OMC Medical
OMC Medical

 Cosmetics Registration in Brazil

Regulatory Authority:

Brazilian Health Surveillance Agency (ANVISA)

Link for RA:

https://www.gov.br/anvisa/pt-br/english

Local regulation:

RDC 07/2015: Technical requirements for the regularization of personal care products, cosmetics and perfumes

Who can register: 

Local Representative

Data to be communicated:

For Notification

  • Product composition sheet (PCS)
  • Function of ingredients in the PCS
  • Ingredients’ bibliography / technical references
  • Physical, chemical and organoleptic specifications of the final product
  • Microbiological specifications of the final product
  • Packaging specifications of the final product
  • Test results of product stability
  • Label artwork (in both original language and Portuguese language)
  • Description of product finality
  • Free sale certification (from the country of origin, if imported)

For Registration: All documentation required for Notification must also be submitted for registration. In addition, two further documents must be submitted to the dossier.

  • Test results proving the products’ claims
  • Safety test data of the product in use

Process: 

Class I: ‘Prior Communication’ is the term for the notification procedure. It is a formal administrative procedure that entails advising Anvisa of the desire to commercialise certain products. Anvisa’s electrical platform, the Cosmetic Automation System, is used for prior communication (SGAS). The company can commercialise its products after the notification process is completed and the notice is published on Anvisa’s website.

Class II: The process begins with submitting a petition using the Anvisa electricity portal. Anvisa begins the evaluation of the company’s registration dossier after receiving the petition and an inspection of the manufacturing facility to confirm compliance with Good Manufacturing Practices. Anvisa announces its decision in the Official Journal (Diario Oficial da Unio – DOU) after the evaluation and inspection are completed, allowing the product to begin marketing.

Timeframe and fees:

Class I:

Notification Fees range from R$ 175.72 to R$ 3,414.32 Brazilian reais, depending on the company’s size.

Anvisa takes 2 months to issue the notice on its website.

Class II:

The cost of registering for Class II cosmetics with Anvisa is determined by the company’s size submitting the application. The fees range from R$ 244.05 to R$ 4.881,00 in Brazilian reais.

The timelines for Anvisa registration of Class II cosmetics are about 90 days.

Additional information: 

If a notification/registration is valid with ANVISA it is considered compliant. Its validity ends after 5 years from the date of approval, and it must be renewed after that time. The renewal process must begin six months before the expiration date. Annual inspections are also required to ensure that regulations are followed.