Last Updated: 2019-05-30
The new Toxic and Concerned Chemical Substances Control Act, previously known as the Toxic Chemical Substance Control Act (TCSCA) was promulgated on Jan 16th, 2019. More than 30 subordinate regulations will be revised or fleshed out accordingly. The new Act, which entails a broader control over chemicals, will take effect one year after the official promulgation, while Article 7, Article 54, Article 65, Article 67 and Article 72 will be effective immediately.
The full contents of the new Act are accessible here (in traditional Chinese and English).
Fig. 1 - Framework of Revised Taiwan TCSCA
Manufacturers or importers of new and existing chemical substances shall comply with registration under the revised TCSCA.
Only representative (OR) rules under EU REACH is not adopted in Taiwan. Taiwan only authorizes domestic importers and manufacturers to appoint a third party representative (TRP) based in Taiwan to assume their chemical registration responsibilities.
For enterprises handling listed toxic chemical substances, corresponding permits, registration or approval should be applied for. Here "Handling" refers to activities such as the manufacture, import, export, sale, transport, use, storage or discarding of chemical substances.
For enterprises handling listed concerned chemical susbatnces exceeding certain quantity announced by the authority, approval should be applied for.
The Toxic and Chemical Substances Bureau (TCSB) was established under the Environmental Protection Administration (EPA) on 28 Dec 2016. The official website of the new bureau is http://www.epa.gov.tw/tcsb/.
The bureau is responsible for harmonization in chemical management, including:
· (1) Regulating, implementation and supervision
· (2) Accident and emergency response,
· (3) Environmental health agents
· (4) Information integration and application,
· (5) Amount and direction of toxics and chemicals, as well as cross-ministerial cooperation
· (6) Development of hazard evaluation methods
· (7) International cooperation, technology research and development and,
· (8) Other issues related to toxics and chemical substances
The legislative progress of the newly revised TCSCA is summarized as below,
· 11 Dec 2013, the amendments of TCSCA were promulgated by Presidential Order(Chemlinked news release on 13 Dec 2013). 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 were required to comply with after 11 Dec 2014.
· Taiwan’s Executive Yuan approved the bill for revision of the Toxic Chemical Substance Control Act on 9 Nov 2017. The revised Act was proposed to be renamed the Toxic and Chemical Substances of Concern Control Act (download), which entails a broader control over chemicals (see ChemLinked news).
· The new Toxic and Chemical Substances of Concern Control Act was promulgated on Jan 16th, 2019. More than 30 subordinate regulations will be revised or fleshed out accordingly (see ChemLinked news).
English version available!
Registration of new and existing chemical substances is a priority concern for the Taiwanese chemical industry. An overview of the management framework is introduced in Figure 1. A detailed implementation scheme, which involves data requirements, tonnage thresholds, exposure and risk assessments, etc., are fleshed out in the Regulation on Registration of New and Existing Chemical Substances.
Followings are some other important supporting documents for Taiwan TCSCA (Find more in ChemLinked regulatory database).
· Toxic Chemical Substances Control Act Enforcement Rules
· Approval Regulation for Class 4 Toxic Chemical Substances
· Permit Registration and Approval Regulations for Toxic Chemical Substances
· Toxic Chemical Substances Labeling and Safety Data Sheets Regulations
· Standard on Toxic Chemical Substances Handling Application Fee and Chemical Registration Fee
Existing Chemical Substance Nomination
Based on the Existing Chemical Substance Nomination (ECN) which ended on 31 December 2010, Taiwan CLA has compiled the draft Taiwan's Existing Chemical Substance Nomination (TCSI). 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 covered approximately 79,000 substances.
To further update the TCSI, another round of SECN (Second SECN, SSECN) was carried out on 1 June in 2014, which will be the last supplementation organized by the MoL (successor of CLA) for nominators to include their substances into the TCSI. 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)
Based on SSECN nomination applications submitted by industry, MOL updated it to include approximately 93,000 substances that were manufactured in or imported into Taiwan between January 1, 1993 and December 31, 2011.
