On November 24, 2021, the European Commission published Commission Regulation (EU) 2021/2045 in the Official Journal of the European Union, amending items 4 to 7 of the four phthalate substances in Annex XIV (List of Authorized Substances) of the REACH Regulation (DEHP, BBP, DBP and DIBP) exemption clauses. The regulation will take effect on the 20th day from the day it was published in the Official Journal of the European Union.

The revised regulations are as follows:

Substances 4 to 7 of Annex XIV of REACH Regulations (ie 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)), A new exemption requirement has been added. At that time, these exemptions must be submitted before the latest application date, otherwise they will be banned after sunset. The newly added latest application dates and sunset dates are as follows:

◆ For DEHP used in food contact materials: June 14, 2023 and December 14, 2024;

◆ For the direct packaging of DEHP, BBP, and DBP for pharmaceutical products: June 14, 2023 and December 14, 2024;

◆ For DEHP used in medical devices: November 27, 2023 and May 27, 2025;

◆ For DEHP, BBP, DBP or DIBP used in the mixture, and any concentration is ≥ 0.1% and <0.3% (by weight): June 14, 2023 and December 14, 2024.

Reminder

If the REACH exemption expires and no company applies for renewal, the relevant products must compulsorily comply with the relevant limit requirements. ZRLK hereby reminds relevant companies to pay close attention to the revision of REACH regulations and replace exempt materials that are about to expire or have expired in advance to avoid compliance problems caused by the expiration of exemptions for products exported to Europe.