Shifting health claim criteria may provoke legal challenge

By Shane Starling

- Last updated on GMT

Related tags European union Ec

A pan-European industry group has criticised the European
Commission for issuing guidance that it will reject scientific
health claim dossiers that do not contain clinical data.

The Alliance for Natural Health (ANH) says the EC has "moved the goalposts"​ in regard to article 13 health claims of the Health and Nutrition Claims regulation and called for a revision of the guidelines. The ANH has submitted a 16-page document outlining its concerns to the UK Food Standards Agency (FSA), after it joined other groups such as the UK Health Food Manufacturers Association (HFMA) at an FSA-chaired meeting on March 27. Untenable ​It says the EC's position on dossier science will lead to the rejection of thousands of claims backed by, as the US Food and Drug Administration (FDA) calls it, "significant scientific agreement".​ Product innovation would also be curtailed if labelling terms like 'antioxidant' and 'superfoods' were lost in the absence of clinical backing as human-trial data was only emerging in these areas. Herbal products were another category that may suffer for this reason. ANH Executive director Robert Verkeek, told the EC's imposition of new criteria after the passing of the deadline for submissions was untenable and could lead to a legal challenge. "We have had legal advice that says the legal platform for the Health and Nutrition Claims regulation is unbelievably shaky and this latest development only amplifies that position,"​ he said. "The aim of the regulation is to ensure consumers have high quality information and choice. The regulation is not meeting its objectives and that may become significant in any legal challenge."​ He estimated as many as 40 per cent of the thousands of the claims the EC is in the process of sifting through before it hands them to the European Food Safety Authority (EFSA) for scientific assessment, may fail to meet human trial demands. Transparency ​He suggested the new criteria was a pragmatic measure designed to cope with a list of submissions that was far greater than expectation,and which may have been a result of the fact initial guidance was "very limited and non-transparent.""Now the applications are in, suddenly the Commission seems to have found a way of culling huge numbers of claims,"​ Verkeek said. "Moving the goalposts is not acceptable if it's being done primarily as a means of making the European institutions' job more manageable." ​In its latest submission, sent April 7, the ANH asked FSA to establish the legal basis by which the EC has been able to reject health claims applications based on evidence from representative animal and in vitro​ models. "Importantly, it may not be ethically acceptable to carry out certain types of study on humans and, ironically, animal studies have, historically, been pivotal to the elucidation of health relationships associated with licensed drugs,"​ ANH said. ANH criticised the EC working group which developed the latest guidelines as it represented only eight of the European Union's 27 Member States. The FSA is collating the input it received from ANH and other groups with a view to making a submission to the EC in the near future. Article 13 claims will be compiled into a central list by the EC after receiving advice from EFSA by January 2010. Claims under consideration are those that:

  • Describe or refer to the role of a nutrient or other substance in growth, development and the functions of the body

  • Relate to psychological and behavioural functions

  • Relate to slimming, weight control, a reduction in the sense of hunger, an increase in the sense of satiety and the reduction of the available energy from the diet

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