Application for product authorisation
The authorisation of a biocidal product or biocidal product family can be carried out via a number of different authorisation processes:
National Authorisation of a biocidal product
Mutual Recognition of a biocidal product authorised in another Member State
Union Authorisation of a biocidal product
Simplified Authorisation of a biocidal product containing an Annex I substance
Authorisation of biocidal products require a product dossier to be submitted in IUCLID format via the R4BP and the application must contain a proposed Summary of the Product Characteristics (SPC) generated through the SPC Editor.
Information, data and risk assessments submitted to defend the biocidal product(s) or family must be fully examined and a decision on product authorisation undertaken by the evaluating Competent Authority (CA). Both the data requirements for biocidal product authorisation and the criteria (Annex VI of the BPR - Uniform Principles) by which the product is evaluated are harmonised at the European level.
The EU legislation framework has always encouraged mutual recognition and the Biocidal Products Regulation (BPR) requires greater cooperation among Member State (MS) countries across the European Union. Where a biocidal product is authorised in one MS, an applicant may seek mutual recognition of the authorisation in another MS. Furthermore, the biocides legislation now allows for Union authorisations across all MS of the EU. In this scenario the European Commission is the authorising body, ECHA co-ordinates the authorisation and the evaluating MS conducts the product assessment of the dossier submitted by the applicant.
If an application for authorisation for an existing notified biocidal product on the Irish market (notified under the National Notification System) has not been submitted, has been rejected, or additional information requested by the CA has not been submitted by the applicant in due time, the notified biocidal product must be revoked from the market and existing stocks are subject to a phase-out period.