Taiwan TCCSCA & OSHA

Toxic and Concerned Chemical Substance Control Act (TCCSCA)

Under the Toxic and Concerned Chemical Substance Control Act (TCCSCA), “new” and “existing” substances must be registered. New substances are substances that are not listed on the Taiwan Chemical Substance Inventory (TCSI). New substances must be registered before manufacture/import. 

Existing substances are those listed on the TCSI. All existing substances manufactured or imported > 100 kg/year need to undergo Phase 1 registration within 6 months. If the substance is designated by the EPA as a Priority Existing Chemical (PEC) and manufactured/imported ≥ 1 tonne/year, it will be subjected to standard PEC registration after Phase 1 registration. The first batch of 106 PECs was published on 11 March 2019. 

All TCCSCA-registered substances are subject to annual reporting. Registration holders need to submit an annual report to the EPA between 1 April and 30 September every year. Annual reports need to include the import / manufactured tonnage for the previous year, substance identity, registration code and contact details of the registrant.

The main deadlines related to new and existing substances:

OSHA

OSHA came into force on 3 July 2014. It requires the registration of new substances and reporting of Priority Management Chemicals by a domestic manufacturer or importer. In addition, OSHA prohibits the handling or use of certain Controlled Chemicals, unless a permit has already been obtained.

OSHA also specifies that manufacturers, importers and distributors of hazardous chemicals must provide labels and SDS in accordance with Taiwanese GHS.

Although non-Taiwanese companies cannot act as the registrant, Yordas Group can help to complete new or existing registrations through our long-standing Third Party Representative (TPR).

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Frequently Asked Questions

• 1. We manufacture chemical substances and export them to Taiwan. Can we complete the registration so that the Taiwan-based importer is exempted from TCCSCA registration?

  Foreign-based companies without a Taiwan local office cannot directly apply for TCCSCA registration. Additionally, there is no Only Representative (OR) concept under Taiwan TCCSCA.

  In real practice, foreign-based companies can support the registration by following the steps below:

  • Foreign companies can find a TPR and ask their importer to appoint a TPR via a notarization process.

  • Once the notarization is approved, the TPR can complete the registration.

  • Please note one successful registration can only cover one importer. If a substance has multiple importers, registration is required for each importer.

  The importer may appoint a Third Party Representative (TPR) to complete registration, and representatives must be legal entities or natural persons in Taiwan.

• 2. To maintain our registrations, do we need to update them?

  All types of registrations must be updated since the validity for all registration types will be 5 years after the approval. The approvals can be extended 6 months before the expiry date.

• 3. How soon will our application be approved?

  It depends on the registration type of the substances. The administrative time is:

  7 days for:

  • New substances small quantity registration

  • PLC prior verification

  • PLC small quantity registration

  • Phase 1 registration

  • CBI protection and extension

  14 days for:

  • New substance simplified registration

  • Application for inclusion in the existing substance inventory.

  45 days for:

  • New substance standard registration

  90 days for:

  • PEC registrations

• 4. If an anhydrous form substance is registered, can the hydrous form be exempted?

  Hydrous and anhydrous forms are not regarded as the same substance. As a result, the hydrous and anhydrous forms of the substance should be registered separately.

• 5. Is it mandatory to submit a joint submission?

  Joint submission is voluntary in the regulation. However, the EPA will consider this mandatory joint submission in the future.

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