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

General_Procedures_2007