The Resolution establishes a notification system for the control of food supplements. The sanitary notification is granted by the Ecuadorian National Agency for Health Regulation, Control and Surveillance – ARCSA.
To obtain the sanitary notification, an individual application for each form of presentation and formulation of the food supplement must be submitted through the online system of ECUAPASS from ARCSA. The following information must be entered:
(i) Product name;
(ii) Brand name or trademark;
(iii) Product composition/ formulation, expressed in decreasing percentage. In the case of plant species, the scientific name and part of the plant used must be indicated;
(iv) Net content;
(v) Packaging description;
(vi) Name and address of manufacturer;
(vii) Shelf-life and storage method.
Additionally, the following documentation should be attached to the application:
(i) Label drafts in Spanish with the dimensions in which the product will be marketed;
(ii) Detailed description of the manufacturing process;
(iii) Description of lot number;
(iv) Organoleptic, physical and chemical, and microbiological specifications established by the manufacturer and in the Ecuadorian Technical Standard for Nutritional Supplements (NTE INEN 2983);
(v) Physical and chemical specifications of the primary packaging material in any format issued by the manufacturer or distributor.
(vi) Power of attorney or authorization issued by the owner of the product to the applicant of the sanitary notification;
For imported products, in addition to the above requirements, the following must be submitted with an apostille or the stamp from the consulate:
(i) Free Sale Certificate, Health Certificate or Export Certificate or its equivalent issued by the competent authority of the country of origin, stating that the product is authorized for human consumption;
(ii) Duly legalized authorization of the owner of the product, in which the applicant is authorized to obtain the sanitary notification in Ecuador.
(iii) Technical documents written in another language must be presented with the translation into Spanish or English. For legal certificates written in another language, these must be presented with the official translation to Spanish.
After including all the required information, the online system will issue a payment order with the corresponding fees for the type of product. This can go from $ 104,53 to $ 714,72 depending on the size of the company.
In case the report contains any objections, the ARCSA will notify the user through the ECUAPASS system within 15 working days. Only 2 rectifications can be made to the original request, otherwise the process will be cancelled.
Once the application is approved, a certificate of sanitary notification will be issued, with a validity of 5 years.