{"id":"F2015L00493","name":"Australia New Zealand Food Standards Code – Schedule 3 – Identity and purity","slug":"australia-new-zealand-food-standards-code-schedule-3-identity-and-purity","collection":"legislative_instrument","jurisdiction":"commonwealth","status":"in_force","isInForce":true,"actNumber":null,"makingDate":null,"administeringDepartment":null,"currentVersion":{"id":93148,"registerId":"commonwealth-F2015L00493-current","compilationNumber":null,"startDate":"2026-04-02","status":"InForce","reasons":null,"registeredAt":null},"sections":[{"sectionNumber":"1","sectionType":"section","heading":"Australia New Zealand Food Standards Code – Schedule 3 – Identity and purity","content":"Schedule 3 Identity and purity\n\nNote 1 This instrument is a standard under the Food Standards Australia New Zealand Act 1991 (Cth). The standards together make up the Australia New Zealand Food Standards Code. See also section 1.1.1—3.\n\nStandard 1.1.1 relates to introductory matters and standards that apply to all foods. Section 1.1.1—15 and S26 require certain substances to comply with relevant specifications. This Standard sets out the relevant specifications.\n\nNote 2 The provisions of the Code that apply in New Zealand are incorporated in, or adopted under, the Food Act 2014 (NZ). See also section 1.1.1—3.\n\nS3—1 Name\n\nThis Standard is Australia New Zealand Food Standards Code – Schedule 3 – Identity and purity.\n\nNote Commencement: \nThis Standard commences on 1 March 2016, being the date specified as the commencement date in notices in the Gazette and the New Zealand Gazette under section 92 of the Food Standards Australia New Zealand Act 1991 (Cth). See also section 93 of that Act.\n\nS3—2 Substances with specifications in primary sources\n\n(1) For subsection 1.1.1—15(2), the specifications are:\n\n(a) any relevant provision listed in the table to subsection (2); or\n\n(b) Combined Compendium of Food Additive Specifications, FAO JECFA Monographs 1 (2005), Food and Agriculture Organisation of the United Nations, Rome, as superseded by specifications published in any of the following:\n\n (i) FAO JECFA Monographs 3 (2006);\n (ii) FAO JECFA Monographs 4 (2007);\n (iii) FAO JECFA Monographs 5 (2008);\n (iv) FAO JECFA Monographs 7 (2009);\n (v) FAO JECFA Monographs 10 (2010);\n (vi) FAO JECFA Monographs 11 (2011);\n (vii) FAO JECFA Monographs 13 (2012);\n (viii) FAO JECFA Monographs 14 (2013);\n (ix) FAO JECFA Monographs 16 (2014);\n (x) FAO JECFA Monographs 17 (2015);\n (xi) FAO JECFA Monographs 19 (2016);\n\n(xii) FAO JECFA Monographs 20 (2017);\n\n(xiii) FAO JECFA Monographs 22 (2018);\n\n(xiv) FAO JECFA Monographs 23 (2019);\n\n(xv) FAO JECFA Monographs 25 (2020);\n\n(xvi) FAO JECFA Monographs 26 (2021); or\n\n(c) United States Pharmacopeial Convention (2022) Food chemicals codex. 13th ed, United States Pharmacopeial Convention, Rockville, MD; or\n\n(d) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives.\n\n(2) The table to this subsection is:\n\nRelevant provisions\n\n| Substance | Provision |\n| --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | ------------------------ |\n| advantame | section S3—5 |\n| amine agarose ion exchange resin | section S3—6 |\n| bentonite | section S3—7 |\n| Bovine lactoferrin | Section S3—46 |\n| Bovine milk fat globule membrane-enriched whey protein concentrate | section S3—53 |\n| bromo-chloro-dimethylhydantoin | section S3—8 |\n| carboxymethyl cellulose ion exchange resin | section S3—9 |\n| cell-cultured quail | section S3—54 |\n| dibromo-dimethylhydantoin | section S3—10 |\n| diethyl aminoethyl cellulose ion exchange resin | section S3—11 |\n| dimethyl ether | section S3—12 |\n| dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA) | section S3—13 |\n| 2′-fucosyllactose sourced from Corynebacterium glutamicum | section S3—51 |\n| 2′-fucosyllactose sourced from Escherichia coli BL21 | section S3—45 |\n| 2′-fucosyllactose sourced from Escherichia coli K‑12 containing the gene for alpha-1,2-fucosyltransferase from either Heliobacter enhydrae, Helicobacter pylori or Bacteroides vulgatus | section S3—40 |\n| 2′-fucosyllactose and difucosyllactose sourced from Escherichia coli K-12 | section S3—47 |\n| 2′-fucosyllactose sourced from Escherichia coli W | section S3—54(A) |\n| 3-fucosyllactose sourced from Escherichia coli K‑12 containing the gene for alpha-1,3-fucosyl-transferase from Helicobacter pylori | section S3—56 |\n| lacto-N-tetraose sourced from Escherichia coli K‑12 | section S3—48 |\n| 6′-sialyllactose sodium salt sourced from Escherichia coli K-12 | section S3—49 |\n| 3′-sialyllactose sodium salt sourced from Escherichia coli K-12 | section S3—50 |\n| ice structuring protein type III HPLC 12 preparation | section S3—14 |\n| isomalto-oligosaccharide | section S3—37 |\n| Isomaltulose | section S3—15 |\n| lacto-N-neotetraose | section S3—41 |\n| L-arginine acetate | section S3—38 |\n| Listeria phage P100 | section S3—16 |\n| 2-Methyloxolane | section S3—52 |\n| mushroom (Agaricus bisporus) chitosan | section S3—55 |\n| Nicotinamide riboside chloride | section S3—44 |\n| nucleotides | sections S3—17 and S3—18 |\n| oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695) | section S3—36 |\n| oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA) | section S3—21 |\n| oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA) | section S3—22 |\n| oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA) | section S3—19 |\n| oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA) | section S3—20 |\n| oxidised polyethylene | section S3—23 |\n| phytosterols, phytostanols and their esters | section S3—24 |\n| quaternary amine cellulose ion exchange resin | section S3—25 |\n| rapeseed protein isolate | section S3—39(A) |\n| resistant maltodextrins | section S3—26 |\n| Salmonella phage preparation (S16 and FO1a) | section S3—33 |\n| steviol glycosides from fermentation | section S3—39 |\n| steviol glycosides produced by enzymatic conversion | section S3—35 |\n| soy leghemoglobin preparation | section S3—42 |\n| sulphonate agarose ion exchange resin | section S3—34 |\n| Sweet osmanthus ear glycolipids | section S3—43 |\n| tall oil phytosterol esters | section S3—27 |\n| yeast—enriched selenium | section S3—28 |\n| yeast—high chromium | section S3—29 |\n| yeast—high molybdenum | section S3—30 |\n\nS3—3 Substances with specifications in secondary sources\n\nIf there is no relevant specification under section S3—2, the specification is a specification listed in one of the following:\n\n(a) British Pharmacopoeia Commission (2014) British Pharmacopoeia 2014. TSO, Norwich;\n\n(b) United States Pharmacopeial Convention (2020) United States Pharmacopeia (43) and the National Formulary (38), (USP 43-NF 38). United States Pharmacopeial Convention, Rockville, MD;\n\n(c) Royal Pharmaceutical Society of Great Britain. Lund W (1994) Pharmaceutical codex: principles and practice of pharmaceutics, 12th ed, Pharmaceutical Press, London;\n\n(d) Sweetman SC (2011) Martindale: the complete drug reference. 37th ed, Pharmaceutical Press, London;\n\n(e) the European Pharmacopoeia 8th Edition, Council of Europe, Strasbourg (2014);\n\n(f) the International Pharmacopoeia 4th Edition, World Health Organization, Geneva (2006 and 2008 supplement);\n\n(g) the Merck Index, 15th Edition, (2013);\n\n(h) the Code of Federal Regulations;\n\n(i) the Specifications and Standards for Food Additives, 9th Edition (2018)’, Ministry of Health and Welfare (Japan); or\n\n(j) the International Oenological Codex (2022), Organisation Internationale de la Vigne et du Vin (OIV).\n\nS3—4 Additional and supplementary requirements\n\nIf there is no relevant specification under section S3—2 or S3—3, or if the monographs referred to in those sections do not contain a specification for identity and purity of a substance relating to arsenic or heavy metals, the specification is that the substance must not contain on a dry weight basis more than:\n\n(a) 2 mg/kg of lead; or\n\n(b) 1 mg/kg of arsenic; or\n\n(c) 1 mg/kg of cadmium; or\n\n(d) 1 mg/kg of mercury.\n\nS3—5 Specifications for advantame\n\nFor advantame, the specifications are:\n\n(a) purity, using the analytical methodology indicated:\n\n (i) assay:\n\n(A) specification—not less than 97.0% and not more than 102.0% on anhydrous basis; and\n\n(B) analytical methodology—high pressure liquid chromatography; and\n\n (ii) specific rotation \\[α\\] 20 D:\n\n(A) specification—between -45° and -38°; and\n\n(B) analytical methodology—Japanese Pharmacopeia; and\n\n (iii) advantame-acid:\n\n(A) specification—not more than 1.0%; and\n\n(B) analytical methodology—HPLC; and\n\n (iv) total other related substances:\n\n(A) specification—not more than 1.5%; and\n\n(B) analytical methodology—HPLC; and\n\n (v) water:\n\n(A) specification—not more than 5.0%; and\n\n(B) analytical methodology—Karl Fischer coulometric titration; and\n\n (vi) residue on ignition:\n\n(A) specification—no more than 0.2%; and\n\n(B) analytical methodology—Japanese Pharmacopeia; and\n\n(b) residual solvents, using gas chromatography:\n\n (i) methyl acetate—no more than 500 mg/kg; and\n (ii) isopropyl acetate—no more than 2 000 mg/kg; and\n (iii) methanol—no more than 500 mg/kg; and\n (iv) 2-Propanol—no more than 500 mg/kg.\n\nS3—6 Specification for amine agarose ion exchange resin\n\n(1) This specification relates to agarose, cross-linked and alkylated with epichlorohydrin and propylene oxide, then derivatised with tertiary amine groups whereby the amount of epichlorohydrin plus propylene oxide does not exceed 250% by weight of the starting amount of agarose.\n\n(2) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH 2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.\n\nS3—7 Specification for bentonite\n\nBentonite must comply with a monograph specification in section S3—2 or section S3—3, except that the pH determination for a bentonite dispersion must be no less than 4.5 and no more than 10.5.\n\nS3—8 Specification for bromo-chloro-dimethylhydantoin\n\n(1) In this section:\n\nbromo-chloro-dimethylhydantoin (CAS Number: 126-06-7) is the chemical with:\n\n(a) the formula C5H6BrClN2O2; and\n\n(b) the formula weight 241.5.\n\n(2) For bromo-chloro-dimethylhydantoin, the chemical specifications are the following:\n\n(a) appearance—solid or free flowing granules;\n\n(b) colour—white:\n\n(c) odour—faint halogenous odour;\n\n(d) melting point—163–164ºC;\n\n(e) specific gravity—1.8–2;\n\n(f) solubility in water—0.2 g/100 g at 25ºC;\n\n(g) stability—stable when dry and uncontaminated.\n\n(3) Bromo-chloro-dimethylhydantoin must be manufactured in accordance with the following process:\n\n(a) solid dimethylhydantoin (DMH) must be dissolved in water with bromine and chlorine;\n\n(b) the reaction must be 0.5 mole bromine and 1.5 mole chlorine for one mole DMH;\n\n(c) during the reaction the pH must be kept basic by the addition of caustic soda;\n\n(d) the wet product must be transferred to a drier where it is dried to a powder at low temperature;\n\n(e) the powder may then be tableted or granulated.