Food Standards Australia New Zealand Regulations 1994

Statutory Rules 1994 No. 286 as amended

made under the

Food Standards Australia New Zealand Act 1991

This compilation was prepared on 1 October 2007
taking into account amendments up to SLI 2007 No. 310

Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra

Contents

1 Name of Regulations [see Note 1]

2 Interpretation

3 Appropriate government agencies

6 Disclosure of confidential commercial information

6A Board of Food Standards Australia New Zealand — prescribed organisations and public bodies from which nominations may be sought (Act s116)

7 Charges

8 Refunds

9 Procedure classification

10 Period within which consideration of proposal must be complete

11 Period within which consideration of applications for standards or variations must be complete

Schedule 1 Appropriate government agencies

Part 1 Departments of the Commonwealth

Part 2 State and Territory authorities

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

Part 1 Commonwealth authorities

Part 2 State and Territory authorities

Part 3 New Zealand authorities

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

Part 1 Science and public health organisations and public bodies

Part 2 Food industry organisations and public bodies

Schedule 3 Charges

Schedule 4 Procedure classification

Notes

1 Name of Regulations [see Note 1]

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

2 Interpretation

(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 22 of the Act.

procedure, for an application, means the procedure of assessment into which the application is classified under section 25 of the Act.

proposal means a proposal prepared under section 55 of the Act.

3 Appropriate government agencies

(1) For paragraph (a) of the definition of appropriate government agency in subsection 4 (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 4 (1) of the Act, each State or Territory authority mentioned in Part 2 of Schedule 1 is prescribed.

6 Disclosure of confidential commercial information

For paragraph 114 (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 s116)

(1) For paragraph 116 (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 116 (3) (a) of the Act mentioned in column 3 of that item.

(2) For paragraph 116 (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 116 (4) (a) of the Act mentioned in column 3 of that item.

7 Charges

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

(2) For subsection 146 (1A) of the Act, the charge for an application that has been classified as a major procedure under Schedule 4 is payable in the following 2 instalments:

(a) 25% — within 20 business days after the notice of acceptance is given under section 27 of the Act;

(b) 75% — as soon as practicable after the public notice given under section 44 of the Act and before the assessment of the submissions under section 45 of the Act.

(3) However, the Authority must repay to the body or person $107 for each hour, if any, by which the time taken to assess the application is less than the hours mentioned in Schedule 4 for the category of application.

8 Refunds

For subsections 24 (2) and 110 (3) of the Act, the refund is $107 for each hour, if any, by which the time taken to assess the application is less than the hours mentioned in Schedule 4 for the category of application.

Example

If an application is withdrawn after 350 hours of work done on an application which is calculated to take 500 hours to process, the refund amount is $16 050, being the 150 unused hours paid at the rate of $107 per hour.

9 Procedure classification

(1) This regulation applies to an application for which charges are payable.

(2) If the Authority accepts an application under section 26 of the Act, the Authority must:

(a) classify the application in accordance with section 25 of the Act and Schedule 4; and

(b) if the application is classified as a major procedure application, determine:

(i) whether the full assessment of the application is likely to require more than 1 050 hours; and

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

10 Period within which consideration of proposal must be complete

For section 83 of the Act, the consideration period ends 9 months after it begins.

11 Period within which consideration of applications for standards or variations must be complete

For subsection 109 (3) of the Act, the consideration period ends:

(a) for a general procedure in Subdivision D of the Act — 9 months after it begins; and

(b) for a minor procedure in Subdivision E of the Act — 3 months after it begins; and

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

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 Families, Community Services and Indigenous Affairs
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	Department of Primary Industries (NSW)
2	NSW Health
3	NSW Food Authority
4	Department of Human Services (Vic)
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 and Fisheries (Qld)
9	Queensland Health
10	Safe Food Queensland
11	Department of Agriculture and Food (WA)
12	Department of Health (WA)
13	Department of Health (SA)
14	Department of Primary Industries and Resources of South Australia
15	Department of Health and Human Services, Tasmania
16	Department of Primary Industries, Water and Environment of Tasmania
17	ACT Health
18	Department of Business, Economic and Regional Development of the Northern Territory
19	Department of Health and Community Services (NT)

Part 3 New Zealand authorities

Item	Authority
1	Environmental Risk Management Authority
2	Ministry of Health
3	Ministry of Agriculture and Forestry
4	New Zealand Food Safety Authority

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 116 (3) (a)
	Australian organisations and public bodies
101	Australian Academy of Science	Subparagraph (vi)
102	CHOICE	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 116 (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 Australia	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 7)

Item	Service or facility provided by the Authority	Provision of the Act	Charge ($)
1	Assessing the application under section 29 of the Act and preparing a draft regulatory measure under section 30 of the Act for:	subparagraph 27 (c) (i)
	(a) a minor procedure application		18 725
	(b) a general procedure level 1 application		53 500
	(c) a general procedure level 2 application		90 950
	(d) a major procedure application:
	(i) base charge; and		112 350
	(ii) if the Authority determines, under regulation 9, that the full assessment of the application is likely to require more than 1 050 hours — for each hour that the assessment will require after the first 1 050 hours		107

Schedule 4 Procedure classification

(regulations 7, 8 and 9)

1 General procedure

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

(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

(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

(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

(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

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

(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

(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

(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.

