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EU Food Supplement Regulation

Lennie Tao Last updated on: Nov 10, 2023

1. Definition

According to Directive 2002/46/EC on the Approximation of the Laws of the Member States Relating to Food Supplements, food supplement is supervised as foodstuffs, with the purpose to supplement the normal diet. Such products are concentrated sources of the following substances, alone or in combination:

  • Nutrients, which refer to vitamins and minerals

  • Other substances with nutritional or physiological effect, such as amino acids, essential fatty acids, fibre, as well as various plants and herbal extracts.

Regarding the dose form, food supplements are in forms 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.

2. Competent authority

Competent authorityReponsibility
European Commission (EC)Developing and implementing laws, authorizing the use of a substance in food/food supplement, etc.
European Food Safety Authority (EFSA)Evaluating product safety, providing scientific advice and support, etc.
Member States
  • Developing national rules (in the absence of EU level legislation)

  • The authorisation procedure related to food supplements is delegated at the national level to the different competent authorities

3. Management mechanism

Enterprises shall comply with the EU level legislation first. For non-harmonized requirements, enterprises need to conform with corresponding national law, if any, in the target Member State. For example, in the absence of harmonized maximum levels for certain vitamins and minerals, some Member States already have their own maximum levels and other related restrictions in place. Some Member States may adopt a notification procedure to supervise food supplements.

Key legislation in EU level include:

4. Ingredient management

  • Annex I of Directive 2002/46/EC lays down a list of vitamins and minerals which may be used in the manufacture of food supplement (e.g., vitamin A). Annex II details a list of substances authorized as the sources of the vitamins and minerals listed in Annex I (e.g., retinol, a permitted source of vitamin A, is listed in Annex II)

  • The use of ingredients other than vitamins and minerals (e.g., botanicals) in the manufacture of food supplements may also be authorized under other specific legislation depending on the nature of the substance (e.g., novel foods, substances for the fortification of food and foods for specific groups)

  • Ingredients outside the above situations may still be used under Member States’ national rules

  • The use of food additives shall conform with Regulation (EC) No 1333/2008 on Food Additives

  • Regulation (EC) No 1925/2006 contains a list of substances whose use in foods is prohibited, restricted or under scrutiny.

5. Mandatory labeling

As per Regulation (EU) No 1169/2011, mandatory labeling items for food supplement include:

  • Name of the food

  • List of ingredients

  • An indication of ingredient or processing aid causing allergy or intolerance

  • Quantity of certain ingredients or categories of ingredients

  • Net quantity of the food

  • Date of minimum durability “best before” or the “use by” date

  • Any special storage conditions and/or conditions of use

  • Name or business name and address of the responsible food business operator

  • Country of origin or place of provenance

  • Instructions for use where it would be difficult to make appropriate use of the food in the absence of such instructions

Besides this Regulation, Directive (EC) 2011/91 requires the labeling of lot indication and Directive 2002/46/EC adds additional labeling items as below:

  • Names of the categories of nutrients or substances that characterize the product or an indication of the nature of those nutrients or substances

  • 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

  • A statement to the effect that the products should be stored out of the reach of young children

  • Amount of the nutrients or substances with nutritional or physiological effect present in the product

Details regarding labeling requirements can be found at ChemLinked's Food Check tool.

6. Nutrition and health claim

Claims are not mandatory in the EU. However, if enterprises choose to use nutrition or/and health claims, they shall comply with the provisions of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods. In this case, it is mandatory to make nutrition labeling of products.

Permitted nutrition and health claims are listed below.


Definition and explanationA list of detailed claims

Nutrition claim

Nutrition claims include content claim and comparative claim. It refers to any claim which states, suggests or implies that a food has particular beneficial nutritional properties due to


1. The energy (calorific value) it

  • Provides

  • Provides at a reduced or increased rate or

  • Does not provide


2. The nutrients or other substances it

  • Contains

  • Contains in reduced or increased proportions or

  • Does not contain

 

Examples include: low energy, energy-reduced, energy free; source of fiber, high fiber

Annex of Regulation (EC) No 1924/2006

Health claim

Health claim refers to any claim that states, suggests or implies that a relationship exists between a food category, a food, or one of its constituents and health. It can be roughly divided into 3 types:

  1. The so-called “Function Health Claims”: Article 13 “Health claims other than those referring to the reduction of disease risk and to children's development and health”, including those:

    ✔ Relating to the growth, development and functions of the body (e.g., “Protein contributes to a growth in muscle mass”)

    ✔ Referring to psychological and behavioural functions (e.g., “Thiamine contributes to normal psychological function”)

    ✔ On slimming or weight-control (e.g., “Glucomannan in the context of an energy restricted diet contributes to weight loss”)

  2. The so-called “Risk Reduction Claims”: Article 14 1 (a) Reduction of disease risk claims. For example: "Plant stanol esters have been shown to reduce blood cholesterol. Blood cholesterol is a risk factor in the development of coronary heart disease."

  3. Health claims referring to children's development and health, as stipulated in Article 14 1 (b). For example: "Vitamin D is needed for the normal growth and development of bone in children."

  • Regulation (EC) No 983/2009 on the authorization and refusal of authorization of certain health claims made on food and referring to the reduction of disease risk and to children’s development and health

  • Regulation (EU) No 432/2012 establishing list of permitted health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health

  • EU Register of Health Claims (including non-authorized health claims)

Read more at Food Supplement Legislation in the EU.

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