Art. 95

Biocidal Products Regulation · 32012R0528 · every event for this act · on EUR-Lex

Transitional measures concerning access to the active substance dossier

3 changes recorded across 3 events, newest first.

in force 2026-06-15 MODIFIED+607 −0§

Amended by Regulation (EU) 2026/1165 32026R1165

applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)

dates added to the text: 2018-06-07, 2026-01-01, 2026-06-15, 2030-12-31

Paragraph 5 now adds a further derogation stating that data protection periods for active substance/product-type combinations lacking an approval decision under Article 89(1), third subparagraph, by 7 June 2018 will end on 31 December 2030.

A new provision also allows data owners to claim compensation for access to their data for the period from 1 January 2026 to 15 June 2026 from a substance or product supplier that benefitted from the absence of protection and was included in the list under paragraph 1 during that period.

Cited: Art. 95, v2

text before / after

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.

in force 2014-04-25 MODIFIED§

Amended by Regulation (EU) No 334/2014 32014R0334

applies from: unknown (the text changed beyond its dates, so no date that moved can be read as the application date)

dates removed: 2016-09-01

Sources disagree — the text comparison found this change; the EU's own amendment metadata does not list it and the amending act's instructions do not mention it. All are shown; none is overruled.

The provision moves from requiring each relevant person to individually submit a dossier, letter of access, or reference to the Agency, to instead having the Agency itself compile and regularly update a public list of active substances with complete substance dossiers and the persons who submitted them.

The later text introduces new defined roles of substance supplier and product supplier, adds provisions on fee payment and verification by the Agency, and adds a new paragraph requiring the Agency to remove suppliers from the list if they fail to submit relevant data within twelve months of a renewal.

The market restriction and data protection end-date provisions are reworded and renumbered, with the data protection end-date provision now tied to whether a decision on inclusion in Annex I to Directive 98/8/EC was taken before 1 September 2013, a condition absent from the earlier text.

Cited: Art. 95, v1 · Art. 95, v2

text before / after, on the event page →

in force 2013-09-01 MODIFIED§

Amended by Regulation (EU) No 736/2013 32013R0736 · Regulation (EU) No 334/2014 32014R0334

applies from: unknown

Sources disagree — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Both are shown; neither is overruled.

No explanation shipped — the structural diff did not see this change, so it carries no text; another signal named the unit and the disagreement ships as `disputed`.

text before / after, on the event page →