Australian Fruit Juice Association News
Codex will look again at health claims science
Fri 07 December 2007
By Alex McNally 05/12/2007 - Codex has agreed its draft rules on health claims needs further work following concerns over what evidence should be required for scientific substantiation.
Critics of the draft have argued that it contained too many references to basing scientific claims to substantiate a health claim on clinical trials.
The International Alliance of Dietary/Food Supplement Associations (IADSA) has said that just to use intervention studies alone would not be feasible.
If clinical trials are accepted as the only scientific evidence, industry could be left picking up the bill and forking out money to carry out expensive trials.
IADSA has insisted that the text should allow more weight than it presently gives to observational and epidemiological studies among others.
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 and drinks should be supported by science - and has caused uncertainty for the industry since coming into force in July because parts of the law have not yet been finalised.
These EU rules would be bolted-on to the Codex regulation as an annex, but any wider implications for Europe are not yet known at this stage.
IADSA director of regulatory affairs David Pineda told NutraIngredients.com the repercussions would not be felt under the Codex text was finalised.
He said: "It remains to be seen how the Codex draft recommendations could impact the regulations of all members of Codex as we are very far still from their adoption.
"There is no expected date for completion although a breakthrough would be desired to happen at next year's Committee meeting."
At the last Codex committee on nutrition and foods for special dietary uses, IADSA said basing all health claims only on human intervention (clinical) studies is not feasible or practical.
Pineda added: "We welcome the decision of the Nutrition Committee that the text should be amended.
"Scientific substantiation should involve a weighing of evidence taking into account the totality of the available data. This includes human studies, as well as observational and epidemiological studies."
Sources of scientific evidence can include generally accepted authoritative information that has been verified and validated over time; human intervention studies; human observational or epidemiological studies; animal and in vitro studies, and traditional knowledge and experience of use.
The Codex text will be reviewed and redrafted by a France-led working group, which will present its conclusions at the next Codex Nutrition Committee meeting in Autumn 2008.
The scientific data that will be accepted for a health claim for botanical problems in EU law has also caused some concern. Lobbyists have called for the traditional use of a botanical to be acceptable as evidence and are opposed to clinical trials.
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