New Guidelines for Food Product Labelling

The National Administration of Medicines, Foods, and Medical Technology (ANMAT) issued Regulation No. 8095/2023, published in the Official Gazette on September 27, which introduces new guidelines for using Health Claims (DPS) on labels of food products. The new Regulation will apply to DPS of food and non-alcoholic beverages ready for consumption, to be later used in advertising aimed at the general public.

The procedure for obtaining recommendations from the DPS Assessment Commission to enroll products in the National Registry of Food Products (RNPA) has been modified.

 

1.           Background and purpose

The Regulation defines DPS as “any representation declaring, suggesting, or implying a relationship between food or a component of such food and health.”

Even though ANMAT had already published a Guideline for the Presentation and Scientific Evaluation of Health Claims in Foods (Regulation No. 7730/2011), the agency considered it necessary to clarify the scope and application of the use recommendations the DPS Assessment Commission issued.

The modifications ANMAT introduced complement existing regulations regarding food labeling and advertising, mainly those outlined in Chapter V of the Argentine Food Code (AFC).

 

2.           Scope

The Regulation classifies DPS in:

•            Nutrient Function Claim: these are DPS describing the physiological function of a nutrient in growth, development, and normal bodily functions.

•            Other Function Claim: this describes specific beneficial effects of consuming a food or its components on the body’s normal biological functions or activities. Such claims relate to a positive contribution to health, the improvement of a function, or the modification or preservation of health.

•            Disease Risk Reduction Claim: this claim links the consumption of a certain food or food component to the reduction of the risk of a disease or health-related condition.

 

3.           Assessment Commission

To fulfill these purposes, the Regulation expands and updates the functions of the DPS Assessment Commission. The new functions include:

•            Evaluating the applications interested parties submit in accordance with the Protocol for Presentation and Scientific Evaluation of DPS, as updated in the Annex of the Regulation.

•            Determining, if there is a change in the composition of a certain food, whether it is necessary to repeat the tests that demonstrated the health effect of the food for which a DPS is being sought.

•            Issuing a recommendation of use with a grounded opinion, following the evaluation of submissions, based on the requirements established in the Presentation and Evaluation Protocol and/or on the tests demonstrating the health effect of the food.

•            Determining if it is necessary to reevaluate any recommendation of use when new evidence becomes available.

Applications submitted before the DPS Assessment Commission must comply with the requirements specified in the DPS Protocol for Presentation and Scientific Evaluation, as detailed in the Annex of the Regulation. Some of the requirements are: applicant’s general information, food or component the DPS refers to, information about the DPS, grounds for the DPS, and evaluation procedure.

Whenever there is a change in the product's composition, the applicant must submit a new request.

 

4.           Prohibitions

These products cannot have DPS:

•            liquid and powdered infant formulas intended for nursing children,

•            dietary supplements,

•            foods for special medical purposes,

•            packaged foods and beverages containing at least one warning label as established in Law No. 27642 to Promote Healthy Eating (front labeling law), and

•            alcoholic beverages.

 

5.           Effective Date

The Regulation came into effect on September 27, 2023.