Toxicological changes:
(a) the presence or increased content of natural toxicants;
(b) the presence of new expressed toxic materials resulting from genetic modifications (e.g., biopesticides);
(c) development of allergenicity
(d) accumulation of toxicants or-microbial contaminants derivedfrom the environment;
(e) changes in the availability of toxins as a result of processing.
Nutritional changes include:
(a) modification of major nutrients micronutrients or antinutrients in the food;
(b) changes in the bioavailability of macro- and/or micronutrients;
(c) changes in nutritional components as a result of processing.
The components of the safety assessment include:
(a) characterization of the host, donor/vector and modified organisms;
(b) characterization of the precision of the process and possibility of pleiotropic or secondary effects;
(c) characterization of novel expressed material ;
(d) characterization of the modified food for wholesomeness.
Taken from: Strategies for assessing the safety of foods produced by biotechnology . WHO,Geneva 1991
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