Brazil Sanitizing Products: ANVISA Rules & Compliance Guide

Sanitizing Products in Brazil: Key Regulatory Guidelines

What Are Sanitizing Products?

Sanitizing products in Brazil cover a wide range of cleaning and disinfecting items, including:

• Insecticides – Combat insects in homes/public spaces.

• Rodenticides – Target rats and rodents.

• Disinfectants – Kill/inhibit microbes on surfaces/environments.

• Detergents – Remove grease and ensure cleanliness.

These products are used in both domestic and institutional settings and are regulated to ensure public health.

Regulatory Authority: ANVISA

• ANVISA (Agência Nacional de Vigilância Sanitária) is Brazil’s National Health Surveillance Agency.

• It classifies and regulates sanitizing products based on their risk level.

Risk-Based Classification

Risk Level	Description	Regulatory Process
Risk 1	Low toxicity, minimal health risk	Notification only (no prior approval)
Risk 2	Higher toxicity or complex use	Pre-market approval required

• Examples:

  • Risk 1: General-purpose detergents

  • Risk 2: Hospital-grade disinfectants, rodenticides

Approval & Validity

• Risk 1: Must be notified to ANVISA; no pre-approval needed.

• Risk 2: Requires registration and pre-market approval by ANVISA.

• Validity: 5 years for both notifications and approvals. Renewable.

Foreign Company Requirements

Foreign companies cannot register products directly with ANVISA. They must:

• Appoint a local Brazilian partner (importer or legal representative).

• The local partner handles:

  • Product registration/notification

  • Importation

  • Distribution

This partner bears full legal responsibility for the product in Brazil.

Why Compliance Is Critical

• Regulatory compliance ensures:

  • Legal market entry

  • Consumer safety

  • Competitive advantage

• Aligning with Brazil disinfectants regulations and household chemicals regulations builds trust with:

  • Regulators (ANVISA)

  • Distributors

  • Consumers

How Freyr Can Help

Freyr supports businesses with:

• ANVISA compliance strategy

• Product classification

• Dossier preparation and submission

Local partner coordination