Advisory Committee on Novel Foods and Processes
Placing on the market of transgenic radicchio rosso and green hearted chicory
Mr A Klepsch
European Commission
DG III
Rue de la Loi 200
B-1049 Brussels
Belgium
23 December 1998
Dear Mr Klepsch
Placing on the market of transgenic radicchio rosso and green hearted chicory
The Competent Food Assessment Body for the UK Competent Authority, the
Advisory Committee on Novel Foods and Processes (ACNFP), has considered the initial report
from the Dutch Competent Authority for the placing on the market of transgenic Radicchio
rosso and green hearted chicory. The UK Competent Authority wishes to raise the following
objections to the marketing of this product:
i) the Dutch Competent Authority’s report does not address the
labelling of these products and foods containing them; and
ii) there is some ambiguity in the application. The UK Competent
Authority wishes to make it clear that approval for environmental cultivation cannot be
obtained under the Novel Foods Regulation 258/97. Before the chicory can be grown in the
EU for food use, approval for environmental cultivation should be pursued under the EC
Directive on the deliberate release into the environment of genetically modified organisms
90/220/EEC.
iii) the Company’s summary document and the Dutch Competent
Authority’s opinion provided insufficient information for the ACNFP to reach a
conclusion on the safety of the products so additional information was requested from the
Company. The ACNFP considers that this additional information does not adequately address
its concerns about harmful, unintended secondary effects from the genetic modification on
phenotype and composition. These issues need to be resolved before the UK Competent
Authority can agree to the marketing of these products.
The ACNFP’s specific concerns are:
a) A marker gene encoding resistance to streptomycin and spectinomycin
was included during formation of the construct. The molecular data supplied does not
conclusively demonstrate that only the desired DNA was transferred into the GM plants and
that this marker is absent. The Committee considers that the PCR analysis used by the
Company is inappropriate in this case and that Southern blot analysis using the entire
marker gene as a probe should be carried out.
b) Further data on composition and phenotype is needed. It is the
Company’s responsibility to establish that the range of compositional variation in a
population derived from GM technology is equivalent to that for non-GM populations. These
species produce bitter compounds which may have a biological effect. There are reports of
possible harmful consequences following contact with or consumption of chicory and there
is a suggestion that sesquiterpene lactone is the cause. There are well-established
methods with which to measure sesquiterpene lactones and such data would reveal unintended
effects on a relevant facet of secondary metabolism. Data on amino-acids and biogenic
amines would also provide reassurance that metabolic disturbance had not taken place as an
unintended consequence of DNA integration and foreign gene expression.
I look forward to your early response to our objections.
Yours sincerely
Mr N Tomlinson
Additives and Novel Foods, Branch 'C'
MAFF
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