Brazil Cosmetic Registration Service
複雑な現地規制を専門家の指導でナビゲート。製品登録から指定代理業務まで。.
包括的なソリューション
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.
選ばれる理由
Navigate Brazil’s complex regulations with speed, clarity, and confidence.
よくある質問
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.