Undergoing public consultation since January 18, 2012, new Brazilian cosmetics regulations will restrict the use of pyrogallol, formaldehyde and paraformaldehyde for cosmetic use, as well as place an outright ban on the use of lead acetate. A new chemical on the list of restricted substances for cosmetic use is Pyrogallol, which is the common name for the chemical benzene-1,2,3-triol, commonly used as a dye for hair.

The EU has restricted this substance since 1976 and the ECHA presently classifies it as harmful if swallowed, inhaled or in contact with the skin, as well as an environmental hazard for aquatic life. In addition, the use of formaldehyde and paraformaldehyde, which were already banned in Brazil as aerosol preservatives, will now be prohibited in all sprays, but their maximum concentrations in permitted applications will remain largely unchanged.

Providing information on labels about conditions of use and warnings for permitted applications of these substances will be mandatory. When pyrogallol is used in hair dye, the maximum concentration allowed will be 5% 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 maximum concentrations of formaldehyde and paraformaldehyde, calculated as free formaldehyde, will differ according to use as a preservative or nail strengthener, but are unchanged since RDC 162 and RDC 16/11. When used as a preservative, the maximum concentration will be 0.1% for oral hygiene products and 0.2% for other uses with obligatory conditions of use and a warning they contain formaldehyde if the concentration exceeds 0.05% of the product. When used as a nail strengthener, the maximum proposed is 5% and a warning to protect cuticles with oil is mandatory. However, both these substances will be completely banned in aerosols and sprays.

The existing prohibition of lead acetate in cosmetics in RDC 16/11 and RDC 48 from 2006 is retained in the current legislation.

In Europe, from 11 July 2013, the existing Cosmetics Directive will be replaced by the new Cosmetic Products Regulations EC1223/2009. The provisions of the new regulation aim to ensure that consumers’ health is protected and that they are well informed by monitoring composition and labeling of products. The regulation also provides for the assessment of product safety and the prohibition of animal testing.
The new Regulations will make marketing cosmetics and personal care products into the EU market more challenging for global manufacturers, especially if they are located outside the EU. O.W.N. will publish a special report on the new regulations in its Fall edition.