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Division 1.3 Comparative analysis

United Kingdom

Original text. Later amendments are not shown.

The comparative analysis of composition and agronomic as well as phenotypic characteristics shall constitute, together with the molecular characterisation, the starting point to structure and conduct the risk assessment of a new genetically modified food and feed.

It shall aim at identifying similarities and differences:

  1. (a)

    in composition, agronomic performance and phenotypic characteristics (intended and unintended alterations) between the genetically modified plant and its conventional counterpart;

  2. (b)

    in composition between the genetically modified food and feed and its conventional counterpart.

Where no appropriate conventional counterpart can be identified, a comparative safety assessment cannot be made and consequently a safety and nutritional assessment of the genetically modified food or feed shall be carried out as for novel foods falling within the scope of Regulation (EC) No 258/97 of the European Parliament and of the Councilf1 that do not have conventional counterparts (such as where the genetically modified food or feed is not closely related to a food or feed with a history of safe use or where a specific trait or specific traits are introduced with the intention of bringing complex changes in the composition of the genetically modified food or feed).

  1. 1.3.1Choice of the conventional counterpart and additional comparators
  2. 1.3.2Experimental design and statistical analysis of data from field trials for comparative analysis
  3. 1.3.3Selection of material and compounds for analysis
  4. 1.3.4Comparative analysis of composition
  5. 1.3.5Comparative analysis of agronomic and phenotypic characteristics
  6. 1.3.6Effects of processing
  7. 1.3.7Conclusion

Annotations

Footnotes

f1

OJ L 43, 14.2.1997, p. 1.