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Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices

Commission Regulation (EU) 2023/2482 of 13 November 2023 amending Regulation (EC) No 1907/2006 of the European Parliament and of the Council as regards the substance bis(2-ethylhexyl) phthalate (DEHP) in medical devices

Regulation (EU) 2023/2482 · Regulation · 3 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 ↗

Article 1

Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.

Article 2

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

Supplementary provisions

ANNEXSupplementary provisions

ANNEX In the table in Annex XIV to Regulation (EC) No 1907/2006, entry nr 4 concerning the substance bis(2-ethylhexyl) phthalate (DEHP) is amended as follows: (1) in column 4 ‘Latest application date’, point (c) is replaced by the following: ‘(c) by way of derogation from point (a): 1 January 2029 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746.’; (2) in column 5 ‘Sunset date’, point (c) is replaced by the following: ‘(c) by way of derogation from point (a): 1 July 2030 for uses in medical devices within the scope of Regulations (EU) 2017/745 and (EU) 2017/746.’.

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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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