New Tonnage Bands Drafted for Taiwan New and Existing Chemical Registration

1. Taiwan’s Regulation on Registration of New and Existing Chemical Substances was drafted. 2. Three registration types will be adopted for Taiwan new chemical registration. 3. Four tonnage bands will be set for standard registration, including 1-100t/y, 100-1000t/y, 1000-10000t/y, and above 10000t/y.

The draft Regulation on Registration of New and Existing Chemical Substances was promulgated pursuant to the Article 7-1, Paragraph 6 of the revised Toxic Chemical Substances Control Act (Taiwan TCSCA, to be effective on the 11 Dec 2014). This draft regulation, issued by Taiwan’s EPA on 25 Aug, addressing the details of registration issues under the revised Taiwan TCSCA, will be subject to a period of public consultation lasting 14 days.

Based on the tonnage band and usage information, three registration types will be adopted for Taiwan new chemical registration, including standard registration, simplified registration, and low-volume registration. However, the applicable scope is dramatically different from the original proposal. The details are specified in the Chart 1 as below.

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Chart. 1 - New Chemical Substance Registration Type under Revised Taiwan TCSCA

Taiwan drafted four tonnage bands (Band 1:1-100t/y, Band 2:100-1000t/y, Band 3: 1000-10000t/y, and Band 4: above 10000t/y) for standard registration which is significantly different compared to EU REACH, K-REACH, China NCSN, etc. It has been designed this way for the benefit of SMEs in Taiwan, according to Mr. Hsu from the Department of Environmental Sanitation and Toxic Substances Control, Taiwan EPA.

Substances classified as carcinogenic, mutagenic or toxic for reproduction (CMRs), regardless of tonnage, will be subject to standard registration. Only general chemical substances and CMRs manufactured or imported in quantities of over 10,000 tonnes a year will be required to submit the hazard and exposure assessment information. In addition, on-site isolated intermediates and polymers are newly drafted to apply the same registration rules of PPORD.

All existing chemicals manufactured or imported over 0.1 ton per year will be subject to the Phase 1 of Taiwan’s existing chemical registration, which will initialize from 1 Sep 2015 to 31 Mar 2016. Phase 2 of existing chemical registration (>1t/y) will launch based on the implementation of Phase 1. At present it is uncertain how many existing substances will be designated and when to start step-wise Phase 2 registration.

All the priority chemical substances designated for Phase 2 registration should comply with standard registration under corresponding tonnage bands based on the annual amount of manufacture or import. However, if the priority chemical substances are defined as CMRs, the corresponding requirements will increase to meet the higher tonnage band requirements. For example, the CRMs (1-100t/y) should submit dossiers required under Band 2 (100-1000t/y).