Guidelines on the assessment of novel foods and processes / Advisory Committee on Novel Foods and Processes.

  • Great Britain. Advisory Committee on Novel Foods and Processes.
Date:
1991
Catalogue details

Licence: Open Government Licence

Credit: Guidelines on the assessment of novel foods and processes / Advisory Committee on Novel Foods and Processes. Source: Wellcome Collection.

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    X. Assessment of a genetic modification procedure 5.34 In situations in which an organism has been altered using genetic modification techniques, the safety assessment of the organism itself, or that of any product derived from such an organism, will centre on the nature of the genetic modification. Any such submission should include detailed information on the following aspects: —identification and characterisation of the host organism, including the strain and the site of the modification; —the nature of the modification, the source of the inserted material and its purity, including the genetic and metabolic relationship between the host organism and the new material, and the stability of the insert within the genome; —the method of insertion, including details of the vector used, the identity of any linker segments or additional stop codons and the amount of vector nucleic acid remaining in the modified organism; —the relationship of the insert with various controlling elements in the genome; —the method of selection of the modified organisms with the appropriate transplanted gene(s), including confirmation of the sequence of the cloned gene and details of any resistance markers used. If the markers code for resistance to drugs in clinical use then evidence that they have been jettisoned or suitably inactivated will normally be necessary; —if the modification is a deletion, how this was achieved together with checks on the specificity of the deletion, as well as any potential effects this might have on upstream or downstream controlling sequences. Xl. Effect of a genetic modification procedure on the known properties of the parent organism 5.35 As well as information on the genetic modification procedure itself, a submission should also include information on any effects of that procedure on the known properties of the host organism. This will include any effects on the toxin-producing capacity of the organism under both normal and extreme conditions, as well as any effects on positive nutritional factors such as vitamin levels. For example, with a genetically modified strain of potato it would be important to determine levels of solanine, as well as levels of vitamin C, both in the potato as harvested and consumed and after extremes of storage; comparison with the non-modified strain may be helpful. Xll. Genetic stability of a modified organism 5.36 It is important to determine the genetic stability of the organism following modification. For micro-organisms it will be important to determine the stability of the organism on storage prior to use in any fermentation, and 18