Commonwealth Numbered Regulations

FOOD STANDARDS AUSTRALIA NEW ZEALAND AMENDMENT REGULATIONS 2004 (NO. 1) 2004 NO. 265 - SCHEDULE 1

(regulation 3)

[1] Regulation 2

omit

In these Regulations,

insert

(1)

In these Regulations,

[2] Regulation 2, after definition of application

insert

"category", in relation to an application, means the category of assessment into which the application is classified under regulation 12.

[3] Regulation 2

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(2) In these Regulations, a reference to the time required to fully assess an application includes the time required for:

(a)

making an initial assessment of the application under section 13 of the Act; and

(b)

making a draft assessment of the application under section 15 of the Act; and

(c)

preparing a draft food regulatory measure, or a draft variation of a food regulatory measure, under section 15A of the Act; and

(d)

making a final assessment in relation to the draft under section 16 of the Act; and

(e)

carrying out all associated activities under Division 2 of Part 3 of the Act in relation to the application.

[4] Subregulation 6A (3), including the note

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[5] Regulation 8

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8 Charges

(1)

Subject to subregulation (2), for subsection 66 (1) of the Act, the charges to be paid to the Authority by a body or person for services and facilities the Authority provides to the body or person are as set out in Schedule 3.

(2) A charge is payable in relation to an application only if:

(a)

the application relates to the development or variation of a food standard, and the development or variation would confer an exclusive, capturable commercial benefit on the applicant; or

(b)

the application has been included in the second or third year of a three year plan and the applicant elects to have the application included in the first year of the work plan.

(3)

For the purposes of paragraph 12 (2) (c) of the Act, an application fee (if any) for an application of the kind mentioned in paragraph (2) (a) of this regulation is taken to accompany the application if it is paid when the applicant is notified, under paragraph 13A (2) (a) of the Act, that the application has been accepted.

(4)

For subsection 35 (1) of the Act, an application is taken not to have been received until the application fee (if any) has been paid.

[6] Subregulation 10 (3)

substitute

(3)

If the application is withdrawn after draft assessment of the application commences but before half of the work required for draft assessment is completed, the Authority must refund half of any amounts paid, in relation to the application, under section 15 of the Act.

[7] Regulation 12

substitute

12 Categories of assessment

(1)

This regulation applies to an application in relation to which charges are payable.

(2)

In making an initial assessment of the application under section 13 of the Act, the Authority must:

(a)

classify the application in accordance with the categories of assessment in Schedule 4; and

(b) if the application is classified as a category 6 application, determine:

(i)

whether the full assessment of the application is likely to require more than 1 850 hours; and

(ii)

if so, how many hours are likely to be required.

[8] Regulations 13 and 14

substitute

13 Outcome of initial assessment
A notification by the Authority, under subsection 13A (2) of the Act, must include the following information:

(a)

the decisions made by the Authority in relation to the matters mentioned in regulation 12, and the reasons for those decisions;

(b)

advice that the applicant may seek review under regulation 14 if the applicant does not agree with the category of assessment into which the application has been classified;

(c)

the amount of any further charges payable by the applicant under section 15 or 16 of the Act;

(d)

advice that, until amounts payable under section 15 of the Act are paid, draft assessment cannot proceed.

14 Review of category of assessment

(1)

Within 28 days after receiving notification under subsection 13A (2) of the Act in relation to an application, the applicant may ask the Authority, in writing, to review the category of assessment into which the application has been classified.

(2) Within 28 days of receiving a request under subregulation (1), the Authority must review the classification of the application and:
(a) either:

(i)

confirm the classification; or

(ii)

set the classification aside and substitute another classification for it; and

(b)

notify the applicant of the outcome of the review.

(3)

Subject to the Administrative Appeals Tribunal Act 1975 , an applicant may make an application to the Administrative Appeals Tribunal for review of a decision made under subregulation (2).

Note
Under section 27A of the Administrative Appeals Tribunal Act 1975 , the decision-maker must give to any person whose interests are affected by the decision notice, in writing or otherwise, of the making of the decision and the person's right to have the decision reviewed. In giving that notice, the decision-maker must have regard to the Code of Practice determined under section 27B of that Act ( Gazette No. S 432, 7 December 1994), accessible on the Internet at:

[9] Regulations 15 to 18

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[10] Schedule 1, Part 1, item 1

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[11] Schedule 1, Part 2

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Part 2 State and Territory authorities

[12] Schedule 1A

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Schedule 1A Modifications or adaptations of Part 3 of the Act under subsection 36 (2) of the Act

(subregulation 4 (2))

Part 1 Modifications and adaptations if the Authority decides not to invite submissions after it accepts an application

1 Subsection 14 (1)
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(1)

After accepting the application, the Authority must give written notice of the matters mentioned in subsection (3) to each appropriate government agency.

