Date: 2022-09-08Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2022/1484 of 7 September 2022 postponing the expiry date of the approval of DDACarbonate 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 postpones the expiry date for the approval of DDACarbonate for use in biocidal products of product-type 8 from January 31, 2023, to July 31, 2025. This postponement is due to ongoing evaluations for renewal, which are expected to extend beyond the original expiry date. The decision was made on September 7, 2022, and becomes effective twenty days after publication in the Official Journal of the European Union.
Key Points / Main Content:
* **Approval and Renewal:**
* DDACarbonate is currently approved under Regulation EU No 528/2012, based on its inclusion in Annex I to Directive 98/8/EC.
* An application for renewal of the approval was submitted on July 31, 2021.
* **Evaluation Process:**
* Switzerland, as the evaluating competent authority, determined that a full evaluation is necessary.
* The evaluating authority has 365 days (with possible suspension of up to 180 days) to perform a full evaluation.
* The European Chemicals Agency (ECHA) must prepare and submit an opinion to the Commission within 270 days of receiving a recommendation from the evaluating authority.
* **Postponement of Expiry Date:**
* The expiry date of the approval for DDACarbonate is postponed to July 31, 2025.
* DDACarbonate remains approved under the conditions set out in Annex I to Directive 98/8/EC until the new expiry date.
Impact Analysis:
* **European Commission:**
* Impact: Responsible for making a final decision on the renewal of DDACarbonate approval after receiving ECHA's opinion.
* Action Required: Review ECHA's opinion and decide whether to renew the approval of DDACarbonate.
* **Evaluating Competent Authority (Switzerland):**
* Impact: Responsible for the full evaluation of the application for renewal.
* Action Required: Continue with the full evaluation of the application and provide a recommendation.
* **European Chemicals Agency (ECHA):**
* Impact: Responsible for preparing and submitting an opinion to the Commission regarding the renewal of approval.
* Action Required: Prepare and submit an opinion to the Commission within 270 days of receipt of a recommendation from the evaluating competent authority.
* **Applicants for DDACarbonate Approval Renewal:**
* Impact: The expiry date for DDACarbonate approval is extended, allowing continued use while the renewal is processed.
* Action Required: Continue to provide any required data to the evaluating competent authority and monitor the progress of the evaluation.
* **Manufacturers and Users of Biocidal Products Containing DDACarbonate:**
* Impact: Can continue to market and use biocidal products containing DDACarbonate (product-type 8) until July 31, 2025, subject to existing conditions.
* Action Required: Ensure continued compliance with the conditions set out in Annex I to Directive 98/8/EC.
Key Entities Referenced
DDACarbonate: An active substance used in biocidal products of product-type 8, the approval of which is being postponed.
Regulation EU No 528/2012: Regulation of the European Parliament and of the Council concerning the making available on the market and use of biocidal products.
European Parliament: One of the legislative bodies of the European Union.
Council of the European Union: One of the legislative bodies of the European Union.
Directive 98/8/EC: Directive of the European Parliament and of the Council concerning the placing of biocidal products on the market.
European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, upholding the EU treaties and managing the day-to-day business of the EU.
European Chemicals Agency: An agency of the European Union that prepares and submits opinions to the Commission on the renewal of active substances.
Brussels: The city where the Commission Implementing Decision was adopted.
8.9.2022 EN Official Journal of the European Union L 233/79
COMMISSION IMPLEMENTING DECISION (EU) 2022/1484
of 7 September 2022
postponing the expiry date of the approval of DDACarbonate 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) DDACarbonate 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 is therefore considered approved under that Regulation subject to the conditions set out in
Annex I to Directive 98/8/EC.
(2) The approval of DDACarbonate for use in biocidal products of product-type 8 (‘the approval’) is to expire on
31 January 2023. On 31 July 2021, an application was submitted in accordance with Article 13(1) of Regulation
(EU) No 528/2012 for the renewal of the approval (‘the application’).
(3) On 26 October 2021, the evaluating competent authority of Switzerland 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 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) 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 and for preparation and submission by the European Chemicals Agency of its
opinion, and the time needed to decide whether the approval of DDACarbonate for use in biocidal products for
product-type 8 may be renewed, the expiry date should be postponed to 31 July 2025.
(7) After the postponement of the expiry date of the approval, DDACarbonate remains approved for use in biocidal
products of product-type 8 subject to the conditions set out in Annex I to Directive 98/8/EC,
(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).L 233/80 EN Official Journal of the European Union 8.9.2022
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of DDACarbonate for use in biocidal products of product-type 8 set out in Annex I to
Directive 98/8/EC is postponed to 31 July 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