Active substances and suppliers
The Biocidal Products Regulation (BPR) aims to make sure that the costs of the data on active substances are fairly shared.
Companies that have not already submitted their own dossier on an active substance under the Biocidal Products Directive (BPD) or the BPR can either submit a dossier, a letter of access, or if all data protection periods have expired, a reference to an existing dossier to ECHA. This information must comply with the data requirements for active substances of the BPR or the BPD.
Applications for inclusion in the list of active substances suppliers (Article 95 list) can only be made by a person established within the EU. The definitions of substance supplier and product supplier, as set out in Article 95(1), second sub-paragraph, specify that those entities must be established in the EU. However, non-EU companies can be represented by an EU representative, for the purpose of Article 95, and be indicated on the list next to their EU representative.
In addition to manufacturers and importers, the amendment of the BPR introduced by Regulation (EU) No 334/2014 on 11 March 2014 also allows product suppliers (e.g. formulators) to apply to be included in the Article 95 list. The amendment requires that the list also specifies the product type (PT) for which an application has been made.
ECHA will publish and regularly update the Article 95 list to include those entities who have made a successful submission of the required information (see link to the Article 95 list).
From 1 September 2015, a biocidal product consisting of, containing, or generating a relevant substance, cannot be made available on the EU market if the substance supplier or product supplier is not included in the list for the product type to which the product belongs.
In the context of the Article 95 list, and limited to active substances in the review programme, the principle of mandatory data sharing applies not only to tests involving vertebrate animals but also to all toxicological, ecotoxicological and environmental fate and behaviour studies, including any such studies not involving tests on vertebrates. This implies that applicants must share and not duplicate studies and tests on vertebrate animals, which should be undertaken as a last resort.
Any substance or product supplier intending to perform tests or studies may, in the case of non-vertebrate animal tests, and must, in the case of vertebrate animal tests, inquire with the Agency whether such tests or studies have already been submitted to any competent authority or to the Agency under the BPD or the BPR.
The Agency will provide the prospective applicant with the contact details of the relevant data submitter. This inquiry step is a pre-condition before any data sharing dispute can be brought before the Agency because the relevant timelines for the dispute procedure are calculated from the date on which the Agency provides the contact details of the data submitter.