Launch Your Cosmetics in Brazil with ANVISA Compliance
Grade 1 Notification · Grade 2 Registration · Local Responsible Holder · Label Review · Technical Dossier
Entering Brazil’s cosmetic market can be complex.
- Grade 1 / Grade 2 classification uncertainty
- ANVISA notification or registration route selection
- Portuguese label requirements
- Local Responsible Holder / importer requirements
- Technical dossier preparation
ZOOP helps cosmetic brands handle these requirements from classification to market release.
Before Registration
Brazil Cosmetic Regulatory Background
In Brazil, the regulation of personal care products, cosmetics, and perfumes is overseen by the National Health Surveillance Agency (ANVISA).
The primary regulation is RDC No. 907/2024 (as amended by RDC No. 949/2024), which incorporates relevant technical regulations established by the MERCOSUR framework and sets out comprehensive requirements for product definitions, classification, labeling and packaging, microbiological control parameters, and market authorization procedures. It also provides specific labeling warnings for products such as aerosols, hair dyes, and sunscreens (Art. 24).
Cosmetic products are regulated according to their risk level and are classified into Grade 1 (lower regulatory oversight) and Grade 2 (higher regulatory oversight) categories. Different pre-market procedures apply to each category. All products are subject to either registration (for a specific list of higher-risk Grade 2 products, such as sunscreens and insect repellents, as defined in Art. 34) or notification (for all other products, including most Grade 1 and other Grade 2 products, as defined in Art. 35).
Definition of Cosmetics in Brazil
Cosmetics are preparations composed of natural or synthetic substances intended for external use on different parts of the human body, including the skin, hair system, nails, lips, external genital organs, teeth, and oral mucosa.
Their sole or primary purpose is to:
- Cleanse
- Perfume the body
- Alter appearance
- Correct body odors
- Protect or maintain the body in good condition
In other words, any product that meets the criteria of composition, external use, and cosmetic purpose is considered a personal care product, cosmetic, or perfume under Brazilian regulations.
| Criteria | Grade 1 | Grade 2 |
|---|---|---|
| Composition | Must not contain: | Contains substances restricted under regulations such as RDC 645/2022 and RDC 530/2021, permitted only if compliant with concentration/usage limits. |
| • UV Filters | ||
| • Grade 2 restricted substances (unless they do not affect classification) | ||
| • Active ingredients that alter the product's nature or mode of use | ||
| Product Claims & Intended Use | • Basic cleansing products | • Sunscreens (adults and children) |
| • Basic skincare products | • Antibacterial hand gels | |
| • Perfumes and body sprays | • Hair straightening products | |
| • Products intended only to improve appearance without active functional ingredients | • Hair straightening and coloring products | |
| • Hair curling products | ||
| • Insect repellents (adults and children) | ||
| • Tanning products | ||
| • Leave-on hair styling creams and pomades | ||
| Target Population | General population | Children (under 12 years old), pregnant women, and individuals with sensitive skin |
Main Compliance Process
Grade 1 Products – Notification; Grade 2 Products – Registration or Notification, valid for 10 years.
Appoint a Local RP
The Brazil-based Responsible Holder must possess a valid Operational Permit (AFE) from ANVISA for the specific product category before any filing begins.
Classification
Classify the product into one of two regulatory routes: Grade 1: Low-risk products:Simplified Notification Grade 2: High-risk/specific-claim products: Full Registration
Dossier Preparation
Compile the technical documents: full formula, Finished product safety test, efficacy evidence (for Grade 2), stability reports, and primary/secondary packaging labels and so on.
Online Submission
Upload the completed technical dossier and submit the application via ANVISA’s electronic portal.
Technical Evaluation
Grade 1: Skips official technical review. Grade 2: Undergoes a comprehensive safety and compliance review by ANVISA.
Publication & Market Release
Grade 1: Authorized for sale immediately after publication on **ANVISA’s portal**. Grade 2: Authorized for sale only after publication in the **Official Federal Gazette (DOU)**.
Post-Market Maintenance
Compliance: Maintain strict adherence to Brazil’s Good Manufacturing Practices (BPFC). 10-Year Renewal: Grade 2 products require formal re-registration every 10 years; Grade 1 products require a continuing sales statement every 10 years.
Required Documents
- Product Formula
- Raw Material Specifications
- Stability & Compatibility Test Reports
- Microbiological Test Report
- Product Safety Assessment
- Portuguese Label Artwork
- Manufacturing Process Description
- Packaging Documentation
Don’t worry — ZOOP helps you prepare and review the required technical documents before submission.
Why Choose ZOOP
Navigate Brazil’s complex regulations with speed, clarity, and confidence.
Comprehensive Solutions
Regulatory solutions to ensure your cosmetic products are fully compliant and ready for the Brazil market.
Managing Grade 1 (Notification) and Grade 2 (Registration) processes with the Brazilian Health Regulatory Agency (ANVISA).
Ensure that product ingredients comply with the lists of permitted, restricted, and prohibited substances published by Anvisa.
Acting as or assisting with your Brazilian Registration Holder (BRH) / local importer requirements.
Assist in preparing and compiling the complete technical documentation required for notification or registration, such as formulation details, safety and efficacy data, and stability studies.
Verify that labeling meets mandatory information requirements, including warnings and conditions of use
Provide ongoing support for label updates, re-registration, cancellation, and other regulatory changes after market launch.
Frequently Asked Questions
How do I determine whether my product is Grade 1 or Grade 2?
The classification depends on the product’s risk level, intended use, and claims.
Grade 1 (Notification) applies to low-risk cosmetics with basic functions.
Grade 2 (Registration) applies to products with specific claims, higher risk, or special usage conditions.
What is the first step in the Brazilian registration process?
The first step is determining the correct regulatory pathway (Grau 1 or Grau 2) based on the product’s characteristics and claims.
What technical documents are required for submission?
1.Bibliography and/or reference for the ingredients.
2.Copy of the original formula of the imported product (for imported products).
3.Microbiological specifications of the finished product.
4.Organoleptic and physico-chemical technical specifications of the finished product.
5.Product’s intended purpose.
6.Qualitative and quantitative formula.
7.Function of each ingredient in the formula.
8.Label artwork/layout project.
9.Summary of data proving the efficacy of the benefits claimed for the product, whenever the nature of the benefit justifies it and whenever it appears on the label.
10.Summary of data proving safety of use, only when specific safety proof is required by current legislation or when a safety attribute is expressed on the label.
11.Summary of stability data.
How is the application submitted?
Applications must be submitted electronically through the official Portal da Anvisa system.
Does Anvisa conduct a technical review for all products?
No.
Grau 1 products are not subject to prior technical review.
Grau 2 products undergo technical evaluation by Anvisa before approval.