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Appendix 2 - Applications received and proposals prepared at 30 June 2013

Section 69 of the Food Standards Australia New Zealand Act 1991 (FSANZ Act) (as was in force prior to 1 July 2007) requires FSANZ to report on its processing of applications and proposals in the following manner:

During 2012–13, FSANZ progressed 4 Applications received prior to 1 October 2007:

  1. 0 were withdrawn
  2. 0 were rejected by FSANZ
  3. 0 were finalised and notified to the Forum
  4. 0 were considered after a request for a review and notified to the Ministerial Council
  5. 4 were still being progressed as at 30 June 2013.

During 2012–13, FSANZ progressed 6 Proposals prepared prior to 1 October 2007:

  1. 0 were abandoned by FSANZ
  2. 0 were finalised and notified to the Ministerial Council
  3. 1 was considered after a request for a review and notified to the Forum
  4. 5 were still being progressed as at 30 June 2013.

(e) Any occasion during 2012–13 that FSANZ, after preparing a draft standard or a draft variation of a standard, failed to make a decision under section 18 of the FSANZ Act (as was in force prior to 1 July 2007) within the period required under section 35 (as was in force prior to 1 July 2007) and a statement of the reasons for that failure:

Nil

(f) Extensions of time FSANZ granted under subsection 35(2) of the FSANZ Act during 2012–13 and the reasons for those extensions:

Nil

(g) The number of applications made to the Administrative Appeals Tribunal during 2012–13 for a review of a decision made by FSANZ:

Nil

(h) The results of the applications made to the Administrative Appeals Tribunal that were determined during 2012–13:

Nil

(i) The number of standards made under the FSANZ Act during 2012–13:

1 (this includes both standards and variations to standards gazetted)

(j) The number of draft standards and draft variations approved during 2012–13 under:

(i) section 18 of the FSANZ Act; or (Final Assessment)

0

(k) The number of occasions during 2012–13 when requests were made under section 21 of the FSANZ Act (as was in force prior to 1 July 2007) for a review of a draft standard or draft variation:

0

(l) The number of occasions during 2012–13 when requests were made under section 22 of the FSANZ Act (as was in force prior to 1 July 2007) for a review of a draft standard or draft variation:

0

(m) The number of occasions during 2012–13 when a draft standard or draft variation was rejected under section 23 of the FSANZ Act (as was in force prior to 1 July 2007):

0

(n) The number of occasions during 2012–13 when requests were made under section 28A of the FSANZ Act (as was in force prior to 1 July 2007) for a review of a standard or variation:

0

(p) The number of occasions during 2012–13 when a standard or variation was revoked or amended under section 28C of the FSANZ Act (as was in force prior to 1 July 2007):

0

Applications received and proposals prepared from 1 October 2007 onwards

Section 152 of the FSANZ Act requires FSANZ to report on its processing of applications and proposals in the following manner:

(aa) The number of applications that were made under section 22 during 2012–13:

14

(ab) The number of applications accepted under subsection 26(1) during 2012–13:

8

(ac) The number of applications rejected under subsection 26(1) during 2012–13 and the reasons for the rejections:

5

PA1076—on the basis that it did not meet the mandatory information requirements under subsection 22(2) of the FSANZ Act, which are set out in Part 3 of the FSANZ Application Handbook. The Administrative Assessment does not consider the merits of the Application.

PA1078—on the basis that it did not meet the mandatory information requirements under subsection 22(2) of the FSANZ Act, which are set out in Part 3 of the FSANZ Application Handbook. The Administrative Assessment does not consider the merits of the Application.

PA1082—on the basis that it did not meet the mandatory information and format requirements under subsection 22(2) of the FSANZ Act which are set out in Part 3 of the FSANZ Application Handbook. The Administrative Assessment does not consider the merits of the Application.

