The purpose of the regulation was to complement and to clarify existing technical requirements and to fill in gaps in the definitions of these products. According to Anvisa, these gaps were generated by the repeal of Decree 79094, dated January 5, 1977, in August 2013.
Definitions
The Agency provides the following definitions:
A sunscreen (bronzeador) is a cosmetic preparation intended to come into contact with the skin, with the sole or principal purpose of protecting it against UVB and UVA radiations without, however, preventing the tanning action of the sun.
A self-tanning (bronzeador simulatório) is the cosmetic that darkens the skin by external application, regardless exposure to solar radiation, it shall be dermatologically innocuous and free of irritating or photosensitizing substances.
A tan activator or accelerator (ativador/acelerador de bronzeado) is intended to promote the darkening of the skin by external application, it shall be dermatologically innocuous, and free of irritating or photosensitizing substances.
The procedures for the regularization of these products with the Anvisa remain unchanged and must comply with the requirements established in regulation RDC No. 7/2015, that is to say that sunscreens are subject to registration, while self-tanning products and tan activators or accelerators are exempt from registration.
Furthermore, sunscreens shall also comply with the requirements of the regulation RDC No. 30/2012.
Labelling rules for sunscreens
As far as labelling is concerned, companies that already have tan activators or accelerators listed with the Anvisa have 180 days to update the labelling of the products, which shall now display on both the primary and secondary packaging, the words: "This product is not a sun protector,” (Este produto não é um protetor solar,)in addition to the warnings already required by regulation RDC No. 7/2015.
