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Chapter 1: Food Standards

​​​​​(October 2019) 

New breeding techniques

In 2018 we issued a consultation paper on how the Food Standards Code applies to food derived using new breeding techniques (NBTs).

The consultation paper sought feedback from the community on whether food derived from NBTs should be captured for pre-market safety assessment approval under Standard 1.5.2 and whether the definitions for ‘food produced using gene technology’ and ‘gene technology’ in Standard 1.1.2–2 should be changed to improve clarity about which foods require pre-market approval.

Following the consultation, we prepared a preliminary report summarising the views of submitters. The preliminary report was released in August 2018, along with submissions. While the submissions show there are diverse views in the community about the safety and regulation of food derived using NBTs, a common thread was that the current definitions are outdated and require amendment.

We have been carefully considering the consultation outcomes and possible options for moving forward, including whether to prepare a proposal to amend the Code. We are aiming to release the final review report in early 2020, at which point we will indicate whether we intend to proceed with a proposal to amend the Code.

Pregnancy warnings on alcohol

At the Ministerial Forum on Food Regulation (the Forum) meeting in October 2018, FSANZ was asked to consider changing the Code to require pregnancy warning labels on packaged alcoholic beverages and that the work be undertaken expeditiously. In response, FSANZ prepared Proposal P1050 – Pregnancy warning labels on alcoholic beverages which was publicly notified in early November 2018.

The primary focus of the proposal is the design and implementation of a mandatory pregnancy warning label.

In early 2019, FSANZ held consultation meetings with the alcohol industry sector and public health groups in both Sydney and Wellington, and with jurisdictions. In response to strong stakeholder support for consumer testing and to add further robustness to the available evidence, FSANZ commissioned consumer testing of the wording of the pregnancy warning label. FSANZ has reviewed existing evidence on the design of warning labels, including evidence on features that attract consumer attention. Outcomes from the consumer testing will supplement the existing evidence base.

Further targeted consultations were held in late June 2019 to seek stakeholder views of a proposed warning label. Findings from consumer testing will be included in the call for submissions report, which is expected to be released in late 2019.

Review of formulated supplementary sports foods standard

Following a stakeholder roundtable in July 2018 on the safety of sports supplements, the Forum agreed to an action plan that included a request to FSANZ to conduct a full review of Standard 2.9.4 – Formulated supplementary sports foods as a matter of priority.

We have prepared a proposal and are currently developing a situational analysis to inform the direction of future sports food regulation. This work will investigate the current complex regulatory environment, including the food medicine interface, compliance with current regulation, and the higher risk appetite of sports food industry players, including importers, and some sports consumers.

The review of this standard will involve working closely with the Australian and New Zealand regulators of therapeutic goods and all jurisdictions in policy and enforcement roles to determine the scope of sports food regulation, and an appropriate approach to managing risk. Due to the complexity of the work, including the broad range of stakeholders and number of products to consider, this proposal will take several years to complete.

Work Plan

As required under Section 20 of the Food Standards Australia New Zealand Act 1991 (the Act), FSANZ maintains a publicly available work plan, which provides details of the progress of all applications and proposals to amend the Code.

Applications received, or proposals prepared before 1 October 2007, continue to be assessed under the procedures in place at that time. The tables below reflect the two types of approach. Information on the different procedures for assessing applications is in the Work Plan.

Table 1: Applications and proposals on the Work Plan

​ As at​ 30 June 2017 ​ 30 June 2018 ​ 30 June 2019

General procedure

15 (4 paid)

19 (10 paid)

20 (8 paid)

Minor procedure

0

0

0

Major procedure

3

1 (paid)

4 (1 paid)

High-level health claims

0

0

0

Urgent applications or proposals

0

1

0

Under review

0

0

0

TOTAL 18 21 24

With the Forum or awaiting notification to the Forum

5

5

7

Estimated waiting time for unpaid applications

5 months approx

5 months approx

6 months approx

Note: Applications can be either paid or unpaid. While the same statutory timeframes apply, work on paid applications starts immediately once payment is received while work on unpaid applications starts when resources become available reflecting the number of applications already underway. The current lead time for starting work on unpaid applications is approximately 6 months, which is consistent with the historical range of 3–9 months. 

 

Table 2: Applications and proposals on the Work Plan (received or prepared before 1 October 2007)

​As at​30 June 201730 June 2018​30 June 2019

Group 1

1

1

1

Group 2

4

4

2

Under review

0

0

0

TOTAL

5

5

3

With the Forum or awaiting notification to the Forum

0

0

0

Estimated waiting time Group 2

0

0

0

 

 Tables 3 and 4 summarise our performance in developing food standards.

