General Procedure
The General Procedure is the default assessment process and involves one round of public comment. For the purposes of cost-recovery under the Regulations, the General Procedure is split into two levels.
Level 1 (up to 500 hours)
For example, an application for a variation of a food regulatory measure involving:
(a) allowing a processing aid that is currently not permitted;
(b) extending permission for use of a food or a food additive;
(c) making a minor change to a labelling requirement;
(d) making a minor change to a compositional requirement for a food;
(e) granting a permission involving a pre-market safety assessment similar to a previous assessment; or
(f) reducing a maximum residue limit.
This kind of application is likely to:
(a) involve an assessment of the risk to public health and safety of average complexity; or
(b) have only a limited social or economic impact; or
(c) require a simple toxicological, nutritional, food technology, dietary modelling or microbiological assessment; or
(d) require a simple assessment of risk management requirements; or
(e) involve any other matter of similar complexity.
Level 2 (up to 850 hours)
For example, an application for a variation of a food regulatory measure involving:
(a) allowing a food or food additive that is not currently permitted;
(b) changing a compositional requirement for a food;
(c) establishing or increasing a maximum permitted concentration for an environmental contaminant or heavy metal;
(d) changing permission to add a nutritive substance;
(e) changing a labelling requirement for a food;
(f) granting a permission involving a pre-market safety assessment similar to a previous assessment;
(g) regulating a new micro-organism.
This kind of application is likely to:
(a) involve a more complex assessment of the risk to public health and safety; or
(b) have a broader social or economic impact; or
(c) require a complete toxicological, nutritional, food technology, dietary modelling or microbiological assessment; or
(d) require targeted consultation with key stakeholders, special interest groups; or
(f) may require comprehensive consideration of risk management requirements; or
(g) insert and amend maximum residue limits; or
(h) require the establishment of high level advisory groups to discuss and interpret scientific evidence and social perceptions; or
(i) involve the development of a community communications strategy to address public concern; or
(j) involve any other matter of similar complexity.
Key Procedural Steps
Step 1 Acceptance or rejection of application
Step 2 Notification to applicant & ‘Early Bird’ public notice
Step 3 &
Step 4 Assessment & draft food regulatory measure developed
Step 5 Notification to applicant and call for public submissions
Step 6 Approval of draft food regulatory measure
Step 7 Notification of approval of draft food regulatory measure to Ministerial Council
Step 8 Gazettal following advice from Ministerial Council to not review the approval decision
