Brazil regulates use of substances in cosmetics

Those substances include lead acetate, pyrogallol, formaldehyde and paraformaldehyde, ingredients the Agency has been looking at making significant changes to, since January 2012.

Now under new rules, Anvisa says that lead acetate with regards to hair dyes should not exceed a maximum concentration of 0.6 percent, and 5 percent for pyrogallol.

Pyrogallol, which is the common name for the chemical benzene-1,2,3-triol is a new chemical to the list of restricted substances, and is a substance the EU has restricted since 1976 and one that ECHA presently classifies as harmful if swallowed, inhaled or in contact with the skin, as well as an environmental hazard for aquatic life.

Formaldehyde and paraformaldehyde are substances currently banned in Brazil as aerosol preservatives, but are being permitted only as a preservative in oral hygiene and other cosmetic products at maximum concentrations of 0.1 percent and 0.2 percent, respectively, and 5 percent as a nail hardener.

"When used as a preservative, the maximum concentration will be 0.1 percent for oral hygiene products and 0.2 percent for other uses with obligatory conditions of use and a warning they contain formaldehyde if the concentration exceeds 0.05 percent of the product."​

Accompanying information is a must​

As the new rules come into play, Anvisa stresses the importance of providing information on labels with regards to the conditions of use and warnings for permitted applications of these substances.

"When pyrogallol is used in hair dye, the maximum concentration allowed will be 5 percent to pH 5 and must be accompanied by a warning that the dye contains pyrogallol, that gloves should be worn, that it may cause allergic reactions, is not for use with facial hair, eyebrows and eyelashes and should be kept out of reach of children​."

The regulatory body also highlights that in the instance of formaldehyde and paraformaldehyde being used as a nail strengthener, a warning to protect cuticles with oil is mandatory and must appear on labeling.