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Provision history · BPR

Art. 95 · Transitional measures concerning access to the active substance dossier

Biocidal Products Regulation · 32012R0528 · every version of this act · on EUR-Lex (external, EUR-Lex)

3 changes recorded across 3 versions, newest first.

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Version in force , Modified +607 −0

Amended by Regulation (EU) 2026/1165 32026R1165 on EUR-Lex (external, EUR-Lex)

Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why

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

Explanation, written by a model and checked against the cited text

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 (external, EUR-Lex)

v1 is the previous version, v2 this one.

Text from EUR-Lex, before and after

Previous version, in force 11 June 2024 02012R0528-20240611 → this version, in force 15 June 2026 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.

Version in force , Modified

Amended by Regulation (EU) No 334/2014 32014R0334 on EUR-Lex (external, EUR-Lex)

Applies from: not readable (the text changed beyond its dates, so no date that moved can be read as the application date) why

dates removed: 2016-09-01

Not in every listWhat this means

Found in the text, but not every source lists it — 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. Only the text comparison found it. All are shown; none is overruled.

Explanation, written by a model and checked against the cited text

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 (external, EUR-Lex) · Art. 95, v2 (external, EUR-Lex)

v1 is the previous version, v2 this one.

Text from EUR-Lex, on this version's page

Version in force , Modified

Amended by Regulation (EU) No 736/2013 32013R0736 on EUR-Lex (external, EUR-Lex) · Regulation (EU) No 334/2014 32014R0334 on EUR-Lex (external, EUR-Lex)

Applies from: not readable why

No text foundWhat this means

A source lists it, but there is no text to show — the EU's own amendment metadata found this change; the text comparison finds no difference in the provision's text. Only the EU's own amendment metadata names it, and it carries no text. Both are shown; neither is overruled.

No explanation shipped — the text comparison did not see this change, so it carries no text; another source named the provision, and it is listed where sources differ.

Text from EUR-Lex, on this version's page