Advisory Committee on Novel Foods and Processes
Evaluation of Stevia rebaudiana Bertoni as a novel food
Dr F Campoli
DGIII/E/i
Rue de la Loi
B-1049 Brussels
Belgium
19 October 1998
Dear Mr Campoli
Evaluation of Stevia rebaudiana Bertoni as a novel food
The UK Competent Authority has examined the opinion from the Belgian CA on this application and agrees with the conclusion they reached, that the data provided are inadequate to support approval of this material as a novel food. We share their
concerns regarding this application and note particularly the lack of information on:-
i) the estimates of likely
intake of the material;
ii) the specification for the
material, which is inadequate, particularly in terms of the level of stevioside. We would
normally expect to see the results of analyses of at least three batches of material to
demonstrate that the material to be sold is of a consistent composition;
iii) the extent to which the
active component stevioside is metabolised by human gut bacteria and the possible
toxicological consequences of such metabolism.
We also note that the active component stevioside has been evaluated previously by both
the EC Scientific Committee for Food and also by the Joint FAO/WHO Expert Committee on
Food Additives (earlier this year) and that both have concluded that the toxicological
data available were inadequate.
After our expert advisory committee had examined the opinion of the Belgian CA, we
received the additional information contained in a revised application from Prof Dr J M C
Geuns, that was circulated with the papers for the Standing Committee meeting on 28/29
October. We assume that submission of these additional data will now result in all the
information being referred to the Scientific Committee for Food, as laid down in the
provisisons of the Novel Food Regulation. However we would make the following points about
the additional information provided:
i) the specification and
analytical data are still not adequate to provide reassurance that this is a consistent
product;
ii) many of the studies quoted
on page 12 of the revised document are conducted on "Stevia extract" but
the composition of this extract is not described;
iii) the subacute and chronic
toxicity studies are conducted on stevioside rather than the dried plant material and
there is still a lack of evidence on the extent to which stevioside present in the dried
plant material might be metabolised by human gut flora and the toxicological consequences
of this in terms of the formation of steviol.
We welcome the opportunity to discuss this application at the Standing Committee for Foodstuffs meeting on 29 October.
Yours sincerely
Mrs S J Hattersley
UK Competant Authority (EU Regulation 258/97)
Copied to:
Dr A Klepsch
Mr N Tomlinson
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