According to the interpretation of the original Chinese regulation, a phase 1 registration No. should be obtained prior to the manufacture and import activities as of the 1st of Sep 2015. In addition, the authority has insisted that it is illegal to manufacture and import exiting chemical substances without a phase 1 registration number. This requirement has come under severe criticism by industry particularly in light of the fact that the update of “Taiwan Existing Chemical Substance Inventory” (TCSI) has been delayed and the online submission system for phase 1 registration only became accessible at the end of August. Although the submission can be made directly if all the dossiers are well prepared, the authority still requires 7 working days for review and approval. Potential registrants have complained that given the current situation and procedural requirements it is practically impossible to complete Phase 1 registration for the hundreds of thousands of existing chemical substances without severely impacting normal manufacture and import activities.
In response, the authority has granted potential registrants a half-year grace period for phase 1 registration ( 1 Sep 2015 to 31 Mar 2016). The final issuance of the TCSI is expected before the 11th of Sep 2015 and is expected to include nearly 100,000 substances. The TCSI will serve as the only reference to determine whether a substance is categorized as existing or new in addition to its corresponding compliance requirements.
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