These Regulations are the Food Standards Australia New Zealand Regulations 1994.

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

Act means the Food Standards Australia New Zealand Act 1991.

application means an application made under section 12 of the Act.

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

exclusive, capturable commercial benefit has the meaning given by subsection 66 (9) of the Act.

proposal means a proposal prepared under section 12AA of the Act.

(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.

3 Appropriate government agencies

(1) For paragraph (a) of the definition of appropriate government agency in subsection 3 (1) of the Act, each Department of the Commonwealth mentioned in Part 1 of Schedule 1 is prescribed.

(2) For paragraph (d) of the definition of appropriate government agency in subsection 3 (1) of the Act, each State or Territory authority mentioned in Part 2 of Schedule 1 is prescribed.

4 Section 36 of the Act: application, modification and adaptation of Part 3 of the Act

(1) This regulation applies if the Authority decides, under subsection 36 (1A) of the Act, not to do something that the Authority is required to do under Part 3 of the Act in relation to an application or a proposal.

(2) For the purposes of subsection 36 (2) of the Act, the provisions of Part 3 of the Act apply in relation to the application or proposal subject to the modifications and adaptations set out in the Part of Schedule 1A that relates to the Authority’s decision.

6 Disclosure of confidential commercial information

For paragraph 39 (4) (b) of the Act, each authority mentioned in Schedule 2 is prescribed.

6A Board of Food Standards Australia New Zealand — prescribed organisations and public bodies from which nominations may be sought (Act s 40)

(1) For paragraph 40 (3) (b) of the Act, each organisation and public body mentioned in column 2 of an item in Part 1 of Schedule 2A is prescribed for the purposes of each subparagraph of paragraph 40 (3) (a) of the Act mentioned in column 3 of that item.

(2) For paragraph 40 (4) (b) of the Act, each organisation and public body mentioned in column 2 of an item in Part 2 of Schedule 2A is prescribed for the purposes of each subparagraph of paragraph 40 (4) (a) of the Act mentioned in column 3 of that item.

7 Additional information about application

For paragraph 12 (2) (b) of the Act, the Authority may request an applicant to give additional information if the application does not contain, or is not accompanied by, sufficient information to enable the Authority to deal with the application in accordance with the Act.

Example

The Authority may request additional information to enable it to determine whether:

(a) it should declare in writing, under paragraph 24 (1) (a) of the Act, that the application is an urgent application; or

(b) the development or variation of a food standard that may result from the application would confer an exclusive, capturable commercial benefit on the person or body that made the application.

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.

9 Refunds — withdrawal before initial assessment

If an applicant withdraws an application before initial assessment of the application commences, the Authority must refund the application fee, if any, paid under section 12 of the Act.

10 Refunds — withdrawal after initial assessment

(1) This regulation applies if an applicant withdraws an application after initial assessment.

(2) If the application is withdrawn before draft assessment of the application commences, the Authority must refund any amounts paid, in relation to the application, under section 15 of the Act.

(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.

(4) If the application is withdrawn after half of the work required for draft assessment is completed but before a final assessment under section 16 of the Act commences, the Authority must refund any amount paid in relation to the making of the final assessment.

11 Refunds — no request for final assessment

If the applicant to whom subsection 16 (3) of the Act applies gives the Authority notice that the applicant will not be asking the Authority to make a final assessment under that subsection, the Authority must refund any amount paid, in relation to the application, under subsection 16 (4) of that Act.

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.

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;

(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:

http://scaleplus.law.gov.au/html/instruments/0/14/0/AATCode.htm

Schedule 1 Appropriate government agencies

(regulation 3)

Part 1 Departments of the Commonwealth

Item	Department
1	Department of Agriculture, Fisheries and Forestry
2	Attorney-General’s Department
3	Department of Education, Science and Training
4	Department of Foreign Affairs and Trade
5	Department of Health and Ageing
6	Department of Industry, Tourism and Resources

Part 2 State and Territory authorities

Item	Authority
1	NSW Agriculture and Fisheries
2	NSW Food Authority
3	Department of Primary Industries (Vic)
4	Department of Sustainability and Environment (Vic)
5	Department of Innovation, Industry and Regional Development (Vic)
6	Department of Primary Industries of Queensland
7	Safe Food Queensland
8	Department of Agriculture of Western Australia
9	Department of Primary Industries and Resources of South Australia
10	Department of Primary Industries, Water and Environment of Tasmania
11	Department of Business, Industry and Resource Development of the Northern Territory

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)

substitute

(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)

substitute

(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)

substitute

(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)

substitute

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

Schedule 2 Prescribed authorities to which confidential commercial information may be disclosed

(regulation 6)

Part 1 Commonwealth authorities

Item	Authority
1	Department of Agriculture, Fisheries and Forestry
2	Attorney-General’s Department
3	Department of Education, Science and Training
4	Department of Family and Community Services
5	Department of Foreign Affairs and Trade
6	Department of Health and Ageing
7	Department of Industry, Tourism and Resources

Part 2 State and Territory authorities

Item	Authority
1	NSW Agriculture and Fisheries
2	NSW Health Department
3	NSW Food Authority
4	Department of Human Services of Victoria
5	Department of Primary Industries (Vic)
6	Department of Sustainability and Environment (Vic)
7	Department of Innovation, Industry and Regional Development (Vic)
8	Department of Primary Industries of Queensland
9	Queensland Health
10	Safe Food Queensland
11	Department of Agriculture of Western Australia
12	Department of Health of Western Australia
13	Department of Human Services of South Australia
14	Department of Primary Industries and Resources of South Australia
15	Department of Health and Human Services of Tasmania
16	Department of Primary Industries, Water and Environment of Tasmania
17	ACT Health
18	Department of Business, Industry and Resource Development of the Northern Territory
19	Department of Health and Community Services of the Northern Territory

Part 3 New Zealand authorities

Item	Authority
1	Environmental Risk Management Authority
2	Ministry of Health
3	Ministry of Agriculture and Forestry

Schedule 2A Board — prescribed organisations and public bodies from which nominations may be sought

(regulation 6A)

Part 1 Science and public health organisations and public bodies

Item	Organisation or public body	Subparagraph of paragraph 40 (3) (a)
	Australian organisations and public bodies
101	Australian Academy of Science	Subparagraph (vi)
102	Australian Consumers’ Association	Subparagraphs (i) and (ii)
103	Australian Institute of Environmental Health	Subparagraphs (i), (iii), (vii) and (viii)
104	Australian Medical Association Limited	Subparagraphs (i) and (vi)
104A	Australian Society for Biochemistry and Molecular Biology Incorporated	Subparagraphs (vi), (vii) and (ix)
105	Australian Veterinary Association Ltd	Subparagraph (x)
106	Consumers’ Health Forum of Australia Incorporated	Subparagraphs (i) and (ii)
107	Dietitians Association of Australia	Subparagraphs (i), (iii), (iv), (v) and (viii)
108	Food Science Australia	Subparagraphs (iii), (iv), (v), (vii) and (viii)
109	National Aboriginal Community Controlled Health Organisation	Subparagraphs (i) and (ii)
110	Nutrition Australia	Subparagraphs (i), (ii) and (v)
111	Nutrition Society of Australia Incorporated	Subparagraphs (iii), (iv), (v) and (viii)
112	Public Health Association of Australia Incorporated	Subparagraphs (i), (ii), (iii), (iv), (v) and (viii)
113	Royal Australian Chemical Institute Incorporated	Subparagraph (iii)
115	The Australian Institute of Food Science and Technology Incorporated	Subparagraphs (i), (iii), (iv), (v), (vii) and (viii)
116	The Australian Society for Microbiology Incorporated	Subparagraph (vii)
117	The Royal Australasian College of Physicians (Faculty of Public Health Medicine)	Subparagraphs (i), (v) and (vi)
	New Zealand organisations and public bodies
150	Association of Crown Research Institutes Incorporated	Subparagraphs (i), (ii), (iii), (vi), (vii), (viii) and (ix)
151	Consumer Forum on Food Safety	Subparagraph (ii)
152	Consumers’ Institute of New Zealand Incorporated	Subparagraphs (ii), (v) and (viii)
153	Health Research Council of New Zealand	Subparagraphs (i), (iv), (v), (vi), (vii) and (ix)
154	Maori Women’s Welfare League Inc	Subparagraphs (i), (ii) and (viii)
155	National Council of Women of NZ (Inc)	Subparagraph (ii)
156	New Zealand Biotech 2003 Incorporated	Subparagraph (ix)
157	The Royal Australasian College of Physicians, New Zealand Committee, Faculty of Public Health Medicine	Subparagraphs (i), (v) and (vi)
158	New Zealand Dietetic Association (Inc)	Subparagraphs (i), (ii), (iii), (iv), (v) and (viii)
159	The New Zealand Institute of Food Science and Technology	Subparagraphs (iii), (viii) and (ix)
160	New Zealand Medical Association Inc	Subparagraphs (i) and (vi)
161	New Zealand Nutrition Foundation	Subparagraphs (v), (vi) and (viii)
162	The Public Health Association of New Zealand Incorporated	Subparagraphs (i), (ii), (iii), (iv), (v), (vi), (vii), (viii) and (ix)
163	The Royal Society of New Zealand	Subparagraphs (vii) and (ix)

