Supporting your obligation for the Toxic Chemical Substance Control Act (TCSCA)

Toxic Chemical Substance Control Act (TCSCA)

Under the Toxic Chemical Substance Control Act (TCSCA), “new” and “existing” substances must be registered. New substances that are not listed on the Taiwan Chemical Substance Inventory (TCSI) must be registered before manufacture/import. Existing substances are those listed on the TCSI and are subject to a number of different registration deadlines.

The first deadline (Phase I registration) for existing substances manufactured or imported >0.1 tonne/year was 31st March 2016. Companies that manufacture or import for the first time after this date must submit a late Phase I registration to the Environmental Protection Administration (EPA).

Following Phase I registration, four batches of “designated” existing substances will be announced by the EPA. These designated substances will be subject to standard registration if manufactured/imported ≥ 1 tonne/year.

Companies that import existing substances without the approval of the EPA will be liable to fines in the range of NT$30,000-300,000.

OSHA

OSHA came into force on 3 July 2014. It requires the registration of new substances and reporting of Priority Management Substances 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 from the Department of Labor.

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

Taiwan’s Globally Harmonised System

TCSCA and OSHA require toxic and hazardous chemicals to be labelled or supplied alongside SDS according to GHS regulations in Taiwan. Mandatory SDS and labelling is also required for chemicals denoted as being “toxic” under TCSCA.

Although foreign companies cannot act as the registrant, Yordas Group can help your Taiwanese importers to complete new or existing registrations through our established Third Party Representative (TPR).

How can we help?

Regulatory Impact Assessment

We can help to assess your company’s chemical substances and products, identify which duties apply and advise on the best strategy towards compliance. Our Regulatory Impact Assessments summarise the process, costs and timelines for registration, allowing you to make effective business decisions about your product.

Registration

The Yordas Group has significant experience in submitting Registrations for a wide range of substances. Our regulatory consultants work very closely with our scientific experts throughout the Registration process on:

  • Substance Identity and “Sameness” checks
  • Data Gap Analysis, Testing Strategies, Read-across Justifications, Expert Assessments, QSAR Modelling and Waivers
  • Commissioning testing and study monitoring Human and Environmental Health Hazard, Exposure and Risk Modelling
  • Chemical Safety Assessment/Report and Exposure Scenarios

In-country Representation

We can support your importers/manufacturers in Taiwan to submit existing or new substance registrations under the TCSCA and OSHA regulations by providing services through our established Taiwanese Third Party Representative.

Preparation of Taiwanese Safety Data Sheets and labels

Yordas can support you at every stage, from classification of substances and mixtures, advising on labelling requirements (including font or hazard pictogram size, hazard and precautionary statement selection) and authoring Safety Data Sheets in the format and language required. We also can research and fill any gaps in your data.

Other services

  • Polymer of Low Concern confirmation
  • Guidance on exemptions and small volume notifications
  • Support to carry out post-registration obligations

Downloads & Resources

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