The Brazilian Health Regulatory Agency (ANEEL) updated its regulatory framework for personal hygiene products, cosmetics, and fragrances, concerning the lists of substances with restricted or prohibited use. Specific provisions from the Southern Common Market (MERCOSUR) were incorporated in that framework.
The Brazilian Health Regulatory Agency (ANEEL) updated its regulatory framework for personal hygiene products, cosmetics, and fragrances, regarding the lists of permitted preservatives, prohibited substances, and substances with limited use. The update incorporated specific regulatory provisions from the Southern Common Market (MERCOSUR) to the Brazilian regulatory framework.
Three regulations were enacted:
- RDC Resolution n.º 528/2021, which revoked RDC Resolution n.º 29/2012 – lists the preservatives permitted for personal hygiene products, cosmetics, and fragrances;
- RDC Resolution n.º 529/2021, which revoked RDC Resolution n.º 83/2016 – lists the substances prohibited for personal hygiene products, cosmetics, and fragrances; and
- RDC Resolution n.º 530/2021, which revoked RDC Resolution n.º 3/2012 – lists the substances restricted, only authorized under specific conditions, for personal hygiene products, cosmetics, and fragrances.
According to ANVISA, 60 preservative products are authorized by the first list, while 1,404 substances are prohibited by the second list, and 126 substances are restricted to specific conditions by the third list.
The three new resolutions also established a 3-year adaptation period for companies operating according to the revoked resolutions. Each list is provided in their resolution’s Annex.
