Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p4
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 8231–11261

For applications that relate to a matter dealt with under Chapters. 3.2–3.7, the purpose of the application relevant to any particular guidelines must be provided.

     D Justification for the application

The application must provide information to indicate why a food regulatory measure is proposed. Such information may, depending on the purpose of the application as outlined according to requirements in section C of this Guideline (3.1.1), include:

    (a) the need for the proposed change
    (b) the advantages of the proposed change over the status quo, taking into account any disadvantages.

Note:

The following general issues should be considered:

    (a) any public health and safety issues related to the proposed change including details of target groups and population groups that may be adversely affected
    (b) any consumer choice issues related to the proposed change
    (c) any evidence that the food industry generally or other specific companies have an interest in, or support, the proposed change.

The application must also contain details of the status of similar applications made in other countries by the applicant, if applicable.

     D.1 Regulatory impact information

The application must include current information and data on the following costs and benefits:

     D.1.1 Costs and benefits of the application

This may include:

    (a) the cost and benefits to the consumer e.g. health benefits
    (b) the costs and benefits to industry and business in general, noting any specific effects on small businesses e.g. savings in production costs
    (c) the costs and benefits to government e.g. increased regulatory costs.

Costs and benefits must be quantified in monetary terms wherever possible, or where this is not possible, other quantitative measures and qualitative evidence must be provided.

Reference must be made to other sections of the application that contain detailed supporting information, where necessary.

Note:

If the OBPR makes a decision that a RIS is required, FSANZ must meet the OBPR's information requirements. In such a case, FSANZ may need to request further information from an applicant before the assessment of the application can continue.

     D.1.2 Impact on international trade

This may include information on the impact of the proposed change on international trade.

     E Information to support the application

The application must contain sufficient supporting information or data to enable the objectives specified in section 18 of the FSANZ Act to be addressed. This includes all information relevant to the consideration of the safety of a substance.

Note:

Where the application relates to matters. referred to in Chapters. 3.2–3.7, please refer to the relevant guideline for specific information requirements. In some instances more than one guideline may apply.

     E.1 Data requirements

Note:

The term 'data' in this document refers, among other things, to units of information; facts; observations; or results of an