\n\n(4) Bromo-chloro-dimethylhydantoin may be assayed in accordance with various analytical methods, including GLC, HPLC, UV and NMR.\n\nNote HPLC offers the best sensitivity.\n\nS3—9 Specification for carboxymethyl cellulose ion exchange resin\n\n(1) This specification relates to regenerated cellulose that has been cross-linked and alkylated with epichlorohydrin and propylene oxide, then derivatised with carboxymethyl groups, as a result of which the amount of epichlorohydrin plus propylene oxide is no more than 70% by weight of the starting amount of cellulose.\n\n(2) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH 2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.\n\nS3—10 Specification for dibromo-dimethylhydantoin\n\n(1) In this section:\n\ndibromo-dimethylhydantoin means the chemical with CAS Number 77-48-5 and formula C5H6Br2N2O2.\n\n(2) For dibromo-dimethylhydantoin, the specifications (which relate to purity) are the following:\n\n(a) dibromo-dimethylhydantoin—no less than 97%;\n\n(b) sodium bromide—no more than 2%;\n\n(c) water—no more than 1%.\n\nS3—11 Specification for diethyl aminoethyl cellulose ion exchange resin\n\n(1) This specification relates to:\n\n(a) regenerated cellulose, cross-linked and alkylated with epichlorohydrin and propylene oxide, then derivatised with tertiary amine groups whereby the amount of epichlorohydrin plus propylene oxide is no more than 70% by weight of the starting amount of cellulose; and\n\n(b) regenerated cellulose, cross-linked and alkylated with epichlorohydrin then derivatised with tertiary amine groups whereby the amount of epichlorohydrin is no more than 10% by weight of the starting amount of cellulose.\n\n(2) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH 2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.\n\nS3—12 Specification for dimethyl ether\n\nFor dimethyl ether, the specifications are the following:\n\n(a) purity—minimum of 99.8%;\n\n(b) methanol—not greater than 200 mg/kg.\n\nS3—13 Specification for dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)\n\nFor docosahexaenoic acid (DHA)-rich dried marine micro-algae (Schizochytrium sp.), the specifications are the following:\n\n(a) full chemical name—4,7,10,13,16,19-docosahexaenoic acid (22:6n-3 DHA);\n\n(b) solids (%)—minimum 95.0;\n\n(c) DHA (%)—minimum 15.0;\n\n(d) lead (mg/kg)—maximum 0.5;\n\n(e) arsenic (mg/kg)—maximum 0.5.\n\nS3—14 Specification for ice structuring protein type III HPLC 12 preparation\n\n(1) In this section:\n\nice structuring protein type III HPLC 12 preparation means the protein excreted from the fermentation of a genetically modified yeast (Saccharomyces cerevisiae) to which a synthetic gene encoding for the protein has been inserted into the yeast’s genome.\n\n(2) For ice structuring protein type III HPLC 12 preparation, the specifications are the following:\n\n(a) assay—not less than 5 g/L active ice structuring protein type III HPLC 12;\n\n(b) pH—3.0+/-0.5;\n\n(c) ash—not more than 2%;\n\n(d) appearance—light brown aqueous preparation;\n\n(e) heavy metals—not more than 2 mg/L;\n\n(f) microbial limits:\n\n (i) total microbial count—<3 000/g; and\n (ii) coliforms—<10/g; and\n (iii) yeast and mould count—<100/g; and\n (iv) Listeria sp.—absent in 25 g; and\n (v) Salmonella sp.—absent in 25 g; and\n (vi) Bacillus cereus—<100/g.\n\nS3—15 Specification for isomaltulose\n\nFor isomaltulose, the specifications are the following:\n\n(a) chemical name—6-O-α-D-glucopyranosyl-D-fructofuranose:\n\n(b) description—white or colourless, crystalline, sweet substance, faint isomaltulose specific odour;\n\n(c) isomaltulose (%)—not less than 98% on a dry weight basis;\n\n(d) water—maximum 6%;\n\n(e) other saccharides—maximum 2% on a dry weight basis;\n\n(f) ash—maximum 0.01% on a dry weight basis;\n\n(g) lead—maximum 0.1 ppm on a dry weight basis.\n\nS3—16 Specification for Listeria phage P100\n\nFor Listeria phage P100, the biological classification is the following:\n\n(a) order—Caudovirales;\n\n(b) family—Myoviridae;\n\n(c) subfamily—Spounaviridae;\n\n(d) genus—twort-like;\n\n(e) species—Listeria phage P100;\n\n(f) GenBank Accession Number—DQ004855.\n\nS3—17 Descriptions and physical constraints for nucleotides\n\nUridine-5′-monophosphate disodium salt (UMP)\n\n(1) For uridine-5′-monophosphate disodium salt (UMP), the specifications are the following:\n\n(a) empirical chemical formula—C9 H11N2 O9PNa2;\n\n(b) the compound must be of the 5 species, with the disodium monophosphate structure attached to the fifth carbon in the central structure;\n\n(c) molecular weight—368.15;\n\n(d) structure or physical character—occurs as a colourless or white crystal or as a white crystalline powder. It is odourless and has a characteristic taste;\n\n(e) solubility—freely soluble in water; very slightly soluble in alcohol.\n\nAdenosine-5′-monophosphate (AMP)\n\n(2) For adenosine-5′-monophosphate (AMP), the specifications are the following:\n\n(a) empirical chemical formula—C10H14N5O7P;\n\n(b) the compound must be of the 5 species, with the monophosphate structure attached to the fifth carbon in the central structure;\n\n(c) molecular weight—347.22;\n\n(d) structure or physical character—occurs as a colourless or white crystal or as a white crystalline powder. It is odourless and has a characteristic acidic taste;\n\n(e) solubility—very slightly soluble in water; practically insoluble in alcohol.\n\nCytidine-5′-monophosphate (CMP)\n\n(3) For cytidine-5′-monophosphate (CMP), the specifications are the following:\n\n(a) empirical chemical formula—C9H14N3O8P;\n\n(b) the compound must be of the 5 species, with the monophosphate structure attached to the fifth carbon in the central structure;\n\n(c) molecular weight—323.20;\n\n(d) structure or physical character—occurs as a colourless or white crystal or as a white crystalline powder. It is odourless and has a characteristic slightly acidic taste;\n\n(e) solubility—very slightly soluble in water; practically insoluble in alcohol.\n\nS3—18 Testing requirements for nucleotides\n\nThe testing requirements for nucleotides are as follows:\n\n(a) physical inspection—white crystals or crystalline powder;\n\n(b) identification:\n\n (i) ultraviolet absorbance: a 1 in 12 500 solution of the powder in 0.01N hydrochloric acid exhibits an absorbance maximum at an absorbance of:\n\n(A) for inosine-5′-monophosphate disodium salt—250 ± 2nm; and\n\n(B) for uridine-5′-monophosphate disodium salt—260 ± 2nm; and\n\n(C) for adenosine-5′-monophosphate—257 ± 2nm; and\n\n(D) for cytidine-5′-monophosphate (CMP)—280 ± 2nm; and\n\n(E) guanosine-5′-monophosphate disodium salt (gMP)—256 ± 2nm; and\n\n (ii) IMP, UMP and gMP must test positive for sodium phosphate; and\n (iii) IMP, UMP, AMP, CMP and gMP must test positive for organic phosphate;\n\n(c) assay (HPLC)—optimum of not less than 96% (corrected for moisture content);\n\n(d) IMP and gMP have a pH of a 1 in 20 solution: between 7.0 and 8.5;\n\n(e) clarity and colour of solution:\n\n (i) 500 mg/10 mL H2O for IMP: is colourless and shows only a trace of turbidity; and\n (ii) 100 mg/10 mL H2O for gMP: is colourless and shows only a trace of turbidity;\n\n(f) moisture:\n\n (i) for inosine-5′-monophosphate disodium salt—not more than 28.5%: Karl Fischer; and\n (ii) for uridine-5′-monophosphate disodium salt—not more than 26.0%: Karl Fischer; and\n (iii) guanosine-5′-monophosphate disodium salt (gMP)—loss in drying of not more than 25% (4 hrs @ 120ºC); and\n (iv) for cytidine-5′-monophosphate (CMP)—loss in drying of not more than 6.0% (4 hrs @ 120ºC); and\n (v) adenosine-5′-monophosphate—loss in drying of not more than 6.0% (4 hrs @ 120ºC);\n\n(g) impurities—all nucleotides:\n\n (i) for IMP, gMP—amino acids: negative; and\n (ii) for IMP, gMP—ammonium salts: negative; and\n (iii) for IMP, UMP, AMP, CMP, gMP—arsenic: not more than 2 ppm; and\n (iv) for IMP, UMP, AMP, CMP, gMP—heavy metals: not more than 10 ppm;\n\n(h) related foreign substances:\n\n (i) for IMP—only 5′-inosinic acid is detected by thin layer chromatography; and\n (ii) for gMP—only 5′-guanylic acid is detected by thin layer chromatography;\n\n(i) bacteriological profile:\n\n (i) \\*SPC—not more than 1 000/g, test per current FDA/BAM procedures; and\n (ii) coliforms—negative by test; test per current FDA/BAM procedures; and\n (iii) yeast and mould—not more than 300/g, test per current FDA/BAM procedures; and\n (iv) Salmonella—negative, test per current FDA/BAM procedures.\n\nS3—19 Specification for oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA)\n\nFor oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA), the specifications are the following:\n\n(a) full chemical name for DHA—4,7,10,13,16,19-docosahexaenoic acid (22:6n-3);\n\n(b) DHA (%)—minimum 35;\n\n(c) \\*trans fatty acids (%)—maximum 2.0;\n\n(d) lead (mg/kg)—maximum 0.1;\n\n(e) arsenic (mg/kg)—maximum 0.1;\n\n(f) mercury (mg/kg)—maximum 0.1;\n\n(g) hexane (mg/kg)—maximum 0.3.\n\nS3—20 Specification for oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA)\n\nFor oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA), the specifications are the following:\n\n(a) full chemical name for ARA—5,8,11,14-eicosatetraenoic acid (20:4n-6 ARA);\n\n(b) ARA (%)—minimum 35;\n\n(c) \\*trans fatty acids (%)—maximum 2.0;\n\n(d) lead (mg/kg)—maximum 0.1;\n\n(e) arsenic (mg/kg)—maximum 0.1;\n\n(f) mercury (mg/kg)—maximum 0.1;\n\n(g) hexane (mg/kg)—maximum 0.3.\n\nS3—21 Specification for oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)\n\nFor oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA), the specifications are the following:\n\n(a) full chemical name—4,7,10,13,16,19-docosahexaenoic acid (22:6n-3 DHA);\n\n(b) DHA (%)—minimum 32;\n\n(c) \\*trans fatty acids (%)—maximum 2.0;\n\n(d) lead (mg/kg)—maximum 0.1;\n\n(e) arsenic (mg/kg)—maximum 0.1;\n\n(f) mercury (mg/kg)—maximum 0.1;\n\n(g) hexane (mg/kg)—maximum 0.3.\n\nS3—22 Specification for oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA)\n\nFor oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA), the specifications are the following:\n\n(a) full chemical name for DHA—4,7,10,13,16,19-docosahexaenoic acid (22:6n-3 DHA);\n\n(b) DHA (%)—minimum 32;\n\n(c) \\*trans fatty acids (%)—maximum 2.0;\n\n(d) lead (mg/kg)—maximum 0.2;\n\n(e) arsenic (mg/kg)—maximum 0.2;\n\n(f) mercury (mg/kg)—maximum 0.2;\n\n(g) hexane (mg/kg)—maximum 10.\n\nS3—23 Specification for oxidised polyethylene\n\n(1) In this section:\n\nASTM refers to standard test methods prepared by the American Society for Testing and Materials.\n\nCAS means the Chemical Abstracts Service (CAS) Registry Number.\n\noxidised polyethylene (CAS 68441-17-8) is the polymer produced by the mild air oxidation of polyethylene.\n\n(2) For oxidised polyethylene, the specifications are the following:\n\n(a) average molecular weight—min 1200 (osmometric);\n\n(b) viscosity at 125C—min 200cP;\n\n(c) oxygen content—max 9.1%;\n\n(d) acid value—max 70 mgKOH/g (ASTM D 1386);\n\n(e) drop point—min 95C (ASTM D 566);\n\n(f) density (20C)—0.93-1.05 g/cm3 (ASTM D 1298, D 1505);\n\n(g) extractable constituents:\n\n (i) in water—maximum 1.5%; and\n (ii) in 10% ethanol—max 2.3%; and\n (iii) in 3% acetic acid—max 1.8%; and\n (iv) in n-pentane—max 26.0%.