Part 2 Food industry organisations and public bodies

Item	Organisation or public body	Subparagraph of paragraph 40 (4) (a)
	Australian organisations and public bodies
201	Australian Chamber of Commerce and Industry	Subparagraphs (i), (ii), (iv), (vi) and (vii)
202	Australian Food and Grocery Council	Subparagraphs (i), (ii), (v), (vi) and (vii)
203	Australian Hotels Association	Subparagraphs (i), (iv), (vi) and (vii)
204	The Australian Industry Group	Subparagraphs (i), (iv), (v), (vi) and (vii)
205	The Australian Retailers Association	Subparagraphs (i), (ii) (iv), (vi) and (vii)
206	Council of Small Business Organisations of Australia Limited	Subparagraphs (iv) and (vi)
207	National Association of Retail Grocers of Australia Pty Ltd	Subparagraphs (ii) and (iv)
208	National Farmers’ Federation Limited	Subparagraphs (iii), (iv), (v) and (vi)
209	Restaurant and Catering Industry of Australia Inc	Subparagraphs (i), (iv), (vi) and (vii)
	New Zealand organisations and public bodies
250	National Association of Retail Grocers and Supermarkets of New Zealand Inc	Subparagraphs (i), (ii) and (iv)
251	New Zealand Grocery Marketers Association (Inc)	Subparagraphs (i), (ii), (iv), (v), (vi) and (vii)
252	New Zealand Retailers Association Incorporated	Subparagraph (ii)

Schedule 3 Charges

(regulation 8)

Item	Service or facility provided by the Authority	Provision of the Act	Charge ($)
1	Making an initial assessment of an application	subparagraph 12 (2) (c) (i)	3 400
2	Giving notices under section 14 of the Act in relation to an application	subparagraph 12 (2) (c) (ii)	600
3	Making a draft assessment of:	paragraph 15 (2) (a)
	(a) a category 1 application		9 783
	(b) a category 2 application		15 644
	(c) a category 3 application		25 116
	(d) a category 4 application		38 938
	(e) a category 5 application		62 082
	(f) a category 6 application:
	(i) base charge; and		108 370
	(ii) if the Authority determines, under regulation 12, that the full assessment of the application is likely to require more than 1 850 hours — for each complete block of 100 hours that the assessment will require after the first 1 850 hours		3 875
4	Giving notices under section 16, 17 or 17A of the Act in relation to an application	paragraph 15 (2) (b)	600
5	Preparation under section 15A of the Act of a draft food regulatory measure, or a draft variation of a food regulatory measure, in relation to:	paragraph 15 (2) (d)
	(a) a category 1 application		642
	(b) a category 2 application		856
	(c) a category 3 application		1 284
	(d) a category 4 application		1 712
	(e) a category 5 application		2 568
	(f) a category 6 application		4 280
6	Making a final assessment in relation to:	subsection 16 (4)
	(a) a category 1 application		3 675
	(b) a category 2 application		5 700
	(c) a category 3 application		9 000
	(d) a category 4 application		13 750
	(e) a category 5 application		21 750
	(f) a category 6 application		37 750

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

(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;

(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

(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;

(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

(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;

(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

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

(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

(d) requiring representation at international forums.

