Treated articles under the biocidal products regulation
Under the BPR any substance, mixture or article which intentionally incorporates a biocide must use a biocidal product containing a compliant active substance. The case-by-case nature of defining treated articles and the issues surrounding the evaluation and approval of active substances that are used principally in treated articles are examined in this review. The challenge of reconciling the ‘one-safe use’ principle for BPR active substance approval within a risk assessment that covers the diverse nature of treated articles uses is also considered.
Unlike the Biocidal Products Directive (BPD) (1), the Biocidal Products Regulation (BPR) (2) includes treated articles within the scope of the legislation, specifically in Article 58 with respect to the rules for placing articles on the market, but also more generally. The reason to regulate treated articles was to increase the overall protection of human health, animal health and the environment from the use of biocidal products, and to address potential discrimination between treated articles originating from within the European Union (EU) and those imported from countries outside the EU.
The definition of a treated article is stated clearly in the BPR: it means any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products. The terms substance, mixture and article take their definition from the REACH regulation (3) and include solid objects and liquid materials.
In practice, defining a treated article can sometimes be uncertain because the action of treating an article could impart a biocidal property to the article. The property may be unintended, ...