Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p47
Version: federal_register_of_legislation:F2016C00156
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includes any reports of potential adverse effects on population sub-groups, particularly at the levels found in food.

     B.3 Use of the plant or fungi in other countries, if applicable

This includes information on the use of the plant or fungi in food products in other countries.

     Chapter 3.5

     Guidelines for applications for new foods

     3.5.1 Foods produced using gene technology

Applications to vary the Code are required to approve the use of new foods produced using gene technology. Approved genetically modified (GM) foods are specified in Schedule 26 – Food produced using gene technology.

The following information is required to support an application for a new genetically modified food. This information is in addition to that specified in Guideline 3.1.1 – General requirements.

Note:

Further explanatory information regarding some of the data requirements for this Guideline (3.5.1) is available in Part 2.3 of this Handbook (GM applications – additional information).

FSANZ is required by paragraph 18(2)(e) of the FSANZ Act to have regard to any written policy guidelines formulated by the Forum.

For the labelling of GM foods, the relevant Guideline is the Labelling of Foods produced or processed using New Technologies.

FSANZ will have regard to these policy principles during the assessment of applications involving foods produced or processed using new technologies. The Guideline is available at http://www.foodstandards.gov.au/code/fofr/fofrpolicy/Pages/default.aspx.

The information requirements outlined below take this Policy Guideline into consideration.

     A Technical information on the food produced using gene technology

The application must contain the following information:

     A.1 Nature and identity of the genetically modified food

This must include all of the following:

    (a) a description of the GM organism from which the new GM food is derived. The description must include the nature and purpose of the genetic modification
    (b) the name, line number and OECD Unique identifier of each of the new lines or strains of GM organism from which the food is derived
    (c) the name the food will be marketed under (if known).

     A.2 History of use of the host and donor organisms

The common and scientific names of host and donor organisms must be stated. Where information relating to an organism has been included in previous safety assessments prepared by FSANZ, it is not necessary to provide any further information. Where an organism has not been considered previously by FSANZ, the following information must be provided.

(a) For the donor organism(s) from which the genetic elements are derived:

       (i) any known pathogenicity, toxicity or allergenicity of relevance to the food;
       (ii) history of use of the organism in the food supply or history of human exposure to the organism through other than intended food use (e.g. as a normal contaminant).

(b) For the host organism