Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p77
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 222519–229209

of food processing or preparation
                                                                          C.1.3 Current use
                                                                          C.1.4 Potential adverse effects
C.2 Plant and animal extracts
                                                                          C.2.1 Method or extraction and composition of extract
                                                                          C.2.2 Use as a food in other countries
                                                                          C.2.3 Toxicity studies
                                                                          C.2.4 Safety assessments from other agencies
C.3 Herbs (both non-culinary and culinary) including extracts
                                                                          C.3.1.1 History of use
                                                                          C.3.2 Composition
                                                                          C.3.3 Method of extraction and composition of extract
                                                                          C.3.4 Use in other countries
                                                                          C.3.5 Potential allergenicity
                                                                          C.3.6 Toxicity studies
                                                                          C.3.7 Safety assessments from other agencies
C.4 Single chemical entities & dietary macrocomponents
                                                                          C.4.1 Toxicokinetics and metabolism
                                                                          C.4.2 Toxicity studies
                                                                          C.4.3 Safety assessments from other agencies
C.5 Microorganisms (including probiotics)
                                                                          C.5.1 Potential pathogenicity
                                                                          C.5.2 Effects on gut microflora
                                                                          C.5.3 Use as a food in other countries
                                                                          C.5.4 Human toleration studies
C.6 Food ingredients derived from a new source
                                                                          C.6.1 Safety of the source organism, including allergen statement
                                                                          C.6.2 Composition
                                                                          C.6.3 Toxicity studies
                                                                          C.6.4 Overseas safety reports
C.7  Foods produced by a process not previously applied to food
                                                                          C.7.1 Details of the new process
                                                                          C.7.2 Toxicity studies
                                                                          C.7.3 Overseas safety reports
                                                                          D.1 List of foods likely to contain the novel food or novel food ingredient
                                                                          D.2 Proposed levels in foods
                                                                          D.3 Information on levels of consumption
                                                                          D.4 Percentage of food group or market
                                                                          D.5 Where consumption has changed, information on likely consumption
                                                                          D.6 Information to show whether the food or ingredient will replace another food
                                                                          D.7 Use in other countries
                                                                          E.1 Nutritional impact information
                                                                          E.2 Public health impact
                                                                          F.1 Demonstrated consumer awareness and understanding
                                                                          F.2 Potential behaviour in response to foods
                                                                          F.3 Demonstration of no adverse effects on any population groups
Irradiated foods (3.5.3)

Check                                                            Page No.  Mandatory requirements
                                                                          A.1 Nature of the food or food ingredient to be irradiated
                                                                          A.2 Technological need
                                                                          A.3  Food products likely to contain irradiated food
                                                                          B Safety information
                                                                          C Nutritional impact

     Checklist for applications for special purpose foods and
     standardised foods

This Checklist is in addition to the Checklist for Guideline 3.1.1 and will assist you in determining if you have met the information requirements as specified in Guidelines 3.6.1–3.6.3.

Standardised foods (3.6.1)

Check                                                    Page No.  Mandatory requirements
                                                                  A.1 Proposed compositional change
                                                                  A.2 List of foods likely to be affected
                                                                  B.1 Nutritional content
                                                                  C.1 Demonstrated consumer understanding of proposed change
                                                                  C.2 Potential adverse health or diet impacts
Special purpose foods – Infant formula products (3.6.2)

Check                                                    Page No.  Mandatory requirements
                                                                  A.1 Purpose of compositional change
                                                                  A.2 Data for supporting