Công văn 18136/QLD-MP 2016 rà soát thành phần sản phẩm mỹ phẩm

THE MINISTRY OF HEALH
THE DRUG ADMINISTRATION OF VIETNAM 

Official Dispatch No. 18136/QLD-MPdated September 15, 2016 of the Drug Administration of Vietnam onchecking ingredients of cosmetic products

To:Producers and traders of cosmetic products

On September 06, 2016, the U.S Food & Drug Administration (FDA) has issued the rule forantisepticsoap, 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), theDrug Administration of Vietnamhas proposed the new rule issued by U.S FDA to theASEAN Secretariatof ACC for discussion at the 25thmeeting 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, theDrug Administration of Vietnamhereby 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.

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

For the Director

The Deputy Director

Do Van Dong

LIST OF 19 STERILANTS WARNED BY U.S FDA

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

1. Cloflucarban

2. Fluorosalan

3. Hexachlorophene

4. Hexylresorcinol

5. Iodophors (Iodine –containing ingredients)

6. IodineComplex(ammonium ether sulfateandpolyoxyethylene sorbitan monolaurate)

7.IodineComplex(phosphate esterofalkylaryloxy polyethylene glycol)

8. Nonylphenoxypoly (ethyleneoxy) ethanoliodine

9. Poloxamer – iodinecomplex

10. Povidone-iodine 5 - 10 %

11. Undecoylium chloride iodinecomplex

12. Methylbenzethonium chloride

13. Phenol

14.Secondary amyltricresols

15. Sodium oxychlorosene

16. Tribromsalan

17. Triclocarban

18. Triclosan

19. Triple dye