Kerona has had many queries recently regarding Article 95 access under the Biocidal Products Regulation (BPR, (EU) No. 528/2012). Many companies have requested assistance to be included in the Article 95 list of biocidal substance and product suppliers.
What is the Article 95 list?
Article 95 of the BPR requires that anyone placing a biocidal product on the market must obtain the active substance or the product from a company that is on the list of approved suppliers maintained by the European Chemicals Agency (ECHA). Not all companies need to be on the Article 95 list: it’s sufficient that one company in the supply chain is listed. The supplier must be listed for the relevant product type to which the biocidal product belongs.
The Article 95 list is regularly updated and can be downloaded from ECHA’s website in PDF or XLS format.
How can a company get on the Article 95 list?
To get onto the Article 95 list for a particular active substance/product type combination, a company must submit to ECHA either: a complete substance dossier; a Letter of Access (LoA) to a dossier; a combination of a LoA to part of a dossier plus complementary data; or a reference to an existing dossier for which all data protection periods have expired. ECHA will then verify whether the dossier or LoA is adequate.
How much does it cost?
Besides the cost of access to the dossier, which is specific to the active substance costs and the nature of the access, there are also ECHA submission fees, as follows:
Fee per submission of a LoA to a dossier already found complete by ECHA or an evaluating competent authority (eCA): €2,000
Fee per submission of a LoA to part of a dossier already found complete by ECHA or an eCA: €20,000
Fee per submission of a new dossier: €40,000
Kerona can help
If you require assistance with Article 95 access, please send an email to firstname.lastname@example.org or contact the team on +353 (0)1 849 5284