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Document 02012R0231-20161103

    Consolidated text: Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council (Text with EEA relevance)

    ELI: http://data.europa.eu/eli/reg/2012/231/2016-11-03

    2012R0231 — EN — 03.11.2016 — 014.001


    This text is meant purely as a documentation tool and has no legal effect. The Union's institutions do not assume any liability for its contents. The authentic versions of the relevant acts, including their preambles, are those published in the Official Journal of the European Union and available in EUR-Lex. Those official texts are directly accessible through the links embedded in this document

    ►B

    COMMISSION REGULATION (EU) No 231/2012

    of 9 March 2012

    laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council

    (Text with EEA relevance)

    (OJ L 083 22.3.2012, p. 1)

    Amended by:

     

     

    Official Journal

      No

    page

    date

    ►M1

    COMMISSION REGULATION (EU) No 1050/2012 of 8 November 2012

      L 310

    45

    9.11.2012

    ►M2

    COMMISSION REGULATION (EU) No 25/2013 of 16 January 2013

      L 13

    1

    17.1.2013

    ►M3

    COMMISSION REGULATION (EU) No 497/2013 of 29 May 2013

      L 143

    20

    30.5.2013

    ►M4

    COMMISSION REGULATION (EU) No 724/2013 of 26 July 2013

      L 202

    11

    27.7.2013

    ►M5

    COMMISSION REGULATION (EU) No 739/2013 of 30 July 2013

      L 204

    35

    31.7.2013

    ►M6

    COMMISSION REGULATION (EU) No 816/2013 of 28 August 2013

      L 230

    1

    29.8.2013

    ►M7

    COMMISSION REGULATION (EU) No 817/2013 of 28 August 2013

      L 230

    7

    29.8.2013

    ►M8

    COMMISSION REGULATION (EU) No 1274/2013 of 6 December 2013

      L 328

    79

    7.12.2013

    ►M9

    COMMISSION REGULATION (EU) No 264/2014 of 14 March 2014

      L 76

    22

    15.3.2014

    ►M10

    COMMISSION REGULATION (EU) No 298/2014 of 21 March 2014

      L 89

    36

    25.3.2014

    ►M11

    COMMISSION REGULATION (EU) No 497/2014 of 14 May 2014

      L 143

    6

    15.5.2014

    ►M12

    COMMISSION REGULATION (EU) No 506/2014 of 15 May 2014

      L 145

    35

    16.5.2014

    ►M13

    COMMISSION REGULATION (EU) No 685/2014 of 20 June 2014

      L 182

    23

    21.6.2014

    ►M14

    COMMISSION REGULATION (EU) No 923/2014 of 25 August 2014

      L 252

    11

    26.8.2014

    ►M15

    COMMISSION REGULATION (EU) No 957/2014 of 10 September 2014

      L 270

    1

    11.9.2014

    ►M16

    COMMISSION REGULATION (EU) No 966/2014 of 12 September 2014

      L 272

    1

    13.9.2014

    ►M17

    COMMISSION REGULATION (EU) 2015/463 of 19 March 2015

      L 76

    42

    20.3.2015

    ►M18

    COMMISSION REGULATION (EU) 2015/649 of 24 April 2015

      L 107

    17

    25.4.2015

    ►M19

    COMMISSION REGULATION (EU) 2015/1725 of 28 September 2015

      L 252

    12

    29.9.2015

    ►M20

    COMMISSION REGULATION (EU) 2015/1739 of 28 September 2015

      L 253

    3

    30.9.2015

    ►M21

    COMMISSION REGULATION (EU) 2016/1814 of 13 October 2016

      L 278

    37

    14.10.2016




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    COMMISSION REGULATION (EU) No 231/2012

    of 9 March 2012

    laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council

    (Text with EEA relevance)



    Article 1

    Specifications for food additives

    Specifications for food additives including colours and sweeteners listed in Annex II and III to Regulation (EC) No 1333/2008 are laid down in the Annex to this Regulation.

    Article 2

    Repeals

    Directives 2008/60/EC, 2008/84/EC and 2008/128/EC are repealed with effect from 1 December 2012.

    Article 3

    Transitional measures

    Foodstuffs containing food additives that have been lawfully placed on the market before 1 December 2012, but do not comply with this Regulation, may continue to be marketed until stocks are exhausted.

    Article 4

    Entry into force

    This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.

    It shall apply from 1 December 2012.

    However, the specifications laid down in the Annex for additives steviol glycosides (E 960) and basic methacrylate copolymer (E 1205) shall apply from the date of entry into force of this Regulation.

    This Regulation shall be binding in its entirety and directly applicable in the Member States.




    ANNEX

    Note: Ethylene oxide may not be used for sterilising purposes in food additives

    Aluminium lakes for use in colours only where explicitly stated.



    Definition:

    Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulphate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.

    HCl insoluble matter

    Not more than 0,5 %

    ΝaΟΗ insoluble matter

    Νot more than 0,5 %, for Ε 127 erythrosine only

    Ether extractable matter

    Not more than 0,2 % (under neutral conditions)

    Specific purity criteria for the corresponding colours are applicable.

    E 100 CURCUMIN



    Synonyms

    CI Natural Yellow 3; Turmeric Yellow; Diferoyl Methane

    Definition

    Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallization. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occurring in turmeric may be present.

    Curcumin is also used as the aluminium lake; the aluminium content is less than 30 %.

    Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane, propan-2-ol.

    Colour Index No

    75300

    Einecs

    207-280-5

    Chemical name

    I  1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione

    II  1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione

    III  1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione

    Chemical formula

    I  C21H20O6

    II  C20H18O5

    III  C19H16O4

    Molecular weight

    I.  368,39

    II.  338,39

    III.  308,39

    Assay

    Content not less than 90 % total colouring matters

    image

    1 607 at ca. 426 nm in ethanol

    Description

    Orange-yellow crystalline powder

    Identification

    Spectrometry

    Maximum in ethanol at ca. 426 nm

    Melting range

    179 °C-182 °C

    Purity

    Solvent residues

    Ethylacetate

    right accolade Not more than 50 mg/kg, singly or in combination

    Acetone

    n-butanol

    Methanol

    Ethanol

    Hexane

    Propan-2-ol

    Dichloromethane: not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 10 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 101 (i) RIBOFLAVIN



    Synonyms

    Lactoflavin;

    Definition

    Colour Index No

     

    Einecs

    201-507-1

    Chemical name

    7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione; 7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine

    Chemical formula

    C17H20N4O6

    Molecular weight

    376,37

    Assay

    Content not less than 98 % on the anhydrous basis

    image

    328 at ca. 444 nm in aqueous solution

    Description

    Yellow to orange-yellow crystalline powder, with slight odour

    Identification

    Spectrometry

    The ratio A375/A267 is between 0,31 and 0,33

    right accolade in aqueous solution

    The ratio A444/A267 is between 0,36 and 0,39

    Maximum in water at ca. 375 nm

    Specific rotation

    [α]D 20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution

    Purity

    Loss on drying

    Not more than 1,5 % (105 °C, 4 hours)

    Sulphated ash

    Not more than 0,1 %

    Primary aromatic amines

    Not more than 100 mg/kg (calculated as aniline)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    ▼M14

    Aluminium lakes of this colour may be used.

    ▼B

    E 101 (ii) RIBOFLAVIN-5′-PHOSPHATE



    Synonyms

    Riboflavin-5′-phosphate sodium

    Definition

    These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate.

    Colour Index No

     

    Einecs

    204-988-6

    Chemical name

    Monosodium(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate; monosodium salt of 5′-monophosphate ester of riboflavin

    Chemical formula

    For the dihydrate form: C17H20N4NaO9P · 2H2O

    For the anhydrous form: C17H20N4NaO9P

    Molecular weight

    514,36

    Assay

    Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P.2H2O

    image

    250 at ca. 375 nm in aqueous solution

    Description

    Yellow to orange crystalline hygroscopic powder, with slight odour

    Identification

    Spectrometry

    The ratio A375/A267 is between 0,30 and 0,34

    right accolade in aqueous solution

    The ratio A444/A267 is between 0,35 and 0,40

    Maximum in water at ca. 375 nm

    Specific rotation

    [α]D 20 between + 38° and + 42° in a 5 molar HCl solution

    Purity

    Loss on drying

    Not more than 8 % (100 °C, 5 hours in vacuum over P2O5) for the dihydrate form

    Sulphated ash

    Not more than 25 %

    Inorganic phosphate

    Not more than 1,0 % (calculated as PO4 on the anhydrous basis)

    Subsidiary colouring matters

    Riboflavin (free): Not more than 6 %

    Riboflavine diphosphate: Not more than 6 %

    Primary aromatic amines

    Not more than 70 mg/kg (calculated as aniline)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    ▼M14

    Aluminium lakes of this colour may be used.

    ▼B

    E 102 TARTRAZINE



    Synonyms

    CI Food Yellow 4

    Definition

    Tartrazine is prepared from 4-amino-benzenesulphonic acid, which is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is then coupled with 4,5-dihydro-5-oxo-1-(4sulphophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.

    Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    19140

    Einecs

    217-699-5

    Chemical name

    Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate

    Chemical formula

    C16H9N4Na3O9S2

    Molecular weight

    534,37

    Assay

    Content not less than 85 % total colouring matters calculated as the sodium salt

    image

    530 at ca. 426 nm in aqueous solution

    Description

    Light orange powder or granules

    Appearance of the aqueous solution

    Yellow

    Identification

    Spectrometry

    Maximum in water at ca. 426 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 1,0 %

    Organic compounds other than colouring matters:

     

    4-hydrazinobenzene sulfonic acid

    right accolade Total not more than 0,5 %

    4-aminobenzene-1-sulfonic acid

    5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid

    4,4′-diazoaminodi(benzene sulfonic acid)

    Tetrahydroxysuccinic acid

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 104 QUINOLINE YELLOW



    Synonyms

    CI Food Yellow 13

    Definition

    Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione or a mixture containing about two thirds 2-(2-quinolyl)indane-1,3-dione and one third 2-(2-(6-methylquinolyl))indane-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.

    Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    47005

    Einecs

    305-897-5

    Chemical name

    The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component)

    Chemical formula

    C18H9N Na2O8S2 (principal component)

    Molecular weight

    477,38 (principal component)

    Assay

    Content not less than 70 % total colouring matters calculated as the sodium salt

    Quinoline Yellow shall have the following composition:

    Of the total colouring matters present:

    — not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates

    — not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates

    — not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate

    image

    865 (principal component) at ca. 411 nm in aqueous acetic acid solution

    Description

    Yellow powder or granules

    Appearance of the aqueous solution

    Yellow

    Identification

    Spectrometry

    Maximum in aqueous acetic acid solution of pH 5 at ca. 411 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 4,0 %

    Organic compounds other than colouring matters:

     

    2-methylquinoline

    right accolade Total not more than 0,5 %

    2-methylquinoline-sulfonic acid

    Phthalic acid

    2,6-dimethyl quinoline

    2,6-dimethyl quinoline sulfonic acid

    2-(2-quinolyl)indan-1,3-dione

    Not more than 4 mg/kg

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 110 SUNSET YELLOW FCF



    Synonyms

    CI Food Yellow 3; Orange Yellow S

    Definition

    Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Sunset Yellow FCF is manufactured by diazotizing 4-aminobenzenesulphonic acid using hydrochloric acid and sodium nitrite or sulphuric acid and sodium nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-sulphonic acid. The dye is isolated as the sodium salt and dried.

    Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    15985

    Einecs

    220-491-7

    Chemical name

    Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate

    Chemical formula

    C16H10N2Na2O7S2

    Molecular weight

    452,37

    Assay

    Content not less than 85 % total colouring matters calculated as the sodium salt

    image

    555 at ca. 485 nm in aqueous solution at pH 7

    Description

    Orange-red powder or granules

    Appearance of the aqueous solution

    Orange

    Identification

    Spectrometry

    Maximum in water at ca. 485 nm at pH 7

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 5,0 %

    1-(Phenylazo)-2-naphthalenol (Sudan I)

    Not more than 0,5 mg/kg

    Organic compounds other than colouring matters:

     

    4-aminobenzene-1-sulfonic acid

    right accolade Total not more than 0,5 %

    3-hydroxynaphthalene-2,7-disulfonic acid

    6-hydroxynaphthalene-2-sulfonic acid

    7-hydroxynaphthalene-1,3-disulfonic acid

    4,4′-diazoaminodi(benzene sulfonic acid)

    6,6′-oxydi(naphthalene-2-sulfonic acid)

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 120 COCHINEAL, CARMINIC ACID, CARMINES



    Synonyms

    CI Natural Red 4

    Definition

    Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa.

    The colouring principle is carminic acid.

    Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2.

    In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess.

    Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations.

    Colour Index No

    75470

    Einecs

    Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4

    Chemical name

    7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid

    Chemical formula

    C22H20O13 (carminic acid)

    Molecular weight

    492,39 (carminic acid)

    Assay

    Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates.

    Description

    Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.

    Identification

    Spectrometry

    Maximum in aqueous ammonia solution at ca. 518 nm

    Maximum in dilute hydrochloric solution at ca. 494 nm for carminic acid

    image

    139 at peak around 494 nm in dilute hydrochloric acid for carminic acid

    Purity

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 122 AZORUBINE, CARMOISINE



    Synonyms

    CI Food Red 3

    Definition

    Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.

    Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    14720

    Einecs

    222-657-4

    Chemical name

    Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate

    Chemical formula

    C20H12N2Na2O7S2

    Molecular weight

    502,44

    Assay

    Content not less than 85 % total colouring matters, calculated as the sodium salt

    image

    510 at ca. 516 nm in aqueous solution

    Description

    Red to maroon powder or granules

    Appearance of the aqueous solution

    Red

    Identification

    Spectrometry

    Maximum in water at ca. 516 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 1 %

    Organic compounds other than colouring matters:

     

    4-aminonaphthalene-1-sulfonic acid

    right accolade Total not more than 0,5 %

    4-hydroxynaphthalene-1-sulfonic acid

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 123 AMARANTH



    Synonyms

    CI Food Red 9

    Definition

    Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Amaranth is manufactured by coupling 4-amino-1-naphthalenesulphonic acid with 3-hydroxy-2,7-naphthalenedisulphonic acid.

    Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    16185

    Einecs

    213-022-2

    Chemical name

    Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate

    Chemical formula

    C20H11N2Na3O10S3

    Molecular weight

    604,48

    Assay

    Content not less than 85 % total colouring matters, calculated as the sodium salt

    image

    440 at ca. 520 nm in aqueous solution

    Description

    Reddish-brown powder or granules

    Appearance of the aqueous solution

    Red

    Identification

    Spectrometry

    Maximum in water at ca. 520 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 3,0 %

    Organic compounds other than colouring matters:

     

    4-aminonaphthalene-1-sulfonic acid

    right accolade Total not more than 0,5 %

    3-hydroxynaphthalene-2,7-disulfonic acid

    6-hydroxynaphthalene-2-sulfonic acid

    7-hydroxynaphthalene-1,3-disulfonic acid

    7-hydroxynaphthalene-1,3-6-trisulfonic acid

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 124 PONCEAU 4R, COCHINEAL RED A



    Synonyms

    CI Food Red 7; New Coccine

    Definition

    Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Ponceau 4R is manufactured by coupling diazotized naphthionic acid to G acid (2-naphthol-6,8- disulphonic acid) and converting the coupling product to the trisodium salt.

    Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    16255

    Einecs

    220-036-2

    Chemical name

    Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate

    Chemical formula

    C20H11N2Na3O10S3

    Molecular weight

    604,48

    Assay

    Content not less than 80 % total colouring matters, calculated as the sodium salt.

    image

    430 at ca. 505 nm in aqueous solution

    Description

    Reddish powder or granules

    Appearance of the aqueous solution

    Red

    Identification

    Spectrometry

    Maximum in water at ca. 505 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 1,0 %

    Organic compounds other than colouring matters:

     

    4-aminonaphthalene-1-sulfonic acid

    right accolade Total not more than 0,5 %

    7-hydroxynaphthalene-1,3-disulfonic acid

    3-hydroxynaphthalene-2,7-disulfonic acid

    6-hydroxynaphthalene-2-sulfonic acid

    7-hydroxynaphthalene-1,3-6-trisulfonic acid

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 127 ERYTHROSINE



    Synonyms

    CI Food Red 14

    Definition

    Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulphate as the principal uncoloured components. Erythrosine is manufactured by iodination of fluorescein, the condensation product of resorcinol and phthalic anhydride

    Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    45430

    Einecs

    240-474-8

    Chemical name

    Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate

    Chemical formula

    C20H6I4Na2O5 H2O

    Molecular weight

    897,88

    Assay

    Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt

    image

    1 100 at ca. 526 nm in aqueous solution at pH 7

    Description

    Red powder or granules.

    Appearance of the aqueous solution

    Red

    Identification

    Spectrometry

    Maximum in water at ca. 526 nm at pH 7

    Purity

    Inorganic iodides

    Not more than 0,1 % (calculated as sodium iodide)

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters (except fluorescein)

    Not more than 4,0 %

    Fluorescein

    Not more than 20 mg/kg

    Organic compounds other than colouring matters:

     

    Tri-iodoresorcinol

    Not more than 0,2 %

    2-(2,4-dihydroxy-3,5-diiodobenzoyl) benzoic acid

    Not more than 0,2 %

    Ether extractable matter

    From a solution of pH from 7 through 8, not more than 0,2 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium Lakes of this colour may be used.

    E 129 ALLURA RED AC



    Synonyms

    CI Food Red 17

    Definition

    Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Allura Red AC is manufactured by coupling diazotized 5-amino-4-methoxy-2-toluenesulphonic acid with 6-hydroxy-2-naphthalene sulphonic acid

    Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    16035

    Einecs

    247-368-0

    Chemical name

    Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate

    Chemical formula

    C18H14N2Na2O8S2

    Molecular weight

    496,42

    Assay

    Content not less than 85 % total colouring matters, calculated as the sodium salt

    image

    540 at ca. 504 nm in aqueous solution at pH 7

    Description

    Dark red powder or granules

    Appearance of the aqueous solution

    Red

    Identification

    Spectrometry

    Maximum in water at ca. 504 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 3,0 %

    Organic compounds other than colouring matters:

     

    6-hydroxy-2-naphthalene sulfonic acid, sodium salt

    Not more than 0,3 %

    4-amino-5-methoxy-2-methylbenezene sulfonic acid

    Not more than 0,2 %

    6,6-oxybis (2-naphthalene sulfonic acid) disodium salt

    Not more than 1,0 %

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    From a solution of pH 7, not more than 0,2 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 131 PATENT BLUE V



    Synonyms

    CI Food Blue 5

    Definition

    Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulphate and/or calcium sulphate as the principal uncoloured components.

    The potassium salt is also permitted.

    Colour Index No

    42051

    Einecs

    222-573-8

    Chemical name

    The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt

    Chemical formula

    Calcium compound: C27H31N2O7S2Ca1/2

    Sodium compound: C27H31N2O7S2Na

    Molecular weight

    Calcium compound: 579,72

    Sodium compound: 582,67

    Assay

    Content not less than 85 % total colouring matters, calculated as the sodium salt

    image

    2 000 at ca. 638 nm in aqueous solution at pH 5

    Description

    Dark blue powder or granules

    Appearance of the aqueous solution

    Blue

    Identification

    Spectrometry

    Maximum in water at 638 nm at pH 5

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 2,0 %

    Organic compounds other than colouring matters:

     

    3-hydroxy benzaldehyde

    right accolade Total not more than 0,5 %

    3-hydroxy benzoic acid

    3-hydroxy-4-sulfobenzoic acid

    N,N-diethylamino benzene sulfonic acid

    Leuco base

    Not more than 4,0 %

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    From a solution of pH 5 not more than 0,2 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 132 INDIGOTINE, INDIGO CARMINE



    Synonyms

    CI Food Blue 1

    Definition

    Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.

    Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Indigo carmine is obtained by sulphonation of indigo. This is accomplished by heating indigo (or indigo paste) in the presence of sulphuric acid. The dye is isolated and subjected to purification procedures.

    Colour Index No

    73015

    Einecs

    212-728-8

    Chemical name

    Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate

    Chemical formula

    C16H8N2Na2O8S2

    Molecular weight

    466,36

    Assay

    Content not less than 85 % total colouring matters, calculated as the sodium salt;

    disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 18 %

    image

    480 at ca. 610 nm in aqueous solution

    Description

    Dark-blue powder or granules

    Appearance of the aqueous solution

    Blue

    Identification

    Spectrometry

    Maximum in water at ca. 610 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 %

    Organic compounds other than colouring matters:

     

    Isatin-5-sulfonic acid

    right accolade Total not more than 0,5 %

    5-sulfoanthranilic acid

    Anthranilic acid

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 133 BRILLIANT BLUE FCF



    Synonyms

    CI Food Blue 2

    Definition

    Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.

    Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    42090

    Einecs

    223-339-8

    Chemical name

    Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate

    Chemical formula

    C37H34N2Na2O9S3

    Molecular weight

    792,84

    Assay

    Content not less than 85 % total colouring matters, calculated as the sodium salt

    image

    1 630 at ca. 630 nm in aqueous solution

    Description

    Reddish-blue powder or granules

    Appearance of the aqueous solution

    Blue

    Identification

    Spectrometry

    Maximum in water at ca. 630 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 6,0 %

    Organic compounds other than colouring matters:

     

    Sum of 2-, 3- and 4-formyl benzene sulfonic acids

    Not more than 1,5 %

    3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid

    Not more than 0,3 %

    Leuco base

    Not more than 5,0 %

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % at pH 7

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 140 (i) CHLOROPHYLLS



    Synonyms

    CI Natural Green 3; Magnesium Chlorophyll; Magnesium Phaeophytin

    Definition

    Chlorophylls are obtained by solvent extraction of strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present coordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

    Colour Index No

    75810

    Einecs

    Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4

    Chemical name

    The major colouring principles are:

    Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Phaeophytin a), or as the magnesium complex (Chlorophyll a)

    Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)

    Chemical formula

    Chlorophyll a (magnesium complex): C55H72MgN4O5

    Chlorophyll a: C55H74N4O5

    Chlorophyll b (magnesium complex): C55H70MgN4O6

    Chlorophyll b: C55H72N4O6

    Molecular weight

    Chlorophyll a (magnesium complex): 893,51

    Chlorophyll a: 871,22

    Chlorophyll b (magnesium complex): 907,49

    Chlorophyll b: 885,20

    Assay

    Content of total combined Chlorophylls and their magnesium complexes is not less than 10 %

    image

    700 at ca. 409 nm in chloroform

    Description

    Waxy solid ranging in colour from olive green to dark green depending on the content of coordinated magnesium

    Identification

    Spectrometry

    Maximum in chloroform at ca. 409 nm

    Purity

    Solvent residues

    Acetone

    right accolade Not more than 50 mg/kg, singly or in combination

    Methyl Ethyl ketone

    Methanol

    Ethanol

    Propan-2-ol

    Hexane

    Dichloromethane:

    Not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 140 (ii) CHLOROPHYLLINS



    Synonyms

    CI Natural Green 5; Sodium Chlorophyllin; Potassium Chlorophyllin

    Definition

    The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralised to form the salts of potassium and/or sodium.

    Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

    Colour Index No

    75815

    Einecs

    287-483-3

    Chemical name

    The major colouring principles in their acid forms are:

    — 3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)

    — and

    — 3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)

    Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function.

    Magnesium complexes may also be present.

    Chemical formula

    Chlorophyllin a (acid form): C34H34N4O5

    Chlorophyllin b (acid form): C34H32N4O6

    Molecular weight

    Chlorophyllin a: 578,68

    Chlorophyllin b: 592,66

    Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.

    Assay

    Content of total chlorophyllins is not less than 95 % of the sample dried at ca. 100 °C for 1 hour.

    image

    700 at ca. 405 nm in aqueous solution at pH 9

    image

    140 at ca. 653 nm in aqueous solution at pH 9

    Description

    Dark green to blue/black powder

    Identification

    Spectrometry

    Maximum in aqueous phosphate buffer at pH 9 at ca. 405 nm and at ca. 653 nm

    Purity

    Solvent residues

    Acetone

    right accolade Not more than 50 mg/kg, singly or in combination

    Methyl ethyl ketone

    Methanol

    Ethanol

    Propan-2-ol

    Hexane

    Dichloromethane:

    not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 10 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS



    Synonyms

    CI Natural Green 3; Copper Chlorophyll; Copper Phaeophytin

    Definition

    Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.

    Colour Index No

    75810

    Einecs

    Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5

    Chemical name

    [Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a)

    [Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b)

    Chemical formula

    Copper chlorophyll a: C55H72Cu N4O5

    Copper chlorophyll b: C55H70Cu N4O6

    Molecular weight

    Copper chlorophyll a: 932,75

    Copper chlorophyll b: 946,73

    Assay

    Content of total copper chlorophylls is not less than 10 %.

    image

    540 at ca. 422 nm in chloroform

    image

    300 at ca. 652 nm in chloroform

    Description

    Waxy solid ranging in colour from blue green to dark green depending on the source material

    Identification

    Spectrometry

    Maximum in chloroform at ca. 422 nm and at ca. 652 nm

    Purity

    Solvent residues

    Acetone

    right accolade Not more than 50 mg/kg, singly or in combination

    Methyl ethyl ketone

    Methanol

    Ethanol

    Propan-2-ol

    Hexane

    Dichloromethane:

    not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Copper ions

    Not more than 200 mg/kg

    Total copper

    Not more than 8,0 % of the total copper phaeophytins

    Aluminium lakes of this colour may be used.

    E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS



    Synonyms

    Sodium Copper Chlorophyllin; Potassium Copper Chlorophyllin; CI Natural Green 5

    Definition

    The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralised to form the salts of potassium and/or sodium.

    Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane.

    Colour Index No

    75815

    Einecs

     

    Chemical name

    The major colouring principles in their acid forms are 3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a) and 3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b)

    Chemical formula

    Copper chlorophyllin a (acid form): C34H32Cu N4O5

    Copper chlorophyllin b (acid form): C34H30Cu N4O6

    Molecular weight

    Copper chlorophyllin a: 640,20

    Copper chlorophyllin b: 654,18

    Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.

