Date: 2025-09-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1814 of 11 September 2025 postponing the expiry date of the approval of lauric acid 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 2025/1814 postpones the expiry date of the approval of lauric acid for use in biocidal products of product-type 19. This decision is made in accordance with Regulation EU No 528/2012 due to delays in the renewal application process. The new expiry date for the approval is set to 30 April 2028. The decision enters into force on the twentieth day following its publication in the Official Journal of the European Union.
**Key Points / Main Content:**
* **Approval Postponement:**
* The expiry date for the approval of lauric acid in biocidal products of product-type 19 is postponed.
* The new expiry date is 30 April 2028.
* This postponement is based on Article 145 of Regulation EU No 528/2012.
* **Application for Renewal:**
* An application for renewal of the approval was submitted on 26 April 2024, under Article 131 of Regulation EU No 528/2012.
* A full evaluation of the application is deemed necessary by the evaluating competent authority of Germany, according to Article 141 of Regulation EU No 528/2012.
* **Evaluation Timeline:**
* The evaluating competent authority is to perform a full evaluation within 365 days of validation, as per Article 81 of Regulation EU No 528/2012.
* The 365-day period may be suspended under certain conditions, according to Article 82 of Regulation EU No 528/2012.
* The European Chemicals Agency (ECHA) is to submit an opinion on the renewal to the Commission within 270 days of receiving a recommendation, as per Article 143 of Regulation EU No 528/2012.
* **Continued Approval Conditions:**
* Following the postponement, lauric acid remains approved under the conditions outlined in the Annex to Implementing Regulation EU No 405/2014.
**Impact Analysis:**
* **Applicant for Renewal:**
* *Impact:* Benefits from the extended expiry date, allowing continued market presence while the renewal application is processed.
* *Action Required:* No immediate action is required, but the applicant should continue to cooperate with the evaluating competent authority and ECHA in the renewal process.
* **Evaluating Competent Authority (Germany):**
* *Impact:* Responsible for the full evaluation of the renewal application.
* *Action Required:* Continue the evaluation process according to the timelines and requirements of Regulation EU No 528/2012.
* **European Chemicals Agency (ECHA):**
* *Impact:* Responsible for preparing and submitting an opinion on the renewal of the approval.
* *Action Required:* Prepare and submit the opinion to the Commission within 270 days of receiving a recommendation from the evaluating competent authority.
* **European Commission:**
* *Impact:* Responsible for making a final decision on the renewal of the approval.
* *Action Required:* Consider the opinion from ECHA and decide whether to renew the approval of lauric acid.
* **Manufacturers and Suppliers of Biocidal Products Containing Lauric Acid:**
* *Impact:* Can continue to market and sell biocidal products containing lauric acid until 30 April 2028, subject to existing conditions.
* *Action Required:* Ensure continued compliance with the conditions set out in the Annex to Implementing Regulation EU No 405/2014.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Commission Implementing Decision (EU) 2025/1814: An official decision by the European Commission postponing the expiry date of the approval of lauric acid.
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.
Lauric acid: An active substance approved for use in biocidal products of product-type 19.
Commission Implementing Regulation (EU) No 405/2014: A regulation approving lauric acid as an existing active substance for use in biocidal products for product-type 19.
European Chemicals Agency: An agency of the European Union that prepares and submits opinions to the Commission on the renewal of active substance approvals.
Germany: The evaluating competent authority of Germany 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.
Brussels: The location where the Commission Implementing Decision (EU) 2025/1814 was adopted.
Official Journal EN
of the European Union L series
2025/1814 12.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1814
of 11 September 2025
postponing the expiry date of the approval of lauric acid 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) Lauric acid was approved as an active substance for use in biocidal products of product-type 19 by Commission
Implementing Regulation (EU) No 405/2014(2)subject to the conditions set out in the Annex to that Regulation.
(2) The approval of lauric acid for use in biocidal products of product-type 19 (‘the approval’) is to expire on 31 October
2025. On 26 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 16 December 2024, the evaluating competent authority of Germany 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, lauric acid 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 405/2014,
(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 405/2014 of 23 April 2014 approving lauric acid as an existing active substance for
use in biocidal products for product-type 19 (OJ L 121, 24.4.2014, p. 8, ELI: http://data.europa.eu/eli/reg_impl/2014/405/oj).
ELI: http://data.europa.eu/eli/dec_impl/2025/1814/oj 1/2EN
OJ L, 12.9.2025
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of lauric acid for use in biocidal products of product-type 19 set out in the Annex to
Implementing Regulation (EU) No 405/2014, 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, 11 September 2025.
For the Commission
The President
Ursula VON DER LEYEN
2/2 ELI: http://data.europa.eu/eli/dec_impl/2025/1814/oj