Proposal P1044 – Plain English Allergen Labelling
In December 2016, we began working on a new proposal to investigate changes to the Code to ensure allergens are declared on food labels more clearly. FSANZ is seeking to improve the clarity of labelling by looking at the use of plain English words and terms when declaring allergens on their food labels. These potential changes will mean allergen-sensitive consumers can better identify foods that are safe to purchase and also make it easier for the food industry to provide safe and accurate information about food allergens.
FSANZ consulted on the proposal from 1 March to 10 May 2018 and is now considering submissions and developing proposed amendments to the Code. We expect to conduct a further round of public consultation in the first half of 2019.
Application A1138 – Food derived from provitamin A rice line GR2E
Rice line GR2E is a genetically modified line developed within the
Golden Rice project that began in the late 1990s with the humanitarian aim of complementing existing vitamin A deficiency control measures in high-risk countries, including Bangladesh, Indonesia, and the Philippines. An application for food approval was submitted by the International Rice Research Institute, a non-government organisation based in the Philippines. GR2E has been modified to produce beta-carotene, a vitamin A precursor that can be metabolised to vitamin A in the human body.
There is no intention to grow or sell GR2E in Australia. The application was made for trade reasons (in the unlikely event that small amounts of Golden Rice may inadvertently be present in shipments of rice to Australia or New Zealand).
The approval of food from GR2E rice was gazetted in February 2018.
Application A1143 – Food derived from DHA canola line NS-B50027-4
This canola line was genetically modified to produce the omega 3 long chain fatty acid docosahexaenoic acid (DHA) in the seeds.
DHA, which is mainly obtained from eating seafood and marine oils, plays a role in physiological functions including regulating inflammation and immune function, and cardiovascular function.
To date, DHA and EPA are primarily sourced from oils extracted from wild‑caught fish, which consume algae containing these healthy oils. The DHA canola line represents a sustainable and land-based source of DHA and EPA to meet demand from aquaculture and the food industry.
The approval of food from the DHA canola line was gazetted in February 2018.
P1024 – Revision of the Regulation of Nutritive Substances and Novel Food
FSANZ is continuing to develop a new framework for regulating nutritive substances and novel foods. In response to stakeholder feedback, FSANZ’s assessment has included discussion of potential benefits that might be possible if the
Food Standards Australia New Zealand Act 1991 was amended. While FSANZ can’t amend the Act, stakeholders have noted Proposal P1024 provides an opportunity for discussion about legislative change, particularly in the context of building a proportionate and agile framework. We conducted targeted stakeholder consultation on this and other aspects of a new framework during 2017–18 and held a stakeholder summit in Sydney on 27 June 2018.
In July 2017 FSANZ publicly released outcomes from our work on 15 EUauthorised health claims. This draws to conclusion most of our work on considering 32 EU-authorised health claims for possible inclusion in the Food Standards Code. The remaining three claims include the two claims about electrolyte drinks which will be considered under a separate project given the connection of the claims to a current proposal on our work plan (Proposal P1030 – Composition and labelling of electrolyte drinks) and a claim about the replacement of digestible starch with resistant starch and reduction in peak postprandial blood glucose concentration.
A consultation paper on the pre-approved general and high level health claims about β-glucan and blood cholesterol was released in August 2017. This consultation was focused on the outcomes from the systematic review of the evidence for the existing high level health claim in the Food Standards Code. FSANZ is considering comments from submitters before determining next steps.
New breeding technology review
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.
FSANZ is in the process of preparing a preliminary report which will include a summary of the issues raised in submissions. The preliminary report, along with submissions, is expected to be published on our website in July 2018.
We aim to conclude the review by the end of 2018, at which time we will consider whether to prepare a proposal to amend the Code.
FSANZ’s Executive team reviews the Work Plan every month. New unpaid applications and proposals do not appear on the Work Plan until the Executive considers their priority and approves timeframes and resources for their consideration to proceed.
Applications received, or proposals prepared before 1 October 2007, continue to be assessed under the procedures in place at that time. The tables below reflects the two types of approaches.
