Date: 2025-09-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1811 of 11 September 2025 postponing the expiry date of the approval of 4,5-Dichloro-2-octyl-2H-isothiazol-3-one for use in biocidal products of product-types 8 and 21 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) 2025/1811 postpones the expiry date of the approval of 4,5-Dichloro-2-octyl-2H-isothiazol-3-one (DCOIT) for use in biocidal products of product types 8 and 21. This decision is made in accordance with Regulation (EU) No 528/2012 due to delays in the evaluation of the renewal applications. The new expiry date for both product types is set to 30 June 2028.
Key Points / Main Content:
* **DCOIT Approval Renewal:**
* Applications were submitted for the renewal of DCOIT approval for product types 8 and 21 under Regulation (EU) No 528/2012.
* A full evaluation of both applications was deemed necessary by the evaluating competent authority of Norway.
* **Expiry Date Postponement:**
* The expiry date for DCOIT approval for product type 8, initially extended to 31 December 2025 by Implementing Decision (EU) 2023/471, is further postponed.
* The expiry date for DCOIT approval for product type 21, set to expire on 31 December 2025, is also postponed.
* The new expiry date for DCOIT approval for both product types 8 and 21 is 30 June 2028.
* **Conditions of Approval:**
* Following the postponement, DCOIT remains approved for use in product types 8 and 21.
* The use of DCOIT remains subject to the conditions outlined in Annex I to Directive 98/8/EC and the Annex to Implementing Regulation (EU) No 437/2014, respectively.
* **Entry into Force:**
* This decision enters into force twenty days after its publication in the Official Journal of the European Union.
Impact Analysis
* **European Commission:**
* Impact: Required to make a final decision on the renewal of DCOIT approval based on the evaluation and opinion from the European Chemicals Agency.
* Action Required: To decide whether to renew the approval of DCOIT based on the provided evaluation and opinion.
* **Evaluating Competent Authority (Norway):**
* Impact: Currently evaluating the applications for renewal of DCOIT approval for product types 8 and 21.
* Action Required: To complete the evaluation of the renewal applications and submit the renewal assessment report to the European Chemicals Agency.
* **European Chemicals Agency (the Agency):**
* Impact: Responsible for preparing and submitting an opinion to the Commission on the renewal of DCOIT approval.
* Action Required: To prepare and submit to the Commission an opinion on the renewal of the approval of DCOIT within 270 days of receipt of a recommendation from the evaluating competent authority.
* **Biocidal Product Manufacturers/Applicants:**
* Impact: Can continue to market and use DCOIT in biocidal products of types 8 and 21 until 30 June 2028, subject to existing conditions.
* Action Required: To continue to comply with the conditions set out in Annex I to Directive 98/8/EC and in the Annex to Implementing Regulation (EU) No 437/2014 respectively for the use of DCOIT in biocidal products.
Key Entities Referenced
4,5-Dichloro-2-octyl-2H-isothiazol-3-one (DCOIT): An active substance used in biocidal products, the approval of which is being discussed and extended in the document.
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: A legislative body of the European Union comprising government ministers from each member state.
European Commission: The executive branch of the European Union, responsible for proposing legislation, implementing decisions, and managing the EU's day-to-day operations.
European Chemicals Agency (ECHA): An agency of the European Union which prepares and submits opinions to the Commission regarding the renewal of active substance approvals.
Norway: The evaluating competent authority assessing the renewal application for DCOIT.
Ursula VON DER LEYEN: The President of the European Commission.
Official Journal EN
of the European Union L series
2025/1811 12.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1811
of 11 September 2025
postponing the expiry date of the approval of 4,5-Dichloro-2-octyl-2H-isothiazol-3-one for use in
biocidal products of product-types 8 and 21 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) 4,5-Dichloro-2-octyl-2H-isothiazol-3-one (‘DCOIT’) 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 until 30 June 2023 under that
Regulation subject to the conditions set out in Annex I to Directive 98/8/EC.
