Rejection of a health claim for isomaltulose

Draft Commission Regulation 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

Annex

Update

The European Commission has informed the World Trade Organization Technical Barriers to Trade (WTO TBT) Committee (G/TBT/N/EU/1025) that it will reject a health claim on 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?

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

Timeline

Expected date of adoption: 2nd quarter 2024.

Expected date of entry into force: approximately 1 month after adoption.

Recommended Actions

Competent authorities of countries that are members of the WTO can submit comments or concerns about potential impacts of this proposal via the National TBT notification authority of the country concerned to the EU TBT Enquiry Point before 26 December 2023.

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. In its scientific opinion of September 2021, EFSA established, on the basis of the data presented, 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 also in line with Commission 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

Draft Commission Regulation 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

What is changing and why?

The EU proposes to reject a health claim on isomaltulose as a source of glucose because the claim is conflicting and confusing to consumers. The health claim is rejected as it may encourage consumption of sugars, while consumers should reduce sugar intake.

Actions

Competent authorities of countries that are members of the WTO can submit comments or concerns about potential impacts of this proposal via the National TBT notification authority of the country concerned to the EU TBT Enquiry Point until 26 December 2023.

Timeline

Expected date of adoption: 2nd quarter 2024.

Expected date of entry into force: approximately 1 month after adoption.

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