Information on the different types of procedures for assessing applications is in the Work Plan on our website at
Table 1: Applications and proposals on the Work Plan (received or prepared from 1 October 2007 onwards)
|AS AT || 30 June 2014||30 June 2015||30 June 2016||30 June 2017||30 June 2018|
|General procedure|| 14 (2 paid)|| 19 (7 paid)|| 17 (1 paid)|| 15 (4 paid)|| 19 (10 paid)|
|Minor procedure|| 0|| 0|| 0|| 0|| 0|
|Major procedure||4 ||3|| 3 ||0 ||1|
|High level health claims|| 0 ||0|| 0|| 0 ||0 |
|Urgent applications or proposals|| 0|| 0 || 0|| 0 || 1|
|Under review ||1|| 0 ||1 ||0|| 0|
|TOTAL ||19|| 22|| 21|| 15 ||21|
|With the Forum or awaiting notification to the Forum ||2 ||8|| 5|| 5|| 5|
|Estimated waiting time for unpaid applications ||6 months approx|| 9 months approx|| 7 months approx|| 7 months approx|
6 months approx
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 2014|| 30 June 2015 ||30 June 2016|| 30 June 2017 ||30 June 2018|
|Group 1 ||4|| 2|| 1|| 1 ||1 |
|Group 2 ||4 ||4 ||4|| 4 ||4 |
|Under review ||0 ||0||0|| 0|| 0 |
|TOTAL ||8|| 6|| 5|| 5|| 5 |
|With the Forum or awaiting notification to the Forum ||0 ||0 ||0 || 0 || 0|
|Estimated waiting time Group 2 ||Unknown|| Unknown ||Unknown||Unknown|| Unknown|
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
| 2013–14 || 2014–15 || 2015–16 || 2016–17|| 2017–18|
|Applications ||4*|| 18|| 19** ||12|| 18|
|Proposals|| 6***|| 6 ||5|| 3|| 3|
|TOTAL ||10 ||24 ||23|| 15 ||21|
* This includes any applications received in one financial year and accepted onto the Work Plan in the following year. This figure therefore may be adjusted in the next Annual Report.
** 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.
*** This includes one proposal which was prepared and then abandoned within this financial year.
Table 4: Applications and proposals finalised
|2013–14 ||2014–15 ||2015–16 ||2016–17 || 2017–18|
|Approvals made by the FSANZ Board||11|| 18 ||23 ||19|| 14|
|Final assessments made by the FSANZ Board ||0 ||1|| 0|| 0|| 0|
|Applications withdrawn or rejected*|
| 5 || 2 ||1 || 3 ||2|
|TOTAL completed ||16|| 21|| 24|| 22 ||1|
* This includes potential applications rejected following an administrative assessment or withdrawn before an administrative assessment was completed.
Further information on the above can be obtained from Appendix 4. There also may be some apparent 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 provides information about any significant variation from the timetable established in the Work Plan for the consideration of applications and proposals during 2017–18.
Applications and proposals to change the Code vary in complexity. For example, processing aid and food additive applications tend to be more straight forward while proposals that involve complex standards can involve significant stakeholder consultation and considerations of wide-ranging and complex issues.
Table 5: Reasons for significant delays in consideration of applications and proposals in 2017–18
|APPLICATION / PROPOSAL || STEP ||VARIATION* ||REASON |
|A1102 – L-carnitine in Food|| Assessment, preparation of draft food regulatory measure and call for submissions ||2 years ||Delay due to the complexity and scope of the application in addition to resourcing issues.|
|A576 – Labelling of Alcoholic Beverages with a Pregnancy Health Advisory Label || Draft assessment|| 9 years 5 months (from date final assessment due)|| Deferred at the request of the applicant.|
| P1024 – Revision of the Regulation of Nutritive Substances & Novel Food|| Assessment || 3 years 8 months|| Delay due to the complexity of issues, variety of stakeholder views and some resourcing issues.|
| P1028 – Infant Formula Products || Assessment|| 2 years || Delay due to complexity of issues, expanded scope, consideration of the divergent stakeholder views and some resourcing issues.|
| P1030 – Composition & Labelling of Electrolyte Drinks|| Assessment|| 3 years 9 months || Delay due to complexity of issues raised in submissions and other work priorities. Project scope has been narrowed in response to submitters concerns.|
| P290 – Food Safety Programs for Catering Operations to the General Public || Final Assessment|| 12 years (from date final assessment due)|| Delayed pending further implementation strategy work required by jurisdictions. |
* Variation based on indicative timeframes in the administrative assessment report against timeframe indicated in FSANZ Work Plan as at 30 June.
