How to Register a Disinfectant with ANVISA?

Disinfectants are products intended for the control of pests and harmful organisms in domestic, commercial, or industrial environments. They include household pesticides, insect control products, rodenticides, and other harmful organism control agents. Due to their potential impact on human health and the environment, these products are strictly regulated by ANVISA.

1. Verification of Regulatory Requirements

Before starting the registration process, it is essential that the company understands the applicable regulatory standards. For disinfectants, the legal framework is outlined in RDC No. 34, dated August 16, 2010, which governs the procedures for registration, registration renewal, and post-registration changes of sanitizing products.

2. Product Classification

The correct classification of the disinfectant is crucial. ANVISA classifies sanitizing products according to their health risk, categorized as either grade 1 or grade 2. Disinfectants generally fall into the grade 2 category, which requires stricter control and rigor in registration due to the associated risks of their use.

3. Necessary Documentation

Documentation is one of the pillars of the registration process. For disinfectants, the following are required:

• Petition Form: Completed and signed by the company's technical responsible party.
• Proof of Payment of the Health Surveillance Inspection Fee (TFVS): The amount varies depending on the size of the company.
• Efficacy and Safety Reports: Includes laboratory studies that prove the efficacy of the disinfectant and its safety for users.
• SDS (Safety Data Sheet): A document that details the product's composition, its risks, and safety measures.
• Labeling: Label information must comply with ANVISA standards, including warnings, usage instructions, and precautions.

4. Submission of the Dossier to ANVISA

After preparing all the documentation, the next step is submitting the complete dossier to ANVISA through the Electronic Petitioning System (SGAS). It is essential to review all documents before submission to ensure they are complete and correct, avoiding delays in the process.

5. Technical Analysis by ANVISA

ANVISA conducts a detailed technical analysis of all the submitted documentation. During this phase, there may be additional requests for information or adjustments to the documentation. The speed of this analysis depends on the product's complexity and the quality of the information provided.

6. Publication of the Registration in the Official Gazette

After approval, the disinfectant's registration is published in the Official Gazette of the Union (DOU). With this publication, the product is officially authorized for manufacturing, import, and commercialization in Brazil.

7. Maintenance of Registration

Disinfectant registration is valid for 10 years and must be renewed before expiration. Additionally, any changes in formulation, labeling, or manufacturer must be communicated to ANVISA through a post-registration change petition.

Registering a disinfectant with ANVISA is a meticulous process involving several steps, from product classification to registration maintenance. Companies must be attentive to regulatory requirements and ensure that all documentation is presented fully and correctly. By doing so, they can ensure that the product meets the required safety and efficacy standards, providing consumer protection and avoiding potential penalties.

To ensure that your company follows all the necessary steps efficiently and in compliance with current regulations, Stone Okamont is ready to help. With expertise in the regularization and registration process of products with ANVISA, Stone Okamont offers specialized support, from document preparation to monitoring the approval process. Trust those who understand the subject and simplify your disinfectant registration with ANVISA with Stone Okamont.