Registration of Functional Food In Brazil
The growing concern about the impact of food on people’s health has led to an interesting scenario for products like functional food. In this article, we will take a look at how to register functional food in Brazil.
Overview
In Brazil, ANVISA, Agência Nacional de Vigilância Sanitária, which is Portuguese for National Health Surveillance Agency, is the government body responsible for certifying the production of food products, although this comes down to only a handful of them. The food products that must be certified by ANVISA prior to commercialization are:
- Food with allegation of functional and/or health properties
- Baby food
- Enteral food
- Food and ingredients that are being introduced to Brazil
- Bioactive substances and isolated probiotics with allegation of functional and/or health properties
The list of products that are exempt from ANVISA’s certification are:
- Food commodities
- Food additives used in compliance to the Boas Práticas de Fabricação, which is Portuguese for Good Manufacturing Practices
- Food additives exempt from registration by the Ministry of Health
- Food ingredients for industrial use, although new ingredients that do not have a record of use in Brazil may be subject ANVISA certification to verify if they are safe to be consumed
- Bakery, delicatessen, confectionery and ice cream products when exclusively destined for direct sale to the customer by the producer in a store, even when the goods are in packages to ease their sale
For all the food products that do not require ANVISA’s certification, the producing company must issue a statement before commencing manufacturing. This statement must be sent to ANVISA at least 10 days before their commercialization starts.
Necessary documentation
In order to apply for a functional food registration in Brazil, you need to submit a technical scientific report containing the following information, which will be analysed by ANVISA:
- Name of the product
- Purpose
- Recommended intake indicated by the manufacturer
- Scientific description of the product's ingredients, separated into botanical, animal or mineral species, where applicable
- Chemical composition with molecular characterization, where applicable, and/or product formulation
- Description of the analytical methodology used to certify the component’s “functional food” allegation
- Text and copy of the product’s label
- Any applicable scientific evidence of the product’s properties, such as studies and reports from international institutions
As scientific evidence, ANVISA accepts:
- Biochemical tests
- Nutritional and/or physiological and/or toxicological tests made on laboratory animals
- Epidemiological studies
- Clinical tests
- Articles published in recognized scientific journals
Scientific articles in English or Spanish do not require translation however, articles in other languages must be accompanied by a translation, not necessarily sworn.
The average processing time for ANVISA to issue the application is 250 days.
In cases where food products are regulated by MAPA, the Ministry of Agriculture, Livestock and Supply, the 403 application is to be submitted to ANVISA, referring to the “Assessment of Food Products with Allegation of Functional and/or Healthy Properties. The results will be sent to both the applicant and to MAPA.
Labelling details
Any company wanting to market their products as “functional food” must state in the product’s packaging an allegation to that product’s health benefits. ANVISA issues a list of authorized allegations for every ingredient with functional or health properties. The allegations can refer to the regular maintenance of health, to the physiological benefits of the ingredients and to a reduction to the risk of disease. Allegations that refer to the cure or prevention of disease are forbidden. Also, no change can be made to the allegations authorized by ANVISA.
There are several ingredient categories for which the functional label may be awarded. The ingredient categories are:
- Fatty acids
- Carotenoids
- Dietary Fiber
- Phytosterols
- Polyols
- Probiotics
- Soy Protein
It is important to say that every ingredient category may have different subdivisions. For example, there are three different Carotenoids - lycopene, lutein and zeaxanthin - and for each of them, there is a specific allegation, which cannot be altered. For example, the specific allegation for Lycopene is “O licopeno tem ação antioxidante que protege as células contra os radicais livres. Seu consumo deve estar associado a uma alimentação equilibrada e hábitos de vida saudáveis”, which is Portuguese for “Lycopene has antioxidant action that protects cells against free radicals. Its consumption must be associated with a balanced diet and healthy lifestyle”.
A list of all authorized allegations can be found via this link.
Also, it is important to mention that any information on functional or health properties of a food product disclosed through any kind of media, cannot differ from the information approved for display on its label as allegation.