Rejection of a health claim for isomaltulose

Commission Regulation (EU) 2024/2105 of 31 July 2024 refusing to authorise a health claim made on foods, other than those referring to the reduction of disease risk and to children’s development and health

Update

The European Commission has rejected a health claim for isomaltulose as a source of glucose to the normal energy-yielding metabolism, because the claim conveys a conflicting and confusing message to consumers.

What is changing?

The health claim that “isomaltulose contributes to normal energy-yielding metabolism” will not be included in the EU list of permitted health claims.

Why?

Making a contribution to energy-yielding metabolism is not specific to isomaltulose; it applies to all energy-containing macronutrients (carbohydrates, proteins, and lipids) that supply the body with metabolisable energy. Isomaltulose is a disaccharide (consisting of one glucose molecule and one fructose molecule), therefore the health claim may encourage consumption of sugars. It is generally accepted scientific advice that consumers’ intake of sugars should be reduced.

Timeline

Date of effect: 21 August 2024.

Background

The European Food Safety Authority (EFSA) delivered an opinion on a health claim targeted at the general population submitted by BENEO GmbH, proposing that “Consumption of foods/drinks containing isomaltulose (Palatinose^TM) replacing other sugars contributes to normal energy-yielding metabolism yet via a slower hydrolysis”. The scope of the scientific evaluation was restricted to the contribution of isomaltulose as a source of glucose to normal energy-yielding metabolism, with the agreement of the applicant. EFSA (2021) established a cause-and-effect relationship between the consumption of isomaltulose and its contribution to normal energy-yielding metabolism. However, since the contribution to energy-yielding metabolism is not specific to isomaltulose, EFSA could not set conditions of use for this claim. That conclusion is in line with Regulation (EU) 2015/83 concerning glucose.

According to Regulation 1924/2006, health claims must be truthful, clear, reliable, and useful to the consumer in choosing a healthy diet. A health claim can only be made if the average consumer can be expected to understand the beneficial effects as expressed in the claim. The Regulation states that health claims made on foods are prohibited unless they are authorised by the Commission and included in a list of permitted claims.

Resources

Sources

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Regulation

Commission Regulation (EU) 2024/2105 refusing to authorise a health claim made on foods

What is changing and why?

The EU has rejected a health claim for isomaltulose as a source of glucose, because the claim is conflicting and confusing to consumers. The health claim may have encouraged consumption of sugars, although it is generally accepted that consumers’ intake of sugars should be reduced.

Timeline

Date of effect: 21 August 2024.

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