Table 6 shows the status of the applications and proposals received or prepared before 1 October 2007 and which remain on the Work Plan.
Table 6: Status of remaining applications and proposals received or prepared before 1 October 2007
|APPLICATION / PROPOSAL ||STEP ||REASON|
|A530 - Permission for English Farmhouse Cheddar made from Raw Milk ||Initial assessment|| Received 12 February 2004. Waiting on advice from the applicant following completion of work on raw milk products (P1022).|
| A531 – Use of Raw Milk in Cheese Production ||Initial assessment|| Received 16 February 2004. Waiting on advice from the applicant following completion of work on raw milk products (P1022).|
| A576 – Labelling of Alcoholic Beverages with a Pregnancy Health Advisory Label ||Draft assessment|| Received 17 February 2006 – see Table 5.|
| 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 assessment|| Prepared 13 May 2004 –
see Table 5.|
Australia and New Zealand Ministerial Forum on Food Regulation
Table 7: Notification outcomes
|2013–14|| 2014–15 ||2015–16 ||2016–17 ||2017–18|
|Approval decisions notified|| 12|| 18|| 23|| 15|| 16|
| Final assessment decisions notified|| 0 ||1 ||0 ||0|| 0|
| Requests for review ||0 ||1 ||0 ||0|| 0|
| Review decisions notified|| 0 ||1|| 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. However, this can only occur if six of the ten ministers request a review. More details on the review process are in the
Under the 2008 Inter-Governmental Food Regulation Agreement, the Forum can only request reviews of FSANZ decisions based on one or more of the following criteria:
- it is not consistent with existing policy guidelines set by the Forum
- it is not consistent with the objectives of the legislation which establishes FSANZ
- it does not protect public health and safety
- it does not promote consistency between domestic and international food standards where these are at variance
- it does not provide adequate information to enable informed choice
- it is difficult to enforce or comply with in both practical or resource terms
- it places an unreasonable cost burden on industry or consumers.
No reviews were requested in 2017–18.
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 2017 to 30 June 2018
Variations to standards arising from 14 applications were gazetted (compared to 15 in 2016–17). Variations to standards arising from 2 proposals were gazetted (compared to 4 in 2016–17). See Appendix 4 for more detail.
Table 8: Gazettal of variations to the Code
|2013–14|| 2014–15|| 2015–16 || 2016–17 ||2017–18 |
|Arising from applications|| 9|| 5|| 14|| 15 || 14|
|Arising from proposals || 2 || 7 || 11 || 4 || 2|
|TOTAL|| 11|| 12|| 25|| 19 || 16|
Table 9: Gazetted food standard variations
|APPLICATION/ PROPOSALS|| DESCRIPTION || DATE OF GAZETTAL|
|A1123 – Isomaltooligosaccharide as a Novel Food || To permit isomalto-oligosaccharide as a novel food for use as an alternative (lower calorie) sweetener and bulk filler in a range of general purpose and special purpose foods.|| Gazetted 13/7/2017 (Amendment 171).|
| A1125 – Endo ß(1,4) Xylanase as a Processing Aid (Enzyme) || To permit the use of the enzyme endo ß(1,4) xylanase, derived from
Pseudoalteromonas haloplanktis, and produced by a genetically modified source of Bacillus subtilis, for use as a processing aid in the manufacture of cereal products.|| Gazetted 7/9/2017 (Amendment 172).|
| A1126 – Pectins & Carrageenan as Processing Aids in Wine (Fining Agent) || To permit pectins and carrageenan as processing aids to remove heat-unstable proteins from Australian produced wine.|| Gazetted 7/9/2017 (Amendment 172).|
| A1135 – Betagalactosidase as a Processing Aid (Enzyme) || To permit the use of a new source of betagalactosidase from a genetically modified strain of
Bacillus licheniformis to be used as a processing aid during the production of reduced lactose or lactose free milk and dairy products|| Gazetted 7/9/2017 (Amendment 172).|
| A1127– Processing Aids in Wine || To seek permission for the use of four processing aids, silver chloride, ammonium bisulphite, chitinglucan and PVI/PVP as processing aids for wine|| Gazetted 26/10/2017 (Amendment 174).|
