On 22 Apr, Taiwan issued the proposal to regulate the approval of Class 4 toxic chemical substances. The draft will be subject to a period of public consultation lasting 14 days. This regulation was drafted pursuant to the Paragraph 5 of Article 7 of the revised TCSCA. This regulation, when finally published, will take effect from the date of issuance.
The draft regulation fleshes out details of the application, review, issuance, modification, extension, cancellation and abolishment of approval documents.
In the previous Taiwan TCSCA, Class 4 toxic chemical substances are only required to report relevant toxicological information. However, under the revised TCSCA, more stringent requirements are imposed on the handling of Class 4 toxic chemical substances. The requirements drafted in this regulation are expanded and are identical to those previously required for Class 1 to 3 toxic chemical substances < large-scale handling standards.
According to Taiwan TCSCA, Class 4 toxic chemical substances are defined as “those chemical substances for which there is concern of pollution to the environment or the endangerment of human health”. Currently 92 substances are classified as Class 4 and subject to the new requirements. Handlers should apply for approval with corresponding local environmental protection administration prior to commencing operations.
In Mar 2013, long before the passage of revision of the TCSCA, consensus had already been reached on the initial approval requirements of Class 4 toxic chemical substances (ChemLinked news release on 21 Mar 2013). Compared with the registration requirements of new and existing chemical substances, the new management requirements of Class 4 toxic substances have been widely accepted.
Companies in possession of regular reporting records which are filed with the authority for further reference prior to the implementation of this regulation will be regarded as having obtained temporary approval and will be granted a three-year grace period for accomplishment of the approval requirements. The grace period will end on 30 June 2017.
The approval will be valid for five years, in this time handler are allowed to apply for an extension of 5 years. The application for extension should be submitted a minimum of 3 months before the approval expires, but no earlier than 6 months before the expiry date.


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