Date: 2025-09-11Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1792 of 10 September 2025 postponing the expiry date of the approval of ethyl butylacetylaminopropionate for use in biocidal products of product-type 19 in accordance with Regulation (EU) No 528/2012 of the European Parliament and of the Council
Issued by European Commission
· Directorate-General for Health and Food Safety
**Executive Summary:**
Commission Implementing Decision EU 2025/1792 postpones the expiry date for the approval of ethyl butylacetylaminopropionate when used in biocidal products of product-type 19. This decision is in response to an application for renewal of the approval and the anticipated delay in the decision-making process. The expiry date is extended to April 30, 2028. The decision enters into force twenty days after its publication in the Official Journal of the European Union.
**Key Points / Main Content:**
* **Approval Renewal and Expiry:**
* An application for renewal of the approval of ethyl butylacetylaminopropionate was submitted on April 25, 2024.
* The initial expiry date for the approval was October 31, 2025.
* **Evaluation Process:**
* Belgium, the evaluating competent authority, determined a full evaluation of the renewal application is necessary.
* The evaluating authority has 365 days for full evaluation, with a possible suspension of up to 180 days for additional data requests.
* The European Chemicals Agency (ECHA) will 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 is postponed to April 30, 2028.
* This postponement allows sufficient time for the examination of the renewal application.
* Ethyl butylacetylaminopropionate remains approved under the conditions set out in the Annex to Implementing Regulation EU No 406/2014.
* **Entry into Force:**
* This decision enters into force twenty days after its publication in the Official Journal of the European Union.
**Impact Analysis**
* **Manufacturers/Applicants of Biocidal Products Containing Ethyl Butylacetylaminopropionate:**
* *Impact:* Continued ability to market and use biocidal products containing ethyl butylacetylaminopropionate (product-type 19) until April 30, 2028, pending the outcome of the renewal application.
* *Action Required:* Ensure continued compliance with the conditions outlined in Implementing Regulation EU No 406/2014.
* **Evaluating Competent Authority (Belgium):**
* *Impact:* Responsibility to complete the full evaluation of the renewal application for ethyl butylacetylaminopropionate.
* *Action Required:* Conduct the evaluation within the regulatory timelines, potentially requesting additional data from the applicant.
* **European Chemicals Agency (ECHA):**
* *Impact:* Obligation to prepare and submit an opinion to the Commission regarding the renewal of the approval.
* *Action Required:* Prepare and submit the opinion within 270 days of receiving the recommendation from the evaluating competent authority.
* **European Commission:**
* *Impact:* Responsible for making a final decision on the renewal of the approval for ethyl butylacetylaminopropionate.
* *Action Required:* Consider the opinion from ECHA and decide whether to renew the approval.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
European Commission: An 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.
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.
European Parliament: The directly elected parliamentary body of the European Union.
Council of the European Union: A component of the EU's legislative branch, where ministers from each member state meet to adopt laws and coordinate policies.
ethyl butylacetylaminopropionate: An active substance approved for use in biocidal products of producttype 19.
Commission Implementing Regulation EU No 406/2014: A Commission regulation that approves ethyl butylacetylaminopropionate as an existing active substance for use in biocidal products for producttype 19.
European Chemicals Agency: An agency of the European Union that prepares and submits an opinion to the Commission on renewal of the approval of active substances.
Official Journal EN
of the European Union L series
2025/1792 11.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1792
of 10 September 2025
postponing the expiry date of the approval of ethyl butylacetylaminopropionate for use in biocidal
products of product-type 19 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 2012 concerning
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) Ethyl butylacetylaminopropionate was approved as an active substance for use in biocidal products of product-type
19 by Commission Implementing Regulation (EU) No 406/2014(2)subject to the conditions set out in the Annex to
that Regulation.
(2) The approval of ethyl butylacetylaminopropionate for use in biocidal products of product-type 19 (‘the approval’) is
to expire on 31 October 2025. On 25 April 2024, 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 12 June 2024, the evaluating competent authority of Belgium 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, for preparation and submission by the European Chemicals Agency of its opinion
and the time needed for the Commission to decide whether to renew the approval, the expiry date should be
postponed to 30 April 2028.
(7) After the postponement of the expiry date of the approval, ethyl butylacetylaminopropionate remains approved for
use in biocidal products of product-type 19 subject to the conditions set out in the Annex to Implementing
Regulation (EU) No 406/2014,
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) No 406/2014 of 23 April 2014 to approve ethyl butylacetylaminopropionate as an
existing active substance for use in biocidal products for product-type 19 (OJ L 121, 24.4.2014, p. 11, ELI: http://data.europa.eu/eli/
reg_impl/2014/406/oj).
ELI: http://data.europa.eu/eli/dec_impl/2025/1792/oj 1/2EN
OJ L, 11.9.2025
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of ethyl butylacetylaminopropionate for use in biocidal products of product-type 19 set out
in the Annex to Implementing Regulation (EU) No 406/2014, is postponed to 30 April 2028.
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, 10 September 2025
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/dec_impl/2025/1792/oj