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Appendix 4 - Report against the FSANZ Act requirements

Applications received and Proposals prepared before 1 October 2007

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 2016–2017, FSANZ progressed 4 Applications received prior to 1 October 2007:

(v) 0 withdrawn;
(vi) 0 rejected by FSANZ;
(vii) 0 finalised and notified to the Forum;
(viii) 0 considered after a request for a review and notified to the Forum; and
(ix) 4 were still being progressed as at 30 June 2017.

During 2016–2017, FSANZ progressed 1 Proposal prepared prior to 1 October 2007:

(v) 0 withdrawn;
(vi) 0 rejected by FSANZ;
(vii) 0 finalised and notified to the Forum;
(viii) 0 considered after a request for a review and notified to the Forum; and
(ix) 1 were still being progressed as at 30 June 2017.

(e) Any occasion during 2016–2017 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 2016–2017 and the reasons for those extensions:

Nil

(g) The number of applications made to the Administrative Appeals Tribunal during 2016–2017 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 2016– 2017:

Nil

(i) The number of standards made under the FSANZ Act during 2016–2017:

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

(j) The number of draft standards and draft variations approved during 2016–2017 under:

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

Nil

(k) The number of occasions during 2016–2017 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 2016–2017 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 2016–2017 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 2016–2017 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 2016–2017 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 2016–2017:

14

(ab) The number of applications accepted under subsection 26(1) during 2016–2017:

12

(ac) The number of applications rejected under subsection 26(1) during 2016–2017 and the reasons for the rejections:

2

PA1145

Rejected at Admin Assessment 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.

PA1148

Rejected at Admin Assessment 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.

(ad) The number of applications withdrawn in 2016–2017 under subsection 24(1) during the current year:

1

(ae) The number of applications accepted under subsection 26(1) during 2016–2017 that FSANZ had not begun to assess under section 29 during 2016–2017:

2

(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 2016–2017:

Nil

(a) the number of applications that were considered under Subdivision D of Division 1 of Part 3 during 2016–2017:

28

(b) the number of applications that were considered under Subdivision E of Division 1 of Part 3 during 2016–2017:

Nil

(c) the number of applications that were considered under Subdivision F of Division 1 of Part 3 during 2016–2017:

Nil

(d) the number of applications that were considered under Subdivision G of Division 1 of Part 3 during 2016–2017:

Nil

(e) for each of those Subdivisions, the number of applications considered under that Subdivision that were disposed of during 2016–2017 and the manner of their disposal:

Subdivision D:

14 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 2016–2017 (for Approval only):

Subdivision D:

8.1 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 2016–2017:

5

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

A1102 33 months

A1127 15 months

A1129 14 months

A1130 14 months

A1131 13.5 months

(g) the number of applications made during 2016–2017 in relation to which a charge fixed under section 146 was payable:

6

(h) the number of applications made during 2016–2017 in relation to which no charge fixed under section 146 was payable:

5

(i) the average number of days that elapsed between the acceptance or rejection under section 26 of an application made during 2016–2017 in relation to which no charge fixed under section 146 was payable, and the commencement of the assessment of the application under section 29:

137.5 days

(j) each occasion during 2016–2017 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:

1

A1102 Due 9 August 2016

(k) each occasion during 2016–2017 on which FSANZ extended the consideration period under subsection 109(4), and the reasons for that extension:

0

(ka) The number of applications declared under section 95 to be urgent applications during 2016–2017:

0

(l) the number of proposals prepared by FSANZ under section 55 during 2016–2017:

3

(la) The number of proposals prepared under section 55 during 2016–2017 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 2016–2017

0

(n) the number of proposals that were disposed of during 2016–2017 and the manner of their disposal:

0

(k) each occasion during 2016–2017 on which FSANZ extended the consideration period under subsection 109(4), and the reasons for that extension:

5 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 2016–2017:

General

20.2 months

Minor

N/A

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

27 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 2016–2017, but that the FSANZ had not disposed of before the end of 2016–2017:

5

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

P1024 54.5 months (prepared 13/12/12)

P1028 47.5 months (prepared 17/7/13)

P1030 41 months (prepared 1/2/14)

P1034 36 months (prepared 30/4/14)

P1044 6.5 months (prepared 19/12/16)

(pc) The number of proposals declared under section 95 to be urgent proposals during 2016–2017:

Nil

In relation to applications or proposals declared to be urgent under section 95, either in 2016–2017 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 2016–2017 for review of decisions of FSANZ:

Nil

(r) the results of the applications made to the Administrative Appeals Tribunal that were determined during 2016–2017:

N/A

(s) the number of standards made during 2016–2017:

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 15 applications and 4 proposals.

