Registration of Food Supplement in Chile

Regulatory Authority
Agencia Nacional de Medicamentos (ANAMED)

Regulatory Website

https://www.ispch.gob.cl/anamed/

• Food supplement

(i) Food supplements, also known as suplimentosalimentarios, are goods manufactured or carefully prepared to support good health and preserve physiological states like adolescence, adulthood, or old age.

(ii) They could consist of a nutrient, a combination of nutrients, and other elements that are found in food naturally, like lipids, vitamins, minerals, amino acids, and dietary fiber, among other substances.

(iii) They could be offered in a variety of traditional forms, including pills, tablets, capsules, liquids, granules, powders, and so forth.

• Food for Supplement

(i) Food for athletes refers to food designed to satisfy the needs of healthy people, particularly athletes who engage in strenuous and continuous physical activity.

(ii) These dishes could consist of a single food component or a combination of them. Nutrients such as proteins, carbs, vitamins, minerals, and other elements that are naturally found in food—like caffeine—may be added, as well as those that are specifically permitted by these standards.

(iii) A product may be considered a food supplement or a fortified food if vitamins and/or minerals are included.

(i) According to the Chilean Food Code, before being marketed, all food types must get an authorization resolution.

(ii) The process needs to be finished with the import area’s “Regional Ministerial Secretariat of Health”

(iii) The following paperwork needs to be sent to SEREMI for imported products:

Certificate from customs which lists the authorized warehouse and the requirements for product transfer. This certificate has an unlimited validity period and a cost that varies according to the product volume.

• A duplicate of the purchase invoice; A copy of the warehouse’s sanitary resolution (authorization);
• A health certificate from the nation of origin that is applicable to every import or a certificate of free product sales;
• Technical sheet in Spanish provided by the product’s maker for goods that are being imported into the nation for the first time or that have a different formulation than previously imported goods.
• Label or proposed label that complies with Chilean labeling laws.

Specific labelling requirements apply to food supplements. The following indications are mandatory:

• Product designation as “suplementoalimentario” (food supplement);
• A warning concerning children as well as pregnant and breastfeeding women;
• A warning that a food supplement is not a replacement to a balanced diet;
• The method of use;
• The daily dose.