Both supplements for sports people and dietary supplements must be registered.
a) General registration requirements
- The sanitary registration requires the presence of the applicant at the Uruguayan Ministry of Public Health.
- The premises of the importer or distributor also need to be registered with the Ministry of Public Health in order to continue with the product registration.
- The following documentation must be submitted:
- Copies of the company registrations and in the case of imported products, certificates of free sale of origin, legalised or apostilled as appropriate.
- Two colour 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:
- FO-13223-002 - Application form for the registration or renewal of food registration, signed by the legal representative and technical director;
- 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.
- CD or pen-drive containing quali-quantitative formula and nutritional information in the Excel spreadsheet (FO-13223-004).
- Proof of payment showing the receipt number and the amount paid (cost is around 25,200 UYU/ 580 USD).
- The sanitary registration is valid for 5 years.
b) Specific registration requirements for dietary supplements
- Although dietary supplements are not officially regulated, the registration procedure from the Ministry of Public Health has a specific form for the “declaration of advertising of dietary supplements” that must be submitted together with the information included above. This is form FO-13223-013 (Declaración sobre publicidad de los suplementos dietarios).
- By filling this declaration, the legal representative and the technical director acknowledge that:
- Any used health claim corresponds to those approved by the Ministry of Public Health;
- The texts of label with which the product is marketed are those approved by the Ministry of Public Health in the registration process. In the event of any modifications, the company will make the corresponding "request for authorization of changes".
- Any advertising carried out in brochures, magazines, web pages and/or social networks, will only include the health claims that were duly approved during the registration of the product. The company will comply with the provisions, although it will not be necessary, in this case, to provide the texts of the materials for its evaluation.
