Taiwan Consults on Draft Guidance on Hazard Assessment and Exposure Assessment for New Chemical Substances

Taiwan Ministry of Labor (MoL) is consulting on the draft guidance on hazard and exposure assessment for new chemical substances. Exposure assessment is required if the new chemical substance is classified as hazardous after hazard assessment. New chemical assessment requirements under MoL and EPA are not identical. On 31 May 2016, Taiwan’s MoL released the draft Guidance on Hazard Assessment and Exposure Assessment for New Chemical Substances. The draft guidance is currently available in Chinese for public consultation. The guidance is drafted under Article 13 of the Occupational Safety and Health Act (OSHA) and Article 28 of the Regulations on New Chemical Substances Registration (MoL’s regulation). It provides an overview of what the hazard assessment and exposure assessment are and how they are performed and documented. Hazard assessment under MoL is applicable to new chemical substances which satisfy one of the following criteria: General new chemical substances manufactured or imported at or over 10t/y, and New chemical substances classified as CMRs, Category 1, manufactured or imported at or over 1 t/y. The objective of hazard assessment is to identify the hazards of new chemical substances and their potential negative effects on human health. If the substance meets the criteria for classification as hazardous, additional exposure assessment will be carried out. However according to the guidance the exposure scenario will only cover workplaces. Almost all aspects of new chemical registration under EPA and MoL are aligned except for hazard & exposure assessment requirements for general new chemical substances (non-CMR). MoL’s regulation 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. For CMRs, both MoL and EPA requires such information at or over 1 t/y. The new chemical registration system under MoL is designed to ensure occupational safety and health of workers in the workplace. It doesn’t require the submission of any eco-toxicological information. Thus the corresponding hazard and exposure assessment is only for human health rather than environment. The assessments under EPA will be focused on the environment. However, so far Taiwan EPA hasn’t issued its own guidance for hazard assessment and exposure assessment.

Chemlinked, 8 June 2016 ;http://chemlinked.com/en/news ;