    Assay

    Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h.

    image

    565 at ca. 405 nm in aqueous phosphate buffer at pH 7,5

    image

    145 at ca. 630 nm in aqueous phosphate buffer at pH 7,5

    Description

    Dark green to blue/black powder

    Identification

    Spectrometry

    Maximum in aqueous phosphate buffer at pH 7,5 at ca. 405 nm and at 630 nm

    Purity

    Solvent residues

    Acetone

    right accolade Not more than 50 mg/kg, singly or in combination

    Methyl ethyl ketone

    Methanol

    Ethanol

    Propan-2-ol

    Hexane

    Dichloromethane:

    not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Copper ions

    Not more than 200 mg/kg

    Total copper

    Not more than 8,0 % of the total copper chlorophyllins

    Aluminium lakes of this colour may be used.

    E 142 GREEN S



    Synonyms

    CI Food Green 4, Brilliant Green BS

    Definition

    Green S consists essentially of sodium N-[4-[[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds.

    Green S is described as the sodium salt. The calcium and the potassium salt are also permitted.

    Colour Index No

    44090

    Einecs

    221-409-2

    Chemical name

    Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium; Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name).

    Chemical formula

    C27H25N2NaO7S2

    Molecular weight

    576,63

    Assay

    Content not less than 80 % total colouring matters calculated as the sodium salt

    image

    1 720 at ca. 632 nm in aqueous solution

    Description

    Dark blue or dark green powder or granules

    Appearance of the aqueous solution

    Blue or green

    Identification

    Spectrometry

    Maximum in water at ca. 632 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 1,0 %

    Organic compounds other than colouring matters:

     

    4,4′-bis(dimethylamino)-benzhydryl alcohol

    Not more than 0,1 %

    4,4′-bis(dimethylamino)-benzophenone

    Not more than 0,1 %

    3-hydroxynaphthalene-2,7-disulfonic acid

    Not more than 0,2 %

    Leuco base

    Not more than 5,0 %

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 150a PLAIN CARAMEL



    Synonyms

    Caustic caramel

    Definition

    Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelisation, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.

    Colour Index No

     

    Einecs

    232-435-9

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Dark brown to black liquids or solids

    Identification

     

    Purity

    Colour bound by DEAE cellulose

    Not more than 50 %

    Colour bound by phosphoryl cellulose

    Not more than 50 %

    Colour intensity (1)

    0,01-0,12

    Total nitrogen

    Not more than 0,1 %

    Total sulphur

    Not more than 0,2 %

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    (1)   Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

    E 150b CAUSTIC SULPHITE CARAMEL



    Synonyms

     

    Definition

    Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.

    Colour Index No

     

    Einecs

    232-435-9

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Dark brown to black liquids or solids

    Identification

     

    Purity

    Colour bound by DEAE cellulose

    More than 50 %

    Colour intensity (1)

    0,05-0,13

    Total nitrogen

    Not more than 0,3 % (2)

    Sulphur dioxide

    Not more than 0,2 % (2)

    Total sulphur

    0,3-3,5 % (2)

    Sulphur bound by DEAE cellulose

    More than 40 %

    Absorbance ratio of colour bound by DEAE cellulose

    19-34

    Absorbance ratio (A 280/560)

    Greater than 50

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    (1)   Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

    (2)   Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

    E 150c AMMONIA CARAMEL



    Synonyms

     

    Definition

    Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used.

    Colour Index No

     

    Einecs

    232-435-9

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Dark brown to black liquids or solids

    Identification

     

    Purity

    Colour bound by DEAE cellulose

    Not more than 50 %

    Colour bound by phosphoryl cellulose

    More than 50 %

    Colour intensity (1)

    0,08-0,36

    Ammoniacal nitrogen

    Not more than 0,3 % (2)

    4-methylimidazole

    Not more than 200 mg/kg (2)

    2-acetyl-4-tetrahydroxy-butylimidazole

    Not more than 10 mg/kg (2)

    Total sulphur

    Not more than 0,2 % (2)

    Total nitrogen

    0,7-3,3 % (2)

    Absorbance ratio of colour bound by phosphoryl cellulose

    13-35

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    (1)   Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

    (2)   Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

    E 150d SULPHITE AMMONIA CARAMEL



    Synonyms

     

    Definition

    Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite).

    Colour Index No

     

    Einecs

    232-435-9

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Dark brown to black liquids or solids

    Identification

     

    Purity

    Colour bound by DEAE cellulose

    More than 50 %

    Colour intensity (1)

    0,10-0,60

    Ammoniacal nitrogen

    Not more than 0,6 % (2)

    Sulphur dioxide

    Not more than 0,2 % (2)

    4-methylimidazole

    Not more than 250 mg/kg (2)

    Total nitrogen

    0,3-1,7 % (2)

    Total sulphur

    0,8-2,5 % (2)

    Nitrogen/sulphur ratio of alcohol precipitate

    0,7-2,7

    Absorbance ratio of alcohol precipitate (3)

    8-14

    Absorbance ratio (A 280/560)

    Not more than 50

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    (1)   Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.

    (2)   Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.

    (3)   Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell).

    ▼M8

    E 151 BRILLIANT BLACK PN

    ▼B



    Synonyms

    CI Food Black 1

    ▼M8

    Definition

    Brilliant Black PN consists essentially of tetrasodium-4-acetamido-5- hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.

    Brilliant Black PN is described as the sodium salt.

    The calcium and the potassium salt are also permitted.

    ▼B

    Colour Index No

    28440

    Einecs

    219-746-5

    Chemical name

    Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate

    Chemical formula

    C28H17N5Na4O14S4

    Molecular weight

    867,69

    Assay

    Content not less than 80 % total colouring matters calculated as the sodium salt

    image

    530 at ca. 570 nm in solution

    Description

    Black powder or granules

    Appearance of the aqueous solution

    Black-bluish

    Identification

    Spectrometry

    Maximum in water at ca. 570 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 4 % (expressed on the dye content)

    Organic compounds other than colouring matters:

     

    4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid

    right accolade Total not more than 0,8 %

    4-amino-5-hydroxynaphthalene-1,7-disulfonic acid

    8-aminonaphthalene-2-sulfonic acid

    4,4′-diazoaminodi-(benzenesulfonic acid)

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % under neutral conditions

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 153 VEGETABLE CARBON



    Synonyms

    Vegetable black

    Definition

    Vegetable activated carbon is produced by the carbonisation of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The activated carbon thus produced is milled by a roller mill and the resulting highly activated powdered carbon is treated by a cyclone. The fine fractio40800n from the cyclone is purified by hydrochloric acid washing, neutralised and then dried. The resulting product is what is known traditionally as vegetable black. Products with a higher colouring power are produced from the fine fraction by a further cyclone treatment or by extra milling, followed by acid washing, neutralising and drying. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture.

    Colour Index No

    77266

    Einecs

    231-153-3

    Chemical name

    Carbon

    Chemical formula

    C

    Atomic weight

    12,01

    Assay

    Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis

    Loss on drying

    Not more than 12 % (120 °C 4 h)

    Description

    Black, odourless powder

    Identification

    Solubility

    Insoluble in water and organic solvents

    Burning

    When heated to redness it burns slowly without a flame

    Purity

    Ash (Total)

    Not more than 4,0 % (ignition temperature: 625 °C)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Polycyclic aromatic hydrocarbons

    Benzo(a)pyrene less than 50 μg/kg in the extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction.

    Alkali soluble matter

    The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless

    E 155 BROWN HT



    Synonyms

    CI Food Brown 3

    Definition

    Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulphate as the principal uncoloured components.

    Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted.

    Colour Index No

    20285

    Einecs

    224-924-0

    Chemical name

    Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)

    Chemical formula

    C27H18N4Na2O9S2

    Molecular weight

    652,57

    Assay

    Content not less than 70 % total colouring matters calculated as the sodium salt.

    image

    403 at ca. 460 nm in aqueous solution at pH 7

    Description

    Reddish-brown powder or granules

    Appearance of the aqueous solution

    Brown

    Identification

    Spectrometry

    Maximum in water of pH 7 at ca. 460 nm

    Purity

    Water insoluble matter

    Not more than 0,2 %

    Subsidiary colouring matters

    Not more than 10 % (TLC method)

    Organic compounds other than colouring matters:

     

    4-aminonaphthalene- 1-sulfonic acid

    Not more than 0,7 %

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (calculated as aniline)

    Ether extractable matter

    Not more than 0,2 % in a solution of pH 7

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 160 a (i) BETA-CAROTENE



    Synonyms

    CI Food Orange 5

    Definition

    These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios.

    Colour Index No

    40800

    Einecs

    230-636-6

    Chemical name

    Beta-carotene; beta, beta-carotene

    Chemical formula

    C40H56

    Molecular weight

    536,88

    Assay

    Not less than 96 % total colouring matters (expressed as beta-carotene)

    image

    2 500 at approximately by 440 nm to 457 nm in cyclohexane

    Description

    Red to brownish-red crystals or crystalline powder

    Identification

    Spectrometry

    Maximum in cyclohexane at 453 nm to 456 nm

    Purity

    Sulphated ash

    Not more than 0,1 %

    Subsidiary colouring matters

    Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters

    Lead

    Not more than 2 mg/kg

    E 160 a (ii) PLANT CAROTENES



    Synonyms

    CI Food Orange 5

    Definition

    Plant carotenes are obtained by solvent extraction of strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.

    The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.

    Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane (1), dichloromethane and carbon dioxide.

    Colour Index No

    75130

    Einecs

    230-636-6

    Chemical name

     

    Chemical formula

    Beta-carotene: C40H56

    Molecular weight

    Beta-carotene: 536,88

    Assay

    Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats

    image

    2 500 at approximately 440 nm to 457 nm in cyclohexane

    Description

     

    Identification

    Spectrometry

    Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm

    Purity

    Solvent residues

    Acetone

    right accolade Not more than 50 mg/kg, singly or in combination

    Methyl ethyl ketone

    Methanol

    Propan-2-ol

    Hexane

    Ethanol

    Dichloromethane

    Not more than 10 mg/kg

    Lead

    Not more than 2 mg/kg

    (1)   Benzene not more than 0,05 % v/v.

    E 160 a (iii) BETA-CAROTENE FROM Blakeslea trispora



    Synonyms

    CI Food Orange 5

    Definition

    Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of strains of the fungus Blakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate or isobutyl acetate followed by propan-2-ol and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product.

    Colour Index No

    40800

    Einecs

    230-636-6

    Chemical name

    Beta-carotene; beta, beta-carotene

    Chemical formula

    C40H56

    Molecular weight

    536,88

    Assay

    Not less than 96 % total colouring matters (expressed as beta-carotene)

    image

    2 500 at approximately 440 nm to 457 nm in cyclohexane

    Description

    Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)

    Identification

    Spectrometry

    Maximum in cyclohexane at 453 nm to 456 nm

    Purity

    Solvent residues

    Ethyl acetate

    right accolade Not more than 0,8 %, singly or in combination

    Ethanol

    Isobutyl acetate: Not more than 1,0 %

    Propan-2-ol: Not more than 0,1 %

    Sulphated ash

    Not more than 0,2 %

    Subsidiary colouring matters

    Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters

    Lead

    Not more than 2 mg/kg

    Microbiological criteria

    Moulds

    Not more than 100 colonies per gram

    Yeasts

    Not more than 100 colonies per gram

    Salmonella spp.

    Absent in 25 g

    Escherichia coli

    Absent in 5 g

    E 160 a (iv) ALGAL CAROTENES



    Synonyms

    CI Food Orange 5

    ▼M8

    Definition

    Mixed carotenes may also be produced from strains of the algae Dunaliella salina. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29.

    The main colouring principle consists of carotenoids of which beta- carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.

    ▼B

    Colour Index No

    75130

    Einecs

     

    Chemical name

     

    Chemical formula

    Beta-Carotene: C40H56

    Molecular weight

    Beta-Carotene: 536,88

    Assay

    Content of carotenes (calculated as beta-carotene) is not less than 20 %

    image

    2 500 at approximately by 440 nm to 457 nm in cyclohexane

    Description

     

    Identification

    Spectrometry

    Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm

    Purity

    Natural tocopherols in edible oil

    Not more than 0,3 %

    Lead

    Not more than 2 mg/kg

    E 160 b ANNATTO, BIXIN, NORBIXIN

    (i)   SOLVENT-EXTRACTED BIXIN AND NORBIXIN



    Synonyms

    CI Natural Orange 4

    Definition

    Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent.

    Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin.

    Bixin and norbixin may contain other materials extracted from the annatto seed.

    The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.

    The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present.

    Colour Index No

    75120

    Einecs

    Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7

    Chemical name

    Bixin: left accolade

    6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate

    6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate

    Norbixin: left accolade

    9′cis-6,6′-Diapocarotene-6,6′-dioic acid

    9′-trans-6,6′-Diapocarotene-6,6′-dioic acid

    Chemical formula

    Bixin:

    C25H30O4

    Norbixin:

    C24H28O4

    Molecular weight

    Bixin:

    394,51

    Norbixin:

    380,48

    Assay

    Content of bixin powders not less than 75 % total carotenoids calculated as bixin.

    Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin

    Bixin:

    image

    2 870 at ca. 502 nm in chloroform

    Norbixin:

    image

    2 870 at ca. 482 nm in KOH solution

    Description

    Reddish-brown powder, suspension or solution

    Identification

    Spectrometry

    Bixin:

    maximum in chloroform at ca. 502 nm

    Norbixin:

    maximum in dilute KOH solution at ca. 482 nm

    Purity

    Solvent residues

    Acetone

    right accolade not more than 50 mg/kg, singly or in combination

    Methanol

    Hexane

    Dichloromethane:

    not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    (ii)   ALKALI EXTRACTED ANNATTO



    Synonyms

    CI Natural Orange 4

    Definition

    Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellana L.)

    Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.

    Colour Index No

    75120

    Einecs

    Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7

    Chemical name

    Bixin: left accolade

    6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate

    6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate

    Norbixin: left accolade

    9′cis-6,6′-Diapocarotene-6,6′-dioic acid

    6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate

    Chemical formula

    Bixin:

    C25H30O4

    Norbixin:

    C24H28O4

    Molecular weight

    Bixin:

    394,51

    Norbixin:

    380,48

    Assay

    Contains not less than 0,1 % of total carotenoids expressed as norbixin

    Norbixin:

    image

    2 870 at ca. 482 nm in KOH solution

    Description

    Reddish-brown powder, suspension or solution

    Identification

    Spectrometry

    Bixin:

    maximum in chloroform at ca. 502 nm

    Norbixin:

    maximum in dilute KOH solution at ca. 482 nm

    Purity

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    (iii)   OIL EXTRACTED ANNATTO



    Synonyms

    CI Natural Orange 4

    Definition

    Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and trans-forms. Thermal degradation products of bixin may also be present.

    Colour Index No

    75120

    Einecs

    Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7

    Chemical name

    Bixin: left accolade

    6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate

    6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate

    Norbixin: left accolade

    9′cis-6,6′-Diapocarotene-6,6′-dioic acid

    9′-trans-6,6′-Diapocarotene-6,6′-dioic acid

    Chemical formula

    Bixin:

    C25H30O4

    Norbixin:

    C24H28O4

    Molecular weight

    Bixin:

    394,51

    Norbixin:

    380,48

    Assay

    Contains not less than 0,1 % of total carotenoids expressed as bixin

    Bixin:

    image

    2 870 at ca. 502 nm in chloroform

    Description

    Reddish-brown powder, suspension or solution

    Identification

    Spectrometry

    Bixin:

    maximum in chloroform at ca. 502 nm

    Norbixin:

    maximum in dilute KOH solution at ca. 482 nm

    Purity

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 160 c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN



    Synonyms

    Paprika Oleoresin

    Definition

    Paprika extract is obtained by solvent extraction of the strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.

    Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate, propan-2-ol and carbon dioxide.

    Colour Index No

     

    Einecs

    Capsanthin: 207-364-1, capsorubin: 207-425-2

    Chemical name

    Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,κ-carotene-6-one

    Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-κ,κ-carotene-6,6′-dione

    Chemical formula

    Capsanthin:

    C40H56O3

    Capsorubin:

    C40H56O4

    Molecular weight

    Capsanthin:

    584,85

    Capsorubin:

    600,85

    Assay

    Paprika extract: content not less than 7,0 % carotenoids

    Capsanthin/capsorubin: not less than 30 % of total carotenoids

    image

    2 100 at ca. 462 nm in acetone

    Description

    Dark-red viscous liquid

    Identification

    Spectrometry

    Maximum in acetone at ca. 462 nm

    Colour reaction

    A deep blue colour is produced by adding one drop of sulphuric acid to one drop of sample in 2-3 drops of chloroform

    Purity

    Solvent residues

    Ethyl acetate

    right accolade Not more than 50 mg/kg, singly or in combination

    Methanol

    Ethanol

    Acetone

    Hexane

    Propan-2-ol

    Dichloromethane:

    not more than 10 mg/kg

    Capsaicin

    Not more than 250 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 160 d LYCOPENE

    (i)   SYNTHETIC LYCOPENE



    Synonyms

    Lycopene from chemical synthesis

    Definition

    Synthetic lycopene is a mixture of geometric isomeres of lycopenes and is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists predominantly of all-trans-lycopene together with 5-cis-lycopene and minor quantities of other isomers. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder.

    Colour Index No

    75125

    Einecs

    207-949-1

    Chemical name

    ψ,ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene

    Chemical formula

    C40H56

    Molecular weight

    536,85

    Assay

    Not less than 96 % total lycopenes (not less than 70 % all-trans-lycopene)

    image at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450

    Description

    Red crystalline powder

    Identification

    Spectrophotometry

    A solution in hexane shows an absorption maximum at approximately 470 nm

    Test for carotenoids

    The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid

    Solubility

    Insoluble in water, freely soluble in chloroform

    Properties of 1 % solution in chloroform

    Is clear and has intensive red-orange colour

    Purity

    Loss on drying

    Not more than 0,5 % (40 °C, 4 h at 20 mm Hg)

    Apo-12’-lycopenal

    Not more than 0,15 %

    Triphenyl phosphine oxide

    Not more than 0,01 %

    Solvent residues

    Methanol not more than 200 mg/kg,

    Hexane, Propan-2-ol: Not more than 10 mg/kg each.

    Dichloromethane: Not more than 10 mg/kg (in commercial preparations only)

    Lead

    Not more than 1 mg/kg

    (ii)    LYCOPENE FROM RED TOMATOES



    Synonyms

    Natural Yellow 27

    Definition

    Lycopene is obtained by solvent extraction of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvent may be used: carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol and hexane. The major colouring principle of tomatoes is lycopene; minor amounts of other carotenoid pigments may be present. Besides the colour pigments the product may contain oil, fats, waxes and flavour components naturally occurring in tomatoes.

    Colour Index No

    75125

    Einecs

    207-949-1

    Chemical name

    Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene

    Chemical formula

    C40H56

    Molecular weight

    536,85

    Assay

    image at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450 .

    Content not less than 5 % total colouring matters

    Description

    Dark red viscous liquid

    Identification

    Spectrophotometry

    Maximum in hexane at ca. 472 nm

    Purity

    Solvent residues

    Propan-2-ol

    right accolade Not more than 50 mg/kg, singly or in combination

    Hexane

    Acetone

    Ethanol

    Methanol

    Ethylacetate

    Sulphated ash

    Not more than 1 %

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    (iii)   LYCOPENE FROM BLAKESLEA TRISPORA



    Synonyms

    Natural Yellow 27

    Definition

    Lycopene from Blakeslea trispora is extracted from the fungal biomass and purified by crystallisation and filtration. It consists predominantly of all-trans-lycopene. It also contains minor quantities of other carotenoids. Propan-2-ol and isobutyl acetate are the only solvents used in the manufacture. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder.

    Colour Index No

    75125

    Einecs

    207-949-1

    Chemical name

    Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, ((all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene

    Chemical formula

    C40H56

    Molecular weight

    536,85

    Assay

    Not less than 95 % total lycopenes and not less than 90 % all-trans-lycopene of all colouring matters

    image at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450

    Description

    Red crystalline powder

    Identification

    Spectrophotometry

    A solution in hexane shows an absorption maximum at approximately 470 nm

    Test of carotenoids

    The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid

    Solubility

    Insoluble in water, freely soluble in chloroform

    Properties of 1 % solution in chloroform

    Is clear and has intensive red-orange colour

    Purity

    Loss on drying

    Not more than 0,5 % (40 °C, 4 h at 20 mm Hg)

    Other carotenoids

    Not more than 5 %

    Solvent residues

    Propan-2-ol: not more than 0,1 %

    Isobutyl acetate: not more than 1,0 %

    Dichloromethane: not more than 10 mg/kg (in commercial preparations only)

    Sulphated ash

    Not more than 0,3 %

    Lead

    Not more than 1 mg/kg

    E 160 e BETA-APO-8′-CAROTENAL (C30)



    Synonyms

    CI Food Orange 6

    Definition

    These specifications apply predominantly to the all-trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

    Colour Index No

    40820

    Einecs

    214-171-6

    Chemical name

    β-Apo-8′-carotenal; trans-β-Apo-8′carotene-aldehyde

    Chemical formula

    C30H40O

    Molecular weight

    416,65

    Assay

    Not less than 96 % of total colouring matters

    image

    2 640 at 460-462 nm in cyclohexane

    Description

    Dark violet crystals with metallic lustre or crystalline powder

    Identification

    Spectrometry

    Maximum in cyclohexane at 460-462 nm

    Purity

    Sulphated ash

    Not more than 0,1 %

    Subsidiary colouring matters

    Carotenoids other than β-apo-8′-carotenal:

    not more than 3,0 % of total colouring matters

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 161 b LUTEIN



    Synonyms

    Mixed Carotenoids; Xanthophylls

    Definition

    Lutein is obtained by solvent extraction of the strains of edible fruits and plants, grass, lucerne (alfalfa) and Tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material.

    Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone and carbon dioxide

    Colour Index No

     

    Einecs

    204-840-0

    Chemical name

    3,3′-dihydroxy-d-carotene

    Chemical formula

    C40H56O2

    Molecular weight

    568,88

    Assay

    Content of total colouring matter not less than 4 % calculated as lutein

    image

    2 550 at ca. 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)

    Description

    Dark, yellowish brown liquid

    Identification

    Spectrometry

    Maximum in chloroform/ethanol (1:9) at ca. 445 nm

    Purity

    Solvent residues

    Acetone

    right accolade Not more than 50 mg/kg, singly or in combination

    Methyl ethyl ketone

    Methanol

    Ethanol

    Propan-2-ol

    Hexane

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 3 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 161g CANTHAXANTHIN



    Synonyms

    CI Food Orange 8

    Definition

    These specifications apply to predominantly all-trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.

    Colour Index No

    40850

    Einecs

    208-187-2

    Chemical name

    β-Carotene-4,4′-dione; canthaxanthin; 4,4′-dioxo-β-carotene

    Chemical formula

    C40H52O2

    Molecular weight

    564,86

    Assay

    Not less than 96 % of total colouring matters (expressed as canthaxanthin)

    image

    2 200
    left accolade

    at ca. 485 nm in chloroform

    at 468-472 nm in cyclohexane

    at 464-467 nm in petroleum ether

    Description

    Deep violet crystals or crystalline powder

    Identification

    Spectrometry

    Maximum in chloroform at ca. 485 nm

    Maximum in cyclohexane at 468-472 nm

    Maximum in petroleum ether at 464-467 nm

    Purity

    Sulphated ash

    Not more than 0,1 %

    Subsidiary colouring matters

    Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 162 BEETROOT RED, BETANIN



    Synonyms

    Beet Red

    Definition

    Beet red is obtained from the roots of strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present.

    Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins.

    Colour Index No

     

    Einecs

    231-628-5

    Chemical name

    (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate

    Chemical formula

    Betanin: C24H26N2O13

    Molecular weight

    550,48

    Assay

    Content of red colour (expressed as betanine) is not less than 0,4 %

    image

    1 120 at ca. 535 nm in aqueous solution at pH 5

    Description

    Red or dark red liquid, paste, powder or solid

    Identification

    Spectrometry

    Maximum in water of pH 5 at ca. 535 nm

    Purity

    Nitrate

    Not more than 2 g nitrate anion/g of red colour (as calculated from assay).

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 163 ANTHOCYANINS



    Synonyms

     

    Definition

    Anthocyanins are obtained by maceration or extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the strains of vegetables and edible fruits, with subsequent concentration and/or purification if necessary. The resulting product can be transformed into powder by an industrial drying process. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material. Ethanol may naturally be present as a result of the maceration process. The colouring principle is anthocyanin. Products are marketed according to their colour strength as determined by the assay. Colour content is not expressed using quantitative units.

    Colour Index No

     

    Einecs

    208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin); 215-849-4 (petunidin)

    Chemical name

    3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin)

    3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin)

    3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin)

    3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin)

    3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin)

    3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin)

    Chemical formula

    Cyanidin: C15H11O6Cl

    Peonidin: C16H13O6Cl

    Malvidin: C17H15O7Cl

    Delphinidin: C15H11O7Cl

    Petunidin: C16H13O7Cl

    Pelargonidin: C15H11O5Cl

    Molecular weight

    Cyanidin: 322,6

    Peonidin: 336,7

    Malvidin: 366,7

    Delphinidin: 340,6

    Petunidin: 352,7

    Pelargonidin: 306,7

    Assay

    image

    300 for the pure pigment at 515-535 nm at pH 3,0

    Description

    Purplish-red liquid, powder or paste, having a slight characteristic odour

    Identification

    Spectrometry

    Maximum in methanol with 0,01 % conc. HCl

    Cyanidin: 535 nm

    Peonidin: 532 nm

    Malvidin: 542 nm

    Delphinidin: 546 nm

    Petunidin: 543 nm

    Pelargonidin: 530 nm

    Purity

    Solvent residues

    Methanol

    Not more than 50 mg/kg

    Ethanol

    Not more than 200 mg/kg

    Sulfur dioxide

    Not more than 1 000  mg/kg per percent pigment

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 170 CALCIUM CARBONATE



    Synonyms

    CI Pigment White 18; Chalk

    Definition

    Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.

    Colour Index No

    77220

    Einecs

    Calcium carbonate: 207-439-9

    Limestone: 215-279-6

    Chemical name

    Calcium carbonate

    Chemical formula

    CaCO3

    Molecular weight

    100,1

    Assay

    Content not less than 98 % on the anhydrous basis

    Description

    White crystalline or amorphous, odourless and tasteless powder

    Identification

    Solubility

    Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.

