinions on measures related to plant health, animal health, food and feed safety.
26.11.2021 EN Official Journal of the European Union L 421/25
COMMISSION IMPLEMENTING REGULATION (EU) 2021/2068
of 25 November 2021
amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval
periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P,
mepiquat, metiram, oxamyl and pyraclostrobin
(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 1107/2009 of the European Parliament and of the Council of 21 October 2009
concerning the placing of plant protection products on the market and repealing Council Directives 79/117/EEC
and 91/414/EEC(1), and in particular Article 17, first paragraph, thereof,
Whereas:
(1) Part A of the Annex to Commission Implementing Regulation (EU) No 540/2011(2)sets out the active substances
deemed to have been approved under Regulation (EC) No 1107/2009.
(2) Commission Implementing Regulation (EU) 2021/52(3) extended the approval period of the active substances
dimoxystrobin, mecoprop-P, metiram, oxamyl and pyraclostrobin until 31 January 2022, and the approval period
of the active substances benfluralin, fluazinam, flutolanil and mepiquat until 28 February 2022.
(3) Applications for the renewal of the approval of those substances were submitted in accordance with Commission
Implementing Regulation (EU) No 844/2012(4), repealed by Commission Implementing Regulation (EU)
2020/1740(5). However, the procedure for the renewal of the approval of those active substances as set out in
Commission Implementing Regulation (EU) No 844/2012 continues to apply in accordance with Article 17(2) of
Commission Implementing Regulation (EU) 2020/1740.
(4) Due to the fact that the assessment of those active substances has been delayed for reasons beyond the control of the
applicants, the approvals of those active substances are likely to expire before a decision has been taken on their
renewal. It is therefore necessary to extend their approval periods.
(5) In addition, an extension of the approval period is required for the active substances fluazinam, flutolanil,
mecoprop-P, mepiquat, metiram and pyraclostrobin to provide the time necessary to carry out an assessment
relating to endocrine disrupting properties of those active substances in accordance with the procedure set out in
Articles 13 and 14 of Implementing Regulation (EU) No 844/2012.
(1) OJ L 309, 24.11.2009, p. 1.
(2) Commission Implementing Regulation (EU) No 540/2011 of 25 May 2011 implementing Regulation (EC) No 1107/2009 of the
European Parliament and of the Council as regards the list of approved active substances (OJ L 153, 11.6.2011, p. 1).
(3) Commission Implementing Regulation (EU) 2021/52 of 22 January 2021 amending Implementing Regulation (EU) No 540/2011 as
regards the extension of the approval periods of the active substances benfluralin, dimoxystrobin, fluazinam, flutolanil, mecoprop-P,
mepiquat, metiram, oxamyl and pyraclostrobin (OJ L 23, 25.1.2021, p. 13).
(4) Commission Implementing Regulation (EU) No 844/2012 of 18 September 2012 setting out the provisions necessary for the
implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European
Parliament and of the Council concerning the placing of plant protection products on the market (OJ L 252, 19.9.2012, p. 26).
(5) Commission Implementing Regulation (EU) 2020/1740 of 20 November 2020 setting out the provisions necessary for the
implementation of the renewal procedure for active substances, as provided for in Regulation (EC) No 1107/2009 of the European
Parliament and of the Council, and repealing Commission Implementing Regulation (EU) No 844/2012 (OJ L 392, 23.11.2020, p. 20).L 421/26 EN Official Journal of the European Union 26.11.2021
(6) As regards cases where the Commission is to adopt a Regulation providing that the approval of an active substance
referred to in the Annex to this Regulation is not renewed because the approval criteria are not satisfied, the
Commission is to set the expiry date at the same date as before this Regulation or at the date of the entry into force
of the Regulation providing that the approval of the active substance is not renewed, whichever date is later. As
regards cases where the Commission is to adopt a Regulation providing for the renewal of an active substance
referred to in the Annex to this Regulation, the Commission will endeavour to set, as appropriate under the
circumstances, the earliest possible application date.
(7) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly.
(8) The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on
Plants, Animals, Food and Feed,
HAS ADOPTED THIS REGULATION:
Article 1
The Annex to Implementing Regulation (EU) No 540/2011 is amended in accordance with the Annex to this Regulation.
Article 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
This Regulation shall be binding in its entirety and directly applicable in all Member States.
Done at Brussels, 25 November 2021.
For the Commission
The President
Ursula VON DER LEYEN26.11.2021 EN Official Journal of the European Union L 421/27
ANNEX
Part A of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows:
(1) in the sixth column, expiration of approval, of row 57, Mecoprop-P, the date is replaced by ‘31 January 2023’;
(2) in the sixth column, expiration of approval, of row 81, Pyraclostrobin, the date is replaced by ‘31 January 2023’;
(3) in the sixth column, expiration of approval, of row 115, Metiram, the date is replaced by ‘31 January 2023’;
(4) in the sixth column, expiration of approval, of row 116, Oxamyl, the date is replaced by ‘31 January 2023’;
(5) in the sixth column, expiration of approval, of row 128, Dimoxystrobin, the date is replaced by ‘31 January 2023’;
(6) in the sixth column, expiration of approval, of row 187, Flutolanil, the date is replaced by ‘28 February 2023’;
(7) in the sixth column, expiration of approval, of row 188, Benfluralin, the date is replaced by ‘28 February 2023’;
(8) in the sixth column, expiration of approval, of row 189, Fluazinam, the date is replaced by ‘28 February 2023’;
(9) in the sixth column, expiration of approval, of row 191, Mepiquat, the date is replaced by ‘28 February 2023’.