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The long-awaited amendments of the New and Existing Chemical Registration Regulation was promulgated on Mar 11th, 2019. The full contents of the updated regulation are accessible here (in Chinese).
The official English translation is accessible here.
Several notable amendments in the revised regulation are highlighted as below:
1. Chemicals beyond the scope of the regulation were clarified, e.g. toxic chemical substances, polymers that fit the “2% Rule” and listed on the inventory of existing chemical substances, etc.
2. Tonnage level that requires hazard & exposure assessment in new chemical registration was adjusted from 1000+t/a to 10+t/a. (in line with MoL’s regulation of new chemical substance registration)
3. Registration certificate for chemical registration will no longer be issued and only a registration number will be provided.
4. The previous Article 16, Article 17 and Article 18 for inventory supplementation, the grace period for new chemical registration and pre-registration were deleted (the articles expired).
5. Phase 1 registration of existing chemicals manufactured/imported over 100kg/a for the first time must be completed within 6 months if the situation applies. In addition, for existing chemical substances manufactured or imported below 100kg/year, registrants can voluntarily apply for phase 1 registration.
6. 106 priority existing chemical substances was designated subject to standard registration from Jan 1st, 2020.
7. Confidentiality protection also applied to existing chemical substances. Confidentiality validity for PLC was changed from 2 years to 5 years aligning with the registration validity of PLC (5 years).
8. Annual reporting of registrant information, registration No., and last year’s volume of manufacture or importation of registered new and existing substances between 1 Apr to 30 Sep is mandatory from 2020.
9. Review periods for registration and CBI application were changed.
10. Written appeal with stated reasons can be submitted to the authority if a registrant has any concerns regarding the results of registration review.
Taiwan is to strengthen the post-market inspection on registered chemicals. Taiwan has newly updated the offline new and existing chemical registration tool “CHEMIST” to version 4, which requires new chemical registrants to submit detailed information of use/storage site, including
registrant storage site,
logistics center distribution site,
downstream users storage site,
registrant use site, and
downstream users use site.
The updated CHEMIST system offers an improved graphical representation of the flow information of new chemical substances and provides support for the follow-up inspection. The above information should be supplemented after registration if it cannot be confirmed when applying for registration.
In addition, the pre-confirmation of chemical commodities on the IT platform of Chemical Commodity Importation Pre-Confirmation has been implemented since 2016, which is at present voluntary. Stakeholders are encouraged to declare and confirm on the CCIP platform before importation if their chemical substances contained in goods are subject to new and existing chemical registration. By cross-matching the data obtained from the CCIP IT platform and obtained from Customs, it will facilitate the post-market inspection (CL news).
