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Taiwan EPA is to revise the Regulation of New and Existing Chemical Substances Registration (EPA’s regulation). The draft amendments were introduced by Taiwan EPA at a seminar held in Taipei on 18 Jul 2017, including some significant changes to hazard & exposure assessment, review period, confidentiality validity, late pre-registration, annual reporting, etc.
Compared to the current version, major changes are proposed as below:
1. Hazard & exposure assessment
MoL’s regulation (regulation of new chemical substance registration under OHSA) requires hazard & exposure assessment for new chemical substances manufactured or imported at or over 10t/y, while EPA’s regulation only requires for those at or over 1000t/y. This part will be aligned to set a quantity threshold of 10t/y.
2. Deletion of expired articles 16 and 17
The supplementation program as articulated in Article 16 of the EPA’s regulation legalizes all chemicals manufactured or imported to the Taiwanese market before 11 Dec 2014 into the inventory of existing chemical substances if the applicants notified the authority of such chemicals before the 31st of Mar 2015.
Article 17 grants a one-year grace period for new chemical substance manufactured/ imported from the 11th of Dec 2014 until the 31st of Dec 2015 after the completion of small quantity registration. The grace period has passed and new chemical substance should re-apply for different registration types accordingly.
The provisions specified in Article 16 and 17 have expired, thus these two articles are proposed to be deleted.
3. Registration certificate
Registration certificate for new and existing chemical substances will be no longer issued. Only an official document with Registration No. will be provided. Currently the registration certificate costs NT$200, and any modification or validity extension will be incur additional charges. It will help to alleviate enterprises' burdens.
4. Dossier supplementation or correction
Currently the application shall be rejected if the registrant fails to make supplementation or correction within the allotted time even if it is due to force majeure. After revision, the registrant shall be given another period after obtaining consent from the authority.
5. Review period
For review period of registration dossier, taking standard registration for example, 45 working days from the date of receipt of the application are required. Where appropriate, the review period can be extended for one time only, meaning a maximum of 90 working days is allotted for the whole review work. The dossier is reviewed by both EPA and MoL and communication is time consuming, although the duration for supplementation or correction is excluded from calculation of the review period. Due to the onerous burden this places on authorities, it is proposed to count the review days by starting all over again after supplementation or correction, which means the authority will have a new 90 working day period to complete review work. Although this is great news for regulatory authorities, for industry it will mean further delays in registration timeline. Potential registrants are recommended to prepare dossier carefully and try to avoid supplementation or correction.
6. Confidentiality validity extended to 5 Years
PLC small quantity registration is valid for five years, while confidentiality is valid for two years, which are not consistent. After revision, the confidentiality validity for PLC will be changed to 5 years.
7. Late pre-registration
Currently for completion of late pre-registration there is no time period prescribed in the regulation. After revision, the period for late pre-registration will be within 6 months if the situation applies. In addition, late pre-registration only applies to existing chemical substances manufactured or imported over 100kg/year for the first time after March 31, 2017. However, after revision, for those below 100kg/year, late pre-registration can be voluntarily applied for if the registrants forecast that in the future the volume will increase to 100kg/year.
8. Annual reporting
It is necessary to review and grasp the circulation of substances in Taiwan. Thus an annual reporting system will be implemented. It is proposed that registrants of both new and existing chemical substances need to report volumes before 31st of Jan each year. The deadline for reporting hasn’t been finalized and will be further discussed.
So far, there is no information on when the draft will actually be released for public comments. ChemLinked will continue to report the issues concerning Taiwan new and existing chemical registration and will do our best to provide you with timely updates.
