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Appendix 4: Report Against the FSANZ ACT Requirements

​​​​​(October 2019)​

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 2018–2019, 2 applications received before 1 October 2007 remained on the Work Plan pending advice from applicants:

1. 0 withdrawn;

2. 0 rejected by FSANZ;

3. 0 finalised and notified to the Forum;

4. 0 considered after a request for a review and notified to the Forum; and

5. 2 were still being progressed as at 30 June 2019.

During 2018–2019, one proposal (prepared before 1 October 2007) remained on our Work Plan:

1. 0 withdrawn;

2. 0 rejected by FSANZ;

3. 0 finalised and notified to the Forum;

4. 0 considered after a request for a review and notified to the Forum; and

5. 1 was still being progressed as at 30 June 2019

(e) Any occasion during 2018–2019 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 2018–2019 and the reasons for those extensions:

Nil

(g) The number of applications made to the Administrative Appeals Tribunal during 2018– 2019 for a review of a decision made by FSANZ:

1

(h) The results of the applications made to the Administrative Appeals Tribunal that were determined during 2018–2019:

Nil

(i) The number of standards made under the FSANZ Act during 2018–2019:

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

(j) The number of draft standards and draft variations approved during 2018–2019 under: Section 18 of the FSANZ Act; or (Final Assessment)

Nil

(k) The number of occasions during 2018–2019 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 2018–2019 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 2018–2019 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):

2

(n) The number of occasions during 2018–2019 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 2018–2019 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 2018–2019:

16

(ab) The number of applications accepted under subsection 26(1) during 2018–2019:

13

(ac) The number of applications rejected under subsection 26(1) during 2018–2019 and the reasons for the rejections:

Nil

(ad) The number of applications withdrawn in 2018–2019 under subsection 24(1) during the current year:

2

(ae) The number of applications accepted under subsection 26(1) during 2018–2019 that FSANZ had not begun to assess under section 29 during 2018–2019:

4

(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 of 2018–2019:

Nil

(a) The number of applications that were considered under Subdivision D of Division 1 of Part 3 during 2018–2019:

14

(b) The number of applications that were considered under Subdivision E of Division 1 of Part 3 during 2018–2019:

Nil

(c) The number of applications that were considered under Subdivision F of Division 1 of Part 3 during 2018–2019:

1

(d) The number of applications that were considered under Subdivision G of Division 1 of Part 3 during 2018–2019:

Nil

(e) For each of those Subdivisions, the number of applications considered under that Subdivision that were disposed of during 2018–2019 and the manner of their disposal:

Subdivision D:

15 Approved

2 Withdrawn

Nil Rejected

Subdivision E:

Nil Approved

Nil Withdrawn

Subdivision F:

Nil Approved

Nil Withdrawn

Subdivision G:

Nil Approved

Nil Withdrawn

 

(f) For each of those Subdivisions, the average time taken to dispose of applications during 2018–2019 (for Approval only):

Subdivision D:

9 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 of 2018–2019:

6

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

A1155 18 months

A1159 16 months

A1160 16 months

A1163 13 months

A1164 13 Months

A1166 13 months

(g) The number of applications made during 2018–2019 in relation to which a charge fixed under section 146 was payable:

9

(h) The number of applications made during 2018–2019 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 2018–2019 in relation to which no charge fixed under section 146 was payable, and the commencement of the assessment of the application under section 29:

143

 

(j) Each occasion during 2018–2019 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:

Nil

 

(k) Each occasion during 2018–2019 on which FSANZ extended the consideration period under subsection 109(4), and the reasons for that extension:

A1155 - Consideration period extended by 6 months due to complexity of the Application.

 

(ka) The number of applications declared under section 95 to be urgent applications during 2018–2019:

Nil

 

(l) The number of proposals prepared by FSANZ under section 55 during 2018–2019:

3

 

(la) The number of proposals prepared under section 55 during 2018–2019 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 2018–2019:

Nil

 

(n) The number of proposals that were disposed of during 2018–2019 and the manner of their disposal:

2 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 2018–2019:

General

N/A

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:

P1024 19 days

P1028 123 days

P1030 21 days

P1044 76 days

P1047 21 days

P1048 21 days

P1049 21 days

P1050 21 days

M1015 21 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 of 2018–2019, but that FSANZ had not disposed of before the end of 2018–2019:

5

 

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

A1155 – 2’–FL and LNnT in infant formula and other products. Delay due to the complexity of new regulatory elements in the application, and issues raised in submissions.

