General procedure Timeframe for completion of assessment: 9 months This procedure applies to all applications or proposals for the variation of a food regulatory measure, unless they are being considered under either the minor, major or high level health claim variation procedures, or are considered ‘urgent’ under Division 4 of the FSANZ Act Application or proposal Applicant or FSANZ Brief description Received Admin assess completed Expected timetable Date completed Consultation opportunities P1030 – Composition and Labelling of Electrolyte Drinks Formerly: Health Claims – Formulated Supplementary Sports Foods & Electrolyte Drinks (Level 3) FSANZ Assessment of compositional and labelling requirements for electrolyte drinks. 28/1/2014 11/2/2014 Commence assessment (Clock start) Mid-Feb 2014 18/2/14 Additional round of consultation to be held Work has recommenced after targeted consultation & in-principle support from key stakeholders. The project scope has been narrowed in response to submitters concerns. Completion of assessment & preparation of draft food reg measure Mid-Aug 2014 14/8/14 Call for submissions Mid-Aug–late Sept 2014 18/8/14–30/9/14 Consultation paper TBA 2nd call for submissions TBA Board to complete consideration TBA Notification to the Forum TBA Anticipated gazettal if no review requested TBA
A1102 – in Food (Level 4) Lonza Ltd via FJ Fleming Food Consulting To permit the sale of in a variety of food categories including dairy products (excluding butter and butter fat), confectionery, cereal and cereal products, food intended for particular nutritional uses, non-alcoholic beverages and gels. 3/9/2014 24/9/2014 Commence Assessment (Clock start) Late Oct 2015 9/11/15 1 call for submissions Clock start and assessment delayed due to other work priorities and the complexity and scope of the Application. Request for further information sent 23 Sept 2016. Information received 9 Jan 2017. Assessment was completed in Aug 2018 and a permission to increase the use in sports foods only has been proposed. Completion of assessment and preparation of draft food reg measure July 2018 6/9/18 Call for submissions Aug-Sept 2018 13/9/18 - 25/10/18 Board to complete Approval Early May 2019 Notification to the Forum Mid May 2019 Anticipated gazettal if no review requested Early June 2019
A1149 – Addition of Steviol Glycosides in Fruit Drinks (Level 1) Australian Beverages Council Ltd (ABCL) 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. 5/7/2017 26/7/2017 Commence Assessment (Clock start) Early Nov 2017 1/8/18 1 Call for Submissions Stop clock 26/1 to 1/8/18 for applicant to provide further information Completion of assessment and preparation of draft food reg measure Early Feb 2018 Call for submissions Mid-Feb-late March 2018 9/10/18 – 6/11/18 Board to complete Approval Early March 2018 6/3/19 Notification to the Forum Mid-March 2018 21/3/19 Anticipated gazettal if no review requested Late May 2018
A1159 – Triacylglycerol lipase from Trichoderma reesei as a processing aid (enzyme) (Level 1) DuPont Australia Pty Ltd To permit the enzyme lipase, triacylglycerol from Trichoderma reesei as a processing aid for the production of bakery products and cereal-based beverages. 22/1/2018 13/2/2018 Commence Assessment (Clock start) Mid Sept 2018 10/10/18 1 call for submissions Completion of assessment and preparation of draft food reg measure Mid-Jan 2019 Call for submissions Late March 2019 5/2/19 – 19/3/19 Board to complete Approval Mid-June 2019 Notification to the Forum Late June 2019 Anticipated gazettal if no review requested Early Sept 2019
A1160 – Aspergillopepsin I from Trichoderma reesei as processing aid (enzyme) (Level 1) DuPont Australia Pty Ltd To permit the enzyme Aspergillopepsin I from Trichoderma reesei as a processing aid for the production of potable alcohol products and protein processing 22/1/2018 13/2/2018 Commence Assessment (Clock start) Mid Sept 2018 22/10/18 1 call for submissions Completion of assessment and preparation of draft food reg measure Mid-Jan 2019 Call for submissions Late march 2019 28/2/19 – 10/4/19 Board to complete Approval Mid-June 2019 Notification to the Forum Late June 2019 Anticipated gazettal if no review requested Early Sept 2019
P1047 – Review of regulatory nutrient reference values (Level 2) FSANZ To review and update the regulatory nutrient reference values in the Australia New Zealand Food Standards Code in light of the 2006 and 2017 Australia/New Zealand nutrient reference values. 20/3/2018 28/3/2018 Commence Assessment (Clock start) Late March 2018 28/3/2018 1 call for submissions Completion of assessment and preparation of draft food reg measure Mid May 2019 Call for submissions Mid May 2019 to Late June 2019 Board to complete Approval Mid Sept 2019 Notification to the Forum Late Sept 2019 Anticipated gazettal if no review requested Late 2019
