Introduction to Taiwan REACH Regulation

Annual Reporting for all New and Existing substances is open for submission between 1st April 2020 and 30th September 2020.

The recent chemical regulation in Taiwan is called Toxic Chemicals and Concerned Substances Control Act (TCCSCA) and it enforced one January 1, 2020. The supplementing regulation for regulating substance registration, Regulation on New and Existing Chemical Substances, was published on March 11 2019. Manufacturers exporting to Taiwan have to comply with the TCCSCA. The compliance obligations are depending on types of substance and its quantity.

Phase One Registration

Manufacturers / Importers, who manufacture/import existing chemical substances in an annual amount of 100 kilograms or more, should apply for the Phase One Registration within 6 months from the date of manufacture/import.

Standard Registration

Taiwan's EPA announced the first batch of Priority Existing Chemical (PEC) in which contains 106 substances. Companies manufacturing/importing PECs with a quantity above 1 TPA need to submit Standard Registration:

Before December 31, 2024 if the Phase One Registration Number was received before December 31, 2019.
Within 5 years if the Phase One registration Number was received after January 1, 2020, starting from January 1 of the year following the date the number was obtained.

Registration for New Chemicals

New Chemical Substances can be registered in three types: Standard registration (above 1 TPA), Simpliﬁed registration (between 100 kilograms to 1 TPA) and Small quantity registration (less than 100 kilograms). Companies need to submit their application 90 days before manufacturing or importing.

Non-Taiwanese manufacturers not willing to disclose their product information to their Taiwanese clients (Importers) can ask the importers to nominate a Representative to fulfil their compliance and annual reporting obligations.

GPC Taiwan can support you to comply with TCCSCA with following services:

Phase One Registration of Existing Substance
New and existing substance (PECs) registration support
Regulatory & compliance Submission to the IT system
Consortia communication
Communication with the competent regulatory authorities (TCSB)
Substance Sameness & Identification related follow up queries
Certificate of compliance and tonnage coverage to the Buyers (on your behalf)
Annual Report for all substances

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Taiwan FDA Releases New Guideline on UV Filters in Cosmetic Products Effective from 1 July 2024

Aug-29-2024

The Taiwan Food and Drug Administration (FDA) has released a new guideline that outlines the official list of ultraviolet (UV) filters permitted ...

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.

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Taiwan to adopt GHS 8 in 2024

Aug-06-2024

On 16 June 2024, Taiwan closed the comment period for the adoption of the eighth revised edition of the Globally Harmonized System of Classificat...

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.  