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Nutrition and Health Claims legislation

Nutrition and Health Claims

EU and national legislation as well as links to guidance documents about acceptable health claims.

  • EU legislation

    Corrigendum (OJ L 12, p3, 18/01/2007) to Regulation (EC) No 1924/2006 (OJ L 404, p9, 30.12.2006) of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods

    Amended by

  • Implementing Rules
    • Commission Regulation (EC) No 353/2008 (OJ L 109, p11, 19.04.2008) of 18 April 2008 establishing implementing rules for applications for authorisation of health claims as provided for in Article 15 of Regulation (EC) No 1924/2006 of the European Parliament and of the Council
    • Commission Regulation (EU) No 432/2012 (OJ L 136, p1, 25.05.2012) of 16 May 2012 establishing a 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
      Amended by:
    • Commission Regulation (EU) No 536/2013 (OJ L 160, p4, 12.06.2013) of 11 June 2013 amending Regulation (EU) No 432/2012 establishing a 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
    • Commission Regulation (EU) No 851/2013 (OJ L 235, p3, 04.09.2013) of 3 September 2013 authorising certain health claims made on foods, other than those referring to the reduction of disease risk and to children’s development and health and amending Regulation (EU) No 432/2012 (OJ L 282, p15, 24/10/2013) of 23 October 2013 amending Regulation (EU) No 432/2012
    • Commission Regulation (EU) No 40/2014 (OJ L 14, p8, 18.01.2014) of 17 January 2014 authorising a health claim made on foods, other than those referring to the reduction of disease risk and to children's development and health and amending Regulation (EU) No 432/2012
    • Consolidated version of Regulation (EU) No 432/2012 (as at 17 May 2021)
    • Commission Regulation (EU) No 907/2013 (OJ L 251, p7, 21.09.2013) of 20 September 2013 setting the rules for applications concerning the use of generic descriptors (denominations)
    • Commission Implementing Decision 2013/63/EU (OJ L 22, 25.1.2013, pp. 25-28) of 24 January 2013 adopting guidelines for the implementation of specific conditions for health claims laid down in Article 10 of Regulation (EC) No 1924/2006
    • Commission Regulation (EU) 2019/343 (OJ L 62, P1, 01.03.2019) of 28 February 2019 providing derogations from Article 1(3) of Regulation (EC) No 1924/2006 of the European Parliament and of the Council on nutrition and health claims made on food for the use of certain generic descriptors
  • National legislation
    • European Communities (Nutrition and Health Claims made on Food ) Regulations 2014 (S.I. No. 11 of 2014)
    • European Union (Nutrition and Health Claims made on Food) (Amendment) Regulations 2021 (S.I. No. 243 of 2021)
  • General provisions

    General labelling provisions are contained in Regulation (EU) No. 1169/2011 on the provision of food information to consumers. This legislation generally prohibits the use of information that would mislead the purchaser or attribute medicinal properties to food. This Regulation on nutrition and health claims complements the general principles in Regulation (EU) No. 1169/2011 and lays down specific provisions concerning the use of nutrition and health claims concerning foods to be delivered as such to the consumer.

    There is a wide variety of claims currently used in the labelling and advertising of foods and under Regulation (EC) No. 1924/2006 which has applied since the 1st July 2007, it is necessary to ensure that the substances for which a claim is made have been shown to have a beneficial nutritional or physiological effect. In order to ensure that the claims made are truthful, the substance that is the subject of the claim must be present (or in the case of a reduced claim present in suitably reduced quantities) in the final product in quantities that are sufficient to produce the nutritional or physiological effect claimed. The substance must also be available to be used by the body (bio available). In addition, and where appropriate, a significant amount of the substance producing the claimed nutritional or physiological effect should be provided by a quantity of the food that can reasonably be expected to be consumed.

    A nutrition or health claim may not be made if it is inconsistent with generally accepted nutrition and health principles or if it encourages or condones excessive consumption of any food or disparages good dietary practice.

    A list of permitted nutrition claims and their specific conditions of use is included in the Annex to Regulation (EC) No. 1924/2006 , examples of claims include claims such as low fat, fat free, sugars-free.

  • Authorisation and refusal of certain health claims

    Regulation (EC) No. 1924/2006 allows for the establishment of a European Union Register of nutrition and health claims made on food. The EU Register includes the following:

    • the nutrition claims and the conditions applying to them as set out in the Annex of Regulation (EC) No. 1924/2006;
    • restrictions adopted in accordance with Article 4(5) of Regulation (EC) No. 1924/2006;
    • the authorised health claims and the conditions applying to them provided for in Articles 13(3) and (5), 14(1), 19(2), 21, 24(2) and 28(6) and the national measures referred to in Article 23(3) of Regulation (EC) No. 1924/2006;
    • a list of rejected health claims and the reasons for their rejection.

    This EU Register of nutrition and health claims has been established and is updated at regular intervals.The Register lists authorised health claims that can be used by all food business operators provided that they comply with the particular conditions of use of the authorised claim and with the principles and requirements of Regulation (EC) No. 1924/2006. It also lists the rejected health claims.

  • Generic Health Claims

    Regulation (EC) No 1924/2006 exempts from its scope specific generic descriptors (denominations) which have traditionally been used to indicate a particularity of a class of foods or beverages which could imply an effect on health following an application by the food business operators concerned. Regulation (EU) No 907/2013 sets out the rules according to which such applications must be made. It permits trade associations representing specific food sectors to submit applications on behalf of their members, in order to avoid multiple applications in respect of the same generic descriptor (denomination). Generic descriptors (denominations) should correspond to a period of at least 20 years proven usage within the Member State(s) prior to the date of entry into force of the Regulation (11 October 2013).

  • Reduction of Disease risk claims and claims referring to children's development and health

    Under Article 14 of Regulation (EC) 1924/2006, reduction of disease risk claims and claims referring to children's development and health may be made where they have been authorised in accordance with the procedure laid down in Articles 15, 16, 17 and 19 of the Regulation. Once authorised, they will be included in an EU list of permitted claims together with all the necessary conditions for their use. The prohibition in Article 7(3) of Regulation (EU) No. 1169/2011 which prevents labelling from attributing to any foodstuff the property of preventing, treating or curing a human disease, or referring to such properties, also applies.

  • Implementing Guidance

    Commission Regulation (EC) No 353/2008 establishes implementing rules for the following applications:

    • applications for authorisation, submitted in accordance with Article 15 of Regulation (EC) No 1924/2006; and
    • applications for the inclusion of a claim in the list provided for in Article 13(3) submitted in accordance with Article 18 of Regulation (EC) No 1924/2006.

    The Regulation requires that each application covers only one relationship between a nutrient or other substance, or food or category of food, and a single claimed effect. The Annex to Commission Regulation (EC) No 353/2008 sets out the technical rules for the preparation and presentation of the application for health claims

    In January 2008, the EU Commission published Guidance on the implementation of Regulation (EC) No 1924/2006 on nutrition and health claims made on foods: Conclusions of the Standing Committee on the Food Chain and Animal Health.