    Purity

    Loss on drying

    Not more than 2,0 % (200 °C, 4 hours)

    Acid-insoluble substances

    Not more than 0,2 %

    Magnesium and alkali salts

    Not more than 1 %

    Fluoride

    Not more than 50 mg/kg

    Antimony (as Sb)

    right accolade Not more than 100 mg/kg, singly or in combination

    Copper (as Cu)

    Chromium (as Cr)

    Zinc (as Zn)

    Barium (as Ba)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 3 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 171 TITANIUM DIOXIDE



    Synonyms

    CI Pigment White 6

    Definition

    Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product.

    The anatase grades of pigmentary titanium dioxide can only be made by the sulphate process which creates a large amount of sulphuric acid as a by-product. The rutile grades of titanium dioxide are typically made by the chloride process.

    Certain rutile grades of titanium dioxide are produced using mica (also known as potassium aluminum silicate) as a template to form the basic platelet structure. The surface of the mica is coated with titanium dioxide using a specialised patented process.

    Rutile titanium dioxide, platelet form is manufactured by subjecting titanium dioxide (rutile) coated mica nacreous pigment to an extractive dissolution in acid followed by an extractive dissolution in alkali. All of the mica is removed during this process and the resulting product is a platelet form of rutile titanium dioxide.

    Colour Index No

    77891

    Einecs

    236-675-5

    Chemical name

    Titanium dioxide

    Chemical formula

    TiO2

    Molecular weight

    79,88

    Assay

    Content not less than 99 % on an alumina and silica-free basis

    Description

    White to slightly coloured powder

    Identification

    Solubility

    Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulphuric acid.

    Purity

    Loss on drying

    Not more than 0,5 % (105 °C, 3 hours)

    Loss on ignition

    Not more than 1,0 % on a volatile matter free basis (800 °C)

    Aluminium oxide and/or silicon dioxide

    Total not more than 2,0 %

    Matter soluble in 0,5 N HCl

    Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.

    Water soluble matter

    Not more than 0,5 %

    Cadmium

    Not more than 1 mg/kg after an extraction with 0,5 N HCl.

    Antimony

    Not more than 2 mg/kg after an extraction with 0,5 N HCl.

    Arsenic

    Not more than 1 mg/kg after an extraction with 0,5 N HCl.

    Lead

    Not more than 10 mg/kg after an extraction with 0,5 N HCl.

    Mercury

    Not more than 1 mg/kg after an extraction with 0,5 N HCl.

    E 172 IRON OXIDES AND IRON HYDROXIDES



    Synonyms

    Iron Oxide Yellow: CI Pigment Yellow 42 and 43

    Iron Oxide Red: CI Pigment Red 101 and 102

    Iron Oxide Black: CI Pigment Black 11

    Definition

    Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.

    Colour Index No

    Iron Oxide Yellow:

    77492

    Iron Oxide Red:

    77491

    Iron Oxide Black:

    77499

    Einecs

    Iron Oxide Yellow:

    257-098-5

    Iron Oxide Red:

    215-168-2

    Iron Oxide Black:

    235-442-5

    Chemical name

    Iron Oxide Yellow: hydrated ferric oxide, hydrated iron (III) oxide

    Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide

    Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide

    Chemical formula

    Iron Oxide Yellow:

    FeO(OH) · H2O

    Iron Oxide Red:

    Fe2O3

    Iron Oxide Black:

    FeO.Fe2O3

    Molecular weight

    88,85:

    FeO(OH)

    159,70:

    Fe2O3

    231,55:

    FeO.Fe2O3

    Assay

    Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron

    Description

    Powder; yellow, red, brown or black in hue

    Identification

    Solubility

    Insoluble in water and in organic solvents

    Soluble in concentrated mineral acids

    Purity

    Water soluble matter

    Not more than 1,0 %

    right accolade By total dissolution

    Arsenic

    Not more than 3 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Chromium

    Not more than 100 mg/kg

    Copper

    Not more than 50 mg/kg

    Lead

    Not more than 10 mg/kg

    Mercury

    Not more than 1 mg/kg

    Nickel

    Not more than 200 mg/kg

    Zinc

    Not more than 100 mg/kg

    E 173 ALUMINIUM



    Synonyms

    CI Pigment Metal

    Definition

    Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.

    Colour Index No

    77000

    Einecs

    231-072-3

    Chemical name

    Aluminium

    Chemical formula

    Al

    Atomic weight

    26,98

    Assay

    Not less than 99 % calculated as Al on an oil-free basis

    Description

    A silvery-grey powder or tiny sheets

    Identification

    Solubility

    Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid.

    Test for aluminium

    A sample dissolved in dilute hydrochloric acid passes test

    Purity

    Loss on drying

    Not more than 0,5 % (105 °C, to constant weight)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 10 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 174 SILVER



    Synonyms

    Argentum

    Definition

    Colour Index No

    77820

    Einecs

    231-131-3

    Chemical name

    Silver

    Chemical formula

    Ag

    Atomic weight

    107,87

    Assay

    Content not less than 99,5 % Ag

    Description

    Silver-coloured powder or tiny sheets

    Identification

     

    Purity

     

    E 175 GOLD



    Synonyms

    Pigment Metal 3; Aurum

    Definition

    Colour Index No

    77480

    Einecs

    231-165-9

    Chemical name

    Gold

    Chemical formula

    Au

    Atomic weight

    197,0

    Assay

    Content not less than 90 % Au

    Description

    Gold-coloured powder or tiny sheets

    Identification

     

    Purity

    Silver

    Not more than 7 %

    right accolade After complete dissolution

    Copper

    Not more than 4 %

    E 180 LITHOLRUBINE BK



    Synonyms

    CI Pigment Red 57; Rubinpigment; Carmine 6B

    Definition

    Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulphate as the principal uncoloured components.

    Colour Index No

    15850:1

    Einecs

    226-109-5

    Chemical name

    Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate

    Chemical formula

    C18H12CaN2O6S

    Molecular weight

    424,45

    Assay

    Content not less than 90 % total colouring matters

    image

    200 at ca. 442 nm in dimethylformamide

    Description

    Red powder

    Identification

    Spectrometry

    Maximum in dimethylformamide at ca. 442 nm

    Purity

    Subsidiary colouring matters

    Not more than 0,5 %

    Organic compounds other than colouring matters:

     

    2-Amino-5-methylbenzenesulfonic acid, calcium salt

    Not more than 0,2 %

    3-hydroxy-2-naphthalenecarboxylic acid, calcium salt

    Not more than 0,4 %

    Unsulfonated primary aromatic amines

    Not more than 0,01 % (expressed as aniline)

    Ether extractable matter

    From a solution of pH 7, not more than 0,2 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Aluminium lakes of this colour may be used.

    E 200 SORBIC ACID



    Synonyms

     

    Definition

    Einecs

    203-768-7

    Chemical name

    Sorbic acid; trans, trans-2,4-Hexadienoic acid

    Chemical formula

    C6H8O2

    Molecular weight

    112,12

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 °C

    Identification

    Melting range

    Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator

    Spectrometry

    A propan-2-ol solution (1 in 4 000 000 ) shows absorbance maximum at 254 ± 2 nm

    Test for double bonds

    Passes test

    Solubility

    Slightly soluble in water, soluble in ethanol.

    Purity

    Water content

    Not more than 0,5 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,2 %

    Aldehydes

    Not more than 0,1 % (as formaldehyde)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 202 POTASSIUM SORBATE



    Synonyms

     

    Definition

    Einecs

    246-376-1

    Chemical name

    Potassium sorbate; Potassium (E,E)-2,4-hexadienoate; Potassium salt of trans, trans 2,4-hexadienoic acid

    Chemical formula

    C6H7O2K

    Molecular weight

    150,22

    Assay

    Content not less than 99 % on the dried basis

    Description

    White crystalline powder showing no change in colour after heating for 90 minutes at 105 °C

    Identification

    Melting range for sorbic acid

    Melting range of sorbic acid isolated by acidification and not recrystallised 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator

    Test for potassium

    Passes test

    Test for double bonds

    Passes test

    Purity

    Loss on drying

    Not more than 1,0 % (105 °C, 3 hours)

    Acidity or alkalinity

    Not more than about 1,0 % (as sorbic acid or K2CO3)

    Aldehydes

    Not more than 0,1 %, calculated as formaldehyde

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 203 CALCIUM SORBATE



    Synonyms

     

    Definition

    Einecs

    231-321-6

    Chemical name

    Calcium sorbate; Calcium salts of trans, trans-2,4-hexadienoic acid

    Chemical formula

    C12H14O4Ca

    Molecular weight

    262,32

    Assay

    Content not less than 98 % on the dried basis

    Description

    Fine white crystalline powder not showing any change in colour after heating at 105 °C for 90 minutes

    Identification

    Melting range for sorbic acid

    Melting range of sorbic acid isolated by acidification and not recrystallised 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator

    Test for calcium

    Passes test

    Test for double bonds

    Passes test

    Purity

    Loss on drying

    Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator

    Aldehydes

    Not more than 0,1 % (as formaldehyde)

    Fluoride

    Not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 210 BENZOIC ACID



    Synonyms

     

    Definition

    Einecs

    200-618-2

    Chemical name

    Benzoic acid; Benzenecarboxylic acid; Phenylcarboxylic acid

    Chemical formula

    C7H6O2

    Molecular weight

    122,12

    Assay

    Content not less than 99,5 % on the anhydrous basis

    Description

    White crystalline powder

    Identification

    Melting range

    121,5 °C -123,5 °C

    Sublimation test

    Passes test

    Test for benzoate

    Passes test

    pH

    About 4 (solution in water)

    Purity

    Loss on drying

    Not more than 0,5 % (3 hours, over sulphuric acid)

    Sulphated ash

    Not more than 0,05 %

    Chlorinated organic compounds

    Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid

    Readily oxidisable substances

    Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

    Readily carbonisable substances

    A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (1), 0,3 ml of ferric chloride TSC (2), 0,1 ml of copper sulphate TSC (3) and 4,4 ml of water

    Polycyclic acids

    On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    (1)   Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml.

    (2)   Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS. 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml.

    (3)   Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (4). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml.

    (4)   Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.

    E 211 SODIUM BENZOATE



    Synonyms

     

    Definition

    Einecs

    208-534-8

    Chemical name

    Sodium benzoate; Sodium salt of benzenecarboxylic acid; Sodium salt of phenylcarboxylic acid

    Chemical formula

    C7H5O2Na

    Molecular weight

    144,11

    Assay

    Not less than 99 % of C7H5O2Na, after drying at 105 °C for four hours

    Description

    A white, almost odourless, crystalline powder or granules

    Identification

    Solubility

    Freely soluble in water, sparingly soluble in ethanol

    Melting range for benzoic acid

    Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator

    Test for benzoate

    Passes test

    Test for sodium

    Passes test

    Purity

    Loss on drying

    Not more than 1,5 % (105 °C, 4 hours)

    Readily oxidisable substances

    Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

    Polycyclic acids

    On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

    Chlorinated organic compounds

    Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid

    Acidity or alkalinity

    Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 212 POTASSIUM BENZOATE



    Synonyms

     

    Definition

    Einecs

    209-481-3

    Chemical name

    Potassium benzoate; Potassium salt of benzenecarboxylic acid; Potassium salt of phenylcarboxylic acid

    Chemical formula

    C7H5KO2·3H2O

    Molecular weight

    214,27

    Assay

    Content not less than 99 % C7H5KO2 after drying at 105 °C to constant weight

    Description

    White crystalline powder

    Identification

    Melting range for benzoic acid

    Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator

    Test for benzoate

    Passes test

    Test for potassium

    Passes test

    Purity

    Loss on drying

    Not more than 26,5 % (105 °C, 4 hours)

    Chlorinated organic compounds

    Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid

    Readily oxidisable substances

    Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

    Readily carbonisable substances

    A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

    Polycyclic acids

    On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

    Acidity or alkalinity

    Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 213 CALCIUM BENZOATE



    Synonyms

    Monocalcium benzoate

    Definition

    Einecs

    218-235-4

    Chemical name

    Calcium benzoate; Calcium dibenzoate

    Chemical formula

    Anhydrous:

    C14H10O4Ca

    Monohydrate:

    C14H10O4Ca·H2O

    Trihydrate:

    C14H10O4Ca·3H2O

    Molecular weight

    Anhydrous:

    282,31

    Monohydrate:

    300,32

    Trihydrate:

    336,36

    Assay

    Content not less than 99 % after drying at 105 °C

    Description

    White or colourless crystals, or white powder

    Identification

    Melting range for benzoic acid

    Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator

    Test for benzoate

    Passes test

    Test for calcium

    Passes test

    Purity

    Loss on drying

    Not more than 17,5 % (105 °C, to constant weight)

    Water insoluble matter

    Not more than 0,3 %

    Chlorinated organic compounds

    Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid

    Readily oxidisable substances

    Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required

    Readily carbonisable substances

    Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

    Polycyclic acids

    On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid

    Acidity or alkalinity

    Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl

    Fluoride

    Not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 214 ETHYL p-HYDROXYBENZOATE



    Synonyms

    Ethylparaben; Ethyl p-oxybenzoate

    Definition

    Einecs

    204-399-4

    Chemical name

    Ethyl-p-hydroxybenzoate; Ethyl ester of p-hydroxybenzoic acid

    Chemical formula

    C9H10O3

    Molecular weight

    166,8

    Assay

    Content not less than 99,5 % after drying for two hours at 80 °C

    Description

    Almost odourless, small, colourless crystals or a white, crystalline powder

    Identification

    Melting range

    115-118 °C

    Test for p-hydroxybenzoate

    Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator

    Test for alcohol

    Passes test

    Purity

    Loss on drying

    Not more than 0,5 % (80 °C, 2 hours)

