Questions and Answers
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.
The text of the Commission Implementing Regulation (EU) No 564/2013 is available at:
The Union list of approved active substances mentioned in Article 9(2) of the BPR is publicly available on the website of DG Environment of the European Commission:
ECHA maintains a similar list on its website:
Pursuant to Article 67(1) of the BPR, as amended by Regulation (EU) No 334/2014, approved active substances are added on this list from the date on which the Commission adopts an implementing Regulation providing that an actice substance is approved.
Prospective applicants, intending to perform new tests on vertebrate animals, have an obligation to find out which tests and studies are already available, by submitting an inquiry through R4BP 3 to ECHA.
Prospective applicants may also inquire about tests and studies not involving tests on vertebrate animals. Accordingly, an inquiry is mandatory when the intention is to perform tests on vertebrate animals and is optional when the intention is to perform tests which do not involve vertebrate animals. An inquiry is also a pre-requisite before a data sharing dispute claim can be submitted to ECHA under Article 63(3) of the BPR (including in cases where the prospective applicant already knows the identity of the data owner).
Once a request for test data (on vertebrate animals or not) has been made to a data owner (or any data submitter that is entitled to negotiate on behalf of the data owner), the parties must make every effort to reach an agreement to ensure that the cost of sharing the information is determined in a fair, transparent and non-discriminatory way, in accordance with the provisions of Article 63(1) and (4) of the BPR. ECHA will provide the inquirer with the contact details of all previous data submitters, when tests or studies were already submitted to the competent authorities or ECHA in connection with an application under the former Directive 98/8/EC or the BPR. Where applicable, the data submitters are required to facilitate the contacts between prospective applicants and data owners.
Please consult the ECHA website on inquiry, available at: http://www.echa.europa.eu/ regulations/biocidal-products-regulation/data-sharing/inquiry and at:
The data sharing obligation also applies to the inclusion in the list of relevant substances and suppliers under Article 95 of the BPR. Note that mandatory data sharing for the purpose of Article 95 extends to all toxicological, eco-toxicological and environmental fate and behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, including any such studies not involving tests on vertebrate animals.Please consult the ECHA website on data sharing (and the related documents), available at: