Presence of the antibiotic resistance marker gene nptII in GM plants for food and feed uses

COMMITTEE FOR MEDICINAL PRODUCTS FOR VETERINARY USE AND COMMITTEE FOR MEDICINAL PRODUCTS FOR HUMAN USE

Presence of the antibiotic resistance marker gene nptII in GM plants for food and feed uses


Background
In a letter dated 25 January 2007, Mr Robert Madelin from the Directorate General for Health and Consumer Protection of the European Commission informed the EMEA that the Commission was considering the authorisation for the placing on the market of the genetically modified potato line EH92-527-1 which contains a genetic modification that harbours an nptII gene as a selectable marker. This gene codes for neomycin phosphotranserase, an enzyme that generally confers resistance to several
antibiotics, the most relevant ones being kanamycin, neomycin, paromycin, butirosin, gentamicin B and geneticin. In its opinion on the application for placing on the market of the genetically modified potato EH92-527-1, the GMO Panel of the European Food Safety Authority (EFSA) concluded that the use of nptII as a selection marker does not pose a risk to the environment or to human and animal health.

As indicated in his letter, the Commission representative is seeking confirmation from EMEA as to whether, notwithstanding the WHO classification, the current or possible uses of the antibiotics for which the nptII gene confers resistance are in line with the opinion of the GMO Panel of EFSA indicating that these antibiotics have no or only minor therapeutic relevance in human medicine and only restricted use
in defined areas of veterinary medicine and, if not, whether the current or possible medicinal uses might have an impact on the conclusions of the EFSA GMO Panel.

In his response letter dated 6 February to Mr Robert Madelin, Dr Thomas Lönngren, the executive director of the EMEA commented that the scientific committeees of the EMEA would be able to comment comprehensively in relation to the issue of possible uses of these antibiotics in human and veterinary medicine. However, it was felt to be more appropriate for EFSA to possibly reconsider the conclusions of the panel in view of any new information provided by the EMEA scientific committees.

CHMP and CVMP overall conclusions
The following is based on the assumption that the substrate specificity of the product of the nptII gene used as a marker in the potato in question is restricted to neomycin and kanamycin (and geneticin), as stated in the opinion published in the EFSA journal (2004) 48:1-18., and does not extend to gentamicin.

This point is important due to different medical uses of these antibiotics.

1. Human medicines considerations
The therapeutic relevance of kanamycin and neomycin in human medicine has been addressed by the GMO panel of EFSA. The EMEA/CHMP can add the following points to that opinion. In summary these points consider a more long-term view recognising the potential development in the aminoglycoside class indicating that the role of these medicinal products might become increasingly relevant.
􀂃 As indicated in the report from the EFSA, Neomycin is indicated in important clinical conditions such as for example in hepatic encephalopathy.

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