Characteristics
This type of application is meant to initiate the assessment process for approval of active substances under the Biocidal Products Regulation (BPR) The application has to be submitted to ECHA, using the R4BP-3 module. One of the member states will evaluate the dossier.
Once the active substance has been approved, authorisations of products based on the active substance can be granted. By way of derogation, a provisional authorisation can be granted provided for a period of maximum three years, provided that the evaluating competent authority has submitted a recommendation for approval of the new active substance (more details in Art. 55 (2) of the BPR).
The BPR introduces formal exclusion and substitution criteria which apply to the evaluation of active substances. In principle, active substances which meet the exclusion criteria will not be approved. However, derogations are foreseen and if applicable, the active substance can be approved for a maximum of five years.
Substances that meet the substitution criteria will undergo public consultation and may be designated candidates for substitution. In that case, approval of the active substance is granted for maximum seven years, and during the evaluation of a biocidal product containing active substances that are considered candidates for substitution, a comparative assessment will be performed.
Substances that meet the requirements for low risk substances can be included in Annex I of the BPR (EU) 528/2012. In that case, the approval of the active substance does not have to be renewed (no expiry). More information about the amendment of Annex I can be found on the ECHA website.
For substances that are included in Annex I, product authorisations can be obtained via the simplified authorisation procedure (in this manual).
More information about the approval of active substances and about the exclusion and substitution criteria can be found on the ECHA website and ECHA’s Practical guide on BPR Approval of active substance.
The legal basis
The national application finds its legal basis in Chapter II of the BPR.
Application type criteria
- For substance approval, existing active substances are distinguished from new active substances, depending on whether they will be completely new on the European market or whether they were on the market on 14 May 2000 and have now been included in the Review Programme. On the ECHA website you can read more about existing and new active substances.
- Active substances are approved for one or more product types (PT). After approval of the active substance for certain product types, only product authorisations for these product types can be granted.
- Active substance approval may also cover treated articles.
Duration of the approval
The approval of an active substance is granted for a defined number of years, not exceeding 10 years and is renewable. Substances that meet the exclusion criteria, but for which a derogation is applicable, can be approved for a maximum of five years. Substances that meet the substitution criteria can be approved for a maximum of seven years.
Data requirements
Article 6 of the BPR (EU) 528/2012 lists the requirements for an application for an active substance approval. Further explanations can be found in ECHA’s Practical guide on BPR – Approval of active substance.
ECHA provides more advice on information requirements as given by Annex II and Annex III to the BPR (EU) 528/2012 in Guidance on biocide legislation Part A (related to dossier sections Volume I – Identity/physico-chemical properties/analytical methodology; Volume II – Efficacy; Volume III – Human health; and Volume IV – Environment).