Standard 1.3.4

Identity and Purity

Purpose

This Standard ensures that food additives, processing aids, novel food substances, vitamins and minerals and nutritive substances added to food in accordance with this Code meet appropriate specifications for identity and purity.  In general, these specifications are those used by the international community.

Table of Provisions

1 Application

2 Substances with specifications in primary sources

3 Substances with specifications in secondary sources

4 Additional and supplementary requirements

Schedule Specifications of identity and purity for substances added to food where there are no references in the monographs specified in Standard 1.3.4

Clauses

1 Application

This Standard applies only to the following substances which are added to food in accordance with this Code, or sold for use in food –

(a) food additives;

(b) processing aids;

(c) vitamins and minerals;

(d) novel food substances; and

(e) nutritive substances.

2 Substances with specifications in primary sources

A substance must comply with a relevant monograph published in one of the following –

(a) the Schedule to this Standard; or

(b) Combined Compendium of Food Additive Specifications, FAO JECFA Monograph 1 (2005) as superseded by specifications published in FAO JECFA Monographs 3 (2006) and FAO JECFA Monographs 4 (2007) and FAO JECFA Monographs 5 (2008) and FAO JECFA Monographs 7 (2009) and FAO JECFA Monographs 10 (2010) and FAO JECFA Monographs 11 (2011), Food and Agriculture Organisation of the United Nations. Rome; or

(c) Food Chemicals Codex (8th Edition) published by Unites States Pharmacopoeia (2012).

3 Substances with specifications in secondary sources

If there is no monograph applying to a substance under clause 2, the substance must comply with a relevant monograph published in one of the following –

(a) the British Pharmacopoeia 2010, TSO, Norwich (2010); or

(b) the United States Pharmacopeia, 34th Revision and The National Formulary, 29th Edition (2010); or

(c) the Pharmaceutical Codex, 12th Edition, Council of the Pharmaceutical Society of Great Britain.  The Pharmaceutical Press, London (1994); or

(d) Martindale; The Complete Drug Reference. The Pharmaceutical Press London (2009); or

(e) the European Pharmacopoeia 6th Edition, Council of Europe, Strasbourg (2007); or

(f) the International Pharmacopoeia 4th Edition, World Health Organization, Geneva (2006 and 2008 supplement); or

(g) the Merck Index, 14th Edition, (2006); or

(h) the Code of Federal Regulations; or

(i) the Specifications and Standards for Food Additives, 7th Edition (2000), Ministry of Health and Welfare (Japan); or

(j) the International Oenological Codex (2010 supplementary edition), Organisation Internationale de la Vigne et du Vin (OIV).

4 Additional and supplementary requirements

Where no monograph applies to a substance by virtue of clauses 2 or 3, or where a monograph contains no specifications for identity and purity of a substance relating to arsenic or heavy metals, the substance must not contain on a dry weight basis more than –

(a) 2 mg/kg of lead;

(b) 1 mg/kg of arsenic;

(c) 1 mg/kg of cadmium;

(d) 1 mg/kg of mercury.

SCHEDULE

This Schedule contains specifications of identity and purity for substances added to food where there are no references in the monographs specified in this Standard.

Specification for high chromium yeast

Physical Tests

Appearance: Fine, free-flowing powder

Colour: Light off-white or light tan

Odour: Slight yeast aroma

Particle size: Min. 90% through a #100 USS screen

Chemical Tests

Moisture: Maximum 6%

Chromium: 1.8 - 2.25 g/kg

Specification for high molybdenum yeast

Physical Tests

Appearance: Fine, free-flowing powder

Colour: Light off-white or light tan

Odour: Slight yeast aroma

Particle size: Min. 85% through a #100 USS screen

Chemical Tests

Moisture: Maximum 6%

Molybdenum: 1.8 - 2.25 g/kg

Specification for oxidised polyethylene

Oxidised polyethylene (CAS 68441-17-8)# is the polymer produced by the mild air oxidation of polyethylene.

Average molecular weight min 1200 (osmometric)

Viscosity at 125C min 200cP

Oxygen content max 9.1%

Acid value: max 70 mgKOH/g

(ASTM D 1386)*

Drop point: min 95 C

(ASTM D 566)*

Density (20C) 0.93 - 1.05 g/cm3

(ASTM D 1298, D 1505)*

Extractable constituents (See note 1):

 in water max. 1.5%

 in 10% ethanol max 2.3%

 in 3% acetic acid max 1.8%

 in n-pentane max 26.0%

# CAS is the Chemical Abstracts Service (CAS) Registry Number.

* ASTM refers to standard test methods prepared by the American Society for Testing and Materials.

Note 1:  Extraction of oxidised Polyethylene

25.0 g of finely ground oxidised polyethylene powder (particle size 300-1000 mm) are 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).

Specification for bromo-chloro-dimethylhydantoin

Bromo-chloro-dimethylhydantoin (CAS Number: 126-06-7)

Formula: C5H6BrCIN2O2

Formula weight: 241.5

Chemical Properties

Appearance: Solid or free flowing granules

Colour: White

Odour: Faint halogenous odour

Melting Point: 163-164ºC

Specific gravity: 1.8-2

Solubility in water: 0.2 g/100 g at 25ºC

Stability: Stable when dry and uncontaminated

Chemical Tests

Manufacturing process: Solid dimethylhydantoin (DMH) is dissolved in water with bromine and chlorine.  The reaction is 0.5 mole bromine and 1.5 mole chlorine for one mole DMH.  During the reaction the pH is kept basic by the addition of caustic soda.  The wet product is transferred to a drier where it is dried to a powder at low temperature.  The powder may then be tableted or granulated.

