Commonwealth Consolidated Regulations Commonwealth Consolidated Regulations(regulations 7, 8 and 9)
1.1 This procedure applies to applications that are not being considered under the minor procedure or the major procedure.
Note The general procedure is the default procedure for considering an application for the development of a food regulatory measure or a variation to a food regulatory measure.
General procedure level 1
1.2 A general procedure application that is likely to require up to 500 hours to fully assess is to be classified as a general procedure level 1 application.
Examples
1 An application for the variation or development of a food regulatory measure involving:
(a) allowing a processing aid that is currently not permitted; or
(b) extending permission for use of a food or a food additive; or
(c) making a minor change to a labelling requirement; or
(d) making a minor change to a compositional requirement for a food; or
(e) granting a permission involving a pre‑market safety assessment similar to a previous assessment; or
(f) reducing a maximum residue limit.
2 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.
General procedure level 2
1.3 A general procedure application that is likely to require up to 850 hours to fully assess is to be classified as a general procedure level 2 application.
Examples
1 An application for the variation or development of a food regulatory measure involving:
(a) allowing a food or food additive that is not currently permitted; or
(b) changing a compositional requirement for a food; or
(c) establishing or increasing a maximum permitted concentration for an environmental contaminant or heavy metal; or
(d) changing permission to add a nutritive substance; or
(e) changing a labelling requirement for a food; or
(f) granting a permission involving a pre‑market safety assessment similar to a previous assessment; or
(g) regulating a new micro‑organism.
2 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
(e) require the provision of advice to advisory groups, peak organisations or other stakeholders; or
(f) require comprehensive consideration of risk management requirements; or
(g) insert and amend maximum residue limit; 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.
2 Minor procedure
2.1 This procedure applies to an application for a variation of a food regulatory measure that, if made, would not directly or indirectly:
(a) impose, vary or remove an obligation on any person; or
(b) create, vary or remove a right of any person; or
(c) otherwise alter the legal effect of the measure.
Examples
A variation would fall within this procedure if its only effect would be:
(a) correcting a typographical error; or
(b) updating a reference to another document; or
(c) amending a cross‑reference within a food regulatory measure; or
(d) omitting provisions of a food regulatory measure that has ceased to have effect; or
(e) any other matter of similar complexity.
2.2 An application that has been classified as a minor procedure is likely to require up to 175 hours to fully assess.
3 Major procedure
3.1 This procedure applies to :
(a) an application for the development of a new food regulatory measure; and
(b) an application for the variation of a food regulatory measure that:
(i) involves scientific or technical complexity that makes it necessary to adopt this procedure for its assessment; or
(ii) involves a significant change to the scope of the food regulatory measure that makes it necessary to adopt this procedure for its assessment.
Examples
1 An application for the development of, or a major variation to, a new food regulatory measure involving:
(a) the development of a new Standard; or
(b) a change to a labelling requirement affecting a wide range of foods; or
(c) a change to a compositional requirement for a food affecting a wide range of foods; or
(d) a change to a nutritive substance permissions affecting a wide range of foods; or
(e) the granting a permission involving a pre‑market safety assessment, with no similar previous assessments; or
(f) any other matter of similar complexity.
2 This kind of application is likely to:
(a) require the use of community meetings including public hearings; or
(b) involve the development of a complete community communications strategy to address public concern; or
(c) require the development and distribution of community education material; or
(d) require representation at international forums; or
(e) require extensive consultation with government agencies, industry, health professionals and consumer groups; or
(f) require establishment of external working parties and advisory groups; or
(g) require a comprehensive assessment of risk management requirements; or
(h) involve any other matter of similar complexity.
Note A minimum of 2 rounds of public comment is likely to be required and consultation might also require the establishment of external working parties or advisory groups to assist with the assessment.
3.2 An application that has been classified as a major procedure application is likely to require more than 1 050 hours to assess fully.