,Chiles Ministry of Health has opened a public consultation on a proposed amendment to Exempt Resolution No. 394/02, which establishes nutritional guidelines for food supplements and their vitamin and mineral content. The proposal seeks to clarify and update the list of food categories excluded from supplementation, in response to regulatory ambiguities linked to the growing use of traditional and non-traditional sugars and sweetening ingredients in foods
Regulatory background and issue identified
Currently, a wide variety of sugarsboth traditional and non-traditionalare used to impart sweetness to foods. In addition, certain additives that provide sweetness as a secondary technological function are increasingly used in food formulations. However, these sugars and sweetening ingredients are not expressly included in the supplementation exclusion list set out in Resolution No. 394/02.
As a result, such products could potentially be used as vehicles for substances with physiological effects, including vitamins, minerals, prebiotics, probiotics, beta-glucans, and omega-3 fatty acids (EPA and DHA). This situation has created interpretative challenges within the existing regulatory framework and has implications for official control and enforcement activities
Proposed amendments under public consultation
The draft amendment focuses on clarifying the scope of excluded food categories by expanding and specifying examples, particularly where the term similar has led to uncertainty.
Item 2 Confectionery products and similar foods
The current wording refers broadly to confectionery products such as chocolates, candies, chewing gum, biscuits, and ice cream. The proposed text significantly expands this description to explicitly include additional examples such as gummies, marshmallows, dulce de leche (manjar), cakes, pastries, and, more generally, all products prepared with sugars (mono- and disaccharides, both traditional and special), non-nutritive sweeteners, sugar alcohols, and any ingredients or additives that provide sweetness.
The rationale is to clearly define the scope of similar products by providing a more comprehensive illustrative list.
Item 3 Preserves and similar products
The existing category covering preserves and similar products (e.g., sweets, jellies, and candied fruits) is proposed to be expanded to explicitly include jams, marmalades, compotes, and candied fruits prepared with traditional and special mono- and disaccharide sugars, non-nutritive sweeteners, sugar alcohols, and any ingredients or additives conferring sweetness.
As with confectionery products, the amendment aims to clarify the meaning of similar through a more detailed enumeration.
Item 4 Sugars, honey, and syrups
The proposal updates the wording of this item to align with the current regulatory framework under Title XVIII of the Chilean Food Sanitary Regulation (RSA), Of Sugars and Honey. The revised text explicitly covers sugars, traditional and special mono- and disaccharides, non-nutritive sweeteners, sugar alcohols, all ingredients or additives that provide sweetness, as well as honey and syrups.
This update is intended to ensure consistency with existing food law terminology and classifications.
Objective of the proposal
The Ministry of Health states that the proposed changes are intended to eliminate regulatory uncertainty, prevent the use of sweetened products as carriers for physiologically active substances subject to supplementation rules, and facilitate consistent interpretation during inspections and enforcement. By clarifying and expanding the exclusion categories, the amendment seeks to strengthen legal certainty for both regulators and food business operators while maintaining coherence with current food regulations Next steps
The draft amendment is currently subject to public consultation. Stakeholders are invited to submit comments before the proposal is finalized and formally adopted into the regulatory framework governing food supplements in Chile.