Food Standards Australia New Zealand Amendment Regulations 2009 (No. )

Schedule 1 Amendments

(regulation 3)

[1] Regulation 2

omit

2 Interpretation

(1) In these Regulations, unless the contrary intention appears:

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2 Definitions

In these Regulations:

[2] Subregulation 2 (1), after definition of application

insert

application consideration process, for an application for the development or variation of a food regulatory measure, other than a high level health claims variation, means the process undertaken by the Authority in relation to the application under:

(a) Part 3 of the Act, other than the Authority’s dealings with the Council; and

(b) any other Commonwealth law.

Example of other Commonwealth law

The Legislative Instruments Act 2003.

[3] Regulations 7 and 8

substitute

7 Charges — general

For subsection 146 (1) of the Act, a body or person must pay to the Authority the charges mentioned in Schedule 3 for the services and facilities mentioned in Schedule 3 that the Authority provides to the body or person.

7A Charges — instalments for general procedure level 3 and 4 applications

(1) For subsection 146 (1A) of the Act, the charge for an application that is classified under Schedule 4 as a general procedure level 3 or 4 application is payable by instalments as follows:

(a) the first instalment is payable within 20 business days after the day the notice of acceptance is given under section 27 of the Act;

(b) the second instalment of 25% of the charge for the application mentioned in item 1 of Schedule 3 is payable as soon as practicable after the day the public notice is given under section 31 of the Act, but before the end of the submission period mentioned in the section.

(2) However, for an application that is withdrawn under section 24 of the Act before the day the public notice is given under section 31 of the Act, and for an application that is rejected by the Authority under paragraph 30 (1) (b) of the Act, the second instalment is:

(a) $115 for each hour, if any, for the time taken (the time taken) for the application consideration process for the application:

(i) after the time the amount mentioned in paragraph (a) of the definition of first instalment is exhausted; and

(ii) before notice of the withdrawal of the application is given to the Authority, or notice of the rejection of the application is given to the applicant; and

(b) payable within 20 business days after the day a notice mentioned in subparagraph (a) (ii) is given.

(3) If notice of the withdrawal of the application is given to the Authority by a person, the Authority must give the person a written notice that sets out the time taken and the amount of the second instalment.

(4) If the Authority gives the applicant notice of the rejection of the application, the notice must include the time taken and the amount of the second instalment.

(5) In this regulation:

first instalment means the total of:

(a) 75% of the charge for the application mentioned in item 1 of Schedule 3; and

(b) the amount mentioned in item 2 of Schedule 3.

7B Charges — instalments for major procedure applications

(1) For subsection 146 (1A) of the Act, the charge for an application that is classified under Schedule 4 as a major procedure application is payable by instalment as follows:

(a) the first instalment is payable within 20 business days after the day the notice of acceptance is given under section 27 of the Act;

(b) the second instalment of 75% of the charge for the application mentioned in item 1 of Schedule 3 is payable as soon as practicable after the day the public notice is given under section 44 of the Act, but before the end of the submission period mentioned in the section.

(2) However, for an application that is withdrawn under section 24 of the Act before the day the public notice is given under section 44 of the Act, and for an application that is rejected by the Authority under paragraph 30 (1) (b) of the Act, the second instalment is:

(a) $115 for each hour, if any, for the time taken (the time taken) for the application consideration process for the application:

(i) after the time the amount mentioned in paragraph (a) of the definition of first instalment is exhausted; and

(ii) before notice of the withdrawal of the application is given to the Authority, or notice of the rejection of the application is given to the applicant; and

(b) payable within 20 business days after the day a notice mentioned in subparagraph (a) (ii) is given.

(4) If the Authority gives the applicant notice of the rejection of the application, the notice must include the time taken and the amount of the second instalment.

(5) In this regulation:

first instalment means the total of:

(a) 25% of the charge for the application mentioned in item 1 of Schedule 3; and

(b) the amount mentioned in item 2 of Schedule 3.

