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Changing regulatory requirements for managing chemical substances in Taiwan

Changing regulatory requirements for managing chemical substances in Taiwan

Over the years, while striving to ensure transparency, traceability and better control of chemical substances manufactured and imported into Taiwan, local authorities have continuously discussed and amended chemical regulations to have the best solutions for the market as well as public welfare. At present, the management of chemical substances and the implementation of chemical regulations are taken care of by the Taiwan Toxic and Chemical Substances Bureau, Environmental Protection Administration.

To enforce traceability and safety monitor of chemical substances, Taiwan authority proposes several regulatory requirements including chemical registration as well as an annual management report. Here are some basic elements of chemical management for entry into the Taiwan market.

All chemical substances are regulated by Taiwan regulations. The following items follow all applicable regulations and are exempted from chemical regulations:

 

  • Chemical substances that occur in nature
  • Chemical substances accompanied in machines or equipment for test-run purposes
  • Intermediates that are inseparable from a chemical reaction in reaction vessels or production processes
  • Chemical substances for national defense purposes
  • By-products or impurities that have no commercial application
  • Chemical substances under customs supervision
  • Waste materials
  • Polymers where the two percent rule is applicable and listed on the announced inventory
  • Mixtures (exemption does not apply to individual constituents of mixtures)
  • Articles (finished products)
  • Others that have been designated and officially announced by the central competent authority
  • Substances with permit and control regulations promulgated by other authorities in charge of subject industry (for example food additives, active pharmaceutical ingredients, environment agents)

A new chemical substance must be registered with its characteristics and estimated annual management volume identified. The submission requirements differ for each type of registration: standard registration, simplified registration and small quantity registration.

 

The requirements are according to chemical characteristics (for example, general new chemical, a chemical with the purpose of scientific research, polymers, etc.) and annual management volume (for example, over one ton a year, 100 kilograms a year to one ton a year and less than 100 kilograms a year).

 

The new chemical substance can be registered through online tools developed by Taiwan authority: click here for more information.

It is very important to clarify the composition of products that are imported or manufactured to ensure all component chemicals are listed in the existing chemical substance database.

 

When the chemical substance cannot be found in the existing chemical database, it will be treated as a new substance, which must be registered before being imported or manufactured. For those chemical substances belonging to existing chemical substances, they must be registered when the import or manufacture volume exceeds 100 kilograms.

 

On the other hand, if any component chemical fulfills the category and limit of toxic chemical substance and concerned chemical substances, the management of the chemical substance shall follow corresponding regulations and apply approval to the authority concerned.

  • Annual management volume: the annual management volume of all registered chemical substances must be monitored by the importer or manufacturer. Since April 2020, an importer or manufacturer must report the annual management volume of each registered chemical substance to the local authority.

  • Toxic and concerned chemical substances: if the chemical substances fulfill the category and limit of toxic chemical substance and concerned chemical substances, the importer and manufacturer must apply to the authority for approval for its import, export, sale, shipment, usage and storage. The labeling, transportation and storage must also follow the Toxic Chemical Substances Labeling and Materials Safety Data Sheets Regulations.

  • Safety data sheet (SDS): the management of the product should always comply with local regulations and indications on SDS to ensure the safety of daily operations.

As Taiwan’s chemical substance market continues to evolve, its regulations will also be updated regularly to ensure safety for consumers and the environment. At DKSH, we understand that being compliant can be a time-consuming process. As a global distributor of specialty chemicals, we will strive to help you understand the processes better, ensure that your products are successfully registered and that they are compliant with all regulatory requirements.

Reach out to me if you want to find out more about managing chemical substances in Taiwan.

Sophia Wu

About the author

Sophia Wu is based in Taipei, Taiwan. She is currently Manager, Regulatory Affairs at DKSH Taiwan Ltd.