Sanitizers are important products for the cleaning, disinfection and conservation of environments. Thinking about it, Stone Okamont has prepared an explanatory material on how to regulate sanitizers with ANVISA.
The regulation process can be complicated, but the regularization of your company in the Brazilian Health Regulatory Agency guarantees its performance and commercialization of the sanitizing company in the Brazilian territory.
Stone Okamont is an advice in regulatory intelligence that offers you the best ways to regulate sanitizing in ANVISA! Check out the content and get your questions answered!
What is sanitizing according to ANVISA?
Sanitizing is the substance intended for applications in environments or objects for the purpose of cleaning, disinfecting or sanitizing.
The term household cleaning is used to classify sanitizers that have the purpose of home use.
How to start the sanitizer regulation with ANVISA?
In order to be able to regulate sanitizing with ANVISA, it is necessary that the manufacturing company is also regularized with the competent agency.
The first step is to obtain the Operating License. Its concession is made from a survey carried out at the establishment by the Local Sanitary Surveillance (VISA).
The approval of the license means that the company has technical and operational conditions for the manufacture and storage of the sanitizer.
Do I need the sanitizer Operation Permits?
The Company Operation Authorization (AFE) is absolutely necessary to regulate sanitizing with ANVISA.
Its approval comes from the analysis done by the Brazilian Health Regulatory Agency.
If the company meets the requirements of ANVISA, it is published in the Official Gazette (DOU) the authorization that regulates the company in accordance with Brazilian legislation.
What are the procedures to regulate sanitizing with ANVISA?
To regulate sanitizing with ANVISA, it is necessary to perform an analysis of its composition and classify the product according to its constitution.
The sanitizers are divided into two categories, being they Risk Class I and Risk Class II. In the evaluation and management of risks are considered:
- Toxicity and concentration of substances;
- Purpose of the sanitizing agent;
- Conditions of use.
Does the Risk Class influence the sanitizer regulate with ANVISA?
If the sanitizer falls into the category I, only one notification is required. The request is made electronically, and the product can be marketed after the disclosure on ANVISA's website.
For the category II sanitizers, commercialization is only allowed after the granting of the registration published in the Official Gazette (DOU).
What does it take to regulate sanitizing with ANVISA?
Some documents must be submitted to register the sanitizer with ANVISA. There are some of them:
- Reports, stability studies and reports;
- General information about the company;
- Report of pH.
The process of product analysis is paramount to be able to make a request that is in accordance with its performance.
There are a lot of bureaucracies to follow, but Stone Okamont is ready to present the best ways to register sanitizing with ANVISA.
Does ANVISA establish prohibitions in the sanitizer regulation?
In order for your regulation not to be denied, you must be aware of the not allowed components.
Substances that exceed the limit or have mutagenic, teratogenic or carcinogenic effects are prohibited by the Brazilian Health Regulatory Agency.
The best solution in regulatory intelligence
Stone Okamont has more than thirty years of experience in ANVISA's regulatory paths. With highly qualified consultants, we present the best solutions for your sanitizing registration with ANVISA.
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