8 Refunds

For subsections 24 (2), 110 (3) and 149 (2) of the Act, and for an application, the applicant’s refund is the total of:

(a) after the Authority has paid the amounts, if any, mentioned in item 2 of Schedule 3 — the balance, if any, of the $10 000 mentioned in the item; and

(b) $115 for each hour, if any, that the time taken for the application consideration process for the application is less than:

(i) for a general procedure level 4 application — the hours mentioned in paragraph 9 (2) (b); and

(ii) for a major procedure application — the hours mentioned in subparagraph 9 (2) (c) (ii); and

(iii) for any other category of application — the maximum hours mentioned in Schedule 4 for the category.

Example

The Authority classifies an application as a general procedure level 2 application because it is likely to take 650 hours for the application consideration process for the application. The application is withdrawn after the applicant has paid $84 750 ($10 000 plus $74 750, the charge for a general procedure level 2 application), and after 500 hours of work have been done. The refund amount is $27 250 ($10 000 plus $17 250, the 150 unused hours paid at the rate of $115 per hour).

[4] Paragraph 9 (2) (b)

substitute

(b) if the application is classified as a general procedure level 4 application — work out how many hours are likely to be taken for the application consideration process for the application; and

(i) if the application consideration process for the application is likely to take 1 200 hours or more; and

(ii) if so, how many hours are likely to be taken.

[5] Schedule 3, table

substitute

Item	Service or facility provided by the Authority	Charge ($)
1	The application consideration process for:
	(a) a minor procedure application	11 500
	(b) a general procedure level 1 application	40 250
	(c) a general procedure level 2 application	74 750
	(d) a general procedure level 3 application	115 000
	(e) a general procedure level 4 application:
	(i) base charge; and	115 000
	(ii) for each hour that the process is likely to take after the first 1 000 hours	115
	(f) a major procedure application:
	(i) base charge; and	138 000
	(ii) if the Authority works out, under regulation 9, that the application consideration process for the application is likely to take 1 200 hours or more — for each hour that the process is likely to take after the first 1 200 hours	115
2	The steps in the application consideration process for an application that are required under any of the following, for which amounts (however described) are payable by the Authority: (a) the Act or another Act; (b) regulations or another instrument made under the Act or another Act	10 000
	Examples of required steps 1 Publishing a notice mentioned in paragraph 34 (1) (c) of the Act in a newspaper. 2 Registering a new standard under the Legislative Instruments Act 2003.

[6] Schedule 4, heading

substitute

Schedule 4 Procedure classification

(regulations 7A, 7B, 8 and 9)

[7] Schedule 4, sections 1.2 and 1.3

substitute

General procedure level 1

1.2 A general procedure application is to be classified as a general procedure level 1 application if the application consideration process for the application is likely to take a maximum of 350 hours.

Examples

1 An application for the variation or development of a food regulatory measure involving:

(a) extending the use of a food or food additive that is permitted under a standard; or

(b) a new source organism for an enzyme; or

(d) a minor change to a compositional requirement for a food; or

(e) 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 less than average complexity; or

(b) have a limited, or no, social or economic impact; or

(c) require a toxicological, nutritional, food technology, dietary modelling or microbiological assessment of less than average complexity; or

(d) require an assessment of risk management measures of less than average complexity; or

(e) involve the development of a basic community communications strategy to address public concern.

Note Section 1.1 provides that the general procedure applies to applications that are not being considered under the minor procedure.

General procedure level 2

1.3 A general procedure application is to be classified as a general procedure level 2 application if the application consideration process for the application is likely to take more than 350 hours, to a maximum of 650 hours.

