Taiwan Regulatory News

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.

The Food and Drug Administration of Taiwan (FDA) is consulting on amending the list of restricted cosmetic ingredients. This revision will create a list of permitted UV filters and abolish the lists o...

The Food and Drug Administration of Taiwan (FDA) is consulting on amending the list of restricted cosmetic ingredients. This revision will create a list of permitted UV filters and abolish the lists of special use and antibacterial ingredients. 

Content of the revision plan

In this notification, FDA called for abolishing the list of specific purpose ingredients in cosmetic products – a positive list of hair dyes such as acid red 91, sunscreen agents and antiperspirant deodorant agents like aluminum chloride. The sunscreen agents would be transferred to a newly created draft list of UV filters. The other 122 substances included on the special use cosmetics list would be transferred to a revised list of ingredients restricted in cosmetic products. 

Under this plan, the list of antimicrobials in cosmetics will be merged in the list of restricted cosmetics. Additionally, FDA has proposed changes to the use restrictions on: 

• Allantoin;
• Inorganic sulfites and bisulfites;
• Thioglycolic acid and its salts;
• Potassium or sodium hydroxide;
• Lithium hydroxide; and 
• 1,3-benzenediol.

Impact of the revision plan 

The consultation period of this plan in until 5^th March 2024. The revised lists are expected to enter into force on 1^st July 2024. If the new list enter into force, the proposed restructuring would align the country with the positive list systems for cosmetics in EU, US and ASEN countries. 

For further information, please contact GPC via compliance@gpcregulatory.cn or Zhengmin@cn.gpcregulatory.com.

On 4 January 2023, the Food and Drug Administration (FDA) of Taiwan published 2 amendments and an announcement regarding the Cosmetics Regulation. The Ministry of Health and Family Welfare is consider...

On 4 January 2023, the Food and Drug Administration (FDA) of Taiwan published 2 amendments and an announcement regarding the Cosmetics Regulation. The Ministry of Health and Family Welfare is considering updating the restricted list of cosmetic ingredients, and the restricted list of cosmetic sunscreens (allowing UV filters) and abolishing special use and antimicrobial compounds. This initiative aims to align Taiwan’s cosmetics regulation with the positive list approach used by the EU, US, and ASEAN countries.

Abolition of the use of Antimicrobial Ingredients

It has been discovered that the EU, US, Japan, ASEAN, and other international countries have not developed lists of antibacterial ingredients for cosmetics, and therefore the antimicrobial list will be abolished.

The abolishment of the Basic Table of Usage and Limitation Regulations for Antibacterial Ingredients in Chemical Components is scheduled to take effect on 1 July. The contents of the abolished list will be added

Amendments to the previous list of restricted substances

In order to enhance the safety of the use of cosmetic ingredients, Taiwan’s FDA updated the draft of the amendment to the Cosmetic Ingredient Use Restriction List. The provisions of the original "List of Names of Ingredients and Restrictions on the Use of Ingredients for Specific Purposes" will be incorporated into the "Table of Restrictions on the Use of Cosmetic Ingredients", "Table of Restrictions on the Use of Chemical Ingredients" and "Table of Restrictions on the Use of Sunscreen Ingredients in Chemical Products", which will be abolished and will take effect on 1 July.

The FDA has also proposed changes to the following ingredients:

1. Allantoin

2. Inorganic sulfites and bisulfites

3. Titanium dioxide

4. Thioglycolic acid and its salts

5. Potassium or sodium hydroxide

6. Lithium hydroxide

7. Calcium hydroxide 

8. 1,3-benzenediol

Restricted Sunscreen Ingredient list

Twenty-seven restricted sunscreen ingredients are combined into the newly drafted Cosmetic Sunscreen Ingredient Usage Restriction List. In accordance with the Cosmetic Hygiene and Safety Management Act, the sunscreen agents specified under the Specific Use Cosmetic Ingredient Names and Use Restrictions List and Titanium Dioxide ingredients originally specified in the Cosmetic Ingredient Use Restriction List were added to the newly formed list.

Deadline for comments

Comments will be accepted at sherrycty@fda.gov.in till 5 March 2024., The updated lists are anticipated to enter into force on 1 July 2024.

On 13th December 2023, Taiwan Food and Drug Administration (FDA) published a notification to solicit comments on amending “List of Prohibited Cosmetic Ingredients”. The revised list was published...

On 13^th December 2023, Taiwan Food and Drug Administration (FDA) published a notification to solicit comments on amending “List of Prohibited Cosmetic Ingredients”. The revised list was published on 13^th December 2023 and it is expected to come into force from 1^st July 2024. 

It included the following 9 ingredients: 

• aminocaproic acid and its salts;
• 3- and 4-(4-Hydroxy-4-methylpentyl) cyclohex-3-ene-1-carbaldehyde; 
• 2,6-Dihydroxy-4-methyl-benzaldehyde (atranol); 
• 3-Chloro-2,6-Dihydroxy-4-methylbenzaldehyde (chloroatranol); 
• perfluorooctane sulfonic acid (PFOS) and its salts potassium perfluorooctanesulfonate, diethanolamine perfluorooctane sulfonate, ammonium perfluorooctane sulfonate and lithium perfluorooctane sulfonate; 
• ammonium pentadecafluorooctanoate;
• perfluorooctanoic acid (PFOA);
• nonadecafluorodecanoic acid (PFDA) and its salts ammonium nonadecafluorodecanoate and sodium nonadecafluorodecanoate; and 
• perfluorononan-1-oic acid and its sodium and ammonium salts.

The solicitation period is 60 days until 14 February 2024. For more information, please contact GPC via compliance@gpcregulatory.com or zhengmin@cn.gpcregulatory.com.