Date: 2022-09-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2022/1486 of 7 September 2022 postponing the expiry date of the approval of acrolein for use in biocidal products of product-type 12 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:
Commission Implementing Decision (EU) 2022/1486 postpones the expiry date of the approval of acrolein for use in biocidal products of product-type 12. This postponement, extending the deadline to 28 February 2025, is due to delays in the evaluation process, specifically the need for additional data assessment. The decision amends Implementing Decision (EU) 2020/1037.
Key Points / Main Content:
* **Expiry Date Postponement:**
* The expiry date for the approval of acrolein for use in biocidal products of product-type 12 is postponed to 28 February 2025.
* This amends the expiry date set out in Implementing Decision (EU) 2020/1037.
* **Reasons for Postponement:**
* The evaluation of the renewal application is delayed because additional data requested from the applicant is required.
* The evaluating competent authority expects to submit the renewal assessment report to the Agency in the third quarter of 2023.
* The approval is likely to expire before a decision on its renewal can be made.
* **Continued Approval Conditions:**
* Acrolein remains approved for use in biocidal products of product-type 12, subject to the requirements outlined in Annex I to Directive 98/8/EC.
* **Entry into Force:**
* This Decision enters into force on the twentieth day following its publication in the Official Journal of the European Union.
Impact Analysis:
* **Applicant:**
* Impact: The applicant gains additional time to maintain approval for acrolein while the evaluation process continues.
* Action Required: Continue to provide any additional data requested by the evaluating competent authority.
* **Evaluating Competent Authority (Czechia):**
* Impact: Must continue the full evaluation of the application for renewal.
* Action Required: Submit the renewal assessment report to the Agency in the third quarter of 2023.
* **European Chemicals Agency (the Agency):**
* Impact: The Agency is responsible for preparing and submitting an opinion to the Commission on the renewal of approval after receiving a recommendation from the evaluating competent authority.
* Action Required: Prepare and submit to the Commission an opinion on renewal of the approval of the active substance.
* **European Commission:**
* Impact: Responsible for deciding whether to renew the approval of acrolein for use in biocidal products for product-type 12.
* Action Required: Examine the application for renewal.
* **Biocidal Product Manufacturers and Users:**
* Impact: Continued ability to use acrolein in product-type 12 biocidal products, subject to existing requirements, until 28 February 2025.
* Action Required: Ensure continued compliance with Annex I to Directive 98/8/EC.
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.
Directive 98/8/EC: A directive of the European Parliament and of the Council concerning the placing of biocidal products on the market.
Acrolein: An active substance used in biocidal products of product-type 12, the approval of which is being postponed.
Czechia: The evaluating competent authority that informed the Commission that a full evaluation of the application was necessary.
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.
Brussels: The city where the Commission Implementing Decision EU 2022/1486 was adopted.
8.9.2022 EN Official Journal of the European Union L 233/83
COMMISSION IMPLEMENTING DECISION (EU) 2022/1486
of 7 September 2022
postponing the expiry date of the approval of acrolein for use in biocidal products of product-type
12 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) Acrolein 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 12. Pursuant to Article 86 of Regulation (EU) No 528/2012, it
was therefore considered approved until 31 August 2020under that Regulation subject to the requirements set out
in Annex I to Directive 98/8/EC.
(2) On 28 February 2019, an application was submitted in accordance with Article 13(1) of Regulation (EU)
No 528/2012 for the renewal of the approval of acrolein for use in biocidal products of product-type 12 (‘the
application’).
(3) On 25 February 2020, the evaluating competent authority of Czechia 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) 2020/1037(3)postponed the expiry date of the approval of acrolein for
use in biocidal products of product-type 12 to 28 February 2023 in order to allow sufficient time for the
examination of the application.
(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) 2020/1037 of 15 July 2020 postponing the expiry date of approval of acrolein for use in
biocidal products of product-type 12 (OJ L 227, 16.7.2020, p. 72).L 233/84 EN Official Journal of the European Union 8.9.2022
(7) On 12 May 2022, the evaluating competent authority informed the Commission that the evaluation is delayed due
to the need to assess additional data requested from the applicant. The evaluating competent authority expects to
submit the renewal assessment report to the Agency in the third quarter of 2023.
(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 evaluation by
the evaluating competent authority, for preparation and submission by the Agency of its opinion and for the
Commission to decide whether to renew the approval of acrolein for use in biocidal products for product-type 12,
the expiry date should be postponed to 28 February 2025.
(9) After the postponement of the expiry date of the approval, acrolein remains approved for use in biocidal products of
product-type 12 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 acrolein for use in biocidal products of product-type 12 set out in Implementing
Decision (EU) 2020/1037 is postponed to 28 February 2025.
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