During its 59th meeting held on 18-20 March 2015, the EU competent authorities (CA) for biocides have adopted the long awaited guidance document on the management of in situ generated active substances under the Biocidal Products Regulation 528/2012 (BPR). In situ generated substances are substances, which are generated at the place of use from one or more precursors.
In essence, the document consists of two main chapters – the first one covers the in situ substances as such, while the second one focuses on the active substance releasers, which are to be differentiated from the active substance. From companies' perspective, the most practical aspects of the guidance are the accompanying annexes, which are as follows:
- Annex I includes a list of the in situ generated active substances split into categories (presented in different columns). The first one refers to the combinations supported in the dossier under evaluation in the review programme; the second one lists the additional active substance combinations that are currently not supported and that might be supported in the future.
- Annex II relates to the relevant releasers – e.g. substances releasing halogen and substances releasing formaldehyde.
- Annex III explains the procedural steps for taking over the role of a participant in the review programme. What does this mean? Essentially, CAs agreed that as of now, when only a precursor has been notified and supported under the review programme (e.g. ammonium sulphate), it will be replaced by the name of the active substance generated in situ and that precursor (e.g. ammonium sulphate generating monochloramine). In parallel to this new practice, opportunity shall also be given to persons wishing to support this precursor being used as an active substance on its own or to support other active substances generated from this precursor to take over the role of participant and to submit an application under the review programme of existing active substances.
However, the guidance document makes it explicitly clear that this last option will only be open to existing active substance (precursor) / product-type combinations still under assessment under the current review programme.
