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Food Supplement Registration in Ecuador

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Food Supplement Registration in Ecuador

Regulatory Authority

Ecuadorian National Agency for Health Regulation, Control and Surveillance – ARCSA.

Timeline

1-2 Months

License Validity

5 Years

Fees

Rages from $ 104,53 to $ 714,72 depending upon company size

Overview

  • Food supplements also known as suplementosalimenticios are classified as foods in Ecuador and are regulated under Resolution (Resolución) ARCSA-DE-028-2016-YMIH, which is a sanitary regulation for the management of food supplements.
  • In Ecuador, food supplements are categorized as foods.
  • Furthermore, NTE INEN 2893:2016, an Ecuadorian Technical Norm, establishes the technical specifications for nutritional supplements, or complementosnutricionales.
  • Food supplements can also be referred to as a nutritional supplement.
  • These are unconventional food products which are intended to supplement the diet of healthy individuals, with a huge source of nutrients with nutritional effect used in lower concentrations than those used for therapeutic indications.
  • They can be marketed in the forms of solid dosage form (tablets, capsules, granules, powders or others), semi-solid dosage form (jellies, gels or others), liquid dosage forms (drops, solution, syrups or others), or other dosage forms of gastrointestinal absorption.
  1. Name of the Product.
  2. Brand name or trademark;
  3. Product composition/ formulation (in decreasing percentage). In the case of plant species, the scientific name and part of the plant used must be indicated;
  4. Net content;
  5. Packaging description;
  6. Name and address of manufacturer;
  7. Shelf-life and storage method.
  • A notification system for the management of dietary supplements is established by the Resolution.
  • The Ecuadorian National Agency for Health Regulation, Control, and Surveillance, or ARCSA, is responsible for granting the sanitary notification.
  • To get the sanitary notification, an individual application for each form of presentation and formulation of the food supplement should be submitted through the online system of ECUAPASS from ARCSA. The following details must be entered:
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Documents that should be attached to the Application

  1.  Label drafts in Spanish with the dimensions in which the product will be marketed;
  2. Brief description of the manufacturing process;
  3. Description of lot number;
  4. Organoleptic, chemical, physical and microbiological specifications established by the manufacturer and in the Ecuadorian Technical Standard for Nutritional Supplements (NTE INEN 2983);
  5. Chemical and Physical specifications of the primary packaging material in any format issued by the manufacturer or distributor.
  6. Power of attorney or authorization issued by the owner of the product to the applicant of the sanitary notification;

Documents Required for the Imported Food Products

  • Along with the requirements listed above, the following must be presented with an apostille or consulate stamp:
  1. Free Sale Certificate, Health Certificate or Export Certificate or its equivalent issued by the competent authority stating that the product is authorized for human consumption.
  2. Valid legalized authorization of the owner of the product, in which the applicant is authorized to obtain the sanitary notification in Ecuador.
  3. Technical documents which are written in another language must be presented with the translation into Spanish or English language. Legal certificates that were issued in a language other than Spanish must be submitted with the certified translation.

Labelling

  • The following information must be published on labels written in Spanish, with the option to have it in other languages as well, in well readable letters, according to the Resolution on the control of dietary supplements:
    1. Product name;
    2. Ingredient list;
    3. Form of presentation;
    4. Usage instructions;
    5. Storage conditions;
    6. Manufacturing and expiration dates;
    7. Batch or lot number;
    8. Name and address of the manufacturer;
    9. Name and address of the distributor (for imported products);
    10. Sanitary notification code or GMP code;
    11. Population group to which the food supplement is directed, when required;
    12. Nutritional information: Nutrients must be included with name, quantity and with a percentage of the recommended daily value, when applicable, and the size of the portion and portions per packaging;
    13. Net content;
    14. Warning statements:
      • Keep out of reach of children;
      • The product is not suitable to be consumed as the only food source. Do not exceed the recommended dose; This product is a food supplement; it is not a medicine, and it does not supply a balanced diet.
      • If you are taking any medication, check with your doctor before taking this product.

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