Regulatory Framework
Brazil regulates cosmetics through ANVISA and the current framework aligned with RDC 752/2022 and Mercosur technical rules. Products are broadly separated between lower-risk Grade I items, which usually follow a notification route, and higher-risk Grade II items, which require a more demanding registration review before launch.
Cosmetic Definition
Any substance or mixture intended for application to the external parts of the human body, or to the teeth and oral mucosa, mainly to clean, perfume, beautify, protect, keep in good condition, or correct body odours.
Grade I: Lower-risk products such as many standard skincare and fragrance products typically follow a simplified notification route.
Grade II: Higher-risk products such as sunscreens, child-focused products, hair dyes, or whitening products usually require a fuller ANVISA registration review.
Responsible Person Requirements
A foreign brand cannot apply directly. A Brazil-based legal entity with the appropriate ANVISA operating licence must act as the local Responsible Person or importer, manage the electronic filing environment, maintain the technical file, and appear in local labelling and authority records.
Compliance Process
- Local Entity and Account Readiness
- Confirm the Brazil-based applicant and validate that its operating licence covers the intended cosmetics business scope.
- Activate the working account in the ANVISA filing environment used for notification or registration.
- Technical Dossier Assembly
- Review the INCI list against local prohibited and restricted ingredient rules and product category expectations.
- Prepare Portuguese artwork, analytical certificates, GMP support, and free-sale or supporting market documents as needed.
- Notification or Registration Filing
- For Grade I products, submit the notification package and confirm the filing record.
- For Grade II products, prepare the fuller technical submission and track ANVISA review questions through approval.
- Local File Maintenance
- Keep the local technical file available for inspections, including stability, microbiology, and claim support.
- Coordinate future amendments when formula, label, or product positioning changes.
Brazil route selection is often driven by product category and risk positioning, so classification should be confirmed before artwork and launch timing are locked.
Deliverables
- Brazil route classification between Grade I and Grade II
- Formula review against ANVISA and Mercosur restrictions
- Portuguese artwork and mandatory label review
- SGAS notification or registration dossier support
- Local technical file and evidence checklist
- Brazil Responsible Person coordination service
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