Taiwan Regulatory News

269 (pps (PFAS as . These chemicals are widely used  can persist in the environment os potential risks to to   management  various WincludePFOS, PFOA, and PFHxS are already banned or restrict...

On 5 August 2025, Taiwan's Environmental Protection Administration (EPA) announced a draft plan to regulate 269 (per- and polyfluoroalkyl substances (PFAS) as Concerned Chemical Substances. These chemicals are widely used and can persist in the environment, posing potential risks to human health. Taiwan is following global trends to strengthen chemical safety management. 

Taiwan’s Ministry of Environment has announced stricter controls on several high- risk chemicals, including PFOS, PFOA, nonylphenol (NP), nonylphenol ethoxylates (NPEO), and cycloterpenes. Starting...

Taiwan’s Ministry of Environment has announced stricter controls on several high- risk chemicals, including PFOS, PFOA, nonylphenol (NP), nonylphenol ethoxylates (NPEO), and cycloterpenes. Starting June 1, 2025, these substances will be listed as toxic or of concern，with new concentration limits and use restrictions. 

PFAS Under Tighter Control 

Perfluorooctane sulfonate (PFOS) and perfluorooctanoic acid (PFOA) are, part of the broader group of per- and polyfluoroalkyl substances (PFAS) , They are known for their persistence in the environment and their ability to accumulate in living organisms., This poses risks to ecosystems and human health. Following international conventions likeIn line with the Stockholm Convention, Taiwan is now regulating over 350 related PFAS compounds. 

Stricter Limits on NP and NPEO 

NP and NPEO, which are classified as endocrine disruptors, have been banned in household cleaning products in Taiwan since 2007. Now, stricter rules will cap their use at 0.1% in cleaning products and high-risk applications, and ban the import of such products. 

Cycloterpenes Ban in Specific Applications 

Due to their toxicity and risk of bioaccumulation, cycloterpenes,  will be banned in antifouling paints, systems, and biocides.

Grace Period and Industry Guidance 

To help businesses transition, the ministry will offer a grace period of one and a half to two years. Officials also encourage industries to find safer alternatives to protect health and the environment. More details are available on the Ministry of Environment’s website or in the Executive Yuan Gazette. 

On 25 April 2025, Taiwan completed its transition to the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8). Full implementation was achieved...

On 25 April 2025, Taiwan completed its transition to the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8). Full implementation was achieved through the publication of updated Chinese National Standards (CNS) under the CNS 15030 series. 

The Bureau of Standards, Metrology and Inspection (BSMI), under the Ministry of Economic Affairs (MOEA), led the adoption process, releasing the revised standards in three phases: 

• 24 October 2024: Ten standards covering physical hazards were published. 

• 24 February 2025: Ten standards on health hazards were issued, including the new hazard class for desensitized explosives. 

• 25 April 2025: Two standards addressing environmental hazards and the general rules for classification and labelling were finalized. 

This phased approach aligns Taiwan’s chemical classification and labelling framework with UN GHS 8 and marks a significant upgrade from the previously adopted GHS 4, which had been in force since December 2014. 

Key Updates to the CNS 15030 Standards 

The updated standards introduce several critical changes, including: 

• New Hazard Class: Desensitized explosives (CNS 15030-29) added. 

• Flammable Gases: Category 1 is now subdivided into 1A and 1B, distinguishing pyrophoric and chemically unstable gases. 

• Aerosols: Category 3 introduced along with and a new class name – Aerosol and Chemicals under Pressure. 

• Revised Criteria: Updates to the definitions, classification criteria, and testing guidelines for acute toxicity, skin corrosion/irritation, and serious eye damage/irritation. 

Background 

Taiwan initiated the revision process in 2024, with the draft CNS 15030 standards undergoing public consultation in June of that year. In total, 23 of the 29 CNS 15030 series standards were revised to reflect GHS 8 provisions. The full list of updated standards is now accessible via the CNS Online Portal. 

Previous Implementation 

Taiwan previously implemented GHS 4 through notices issued by the Ministry of Labour and the Environmental Protection Administration in 2014. That version served as the basis for CNS 15030-1 to CNS 15030-28. 

On March 7, 2025, Taiwan’s Ministry of Labor (MoL) announced proposed changes to the regulations for the registration of new chemical substances. A draft version of the updated regulation is now ope...

On March 7, 2025, Taiwan’s Ministry of Labor (MoL) announced proposed changes to the regulations for the registration of new chemical substances. A draft version of the updated regulation is now open for public comment. The deadline for submitting comments is 60 days from March 7, 2025.

Current Regulatory Framework

Currently, there are two separate regulatory systems for registering new chemicals: one under the Ministry of Labor (MoL) and another under the Ministry of Environment (MoEnv). Since much of the required data overlaps, the MoL plans to revise its regulation to reduce duplication and make the process more efficient.

Key Proposed Changes

• Mutual Recognition of Registrations: If a company has already registered a new chemical with the MoEnv, it will no longer need to re-register the same substance with the MoL.
• Updated Legal Terminology: The name of the law has been updated from Toxic Chemical Substances Control Act to Toxic and Concerned Chemical Substances Control Act.
• Removal of Obsolete Transitional Provisions: Two transitional provisions related to older substances are being removed, as their deadlines have already passed.