| A1139 – Food derived from Potato Lines F10, J3, W8, X17 & Y9 || To seek approval for food derived from genetically modified potato lines F10, J3, W8, X17 and Y9, which has late blight protection, low acrylamide potential, reduced browning (black spot) and lower reducing sugars.|| Gazetted 7/12/2017 (Amendment 175).|
| A1140 – Food derived from Herbicide-tolerant Canola Line MS11 || To seek approval for food derived from herbicidetolerant, male-sterile canola line MS11, genetically modified to provide tolerance to the herbicide glufosinate-ammonium.|| Gazetted 7/12/2017 (Amendment 175).|
| A1130 – Triacylglycerol Lipase as a Processing Aid (Enzyme) || To permit the use of triacylglycerol lipase from
Candida cylindracea as a processing aid in baking, dairy foods processing and fats and oils processing.|| Gazetted 11/1/2018 (Amendment 176).|
| A1131 – Aqualysin 1 (Protease) as a Processing Aid (Enzyme) || To permit the use of aqualysin 1 sourced from Bacillus subtilis containing the aqualysin 1 gene from Thermus aquaticus for use as a processing aid in the manufacture of bakery products.|| Gazetted 11/1/2018 (Amendment 176).|
| A1138 – Food derived from Provitamin A Rice Line GR2E || To seek approval for food derived from rice line GR2E genetically modified to contain increased levels of provitamin A in the grain.|| Gazetted 22/2/2018 (Amendment 177).|
| A1143 – Food derived from DHA Canola Line NS-B50027-4 || To seek approval for food derived from canola line NS-B50027-4, genetically modified to produce omega-3 long chain polyunsaturated fatty acids, particularly DHA, in the seed.|| Gazetted 22/2/2018 (Amendment 177).|
| A1136 – Protein Glutaminase as a Processing Aid (Enzyme) || To permit the use of protein-glutaminase from
Chryseobacterium proteolyticum as a processing aid to improve protein functionality in baking, noodle, dairy, meat, fish and yeast products.|| Gazetted 3/5/2018 (Amendment 178).|
| A1142 – Addition of Prescribed Method of Analysis for Resistant Starch || To add a method of analysis for dietary fibre and other fibre content for specifically named fibre content of food (resistant starch).|| Gazetted 24/5/2018 (Amendment 179).|
| A1147 – Food derived from Herbicide-tolerant Cotton Line GHB811 || To seek approval for food derived from cotton line GHB811, genetically modified to provide resistance to isoxaflutole and glyphosate.|| Gazetted 24/5/2018(Amendment 179). |
| M1014 – Maximum Residue Limits (2016) || To consider varying certain maximum residue limits for residues of agricultural and veterinary chemicals that may occur in food.|| Gazetted 7/12/2017 (Amendment 175).|
| P1045 – Code Revision (2017)|| To make minor amendments including the correction of typographical errors and formatting issues and updating of references.|| Gazetted 7/9/2017 (Amendment 172)|
Maximum residue limits
Maximum residues limits (MRLs) are set for chemicals at levels that reflect the highest concentrations that may occur 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 2017–18 FSANZ undertook 208 MRLrelated dietary exposure assessments (DEAs) for agricultural and veterinary (agvet) chemicals which included routine reviews of Australian Pesticides and Veterinary Medicines Authority (APVMA) DEAs and the 2017 MRL harmonisation proposal, Proposal M1015. The MRL process also resulted in the establishment of 35 all other foods (AoF)3 MRLs for low level inadvertent chemical residues in food, for the chemicals assessed as suitable to have this MRL category.
Proposal M1015, considered 128 agvet chemicals for a total of 360 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. 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.
3 AoF MRLs refer to
all other foods except animal food commodities
MRLs which are set on a case-by-case basis to prevent the application of zero tolerance to food commodities with low level inadvertent residues of chemicals that result from farming processes such as spray drift and crop rotation following their legitimate use on other foods.
Table 10: Dietary exposure assessment notifications and approvals
|2012–13 ||2013–14 ||2014–15 || 2015–16 || 2016–17 ||2017–18 |
|Number of regular DEA notifications || 29 || 27 || 29 || 38 || 27 || 22|
| Number of DEA approved || 93 || 112 || 92 || 122|| 84|| 87|
| Emergency Permit DEA notifications || 1|| 5|| 1 || 0|| 0 || 1|
DEAs relating to pesticide contamination incident(s)
| – || – || –|| –|| 13 |
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