Taiwan TCSCA - Toxic Chemical Substance Control Act

Taiwan adopted the newly revised Toxic Chemical Substance Control Act (TCSCA) on 11 Dec 2013, promulgated by Presidential Order 10200225131. The core of the revised TCSCA is a registration scheme which requires manufacturers and importers to register their new and existing chemical substances prior to entering Taiwan’s market. Additionally, Taiwan will strengthen the management of Class 4 toxic chemical substances. These new requirements should be complied with after 11 Dec 2014.

Contents

Taiwan regulation:
Presidential Order No. 10200225131
Toxic Chemical Substance Control Act (TCSCA)
Passed by Legislative Yuan
Compentent Authority
Taiwan Environmental Protection Administration (EPA)
History
Passed 22 Nov 2013
Come into force 22 Nov 2014
Status: Future legislation

Taiwan EPA

© Copyright 2014 Taiwan EPA All Rights Reserved

 

Management Framework

Fig. 1 - Framework of Revised Taiwan TCSCA (Toxic Chemical Substance Control Act, Taiwan)

Who's Affected

Manufacturers or importers of new and existing chemical substances shall comply with registration under the revised TCSCA.

Only representatives (OR) will be used, which will allow non-Taiwanese companies to appoint a third party based in Taiwan to submit registrations on their behalf. Although the provision on OR usage was not written into the revised TCSCA, it will probably be included in the follow-up regulation. 

Authority

The Ministry of Natural Resources and Environmental Protection (MNREP) will be established to replace Taiwan’s Environmental Protection Administration in 2014. After institutional restructuring, a department of chemicals and pollution control will be formed under the Ministry, including 5 divisions, one of which will be specifically in charge of registration and evaluation of chemicals under the revised TCSCA. About 50 people will work in this division. Additionally, a team of external specialists will be hired to provide assistance with dossier review. (Chemlinked news release on 4 Dec 2013)

Legislative Progress

The legislative progress of the newly revised TCSCA is summarized as below,

Supporting Documents

Registration of new and existing chemical substances is a priority concern for the Taiwanese chemical industry. An overview of the management framework is drafted in Figure 1. A detailed implementation scheme, which involves data requirements, tonnage thresholds, exposure and risk assessments, etc., are currently being fleshed out and will be published for public consultation and hearing in the Q1 or Q2 in 2014, including,

  • Regulation for the Registration of Chemical Substances (to be drafted);
  • Toxic Chemical Substances Control Act Enforcement Rules (to be revised)
  • Regulation for the Approval of Class 4 Toxic Chemical Substances (to be drafted);
  • Regulation for the Review of Chemical Substance Registration Applications (to be drafted);
  • Toxic Chemical Substances Labeling and Materials Safety Data Sheets Regulations (to be revised)
  • Toxic Chemical Substances Handling Application Fee Standards (to be revised)
  • Regulations for the Toxic Chemical Substances Disaster Emergency Vehicles (to be drafted jointly with the Ministry of Transportation and Communications).

Existing Chemical Substance Nomination

Based on the Existing Chemical Substance Nomination (ECN) which ended on 31 December 2010, Taiwan CLA has compiled the draft Existing Chemical Substance Nomination (ECSI). To update the inventory, on 18 April 2012, the CLA issued the Direction for Supplementary Existing Chemical Substance Nomination (SECN) to guide the SECN on a voluntary basis. Eligible nominators were encouraged to nominate chemical substances during 1 June 2012 to 31 August 2012. Updated on 22 Dec 2012, the inventory, which covers approximately 79,000 substances, is now available on the CSNN website. However, it is not the finalized inventory used as the gold standard reference for screening priority chemicals for step-wise existing chemical registration and judging whether a substance is new and subject to new chemical registration under the revised TCSCA.

To establish the final ECSI, another new round of SECN will be carried out as early as May or June in 2014, which will be the last chance for nominators to include their substances into the ECSI. The nomination criteria are the same as the last SECN as specified below (Italics).

Chemical substances imported to or manufactured, handled, used, or sold in Taiwan between January 1st, 1993 and December 31st, 2011, and are not listed in the National Existing Chemical Substance Inventory (draft) as existing chemical substances can be nominated pursuant to this Direction.

‐‐‐Direction of SECN (04/18/2012)

Taiwan’s Supplementary ECN is very much alike the IECSC Supplementation of China REACH. The Chinese IECSC Supplementation has been cancelled since 18 November 2011. Taiwan’s forthcoming round of SECN is expected to be concluded before the implementation of the revised TCSCA, which will take effect on 11 Dec 2014. 

How to Comply

New Chemical Substance Registration

The completeness of the national existing chemical substance inventory is a prerequisite for Taiwan new chemical substance notification. Substances not listed in the ECSI are regarded as new chemical substances subject to new chemical substance registration under the revised TCSCA except they meet the following exemption conditions:

Exemption Conditions:

  • (1) Polymer applicable to the 2 % Rule
  • (2) Polymer of low concern below 1 t/y
  • (3) For scientific research below 1 t/y
  • (4) Incidental reaction products or impurities without intended commercial purpose
  • (5) Inseparable intermediates
  • (6) Mixture (not applicable to chemical substances in the mixture containing new chemical substance)
  • (7) Articles (not applicable if the substances contained in the article will be intentionally released during normal use)
  • (8) Wastes
  • (9) A substance or a polymer occurred in nature
  • (10) Chemical substances accompanied in the machines and equipment for test‐run purpose
  • (11) Chemical substances under customs supervision
  • (12) Chemical substances for national defense purpose

The new chemical substance should be registered 90 days before manufacture or importation. Based on the tonnage band and usage information, three registration types will be adopted, including standard registration, simplified registration, and low-volume registration.

