To market biocidal products in the EU, you need to be on the Article 95 list or have a Letter of Access to this. Until now, there has been rules protecting the data behind the Article 95 approvals, but this may soon be over.
Article 95 of the Biocidal Products Regulation states: “By way of derogation from Article 60 of this Regulation, all data protection periods for substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but not yet approved under this Regulation shall end on 31 December 2025.”
Only 45% are approved
This means that if an active substance dossier approved on the Article 95 list is still not approved under Annex II of the review programme by 31 December 2025, the data protection for the dossier will cease.
So far, only about 45% of all active substances/product type combinations in the Annex II of the review programme have been approved. Accordingly, 55% of the active substances still need to be approved and may be at risk of being without data protection after the above date.
To find out more about how the biocidal rules apply to your product and active substance, please contact:
Jack Frausing Nielsen
jafn@dhigroup.com
Tel +45 4516 9128
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