III. REGISTRATION OF MODIFIED FOODS AND DIETARY SUPPLEMENTS IN URUGUAY
The procedure must be carried out through the VUCE platform (Single Window for Foreign Trade).
To submit the product registration, the premises of the importer or distributor also need to be registered with the Ministry of Public Health.
The following documentation must be submitted:
• Copies of the company registrations and in the case of imported products, certificates of free sale of origin, legalized or apostilled as appropriate.
• Two color copies of the label (in real size) signed by the technical manager. If the product contains an insert label, it must also be attached.
• Filled application forms:
o FO-13223-002 - Application form for the registration or renewal of food registration, signed by the legal representative and technical director;
o FO-13223-004 - Form for qualitative-quantitative formula and nutritional information.
• Monograph of the product, signed by the technical manager with the following information:
• Name and brand of the product;
• Forms of presentation and net content;
• Qualitative-quantitative formulas (Annex 1 of Application form FO-13223-002)
• Nutritional information (Annex 2 of Application form FO-13223-002)
• Characteristics of the package;
• Storage conditions and proposed shelf-life. Studies carried out and conclusions of the stability of the product;
• Origin and specifications of the raw materials used;
• In the case of using raw materials of plant and/or animal origin, they must comply with the maximum limits for biological residual substances;
• If any of the components is of animal origin, the corresponding import authorization must be requested from the Ministry of Livestock, Agriculture and Fisheries;
• Flow diagram of the elaboration process indicating the Critical Points and Critical Control Points;
• Physicochemical and microbiological specifications of the finished product;
• Code for batch identification, its printing method and expiration date;
• Safety studies for new ingredients/foods: Safety data are not needed when the ingredients have been approved as new or novel food/ingredient by Brazil ANVISA or the EU;
• If it is not a new food/ingredient, but instead, there is a history of use, documented evidence of that use in the corresponding countries must be provided, showing its inclusion in specific Food Codes and providing information on the safety profile of the product.
Additionally, a “Statement on advertising of Dietary Supplements” must be also submitted, by filling out the declaration form FO-13223-013 (Declaración sobre publicidad de los suplementos dietarios).
The fees are 20 UR and the payment is made through the VUCE platform.
