Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p12
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 31478–34383

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 a potential public health and safety risk associated with the food

The application must contain the following information:

     B.1 Data to indicate that one or more consumer groups are unaware of the public health and safety risk

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

    (a) currently available information regarding use and consumption of the food
    (b) reports of epidemiology studies or case studies of consumers. being at risk through consumption of the food or food ingredient
    (c) data from consumer surveys indicating a potential risk associated with the use of the food or food ingredient.

     3.2.3 Declaration of allergens

An application is required to vary the Code to include or change the requirements for mandatory declaration of certain foods or food ingredients, which are listed in Standard 1.2.3 – Information requirements – warning statements, advisory statements and declarations.

     A Additional information to support addition of an allergen to the list of declared foods

The following additional information is required to support an application to add an allergenic food on the list of foods in the Standard which are required to be declared on the label. This information is in addition to that specified in Guidelines 3.1.1 – General requirements and 3.2.1 – General food labelling.

The application must contain the following information:

     A.1 Information to demonstrate the food causes an IgE-mediated allergy

This includes clinical data associating IgE-mediated allergic reactions with the specific food including one or more of the following:

(a) patient history
(b) skin testing
(c) double-blind placebo-controlled food challenges (DBPCFC).

     A.2 Information on the incidence in the population of allergic reactions to the food

This includes published data or data derived from allergy clinics on the incidence of allergic reactions to the food in the population.

     A.3 Information on the severity of the allergic reaction to the food in relation to the amount of food consumed

This includes clinical reports on the range of symptoms associated with the allergic reaction and an estimate of the amount of food that may provoke these symptoms.

     A.4 Information on the extent of use in the food supply and the range of food containing the allergen

This includes information on the quantity of the allergen in the food supply and an indication of the range of foods where it is used. As much as possible, projections for extended use in the immediate and near future should also be included.

     B Additional information to support removal of a