Biocides: regulatory context
A biocidal product is an active substance or a mixture containing or generating one or more active substances, with the intention of detroying, deterring, rendering harmeless, preventing the action of, or otherwise exerting a controlling effect on, any harmful organism by any means other than mere physical or mechanical action (Article 3 of Regulation (EU) No.528/2012).
To obtain authorisation for an active substance or biocidal product within the European Union, you need to submit, as per the requirements of Regulation (EU) No. 28/2012, an application for approval or authorisation including a data package with supporting studies and tests which will be used firstly to prepare a human, health and environmental risk assessment, and secondly assess its efficacy.
All active substances used for biocidal purposes placed on the European market before 14/05/2000 are subject to a review programme described by Delegated Regulation (EU) No.1062/2014 amended by regulation (EU) No. 2017/698. For each substance, this leads to its approval or rejection, by product type, and its inclusion on the Union list of approved active substances for biocidal products. Active substance suppliers must be on the “Article 95” list.
Biocidal products containing one or more still unapproved active substances come under a transitional period.