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 Revises Guidelines for Cosmetics Containing Nanomaterials to Enhance Safety and Regulation

Dec-17-2024

On November 8, 2024, the Taiwan Food and Drug Administration (FDA) announced revised guidelines for Risk Assessment for Cosmetics Containing Nano...

On November 8, 2024, the Taiwan Food and Drug Administration (FDA) announced revised guidelines for Risk Assessment for Cosmetics Containing Nanomaterials. The updates aim to strengthen regulations, ensure product safety, and align with international standards. These guidelines provide guidance to manufacturers and importers in evaluating the safety and properties of nanomaterial-containing cosmetics.

Key Highlights of the Revised Guidelines

Definition of Nanomaterial-Containing Cosmetics

Nanomaterial-containing cosmetics are products formulated with intentionally manufactured nanomaterials that are insoluble or non-biodegradable. These materials have dimensions or internal structures in the nanoscale range (1-100 nanometers) and may have unique properties and risks compared to conventional ingredients.

Alignment with International Standards

The revised guidelines follow the definitions and practices of global organizations such as the International Cooperation on Cosmetics Regulation (ICCR) and the International Organization for Standardization (ISO). According to ISO/TS 80004-1:2023, nanomaterials are materials with at least one external or internal dimension in the nanoscale range.

Comprehensive Risk Assessment

The guidelines provide a two-step framework for assessing the physicochemical properties of nanomaterials (e.g., particle size, shape, surface chemistry) and conducting safety evaluations (e.g., exposure analysis, toxicological studies) to ensure the safety of cosmetics before market approval.

Product Information File (PIF)

Manufacturers are required to prepare a PIF to document the quality and safety of their products. This includes detailed data on the physicochemical and toxicological properties of nanomaterials, which must be reviewed by qualified personnel to confirm the safety of the product.

Industry Reference

The guidelines provide detailed risk assessment criteria and an appendix outlining key evaluation parameters. These resources are intended to assist manufacturers conduct thorough reviews during product development and ensure compliance.

Access to the Guidelines

The revised Guidelines for Risk Assessment of Cosmetics Containing Nanomaterials are available on the official website of the Taiwan FDA. Interested parties can find the document under the "Announcements" section and the "Cosmetics Business Area > Cosmetics Regulations Area > Guidelines" page.

For more details, visit the Taiwan FDA website here.

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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.