Anvisa’s new rules for sanitizers: modernization and more safety for consumers

On August 20, 2025, the Brazilian Health Regulatory Agency (Anvisa) published two rules that significantly update the regulatory framework for sanitizing products in Brazil:

• Collegiate Board Resolution (RDC) 989/2025, and
• Normative Instruction (IN) 394/2025.

These rules replace the old RDC 59/2010, bringing changes ranging from risk classification to new labeling, safety, and marketing requirements. The main objective is to guarantee safer products for the population, while at the same time seeking regulatory harmonization with Mercosur to facilitate trade between the bloc’s countries.

How did this update come about?

The review process began in 2019, during the 50th Meeting of Mercosur’s Working Subgroup (SGT) No. 11, held in Buenos Aires. At the time, a proposal was launched to bring Brazilian legislation into line with the common technical regulation for the registration and notification of sanitizers.

This proposal was submitted to Public Consultation No. 776 in February 2020, allowing for the participation of society and companies in the sector.

However, due to climatic differences between the countries, there was no consensus on certain points, especially those related to analytical tolerances and product shelf life. As a solution, Anvisa decided to split the regulations:

• RDC 989/2025 covers the aspects harmonized by Mercosur.
• IN 394/2025 maintained Brazil’s specificities, preserving advances already made and detailing additional criteria.

Main changes established

1. Risk classification

Sanitizing products are still divided into two categories:

• Risk 1 (notification): products with a lower risk potential.
• Risk 2 (registration): products that require greater sanitary control.

An important point is the definition of the criteria for assessing toxicity (LD50). Now, the analysis considers whether the product is in its pure form for direct sale or in final dilution for professional use, bringing more precision and standardization to the evaluation.

2. Security requirements

• Prohibition of the use of carcinogenic, mutagenic, or teratogenic substances.
• The requirement that anionic surfactants be biodegradable reinforces care for the environment.

3. Labeling and packaging

The labeling of sanitizers has been modernized to ensure clarity and avoid misleading information. Among the highlights:

• Prohibition of the use of appealing phrases.
• Mandatory inclusion of the telephone number of Poison Centers.
• Greater standardization of mandatory warnings.
• Prohibition on reusing food packaging to store sanitizers.

These measures enhance transparency for consumers and reduce the risk of home accidents.

4. Volume limits for over-the-counter sales

Risk 1 (notification) products may be sold in packages of up to 10 liters or 10 kg, which increases clarity in the regulation of trade in these items.

5. National specificities (IN 394/2025)

The Normative Instruction complements the RDC, bringing in points that have not been harmonized in Mercosur:

• Volume limits for other product categories.
• Analytical tolerances for quality control.
• Technical criteria for proving shelf life, based on stability tests.

Impacts for the sector and consumers

Anvisa believes that the update will have a positive impact on different fronts:

• Consumers: will have access to safer products, with clearer and more reliable information.
• Productive sector: gains greater regulatory predictability and the possibility of easier access to Mercosur markets, boosting the competitiveness of Brazilian companies.
• Public health: reinforcing the Agency’s commitment to protecting the population from risks associated with poorly regulated products.

The publication of RDC 989/2025 and IN 394/2025 marks a significant step in modernizing the Brazilian regulatory environment for sanitizers. In addition to bringing the country into line with international standards, the regulations strengthen the safety, transparency, and quality of the products available on the market.

For companies in the sector, understanding and correctly applying these new requirements will be essential to ensure regulatory compliance and maintain competitiveness in a scenario of greater integration with Mercosur.