Table 4. Essential
information for safety assessment of novel foods. (As laid down
in Commission Recommendation 97/618/EC of 29 July 1997 concerning the
scientific aspects and the presentation of information necessary to
support applications for the placing on the market of novel foods and
novel food ingredients and the preparation of initial assessment reports
under Regulation (EC) No 258/97 of the European Parliament and of the
Council). |
I. Specification of the novel foods. |
II. Effect of the production process applied to the novel foods. |
III. History of the organism used as the source of the novel foods. |
IV. Effect of the genetic modification on the properties of the host organism. |
V. Genetic stability of the GMO used as novel foods source. |
VI. Specificity of expression of novel genetic material. |
VII. Transfer of genetic material from GMO. |
VIII. Ability of the GMM to survive in and colonize the human gut. |
IX. Anticipated intake/extent of use of the novel foods. |
X. Information from previous human exposure to the novel foods or its source. |
XI. Nutritional information on the novel foods. |
XII. Microbiological information on the novel foods. |
XIII. Toxicological information on the novel foods. |
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