Personal Hygiene Products, Cosmetics and Fragrances

Publicado em 29/10/2020 16h13

Personal hygiene products, cosmetics and fragrances are preparations made from natural or synthetic substances, for external use in various parts of the human body, skin, hair, nails, lips, external genitals, teeth and mucous membranes of the oral cavity, with the sole or principal purpose of cleaning, perfuming, altering and correcting bodily odors and / or protecting or keeping them in good condition.

Market authorizations

The general regulation applicable to market authorization for personal hygiene products, cosmetics and fragrances is Resolution RDC 07/2015 (amended by Resolution RDC 237/2018). Only those products listed in Annex VIII are subject to the pre-market approval procedures (sunscreen and suntan, hair strengtheners, topical insect repellents and antiseptic gels for hands).

Products that are not included in Annex VIII of Resolution RDC 07/2015 are considered exempt from pre-market approval by Anvisa. These products are subject to a notification procedure, aiming at informing Anvisa about the intention to market a product exempted from pre-market approval. The notification procedure is carried out online, via the SGAS System, by the Brazilian company responsible for the product in Brazil.

Pre-market approvals are valid for five years from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods. Notifications are valid for five years from the date when the online protocol is finalized, and may be renewed for equal and successive periods.

Please note that it is not possible for foreign companies to make administrative arrangements for issuing market authorizations directly with Anvisa. Foreign companies shall have partner companies legally constituted in Brazil that will be legally responsible for the products imported to and distributed in the Brazilian territory.

Applicable regulations

These are the main regulations applicable relating to the market authorization (pre-market approval and notification) of personal hygiene products, cosmetics and fragrances exported to Brazil: