Resolution RES No. 16 approving the Technical Regulation for Procedures on Registration of Food and/or New Ingredients.

This Resolution approves the Technical Regulation for Procedures on Registration of Food and/or New Ingredients. This Regulation applies to the registration of new food and/or ingredients for human consumption, with no history of consumption in the country, or food containing substances already consumed and that will be added or used at levels much higher than those currently observed in food. Excluded from this regulation are food additives and co-adjuvants of manufacturing technology. The Scientific Technical Report must contain the following information: name of the product; purpose of use; recommendations of the manufacturer; ingredients of the product, according to botanical, animal or mineral species, when appropriate; chemical composition with molecular characterization, where appropriate, and formulation of the product; description of the analytical methodology for evaluating food ingredient; scientific evidence applicable to the safety of use: nutritional and/or physiological and/or toxicological tests in experimental animals. The National Sanitary Surveillance Agency shall review this Regulation at least two years after their entry into force.