Taiwan EPA issues regulations on new substance and existing substance registrations.

On 5 Dec 2014, EPA issues Regulations on New and Existing Substance Registrations under TCSCA. In this pose, we will take a look at the new regulation and help you understand the types of registration and data required for different types of registrations.

Under TCSCA, enterprises manufacturing or importing new substances or a given quantity of existing chemical substances shall register those substances with the Environmental Protection Administration (EPA). Enterprises that manufacture or import new substances or existing toxic chemical substances without the approval of the EPA will be liable to fines in the range of NT$200,000-2 million for manufacturers or NT$30,000-300,000 for importers.

Registration of New Substances - Exemptions

The following new substances are exempt from registrations under TCSCA.

• Naturally occurring substances;
• Chemical substances accompanied in machines and equipment for test-run purposes;
• Non-isolated intermediates;
• Chemical substances for national defense purposes or under customs supervision;
• Waste;
• Mixture(only applicable to a substance in a mixture);
• Article(only applicable to a substance intended to be released from an article);
• Polymer meeting 2% rule with all monomers listed;
• Chemicals subject to other laws such as pesticides, environmental agents, pharmaceuticals, cosmetics, food additives, etc.

Registration of New Substances - Types of Registration and Requirements

There are three types of registrations for new substances under TCSCA depending on the uses and volume of the new substances: small quantity registration, simplified registration and standard registration.

The picture below shows how to determine which type of registration is required for a new substance.

  

For standard registration, toxicology and eco-toxicology data requirements increase with the volume of the new substances to be registered.There are 4 levels(1-10t, 10-100t/y, 100-1000t/y, 1000t/y+). Detailed data requirements for standard registration under TCSCA can be found here.

 - See more at: 
http://www.chemsafetypro.com/Topics/Taiwan/Taiwan_TCSCA_Registration.html