Conditions of use of health claims

Authorised claims are not specific to one product or applicant

Authorised nutrition and health claims are not specific to one product or applicant, but apply to a food category, a food or an ingredient of food. Any food business operator can use an authorised claim in the marketing of their own product, provided the conditions of use of the claim are fulfilled in the product and the food package carries the labelling required due to the use of the claim.

By virtue of Article 13.5, the Commission can grant data protection to an authorised health claim, whereby the use of the health claim can be restricted for a certain period of time to the benefit of the applicant.


Conditions of use of health claims

Specific conditions of use have been determined for each authorised health claim, and in some cases also the conditions or restrictions of use or a warning statement. If a claim is to be included in the labelling or marketing of the product, the product and its labelling shall fulfil these conditions. The conditions of use are found in the Regulation under which the product has been authorised as well as in the Commission register of claims.

For several health claims, the condition of use is that the food contains a significant amount of the vitamin or mineral in question, i.e. fulfils the conditions of nutrition claim "source of".

Product categories

Some health claims are authorised for use only in specific product categories. In that case it must be verified that the health claim is only used in foods included in that food category.

For example, "Plant sterols and plant stanol esters have been shown to lower/reduce blood cholesterol. High cholesterol is a risk factor in the development of coronary heart disease" is an authorised Article 14(1)a health claim.

  • The conditions of use of this claim are specified as follows: "Information to the consumer that the beneficial effect is obtained with a daily intake of 1.5-2.4 g plant sterols. Reference to the magnitude of the effect may only be made for foods within the following categories: yellow fat spreads, dairy products, mayonnaise and salad dressings. When referring to the magnitude of the effect, the entire range "7 to 10%" and the duration to obtain the effect "in 2 to 3 weeks" must be communicated to the consumer".


Use of equivalent wordings

The Claims Regulation states that in addition to the authorised wording, health claims may be made using equivalent wordings, which have the same meaning for the consumer, because they describe the same relationship between the food category, the food or an ingredient of food and health.

Evira recommends that the wording given in the Regulation is used in each nutrition and health claim.

If the operator uses some other equivalent wording, the operator shall ensure that the wording is likely to have the same meaning for the consumer. It is particularly important to ensure that the presented wording is not stronger than the wording given in the Regulation.

Common guidelines for member countries regarding the flexibility of health claim wording principles