\n\nNote Extraction of oxidised polyethylene—25.0 g of finely ground oxidised polyethylene powder (particle size 300–1 000 μm) is extracted for 5 hours in the Soxhlet apparatus with 350 mL of solvent. The solvent is then distilled off and the distillation residue is dried in a vacuum oven at 80–90°C. After weighing the obtained residue, the components soluble in the solvent are calculated in % weight (based on the initial weight used).\n\nS3—24 Specification for phytosterols, phytostanols and their esters\n\n(1) Subject to subsections (2) and (3), \\*phytosterols, phytostanols and their esters must comply with a monograph specification in section S3—2 or section S3—3.\n\n(2) However, for a mixture which contains no less than 950 g/kg of phytosterol and phytostanols, the concentration of hexane, isopropanol, ethanol, methanol or methyl ethyl ketone either singly or in combination must be no more than 2 g/kg.\n\n(3) The \\*total plant sterol equivalents content must contain no less than 95% des-methyl sterols.\n\nS3—25 Specification for quaternary amine cellulose ion exchange resin\n\n(1) This specification relates to regenerated cellulose, cross-linked and alkylated with epichlorohydrin and propylene oxide, then derivatised with quaternary amine groups whereby the amount of epichlorohydrin plus propylene oxide is no more than 250% by weight of the starting amount of cellulose.\n\n(2) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH 2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.\n\nS3—26 Specification for resistant maltodextrins\n\nFor resistant maltodextrins, the specifications are the following:\n\n(a) chemical structure—glucopyranose linked by α(1-4), α(1-6), α/β(1-2), and α/β(1-3) glucosidic bonds; and contains levoglucosan;\n\n(b) dextrose equivalent—8-12;\n\n(c) appearance—free-flowing fine powder;\n\n(d) colour—white;\n\n(e) taste/odour—slightly sweet/odourless;\n\n(f) solution—clear;\n\n(g) pH (in 10% solution)—4-6;\n\n(h) moisture (%)—maximum 5;\n\n(i) ash (%)—maximum 0.2;\n\n(j) arsenic (ppm)—maximum 1;\n\n(k) heavy metals (ppm)—maximum 5;\n\n(l) microbiological:\n\n (i) \\*SPC (cfu/g)—maximum 300;\n (ii) yeast and mould (cfu/g)—maximum 100;\n (iii) Salmonella—negative to test;\n (iv) coliforms—negative to test.\n\nS3—27 Specification for tall oil phytosterol esters\n\n(1) In this section:\n\ntall oil phytosterol esters are phytosterols derived from tall oil pitch esterified with long-chain fatty acids derived from edible vegetable oils\n\n(2) For tall oil phytosterol esters, the specifications are the following:\n\n(a) phytosterol content:\n\n (i) phytosterol esters plus free phytosterols—no less than 97%; and\n (ii) free phytosterols after saponification—no less than 59%; and\n (iii) free phytosterols—no more than 6%; and\n (iv) steradienes—no more than 0.3%;\n\n(b) sterol profile based on input sterols:\n\n (i) campesterol—no less than 4.0% and no more than 25.0%; and\n (ii) campesterol—no more than 14.0%; and\n (iii) B-sitosterol—no less than 36.0% and no more than 79.0%; and\n (iv) B-sitostanol—no less than 6.0% and no more than 34%; and\n (v) fatty acid methylester—no more than 0.5%; and\n (vi) moisture—no more than 0.1%; and\n (vii) solvents—no more than 50 mg/kg; and\n (viii) residue on ignition—no more than 0.1%;\n\n(c) heavy metals:\n\n (i) iron—no more than 1.0 mg/kg; and\n (ii) copper—no more than 0.5 mg/kg; and\n (iii) arsenic—no more than 3 mg/kg; and\n (iv) lead—no more than 0.1 mg/kg;\n\n(d) microbiological:\n\n (i) total aerobic count—no more than 10 000 cfu/g; and\n (ii) combined moulds and yeasts—no more than 100 cfu/g; and\n (iii) coliforms—negative; and\n (iv) Escherichia coli—negative; and\n (v) Salmonella—negative.\n\nS3—28 Specification for yeast—selenium-enriched\n\n(1) Selenium-enriched yeasts are produced by culture in the presence of sodium selenite as a source of selenium.\n\n(2) These yeasts must contain selenium according to the following criteria:\n\n(a) total selenium content—no more than 2.5 mg/g of the dried form as marketed;\n\n(b) levels of organic selenium (% total as extracted selenium):\n\n (i) selenomethionine—no less than 60% and no more than 85%; and\n (ii) other organic selenium compounds (including selenocysteine)—no more than 10%;\n\n(c) levels of inorganic selenium (% total extracted selenium)—no more than 1%.\n\nS3—29 Specification for yeast—high chromium\n\nFor high chromium yeast:\n\n(a) the physical specifications are the following:\n\n (i) appearance—fine, free-flowing powder;\n (ii) colour—light off-white or light tan;\n (iii) odour—slight yeast aroma;\n (iv) particle size—minimum 90% through a #100 USS screen; and\n\n(b) the chemical specifications are the following:\n\n (i) moisture—maximum 6%;\n (ii) chromium—1.8-2.25 g/kg.\n\nS3—30 Specification for yeast—high molybdenum\n\nFor high molybdenum yeast:\n\n(a) the physical specifications are the following:\n\n (i) appearance—fine, free-flowing powder;\n (ii) colour—light off-white or light tan;\n (iii) odour—slight yeast aroma;\n (iv) particle size—minimum 85% through a #100 USS screen; and\n\n(b) the chemical specifications are the following:\n\n (i) moisture—maximum 6%;\n (ii) molybdenum—1.8–2.25 g/kg.\n\nS3—33 Specifications for Salmonella phage preparation (S16 and FO1a)\n\n(1) In this section:\n\na preparation means a Salmonella phage preparation (S16 and FO1a).\n\nSalmonella phage preparation (S16 and FO1a) means a solution of a 1:1 blend of Salmonella phage S16 and Salmonella phage FO1a.\n\n(2) Salmonella phage S16 in a preparation must comply with the specification in subsection (4).\n\n(3) Salmonella phage FO1a in a preparation must comply with the specification in subsection (5).\n\n(4) The biological classification for Salmonella phage S16 in a preparation is the following:\n\n(a) order—Caudavirales;\n\n(b) family—Myoviridae;\n\n(c) genus—T4-like;\n\n(d) species—Salmonella phage S16;\n\n(e) GenBank Accession Number—HQ331142\n\n(5) The biological classification for Salmonella phage FO1a in a preparation is the following:\n\n(a) order—Caudavirales;\n\n(b) family—Myoviridae;\n\n(c) genus—FelixO1-like;\n\n(d) species— Salmonella phage FO1a;\n\n(e) GenBank Accession Number—JF461087.\n\nS3—34 Specification for sulphonate agarose ion exchange resin\n\n(1) This specification relates to agarose, cross-linked with epichlorohydrin and reacted with allyl glycidyl ether or propylene oxide, then derivatised with sulphonate groups whereby the amount of epichlorohydrin plus allyl glycidyl ether or propylene oxide does not exceed 250% by weight of the starting quantity of agarose.\n\n(2) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH 2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.\n\nS3—35 Specification for steviol glycosides produced by enzymatic conversion\n\n (1) In this section:\n\nprescribed rebaudiosides are:\n\n (a) rebaudioside D;\n\n(b) rebaudioside M; and\n\n(c) rebaudioside AM.\n\nrebaudioside AM means the steviol glycoside with the chemical name: 13-\\[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy\\]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester.\n\n(1A) This specification relates to a steviol glycosides preparation obtained from the leaves of the Stevia rebaudiana Bertoni plant.\n\n(2) The preparation must be obtained from the leaves of the Stevia rebaudiana Bertoni plant by using one of the following processes:\n\n(a) by enzymatic conversion of purified stevia leaf extract to produce rebaudioside M using enzymes that:\n\n(i) contain both UDP‑glucosyltransferase and sucrose synthase (EC 2.4.1.13) components; and\n\n(ii) are sourced from both of the following:\n\n(a) a Pichia pastoris strain expressing UGT-A;\n\n(b) a Pichia pastoris strain expressing both UGT-B1 and UGT-B2;\n\n(b) by enzymatic conversion of purified stevia leaf extract to produce rebaudioside D using an enzyme that:\n\n(i) contains both UDP‑glucosyltransferase and sucrose synthase (EC 2.4.1.13) components; and\n\n(ii) is sourced from Pichia pastoris strain UGT-A;\n\n(c) by enzymatic conversion of purified stevia leaf extract to produce one or more prescribed rebaudiosides using a combination of enzymes that contains:\n\n(i) a UDP-glucosyltransferase from Stevia rebaudiana sourced from Escherichia coli; and\n\n(ii) a UDP-glucosyltransferase from Solanum lycopersicum sourced from Escherichia coli; and\n\n(iii) a sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli.\n\n(d) by enzymatic conversion of purified stevia leaf extract to produce rebaudioside E using an enzyme that:\n\n(i) contains both of the following components:\n\n(A) UDP‑glucosyltransferase; and\n\n(B) sucrose synthase (EC 2.4.1.13); and\n\n(ii) is sourced from Pichia pastoris strain UGT-A;\n\n(e)    by enzymatic conversion of purified stevia leaf extract to produce rebaudioside M using all of the following enzymes:\n\n(i) UTP-glucose-1-phosphate uridylyltransferase (EC 2.7.7.9) sourced from Escherichia coli K-12; and\n\n(ii) UDP-glucosyltransferase sourced from Escherichia coli K-12; and\n\n(iii) sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli K-12;\n\n(f)      by enzymatic conversion of purified stevia leaf extract to produce rebaudioside I using both of the following enzymes:\n\n(i) UTP-glucose-1-phosphate uridylyltransferase (EC 2.7.7.9) sourced from Escherichia coli K-12; and\n\n(ii) sucrose synthase (EC 2.4.1.13) sourced from Escherichia coli K-12;\n\n(g)    by enzymatic conversion of purified stevia leaf extract to produce rebaudioside M using a combination of enzymes that contains:\n\n (i) UDP-glucosyltransferases from Stevia rebaudiana sourced from Escherichia coli BL21; and\n (ii) sucrose synthase (EC 2.4.1.13) from Arabidopsis thaliana sourced from Escherichia coli BL21.\n\n(2A) The final product may be spray dried.\n\n(3) The preparation may contain different individual steviol glycosides.\n\n(4) The specifications are the following:\n\n(a) Description—white to light yellow powder, approximately 150 to 300 times sweeter than sucrose;\n\n(b) Assay—not less than 95% of steviol glycosides on the dried basis;\n\n(c) Solubility—freely soluble in water;\n\n(d) pH—between 4.5 and 7.0 (1% solution);\n\n(e) Total ash—not more than 1%;\n\n(f) Loss on drying—not more than 6% (105°C, 2 hour);\n\n(g) Residual solvents: Not more than 200 mg/kg methanol\n\nNot more than 5000 mg/kg ethanol\n\n(h) Arsenic—not more than 1 mg/kg;\n\n(i) Lead—not more than 1 mg/kg;\n\n(j) INS number—960.\n\nS3—36 Specification for oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695)\n\nFor oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695), the specifications are the following:\n\n(a) full chemical name—4,7,10,13,16,19-docosahexaenoic acid (22:6n-3 DHA);\n\n(b) DHA (%)—minimum 35;\n\n(c) EPA (%)—maximum 10;\n\n(d) \\*trans fatty acids (%)—maximum 2.0;\n\n(e) lead (mg/kg)—maximum 0.1;\n\n(f) arsenic (mg/kg)—maximum 0.1;\n\n(g) mercury (mg/kg)—maximum 0.1;\n\n(h) hexane (mg/kg)—maximum 0.3.