Concluded Consultation on New Regulation for Novel Foods & Novel Ingredients

    Last September, Chile completed its open public consultation on a framework to regulate Novel Foods and Novel Ingredients, including substances intended for use in Food Supplements. If adopted, this will establish Chile’s first formal regulation for Novel Foods.

    Previously, Chile referenced the international Codex Alimentarius guidelines for new additives not yet included in its lists.

    The proposal is based on Article 106 of the Sanitary Regulation of Foods and reinforces that Novel Foods and Novel Ingredients must meet national safety standards and contribute to the population’s nutrition.

    According to the proposal:

        1. Novel Food, Novel Ingredient or Food Component: the food, ingredient or food component obtained through physicochemical synthesis processes or through natural processes that do not resemble compounds or molecules with a history of safe human consumption.

        2. It is out of scope of the proposal:

              • Review of new substances with technological effects on food (food additives);

              • Review of biotechnological procedures that will modify food and/or raw materials;

              • Review of health claims.

        3. The requirements and process for evaluation and approval are:

              • Applications for evaluation can initially be submitted to the Sub-Secretariat of Public Health, or alternatively, to a public institution or the Ministry of Health;

              • The Ministry of Health will notify applicants within 180 days whether their application is admissible, based on established requirements.

              • The report will then undergo public consultation (national and international) for a minimum of 60 days, while safeguarding property rights confidentiality;

              • If the request is accepted, and once all comments from the public consultation have been addressed, the outcome will be published under the resolution of the Ministry of Health.