Taiwan Regulatory News

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.

On 13 December 2023, the Taiwanese Ministry of Health and Welfare published a revised list of prohibited substances in cosmetics. The list will take effect on 1 July 2024. Taiwan’s Food and Drug Adm...

On 13 December 2023, the Taiwanese Ministry of Health and Welfare published a revised list of prohibited substances in cosmetics. The list will take effect on 1 July 2024. Taiwan’s Food and Drug Administration (FDA) is seeking feedback on perfluorooctane sulfonic acid (PFOS), perfluorooctanoic acid (PFOA), and seven other substances included in the published revised list.

About the revised list of prohibited substances

The list of substances added to the prohibited list is as follows:

Exemptions are proposed for FDA-approved human-derived cells, tissues, and products, but zirconium and its constituents are banned from all cosmetics, including spray cosmetics.

Deadline for comments

The draft is open for public comment for 60 days (till 15 February 2024) from the date of its publication. Comments can be sent to the authority at joyin@fda.gov.tw.

Control of PFAS in industry

On 20 December 2023, Taiwan's Ministry of Environment (MoE) presented a plan to manage persistent organic pollutants (POPs) under the Stockholm Convention, including PFAS such as PFOS, PFOA, and perfluorohexane sulfonic acid (PHFxS). It was presented in the “Seminar on the Current Status and Future Prospects of Per- Polyfluorofluoroalkyl Substances (PFAS) Management" at the Socrates Hall of the Chiitai University Convention Center. The plan aims to manage pollution sources, control the spread of pollutants, integrate international regulations, control industrial use, and communicate risks. The MoE will encourage the industry to reduce the use of PFASs, strengthen communication, and educate the public. The plan was outlined during a workshop on PFAS.

The MoE emphasizes the need for continuous inter-ministerial cooperation to effectively control PFAS, reduce health risks, and protect public safety, while promoting a healthy and sustainable environment.

On October 2023, Taiwan Food and Drug Administration (TFDA) Taiwan updated its guidance for Product Information File (PIF) for cosmetics. It includes guidelines on the preparation of PIF, manual for ...

On October 2023, Taiwan Food and Drug Administration (TFDA) Taiwan updated its guidance for Product Information File (PIF) for cosmetics. It includes guidelines on the preparation of PIF, manual for the establishment of PIF, and PIF checklist. The main revision are on the documents of terminology and references for documents, PIF documents, and the alternatives to animal testing. All the documents came into force upon their release on 2 October 2023. 

If you have any further inquiry regarding Taiwan REACH TCCSCA or cosmetic registration, please contact GPC via compliance@gpcregulatory.cn or zhengmin@cn.gpcregulatory.com. 

In April 2023, Taiwan’s EPA published two draft documents for dossier preparation and is now searching for public comments. The first document is the Overview of QSAR Model Validation Methods (draft...

In April 2023, Taiwan’s EPA published two draft documents for dossier preparation and is now searching for public comments. The first document is the Overview of QSAR Model Validation Methods (draft) (in Mandarin). The document was initially prepared by the European Chemicals Agency (ECHA) and the OECD. With the permission from the OECD, Taiwan’s Toxic and Chemical Substances Bureau (TCSB) translated the “Guidance Document on the Validation of (Quantitative) Structure-Activity Relationship [(Q)SAR] Models, OECD Series on Testing and Assessment, No. 69, OECD, 2014” into Mandarin to facilitate the preparation of dossiers for companies.

The second document considers the grouping of chemicals, based on the document the “Guidance on Grouping of Chemicals, Second Edition, OECD Series on Testing and Assessment, No. 194, OECD, 2017” published by the OECD. This document is also translated into Mandarin. The purpose of this document is to avoid unnecessary animal testing when alternative methods are available for data generation.

The authority specifies that these two documents can only be used as reference documents. Compliance obligations need to follow the Regulations of New and Existing Chemical Substances Registration.

Both documents are available on TCSB’s website. Comments for these two draft documents are welcome and should be sent via mail to Chemist@eri.com.tw.

On 24 March 2023 Taiwan’s EPA published the updated Guidance for New and Existing Chemical Substance Phase One Registration and Guidance on Chemical Substances Hazard and Exposure Assessment. The up...

On 24 March 2023 Taiwan’s EPA published the updated Guidance for New and Existing Chemical Substance Phase One Registration and Guidance on Chemical Substances Hazard and Exposure Assessment. The updated guidelines aim to help companies to meet their dossier submission obligations under the Toxic and Chemical Substances of Concern Control Act (TCSCCA). 

Phase one registration is required for existing chemical substances manufactured in or imported to Taiwan with the quantity above 100 kg. Registrants that completed Phase One Registration will receive a Registration Number. Based on the issued date of this number, companies need to submit dossier in following date:

• Phase One Registration received before 31 December 2019 and the tonnage reaches 1 TPA, companies should complete dossier submission by 31 December 2024.
• Phase One Registration received after 1 January 2020 and the tonnage reaches 1 TPA in the same year, companies should complete dossier submission within 5 years.

For inquiry on Taiwan TCCSCA, contact compliance@gpcregulatory.com