1. Why the brand needs an importer

In Brazil, whoever imports personal hygiene products, cosmetics and fragrances must be a company holding an Anvisa Operating Authorization (AFE) for that class of products and a licence from the local sanitary authority (RDC 907/2024, art. 38). Each product's regularization is filed in that company's name — the holder of the regularization — who bears administrative, civil and criminal responsibility for it (art. 3, XXI).

In practice, the "importer of record" is whoever holds the notification or registration, signs the statement of responsibility, and appears on the label with its corporate name, CNPJ, AFE number and process number (art. 13, II). The foreign brand remains the owner of the product and its intellectual property; sanitary title in Brazil belongs to the importer.

2. Regulatory responsibility

  • Statement of responsibility signed by the Technical Officer and the legal representative, declaring that the product meets the regulations and that the company holds safety and efficacy data (art. 5, III, and Annex II).
  • Dossier safekeeping: formula, specifications, stability, safety, efficacy, manufacturing process and batch coding, available to the sanitary authority (arts. 8 and 9).
  • Labelling in Portuguese, with the holder's details and the consumer service contact (arts. 13 and 20).
  • Cosmetovigilance: monitoring and assessing adverse events, and reporting serious ones to Anvisa (RDC 894/2024).
  • Inspections of the facility by the sanitary authority, and cancellation of the regularization in the event of non-compliance (arts. 39 and 45), with the penalties set out in Law No. 6,437/1977 (art. 46).

3. Operations

The importer files the import licence and obtains Anvisa's consent, follows the customs clearance, receives the cargo at a licensed warehouse and maintains batch, expiry and traceability control. When labelling is supplemented at destination, this happens before the sale (RDC 907/2024, art. 21). Good Manufacturing Practices are verified through inspection at the importer's facility (art. 39). See the step-by-step importing guide.

4. Commercial

Beyond the sanitary side, the importer is usually also the distributor: it sells to stores, retail chains and aesthetics clinics, issues the tax documentation, plans replenishment from sell-out data, and runs trade marketing at the point of sale. For the brand, this means a single point of contact in the country for regulatory, operational and commercial matters.

5. Partnership models

01

Exclusive national distribution

The importer regularizes, imports and distributes the brand nationwide as its sole partner, under a jointly agreed commercial plan.

02

Non-exclusive distribution

The importer carries the brand in its B2B channels alongside other routes the brand already operates or intends to open in Brazil.

03

Import, warehousing and dispatch for the brand

The brand keeps its own commercial relationships. The importer acts as the holder of the regularization, holds the inventory and ships to the brand's B2B customers.

In any model, the holder of the regularization is defined case by case and set out in the contract, including what happens to the regularized filings if the partnership ends.

6. How to choose an importer

Seven questions to ask before signing:

  1. Is the AFE to import cosmetics, fragrances and hygiene products published? If it's still in progress, is the status clearly communicated?
  2. Is there a facility sanitary licence, and a Technical Officer registered with the professional council?
  3. Is the warehouse owned or contracted, and is it licensed for products under sanitary surveillance?
  4. Is there a documented process for technical screening of formula, label and claims before shipment?
  5. Who will be the holder of the regularization, and what does the contract provide for if the partnership ends?
  6. Does the importer reach the channel the brand wants: pharmacies, perfumeries, e-commerce, clinics?
  7. Does communication happen in English, with defined response times?

Azhara answers these questions in every initial conversation. Our AFE and sanitary licence are in progress; we disclose the stage of the process before any agreement, and we do not sell products under sanitary surveillance until publication.

Informational content, based on the regulations in force on the update date. It does not replace legal advice on distribution contracts.

Sources

  • Anvisa. RDC No. 907, of September 19, 2024, arts. 3, 5, 8, 9, 13, 20, 21, 38, 39, 45 and 46, and Annex II.
  • Anvisa. RDC No. 894, of 2024: Good Cosmetovigilance Practices.
  • Anvisa. RDC No. 81, of November 5, 2008, and subsequent updates: import licensing with sanitary consent.
  • Law No. 6,437, of August 20, 1977: violations of federal sanitary legislation.
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