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Appendix 2: Report against FSANZ Act requirements

Section 69 of the Food Standards Australia New Zealand Act 1991 (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 2015–16, FSANZ progressed 4 applications received prior to 1 October 2007:

(v) 0 were withdrawn;

(vi) 0 were rejected by FSANZ;

(vii) 0 were finalised and notified to the Forum;

(viii) 0 were considered after a request for a review and notified to the Forum; and

(ix) 4 were still being progressed as at 30 June 2016.

During 2015–16, FSANZ progressed 2 proposals prepared prior to 1 October 2007:

(v) 1 was abandoned by FSANZ;

(vi) 0 were finalised and notified to the Forum;

(vii) 0 were considered after a request for a review and notified to the Forum; and

(viii) 1 was still being progressed as at 30 June 2016.

(e) Any occasion during 2015–16 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 2015–16 and the reasons for those extensions:

Nil

(g) The number of applications made to the Administrative Appeals Tribunal during 2015–16 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 2015–16:

Nil

(i) The number of standards made under the FSANZ Act during 2015–16:

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

(j) The number of draft standards and draft variations approved during 2015–16 under:

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

Nil

(k) The number of occasions during 2015–16 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:

Nil

(l) The number of occasions during 2015–16 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:

Nil

(m) The number of occasions during 2015–16 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):

Nil

(n) The number of occasions during 2015–16 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:

Nil

(p) The number of occasions during 2015–16 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):

Nil

Applications received and Proposals prepared from 1 October 2007 onwards

Section 152 of the Food Standards Australia New Zealand Act 1991 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 2015–16:

19

(ab) The number of applications accepted under subsection 26(1) during 2015–16:

19

(ac) The number of applications rejected under subsection 26(1) during 2015–16 and the reasons for the rejections:

Nil

(ad) The number of applications withdrawn in 2015–16 under subsection 24(1) during the current year:

Nil

(ae) The number of applications accepted under subsection 26(1) during 2015–16 that FSANZ had not begun to assess under section 29 during 2015–16:

8

(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 2015–16:

Nil

(a) The number of applications that were considered under Subdivision D of Division 1 of Part 3 during 2015–16:

25

(b) The number of applications that were considered under Subdivision E of Division 1 of Part 3 during 2015–16:

Nil

(c) The number of applications that were considered under Subdivision F of Division 1 of Part 3 during 2015–16:

Nil

(d) The number of applications that were considered under Subdivision G of Division 1 of Part 3 during 2015–16:

Nil

(e) For each of those Subdivisions, the number of applications considered under that Subdivision that were disposed of during 2015–16 and the manner of their disposal:

Subdivision D:
13 Approved
1 Withdrawn
0 Rejected

Subdivision E:
0 Approved
0 Withdrawn

Subdivision F:
0 Approved
0 Withdrawn

Subdivision G:
0 Approved
0 Withdrawn

(f) For each of those Subdivisions, the average time taken to dispose of applications during 2015–16 (for Approval only):

Subdivision D:
8 months
A1100 8 months
A1104 11.5 months
A1106 8 months
A1107 7 months
A1108 8.5 months
A1109 7 months
A1110 7 months
A1111 8.5 months
A1112 8 months
A1114 7 months
A1116 8.5 months
A1118 8.5 months
A1120 6.5 months

Subdivision E:
N/A

Subdivision F:
N/A

Subdivision G:
N/A

(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 2015–16:

2

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

A1102 21 months
A1113 13 months

(g) The number of applications made during 2015–16 in relation to which a charge fixed under section 146 was payable:

4

(h) The number of applications made during 2015–2016 in relation to which no charge fixed under section 146 was payable:

14

(i) The average number of days that elapsed between the acceptance or rejection under section 26 of an application made during 2015–16 in relation to which no charge fixed under section 146 was payable, and the commencement of the assessment of the application under section 29:

206 days

A1117 accepted 7 August 2015, clock start 7 March 2016 (213 days)

A1119 accepted 16 October 2015, clock start 5 April 2016 (172 days)

A1121 accepted 9 November 2015, clock start 28 June 2016 (232 days)

(j) Each occasion during 2015–16 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:

2

A1095 Due 14 September 2015, completed 24 March 2016

A1104 Due 17 September 2015, completed 3 December 2015

(k) Each occasion during 2015–16 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 2015–16:

Nil

(l) The number of proposals prepared by FSANZ under section 55 during 2015–16:

5

(la) The number of proposals prepared under section 55 during 2015–16 that FSANZ had not begun to assess under section 59 during that year:

Nil

(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 2015–16

Nil

(n) The number of proposals that were disposed of during 2015–16 and the manner of their disposal:

10 Approved
0 Abandoned

(o) The average time taken to dispose of proposals under each of Subdivisions D, E, F, G and H of Division 2 of Part 3 during 2015–16:

General
13.5 months
P1016 51.5 months
P1031 20.5 months
P1037 6 months
P1038 3.5 months
P1039 7 months
P1041 6 months
M1011 10 months
M1012 3.5 months

Minor
3 months
P1040 3 months
M1013 3 months

Major
N/A

High level health claim variation
N/A

(p) The average number of days that have elapsed between the preparation of a proposal under section 55 to which Subdivision G of Division 1 of Part 3 does not apply and the commencement of the assessment of the proposal under section 59:

26 days
P1039 13 days
P1040 24 days
P1041 13 days
P1042 15 days
M1013 63 days

(pa) The number of proposals prepared under section 55 during a previous financial year that FSANZ had begun to assess under section 59 before the end 2015–16, but that FSANZ had not disposed of before the end of 2015–16:

6

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

P1024 42.5 months (prepared 13/12/12)

P1026 28 months (prepared 1/3/13)

P1027 38.5 months (prepared 18/4/13)

P1028 35.5 months (prepared 17/7/13)

P1030 17 months (prepared 1/2/14)

P1034 26 months (prepared 30/4/14)

(pc) The number of proposals declared under section 95 to be urgent proposals during 2015–16:

Nil

In relation to applications or proposals declared to be urgent under section 95, either in 2015–16 or in previous financial years, the number which were disposed of under section 101 and the manner of their completion:

Nil

(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:

Nil

(q) The number of applications made to the Administrative Appeals Tribunal during 2015–16 for review of decisions of FSANZ:

Nil

(r) The results of the applications made to the Administrative Appeals Tribunal that were determined during 2015–16:

N/A

(s) The number of standards made during 2015–16:

Gazettal and registration on the Federal Register of Legislation of amendments to the Australia New Zealand Food Standards Code occurs throughout the year after the Forum notifies FSANZ that it does not need to review its decision on a Standard or a variation to a Standard; or if, after a review by FSANZ, the Forum accepts or amends the Standards or variation to a Standard. Each series of amendments is sequentially numbered.

FSANZ gazetted amendments to the Australia New Zealand Food Standards Code relating to 14 applications and 11 proposals.

