Taiwan Regulatory News

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).  

The Environmental Protection Administration (EPA) of Taiwan has amended some of the articles of Regulations for the Labelling and Materials Safety Data Sheets for Toxic and Concerned Chemical Substanc...

The Environmental Protection Administration (EPA) of Taiwan has amended some of the articles of Regulations for the Labelling and Materials Safety Data Sheets for Toxic and Concerned Chemical Substances. The amended regulation came into force on 4 November 2022, except for Articles 3 and 4 where it will be effective from 31 October 2023.

The amendments were based on a consultation that was published on 21 July 2022 and closed on 20 August 2022. The amendment was made to align with the EU’s Regulation on Classification, Labelling, Packaging of Substances and Mixtures (CLP Regulations).

Before the amendments, companies only needed to indicate the hazardous substances presented in the mixtures. Now, companies have to list all hazardous substances on the SDS and the label. The information on hazardous substances can be labelled in two ways. Companies can include the hazard information if the testing report is available for the mixture. If there is no available testing result for mixtures, companies should follow the national standard CNS 15030 to label the substances’ hazards.

Articles 3 and 4 of the regulation concern the labelling requirements and the packaging size. See earlier news on this.

On August 17, 2022, Taiwan’s Food and Drug Administration (FDA) published an amendment to the Safe Guidance of Cosmetic products used by children. The new amendment specifies certain chemicals shou...

On August 17, 2022, Taiwan’s Food and Drug Administration (FDA) published an amendment to the Safe Guidance of Cosmetic products used by children. The new amendment specifies certain chemicals should not be used cosmetic used by children. To summarize the new requirements:

• Infant related cosmetic products should not contain Escherichia coli, Pseudomonas aeruginosa, Staphylococcus aureus, in addition to Candida albicans specified in the previous guidance.
• Cosmetic products containing Calcium salicylate, Magnesium salicylate, MEA-salicylate 、 Sodium salicylate, Potassium salicylate, TEA-salicylate need to specify children below three years should not use (shampoo related product are exception). In the earlier guidance, only salicylic acid is mentioned.
• Cosmetic products containing Hydrogen peroxide, Urea peroxide should include label “children under 12 years old are not recommended to use”.
• Cosmetic products containing ingredients of Camphor, Menthol, Methyl Salicylate should include label “children below 2 years old are recommended to not use”. Earlier, it only mentions use before consulting doctors or pharmacist.
• Nail polisher related cosmetics that contain ingredients Toluene should include label, “avoid contact with children”  
• Ccosmetics products ingredients Thioglycolic acid, Potassium hydroxide, Sodium hydroxide should include “should storage at site not reachable by children”  
• For non-medicinal toothpastes with a fluoride content of 0.1 to 0.15%, if there is no indication that children are prohibited from using it, it should be stated as "The maximum size of rice grains per time for children under 3 years old; the maximum size of a pea per time for children aged 3 to 6 years," And try to avoid swallowing.”
• Non-medicated toothpastes and mouthwashes contain Strontium compounds should include labels “Not recommended for frequent use on children”  
• Cosmetics contain talc (Talc) ingredients, it is recommended to label "keep away from mouth and nose when children use it".
• Cosmetics containing Iodopropynyl butylcarbamate should be marked with the precaution "Not for use by children under 3 years old" (bath and shampoo products are exempt from the precautions)
• Oral, lip and eye cosmetics contain silver chloride should label “Not for use by children under 3 years old”.
• Cosmetics contain ingredients of Butylparaben, Propylparaben, Sodium propylparaben, Sodium butylparaben, Potassium butylparaben, Potassium propylparaben should include lable: “Do not use on children under 3 years of age on the diaper area”
• Cosmetic products containing ingredients of Ethyl lauroyl arginate HCl should include label of “Not for use by children under 10 years old”.

The Safe Guidance of Cosmetic products used by children was first published in 2016 to ensure safety of cosmetic products used by children. With this new guidance, cosmetic companies will need to include those labels or warning text on their products.

Taiwan’s EPA plans to modify the “Regulations for the Labelling and Materials Safety Date Sheets for Toxic and Concerned Chemical Substances” and is consulting until 20 August. This modification...

Taiwan’s EPA plans to modify the “Regulations for the Labelling and Materials Safety Date Sheets for Toxic and Concerned Chemical Substances” and is consulting until 20 August. This modification is to harmonize with EU’s Regulation on the classification, labelling and packaging (CLP) and to ensure the information of the labelling for toxic and concerned chemicals is clearly conveyed.

The current labelling is consisted of pictogram and content. On the content, it includes name, hazardous ingredients, cautious and warning words, hazard statement, precautionary statements, manufactures/suppliers’ information (e.g., name, address, telephone number).

According to the draft amendment published on July 21, key modifications are:

• Adding containers and packaging’ smallest size requirement. Manufacturers may use fordable labels or attached to the containers if the surfaces or materials of the containers are limited. 
• For toxic and concerned chemicals substances, if the hazardous characteristics cannot be classified in accordance with the classification schemed in the National Standard CNS 15030, manufacturers are allowed to only label name, hazardous ingredients and manufacturer/suppliers’ info.
• For package under 100 ml, it only needs to label name, pictogram and cautious and warning words.
• The government may issue specific wording to certain chemicals that are under control. For instance, in order to manage the use of Nitrous oxide (laughing gas), the government may ask manufacturers to include “restricted for industrial use, prohibited for recreational use”  

After the modification, Taiwanese government will give manufacturers one-year grace period to adopt to the new labelling requirements, which as the EPA stated is 31 August 2023.  

This modification can help industries to prepare the labelling more consistent with both export and import requirements. For package/container under 100 ml, the label requirements are reduced.