Biocides

Biocidal products are used to control unwanted organisms that are harmful to human or animal health, or that cause damage to human activities. Important examples of biocides are insecticides (except those used for plant protection purposes), disinfectants and preservatives for materials such as wood and fibres, and anti-fouling paints for ships. As mentioned previously, biocides were regulated in a directive from 1998 but are since 2012 subject to the requirements of Regulation (EU) No 528/2012 concerning the making available on the market and use of biocidal products.5⁶

In more specific terms a biocidal product is primarily any substance or mixture consisting of, containing, or generating one or more active substances, with the intention of destroying, deterring, rendering harmless, preventing the action of, or otherwise exerting a controlling effect on any harmful organism by any means other than mere physical or mechanical action. A list of the types of biocidal products covered by the Regulation and their descriptions is set out in Annex V. Unless otherwise stated, the Regulation does not apply to biocidal products or treated articles that are within the scope of a number of other EU legal acts, including Regulation 1107/2009 on plant protection products. In that sense the rules on biocides are subsidiary to those on PPPs. (Arts 1—3.)

The procedure for approval is similar to that for PPPs in the sense that active substances must be approved and listed through a common EU procedure whereas biocidal products are approved by individual Member States. A procedure for mutual recognition may then be used for getting access to the markets of other Member States. However, the Biocides Regulation also provides for a centralised authorisation procedure resulting in an authorisation which allows the applicant to place a biocidal product directly on the entire EU market (Art 17). Union authorisation can be granted for most biocidal products with similar conditions of use across the Union.

Active substances potentially meeting substitution criteria must undergo a public consultation and may be designated as candidates for substitution during the approval procedure. During the evaluation for authorisation of a biocidal product containing active substances considered as candidates for substitution, a comparative assessment must be performed. (Arts 10 and 23.)