Amendment No. 164 (21 July 2016)
A1109 – Glutaminase from Bacillus amyloliquefaciens as a Processing Aid (Enzyme) To permit glutaminase derived from Bacillus amyloliquefaciens as a processing aid in the production of certain seasoning ingredients or foods used for seasoning as an alternative to the use of monosodium glutamate.
A1116 – Food derived from Herbicide-tolerant & insect-protected Corn Line MZIR098 To seek approval for food derived from a genetically modified corn line MZHiR098 that is tolerant to the herbicide glufosinate ammonium and protected against corn rootworm.
A1120 – Agarose ion Exchange Resin as a Processing Aid for Lactoferrin Production To permit the use of agarose ion exchange resin as a processing aid in the production of high purity lactoferrin from bovine milk and milk-related products.
Amendment No. 165 (1 September 2016)
A1118 – Food derived from Herbicide-tolerant Corn Line MON87419 To seek approval for food derived from genetically modified corn line MON87419 which is tolerant to dicamba and glufosinate herbicides.
P1041 – Removal of Country of Origin Labelling Requirements To remove country of origin labelling requirements from the Australia New Zealand Food Standards Code as part of proposed new arrangements where the requirements will fall under Australian Consumer Law.
Amendment No. 166 (12 January 2017)
A1090 – voluntary Addition of vitamin D to Breakfast Cereal To permit the voluntary addition of vitamin D to breakfast cereal.
A1113 – Extension of Use of Propionates in Processed Meat To request the extension of use of propionates as anti-microbial preservatives in processed meat products.
A1115 – irradiation of Blueberries & Raspberries To seek permission to irradiate blueberries and raspberries for phytosanitary purposes against fruit flies and other critical plant pests, at levels between 150 Gray (Gy) and 1 kGy.
P1027 – Managing Low-level Ag & vet Chemicals without MRLs To manage low-level agricultural and veterinary chemicals without MRLs (i.e. the food is not listed in Schedule 20, but the chemical is).
Amendment No. 167 (9 February 2017)
A1117 – Extension of Use of L-cysteine as a Food Additive To extend the use of L-cysteine monohydrochloride to limit enzymatic browning of fresh-cut avocado and banana and so extend the shelf-life.
A1119 – Addition of Water to facilitate Wine Fermentation To permit the addition of water to dilute high sugar to aid fermentation in the production of wine, sparkling wine and fortified wine.
A1128 – Food derived from reduced Acrylamide Potential & Browning Potato Line E12 To seek approval for food derived from a genetically modified potato line, E12 which has reduced acrylamide potential and reduced browning (black spot).
Amendment No. 168 (13 April 2017)
A1132 – Broaden Definition of Steviol Glycosides (intense Sweetener) To expand the definition of steviol glycosides for use as an intense sweetener to include all steviol glycosides present in the Stevia rebaudiana Bertoni leaf.
P1043 – Code Revision (2016) To make minor amendments including the correction of typographical errors, inconsistencies and formatting issues and updating of references.
Amendment No. 169 (11 May 2017)
P1042 – Low THC Hemp Seeds as Food To develop a food regulatory measure to permit the addition to food of products from seeds of low tetrahydrocannabinol varieties of Cannabis sativa.
Amendment No. 170 (25 May 2017)
A1121 – Oryzin (Protease) as a Processing Aid (Enzyme) To permit the use of oryzin (protease) from Aspergillus melleus as an enzyme for use in baking, flavouring production and dairy, egg, meat, fish, protein and yeast processing.
A1124 – Alternative DHA-rich Algal Oil for infant Formula Products To permit the addition of DHA-rich algal oil from Schizochytrium sp. as an alternative or replacement oil for other currently permitted DHA-rich algal oils added to infant formula products.
A1133 – Maximum Residue Limits for Avilamycin in specific Pig Commodities To establish MRLs for avilamycin in specific pig commodities for import harmonisation purposes.
A1134 – increased Concentration of Plant Sterols in Breakfast Cereals To seek approval for the exclusive use for 15 months of an increased concentration of plant sterols to be added to breakfast cereals under the novel food provisions.
P1026 – Lupin as an Allergen To consider options to regulate food containing lupin as a food allergen.

(t) the number of draft standards and draft variations approved during 2016–2017 under each of the following:

(i) section 33 and 63:

19

(ii) section 41 and 69:

Nil

(iii) section 52 and 78:

Nil

(iv) section 97

Nil

(ta) the number of variations given to the Authority under subsection 82(6) during 2016–2017

The Australian Pesticides and Veterinary Medicines Authority gazetted and registered on the Federal Register of Legislation 11 amendments to Schedule 20:

APVMA 7, 2016 26 July 2016

APVMA 8, 2016 23 August 2016

APVMA 9, 2016 4 October 2016

APVMA 10, 2016 15 November 2016

APVMA 11, 2016 29 November 2016

APVMA 1, 2017 10 January 2017

APVMA 2, 2017 7 February 2017

APVMA 3, 2017 21 March 2017

APVMA 4, 2017 18 April 2017

APVMA 5, 2017 16 May 2017

APVMA 6, 2017 13 June 2017

(u) the number of occasions during 2016–2017 when requests were made by the Council under Division 3 of Part 3 for a review of a draft standard or draft variation:

Nil

(v) the number of occasions during 2016–2017 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 2016–2017 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 2016–2017 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 2016–2017:

No guidelines were notified.

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

N/A

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