When mixtures, substances or articles are treated with biocidal products, they are called ‘treated articles’. The biocidal products protect the articles from harmful organisms like pests, mould and bacteria.
Definition (BPR art.3 par.1) ‐ ‘treated article’ means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products.
Treated articles are covered by the rules set in the Chapter XIII of the BPR. According to the regulation, biocides can only be placed on the market (defined as first making available on the market) after a national or EU authorisation and an evaluation of their risks have taken place. The same is the case for active substances, which also need to be approved before they can be used in a biocide.
Articles that have been treated with a biocide do not need authorisation, but they can only be placed on the EU market when the active substance in the biocide has been approved for the specific use or be under review.
As responsible for the article, you need to ensure that the article is treated with an active substance that is allowed in the EU. This applies to articles manufactured in the EU as well as articles imported to be sold within the EU. In addition, articles manufactured within the EU can only be treated with allowed biocidal products. This applies from 1 March 2017.
Your company must provide information about the biocidal treatment of the article to any consumer asking for it. The information shall be provided free of charge, within 45 days. You must also be able to show that the biocide has the intended effect.
Treated articles that have a primary biocidal function are considered biocidal products. For example, an anti‐bacterial wipe is a biocidal product – not a treated article – because its sole purpose is to control bacteria.
Treated articles are divided in three categories depending on their reference to active substances and their biocidal properties:
- Treated articles with no claim or reference to biocidal properties, for example, paint or ink.
- Treated articles with a claim referring to biocidal properties, for example, textiles treated with silver for antibacterial purposes.
- Treated articles with no reference to biocidal properties but with approved active substances and related labelling requirements.
The dividing line between treated article and biocidal product is open to case‐by‐case interpretation and the use of biocidal products in the treatment of textiles is an illustration of this point. Textiles are treated for many reasons depending on the end use. Antimicrobial substances are included to prevent deterioration (e.g. mould suppression), or to act as odour control agents in clothing, or to provide some form of antimicrobial barrier in heathcare applications.
The primary purpose of the textile will almost always be a physical intention: to function within an item of clothing, or to act as a covering of some type, etc. The inclusion of a biocide to provide a chemical action will usually be secondary, even if its presence is announced, hence the strength of any claim associated with the biocide is seen as the key factor in deciding if the article is a biocidal product.
Whilst the definition of a treated article is clearly stated in the Regulation, in practice it can be harder to predict whether treatment will create a treated article or a biocidal product. The purpose of treatment and associated claims will be key factors in the decision and the EU Commission may be required as the ultimate arbiter in borderline cases.