 

Table 3: Total applications received and accepted onto the Work Plan and proposals prepared

As at2016–172017–182018–19

Applications

12

18

11

Proposal

3

3

2

TOTAL

15

21

13

Note: This includes one cost-recovered application which was rejected because the applicant chose not to pay the fees owing for an exclusive capturable commercial benefit by the due date.

 

Table 4: Applications and proposals finalised

As at2016–172017–182018–19

Approvals made by the FSANZ Board

19

14

20

Final assessments made by the FSANZ Board

0

0

0

Applications withdrawn or rejected*

3

2

4

TOTAL completed

 

22

 

16

 

24

 

Note: This includes potential applications rejected following an administrative assessment or withdrawn before an administrative assessment was completed.

More information on the figures above are in Appendix 4. There may also be some discrepancies where decisions have been made in one financial year and the notification of that decision is made in the next financial year.

Table 5 shows the status of the applications and proposals received or prepared before 1 October 2007 and which remain on the Work Plan.  

Table 5: Status of remaining applications and proposals received or prepared before 1 October 2007

Application / Proposal Step Reason

A576 – Labelling of Alcoholic Beverages with a Pregnancy Health Advisory Label

Draft assessment

Received 17 February 2006 – deferred at the request of the Applicant and consideration of
P1050.

A613 – Definitions for Nutritive Substance & Nutritive Ingredient

Initial assessment

Received 11 August 2007. Waiting on advice from the Applicant and consideration of
P1024.

P290 – Food Safety Programs for Catering Operations to the General Public

Final

Prepared 13 May 2004 – deferred pending a new proposal.

 

Table 6: Notification outcomes of the Australia and New Zealand Ministerial Forum on Food Regulation

2016–17 2017–18 2018–19

Approval decisions notified

15

16

20​

Final assessment decisions notified

0

0

​0

Requests for review

0

0

​0

​Review decisions notified

​0

​0

​0

 

Reviews requested by the Australia and New Zealand Ministerial Forum on Food Regulation

The forum is notified of FSANZ decisions to vary standards. Ministers can request a review of a FSANZ decision following notification provided that six of the ten ministers request the review. More details on the review process are in the Application Handbook.

Under the 2008 Inter–Governmental Food Regulation Agreement, the forum can request reviews of FSANZ decisions based on one or more of the following criteria:

1.  it is not consistent with existing policy guidelines set by the forum

2.  it is not consistent with the objectives of the legislation which establishes FSANZ

3.  it does not protect public health and safety

4.  it does not promote consistency between domestic and international food standards where these are at variance

5.  it does not provide adequate information to enable informed choice

6.  it is difficult to enforce or comply with in both practical or resource terms

7.  it places an unreasonable cost burden on industry or consumers.

No reviews were requested in 2018–19.

Ministerial policy guidelines and statements

The forum is responsible for developing food regulatory policy for domestic and imported foods and developing policy guidelines for setting food standards for domestic and imported foods. In developing or reviewing food regulatory measures and variations to food regulatory measures, under section 18 of the FSANZ Act, FSANZ must have regard to any written policy guidelines formulated by ministers and notified to FSANZ for these purposes.

No guidelines were notified.

Gazettal of variations 1 July 2018 to 30 June 2019

Variations to standards arising from 14 applications were gazetted (compared to 14 in 2017–18). Variations to standards arising from 3 proposals were gazetted (compared to 2 in 2017–18). See Appendix 4 for more detail.

Table 7: Gazetted food standard variations

​Application / ProposalDescription​Date of gazettal ​

A1129 – Monk Fruit Extract as a Food Additive

To permit monk fruit extract as a food additive, specifically as an intense sweetener.

No review requested by Forum Gazetted 23 January 2019 (Amendment 183)

A1137 – Polysorbate 20 as a Food Additive

To permit the use of polysorbate 20 as an emulsifier.

No review requested by Forum Gazetted 29 November 2018 (Amendment 182)

A1144 – Re-categorising coconut milk for food additive permissions

To consider whether the food category for food additive permissions for coconut milk products is more appropriate under fruits, rather than beverages.

No review requested by Forum Gazetted 23 August 2018 (Amendment 180)

A1146 – Thermolysin (Protease) as a Processing Aid (Enzyme) (Level 2)

To permit the use of thermolysin (protease) from Anoxybacillus caldiproteolyticus as a processing aid in protein, dairy, egg, meat and fish processing and flavour production.

No review requested by Forum Gazetted 23 October 2018 (Amendment 181)

A1149 – Addition of Steviol Glycosides in Fruit Drinks

To amend 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.

No review requested by Forum Gazetted 6 May 2019 (Amendment 185)

A1151 – ß-Galactosidase from Papiliotrema terrestris as a Processing Aid (Enzyme)

To amend Schedule 18 of the Australia New Zealand Food Standards Code to include ß-Galactosidase from Papiliotrema terrestris as a Processing Aid.

