
Food Standards Australia New Zealand Regulations 1994
Statutory Rules 1994 No. 286 as amended
made under the
This compilation was prepared on 1 July 2010
taking into account amendments up to SLI 2010 No. 103
Prepared by the Office of Legislative Drafting and Publishing,
Attorney‑General’s Department, Canberra
Contents
                       1    Name of Regulations [see Note 1]                                    3
                       2    Definitions                                                                      3
                       3    Appropriate government agencies                                     3
                       6    Disclosure of confidential commercial information              4
                     6A    Board of Food Standards Australia New Zealand — prescribed organisations and public bodies from which nominations may be sought (Act s116)                    4
                       7    Charges — general                                                         4
                     7A    Charges — instalments for general procedure level 3 and 4 applications          4
                     7B    Charges — instalments for major procedure applications    6
                       8    Refunds                                                                         7
                       9    Procedure classification                                                  7
                      10    Period within which consideration of proposal must be complete         8
                      11    Period within which consideration of applications for standards or variations must be complete  8
Schedule 1            Appropriate government agencies                               9
Part 1                     Departments of the Commonwealth                                  9
Part 2                     State and Territory authorities                                          9
Schedule 2Â Â Â Â Â Â Â Â Â Â Â Â Prescribed authorities to which confidential commercial information may be disclosed 11
Part 1                     Commonwealth authorities                                             11
Part 2                     State and Territory authorities                                        11
Part 3                     New Zealand authorities                                                 12
Schedule 2A          Board — prescribed organisations and public bodies from which nominations may be sought                                                                                   13
Part 1Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Science and public health organisations and public bodies 13
Part 2                     Food industry organisations and public bodies                 15
Schedule 3            Charges                                                                      17
Schedule 4            Procedure classification                                             18
Notes                                                                                                         23
1Â Â Â Â Â Â Â Â Â Â Â Â Â Name of Regulations [see Note 1]
               These Regulations are the Food Standards Australia New Zealand Regulations 1994.
2Â Â Â Â Â Â Â Â Â Â Â Â Â Definitions
               In these Regulations:
Act means the Food Standards Australia New Zealand Act 1991.
application means an application made under section 22 of the Act.
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.
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.
3Â Â Â Â Â Â Â Â Â Â Â Â Â 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.
6Â Â Â Â Â Â Â Â Â Â Â Â Â 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 — 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.
        (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)   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.
8Â Â Â Â Â Â Â Â Â Â Â Â Â 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).
9Â Â Â Â Â Â Â Â Â Â Â Â Â 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 general procedure level 4 application — work out how many hours are likely to be taken for the application consideration process for the application; and
               (c)   if the application is classified as a major procedure application, work out:
                         (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.
10Â Â Â Â Â Â Â Â Â Â Â Period within which consideration of proposal must be complete
               For section 83 of the Act, the consideration period ends 9 months after it begins.
11Â Â Â Â Â Â Â Â Â Â Â 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
               (c)   for a major procedure in Subdivision F of the Act — 12 months after it begins.
