EFSA offers new guidance on supplement regulation in the EU

12 Aug 2024 --- The European Food Safety Authority (EFSA) continues its conversation with Nutrition Insight about the bloc’s current regulations and consumer advice on dietary supplementation and botanicals

In its most recent guidance, the EFSA states that while dietary supplements may be used to maintain general health, mental and athletic performance and the immune system, they are not considered medical and not intended to treat disease.

For this reason, an EFSA spokesperson tells us that dietary supplements and botanicals are regulated as foods in the EU. “Please refer to Food Supplements Directive 2002/46/European Commission (EC): ‘There is an increasing number of products marketed in the (European) Community as foods containing concentrated sources of nutrients and presented for supplementing the intake of those nutrients from the normal diet.’”

“As well as Regulation (EC) No 1925/2006 for the addition of vitamins, minerals and other substances to foods, including various plants and herbal extracts. ‘Vitamins and minerals are added to foods by manufacturers for a number of purposes, including to restore their content where this has been reduced during manufacturing, storage or handling procedures or to provide a similar nutritional value to foods for which they are intended as alternatives.’”

Supplements and a healthy diet

The same EC Regulation further asserts: “An adequate and varied diet can, under normal circumstances, provide all necessary nutrients for normal development and maintenance of a healthy life in quantities such as those established and recommended by generally acceptable scientific data.”

Food with added vitamins and minerals are shown to be important for most Europeans to fully meet nutrient requirements.“However, surveys show that this ideal situation is being achieved neither for all vitamins and minerals nor by all groups of the population across the (European) Community. Foods to which vitamins and minerals have been added appear to make an appreciable contribution to the intake of these nutrients and, as such, may be considered to make a positive contribution to overall intakes.”

Concerning the EU’s definition of supplements as foods, the EFSA spokesperson points to the “general EU food law, primarily Regulation (EC) No 178/2002 for the definition of food (Art 2).”

“As outlined in Regulation (EC) No 1925/2006, the addition of vitamins, minerals and other substances to foods is regulated in member states by differing national rules.”

Harmonized regulation

The recent EFSA advice asserts that dietary supplement intake is most important for the societal groups most prone to nutritional deficiencies including pregnant women, infants, people with insufficient access to sunlight and vegans.

“We do not have further data on nutritional deficiencies in Europe and what populations may benefit most from food supplements. You may wish to check with national competent authorities regulating food supplements and the EFSA work on dietary reference values (DRVs) for nutrients and FAQ,” the spokesperson details.

On DRVs, the EFSA states: “This is an umbrella term for a set of nutrient reference values that includes the average requirement, the population reference intake, the adequate intake and the reference intake range for macronutrients. These values guide professionals on the amount of a nutrient needed to maintain health in an otherwise healthy individual or group of people.”

DRVs are the EFSA’s set of nutrient reference values aimed at the relevant policymakers.DRVs are not meant to serve as dietary recommendations for individuals, but by both EU-wide and member state-based policy makers to issue recommendations on nutrient intake to consumers. DRVs are further used as the basis for information on food labels and for the establishment of dietary guidelines.

“EFSA’s role is to provide independent scientific advice to “EU risk managers” (the EC and the member states,” the spokesperson tells us.

The authority has introduced two new DRVs this year. In June, EFSA set the safe level of iron intake at 40 mg/day for adults (including pregnant and lactating women), 5 mg/day for infants aged between four and 11 months (including iron intakes from fortified food and food supplements, but not from infant or follow-on formula), 10 mg/day for children aged one to three and 35 mg/day for adolescents aged 15–17.

“Excessive intake of iron, when maintained over prolonged periods of time, can lead to negative health effects, in particular on the liver. High-dose iron supplements may also cause adverse effects in the gastrointestinal tract.”

This month, the EFSA published a scientific opinion on the revision of the tolerable upper intake level for vitamin E. “A systematic literature review was conducted to assess the adverse health effects of excess intake of vitamin E, namely risk of impaired coagulation and bleeding, cardiovascular disease and prostate cancer.”

The scientific review did not produce an outcome differing to previous findings, and the already established upper intake levels remain in place.

By Milana Nikolova

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