Health Claims

In accordance with Regulation (EC) 1924/2006 (the claims regulation), a nutrition claim is any message or representation that is not mandatory under the legislation which states, suggests or implies that a food has particular beneficial nutritional properties due to the energy, nutrients or other substances that it contains, does not contain or contains in reduced or increased proportions. 

A list of permitted nutrition claims and their specific conditions of use is included in the Annex of Regulation (EC) 1924/2006.

Any claim considered to have the same meaning for consumers as a nutrition claim should be subject to the same conditions of use indicated therein. For example, claims related to the addition of vitamins and minerals such as ‘with ...’, ‘restored ...’, ‘added ...’, or ‘enriched ...’ should be subject to the conditions set for the claim ‘source of ...’.

In accordance with Regulation (EC) 1924/2006 (the claims regulation), a health claim is any message or representation that is not mandatory under the legislation which states, suggests or implies that a beneficial effect exists between a food category, a food or one of its constituents and health.

 Health claims are divided into 3 different type of claims:

§  Function health claims (or Article 13 claims), related to the growth, development and functions of the body; psychological and behavioral functions; or slimming or weight-control;

§  Risk reduction claims (or Article 14.1.(a) claims), related to the reduction of a risk factor in the development of a disease;

§  Claims referring to children’s development (or Article 14.1.(b) claims), related to children’s development and health, e.g. for normal growth and development of bone in children.

There is a harmonized EU list for function health claims (also known as “Article 13 claims”). The Regulation (EU) 432/2012 establishes a list of permitted claims, which can also be found in the EU Register of Nutrition and Health Claims. These claims have been approved by the European Commission after the European Food Safety Authority (EFSA) has carried out a scientific evaluation on the evidence of the claimed benefits. In addition, under certain conditions “on-hold” claims may be used.

 Risk reduction claims and those referring to children's development (“Article 14 claims”) follow a different authorization procedure based on individual applications. Different regulations have been adopted following individual assessments providing a list of authorized and refused claims.

Due to the lack of human intervention studies on plant substances (so-called "botanicals") used in foods, which are required for the full scientific evaluation by the European Food Safety Authority (EFSA), the European Commission established in 2012 an “on-hold'” list of 2,078 health claims for botanicals, pending final evaluation by EFSA.

 These claims may still be used on the EU market provided that they comply with the general principles and conditions of Regulation (EC) 1924/2006 and the relevant national provisions. Not all Member States allow the use of “on-hold” claims, therefore it is important to approach their use on a case-by-case basis.

In May 2020, the European Commission completed the Evaluation of the Regulation on Nutrition and Health Claims. The evaluation findings recognize a gap on the current rules set in the Claims Regulation when it comes to the evaluation of plants and their preparations, which have a long traditional history of use linked to health benefits.

It has been suggested to explore the route of “traditional use” in the efficacy assessment of health claims in botanicals, together with a harmonized approach for the safety assessment of botanicals at the EU level. Further work on these two areas may therefore follow.

The claims regulation had foreseen the setting of nutrient profiles to restrict the use of claims in foods by 2009. Nutrient profiles are nutritional requirements that foods must meet in order to bear nutrition and health claims. However, there has not been any agreement on the criteria to set such profiles, leading to the absence of nutrient profiles to date.

The findings from the Evaluation of the Regulation on Nutrition and Health Claims, completed by the European Commission in May 2020, suggest that the objective of the setting of nutrient profiles to restrict the use of claims to those foods with a more “healthful” nutritional composition is still pertinent and necessary to protect the consumer. Therefore, the setting of nutrient profiles should still be considered.

Yes. The list of permitted health claims established by Regulation (EU) 432/2012 is regularly updated with newly authorized health claims subject to individual application submitted pursuant to Article 13(5) of Regulation (EC) No 1924/2006.

Applications for authorization for new health claims may be made on an ongoing basis. However, it is not possible to request the addition of a new claim to the “on-hold” list, since these are claims on pending evaluation. Botanical claims which are not included in the “on-hold” list cannot be made unless authorized.

General, non-specific health claims are allowed if these are accompanied by a relevant authorized health claim. Both claims should be located in close proximity to each other or linked through an asterisk, as recognized by the European Court of Justice in the beginning of 2020.

Furthermore, the references to general, non-specific benefits of the nutrient or the food must be justified by scientific evidence.

Claims such as “pre- or pro-biotic” or “Contains antioxidants” are considered general, non-specific health claims and should therefore be accompanied by an authorized claim:

• The term “antioxidant” demonstrates the same health relationship as “contributes to the protection of cells from oxidative stress”. This could be used for example if the product contains vitamin E for which this claim is authorized.
• In the case of probiotics, there are no authorized claims and therefore its use is not permitted (except in Italy and the Netherlands that use a different national approach for these claims).

The claims regulation also applies to trademarks and other brand names which may be construed as nutrition or health claims. They must therefore be accompanied by a specific, authorized or "on-hold" health claim.

However, a transition period is granted until January 19, 2022 for trademarks and brand names existing before January 1, 2005. In accordance with a rule from the EU Court of Justice, this is also possible for products which were medicinal products before 2005 and later categorized as food products, provided that its physical characteristics and trademark or brand name remains the same.

In any case, the name should not suggest an effect which goes beyond the specific claim accompanying it, nor suggest properties of prevention, treatment or cure of diseases or even refer to significant changes in physiological functions.

The following claims are not allowed:

§  Claims suggesting that health could be affected by not consuming the food;

§  Claims which make reference to the rate or amount of weight loss;

§  Use of testimonials from individual doctors or health professionals,

§  Therapeutic or medicinal claims.

The claims regulation provides for some flexibility of wording of authorized health claims to facilitate consumer understanding. EU Member States agreed on some “General principles on flexibility of wording for health claims”.

 The general recommendation is that the claims used are as close as possible to the authorized wording. If the wording of a health claim is adapted, the wording must mean the same to the consumer as the authorized claim, and in no case, should be “stronger”.

 Lastly, it is important that the claimed effect is linked to the substance for which claims have been authorized and not to the product.

The claims regulation also applies in commercial communication that reaches the end consumer, such as promotional campaigns. However, it does not apply in non-commercial communications such as in dissemination of educative material such as dietary guidelines, in advice issued by public health authorities or in information in the press and in scientific publications.