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Application to Amend the Australia and New Zealand Food Standard Code for the Use of Potassium Polyaspartate As an Additive for Wine

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Application to Amend the Australia and New Zealand Food Standard Code for the Use of Potassium Polyaspartate As an Additive for Wine PART A: APPLICATION TO AMEND THE AUSTRALIA AND NEW ZEALAND FOOD STANDARD CODE FOR THE USE OF POTASSIUM POLYASPARTATE AS AN ADDITIVE FOR WINE Prepared for: Food Standards Australia New Zealand PO Box 786 CANBERRA BC ACT 2610 Submitted by: Enartis Pacific Pty Ltd Contact person: Prepared by: Date: February 2018 Contents A. Technical information on the food additive 22 A.1 Nature and technological purpose of the additive 22 A.2 Information to enable identification of the additive 36 A.3 Information on the chemical and physical properties of the additive 38 A.4 Information on the impurity profile 40 A.5 Manufacturing process 43 A.6 Specification for identity and purity 45 A.7 Information for food labelling 54 A.8 Analytical method for detection 55 A.9 Potential additional purposes of the food additive when added to food 65 B. Information related to the safety of the food additive 66 B.1 Information on the toxicokinetics and metabolism of the food additive and, if necessary, its degradation products or major metabolites 68 B.2 Information on the toxicity of the food additive and, if necessary, its degradation products and major metabolites 75 B.3 Safety assessment reports prepared by international agencies or other national government agencies, if available 102 B.4 Supplementary safety information 104 C. Information related to the dietary exposure to the food additive 104 C.1 A list of the food groups or foods proposed to contain the food additive, or changes to currently permitted foods 104 C.2 The maximum proposed level or the concentration range of the food additive for each food group or food, or the proposed changes to the currently permitted levels. 104 C.3 For foods or food groups not currently listed in the most recent Australian or New Zealand National Nutrition Surveys (NNSs), information on the likely level of consumption. 104 C.4 The percentage of the food group in which the food additive is proposed to be used or the percentage of the market likely to use the food additive 104 C.5 Information relating to the use of the food additive in other countries, if applicable 105 C.6 For foods where consumption has changed in recent years, information on likely current food consumption 107 C.7 Supplementary dietary exposure information 108 Checklist for General requirements General requirements (3.1.1) Check Page Mandatory requirements No. A Form of application Application in English Executive Summary (separated from main application electronically) Relevant sections of Part 3 clearly identified Pages sequentially numbered Electronic copy (searchable) All references provided B Applicant details C Purpose of the application D Justification for the application Regulatory impact information Impact on international trade E Information to support the application Data requirements F Assessment procedure General Major Minor High level health claim variation G Confidential commercial information CCI material separated from other application material Formal request including reasons Non-confidential summary provided H Other confidential information Confidential material separated from other application material Formal request including reasons I Exclusive Capturable Commercial Benefit Justification provided J International and other national standards International standards Other national standards K Statutory Declaration L Checklist/s provided with application 3.1.1 Checklist All page number references from application included Any other relevant checklists for Chapters 3.2–3.7 Checklist for applications for substances added to food Food additives (3.3.1) Check Page Mandatory requirements No. A.1 Nature and technological purpose information A.2 Identification information A.3 Chemical and physical properties A.4 Impurity profile A.5 Manufacturing process A.6 Specifications A.7 Food labelling A.8 Analytical detection method A.9 Additional functions B.1 Toxicokinetics and metabolism information B.2 Toxicity information B.3 Safety assessments from international agencies C.1 List of foods likely to contain the food additive C.2 Proposed levels in foods C.3 Likely level of consumption C.4 Percentage of food group to contain the food additive C.5 Use in other countries (if applicable) C.6 Where consumption has changed, information on likely consumption 4 GENERAL REQUIREMENTS A. SUMMARY Potassium polyaspartate is the potassium salt of polyaspartic acid, produced from L-aspartic acid, which is a naturally occurring amino acid in wine, and potassium hydroxide (98% purity). Studies have verified that potassium polyaspartate has stabilizing properties