In addition to the ECN, SECN and SSECN carried out by the MoL, EPA held another supplementation, whcih allows chemicals manufactured or imported to the Taiwanese market before 11 Dec 2014 included into the invnetory as existing chemical substances. Companies must provide proof of these substances previous manufacture or import before 31 Mar 2015, as specified in the Article 16 of the Regulation on Registration of New and Existing Chemical Substances under TCSCA. The inventory is updated based on the review results of this supplementation. The TCSI currently contains around 101,089 substances following 3 rounds of nominations held by the MoL and the supplementation program held by the EPA. The online search of the inventory is available here.
How to Comply
New Chemical Substance Registration
The associated registration obligations required for new chemicals is specified in the Regulation on Registration of New and Existing Chemical Substances. The completeness of Taiwan's existing chemical substance inventory (TCSI) is a prerequisite for Taiwan new chemical substance registration. Substances not listed in the TCSI are regarded as new chemical substances subject to new chemical substance registration under the revised TCSCA except they meet the following exemption conditions:
· (1) Naturally occurring substances
· (2) Chemical substances accompanied in the machines and equipment for test‐run purpose
· (3) Inseparable intermediates from the chemical reaction in the reaction vessel or in the production process
· (4) Chemical substances for national security or national defense purposes
· (5) Chemical substances under customs supervision
· (6) Chemcial wastes produced or releassed from industrial process
· (7) By-products or impurities that are of no commerical application
· (8) Mixtures (not applicable to the individual chemical constituents of the mixture)
· (9) Articles (not applicable if the substances contained in the article will be intentionally released during normal use)
· (10) A polymer for which the 2% rule is applicable and listed on the inventory of existing chemical substances
· (11) Others already regulated by existing laws and regulations, e.g. agro-pesticides, fertilizers, cosmetics, foods, food addiives, toxic chemical substances, etc.
* It should be noted that for a chemical substance manufactured or imported as a raw material of the above mentioned items, the chemical substance shall be subject to the provisions of the Regulation on Registration of New and Existing Chemical Substances.
The new chemical substance should be registered 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
Fig. 3 - New Chemical Substance Registration Procedure under Revised Taiwan TCSCA
Fig. 4 - Data Requirements of New Chemical Substance Registration under Revised Taiwan TCSCA
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 or a concerned chemcial substance (See Certificate Sample below). These substances, if further evaluated and categorized officially into the existing four Classes of toxic chemical substances, will be accordingly regulated.
Fig. 5 - New Chemical Substance Registration Certificate (Example)
Existing Chemical Substance Registration
All existing chemicals manufactured or imported over 0.1 ton per year are 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. Taiwan pre-registration of existing chemical substances finished at the end of March (CL news). As of April 1st 2016, the late pre-registration of existing chemical substances has been open (CL news).
Fig. 6 - Data Requirements of Phase I Registration under Revised Taiwan TCSCA
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. Priority existing chemical substances (PECs) are subject to mandatory standard registration.
The first batch of PEC list has been released as Annex 6 of the revised Regulation on Registration of New and Existing Chemical Substances (click here to download the list). The tonnage threshold for standard registration is set as 1 ton per year, consistent with EU REACH. Four tonnage bands (1-10t/y, 10-100t/y, 100-1000t/y, 1000+ t/y) is set with corresponding data requirements identical to new chemical registration requirements. However, the registration deadline will be based on the volume when applying for phase 1 registration (pre-registration/late pre-registration) and the date on which the phase 1 registration number is obtained.
Joint registration is not mandatory. Two or more manufactures or importers applying for registration of the same new chemical substance may jointly or successively submit application for registration approval. Tonnage accumulation is required for joint submission, which may result in higher data requirements. For existing chemical substances, the registrant having finished standard registration with higher tonnage levels can let the enterprises of the same level or enterprises with lower tonnage levels buy the LOA (letter of access) and give them access to the joint submission with a data token. However, for registration of higher tonnage levels, the data cannot be passed in the form of data token from the registrant with a lower tonnage level. The data should be purchased from the data holder and complete additional experiments required by higher level to complete the registration. Cost sharing agreements are negotiated by the registrants, and the EPA will intervene to coordinate only on request.
