Taiwan Guideline for Hazard Assessment and Exposure Assessment of New Chemical Substances (Draft) is Published for Public Comment

Taiwan Occupational Safety and Health Administration, Ministry of Labor released the Guideline for Hazard Assessment and Exposure Assessment of New Chemical Substance (Draft) on 31 May 2016 for public comments.

This Guideline is formulated in accordance with Item 1 of Article 6 of Regulation on New Chemical Substance Registration, for the purpose of assisting registrants in completing hazard assessment and exposure assessment as well as recording relevant information based on Article 13 of Occupational Safety and Health Act (OSHA) and Article 28 of Regulation on New Chemical Substance Registration  

In accordance with the Regulation on New Chemical Substance Registration released by Ministry of Labor (MOL), the new chemical substance satisfying the following conditions should execute hazard assessment:

  1. New chemical substances imported or manufactured over 10 tons per year; or
  2. New chemical substances that are classified as CMR category 1 based on CNS 15030 and are imported or manufactured over 1 tons per year.

After hazard assessment, if the assessed new chemical substance is considered as hazardous substances in accordance with Guideline for Hazard Assessment and Exposure Assessment of New Chemical Substance (Draft), exposure assessment is also necessary.

Because OSHA mainly focuses on labor safety, in accordance with Regulation on New Chemical Substance Registration released by MOL, only physico-chemical and healthy toxicological data are required. Hazard or exposure assessment on physico-chemical and healthy toxicological properties will be executed. Environmental hazards assessment, environmental exposure and description of environmental risk characteristics, etc. are not necessary in accordance with the Guideline and Regulation on New Chemical Substance Registration.

On the other hand, in accordance with Toxic Chemical Substance Control Act (TCSCA) released by Environmental Protection Administration (EPA), for general new chemical substances imported or manufactured over 10 tons per year, except the specific substances such as on-site isolated intermediates, R&D, PPORD, polymers, or polymers of low concerns, the hazard or exposure assessment not only for physico-chemical and healthy toxicological properties but also for environmental properties should be conducted. And after the hazard assessment, if the new substance is identified as a hazardous substance, which has the specific physico-chemical, human health, or environmental GHS categories, or is identified as PBT or vPvB substance, then exposure assessment need to be conducted. However, up to now, EPA has not released any detail guideline related to hazard or exposure assessment. 


CIRS warmly reminds that, for the registration of new chemical substance under MOL and EPA, the windows for submitting dossiers have been united to reduce the burden of regulation compliance. As a result, one copy of dossier for standard registration will be reviewed by EPA and MOL respectively at the same time. The submitted dossier should satisfy the requirements of both TCSCA and OSHA simultaneously. So, for the general new chemical substances imported or manufactured over 10 tons per year, the hazard or exposure assessment of the registration according to Guideline for Hazard Evaluation and Exposure Assessment of New Chemical Substance released by MOL cannot be enough to meet the registration requirements. In the light of EPA having not released the detail guideline on hazard or exposure assessment, CIRS suggests that it can be conducted according to some internationally accepted assessment methods.

If you have any questions or suggestions to the draft Guideline, please feel free to contract CIRS at service@cirs-reach.com. CIRS will send your suggestions to Taiwan Authority in time.