European legislation regulating the use and labelling of biocidal products (the "Regulation") came into force on 1 September 2013. Biocides are chemicals used to suppress organisms that are harmful to human or animal health, or that cause damage to natural or manufactured materials. Examples of biocidal products are disinfectants and insect repellants. However, because of their intrinsic properties biocides can pose risks to humans, animals and the environment.
The Regulation aims to improve the functioning of the internal market in biocidal products whilst ensuring a high level of environmental and human health protection. This article focuses, in particular, on the regime applied to products which are simply treated with biocidal products ("treated articles"), as opposed to the biocidal products themselves.
To what products do the Regulations apply?
The Regulation applies to treated articles, which are defined as "any substance, mixture or article which has been treated with, or intentionally incorporates, one or more biocidal products". A treated article cannot be placed on the EU market unless the active substance in the biocidal product used to treat the article is approved for use in the EU. There are also labelling requirements for these treated articles, discussed below. To further complicate matters, where a treated article has a "primary biocidal function", the treated article itself morphs into a biocidal product, for the purpose of the Regulation. This carries with it far more onerous regulatory and authorisation requirements. It is important that Irish companies can distinguish between those products which are classified as biocidal products and those which are treated articles.
What are products with a "biocidal function"?
Unfortunately, the Regulation does not provide a definition of what constitutes a "primary biocidal function". However, the European Commission's draft FAQ indicates that a biocidal function is "the function of destroying, deterring, rendering harmless, preventing the action or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action." This function becomes a primary one where it is of "first rank, importance or value compared to the other functions of the treated article".
Interestingly the draft FAQ also states that claims made about a product can affect its classification as having a primary biocidal function, or...