Toiletries, Cosmetics and Perfumes

Anvisa defines Personal Hygiene Products, Cosmetics and Perfumes as being preparations consisting of natural or synthetic substances, for external use in the different parts of the human body, skin, capillary system, nails, lips, external genitals, teeth and mucous membranes of the oral cavity, with the sole or main purpose of cleaning, perfuming, altering their appearance and / or correcting body odors and either protecting or maintaining them in good condition.

To guarantee the consumer the purchase of safe and quality products, Anvisa is responsible for authorizing the marketing of these articles, by granting registration or notification.

The classification of cosmetic products is done by two groups:

grade 1 products; grade 2 products.

The criteria for this classification were defined according to the probability of the occurrence of unwanted effects due to the inappropriate use of the product, its formulation, purpose of use, areas of the body to which they are intended and care to be observed when using it. Some categories of products subject to health surveillance were exempted from the requirement to register prior to commercialization because they represent less risk to health.

In order to manufacture or import the products, companies must have Anvisa Operation Authorization for the activities and classes of products they wish to sell (personal care, cosmetic and / or perfume products) and must have a license from the competent Sanitary Authority.

Compliance with Good Manufacturing Practices will be verified at the producer and / or importer establishment through inspection carried out by the competent Sanitary Authority.

For products exempt from registration, the company must make a prior communication to Anvisa, which is the administrative procedure to be applied to inform Anvisa of the intention to sell a product exempt from registration by means of notification.

The registration of personal hygiene products, cosmetics and perfumes will be valid for 10 (ten) years, counting from the day of its publication in the Official Gazette of the Union, and can be revalidated successively for an equal period.

Those interested in maintaining the regularization of personal hygiene products, cosmetics and perfumes exempt from registration need to file, in the Cosmetics Automation System (SGAS), the declaration of interest in the continued commercialization of products every 10 (ten) years, counted from the day of product notification to Anvisa.

Personal hygiene products, cosmetics and perfumes exempt from registration are exempt from revalidation.