Resolution RES No. 19 approving the Technical Regulation for Procedures with Functional and/or Health Properties Claim in Labelling.

This Resolution approves the Technical Regulation for Procedures with Functional and/or Health Properties Claim in Labelling. This Regulation applies to procedures for registration of food with functional and/or health properties claim on labelling, without prejudice to other regulatory provisions for food registration. For the purpose of this regulation, the interested party must submit, in addition to the documents required by legislation, a Scientific Technical Report containing the following information: name of the product; purpose of use; recommendations of the manufacturer; scientific description of the ingredients of the product, according to species of botanical, animal or mineral origin, where appropriate; chemical composition with molecular characterization, where appropriate, and or formulation of the product; description of the analytical methodology for the evaluation of the components object of the claim; etc. The National Sanitary Surveillance Agency shall review this Regulation on Procedures for Registration at least two years after their entry into force.