New active substance
Companies have to apply for approval of an active substance by submitting a dossier to ECHA. After the validation check has been performed by ECHA, the evaluating competent authority carries out a completeness check and an evaluation within one year.
The result of the evaluation is forwarded to ECHA's Biocidal Products Committee, which prepares an opinion within 270 days. The opinion serves as a basis for the decision-making by the European Commission and the Member States. The approval of an active substance is granted for a defined number of years, not exceeding ten years.
A similar process takes place for the renewal of the approval of an active substance, where, depending on the amount of new studies available at the renewal, a distinction is made between a full evaluation and a limited evaluation. The application to ECHA has to be submitted 550 days before the expiry date of the approval.
The BPR introduces exclusion and substitution criteria as new elements.