Food Supplements

Food is defined in article 2 of Regulation 178/2002 as “any substance or product, whether processed, partially processed or unprocessed, intended to be, or reasonably expected to be ingested by humans”.

As opposed to that, ‘food supplements’ as defined in article 2 (a) of Directive 2002/46 are foodstuffs with the purpose to supplement the normal diet.

Pursuant to article 2 (a) of Directive 2002/46, food supplements are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination. They are marketed in dose form, such as capsules, pastilles, tablets, pills and other similar forms, sachets of powder, ampoules of liquids, drop dispensing bottles, and other similar forms of liquids and powders designed to be taken in measured small unit quantities. Food supplements are not designed to replace a balanced and healthy diet.

While food supplements have the purpose to supplement the normal diet, fortified foods are, pursuant to Regulation 1925/2006, regular foodstuffs that are part of the normal diet and to which vitamins, minerals or other substances with a nutritional or physiological effect have been added. An example would be a fruit juice with added calcium or magnesium.

There is no harmonized definition on EU level for a measured small unit quantity. Member states have either guidelines or decide on a case-by-case basis. While the French guidelines set up a maximum of 25g (or 100 kcal) per portion and up to 250 ml dilution, Finland has set the threshold at 200 kJ/50 kcal of energy per recommended daily portion or a maximum volume of 100 ml. The Portuguese guidelines set the limit at 25 g or 25 ml. A dose that is considered generally small, is one teaspoon or tablespoon.

Food supplements usually consist of vitamins, minerals or other substances with a nutritional or physiological effect. There is no comprehensive list of substances that may be used in food supplements, however restrictions on EU level and in national laws must be observed. For instance, only the sources of nutrients listed in Annex II to Directive 2002/46 may be used in food supplements. Several EU Member States have positive or negative lists on botanicals or other substances that may or may not be used in food supplements.

There are no EU-wide maximum limits for Vitamins and minerals in food supplements. Several EU Member States, like Belgium or Italy, have established maximum levels, Others, like France and Germany have recommendations with a general setting point. Spain refers to the EFSA safe upper levels.

Pursuant to article 6, section 1 of Directive 2002/46, food supplements must be sold under the name “food supplement”, which, according to article 9, section 1 (a) of Regulation 1169/2011 must appear on the label.

In addition, as per article 6 of Directive 2002/46, the label must include the names of the categories of nutrients or substances that characterize the product or an indication of the nature of those nutrients or substances; the portion of the product recommended for daily consumption; a warning not to exceed the stated recommended daily dose; a statement to the effect that food supplements should not be used as a substitute for a varied diet and a statement to the effect that the products should be stored out of the reach of young children.

In addition to the precautions mentioned above, further warnings may be required under national law, for instance when the product contains certain botanicals. For example, French law requires extensive warnings when a product contains green tea preparations. On products containing green tea preparations in France, the following warning statement needs to be included: “Not suitable for children, adolescents and pregnant and breastfeeding women. Do not take taken on an empty stomach”. Under Belgian law ingredients derived from the species Brassica oleracea trigger the warning that people with hypothyroidism and people being in treatment for other thyroid issued should consult their physician before use.

No. Pursuant to article 6, section 2 of Directive 2002/46, the labelling, presentation and advertising must not attribute to food supplements the property of preventing, treating or curing a human disease, or refer to such properties.

While, pursuant to article 7 of Directive 2002/46, the labelling, presentation and advertising of food supplements must not suggest that a balanced and varied diet cannot provide appropriate quantities of nutrients in general, the labelling may include authorized health claims as per Regulation 432/2012. However, pursuant to article 12 (a) of Regulation 1924/2006, these claims must never suggest that health could be affected by not consuming the food.

Yes. Particularly for products addressed to children above 3 years of age there are no particular restrictions in EU law, Belgian law or French law. On national level, the maximum nutrient amounts for children may differ from those for adults, but not all Member States have adopted different amounts.

As food supplements are a category of food, all substances that are unfit for human consumption may not be used in food supplements either. In addition, no unauthorized novel food may be used in food supplements, and the use of certain additives may be prohibited or restricted in food supplements. The European Commission maintains a list of substances whose use in foods is prohibited, restricted or under community scrutiny. Currently, these are Ephedra herb and Yohimbe bark and all the preparations originating from them. The usage of trans fats is restricted to maximum 2 grams per 100 grams of fat.