Food supplements (suplementos alimenticios) are classified as foods in Ecuador and are regulated under Resolution (Resolución) ARCSA-DE-028-2016-YMIH (hereinafter, the Resolution), on the sanitary regulation for the control of food supplements. Additionally, there is an Ecuadorian Technical Norm that sets the technical requirements for nutritional supplements (complementos nutricionales): NTE INEN 2893:2016.
Food supplements, which can also be referred to as nutritional supplements, are unconventional food products intended to supplement the dietof healthy individuals, with a concentrated source of nutrients with nutritional effect used in lower concentrations than those used for therapeutic indications.
They can be marketed in solid forms (tablets, capsules, granules, powders or others), semi-solid (jellies, gels or others), liquid (drops, solution, syrups or others), or other forms of gastrointestinal absorption.
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 supplementmust be submitted through the online system of ECUAPASS from ARCSA. The following information must be entered:
Brand name or trademark;
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;
Name and address of manufacturer;
Shelf-life and storage method.
Additionally, the following documentation should be attached to the application:
Label drafts in Spanish with the dimensions in which the product will be marketed;
Detailed description of the manufacturing process;
Description of lot number;
Organoleptic, physical and chemical, and microbiological specifications established by the manufacturer and in the Ecuadorian Technical Standard for Nutritional Supplements (NTE INEN 2983);
Physical and chemical specifications of the primary packaging material in any format issued by the manufacturer or distributor;
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 apostilleor the stamp from the consulate:
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;
Duly legalized authorization of the owner of the product, in which the applicant is authorized to obtain the sanitary notification in Ecuador;
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, acertificate of sanitary notification will be issued, with a validity
Food supplements can contain a concentrated source of nutrients with nutritional effect, used alone or in combination, such as vitamins, minerals, proteins, carbohydrates, amino acids, essential fatty acids, plants, plant extracts, probiotics and other permitted substances. These can come from natural or synthetic sources.
Minimum levels for vitamins and minerals are set at 15% of the Recommended Daily Allowance (RDA) set by FAO / WHO. Maximum levels are based on Upper Levels (UL) set per population group. The Ecuadorian Technical Norm NTE INEN 2893:2016 includes a table with the ULs.
For other ingredients, maximum levels higher than RDAs or Upper Levels (UL) must be justified from tables of the U.S. IOM or other recognized body.
The substances in the food supplement must be stable under the usual conditions of packaging, storage, distribution and consumption.
Substances in food supplements may not contain ingredients that represent health risks, such as pesticide residues, antibiotics, or veterinary drugs, narcotic, psychotropic or dependency-generating substances, among others. The addition of nutrients to the product must not give rise to harmful effects on health.
In food supplements intended for athletes, hormones or compounds with anabolic effect, substances with stimulating action on the nervous system or other substances considered doping that appear on the list of substances of the International Convention Against Doping in Sport cannot be added.
The labelling of food products is governed by the Regulation RTE INEN 022:2014, which in 2014 introduced a front-of-pack traffic light labelling scheme to warn consumers about those products that are high in sugar, fat and salt. In accordance with Article 5.5.6, food supplements are exempted from this labelling scheme.
Additionally, the Regulation establishes that the following Ecuadorian Technical Norms should be met:NTE INEN 1334 – 1:2011 and NTE INEN 1334 – 2:2011, which set the general requirements on food labelling and nutritional labelling, respectively.
b) Food supplements
The Resolution on the control of food supplements mandates the following information to be disclosed on the labels written in Spanish, with the possibility to have it as well in other languages, in clearly legible characters:
Form of presentation;
Manufacturing and expiration dates;
Batch or lot number;
Name and address of the manufacturer;
Name and address of the distributor (for imported products);
Sanitary notification code or GMP code;
Population group to which the food supplement is directed, when required;
Nutritional information: Nutrients must be included with name, quantityand with a percentage of the recommended daily value, when applicable, and the size of the portion and portions per packaging;
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.
In Ecuador, nutrition and health claims are permitted in food supplements. In accordance with the Ecuadorian Technical Norm NTE INEN 2893:2016, food supplements should comply with the labelling requirements set for nutrition and health claims under NTE INEN 1334 – 3:2011.
Article 18.104.22.168 of this norm refers to Appendix Y of the Ecuadorian Technical Norm NTE INEN 2587:2011 on functional foods, which sets the requirements on the use of health claims in functional foods. This appendix permits the use of authorized health claims and conditions from the European Commission and from the US Food and Drug Agency.