Cosmetics Regulatory Support in Brazil

Overview

Cosmetics market in Brazil is anticipated to grow at significant level due to changing lifestyle and growing demand for skin-care. In addition to this, increasing consumer awareness regarding skin-care aids the market growth in Brazil. Cosmetics must be subjected to cosmetics notification or cosmetic product registration with the Agencia Nacional de Vigilancia Sanitaria (ANVISA), which regulates the Cosmetics Registration, production, import and trade of cosmetics in Brazil.

Classification of Cosmetic Products

The principal purpose of the Cosmetics, and Personal hygiene products like fragrances is cleaning, perfuming, altering, and correcting bodily odors and keeping them in good condition. These products are made from natural or synthetic substances, for external use on various parts of the human body, such as skin, hair, nails, lips, external genitals, teeth, and mucous membranes of the oral cavity.

Cosmetic products in Brazil are classified as Grade I and Grade II, based on the level of risk.

Registration of Cosmetic Products

Market Authorization

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 the 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 exempted from pre-market approval by ANVISA. Pre-market approvals are valid for five (5) 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 (5) 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 the ANVISA. Foreign companies shall have partner companies legally constituted in Brazil which will be legally responsible for the products imported to and distributed in the Brazilian territory.

Cosmetic Notification

Products categorized as Risk Class I must undergo Cosmetic Notification.

Cosmetics categorized as Risk Class I must be notified to the ANVISA by the manufacturing or importing company established in Brazil. 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. It is not necessary to wait for ANVISA´s approval to place the product on the market.

Cosmetic Registration

Products categorized as Risk Class II must undergo Cosmetic Registration.

Cosmetics categorized as Risk Class II must be submitted to the ANVISA by the manufacturing or importer company established in Brazil. These products will be analyzed by the ANVISA and it is necessary to wait for ANVISA´s approval after the submission of the dossier. This means that all the products categorized as Risk II will be analyzed by the ANVISA. It is also necessary to wait for ANVISA´s approval to place the product on the market.

Product Maintenance & Compliance

Sl. No

Validity of Registration Certificate

Renewal

Post-approval Changes (Variations)

01

The certificate of registration is valid for five (5) years.

The renewal application must be submitted six (6) months before expiration of the existing registration certificate, along with documents mentioned in the current regulation. For the products submitted to the Notification process is also necessary to request the renewal of the notified product.

Any change of notified or registered cosmetics must be sent to ANVISA with relevant documents in accordance with current requirements.

Freyr Expertise

  • End-to-end Product Registration
  • Strategic Regulatory Guidance and Regulatory Affairs Support during Product Development
  • Interpreting the Regulations and Developing the Regulatory Documentation in Accordance with the Health Authority Guidance
  • Carrying Out the Gap Analysis and Reviewing the Documents
  • Cosmetic Artwork & Label Management
  • Represent RA CMC in Health Authority Meetings and Lead or Support Regulatory Document Preparation Activities for Meetings with Health Authorities on Regulatory-related Matters.
  • Interacting with the Health Authority
  • Query Support Management till Approval
  • Cosmetic Product Compliance & Maintenance

 

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