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Taiwan TCSCA Registration

By Little Pro on 2015-12-31 Views:  Update:2017-01-18

Under TCSCA, enterprises manufacturing or importing new substances or a given quantity of existing chemical substances shall register those substances with the Environmental Protection Administration (EPA). Enterprises that manufacture or import new substances or existing toxic chemical substances without the approval of the EPA will be liable to fines in the range of NT$200,000-2 million for manufacturers or NT$30,000-300,000 for importers.

On 5 Dec 2014, EPA issues Regulations on New and Existing Substance Registrations under TCSCA. This regulation has set out detailed information requirements for chemical registrations under TCSCA. In this post, we will take a look at the new regulation and help you understand the types of registration and data required for different types of registrations. Since a new substance also requires notification under the Occupational Safety and Health Act(OSHA), we have compared new substance notification under TCSCA with new substance notification under OSHA.

Overview of Substance Registrations under TCSCA

Under TCSCA, registrants are domestic manufacturers(M) and importers(I) of chemical substances. Domestic manufacturers and importers can appoint third-party representatives to handle substance registrations via notarized appointment letters. Foreign companies cannot submit substance registrations by appointing a local only representative.

Category Registration Type Who/When
Registration of New Substance
  • Standard registration, simplified registration or small quantity registration;
  • Depending on volume and uses;
  • Who: M/I/representative
  • When: 90d prior to M/I;
Registration of Existing Substances
  • Phase I registration: All existing substances(>=0.1t/y);
  • Post Phase I registration: An existing chemical substance manufactured or imported, for the first time, with volume >=0.1t/y, after 31 March 2016;
  • Standard registration: Designated existing substances(>=1t/y) announced by the EPA;
  • Who: M/I/Representative
  • Phase I registration deadline: 31 March 2016
  • Standard registration: Grace period will be designated by the EPA.

The picture below shows how to determine if a new substance or existing substance requires registration under TCSCA.

Taiwan TCSCA Procedure

Registration of New Substances - Exemptions

The following new substances are exempt from registrations under TCSCA.

  • Naturally occurring substances;
  • Chemical substances accompanied in machines and equipment for test-run purposes;
  • Non-isolated intermediates;
  • Chemical substances for national defense purposes or under customs supervision;
  • Waste;
  • Mixture(only applicable to a substance in a mixture);
  •  
  • Article(only applicable to a substance intended to be released from an article);
  •  
  • Polymer meeting 2% rule with all monomers listed;
  • Chemicals subject to other laws such as pesticides, environmental agents, pharmaceuticals, cosmetics, food additives, etc.

Registration of New Substances - Types of Registration and Requirements

There are three types of registrations for new substances under TCSCA depending on the uses and volume of the new substances: small quantity registration, simplified registration and standard registration.

The picture below shows how to determine which type of registration is required for a new substance.

Taiwan TCSCA registration type.

The table summarizes information requirements for above 3 types of registration.

Small Quantity Registration
  • Basic identification of the registrant and substance
  • Manufacture and use info
Simplified Registration
  • Basic identification of the registrant and substance
  • Manufacture, use and exposure info
  • Hazard classification and labelling
  • Safe use information
  • Physical and chemical properties
Standard Registration
  • Basic identification of the registrant and substance
  • Manufacture, use and exposure info
  • Hazard classification and labelling
  • Safe use information
  • Physical and chemical properties
  • Toxicological information
  • Eco-toxicological information
  • Hazard assessment
  • Exposure assessment

For standard registration, toxicology and eco-toxicology data requirements increase with the volume of a substance to be registered. There are 4 levels (Level I 1-10t, Level II 10-100t/y, Level III 100-1000t/y, and Level IV 1000t/y+). On-site isolated intermediates and substances for R&D or PPORD purpose benefit from reduced data requirements (level I data). Data requirements for CMR substances are more stringent than regular substances.

Download detailed data requirements for different types of substance registrations under TCSCA.