\n\nS3—37 Specification for isomalto-oligosaccharide\n\nFor isomalto-oligosaccharide (IMO), the specifications are the following:\n\n(a) chemical structure—IMO is a mixture of glucose oligomers with α 1→6 glycosidic linkages that include isomaltose, panose, isomaltotriose, isomaltopentaose and various branched oligosaccharides;\n\n(b) description—a white crystalline powder or transparent clear pale yellow coloured syrup;\n\n(c) IMO content (dry weight)—not less than 90% (powder) and not less than 75% (syrup);\n\n(d) oligosaccharides—not less than 55% with a degree of polymerisation of 3 or more;\n\n(e) glucose (dry weight)—not more than 5%;\n\n(f) moisture—not more than 5% for the powder, not applicable for syrup;\n\n(g) ash (dry weight)—not more than 0.3%.\n\nS3—38 Specification for L-arginine acetate\n\nFor L-arginine acetate, the specifications are the following:\n\n(a) full chemical name—(2S)-2-amino-5-(diaminomethylideneamino) pentanoic acid acetate;\n\n(b) description—white crystalline powder;\n\n(c) chemical formula—C8H18N4O4;\n\n(d) CAS number—71173-62-1;\n\n(e) purity (assay, on dried basis)—98.0-101.0%;\n\n(f) loss on drying—maximum 0.5%;\n\n(g) lead—maximum 0.4 mg/kg;\n\n(h) arsenic—maximum 1 mg/kg;\n\n(i) cadmium—maximum 0.2 mg/kg;\n\n(j) mercury—maximum 0.4 mg/kg.\n\nS3—39 Specification for steviol glycosides from fermentation\n\n(1) This specification relates to a steviol glycosides preparation that:\n\n(a) is obtained from fermentation;\n\n(b) is not obtained from the leaves of the Stevia rebaudiana Bertoni plant; and\n\n(c) contains steviol glycosides that are only derived from one of the following:\n\n(i) Saccharomyces cerevisiae strain CD15407 containing novel genes for the production of steviol glycosides;\n\n(ii) Saccharomyces cerevisiae strain Y63348 containing novel genes for the production of steviol glycosides;\n\n(iii) Yarrowia lipolytica strain VRM0014 containing novel genes for the production of steviol glycosides.\n\n(2) The specifications are the following:\n\n(a) Description—white to light yellow powder, approximately 200 to 300 times sweeter than sucrose;\n\n(b) Assay—not less than 95% of steviol glycosides on the dried basis;\n\n(c) Solubility—freely soluble in water;\n\n(d) pH—between 4.5 and 7.0 (1% solution);\n\n(e) Total ash—not more than 1%;\n\n(f) Loss on drying—not more than 6% (105°C, 2 hour);\n\n(g) Residual solvents—not more than 200 mg/kg methanol and not more than 5000 mg/kg ethanol;\n\n(h) Arsenic—not more than 1 mg/kg;\n\n(i) Lead—not more than 1 mg/kg;\n\n(j) Cadmium—not more than 1 mg/kg;\n\n(k) Mercury—not more than 1 mg/kg;\n\n(l) The final product may be spray dried.\n\nS3—39(A) Specification for rapeseed protein isolate\n\nFor rapeseed protein isolate, the specifications are the following:\n\n(a) Composition:\n\n (i) Total protein (%) – no less than 90; and\n (ii) Carbohydrates (%) – no more than 7; and\n (iii) Fat (%) – no more than 5; and\n (iv) Ash (%) – no more than 5; and\n (v) Moisture (%) – no more than 7;\n\n(b) Purity:\n\n (i) Glucosinolates (μmol/g) – no more than 1;\n (ii) Erucic acid (%) – no more than 0.005;\n (iii) Phytates (% w/w) – no more than 1.5;\n\n(c) Metals:\n\n (i) Lead (mg/kg) – no more than 0.5;\n\n(d) Microbiological:\n\n (i) Total plate count (cfu/g) no more than 10,000; and\n (ii) Escherichia coli (cfu/10g) absent; and\n (iii) Salmonella spp. (cfu/25g) absent; and\n (iv) Yeasts and moulds (cfu/g) less than 100.\n\nS3—40 Specification for 2′-fucosyllactose sourced from Escherichia coli K-12\n\nFor 2′\\-fucosyllactose (2′\\-FL) sourced from Escherichia coli K-12 containing the gene for alpha-1,2-fucosyltransferase from either Heliobacter enhydrae, Helicobacter pylori or Bacteroides vulgatus, the specifications are the following:\n\n(a) chemical name—α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose;\n\n(b) chemical formula—C18H32O15;\n\n(c) molecular weight—488.44 g/mol;\n\n(d) CAS number—41263-94-9;\n\n(e) description— white to off-white powder\n\n(f) 2′-FL—not less than 83%;\n\n(g) D-lactose—not more than 10.0%;\n\n(h) L-fucose—not more than 2.0%;\n\n(i) difucosyl-D-lactose—not more than 5.0 %;\n\n(j) 2′-fucosyl-D-lactulose—not more than 1.5 %;\n\n(k) sum of saccharides (2′-FL, D-lactose, L-fucose, difucosyl-D-lactose, 2′-fucosyl-D-lactulose)—not less than 90%;\n\n(l) pH (20°C, 5% solution)—3.0-7.5;\n\n(m) water—not more than 9.0%;\n\n(n) ash, sulphated—not more than 2.0%;\n\n(o) acetic acid—not more than 1.0%;\n\n(p) residual proteins—not more than 0.01%;\n\n(q) microbiological:\n\n(i) aerobic mesophilic bacteria total count—not more than 3,000 cfu/g;\n\n(ii) yeasts—not more than 100 cfu/g;\n\n(iii) moulds—not more than 100 cfu/g;\n\n(iv) endotoxins—not more than 10 EU/mg.\n\nS3—41 Specification for lacto-N-neotetraose\n\nFor lacto-N-neotetraose (LNnT), the specifications are the following:\n\n (a) chemical name—–β-D-galactopyranosyl-(1→4)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucopyranose\n\n(b) chemical formula—–C26H45NO21\n\n(c) CAS number—–13007-32-4\n\n(d) description—–white to off white powder or agglomerates\n\n(e) assay (water free) for sum of LNnT, lactose, lacto-N-triose II, and para\\-lacto-N-hexaose—–not less than 95.0%\n\n(f) assay (water free) LNnT—–not less than 92.0%\n\n(g) D-lactose—–not more than 3.0%\n\n(h) lacto-N-triose II—–not more than 3.0%\n\n(i) para\\-lacto-N-neohexaose—–not more than 3.0%\n\n(j) LNnT fructose isomer—–not more than 1.0%\n\n(k) pH (20°C, 5% solution) —–4.0 to 7.0\n\n(l) water—–not more than 9.0%\n\n(m) ash, sulphated—–not more than 1.5%\n\n(n) methanol—–not more than 100 mg/kg\n\n(o) residual proteins—–not more than 0.01%\n\n(p) lead—–not more than 0.1 mg/kg\n\n (q) microbiological:\n (i) Salmonella—–absent in 25 g\n (ii) total plate count—–not more than 500 cfu/g\n (iii) Enterobacteriaceae—–absent in 10 g\n (iv) Cronobacter (Enterobacter) sakazakii—–absent in 10 g\n (v) Listeria monocytogenes—–absent in 25 g\n (vi) Bacillus cereus—–not more than 50 cfu/g\n (vii) yeasts—–not more than 10 cfu/g\n (viii) moulds—–not more than 10 cfu/g\n\n(ix) residual endotoxins—–not more than 10 EU/mg\n\nS3—42 Specification for a soy leghemoglobin preparation\n\nNote Subsections S26—3(5) and (7) require a soy leghemoglobin preparation to comply with the specifications set out in this section.\n\nFor a soy leghemoglobin preparation, the specifications are the following:\n\n(a) soy leghemoglobin protein—maximum 9.0%;\n\n(b) soy leghemoglobin protein purity—minimum 65%;\n\n(c) appearance—dark red concentrated liquid;\n\n(d) solids— maximum 26%;\n\n(e) fat—maximum 2.0%;\n\n(f) carbohydrate—maximum 6.0%;\n\n(g) pH—5-10;\n\n(h) moisture—maximum 90%;\n\n(i) ash—maximum 4.0%;\n\n(j) lead—maximum 0.4 mg/kg;\n\n(k) arsenic—maximum 0.05 mg/kg;\n\n(l) mercury—maximum 0.05 mg/kg;\n\n(m) cadmium—maximum 0.2 mg/kg;\n\n(n) microbiological:\n\n (i) Escherichia coli—negative to test;\n (ii) Salmonella spp.—negative to test;\n (iii) Listeria monocytogenes—negative to test.\n\nS3—43 Specification for sweet osmanthus ear glycolipids\n\nFor sweet osmanthus ear glycolipids, the specifications are the following:\n\n(a) CAS number—2205009-17-0;\n\n(b) chemical structure—a mixture of long-chain glycolipids obtained from the fermentation and filtration of the non-GMO Dacryopinax spathularia strain MUCL 53181;\n\n(c) description—off-white to ivory powder;\n\n(d) pH—between 5.0 and 7.0 (1% aqueous solution);\n\n(e) water—less than 5%;\n\n(f) protein—less than 3%;\n\n(g) fat—less than 2%;\n\n(h) total glycolipid content on a dry weight basis for the powder—no less than 93%;\n\n(i) lead—not more than 2 mg/kg;\n\n(j) arsenic—not more than 1 mg/kg;\n\n(k) cadmium— not more than 1 mg/kg;\n\n(l) mercury— not more than 1 mg/kg;\n\n(m) microbial limits:\n\n (i) total aerobic microbial count—not more than 100 cfu/g;\n (ii) total yeast and mould count—not more than 10 cfu/g;\n (iii) coliforms—not more than 3 MPN/g;\n (iv) Escherichia coli—not more than 3 MPN/g.\n\nS3—44 Specification for Nicotinamide riboside chloride\n\n(1) In this section,\n\nNicotinamide riboside chloride (CAS Number 23111-00-4) is the chemical with:\n\n(a) the chemical name Pyridinium, 3-(aminocarbonyl)-1-β-D-ribofuranosyl-, chloride (1:1);\n\n(b) the formula C11H15N2O5·Cl;\n\n(c) the formula weight 290.7 g/mol.\n\n(2) For Nicotinamide riboside chloride, the specifications are the following:\n\n(a) description—a white to light brown powder;\n\n(b) solubility—freely soluble in water;\n\n(c) assay—not less than 90.0 w/w % and not more than 103 w/w %;\n\n(d) water—not more than 2.0 w/w %;\n\n(e) residual solvents:\n\n(i) acetone—not more than 5000 ppm; and\n\n(ii) methanol—not more than 1000 ppm; and\n\n(iii) acetonitrile—not more than 50 ppm; and\n\n(iv) methyl tert-butyl ether—not more than 500 ppm;\n\n(f) reaction by-products:\n\n(i) methyl acetate—not more than 1000 ppm; and\n\n(ii) acetamide—not more than 27 ppm; and\n\n(iii) acetic acid—not more than 5000 ppm;\n\n(g) arsenic and heavy metals:\n\n(i) arsenic—not more than 1 ppm; and\n\n(ii) mercury—not more than 1 ppm; and\n\n(iii) cadmium—not more than 1 ppm; and\n\n(iv) lead—not more than 0.5 ppm;\n\n(h) microbial limits:\n\n(i) \\*SPC—maximum 1000 cfu/g; and\n\n(ii) yeast and mould—maximum 100 cfu/g; and\n\n(iii) Escherichia coli—absent in 10 g\n\nS3—45 Specification for 2′\\-fucosyllactose sourced from Escherichia coli BL21\n\nFor 2′-fucosyllactose (2′-FL) sourced from Escherichia coli BL21, the specifications are the following:\n\n(a) chemical name—α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose\n\n(b) chemical formula—C18H32O15\n\n(c) CAS number—41263-94-9\n\n(d) description—either a white to ivory powder, or a colourless to slightly yellow liquid\n\n(e) 2′-FL—not less than 90.0%\n\n(f) D-lactose—not more than 5.0%\n\n(g) L-fucose—not more than 3.0%\n\n(h) 3-fucosyllactose—not more than 5.0%\n\n(i) difucosyllactose—not more than 5.0%\n\n(j) fucosyl-galactose—not more than 3.0%\n\n(k) glucose—not more than 3.0%\n\n(l) galactose—not more than 3.0%\n\n(m) water—not more than 9.0% for powder, not applicable for liquid\n\n(n) solids—45% w/v (± 5%) dry matter in water, not applicable for powder\n\n(o) ash, sulphated—not more than 0.5%\n\n(p) residual proteins—not more than 0.01%\n\n(q) lead—not more than 0.02 mg/kg\n\n(r) arsenic—not more than 0.2 mg/kg\n\n(s) cadmium—not more than 0.1 mg/kg\n\n(t) mercury—not more than 0.5 mg/kg\n\n(u) microbiological:\n\n(i) Salmonella—absent in 100 g for powder, absent in 200 mL for liquid\n\n(ii) total plate count—not more than 10000 cfu/g for powder, not more than 5000 cfu/g for liquid\n\n(iii) coliform/Enterobacteriaceae—absent in 11 g for powder, absent in 22 mL for liquid\n\n(iv) Cronobacter sakazakii—absent in 100 g for powder, absent in 200 mL for liquid\n\n(v) yeast and mould—not more than 100 cfu/g for powder, not more than 50 cfu/g for liquid\n\n(vi) aflatoxin M1—not more than 0.025 μg/kg\n\n(vii) endotoxins—not more than 10 EU/mg\n\n(viii) GMO detection—not detected.\n\nS3—46 Specification for bovine lactoferrin\n\n(1) In this section, bovine lactoferrin is a protein derived from cow’s milk and consisting of a single polypeptide chain of 689 amino acids.