2 Paragraph 14 (3) (e)
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(e)

state that the Authority will not invite submissions on matters relevant to the application.

Part 2 Modifications and adaptations if the Authority decides not to invite submissions in relation to a proposal

3 Subsection 14A (1)
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(1)

After preparing a proposal for the development or variation of a food regulatory measure, the Authority must give written notice of the matters mentioned in subsection (3) to each appropriate government agency.

4 Paragraph 14A (3) (d)
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(d)

state that the Authority will not invite submissions on matters relevant to the proposal.

[13] Schedule 2, Part 1, item 1

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[14] Schedule 2, Part 2

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Part 2 State and Territory authorities

[15] Schedule 2A, Part 1, item 106

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[16] Schedule 2A, Part 1, item 113

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[17] Schedule 2A, Part 1, items 152 and 153

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[18] Schedule 2A, Part 1, items 156 to 160

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[19] Schedule 2A, Part 1, item 162

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[20] Schedule 2A, Part 2, items 204 and 205

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[21] Schedule 2A, Part 2, item 207

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[22] Schedule 2A, Part 2, item 209

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[23] Schedule 2A, Part 2, items 251 and 252

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[24] Schedule 3

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Schedule 3 Charges

(regulation 8)

Schedule 4 Categories of assessment

(regulation 12)

1 Category 1 applications

An application that is likely to require up to 200 hours to fully assess is to be classified as a category 1 application.

Examples
An application for a variation of a food regulatory measure involving:
(a) updating a definition, permission or requirement for food; or
(b) another simple variation.
This kind of application would typically:
(a) pose no additional risk to public health and safety; or
(b) have no change to existing social or economic impact; or
(c) not require a safety assessment; or
(d) require limited public consultation; or
(e) be unlikely to require notification to the World Trade Organisation.
2 Category 2 applications

An application that is likely to require between 201 and 300 hours to fully assess is to be classified as a category 2 application.

Examples
An application involving any of the matters mentioned in clause 1, or any of the following:
(a) allowing a processing aid that is currently not permitted;
(b) extending a 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.
This kind of application would typically:
(a) involve an assessment of the risk to public health and safety of a low 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) require limited public consultation; or
(f) require notification to the World Trade Organisation.
3 Category 3 applications

An application that is likely to require between 301 and 450 hours to fully assess is to be classified as a category 3 application.

Examples
An application involving any of the matters mentioned in clause 2, or reviewing a food standard or part of a food standard, including any of the following:
(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) regulating a new micro-organism.
This kind of application would typically:
(a) involve an assessment of the risk to public health and safety of average complexity; 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.
4 Category 4 applications

An application that is likely to require between 451 and 650 hours to fully assess is to be classified as a category 4 application.

Examples
An application involving any of the matters mentioned in clause 3, a major variation to an existing standard or the development of a new standard, involving any of the following:
(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) regulating a new micro-organism;
(g) any other matter of similar complexity.
This kind of application would typically:
(a) require extensive consultation with government agencies, industry, health professionals and consumer groups; or
(b) require establishment of external working parties and advisory groups; or
(c) require a comprehensive assessment of risk management requirements.
5 Category 5 applications

An application that is likely to require between 651 and 1 050 hours to fully assess is to be classified as a category 5 application.

Examples
An application involving any of the matters mentioned in clause 4, and:
(a) involving independent peer review of the risk analysis; or
(b) requiring the establishment of high level advisory groups to discuss and interpret scientific evidence and social perceptions; or
(c) involving the development of a community communications strategy to address public concern; or
(d) requiring the provision of advice to a wide range of stakeholders.
6 Category 6 applications

An application that is likely to require more than 1 050 hours to fully assess is to be classified as a category 6 application.

Examples
An application involving any of the matters mentioned in clause 4 or 5, and:
(a) requiring the use of community forums including public hearings; or
(b) involving the development of a complete community communications strategy to address public concern; or
(c) requiring the development and distribution of community education material; or
(d) requiring representation at international forums.