Amendment No. 156 (6 August 2015)
A1097 — Food derived from Herbicide-tolerant and Insect-protected Corn Line MON87411 To seek approval for food derived from a genetically modified glyphosate-tolerant and corn rootworm-protected corn line
A1098 — Serine Protease (Chymotrypsin) as a Processing Aid (Enzyme) To seek approval of a new enzyme, serine protease (chymotrypsin), sourced from a genetically modified strain of Bacillus licheniformis as a processing aid in the production of protein hydrolysates
A1099 — Serine Protease (Trypsin) as a Processing Aid (Enzyme) To seek approval of a new enzyme, serine protease (trypsin), sourced from a genetically modified strain of Fusarium venenatum as a processing aid in the production of protein hydrolysates
Amendment No. 157 (3 September 2015)
A1101 — Commencement of Dietary Fibre Claim Provisions To delay the commencement of provisions in Standard 1.2.7 for nutrition content claims about dietary fibre from 18 January 2016 for 12 months i.e. 18 January 2017
A1103 — Citric and Lactic Acids as Food Additives in Beer and Related Products To permit the extension of use of citric and lactic acids as food additives in beer
P1035 — Gluten Claims about Foods containing Alcohol To permit nutrition content claims about gluten in relation to foods (including beverages) containing more than 1.15% alcohol by volume
P1036 — Code Revision — Consequentials and Corrective Amendments To update the P1025 — Code Revision version of the Code to account for variations to the existing Code made in A1092, A1096, P1022 and P1029 and to correct errors
Amendment No. 158 (22 October 2015)
M1012 — Amendments to Standard 1.4.2 To consider introducing certain temporary MRLs for residues of agricultural and veterinary chemicals that may occur in food, in order to align standards with the APVMA temporary MRLs for coumatetralyl and warfarin in pork commodities
Amendment No. 159 (7 December 2015)
A1106 — Food derived from Herbicide-tolerant and Insect-protected Corn Line 4114 To seek approval for food derived from a genetically modified glufosinate-tolerant and insect-protected corn line DP-004114-3
A1107 — Asparaginase from Bacillus subtilis as a Processing Aid (Enzyme) To permit the use of a new microbial source for Asparaginase sourced from a genetically modified strain of Bacillus subtilis for use in food production to reduce the risk of acrylamide formation
P1016 — Hydrocyanic Acid in Apricot Kernels and other Foods To consider an amendment for hydrocyanic acid in raw apricot kernels, foods derived from them and potentially other foods
P1037 — Amendments associated with Nutrition Content and Health Claims To address inconsistencies and lack of clarity associated with Standard 1.2.7 and related standards to ensure that 1.2.7 operates as intended and also to provide exemptions for certain Health Star Rating label elements from 1.2.7 requirements
P1038 — Vitamin and Mineral Claims and Sodium Claims about Food containing Alcohol To address an inconsistency in the conditions for vitamin and mineral claims between Standards 1.2.7 and 1.3.2 and to permit nutrition content claims about salt and sodium in relation to foods (excluding beverages) containing more than 1.15% alcohol by volume
Amendment No. 160 (14 January 2016)
A1108 — Rebaudioside M as a Steviol Glycoside Intense Sweetener To include rebaudioside M in the list of permitted steviol glycoside products used as intense sweeteners
A1110 — Food derived from Insect-protected Soybean Line MON87751 To seek approval for food derived from a genetically modified insect-protected soybean line MON87511
Amendment No. 161 (22 February 2016)
A1100 — Maximum Permitted Level of Acesulphame Potassium in Chewing Gum To increase the maximum permitted level of acesulphame potassium (Ace-K) in chewing gum to align with the international regulations and so standardise formulations
A1104 — Voluntary Addition of Vitamins and Minerals to Nut- and Seed-based Beverages To seek permission for the voluntary addition of a range of vitamins and minerals to nut and seed-based beverages that provides a milk alternative for consumers with allergic/intolerant conditions
P1040 — Code Revision — Consequential and Corrective Amendments II To update the revised Code to correct typographical and transcription errors
M1013 — Schedule 20 — MRLs — Consequentials and Corrective Amendments To update Schedule 20 (commencing 1 March 2016) to reflect amendments made to Schedule 1 of current Standard 1.4.2 in 2015 and to correct technical and formatting errors
Amendment No. 162 (21 April 2016)
A1112 — Food derived from Herbicide-tolerant Corn Line MZHG0JG To seek approval for food derived from a genetically modified corn line MZHG0JG that is tolerant to the herbicides glyphosate and glufosinate ammonium
A1114 — Food derived from High Yield Corn Line MON87403 To seek approval for food derived from a genetically modified corn line MON87403 modified for increased yield
Amendment No. 163 (19 May 2016)
A1111 — Bacteriophage S16 and FO1a as a Processing Aid To seek approval for a preparation of two bacteriophages (S16 and FO1a) (Salmonelex™) as a processing aid to reduce Salmonella contamination in specific foods
P1031 —
Allergen Labelling Exemptions
To allow for specific exemptions from allergen declarations for glucose syrups from wheat starch, fully refined soy oil, soy derivatives (tocopherols and phytosterols), and distilled alcohol from wheat or whey
P1039 — Microbiological Criteria for Infant Formula To amend the Code to include food safety microbiological criteria for infant formula, aligning with international (Codex) standards
M1011 — Maximum Residue Limits (2015) To consider varying certain maximum residue limits for residues of agricultural and veterinary chemicals that may occur in food

(t) The number of draft standards and draft variations approved during 2015–16 under each of the following:

(i) section 33 and 63:

21

(ii) section 41 and 69:

2

(iii) section 52 and 78:

Nil

(iv) section 97:

Nil

(ta) The number of variations given to the Authority under subsection 82(6) during 2015–16:

The Australian Pesticides and Veterinary Medicines Authority gazetted and registered on the Federal Register of Legislation eight amendments to Schedule 1 of Standard 1.4.2:

APVMA 5, 2015 14 July 2014
APVMA 6, 2015 11 August 2015
APVMA 7, 2015 8 September 2015
APVMA 8, 2015 6 October 2015
APVMA 9, 2015 3 November 2015
APVMA 10, 2015 1 December 2015
APVMA 1, 2016 12 January 2016
APVMA 2, 2016 9 February 2016

 

The Australian Pesticides and Veterinary Medicines Authority gazetted and registered on the Federal Register of Legislation six amendments to Schedule 20:

APVMA 1, 2016 1 March 2016
APVMA 2, 2016 8 March 2016
APVMA 3, 2016 5 April 2016
APVMA 4, 2016 3 May 2016
APVMA 6, 2016 31 May 2016
APVMA 7, 2016 28 June 2016

(u) The number of occasions during 2015–16 when requests were made by the Council under Division 3 of Part 3 for a review of a draft standard or draft variation:

1

(v) The number of occasions during 2015–16 when a draft standard or draft variation was rejected by the Council under Division 3 of Part 3:

Nil

(w) The number of occasions during 2015–16 when requests were made by the Council under Division 4 of Part 3 for a review of a standard or variation:

Nil

(x) The number of occasions during 2015–16 when a standard or variation was revoked or amended by the Council under Division 4 of Part 3:

Nil

(y) A summary of policy guidelines notified to FSANZ during 2015–16:

No guidelines were notified.

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

N/A

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