gulation/activesubstancesuppliers
Questions and Answers
Biocidal Products Regulation
* Active substance suppliers
Biocidal Products Regulation
Active substance suppliers
Version: 1.1
Latest update: 04/07/2014
Given the Agency's work required to analyse submissions for inclusion in the list of relevant substances and suppliers referred to in Article 95 of the BPR, it is appropriate to levy a fee for these types of submissions. The applicable fees are laid down in the Commission Implementing Regulation (EU) No. 564/2013 of 18 June 2013 on the fees and charges payable to ECHA pursuant to Regulation (EU) No 528/2012.
The amount of work required for such a submission will vary significantly depending on whether the person submits a letter of access or a new dossier, since, in the latter case, ECHA will have to check that the dossier complies with Annex II to the BPR or, where appropriate, Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive.
Annex III of the aforementioned Commission Implementing Regulation (EU) No 564/2013 sets the applicable fees depending on the type of the submission under Article 95 of the BPR:
- 2 000 EUR per submission of a letter of access to a dossier already found complete by the Agency or an evaluating competent authority;
- 20 000 EUR per submission of a letter of access to part of a dossier already found complete by the Agency or an evaluating competent authority, together with complementary data;
- 40 000 EUR per submission of a new dossier.
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