The legal basis
The national authorisation finds its legal basis in article 29 – 30 of the BPR (EU) 528/2012.
Application type criteria
Prior condition for an national authorisation application of a biocidal product:
- Its active substances have been approved for the relevant product-type and any conditions specified for those active substances are met; (BPR (EU) 528/2012, art. 19);
- Its active substance has not yet been approved, but a biocidal product containing a new active substance can be authorised for a period not exceeding three years. Such a provisional authorisation may be granted only if the evaluating competent authority has submitted a recommendation for approval of the new active substance (more details in Art. 55 (2) of the BPR).
Article 20 and 21 of the BPR (EU) 528/2012 lists the requirements for an application for a national authorisation of a biocidal product.
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).
With regard to practical information for this type of application on characteristics, BPR requirements and best practices to fulfil them, check ECHS's Practical guide on BPR .
Data requirements for an application depend on the date of submission of that application.