17/12/2018

How to regulate functional food with ANVISA

Learn how to regulate functional food with ANVISA with the new Stone Okamont material!

Some types of food, such as processed foods, are under the jurisdiction of the Brazilian Health Regulatory Agency. In this way, not being different, foods with functional properties must also be registered with ANVISA.

Stone Okamont has a team of highly specialized consultants who are ready to assist you and assist in the classification and preparation of the process to regulate functional food in ANVISA! Check out!

 

What are foods with functional properties?

ANVISA defines foods with functional properties such as those related to the metabolic or physiological role they play.

This means that the nutrient, or not nutrient, affects the growth, development, maintenance and other normal functions of the human organism.

 

Operation License to regulate functional food with ANVISA

First, before starting to regulate functional food in ANVISA, it is necessary to regularize its establishment.

The Operating License comes from a survey carried out by VISA, the Local Sanitary Surveillance.

The establishment needs to be in accordance with the requirements, that is, have the technical and operational conditions to carry out the intended activity.

Once your company is properly regularized, you can start the procedure to regulate functional food with ANVISA!

 

How to regulate functional food with ANVISA?

In order to regulate functional food with ANVISA, some prerogatives of the Brazilian Health Regulatory Agency must be followed.

Many documents are required to file the petition. Between them:

  • Consumer recommendation indicated by the manufacturer;
  • Formulation of the product;
  • Description of the analytical methodology.

In addition, to regulate functional food with ANVISA, care must be taken not to disclose information or functional properties different from those contained in the Brazilian Health Regulatory Agency.

 

Do I need to renew the regulation of functional food with ANVISA?

The Brazilian Health Regulatory Agency establishes a period of 60 (sixty) days for the granting of the documentation of the registry.

The renewal of the registration of functional food in ANVISA must be done every 10 (ten) years. It is important to know that the registration is valid throughout the national territory.

 

Is AFE required to regulate functional food with ANVISA?

The Operation Permits, the AFE, is required to regulate food with ANVISA!

However, different from how it is normally done with other products, it is not necessary to file an AFE petition to regulate functional food with ANVISA.

The authorization will be automatically guaranteed after registration is approved by the Brazilian Health Regulatory Agency.

 

Food that already has a registration with ANVISA

If your food is already registered with the Brazilian Health Regulatory Agency, it is possible to change the registry to claim functional properties.

For this, it is necessary to adopt administrative procedures to change the formula and / or labeling, besides presenting scientific technical report.

Registering functional food withANVISA can be a very bureaucratic task. But do not worry! Stone Okamont is ready to serve you with Zero Bureaucracy.

 

What is the best way to regulate functional food with ANVISA?

Stone Okamont is a regulatory intelligence advisory and consultancy with more than 30 years of experience!

We have trained professionals, attentive to the most diverse demands of the Brazilian Health Regulatory Agency, ready to regulate functional food with ANVISA with excellence!

Contact us, start your regulation processes and let your company closer to success! Click here!

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