??On 1st December, the National Health Surveillance Agency (ANVISA) launched the firts version of Guide N° 55, for the assessment of functional and health property claims of bioactive substances present in foods and food supplements.
This guide is a non-regulatory document, but involves the ANVISA's approach and best pracices for examining those applications seeking an approval of benefits related to determinated bioactive substances present in food. It aims to help the applicant qualify the information to be presented and thus streamline the process, avoiding technical requirements, and increasing the the chance of favorable decisions.
Guide No. 55 defines the types of claims - functional property, including fully recognised, and health property - and distinguishes the criteria and those procedures applicable to each type, providing instruments to evaluate the quality of the selected studies and the consistency of the evidence in the direction of the effect, considering the interventional or prospective observational studies.
Although the guide is already in force and can be used by interested companies, it will be open for contributions for one year, i.e. until 7 December 2022. Contributions should be submitted on the appropriate form (only available online).
Reach out to us to know more about the use of claims on food and food supplement labels in Latin America and the Caribbean.
10 December, 2021
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