\n\n(2) For bovine lactoferrin, the specifications are the following:\n\n(a) description—a pink to reddish brown coloured, free-flowing powder;\n\n(b) protein (N x 6.38)—more than 93.0%;\n\n(c) purity—more than 95.0%;\n\n(d) moisture—less than 4.5 g/100 g;\n\n(e) ash—not more than 1.5 g/100 g;\n\n(f) iron—not more than 35 mg/100 g;\n\n(g) pH (2% solution)—5.2 to 7.2;\n\n(h) solubility transmittance (2% solution, 20°C)—transparent;\n\n(i) lead—not more than 1 mg/kg;\n\n(j) microbial limits:\n\n (i) Salmonella spp.—absent in 25 g;\n (ii) Listeria monocytogenes—–absent in 25 g;\n (iii) Cronobacter spp.—–absent in 10 g.\n\nS3—47 Specification for a combination of 2′-fucosyllactose and difucosyllactose sourced from Escherichia coli K-12\n\nFor a mixture of 2′-fucosyllactose (2′-FL) and difucosyllactose (DFL) sourced from Escherichia coli K-12 containing the gene for alpha-1,2-fucosyltransferase from Helicobacter pylori, the specifications are the following:\n\n(a) chemical names:\n\n(i) for 2′-FL––α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose;\n\n(ii) for DFL––α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-\\[α-L-fucopyranosyl-(1→3)\\]-D-glucose;\n\n(b) chemical formulas:\n\n(i) for 2′-FL––C18H32O15;\n\n(ii) for DFL––C24H42O19;\n\n(c) molecular weights:\n\n(i) for 2′-FL––488.44 g/mol;\n\n(ii) for DFL––634.58 g/mol;\n\n(d) CAS numbers:\n\n(i) for 2′-FL––41263-94-9;\n\n(ii) for DFL––20768-11-0;\n\n(e) description––white, white to off-white, or off-white powder, agglomerates, or powder with agglomerates;\n\n(f) 2′-FL––not less than 75.0% (water free);\n\n(g) DFL––not less than 5.0% (water free);\n\n(h) sum of 2′-FL and DFL––not less than 85.0% (water free);\n\n(i) sum of human identical milk saccharides: 2′-FL, DFL, D-lactose, L-fucose, 3-fucosyllactose ––not less than 92.0% (water free);\n\n(j) D-lactose––not more than 10%;\n\n(k) L-fucose––not more than 1.0%;\n\n(l) 2'-fucosyl-D-lactulose––not more than 2.0%;\n\n(m) pH (20°C, 5% solution)––4.0-6.0;\n\n(n) water––not more than 6.0%;\n\n(o) ash, sulphated––not more than 0.8%;\n\n(p) residual protein––not more than 0.01%;\n\n(q) lead––not more than 0.1 mg/kg;\n\n(r) microbiological:\n\n(i) aerobic mesophilic bacteria total count––not more than 1,000 cfu/g;\n\n(ii) Enterobacteriaceae––absent in 10 g;\n\n(iii) yeasts––not more than 100 cfu/g;\n\n(iv) moulds––not more than 100 cfu/g;\n\n(v) residual endotoxins––not more than 10 EU/mg.\n\nS3—48 Specification for lacto-N-tetraose sourced from Escherichia coli K-12\n\nFor lacto-N-tetraose (LNT) sourced from Escherichia coli K-12 containing the gene for beta-1,3-N-acetylglucosaminyltransferase from Neisseria meningitides and the gene for beta-1.3-galactosyltransferase from Helicobacter pylori, the specifications are the following:\n\n(a) chemical name––β-D-galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-glucose;\n\n(b) chemical formula––C26H45NO21;\n\n(c) molecular weight––707.63 g/mol;\n\n(d) CAS number––14116-68-8;\n\n(e) description––white, white to off-white, or off-white powder, agglomerates, or powder with agglomerates;\n\n(f) LNT––not less than 70.0% (water free);\n\n(g) sum of human identical milk saccharides: LNT, D-lactose, lacto-N-triose II––not less than 90.0% (water free);\n\n(h) D-lactose––not more than 12.0%;\n\n(i) lacto-N-triose II––not more than 10.0%;\n\n(j) para\\-lacto-N-hexaose-2––not more than 3.5%;\n\n(k) β-D-Galactopyranosyl-(1→3)-2-acetamido-2-deoxy-β-D-glucopyranosyl-(1→3)-β-D-galactopyranosyl-(1→4)-D-fructose (LNT fructose isomer)––not more than 1.0%;\n\n(l) pH (20°C, 5% solution)––4.0-6.0;\n\n(m) water––not more than 6.0%;\n\n(n) residual protein––not more than 0.01%;\n\n(o) ash, sulphated––not more than 0.5%;\n\n(p) lead––not more than 0.1 mg/kg;\n\n(q) microbiological:\n\n(i) aerobic mesophilic bacteria total count––not more than 1,000 cfu/g;\n\n(ii) Enterobacteriaceae––absent in 10 g;\n\n(iii) yeasts––not more than 100 cfu/g;\n\n(iv) moulds––not more than 100 cfu/g;\n\n(v) residual endotoxins––not more than 10 EU/mg.\n\nS3—49 Specification for 6′-sialyllactose sodium salt sourced from Escherichia coli K-12\n\nFor 6′-sialyllactose (6′-SL) sodium salt sourced from Escherichia coli K-12 containing the gene for alpha-2,6-sialyltransferase from Photobacterium damsela and CMP-Neu5Ac synthetase, Neu5Ac synthetase, N-acetylglucosamine-6-phosphatase epimerase from Campylobacter jejuni, the specifications are the following:\n\n(a) chemical name––N-acetyl-α-D-neuraminyl-(2→6)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt;\n\n(b) chemical formula––C23H38NO19Na;\n\n(c) molecular weight––655.53 g/mol;\n\n(d) CAS number––157574-76-0;\n\n(e) description––white, white to off-white, or off-white powder, agglomerates, or powder with agglomerates;\n\n(f) 6′-SL sodium salt––not less than 90.0% (water free);\n\n(g) sum of human identical milk saccharides: 6′-SL sodium salt, D-lactose, sialic acid––not less than 94.0% (water free);\n\n(h) D-lactose––not more than 5.0%;\n\n(i) sialic acid––not more than 2.0%;\n\n(j) sialyl-lactulose––6’- isomer––not more than 3.0%;\n\n(k) sodium––2.5-4.5%;\n\n(l) chloride––not more than 1.0%;\n\n(m) pH (20°C, 5% solution)––4.5-6.0;\n\n(n) water––not more than 6.0%;\n\n(o) residual protein––not more than 0.01%;\n\n(p) lead––not more than 0.1 mg/kg;\n\n(q) microbiological:\n\n(i) aerobic mesophilic total plate count––not more than 1,000 cfu/g;\n\n(ii) Enterobacteriaceae––absent in 10 g;\n\n(iii) yeasts––not more than 100 cfu/g;\n\n(iv) moulds––not more than 100 cfu/g;\n\n(v) residual endotoxins––not more than 10 EU/mg.\n\nS3—50 Specification for 3′-sialyllactose sodium salt sourced from Escherichia coli K-12\n\nFor 3′-sialyllactose (3′-SL) sodium salt sourced from Escherichia coli K-12 containing the gene for alpha-2,3-sialyltransferase from Neisseria meningitides and CMP-Neu5Ac synthetase, Neu5ac synthase, N-acetylglucosamine-6-phosphatase epimerase from Campylobacter jejuni, the specifications are the following:\n\n(a) chemical name––N-acetyl-α-D-neuraminyl-(2→3)-β-D-galactopyranosyl-(1→4)-D-glucose, sodium salt;\n\n(b) chemical formula––C23H38NO19Na;\n\n(c) molecular weight––655.53 g/mol;\n\n(d) CAS number––128596-80-5;\n\n(e) description––white, white to off-white, or off-white powder, agglomerates, or powder with agglomerates;\n\n(f) 3′-SL sodium salt––not less than 88.0% (water free);\n\n(g) sum of human identical milk saccharides: 3′-SL sodium salt, D-lactose, sialic acid––not less than 90.0% (water free);\n\n(h) D-lactose––not more than 5.0%;\n\n(i) sialic acid––not more than 1.5%;\n\n(j) sialyl-lactulose-3′-isomer––not more than 5.0%;\n\n(k) sodium––2.5-4.5%;\n\n(l) chloride––not more than 1.0%;\n\n(m) pH (20°C, 5% solution)––4.5-6.0;\n\n(n) water––not more than 8.0%;\n\n(o) residual protein––not more than 0.01%;\n\n(p) lead––not more than 0.1 mg/kg;\n\n(q) microbiological:\n\n(i) aerobic mesophilic total plate count––not more than 1,000 cfu/g;\n\n(ii) Enterobacteriaceae––absent in 10 g;\n\n(iii) yeasts––not more than 100 cfu/g;\n\n(iv) moulds––not more than 100 cfu/g;\n\n(v) residual endotoxins––not more than 10 EU/mg.\n\nS3—51 Specification 2′-fucosyllactose sourced from Corynebacterium glutamicum\n\nFor 2′-fucosyllactose (2′-FL) sourced from Corynebacterium glutamicum, the specifications are the following:\n\n(a)        chemical name—α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose;\n\n(b)        chemical formula—C18H32O15;\n\n(c)        molecular weight—488.44 g/mol;\n\n(d)        CAS number—41263-94-9;\n\n(e)        description—white to off-white/ivory powder;\n\n(f)        2′-FL—not less than 94% (water free);\n\n(g)        D-lactose—not more than 3.0% (water free);\n\n(h)        L-fucose—not more than 3.0% (water free);\n\n(i)         3-fucosyllactose—not more than 3.0% (water free);\n\n(j)         difucosyl-D-lactose—not more than 2.0% (water free);\n\n(k)        glucose—not more than 3.0% (water free);\n\n(l)         galactose—not more than 3.0% (water free);\n\n(m)      water—not more than 9.0%;\n\n(n)        ash, sulphated—not more than 0.5%;\n\n(o)        ethanol—not more than 1,000 mg/kg (for crystallised product from solvent only);\n\n(p)        residual proteins—not more than 0.005%;\n\n(q)        lead—not more than 0.02 mg/kg;\n\n(r)         arsenic—not more than 0.03 mg/kg;\n\n(s)        cadmium—not more than 0.01 mg/kg;\n\n(t)         mercury—not more than 0.05 mg/kg;\n\n(u)        microbiological:\n\n(i)         total plate count—not more than 500 cfu/g;\n\n(ii)        coliforms—not more than 10 cfu/g;\n\n(iii)       yeasts and moulds—not more than 100 cfu/g;\n\n(iv)       aflatoxin M1—not more than 0.025 µg/kg;\n\n(v)        residual endotoxins—not more than 10 EU/mg\n\nS3—52 Specification for 2-Methyloxolane\n\nFor 2-Methyloxolane, the specifications are the following:\n\n(a) chemical name—2-Methyloxolane;\n\n(b) chemical formula—C5H10O;\n\n(c) CAS Number—96-47-9;\n\n(d) purity (on a dry weight basis)—not less than 99.9%;\n\n(e) ethanol (on a dry weight basis)—not more than 450 mg/kg;\n\n(f) furan (on a dry weight basis)—not more than 50 mg/kg;\n\n(g) 2-methylfuran (on a dry weight basis)—not more than 500 mg/kg.\n\nS3—53 Specification for bovine milk fat globule membrane-enriched whey protein concentrate\n\n(1) In this section, bovine milk fat globule membrane-enriched whey protein concentrate is a preparation of cow’s milk consisting of lipids and proteins.\n\n(2) For bovine milk fat globule membrane-enriched whey protein concentrate, the specifications are the following:\n\n(a) description—off white powder;\n\n(b) total protein—not less than 69.0% and not more than 76.0%;\n\n(c) lactose—not more than 2.0%;\n\n(d) fat—not less than 16.0% and not more than 22.0%;\n\n(e) phospholipids—not less than 6.0% and not more than 10.0%;\n\n(f) sphingomyelin—not less than 1.3% and not more than 2.3%;\n\n(g) ash—not more than 3.0%;\n\n(h) moisture—not more than 5.0%;\n\n(i) arsenic—not more than 0.2 mg/kg;\n\n(j) cadmium—not more than 0.1 mg/kg;\n\n(k) lead—not more than 0.05 mg/kg;\n\n(l) mercury—not more than 0.02 mg/kg;\n\n(m) microbial limits:\n\n (i) total plate count (30°C)—not more than 10000 cfu/g;\n (ii) total plate count (55°C)—not more than 1000 cfu/g;\n (iii) Bacillus cereus—not more than 50 cfu/g;\n (iv) Sulphite-reducing Clostridia—not more than 10 cfu/g;\n (v) Enterobacteriaceae—not more than 10 cfu/g;\n (vi) Coagulase-positive staphylococci—absent in 1 g;\n (vii) Yeast and moulds—not more than 10 cfu/g.\n\nS3—54(A) Specification for 2′-fucosyllactose sourced from Escherichia coli W\n\nFor 2′-fucosyllactose (2′-FL) sourced from Escherichia coli W containing the gene for alpha-1,2-fucosyltransferase from Helicobacter mustelae, the specifications are the following:\n\n(a) chemical name—α-L-fucopyranosyl-(1→2)-β-D-galactopyranosyl-(1→4)-D-glucopyranose;\n\n(b) chemical formula—C18H32O15;\n\n(c) molecular weight—488.44 g/mol;\n\n(d) CAS number—41263-94-9;\n\n(e) description—white to off-white powder;\n\n(f) 2′-FL—not less than 82% (water free);\n\n(g) D-lactose—not more than 5.0% (water free);\n\n(h) L-fucose—not more than 1.0% (water free);\n\n(i) fucosylgalactose—not more than 3.0% (water free);\n\n(j) difucosyllactose (difucosyl-d-lactose)—not more than 3.0% (water free);\n\n(k) glucose and galactose—not more than 1.0% (water free);\n\n(l) water—not more than 9.0%;\n\n(m) ash, sulphated—not more than 0.5%;\n\n(n) residual proteins—not more than 0.01%;\n\n(o) lead—not more than 0.1 mg/kg;\n\n(p) arsenic—not more than 0.1 mg/kg;\n\n(q) cadmium—not more than 0.1 mg/kg;\n\n(r) mercury—not more than 0.1 mg/kg;\n\n(s) microbiological:\n\n (i) aerobic mesophilic bacteria total count—not more than 1,000 cfu/g;\n (ii) yeasts and moulds—not more than 100 cfu/g;\n (iii) Enterobacteriaceae—absent in 10 g;\n (iv) residual endotoxins—not more than 10 EU/g.