Functional Drinks - Part III: Regulation and the EFSA Evaluation Process
As stated previously, there is no more challenging issue for producers of functional drinks than the debate around how health claims should be substantiated and communicated through labelling and marketing. This is underlined by the extensive health claims evaluation process conducted by the European Food Safety Authority (EFSA) which was concluded in July.
This process effectively served as the most thorough examination of the health claims made on behalf of functional foods and drinks by a regulatory body to date, and by any objective judgment the performance could only be described as poor.
That process and where it leaves the functional drinks category are examined in the third section of this briefing.
EU policy on functional foods and drinks claims
It is important to note that the EFSA assessment process forms part of a wider EU policy on functional foods and drinks dating back to 2006/2007, specifically Regulation (EC) No 1924/2006 on nutrition and health claims made on food.
Under the regulation, all health claims for food and drinks must be based on good scientific evidence and be reviewed and approved by EFSA.
The evaluations of ‘general function’ health claims for food and drinks products completed in July relate to claims defined under Article 13.1 of the Regulation covering the role of a nutrient/substance in growth, development and the functions of the body; psychological and behavioural functions; slimming and weight control or reduction of hunger, increase of satiety or the reduction of available energy from the diet.
The evaluation work was carried out by EFSA’s Panel on Dietetic Products, Nutrition and Allergies (NDA Panel). The publication of the final 35 evaluations marked the completion of over three years’ work. Since 2008, the Panel has assessed 2,758 food-related general function health claims to determine whether they were “supported by sound scientific evidence, thereby assisting the European Commission and Member States in establishing a list of claims authorised for food”.
While Professor Albert Flynn, chair of the NDA Panel, said its evaluation had concluded that “a considerable number of claims” are backed by sound science, the fact that EFSA made favourable adjudications on only around one in five of the claims assessed confirmed for many that the underlying scepticism around functional foods and drinks was justified.
The winners and losers
EFSA said the favourable assessments mainly related to the following areas:
- vitamins and minerals
- specific dietary fibres related to blood glucose control, blood cholesterol, or weight management
- live yoghurt cultures and lactose digestion
- antioxidant effects of polyphenols in olive oil
- walnuts and improved function of blood vessels
- meal replacement and weight control
- fatty acids and function of the heart
- the role of a range of sugar replacers (such as xylitol and sorbitol) in maintaining tooth mineralisation or lowering the increase of blood glucose levels after meals
- carbohydrate-electrolyte drinks/creatine and sports performance, a particularly important and positive outcome for sports drinks manufacturers.
Unfavourable opinions were issued where “a relationship between the food and the claimed effect” could not be established. EFSA summarised the reasons for negative assessments as follows:-
- lack of information to identify the substance on which the claim was based. Here, EFSA mentioned claims on probiotics and dietary fibre in particular
- lack of evidence that the claimed effect was beneficial to the maintenance or improvement of the functions of the body, for example in relation to antioxidant properties on renal water elimination
- lack of precision regarding the health claim being made, such as claims referring to terms such as “energy” and “vitality”
- lack of human studies with reliable measures of the claimed health benefit
- claims referring to food categories which were considered to be too broad, such as “fruits and vegetables” and “dairy products”, to be linked to specific effects.
Continuing evaluation and guidance for companies
EFSA is in the process of evaluating a limited number of general function health claims which were withdrawn and re-submitted during the evaluation process. EFSA says it expects to receive the claims for reassessment from the European Commission before the end of November 2011 and the precise timetable for the further assessment will be drawn up once the re-submission process has been completed. Having concluded this substantial package of general function health claims, EFSA’s NDA Panel will continue to assess general function health claims on an ongoing basis, along with health claims related to children’s development or health, and specific disease reduction.
Some manufacturers have criticised the European Commission and EFSA for not giving sufficiently precise guidance on how to submit claims and what information to provide. Given that this was a new directive, some misinterpretation or lack of clarity at the outset was probably not surprising. EFSA says that over the three years it has made great efforts to give food and manufacturers all the information they require.
To this end, at a stakeholder meeting last year, EFSA finalised a guidance document for health claims related to gut and immune function. It also launched online consultations on guidance for health claims related to the following areas: bone, joint and oral health; oxidative damage and cardiovascular health; and satiety, weight management and blood glucose concentrations. It also plans to create a helpdesk to assist applicants.
The reason for such a large number of claims being evaluated by EFSA in a series of six tranches over the past three years is due to the number of products already in the marketplace in 2007 when the new EU regulation came into force. On a continuing basis, any new functional foods and products will be subject under EU law to the same scrutiny as and when they are introduced.
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