    Sulphated ash

    Not more than 0,05 %

    p-Hydroxybenzoic acid and salicylic acid

    Not more than 0,35 % expressed as p-hydroxybenzoic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 215 SODIUM ETHYL p-HYDROXYBENZOATE



    Synonyms

     

    Definition

    Einecs

    252-487-6

    Chemical name

    Sodium ethyl p-hydroxybenzoate; Sodium compound of the ethyl ester of p-hydroxybenzoic acid

    Chemical formula

    C9H9O3Na

    Molecular weight

    188,8

    Assay

    Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis

    Description

    White, crystalline hygroscopic powder

    Identification

    Melting range

    115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator

    Test for p-hydroxybenzoate

    Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C

    Test for sodium

    Passes test

    pH

    9,9-10,3 (0,1 % aqueous solution)

    Purity

    Loss on drying

    Not more than 5 %, (by vacuum drying in a sulphuric acid desiccator)

    Sulphated ash

    37 to 39 %

    p-Hydroxybenzoic acid and salicylic acid

    Not more than 0,35 % expressed as p-hydroxybenzoic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 218 METHYL p-HYDROXYBENZOATE



    Synonyms

    Methylparaben; Methyl-p-oxybenzoate

    Definition

    Einecs

    243-171-5

    Chemical name

    Methyl p-hydroxybenzoate; Methyl ester of p-hydroxybenzoic acid

    Chemical formula

    C8H8O3

    Molecular weight

    152,15

    Assay

    Content not less than 99 % after drying for two hours at 80 °C

    Description

    Almost odourless, small colourless crystals or white crystalline powder

    Identification

    Melting range

    125 °C - 128 °C

    Test for p-hydroxybenzoate

    Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C

    Purity

    Loss on drying

    Not more than 0,5 % (80 °C, 2 hours)

    Sulphated ash

    Not more than 0,05 %

    p-Hydroxybenzoic acid and salicylic acid

    Not more than 0,35 % expressed as p-hydroxybenzoic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 219 SODIUM METHYL p-HYDROXYBENZOATE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Sodium methyl p-hydroxybenzoate; Sodium compound of the methylester of p-hydroxybenzoic acid

    Chemical formula

    C8H7O3Na

    Molecular weight

    174,15

    Assay

    Content not less than 99,5 % on the anhydrous basis

    Description

    White, hygroscopic powder

    Identification

    Melting range

    The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 °C for two hours, have a melting range of 125 °C to 128 °C

    Test for sodium

    Passes test

    pH

    9,7-10,3 (0,1 % solution in carbon dioxide free water)

    Purity

    Water content

    Not more than 5 % (Karl Fischer method)

    Sulphated ash

    40 % to 44,5 % on the anhydrous basis

    p-Hydroxybenzoic acid and salicylic acid

    Not more than 0,35 % expressed as p-hydroxybenzoic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 220 SULPHUR DIOXIDE



    Synonyms

     

    Definition

    Einecs

    231-195-2

    Chemical name

    Sulphur dioxide; Sulphurous acid anhydride

    Chemical formula

    SO2

    Molecular weight

    64,07

    Assay

    Content not less than 99 %

    Description

    Colourless, non-flammable gas with strong pungent suffocating odour

    Identification

    Test for sulphurous substances

    Passes test

    Purity

    Water content

    Not more than 0,05 % (Karl Fischer method)

    Non-volatile residue

    Not more than 0,01 %

    Sulphur trioxide

    Not more than 0,1 %

    Selenium

    Not more than 10 mg/kg

    Other gases not normally present in the air

    No trace

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 221 SODIUM SULPHITE



    Synonyms

     

    Definition

    Einecs

    231-821-4

    Chemical name

    Sodium sulphite (anhydrous or heptahydrate)

    Chemical formula

    Anhydrous:

    Na2SO3

    Heptahydrate:

    Na2SO37H2O

    Molecular weight

    Anhydrous:

    126,04

    Heptahydrate:

    252,16

    Assay

    Anhydrous:

    Not less than 95 % of Na2SO3 and not less than 48 % of SO2

    Heptahydrate:

    Not less than 48 % of Na2SO3 and not less than 24 % of SO2

    Description

    White crystalline powder or colourless crystals

    Identification

    Test for sulphite

    Passes test

    Test for sodium

    Passes test

    pH

    8,5-11,5 (anhydrous: 10 % solution; heptahydrate: 20 % solution)

    Purity

    Thiosulphate

    Not more than 0,1 % based on the SO2 content

    Iron

    Not more than 10 mg/kg based on the SO2 content

    Selenium

    Not more than 5 mg/kg based on the SO2 content

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼M3

    E 222 SODIUM HYDROGEN SULPHITE

    ▼B



    Synonyms

     

    Definition

    Einecs

    231-921-4

    Chemical name

    Sodium bisulphite; Sodium hydrogen sulphite

    Chemical formula

    NaHSO3 in aqueous solution

    Molecular weight

    104,06

    Assay

    Content not less than 32 % w/w NaHSO3

    Description

    A clear, colourless to yellow solution

    Identification

    Test for sulphite

    Passes test

    Test for sodium

    Passes test

    pH

    2,5-5,5 (10 % aqueous solution)

    Purity

    ▼M3

    Iron

    Not more than 10 mg/kg based on the SO2 content

    ▼B

    Selenium

    Not more than 5 mg/kg based on the SO2 content

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 223 SODIUM METABISULPHITE



    Synonyms

    Pyrosulphite; Sodium pyrosulphite

    Definition

    Einecs

    231-673-0

    Chemical name

    Sodium disulphite; Disodium pentaoxodisulphate

    Chemical formula

    Na2S2O5

    Molecular weight

    190,11

    Assay

    Content not less than 95 % Na2S2O5 and not less than 64 % of SO2

    Description

    White crystals or crystalline powder

    Identification

    Test for sulphite

    Passes test

    Test for sodium

    Passes test

    pH

    4,0-5,5 (10 % aqueous solution)

    Purity

    Thiosulphate

    Not more than 0,1 % based on the SO2 content

    Iron

    Not more than 10 mg/kg based on the SO2 content

    Selenium

    Not more than 5 mg/kg based on the SO2 content

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 224 POTASSIUM METABISULPHITE



    Synonyms

    Potassium pyrosulphite

    Definition

    Einecs

    240-795-3

    Chemical name

    Potassium disulphite; Potassium pentaoxo disulphate

    Chemical formula

    K2S2O5

    Molecular weight

    222,33

    Assay

    Content not less than 90 % K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate

    Description

    Colourless crystals or white crystalline powder

    Identification

    Test for sulphite

    Passes test

    Test for potassium

    Passes test

    Purity

    Thiosulphate

    Not more than 0,1 % based on the SO2 content

    Iron

    Not more than 10 mg/kg based on the SO2 content

    Selenium

    Not more than 5 mg/kg based on the SO2 content

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 226 CALCIUM SULPHITE



    Synonyms

     

    Definition

    Einecs

    218-235-4

    Chemical name

    Calcium sulphite

    Chemical formula

    CaSO3·2H2O

    Molecular weight

    156,17

    Assay

    Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2

    Description

    White crystals or white crystalline powder

    Identification

    Test for sulphite

    Passes test

    Test for calcium

    Passes test

    Purity

    Iron

    Not more than 10 mg/kg based on the SO2 content

    Selenium

    Not more than 5 mg/kg based on the SO2 content

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼M8

    E 227 CALCIUM HYDROGEN SULPHITE

    ▼B



    Synonyms

     

    Definition

    Einecs

    237-423-7

    Chemical name

    Calcium bisulphite; Calcium hydrogen sulphite

    Chemical formula

    Ca(HSO3)2

    Molecular weight

    202,22

    Assay

    6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]

    Description

    Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide

    Identification

    Test for sulphite

    Passes test

    Test for calcium

    Passes test

    Purity

    Iron

    Not more than 10 mg/kg based on the SO2 content

    Selenium

    Not more than 5 mg/kg based on the SO2 content

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼M8

    E 228 POTASSIUM HYDROGEN SULPHITE

    ▼B



    Synonyms

     

    Definition

    Einecs

    231-870-1

    Chemical name

    Potassium bisulphite; Potassium hydrogen sulphite

    Chemical formula

    KHSO3 in aqueous solution

    Molecular weight

    120,17

    Assay

    Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)

    Description

    Clear colourless aqueous solution

    Identification

    Test for sulphite

    Passes test

    Test for potassium

    Passes test

    Purity

    Iron

    Not more than 10 mg/kg based on the SO2 content

    Selenium

    Not more than 5 mg/kg based on the SO2 content

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 234 NISIN



    Synonyms

     

    Definition

    Nisin consists of several closely related polypeptides produced by strains of Lactococcus lactis subsp. lactis

    Einecs

    215-807-5

    Chemical name

     

    Chemical formula

    C143H230N42O37S7

    Molecular weight

    3 354,12

    Assay

    Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %

    Description

    White powder

    Identification

     

    Purity

    Loss on drying

    Not more than 3 % (102 °C to 103 °C, to constant weight)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 235 NATAMYCIN



    Synonyms

    Pimaricin

    Definition

    Natamycin is a fungicide of the polyene macrolide group, and is produced by strains of Streptomyces natalensis and other relevant species

    Einecs

    231-683-5

    Chemical name

    A stereoisomer of 22-(3-Amino-3,6-dideoxy-β-D- mannopyranosyloxy)-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25-carboxylic acid.

    Chemical formula

    C33H47O13N

    Molecular weight

    665,74

    Assay

    Content not less than 95 % on the dried basis

    Description

    White to creamy-white crystalline powder

    Identification

    Colour reactions

    On adding a few crystals of natamycin on a spot plate, to a drop of:

    concentrated hydrochloric acid, a blue colour develops,

    concentrated phosphoric acid, a green colour develops,which changes into pale red after a few minutes

    Spectrometry

    A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm

    pH

    5,5-7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)

    Specific rotation

    [α]D 20 + 250° to + 295° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material)

    Purity

    Loss on drying

    Not more than 8 % (over P2O5, in vacuum at 60 °C to constant weight)

    Sulphated ash

    Not more than 0,5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 100 colonies per gram

    E 239 HEXAMETHYLENE TETRAMINE



    Synonyms

    Hexamine; Methenamine

    Definition

    Einecs

    202-905-8

    Chemical name

    1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine

    Chemical formula

    C6H12N4

    Molecular weight

    140,19

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Colourless or white crystalline powder

    Identification

    Test for formaldehyde

    Passes test

    Test for ammonia

    Passes test

    Sublimation point:

    Approximately 260 °C

    Purity

    Loss on drying

    Not more than 0,5 % (at 105 °C in vacuum over P2O5 for 2 hours)

    Sulphated ash

    Not more than 0,05 %

    Sulphates

    Not more than 0,005 % expressed as SO4

    Chlorides

    Not more than 0,005 % expressed as Cl

    Ammonium salts

    Not detectable

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 242 DIMETHYL DICARBONATE



    Synonyms

    DMDC; Dimethyl pyrocarbonate

    Definition

    Einecs

    224-859-8

    Chemical name

    Dimethyl dicarbonate; Pyrocarbonic acid dimethyl ester

    Chemical formula

    C4H6O5

    Molecular weight

    134,09

    Assay

    Content not less than 99,8 %

    Description

    Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion

    Identification

    Decomposition

    After dilution positive tests for CO2 and methanol

    Melting point

    17 °C

    Boiling point

    172 °C with decomposition

    Density 20 °C

    Approximately 1,25 g/cm3

    Infrared absorption spectrum

    Maxima at 1 156 and 1 832  cm-1

    Purity

    Dimethyl carbonate

    Not more than 0,2 %

    Chlorine, total

    Not more than 3 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼M12

    E 243 ETHYL LAUROYL ARGINATE



    Synonyms

    Lauric arginate ethyl ester; lauramide arginine ethyl ester; ethyl-Να-lauroyl-L-arginate·HCl; LAE;

    ▼M19

    Definition

    Ethyl lauroyl arginate is synthesized by esterifying arginine with ethanol, followed by reacting the ester with lauroyl chloride, in aqueous media at a controlled temperature between 10 and 15 °C and at a pH between 6,7 and 6,9. The resultant ethyl lauroyl arginate is recovered as the hydrochloride salt, which is filtered and dried.

    ▼M12

    ELINCS

    434-630-6

    Chemical name

    Ethyl-Να-dodecanoyl-L-arginate·HCl

    Chemical formula

    C20H41N4O3Cl

    Molecular Weight

    421,02

    Assay

    Not less than 85 % and not more than 95 %

    Description

    White powder

    Identification

     

    Solubility

    Freely soluble in water, ethanol, propylene glycol and glycerol

    Purity

     

    Να-Lauroyl-L-arginine

    Not more than 3 %

    Lauric acid

    Not more than 5 %

    Ethyl laurate

    Not more than 3 %

    L-Arginine·HCl

    Not more than 1 %

    Ethyl arginate·2HCl

    Not more than 1 %

    Lead

    Not more than 1 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼B

    E 249 POTASSIUM NITRITE



    Synonyms

     

    Definition

    Einecs

    231-832-4

    Chemical name

    Potassium nitrite

    Chemical formula

    KNO2

    Molecular weight

    85,11

    Assay

    Content not less than 95 % on the anhydrous basis (1)

    Description

    White or slightly yellow, deliquescent granules

    Identification

    Test for nitrite

    Passes test

    Test for potassium

    Passes test

    pH

    6,0-9,0 (5 % solution)

    Purity

    Loss on drying

    Not more than 3 % (4 hours, over silica gel)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    (1)   May only be sold in a mixture with salt or a salt substitute.

