Document ID: chunk:federal_register_of_legislation:F2016C00156:body:0:p76
Version: federal_register_of_legislation:F2016C00156
Segment Type: other
Provision Reference: 
Character Range: 216398–223115

                                                         G.2 Actual or potential behaviour of consumers
                                                         H.3 Demonstration of no adverse effects on any population groups
                                                         H.3 Demonstration of no adverse effects on any population groups

     Checklist for applications for contaminants and
     natural toxicants

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 3.4.1–3.4.3.

Chemical contaminant and natural toxicant maximum levels (3.4.1)

Check                                                             Page No.  Mandatory requirements
                                                                           A.1 Nature of contaminant or natural toxicant
                                                                           A.2 Analytical detection method
                                                                           B.1 Toxicokinetics & metabolism information
                                                                           B.2 Toxicity studies
                                                                           B.3 Human studies relevant to safety
                                                                           C.1 List of foods where maximum level is proposed
                                                                           C.2 Survey data on contaminant or toxicant levels in foods
                                                                           C.3 Information on levels of consumption
                                                                           C.4 Where consumption has changed, information on likely consumption
Microbiological limits (3.4.2)

Check                                                             Page No.  Mandatory requirements
                                                                           A.1 Raw inputs, production and manufacturing process
                                                                           A.2 Food technology
                                                                           B.1 Nature of the microbiological hazard
                                                                           B.2 Source & prevalence of contamination
                                                                           B.3 Consumer handling and use
                                                                           C.1 Nutritional impact
                                                                           D.1 Dietary exposure
Prohibited and restricted plants and fungi (3.4.3)

Check                                                             Page No.  Mandatory requirements
                                                                           A.1 Nature of plant or fungi
                                                                           A.2 Identity and levels of natural toxicants
                                                                           B.1 Toxicity studies
                                                                           B.2 Human toxicity case studies
                                                                           B.3 Use in other countries

     Checklist for applications for new 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 3.5.1–3.5.3.

Foods produced using gene technology (3.5.1)

Check                                                            Page No.  Mandatory requirements
                                                                          A.1 Nature and identity
                                                                          A.2 History of use of host and donor organisms
                                                                          A.3 Nature of genetic modification
                                                                          B.1 Characterisation and safety assessment
                                                                          B.2 New proteins
                                                                          B.3 Other (non-protein) new substances
                                                                          B.4 Novel herbicide metabolites in GM herbicide-tolerant plants
                                                                          B.5 Compositional analyses
                                                                          C Nutritional impact of GM food
                                                                          D Other information
Novel foods (3.5.2)

Check                                                            Page No.  Mandatory requirements
                                                                          A. Exclusive use
                                                                          B.1 Type of novel food
                                                                          B.2 Information on potential beneficial outcomes
                                                                          B.3 Chemical and physical properties
                                                                          B.4 Impurity profile
                                                                          B.5 Manufacturing process
                                                                          B.6 Specification for  identity and purity
                                                                          B.7 Analytical detection method
C.1 Plant or animal extracts
                                                                          C.1.1 Extraction and composition
                                                                          C.1.2 Effects 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