Brazil’s health agency (ANVISA) has recently amended the regulations on the use of certain substances in cosmetics. Four chemicals are concerned: lead acetate, pirogalol, formaldehyde and paraformaldehyde. Actually, this new text consists in the transposition in Brazilian law of a Resolution (GMC No. 51/08) adopted by the Mercosur’s common market regulatory harmonization.

According to the resolution RDC 15/2013 of March 26, 2013 (published on March 27, 2013), ANVISA conditions the use of these substances in cosmetics to the respect of following conditions:

- Lead acetate. In hair dyes only, at a maximum concentration of 0.6%, expressed as lead, and subject to compliance with purity and labelling requirements.

- Pirogalol (or pirogallol or benzene-1,2,3-triol). Used only as an oxidation hair dye at a maximum concentration of 5%, and subject to compliance with purity and labelling requirements.

- Formaldehyde and paraformaldehyde. Used only as preservatives, at a maximum concentration of 0.1% in oral hygiene products and 0.2% in all other categories. Formaldehyde can also be used as nail hardener, up to a concentration of 5%. Also subject to compliance with purity and labelling requirements.

Here below are the corresponding pages of Brazil’s official journal of (in Portuguese):

RDC 15/2013 - 1
RDC 15/2013 - 2