Division 1.6.4 Nutritional studies of genetically modified feed

The applicant shall determine the necessity and design of further nutritional studies on the basis of the introduced trait(s), the outcome of the comparative analysis, and the 90-day feeding study, where available. Supplementary information regarding the nutritional value may be obtained from comparative growth performance studies conducted with other animal species, such as broiler chickens, addressing the nutritional assessment of genetically modified feed. When nutritional studies are conducted, the control diet(s) shall include the conventional counterpart and where appropriate additional comparator(s).

In the case of genetically modified feed with improved nutritional characteristics, feeding studies with target animal of food producing species shall be conducted to assess the impact on the feed. In the case of genetically modified plants modified for improved content and bioavailability of nutrients, studies with target food producing animal species shall be conducted to determine the bioavailability of individual nutrients in the genetically modified plant compared to its conventional counterpart. In the case of genetically modified plants specifically modified with traits to enhance animal performance through increased nutrient density (such as increased oil content) or an enhanced level of a specific nutrient (such as an essential amino acid or a vitamin), an appropriate control diet using its conventional counterpart shall be formulated by supplementing it with the specific nutrient to the extent of the change effected in the genetically modified plant. Regarding co-products (such as oilseeds meals), from which the ingredient targeted by the genetic modification has been extracted, these may be compared with co-products produced from the conventional counterpart.

Target animal feeding studies shall span either the growing and/or finishing period to slaughter for chickens, pigs, and cattle for fattening or a major part of a lactation cycle for dairy cows, or laying cycle for laying hens or quails. For feedstuffs intended only for aquaculture, growth studies with aquatic species such as carp, catfish, salmonidae or typical herbivores shall be chosen.

When appropriate, tests with various experimental designs shall be provided to demonstrate that the nutritionally improved genetically modified plant fulfils the expected nutritional value. The exact experimental design and statistical approaches of feeding experiments in food producing animals to test the nutritional value of genetically modified feed, modified for enhanced nutritional characteristics, shall depend on the targeted animal species, type of plant trait(s) studied and the size of the expected effect. The experimental diets shall be formulated in such a way that the key measured endpoints are responsive to a difference in the quantity and/or availability of the nutrient in question. Endpoint measurements shall vary with the target species used in the study, but shall include feed intake, body weight, animal performance and bioavailability of nutrients.

More detailed guidance for the application of the requirements of this Section is available F1from the Food Safety Authority.