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 otherwise. For example, this can be determined by reference to the prominence of the claim made on the product, or, more particularly, if a claim of public health relevance is made. Examples such as "Fight germs", "Provide antibacterial protection" and "Control fungus" are cited as examples. This may even be triggered where such health claims are merely implied by the person placing the article on the market.
What are the new labelling requirements?
The Regulation provides for certain labelling responsibilities on the person responsible for placing a treated article on the market. The labelling requirement is triggered where:
(i) a treated article contains a biocidal product and a claim is made by the manufacturer as to its biocidal properties; or
(ii) in relation to the active substance concerned, having particular regard to the possibility of contact with humans or release into the environment, the conditions associated with the approval of the active substance so require.
Quite an extensive amount of information must be included on the label. This includes, amongst other things, the list of biocidal products incorporated, the biocidal property of the products and any relevant instructions for use. Where a person or company imports a product into the EU that is a biocidal product or a treated article, it will be responsible for fulfilling the labelling requirement and for checking that the active substances used in the products are authorised under the Regulation.
How does the Regulation affect products stored in Ireland?
Irish companies may, on foot of these Regulations, be required to adopt certain measures to ensure their products comply with its provisions. The Regulation can have major effects, both in terms of time and money, on inventory supplies, packaging and turnaround times for products in the Irish market.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
