News Details

On 20 July , 2026  Taiwan's Ministry of Environment (MOE) has released a draft amendment proposing to add six additional substances to the Concerned Chemical Substances list under the Toxic and Concerned Chemical Substances Control Act. The proposal aims to strengthen chemical risk management, improve supply chain traceability, and reduce potential risks to human health and the environment. The amendment also introduces new concentration thresholds, labelling obligations, approval requirements, and transition periods for affected businesses.

Summary

The draft amendment proposes to regulate six additional chemicals by introducing requirements for manufacturing, importing, selling, using, and storing these substances. Depending on the substance and concentration, companies may be required to obtain prior approval, submit monthly operational reports, maintain operational records, prepare Safety Data Sheets (SDSs), and update product labels and packaging.

Existing operators will be provided with a transition period to comply with the new requirements before full implementation.

Six Chemicals Proposed for Regulation

The proposed amendment would add the following substances:

• Toluidine Red (C.I. Pigment Red 3) – CAS No. 2425-85-6
• Para Red – CAS No. 6410-10-2
• Bisphenol B – CAS No. 77-40-7
• Bisphenol F – CAS No. 620-92-8
• 2-Methyl-4-(methylthio)-2-morpholinopropiophenone (MMMP) – CAS No. 71868-10-5
• Gamma-Butyrolactone (GBL) – CAS No. 96-48-0

Why Are These Chemicals Being Added?

According to the Ministry of Environment:

• Toluidine Red and Para Red have been identified through the Rapid Alert System for Food and Feed (RASFF) due to potential food safety concerns.
• Bisphenol B has already been included on the Substance of Very High Concern (SVHC) Candidate List in the European Union.
• Bisphenol F has also been proposed for inclusion on the SVHC Candidate List because of its potential endocrine-disrupting properties.
• MMMP has been identified internationally as a New Psychoactive Substance (NPS) and may present reproductive toxicity and neurological risks if misused.
• Gamma-Butyrolactone (GBL) has legitimate industrial applications but may also pose health risks when improperly used.

Proposed Regulatory Requirements

The draft introduces different regulatory requirements based on each substance.

Toluidine Red and Para Red

Key proposed requirements include:

• Control concentration: 30%
• Prior approval before manufacture, import, sale, use or storage
• Monthly reporting of operational activities
• Operational records must be maintained
• Safety Data Sheets required
• Containers and packaging must display the Chinese warning:
  • "Not for use in food and feed."

Bisphenol B and Bisphenol F

Key proposed requirements include:

• Control concentration: 1%
• Prior approval before operation
• Monthly reporting
• Operational record keeping
• Safety Data Sheets and compliant labeling required

MMMP

Key proposed requirements include:

• Control concentration: 90%
• Prior approval before operation
• Monthly reporting
• Operational record keeping
• Safety Data Sheets required
• Containers and packaging must display:
  • "For Industrial Use Only."

Gamma-Butyrolactone (GBL)

The proposal introduces a two-tier regulatory approach:

• 20% to below 90%
  • Labeling and Safety Data Sheet requirements apply.
  • Containers and packaging must display "For Industrial Use Only."
• 90% and above
  • Full regulatory requirements apply, including prior approval, monthly reporting, operational records, labeling and Safety Data Sheets.

Compliance Timeline

The draft amendment provides an implementation schedule for existing operators:

• From January 1, 2027: Companies must begin maintaining operational records and submitting periodic reports.
• By July 1, 2028: Companies must obtain the required approvals and complete labeling, packaging, and Safety Data Sheet compliance.
• Other regulatory obligations will take effect from the official announcement date.

Additional Restrictions

The Ministry also announced that once the six substances are officially designated as Concerned Chemical Substances:

• Sales through online platforms that cannot verify the identity of buyers will be prohibited.
• Administrative penalties may reach NTD 300,000 for non-compliance.
• Serious violations resulting in death or significant harm to human health may lead to severe criminal penalties under Taiwanese law.

What Companies Should Do

Companies manufacturing, importing, distributing, or using any of the six proposed substances in Taiwan should begin reviewing their compliance obligations. Businesses are encouraged to assess product portfolios, concentration levels, labeling, Safety Data Sheets, operational record systems, and approval requirements in preparation for the final regulation.