Active substances
Information on active substance approvals and on in situ generated active substances.
Status of active substances in the EU-review
An active substance is a substance or a micro-organism that has an action on or against harmful organisms.
In order to allow an active substance for use in a biocidal product of a certain product type, an application for the approval of that active substance/product type combination has to be submitted, which will be examined by the evaluating authority. Approval or non-approval decisions are taken by the European Commission and published in the Official Journal of the European Union. Substances that have been approved are included on the so-called “Union list”.
Biocidal products that contain active substances which have not been approved or for which no application for approval has been submitted cannot be placed on the market.
As regards the marketability of biocidal products that contain active substances for which an approval process is underway, a distinction has to be drawn between existing and new active substances.
Approval is not only required for the active substances contained in a biocidal product; the biocidal products themselves also require authorisation.
Approval of biocidal active substances
Futher information on the approval procedure of biocidal active substances, on "new", "existing" and already approved active substances, on candidates for substitution and more can be found on the Homepage of the European Chemicals Agency (ECHA).
In situ generated active substances
In situ generated active substances are substances which are produced from one or more precursor substances at the location of their use. They are a special type of active substance for which special rules apply. Further information can be found on the hompage of the European Chemicals Agency (ECHA).
Non-approved active substances - end of marketability
The decision on non-approval is taken by the Commission, which keeps lists of active substance/product type combinations.
The placing on the market of biocidal products for the respective product types containing these substances as active substances shall be prohibited with effect from the date specified in the respective Commission Decision.
To access the decisions of the Commission concerning the non-inclusion of certain active substances we recommend using the advanced search function on the EUR-Lex (european law) homepage with following search criteria: search in text/title with the keywords “non-inclusion 98/8/EC” or “non-approval 528/2012“; nature of the legal act: decision.