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

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.