Commission Regulation (EU) 2021/2045 amended Annex XIV of the REACH Regulation (1907/2006), which contains the list of substances subject to authorisation.
The substances bis(2-ethylhexyl) phthalate (DEHP), benzyl-butyl-phthalate (BBP), dibutyl phthalate (DBP) and diisobutylphthalate (DIBP), listed in entries 4 to 7 of Annex XIV of Regulation (EC) No 1907/2006, have been assessed in relation to their health and environmental concerns (endocrine disrupting properties and reproductive toxicity). As a result, these new provisions, regarding the need for authorization for certain uses, have been introduced:
DEHP
Date by which applications for authorisation must be received:
- 14 June 2023 for use in:
- materials intended to come into contact with foodstuffs falling within the scope of Regulation (EC) No. 1935/2004;
- immediate packaging of medicinal products covered by 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/weight.
- 27 November 2023 for uses in medical devices falling within the scope of Directives 90/385/EEC, 93/42/EEC and 98/79/EC.
BBP
Date by which applications for authorisation must be received:
- 14 June 2023 for use in:
- immediate packaging of medicinal products covered by Regulation (EC) No 726/2004, Directive 2001/82/EC and/or Directive 2001/83/EC;
- mixtures containing BBP in concentrations equal to or greater than 0,1 % and less than 0,3 % weight/weight.
DIBP
Date by which applications for authorisation must be received:
- 14 June 2023 for uses in mixtures containing DIBP at or above 0,1 % and below 0,3 % weight/weight.
The full text of the Regulation is available at this link.