    E 250 SODIUM NITRITE



    Synonyms

     

    Definition

    Einecs

    231-555-9

    Chemical name

    Sodium nitrite

    Chemical formula

    NaNO2

    Molecular weight

    69,00

    Assay

    Content not less than 97 % on the anhydrous basis (1)

    Description

    White crystalline powder or yellowish lumps

    Identification

    Test for nitrite

    Passes test

    Test for sodium

    Passes test

    Purity

    Loss on drying

    Not more than 0,25 % (4 hours, over silica gel)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    (1)   May only be sold in a mixture with salt or a salt substitute.

    E 251 SODIUM NITRATE

    (i)   SOLID SODIUM NITRATE



    Synonyms

    Chile saltpetre; Cubic or soda nitre

    Definition

    Einecs

    231-554-3

    Chemical name

    Sodium nitrate

    Chemical formula

    NaNO3

    Molecular weight

    85,00

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    White crystalline, slightly hygroscopic powder

    Identification

    Test for nitrate

    Passes test

    Test for sodium

    Passes test

    pH

    5,5-8,3 (5 % solution)

    Purity

    Loss on drying

    Not more than 2 % (105 °C, 4 hours)

    Nitrites

    Not more than 30 mg/kg expressed as NaNO2

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    (ii)   LIQUID SODIUM NITRATE



    Synonyms

     

    Definition

    Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.

    Einecs

    231-554-3

    Chemical name

    Sodium nitrate

    Chemical formula

    NaNO3

    Molecular weight

    85,00

    Assay

    Content between 33,5 % and 40,0 % of NaNO3

    Description

    Clear colourless liquid

    Identification

    Test for nitrate

    Passes test

    Test for sodium

    Passes test

    pH

    1,5-3,5

    Purity

    Free nitric acid

    Not more than 0,01 %

    Nitrites

    Not more than 10 mg/kg expressed as NaNO2

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 0,3 mg/kg

    This specification refers to a 35 % aqueous solution.

    E 252 POTASSIUM NITRATE



    Synonyms

    Chile saltpetre; Cubic or soda nitre

    Definition

    Einecs

    231-818-8

    Chemical name

    Potassium nitrate

    Chemical formula

    KNO3

    Molecular weight

    101,11

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    White crystalline powder or transparent prisms having a cooling, saline, pungent taste

    Identification

    Test for nitrate

    Passes test

    Test for potassium

    Passes test

    pH

    4,5-8,5 (5 % solution)

    Purity

    Loss on drying

    Not more than 1 % (105 °C, 4 hours)

    Nitrites

    Not more than 20 mg/kg expressed as KNO2

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 260 ACETIC ACID



    Synonyms

     

    Definition

    Einecs

    200-580-7

    Chemical name

    Acetic acid; Ethanoic acid

    Chemical formula

    C2H4O2

    Molecular weight

    60,05

    Assay

    Content not less than 99,8 %

    Description

    Clear, colourless liquid having a pungent, characteristic odour

    Identification

    Boiling point

    118 °C at 760 mm pressure (of mercury)

    Specific gravity

    About 1,049

    Test for acetate

    A one in three solution gives positive tests for acetate

    Solidification point

    Not lower than 14,5 °C

    Purity

    Non-volatile residue

    Not more than 100 mg/kg

    Formic acid, formates and other oxidisable substances

    Not more than 1 000  mg/kg expressed as formic acid

    Readily oxidisable substances

    Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 0,5 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼M2

    E 261 (i) POTASSIUM ACETATE

    ▼B



    Synonyms

     

    Definition

    Einecs

    204-822-2

    Chemical name

    Potassium acetate

    Chemical formula

    C2H3O2K

    Molecular weight

    98,14

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour

    Identification

    pH

    7,5-9,0 (5 % aqueous solution)

    Test for acetate

    Passes test

    Test for potassium

    Passes test

    Purity

    Loss on drying

    Not more than 8 % (150 °C, 2 hours)

    Formic acid, formates and other oxidisable substances

    Not more than 1 000  mg/kg expressed as formic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼M2

    E 261 (ii) POTASSIUM DIACETATE



    Synonyms

     

    Definition

    Potassium diacetate is a molecular compound of potassium acetate and acetic acid

    Einecs

    224-217-7

    Chemical name

    Potassium hydrogen diacetate

    Chemical formula

    C4H7KO4

    Molecular weight

    158,2

    Assay

    Content 36 to 38 % of free acetic acid and 61 to 64 % of potassium acetate

    Description

    White crystals

    Identification

    pH

    4,5-5 (10 % aqueous solution)

    Test for acetate

    Passes test

    Test for potassium

    Passes test

    Purity

    Water content

    Not more than 1 % (Karl Fischer method)

    Formic acid, formates and other oxidisable substances

    Not more than 1 000  mg/kg expressed as formic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼B

    E 262 (i) SODIUM ACETATE



    Synonyms

     

    Definition

    Einecs

    204-823-8

    Chemical name

    Sodium acetate

    Chemical formula

    C2H3NaO2·nH2O (n = 0 or 3)

    Molecular weight

    Anhydrous:

    82,03

    Trihydrate:

    136,08

    Assay

    Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis

    Description

    Anhydrous:

    White, odourless, granular, hygroscopic powder

    Trihydrate:

    Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air

    Identification

    pH

    8,0-9,5 (1 % aqueous solution)

    Test for acetate

    Passes test

    Test for sodium

    Passes test

    Purity

    Loss on drying

    Anhydrous:

    Not more than 2 % (120 °C, 4 hours)

    Trihydrate:

    Between 36 and 42 % (120 °C, 4 hours)

    Formic acid, formates and other oxidisable substances

    Not more than 1 000  mg/kg expressed as formic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 262 (ii) SODIUM DIACETATE



    Synonyms

     

    Definition

    Sodium diacetate is a molecular compound of sodium acetate and acetic acid

    Einecs

    204-814-9

    Chemical name

    Sodium hydrogen diacetate

    Chemical formula

    C4H7NaO4·nH2O (n = 0 or 3)

    Molecular weight

    142,09 (anhydrous)

    Assay

    Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate

    Description

    White, hygroscopic crystalline solid with an acetic odour

    Identification

    pH

    4,5-5,0 (10 % aqueous solution)

    Test for acetate

    Passes test

    Test for sodium

    Passes test

    Purity

    Water content

    Not more than 2 % (Karl Fischer method)

    Formic acid, formates and other oxidisable substances

    Not more than 1 000  mg/kg expressed as formic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 263 CALCIUM ACETATE



    Synonyms

     

    Definition

    Einecs

    200-540-9

    Chemical name

    Calcium acetate

    Chemical formula

    Anhydrous:

    C4H6O4Ca

    Monohydrate:

    C4H6O4Ca·H2O

    Molecular weight

    Anhydrous:

    158,17

    Monohydrate:

    176,18

    Assay

    Content not less than 98 % on the anhydrous basis

    Description

    Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder

    Identification

    pH

    6,0-9,0 (10 % aqueous solution)

    Test for acetate

    Passes test

    Test for calcium

    Passes test

    Purity

    Loss on drying

    Not more than 11 % (155 °C to constant weight, for the monohydrate)

    Water insoluble matter

    Not more than 0,3 %

    Formic acid, formates and other oxidisable substances

    Not more than 1 000  mg/kg expressed as formic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 270 LACTIC ACID



    Synonyms

     

    Definition

    Consists of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically.

    Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyses to lactic acid.

    Einecs

    200-018-0

    Chemical name

    Lactic acid; 2-Hydroxypropionic acid; 1-Hydroxyethane-1-carboxylic acid

    Chemical formula

    C3H6O3

    Molecular weight

    90,08

    Assay

    Content not less than 76 %

    Description

    Colourless or yellowish, nearly odourless, syrupy liquid to solid

    Identification

    Test for lactate

    Passes test

    Purity

    Sulphated ash

    Not more than 0,1 %

    Chloride

    Not more than 0,2 %

    Sulphate

    Not more than 0,25 %

    Iron

    Not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Note: This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content

    E 280 PROPIONIC ACID



    Synonyms

     

    Definition

    Einecs

    201-176-3

    Chemical name

    Propionic acid; Propanoic acid

    Chemical formula

    C3H6O2

    Molecular weight

    74,08

    Assay

    Content not less than 99,5 %

    Description

    Colourless or slightly yellowish, oily liquid with a slightly pungent odour

    Identification

    Melting point

    – 22 °C

    Distillation range

    138,5 °C to 142,5 °C

    Purity

    Non-volatile residue

    Not more than 0,01 % when dried at 140 °C to constant weight

    Aldehydes

    Not more than 0,1 % expressed as formaldehyde

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 281 SODIUM PROPIONATE



    Synonyms

     

    Definition

    Einecs

    205-290-4

    Chemical name

    Sodium propionate; Sodium propanoate

    Chemical formula

    C3H5O2Na

    Molecular weight

    96,06

    Assay

    Content not less than 99 % after drying for two hours at 105 °C

    Description

    White crystalline hygroscopic powder, or a fine white powder

    Identification

    Test for propionate

    Passes test

    Test for sodium

    Passes test

    pH

    7,5-10,5 (10 % aqueous solution)

    Purity

    Loss on drying

    Not more than 4 % (105 °C, 2 hours)

    Water insoluble matter

    Not more than 0,1 %

    Iron

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 282 CALCIUM PROPIONATE



    Synonyms

     

    Definition

    Einecs

    223-795-8

    Chemical name

    Calcium propionate

    Chemical formula

    C6H10O4Ca

    Molecular weight

    186,22

    Assay

    Content not less than 99 %, after drying for two hours at 105 °C

    Description

    White crystalline powder

    Identification

    Test for propionate

    Passes test

    Test for calcium

    Passes test

    pH

    6,0-9,0 (10 % aqueous solution)

    Purity

    Loss on drying

    Not more than 4 % (105 °C, 2 hours)

    Water insoluble matter

    Not more than 0,3 %

    Iron

    Not more than 50 mg/kg

    ▼M16

    Fluoride

    Not more than 20 mg/kg

    ▼B

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 283 POTASSIUM PROPIONATE



    Synonyms

     

    Definition

    Einecs

    206-323-5

    Chemical name

    Potassium propionate; Potassium propanoate

    Chemical formula

    C3H5KO2

    Molecular weight

    112,17

    Assay

    Content not less than 99 % after drying for two hours at 105 °C

    Description

    White crystalline powder

    Identification

    Test for propionate

    Passes test

    Test for potassium

    Passes test

    Purity

    Loss on drying

    Not more than 4 % (105 °C, 2 hours)

    Water insoluble matter

    Not more than 0,1 %

    Iron

    Not more than 30 mg/kg

    Fluoride

    Not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 284 BORIC ACID



    Synonyms

    Boracic acid; Orthoboric acid; Borofax

    Definition

    Einecs

    233-139-2

    Chemical name

     

    Chemical formula

    H3BO3

    Molecular weight

    61,84

    Assay

    Content not less than 99,5 %

    Description

    Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite

    Identification

    Melting point

    At approximately 171 °C

    Burning test

    Burns with a nice green flame

    pH

    3,8-4,8 (3,3 % aqueous solution)

    Purity

    Peroxides

    No colour develops with added KI-solution

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 285 SODIUM TETRABORATE (BORAX)



    Synonyms

    Sodium borate

    Definition

    Einecs

    215-540-4

    Chemical name

    Sodium tetraborate; Sodium biborate; Sodium pyroborate; Anhydrous tetraborate

    Chemical formula

    Na2B4O7

    Na2B4O7·10H2O

    Molecular weight

    201,27

    Assay

     

    Description

    Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water

    Identification

    Melting range

    Between 171 °C and 175 °C with decomposition

    Purity

    Peroxides

    No colour develops with added KI-solution

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 290 CARBON DIOXIDE



    Synonyms

    Carbonic acid gas; Dry ice (solid form); Carbonic anhydride

    Definition

    Einecs

    204-696-9

    Chemical name

    Carbon dioxide

    Chemical formula

    CO2

    Molecular weight

    44,01

    Assay

    Content not less than 99 % v/v on the gaseous basis

    Description

    A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders

    Identification

    Precipitate formation

    When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid

    Purity

    Acidity

    915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)

    Reducing substances, hydrogen phosphide and sulphide

    915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution

    Carbon monoxide

    Not more than 10 μl/l

    Oil content

    Not more than 5 mg/kg

    E 296 MALIC ACID



    Synonyms

    Pomalous acid

    Definition

    Einecs

    230-022-8, 210-514-9, 202-601-5

    Chemical name

    hydroxybutanedioic acid; hydroxysuccinic acid

    Chemical formula

    C4H6O5

    Molecular weight

    134,09

    Assay

    Content not less than 99,0 %

    Description

    White or nearly white crystalline powder or granules

    Identification

    Melting range

    127-132 °C

    Test for malate

    Passes test

    Purity

    Sulphated ash

    Not more than 0,1 %

    Fumaric acid

    Not more than 1,0 %

    Maleic acid

    Not more than 0,05 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 297 FUMARIC ACID



    Synonyms

     