Notes to the Food Standards Australia New Zealand Regulations 1994

Note 1

The Food Standards Australia New Zealand Regulations 1994 (in force under the Food Standards Australia New Zealand Act 1991) as shown in this compilation comprise Statutory Rules 1994 No. 286 amended as indicated in the Tables below.

Under the Legislative Instruments Act 2003, which came into force on 1 January 2005, it is a requirement for all non‑exempt legislative instruments to be registered on the Federal Register of Legislative Instruments. From 1 January 2005 the Statutory Rules series ceased to exist and was replaced with Select Legislative Instruments (SLI series). Numbering conventions remain the same, ie Year and Number.

Table of Instruments

Year and number	Date of notification in Gazette or FRLI registration	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]
2007 No. 310	28 Sept 2007 (see F2007L02390)	1 Oct 2007	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; 2007 No. 310
R. 3.................	am. 2000 No. 122
	rs. 2002 No. 119
	am. 2007 No. 310
R. 4.................	am. 2002 No. 119
	rep. 2007 No. 310
R. 5.................	rep. 2002 No. 119
R. 6.................	rs. 2000 No. 122; 2002 No. 119; 2007 No. 310
R. 6A................	ad. 2001 No. 341
	rep. 2004 No. 265
	am. 2007 No. 310
R. 7.................	ad. 2000 No. 122
	rs. 2007 No. 310
Example to r. 7.........	am. 2002 No. 119
R. 8.................	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2004 No. 265; 2007 No. 310
Note 1 to r. 8 (1)........	am. 2002 No. 119
	rep. 2007 No. 310
Heading to r. 9..........	rs. 2002 No. 119; 2007 No. 310
R. 9.................	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2007 No. 310
Heading to r. 10.........	rs. 2002 No. 119; 2007 No. 310
R. 10................	ad. 2000 No. 122
	am. 2002 No. 119; 2004 No. 265
	rs. 2007 No. 310
Heading to r. 11.........	rs. 2002 No. 119; 2007 No. 310
R. 11................	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2007 No. 310
Heading to r. 12.........	rs. 2002 No. 119; 2004 No. 265
	rep. 2007 No. 310
R. 12................	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2004 No. 265
	rep. 2007 No. 310
Heading to r. 13.........	rs. 2002 No. 119; 2004 No. 265
	rep. 2007 No. 310
Rr. 13, 14.............	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2004 No. 265
	rep. 2007 No. 310
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; 2007 No. 310
Schedule 1A
Schedule 1A...........	ad. 2002 No. 119
	rs. 2004 No. 265
	am. 2007 No. 310
Schedule 2
Schedule 2............	rs. 2002 No. 119
	am. 2004 No. 265; 2007 No. 310
Schedule 2A
Schedule 2A...........	ad. 2001 No. 341
	am. 2002 No. 38; 2004 No. 265; 2007 No. 310
Schedule 3
Schedule 3............	ad. 2000 No. 122
	am. 2002 No. 119
	rs. 2004 No. 265; 2007 No. 310
Schedule 4
Schedule 4............	ad. 2004 No. 265
	rs. 2007 No. 310

Table A Application, saving or transitional provisions

Statutory Rules 2004 No. 265

4 Transitional

(1) Despite the amendments made by items [5], [7], [9] and [24] of Schedule 1, regulations 12, 15, 16 and 17 of, and Schedule 3 to, the old Regulations continue to apply to an application for the development or variation of a food regulatory measure if, in relation to the application, a charge or fee was paid before the commencement of these Regulations under regulation 8 or 18 of the old Regulations.

(2) In this regulation:

old Regulations means the Food Standards Australia New Zealand Regulations 1994, as in force immediately before the commencement of these Regulations.

Select Legislative Instrument 2007 No. 310

4 Transitional

4.1 The Food Standards Australia New Zealand Regulations 1994 as in force immediately before 1 October 2007 continue to apply to an application or a proposal made before 1 October 2007.

4.2 In this regulation:

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

former Act means the Food Standards Australia New Zealand Act 1991 as in force immediately before 1 July 2007.

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