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.
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:
- the Dutch Competent Authority's report does not address the labelling of these products and foods containing them; and
- 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.
- 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 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.
- 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'