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Changes to biocidal product regulations in 2025 – key information

The year 2025 brings significant changes to the regulations on biocidal products in the European Union. The new regulations aim to increase the safety of using these products and protect public health and the environment. Below we present the most important changes along with their legal bases.

1. Extension of the active substance evaluation program in Poland

In accordance with the Announcement of the President of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products in Poland of 17 December 2024 , the validity period of biocidal product marketing authorizations that expired on 31 December 2024 was extended to 31 December 2030. The condition for the extension was that the responsible entities submitted an appropriate declaration of consent to change the validity period of the authorization. In the absence of such a declaration, the authorization expired at the end of 2024.

Update of the list of biocidal products

Due to the above changes, the Polish List of Biocidal Products has been updated. Marketing authorisation holders and users should regularly check this list to ensure that the products they use have current marketing authorisations. The current list is available on the website of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products at: https://www.gov.pl/web/urpl/wykaz-produktow-biobojczych3

Failure to submit an application for renewal of the permit within the required time period may result in the permit expiring on the day it expires. In such a situation, trade in a given biocidal product becomes illegal, which may lead to legal sanctions and the need to withdraw the product from the market.

In such a situation, in accordance with the regulations, it is possible to grant a period for the use of existing stocks of this product. However, it should be noted that the granting of this period is subject to the decision of the competent authority and may not be granted if continued use of the product would pose an unacceptable risk to human health, animals or the environment.

In accordance with Article 52 of Regulation (EU) No 528/2012 (BPR):

The period for making available on the market may not exceed 180 days from the date of expiry of the authorisation.
end-users to use existing stocks shall not exceed an additional 180 days after the end of the commercial availability period.

This means that the total maximum time for using up stocks is 360 days from the expiry date of the permit.

Pursuant to Article 29 of the Act of 9 October 2015 on biocidal products:

The period for making available on the market may not exceed 180 days from the date of expiry of the authorisation.
The period for use of existing stocks by end users may not exceed 365 days from the date of expiry of the authorisation.

In practice, this means that after the authorisation to market a biocidal product expires:

Distributors may continue to make the product available on the market for a maximum of 180 days .
End users may use purchased products for a maximum of 365 days from the date the authorization expires.

2. Changes to the approval of active substances

In 2025, the European Commission issued a number of decisions regarding the approval or non-approval of specific active substances:

Cypermethrin : Commission Implementing Decision (EU) 2025/362 of 21 February 2025 extended the approval of cypermethrin for use in biocidal products for product-type 8.
5-chloro-2-methyl-2H-isothiazol-3-one (CIT) : Pursuant to Commission Implementing Decision (EU) 2025/357 of 21 February 2025 , this substance is not approved for use in biocidal products for product-type 6.
Spinosad : Commission Implementing Decision (EU) 2025/349 of 21 February 2025 extended the approval of spinosad for product-type 18.

Recommendations for entrepreneurs:

Monitoring changes : Regular monitoring of the European Commission's decisions on active substances is crucial to ensure that products comply with applicable regulations.
Adjusting product formulations : If an active substance is not approved, it may be necessary to develop new product formulations or withdraw them from the market.

3. Public consultation on ethanol

The European Chemicals Agency (ECHA) launched a public consultation on 7 March 2025 on ethanol as an active substance used in biocidal products in product types 1, 2 and 4. The aim of the consultation is to identify potential safer alternatives to ethanol in these applications.

Details about product groups:

Product Group 1 (PT 1): Personal hygiene products such as hand sanitizers.
Product group 2 (PT 2): Disinfectants and algaecides not intended for direct contact with humans or animals.
Product Group 4 (PT 4): Products used in food and feed areas.

This consultation is part of the process of evaluating active substances in biocidal products, which aims to ensure a high level of protection for human health and the environment. ECHA encourages interested parties, including manufacturers, suppliers and end-users, to submit their views and information on available alternatives to ethanol in these applications.

The deadline for submitting comments is 28 April 2025.

To participate in the consultation or obtain more information, please visit ECHA's public consultation on substances potentially candidates for substitution page.

Why is it important?

Opportunity to comment : Businesses and other interested parties have the opportunity to submit their opinions on the use of ethanol in biocidal products.
Impact on future regulation : The consultation results may impact future decisions on the approval or restriction of the use of ethanol in biocidal products.

4. Changing CLP, what changes in 2025?

In 2025, significant changes to the classification, labelling and packaging (CLP) rules for chemicals that have a direct impact on biocidal products will come into force. Under Commission Delegated Regulation (EU) 2023/707 of 19 December 2022, new hazard classes have been introduced, such as endocrine disrupting ( ED ), persistent, bioaccumulative and toxic ( PBT ), very persistent and very bioaccumulative ( vPvB ), persistent, mobile and toxic ( PMT ) and very persistent and very mobile ( vPvM ). These changes apply from 20 April 2023, but for substances placed on the market for the first time after 1 May 2025, classification in accordance with the new rules becomes mandatory. Substances already on the market before this date must be reclassified and labelled in line with the new requirements by 1 November 2026. For mixtures , the new rules will apply from 1 May 2026 for those placed on the market for the first time after this date, while mixtures already on the market must comply with the new requirements by 1 May 2028.

In the face of dynamic changes in regulations concerning biocidal products, it is crucial to continuously monitor new legal acts and adapt your business to current requirements. In case of doubts or need for support in interpreting regulations, it is worth using professional advice.

PICTOPLAN is a company specializing in legal advice in the field of chemicals, including biocidal product regulations, transport of dangerous goods and contract law. We offer comprehensive services such as:

Registration of biocidal products in accordance with the Biocidal Products Act and Regulation BPR 528/2012 and the Polish Biocidal Products Act;
Preparation of safety data sheets in accordance with the latest legal acts;
Classification of substances and mixtures taking into account the amended CLP Regulation 1272/2009;
Advice on the transport of dangerous goods (ADR) , including classification of goods, selection of means of transport and packaging, internal audits and on-the-job training;

With many years of experience and an analytical approach, PICTOPLAN supports entrepreneurs in conducting their business in accordance with regulations, while helping to achieve business goals. We encourage you to contact us to discuss your individual needs and develop a joint action plan.

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Changes to biocidal product regulations in 2025 – key information

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