Anvisa Cosmetic Notification and Registration Update
Any change to a cosmetic product already registered or notified with Anvisa must be evaluated for regulatory impact. At Sobel, we guide companies through the Anvisa cosmetic registration update process, so your products remain legally available on the Brazilian market.
- Cosmetic manufacturers updating formulas, labels, or packaging.
- Importers who need to modify notified or registered products in Brazil.
- Regulatory teams managing portfolios of Grade I and Grade II cosmetics.
- Companies correcting previous records or adjusting dossiers for compliance.
Our specialists help you manage updates smoothly, reducing risks of delays or compliance gaps.
Why do you need this service?
Every modification to a cosmetic product can trigger new regulatory requirements. Missing a step may put your product at risk of suspension or market withdrawal.
With a clear update strategy and well-prepared documentation, your process moves forward more efficiently and avoids unnecessary rework.
Staying aligned with Anvisa’s evolving rules ensures your products remain competitive and continuously available in the Brazilian market.
Achieve Anvisa compliance
Anvisa requires that updates to cosmetic products follow strict notification or registration pathways, depending on product classification.
Our team maps the correct route for your product and prepares the documents in the right format. Compliance at every step.
Sobel covers all details of the Anvisa cosmetic notification or registration update process.
Related
Services
From dossier compilation to label review, Sobel covers all details of the Anvisa cosmetic registration update process.
We also offer complementary services to support your compliance strategy:
Anvisa Gap Analysis
Identify gaps in documents to improve compliance before registration or notification.
Internal Audit for Cosmetics Manufacturers
Be compliant with GMP and Anvisa before your next inspection.
Brazilian Regulatory Representative
We act as your regulatory representative and manage Anvisa registration and notification.
Move forward with clarity and compliance
Sobel’s consultants bring technical clarity, document validation, and step-by-step coordination with Anvisa requirements.
From minor adjustments to major modifications, we help you reduce risks, save time, and keep your cosmetics active on the Brazilian market.
1. When does a product update need to be submitted to Anvisa?
Any time there is a change to the formula, packaging, label, or documentation, it must be evaluated for regulatory impact. Many of these updates require a formal submission to Anvisa to keep the product legally on the market.
2. What is the difference between notification and registration?
Notification (Grade I) applies to low-risk cosmetics and follows a simplified pathway. Registration (Grade II) applies to higher-risk cosmetics and requires a more detailed review and approval by Anvisa.
3. What documents are usually required for an update?
Typically, Anvisa requests updated technical documentation, a responsibility term and more. At Sobel, we prepare a tailored checklist of required documents for each case, so your team knows exactly what to provide.
4. How do I track the progress of my update?
After submission, you can follow the protocol until the update is published in the Federal Official Gazette (DOU). Publication confirms that the update is officially recognized. For Sobel partners, our team handles this monitoring directly, ensuring each step is tracked until final approval.
5. Who is allowed to submit cosmetic updates to Anvisa?
Foreign companies cannot submit directly. A Brazilian legal representative must hold the notification or registration and be responsible for the submission.
