The European Commission has published Regulation 2021/2045 amending Annex XIV by adding endocrine disrupting properties to DEHP, BBP, DBP and DIBP:
- Bis(2-ethylhexyl) phthalate (DEHP) - for human health and the environment;
- Benzyl butyl phthalate (BBP) - for human health;
- Dibutyl phthalate (DBP) - for human health;
- Diisobutyl phthalate (DIBP) - for human health.
As a result of the amendments to Annex XIV, some previously exempted uses1 will require authorisation:
- medical devices and food contact materials containing DEHP
- mixtures containing either DEHP, BBP, DBP or DIBP at concentrations greater than or equal to 0.1% by weight
- immediate packaging of medicinal products containing DEHP, BBP or DBP
Applications for authorisation to use any of these substances in food contact materials, packaging of medicinal products or mixtures (at concentrations above 0.1%) will have to be submitted by 14 June 2023.
For DEHP in medical devices, the deadline is 27 November 2023.
The Regulation was published in the Official Journal on 24 November and entered into force on 14 December 2021.
1 by application of the provisions of Articles 60.2 and 56.5 of the REACH regulation