Công văn 18136/QLD-MP năm 2016 về rà soát thành phần công thức sản phẩm mỹ phẩm do Cục Quản lý Dược ban hành

To: Producers and traders of cosmetic products

On September 06, 2016, the U.S Food & Drug Administration (FDA) has issued the rule for antiseptic soap, hand and body wash products containing one or more of 19 sterilants (the list of 19 sterilants is enclosed hereto) which shall be only sold on the US market up to September 06, 2017 inclusively (12 months as of the issuance of the said rule) because producers did not demonstrate that these products are more effective than products which do not contain any of the said sterilants.

As a member of the ASEAN Cosmetic Committee (ACC), the Drug Administration of Vietnam has proposed the new rule issued by U.S FDA to the ASEAN Secretariat of ACC for discussion at the 25th meeting of the ASEAN Cosmetic Scientific Body (ACSB) organized in Brunei in the next November in order that ACC may make decision thereof.   

Pending the official decision by ACC, for the purposes of ensuring efficiency and safety of users as well as avoiding waste for producers and traders of cosmetic products, the Drug Administration of Vietnam hereby request producers and traders of cosmetic products to actively check ingredients of antiseptic cosmetic products which have been registered with governing bodies (the Drug Administration of Vietnam or Departments of Health), make plans for replacing sterilants contained in produced and imported cosmetic products in order to ensure that only actually effective cosmetic products are sold to consumers, and submit reports thereof to the Drug Administration of Vietnam and Department of Health of province or city where the producer/trader locates.

The Drug Administration of Vietnam shall update and inform regulations by ACC for 19 sterilants mentioned above to producers/traders of cosmetic products in a timely manner for implementation.

LIST OF 19 STERILANTS WARNED BY U.S FDA

(Enclosed to the Official Dispatch No. 18136/QLD-MP dated September 15, 2016 by the Drug Administration of Vietnam)

1. Cloflucarban

2. Fluorosalan

3. Hexachlorophene

4. Hexylresorcinol

5. Iodophors (Iodine – containing ingredients)

6. Iodine Complex (ammonium ether sulfate and polyoxyethylene sorbitan monolaurate)

7. Iodine Complex (phosphate ester of alkylaryloxy polyethylene glycol)

8. Nonylphenoxypoly (ethyleneoxy) ethanoliodine

9. Poloxamer – iodine complex

10. Povidone-iodine 5 - 10 %

11. Undecoylium chloride iodine complex

12. Methylbenzethonium chloride

13. Phenol

14. Secondary amyltricresols

15. Sodium oxychlorosene

16. Tribromsalan

17. Triclocarban

18. Triclosan

19. Triple dye

---------------

This document is handled by Dữ Liệu Pháp Luật . Document reference purposes only. Any comments, please send to email: [email protected]