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Regulation (EU) 2026/1165 of the European Parliament and of the Council of 20 May 2026 amending Regulation (EU) No 528/2012 as regards the extension of certain data protection periods (Text with EEA relevance)

Regulation (EU) 2026/1165 of the European Parliament and of the Council of 20 May 2026 amending Regulation (EU) No 528/2012 as regards the extension of certain data protection periods (Text with EEA relevance)

Regulation (EU) 2026/1165 · Regulation · 2 articles

Data as of 2026-07-04 · Compiled from an official source version. Later amendments or repeals may not be reflected; the official text prevails. · Read the official text ↗

Amendments to Regulation (EU) No 528/2012

Article 1

Regulation (EU) No 528/2012 is amended as follows: (1) in Article 60, paragraph 1, the second subparagraph is replaced by the following: ‘Without prejudice to Article 95(5), second subparagraph, protection periods under this Article which have expired shall not start to run again.’ ; (2) in Article 95, paragraph 5, the following subparagraphs are added: ‘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.’.

Entry into force

Article 2

This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .

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Source: EUR-Lex (Publications Office of the EU), © European Union, reuse permitted under Commission Decision 2011/833/EU.

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