1. Who can import

Personal hygiene products, cosmetics and fragrances are goods subject to sanitary surveillance. The company that imports them must meet four conditions before its first shipment:

  • Anvisa Operating Authorization (AFE) to import the class of products it intends to regularize (RDC 907/2024, art. 38).
  • Sanitary licence for the facility, issued by the local health surveillance authority (same article).
  • Siscomex (Radar) authorization with Brazil's Federal Revenue Service, to operate in foreign trade.
  • A qualified Technical Officer, with the company registered with the corresponding professional council. In Azhara's case, CRF-SP.

Compliance with Good Manufacturing Practices is verified at the importing facility through inspection by the sanitary authority (art. 39). Without this full set of requirements, no product can be regularized in the company's name, and without regularization there is no Anvisa consent for the import licence.

2. Technical screening before shipment

The cheapest moment to fix a problem is before the product exists in its Brazilian version. Screening covers five points:

  • Formula and INCI checked against Anvisa's lists: prohibited substances (RDC 529/2021), restricted substances (RDC 530/2021), preservatives (RDC 528/2021), colorants (RDC 628/2022) and UV filters (RDC 600/2022).
  • Risk classification as Grade 1 or Grade 2, under Annex I of RDC 907/2024, as amended by RDC 949/2024. It depends on the formula, the area of application, the target audience and the claims. See our guide to Grade 1 and Grade 2.
  • Claims: the label cannot attribute therapeutic properties to the product, in any language (arts. 12 and 22).
  • Labelling: mandatory information in Brazilian Portuguese, including the composition (art. 20 and RDC 898/2024). An incomplete original label can be supplemented with a sticker, applied at origin or at destination, always before the product is sold (art. 21).
  • Remaining shelf life compatible with transit time, customs clearance and retail turnover.

3. Product regularization

Every product is regularized in the name of a Brazilian holder, who is administratively, civilly and criminally accountable for it (art. 3, XXI). There are two paths:

  • Notification, for products exempt from registration: most groups, both Grade 1 and Grade 2. An electronic procedure on Anvisa's portal; sale is permitted once it is published on the portal (art. 32, § 1).
  • Registration, for the nine groups in art. 34: sunscreen (adult and children's), insect repellent (adult and children's), tanning product, hand sanitiser gel, hair straighteners, hair straightening-and-dyeing products and perming products. Sale is permitted after publication in the Federal Official Gazette (art. 32, § 2).

The dossier (art. 8) brings together the qualitative and quantitative formula in INCI, a copy of the imported product's original formula, physicochemical and microbiological specifications, the label artwork, and stability, safety and efficacy summaries where claims are made. The company also keeps the complete data, the manufacturing process and the batch-coding system available to the authority (art. 9). A free-sale certificate from the country of origin is not required (art. 10).

Registration is valid for ten years and can be renewed. Notified products are not renewed, but require a declaration of continued commercial interest every ten years (arts. 40 and 41).

4. Import licensing

Cosmetics are subject to non-automatic licensing in Siscomex. The importer files the import licence (LI, or LPCO in the Portal Único) and Anvisa reviews the request before granting consent; granting consent may involve a physical inspection of the cargo before customs clearance (RDC 81/2008 and subsequent updates). Shipments arrive by sea, through the ports of Santos or Paranaguá, or by air, through Guarulhos or Viracopos airports; the choice depends on the origin, cost and lead time of each shipment.

5. Taxes

Import duty, IPI, PIS/Cofins-Import and ICMS all apply on importation, at rates that vary by tariff classification (NCM, chapter 33 for most cosmetics) and by the destination state. Brazil's tax reform, now in transition, with the new CBS and IBS taxes, will reshape this picture over the coming years. Shelf price needs to be modelled with these costs before negotiating with the brand.

6. From customs clearance to sale

  • Receipt at a licensed warehouse, with batch and expiry control and traceability for every unit dispatched.
  • Supplementary labelling, when done at destination, before the product is sold (art. 21, § 2).
  • Cosmetovigilance: monitoring, recording and assessing adverse events, and reporting serious ones to Anvisa (RDC 894/2024).
  • B2B distribution with tax and sanitary documentation in order, so the retailer can prove the product's regular origin.

7. Timelines

Indicative. Notification: publication on the portal within days of a correctly filed application. Registration: months, depending on Anvisa's queue and any requirements raised. International transit: weeks by sea, days by air. Before that, technical screening and dossier preparation typically take weeks once the brand's complete documentation is received.

8. Common mistakes

  • Labelling only in English, or without the composition in Portuguese.
  • Therapeutic claims on the label or in sales material ("treats," "cures," "anti-inflammatory").
  • An ingredient restricted to Grade 2 products used in a product notified as Grade 1.
  • Remaining shelf life too short for the retail cycle.
  • Underestimating taxes and logistics costs in the final price.
  • Starting regularization before defining, in the contract, who will be the holder.
Informational content, based on the regulations in force on the update date. It does not replace the regulatory analysis of a specific product, nor legal or tax advice.

Sources

  • Anvisa. RDC No. 907, of September 19, 2024: definition, classification, labelling and regularization procedures for personal hygiene products, cosmetics and fragrances.
  • Anvisa. RDC No. 949, of December 12, 2024: amends RDC 907/2024 and Annex I (Grade 1 and Grade 2 classification). In force since April 7, 2025 (RDC 966/2025).
  • Anvisa. RDC No. 898, of August 28, 2024: composition in Portuguese on the label.
  • Anvisa. RDC No. 894, of 2024: Good Cosmetovigilance Practices.
  • Anvisa. RDC No. 81, of November 5, 2008, and subsequent updates: import of goods and products subject to sanitary surveillance.
  • gov.br. "Request regularization of cosmetics exempt from registration" service.
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