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Taiwan New and Existing Chemical Substances Registration under TCSCA/OSHA

Overview

The year 2015 will witness new changes to the chemical substance management in Taiwan, resulted from the newly amended Toxic Chemical Substances Control Act (TCSCA) and Occupational Safety and Health Act (OSHA).

Authorized by Article 7-1 of the TCSCA, Taiwan’s Environmental Protection Administration (EPA) promulgated the “Regulation on New Chemical Substance and Existing Chemical Substance Registration”, which came into force on 11 Dec 2014. As the regulation aims at source management of chemical substances, TCSCA will have new and existing chemical substances under control, by imposing registration obligations to relevant stakeholders before their market accession.

Additionally, Taiwan’s Ministry of Labor (Taiwan MOL) offcially announced the “Regulation on New Chemical Substance Registration and Management” based on Article 13 of the OSHA amended in Jul 2013. This regulation entered into force on 1 Jan 2015.

Affected Boidies

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

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*Non-Taiwanese company is not able to submit an application directly or appoint a representative to register the chemicals on their behalf.The application has to be submitted by the domestic importers.

*Non-Taiwanese exporters shall involve in the registration by providing relative information to local importer or TPR.

*The domestic manufacturers or importers can submit an application by themselves or with the help of the third-party representative.

Exemptions

The regulations shall not apply to any of the following conditions under TCSCA and OSHA:

? Naturally occurring substances;

? Chemical substances accompanied in the machines and equipments for test-run purpose;

? Inseparable intermediates from the chemical reaction in the reaction vessel or in the production process;

? Chemical substances for national defense purpose;

? Chemical substances under customs supervision;

? Wastes (Incidental reaction products or impurities without intended commercial purpose);

? Mixture (not applicable to individual component contained in the mixture);

? Articles (no matter whether the substances contained in the article will be intentionally released during normal use);

? Polymer applicable to the 2 % Rule & listed in Taiwan ECSI;

? Others designated by the central competent authority;

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:

* This chart integrates the requirements under both TCSCA and OSHA.

* Substance of Carcinogenic, Mutagenic or Toxic for Reproduction (CMR) refers to a substance that meets any criteria of carcinogenicity category 1;mutagenicity category 1; reproductive toxicity category 1, based on R.O.C. National Standards (CNS) 15030.

* Generally, a registrant should submit hazard & exposure assessment if the annual quantity of new substance is over 10 tons. However, when the substance?turns out to have no designated PC/TOX/ECO-TOX hazard classification, exposure assessment is then exempted. If annual quantity of new substance is over 1000 tons, a registrant should submit both hazard assessment and exposure assessment.

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.

Compliance Strategies

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 (till 31 Mar 2015)

>> MOL Transitional Registration for New Chemical Substance (till 31 Mar 2015)

>> Identification and Registration for Polymer of Low Concern

>> Existing Chemical Substance Registration

>> Application for Grace Period of New Chemical Substance

>> New Chemical Substance Registration (Small Quantity, Simple, and Standard)

>> Test Monitoring Service

>> Data Sharing Service

>> Risk Assessment Report Preparation and Submission

>> Taiwan Safety Data Sheet (SDS) and Label Preparation

? Post-Registration

>> Communication with Competent Authorities/Experts

>> Registration Certificate Renew/Change

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