Disinfectants and ANVISA: What you need to know to sell?

Disinfectants fall into the category of sanitizers, which includes products intended for sanitizing and disinfecting environments and surfaces. They can be divided into two main categories:

• General-purpose disinfectants: Suitable for domestic cleaning, such as floors, bathrooms and kitchens.
• Professional use disinfectants: Used in specific environments, such as hospitals, industries and commercial establishments, where greater disinfecting power is required.

Each category has different requirements in terms of registration and regulation. For example, disinfectants for professional use require stricter proof of efficacy, while those for general use have slightly simpler rules, but still need to follow ANVISA standards.

In order to market disinfectants, it is mandatory to register the product with ANVISA. This process involves submitting documents and tests that prove the product's safety and efficacy. The main requirements include:

• Technical documentation: Includes information on the composition, manufacturing method and specifications of the product.
• Efficacy tests: Tests that demonstrate the product's ability to eliminate microorganisms.
• Safety assessment: Analysis of the risks associated with using the product, such as toxicity and irritation potential.
• Proposed labeling: The label must follow ANVISA standards, with clear and precise information.

The registration process can be complex and time-consuming, so it is advisable to enlist the support of a professional or specialized consultancy.

The labeling of disinfectants must follow ANVISA standards, with clear and mandatory information:

• Name of the product and its purpose.
• Method of use and dilution, if necessary.
• Name and CNPJ of the manufacturer or importer.
• ANVISA registration number..

Advertising for these products is also regulated. It is forbidden to make misleading claims or claims that cannot be scientifically proven, such as “100% effective” or “long-lasting protection”, without studies to back up these claims.

ANVISA carries out constant inspections to ensure that disinfectants on the market meet safety and efficacy standards. Companies that fail to comply with the rules can face penalties such as fines, product seizure and even deregistration.

To avoid problems, it is essential to keep up to date with ANVISA regulations and carry out periodic checks to ensure that products comply. In addition, it is important to be aware of possible changes in regulations, which may occur in response to new scientific discoveries or public health needs.

Stone Okamont simplifies regulation, helping with approval by ANVISA and other bodies. Our team of experts is ready to help you throughout the process. Count on us to bring your product to market with efficiency and quality.