Taiwan Regulatory News

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.   

The Taiwan Food and Drug Administration (TFDA) has announced significant regulatory changes for the cosmetics industry, set to take effect on 1 July 2024. These changes primarily involve the restructu...

The Taiwan Food and Drug Administration (TFDA) has announced significant regulatory changes for the cosmetics industry, set to take effect on 1 July 2024. These changes primarily involve the restructuring of cosmetic ingredient lists and the reclassification of specific purpose cosmetics to general cosmetics, as well as enhanced reporting and compliance requirements. These updates are designed to ensure the safety and quality of cosmetic products.

Restructuring of Ingredient Lists

The TFDA will abolish the current List of Specific Purpose Ingredients and the List of Antibacterial Ingredients Allowed in Cosmetic Products. A new List of UV Filters will be established, and changes will be made to the List of Ingredients Restricted in Cosmetic Products. This includes the addition of 122 new ingredients, the revision of 31 ingredients and the deletion of 2 ingredients from the restricted list.

Reclassification of Cosmetics

Starting 1 July 2024, specific purpose cosmetics (e.g., sunscreen, hair dye, tooth whitening) will be reclassified as general cosmetics. This transition will shift the regulatory requirements from pre-market registration to a more streamlined notification process and the establishment of a Product Information File (PIF). This change aims to simplify the compliance process for cosmetic companies, reduce the administrative burden and expedite product launches.

Compliance and Reporting Requirements

Cosmetics manufacturers and importers must comply with the new notification system and prepare PIFs for inspection by the TFDA. The notification system will require detailed information about the product, including safety assessments and compliance with Good Manufacturing Practices (GMP).

Phased Compliance Schedule

To facilitate a seamless transition, the TFDA has established a phased compliance schedule:

• Specific Purpose Cosmetics: Must comply by 1 July 2024.

• Non-Specific Purpose Cosmetics for Infants, Lips, or Eyes: Compliance required by 1 July 2025.

• Other Non-Specific Purpose Cosmetics: Compliance required by 1 July 2026.

The new regulations are designed to improve the safety and quality of cosmetic products. Cosmetics companies are advised to prepare for these changes to ensure seamless compliance by the 1 July 2024 deadline.

Effective June 6, 2024, the Occupational Safety and Health Administration (OSHA) under the Ministry of Labour  in Taiwan has implemented amendments to the "Regulations for Governing Designating and H...

Effective June 6, 2024, the Occupational Safety and Health Administration (OSHA) under the Ministry of Labour  in Taiwan has implemented amendments to the "Regulations for Governing Designating and Handling of Priority Management Chemicals." These revisions aim to further develop the safety protocols and management practices for hazardous chemicals in workplaces, focusing on strict reporting requirements to improve safety measures to protect workers’ health and the environment.

Key Changes to the Regulations

The revised regulations prioritise the management of hazardous chemicals. These include carcinogens, mutagens, reproductive toxicants, respiratory sensitizers, substances causing serious eye damage and specific target organ toxicants (STOT). These classifications follow national standards (CNS 15030).

Reporting Requirements

Operators must submit detailed reports to the Central Authority. There are three types of reporting.

• Initial Reporting: Submit comprehensive details about operations, including chemical quantities and handling practices, including any changes in operations.

• Periodic Reporting: Provide annual updates on the use and management of chemicals.

• Dynamic Reporting: Report any significant changes in chemical quantities within 30 days of the change to ensure data is kept up to date.

Enforcement and Penalties

The amendments impose strict penalties for non-compliance, including fines for false information, failure to report or errors in submissions. Products that are exempted from the updated priority manager measure are industrial waste, tobacco, food, beverages, medicines, cosmetics, finished products, fire extinguishers and consumer goods for non-industrial use.

Safety Measures

Operators are required to maintain accurate records and follow strict safety measures when handling hazardous chemicals. By enforcing stricter reporting requirements and improving safety protocols, the Ministry of Labour aims to reduce the risks associated with hazardous chemicals to protect workers and the environment.

Conclusion

The updated regulations highlight the government's dedication to maintain high workplace safety standards by imposing a stricter chemical management system.

On 24 April, 2024, in compliance with the Stockholm Convention, Taiwan’s Ministry of Environment (MOE) added perfluorohexane sulfonic acid and its related compounds as toxic chemicals. This amendmen...

On 24 April, 2024, in compliance with the Stockholm Convention, Taiwan’s Ministry of Environment (MOE) added perfluorohexane sulfonic acid and its related compounds as toxic chemicals. This amendment aims to strengthen the regulation of perfluoroalkyl compounds and set a stricter control to prevent environmental pollution and human harm.

Details of the New Regulation

Perfluorohexane sulfonic acid and its related compounds are now categorised as Class I toxic chemicals and are subject to management regulations. Additionally, perfluorooctane sulfonic acid (PFOS), its lithium salt (PFOS-Li), perfluorooctanesulfonyl fluoride (PFOSF), and perfluorooctanoic acid (PFOA) will be phased out from Class B fire-fighting foam equipment in accordance with the Stockholm Convention's deadline.

Sales and Import Ban

Regarding the sales of sulfonic acid, its salts and related compounds, currently there is a comprehensive ban on manufacturing, sales and import. However, exemptions will be made for research, testing and relevant educational purposes.

Environmental and Human Health Protection

To mitigate the harmful impact on environment and human from perfluoro and polyfluoroalkyl substances (PFAS), the administration has regulated PFOS, PFOS-Li, PFOSF and PFOA as toxic chemicals in accordance with the law. This amendment will strengthen the regulation of PFASs, exert a stricter control and eliminate their use in current firefighting foam equipment for Class B fires according to the deadline of the Stockholm Convention.

On April 11, 2024, Taiwan’s Food and Drug Administration under the Ministry of Health and Welfare announced the types of cosmetics and implementation dates for which product information files (PIFs)...

On April 11, 2024, Taiwan’s Food and Drug Administration under the Ministry of Health and Welfare announced the types of cosmetics and implementation dates for which product information files (PIFs) should be established.

About the Cosmetic PIF

The cosmetic PIF must contain the following (according to Article 3 of the Cosmetic Product Information File Management Regulations):

1. Basic information about the product: the name of the product, the category of the product,
2. dosage form, purpose, the names and addresses of manufacturing facilities, information
3. of product manufacturers or importers.
4. Evidentiary documents of completing product notification.
5. Full ingredient names and the individual content.
6. The outer packaging of the products, containers, labels, or leaflets.
7. GMP compliance certificates or self-declarations which the manufacturing facilities
8. comply with cosmetic Good Manufacturing Practice Regulations.
9. Manufacturing methods and procedures.
10. Usage methods, body parts, dosage, frequencies, and the targeted population.
11. Adverse effects of the product application.
12. Physical and chemical characteristics of the products and individual ingredients.
13. Toxicological data of the ingredients.
14. The product stability test reports.
15. The microbiological test reports.
16. The antimicrobial effectiveness test reports.
17. Supporting information on the functional assessments.
18. Information about the packaging materials which have contact with the products.
19. Product safety information

The Cosmetic Hygiene and Safety Act requires companies to establish a PIF before launching a product in Taiwan, according to the Cosmetic Hygiene and Safety Act.