Taiwan's EPA published 'Guidance on Existing Chemical Substances Standard Registration'

According to Taiwan’s Toxic and Concerned Chemical Substance Control Act (TCCSCA), new and existing substances must be registered in Taiwan. The first batch of 106 PECs was published on 11 March 2019. Taiwan’s EPA published the draft of Guidance for Standard Registration of Designated Chemical Substances by stages in September 2019. After a long waiting, the official guidance for standard registration, Guidance on Existing Chemical Substances Standard Registration (1st version), was released on 9 June 2020. In comparison with the Guidance published in September 2019, the new guidance accepts data from more choices. According to recently published guidance, reports from laboratories of universities in Taiwan are acceptable for data on chemical and physical properties. For toxicological and ecotoxicological information, Taiwan’s EPA accepts reports from laboratories of universities in Taiwan and laboratories with certification of ISO 17025. If animal testing is required for obtaining toxicological and ecotoxicological information, the experiment must form an Institutional Animal Care and Use Committee (IACUC) and follow Animal Protection Law (enforced on 16 December 2018).

According to recently released guidance, a registration number will be issued after registrants submit information (1) to (6) in Appendix 7 (see table below). Taiwan’s EPA reserves the right to ask registrants to provide information on hazard assessment (7) and exposure assessment (8) later.

The recently published Guidance can be seen as an effort from Taiwan’s EPA to facilitate companies to comply with standard registration of 106 PECs. Companies are recommended to set up their regulatory team to fulfil their obligations or contact compliance service providers to learn about their options (e.g. joint registration and benefits of registration via Third Party Representative).

No.	Section
1	Information of the registrant and basic identification of the substance
2	Information on manufacture, use and exposure of the substance
3	Hazards classification and labelling
4	Safe use information
5	Physical and chemical properties
6	Toxicological information
7	Ecotoxicological information
8	Hazard assessment
9	Exposure assessment

For more information or queries, please write to us at: compliance@gpcregulatory.com

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Taiwan's EPA published 'Guidance on Existing Chemical Substances Standard Registration'

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