Request a Demo
Taiwan EPA issued on 29 Mar 2018 the draft revisions to the Regulation of New and Existing Chemical Substances Registration. The draft proposal is currently undergoing a 60-day public consultation.
The Regulation of New and Existing Chemical Substances Registration has been implemented since 11th of Dec 2014. The regulation details the registration requirements of new and existing chemical substances in Taiwan, as well as information dissemination and confidential business information protection, etc. Taiwan EPA has drafted revisions to the regulation in Sep 2017 and this is an updated revision proposed based on the feedbacks collected from the industry.
Major revisions compared to the current practice are summarized as below:
1. Inapplicable conditions
In this proposal, it is clarified that toxic chemical substances regulated under TCSCA are beyond the scope of the regulation.
In addition, the regulation also lists other chemicals beyond the scope of the regulation which are already regulated by existing laws and regulations, e.g. agro-pesticides, fertilizers, cosmetics, foods, etc. However, substances manufactured or imported as raw materials for the above mentioned substances or articles are still within the scope of the regulation.
2. Hazard & exposure assessment
Currently EPA’s regulation only requires hazard & exposure assessment for new chemical substances manufactured or imported at or over 1000t/y. The quantity threshold will be changed to 10t/y in line with MoL’s regulation of new chemical substance registration under OHSA. In addition, the current complex description of registration types will be attached with an intuitive table for better understanding.
3. Registration certificate
To reduce administrative cost and alleviate registrants' burdens, the registration certificate for chemical registration will be no longer issued and only a registration number will be provided. Thus the costs relating to issuance, modification or extension of registration certificate will be eliminated.
4. Joint registration of new chemical
The validity of joint registration is clarified in the proposal. If a later registrant of the same new substance apply for joint registration with consent of the original registrant, the validity period of his registration granted under joint registration shall remain the same as the original registration.
5. Extension of registration
Currently the registration extension shall be made by registrants three months before the expiration. After revision, the application period will be set as “three to six months before the expiration”.
6. Expired article 16 and article 17
The supplementation program (article 16) for listing chemicals manufactured/imported to the Taiwanese market before 11 Dec 2014 into the inventory of existing chemical substances closed after 31st of Mar 2015. Article 17 for granting a one-year grace period for new chemical substances manufactured/ imported from the 11th of Dec 2014 until the 31st of Dec 2015 also expired. Thus these two articles are proposed to be deleted.
7. Late pre-registration
Currently late pre-registration only applies to existing chemical substances manufactured or imported over 100kg/year for the first time after 1 Apr, 2017 and there is no time requirement specified for completion of late pre-registration. After revision, the period for completing late pre-registration will be within 6 months if the situation applies. In addition, for existing chemical substances manufactured or imported below 100kg/year, registrants can voluntarily apply for late pre-registration if the future volume may exceed 100kg/year.
8. Priority existing chemicals for standard registration
The long-awaited list of priority existing chemical substances (PECs) subject to Taiwan’s standard registration of existing chemical substances (Phase 2 existing chemical registration) is drafted to contain 106 substances as Attachment 6 of the regulation. Corresponding registration deadlines and data requirements are proposed as well (ChemLinked news).
9. Confidentiality validity period
After revision, the confidentiality validity for PLC will be changed from 2 years to 5 years aligning with the registration validity of PLC (5 years). In addition, as newly proposed the confidentiality of existing chemical substance will be valid for five years. A maximum duration of confidentiality protection for existing chemical registration information will be 10 years.
10. Annual reporting
An annual reporting mechanism will be introduced. The submission of annual report including registrant information, registration No., and the volume of manufacture or importation, will start on 1 Apr and will end on 30 Sep each year.
11. Review period
Review period for the standard registration of existing chemical substances is proposed as 90 working days. Review period for confidentiality protection application or extension is proposed as 7 working days (currently 45 working days). In addition, it is proposed to count the review days by starting all over again if supplementation or correction of information occurs, which may see a further delay in registration.
12. Appeal
As newly proposed, if a registrant has any concerns regarding the results of registration review, written appeal with stated reasons can be submitted within 30 working days after receiving the notification of review results. The appeal shall be made once only. This provision is added to align with the MoL’s regulation of new chemical substance registration.
