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Taiwan New and Existing Chemical Substances Registration under TCSCA/OSHA

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Overview

The year 2015 will see new changes to the chemical substance management in Taiwan, resulted from the newly amended Toxic Chemical Substances Control Act (TCSCA). As the regulation that aims at source management of chemical substance, TCSCA will have all new and existing chemical substance under control once exceeds certain annual quantities (as specified in Article 7-1), by imposing registration obligation to relevant stakeholders before their market accession. Taiwan’s Environmental Protection Administration (Taiwan EPA) is now taking the role as competent authority to approve submitted registration application.

Authorized by Article 7-1 of the TCSCA, the EPA promulgated the “Regulation of New Chemical Substances and Existing Chemical Substances Registration” (TCSCA regulation of registration), which took effect on 11 December 2014.

Additionally, Taiwan’s Ministry of Labor (Taiwan MOL) officially announced the “Regulation of New Chemical Substances Registration and Management” (OSHA regulation of registration) based on Article 13 of the Occupational Safety and Health Act (OSHA) amended in July 2013. This regulation entered into force on 1 January 2015.

Affected Bodies

Both TCSCA and OSHA have mandated chemical registration shall be the responsibility upon manufacturers or importers. Leaving out Non-Taiwanese companies as certificate holder indicates central government’s regulatory emphasis swinging to manufacturers and importers.

*Non Taiwanese exporting company is not able to launch an application directly or appoint a representative to register the chemicals on their behalf. The application has to be launched by the domestic importers. But it does not mean the non-Taiwanese exporter has nothing to do with the registration, instead they play an important role in the regulatory compliance work.

*The domestic manufacturers or importers can launch an application by themselves or with the help of the representative.

Exemptions

The Regulations shall not apply to any of the following conditions under TCSA and OSHA:

TCSI: Taiwan Chemical Substances Inventory, contains around 100,000 substances

New Chemical Substance Registration under TCSCA and OSHA

Under both TCSCA and OSHA, a new chemical substance is defined as any chemical substance that is not included in Taiwan’s Chemical Substance Inventory (TCSI). The regulations require new chemical substances to be registered based on their tonnage bands, annual quantities of manufacture or import and their chemical usage.

The specific registration type is determined both by the properties of the substances as well as the corresponding usage, which is shown in the following chart:

Existing Chemical Substance Registration under TCSCA

Generally, it is a gradual process for the management of existing chemical substance which splits into Phase 1 and Phase 2 registration.

According to TCSCA, Phase 1 pre-registration will begin from 1 September 2015 to 31 March 2016 and late pre-registration from 31 March 2016 for an existing chemical substance manufactured or imported with an annual quantity of 100 kilograms or more. The main purpose of Phase 1 registration is to establish the source manufacturers or importers of existing chemical substances in Taiwan.

After that, Taiwan EPA will do the evaluation work to single out certain substances required for Phase 2 registration, based on their exposure amount and hazardous properties.

Penalties

Companies that fail to comply with the regulation prior to manufacturing or importing chemical substances will be severely penalized.

Our Services

Pre-Registration

Comprehensive Regulatory Information

Local Third Party Representative Service

New Chemical Substance search

Training and Consultancy Service

Overall Registration Proposal (including Exemption Analysis, Data Assessment, Data Gap Analysis, etc.)

Registration

Business Confidential Information Application

EPA Existing Chemical Substance Nomination (a.k.a Article 17 under TCSCA regulation of registration, till 31, March, 2015)

MOL Transitional Registration for New Chemical Substance (a.k.a Article 11 under OSHA regulation of registration,  till 31, March, 2015)

Polymer of Low Concern Identification and Registration

Existing Chemical Substance Registration

Application for Grace Period of New Chemical Substance

New Chemical Substance Registration (Low-volume, Simple, and Standard)

Test Monitoring Service

Data Sharing

Risk Assessment Report Preparation and Submission

Taiwan Safety Data Sheet (SDS) and Labeling Preparation

Post-Registration

Communication with Competent Authorities/Experts

Registration Certificate Renew/Change

Last Updated on Friday, 30 January 2015 03:04

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