ANVISA classifies flavorings as cosmetics and therefore the registration of this product is mandatory, that is, they must be properly regulated to be commercialized.
Even for simple and usual occasions, flavorings can cause reactions, and for this reason, the presentation of a range of tests and studies is essential in the regularization process.
Most of the information needed to assess the potential risk of a product comes from studies of the ingredients that make up its formula. The safety assessment of these ingredients follows a strict parameter stipulated in current legislation.
To regularize flavorings at ANVISA, we need to go through the company's regularization steps, which consist of obtaining the Operating License and the Operation Authorization. After completing these steps, you will be able to start the product registration process.
We know that regulatory processes are bureaucratic and complicated, that's why we created this article in order to help you.
This content will be divided into 3 parts: Operating License, Operation Authorization and Product Registration. In this way, the reading can be directed towards your current doubts.
See what are the necessary steps to obtain regularization of flavorings at ANVISA.
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Step 1: Operating License (VISA) for Flavorings
Before asking the regularization of flavorings at ANVISA, the first step is to obtain the Operating License for your establishment.
The Operating License, issued by the Sanitary Surveillance (VISA), authorizes the operation of your company's activities, after verifying compliance with all the rules established by the RDC corresponding to the activity that will be performed. It is the most judicious phase of the entire process.
In this process, the company is responsible for adapting its physical structure to receive inspection by a VISA’s agent, who will assess the local technical and operational conditions, so that your establishment can operate and take you to the next step, which is the Company Operation Authorization.
The Operating License is necessary and indispensable for the next step, which is the petition for the Operating Permit for the Company.
Step 2: Company Operation Authorization (ANVISA) for Flavorings
The Company Operation Authorization (AFE) is one of the most important regulatory steps for the success of your business, and for this reason, it is necessary to have specialized technical support.
The Company Operation Authorization, better known as “AFE”, is an ANVISA permission for the company to carry out its activities. The document, which will be published in the Federal Official Gazette (DOU), must be requested to start activities such as: manufacturing, distributing, storing, transporting, importing or exporting.
In this phase there are petitions, verification of documents, collection of fees, among others. Each category requires specific documentation and it is very important to pay attention to the base documents, as the lack of these can result in instant rejection.
Obtaining the AFE indicates that the company operates in accordance with brazilian legislation and is able to operate nationwide.
Step 3: Flavoring Registration (ANVISA)
The Product Registration is the document issued by ANVISA legalizing its commercialization. After petitioning the process, the Agency will analyze the documentation presented to make sure that the product complies with current legislation and is suitable for commercialization.
In this final step, information is presented, such as composition, qualitative and quantitative analysis of the product, instructions for use, disposal instructions, among others. In other words, a well-prepared dossier is essential for approving the product's registration at ANVISA.
How can we help Regulate Flavorings?
Our regulatory affairs department is responsible for the regularization of products and establishments. Our role is to guide and provide technical support in order to establish the ideal regulatory strategy for the company's success and competitive advantage.
Talk to those who understand! Count on Stone Okamont to regulate flavorings at ANVISA. We have a body of trained professionals ready to meet the needs of your company and product.
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