Schedule 1Â Â Â Â Â Â Â Appropriate government agencies
(regulation 3)
Part 1Â Â Â Â Â Â Â Â Â 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 2Â Â Â Â Â Â Â Â Â 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 2Â Â Â Â Â Â Â Prescribed authorities to which confidential commercial information may be disclosed
(regulation 6)
Part 1Â Â Â Â Â Â Â Â Â 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 2Â Â Â Â Â Â Â Â Â 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 3Â Â Â Â Â Â Â Â Â 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 1Â Â Â Â Â Â Â Â Â 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 2Â Â Â Â Â Â Â Â Â 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 3Â Â Â Â Â Â Â Charges
(regulation 7)
Item | Service or facility provided by the Authority | Charge ($) |
1 | The application consideration process for: | |
| Â Â (a)Â a minor procedure application | 11 500 |
| Â Â (b)Â a general procedure level 1 application | 40 250 |
| Â Â (c)Â a general procedure level 2 application | 74 750 |
| Â Â (d)Â a general procedure level 3 application | 115 000 |
| Â Â (e)Â a general procedure level 4 application: | |
| Â Â Â Â Â Â Â Â (i)Â Â base charge; and | 115 000 |
| Â Â Â Â Â Â Â (ii)Â Â for each hour that the process is likely to take after the first 1 000 hours | 115 |
| Â Â (f)Â a major procedure application: | |
| Â Â Â Â Â Â Â Â (i)Â Â 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: Â Â (a)Â the Act or another Act; Â Â (b)Â 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. | |
Schedule 4Â Â Â Â Â Â Â Procedure classification
(regulations 7A, 7B, 8 and 9)
1Â Â Â Â Â Â Â Â Â Â Â Â Â 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 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)Â Â Â Â Â extending the use of a food or food additive that is permitted under a standard; or
(b)Â Â Â Â Â a new source organism for an enzyme; or
(c)Â Â Â Â Â a minor change to a labelling requirement; or
(d)Â Â Â Â Â a minor change to a compositional requirement for a food; or
(e)Â Â Â Â Â reducing a maximum residue limit.
2 This kind of application is likely to:
(a)Â Â Â Â Â involve an assessment of the risk to public health and safety of less than average complexity; or
(b)Â Â Â Â Â have a limited, or no, social or economic impact; or
(c)Â Â Â Â Â require a toxicological, nutritional, food technology, dietary modelling or microbiological assessment of less than average complexity; or
(d)Â Â Â Â Â require an assessment of risk management measures of less than average complexity; or
(e)Â Â Â Â Â 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)Â Â Â Â Â extending the use of a substance to a specific food; or
(b)Â Â Â Â Â a pre‑market approval similar to a previous approval; or
(c)Â Â Â Â Â a new micro‑organism; or
(d)Â Â Â Â Â changing a compositional requirement for a food; or
(e)Â Â Â Â Â inserting or increasing a maximum residue limit.
2 This kind of application is likely to:
(a)Â Â Â Â Â involve an assessment of the risk to public health and safety of average complexity; or
(b)Â Â Â Â Â have a low social or economic impact; or
(c)Â Â Â Â Â require a toxicological, nutritional, food technology, dietary modelling or microbiological assessment of average complexity; or
(d)Â Â Â Â Â require an assessment of risk management measures of average complexity; or
(e)Â Â Â Â Â 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)Â Â Â Â Â extending the use of a substance to a range of foods; or
(b)Â Â Â Â Â changing a labelling requirement for a food; or
(c)Â Â Â Â Â a pre‑market approval; or
(d)Â Â Â Â Â establishing or increasing a maximum permitted concentration for an environmental contaminant or heavy metal.
2 This kind of application is likely to:
(a)Â Â Â Â Â involve an assessment of the risk to public health and safety of greater than average complexity; or
(b)Â Â Â Â Â have a broad social or economic impact; or
(c)Â Â Â Â Â require a toxicological, nutritional, food technology, dietary modelling or microbiological assessment of greater than average complexity; or
(d)Â Â Â Â Â require an assessment of risk management measures of greater than average complexity; or
(e)Â Â Â Â Â involve the development of a complex community communications strategy to address public concern; or
(f)Â Â Â Â Â Â require targeted consultation with key stakeholders or special interest groups; or
(g)Â Â Â Â Â 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)Â Â Â Â Â adding a new substance to a limited range of foods; or
(b)Â Â Â Â Â changing a labelling requirement for a limited range of foods; or
(c)Â Â Â Â Â a complex pre‑market approval.
