Brazil Cosmetic Registration (ANVISA – Agência Nacional de Vigilância Sanitária)

1. Regulatory Authority & Framework

Cosmetics in Brazil are regulated under:

• RDC 07/2015 – Cosmetic Registration & Notification
• RDC 528/2021 – Updated labeling requirements
• RDC 211/2005 – GMP for cosmetics
• Mercosur GMC Resolutions (Brazil follows Mercosur Cosmetic Harmonization)

Regulatory agency:
ANVISA – Brazilian Health Regulatory Agency

2. Cosmetic Classification (Class I / Class II)

Brazil divides cosmetics into two risk categories:

Key principle:
Most routine cosmetics are Class I Notification.
Only certain functional/therapeutic-like cosmetics require Class II Registration.

3. Registration Pathways

3.1 Class I – Low-Risk Cosmetic (NOTIFICATION)

• Submission: Online notification via ANVISA system
• No pre-market review
• Product may be marketed immediately after notification
• Validity: 5 years

This is used for ~90% of cosmetic products.

3.2 Class II – High-Risk Cosmetic (REGISTRATION)

Required for products with special claims or safety concerns:

Examples:

• Sunscreens
• Hair dyes
• Anti-acne (cosmetic-level)
• Products with strong active ingredients
• Skin-whitening/brightening with functional actives

Process:

• Full technical dossier evaluation
• ANVISA review: 2–6 months
• Validity: 5 years

4. Local Responsible Company Requirement

Foreign manufacturers cannot register directly.

A Brazil-based legal entity must act as the:

• Detentor do Registro (Registration Holder)
• Responsible Person for PMS, labeling, recalls, compliance
• Appears on product packaging

Changing the holder requires new notification/registration.

5. Dossier Requirements

Brazil uses a Mercosur-aligned dossier structure, similar to EU + ASEAN but with ANVISA-specific requirements.

A. Administrative Documents

• GMP Certificate (RDC 211/2005 or ISO 22716)
• Authorization Letter (POA) from manufacturer
• Free Sale Certificate (FSC) or Marketing Authorization from origin country
• Brazilian company licenses (CNPJ, operating permit)
• Label drafts (Portuguese)

B. Technical File

Required for both Class I & Class II (but reviewed in Class II only):

1. Formula (% breakdown)
2. Raw material specifications
3. Stability study
4. Microbiological testing
5. Heavy metal testing
6. Physicochemical specifications
7. Safety assessment
8. Efficacy/claims substantiation (mandatory for Class II and functional claims)
9. Manufacturing process & GMP evidence
10. Packaging compatibility tests

Class II requires deeper toxicological and efficacy evidence.

6. Labeling Requirements (Portuguese Mandatory)

Aligned with RDC 528/2021 & Mercosur standards.

Must include:

• Product name & function
• Batch/lot number
• Manufacturing & expiry date
• Net content
• Complete ingredient list (INCI)
• Country of origin
• Usage instructions
• Warnings for restricted ingredients (AHA, retinoids, hair dyes, SA)
• Name & CNPJ of Brazilian Registration Holder
• Claims must be truthful, verifiable, and non-medical

Brazil is especially strict with:

• Whitening/brightening claims
• Anti-aging claims
• Thermal protection claims
• Acne control claims

7. Ingredient Restrictions (Mercosur Annex Lists)

Brazil follows Mercosur ingredients list aligned loosely with EU:

• Annex II – Prohibited substances
• Annex III – Restricted substances
• Annex IV – Preservatives
• Annex V – UV filters
• Annex VI – Colorants

Common restrictions:

• Hydroquinone → prohibited
• Mercury → zero tolerance
• AHA, SA → concentration & pH limits
• Hair dye ingredients require warnings
• Sunscreens must follow UV filter list

8. Fees & Timelines

Government Fees

• Class I Notification: ~BRL 100–300
• Class II Registration: ~BRL 500–1,500

Timelines

Class I is one of the fastest cosmetic approvals in all LATAM.

9. Importation Requirements

To import cosmetics into Brazil:

• Valid Notification/Registration in ANVISA
• Import license under SISCOMEX
• Portuguese labeling compliant with ANVISA
• Customs may sample/test
• Products with claims may be checked for claims substantiation
• High failure rates for products containing prohibited whitening ingredients

10. Post-Market Surveillance (PMS)

ANVISA conducts:

• Random sampling & testing
• Inspections of importers/distributors
• Online surveillance for claims
• Enforcement actions (recalls, suspensions, fines)
• Verification of GMP compliance

Registration holder responsibilities:

• Maintain technical dossier for 5 years after expiry
• Report adverse events
• Implement recalls if required

Brazil is strict—many imported whitening products have been banned.

11. Borderline Product Classification

Cannot be registered as cosmetics:

• Acne treatment with actives like BPO (>0%), retinoids
• Melasma treatment (“treat melasma”)
• Hair growth/anti-hair loss
• Scar or wound healing products
• Antiseptics/disinfectants
• Medicated shampoos (e.g., ketoconazole)
• Anti-inflammatory creams
• Any product making therapeutic claims

These fall under ANVISA drug or OTC regulations.

12. Consulting Notes for Your Portfolio

13. Advantages of Brazil Cosmetic Market

• Largest cosmetic market in Latin America
• Fast entry for Class I products (instant notification)
• Strong demand for Asian skincare (K-beauty, J-beauty, C-beauty)
• Mercosur harmonization → easier expansion to Argentina, Uruguay, Paraguay
• Clear distinction between classes reduces regulatory burden