Assay

Procedure: Various analytical methods exist for analysis, namely, GLC, HPLC, UV and NMR.  HPLC offers the best sensitivity.

Specifications for nucleotides

Description / Physical Constraints

Uridine – 5′ monophosphate disodium salt (UMP)

1. Empirical chemical formula: C9 H11N2 O9PNa2

In addition the compound must be of the 5 species, ie the disodium monophosphate structure is attached to the fifth carbon in the central structure.

2. Molecular weight: 368.15

3. Structure/ Physical character: Occurs as a colourless or white crystal or as a white crystalline powder.  It is odourless and has a characteristic taste.

4. Solubility: Freely soluble in water; very slightly soluble in alcohol.

Adenosine- 5′ monophosphate (AMP)

1. Empirical chemical formula: C10H14N5O7P

In addition the compound must be of the 5 species, ie the monophosphate structure is attached to the fifth carbon in the central structure.

2. Molecular weight: 347.22

3. Structure/ Physical character: Occurs as a colourless or white crystal or as a white crystalline powder.  It is odourless and has a characteristic acidic taste.

4. Solubility: Very slightly soluble in water; practically insoluble in alcohol.

Cytidine – 5′ monophosphate (CMP)

1. Empirical chemical formula: C9H14N3O8P 

In addition the compound must be of the 5 species, ie the monophosphate structure is attached to the fifth carbon in the central structure.

2. Molecular weight: 323.20

3. Structure/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.

4. Solubility: Very slightly soluble in water; practically insoluble in alcohol.

Testing Requirements for Nucleotides

1. Physical inspection: white crystals or crystalline powder

2. Identification:

(a) Ultraviolet absorbance: a 1 in 12,500 solution of the powder in 0.01N hydrochloric acid exhibits an absorbance maximum at:

(b) IMP, UMP and GMP must test positive for sodium phosphate

(c) IMP,UMP,AMP, CMP and GMP must test positive for organic phosphate

3. Assay (HPLC):

Optimum - not less than 96% (corrected for moisture content).

4. IMP and GMP have a pH of a 1 in 20 solution: between 7.0 and 8.5

5. Clarity and colour of solution:

500 mg/10 mL H2O for IMP: is colourless and shows only a trace of turbidity

100 mg/10 mL H2O for GMP: is colourless and shows only a trace of turbidity

6. Moisture

7. Impurities – all nucleotides

8. Related foreign substances:

For IMP: only 5′ - inosinic acid is detected by thin layer chromatography

For GMP: only 5′ - guanylic acid is detected by thin layer chromatography

9. Bacteriological profile

(a) SPC: not more than 1000/g, test per current FDA/BAM procedures

(b) Coliforms: Negative by test; test per current FDA/BAM procedures

(c) Yeast and mould: not more than 300/g, test per current FDA/BAM procedures

(d) Salmonella: negative, test per current FDA/BAM procedures.

Specification for carboxymethyl cellulose ion exchange resin

(a) This specification relates to regenerated cellulose, cross-linked and alkylated with epichlorohydrin and propylene oxide, then derivatised with carboxymethyl groups whereby the amount of epichlorohydrin plus propylene oxide is no more than 70% by weight of the starting quantity of cellulose.

(b) 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.

(c) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.

Specification for quaternary amine cellulose ion exchange resin

(a) 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 quantity of cellulose.

(b) 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.

(c) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.

Specification for diethyl aminoethyl cellulose ion exchange resin

(a) This specification relates to:

(i) 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 quantity of cellulose; and

(ii) 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 quantity of cellulose.

(b) 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.

(c) When subjected to the extraction regime listed in the 21 CFR § 173.25(c)(4), but using dilute hydrochloric acid at pH2 in place of 5% acetic acid, the ion exchange resins shall result in no more than 25 ppm of organic extractives.

Specification for dried marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)

Specification for oil derived from marine micro-algae (Schizochytrium sp.) rich in docosahexaenoic acid (DHA)

Specification for oil derived from the algae Crypthecodinium cohnii rich in docosahexaenoic acid (DHA)

Specification for oil derived from the fungus Mortierella alpina rich in arachidonic acid (ARA)

Specification for resistant maltodextrins

Specification for oil derived from marine micro-algae (Ulkenia sp.) rich in docosahexaenoic acid (DHA)

Specification for ice structuring protein type III HPLC 12 preparation

Ice structuring protein type III HPLC 12 preparation is a 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.

Specification for isomaltulose

Specification for agarose ion exchange resin

(a) 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 quantity of agarose.

(b) 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.

(c) 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.

Specification for bentonite

Bentonite must comply with a monograph specification in clause 2 or clause 3 of this Standard, except that the pH determination for a bentonite dispersion must be no less than 4.5 and no more than 10.5.

Specification for phytosterols, phytostanols and their esters

(1) Subject to subclauses (2) and (3), phytosterols, phytostanols and their esters must comply with a monograph specification in clause 2 or 3 of this Standard.

(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.

(3) The total plant sterol equivalents content must contain no less than 95% des-methyl sterols.

Specification for tall oil phytosterol esters

Tall oil phytosterol esters are phytosterols derived from Tall Oil Pitch esterified with long-chain fatty acids derived from edible vegetable oils

Specifications for Advantame

1. Purity

2. Residual Solvents

Specification for dimethyl ether

Specification for dibromo-dimethylhydantoin

Specification for Listeria phage P100