similar to those of the metatartaric acid (MTA) and carboxymethylcellulose (CMC), but is much more stable over time as well as filterable and unaffected by heat, which maintains the quality of the wine while increasing its cellaring or storage potential (shelf-life). Further, it does not have negative impacts on the sensory properties, such as colour, of the resultant wine. It is a completely biodegradable environmentally- friendly alternative to traditional polyanionic materials. Compared with physical stabilisation techniques such as cold stabilisation, electrodialysis and ion-exchange resins, use of potassium polyaspartate is labour, energy and water efficient, and hence cost competitive. Potassium polyaspartate is thus proposed for use as a stabiliser against tartrate crystal precipitation in wine (red, rosé and white wine) at the typical use level of 100 to 200 mg/L and at a maximum use level of 300 mg/L, depending on the level of instability of the wine to be treated. The European Food Safety Authority (EFSA) evaluated the safety of potassium polyaspartate as a food additive and in its opinion of 9 March 2016 (EFSA Journal, 2016)1 concluded that there was no safety concern from the proposed use in wine at a maximum use level of 300 mg/L and typical levels in the range of 100-200 mg/L. It has accordingly been approved and authorised for use as an additive for wine in the European Union (EU) in COMMISSION REGULATION (EU) 2017/1399 of 28 July 2017 amending Annex II to Regulation (EC) No 1333/2008 of the European Parliament and of the Council and the Annex to Commission Regulation (EU) No 231/2012 as regards potassium polyaspartate and COMMISSION DELEGATED REGULATION (EU) 2017/1861 of 2 August 2017 amending Regulation (EC) No 606/2009 as regards certain oenological practices).2 In addition, at the 50th session of the Codex Alimentarius Commission on Food Additives (JECFA), the EU and its Member States proposed that potassium polyaspartate used as a stabiliser in wine be added to the priority list of substances proposed for evaluation by JECFA. To ensure consistency with international wine standards it is requested to amend the table to section S15—5 of Schedule 15 Substances that may be used as food additives in the food category 14.2.2 Wine, sparkling wine and fortified wine to include potassium polyaspartate as an additive, at a maximum of GMP. It is also requested that Standard 4.5.1 Wine Production Requirements (Australia only) be amended to include polyaspartate in the Table to clause 3, at a maximum of GMP. Standard 1.3.4 requires that substances added to food, including additives, comply with relevant specifications as detailed in the Code. Potassium polyaspartate meets the OIV specification (OIV-OENO 572-2017), which is one of the secondary references for specifications in Standard 1.3.4 (Identity and Purity). Therefore, no new specification is required for the Code. 1 EFSA Journal 2016;14(3):4435 2 http://eur-lex.europa.eu/legal-content/EN/TXT/PDF/?uri=CELEX:32017R1399&from=EN 5 B. APPLICANT DETAILS Applicant ENARTIS PACIFIC PTY LTD Contact person (Australia) Street Address 21 Yorkshire Street - Richmond Victoria 3121 - Australia Nature of applicant’s business Enartis Pacific Pty Ltd is part of the international Esseco Group S.r.l. which develops, produces, and sells inorganic chemical products and products for the winemaking industry worldwide. It offers sulphur derivatives, including sulphite crystals and solutions, liquid sulphur dioxide (compressed and liquefied gas), sodium hydrosulphite, sulphuric acid, and fuming sulphuric acid; and general chemical products, such as caustic potash, potassium carbonate and chlorinated derivatives, chloroparaffins, TMP, NPG, potassium and sodium formates, crushed sulphur, micronized and granulated sulphur, acetates, and ammonium carbonates. The company also offers processing aids and additives, including purifying agents, enzymes, yeasts, tannins, malolactic bacteria, stabilizers, and sulphiting agents, as well as research, wine testing, consultancy, and cellar services for the winemaking industry. It offers its products for various applications, including natural preservatives for foodstuffs, nutritional supplements and animal feeds, rubber vulcanizes, high-efficiency batteries production, pharmaceutical and personal care products, fixatives for photography and radiology, anti-fungal products and agricultural fertilizers, paper bleaching agents and furniture glues, airport runway de- icers, industrial detergents, and more. Esseco Group Srl was formerly known as Esseco Srl and changed its name to Esseco Group Srl in 2004. The company was founded in 1921 and is based in Trecate, Italy with operations worldwide. Other companies in the group include Enartis, Ever, Martin Vialatte, Oenofrance and Station Oenotechnique de Champagne. Details of other individuals, companies or organisations associated
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