Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p49
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 132180–135271

biochemical function and phenotypic effects of all new substances (e.g. a protein or an untranslated RNA) that are expressed in the new GM organism, including their levels and site of accumulation, particularly in edible portions
    (b) information about prior history of human consumption of the new substances, if any, or their similarity to substances previously consumed in food.
    (c) information on whether any new protein has undergone any unexpected post-translational modification in the new host
    (d) where any ORFs have been identified (in subparagraph A.3(c)(v) of this Guideline (3.5.1)), bioinformatics analyses to indicate the potential for allergenicity and toxicity of the ORFs.

     B.2 New proteins

If it can be shown the new protein(s) is identical to one previously assessed by FSANZ, the only other safety information that must be provided is an updated bioinformatics comparison of the amino acid sequence to known protein toxins, anti-nutrients and allergens.

Where the new protein is not identical to one previously assessed by FSANZ, the following must be provided:

(a) information on the potential toxicity of any new proteins, including:

       (i) a bioinformatic comparison of the amino acid sequence of each of the new proteins to known protein toxins and anti-nutrients (e.g. protease inhibitors, lectins)
       (ii) information on the stability of the protein to proteolysis in appropriate gastrointestinal model systems
       (iii) an animal toxicity study if the bioinformatic comparison and biochemical studies indicate either a relationship with known protein toxins/anti-nutrients or resistance to proteolysis.

    (b) information on the potential allergenicity of any new proteins, including:

       (i) source of the new protein
       (ii) a bioinformatics comparison of the amino acid sequence of the novel protein to known allergens
       (iii) the new protein's structural properties, including, but not limited to, its susceptibility to enzymatic degradation (e.g. proteolysis), heat and/or acid stability
       (iv) specific serum screening where a new protein is derived from a source known to be allergenic or has sequence homology with a known allergen
       (v) information on whether the new protein(s) have a role in the elicitation of gluten-sensitive enteropathy, in cases where the introduced genetic material is obtained from wheat, rye, barley, oats, or related cereal grains.

Where the new protein has been produced from an alternative source (e.g. microbial expression system) in order to obtain sufficient quantities for analysis, information must be provided to demonstrate that the protein tested is biochemically, structurally and functionally equivalent to that expressed in the food produced using gene technology.

Information on the potential toxicity and potential allergenicity of a newly expressed protein is also not required if:

    (a) the protein is expressed from a transferred gene that is derived from the same species as the host or a species that is cross-compatible with the host, provided