Banned biocides in the EU: what manufacturers and distributors must do in 2026

Key data

If your company manufactures or distributes disinfectant biocides, film preservatives or fiber preservatives in the EU, this decision directly affects you. The European Commission has denied approval of poly(dimethyloctadecyl[3-trihydroxysilyl)propyl]ammonium) as an existing active substance through the Implementing Decision (EU) 2026/1424, published on 3 July 2026 and effective from 30 June 2026. The result is clear: any biocide containing this substance is excluded from the European market.

What does this regulation establish?

The Regulation (EU) No 528/2012 requires that all active substances used in biocides be approved at European level before products containing them can be marketed. The substance evaluated—poly(dimethyloctadecyl[3-trihydroxysilyl)propyl]ammonium)—was an "existing active substance", meaning it was already on the market before the regulation came into force and was undergoing review.

Following technical and scientific evaluation, the Commission has concluded that this substance does not meet the requirements for approval in any of the three product types for which it was requested:

The direct consequence is that biocidal products containing this substance cannot be marketed or used in the EU. Member States, for their part, must adapt their current national authorizations to align with this decision.

Economic and operational impact

Non-approval generates two types of costs for affected companies:

• Reformulation costs: Companies wishing to continue marketing their products in types 2, 7 and 9 must replace the denied active substance with another approved under Regulation 528/2012. This involves technical development, new testing and, in many cases, new product authorizations.
• Withdrawal costs: Products that cannot be reformulated must be withdrawn from the market. This includes managing existing stock, communicating with customers and distributors, and possible loss of market share.

Additionally, Member States must revoke or modify national authorizations for products containing this substance, which can create a domino effect in distribution chains. Companies with products authorized in several EU countries must coordinate withdrawal or reformulation in all of them simultaneously.

The regulation provides for a transitional period for companies to adapt, although the decision does not specify its exact duration: this period will be determined within the framework of national authorization revocation procedures.

Who does it affect?

• Disinfectant biocide manufacturers (type 2): companies in the industrial cleaning, hospital hygiene and surface disinfection sectors.
• Film preservative manufacturers (type 7): companies in paints, varnishes, coatings, adhesives and sealants that use biocides to protect the product in the container or applied film.
• Fiber and material preservative manufacturers (type 9): companies in the textile, leather, rubber and polymeric materials sectors that incorporate biocides to protect their products.
• Distributors and marketers of any of the above products in the European market.
• Pest control companies that use biocidal products with this active substance.
• National authorities of Member States responsible for biocide authorizations, which must review and adapt their registers.

Practical example

Imagine a Spanish paint manufacturing company that markets a film preservative (type 7) containing poly(dimethyloctadecyl chloride) as an active substance. This company has a current national authorization for that product and distributes it in Spain, France and Germany.

With Decision 2026/1424 in force from 30 June 2026, the company faces this scenario:

1. The authorities of the three countries must revoke or modify the national authorization of the product.
2. The company cannot continue manufacturing or selling that product with the current formulation.
3. It must choose between: (a) reformulating the product by replacing the denied substance with another approved one, with associated development and registration costs, or (b) withdrawing the product from the market and managing existing stock.
4. During the transitional period, it may sell off already manufactured stock under the conditions established by national authorities.

What should companies do now?

1. Audit the product portfolio: Identify all biocides marketed that contain poly(dimethyloctadecyl[3-trihydroxysilyl)propyl]ammonium) in product types 2, 7 and 9.
2. Review current national authorizations: Contact the competent authorities of each Member State where the product is marketed to learn about revocation timelines and transitional period conditions.
3. Evaluate reformulation feasibility: Analyze with the technical team whether there is an alternative active substance approved under Regulation 528/2012 that can replace the denied one without compromising product efficacy.
4. Plan stock management: If withdrawal is chosen, establish a plan for managing existing inventory, including communication to distributors and customers.
5. Monitor transitional timelines: Closely follow national authority decisions on grace periods for marketing and use of already authorized products.
6. Consult specialized biocide regulation advice: Reformulation and new registration of a biocide is a complex technical and legal process that requires specific expertise in Regulation 528/2012.

Official source

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Disclaimer: This article is for informational purposes only and does not constitute legal advice. For specific decisions, consult a qualified professional. Source: https://eur-lex.europa.eu/./legal-content/AUTO/?uri=OJ:L_202601424