The National Health Surveillance Agency (ANVISA) of Brazil has produced a guide to assist the food industry in preparing applications for the use of probiotics in food and food products sold in that country.
Under a resolution issued last year (RDC No. 241/2018), the use of probiotics in food requires an evaluation by ANVISA prior to that food being placed on the market. The scope of ANVISA’s evaluation includes verification of the identity of the probiotic, and a review of claims regarding the safety and potentially-beneficial effects of the probiotic ingredient.
Issued in late March, ANVISA’s document, “Guide for Procedural Instruction for Probiotic Assessment Request for Food Use,” describes the procedures for submitting an application to the Agency, and details on the specific information expected in reports and any other scientific data submitted in support of the application.
Similar to guidance documents issued by regulatory authorities around the world, the guide issued by ANVISA is not a regulation and is only intended to provide insight into the Agency’s approach regarding probiotics.
The text of ANVISA’s guidance on probiotic food applications (in Portuguese) is available here [ PDF 756 kB ].