M1016 – Maximum Residue Limits (2018) (Level 1) FSANZ To consider varying certain maximum residue limits (MRLs) for residues of specified agricultural and veterinary chemicals that may occur in food commodities. 16/4/2018 3/5/2018 Commence Assessment (Clock start) 20 July 2018 20/7/18 11/12/18 – 20/1/19 Completion of assessment and preparation of draft food reg measure Late Sept 2018 Call for submissions Early Dec/Feb 2019 Board to complete Approval Mid- June 2019 Notification to the Forum Late-June Anticipated gazettal if no review requested Late Sep 2019
A1162 – Triacylglycerol lipase from Trichoderma reesei as a PA (Enzyme) Paid (Level 1) AB Enzymes GmbH To permit the use of enzyme triacylglycerol lipase from Trichoderma reesei as a processing aid in the manufacturing of cereal based products 10/5/2018 24/5/2018 Commence Assessment (Clock start) Early Nov 2018 29/6/18 13/11/18 – 18/12/18 6/3/19 21/3/19 1 call for submissions Completion of assessment and preparation of draft food reg measure Mid-Nov 2018 Call for submissions Late-Nov 2018 – Early Jan 2018 Board to complete Approval Early March 2019 Notification to the Forum Mid-March 2019 Anticipated gazettal if no review requested Mid-May 2019
A1163 – Food Irradiation definition of herbs and spices (Level 1) Sapro Australia Pty Ltd To vary Food Standard 1.5.3 Irradiation of Food to remove the reference to Schedule 22 in relation to the definition of Herbs and Spices. 14/5/2018 31/5/2018 Commence Assessment (Clock start) Mid Jan 2019 24/1/19 1 call for submissions Completion of assessment and preparation of draft food reg measure Early May 2019 Call for submissions Mid-May-End June 2019 Board to complete Approval Early Oct 2019 Notification to the Forum Mid Oct 2019 Anticipated gazettal if no review requested Late Jan 2020
A1164 – Pullulanase from Bacillus licheniformis as a processing aid (enzyme) (Level 1) DuPont Australia Pty Ltd To seek approval for the use of Pullulanase from a recombinant strain of Bacillus licheniformis as a processing aid in food. 29/5/2018 20/6/2018 Commence Assessment (Clock start) Mid-Jan 2018 24/1/19 1 call for submissions Completion of assessment and preparation of draft food reg measure Early April 2019 Call for submissions Early April – mid-May 2019 Board to complete Approval Mid Sept 2019 Notification to the Forum Late Sept 2019 Anticipated gazettal if no review requested Late October 2019
A1165 – Lysophospholipase from Trichoderma reesei as a Processing Aid (Enzyme) Paid (Level 1) AB Enzymes GmbH To permit the use of lysophospholipase enzyme from Trichoderma reesei as a processing aid for use in starch processing 4/6/2018 25/6/2018 Commence Assessment (Clock start) Late July 2019 27/7/18 13/11/18 - 18/12/18 6/3/19 21/3/19 1 call for submissions Completion of assessment and preparation of draft food reg measure Early Nov 2018 Call for submissions Early Nov – mid Dec 2018 Board to complete Approval Early March 2019 Notification to the Forum Mid-March 2019 Anticipated gazettal if no review requested Mid- May 2019
A1167 – Lactase from Bacillus subtilis as a Processing Aid (Enzyme) Paid (Level 1) Dupont Australia Pty Ltd to permit the use of lactase enzyme from Bacillus subtilis as a processing aid for use in dairy processing. 12/6/2018 2/7/2018 Commence Assessment (Clock start) Early March 2019 17/8/18 22/11/18 – 17/1/19 6/3/19 21/3/19 1 call for submissions Completion of assessment and preparation of draft food reg measure Early Nov 2019 Call for submissions Mid Nov 2018 – Early Jan 2019 Board to complete Approval Early March 2019 Notification to the Forum Anticipated gazettal if no review requested MidMay 2019
A1168 – Glucoamylase from GM Aspergillus niger as a PA (Enzyme) Paid (Level 1) Novozymes Australia Pty Ltd to permit the use of glucoamylase produced from a GM modified strain of Aspergillus niger as a PA. 4/7/2018 25/7/2018 Commence Assessment (Clock start) Mid-Aug 2018 15/8/18 6/12/18 – 31/1/19 1 call for submissions Completion of assessment and preparation of draft food reg measure Early Dec 2018 Call for submissions Mid-Dec 2018 – early Feb 2019 Board to complete Approval Early May 2019 Notification to the Forum Mid-May 2019 Anticipated gazettal if no review requested Late July 2019
