Contents x
    5. Claim Requirements
    • 6 Mins to read
    • Dark
      Light
    Contents

    5. Claim Requirements

    • 6 Mins to read
    • Dark
      Light
    Article summary

    General Foods
    United Kingdom (UK)

    This section provides information on the definition of different types of claims and any restrictions or allowance of claims as well as claim registration processes.

    5.1 Overview of Claims

    5.1.1 Types & Definitions

    Claims are regulated by Regulation (EC) 1924/2006 on nutrition and health claims [1]. There are two categories of claims on foods in the EU: nutrition claims and health claims. Nutrition claims refer to what a food contains: content claims and comparative claims. Health claims refer to what a food does and refer to general function claims, claims related to a reduction of disease risk, and claims related to the growth and development of children.

    Nutrition claims

    Under Article 2 of Regulation (EC) 1924/2006, ‘nutrition claim’ means any claim that states, suggests, or implies that a food has particular beneficial nutritional properties due to:

    1. the energy (calorific value) it
      1. provides;
      2. provides at a reduced or increased rate; or
      3. does not provide; and/or
    2. the nutrients or other substances it
      1. contains;
      2. contains in reduced or increased proportions; or
      3. does not contain.

    Content claims (Article 8) refer to the nutritional composition of a food that meets a specific amount criteria, e.g. “source of vitamin D”.

    Comparative claim (Article 9) compares the nutritional composition of a range of foods within the same food category e.g. “30% less fat”.

    Health claims means any claim that states, suggests, or implies that a relationship exists between a food category, a food, or one of its constituents and health.

    The UK has a separate nutrition and health claim register, which aligns with the EU. If making claims for the UK market, a check on the Great Britain Nutrition and Health Claims Register (NHC) is required since the UK has left the EU. Only authorized claims in the GB NHC register may be used in Great Britain. The annex to the Great Britain NHC register lists health claims authorized on the basis of propriety (privately owned) data [2].

    5.1.2 List of Prohibited Claims

    Nutrition and health claims shall not:

    1. be false, ambiguous, or misleading;
    2. give rise to doubt about the safety and/or the nutritional adequacy of other foods;
    3. encourage or condone excess consumption of food;
    4. state, suggest, or imply that a balanced and varied diet cannot provide appropriate quantities of nutrients in general;
    5. refer to changes in bodily functions that could give rise to or exploit fear in the consumer, either textually or through pictorial, graphic, or symbolic representations.

    5.2 Nutritional Claims

    5.2.1 Permitted Claims

    Currently, there are 30 permitted nutrition claims. Any food business operator can use a nutrition claim on a food label provided the conditions to make a claim are satisfied as outlined in Annex 1 of Regulation (EC) 1924/2006, lastly amended by Regulation (EU) 1047/2012 [1].

    A nutrition claim draws the consumer's attention to a specific nutrient aspect of a product.

    5.2.2 Nutritional Claim Registration

    N/A

    5.3 Health Claims

    There are 4 main types of health claims in the EU:

    1. General, nonspecific health claims. These types of claims refer to health or well-being (Article 10). They must be supported by a related specific Article 13 or 14 health claim close to the general claim or suitably signposted, for example, with an asterisk. [1]
    2. Health claims other than those referring to the reduction of disease risk (Article 13). These can relate to the growth, development, and functions of the body; to psychological and behavioral functions; or to slimming or weight control. (However, claims that refer to the rate or amount of weight loss are not allowed). Article 13(1) function claims are based on “generally accepted scientific data;” whereas Article 13(5) claims are based on newly developed scientific data.
    3. Reduction of disease risk claims (Article 14 1a). These claims should also bear a statement indicating that the disease to which the claim is referring has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.
    4. Children’s growth and development (Article 14 1b). These claims are supported by scientific studies in children. There are 12 authorized health claims for children’s growth and development. Food products for children cannot bear adult claims.

    A health claim draws the consumers' attention to the health benefits associated with a nutrient claim.

    5.3.1 Permitted Claims

    A public EU Register of Health Claims lists all authorized and non-authorized health claims [3].

