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Date: 2022-03-28 Category: Not Applicable State: Union Government Country: Europe

Commission Implementing Regulation (EU) 2022/489 of 25 March 2022 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances flubendiamide, L-ascorbic acid, spinetoram and spirotetramat (Text with EEA relevance)

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

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Executive Summary & Key Takeaways

**Executive Summary:** This Commission Implementing Regulation (EU) 2022/489 amends Implementing Regulation (EU) No 540/2011, adjusting the approval periods for flubendiamide, L-ascorbic acid, spinetoram, and spirotetramat. The regulation reinstates the original expiration dates for these substances, nullifying extensions granted by Implementing Regulation (EU) 2020/2007. It takes effect twenty days after its publication in the Official Journal of the European Union. **Key Points / Main Content:** * **Amendment:** * Amends Implementing Regulation (EU) No 540/2011 regarding approved active substances. * **Substance Approval Periods:** * Revises the expiration dates for: * Spirotetramat: 30 April 2024 * L-ascorbic acid: 30 June 2024 * Spinetoram: 30 June 2024 * Flubendiamide: 31 August 2024 * **Justification:** * Extensions granted by Implementing Regulation (EU) 2020/2007 are no longer justified because no applications for renewal were submitted within the required timeframe. * **Entry into Force:** * The regulation takes effect twenty days after publication in the Official Journal of the European Union. **Impact Analysis** **Stakeholders:** * **European Commission:** * Impact: Responsible for implementing and enforcing the amended regulation. * Action Required: Update relevant databases and communicate the changes to member states and stakeholders. * **Manufacturers/Applicants of Flubendiamide, L-ascorbic acid, Spinetoram and Spirotetramat:** * Impact: Must comply with the revised expiration dates for these active substances. * Action Required: Adjust production and marketing strategies to align with the reinstated deadlines; consider submitting renewal applications if continued approval is desired. * **Member States:** * Impact: Must ensure national regulations align with the amended Implementing Regulation. * Action Required: Update national databases, inform relevant stakeholders (farmers, distributors, etc.), and enforce the revised expiration dates. * **Users of Plant Protection Products Containing These Substances (e.g., Farmers):** * Impact: Must be aware of the revised expiration dates and potential changes in the availability of products containing these substances. * Action Required: Adjust crop protection strategies as necessary and 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. Commission Implementing Regulation EU 2022/489: A specific European Union regulation being implemented, amending Implementing Regulation EU No 540/2011 regarding approval periods of certain active substances. 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: A European Union regulation implementing Regulation EC No 1107/2009 regarding the list of approved active substances. flubendiamide: An active substance whose approval period is being addressed in the regulation. L-ascorbic acid: An active substance whose approval period is being addressed in the regulation. spinetoram: An active substance whose approval period is being addressed in the regulation. spirotetramat: An active substance whose approval period is being addressed in the regulation.
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28.3.2022 EN Official Journal of the European Union L 100/7 COMMISSION IMPLEMENTING REGULATION (EU) 2022/489 of 25 March 2022 amending Implementing Regulation (EU) No 540/2011 as regards the approval periods of the active substances flubendiamide, L-ascorbic acid, spinetoram and spirotetramat (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 B of the Annex to Commission Implementing Regulation (EU) No 540/2011(2)sets out the active substances approved under Regulation (EC) No 1107/2009. (2) Commission Implementing Regulation (EU) 2020/2007(3) extended the approval period of the active substance spirotetramat from 30 April 2024 until 31 July 2024, spinetoram and L-ascorbic acid from 30 June 2024 until 30 September 2024 and flubendiamide from 31 August 2024 until 30 November 2024. The extensions were necessary because Commission Implementing Regulation (EU) 2020/1740(4) advanced the date of submission of the dossiers in support of the renewal of approval by 3 months. Therefore, it was necessary to maintain the date of the dossier submission as required under Commission Implementing Regulation (EU) No 844/2012(5), while giving applicants time to prepare and submit the dossiers in the required format. (3) As regards flubendiamide, L-ascorbic acid, spinetoram and spirotetramat, no applications for renewal of approval in accordance with Article 5(1) of Implementing Regulation (EU) 2020/1740 were submitted within 3 years before the respective expiry date of approval laid down in the Annex to this Regulation. (4) The extensions of the approval periods of those active substances, provided for by Implementing Regulation (EU) 2020/2007, are no longer justified. It is therefore appropriate to provide that the approvals of these substances expire at the dates they would expire without the extension. (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) 2020/2007 of 8 December 2020 amending Implementing Regulation (EU) No 540/2011 as regards the extension of the approval periods of the active substances 1-decanol, 1,4-dimethylnaphthalene, 6-benzyladenine, acequinocyl, Adoxophyes orana granulovirus, aluminium sulfate, amisulbrom, Aureobasidium pullulans (strains DSM 14940 and DSM 14941), azadirachtin, Bacillus pumilus QST 2808, benalaxyl-M, bixafen, bupirimate, Candida oleophila strain O, chlorantra­ niliprole, disodium phosphonate, dithianon, dodine, emamectin, flubendiamide, fluometuron, fluxapyroxad, flutriafol, hexythiazox, imazamox, ipconazole, isoxaben, L-ascorbic acid, lime sulphur, orange oil, Paecilomyces fumosoroseus strain FE 9901, pendimethalin, penflufen, penthiopyrad, potassium phosphonates, prosulfuron, Pseudomonas sp. strain DSMZ 13134, pyridalyl, pyriofenone, pyroxsulam, quinmerac, S-abscisic acid, sedaxane, sintofen, sodium silver thiosulfate, spinetoram, spirotetramat, Streptomyces lydicus strain WYEC 108, tau-fluvalinate, tebufenozide, tembotrione, thiencarbazone, valifenalate, zinc phosphide (OJ L 414, 9.12.2020, p. 10). (4) 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). (5) 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).L 100/8 EN Official Journal of the European Union 28.3.2022 (5) Implementing Regulation (EU) No 540/2011 should therefore be amended accordingly. (6) 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 March 2022. For the Commission The President Ursula VON DER LEYEN28.3.2022 EN Official Journal of the European Union L 100/9 ANNEX Part B of the Annex to Implementing Regulation (EU) No 540/2011 is amended as follows: (1) in the sixth column, expiration of approval, of row 60, spirotetramat, the date is replaced by ‘30 April 2024’; (2) in the sixth column, expiration of approval, of row 66, L-ascorbic acid, the date is replaced by ‘30 June 2024’; (3) in the sixth column, expiration of approval, of row 67, spinetoram, the date is replaced by ‘30 June 2024’; (4) in the sixth column, expiration of approval, of row 74, flubendiamide, the date is replaced by ‘31 August 2024’.

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