Regulatory Prohibition Of Hexachlorophene For Use In Cosmetic Formulations

Written by Cosmoally Team • 22-Dec-2020 • Cosmetic

Regulatory Prohibition Of Hexachlorophene For Use In Cosmetic Formulations

Different countries and regions worldwide regulate cosmetics under different legal frameworks that all have their own particular rules and regulations. The regulatory system and advertising of cosmetic items ensuring safety and efficacy are the most imperative elements for the cosmetic industry’s development. The terminology, labelling, and safety of cosmetic products and colorant regulations are different for different nations. Cosmetic manufacturers have a legal responsibility to the consumers for the safety, quality, and labeling of their products. Sometimes safe cosmetics, when people use them in the right way, may be unsafe when used incorrectly. All cosmetic products must have some directions for use or warning labels so that people use them in the right manner. Some ingredients may be safe in cosmetic products such as cleansers that are immediately washed off the skin, but not for the products that we leave on the skin for long hours. Likewise, ingredients that are safe for use on the nails and hair can be unsafe when used near the eyes or on the skin. But as per law a cosmetic cannot contain any such ingredient that makes the product harmful when consumers use it as per label or in the customary or expected way.

In India, the import of certain cosmetic products is prohibited as per Section 10 of the Drugs & Cosmetics Act and Rules 134A, 135,135A of the Cosmetics and Drugs Rules, 1945 and the Bureau of Indian Standards (BIS). Under this law, cosmetics with Hexachlorophene (HCP) are prohibited from being manufactured and imported in India. This regulation came because HCP, a synthetic compound, has been associated with several hazards over the years. Recent studies showed that hexachlorophene can be absorbed through the skin into the bloodstream and that this absorption resulted in damage to the nervous system of infants. HCP has become a ubiquitous chemical since its discovery in 1939 and used in ENT products, medicated soaps, shampoos, foot powders, underarm deodorants, baby lotion, shoe liners, shower curtains, and wearing apparel in varying amounts.

As per US FDA, HCP has toxic effect and ability to penetrate human skin, HCP can be used only in case no other preservative has shown effectiveness. As per the rule, the HCP concentration in a cosmetic may not exceed 0.1 percent, and it may not be used in cosmetics that are applied to mucous membranes, such as the lips. Such use of hexachlorophene shall be limited to situations where an alternative preservative has not yet been shown to be as effective or where adequate integrity and stability data for the reformulated product are not yet available.

Antibacterial ingredients used as alternatives for hexachlorophene in cosmetic products must be adequately tested for safety prior to marketing. Without safety testing prior to marketing, the product may be considered adulterated and will be considered misbranded unless it has a conspicuous front panel statement that the product has not been adequately tested for safety and may be hazardous.