With an extremely heated market, the segment of food supplements has managed to gain significant space in the Brazilian national economy, which promises a safe growth for the sector in the coming years.
In addition to the high demand for food supplements, the new legislation published by the Brazilian Agency of Sanitary Vigilance Agency (ANVISA) in 2018 brings an achievement for the sector, which in addition to becoming a unified class within the segments regulated by ANVISA, now has advantages and rules specific to the segment.
Stone Okamont has prepared you exclusive content that has changed the regulatory routine of the segment, and brings technical details to companies that are starting projects in this area.
The objective of the food's supplements new legislation is to bring together in one set all the rules, rules and guidelines of ANVISA for the manufacture and legalization of food supplements.
Before these new rules there was no specific legislation for supplements. Manufacturers should follow a variety of standards for food and medicines. This generalization led to difficulties in the evaluation of ANVISA and in the framing of the new product in the market.
With the changes, this new category gains specific standards in composition, permitted or prohibited ingredients, quality, safety and labeling.
The composition of food supplements is now controlled by a specific regulation which limits substances and quantities. This rule guarantees the safety of a rich nutritional value for products marketed in Brazil.
Other ingredients may be used in the preparation of food supplements to provide flavor, color or flavor or to dissolve, dilute, disperse or otherwise alter their consistency or shape, provided that they meet the following requirements:
I - They are traditionally used in food preparation;
II - Meet the respective standards of identity and quality;
III - Are not classified as food additives or technology adjuvants; and others.
I want to compare the composition of my product with the new rules
The new rules are not only designed to guarantee high-quality food supplements, but also to ensure labels and packaging that are highly informative to consumers.
Among the main rules that regulate the new labels, we emphasize that they must contain:
I) The phrase "Food Supplement" in a prominent plan on the packaging;
II) The quantity and the frequency of consumption for each of the population groups;
III) the instructions for storage, even after opening the package; Among others.
The companies that already have supplements in commercialization will have the term of five years to adapt their products to the new norms established by the new Resolution of the Board of Directors (RDC).
However, new food supplements should already be marketed according to the new rules in force.
With the new changes, the scenario to regularize food supplements at ANVISA became simpler and leaner.
However, the suitability of the formula, nutritional values, labels and other regulations must be correctly presented to avoid damages and rework.
Therefore, Stone Okamont has experienced, highly specialized consultants and updated the new and constant legislative changes of ANVISA to lead its product for approval and release for commercialization.
Do you have any questions about the new norms for regulating food supplements? Contact us, know our solutions and regularize your product!