On 24 November 2021, the Official Journal of the European Union 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). This Regulation shall enter into force on the twentieth day following that of its publication in the Official Journal of the European Union.

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.

URL：

https://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32021R2045&from=EN

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