Chapters describe Agrobacterium co-cultivation, including one leading to germ line transformation with no need for tissue culture-based generation; the manipulation of gene expression and characterizations of the recombinant locus and transgenic plants; and issues of genetic modification risk assessment, field trials, and substantial equivalence in terms of transcriptomics, proteomics, and metabolomics.
The type of information necessary is dependent upon whether the food product requires a full application or qualifies for a substantial equivalence application.
It has been stated that there is a substantial equivalence between the genetically modified product (GMO) and that obtained by selecting genetic characteristics (that is by means of naturally crossbreeding plants as has been done by man over the course of thousands of years).
In a similar vein, Part 2 details the behind-the-scenes lobbying around the issues of genetically modified foods, in particular the issue of substantial equivalence and the need for premarket testing and labelling.
The test for substantial equivalence will then be, first, whether the state has demonstrated its respect for or acceptance of the main general goals of the Convention, and enacted laws or regulations which are conducive to their realization; and, if so, whether the effect of such laws or regulations is to ensure that in all material respects the subordinate goals of the Convention are achieved,a9 In practice, this means that, in the absence of ratification of a Convention listed in the Appendix by a member, national laws, and regulations adopted with regard to the appended Convention can be different in detail.
Chapter Titles: Introduction; Legislation and Recommendations on Novel Foods and Novel Foods Ingredients, Information, Genetically Modified Organisms, Hygiene, Environmental Control; Determination of Substantial Equivalence - Concept, Different Grades, Information; Information and Methods for making Safety Assessments of Novel Foods; Information needed in Safety Assessments of Novel Foods; Some organisations offering Safety Assessments of Foods in Europe.
