Codex to discuss health claims science
reaching rules governing nutrient compounds in foods - and
crucially discuss whether health claims should be based only on
clinical studies.
Although Codex is not a regulatory body, its decisions are used as a benchmark of discussion should trade disputes arise in the future, and while Codex does not have the same force of law as an EU directive or national legislation, it is used as a reference point for countries that are looking at revising or creating legislation. In Europe, the EU has already unveiled its own health claims regulation - which says claims about foods should be supported by science - and has caused uncertainty for the industry since coming into force in July. The Codex meeting next week will vote upon whether scientific evidence should be based solely on clinical studies. This suggestion has come under fire from trade groups who say this would be "unfeasible." Codex members will also vote on a draft revised standard for infant formula, a list of nutrients aimed at infants and young children. The group will also vote on nutrient reference values for labelling, and the production and processing standards regarding nutritional quality and safety. The European Commission has commented on four of the agenda items, in many cases suggesting new wording. Clinical studies The work for scientific basis for health claims began at the 22nd session of the Codex committee on nutrition and foods for special dietary uses. One proposed criteria, which has been drawn up by the International Life Science Institute, says that a claim should be based on human data "primarily from intervention studies." Subsequent comments from member states said that all health claims should be based on evidence provided by human intervention (clinical) studies, "irrespective of whether the health claim is applied to the whole diet, food group, food or a property of the food." Animal model studies and in vitro studies may be used as supporting knowledge but should never be considered as "sufficient per se to substantiate any type of health claim." Not feasible The International Alliance of Dietary/Food Supplement Associations (IADSA) has said that just to use intervention studies alone would not be feasible. IADSA director of regulatory affairs David Pineda said: "While we agree the text is moving in the right direction, the text still needs to be amended to allow evidence from human experimental and observational studies to form the basis of health claims." David Richardson, scientific adviser to the UK Council for Responsible Nutrition, said: "Scientific substantiation should take into account the totality of the available data and involve a weighing of evidence. "Human studies are given more weight than animal, in vitro and observational studies, but it is important for the Codex text to show that a health claim can be substantiated on case-by-case bases by a number of different evidence sources." Codex should also consider evidence from history of use, he added. The 29th Codex committee on nutrition and foods for special dietary uses will be held in Germany from Monday to Friday. Regardless of the outcome of the vote, it is likely more work will be needed on the draft recommendations before they are finalized.
