Food Standards (Proposal P1025 – Code Revision) Variation
The Board of Food Standards Australia New Zealand gives notice of the making of this standard under section 92 of the Food Standards Australia New Zealand Act 1991. The Standard commences on 1 March 2016.
Dated 25 March 2015
Standards Management Officer
Delegate of the Board of Food Standards Australia New Zealand
Note:
This Standard will be published in the Commonwealth of Australia Gazette No. FSC 96 on 10 April 2015.
Schedule 3 Identity and purity
Note 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.
Standard 1.1.1 relates to introductory matters and standards that apply to all foods. Section 1.1.1—15 requires certain substances to comply with relevant specifications. This Standard sets out the relevant specifications.
Note 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.
S3—1 Name
This Standard is Australia New Zealand Food Standards Code – Schedule 3 – Identity and purity.
Note Commencement:
This 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.
S3—2 Substances with specifications in primary sources
(1) For subsection 1.1.1—15(2), the specifications are:
(a) any relevant provision listed in the table to subsection (2); or
(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Specifications, FAO JECFA Monographs 1 (2005), Food and Agriculture Organisation of the United Nations, Rome, as superseded by specifications published in any of the following:
(i) FAO JECFA Monographs 3 (2006);
(ii) FAO JECFA Monographs 4 (2007);
(iii) FAO JECFA Monographs 5 (2008);
(iv) FAO JECFA Monographs 7 (2009);
(v) FAO JECFA Monographs 10 (2010);
(vi) FAO JECFA Monographs 11 (2011);
(vii) FAO JECFA Monographs 13 (2012); or
(c) United States Pharmacopeial Convention (2014) Food chemicals codex. 9th ed, United States Pharmacopeial Convention, Rockville, MD; or
(d) Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives.
(2) The table to this subsection is:
Relevant provisions
Substance
Provision
advantame
section S3—5
agarose ion exchange resin
section S3—6
bentonite
section S3—7
bromo-chloro-dimethylhydantoin
section S3—8
carboxymethyl cellulose ion exchange resin
section S3—9
dibromo-dimethylhydantoin
section S3—10
diethyl aminoethyl cellulose ion exchange resin
section S3—11
dimethyl ether
section S3—12
dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)
section S3—13
ice structuring protein type III HPLC 12 preparation
section S3—14
isomaltulose
section S3—15
Listeria phage P100
section S3—16
nucleotides
sections S3—17 and S3—18
oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA)
section S3—19
oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA)
section S3—20
oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)
section S3—21
oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA)
section S3—22
oxidised polyethylene
section S3—23
phytosterols, phytostanols and their esters
section S3—24
quaternary amine cellulose ion exchange resin
section S3—25
resistant maltodextrins
section S3—26
tall oil phytosterol esters
section S3—27
yeast—enriched selenium
section S3—28
yeast—high chromium
section S3—29
yeast—high molybdenum
section S3—30
S3—3 Substances with specifications in secondary sources
If there is no relevant specification under section S3—2, the specification is a specification listed in one of the following:
(a) British Pharmacopoeia Commission (2014) British Pharmacopoeia 2014. TSO, Norwich;
(b) United States Pharmacopeial Convention (2013) United States pharmacopeia and the national formulary. 37th revision. 32nd ed, United States Pharmacopeial Convention, Rockville, MD;
(c) Royal Pharmaceutical Society of Great Britain. Lund W (1994) Pharmaceutical codex: principles and practice of pharmaceutics, 12th ed, Pharmaceutical Press, London;
(d) Sweetman SC (2011) Martindale: the complete drug reference. 37th ed, Pharmaceutical Press, London;
(e) the European Pharmacopoeia 8th Edition, Council of Europe, Strasbourg (2014);
(f) the International Pharmacopoeia 4th Edition, World Health Organization, Geneva (2006 and 2008 supplement);
(g) the Merck Index, 15th Edition, (2013);
(h) the Code of Federal Regulations;
(i) the Specifications and Standards for Food Additives, 8th Edition (2007), Ministry of Health and Welfare (Japan); or
(j) the International Oenological Codex (2013), Organisation Internationale de la Vigne et du Vin (OIV).
S3—4 Additional and supplementary requirements
If 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:
(a) 2 mg/kg of lead; or
(b) 1 mg/kg of arsenic; or
(c) 1 mg/kg of cadmium; or
(d) 1 mg/kg of mercury.