A1169 – from Trichoderma reesei as a PA (enzyme) (Level 1) Dupont Australia Pty Ltd to permit the use of Alpha-glucosidase enzyme from A Recombinant Strain of Trichoderma reesei as a processing aid. 1/8/2018 17/8/2018 Commence Assessment (Clock start) Early March 2019 22/2/19 1 call for submissions Completion of assessment and preparation of draft food reg measure Early July 2019 Call for submissions Early 2019 Board to complete Approval Early Dec 2019 Notification to the Forum Mid-Dec 2019 Anticipated gazettal if no review requested Late Feb 2019
P1049 - Carbohydrate and sugar claims on alcoholic beverages FSANZ To clarify the Food Standards Code with respect to claims about carbohydrate content and the components of carbohydrate (such as sugar) in relation to alcoholic beverages. 15/8/2018 24/8/2018 Commence Assessment (Clock start) Late Aug 2018 29/8/18 1 call for submissions Completion of assessment and preparation of draft food reg measure End April 2019 Call for submissions Early May – mid June 2019 Board to complete Approval Mid Sept 2019 Notification to the Forum End Sept 2019 Anticipated gazettal if no review requested Mid Dec 2019
A1170 - Rebaudioside MD as a Steviol Glycoside from Saccharomyces cerevisiae Paid (Level 1) Cargill Incorporated To seek approval for a steviol glycoside mixture (Reb MD) for use as an intense sweetener, produced from a genetically modified Saccharomyces cerevisiae. 24/8/2018 7/9/2018 Commence Assessment (Clock start) Early March 2019 16/10/18 1 call for submissions Completion of assessment and preparation of draft food reg measure Early July 2019 Call for submissions Early 2019 Board to complete Approval Early Dec 2019 Notification to the Forum Mid-Dec 2019 Anticipated gazettal if no review requested Early Feb 2020
A1171 - from GM Aspergillus oryzae as a PA (Enzyme) Puratos NV (Puratos) to permit the use of Endo-Inulinase produced from a GM modified strain of Aspergillus oryzae as a PA. 25/9/2018 16/10/2018 Commence Assessment (Clock start) May 2019 call for submissions Completion of assessment and preparation of draft food reg measure August 2019 Call for submissions October 2019 Board to complete Approval Dec 2019 Notification to the Forum January 2020 Anticipated gazettal if no review requested January 2020
A1172 - Enzymatic production of Rebaudioside D Paid (Level 1) SweeGen Inc. to seek approval for a new specification for rebaudioside D produced by an enzymatic conversion method. 10/10/18 31/10/18 Commence Assessment (Clock start) Late Nov 2018 5/11/2018 12/2/19 – 26/3/19 Completion of assessment and preparation of draft food reg measure Late March 2019 Call for submissions Early Apr-mid may 2019 Board to complete Approval Early Aug 2019 Notification to the Forum Mid Aug 2019 Anticipated gazettal if no review requested Late Oct 2019
P1050 - Pregnancy warning labels on alcoholic beverages FSANZ to consider a mandatory labelling standard for pregnancy warning labels on packaged alcoholic beverages 31/10/18 01/11/18 Commence Assessment (Clock start) Early Nov 2018 1/11/2018 Completion of assessment and preparation of draft food reg measure End Feb 2019 Call for submissions Early August – Late August 2019 Board to complete Approval Mid October 2019 Notification to the Forum Mid October 2019 Anticipated gazettal if no review requested December 2019
A1173 - Minimum protein in follow-on formula Paid (Level 2) Nestle Australia Ltd and Nestle New Zealand Limited to vary the minimum protein requirement in follow-on formula. 23/10/18 12/11/18 Commence Assessment (Clock start) Early Jan 2019 3/1/2019 Completion of assessment and preparation of draft food reg measure Mid May 2019 Call for submissions Mid June – late July 2019 Board to complete Approval Mid Sept 2019 Notification to the Forum Late Sept 2019 Anticipated gazettal if no review requested December 2019
A1174 - Xylanase from Trichoderma reesei as a PA (Enzyme) Dupont Australia Pty Ltd to permit the use of Xylanase from Trichoderma reesei as a Processing Aid. 3/12/18 20/12/18 Commence Assessment (Clock start) Mid-June 2019 Completion of assessment and preparation of draft food reg measure Early Oct 2019 Call for submissions Mid-Oct - Late Nov 2019 Board to complete Approval Early March 2020 Notification to the Forum Mid-March 2020 Anticipated gazettal if no review requested Late May 2020
A1175 - Rapeseed protein as a novel food DSM Nutritional Products Asia Pacific to permit the use of rapeseed protein as a novel food 20/2/2019 14/3/2019 Commence Assessment (Clock start) Completion of assessment and preparation of draft food reg measure Call for submissions Board to complete Approval Notification to the Forum Anticipated gazettal if no review requested