\n\nS3—54 Specification for cell-cultured quail\n\n(1) For the purposes of this specification, cell-cultured quail means quail cells obtained from culturing embryonic fibroblast cells (cell line 221523-Fib-Quail) sourced from Coturnix japonica.\n\n(2) For cell-cultured quail, the specifications are the following:\n\n(a) protein––not less than 4%;\n\n(b) moisture––not less than 80%;\n\n(c) ash––not more than 1.5%;\n\n(d) fat––not less than 0.5% and not more than 3.0%;\n\n(e) carbohydrates––not more than 1%.\n\nS3—55 Specification for mushroom (Agaricus bisporus) chitosan\n\nFor mushroom (Agaricus bisporus) chitosan, the specifications are the following:\n\n1. chemical structure—a natural co-polymer and comprises a chitin moiety (N-acetyl-d-glucosamine units) covalently linked to a beta-glucans moiety (glucose units);\n2. source–Agaricus bisporus.\n\n(c) description—white to beige, odourless and flavourless powder, almost completely insoluble in aqueous or organic medium;\n\n(d) average molecular weight—10 to 400 kDa;\n\n(e) degree of deacetylation—70.0 to 95.0 mol%;\n\n(f) water—less than 5.0%;\n\n(g) total chitosan content on a dry weight basis—not less than 95.0%;\n\n(h) total beta-glucan content on a dry weight basis—not more than 5.0%.\n\nS3—56 Specification for 3-fucosyllactose sourced from Escherichia coli K-12\n\nFor 3-fucosyllactose (3-FL) sourced from Escherichia coli K-12 containing the gene for alpha-1,3-fucosyl-transferase from Helicobacter pylori, the specifications are the following:\n\n(a) chemical name—β-D-Galactopyranosyl-(1-4)-\\[α-L-fucopyranosyl-(1-3)\\]-D-glucose;\n\n(b) chemical formula—C18H32O15;\n\n(c) molecular weight—488.44 g/mol;\n\n(d) CAS number—41312-47-4;\n\n(e) description—white to off-white powder or agglomerates;\n\n(f) sum of saccharides (3-FL, D-lactose, L-fucose, 3-fucosyl-lactulose)—not less than 92.0% (water free);\n\n(g) 3-FL—not less than 90.0% (water free);\n\n(h) L-fucose—not more than 1.0%;\n\n(i) D-lactose—not more than 5.0%;\n\n(j) 3-fucosyllactulose—not more than 1.5%;\n\n(k) Sum of other carbohydrates—not more than 5.0%;\n\n(l) pH (20°C, 5% solution)—3.2 to 7.0;\n\n(m) water—not more than 6.0%;\n\n(n) ash, sulphated—not more than 0.5%;\n\n(o) residual proteins—not more than 0.01%;\n\n(p) lead—not more than 0.05 mg/kg;\n\n(q) microbiological:\n\n (i) aerobic mesophilic bacteria total count—not more than 1,000 cfu/g;\n (ii) Enterobacteriaceae—absent in 10 g;\n (iii) yeasts—not more than 100 cfu/g;\n (iv) moulds—not more than 100 cfu/g;\n\n(v) residual endotoxins—not more than 10 EU/mg.\n\nAmendment History\n\nThe Amendment History provides information about each amendment to the Schedule. The information includes commencement or cessation information for relevant amendments.\n\nThese amendments are made under section 92 of the Food Standards Australia New Zealand Act 1991 unless otherwise indicated. Amendments do not have a specific date for cessation unless indicated as such.\n\nAbout this compilation\n\nThis is compilation No. 34 of Schedule 3 as in force on 20 January 2026 (up to Amendment No. 247). It includes any commenced amendment affecting the compilation to that date.\n\nPrepared by Food Standards Australia New Zealand on 20 January 2026.\n\nUncommenced amendments or provisions ceasing to have effect.\n\nTo assist stakeholders, the effect of any uncommenced amendments or provisions which will cease to have effect, may be reflected in the Schedule as shaded boxed text with the relevant commencement or cessation date. These amendments will be reflected in a compilation registered on the Federal Register of Legislation including or omitting those amendments and provided in the Amendment History once the date is passed.\n\nThe following abbreviations may be used in the table below:\n\nad = added or inserted am = amended\n\nC\\[x\\] = Compilation No. x ed = editorial change\n\nexp = expired or ceased to have effect rep = repealed\n\nrs = repealed and substituted\n\nSchedule 3 was published in the Food Standards Gazette No. FSC96 on 10 April 2015 as part of Amendment 154 (F2015L00493 –- 2 April 2015) and has since been amended as follows:\n\n| Section affected | A’ment No. | FRL registrationGazette | Commencement(Cessation) | How affected | Description of amendment |\n| -------------------------------------------- | ---------- | -------------------------------------------------------------------------------------- | ----------------------- | ------------ | ----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |\n| S3—2(1) | 168 | F2017L0041411 April 2017FSC11013 April 2017 | 13 April 2017 | am | Update list of references. |\n| S3—2(1)(b) | 172 | F2017L011426 Sept 2017FSC1147 Sept 2017 | 7 Sept 2017 | am | Update list of references. |\n| table to S3—2(2) | 163 | F2016L0078712 May 2016FSC10519 May 2016 | 19 May 2016 | ad | Provision for Salmonella phage preparation (S16 and FO1a). |\n| table to S3—2(2) | 164 | F2016L0120421 July 2016FSC10621 July 2016 | 21 July 2016 | am | Reference to agarose ion exchange resin replaced with amine agarose ion exchange resin. |\n| table to S3—2(2) | 164 | F2016L0120421 July 2016FSC10621 July 2016 | 21 July 2016 | ad | Entry for sulphonate agarose ion exchange resin. |\n| table to S3—2(2) | 168 | F2017L0040910 April 2017FSC11013 April 2017 | 13 April 2017 | ad | Entry for steviol glycosides from Stevia rebaudiana Bertoni. |\n| table to S3—2(2) | 170 | F2017L0058623 May 2017FSC11225 May 2017 | 25 May 2017 | ad | Entry for oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695). |\n| table to S3—2(2) | 171 | F2017L0091511 July 2017FSC11313 July 2017 | 13 July 2017 | ad | Entry for isomalto-oligosaccharide. |\n| table to S3—2(2) | 173 | F2017L0117613 Sept 2017FSANZ Notification Circular 24-17 (Urgent Proposal)14 Sept 2017 | 14 Sept 2017 | ad | Entry for L-arginine acetate. |\n| S3—3 | 168 | F2017L0041411 April 2017FSC11013 April 2017 | 13 April 2017 | am | Update reference in paragraph (j). |\n| S3—3 | 172 | F2017L011426 Sept 2017FSC1147 Sept 2017 | 7 Sept 2017 | am | Update reference in paragraph (j). |\n| S3—6 | 164 | F2016L0120421 July 2016FSC10621 July 2016 | 21 July 2016 | am | Reference to agarose ion exchange resin replaced with amine agarose ion exchange resin. |\n| S3—6(2), (3) | 168 | F2017L0041411 April 2017FSC11013 April 2017 | 13 April 2017 | rs | Specification updated to be consistent with a more recent specification. |\n| S3—9(2), (3) | 168 | F2017L0041411 April 2017FSC11013 April 2017 | 13 April 2017 | rs | Specification updated to be consistent with a more recent specification. |\n| S3—11(2), (3) | 168 | F2017L0041411 April 2017FSC11013 April 2017 | 13 April 2017 | rs | Specification updated to be consistent with a more recent specification. |\n| S3—25(2), (3) | 168 | F2017L0041411 April 2017FSC11013 April 2017 | 13 April 2017 | rs | Specification updated to be consistent with a more recent specification. |\n| S3—27(2) | 157 | F2015L013741 Sept 2015FSC993 Sept 2015 | 1 March 2016 | am | Correction of typographical error in subparagraph (b)(ii). |\n| S3—27(2) | 161 | F2016L0012018 Feb 2016FSC10322 Feb 2016 | 1 March 2016 | am | Correction to typographical error in units for total aerobic count. |\n| S3—31 | 160 | F2016L0004112 Jan 2016FSC10214 Jan 2016 | 1 March 2016 | ad | Specification for rebaudioside M. |\n| S3—32 | 160 | F2016L0004112 Jan 2016FSC10214 Jan 2016 | 1 March 2016 | ad | Specification for steviol glycoside mixture including rebaudioside M. |\n| S3—33 | 163 | F2016L0078712 May 2016FSC10519 May 2016 | 19 May 2016 | ad | Specification for Salmonella phage preparation (S16 and FO1a). |\n| S3—34 | 164 | F2016L0120421 July 2016FSC10621 July 2016 | 21 July 2016 | ad | Specification for sulphonate agarose ion exchange resin. |\n| S3—35 | 168 | F2017L0040910 April 2017FSC11013 April 2017 | 13 April 2017 | ad | Specification for steviol glycosides from Stevia rebaudiana Bertoni. |\n| S3—36 | 170 | F2017L0058623 May 2017FSC11225 May 2017 | 25 May 2017 | ad | Specification for oil derived from marine micro-algae Schizochytrium sp. (American Type Culture Collection (ATCC) PTA-9695). |\n| S3—37 | 171 | F2017L0091511 July 2017FSC11313 July 2017 | 13 July 2017 | ad | Specification for isomalto-oligosaccharide. |\n| S3—38 | 173 | F2017L0117613 Sept 2017FSANZ Notification Circular 24-17 (Urgent Proposal)14 Sept 2017 | 14 Sept 2017 | ad | Specification for L-arginine acetate. |\n| S3—2(1)(b) | 182 | F2018L0159423 Nov 2018FSC12329 Nov 2018 | 29 November 2018 | am | Update international references |\n| S3—2(1)(c) | 182 | F2018L0159423 Nov 2018FSC12329 Nov 2018 | 29 November 2018 | am | Update international references |\n| S3—28(2)(a) | 182 | F2018L0159423 Nov 2018FSC12329 Nov 2018 | 29 November 2018 | am | Correction typographical error |\n| S3—35(2) | 183 | F2019L0003911 Jan 2019FSC12423 Jan 2019 | 23 January 2019 | am | Specification for Stevia rebaudiana Bertoni plant. |\n| S3—2(2) | 187 | F2019L0113528 Aug 2019FSC1285 Sept 2019 | 5 September 2019 | ad | Specification for steviol glycosides from fermentation; specification for Rebaudioside MD |\n| S3—35(2)(b) | 187 | F2019L0113628 Aug 2019FSC1285 Sept 2019 | 5 September 2019 | am | Specification for Rebaudioside D |\n| S3—35(1) | 191 | F2020L0015320 Feb 2020FSC13226 Feb 2020 | 26 February 2020 | am | Specification for steviol glycosides obtained from the leaves of the Stevia rebaudiana Bertoni plant |\n| S3—35(2)(d) | 191 | F2020L0015320 Feb 2020FSC13226 Feb 2020 | 26 February 2020 | ad | Specification to produce one or more prescribed rebaudiosides by enzymatic conversion of purified stevia leaf extract |\n| S3—35(4)(a) | 191 | F2020L0015320 Feb 2020FSC13226 Feb 2020 | 26 February 2020 | am | Specification of description |\n| S3—35(2)(d) | 193 | F2020L0093723 July 2020FSC13428 July 2020 | 28 July 2020 | am | Specification to produce rebaudioside E from enzymatic conversion of purified stevia leaf extract |\n| S3—2(2) | 198 | F2021L0033225 March 2021FSC 13926 March 2021 | 26 March 2021 | ad | Specification for 2′-O-fucosyllactose and lacto-N-neotetraose |\n| S3—42 | 198 | F2021L0032625 March 2021FSC 13926 March 2021 | 26 March 2021 | ad | Specification for a soy leghemoglobin preparation |\n| S3—2(2) | 198 | F2021L0032725 March 2021FSC 13926 March 2021 | 26 March 2021 | ad | Specification for Sweet osmanthus ear glycolipids |\n| S3—2(1)(b) | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | am | Update international references (xii), (xiii) and (xiv) |\n| S3—2(1)(c) | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | rs | Update international references |\n| S3—2(2) | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | am | Entries for resistant maltoextrins, Salmonella phage preparation (S16 and FO1a), steviol glycosides from fermentation, steviol glycosides produced by enzymatic conversion |\n| S3—3(b) | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | rs | Update international references |\n| S3—3(i) | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | am | Update international references |\n| S3—31 | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | rep | Repeal section S3—31 |\n| S3—32 | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | rep | Repeal section S3—32 |\n| S3—35 | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | am | Insert specification for steviol glycosides produced by enzymatic conversion |\n| S3—35(2) | 200 | F2021L006842 June 2021FSC 1413 June 2021 | 3 June 2021 | rs | Insert specification for steviol glycosides produced by enzymatic conversion |\n| table to S3—2(2) | 198 | F2021L0032424 March 2021FSC 13926 March 2021 | 30 June 2021 | aded C16 | Insert entry for rapeseed protein isolateEditorial change to update a provision cross-reference |\n| S3—39(A) | 198 | F2021L0032424 March 2021FSC 13926 March 2021 | 30 June 2021 | aded C16 | Insert specification for rapeseed protein isolate. Section S3—40 (first occurring) was renumbered as section S3—39(A) by editorial change |\n| table to S3 —39(2) | 201 | F2021L0098514 Jul 2021FSC 14222 July 2021 | 22 July 2021 | Ad | Insert entry for Rebaudioside M |\n| table to S3 —39(2) | 203 | F2021L0143114 October 2021FSC 14421 October 2021 | 21 October 2021 | Ad | Insert entry for Nicotinamide riboside chloride |\n| S3—44 | 203 | F2021L0143114 October 2021FSC 14421 October 2021 | 21 October 2021 | Ad | Insert specification for Nicotinamide riboside chloride |\n| S3—39(1) and (2) | 204 | F2021L016902 Dec 2021FSC 1456 Dec 2021 | 6 December 2021 | am | Insert specification for steviol glycoside preparation |\n| table to S3—2(2) | 205 | F2022L0003818 Jan 2022FSC 14620 Jan 22 | 20 January 2022 | am | 2′-O-fucosyllactose to 2′-fucosyllactose sourced from Escherichia coli K-12 |\n| table to S3—2(2) | 205 | F2022L0003818 Jan 2022FSC 14620 Jan 22 | 20 January 2022 | ad | 2′-fucosyllactose sourced from Escherichia coli BL21 |\n| S3—40 | 205 | F2022L0003818 Jan 2022FSC 14620 Jan 22 | 20 January 2022 | am | 2′-O-fucosyllactose to 2′-fucosyllactose sourced from Escherichia coli K-12 |\n| S3—45 | 205 | F2022L0003818 Jan 2022FSC 14620 Jan 22 | 20 January 2022 | ad | Insert specification for 2′-fucosyllactose sourced from Escherichia coli BL21 |\n| S3-2(2) | 209 | F2022L0096411 July 2022FSC 14915 July 2022 | 15 July 2022 | am | Insert entry for 2′-fucosyllactose sourced from Escherichia coli K-12 |\n| S3—40 | 209 | F2022L0096411 July 2022FSC 14915 July 2022 | 15 July 2022 | am | Insert specification for 2’—fucosyllactose sourced from Escherichia coli K-12 |\n| table to S3—2(2) | 217 | F2023L0045219 April 2023FSC15721 April 2023 | 21 April 2023 | ad | Insert entry for bovine lactoferrin |\n| S3—46 | 217 | F2023L0045219 April 2023FSC15721 April 2023 | 21 April 2023 | ad | Insert specification for bovine lactoferrin |\n| S3—2(1) and S3-3 | 220 | F2023L0100411 July 2023FSC16019 July 2023 | 19 July 2023 | rs | Repeal and substitute updated references |\n| S3—14, 18, 26, 27, 39, 39(A), 41, 42, 43, 44 | 220 | F2023L0100411 July 2023FSC16019 July 2023 | 19 July 2023 | rs | Repeal and substitute formatting (capitialisations, italics, acronym, bullets and numbering) |\n| S3—2(2) | 223 | F2023L0156127 Nov 2023FSC16330 Nov 2023 | 30 Nov 2023 | ad | Insert entries for each of the following, 2′-fucosyllactose and difucosyllactose sourced from Escherichia coli K-12, lacto-N-tetraose sourced from Escherichia coli K-12, 6′-sialyllactose sodium salt sourced from Escherichia coli K-12,3′-sialyllactose sodium salt sourced from Escherichia coli K-12 |\n| S3—47 | 223 | F2023L0156127 Nov 2023FSC16330 Nov 2023 | 30 Nov 2023 | ad | Insert specifications after S3-46 for each of the following, 2′-fucosyllactose and difucosyllactose sourced from Escherichia coli K-12, lacto-N-tetraose sourced from Escherichia coli K-12, 6′-sialyllactose sodium salt sourced from Escherichia coli K-12, 3′-sialyllactose sodium salt sourced from Escherichia coli K-12 |\n| S3-35(2) | 225 | F2024L0007917 January 2024FSC16519 January 2024 | 19 January 2024 | rs | Omit and substitute the S3-35 Specification for steviol glycosides produced by enzymatic conversion |\n| S3-2(2), 40 | 228 | F2024L0058729 May 2024FSC16831 May 2024 | 31 May 2024 | rs | Omit and substitute entry for 2′-fucosyllactose to include Heliobacter enhydrae |\n| S3-2(2) | 230 | F2024L0098912 August 2024FSC 17015 August 2024 | 15 August 2024 | ad | Insert into table 2′-fucosyllactose sourced from Corynebacterium glutamicum |\n| S3-51 | 230 | F2024L0098912 August 2024FSC 17015 August 2024 | 15 August 2024 | ad | Insert Specification for 2′-fucosyllactose sourced from Corynebacterium glutamicum |\n| S3—2(2) | 234 | F2025L000128 January 2025FSC 17413 January 2025 | 13 January 2025 | ad | Insert 2-Methyloxolane into S3—2(2) table. |\n| S3—52 | 234 | F2025L000128 January 2025FSC 17413 January 2025 | 13 January 2025 | ad | Insert Section S3—52, Specification for 2-Methyloxolane |\n| S3—2(2) | 239 | F2025L0068918 June 2025FSC 17918 June 2025 | 18 June 2025 | am | Insert cell-cultured quail into S3—2(2) table |\n| S3—54 | 239 | F2025L0068918 June 2025FSC 17918 June 2025 | 18 June 2025 | aded C29 | Insert Section S3—54, Specification for cell-cultured quailSection S3—54 was inserted after section S3—52 |\n| S3—2(2) | 240 | F2025L0085718 July 2025FSC 18022 July 2025 | 22 July 2025 | ad | Insert Bovine milk fat globule membrane-enriched whey protein concentrate into S3—2(2) table |\n| S3—53 | 240 | F2025L0085718 July 2025FSC 18022 July 2025 | 22 July 2025 | ad | Insert Section S3—53, Specification for bovine milk fat globule membrane-enriched whey protein concentrate |\n| S3—2(2) | 240 | F2025L0085818 July 2025FSC 18022 July 2025 | 22 July 2025 | aded C30 | Insert 2′-fucosyllactose sourced from Escherichia coli W into S3—2(2) tableEditorial change to update a provision cross-reference |\n| S3—54(A) | 240 | F2025L0085818 July 2025FSC 18022 July 2025 | 22 July 2025 | aded C30 | Insert Section S3—54(A), Specification for 2′-fucosyllactose sourced from Escherichia coli WEditorial change to renumber section S3—54 (first occurring) as section S3—54(A) |\n| S3—35(2) | 243 | F2025L0098826 August 2025FSC 1832 Sept 2025 | 2 September 2025 | rs | Replace protein engineered enzymes with enzymes |\n| S3—35(2) | 243 | F2025L0098826 August 2025FSC 1832 Sept 2025 | 2 September 2025 | rs | Replace a protein engineered enzyme with an enzyme |\n| S3—2(2) | 244 | F2025L0108111 Sep 2025FSC 18416 Sep 2025 | 16 September 2025 | am | Insert mushroom (Agaricus bisporus) chitosan into S3—2(2) table |\n| S3—55 | 244 | F2025L0108111 Sep 2025FSC 18416 Sep 2025 | 16 September 2025 | ad | Insert Section S3—55 Specification for mushroom (Agaricus bisporus) chitosan |\n| S3—35(2) | 245 | F2025L0125821 October 2025FSC18528 October 2025 | 28 October 2025 | ad | Insert subsection (g) by enzymatic conversion of purified stevia leaf extract to produce rebaudioside M using a combination of enzymes |\n| S3—2(2) | 247 | F2026L0002215 January 2026FSC 18720 January 2026 | 20 January 2026 | am | Insert into table 3-fucosyllactose sourced from Escherichia coli K-12 |\n| S3—56 | 247 | F2026L0002215 January 2026FSC 18720 January 2026 | 20 January 2026 | ad | Insert new subsection 56 Specification for 3-fucosyllactose sourced from Escherichia coli K-12 |","sortOrder":0}],"analysis":{"flash_summary":{"complexity_score":9,"scope_assessment":{"changed":true,"description":"The Schedule has materially expanded since its original publication. Its core purpose—setting identity and purity specifications—remains the same, but the list of covered substances and the technical detail have grown substantially. The Amendment History shows numerous additions of novel ingredients and production routes (examples: multiple human milk oligosaccharides and source‑specific variants in S3—40 to S3—51 and S3—56; cell‑cultured quail in S3—54; mushroom chitosan in S3—55; 2‑Methyloxolane solvent in S3—52; various fermentation‑ or enzyme‑sourced steviol glycosides in S3—35 and S3—39). The Schedule now explicitly specifies particular microorganisms, engineered enzymes and processing routes for many ingredients. That expansion broadens regulatory coverage from classical food additives and processing aids toward novel biotech‑derived ingredients and production methods, increasing the Schedule's reach into new product classes and potentially changing who must engage with the approval and compliance process."},"complexity_factors":["Over 50 substance‑specific specifications listed in S3—2(2) with separate S3—# sections for each substance (many with multiple sublimits and tests).","Multiple external primary reference sources with sequential JECFA Monographs and other international standards referenced (S3—2(1)(b)-(d)); secondary references in S3—3 include at least 10 pharmacopeias/codices.","Detailed numeric limits across chemical (assay, specific rotation), residual solvents, heavy metals, microbiological limits and physical properties for many substances (e.g. S3—5 advantame; S3—18 nucleotides; S3—44 Nicotinamide riboside chloride).","Numerous distinct source/production‑route conditions that create branching logic (e.g. multiple organism‑specific specifications for the same compound: various 2'-fucosyllactose specs in S3—40, S3—45, S3—51, S3—54(A)).","Prescribed analytical methods in many sections (HPLC, GC, Karl Fischer, specified test procedures), increasing operational detail and conditional testing requirements.","Fallback rule (S3—4) that applies only if no primary/secondary specification exists — introduces layered conditionality.","Extensive amendment history and rolling insertions (many recent additions for novel ingredients), resulting in renumbering and cross‑reference complexity.","Subsections that specify production processes or strain identities (e.g. S3—14 ice structuring protein produced in GM yeast; S3—33 Salmonella phage prep) which adds legal and technical specificity.","Nested microbiological specifications with different sampling unit sizes and tests (e.g. absence in 25 g, absence in 100 g, colony forming units limits) across different substances."],"plain_english_summary":"**What this instrument does (mechanically)\n\n- This Schedule (Schedule 3 to the Australia New Zealand Food Standards Code) sets detailed \"identity and purity\" specifications for named substances that may be used in food. That means for each listed substance it either: (a) points to an external monograph or compendium as the defining specification (see S3—2 and S3—3); or (b) provides a substance‑specific set of chemical, physical and microbiological requirements (the many S3—# sections). Where no monograph applies, the Schedule gives fallback maximum levels for certain heavy metals (S3—4).