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Whether a substance is new or existing is critical in undertaking chemical registration in Taiwan. All new chemical substances should be registered immediately. For most existing chemical, Phase I registration (only basic information required) is enough. Only chemicals designated as priority should comply with the Phase 2 standard registration. However, at present self-assessment referencing the online chemicals inventory is the only method available to determine chemical status and according to Taiwan EPA there will be no provision of a more comprehensive inquiry system in future, a subject of considerable concern for industry.
Under the regulatory frameworks of most international chemical management systems, after consulting the online inventories, if the status of a chemical is still unclear, it is strongly recommended to submit a formal inquiry to the competent authority for comprehensive search, particularly given the fact that confidential substances are not known to the public. This concept is widely accepted in EU, China, Korea, etc. However, it seems that a similar system will not be applied in Taiwan. Although ChemLinked have made numerous inquiries to the EPA helpdesk for advice on this kind of issue, the answer we get back is that the Taiwan authority will not provide such service.
According to Taiwan EPA, the online search results of Taiwan’s existing chemical substance inventory (TCSI) is the only yard stick to define whether the substance is new or existing. Some information, e.g. chemical name, CAS No. applied to data protection during the previous ECN, SECN, SSECN and the EPA supplementation program ended on 31 Mar 2015 are unsearchable online. For such cases, although the substance is listed in the TCSI, the search result would be N/A and accordingly it should be regarded as a new chemical substance.
Europe:
Under EU REACH, an inquiry dossier would be required to submit to ECHA prior to the registration for non-phase in substances (new substances). It is free of charge. ECHA confirms if the substance is new and if it has already been registered by another registrant or not. The previous registrant will be introduced to the inquirer if it has been registered before with information on data endpoints.
China:
For China new chemical notification (China NCSN, a.k.a China REACH), China authorities offers an inquiry service of new chemical substances for clients since 15 Oct 2003 when the China new chemical substance notification system was first implemented. The fee was adjusted to 600 per substance since 2013 (CL news). The inquiry result is a definite conclusion, either “the substance is a new chemical substance” or “the substance is not a new chemical substance”. Compared to EU REACH, it can only provide you a simple yes or no result.
Korea:
As for K-REACH, if the substance of your concern cannot be searched through the online Korea Existing Chemicals Inventory (KECI), an inquiry dossier for confidential check can also be submitted to confirm whether the substance is new.
Taiwan EPA has described their current practices as a way to prevent commercial espionage. The TCSI will be finalized before Sep of this year when the Phase I existing chemical registration will begin. The authority is under pressure to reconsider their decision and as such there is a high potential for amendments to be made in the interim.