Notes to the Food Standards Australia New Zealand Regulations 1994

Note 1

The Food Standards Australia New Zealand Regulations 1994 (in force under the Error! Reference source not found.) as shown in this compilation comprise Statutory Rules Error! Reference source not found. No. Error! Reference source not found. amended as indicated in the Tables below.

Table of Statutory Rules

Year and number	Date of notification in Gazette	Date of commencement	Application, saving or transitional provisions
1994 No. 286	23 Aug 1994	23 Aug 1994
2000 No. 122	22 June 2000	1 July 2000	—
2001 No. 341	21 Dec 2001	21 Dec 2001	—
2002 No. 38	7 Mar 2002	7 Mar 2002	—
2002 No. 119	14 June 2002	1 July 2002 (see r. 2 and Gazette 2002, No. GN30)	—
2004 No. 265	26 Aug 2004	26 Aug 2004	R. 4 [see Table A]

Table of Amendments

ad. = added or inserted am. = amended rep. = repealed rs. = repealed and substituted
Provision affected	How affected
R. 1.................	rs. 2000 No. 122; 2002 No. 119
R. 2.................	am. 2000 No. 122; 2002 No. 119; 2004 No. 265
R. 3.................	am. 2000 No. 122
	rs. 2002 No. 119
R. 4.................	am. 2002 No. 119
R. 5.................	rep. 2002 No. 119
R. 6.................	rs. 2000 No. 122; 2002 No. 119
R. 6A................	ad. 2001 No. 341
	rep. 2004 No. 265
R. 7.................	ad. 2000 No. 122
Example to r. 7.........	am. 2002 No. 119
R. 8.................	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2004 No. 265
Note 1 to r. 8 (1)........	am. 2002 No. 119
Heading to r. 9..........	rs. 2002 No. 119
R. 9.................	ad. 2000 No. 122
	am. 2002 No. 119
Heading to r. 10.........	rs. 2002 No. 119
R. 10................	ad. 2000 No. 122
	am. 2002 No. 119; 2004 No. 265
Heading to r. 11.........	rs. 2002 No. 119
R. 11................	ad. 2000 No. 122
	am. 2002 No. 119
Heading to r. 12.........	rs. 2002 No. 119; 2004 No. 265
R. 12................	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2004 No. 265
Heading to r. 13.........	rs. 2002 No. 119; 2004 No. 265
Rr. 13, 14.............	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2004 No. 265
Heading to r. 15.........	rs. 2002 No. 119
	rep. 2004 No. 265
R. 15................	ad. 2000 No. 122
	am. 2002 No. 119
	rep. 2004 No. 265
Heading to r. 16.........	rs. 2002 No. 119
	rep. 2004 No. 265
R. 16................	ad. 2000 No. 122
	rep. 2004 No. 265
Rr. 17, 18.............	ad. 2000 No. 122
	rep. 2004 No. 265
Schedule 1
Schedule 1............	rs. 2002 No. 119
	am. 2004 No. 265
Schedule 1A
Schedule 1A...........	ad. 2002 No. 119
	rs. 2004 No. 265
Schedule 2
Schedule 2............	rs. 2002 No. 119
	am. 2004 No. 265
Schedule 2A
Schedule 2A...........	ad. 2001 No. 341
	am. 2002 No. 38; 2004 No. 265
Schedule 3
Schedule 3............	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2004 No. 265
Schedule 4
Schedule 4............	ad. 2004 No. 265