A food that beneficially affects one or more target functions in the body beyond adequate nutritional effects in a way that is relevant to either an improved state of health and well-being and/or reduction of risk of disease. It is consumed as part of a normal food pattern. It is not a pill, a capsule or any form of dietary supplement.

European Commission, EU

Natural or processed foods that contain biologically active compounds; which, in defined, effective, and non-toxic amounts, provide a clinically proven and documented health benefit utilizing specific biomarkers for prevention, management, or treatment of chronic diseases or its symptoms.

Functional Food Centre, US

In Europe, the placement of most foods on the market does not require prior authorization, offering a relatively open framework for food producers. However, this general rule has important exceptions, particularly when it comes to the fortification, enhancement, or enrichment of foods, or when promoting their health benefits. Fortification refers to the addition of nutrients that were not originally present in the food, while enhancement involves restoring nutrients lost during processing. Enrichment, on the other hand, aims to improve the nutritional quality of a product, either naturally or through processing. For foods falling under these categories—or those classified as "novel foods"—specific regulatory frameworks, such as the Novel Foods Regulation, must be carefully considered. This regulation outlines which foods and ingredients require authorization before they can be marketed, ensuring both consumer safety and transparency in the food industry.

The addition of vitamins and minerals to foods, as well as the communication of nutrition and health claims, are subject to strict regulatory oversight. Regulation (EC) No. 1924/2006 specifically governs Nutrition and Health Claims, ensuring that any statements made about the health benefits of a food product are accurate, scientifically substantiated, and not misleading to consumers. Meanwhile, Regulation (EC) No. 1925/2006 regulates the addition of vitamins and minerals to foods, establishing rules on which substances can be used, their permitted levels, and the conditions under which they may be added. These regulations work together to maintain high standards of food safety, protect consumer interests, and promote fair competition within the food industry.

Hear what the expert Dr. Maria Hayes says.
Maria, from Teagasc, the Agriculture and Food Development Authority in Dublin, talks about functional ingredients and the regulatory challenges of innovative aquaculture products, and how these are addressed in the ALGAE4IBD project.

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