Argentina's National Drug, Food and Medical Technology Administration (ANMAT) has issued a resolution forbidding the use of antibacterial substances in products for personal hygiene, such as liquid soaps, solid soaps, foams, gels and all kinds of antiseptic wash products for hands and body that are designed for use with water and subsequent rinse.
Resolution No. 13,832/2016, which has been issued in late December 2016, forbids the use of eight ingredients in antibacterial products. The involved substances are Cloflucarban, Fluorosalan, Hexylresorcinol, Amiltricresoles secundarios, Methylbenzetonium Chloride, Oxicloroseno de sodio, Triclocarban, and Triclosan (in the case of Triclosan limited to certain products, such as soaps, among others). For certain other products such as toothpaste, mouth washes, deodorants, facial creams, and nail cleaning products, the allowable concentration of Triclosan is limited.
This resolution of the ANMAT is based upon a final rule of the FDA (21 CFR Part 310 "Safety and Effectiveness of Consumer Antiseptics; Topical Antimicrobial Drugs Products for Over-the-Counter Human Use"), that was issued in September 2016 on the same subject, and which will come into force in September 2017. Within that reasoning, ANMAT supports its decision by asserting that there is reliable scientific data indicating that in the long term exposure to certain active ingredients used within antibacterial products may represent risks to the general health, both relating to triggering resistance to antimicrobials and hormonal effects. Some other arguments incorporated by reference to the FDA's ruling also indicate that there is no scientific evidence that antibacterial products comprising the banned active ingredients are more efficient than regular soaps in preventing diseases and/ or infections.
Different to the FDA ruling that will come into force in September 2017, ANMAT's new resolution will come into force in late December 2018. However, the Argentine OTC industry is already planning ahead to abide by the new regulation.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.
