On 24 November 2021, the European Commission has published Commission Regulation (EU) 2021/2045 to approve the amendments of Annex XIV to REACH Regulation (EC) No 1907/2006, regards the substances Bis(2-ethylhexyl) phthalate (DEHP, CAS No. 117-81-7), Benzyl butyl phthalate (BBP, CAS No. 85-68-7), Dibutyl phthalate (DBP, CAS No. 84-74-2), Diisobutyl phthalate (DIBP, CAS No. 84-69-5). The amendment shall enter into force on 14 December 2021.

The content of the amendment is as follows:

New transitional arrangements have been added in the substances DEHP, BBP, DBP and DIBP (entries 4 to 7). The new transitional arrangements related to food contact material, immediate packaging of medicinal products, medical device and mixtures, with the following newly added latest applicable date and sunset date:

1. For DEHP used in food contact material: 14 June 2023 and 14 December 2024;
2. For DEHP, BBP, DBP used in immediate packaging of medicinal products: 14 June 2023 and 14 December 2024;
3. For DEHP used in medical devices: 27 November 2023 and 27 May 2025;
4. For DEHP, BBP, DBP or DIBP of ≥ 0.1% and < 0.3% by weight (each) used in mixtures: 14 June 2023 and 14 December 2024.

Note:
Annex XIV - List of substances subject to authorisation

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