Major procedure Timeframe for completion of assessment: 12 months This procedure applies to applications or proposals for the development of a new food regulatory measure and an application or proposal for the variation of a food regulatory measure that involves such scientific or technical complexity that it is necessary to adopt this procedure in considering it; or involves such a significant change to the scope of the food regulatory measure that it is necessary to adopt this procedure in considering it. For applications, this timeframe may be extended by up to 6 months if it is not practicable for completion to occur within 12 months. Extensions and the reasons for the extension are included in the FSANZ Annual Report. Application or proposal Applicant or FSANZ Brief description Received Admin assess completed Expected timetable Date completed Consultation opportunities P1024 – Revision of the Regulation of Nutritive Substances & Novel Foods FSANZ To develop an alternative framework for the regulation of nutritive substances and novel foods in the Code. 28/11/2012 13/12/2012 Commence Assessment (Clock start) Mid-Dec 2012 16/12/2012 2 call for submissions remaining. Additional round of consultation included. Delayed due to other work priorities and as stakeholder views varied significantly on some aspects of the approach presented following the assessment. FSANZ will now consult further on these issues before developing a draft food regulatory measure. Completion of assessment Mid-Nov 2015 1/12/2015 1st Call for submissions Mid-Nov 2015–late Feb 2016 Consultation paper prepared Late May 2017 13/6/2017 2nd call for submissions Early June– mid-July 2017 Preparation of draft food reg measure TBC 3nd call for submissions TBC
P1028 – Infant Formula FSANZ To revise and clarify standards relating to infant formula comprising category definitions, composition and labelling. 8/7/2013 17/7/2013 Commence Assessment (Clock start) Late July 2013 7/11/2013 2 calls for submissions remaining. Additional targeted consultation may be held. Scope of project was expanded in 2017 to include infant formula products for special dietary use. Consultation paper 1 prepared Late May 2016 23/02/2016 Consultation paper 2 prepared Early October 3/8/2017 – 3/10/2017 1st call for submissions June 2019 Preparation of draft food reg measure TBA 2nd call for submissions TBA Board to complete Approval TBA Notification to the Forum Late 2019 Anticipated gazettal if no review requested Early 2020
P1044 – Plain English Allergen Labelling FSANZ To standardise the use of plain English terminology for allergen declarations on food labels 15/12/2016 19/12/2016 Commence Assessment (Clock start) Early Feb 2017 28/2/2017 2 calls for submissions Completion of assessment Mid-Sept 2017 23/2/2018 1st call for submissions Early Oct 2017Mid-Nov 2017 1/3/2018 to 10/5/2018 (previously 12/4/2018) Preparation of draft food reg measure Mid 2020 2nd call for submissions Mid 2019 Board to complete Approval Mid-June 2020 Notification to the Forum Late June 2020 Anticipated gazettal if no review requested Early Sept 2020
raised issues of only minor significance or complexity. A related process can be used if FSANZ considers that the part of the assessment would be a duplication of work already done, or a process already gone through, by another government agency in Australia or New Zealand. Group 1 Applications and proposals received prior to 1 October 2007 having health/safety considerations and/or consumer interest being progressed as a priority. Application or proposal Applicant or FSANZ Date received Brief description Start (S) & finish (F) dates Work Plan category Stage completed Expected timetable Consultation opportunities IA DA P290 – Food Safety Programs for Catering Operations to the General Public FSANZ 10/2/2004 To amend Standard 3.2.1 to make food safety programs mandatory in catering operations serving food to the general public. S 13/5/2004 4 ✔ ✔ * Unknown – on hold. Consultation completed. At Final Assessment. Further implementation strategy work required by jurisdictions. Group 2 Applications and proposals received prior to 1 October 2007, and are scheduled for commencement in order of receipt Stage completed