2 This kind of application is likely to:
(a)Â Â Â Â Â involve an extensive and complex assessment of the risk to public health and safety; or
(b)Â Â Â Â Â have a broad and significant social or economic impact; or
(c)Â Â Â Â Â require an extensive and complex toxicological, nutritional, food technology, dietary modelling or microbiological assessment; or
(d)Â Â Â Â Â require an extensive and complex assessment of risk management measures; or
(e)Â Â Â Â Â involve the development of an extensive and complex community communications strategy to address public concern; or
(f)Â Â Â Â Â Â require targeted consultation with key stakeholders or special interest groups; or
(g)Â Â Â Â Â require the development and distribution of community education material; or
(h)Â Â Â Â Â 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.
2Â Â Â Â Â Â Â Â Â Â Â Â Â 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)Â Â Â Â Â correcting a typographical error; or
(b)Â Â Â Â Â updating a reference to another document; or
(c)Â Â Â Â Â amending a cross‑reference within a food regulatory measure; or
(d)Â Â Â Â Â omitting provisions of a food regulatory measure that have ceased to have effect.
    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.
3Â Â Â Â Â Â Â Â Â Â Â Â Â 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 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)Â Â Â Â Â developing a new standard; or
(b)Â Â Â Â Â changing a labelling requirement affecting a wide range of foods; or
(c)Â Â Â Â Â changing a compositional requirement for a wide range of foods; or
(d)Â Â Â Â Â adding a new substance affecting a wide range of foods; or
(e)Â Â Â Â Â a pre‑market approval, with no similar previous approvals.
2 This kind of application is likely to:
(a)Â Â Â Â Â involve a very extensive and complex assessment of the risk to public health and safety; or
(b)Â Â Â Â Â have a very broad and significant social or economic impact; or
(c)Â Â Â Â Â require a very extensive and complex toxicological, nutritional, food technology, dietary modelling or microbiological assessment; or
(d)Â Â Â Â Â require a very extensive and complex assessment of risk management measures; or
(e)Â Â Â Â Â involve the development of a very extensive and complex community communications strategy to address public concern; or
(f)Â Â Â Â Â Â require targeted consultation with key stakeholders or special interest groups; or
(g)Â Â Â Â Â require the development and distribution of community education material; or
(h)Â Â Â Â Â require extensive consultation with government agencies, industry, health professionals and consumer groups; or
(i)Â Â Â Â Â Â require the establishment of high‑level advisory groups to discuss and interpret scientific evidence and social perceptions; or
(j)Â Â Â Â Â Â 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.
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.
For all relevant information pertaining to application, saving or transitional provisions see Table A.
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 |
2007 No. 310 | 28 Sept 2007 (see F2007L02390) | 1 Oct 2007 | R. 4 |
2010 No. 103 | 25 May 2010 (see F2010L00600) | 1 July 2010 | R. 4 |
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; 2010 No. 103 |
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; 2010 No. 103 |
Example to r. 7..................... | am. 2002 No. 119 |
| rep. 2007 No. 310 |
R. 7A....................................... | ad. 2010 No. 103 |
R. 7B...................................... | ad. 2010 No. 103 |
R. 8......................................... | ad. 2000 No. 122 |
| am. 2002 No. 119 |
| rs. 2004 No. 265; 2007 No. 310; 2010 No. 103 |
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 |
| am. 2010 No. 103 |
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 |
| am. 2010 No. 103 |
Schedule 4 | |
Heading to Schedule 4....... | rs. 2010 No. 103 |
Schedule 4............................ | ad. 2004 No. 265 |
| rs. 2007 No. 310 |
| am. 2010 No. 103 |
Table AÂ Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Â Application, saving or transitional provisions
Statutory Rules 2004 No. 265
4Â Â Â Â Â Â Â Â Â Â Â Â Â 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
4Â Â Â Â Â Â Â Â Â Â Â Â Â 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.
Select Legislative Instrument 2010 No. 103
4Â Â Â Â Â Â Â Â Â Â Â Â Â Transitional
               The Food Standards Australia New Zealand Regulations 1994, as in force immediately before 1 July 2010, continue to apply to an application made before that day under section 22 of the Food Standards Australia New Zealand Act 1991.