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24 Mar. 2022, the European Commission has adopted the amendments to Annexes VI to X regarding the information requirements to the HO168娱乐 Regulation. The amendments will apply from 14 Oct. 2022.

Major amendments are as follows:

1). Under the current Annex VI of HO168娱乐 Regulation, if related enterprises entrust an OR (Only Representative) to complete HO168娱乐 registration on their behalf, information of the OR is required only. However, the amendments require basic information of the non-EU enterprises who appointed the OR as well, including name, address, telephone number, email address, contact person, location of the production site, enterprise website, etc.

2) Certain rules regarding the exemption situations set out in Annexes VII to X to Regulation (EC) No 1907/2006 should be amended. The information requirements on testing for mutagenicity and for reproductive toxicity, and aquatic toxicity become clearer. For instance, if the long-term aquatic toxicity study on fish is available, the short-term toxicity testing on fish does not need to be conducted; if the substance is poorly water soluble, the short-term toxicity testing on fish does not need to be conducted.

3). In vivo tests are reduced;

As one of the most influential chemical regulations around the world, the HO168娱乐 Regulation has been implemented for more than 15 years. However, the HO168娱乐 Regulation is still constantly improved and revised. CIRS warmly reminds that related enterprises should still pay close attention to the Regulation so as to ensure the business trade with EU goes smoothly.

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Further Information

Commission Regulation (EU) 2022/477 of 24 March 2022 amending Annexes VI to X to HO168娱乐 Regulation