Changes to Cosmetics Regulations for Brazil

Undergoing public consultation since January 18, 2012, new Brazilian cosmetics regulations will restrict the use of pyrogallol, formaldehyde and paraformaldehyde as well as place an outright ban on the use of lead acetate.
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June 6, 2012 - PRLog -- The most significant changes to the proposed regulations will be a new chemical on the list of restricted substances for cosmetic use: Pyrogallol, which is the common name for the chemical benzene-1,2,3-triol, and commonly finds use in hair dyes. 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.

About SGS Cosmetics Solutions
For the cosmetics industry (, SGS provides solutions that include analysis, testing and assays to certify products conform to all the regulations that apply in international markets. For Brazil, SGS has testing facilities to determine whether products contain substances that are restricted using the most modern methods, with laboratories accredited by Inmetro NBR and ISO/EIC 17025. They also perform chemical and physical analyses to evaluate and validate the properties of products such as pH and viscosity as well as the concentrations of substances they contain, as well as microbiological assays in accordance with RDC 481/99.

Please contact the local SGS experts if you require further information.

SGS Consumer Testing Services

Adriana Moreira
Sales Executive
SGS - Brazil
Av. Andrômeda, 832 – 5º. and.
CEP 06473-000 – Barueri/SP

t:  +55 11 3883 8807

SGS is the world’s leading inspection, verification, testing and certification company. SGS is recognized as the global benchmark for quality and integrity. With 70'000 employees, SGS operates a network of over 1'350 offices and laboratories around the world.
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