Understanding Treated Articles and Biocidal Product Regulations
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.
“BPR Article 3, Paragraph 1, defines a ‘treated article’ as a substance, mixture, or item deliberately containing 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. Make sure to treat the article with an EU-approved active substance, for both EU-made and imported items for EU sale. Moreover, EU-produced articles must use permitted 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 undergo various treatments based on their purpose. They incorporate antimicrobial agents to hinder decay, control odors in attire, or form barriers in healthcare.
The textile’s main purpose is typically physical, functioning within clothing or as some type of covering. Adding a biocide for chemical action is usually secondary. The strength of the biocide claim becomes crucial in determining the article’s biocidal nature.
Although the Regulation clearly defines a treated article, predicting whether treatment results in such an article or a biocidal product can be challenging in practice. The decision relies on the treatment’s purpose and claims. The EU Commission might step in for borderline cases.