1.As of 1 September 2013, any person wishing to place active substance(s) on the Union market on its own or in biocidal products (the ‘relevant person’) shall, for every active substance that they manufacture or import for use in biocidal products, submit to the Agency:
(a)a dossier complying with the requirements of Annex II or, where appropriate, with Annex IIA to Directive 98/8/EC; or
(b)a letter of access to a dossier as referred to under point (a); or
(c)a reference to a dossier as referred to under point (a) and for which all data protection periods have expired.
If the relevant person is not a natural or legal person established within the Union, the importer of the biocidal product containing such active substance(s) shall submit the information required under the first subparagraph.
2.The Agency shall make publicly available the list of persons that have made a submission in accordance with paragraph 1 or for whom it has taken a decision in accordance with Article 63(3). The list shall also contain the names of persons who are participants in the work programme established under the first subparagraph of Article 89(1) or have taken over the role of the participant.
3.Without prejudice to Article 93, as of 1 September 2015, a biocidal product shall not be made available on the market if the manufacturer or importer of the active substance(s) contained in the product, or where relevant, the importer of the biocidal product, is not included in the list referred to in paragraph 2.
Without prejudice to Articles 52 and 89, disposal and use of existing stocks of biocidal products containing an active substance, for which no relevant person is included in the list referred to in paragraph 2, may continue until 1 September 2016.
1.As of 1 September 2013, the Agency shall make publicly available and shall regularly update a list of all active substances, and all substances generating an active substance, for which a dossier complying with Annex II to this Regulation or with Annex IIA or IVA to Directive 98/8/EC and, where relevant, Annex IIIA to that Directive (‘the complete substance dossier’) has been submitted and accepted or validated by a Member State in a procedure provided for by this Regulation or that Directive (‘the relevant substances’). For each relevant substance, the list shall also include all persons having made such a submission or a submission to the Agency in accordance with the second subparagraph of this paragraph, and indicate their role as specified in that subparagraph, and the product-type(s) for which they have made a submission, as well as the date of inclusion of the substance in the list.
A person established within the Union who manufactures or imports a relevant substance, on its own or in biocidal products (‘the substance supplier’) or who manufactures or makes available on the market a biocidal product consisting of, containing or generating that relevant substance (‘the product supplier’), may at any time submit to the Agency either a complete substance dossier for that relevant substance, a letter of access to a complete substance dossier, or a reference to a complete substance dossier for which all data protection periods have expired. Following the renewal of the approval of an active substance, any substance supplier or product supplier may submit to the Agency a letter of access to all the data which was considered by the evaluating competent authority as relevant for the purpose of the renewal, and for which the protection period has not yet expired (‘the relevant data’).
The Agency shall inform the submitting supplier of the fees payable under Article 80(1). It shall reject the application if the submitting supplier fails to pay those fees within 30 days and shall inform the submitting supplier accordingly.
Upon receipt of the fees payable under Article 80(1), the Agency shall verify whether the submission complies with the second subparagraph of this paragraph and shall inform the submitting supplier accordingly.
2.As of 1 September 2015, a biocidal product consisting of, containing or generating a relevant substance, included in the list referred to in paragraph 1, shall not be made available on the market unless either the substance supplier or the product supplier is included in the list referred to in paragraph 1 for the product-type(s) to which the product belongs.
3. For the purposes of thismaking a submission in accordance with the second subparagraph of paragraph 1 of this article, Article 63(3) of this Regulation shall apply to all toxicological, ecotoxicological and forenvironmental existingfate activeand behaviour studies relating to substances listed in Annex II to Regulation (EC) No 1451/2007, Article 63(3) of this Regulation shall apply to all toxicological and ecotoxicological studies including any toxicological and ecotoxicologicalsuch studies not involving tests on vertebrates.
4. TheA relevantsubstance personsupplier or a product supplier included in the list referred to in paragraph 1 to whom a letter of access has been issued for the purpose of this Article or a right to refer to a dossier on the active substancestudy has been issuedgranted in accordance with paragraph 3 shall be entitled to allow applicants for the authorisation of a biocidal product containing that active substance to make reference to that letter of access or that study for the purposes of Article 20(1).
5. By way of derogation from Article 60 of this Regulation,60, all data protection periods for active substance/product-type combinations listed in Annex II to Regulation (EC) No 1451/2007, but for which a decision on inclusion in Annex I to Directive 98/8/EC was not yettaken approvedbefore under1 thisSeptember Regulation2013, shall end on 31 December 2025.
6.4. ThisParagraphs Article1 to 5 shall not apply to active substances listed in Annex I in categories 1 to 5 and category 7 or to biocidal products containing only such active substances.
7.The Agency shall regularly update the list referred to in paragraph 1 of this Article. Following the renewal of the approval of an active substance, the Agency shall remove from the list any substance supplier or product supplier who has not, within 12 months of the renewal, submitted all the relevant data or a letter of access to all the relevant data, either in accordance with the second subparagraph of paragraph 1 of this Article or in an application in accordance with Article 13.