Sterillium liquid cancelled by the EU: what healthcare and cleaning companies must do

Key data

If your company uses Sterillium liquid as a regular disinfectant, you have a problem to solve right now. The European Commission has cancelled the authorization of this biocide widely used in healthcare and professional environments through the Commission Implementing Regulation (EU) 2026/2504, published on 13 November 2026. This is not a labelling change or a partial restriction: it is the total cancellation of Union authorization.

The regulation repeals the previous Commission Implementing Regulation (EU) 2025/1867, which was the one that supported the authorization in force until now. From the timeframes established by the regulation, manufacturing, distributing or using Sterillium liquid without legal coverage exposes the company to administrative sanctions.

What does this regulation establish?

Commission Implementing Regulation (EU) 2026/2504 acts under the Regulation (EU) No 528/2012 on biocides, the European framework that regulates the commercialization and use of biocidal products throughout the EU. Under this framework, the Commission may cancel authorizations when the product no longer meets the conditions that justified its approval.

The following table summarizes the specific regulatory change introduced by this provision:

The cancellation has European scope: it affects all Member States, including Spain. Specific sanctions for non-compliance will be determined in accordance with each country's national transposition legislation.

Economic and operational impact

The impact is not only regulatory: it has direct consequences on the daily operations and costs of affected companies.

• Stock review and management: Products already purchased must be evaluated. Maintaining stock of an unauthorized biocide may pose legal risk if it continues to be used or distributed after the established timeframes.
• Replacement cost: Identifying, approving and purchasing an alternative disinfectant with current authorization involves time, evaluation costs and possible adjustments to internal protocols.
• Protocol updates: Hospitals, clinics, cleaning companies and hospitality establishments that have Sterillium liquid integrated into their disinfection procedures will need to rewrite and validate those protocols with the new product.
• Sanction risk: Non-compliance may result in administrative sanctions in accordance with national transposition legislation. The exact amount will depend on applicable Spanish legislation, but the risk is real and auditable in health inspections.
• Supply chain impact: Distributors that have Sterillium liquid in their catalogue must withdraw the product from their commercial offer and communicate this to their customers.

Who does it affect?

• Manufacturers of Sterillium liquid or products containing it: must cease production and commercialization within the established timeframes.
• Distributors and wholesalers in the professional hygiene and disinfection products sector: must withdraw the product from their catalogue and manage existing stock.
• Healthcare facilities (hospitals, clinics, medical practices, health centres): regular users of this disinfectant who must update their hand and surface hygiene protocols.
• Professional cleaning companies: must review the products used in their service contracts and replace Sterillium liquid with authorized alternatives.
• Hospitality sector (hotels, restaurants, catering): establishments that use this biocide in their hygiene protocols must seek substitutes with current authorization.
• Procurement and quality managers in any company that has Sterillium liquid in its inventory of cleaning or disinfection products.

Practical example

A dental clinic with three surgeries uses Sterillium liquid as a hand disinfectant between patients and for cleaning work surfaces. It has several litres in storage purchased two months ago.

Following the publication of Commission Implementing Regulation (EU) 2026/2504, the clinic must:

1. Stop purchasing new units of Sterillium liquid immediately.
2. Consult the specific timeframes for cessation of use set by the regulation to determine how long it can consume existing stock without incurring an infraction.
3. Identify an alternative disinfectant with current authorization under Regulation (EU) 528/2012 and validate it with its prevention manager or health advisor.
4. Update the clinic's hygiene protocol with the new product, including safety data sheets and usage records.

If the clinic does not act and a health inspector detects the use of Sterillium liquid outside the permitted timeframe, it could face administrative sanctions in accordance with Spanish legislation transposing Regulation (EU) 528/2012.

What should companies do now?

1. Verify if you use or distribute Sterillium liquid: Review your inventory, your supply contracts and your disinfection protocols to confirm whether this biocide is present in your operations.
2. Consult the exact cessation timeframes: Commission Implementing Regulation (EU) 2026/2504 establishes the timeframes for cessation of commercialization and use. Access the full text in the EU Official Journal to know the specific dates.
3. Manage existing stock: Evaluate what to do with units already purchased. Do not assume you can continue using them indefinitely: the regulation's timeframes set the legal limit.
4. Identify authorized alternatives: Look for disinfectants with current authorization under Regulation (EU) 528/2012. The ECHA Biocidal Products Registry is the reference source for verifying active authorizations.
5. Update internal protocols: Rewrite disinfection procedures with the new product, including safety data sheets, instructions for use and required records.
6. Inform your supply chain: If you are a distributor, communicate the cancellation to your customers and remove the product from your catalogue to avoid liability for selling an unauthorized biocide.
7. Document the transition process: Keep evidence of actions taken (date of stock withdrawal, new product adopted, protocol updates). This documentation is your best defence in an inspection.

Official source

Consult complete regulation in official source

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_202602504