(2) On 23 December 2021, an application was submitted in accordance with Article 13(1) of Regulation (EU)
No 528/2012 for the renewal of the approval of DCOIT for use in biocidal products of product-type 8.
(3) On 24 October 2022, the evaluating competent authority of Norway 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 for the renewal
of the approval of DCOIT for use in biocidal products of product-type 8 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.
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(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, ELI: http://data.europa.eu/eli/dir/1998/8/oj).
ELI: http://data.europa.eu/eli/dec_impl/2025/1811/oj 1/3EN
OJ L, 12.9.2025
(6) Commission Implementing Decision (EU) 2023/471(3)postponed the expiry date of the approval of DCOIT for use
in biocidal products of product-type 8 to 31 December 2025, in order to allow sufficient time for the examination
of the application.
(7) On 26 February 2025, the evaluating competent authority informed the Commission that the evaluation of the
application for the renewal of the approval of DCOIT for use in biocidal products of product-type 8 is delayed due
to the need for additional time to complete the assessment of endocrine-disrupting properties. The evaluating
competent authority expects to submit the renewal assessment report to the Agency in 2027.
(8) DCOIT was also approved as an active substance for use in biocidal products of product-type 21 by Commission
Implementing Regulation (EU) No 437/2014(4)subject to the conditions set out in the Annex to that Regulation.
(9) The approval of DCOIT for use in biocidal products of product-type 21 is to expire on 31 December 2025. On
28 June 2024, an application was submitted in accordance with Article 13(1) of Regulation (EU) No 528/2012 for
the renewal of the approval of DCOIT for use in biocidal products of product-type 21.
(10) On 26 February 2025, the evaluating competent authority of Norway 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 for the renewal of
the approval of DCOIT for use in biocidal products of product-type 21 was necessary.
(11) Consequently, for reasons beyond the control of the applicant, the approval of DCOIT for use in biocidal products of
product-types 8 and 21 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 of DCOIT for use in biocidal products of product-types 8 and 21 for a
period of time sufficient to enable the examination of the applications. Taking into account the time-limits for
evaluation by the evaluating competent authority, for preparation and submission by the Agency of its opinions and
the time needed for the Commission to decide whether to renew the approval of DCOIT, the expiry date for use in
biocidal products of product-types 8 and 21 should be postponed to 30 June 2028.
(12) After the postponement of the expiry date of the approval, DCOIT remains approved for use in biocidal products of
product-types 8 and 21, subject to the conditions set out in Annex I to Directive 98/8/EC and in the Annex to
Implementing Regulation (EU) No 437/2014 respectively,
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of 4,5-Dichloro-2-octyl-2H-isothiazol-3-one for use in biocidal products of product-type 8
set out in Annex I to Directive 98/8/EC is postponed to 30 June 2028.
Article 2
The expiry date of the approval of 4,5-Dichloro-2-octyl-2H-isothiazol-3-one for use in biocidal products of product-type
21 set out in the Annex to Implementing Regulation (EU) No 437/2014 is postponed to 30 June 2028.
(3) Commission Implementing Decision (EU) 2023/471 of 2 March 2023 postponing the expiry date of the approval of 4,5-Dichloro-
2-octyl-2H-isothiazol-3-one 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 (OJ L 68, 6.3.2023, p. 179; ELI: http://data.europa.eu/eli/dec_impl/2023/471/oj).
(4) Commission Implementing Regulation (EU) No 437/2014 of 29 April 2014 approving 4,5-Dichloro-2-octyl-2H-isothiazol-3-one as
an existing active substance for use in biocidal products for product-type 21 (OJ L 128, 30.4.2014, p. 64; ELI: http://data.europa.eu/
eli/reg_impl/2014/437/oj).
2/3 ELI: http://data.europa.eu/eli/dec_impl/2025/1811/ojEN
OJ L, 12.9.2025
Article 3
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
ELI: http://data.europa.eu/eli/dec_impl/2025/1811/oj 3/3