Criteria for the molecular characterisation of GMOs for medical and veterinary applications

In recent years in the Netherlands clinical and veterinary studies involving genetically modified organisms (GMOs) have been regularly carried out. This ‘deliberate release into the environment’ of GMOs can pose risks to humans and the environment. To assess the possible environmental risks, these GMOs must be characterised in sufficient detail. In this advisory report COGEM explains how and in what detail the genome of a GMO for a medical or veterinary application should be described in order to carry out the risk assessment.

COGEM differentiates between three different aspects of genetic characterisation. The first is the characterisation of the parental organism. The characteristics of the parental organism form the basis for the environmental risk assessment, an important requirement for which is the confirmation of the identity of the organism. The second aspect is the molecular characterisation of the intended modification. To correctly determine how the modification will influence the environmental risks it is necessary to know that the actual modification made in the GMO is the same as the intended modification. The third aspect of the molecular characterisation is the possible presence of unintended modifications. Unintended modifications to the genome of a GMO may be made during its production as a result of natural processes. These modifications may affect the fitness of the GMO and therefore the outcome of the environmental risk assessment.

To obtain a better understanding of the aspects mentioned above, COGEM is in favour of a sequence analysis of the whole genome of the GMO. However, the Commission notes that the nucleotide sequence does not necessarily have to be submitted with the application for consent. In principle, it is only necessary to provide the results of the comparison between the expected and actual order of sequences and the impact of any possible deviations. The advice also suggests other methods which can be used to investigate these aspects.

If the above-mentioned requirements are met, COGEM is of the opinion that the genetic characterisation of GMOs will be sufficient to support a sound assessment of the environmental risks.