Taiwan issued the Proposed Amendment to Toxic Chemical Substances Control Act (the Act) and the Proposed Amendment to Regulation for New and Existing Chemical Substances Registration (the Regulation). If adopted, the amended Act and revised Regulation would impose more stringent requirements on companies that handle toxic chemicals and on manufacturers and importers of new and existing chemical substances.
By Sally Li, STC Teaming Partner
Specialty Technical Consultants, Inc. (STC) is an EHSQ Alliance Affiliate.
The Toxic Chemical Substances Control Act (the Act) was originally adopted on 26 November 1986. The Act serves as umbrella legislation, defining and classifying toxic chemical substances and requiring manufacturers, handlers, and importers to conduct hazard assessments for, report, register, and appropriately manage toxic chemicals.
The most recent amendment to the Act (dated 11 December 2013) required chemical manufacturers and importers to register new and existing chemical substances prior to bringing them into Taiwan.
On 11 December 2014, the Taiwan EPA issued the Regulation for New and Existing Chemical Substances Registration (the Regulation) to specify the registration requirements for new and existing chemical substances.
The Proposed Act
The Proposed Act would be renamed Toxic and Chemical Substances of Concern Control Act. As the new name suggests, the Act would add the category “chemical substances of concern” and impose safety requirements for facilities that handle them. “Chemical substances of concern” are chemical substances with endocrine-disrupting characteristics or other hazards that are a concern for the domestic and international community.
Additionally, the Proposed Act imposes stricter requirements on emergency response personnel in case of chemical accidents and adds whistleblower protection requirements for reporting violations.
The Proposed Act received approval from the Executive Yaun (a government body) in November 2017. It is now awaiting one of the final steps in the legislative process, approval by the Legislative Yuan.
The Proposed Regulation
The Taiwan EPA first issued the Proposed Regulation on 14 September 2017, and it was open for public consultation for 60 days. On March 29, 2018, the Taiwan EPA issued the second version of the Proposed Regulation. The Taiwan EPA is currently accepting public comments until May 29, 2018.
The Proposed Regulation would make the following changes to the current regulation:
The current regulation does not apply to certain chemical substances that are regulated by other acts and regulations, such as animal feed, pesticides, medicines, cosmetics, food, and food additives. Under the Proposed Regulation, the raw materials used to manufacture such chemical substances would be subject to regulation.
Threshold level for hazard and exposure assessment
The current regulation requires a hazard and exposure assessment to be included in the registration of new and existing chemical substances if such chemicals are not Class 1 Carcinogenic, Mutagenic, or Toxic for Reproduction Substances and if the annual importing or manufacturing amount of such chemicals is equal to or greater than 1,000 tonnes. The Proposed Regulation would amend the annual threshold level to 10 tonnes. The lower threshold means that hazard and exposure assessments would be required for more chemical registrations.
Under the Proposed Regulation, a registration number would be provided upon approval of the New and Existing Chemical Registration. A registration certificate will no longer be given.
Review period for existing chemical registrations
Under the Proposed Regulation, the review period for existing chemical registration would be 90 days (with one permitted extension). The current Regulation does not specify the review period.
Phase one registration deadline
Under the Proposed Regulation, manufacturers and importers of an existing chemical substance would be required to complete the phase one registration within 6 months after their annual manufacturing and importing amount for that chemical reaches 100 kg or more for the first time. The current regulation does not specify the registration deadline. Manufacturers and importers may voluntarily register the existing chemical even if the amount imported and manufactured is less than 100 kg per year.
Phase two registration for the high priority existing chemical substances
The Proposed Regulation, for the first time, includes a list of 106 different high priority existing chemical substances and would require the manufactures and importers of these chemical substances to complete a more comprehensive phase two registration. Examples of the high priority substances are acrylic acid, aluminum sulfate, benzaldehyde, and benzophenone. Information required for the phase two registration is similar to that required for the standard registration of new chemicals and includes the following:
- Basic information about the registrant and the chemical substance's identification
- The substance’s manufacture and use information
- Hazards classification
- Safe use information
- Physiochemical properties
- Toxicological information
- Ecotoxicological information
- A hazard assessment report
- An exposure assessment report
The timeline for completing phase two registration depends on the manufacturing and importing amount reported for phase one registration. Manufacturers and importers who complete the phase one registration by December 31, 2018, would need to complete the phase two registration by the following timeline:
- December 31, 2020, if the annual manufacturing and importing amount for phase one registration is more than more than 100 tonnes; and
- December 31, 2021, if the annual manufacturing and importing amount for phase one registration is more than 1 tonne but less than 100 tonnes.
Manufacturers and importers who complete the phase one registration after December 31, 2018, would need to complete the phase two registration by the following timeline:
- Within 2 years if the annual manufacturing and importing amount for phase one registration is more than 100 tonnes; and
- Within 3 years if the annual manufacturing and importing amount for phase one registration is more than 1 tonne but less than 100 tonnes.
For manufacturers and importers whose annual manufacturing and importing amount for phase one registration is less than 1 tonne, phase two registration would need to be completed within 3 years from the date that their actual annual manufacturing and importing amount reaches 1 tonne.
The current regulation allows a confidential business information (CBI) application for new chemical registrations. The Proposed Regulation would extend the CBI application to include phase 1 registration of existing chemical substances. The validity period for standard registration, phase 1 existing chemical substances registration, and polymers with low concern (PLC) registration would be 5 years, and the validity period for simplified and small amount registration would be 2 years.
The current regulation does not impose any annual reporting requirements. Under the Proposed Regulation, starting in 2019 manufacturers and importers of the new and existing chemicals of concern would need to submit to the relevant Authority the registrant information, registration number, and amount of chemical manufactured or imported from the previous year. The reporting period is between 1 April and 30 September each year.
The proposed Act and Regulation will likely be adopted in 2019, with implementation later in the year.
Ms. Sally Li is a licensed attorney with eight years of experience in the environmental, health, and safety (EHS) compliance field. Sally advises clients on a full range of EHS regulatory compliance issues with a focus on the East Asia region, including China, Taiwan, Hong Kong, and Macau. Sally has extensive experience in tracking EHS-related legislative developments, maintaining regulatory baselines, and designing EHS audit protocols for industrial sectors, such as the chemical, manufacturing, retail, petroleum, and pharmaceutical industries. Sally is fluent in both English and Chinese and has supported STC with the update of its EHS Protocols for China and Taiwan, both of which are available through Specialty Technical Publishers of Vancouver, Canada (https://stpub.com/)
Republished with permission.
For more information about STC, see www.specialtytechnicalconsultants.com.
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