New Regulatory Changes for the Brazilian Cosmetic Manufacturers

The Brazilian Health Regulatory Agency notifies World Trade Organization (WTO) of several resolutions for cosmetics and personal hygiene products which are proposed to enter into force with the earliest start being on May 2, 2022. Earlier in March 2022, Brazilian Health Regulatory Agency (ANVISA) announced a few regulations regarding technical requirements and defined criteria for either labelling or composition of applicable products.

For product manufacture, the conditions for chemical use of lead acetate, formaldehyde, paraformaldehyde and pyrogallol are stated, which also internalizes another resolution from the national legal system MERCOSUR (GMC MERCOSUR Resolution number 48/2010).

Extra attention has been put on personal hygiene products (PHPs) as much as on cosmetics, especially on detailed information displayed such as labelling of composition, warnings, and technical definitions like the inclusion of substance concentration, etc. General rules for exporting Brazilian-made products and temporary regulations applicable with regard to the emergency international public health state under SARS-CoV-2 are also proposed; for instance, on the manufacture and marketing of antiseptic preparations or sanitizers.

Resolutions aforementioned are mostly expected to start from May 2, 2022, with no applicable final date for comments; whereas resolution for the obligation to label product composition in Portuguese (i.e. Resolution - RDC number 646)’s entry date is scheduled for November 1, 2023.