BRAZIL – ANVISA PUBLISHES GUIDANCE FOR THE EVALUATION OF PROBIOTICS by Nikolaas Tilkin-Franssens

In Brazil the use of probiotics in food is subject to prior approval as prescribed by Resolution 241 of July 2018. The responsible instance for the approval is the Brazilian Food Safety Authority ANVISA. The latter has published the instruction guide for the application for evaluation of probiotics for use in food.

Brazilian probiotics’ legislation is based on the WHO/FAO definition holding that probiotics are Live microorganisms which when administered in adequate amounts confer a health benefit on the host. This entails that non-viable micro-organisms, even where there is evidence of their health benefit, as they are not covered by the definition of probiotics. The evaluation of probiotics by ANVISA consist of three main pillars; (1) unequivocal proof of the identity of the strain of microorganism, (2) its safety and (3) its beneficial effect. The published instruction guide provides further clarification to the procedure and required documentation to proof the safety and benefit of probiotic substances in line with local legislation. Of related importance are Resolution 243 of 26 July 2018 regulating food supplements (Resolução RDC nº 243, de 26 de julho de 2018, que dispõe sobre os requisitos sanitários dos suplementos alimentares) and Resolution 18 of 30 April 1999 on the use of claims on the labelling of foods (Resolução nº 18, de 30 de abril de 1999, que aprova o regulamento técnico que estabelece as diretrizes básicas para análise e comprovação de propriedades funcionais e ou de saúde alegadas em rotulagem de alimentos).

The ANVISA Guide further illustrates the components of the technical dossier required for the evaluation of probiotics. The overall objective of the evaluation is to identify the strain of the micro-organism as well as the intended claims, information about the product, the target population, recommended dosage, restrictions of use, warnings and potential adverse health effects. The instruction guide describes identification of the strain and safety evaluation in depth followed by scientific references that can support the use of claims. Important to note is that ANVISA specifically requires the benefit of the designated strain can be demonstrated rather than a reference to the benefit of probiotics in general.

ANVISA - Guia para instrução processual de petição de avaliação de probióticos para uso em alimentos - link