Taiwan Regulatory News

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.

The Taiwan Food and Drug Administration (FDA) has released a new guideline that outlines the official list of ultraviolet (UV) filters permitted for use in cosmetic products. The regulations, which ar...

The Taiwan Food and Drug Administration (FDA) has released a new guideline that outlines the official list of ultraviolet (UV) filters permitted for use in cosmetic products. The regulations, which are effective from 1 July 2024, have been translated into English from the original Chinese version, with the Chinese version prevailing in cases of inconsistency. The guideline lists the chemical names, International Nomenclature of Cosmetic Ingredients (INCI) names, CAS numbers, use restrictions, maximum concentrations and any required precautions for each UV filter.

The list includes 27 UV filters with specific details as follows:

1. Ethylhexyl Dimethyl PABA (Padimate O) - Maximum concentration: 8%.

2. Benzophenone-3 (Oxybenzone) - Maximum concentration: 6% (0.5% when used for product protection).

   - Precaution: Contains Benzophenone-3.

3. Benzophenone-4/5 (Sulisobenzone) - Maximum concentration: 5% (as acid).

4. Homosalate - Maximum concentration: 10%.

5. Ethylhexyl Methoxycinnamate (Octinoxate) - Maximum concentration: 10%.

6. Ethylhexyl Salicylate (Octisalate) - Maximum concentration: 5%.

7. Phenylbenzimidazole Sulfonic Acid (Ensulizole) - Maximum concentration: 8% (as acid).

8. Butyl Methoxydibenzoylmethane (Avobenzone) - Maximum concentration: 5%.

9. Terephthalylidene Dicamphor Sulfonic Acid (Ecamsule)** - Maximum concentration: 10% (as acid).

10. Octocrylene - Maximum concentration: 10%.

11. Zinc Oxide - Maximum concentration: 25% (less than 10% when used as an astringent).

12. Drometrizole Trisiloxane - Maximum concentration: 15%.

13. Methylene Bis-Benzotriazolyl Tetramethylbutylphenol (Bisoctrizole) - Maximum concentration: 10%.

14. Bis-Ethylhexyloxyphenol Methoxyphenyl Triazine (Bemotrizinol)- Maximum concentration: 10%.

15. Polysilicone-15 - Maximum concentration: 10%.

16. Ethylhexyl Triazone- Maximum concentration: 5%.

17. Diethylamino Hydroxybenzoyl Hexyl Benzoate - Maximum concentration: 10%.

18. Benzylidene Camphor Sulfonic Acid - Maximum concentration: 6% (as acid).

19. Camphor Benzalkonium Methosulfate - Maximum concentration: 6%.

20. Diethylhexyl Butamido Triazone (Iscotrizinol) - Maximum concentration: 10%.

21. Disodium Phenyl Dibenzimidazole Tetrasulfonate - Maximum concentration: 10% (as acid).

22. soamyl p-Methoxycinnamate (Amiloxate) - Maximum concentration: 10%.

23. 4-Methylbenzylidene Camphor (Enzacamene) - Maximum concentration: 4%.

24. PEG-25 PABA - Maximum concentration: 10%.

25. Polyacrylamidomethyl Benzylidene Camphor - Maximum concentration: 6%.

26. Tris-Biphenyl Triazine - Maximum concentration: 10%.

   - Restriction: Prohibited for use in spray products.

27. Titanium Dioxide - Maximum concentration: 25%.

Additional Regulations

- UV filters not listed in this guideline or not approved by the European Union, the United States or Japan may not be used in cosmetics.

- Products claiming to provide sun protection must include supporting documentation for sun protection efficacy in their product information file.

This guideline sets forth the regulations for UV filters in cosmetic products, detailing specific ingredients, concentrations and restrictions effective from 1 July 2024. Compliance with these guidelines is crucial for manufacturers to ensure product safety and efficacy in line with international standards.

On 16 June 2024, Taiwan closed the comment period for the adoption of the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8) through the CNS ...

On 16 June 2024, Taiwan closed the comment period for the adoption of the eighth revised edition of the Globally Harmonized System of Classification and Labelling of Chemicals (GHS 8) through the CNS 15030 standard. In order to align with UN GHS 8, the Ministry of Economic Affairs (MOEA) under the Bureau of Standards, Metrology and Inspection (BSMI) of Taiwan is in charge of updating the CNS 15030 serial standards. 21 of the present 29 CNS 15030 series standards will be changed, and a new hazard class for desensitized explosives (CNS 15030-29) will be introduced. 

Similar to China, Taiwan is revising its Chinese National Standard (CNS) to align the GHS framework with GHS 8. Major updates to the CNS 15030 series standards are being worked on in Taiwan, and results are expected by the end of 2024.     

Taiwan transitioning to GHS 8 

Taiwan is currently awaiting the final release of the official standard. Once released, GHS 8 will be adopted in Taiwan and the GHS 4 provisions will be repealed.  

Key Updates to CNS 15030 Standards   

The classification and hazard categories have been updated as follows:  

• Desensitized Explosives: A new hazard class and corresponding new elements for the hazard class and labelling have been added.  

• Flammable Gases: Category 1 has been divided into Category 1A and 1B, with flammable gases, chemically unstable gases and pyrophoric gas classified under Category 1A.  

• Aerosols: Aerosol Category 3 has been added and the name of the class has been changed to ‘Aerosol and Chemicals under Pressure’. The definition of chemicals under pressure has been introduced.  

• Other Revisions: Definitions, classification criteria and OECD testing guidelines for acute toxicity, skin corrosion/irritation and serious eye damage/eye irritation have been revised.   

Previously Taiwan adopted GHS 4  

Since 1 December 2014, Taiwan has been using the fourth revised edition of UN GHS. The Ministry of Labour (MoL) Notice No. 10302007861 of 27 June 2014 and the Environmental Protection Administration (EPA) Notice No. 1030094561 of 10 November 2014, together established the Chinese National Standard CNS 15030: Classification and Labelling of Chemicals, were used to adopt GHS 4. Taiwan has already released 28 CNS standards (CNS 15030-1 to CNS 15030-28) in accordance with GHS 4.