P1024 – Revision of the Regulation of Nutritive Substances & Novel Food. Delay due to the complexity of issues, variety of stakeholder views and some resourcing issues. An improved framework will consider a number of broader legislative and policy issues which have arisen. P1024 has been divided into two stages for further progression in 2019.

P1028 – Infant Formula Products. Delay due to complexity of issues, expanded scope, consideration of the divergent stakeholder views and some resourcing issues. Work on this large and complex project is progressing. We have been undertaking targeted consultation to progress our assessment to this stage. All issues previously considered in the 2016 (infant formula) and 2017 (special use infant formula) consultation papers will be addressed in the 1st Call for Submissions for release toward end of 2019.

P1030 – Composition & Labelling of Electrolyte Drinks. Delay due to complexity of issues raised in submissions and other work priorities. Project scope has been narrowed in response to submitter’s concerns. A consultation discussion paper is planned for release later in 2019.

 

(pc) The number of proposals declared under section 95 to be urgent proposals during 2018–2019:

Nil

 

In relation to applications or proposals declared to be urgent under section 95, either in 2018–2019 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 2018– 2019 for review of decisions of FSANZ:

Nil

 

(r) The results of the applications made to the Administrative Appeals Tribunal that were determined during 2018–2019:

N/A

 

(s) The number of standards made during 2018–2019:

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 16 applications, and one proposal.

 

Amendment No. 181 (23 October 2018)
A1146 – Thermolysin (Protease) as an enzyme processing aid Permit the use of thermolysin (protease) from Anoxybacillus caldiproteolyticus  as a processing aid in protein, dairy, egg, meat and fish processing and flavour production.
Amendment No. 182 (29 November 2018)
Application A1137 - Polysorbate 20 as a Food AdditivePermit the use of polysorbate 20 as an emulsifier
Amendment No. 183 (23 January 2019)
A1129 – Monk Fruit Extract as a Food AdditivePermit monk fruit extract as a food additive, specifically as an intense sweetener
A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40Seek approval for food derived from SHO safflower lines 26 and 40, genetically modified to produce high levels of oleic acid in the seed.
A1157 – Enzymatic production of Rebaudioside MSeek approval for a new specification for rebaudioside M produced by an enzymatic conversion method.
A1158 – Rosemary extract as a food additivePermit the use of rosemary extract as a food additive with the technological purpose of antioxidant.
Amendment No. 184 (27 February 2019)
A1161 – Potassium Polyasparatate as a food additive in winePermit the use of Potassium Polyaspartate as a food additive in wine at a maximum permitted limit of 100mg/L
Amendment No. 185 (6 June 2019)
A1149 – Addition of Steviol Glycosides in Fruit DrinksAmend Schedule 15 relating to Standard 1.3.1 of the Australian New Zealand Food Standards Code (FSC), to include the addition of steviol glycosides in Fruit Drinks at a level of 200 mg/kg steviol equivalents.
A1162 – Triacylglycerol lipase preparation from Trichoderma reesei as a PA (Enzyme)Permit the use of enzyme triacylglycerol lipase from Trichoderma reesei as a processing aid in the manufacturing of cereal based products.
A1165 – Lysophospholipase from Trichoderma reesei as a PA (Enzyme)Permit the use of lysophospholipase enzyme from Trichoderma reesei as a processing aid for use in starch processing
A1167 – Lactase from Bacillus subtilis as a PA (Enzyme)Permit the use of  lactase enzyme from Bacillus subtilis as a processing aid for use in dairy processing.

 

(t) The number of draft standards and draft variations approved during 2018–2019 under each of the following:

Section 33 and 63:

16

Section 41 and 69:

Nil

Section 52 and 78:

Nil

Section 97:

Nil

(ta) The number of variations given to the Authority under subsection 82(6) during 2018– 2019:

The Australian Pesticides and Veterinary Medicines Authority gazetted and registered on the Federal Register of Legislation 10 amendments to Schedule 20:

Gazette No. 9, 7 May 2019

Gazette No. 7, 9 April 2019

Gazette No. 4, 26 February 2019

Gazette No. 2, 29 January 2019

Gazette No. 24, 4 December 2018

Gazette No. 22, 6 November 2018

Gazette No. 19, 25 September 2018

Gazette No. 17, 28 August 2018

Gazette No. 16, 14 August 2018

Gazette No. 13, 3 July 2018

(u) The number of occasions during 2018–2019 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 2018–2019 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 2018–2019 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 2018–2019 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 2018–2019:

No guidelines were notified.

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

N/A

 

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