Health claims according to article 13 and 14
Health claims regulated under Article 13 of Regulation (EC) No. 1924/2006 are based on generally accepted scientific evidence and are summarized in a list of 450 authorized claims, as outlined in Regulation (EU) No. 432/2012. These claims primarily focus on the role of nutrients or substances in the growth, development, and functions of the body, as well as their contribution to psychological and behavioral functions. While these claims are pre-authorized, manufacturers and importers must still hold scientific documentation to substantiate the claim for their specific product and provide it to national authorities upon request. This ensures that only well-supported claims reach consumers, maintaining trust and transparency in the food market.
Health claims falling under Article 14 are subject to a more rigorous individual authorization procedure. These claims typically involve risk reduction or children’s development and health, requiring a higher level of scientific substantiation. Unlike Article 13 claims, which are pre-approved, Article 14 claims must undergo a case-by-case evaluation by the European Food Safety Authority (EFSA) before they can be used. This process ensures that claims related to disease risk reduction or specific health benefits for vulnerable groups, such as children, are thoroughly vetted and scientifically validated.
Example of health claims - Omega-3 fatty acids
Omega-3 fatty acids, specifically eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA), are associated with several authorized health claims. For instance, "EPA and DHA contribute to the normal function of the heart", while "alpha-linolenic acid (ALA) contributes to the maintenance of normal blood cholesterol levels". To use these claims, the food must meet specific conditions: it must be at least a source of EPA and DHA or ALA, as defined in the Annex to Regulation (EC) No. 1924/2006. Consumers must also be informed that the beneficial effect of EPA and DHA is obtained with a daily intake of 250 mg, while for ALA, the effect is achieved with a daily intake of 2 g. These conditions ensure that claims are both meaningful and achievable through normal dietary habits.
Example of health claims - DHA in microalgae Schizochytrium sp.
"DHA contributes to the maintenance of normal brain function" and "DHA contributes to the maintenance of normal vision." These health claims are permitted only if the food product meets minimum requirements, including being a source of DHA as defined in the relevant regulations. The claim must also inform consumers about the necessary daily intake of DHA to achieve the stated benefits. This ensures that consumers receive accurate and actionable information about the health benefits of DHA.
Example of health claims - saturated and unsaturated fatty acids
Claims related to saturated and unsaturated fatty acids emphasize the importance of dietary fat quality. For example, the claim "Reducing consumption of saturated fat contributes to the maintenance of normal blood cholesterol levels" can only be used for foods that are low in saturated fat or reduced in saturated fat, as defined in the Annex to Regulation (EC) No. 1924/2006. Similarly, the claim "Replacing saturated fats in the diet with unsaturated fats contributes to the maintenance of normal blood cholesterol levels" applies only to foods that are high in unsaturated fats, such as those containing oleic acid. These claims are supported by scientific assessments published in the EFSA Journal and are designed to guide consumers toward heart-healthy dietary choices.
Example of health claims - meat or fish
A specific health claim highlights the role of meat or fish in improving iron absorption when consumed with other iron-containing foods. The claim states that "Meat or fish contributes to the improvement of iron absorption when eaten with other foods containing iron." To use this claim, the product must contain at least 50 g of meat or fish per quantified portion. Additionally, consumers must be informed that the beneficial effect is achieved by consuming 50 g of meat or fish together with foods containing non-haem iron. This claim, authorized under EFSA Journal 2011;9(4):2040, underscores the importance of dietary combinations in enhancing nutrient absorption and supports informed food choices for better nutritional outcomes.