Sanitizing products

What are sanitizing products?

According to the definition given by Law 6.360/1976, sanitizing products are cleaning products, antimicrobial products for objects and 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 households, 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 marketing authorization approval procedures, also known as pre-marketing approval. Products in Risk class 1 category are exempt from pre-marketing approval and are subject to a notification procedure, with the objective of informing Anvisa about the intention to market a product exempt from pre-market approval.

To submit a marketing authorization or notification request for a sanitizing product with ANVISA, companies must hold a valid AFE (Autorização de Funcionamento de Empresa – Company Operation Authorization). 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 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.

Marketing authorization approvals are valid for 10 years from the date of their publication in the Brazilian Federal 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 Fora

The Cosmetics and Sanitizing Products General Office (GGCOS) actively participate in international fora and regional initiatives aimed at harmonizing the regulation and surveillance 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 sanitizing 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 to 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 Risk I Products.
• Resolution RDC 699/2022: Bleaches.
• Resolution RDC 813/2023: Hypochlorite-based products.
• Resolution RDC 648/2022: Prohibition of benzene and limits to the compound including it 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 to clean 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 devices.
• 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.

Tobacco Products

Share:  Share by Facebook Share by Twitter Share by LinkedIn Share by WhatsApplink to Copy to Clipboard

Published on Oct 29, 2020 04:42 PM Updated on Mar 08, 2026 10:22 PM

Marketing authorization of Tobacco-Derived Smoking Products

All tobacco-derived smoking products, whether manufactured in Brazil or imported, must be granted marketing authorization by ANVISA to be commercialized in the country.

Each product must have marketing authorization requested by the interested company, which must be either the Brazilian manufacturer or an importer legally established in the country.

A product can only be commercialized after the marketing authorization approval has been published in the Federal Official Gazette. The marketing authorization is valid for one year from the date of publication. Therefore, for the company to maintain the right to continue selling the product granted marketing authorization, it must renew the product marketing authorization annually. It should be noted that the approved product does not have a marketing authorization number. The sanitary status of the product can be verified on ANVISA’S website.

To request a marketing authorization for a tobacco product with Anvisa, the interested company (manufacturer or importer) must submit a dossier containing various information about the product. The submission is made electronically, and the Inspection and Health Surveillance Fee must be paid. In 2012, Brazil banned the use of additives that enhance the sensation of use or make the products more attractive, such as flavoring agents.

The main information the dossier must contain includes:

• List of tobacco types and parts of the plant used;
• List of all compounds used in the manufacture of the product and their respective purposes and quantities, i.e. the product’s composition;
• Physical and chemical parameters of filters and wrappings (length, circumference, ventilation, pressure drop, chemical composition, weight, and permeability), in the case of products with filters;
• Analytical report on the substances and parameters present in total tobacco. For cigarette-type products, primary and secondary stream analyses (Hoffman List) are also required. For cigars, analyses of nicotine, carbon monoxide, and tar (TNCO) in the primary stream are required;
• Product packaging layout.

The marketing authorization of tobacco-derived smoking products aims to:

• Establish minimum parameters to be followed by such products;
• Ensure the availability of essential information about products commercialized in Brazil;
• Monitor products and any changes made to their composition through marketing authorization renewal;
• Gather information on product composition (total tobacco composition), enabling regulatory improvements and the adoption of health measures that contribute to tobacco control and reduce product attractiveness;
• Provide a framework for determining product regularity, ensuring that any product lacking marketing authorization is deemed irregular.

The marketing authorization of tobacco-derived smoking products complies with Articles 9 and 10 of the WHO Framework Convention on Tobacco Control (FCTC) (Decree No. 5,658/2006), which address knowledge of the composition and emissions of tobacco products. The FCTC also establishes that the public must be informed about product composition, which is done within the limits of confidentiality requirements, through publication in the Product Consultation.

Health Warnings

All tobacco products commercialized in Brazil must bear health warnings covering 100% of the back, 100% of one side, and 30% of the front of the package. Health warnings have been mandatory for over 25 years, and pictorial warnings were introduced in 2002 and have been mandatory ever since.

Anvisa is responsible for periodically publishing health warning images and messages. In 2024, Anvisa published images and messages to be used between November 2025 and November 2027.

Compliance with the health warning requirements for the product to be granted marketing authorization is verified during the analysis of the marketing authorization dossier.

Electronic Smoking Devices

Since 2009, the sale, advertising, and import of electronic smoking devices have been prohibited. In 2024, after a robust regulatory impact assessment based on scientific evidence, new regulations were published maintaining the ban on any type of commercial activity related to electronic smoking devices.

The 2024 regulation classifies electronic smoking devices into:

• Liquid-based products, which include electronic cigarettes;
• Solid-based products, which include heated tobacco products; and
• Hybrid-based products, which use both liquid and solid refills, including leaves.

Regardless of the type of matrix used, all electronic smoking devices are prohibited in Brazil.

Participation in International Fora

WHO Framework Convention on Tobacco Control (WHO FCTC) – The FCTC is the first international treaty negotiated under the auspices of the WHO, aiming to protect people from the health, social, environmental, and economic consequences of tobacco consumption and exposure to tobacco smoke. The treaty sets out general measures to reduce tobacco use and exposure. ANVISA participates in groups that discuss key aspects of regulations and practices to ensure the best possible implementation of FCTC articles within its scope, considering national scenarios and existing regulations.

Conference of the Parties and Meeting of the Parties (COP and MOP of the WHO FCTC) – ANVISA regularly participates in the Brazilian delegation to the COP and MOP, providing technical support for discussions and decisions related to the FCTC articles and the Protocol that fall within ANVISA’S jurisdiction.

Additionally, ANVISA participates in the expert group on Articles 9 and 10 of the WHO FCTC (contents and emissions of tobacco products and disclosure of this information) and provides technical support to other countries on specific topics such as marketing authorization of smoking products, regulation of additives in tobacco products, regulation of electronic smoking devices, and enforcement actions, among others.

Global Tobacco Regulators Forum (GTRF) – The GTRF is a WHO-linked group comprising the world’s leading tobacco control regulatory authorities. Anvisa is one of the founding and longest-standing members and currently serves on its management committee. During its meetings, regulators discuss topics related to tobacco products, particularly the implementation of Articles 9 and 10 of the FCTC, enforcement challenges, and emerging issues. The GTRF conducts studies and research at the request of its members or the WHO. An ANVISA staff member currently coordinates research on policies related to the use of additives in tobacco and nicotine products.

WHO Study Group on Tobacco Product Regulation (TobReg) – TobReg is composed of international experts from various fields. ANVISA’S participation aims to contribute the expertise accumulated by the agency over the years. The group advises the WHO by providing scientifically sound and evidence-based recommendations on the regulation of tobacco products and by addressing knowledge gaps in the regulation of nicotine and tobacco products. Such recommendations are published in the Technical Report Series (TRS), with the objective of reducing tobacco demand and protecting public health.

Applicable Regulations

The following are the main regulations applicable relating to tobacco and smoking products exported to Brazil:

• Resolution RDC 195/2017: Packaging and advertisement
• Resolution RDC 14/2012: Regulation of brand names, allegations in the packaging, addictives 
• Law 12.546/2011: Limitations to the advertisement of tobacco products
• Resolution RDC 304/2002: Prohibits the sale of food products that simulate tobacco products or their packaging
• Resolution RDC 226/2018: Online requirement for market authorization of tobacco products