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EFSA publishes second series of opinions on ‘general function’ health claims

EFSA has published a second series of opinions on a list of ‘general function’ health claims compiled by Member States and the European Commission[1]. 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, e.g. “probiotics”;
  • lack of evidence that the claimed effect is indeed beneficial to the maintenance or improvement of the functions of the body (e.g. food with “antioxidant properties”);
  • lack of human studies with reliable measures of the claimed health benefit [2].

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. This 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. In carrying out its work, EFSA combines similar claims (e.g. by substance and/or the benefit) in order to form coherent opinions.

EFSA engages regularly with stakeholders and is aware of the importance of clarifying the process followed by the NDA Panel in the evaluation of claims. A briefing document describes how EFSA has followed consistent procedures for evaluation of Article 13.1 health claims, including the use of uniform scientific criteria for substantiation of claims and for the characterisation of foods. The document (updated on 17th November 2009) is available on EFSA’s website.

EFSA expects to complete this work by 2011 depending on the final number of claims received. EFSA 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.

[1] General function’ claims defined under Article 13.1 of the Regulation 1924/2006 on nutrition and health claims made on food include: 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. These claims do not include those related to child development or health or disease risk reduction.

[2] The NDA Panel has no pre-established formula in relations to the number or type of studies required for substantiation of a claim; it takes all pertinent scientific data into consideration. In common with the standards used by Codex Alimentarius and the US Food and Drug Administration, human studies are central to substantiation and there is a hierarchy of evidence: randomised controlled trials followed by observational studies while animal studies or in vitro research may also be taken into account.

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