What counts as a treated article.
Article 3(1)(l) BPR: “any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products”.
The primary function decides. If an article’s main function is biocidal, it is a biocidal product and needs authorisation. If the biocidal effect is an added function, it stays a treated article. Commission guidance on treated articles and masterbatches explains the distinction.
| Example | Classification | Reason |
|---|---|---|
| Sports shirt with an odour-control finish | treated article | primary function is clothing |
| Plastic handle with an antimicrobial additive | treated article | primary function is the handle |
| Disinfectant wipe | biocidal product | primary function is disinfection |
| Masterbatch meant to give plastic parts a biocidal property | usually a biocidal product | transfers the property to other articles |
Approved active substances only.
Under Article 58(2), a treated article may only be placed on the market if every active substance it contains is approved for the relevant product-type and use, or listed in Annex I, and the conditions of approval are met. This also applies to imported articles.
Transitionally, Article 94 permits substances that were in the EU review programme for the product-type, or under application, on 1 September 2016. If such a substance is rejected, 180 days remain.
The product-type follows from the purpose (Annex V). Product-type 9 preserves fibres, leather, rubber and polymers, also against surface colonisation and odour. Product-type 2 covers products giving textiles, paints or other materials disinfecting properties.
What the label must show.
Labelling is required if the manufacturer claims a biocidal property, such as “antibacterial”, or an active substance approval requires it (Article 58(3)). Whoever places the article on the market is responsible.
The label must be clearly visible, easily legible and appropriately durable. If size or function requires it, the label may go on the packaging, instructions or warranty, in the official language of the Member State unless it provides otherwise (Article 58(6)).
Consumers may ask about the biocidal treatment; the supplier must answer free of charge within 45 days (Article 58(5)).
Equivalent labelling under sector-specific law takes precedence (Article 58(3)).
Label anatomy: mandatory information for a treated article
- ① Contains biocidal products.
- ② [substantiated property]
- ③ [active substance]
- ④ [nanomaterial] (nano)
- ⑤ [instructions]
visible · legible · durable · official language (Art. 58(6))
- A statement that the article incorporates biocidal products (point a)
- The biocidal property attributed to the article, only where substantiated (point b)
- Names of all active substances in the biocidal products (point c)
- Names of all nanomaterials, followed by “(nano)” (point d)
- All relevant instructions for use, including precautions (point e)
① to ⑤ = Art. 58(3)(a) to (e)
Advertising: limits set by law and the courts.
Advertising for biocidal products must not mislead about risks to human or animal health, the environment or efficacy. It must never use “low-risk biocidal product”, “non-toxic”, “harmless”, “natural”, “environmentally friendly”, “animal friendly” or any similar indication.
On 20 June 2024 the Court of Justice of the EU ruled that “similar indications” are any statements that play down or deny risks, general or specific. The case concerned a disinfectant advertised as “skin-friendly”.
On 23 January 2025 Germany’s Federal Court of Justice banned “gentle on the skin” and “skin-friendly product solution” for a disinfectant foam. The product’s actual hazard is irrelevant; an abstract risk of misleading users suffices.
Article 72 covers advertising for biocidal products. For the treated article itself, Article 58(3) (substantiated properties only) and unfair competition law apply. Advertising the biocidal product, such as a masterbatch, falls directly under Article 72.
| Wording | Assessment |
|---|---|
| “skin-friendly”, “gentle on the skin” | prohibited as a similar indication (CJEU, BGH) |
| “antibacterial” without a test report | not substantiated, risk of misleading (Art. 58(3)(b); unfair competition law) |
| “antibacterial finish, tested to ISO 20743” plus complete label | usual route if test data and substance status are in order |
How to treat your product in line with the BPR.
01
Classify
decide whether your product is a treated article or, given its primary function, a biocidal product.
02
Define the purpose
material protection, odour control or a disinfecting property. This sets the product-type, such as 9 or 2.
03
Check the active substances
each must be approved for that product-type, listed in Annex I or covered by Article 94.
04
Clarify the biocidal product
if treated in the EU, the product used (such as a masterbatch) needs authorisation or transitional marketability (Articles 17 and 89).
05
Substantiate the effect
test each claimed property with a suitable method on the finished material. OECD guidance covers efficacy tests for treated articles.
06
Design the label
five mandatory items, visible, legible, durable, in the official language.
07
Review advertising
substantiated properties only, nothing that plays down risks. Keep documents ready for enquiries within 45 days.
For your product
What this means for your product.
Incorporating Z-Chitosan into a product and claiming an antimicrobial property usually means placing a treated article on the market. Whether the components of Z-Chitosan are approved or under review for the relevant product-type is clarified before each project.