Registration of New Substance - Review Period and Validity of Registration Document

Type Review Period and Validity
Small Quantity Registration
  • Review Period: 7 working days;
  • Validity: 2 years(*);
  • *The validity of registration document for PLC is 5 years.
Simplified Registration
  • Review Period: 14 working days;
  • Validity: 2 years;
Standard Registration
  • Review Period: 45 working days;
  • Validity: 5 years;

New substances that are registered under standard registration or polymer of low concern registered under small quantity registration will be added to the inventory of existing substances 5 years after registration has been completed.

Registration of New Substances - Transitional Measures

The guidance has also set transitional measures for new substances manufactured in or imported into Taiwan before 11 Dec 2014 and between the period of 11 Dec 2014 to 11 Dec 2015.

Before 11 Dec 2014
  • Submission of proof document that substances have been manufactured or imported before 11 Dec 2014;
  • Deadline of submission: 31 March 2015;
  • The substances will be added to existing substance inventory and subject to existing substance registrations;
Between 11 Dec 2014 & 31 Dec 2015
  • Eligible for small quantity registration;
  • Validity of registration: 1 year;
Standard Registration
  • Review Period: 45 working days;
  • Validity: 5 years;

Registration of Existing Substances - Phase I Registration

Phase I registration is equivalent to pre-registration under EU REACH regulation and it needs to be submitted individually. The information required is very simple and includes registrant's contact info, substance identification, quantity, and info on manufacture and uses. The purpose of Phase I registration is to gather information on substances circulated in Taiwan, help EPA designate existing substances subject to registration and assist joint submission of existing substance registrations.

Registration of Existing Substances - Standard Registration

EPA will announce the list of designated existing substances subject to standard registration in 4 batches. Each batch will be given a grace period of 2-3 years. The first batch is expected to be announced in 2016. Data requirement is the same as standard registration of new substances.

Joint Submission

For both new substances and existing substances, co-registrants may apply for joint registration under agreement.

For joint registration that is agreed by co-registrants, but no agreement is reached upon the cost sharing of registration information, the competent authority may determine the cost to be equally shared at the request of the later co-registrants. Then use of registration information is approved after the shared cost has been paid.

New Substance Notification: OSHA vs TCSCA.

Both OSHA and TCSCA require a new substance to be notified prior to its production and importation. While the type of new substance notification is the same and required data is similar, there are many differences between notifying a new substance under OSHA and notifying a new substance under TCSCA. The table below summarizes the main differences between OSHA and TCSCA when it comes to new substance notification.

Items OSHA TCSCA
Registration Target
  • OSHA: New substances;
  • TCSCA: New substances and existing substances;
Type of Notification
  • OSHA: Standard registration, simplified registration and small quantity Registration;
  • TCSCA: Same as OSHA with one additional type: Phase I registration of existing substances.
Standard Registration - Hazard Data
  • OSHA: Same as TCSCA's requirement except no need of eco-toxicology data;
  • TCSCA: Extra requirement on eco-toxicology data and PBT/vPvB assessment;
Chemical Risk Assessment
  • OSHA: Required for >=1t/yCMR substances and >=10t/y regular new substances;
  • TCSCA: Required for >=1t/y CMR substances and >=1000t/y regular substances.
Transitional Measures
  • OSHA: New substances manufactured or imported into Taiwan prior to 11 Dec 2014 need to go through small quantity registration process; certificate valid for 1 year only.
  • TCSCA: Substances M/I prior to 11 Dec 2014 are eligible for inclusion in existing substance inventory without notification.
Registration Platform

The Ministry of Labor is discussing with EPA to form a single window for companies to submit new substance registrations in Taiwan. However, data and dossiers submitted need to meet the requirements of both Ministries.

More info about OSHA.

Reference & Resources

Click here to access all references and resources for Taiwan including the English translation of regulations, regulatory lists and useful links to the websites of competent authorities.

 

 Tags: Topics - TaiwanREACH-like Regulation and Registration

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