Application or proposal Applicant or FSANZ Date received Brief description Start (S) & finish (F) dates Work Plan category Expected timetable Consultation opportunities IA DA A576 – Labelling of Alcoholic Beverages with a Pregnancy Health Advisory Label Alcohol Advisory Council of New Zealand (Health Promotion Agency subsequently taken over application) 17/2/2006 To require a health advisory label on alcoholic beverage containers advising of the risks of consuming alcohol when planning to become pregnant and during pregnancy. S 26/7/2007 F 28/1/2009 5 ✔ Work has been deferred noting the Forum has referred the matter to FSANZ. To be advised A613 – Definitions for Nutritive Substance & Nutritive Ingredient Orafti 21/8/2007 To amend the definition of ‘nutritive substance’ and include a definition for ‘nutritive ingredient’ in Standard 1.1.1. S 3rd Qtr 2008 F 5 On hold pending advice from the Applicant and consideration of P1024. Following release of Initial and Draft Assessment Reports. Under review Where the Forum has requested a review of FSANZ’s decision on draft variations arising from an application or proposal. Application or Proposal Applicant or FSANZ Brief description Review Start (S) & Finish (F) Dates (1) Review completed Start (S) & finish (F) Dates (2) Post review outcome Consultation opportunities
Finalised projects Applications and proposals finalised from 1 July 2018 – 30 June 2019 Application or proposal Applicant or FSANZ Brief description Final consideration by FSANZ Board Outcome A1161 – Potassium Polyasparatate as a food additive in wine Enartis Pacific Pty Ltd to permit the use of Potassium Polyaspartate as a food additive in wine at a maximum permitted limit of 100mg/L 5 December 2018 No review requested by Forum Gazetted 27 February 2019 (Amendment 184) A1129 – Monk Fruit Extract as a Food Additive Saraya Co Ltd To permit monk fruit extract as a food additive, specifically as an intense sweetener. 31 October 2018 No review requested by Forum Gazetted 23 January 2019 (Amendment 183) A1156 – Food derived from Super High Oleic Safflower Lines 26 and 40 GO Resources Pty Ltd To seek approval for food derived from SHO safflower lines 26 and 40, genetically modified to produce high levels of oleic acid in the seed. 31 October 2018 No review requested by Forum Gazetted 23 January 2019 (Amendment 183) A1157 –Enzymatic production of Rebaudioside M Blue California To seek approval for a new specification for rebaudioside M produced by an enzymatic biosynthesis method. 31 October 2018 No review requested by Forum Gazetted 23 January 2019 (Amendment 183) A1158 – Rosemary extract as a food additive KALSEC INC To permit the use of rosemary extract as a food additive with the technological purpose of antioxidant. 31 October 2018 No review requested by Forum Gazetted 23 January 2019 (Amendment 183)
A530 – Permission for English Farmhouse Cheddar made from Raw Milk Fromagent to allow the importation and sale of the raw milk cheeses, Keens Farm Cheddar and Montgomery Cheddar 5 December 2018 Rejected A531 – Use of Raw Milk in Cheese Production Cheese Choice via Will Studd to enable the production and sale of any cheese made from unpasteurised milk. 5 December 2018 Rejected A1137 – Polysorbate 20 as a Food Additive Earlee Products Pty Ltd via FJ Fleming Food Consulting To permit the use of polysorbate 20 as an emulsifier 6 September 2018 No review requested by Forum Gazetted 29 November 2018 (Amendment 182) P1046 – L-amino acid acetate in Food for Special Medical Purposes FSANZ To remove a negative impact on trade in food for special medical purposes (FSMP) by permitting acetate forms of L-amino acids. 6 September 2018 Reaffirmed P1048 – Code revision 2018 FSANZ To make minor amendments including the correction of typographical errors, inconsistencies and formatting issues and updating of references 6 September 2018 No review requested by Forum Gazetted 29 November 2018 (Amendment 182) A1146 – Thermolysin (Protease) as a Processing Aid (Enzyme) (Level 2) Amano Enzyme Inc 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. 8 August 2018 No review requested by Forum Gazetted 23 October 2018 (Amendment 181) A1144 – Re-categorising coconut milk for food additive permissions Food and Beverage Importers Association (FBIA) To consider whether the food category for food additive permissions for coconut milk products is more appropriate under fruits, rather than beverages 7 June 2018 No review requested by Forum Gazetted 23 August 2018 (Amendment 180) A1151 – ß-Galactosidase from Papiliotrema terrestris Amano Enzyme Inc To amend Schedule 18 of the Australia New Zealand Food Standards Code to include 7 June 2018 No review requested by Forum Gazetted 23 August 2018