    5.3.2 Health Claim Registration

    Applicants must submit a formal dossier for Article 13(5) and Article 14 (1.a and 1.b) claims. To inform an application, the EFSA has developed guidance for the preparation and presentation of a health claim application [4] which includes information on the pre-submission phase. When evaluating a health claim dossier, the EFSA evaluates the extent to which:

    • The food/constituent is defined/characterized,
    • The claimed effect is “beneficial to human health,” and
    • Scientific evidence of a cause-and-effect relationship is established.

    A negative answer in any of the three steps indicates the claim is not suitable for authorization. For point 2 (beneficial to human health), the EFSA has published a series of guidance documents [5] on the scientific requirements for health claims related to:

    1. Functions of the nervous system, including psychological functions;
    2. Physical performance;
    3. Bone, joints, skin, and oral health;
    4. Appetite ratings, weight management, and blood glucose concentrations;
    5. The immune system, the gastrointestinal tract, and defense against pathogenic microorganisms; and
    6. Antioxidants, oxidative damage, and cardiovascular health.

    The EFSA evaluates each health claim application, and the result is published as a scientific opinion. The conclusions of an EFSA scientific opinion evaluating a health claim can be:

    1. A cause-and-effect relationship has been established,
    2. There is insufficient evidence to establish a cause-and-effect relationship, or
    3. A cause-and-effect relationship has not been established.

    After the finalization of a scientific opinion by the EFSA, it is up to the EC and member states to decide on the authorization of a health claim. Only health claims that carry the conclusion “a cause-and-effect has been established” qualify for authorization.

    Applications seeking authorization of a health claim for use in the GB market should be submitted to the competent authorities via the DHSC mailbox (which centrally coordinates applications for all GB nations. To submit an application for a claim to be authorized for use in:

    • England Only – please contact the competent authority via the DHSC Mailbox
    • Scotland Only – please contact the competent authority via the Foods Standards Scotland Mailbox
    • Wales Only – please contact the competent authority via the Welsh Government Mailbox

    The application form follows the approach provided by EFSA for claims to be used in the EU but with modifications for use in GB.

    The UK guidance for industry recommends that applicants check beforehand whether their product falls into the definition of a medicinal product or a novel food before applying.

    5.4 Other Notes or Requirements for Claims

    A trademark, brand name, or fancy name appearing in the labeling, presentation, or advertising of food which may be construed as a nutrition or health claim may be used without undergoing the authorization procedures provided for in this Regulation, provided that it is accompanied by a related nutrition or health claim in that labeling, presentation or advertising which complies with the provisions of this Regulation.

    Conditions for use in making claims

    Article 10 of the regulation (EC) 1924/2006 states that when making a health claim there are certain conditions and additional statements that would be required on the pack:

    1. A statement referring to a varied and balanced diet for a healthy lifestyle
    2. Quantity of food required for the claimed benefit
    3. Warning for those to whom it presents a health risk
    4. Statement for those who should avoid the foods

    5.5 References

    1. Regulation (EC) No 1924/2006 of the European Parliament and of the Council of 20 December 2006 on nutrition and health claims made on foods

    https://eur-lex.europa.eu/legal-content/EN/ALL/?uri=celex%3A32006R1924


    2. Great Britain nutrition and health claims (NHC) register

    https://www.gov.uk/government/publications/great-britain-nutrition-and-health-claims-nhc-register


    3. EU register of health claims

    https://food.ec.europa.eu/safety/labelling-and-nutrition/nutrition-and-health-claims/eu-register-health-claims_en1


    4. European Food Safety Authority. Scientific and technical guidance for the preparation and presentation of a health claim application. EFSA J. 2021;19(3):6554

    https://efsa.onlinelibrary.wiley.com/doi/epdf/10.2903/j.efsa.2021.6554


    5. European Food Safety Authority. Nutrition applications: Regulations and guidance

    https://www.efsa.europa.eu/en/applications/nutrition/regulationsandguidance


    Was this article helpful?
    What's Next