Do you need to register your cosmetics before selling in Brazil?
Yes. Every cosmetic product sold in Brazil must be either notified (Grau 1) or registered (Grau 2) with ANVISA before it can be legally marketed. There are no exceptions for e-commerce, dropshipping, or small quantities.
Importing without registration risks customs seizure, fines up to R$ 1.5 million, and permanent platform bans on Mercado Livre and Amazon Brazil.
Grau 1 (Notificação) vs Grau 2 (Registro): which one applies to you?
| Factor | Grau 1 (Notificação) | Grau 2 (Registro) |
|---|---|---|
| Risk level | Low risk | High risk |
| Process | Online notification, simpler | Full registration, rigorous review |
| Government fee | Free | ~R$ 2,500-5,000 |
| Timeline | 6-12 months | 12-24 months |
| Product types | Basic skincare, makeup, perfume, shampoo, conditioner | Sunscreen, anti-acne, hair dye, anti-aging, baby products, antiperspirant |
| Testing required | Basic safety assessment | Additional efficacy tests (SPF, stability, etc.) |
How to determine your product's grade:
- Does it claim SPF or sun protection? → Grau 2
- Does it treat acne, wrinkles, or hair loss? → Grau 2
- Is it a hair dye or bleach? → Grau 2
- Is it for babies or children under 3? → Grau 2
- Is it a basic moisturizer, lipstick, or perfume? → Grau 1
Step 1: Prepare your documentation
Before starting the ANVISA process, gather these documents:
Required for both Grau 1 and Grau 2:
- Complete ingredient list (INCI names, concentrations) — must match the final formula
- Product Safety Report (PSR) — prepared by a qualified technical responsible (Responsável Técnico)
- GMP certificate — ISO 22716 accepted, must be current and properly notarized
- Portuguese label — all text must be in Portuguese per RDC 752/2022
- Brazilian Responsible Technical Person (PTR) — a licensed pharmacist or chemist based in Brazil
Additional for Grau 2:
- Efficacy test reports — SPF validation for sunscreens, stability testing
- Clinical safety data — for products with active ingredients
- Additional toxicological data — for products with restricted ingredients at higher concentrations
Step 2: Appoint a Brazilian PTR (Responsável Técnico)
This is mandatory for all foreign brands. Your PTR is the legal representative for your product in Brazil and their name appears on the label. Options:
| Option | Cost | Best for |
|---|---|---|
| Hire a regulatory consultant as PTR | $2,000-5,000/year | Small brands, 1-10 SKUs |
| Partner with a Brazilian distributor | Negotiated into margin | Brands seeking local distribution |
| Set up a Brazilian subsidiary | $10,000+ | Large brands with significant Brazil presence |
Step 3: Submit your application
For Grau 1, submit through ANVISA's online notification system (Sistema de Notificação). For Grau 2, submit through the full registration system (Sistema de Peticionamento).
Key fields to complete:
- Product name (must match the label exactly)
- Complete INCI ingredient list with concentrations
- Product category and intended use
- Manufacturer information
- PTR information
- GMP certificate details
Step 4: Wait for technical review
ANVISA's review process includes:
- Initial queue: 2-3 months (varies by backlog)
- Technical evaluation: 3-6 months for Grau 1, 6-12 months for Grau 2
- Complementation (if needed): +2-4 months per round
Common reasons for complementation:
- Ingredient list doesn't match the PSR
- Label doesn't comply with RDC 752/2022
- GMP certificate is expired or not properly notarized
- Missing PTR designation
- Product claims trigger drug classification
Step 5: Receive your registration number
Once approved, you'll receive:
- Grau 1: Notification number (starts with specific prefix)
- Grau 2: Registration number (starts with specific prefix)
This number must appear on your product label before sale.
Total cost breakdown (realistic 2025 estimates)
| Cost item | Grau 1 | Grau 2 |
|---|---|---|
| Government fee | Free | ~$400-800 |
| PTR retainer (annual) | $2,000-5,000 | $2,000-5,000 |
| PSR preparation | $500-2,000 | $1,000-3,000 |
| Label translation/adaptation | $300-800 | $300-800 |
| GMP documentation | $500 | $500 |
| Additional testing | $0 | $3,000-8,000 |
| Consultant fees (full service) | $3,000-7,000 | $5,000-12,000 |
| Total per SKU | $5,000-10,000 | $10,000-25,000 |
Money-saving strategies
- Start with your hero SKU. Perfect the process with one product, then batch the rest
- Stagger submissions by 2-3 weeks. Incorporate feedback from the first into subsequent applications
- Negotiate volume rates. If you have 5+ SKUs, most consultants offer discounts
- Partner with a distributor. They often absorb PTR costs in exchange for exclusivity
Timeline: what to expect
| Phase | Grau 1 | Grau 2 |
|---|---|---|
| Preparation | 1-2 months | 2-3 months |
| Initial review queue | 2-3 months | 2-3 months |
| Technical evaluation | 3-6 months | 6-12 months |
| Complementation (if needed) | +2-4 months | +2-4 months |
| Final approval | 1-2 weeks | 1-2 weeks |
| Total realistic | 6-12 months | 12-24 months |
Common mistakes that delay approval
- Using English labels. All label text must be Portuguese. Not "mostly Portuguese" — 100%.
- Assuming EU/FDA compliance = ANVISA compliance. ANVISA has unique restrictions.
- Incomplete ingredient lists. "Fragrance" isn't enough — disclose allergens and restricted components.
- Drug claims on cosmetic labels. "Treats acne" pushes you into drug registration (2-3 years).
- Hiring a PTR without cosmetics experience. A general pharmacist won't know ANVISA's specific requirements.
Next steps
Don't navigate ANVISA registration alone. Use our free compliance checker to verify your ingredient list before you start the registration process — catching issues early saves months of delays.