No review requested by Forum Gazetted 23 August 2018 (Amendment 180)

A1153 – Endo xylanase from T. reesei as a Processing Aid

To amend Schedule 18 of the Australia New Zealand Food Standards Code to include a genetically modified strain of Trichoderma reesei as permitted source for Endo-1,4 (3) – ß-xylanase (E.C.3.2.1.8).

No review requested by Forum Gazetted 23 August 2018 (Amendment 180)

A1154 – Food derived from insect–protected cotton line MON88702

To seek approval for food derived from a genetically– modified insect–protected cotton line, MON88702.

No review requested by Forum Gazetted 23 August 2018 (Amendment 180)

A1158 – Rosemary extract as a food additive

To permit the use of rosemary extract as a food additive with the technological purpose of antioxidant.

No review requested by Forum Gazetted 23 January 2019 (Amendment 183)

A1167 – Lactase from Bacillus subtilis as a Processing Aid (Enzyme)

To permit the use of lactase enzyme from Bacillus subtilis as a processing aid for use in dairy processing.

No review requested by Forum Gazetted 6 May 2019 (Amendment 185)

A1161 – Potassium Polyasparatate as a food additive in wine

​To permit the use of Potassium Polyaspartate as a food additive in wine at a maximum permitted limit of 100mg/L.

No review requested by Forum Gazetted 27 February 2019 (Amendment 184)

P1046 – L–amino acid acetate in Food for Special Medical Purposes

To remove a negative impact on trade in food for special medical purposes (FSMP) by permitting acetate forms of L-amino acids.

Reaffirmed

P1048 – Code revision 2018

To make minor amendments including the correction of typographical errors, inconsistencies and formatting issues and updating of references.

No review requested by Forum Gazetted 29 November 2018 (Amendment 182)

M1015 – Maximum residue limits

To consider varying certain maximum residue limits for residues of agricultural and veterinary chemicals that may occur in food.

No review requested by Forum Gazetted 23 August 2018 (Amendment 180)

 

Maximum residue limits

Maximum residue limits (MRLs) are listed in Schedule 20 of the Code and are set for agricultural and veterinary (agvet) chemicals at levels that reflect the highest concentrations that may occur in foods from the approved conditions of use. MRLs are therefore not direct safety limits but nevertheless FSANZ undertakes an assessment to ensure that the residues are safe for the consumer.

In 2018–19 FSANZ undertook 185 MRL–related dietary exposure assessments (DEAs) for agvet chemicals. This included routine reviews of Australian Pesticides and Veterinary Medicines Authority (APVMA) DEAs and the 2018 MRL harmonisation proposal, Proposal M1016. The MRL process also resulted in the establishment of 29 All other foods except animal food commodities (AoF)[1] MRLs for low-level inadvertent chemical residues in food, for the chemicals assessed as suitable to have this in MRL category.

Proposal M1016, considered 99 agvet chemicals for a total of 88 DEAs and 234 chemical/ food commodity combinations requested by domestic and overseas stakeholders. The proposal ensured that the existence or absence of Australian MRLs in Schedule 20 of the Code did not pose a barrier to food trade. It allowed Australia to meet its WTO obligations while enabling the importation of safe food commodities.

The APVMA also has the power to amend permitted MRLs in Schedule 20 as a result of amendments to domestic use of agricultural and veterinary chemicals (see Appendix 4 for further information).

We are required by the FSANZ Act to provide advice about applications and variations that are being considered by the APVMA that may result in an amendment to the Code. FSANZ considered 97 DEAs from 18 APVMA notifications of proposed amendments for 278 food/chemical commodity combinations. We notify the public via our Notification Circular of progress with any proposed amendments during the APVMA’s MRL consideration process.

FSANZ continues to liaise closely with the APVMA and the Department of Agriculture and Water Resources to ensure that agvet chemical residues in the Australian food supply do not pose health and safety concerns to consumers.

Table 8: Summary of routine APVMA and Harmonisation proposal MRL DEAs (up to 30 June 19)

Year 2012–13 2013–14 2014–15 2015–16 2016–17 2017– 18 2018–19

Number of regular DEA notifications

29

27

29

38

27  

22

18

Number of DEA approved

93

112

92

122

84

87

97

Emergency Permit DEA notifications

1

5

1

0

0

0

1

DEAs relating

to pesticide

contamination

incident(s)

13

 

Proposal numberM1008M1009M1010M1011M1014M1015M1016

MRL harmonisation request DEAs

25

70

93

48

72

 

90

88

Total DEAs (routine and harmonisation requests)

118

182

185

170

156

177

185

 

 

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