Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p35
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 93796–96761

an enzyme processing aid derived from a genetically-modified microorganism

The application must contain the following additional information:

     E.1  Information on the methods used in the genetic modification of the source organism

This includes information on the nature of the genetic modification and the steps used to construct the final production strain.

The application should provide, as a minimum, the following information:

    (a) a full description of the gene construct, including information on the size, source and function of all genetic components, including marker genes
    (b) full details of any modifications to the DNA or amino acid sequence of the enzyme
    (c) a full description of the final production strain, including the steps and methods used to construct it, the integration site (plasmid or chromosome) of the introduced gene and organisation of all inserted genetic material
    (d) information on the stability of the inserted gene.

     F Information related to the dietary exposure to the processing aid

Note:

FSANZ may undertake a dietary exposure assessment for processing aid applications when a residue of the processing aid or its metabolites is expected in the final food. This assessment will be undertaken using a custom-made computer program, HARVEST, which combines food consumption data from the latest Australian and New Zealand National Nutrition Surveys, together with food chemical concentration derived from analytical data on the level of the processing aid or its metabolite in the final foods. The information required to undertake this assessment will be derived from different sources, including the application.

The application must contain the following information:

     F.1 A list of foods or food groups likely to contain the processing aid or its metabolites

The food list should be based on the food group descriptions in the table to S15—5.

     F.2 The levels of residues of the processing aid or its metabolites for each food or food group

The chemical identity of the residue must be stated.

     F.3 For foods or food groups not currently listed in the most recent Australian or New Zealand National Nutrition Surveys (NNSs), information on the likely level of consumption

This includes any consumption information for food groups not included in the most recent Australian or New Zealand NNSs which relate to the application. Data distinguishing likely consumption levels among target and non-target groups are preferred.

Note:

Information on likely consumption can be based on proposed levels of consumption (grams per day) or on consumption data for these foods from a similar market in another country. The most recent NNSs are the 2011–12 National Nutrition and Physical Activity Survey (NNPAS) component of the 2011–13 Australian Health Survey  (2 years. and above), the 2008–09 New Zealand NNS (15 years. and above) and the 2002 New Zealand Children's NNS