Fig. 2 - New Chemical Substance Registration Type under Revised Taiwan TCSCA (Toxic Chemical Substance Control Act, Taiwan)

Registration approval is contingent on a number of conditions and may require a number of compulsory handling restrictions to be implemented due to the potential of the substance being classified as a toxic chemical substance (See Certificate Sample below). These toxic chemical substances, if further evaluated and categorized officially into the existing four Classes of toxic chemical substances, will be accordingly regulated. It should be noted that Taiwan will regulate nanomaterial in its chemical registration system, however, the details will be specified in the subordinate implementation specifications.
The associated registration obligations required for new chemicals still need to be specified in the Regulation for the Registration of Chemical Substances, a subordinate regulation to be drafted under TCSCA. Companies are suggested to generate some data in advance if they are already manufacturing or exporting new substances to Taiwan in high volumes. 

Fig. 3 - New Chemical Substance Registration Certificate (Example)

 

Fig. 4 - New Chemical Substance Registration Procedure under Revised Taiwan TCSCA (Toxic Chemical Substance Control Act, Taiwan)

Fig. 5 - Data Requirements of New Chemical Substance Registration under Revised Taiwan TCSCA (Toxic Chemical Substance Control Act, Taiwan)

 

Existing Chemical Substance Registration

All existing chemicals manufactured or imported over 0.1 ton per year will be subject to the Phase 1 of Taiwan’s existing chemical registration system, which only requires submission of the most basic information including registrants’ information, chemical name (EN/CN), annual amount and usage information for approval prior to the actual manufacture or importation. Based on the information collected, if the substance volume is large and designated as highly hazard or lacking specific data, it will be probably designated as a priority chemical substance subject to the Phase 2 registration. If your substances are not listed in the priority list, Phase 2 registration is not required.

Fig. 6 - Data Requirements of Phase I Registration under Revised Taiwan TCSCA (Toxic Chemical Substance Control Act, Taiwan)

Priority chemical substances are subject to mandatory standard registration under the revised TCSCA. This PEC list will be released in three separate batches (priority 1, priority 2 and priority 3 substances) with higher priority substances published first. As planned, the Phase 2 registration will be further divided into four stages specified as below.

Existing chemical registration

Applicable scope

Phase I

All existing chemicals ≥ 0.1 t/y

Phase II

Category 1

Batch 1 substances ≥ 10 t/y

Category 2

10 t/y > Batch 1 substances ≥ 1 t/y and Batch 2 substances ≥ 10 t/y

Category 3

10 t/y > Batch 2 substances ≥ 1 t/y and Batch 3 substances ≥ 10 t/y

Category 4

10 t/y > Batch 3 substances ≥ 1 t/y

Registration dossiers will have to include data on physicochemical, toxicological, exposure and assessment data etc. After information is submitted and evaluated, substances will be categorized into the existing four Classes of toxic chemical substances according to their hazard properties. Detailed implementation specifications are expected in the guidance documents to be delivered in 2014.

Fig. 7 - Existing Chemical Substance Registration under Revised Taiwan TCSCA (Toxic Chemical Substance Control Act, Taiwan)

Joint Submission

For new chemical substances, individual submission is suggested. The potential registrants can decide whether to make joint submission or not. However, for existing chemical substances, joint submission will be mandatory. Joint registrants or early and late registrants of the same substance can utilize data already submitted by other registrants to avoid duplication of testing data. Cost sharing agreements are negotiated by the registrants, and the EPA will intervene to coordinate only on request. Individual submission could be applicable where confidentiality and cost issues arise and approval obtained from Taiwan EPA in advance.

The revised TCSCA does not currently include a data submission protocol for joint submission. However, it will be written into the follow-up regulations.

Toxic Chemical Management

So far, Taiwan's toxic chemical substances list (TCSL) regulates 302 types of toxic chemical substances including:

  • 103 Class 1 substances
  • 100 Class 2 substances
  • 73 Class 3 substances
  • 92 Class 4 substances (latest update on 24 Jan 2013)

The 302 toxic chemical substances already validated with their chemical identity are excluded from the scope of chemical registration under the revised TCSCA. An estimated 5,384 stakeholders are currently involved in the handling of this class of toxic chemicals. They will need to notify the EPA that their substances are already included in the TCSL and act in accordance with the current management practices. (Chemlinked news release on 28 Jan 2013)

Articles for stricter management i.e. Class 4 toxic chemicals, which are characterized by their heightened potential for damage to human health and the environment, will take effect one year after the revised TCSCA is officially promulgated on 11 Dec 2014. It is necessary to apply for approval documents prior to commencement of commercial operations. It is also necessary to detail information on toxicity and pollution control measures on containers, packaging, handling sites and facilities, and prepare SDS for reference.

 (Note* some overlap exists between Class 1, Class 2 and Class 3)

News

 

Any question?
Ms. Nadine He
Regulatory Analyst | China NCSN, K-REACH, Taiwan TCSCA
P. R. China, Hangzhou
Email: NadineChemLinked.com
Services Offered: Phone consultation, Email consultation, Market report, Private Visit, Customer Project
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Dr. Olivia Sun SERVICE PROVIDER
Regulatory Analyst | China NCSN, K-REACH, Taiwan TCSCA
P. R. China, Hangzhou
Services Offered: Consultation & training, Taiwan TCSCA registration