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New Public Consultation: Modification to the Sanitary Regulations of Foods in Relation to Food Supplements and Other Matters 

by Legal Alert

Published: September, 2019

Submission: November, 2019


The Ministry of Health has published a new public consultation process regarding proposed modifications to the Preliminary Titles; II "Food"; XXVII "Of Alcoholic Beverages, Fruit and Vegetable Juices and Bottled Waters"; and XXIX “Of the Food Supplements and Foods for Athletes” of Decree No. 977/1997 that establishes the Sanitary Regulations for Foods (hereinafter, “ RSA ”).

This process will be available for the reception of observations until October 5, 2019 .

Among the most relevant aspects of this consultation, there are important modifications to the applicable regulations regarding food supplements in Chile, among which we can highlight:

  • Limitation of the concept "Product for Athletes " : The proposed new article 537 bis indicates a closed list of foods that may use the name "Product for Athletes" and eliminates all provisions currently regulating Food for Athletes in the RSA .

    According to this article, one may use the term "Product for Athletes" foods that qualify as isotonic drinks, protein supplements, amino acid supplements or creatine supplements . Thus, the use of the concept "Product" or "Food" for athletes would be prohibited for any product that does not meet the regulatory requirements of these categories.

  • New category of “Supplemented Foods” : This proposal replaces Paragraph II of Title XXIX of the RSA, currently referred to as “Foods for Athletes”, creating a new category of “Supplemented Foods” (art. 538 et seq.). Thus, proposed article 538 defines “Supplemented Foods” as “ foods that do not have a pharmaceutical presentation format , to which one or more vitamins and minerals have been added in supplementation concentrations, or that have addition of other naturally present substances. in food ”

    In this context, it is established that the compounds or ingredients used to add vitamins, minerals and others must be those indicated in the Codex Alimentarius document CAC / GL 10-1979.

    Additionally, a ban is established to formulate foods that qualify as “High in” one or more critical nutrients, such as “Supplemented Foods”.

    Advertising of “Supplemented Foods” : The proposal provides that declarations of healthy nutritional properties may be used, to the extent that they comply with the requirements established for this (Resolution No. 860/2017).

    These foods must indicate, on the face or main panel of the label or on a visible part of the label, “FOOD SUPPLEMENTED WITH…”, followed by the corresponding nutrient or substances, in compliance with the graphic requirements established therein. In addition, it includes the obligation to incorporate the message: “IN PREGNANT CHILDREN AND WOMEN OR DURING BREASTFEEDING THIS PRODUCT MUST BE RECOMMENDED BY A HEALTH PROFESSIONAL” in the labeling and advertising of these products, as well as the application of the same requirements established for the table of nutritional information regarding food supplements.

  • Change in the definition of “food supplement” : The proposal contains a modification of the definition of food supplement contained in Article 534 of the RSA. Although the proposed new definition, contains all the elements of the definition currently in force, it includes certain new aspects, mainly, the requirement that, to be qualified as food supplements, the products “ must have presentations for consumption exclusively orally, such as powders, liquids, granules, tablets, tablets, capsules or the like, of conventional release . ”

    In this context, the proposed new second paragraph of article 535 restricts the compounds or ingredients that can be used in food supplements to add vitamins, minerals and other substances, to those indicated in the updated Codex Alimentarius document CAC / GL 10-1979 .

    Likewise, the definitions of supplementation and complementation currently contained in sections 5 and 6 of article 106 of the RSA are eliminated.

  • Rules on advertising : The proposal includes a change in the wording of the first paragraph of article 537, clarifying that the labeling and advertising of food supplements must conform both to the general rules applicable to any food product, as well as to the special rules established for That category.

    Likewise, this new article 537 provides the graphic requirements that the name “Food Supplement” must comply with and modifies the warning messages that these products must carry.

    In addition, this proposal incorporates a new obligation in the advertising of supplements, establishing the obligation to incorporate the message"Supplements do not replace a balanced diet according to the Food Guidelines" , in all advertising of these products made by mass media.

  • Information in nutritional table : On the other hand, the new wording of article 537 incorporates the obligation to include the content of nutrients or other special substances that have been incorporated for supplementation purposes in the table of nutritional information of the product, for every 100 g per serving portion Likewise, the obligation to label the maximum number of consumption portions of the product per dayis incorporated.

    Finally, it is established that food supplements should always be marketed packaged from the processing establishment, preventing the sale of these products in other formats (for example, fractionated or in bulk).
  • Modification of the exceptions to the obligation to label the descriptor "High on" : Finally, the consultation modifies the exceptions to the obligation to label the nutritional descriptor "High on", established in Article 120 bis of the RSA, eliminating the " food for athletes ”that“ meet the requirements described in letters a), b), c) and d) of article 540. ”of said exception. It should be noted that the proposal does not incorporate “Supplemented Foods” within the excepted categories.

Finally, the public consultation incorporates, in addition, three complementary documents to the proposed amendments to the RSA, in relation to levels for supplementation and declarations that can be made regarding food supplements. 
These complementary documents to the proposal are:

a) Resolution that “ Establishes the Guidelines for the Declaration of Function Properties of Nutrients in Food Supplements ”;
b) Resolution that “ Establishes Authorized Nutritional Properties in Food Supplements ”; and
c) Resolution that “ Establishes Nutritional Guidelines on Food Supplements and Supplemented Foods and their Contents in Vitamins, Minerals and other substances ”.

More information and the full text of the public consultation are available 






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