On November 24, 2021, the European Commission published Commission Regulation (EU) 2021/2045 in the Official Journal of the European Union, amending the four phthalate substances in items 4 to 7 in Annex XIV (List of Authorized Substances) of the REACH Regulation (DEHP, BBP, DBP and DIBP) exemptions. The regulation comes into force on the 20th day from the date of its publication in the Official Journal of the European Union.
The amendments to the regulations are as follows:
Substances in items 4 to 7 of Annex XIV of REACH regulations (i.e. bis(2-ethyl)hexyl phthalate (DEHP, CAS number: 117-81-7), butyl benzyl phthalate (BBP, CAS number) : 85-68-7), dibutyl phthalate (DBP, CAS number: 84-74-2), diisobutyl phthalate (DIBP, CAS number: 84-69-5)), Added new exemptions. At that time, these exempted uses will need to submit an exemption application by the latest application date or they will be disabled after the sunset date. The newly added latest application date and sunset date are as follows:
For DEHP for food contact materials: June 14, 2023 and December 14, 2024;
For DEHP, BBP, DBP for direct packaging of medicinal products: June 14, 2023 and December 14, 2024;
For DEHP for medical devices: November 27, 2023 and May 27, 2025;
For DEHP, BBP, DBP or DIBP for mixtures and either concentration ≥ 0.1% and < 0.3% by weight: June 14, 2023 and December 14, 2024.