Article 1
Annex XIV to Regulation (EC) No 1907/2006 is amended in accordance with the Annex to this Regulation.
Commission Regulation (EU) 2021/2045 of 23 November 2021 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)
Commission Regulation (EU) 2021/2045 of 23 November 2021 amending Annex XIV to Regulation (EC) No 1907/2006 of the European Parliament and of the Council concerning the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) (Text with EEA relevance)
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 2
This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union .
Supplementary provisions
ANNEXSupplementary provisions
ANNEX Entries 4 to 7 in the table in Annex XIV to Regulation (EC) No 1907/2006 are replaced by the following entries: Entry Nr Substance Intrinsic property(ies) referred to in Article 57 Transitional arrangements Exempted (categories of) uses Review periods Latest application date (1) Sunset date (2) ‘4. Bis(2-ethylhexyl) phthalate ( DEHP ) EC No : 204-211-0 CAS No : 117-81-7 Toxic for reproduction (category 1B) Endocrine disrupting properties (Article 57(f) – human health) Endocrine disrupting properties (Article 57(f) – environment) (a) 21 August 2013 (*) (b) By way of derogation from point (a): 14 June 2023 for uses in: — food contact materials within the scope of Regulation (EC) No 1935/2004; — immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC; — mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight; (c) By derogation of point (a): 27 November 2023 for uses in medical devices within the scope of Directives 90/385/EEC, 93/42/EEC and 98/79/EC. (a) 21 February 2015 (**) (b) By way of derogation from point (a): 14 December 2024 for uses in: — food contact materials within the scope of Regulation (EC) No 1935/2004; — immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC; — mixtures containing DEHP at or above 0,1 % and below 0,3 % weight by weight; (c) By derogation of point (a): 27 May 2025 for uses in medical devices within the scope of Directives 90/385/EEC, 93/42/EEC and 98/79/EC. - - 5. Benzyl butyl phthalate ( BBP ) EC No : 201-622-7 CAS No : 85-68-7 Toxic for reproduction (category 1B) Endocrine disrupting properties (Article 57(f) – human health) (a) 21 August 2013 (*) (b) By way of derogation from point (a): 14 June 2023 for uses in: — immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC; — mixtures containing BBP at or above 0,1 % and below 0,3 % weight by weight. (a) 21 February 2015 (**) (b) By way of derogation from point (a): 14 December 2024 for uses in: — immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC; — mixtures containing BBP at or above 0,1 % and below 0,3 % weight by weight. - - 6. Dibutyl phthalate ( DBP ) EC No : 201-557-4 CAS No : 84-74-2 Toxic for reproduction (category 1B) Endocrine disrupting properties (Article 57(f) – human health) (a) 21 August 2013 (*) (b) By way of derogation from point (a): 14 June 2023 for uses in: — immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC; — mixtures containing DBP at or above 0,1 % and below 0,3 % weight by weight. (a) 21 February 2015 (**) (b) By way of derogation from point (a): 14 December 2024 for uses in: — immediate packaging of medicinal products covered under Regulation (EC) No 726/2004, Directive 2001/82/EC, and/or Directive 2001/83/EC; — mixtures containing DBP at or above 0,1 % and below 0,3 % weight by weight. - - 7. Diisobutyl phthalate (DIBP) EC No : 201-553-2 CAS No : 84-69-5 Toxic for reproduction (category 1B) Endocrine disrupting properties (Article 57(f) – human health) (a) 21 August 2013 (*) (b) By way of derogation from point (a): 14 June 2023 for uses in mixtures containing DIBP at or above 0,1 % and below 0,3 % weight by weight. (a) 21 February 2015 (**) (b) By way of derogation from point (a): 14 December 2024 for uses in mixtures containing DIBP at or above 0,1 % and below 0,3 % weight by weight. - -’
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