EU biocides · Reg (EU) 528/2012 (BPR)
Biocidal product or treated article?
Under the Biocidal Products Regulation, a biocidal product needs active-substance approval + product authorisation + an Article 95 supplier; a treated article does not need authorisation but its substances must be approved or under evaluation. Find your route.
The rule, in one line
Under Regulation (EU) 528/2012, a biocidal product may only be made available once its active substance is approved (or under the review programme) for the relevant product type AND the product is authorised, with the substance/product supplier on the Article 95 list (since 1 September 2015). A treated article is not itself authorised, but since 1 March 2017 it may only be placed on the market if every biocidal active substance is approved, listed in Annex I, or under evaluation for the relevant product type — and it must meet the Article 58 labelling rules. A treated article that makes a primary biocidal claim is itself treated as a biocidal product.
Official sources: Regulation (EU) 528/2012 · ECHA — Treated articles · ECHA — Article 95 list
BPR route verdict
Likely a biocidal product
Your product is likely a biocidal product. It needs active-substance approval (or the review programme) for the relevant product type, product authorisation, and the supplier on the Article 95 list before it is made available or used.
Still to do (biocidal-product route)
- Obtain product authorisation (national, Union, or via mutual recognition) before placing the product on the market or using it.
Per-product memo
BPR route memo (PDF) · €29
A print-ready pack for one product: the route verdict, the authorisation + Article 95 + treated-article gates, the relevant dates, and source links — for your compliance file.
This is guidance, not legal advice. The export restates the route for your inputs; it does not check the live ECHA substance status for you.
What this tool is — and isn't
This checker routes the biocidal-product-vs-treated-article question under Regulation (EU) 528/2012 and flags the authorisation + Article 95 + substance-status gates, using ECHA + EUR-Lex. It is an estimate and orientation, not legal advice and not a substitute for a Member State Competent Authority ruling or the ECHA databases. Confirm the live approval status for your active substance and product type on ECHA. Verify against the linked official sources.
How the determination works
1. Classify the product
If the primary function is to destroy/deter/render harmless harmful organisms (or it makes a biocidal claim), it is a biocidal product. If it is an article treated mainly to protect itself, it is a treated article.
2. Gate on the active substance
Both routes require the active substance to be approved or under evaluation for the relevant product type. If it is neither, the product or treated article cannot be placed on the EU market.
3. The route-specific duties
A biocidal product also needs product authorisation and an Article 95 supplier. A treated article needs no authorisation but must meet Article 58 labelling. The live substance status is your input — check ECHA.
Frequently asked questions
- What is the difference between a biocidal product and a treated article?
- A biocidal product's purpose is to control harmful organisms and needs authorisation. A treated article is an article treated with a biocidal product to protect itself; it does not need authorisation, but its substances must be approved/under evaluation and Article 58 labelling applies.
- Does my product need authorisation?
- A biocidal product does — at national or Union level (or via mutual recognition). A treated article does not, but it has its own substance-approval and labelling rules.
- What is the Article 95 list?
- Since 1 September 2015, a biocidal product cannot be made available on the EU market unless its substance/product supplier is on ECHA's Article 95 list for the relevant product type.
- When could I no longer use unapproved-substance treated articles?
- Since 1 March 2017, an article treated with a biocidal product whose active substance is not approved, listed in Annex I, or under assessment for the relevant product type cannot be placed on the EU market.
- My article makes a disinfecting claim — what is it?
- A treated article that makes a primary biocidal claim to users is itself treated as a biocidal product, so the full biocidal-product route applies.
- Is this legal advice?
- No. This tool routes the classification and flags the gates. It is orientation, not legal advice or a Competent-Authority ruling. Confirm the live substance status on ECHA and verify against the linked official sources.