Division 1.3.6 Effects of processing

The applicant shall assess whether or not the processing and/or preserving technologies applied are likely to modify the characteristics of genetically modified end products compared with their respective conventional counterpart. The applicant shall provide a description of the different processing technologies in sufficient detail, paying special attention to the steps which may lead to significant changes in the product content, quality or purity.

Genetic modification can target metabolic pathways resulting in changes in the concentration of non-protein substances or in new metabolites (such as in nutritionally enhanced foods). Processed products may be assessed together with the assessment of the genetically modified plant for the safety of the genetic modification, or a processed product may be assessed separately. The applicant shall provide the scientific rationale for the risk assessment of these products. On a case-by-case basis, the submission of additional experimental data shall be considered by the applicant.

When appropriate, depending on the product, information shall be necessary on the composition, level of undesirable substances, nutritional value and metabolism, as well as on the intended use.

When appropriate, depending on the nature of the newly expressed protein(s), it shall be necessary to assess the extent to which the processing steps lead to the concentration or to the elimination, denaturation and/or degradation of these protein(s) in the final product.