Brazil Cosmetics Importer Requirements: AFE, CNPJ & Local Roles

Quick overview

Official-source review: October 19, 2026 · For: Overseas cosmetic brands evaluating Brazilian importers, product holders and trading partners.

A brand may find a Brazilian distributor before it understands the difference between product regularization, import execution and wholesale distribution. The right due-diligence question is not simply “Does the partner have ANVISA approval?” It is which Brazilian legal entity will perform each regulated activity, what is that entity actually authorized to do, and who is responsible for the product's ANVISA record?

1. Four roles that should not be collapsed

• Role: Product regularização holder / Main responsibility: Holds the applicable regulatory product record and related obligations / Evidence to request: Brazilian entity identity, product record, relevant authorization and responsibilities
• Role: Importer of record / Main responsibility: Performs or participates in import-related activities / Evidence to request: CNPJ, import-related AFE, local permits and customs arrangements
• Role: Wholesaler or distributor / Main responsibility: Supplies other businesses and commercial channels / Evidence to request: Distribution activity permissions and storage arrangements
• Role: Third-party trading company / Main responsibility: Imports under an applicable por conta e ordem or por encomenda model / Evidence to request: Relevant RDC 939/2024 AFE, product category, contracts and allocation of duties

One company can perform multiple functions, but authorization is not automatically broader because the business combines roles. Different companies cannot simply use each other's AFE. The table is a commercial diligence framework; the licensing decision depends on actual regulated activities. [BR-S04][BR-S05]

2. What do CNPJ and AFE establish?

A CNPJ identifies a Brazilian legal entity. It is essential for checking which company is actually contracting with a brand, but a CNPJ is not permission by itself to import cosmetics. AFE means Autorização de Funcionamento de Empresa, ANVISA's business authorization for covered activities.

Official requirement: ANVISA's FAQ identifies imports, distribution, storage and transport of cosmetics among activities subject to its AFE framework. It distinguishes wholesale cosmetics activity, generally requiring an AFE, from ordinary retail cosmetics activity, which is exempt from AFE. The company's approved activities and product categories, not just the existence of a number, should be verified. [BR-S04]

For each relevant entity request its full legal name, CNPJ, registered address, AFE number, authorized activities and product category, current record, local sanitary authorization where applicable and site details. Review branches, contracted warehouses and carriers as separate operational questions.

3. Import authorization is not the same as distribution authorization

ANVISA's import/distribution FAQ explains that companies importing products for commercial distribution may need their authorized scope expanded to distribution, rather than assuming that import activity covers wholesale. Outsourced storage and transport arrangements likewise require verification of the contracted provider's actual regulatory position. [BR-S04]

An import service provider may therefore not be ready to undertake the brand's entire downstream sales operation. The contract should spell out importing, inventory ownership, storage, sales, returns, recalls, complaints and record access—and align those duties with the legal actors doing the work.

4. Third-party imports: *por conta e ordem* and *por encomenda*

Official requirement: ANVISA's RDC 939/2024 FAQ states that, in por conta e ordem or por encomenda third-party import models, the trading company needs AFE for the relevant product category. The third-party entity for whose account or order the import is performed must be both the holder of the product regularization and an ANVISA AFE holder. A commercial contract does not transfer either legal status to another company. [BR-S05]

Before appointing a trading provider, establish who purchases and pays for the goods, who is named in the import documentation, who holds product regularização, what product category the trading company is authorized to import, and who sells to the Brazilian customer. A holder's declaration (DDR) or other authorization may be relevant depending on the structure and the active import requirements; do not treat a generic brand letter as universal proof of compliance.

Customs and tax consequences of the chosen model require the appropriate Brazilian professional advice; this checklist is not a substitute for that review.

5. How should the Responsible Technical professional (RT) be handled?

A Responsável Técnico is a professionally qualified individual responsible for relevant technical coverage. This is distinct from a Responsável Legal, who represents the company legally. ANVISA's corporate registration material explains these roles and their registration relationships. [BR-S13]

Do not assume every separately named product holder must automatically employ one additional RT without examining its activities and local licensing requirements. Equally, do not assume the holder, trading provider and warehouse can simply share one professional's coverage without reviewing the applicable professional and regulatory rules. For certain import-label situations, ANVISA specifically discusses batch-manufacture declarations signed by the importer company's RT. [BR-S07]

A proper diligence file should establish the professional's qualification, scope, relationship to the entity and any required registrations or local sanitary license conditions.

6. Three possible partnership structures

Model A — One Brazilian partner performs several functions. A single properly authorized company may hold the product, import and distribute it. Fewer relationships may simplify communication, while control of documentation and distribution rights needs clear contractual treatment.

Model B — Separate product holder and importing trading company. Under the RDC 939/2024 third-party import structure, the holder cannot be an AFE-less shell: the product-regularization holder must hold ANVISA AFE, and the trading company must also hold AFE for the relevant product category. Their authorization scopes, product records, instructions and contracts must align. [BR-S05]

Model C — Holder, importer and distributor are separate. This can work where responsibilities are traceable and records move reliably among participants. More entities do not by themselves mean better compliance.

These are operating-model examples, not mandatory structures prescribed for every launch.

7. Due diligence checklist for a Brazilian cosmetics partner

• Legal name, CNPJ and contracting entity match.
• Planned importer, holder, distributor and service functions are written down.
• AFE records and approved activities are current and cover the planned work.
• The proposed import model is identified in commercial and customs documents.
• For third-party importing, the trading provider's specific AFE position has been checked.
• Local sanitary permissions, RT and warehousing/transport arrangements have been reviewed.
• Any DDR or other holder authorization is scoped to the correct products and parties.
• Ownership and access rules for submissions, technical data and final artwork are documented.
• Post-market changes, complaints and escalation duties have named owners.
• A Brazilian customs broker has checked the shipment-specific import documentation.

Frequently asked questions

If an agent has an AFE, can it automatically import any cosmetic? No. Check the approved activity, product category, legal entity and whether the proposed third-party model fits. [BR-S04][BR-S05]

Must the ANVISA product holder be the same company as the importer? Not necessarily. Under the RDC 939/2024 third-party models, however, the product-regularization holder must itself hold ANVISA AFE, and the trading importer must hold AFE for the relevant product category. [BR-S05]

Can product compliance work begin before we appoint an importer? Yes. Brands can assess classification, ingredients, labels and evidence gaps while carrying out local partner due diligence. They still need a compliant party structure for formal filing and imports.

Does an AFE also settle customs registration and clearance? No. These are different regulatory and operational checks. [BR-S12]