Amending Annex XIV to REACH Regulation
Europe
Amending Annex XIV to REACH Regulation
On 24th November 2021, the European Union (EU) published Regulation (EU) No 2021/2045 with an amendment to, Annex XIV to Regulation (EC) No 1907/2006 of REACH, which entered in force on 13th January 2022.
This amendment replaces the following information in the table in Annex XIV to REACH for entries 4-7:
Entry Nr |
Substance |
Intrinsic property(ies) referred to in Article 57 |
Transitional arrangements |
|
Latest application date |
Sunset date |
|||
‘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. |