Taiwan Regulatory News

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

On February 16, 2023, the Environmental Protection Administration Executive Yuan of Taiwan announced the notice “Regulated businesses and requirements for restrictions on packaging used in internet ...

On February 16, 2023, the Environmental Protection Administration Executive Yuan of Taiwan announced the notice “Regulated businesses and requirements for restrictions on packaging used in internet shopping”, which will come into effect on July 1, 2023.

The regulation applies to internet retailers but individual retailers on e-commerce platform are exempted.  The restrictions include:

• Packaging materials cannot contain polyvinyl chloride (PVC)

• Paper packaging boxes and bags and cardboard products should use the material of the original colour and the mixed rate of recycled paper should be more than 90%.

• The blending ratio of recycled materials should be 25% or more for plastic packaging boxes/bags and cushioning materials.

To reduce the use of plastics, the authority also requires companies with capital above 50 million NTD to work on:

• For goods with weight between 250 gram and 1 kilogram, the weight ratios between packaging and total weight should be less than 40 %.  

•  For goods with weight between 1 kilogram and less than 3 kilograms, the weight ratios between packaging and total weight should be less than 30 %. 

• For goods with weight above 3 kilograms, the weight ratios between packaging and total weight should be less than 15 %. 

To encourage the reduction of plastic packaging, the authority also sets goals for companies with capital above 150 million to reduce to 25 % by 2024, 30% by 2025 and 35 % by 2030. 

On 12 January 2023, Taiwan’s EPA announced the amendment of the notice “List of chemicals of concern subject to control and management requirements for handling them”, adding 15 concerned chemic...

On 12 January 2023, Taiwan’s EPA announced the amendment of the notice “List of chemicals of concern subject to control and management requirements for handling them”, adding 15 concerned chemical substances to the list. Out of the 15 newly added substances, it includes 5 chemical substances with food safety risks and concern, 8 explosive precursor chemicals, and 2 new psychoactive substances.

After the announcement, the 15 substances have been immediately prohibited from being traded online or on other platforms that cannot identify the trading parties. Existing handlers shall obtain approval documents and meet labelling requirements before 1 February 2024. Existing handlers should also submit monthly declaration. For new handlers, however, there is no grace period of such.

Appendix one – chemicals that concerns people livelihood 

English Name

CAS No.

Announced Date

Nitrous Oxide

1002 4- 97-2

2023-01-12 (updated)

Hydrogen Fluoride

7664 -39- 3

2023-01-12 (updated)

1,4- Butanediol

110- 63-4

2023-01-12

(S)- 5,6,6a,7- tetrahydro1,2,9,10- tetramethoxy-6- methyl-4H-dibenzo[de,g]quino line

475- 81-0

2023-01-12

Appendix two – chemicals that has food safety concern 

English Name

CAS No.

Announced Date

Lead monoxide

1317- 36-8

2023-01-12

Lead tetroxide

1314- 41-6

2023-01-12

Sodium sulfide

1313- 82-2

2023-01-12

Sodium thiocyana te

540-72- 7

2023-01-12

Β-Naphthol

135-19- 3

2023-01-12

Appendix two – explosive chemicals 

English Name

CAS No.

Announced Date

Ammonium nitrate

6484 - 52 - 2

2023-01-12 (updated)

Calcium nitrate

10124 - 37 - 5

2023-01-12

Sodium nitrate

7631 - 99 - 4

2023-01-12

Calcium ammonium nitrate

15245 - 12 - 2

2023-01-12

Nitromethane

75 -52 - 5

2023-01-12

Sodium azide

26628 - 22 - 8

2023-01-12

Ammonium perchlorate

7790- 98-9

2023-01-12

Sodium perchlorate

7601- 89-0

2023-01-12

Aluminium phosphide

20859- 73-8

2023-01-12

In 2013 voluntary national standard, CNS 15663 Guidance to Reduce the Use of Restricted Chemical Substances in Electrical and Electronic Equipment (EEE), was released by the Taiwanese Bureau of Standa...

In 2013 voluntary national standard, CNS 15663 Guidance to Reduce the Use of Restricted Chemical Substances in Electrical and Electronic Equipment (EEE), was released by the Taiwanese Bureau of Standard, Metrology and Inspection (BSMI). The standard outlines the EEE items covered, the concentration limits for 6 hazardous compounds, and the marking procedures for the presence of hazardous substances in EEE products. It is frequently referred to as Taiwan RoHS since the standard is extremely similar to the RoHS regulations in China and the EU. 

On December 23, 2022, the BSMI of Taiwan published regulations, requiring inspection of electrical UV disinfection equipment. The rules went into effect straightaway, and imported and domestically produced goods will be subject to inspection beginning May 1, 2023. These regulations contain Taiwan RoHS, also known as Section 5 "Marking of Presence" of the CNS 15663 (2013) standard. This indicates that Taiwan RoHS governs UV disinfection electrical equipment. 

Requirements:  

• Manufacturers and importers must require Registration of Product Certificate (RPC). 

• The items must comply with the CNS 15050 testing standard for controlled substances and have the BSMI mark and RoHS label on their packaging. 

• The Medical Device Management Act defines UV disinfection equipment as medical devices, therefore they are exempt from the new regulations. 

Lead, mercury, cadmium, hexavalent chromium, polybrominated biphenyls (PBBs), and polybrominated diphenyl ethers (PBDEs) are among the substances that have concentration limitations enforced, according to the CNS 15663 Guidance on Reducing Restricted Chemicals in Electrical and Electronic Equipment (EEE).