S3—5 Specifications for advantame
For advantame, the specifications are:
(a) purity, using the analytical methodology indicated:
(i) assay:
(A) specification—not less than 97.0% and not more than 102.0% on anhydrous basis; and
(B) analytical methodology—high pressure liquid chromatography; and
(ii) specific rotation [α] 20 D:
(A) specification—between -45° and -38°; and
(B) analytical methodology—Japanese Pharmacopeia; and
(iii) advantame-acid:
(A) specification—not more than 1.0%; and
(B) analytical methodology—HPLC; and
(iv) total other related substances:
(A) specification—not more than 1.5%; and
(B) analytical methodology—HPLC; and
(v) water:
(A) specification—not more than 5.0%; and
(B) analytical methodology—Karl Fischer coulometric titration; and
(vi) residue on ignition:
(A) specification—no more than 0.2%; and
(B) analytical methodology—Japanese Pharmacopeia; and
(b) residual solvents, using gas chromatography:
(i) methyl acetate—no more than 500 mg/kg; and
(ii) isopropyl acetate—no more than 2 000 mg/kg; and
(iii) methanol—no more than 500 mg/kg; and
(iv) 2-Propanol—no more than 500 mg/kg.
S3—6 Specification for agarose ion exchange resin
(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.
(2) The resins are limited to use in aqueous process streams for the removal of proteins and polyphenols from beer. The pH range for the resins shall be no less than 2 and no more than 5, and the temperatures of water and food passing through the resin bed shall not exceed 2˚C. pH and temperature restrictions do not apply to cleaning processes.
(3) 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.
S3—7 Specification for bentonite
Bentonite 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.
S3—8 Specification for bromo-chloro-dimethylhydantoin
(1) In this section:
bromo-chloro-dimethylhydantoin (CAS Number: 126-06-7) is the chemical with:
(a) the formula C5H6BrClN2O2; and
(b) the formula weight 241.5.
(2) For bromo-chloro-dimethylhydantoin, the chemical specifications are the following:
(a) appearance—solid or free flowing granules;
(b) colour—white:
(c) odour—faint halogenous odour;
(d) melting point—163–164ºC;
(e) specific gravity—1.8–2;
(f) solubility in water—0.2 g/100 g at 25ºC;
(g) stability—stable when dry and uncontaminated.
(3) Bromo-chloro-dimethylhydantoin must be manufactured in accordance with the following process:
(a) solid dimethylhydantoin (DMH) must be dissolved in water with bromine and chlorine;
(b) the reaction must be 0.5 mole bromine and 1.5 mole chlorine for one mole DMH;
(c) during the reaction the pH must be kept basic by the addition of caustic soda;
(d) the wet product must be transferred to a drier where it is dried to a powder at low temperature;
(e) the powder may then be tableted or granulated.
(4) Bromo-chloro-dimethylhydantoin may be assayed in accordance with various analytical methods, including GLC, HPLC, UV and NMR.
Note HPLC offers the best sensitivity.
S3—9 Specification for carboxymethyl cellulose ion exchange resin
(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.
(2) The resins are limited to use in aqueous process streams for the isolation and purification of protein concentrates and isolates. The pH range for the resins shall be no less than 2 and no more than 10, and the temperatures of water and food passing through the resin bed must be no more than 40°C.
(3) 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.
S3—10 Specification for dibromo-dimethylhydantoin
(1) In this section:
dibromo-dimethylhydantoin means the chemical with CAS Number 77-48-5 and formula C5H6Br2N2O2.
(2) For dibromo-dimethylhydantoin, the specifications (which relate to purity) are the following:
(a) dibromo-dimethylhydantoin—no less than 97%;
(b) sodium bromide—no more than 2%;
(c) water—no more than 1%.
S3—11 Specification for diethyl aminoethyl cellulose ion exchange resin
(1) This specification relates to:
(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
(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.
(2) The resins are limited to use in aqueous process streams for the isolation and purification of protein concentrates and isolates. The pH range for the resins shall be no less than 2 and no more than 10, and the temperatures of water and food passing through the resin bed must be no more than 50°C.
(3) 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.
S3—12 Specification for dimethyl ether
For dimethyl ether, the specifications are the following:
(a) purity—minimum of 99.8%;
(b) methanol—not greater than 200 mg/kg.
S3—13 Specification for dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)
For docosahexaenoic acid (DHA)-rich dried marine micro-algae (Schizochytrium sp.), the specifications are the following:
(a) full chemical name—4,7,10,13,16,19-docosahexaenoic acid (22:6n-3 DHA);
(b) solids (%)—minimum 95.0;
(c) DHA (%)—minimum 15.0;
(d) lead (mg/kg)—maximum 0.5;
(e) arsenic (mg/kg)—maximum 0.5.
S3—14 Specification for ice structuring protein type III HPLC 12 preparation
(1) In this section:
ice 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.
(2) For ice structuring protein type III HPLC 12 preparation, the specifications are the following:
(a) assay—not less than 5 g/L active ice structuring protein type III HPLC 12;
(b) pH—3.0+/-0.5;
(c) ash—not more than 2%;
(d) appearance—light brown aqueous preparation;
(e) heavy metals—not more than 2 mg/L;
(f) microbial limits:
(i) total microbial count—
