Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p11
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 28731–31723

place.

     B.3 Information to demonstrate that the proposed labelling change will not have any adverse health or diet impacts on any population groups (e.g. age or cultural groups)

Note:

The extent of the impact of a food labelling change on consumer understanding and behaviour will vary depending on:

(a) the nature of the labelling change
(b) the foods to which it will apply.

Thus the amount of information necessary to address the impact on consumer understanding and behaviour will depend on the level of impact. Consultation with FSANZ may be necessary to examine the expected level of impact.

Also, there may be situations where consumer impact from the proposed labelling is not required e.g. where there is an identified public health benefit associated with the labelling change, or where the impact is on industry rather than consumers.

     3.2.2 Warning and advisory statements

An application to vary the Code is required to include or change the mandatory warning and advisory requirements that are listed in Standard 1.2.3 – Information requirements – warning statements, advisory statements and declarations or Schedule 9 – Mandatory advisory statements.

Note:

Warning statements are generally reserved for well-characterised, potentially life-threatening public health and safety risks where the target population is unaware of the potential risk and a prescribed labelling statement is needed to alert consumers. Advisory statements may be used to advise the general population or a specific target population of potential public health and safety risks associated with a food.

The following additional information is required to support an application to include or change a mandatory warning or advisory statement in relation to a food or food ingredient.

This information is in addition to that specified in Guideline 3.1.1 – General requirements and 3.2.1 – General food labelling. Declaration of allergens is considered under Guideline 3.2.3.

     A Additional information related to the safety of the food or food ingredient

The application must contain the following information:

     A.1 Data to indicate that the food or food ingredient presents a potential health concern to one or more population groups

This includes one or more of the following types of information:

(a) epidemiology studies on the target population group(s)
(b) clinical studies on individuals from the target population group(s)
(c) case studies of affected individuals
(d) reports adverse food-medicine interactions in individuals
(e) reports of safety studies in experimental animals

Note:

The nature of the target population will vary with the particular potential health concern. Examples of mandatory advisory statements can be found in the Code in the table to section S9—2. Examples of mandatory warning statements and declarations can be found in sections 1.2.3—3, 4 and 5 in the Code.

     B Additional information related to consumers' awareness of