Brazil Sanitizing Products: ANVISA Rules & Compliance Guide

Brazil Sanitizing Products: ANVISA Rules & Compliance Guide

Sanitizing Products in Brazil: Key Regulatory Guidelines

Brazil represents one of the largest consumer markets in Latin America, with rising demand for hygiene and sanitation products. For companies looking to enter this market, understanding the regulatory framework governed by ANVISA (National Health Surveillance Agency) is essential to ensure compliance, market approval, and consumer safety.

What Are Sanitizing Products?

Sanitizing products in Brazil include a wide range of substances used for cleaning, disinfecting, and pest control in homes, public spaces, and industrial environments. The main categories include:

• Insecticides – Target and eliminate insects in residential or public areas.
• Rodenticides – Control rodent populations such as rats and mice.
• Disinfectants – Kill or inhibit microorganisms on surfaces or in environments.
• Detergents – Remove grease and ensure hygiene in kitchenware and surfaces.

Regulatory Classification by Risk

ANVISA classifies sanitizing products into two risk categories:

• Risk Category 1:
• Low-toxicity products with minimal risk to human or animal health.
• Do not require pre-market approval, but must be notified to ANVISA.
• Simplified regulatory process.
• Risk Category 2:
• Higher-risk products requiring full pre-market approval.
• Subject to technical review of composition, safety, and intended use.
• Approval must be secured before commercialization.

Approval and Validity

• Risk 1: Notification only; valid for 5 years, renewable.
• Risk 2: Pre-market approval required; also valid for 5 years, renewable.

Requirements for Foreign Companies

Foreign companies cannot register products directly with ANVISA. Instead, they must:

• Appoint a local Brazilian company as the Market Authorization Holder (MAH).
• The MAH will handle importation, registration, and distribution.
• This partner is legally responsible for regulatory compliance in Brazil.

Why Regulatory Compliance Matters

• Compliance with ANVISA regulations ensures a smooth and legal market entry.
• Helps build consumer trust and brand reputation.
• Enables alignment with Brazil’s disinfectant and household chemical safety standards.
• Non-compliance can result in penalties, product recalls, or market bans.

How Freyr Can Help

Freyr offers end-to-end regulatory support for sanitizing products in Brazil, helping you:

• Navigate ANVISA classification and registration.
• Identify appropriate product risk category.
• Partner with a compliant local MAH.
• Achieve full regulatory chemical compliance for hassle-free market entry.