Cosmetics Regulatory Services in Brazil

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Overview

The cosmetics market in Brazil is expected to grow at a significant rate in near future due to lifestyle changes and a growing demand for skincare among people. Specifically, increasing consumer awareness regarding skincare is predicted to aid market growth. Cosmetics must be subjected to the Cosmetics Notification or Cosmetics Registration with the Agência Nacional de Vigilância Sanitária (ANVISA), or the National Health Surveillance Agency/Brazilian Health Regulatory Agency, the authority that regulates the production, import, and trade of cosmetics in the country. In Brazil, cosmetics are classified into Grade I and Grade II, based on the level of risk they pose. As per the ANVISA cosmetics regulations, there are two (02) ways to authorize cosmetics in the Brazilian market, which are as follows:

  • Cosmetic Notification of Grade I cosmetic products.
  • A prior Cosmetic Registration of Grade II cosmetic products.

Companies legally constituted in Brazil, which have the ANVISA Operation Permit (AFE), can import and notify/register their cosmetics in Brazil. Therefore, overseas manufacturers should have in place a commercial agreement with the local company that will undertake the technical and legal functions and notify/register the cosmetics with the ANVISA. Cosmetic Notification of Grade I cosmetics and Cosmetic Registration of Grade II cosmetics must be done through the petition system. Company registration is the first step to obtaining access to the petitioning system, following which the identification of the appropriate subject code of the petition and the required documentation are submitted to file the petition. Once the company submits the notification of cosmetic products to the ANVISA, they can immediately place the product in the market. The process of registration of Grade II cosmetic products is initiated by submitting an online petition. Post receiving the petition, the ANVISA reviews the registration dossier to ensure product compliance. The result of the petition is published in the official gazette in the form of a registration number. Upon successful registration, products can be imported into and distributed across the Brazilian market.

To accelerate and simplify the Cosmetic Notification/Cosmetic Registration process and market entry procedures for foreign manufacturers in Brazil, Freyr supports organizations with specialized services like developing strategic and well-defined processes. Our team of Regulatory experts is proven to assist applicants in adept cosmetic formulation review/cosmetic ingredient review, cosmetic labeling review, cosmetic claims review, and cosmetic application with accurate documentation as per the ANVISA regulations, and other process-related services.

Expertise

Freyr Expertise

  • Cosmetic product formulation review/cosmetic ingredient review as per the ANVISA cosmetics regulations.
  • Cosmetic claims review.
  • Cosmetic labeling as per the Brazilian cosmetics regulations/cosmetic labeling requirements.
  • Dossier compilation.
  • Cosmetic Notification/Cosmetic Registration with the ANVISA.
  • Ad-hoc query support.
  • Regulatory Intelligence (RI) services.
Freyr Advantages

ADVANTAGES

Freyr Advantages

 

End-to-end cosmetic Regulatory consultation

 

Quick turnarounds and a faster time-to-market

 

A qualified team of experts with hands-on experience across all cosmetic categories such as skin care, hair care, baby care, oral care, beauty products, etc.

 

Support for region-specific Regulatory complexities

 

Strategic local Health Authority (HA) contacts.

 

A structured and cost-effective approach to ensure product compliance.