Date: 2022-09-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2022/1487 of 7 September 2022 postponing the expiry date of the approval of etofenprox for use in biocidal products of product-type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council (Text with EEA relevance)
Issued by European Commission
· Directorate-General for Health and Food Safety
Executive Summary:
This Commission Implementing Decision (EU) 2022/1487 postpones the expiry date of the approval of etofenprox for use in biocidal products of product type 8, as per Regulation (EU) No 528/2012. The decision is due to delays in the evaluation process, specifically regarding endocrine-disrupting properties. The new expiry date is set for 31 October 2026. The decision enters into force twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Approval Renewal:**
* An application for renewal of the approval of etofenprox for product-type 8 biocidal products was submitted on 27 July 2018.
* A full evaluation of the application is deemed necessary.
* The evaluating competent authority expects to submit the renewal assessment report in the first quarter of 2025.
* **Expiry Date Postponement:**
* The expiry date of the approval of etofenprox is postponed to 31 October 2026.
* This postponement is due to delays in the evaluation process, specifically the need for additional studies on endocrine-disrupting properties.
* Etofenprox remains approved under the conditions outlined in Annex I to Directive 98/8/EC.
* **Legal Basis and Implementation:**
* This decision is based on Regulation (EU) No 528/2012, particularly Article 145.
* This decision amends Implementing Decision EU 2019/994.
* The decision enters into force twenty days after publication in the Official Journal of the European Union.
Impact Analysis:
* **Etofenprox Manufacturers/Applicants:**
* *Impact:* Continued ability to market and use etofenprox in biocidal products of product type 8 until 31 October 2026, pending the outcome of the renewal application.
* *Action Required:* Continue to cooperate with the evaluating competent authority by providing any requested data necessary for the evaluation, including data related to endocrine-disrupting properties.
* **Evaluating Competent Authority (Austria):**
* *Impact:* Extended timeframe to complete the evaluation of etofenprox, including the assessment of endocrine-disrupting properties.
* *Action Required:* Submit the renewal assessment report to the European Chemicals Agency (the Agency) in the first quarter of 2025.
* **European Chemicals Agency (the Agency):**
* *Impact:* Will receive the renewal assessment report from the evaluating competent authority.
* *Action Required:* Prepare and submit to the Commission an opinion on the renewal of the approval of etofenprox, within 270 days of receipt of the recommendation from the evaluating competent authority.
* **European Commission:**
* *Impact:* Responsible for deciding whether to renew the approval of etofenprox for use in biocidal products of product type 8.
* *Action Required:* Decide on the renewal of approval of Etofenprox based on the opinion of the Agency.
* **Member States:**
* *Impact:* Must recognize the extended approval period for etofenprox.
* *Action Required:* Ensure that biocidal products containing etofenprox are allowed on the market until 31 October 2026, subject to existing requirements.
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, upholding the EU treaties and managing the day-to-day business of the EU.
Regulation EU No 528/2012: A regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
Etofenprox: An active substance used in biocidal products of product type 8, the approval of which is being postponed.
Directive 98/8/EC: A directive of the European Parliament and of the Council concerning the placing of biocidal products on the market.
European Chemicals Agency: An agency of the European Union which prepares and submits to the Commission an opinion on renewal of the approval of the active substance.
Austria: Country within the European Union; the evaluating competent authority that performed the evaluation of the application.
Ursula VON DER LEYEN: The President of the European Commission.
8.9.2022 EN Official Journal of the European Union L 233/85
COMMISSION IMPLEMENTING DECISION (EU) 2022/1487
of 7 September 2022
postponing the expiry date of the approval of etofenprox for use in biocidal products of product-
type 8 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the
Council
(Text with EEA relevance)
THE EUROPEAN COMMISSION,
Having regard to the Treaty on the Functioning of the European Union,
Having regard to Regulation (EU) No 528/2012 of the European Parliament and of the Council of 22 May 2012concerning
the making available on the market and use of biocidal products(1), and in particular Article 14(5) thereof,
After consulting the Standing Committee on Biocidal Products,
Whereas:
(1) Etofenprox was included in Annex I to Directive 98/8/EC of the European Parliament and of the Council(2)as an
active substance for use in biocidal products of product-type 8. Pursuant to Article 86 of Regulation (EU)
No 528/2012, it was therefore considered approved under that Regulation until 31 January 2020 subject to the
requirements set out in Annex I to Directive 98/8/EC.
(2) On 27 July 2018, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012
for the renewal of the approval of etofenprox for use in biocidal products of product-type 8 (‘the application’).
(3) On 19 December 2018, the evaluating competent authority of Austria informed the Commission that it had decided,
pursuant to Article 14(1) of Regulation (EU) No 528/2012, that a full evaluation of the application was necessary.
Pursuant to Article 8(1) of that Regulation, the evaluating competent authority is to perform a full evaluation of the
application within 365 days of its validation.
(4) The evaluating competent authority may, as appropriate, require the applicant to provide sufficient data to carry out
the evaluation, in accordance with Article 8(2) of Regulation (EU) No 528/2012. In that event, the 365-day period is
suspended for a period that may not exceed 180 days in total unless a longer suspension is justified by the nature of
the data requested or by exceptional circumstances.
(5) Within 270 days of receipt of a recommendation from the evaluating competent authority, the European Chemicals
Agency (‘the Agency’) is to prepare and submit to the Commission an opinion on renewal of the approval of the
active substance in accordance with Article 14(3) of Regulation (EU) No 528/2012.
(6) Commission Implementing Decision (EU) 2019/994(3)postponed the expiry date of the approval of etofenprox for
use in biocidal products of product-type 8 to 31 October 2022in order to allow sufficient time for the examination
of the application.
(7) On 11 April 2022, the evaluating competent authority informed the Commission that the evaluation is delayed
further because additional studies are needed to assess the criteria for the determination of endocrine-disrupting
properties of etofenprox. The evaluating competent authority expects to submit the renewal assessment report to
the Agency in the first quarter of 2025.
(1) OJ L 167, 27.6.2012, p. 1.
(2) Directive 98/8/EC of the European Parliament and of the Council of 16 February 1998 concerning the placing of biocidal products on
the market (OJ L 123, 24.4.1998, p. 1).
(3) Commission Implementing Decision (EU) 2019/994 of 17 June 2019 postponing the expiry date of approval of etofenprox for use in
biocidal products of product-type 8 (OJ L 160, 18.6.2019, p. 26).L 233/86 EN Official Journal of the European Union 8.9.2022
(8) Consequently, for reasons beyond the control of the applicant, the approval is likely to expire before a decision has
been taken on its renewal. It is therefore appropriate to postpone the expiry date of the approval for a period of
time sufficient to enable the examination of the application. Taking into account the time-limits for evaluations by
the evaluating competent authorities and for preparation and submission by the Agency of its opinion and the time
needed for the Commission to decide whether to renew the approval of etofenprox for use in biocidal products for
product-type 8, the expiry date should be postponed to 31 October 2026.
(9) After the postponement of the expiry date of the approval, etofenprox remains approved for use in biocidal products
of product-type 8 subject to the requirements set out in Annex I to Directive 98/8/EC,
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of etofenprox for use in biocidal products of product-type 8 set out in Implementing
Decision (EU) 2019/994 is postponed to 31 October 2026.
Article 2
This Decision shall enter into force on the twentieth day following that of its publication in the Official Journal of the
European Union.
Done at Brussels, 7 September 2022.
For the Commission
The President
Ursula VON DER LEYEN