Source: https://www.legislation.gov.au/Details/F2007L02390
Timestamp: 2019-12-08 02:22:23
Document Index: 437604879

Matched Legal Cases: ['art 2', 'art 2', 'art 1', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 3', 'art 1', 'art 1', 'art 2', 'art 2']

Food Standards Australia New Zealand Amendment Regulations 2007 (No. 1)
Details: F2007L02390
- F2007L02390
SLI 2007 No. 310 Regulations as made
These Regulations amend the Food Standards Australia New Zealand Regulations 1994 with consequential amendments arising from amendments to the Food Standards Australia New Zealand Act 1991 that received Royal Assent on 28 June 2007.
Food Standards Australia New Zealand Amendment Regulations 2007 (No. 1)1
Select Legislative Instrument 2007 No. 310
I, PHILIP MICHAEL JEFFERY, Governor‑General of the Commonwealth of Australia, acting with the advice of the Federal Executive Council, make the following Regulations under the Food Standards Australia New Zealand Act 1991.
These Regulations are the Food Standards Australia New Zealand Amendment Regulations 2007 (No. 1).
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.
[1] Subregulation 2 (1), definitions of application, category, exclusive, capturable commercial benefit and proposal
procedure, for an application, means the procedure of assessment into which the application is classified under section 25 of the Act.
[2] Subregulation 2 (2)
[3] Subregulations 3 (1) and (2)
[4] Regulations 4 and 6
6 Disclosure of confidential commercial information
For paragraph 114 (4) (b) of the Act, each authority mentioned in Schedule 2 is prescribed.
[5] Regulation 6A, including the heading
[6] Regulations 7 to 14
(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.
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.
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.
(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.
[7] Schedule 1, Part 2
Part 2 State and Territory authorities
Department of Business, Economic and Regional Development of the Northern Territory
[8] Schedule 1A
[9] Schedule 2, Part 1, item 4
[10] Schedule 2, Part 2, items 1 and 2
[11] Schedule 2, Part 2, item 4
[12] Schedule 2, Part 2, item 8
[13] Schedule 2, Part 2, items 11 to 13
[14] Schedule 2, Part 2, item 15
[15] Schedule 2, Part 2, items 18 and 19
[16] Schedule 2, Part 3, after item 3
[17] Schedule 2A, Part 1, column 3, heading
Subparagraph of paragraph 116 (3) (a)
[18] Schedule 2A, Part 1, item 102, column 2
[19] Schedule 2A, Part 2, column 3, heading
Subparagraph of paragraph 116 (4) (a)
[20] Schedule 2A, Part 2, item 209, column 2
[21] Schedules 3 and 4
Schedule 3 Charges
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)
(d) a major procedure application:
(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
(regulations 7, 8 and 9)
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.
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.
(a) allowing a processing aid that is currently not permitted; or
(b) extending permission for use of a food or a food additive; or
(c) making a minor change to a labelling requirement; 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.
(b) have only a limited social or economic impact; or
(c) require a simple toxicological, nutritional, food technology, dietary modelling or microbiological assessment; or
(d) require a simple assessment of risk management requirements; or
(e) involve any other matter of similar complexity.
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.
(a) allowing a food or food additive that is not currently permitted; or
(b) changing a compositional requirement for a food; or
(c) establishing or increasing a maximum permitted concentration for an environmental contaminant or heavy metal; 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.
(a) involve a more complex assessment of the risk to public health and safety; or
(b) have a broader social or economic impact; or
(c) require a complete toxicological, nutritional, food technology, dietary modelling or microbiological assessment; or
(d) require targeted consultation with key stakeholders, special interest groups; or
(e) require the provision of advice to advisory groups, peak organisations or other stakeholders; or
(f) require comprehensive consideration of risk management requirements; 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
(c) otherwise alter the legal effect of the measure.
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
(c) amending a cross‑reference within a food regulatory measure; 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
(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.
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
(c) a change to a compositional requirement for a food 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.
(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
(c) require the development and distribution of community education material; 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.