General Release

Note! The information needed for a regulatory application must be considered on a case by case basis. Depending on the crop and trait, certain types of information will not be relevant. See OECD documents for specific guidelines for many crops and genes.

• Description of the host plant
• Agronomic and phenotypic characteristics of the plant
• Possibility of gene flow between the transgenic plants and sexually compatible relatives
• Information on the characteristics of the novel product (transgene)
• Potential changes in levels of weediness or invasiveness of the GM crops or their wild relatives
• Potential non-target effects of the transgene product
• Compositional characteristics of the plant products
• Pathogenic, toxicity and anti-nutrient effect of any new products
• Allergenicity of new products

• Common name, scientific name and taxonomic classification.
• How the plant is typically cultivated, transported and stored.
• Breeding characteristics (ie. selfed vs. outcrossing)
• Sexually compatible relatives in proximity of cultivation
• Likelihood of successful hybridization with compatible relatives
• Weediness or invasiveness of host and compatible relatives
• Any known toxicity or allergenicity
• Special processing required to make the plant safe to eat
• Part of the plant used as a food source

For many crops, this information on the host plant is included in OECD consensus documents or biology documents, which are accepted by reference or hard-copy inclusion in a regulatory dossier.

For further information on pollen flow and hybridization click here.

• The method used for the modification.
• Information on the DNA used to modify the plant including the source (e.g., plant, microbial, viral, synthetic), identity and expected function in the plant.
• Details of all genetic components of the vector used to produce or process DNA for transformation of the host organism.
• Information on all the genetic components including marker genes, regulatory and other elements affecting the function of the DNA.
• Location and orientation of the sequence in the final vector/construct and function.

For more details on how GE crops are produced click here.

• Number of insertion sites.
• Organization of the inserted genetic material at each insertion site.
• Sequence data of the inserted material and ,in some countries, the flanking regions bordering the site of insertion, sufficient to identify substance (s) expressed as a consequence of the insertion. Determination of whether new reading frames are created as a result of the insertion or genes are interrupted. New open reading frames should be assessed for their potential to be expressed (i.e. promoter and terminator regions) and for their potential allergenicity or toxicity by bioinformatics.
• Identification of any new open reading frames within the inserted DNA and flanking regions.
• Gene product and its function
• Level and site of expression of the expressed gene product in the plant
• Amount of the target gene product , or in the case of a non-protein end-product (e.g. product of enzymatic activity of the target genes), the ultimate compound produced.
• Information on deliberate modifications made to the amino acid sequence of the expressed protein
• Evidence that the expressed trait is stable through several generations consistent with laws of inheritance.
• Demonstration that the newly expressed trait(s) are present in the appropriate tissues

For more details on how GE crops are produced click here.

• Ash, moisture content, crude protein, crude fat, and various carbohydrates.
• Protein amino acid profile.
• Quantitative and qualitative composition of total lipids, i.e., saponifiable and nonsaponifiable components, complete fatty acid profile, phospholipids, sterols, cyclic fatty acids and known toxic fatty acids.
• Composition of the carbohydrate fraction e.g., sugars, starches, chitin, tannins, nonstarch polysaccharides and lignin.
• Qualitative and quantitative composition of micronutrients, i.e., significant vitamin and mineral analysis.
• Presence of naturally occurring or adventitious anti-nutritional factors e.g., phytates, trypsin inhibitors, etc.

The compositional data needed in a regulatory dossier should be determined on a case by case basis. They depend upon what the OECD consensus documents may indicate as important, and for what substances for which the crop is considered an important source.

For more details on how the food safety of GE crops is determined, click here.

• Indicate if the donor organism(s) is a known source of toxins.
• Determine amino acid sequence homology comparison of the newly expressed protein and known protein toxins and anti-nutrients.
• Demonstrate the susceptibility of each newly expressed protein to simulated gastric fluid, and in some cases, simulated intestinal fluid.
• Where a host other than the transgenic plant is used to produce sufficient quantities of the newly expressed protein for toxicological analyses, demonstrate the structural, functional and biochemical equivalence of the non-plant expressed protein with the plant expressed protein.
• Oral toxicity study(s) completed for newly expressed proteins. A 14-day oral gavage study is usually required. Some jurisdictions ask for longer studies.

For more details on how the food safety of GE crops is determined, click here.

• Indicate if the donor organism(s) is a known source of allergens.
• Amino acid sequence homology comparison of the newly expressed protein and known allergens.
• Demonstrate the susceptibility of each newly expressed protein to SGF and sometimes SIF digestion.
• Where a host other than the transgenic plant is used to produce sufficient quantities of the newly expressed protein for toxicological analyses, demonstrate the structural, functional and biochemical equivalence of the non-plant expressed protein with the plant expressed protein.
• For those proteins that originate from a source known to be allergenic, or have sequence homology with a known allergen, additional immunological assays be warranted.

For more details on how the food safety of GE crops is determined, click here.

• The organisms most likely to be harmed by the transgene product.
• The level of toxicity in those organisms
• The likelihood of exposure of these organisms to toxic levels of the transgene product in widespread planting of the GM crop

Note! This information is only required for GM crops with transgenes that express pesticidal proteins.