Biocidal Products Regulation

02012R0528-20240611 → 02012R0528-20260615

Article 60 Data protection periods 1. Data submitted for the purposes of Directive 98/8/EC or of this Regulation shall benefit from data protection under the conditions laid down in this Article. The protection period for the data shall start when they are submitted for the first time. Data protected Without prejudice to Article 95(5), second subparagraph, protection periods under this Article or for which the protection period under this Article has have expired shall not be protected start to run again. 2. The protection period for data submitted with a view to the approval of an existing active substance shall end 10 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type. The protection period for data submitted with a view to the approval of a new active substance shall end 15 years from the first day of the month following the date of adoption of a decision in accordance with Article 9 on the approval of the relevant active substance for the particular product-type. The protection period for new data submitted with a view to the renewal or review of the approval of an active substance shall end five years from the first day of the month following the date of the adoption of a decision in accordance with Article 14(4) concerning the renewal or the review. 3. The protection period for data submitted with a view to the authorisation of a biocidal product containing only existing active substances shall end 10 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5). The protection period for data submitted with a view to the authorisation of a biocidal product containing a new active substance shall end 15 years from the first day of the month following the first decision concerning the authorisation of the product taken in accordance with Article 26(3), 30(1), 33(3), 33(4), 34(6), 34(7), 36(4), 37(2), 37(3) or 44(5). The protection period for new data submitted with a view to the renewal or amendment of the authorisation of a biocidal product shall end five years from the first day of the month following the decision concerning the renewal or amendment of the authorisation.

02012R0528-20240611 → 02012R0528-20260615

Article 95 Transitional measures concerning access to the active substance dossier 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 … 534 unchanged words … 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 taken before 1 September 2013, shall end on 31 December 2025. By way of derogation from the first subparagraph of this paragraph, all data protection periods for active substance/product-type combinations for which a decision on the approval has not been adopted in accordance with Article 89(1), third subparagraph, by 7 June 2018, shall end on 31 December 2030. Data owners may claim compensation for access to their data for the period from 1 January 2026 to 15 June 2026 from a substance supplier or product supplier having benefitted from the absence of protection and having been included in the list referred to in paragraph 1 of this Article during that period. 6. Paragraphs 1 to 5 shall not apply to substances listed in Annex I in categories 1 to 5 and category 7 or to biocidal products containing only such 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.