Registering a new active substance
Are all the biocides contained in (or generated by) your product part of the EU BPR review programme? Branch 5 on the decision tree looks at what you need to do if the answer is no and a new biocide (active substance) dossier must be submitted to ECHA for approval.
It is not possible to place on the market anywhere in the EU a biocidal product containing an active substance that is not either, approved for use under the BPR for that particular product type, or included in the BPR active substance review programme.
If your product contains such an active substance, it will be necessary to obtain authorisation for this active substance under the BPR for the specific product type.
Approval of an active substance requires submission of a dossier for the active substance as well as a dossier for at least one representative biocidal product containing the active substance.
The dossier must first be submitted to ECHA where the information provided format checked and validated step by the evaluating competent authority (eCA). Once the application is validated the dossier evaluation process starts.
The evaluation process is followed by an opportunity for applicant comments, then a peer review by the Biocidal Products Committee (BPC). The final decision on the approval of the active substance is taken by the European Commission.
To learn more about the data requirements, application process and approval of new active substances under the BPR, keep an eye out for our soon to be published “Introduction to the Biocidal Products Regulation” e-book.