Date: 2025-09-12Category: Not ApplicableState: Union GovernmentCountry: Europe
Commission Implementing Decision (EU) 2025/1808 of 11 September 2025 postponing the expiry date of the approval of Pythium oligandrum strain M1 for use in biocidal products of product-type 10 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 2025/1808 postpones the expiry date for the approval of Pythium oligandrum strain M1 for use in biocidal products of product-type 10. This postponement is due to the ongoing evaluation of an application for renewal of the approval. The new expiry date is set to 30 June 2028. The decision enters into force twenty days after its publication in the Official Journal of the European Union.
Key Points / Main Content:
Approval Postponement:
* The expiry date of the approval of Pythium oligandrum strain M1 for use in biocidal products of product-type 10 is postponed.
* The new expiry date is 30 June 2028.
* This postponement amends the expiry date as set out in the Annex to Implementing Regulation EU 2015/1610.
Reason for Postponement:
* An application for renewal of the approval was submitted on 28 June 2024.
* A full evaluation of the application is deemed necessary by the evaluating competent authority of Czech Republic.
* The current approval is likely to expire before a decision on its renewal can be made.
Continued Approval Conditions:
* Pythium oligandrum strain M1 remains approved for use in biocidal products of product-type 10.
* The conditions set out in the Annex to Implementing Regulation EU 2015/1610 continue to apply.
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:
European Commission:
Impact: The Commission is responsible for implementing the decision to postpone the expiry date.
Action Required: Ensure the postponement is reflected in relevant documentation and systems.
European Chemicals Agency:
Impact: The ECHA is required to prepare and submit to the Commission an opinion on the renewal of the active substance.
Action Required: Prepare and submit to the Commission an opinion on renewal of the approval of the active substance.
Evaluating Competent Authority (Czech Republic):
Impact: The evaluating competent authority is performing a full evaluation of the application
Action Required: Perform a full evaluation of the application within 365 days of its validation.
Applicant for Renewal:
Impact: The applicant benefits from the extended expiry date while the renewal application is under evaluation.
Action Required: Continue to cooperate with the evaluating competent authority by providing any necessary data.
Biocidal Product Manufacturers and Users:
Impact: Continued access to Pythium oligandrum strain M1 for use in product-type 10 biocidal products.
Action Required: Ensure continued compliance with the conditions set out in the Annex to Implementing Regulation EU 2015/1610.
Key Entities Referenced
European Union: A political and economic union of member states located primarily in Europe.
Pythium oligandrum strain M1: An active substance approved for use in biocidal products of product type 10.
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.
Commission Implementing Regulation EU 2015/1610: A Commission Implementing Regulation approving Pythium oligandrum strain M1 as an active substance for use in biocidal products for product type 10.
European Chemicals Agency: An agency of the European Union that prepares and submits opinions to the Commission regarding the renewal of active substances.
Czech Republic: A country in Central Europe whose evaluating competent authority informed the Commission regarding the evaluation of the application.
Treaty on the Functioning of the European Union: One of the primary treaties of the European Union.
Ursula VON DER LEYEN: The President of the European Commission.
Official Journal EN
of the European Union L series
2025/1808 12.9.2025
COMMISSION IMPLEMENTING DECISION(EU) 2025/1808
of 11 September 2025
postponing the expiry date of the approval of Pythium oligandrumstrain M1 for use in biocidal
products of product-type 10 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) Pythium oligandrumstrain M1 was approved as an active substance for use in biocidal products of product-type 10 by
Commission Implementing Regulation (EU) 2015/1610(2) subject to the conditions set out in the Annex to that
Regulation.
(2) The approval of Pythium oligandrum strain M1 for use in biocidal products of product-type 10 (‘the approval’) 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 (‘the application’).
(3) On 25 February 2025, the evaluating competent authority of Czech Republic 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 June 2028.
(7) After the postponement of the expiry date of the approval, Pythium oligandrumstrain M1 remains approved for use in
biocidal products of product-type 10 subject to the conditions set out in the Annex to Implementing Regulation
(EU) 2015/1610,
(1) OJ L 167, 27.6.2012, p. 1, ELI: http://data.europa.eu/eli/reg/2012/528/oj.
(2) Commission Implementing Regulation (EU) 2015/1610 of 24 September 2015 approving Pythium oligandrumstrain M1 as an active
substance for use in biocidal products for product-type 10 (OJ L 249, 25.9.2015, p. 20; ELI: http://data.europa.eu/eli/reg_impl/2015/
1610/oj).
ELI: http://data.europa.eu/eli/dec_impl/2025/1808/oj 1/2EN
OJ L, 12.9.2025
HAS ADOPTED THIS DECISION:
Article 1
The expiry date of the approval of Pythium oligandrumstrain M1 for use in biocidal products of product-type 10 set out in
the Annex to Implementing Regulation (EU) 2015/1610, is postponed to 30 June 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/2025/1808/oj