Taiwan to Relieve Industry Compliance Burden during New Chemical and Phase 2 Registration

Phase 2 Registration, i.e. standard registration for Taiwan’s existing chemical substance has been in the spotlight since Taiwan EPA issued the draft revisions to the Regulation of New and Existing Chemical Substances Registration on Mar 29th, 2018. Ms. Cherish Ni, the vice president of ERI Company offered an insightful presentation on the latest revision on Measurements of New Chemical Substances Registration in Taiwan and Updates on Standard Registration of Existing Chemicals during REACH24h’s 10th Chemical Regulatory Annual Conference on Sep 10, 2018.

Several notable amendments in the draft include:

1. Tonnage level that requires hazard & exposure assessment in new chemical registration has been adjusted from 1000+t/a to 10+t/a. (This does not affect practical compliance. The tonnage requirements under MOL is 10+t/a, EPA has adjusted the regulation only to harmonize the regulations.)

2. Refer to MOL ”Regulation of New Chemical Substances Registration” and combine registration level and registration type, indicated in appendix

3. Delete current Article 16, Article 17, Appendix 4 and Appendix 7 (validity period expired).

4. Official document and registration number for approved chemical substances will be issued instead of registration certificates.

5. In cases where supplementation or correction can’t be completed within the deadline due to force majeure, this should be reported to the central competent authority and after approval, supplementation or correction shall be finished within a reasonable time. The time for central competent authority to review is recalculated: after supplementation or correction, the review time will be recalculated, reducing pressures associated with time limits under the joint review mechanism of EPA and MOL. Taiwan’s current review period requirements puts quite pressure on both enterprises and authorities and is considered “the most stringent requirement in the world”- according to Ms. Cherish Ni.

   SQR & PLC advanced confirmation & Phase 1 registration	Simplified Registration	Standard Registration
   7 working days	14 working days	45 working days

   Under current regulations, the registration will be rejected if supplementation or correction is not completed before the deadline.
   

6. Adjust the qualification and requirements of phase 1 registration- for chemicals manufactured/imported over 100kg. After April 1, 2016 phase 1 registration must be applied for within 6 months of import/manufacture.

7. Approved new chemical substances and existing chemical substances must report their previous year's manufactured or imported quantity between Mar and Jun of each year.

The amendments in the draft harmonize regulations in Taiwan and also simplify registration procedures. The draft will relieve the pressures associated with both compliance and supervision for both authorities and industry. However the registration charge standard is considered low compared with other that adopted by Taiwan’s global counterparts and for this reason we can expect an increase in charges in future.