\n\n- The specifications cover composition (assay/purity), permitted impurities and residual solvents, limits for heavy metals and microbial contaminants, physical properties (appearance, pH, moisture, etc.), and the analytical methods to be used for testing in many cases (e.g. HPLC, GC, Karl Fischer) (see, e.g., S3—5 advantame; S3—18 nucleotides; S3—12 dimethyl ether).\n\n- The Schedule also lists the named substances for which a specification exists (the table in S3—2(2)). That table and the accompanying sections have been amended many times to add new substances and specifications (see the Amendment History).\n\nWho this affects\n\n- Food ingredient manufacturers and processors who make or market the listed substances.\n- Food manufacturers that buy those ingredients to formulate finished foods (they must ensure incoming ingredients meet the stated specifications).\n- Importers and exporters of the specified substances (customs and compliance hinge on meeting these specs).\n- Food testing laboratories (they must be able to perform the specified assays and microbiological tests).\n- Regulators and enforcement authorities in Australia and New Zealand who check compliance with the Code.\n\nWhy it matters (claimed purpose and practical implications)\n\n- The stated purpose (from the Code) is to provide clear specifications so substances required by the Code to \"comply with relevant specifications\" can be judged consistently (S3—2 and the notes). That clarifies what \"identity and purity\" means for each named ingredient.\n\n- Practical consequences and trade-offs:\n - Certainty and market access: For ingredients that now have a Schedule 3 specification (for example, a range of human‑milk‑oligosaccharides — see S3—40 to S3—51; cell‑cultured quail — S3—54; steviol glycosides produced by various methods — S3—35 and S3—39), manufacturers and importers gain a clear regulatory target. If a batch meets the listed specification it is demonstrably compliant with the Code's identity/purity requirement.\n - Compliance costs: The Schedule frequently prescribes specific analytic tests and tight limits (chemical, microbiological and residual solvent limits). Meeting and documenting those requirements increases testing and quality‑control costs for suppliers and downstream food manufacturers (see, e.g., S3—5 advantame; S3—18 nucleotides; S3—44 Nicotinamide riboside chloride).\n - Market effects and incentives: Because specifications are itemised by named substance and, in many cases, by production route or source organism (for example specific E. coli, Corynebacterium or yeast strains are listed for particular oligosaccharides and steviol glycosides — see S3—40, S3—45, S3—51, S3—35), the Schedule can reduce ambiguity for suppliers of those exact products. That benefits manufacturers who already produce to those specifications. It may disadvantage suppliers of similar but slightly different products that do not match a named specification, who then must either invest to meet the spec, apply for their own specification/approval, or avoid the Australian/New Zealand market for that ingredient.\n - Substitution and product design: Food formulators may choose ingredients that already have Schedule 3 specs to reduce regulatory risk, which can shift demand away from un‑specified alternatives.\n - Testing capacity and enforcement: The Schedule prescribes methods and numerical limits; enforcement requires competent testing laboratories and regulators able to interpret and apply the tests. That is an implementation cost and a potential bottleneck in supply chains.\n\nCosts, incentives and concentrated vs. diffuse effects (testing against the stated purpose)\n\n- Who pays: manufacturers and importers pay for compliance testing, quality control, possible reformulation and record keeping. Downstream food businesses may pay higher ingredient prices if suppliers pass on testing and certification costs.\n- Who decides/discretion: FSANZ (via the Code) sets the specifications; enforcement is carried out by state/territory regulators and New Zealand authorities under their Food Acts.\n- Concentrated benefits vs diffuse costs: Several specifications identify a production organism or a production route (e.g. particular microbial strains or fermentation processes for human milk oligosaccharides and some steviol glycosides — see S3—40, S3—45, S3—51, S3—35). That creates concentrated, identifiable benefits for producers of the expressly‑named products (they get a ready regulatory standard). The costs (testing burden, possible exclusion from the market) are diffuse across suppliers and purchasers who must meet the specification or find alternatives.\n- Trade‑offs and unintended consequences: The Schedule reduces uncertainty for named products but can raise entry costs for novel suppliers or variants. It can channel innovation toward products that align with existing specifications and away from variants that would need a bespoke approval pathway. Analytical detail (specified methods and tight limits) reduces interpretive discretion for regulators but increases technical compliance demands.\n\nImplementation risk and compliance burden\n\n- Laboratories must be competent in the specified methods (HPLC, GC, Karl Fischer titration, microbiological testing) for enforcement to be consistent. For novel substances with low volume, local lab capacity or cost may be an issue.\n- The Schedule is prescriptive; manufacturers must maintain documentation and testing to show compliance. For novel ingredients or alternative production routes, manufacturers may need to seek an amendment or approval to have a matching specification.\n\nConcrete examples (sections cited)\n\n- Reference sources and fallbacks: S3—2 lists primary references (e.g. FAO JECFA monographs, Food Chemicals Codex, EU Regulation 231/2012); S3—3 lists secondary pharmacopeias and codices; S3—4 gives default heavy metal limits when no monograph exists.\n- Novel ingredients: cell‑cultured quail (S3—54), mushroom (Agaricus bisporus) chitosan (S3—55), bovine milk fat globule membrane‑enriched whey protein concentrate (S3—53).\n- Human‑milk‑oligosaccharides and related saccharides with source‑specific specifications: multiple sections (S3—40, S3—45, S3—47, S3—48, S3—49, S3—50, S3—51, S3—54(A), S3—56).\n- Processing solvents and reagents: 2‑Methyloxolane (S3—52), dimethyl ether (S3—12), residual solvent limits for advantame (S3—5).\n- Sweeteners: multiple steviol glycoside specifications covering different production routes including fermentation and enzymatic conversion (S3—35, S3—39).\n\nBottom line (practical summary)\n\n- This Schedule creates clear, binding identity and purity targets for a long list of named food substances and points to international monographs where appropriate (S3—2–S3—4). That clarity helps manufacturers and regulators know what \"compliant\" looks like. It also raises technical and testing obligations for suppliers and may channel market behaviour toward ingredients and production methods that already match the Schedule's detailed specs. Where specifications name particular production strains or processes, the effect is to formalise regulatory recognition for those exact products (see the cited sections above)."},"kimi_summary":{"_metrics":{"completionTokens":1189},"content_quality":"ok","complexity_score":8,"scope_assessment":{"changed":true,"description":"The Schedule has expanded dramatically from its original scope as a simple reference to international food additive specifications. It now functions as a comprehensive repository for novel food technologies including: cell-cultured animal products, precision fermentation using multiple engineered microbial strains, enzymatically modified natural extracts, human-identical milk oligosaccharides produced by recombinant bacteria, bacteriophage biocontrol agents, and bioactive lipids from microbial sources. The original framework assumed primarily extracted or chemically synthesised additives; the current version regulates complex biological manufacturing processes with living organisms, requiring specifications for genetic provenance, fermentation conditions, and downstream purification — a fundamental shift from chemical identity to biological process control."},"complexity_factors":["Extensive cross-referencing to external standards (JECFA monographs, USP, EU regulations, multiple pharmacopoeias) requiring simultaneous consultation of non-Australian documents","56 individual substance-specific sections with highly technical chemical specifications including molecular weights, CAS numbers, and stereochemical nomenclature","Nested conditional logic in S3-2, S3-3, and S3-4 creating a three-tier fallback system for determining applicable specifications","Multiple manufacturing pathways for identical end products (e.g., five different enzymatic processes for steviol glycosides in S3-35)","Precise quantitative thresholds with multiple units (mg/kg, ppm, % w/w, w/v, cfu/g) requiring careful conversion and interpretation","Genetically modified organism (GMO) provenance requirements specifying exact bacterial strains and gene sources for fermented ingredients","Inconsistent section numbering (S3-39, S3-39(A), S3-40, S3-45, S3-47, S3-48, S3-49, S3-50, S3-51, S3-52, S3-53, S3-54, S3-54(A), S3-55, S3-56) reflecting historical amendments rather than logical sequencing","Extensive amendment history (247 amendments) with editorial renumbering creating potential confusion about current provision locations"],"plain_english_summary":"This Schedule sets mandatory identity, purity and contaminant limits for certain food substances used in Australia and New Zealand, telling manufacturers and testing labs what specifications and analytical methods are required before ingredients can be sold or used.\n\nIt relies on a three-tier lookup (international standards first, pharmacopeias second, and strict default heavy‑metal limits if none exist) and covers a wide range of novel and specialty ingredients—supporting food innovation while protecting public health."},"flash_summary_failed":{"failed":true,"reason":"A positive credit balance is required for all requests, including BYOK, so fallback providers remain available. Add credits at https://vercel.com/d?to=%2F%5Bteam%5D%2F%7E%2Fai%3Fmodal%3Dtop-up to continue.","source":"analysis-cron"}},"importantCases":[],"_links":{"self":"/api/acts/australia-new-zealand-food-standards-code-schedule-3-identity-and-purity","history":"/api/acts/australia-new-zealand-food-standards-code-schedule-3-identity-and-purity/history","analysis":"/api/acts/australia-new-zealand-food-standards-code-schedule-3-identity-and-purity/analysis","conflicts":"/api/acts/australia-new-zealand-food-standards-code-schedule-3-identity-and-purity/conflicts","importantCases":"/api/acts/australia-new-zealand-food-standards-code-schedule-3-identity-and-purity/important-cases","documents":"/api/acts/australia-new-zealand-food-standards-code-schedule-3-identity-and-purity/documents"}}