Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p32
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 85556–88596

an enzymatic processing aid.

     B Information related to the safety of a chemical processing aid

The application must contain the following information:

     B.1 General information on the industrial use of the chemical

This includes any information on non-food industrial uses for the chemical, particularly where the information is relevant to human safety.

     B.2 General information on the use of the chemical as a food processing aid in other countries

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

     B.3 Data on the toxicokinetics and metabolism of the chemical processing aid and, if necessary, its metabolites

    (a) For an application for a new chemical processing aid, this includes detailed reports of all studies conducted in animals or humans to examine the metabolic fate of the processing aid and, if necessary, its major metabolites; particularly when a residue of the chemical processing aid or its metabolites is expected in the final food.

    (b) For an application to extend the use of a currently permitted processing aid, this includes only the reports of studies conducted since the last safety evaluation by FSANZ. If no previous evaluation by FSANZ is available, published papers. and /or a comprehensive review article on this matter should be included.

     B.4 Information on the toxicity of the chemical processing aid and, if necessary, its major metabolites

    (a) For an application for a new chemical processing aid, this includes detailed reports of all in vitro and in vivo studies conducted in animals or humans to examine the toxicity of the chemical processing aid and, if necessary, its metabolites; particularly when a residue of the chemical processing aid or its metabolite is expected in the final food.

    The application should address, as a minimum, the following categories of studies:

    (a) acute toxicity
    (b) short-term toxicity.

    The application should also address the following categories of studies, if data are available:

    (a) long-term toxicity and carcinogenicity
    (b) reproductive toxicity
    (c) developmental toxicity
    (d) genotoxicity
    (e) special studies such as neurotoxicity or immunotoxicity.

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

    (b) For an application to extend the use of a currently permitted chemical processing aid, this need only include the detailed reports of studies conducted since the last safety evaluation by FSANZ. If no previous evaluation by FSANZ is available, this 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