Examples

1 An application for the variation or development of a food regulatory measure involving:

(a) extending the use of a substance to a specific food; or

(b) a pre‑market approval similar to a previous approval; or

(d) changing a compositional requirement for a food; or

(e) inserting or increasing 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 a low social or economic impact; or

(c) require a toxicological, nutritional, food technology, dietary modelling or microbiological assessment of average complexity; or

(d) require an assessment of risk management measures of average complexity; or

(e) involve the development of a community communications strategy to address public concern.

General procedure level 3

1.4 A general procedure application is to be classified as a general procedure level 3 application if the application consideration process for the application is likely to take more than 650 hours, to a maximum of 1 000 hours.

Examples

1 An application for the variation or development of a food regulatory measure involving:

(a) extending the use of a substance to a range of foods; or

(b) changing a labelling requirement for a food; or

(d) establishing or increasing a maximum permitted concentration for an environmental contaminant or heavy metal.

2 This kind of application is likely to:

(a) involve an assessment of the risk to public health and safety of greater than average complexity; or

(b) have a broad social or economic impact; or

(c) require a toxicological, nutritional, food technology, dietary modelling or microbiological assessment of greater than average complexity; or

(d) require an assessment of risk management measures of greater than average complexity; or

(e) involve the development of a complex community communications strategy to address public concern; or

(f) require targeted consultation with key stakeholders or special interest groups; or

(g) require the provision of advice to advisory groups, peak organisations or other stakeholders.

General procedure level 4

1.5 A general procedure application is to be classified as a general procedure level 4 application if the application consideration process for the application is likely to take more than 1 000 hours.

Examples

1 An application for the variation or development of a food regulatory measure involving:

(a) adding a new substance to a limited range of foods; or

(b) changing a labelling requirement for a limited range of foods; or

2 This kind of application is likely to:

(a) involve an extensive and complex assessment of the risk to public health and safety; or

(b) have a broad and significant social or economic impact; or

(c) require an extensive and complex toxicological, nutritional, food technology, dietary modelling or microbiological assessment; or

(d) require an extensive and complex assessment of risk management measures; or

(e) involve the development of an extensive and complex community communications strategy to address public concern; or

(f) require targeted consultation with key stakeholders or special interest groups; or

(g) require the development and distribution of community education material; or

(h) require the establishment of external working groups to discuss and interpret scientific evidence and social perceptions.

Note Section 1.1 provides that the general procedure applies to applications that are not being considered under the major procedure.

[8] Schedule 4, section 2.1, examples, paragraphs (d) and (e)

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(d) omitting provisions of a food regulatory measure that have ceased to have effect.

[9] Schedule 4, section 2.2

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2.2 The application consideration process for an application that is classified as a minor procedure application is likely to take a maximum of 100 hours.

[10] Schedule 4, sections 3.1 and 3.2

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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 the application consideration process for the application; or

(ii) involves a significant change to the scope of the food regulatory measure that makes it necessary to adopt this procedure for the application consideration process for the application.

Examples

1 An application for the development of a new food regulatory measure, or a major variation to a food regulatory measure, involving:

(a) developing a new standard; or

(b) changing a labelling requirement affecting a wide range of foods; or

(d) adding a new substance affecting a wide range of foods; or

(e) a pre‑market approval, with no similar previous approvals.

2 This kind of application is likely to:

(a) involve a very extensive and complex assessment of the risk to public health and safety; or

(b) have a very broad and significant social or economic impact; or

(c) require a very extensive and complex toxicological, nutritional, food technology, dietary modelling or microbiological assessment; or

(d) require a very extensive and complex assessment of risk management measures; or

(e) involve the development of a very extensive and complex community communications strategy to address public concern; or

(f) require targeted consultation with key stakeholders or special interest groups; or

(g) require the development and distribution of community education material; or

(h) require extensive consultation with government agencies, industry, health professionals and consumer groups; or

(i) require the establishment of high-level advisory groups to discuss and interpret scientific evidence and social perceptions; or

(j) require community meetings including public hearings.

3.2 The application consideration process for an application that is classified as a major procedure application is likely to take 1 200 hours or more.