Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p33
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 88295–91216

should include reports of any evaluation by the Joint (FAO/WHO) Expert Committee on Food Additives (JECFA) or equivalent expert group.

     B.5  Safety assessment reports prepared by international agencies or other national government agencies, if available

This includes safety assessment reports prepared by JECFA (unless provided under subsection B.4 of this Guideline (3.3.2)) or by other national or supranational agencies responsible for food safety.

     C Information related to the safety of an enzyme processing aid

The application must contain the following information:

     C.1 General information on the use of the enzyme as a food processing aid in other countries

This includes any information on the use of the enzyme as a processing aid in other countries, particularly where the information is relevant to human safety.

     C.2 Information on the potential toxicity of the enzyme processing aid

This includes the following for all enzymatic processing aids:

    (a) information on the enzyme's prior history of human consumption and its similarity to proteins with a history of safe human consumption
    (b) information on any significant similarity between the amino acid sequence of the enzyme and that of known protein toxins.

In the case of an enzyme which does not have a history of safe human consumption, or where there is significant similarity between the amino acid sequence of the enzyme and that of a known protein toxin, the following additional information must be provided:

    (c) information on the stability of the enzyme to degradation in appropriate gastric and, if applicable, intestinal model digestion systems.

In the case that the enzyme is tested for stability and found to be stable, the following data must be provided:

    (d) Acute or short term oral toxicity studies in a rodent species.

Where data are not considered relevant to the safety assessment of the enzyme, an explanatory statement must be provided.

There is no requirement to routinely conduct acute or short term oral toxicity studies or genotoxicity studies on enzyme processing aids. However, if such data already exists, it should also be provided.

     C.3 Information on the potential allergenicity of the enzyme processing aid

Note:

The information provided in this subsection will enable FSANZ to consider whether:

(a)  the enzyme is one to which certain individuals may already be sensitive; and
(b)  an enzyme new to the food supply is likely to elicit allergic reactions in some individuals.

This includes the following for all enzymatic processing aids:

    (a) the source of the enzyme processing aid
    (b) an analysis of similarity between the amino acid sequence of the enzyme and that of known allergens.

    In the case of an enzyme derived from an allergenic source, or where there is significant similarity between the amino acid sequence of the enzyme and