PA1084—on the basis that it did not meet the mandatory information requirements under subsection 22(2) of the FSANZ Act which are set out in Part 3 of the FSANZ Application Handbook. The Administrative Assessment does not consider the merits of the Application.

PA1086—on the basis that it did not meet the mandatory information requirements under subsection 22(2) of the FSANZ Act which are set out in Part 3 of the FSANZ Application Handbook. The Administrative Assessment does not consider the merits of the Application.

(ad) The number of applications withdrawn in 2012–13 under subsection 24(1) during the current year:

1

(ae) The number of applications accepted under subsection 26(1) during 2012–13 that FSANZ had not begun to assess under section 29 during 2012–13:

0

(af) The number of applications accepted under subsection 26(1) during a previous financial year that FSANZ had not begun to assess under section 29 before the end 2012–13:

0

(a) the number of applications that were considered under Subdivision D of Division 1 of Part 3 during 2012–13 (considered means on our books at some stage during the year from when the clock started):

General Procedure
18

(b) the number of applications that were considered under Subdivision E of Division 1 of Part 3 during 2012–13:

Minor Procedure
0

(c) the number of applications that were considered under Subdivision F of Division 1 of Part 3 during 2012–13:

Major Procedure
2

(d) Health claims

not applicable

(e) for each of those Subdivisions, the number of applications considered under that Subdivision that were disposed of during 2012–13 and the manner of their disposal (disposal means not on our books any more):

Subdivision D
Subdivision E
Subdivision F
13 Approved
0
1 Approved
1 Withdrawn
 
1 Withdrawn
0 Rejected
 
 

(f) for each of those Subdivisions, the average time taken to dispose of applications during 2012–13 (for Approval only):

Subdivision D
10.7 months
A1039 24 months
A1043 17 months (not including 4.5 months for further info)
A1055 23 months (not including 7 months for further info)
A1064 8.5 months
A1065 8 months
A1066 8 months
A1068 8 months
A1069 9 months
A1070 6.5 months
A1071 7 months
A1073 8.5 months
A1074 8 months
A1083 3 months

Subdivision E
not applicable

Subdivision F
15 months
A1045 15 months

(fa) The number of applications accepted under subsection 26(1) during a previous financial year that FSANZ had begun to assess under section 29 before the end of the current year, but that FSANZ had not disposed of before the end of 2012–13:

0

(fb) For an application covered by Paragraph (fa), the period that has elapsed since the application was accepted under subsection 26(1):

n/a

(g) the number of applications made during 2012–13 in relation to which a charge fixed under section 146 was payable:

5

(h) the number of applications made during 2012–13 in relation to which no charge fixed under section 146 was payable:

3

(i) the average number of days that elapsed between the acceptance or rejection under section 26 of an application made during 2012–13 in relation to which no charge fixed under section 146 was payable, and the commencement of the assessment of the application under section 29:

92.5 days
A1077 accepted 11 October 2012, clock start 18 February 2013 (130 days)
A1079 accepted 1 February 2013, clock start 28 March 2013 (55 days)

(j) each occasion during 2012–13 on which the consideration period under section 109 elapsed without FSANZ completing the procedure that FSANZ must, under Subdivision C of Division 1, adopt in considering the application:

A1039 Approval due: 3 August 2011. Approved: 31 October 2012
A1043 Approval due: 30 July 2012. Approved: 6 December 2012
A1055 Approval due: 13 March 2012. Approved: 8 May 2013

(k) each occasion during 2012–13 on which FSANZ extended the consideration period under subsection 109(4), and the reasons for that extension:

Nil

(ka) The number of applications declared under section 95 to be urgent applications during 2012–13:

0

(l) the number of proposals prepared by FSANZ under section 55 during 2012–13: (Preparation)

7

(la) The number of proposals prepared under section 55 during 2012–13 that FSANZ had not begun to assess under section 59 during that year:

0

(lb) The number of proposals prepared under section 55 during a previous financial year that FSANZ had not begun to assess under section 59 before the end of 2012–13:

0

(n) the number of proposals that were disposed of during 2012–13 and the manner of their disposal:

4 Approved

(o) the average time taken to dispose of proposals under each of Subdivisions D, E, F and H of Division 2 of Part 3 during 2012–13:

General
5 months
P1023 3 months
M1008 7 months

Major
n/a

(p) the average number of days that elapsed between the preparation of a proposal during 2012–13 under each of sections 55 and 81 and the commencement of the assessment of the proposal under section 59:

5 days
P1022 24 days
P1023 3 days
P1024 3 days
P1025 0 days
P1027 0 days
M1009 0 days

(pa) The number of proposals prepared under section 55 during a previous financial year that the FSANZ had begun to assess under section 59 before the end of 2012–13, but that the FSANZ had not disposed of before the end of 2012–13:

6

(pb) For a proposal covered by paragraph (pa), the period that has elapsed since the proposal was prepared under section 55:

P1005 51.5 months
P1014 20.5 months
P1015 18.5 months
P1016 17 months
P1017 17 months
P1019 15 months

(pc) The number of proposals declared under section 95 to be urgent proposals during 2012–13:

0

(pd) The number of occasions during the current year when the 12-month period referred to in subsection 101(1) ended with no decision having been made under that subsection and the reasons for no decision having been made:

n/a

(q) the number of applications made to the Administrative Appeals Tribunal during 2012–13 for review of decisions of FSANZ:

Nil

(r) the results of the applications made to the Administrative Appeals Tribunal that were determined during 2012–13:

An application was lodged in the Administrative Appeals Tribunal on 6 June 2011 by Axiome Pty Ltd, on behalf of Cognis GmbH, seeking review of a FSANZ decision to refuse an application to amend Standard 5.1 in the Code (Application A1005). The amendment had been sought in order to allow a brand of a conjugated linoleic acid triglyceride preparation (CLA) to be sold as a novel food. The review by the Tribunal involved two issues: whether CLA was a novel food for the purposes of the Standard, and, if so, whether FSANZ's decision to reject the application was the correct or preferable one.

The Tribunal handed down its decision on 24 August 2012. The Tribunal affirmed FSANZ's decision. It found that CLA was a novel food subject to the Standard. The Tribunal also rejected the applicant's arguments that regulatory safety assessments and approvals and consumption for or of CLA in other countries meant that its use in Australia or New Zealand did not require a further health assessment. The Tribunal agreed with FSANZ that a health assessment was required as the available evidence did not establish CLA's safety.

(s) the number of standards made during 2012–13 (Gazettal):

18

(t) the number of draft standards and draft variations approved during 2012–13 under each of the following:

Approval A's—General & Major Approval A's—Minor
(i) section 33: (ii) section 41:
18 0

(u) the number of occasions during 2012–13 when requests were made by the Ministerial Council under Division 3 of Part 3 for a review of a draft standard or draft variation:

1

(v) the number of occasions during 2012–13 when a draft standard or draft variation was rejected by the Ministerial Council under Division 3 of Part 3:

0

(w) the number of occasions during 2012–13 when requests were made by the Council under Division 3 of Part 3 for a review of a standard or variation:

n/a

(x) the number of occasions during 2012–13 when a standard or variation was revoked or amended by the Ministerial Council under Division 3 of Part 3:

0

In relation to applications or proposals declared to be urgent under section 95, either in 2012–13 or in previous financial years, the number which were disposed of under section 101 and the manner of their completion:

n/a

In relation to applications or proposals declared to be urgent under section 95, either in 2012–13 or in previous financial years, the number of occasions where disposal did not occur within 12 months of the date of effect of the publication of a standard under section 97:

n/a

(y) a summary of policy guidelines notified to FSANZ during 2012–13:

Nil

(z) such other matters (if any) as are specified in the Regulations:

Nil

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