Companies will still be required to submit core information, including:

• Identification of the chemical
• Details on how it is manufactured and used
• Hazard and safety data
• Toxicological information
• Environmental impact data

On 13 February 2025, Taiwan’s Occupational Safety and Health Administration (OSHA) announced that companies handling certain Priority Management Chemicals must submit additional operational data by ...

On 13 February 2025, Taiwan’s Occupational Safety and Health Administration (OSHA) announced that companies handling certain Priority Management Chemicals must submit additional operational data by 31 March 2025. This requirement is in line with Article 12 of the Regulations on the Designation and Operation Management of Priority Management Chemicals, which allows authorities to request additional data, such as updated Safety Data Sheets (SDS), to assess chemical exposure risks.

20 Chemicals Identified for Additional Reporting

The Ministry of Labor has identified 20 chemicals, including boric acid, cobalt compounds, ethylene glycol derivatives, and hydrogen fluoride, that require additional data submission. This requirement applies to both pure substances and mixtures containing more than 1% of these chemicals.

List of Affected Chemicals

Regulatory Basis and Compliance Requirements

Under Article 12 of the Regulations on the Designation and Operation Management of Priority Management Chemicals, the Ministry of Labor can require companies to provide additional operational data for exposure risk assessment. The data requested for 2025 is SDSs. Companies handling these substances must submit SDS files via the PRoChem platform by 31 March 2025.

Submission Process

Companies must log in to the PRoChem platform and upload SDS files under the "Priority Management Chemicals Management" section. If more than one chemical is handled, each SDS must be uploaded separately.

Failure to submit SDS files by the 31 March 2025 deadline may result in regulatory penalties.

On January 27, 2025, Taiwan’s Food and Drug Administration and Ministry of Health and Welfare proposed new labelling requirements for specific essence and spice ingredients.  The purpose of this or...

On January 27, 2025, Taiwan’s Food and Drug Administration and Ministry of Health and Welfare proposed new labelling requirements for specific essence and spice ingredients.  The purpose of this order is to ensure consumers receive accurate information.

Proposed amendments

The amendment focuses on changing Article 7 of the Labeling Requirements for Cosmetic Packaging, Containers, Labels, or Directions. Key changes include:

• Essences and spices may be labelled as fragrance, Flavor, Fragrance, Parfum, Perfume, or Aroma, except when specific fragrance or flavor ingredients are required to be labelled in cosmetics.
• When the concentration of any of the essences or spice ingredient listed in the Annex exceeds the following levels, the specific ingredient must be disclosed on the label. It may not be labelled as simply "Flavor," "Fragrance," "Parfum," "Perfume," or "Aroma":

• For rinse-off products: concentration greater than 0.01%.
• Products not classified as 'rinse-off products': usage concentration greater than 0.001%.

Comments

The proposed draft was notified to the World Trade Organization (WTO) on January 27, 2025, and is open for comments for 60 days from the date of publication. Comments can be submitted to the WTO at tbtenq@bsmi.gov.tw .

On November 8, 2024, the Taiwan Food and Drug Administration (FDA) announced revised guidelines for Risk Assessment for Cosmetics Containing Nanomaterials. The updates aim to strengthen regulations, e...

On November 8, 2024, the Taiwan Food and Drug Administration (FDA) announced revised guidelines for Risk Assessment for Cosmetics Containing Nanomaterials. The updates aim to strengthen regulations, ensure product safety, and align with international standards. These guidelines provide guidance to manufacturers and importers in evaluating the safety and properties of nanomaterial-containing cosmetics.

Key Highlights of the Revised Guidelines

1. Definition of Nanomaterial-Containing Cosmetics

Nanomaterial-containing cosmetics are products formulated with intentionally manufactured nanomaterials that are insoluble or non-biodegradable. These materials have dimensions or internal structures in the nanoscale range (1-100 nanometers) and may have unique properties and risks compared to conventional ingredients.

2. Alignment with International Standards

The revised guidelines follow the definitions and practices of global organizations such as the International Cooperation on Cosmetics Regulation (ICCR) and the International Organization for Standardization (ISO). According to ISO/TS 80004-1:2023, nanomaterials are materials with at least one external or internal dimension in the nanoscale range.

3. Comprehensive Risk Assessment

The guidelines provide a two-step framework for assessing the physicochemical properties of nanomaterials (e.g., particle size, shape, surface chemistry) and conducting safety evaluations (e.g., exposure analysis, toxicological studies) to ensure the safety of cosmetics before market approval.

4. Product Information File (PIF)

Manufacturers are required to prepare a PIF to document the quality and safety of their products. This includes detailed data on the physicochemical and toxicological properties of nanomaterials, which must be reviewed by qualified personnel to confirm the safety of the product.

5. Industry Reference

The guidelines provide detailed risk assessment criteria and an appendix outlining key evaluation parameters. These resources are intended to assist manufacturers conduct thorough reviews during product development and ensure compliance.

Access to the Guidelines

The revised Guidelines for Risk Assessment of Cosmetics Containing Nanomaterials are available on the official website of the Taiwan FDA. Interested parties can find the document under the "Announcements" section and the "Cosmetics Business Area > Cosmetics Regulations Area > Guidelines" page.

For more details, visit the Taiwan FDA website here.