Sanitizing products

Publicado em 29/10/2020 16h37 Atualizado em 19/08/2025 17h00

What are Sanitizing products?

According to the definition given by Law 6.360/1976, sanitizing products are cleaning products, antimicrobial products for objects e environments, and domestic pesticides, which are substances or preparations intended for household sanitation, disinfection or disinfestation in collective and/or public environments, in places of common use and in the treatment. They include:

Insecticides: intended for combating, preventing and controlling insects in households, private places and places of public use and their surroundings;
Rodenticides: intended for the control of rats, mice and other rodents, in domiciles, vessels, enclosures and places of public use, containing active substances, isolated or in combination, which do not present a risk to human or animal life or health when used in accordance with their recommendations;
Disinfectants: intended to destroy, indiscriminately or selectively, microorganisms, when applied to inanimate objects or environments;
Detergents: intended to dissolve fats and for the hygiene of containers and household applications.

Market authorizations

The general regulation applicable to marketing authorization for Sanitizing products is Resolution RDC 59/2010.

Products described in this Resolution as Risk class 2 are subject to the registration approval procedures, also known as pre-marketing approval. Products in the Risk class 1 category are exempt from pre-marketing approval and are subject to a notification procedure, aiming at informing Anvisa about the intention to market a product exempted from pre-market approval.

To submit a registration or notification request for a sanitizing product with ANVISA, companies must hold a valid AFE (Autorização de Funcionamento de Empresa). This is a mandatory authorization that allows a company to engage in activities such as the manufacture, import, export, storage, and distribution of products subject to health regulation.

For sanitizing products products in Brazil, however, GMP (Good Manufacturing Practices) certification is not required. Nevertheless, companies are expected to comply with appropriate quality and safety standards aligned with good manufacturing principles to ensure product safety and consumer protection.

Registration approvals are valid for 10 years from the date of their publication in the Brazilian Official Gazette, and may be renewed for equal and successive periods. Similarly, notifications are valid for 10 years from the date of completion of the online protocol, and may also be renewed for equal and successive periods.

Please note that foreign companies are not allowed to directly obtain marketing authorizations with Anvisa. In order to market products in Brazil, foreign companies must partner with Brazilian companies legally established in the country, which will act as the legal holders and responsible parties for the products imported and distributed within Brazilian territory.

International Forums

The Cosmetics and Sanitizing Products General Office (GGCOS)actively participates in international forums and regional initiatives aimed at harmonizing the regulation and oversight of these products. A key forum where Anvisa plays a significant role is Mercosur, a regional trade bloc that includes Brazil, Argentina, Paraguay, and Uruguay, alongside engagement in other technical cooperation platforms with global impact.

Within Mercosur, Anvisa collaborates with regulatory authorities from member countries to develop and harmonize technical regulations for sanitizer products, which include disinfectants and other products used for public health and hygiene. Anvisa’s role involves technical leadership in drafting resolutions, contributing to scientific discussions, and negotiating common criteria for product safety, efficacy, labeling, and quality control. The goal is to facilitate trade within the region while maintaining high standards of health protection for the population.

Anvisa’s participation in Mercosur and other international cooperation platforms demonstrates its commitment to regulatory harmonization, regulatory convergence, public health protection, and regional integration. By engaging with other health authorities, Anvisa helps ensure that sanitizer products marketed in Brazil and neighboring countries are safe, effective, and meet consistent technical standards.

Applicable regulations

The following are the main regulations applicable to the marketing authorization (registration/pre-marketing approvals and notification) of sanitizing products exported to Brazil:

Resolution RDC 692/2022: Electronic procedure for notification of Products of Risk I.
Resolution RDC 699/2022: Bleaches.
Resolution RDC 813/2023: Hypochlorite based products.
Resolution RDC 648/2022: Prohibition of benzene and limits to the compound as a contaminant.
Resolution RDC 685/2022: Preservatives.
Resolution RDC 682/2022: Technical requirements for disinfectant products.
Resolution RDC 694/2022: Cleaning products.
Resolution RDC 703/2022: Enzymatic detergents of restricted use in healthcare establishments for cleaning medical devices.
Resolution RDC 680/2022: Odor neutralizers.
Resolution RDC 679/2022: Bacteria-based sanitizing products.
Resolution RDC 774/2023: Antimicrobial products.
Resolution RDC 700/2022: Antimicrobial products used in critical and semi-critical articles.
Resolution RDC 697/2022: Procedures and technical requirements for the market authorization of sanitizing products that are corrosive to the skin or that cause serious eye damage.
Resolution RDC 649/2022: Specific requirements for products containing inhalants.