Toxic Chemical Management
Taiwan EPA announces toxic chemical substances as Class 1, Class 2, Class 3 or Class 4 according to the classification criteria given below.
· Class 1 toxic chemical substances: those chemical substances that are not prone to decompose in the environment or that pollute the environment or endanger human health due to bioaccumulation, bioconcentration or biotransformation.
· Class 2 toxic chemical substances: those chemical substances that cause tumors, infertility, teratogenesis, genetic mutations or other chronic diseases.
· Class 3 toxic chemical substances: those chemical substances that endanger human health or the lives of biological organisms immediately upon exposure.
· Class 4 toxic chemical substances: those chemical substances for which there is concern of pollution of the environment or the endangerment of human health.
So far, Taiwan's toxic chemical substances list (TCSL) regulates 340 types of toxic chemical substances (click here to download the list) including:
· 114 Class 1 substances
· 100 Class 2 substances
· 73 Class 3 substances
· 120 Class 4 substances (latest update on Mar 5th, 2019)
(Note* some overlap exists between Class 1, Class 2 and Class 3)
The 340 toxic chemical substances already validated with their chemical identity are excluded from the scope of chemical registration under the revised TCSCA. An estimated more than 5,000 stakeholders are currently involved in the handling of toxic chemicals. They need to act in according with Taiwan TCSCA.
Toxic chemical substance handlers shall apply for permits, registration documents and approval documents for toxic chemical substances of Class 1, 2 or 3 with the corresponding competent authority of municipality, county or city level. However, when the total quantity handled is lower than the large-scale handling standard official released, the handler can apply for the approval documents rather than the permit or registration (see details).
For Class 4 toxic chemicals, which are characterized by their heightened potential for damage to human health and the environment, it is necessary to apply for approval documents prior to commencement of commercial operations (see details). 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.
Concerned Chemical Substance Management
The revised Act expands the control from toxic chemicals to concerned substances, which will cover more food safety risk chemicals, hazardous chemicals (explosive, corrosive), drug precursors, explosive precursors. For management of concerned chemical substances, the authority will announce control concentration standards and graded handling quantity. Only necessary operations shall be announced and regulated. The handler shall produce regular reports concerning the specified handling of concerned chemical substances, and such records must be properly preserved for future reference. It should be noted that the release quantity is not required to report for concerned chemicals.Based on hazards, some substances will be subject to risk prevention and response provisions (e.g. provide emergency response plan, establish a mutual aid group, equip with detection and alarm equipment, etc.).
· 27 Feb 2018 Taiwan’s Toxic Chemical Substances List to Be Appended
· 19 Sep 2016 Taiwan's Existing Chemicals Inventory to Be Corrected
· 5 Apr 2016 Taiwan Launches Late Pre-registration from April 1st
· 18 Mar 2015 Taiwan TCSCA and OSHA Single Registration System
· 30 Dec 2014 Taiwn Not to Implement OR Concept
· 26 Nov 2014 Taiwan Updated Chemical Registration Tool
· 10 Jan 2014 Taiwan Publishes Official English Version of TCSCA
· 13 Dec 2013 Taiwan's Newly Revised TCSCA Formally Announced
· 25 Nov 2013 Taiwan's Legislative Yuan Approved Revised TCSCA
· 28 Jun 2013 Taiwan May Approve Amendments of TCSCA in Late July
· 28 Jan 2013 Taiwan Updates Toxic Chemical Substance List
Expert Articles & Ebook
1. Nadine He, 12 Apr 2018 Taiwan Issues Draft Amendments of New and Existing Chemical Registration Regulation
2. Nadine He, 27 Jul 2017 Taiwan to Revise New and Existing Chemical Registration Regulation
3. Shawn Xiang, 13 Jul 2015 Taiwan Existing Chemical Substance Phase 1 Registration: Concise Overview of Critical Checkpoints
4. Shawn Xiang, 28 Jan 2015 "How to Protect Your Confidential Information under Taiwan TCSCA/OSHA"