Ecuador´s National Agency for Health Regulation, Control and Surveillance (ARCSA) has published Resolution ARCSA-DE-2021-012-AKRG amending the country´s Sanitary Regulation for the control of food supplements (previously regulated under Resolution ARCSA-DE-028-2016-YMIH).

This provides clearer rules on the use of some ingredients for the category that were not previously described in the regulation. The main points of the resolution are:

• The nutrients definition has been revised including trace-elements, antioxidants, probiotics, polyphenols as nutrients.
• The definition of food supplements includes a ?nutritional or physiological effect. Apart from probiotics, food supplements should not exert a therapeutic action.
• A definition for probiotics and some provisions for adding such ingredients in food supplements are foreseen
• Food additives listed on the Codex Alimentarius, European Food Safety Authority (EFSA), and US Food and Drug Agency (FDA) could be accepted.
• A negative list of ingredients is provided by the new rule.
• The use of enzymes is restricted as ingredients.

These changes are already enforced. 

Please contact us to learn more about food-related concerns or for advice on food supplement regulations in Latin America and the Caribbean.

September 29, 2021 

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