EFSA acts on neutraceutical dietary health claims

The European Food Safety Authority (EFSA) has published a second series of opinions on a list of 'general function' health claims compiled by member states and the European Commission.

Scientific experts on EFSA's panel on Dietetic Products, Nutrition and Allergies (NDA) assessed all available scientific data submitted to substantiate the 416 health claims. These opinions have been sent to the European Commission and to member states which will ultimately decide whether to authorise these claims or not.

The evaluations of the NDA panel were positive when there was sufficient scientific evidence available to support the claim, such as those related to vitamins and minerals. Experts issued unfavourable opinions on most of the claims in the second series due to the poor quality of the information provided to EFSA, including:

- Lack of information to identify the substance on which the claim is based, for example 'probiotics'.

- Lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body, such as food with 'antioxidant properties'.

- Lack of human studies with reliable measures of the claimed health benefit.

This is the second series of opinions on general function health claims and the panel is continuing its work on the remaining claims on the list. A phased approach has been adopted due to the very large number of claims received for evaluation and the requirement for EFSA to publish opinions soon after adoption in order to ensure transparency.

EFSA expects to complete this work by 2011 depending on the final number of claims received. EFSA says it is liaising with the European Commission to set out a more precise timetable for completing the work, taking into account any additional claims to be evaluated.

Meanwhile, following a request from the European Commission, the NDA panel was asked to provide a scientific opinion on a list of health claims pursuant to Article 13 of Regulation (EC) No 1924/2006. This opinion addresses the scientific substantiation of health claims in relation to carbohydrates that induce low/reduced glycaemic responses and carbohydrates with a low glycaemic index. The scientific substantiation is based on the information provided by the member states in the consolidated list of Article 13 health claims and references that EFSA has received from member states or directly from stakeholders.

The food constituents that are the subject of the health claim are carbohydrates that induce a low/reduced glycaemic response and carbohydrates with a low glycaemic index (for example <55). The panel considers that carbohydrates that induce a low/reduced glycaemic response and carbohydrates with a low glycaemic index (for example <55) are not sufficiently characterised.

On the basis of the data presented, the panel concluded that a cause and effect relationship has not been established between the consumption of carbohydrates that induce a low/reduced glycaemic response or carbohydrates with a low glycaemic index and the claimed effects.

EFSA's first series of opinions were published late last year after the NDA evaluated the scientific evidence for more than 500 claims.

Those opinions provide scientific advice on 523 health claims relating to over 200 foods and food components such as vitamins and minerals, fibre, fats, carbohydrates, 'probiotic' bacteria, and botanical substances.

For approximately one third of the claims the outcomes of the evaluations were favourable as there was sufficient scientific evidence to support the claims. These related mainly to functions of vitamins and minerals, and also included dietary fibres, and fatty acids for maintenance of cholesterol levels, and sugar-free chewing gum for maintenance of dental health.

Almost half of the evaluations with unfavourable outcomes were owing to a lack of information on the substance on which the claim is based, for example 'probiotic' bacteria and botanical substances.

Without clear identification of the substance in question, the panel could not verify that the scientific evidence provided to EFSA related to the same substance for which the health benefits were claimed.

Commenting on these results, professor Albert Flynn, chair of EFSA's NDA panel stated: "EFSA's independent scientific advice will help ensure that the health claims made on foods are accurate and helpful to consumers in making healthy diet choices. The scientific opinions will inform future decisions of the Commission and member states concerning the authorisation of health claims."

Meanwhile, the Global Organisation for EPA and DHA Omega-3s (GOED) and a consortium of eight leading scientific, trade, and consumer advocacy organisations have petitioned the US Institute of Medicine (IOM) to convene an expert panel to establish clear dietary reference intakes (DRIs) for the EPA and DHA omega-3 fatty acids.

GOEC says industry support is urgently needed both to provide comments of support for the initiative and to encourage legislators to fund the IOM review. As part of this, the organisation has launched a website to provide a convenient method of submitting comments and reaching legislators at www.omega3petition.org.

GOED, whose members include Alpha Laval, Unilever, Monsanto, BASF Plant Sciences, Lonza, DSM and Cognis, believes newly established DRIs would have a profound effect on both the industry and consumers. "Omega-3s are one of the fastest growing and largest segments of the food and supplement business, which is why this issue impacts every company within this sector," said Adam Ismail, executive director.

"In the past decade or so, research on omega-3 fatty acids, EPA and DHA in particular, has evolved to suggest we may be facing a serious public health problem. Most Americans appear to be falling short in their consumption of EPA and DHA, which studies show are important for cardiovascular health and brain development," added Andrew Shao, vice president, Scientific and Regulatory Affairs, Council for Responsible Nutrition, and a co-signer of the petition.

A study in PLoS Medicine has already identified EPA and DHA inadequacy as the sixth leading cause of preventable death in the US. Andrew Shao states: "Taking a simple EPA and DHA-containing product could help fill the nutrition gaps, but until DRIs are established both policy makers and consumers have no way of knowing what the target intakes should be and by how much they're falling short. By not acting on this important initiative, we place the health of Americans and Canadians at risk"

The petition comes at an important time, as leaders on Capitol Hill are looking at healthcare reform, prevention needs to be a primary focus in these discussions.

An investment of approximately US$1.0-1.5 million is needed from the US and Canadian governments to fund the IOM review.

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