How to regularize food at ANVISA?

How does ANVISA categorize foods?

It is necessary to pay attention to the categories established by Anvisa to develop the food regulation procedure.

Foods can fall into one of three categories, according to the regulations:

 foods requiring registration prior to marketing.

 Foods that do not need to be registered before being sold.

 foods that do not need to be registered and communicate the start of production.

The regularization process can begin once it has been determined which of these categories the food falls into.

What ANVISA rules govern the food regularization process?

The food registration procedure must follow a series of regulations depending on the classification category, but Anvisa has three resolutions that establish food registration:

 Resolution No. 22/2000, which provides for the basic procedures for registration and exemption from the obligation to register imported products related to the food sector.

 Resolution No. 23/2000, which provides guidance on the manual of basic procedures for registering and waiving the obligation to register products pertaining to the food sector.

 The Differentiated Contracting Regime (RDC) No. 27/2010, which provides for the categories of exempt food and packaging with mandatory sanitary registration.

What is your company's obligation to keep it regularized before the health authorities?

- Possess a valid Sanitary Permit or Operating License issued by the state, federal district or municipality.

- Put the good manufacturing practices specified in the law. Prepare the Good Manufacturing Practices Manual and present it to regulatory bodies at the time of inspection or upon request.

- Implement and make available the Good Manufacturing/Storage Practices Manual and all other stages of the production process.

- Maintain control over the production process with effective methodology in key points that may result in risks to the consumer's health.

- Officially notify the health authority of the places where its products are sold within 30 days of the start of marketing, and request that the health authority collect samples for quality control analysis.

How does the food regularization process occur at ANVISA?

When food registration requests arrive at Anvisa, they are organized chronologically and await the analysis process. Food registration requests are sent along with all requested information and supporting documentation.

Anvisa analyzes two factors in relation to the food record:

Document analysis is carried out at this stage to ensure that all administrative documents required by the sanitary standards of the process have been presented. Document analysis complies with the guidelines established in Annex III of Resolution No. 23/2000, as well as the specific technical standards for the food category considered.

Technical analysis: Step that evaluates the food, if it meets the requirements established in the technical regulations for that category, as well as the regulations for food additives and technology adjuvants.

After completing the two steps of a predetermined request, a request for registration of maintenance, indecision or technical requirements may be made.

How do I start a food registration process?

Collecting the information needed to set up the procedure is the first step in the food registration process. Our team of experts can help your business today. Contact us right now!