- Department:Evaluation Management Division
To strengthen the management of chemical substances, the Ministry of Environment issued a public notice today proposing to list Toluidine Red, Para Red, Bisphenol B (BPB), Bisphenol F (BPF), 2-Methyl-4'-(methylthio)-2-morpholinopropiophenone (MMMP), and gamma-Butyrolactone (GBL) as Concerned Chemical Substances. Based on their characteristics, five types of operations—namely manufacture, import, sale, use, and storage—shall be subject to control, and relevant management measures shall be promulgated to mitigate the risks of human health and environmental hazards resulting from improper operation.
Toluidine Red and Para Red are chemical substances subject to alerts issued by the European Union’s Rapid Alert System for Food and Feed (RASFF) and carry potential food safety risk concerns. To prevent their inflow into the food supply chain and achieve source control, these substances are listed as Concerned Chemical Substances with Food Safety Risk Concerns. The control concentration standard is set at 30%. Prior to any operations, operators shall apply for an approval document, submit monthly operating records, and ensure proper labeling alongside Safety Data Sheets (SDS). The containers and packaging thereof shall explicitly state in Chinese: "Forbidden for Use in Food and Feed."
In consideration of the gradual expansion of global regulatory control over bisphenol compounds—wherein Bisphenol B (BPB) has been included in the European Union’s Substances of Very High Concern (SVHC) candidate list and Bisphenol F (BPF) exhibits potential endocrine-disrupting properties—such substances present potential exposure risks due to their applications in consumer products. To track and strengthen source-to-distribution management and to prevent chemical substitution among structurally similar substances, Bisphenol B and Bisphenol F are hereby listed as Concerned Chemical Substances under Public Consumer Issues to subject them to enhanced regulation, thereby mitigating the adverse impacts of endocrine-disrupting chemicals on the domestic environment and public health. The control concentration standard is set at 1%. Prior to any operations, operators shall apply for an approval document, submit monthly operating records, and ensure proper labeling alongside Safety Data Sheets (SDS).
Furthermore, pursuant to directives from the Executive Yuan, the Ministry of Environment has included MMMP and GBL under the regulatory scope of Concerned Chemical Substances. The Ministry of Environment further elaborates that both MMMP and GBL possess defined industrial applications; therefore, to balance legitimate operational needs with the prevention of improper use, these substances are hereby listed as Concerned Chemical Substances under Public Consumer Issues to strengthen source-to-destination management and risk prevention. The control concentration standard for MMMP is set at 90%. Prior to any operations, operators shall apply for an approval document, submit monthly operating records, and ensure proper labeling alongside Safety Data Sheets (SDS). The containers and packaging thereof shall explicitly state in Chinese: "For Industrial Use Only."
The Ministry of Environment emphasizes that upon the designation and announcement of these six substances as Concerned Chemical Substances, their sale on online platforms or other channels where the identities of the transacting parties cannot be verified shall be prohibited immediately. Violations of these provisions shall be punishable by a maximum administrative fine of NTD 300,000 in accordance with the law; where such violations result in death or cause severe harm to human health, offenders shall be subject to life imprisonment or a fixed-term imprisonment of not less than seven years. In consideration of domestic usage status, existing operators shall be granted a grace period regarding compliance with requirements such as applying for approval documents and labeling containers and packaging. In addition to creating operating records and making regular reporting as of the date of announcement, existing operators shall obtain approval documents and complete required matters including container and packaging labeling within one year and six months from the date of announcement.
For relevant materials concerning this public notice, please refer to the News Section of the Ministry of Environment to download the attached files ( https://enews.moenv.gov.tw/ ), or download them from the Executive Yuan Gazette Online ( https://gazette.nat.gov.tw/egFront/ ) starting three days from the date of public notice. Comments or recommendations for amendments from all sectors are welcome and may be submitted to the Ministry of Environment (Email: zhijun.jian@moenv.gov.tw) within 60 days following the day after the publication of this notice for reference in regulatory revisions.