    Definition

    Einecs

    203-743-0

    Chemical name

    trans-Butenedioic acid; trans-1,2-Ethylene-dicarboxylic acid

    Chemical formula

    C4H4O4

    Molecular weight

    116,07

    Assay

    Content not less than 99,0 % on the anhydrous basis

    Description

    White crystalline powder or granules

    Identification

    Melting range

    286-302 °C (closed capillary, rapid heating)

    Test for double bonds

    Passes test

    Test for 1,2-dicarboxylic acid

    Passes test

    pH

    3,0-3,2 (0,05 % solution at 25 °C)

    Purity

    Loss on drying

    Not more than 0,5 % (120 °C, 4 hours)

    Sulphated ash

    Not more than 0,1 %

    Maleic acid

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 300 ASCORBIC ACID, L-ASCORBIC ACID



    Synonyms

    L-xylo-Ascorbic acid; L(+)- Ascorbic acid

    Definition

    Einecs

    200-066-2

    Chemical name

    L-ascorbic acid; Ascorbic acid; 2,3-Didehydro-L-threo-hexono-1,4-lactone; 3-Keto-L-gulofuranolactone

    Chemical formula

    C6H8O6

    Molecular weight

    176,13

    Assay

    contains not less than 99 % of C6H8O6 after drying in a vacuum desiccator over sulphuric acid for 24 hours,

    Description

    White to pale yellow, odourless crystalline powder

    Melting range

    Between 189 °C and 193 °C with decomposition

    Identification

    Test for ascorbic acid

    Passes test

    pH

    Between 2,4 and 2,8 (2 % aqueous solution)

    Specific rotation

    [α]D 20 between + 20,5° and + 21,5° (10 % w/v aqueous solution)

    Purity

    Loss on drying

    Not more than 0,4 % (in vacuum over sulphuric acid, 24 hours)

    Sulphated ash

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 301 SODIUM ASCORBATE



    Synonyms

    Sodium L-ascorbate; L-Ascorbic acid monosodium salt

    Definition

    Einecs

    205-126-1

    Chemical name

    Sodium ascorbate; Sodium L-ascorbate; 2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate; 3-Keto-L-gulofurano-lactone sodium enolate

    Chemical formula

    C6H7O6Na

    Molecular weight

    198,11

    Assay

    Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na

    Description

    White or almost white, odourless crystalline powder which darkens on exposure to light

    Identification

    Test for ascorbate

    Passes test

    Test for sodium

    Passes test

    pH

    Between 6,5 and 8,0 (10 % aqueous solution)

    Specific rotation

    [α]D 20 between + 103° and + 106° (10 % w/v aqueous solution)

    Purity

    Loss on drying

    Not more than 0,25 % (in vacuum over sulphuric acid, 24 hours)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 302 CALCIUM ASCORBATE



    Synonyms

    Calcium ascorbate dihydrate

    Definition

    Einecs

    227-261-5

    Chemical name

    Calcium ascorbate dihydrate; Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate

    Chemical formula

    C12H14O12Ca·2H2O

    Molecular weight

    426,35

    Assay

    Content not less than 98 % on a volatile matter-free basis

    Description

    White to slightly pale greyish-yellow odourless crystalline powder

    Identification

    Test for ascorbate

    Passes test

    Test for calcium

    Passes test

    pH

    Between 6,0 and 7,5 (10 % aqueous solution)

    Specific rotation

    [α]D 20 between + 95° and + 97° (5 % w/v aqueous solution)

    Purity

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Volatile matter

    Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 304 (i) ASCORBYL PALMITATE



    Synonyms

    L-ascorbyl palmitate

    Definition

    Einecs

    205-305-4

    Chemical name

    Ascorbyl palmitate; L-ascorbyl palmitate; 2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate; 6-palmitoyl-3-keto-L-gulofuranolactone

    Chemical formula

    C22H38O7

    Molecular weight

    414,55

    Assay

    Content not less than 98 % on the dried basis

    Description

    White or yellowish-white powder with a citrus-like odour

    Identification

    Melting range

    Between 107 °C and 117 °C

    Specific rotation

    [α]D 20 between + 21° and + 24° (5 % w/v in methanol solution)

    Purity

    Loss on drying

    Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)

    Sulphated ash

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 304 (ii) ASCORBYL STEARATE



    Synonyms

     

    Definition

    Einecs

    246-944-9

    Chemical name

    Ascorbyl stearate; L-ascorbyl stearate; 2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate; 6-stearoyl-3-keto-L-gulofuranolactone

    Chemical formula

    C24H42O7

    Molecular weight

    442,6

    Assay

    Content not less than 98 %

    Description

    White or yellowish, white powder with a citrus-like odour

    Identification

    Melting point

    About 116 °C

    Purity

    Loss on drying

    Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)

    Sulphated ash

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 306 TOCOPHEROL-RICH EXTRACT



    Synonyms

     

    Definition

    Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols

    Contains tocopherols such as d-α-, d-β-, d-γ- and d-δ-tocopherols

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

    430,71 (d-α-tocopherol)

    Assay

    Content not less than 34 % of total tocopherols

    Description

    Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form

    Identification

    By suitable gas liquid chromatographic method

     

    Specific rotation

    [α]D 20 not less than + 20°

    Solubility

    Insoluble in water. Soluble in ethanol. Miscible in ether

    Purity

    Sulphated ash

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 307 ALPHA-TOCOPHEROL



    Synonyms

    dl-α-Tocopherol; (all rac)-α-Tocopherol

    Definition

    Einecs

    233-466-0

    Chemical name

    DL-5,7,8-Trimethyltocol; DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

    Chemical formula

    C29H50O2

    Molecular weight

    430,71

    Assay

    Content not less than 96 %

    Description

    Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light

    Identification

    Solubility

    Insoluble in water, freely soluble in ethanol, miscible in ether

    Spectrophotometry

    In absolute ethanol the maximum absorption is about 292 nm

    Specific rotation

    [α]D 25 0° ± 0,05° (1 in 10 solution in chloroform)

    Purity

    Refractive index

    [n]D 20 1,503-1,507

    Specific absorption in ethanol

    image

    (292 nm) 71-76

    (0,01 g in 200 ml of absolute ethanol)

    Sulphated ash

    Not more than 0,1 %

    Lead

    Not more than 2 mg/kg

    E 308 GAMMA-TOCOPHEROL



    Synonyms

    dl-γ-Tocopherol

    Definition

    Einecs

    231-523-4

    Chemical name

    2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

    Chemical formula

    C28H48O2

    Molecular weight

    416,69

    Assay

    Content not less than 97 %

    Description

    Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light

    Identification

    Spectrometry

    Maximum absorptions in absolute ethanol at about 298 nm and 257 nm

    Purity

    Specific absorption in ethanol

    image

    (298 nm) between 91 and 97

    image

    (257 nm) between 5,0 and 8,0

    Refractive index

    [n]D 20 1,503-1,507

    Sulphated ash

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 309 DELTA-TOCOPHEROL



    Synonyms

     

    Definition

    Einecs

    204-299-0

    Chemical name

    2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

    Chemical formula

    C27H46O2

    Molecular weight

    402,7

    Assay

    Content not less than 97 %

    Description

    Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light

    Identification

    Spectrometry

    Maximum absorptions in absolute ethanol at about 298 nm and 257 nm

    Purity

    Specific absorption

    image

    in ethanol

    image

    (298 nm) between 89 and 95

    image

    (257 nm) between 3,0 and 6,0

    Refractive index

    [n]D 20 1,500-1,504

    Sulphated ash

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 310 PROPYL GALLATE



    Synonyms

     

    Definition

    Einecs

    204-498-2

    Chemical name

    Propyl gallate; Propyl ester of gallic acid; n-propyl ester of 3,4,5-trihydroxybenzoic acid

    Chemical formula

    C10H12O5

    Molecular weight

    212,20

    Assay

    Content not less than 98 % on the anhydrous basis

    Description

    White to creamy-white, crystalline, odourless solid

    Identification

    Solubility

    Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol

    Melting range

    Between 146 °C and 150 °C after drying at 110 °C for four hours

    Purity

    Loss on drying

    Not more than 0,5 % (110 °C, 4 hours)

    Sulphated ash

    Not more than 0,1 %

    Free acid

    Not more than 0,5 % (as gallic acid)

    Chlorinated organic compound

    Not more than 100 mg/kg (as C1)

    Specific absorption in ethanol

    image

    (275 nm) not less than 485 and not more than 520

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 311 OCTYL GALLATE



    Synonyms

     

    Definition

    Einecs

    213-853-0

    Chemical name

    Octyl gallate; Octyl ester of gallic acid; n-octyl ester of 3,4,5-trihydroxybenzoic acid

    Chemical formula

    C15H22O5

    Molecular weight

    282,34

    Assay

    Content not less than 98 % after drying at 90 °C for six hours

    Description

    White to creamy-white odourless solid

    Identification

    Solubility

    Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol

    Melting range

    Between 99 °C and 102 °C after drying at 90 °C for six hours

    Purity

    Loss on drying

    Not more than 0,5 % (90 °C, 6 hours)

    Sulphated ash

    Not more than 0,05 %

    Free acid

    Not more than 0,5 % (as gallic acid)

    Chlorinated organic compound

    Not more than 100 mg/kg (as C1)

    Specific absorption in ethanol

    image

    (275 nm) not less than 375 and not more than 390

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 312 DODECYL GALLATE



    Synonyms

    Lauryl gallate

    Definition

    Einecs

    214-620-6

    Chemical name

    Dodecyl gallate; n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid; Dodecyl ester of gallic acid

    Chemical formula

    C19H30O5

    Molecular weight

    338,45

    Assay

    Content not less than 98 % after drying at 90 °C for six hours

    Description

    White or creamy-white odourless solid

    Identification

    Solubility

    Insoluble in water, freely soluble in ethanol and ether

    Melting range

    Between 95 °C and 98 °C after drying at 90 °C for six hours

    Purity

    Loss on drying

    Not more than 0,5 % (90 °C, 6 hours)

    Sulphated ash

    Not more than 0,05 %

    Free acid

    Not more than 0,5 % (as gallic acid)

    Chlorinated organic compound

    Not more than 100 mg/kg (as Cl)

    Specific absorption in ethanol

    image

    (275 nm) not less than 300 and not more than 325

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 315 ERYTHORBIC ACID



    Synonyms

    Isoascorbic acid; D-Araboascorbic acid

    Definition

    Einecs

    201-928-0

    Chemical name

    D-Erythro-hex-2-enoic acid γ-lactone; Isoascorbic acid; D-Isoascorbic acid

    Chemical formula

    C6H8O6

    Molecular weight

    176,13

    Assay

    Content not less than 98 % on the anhydrous basis

    Description

    White to slightly yellow crystalline solid which darkens gradually on exposure to light

    Identification

    Melting range

    About 164 °C to 172 °C with decomposition

    Test for ascorbic acid/colour reaction

    Passes test

    Specific rotation

    [α]D 25 10 % (w/v) aqueous solution between – 16,5° to – 18,0°

    Purity

    Loss on drying

    Not more than 0,4 % after drying under (reduced pressure on silica gel, 3 hours)

    Sulphated ash

    Not more than 0,3 %

    Oxalate

    To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear

    Lead

    Not more than 2 mg/kg

    E 316 SODIUM ERYTHORBATE



    Synonyms

    Sodium isoascorbate

    Definition

    Einecs

    228-973-9

    Chemical name

    Sodium isoascorbate; Sodium D-isoascorbic acid; Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone; 3-keto-D-gulofurano-lactone sodium enolate monohydrate

    Chemical formula

    C6H7O6Na·H2O

    Molecular weight

    216,13

    Assay

    Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis

    Description

    White crystalline solid

    Identification

    Solubility

    Freely soluble in water, very slightly soluble in ethanol

    Test for ascorbic acid/colour reaction

    Passes test

    Test for sodium

    Passes test

    pH

    5,5 to 8,0 (10 % aqueous solution)

    Specific rotation

    [α]D 25 10 % (w/v) aqueous solution between + 95° and + 98°

    Purity

    Loss on drying

    Not more than 0,25 % after drying (in vacuum over sulphuric acid, 24 hours)

    Oxalate

    To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear.

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)



    Synonyms

    TBHQ

    Definition

    Einecs

    217-752-2

    Chemical name

    Tert-butyl-1,4-benzenediol; 2-(1,1-Dimethylethyl)-1,4-benzenediol

    Chemical formula

    C10H14O2

    Molecular weight

    166,22

    Assay

    Content not less than 99 % of C10H14O2

    Description

    White crystalline solid having a characteristic odour

    Identification

    Solubility

    Practically insoluble in water; soluble in ethanol

    Melting point

    Not less than 126,5 °C

    Phenolics

    Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced

    Purity

    Tertiary-Butyl-p-benzoquinone

    Not more than 0,2 %

    2,5-Di-tertiary-butyl hydroquinone

    Not more than 0,2 %

    Hydroxyquinone

    Not more than 0,1 %

    Toluene

    Not more than 25 mg/kg

    Lead

    Not more than 2 mg/kg

    E 320 BUTYLATED HYDROXYANISOLE (BHA)



    Synonyms

    BHA

    Definition

    Einecs

    246-563-8

    Chemical name

    3-Tertiary-butyl-4-hydroxyanisole; A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole

    Chemical formula

    C11H16O2

    Molecular weight

    180,25

    Assay

    Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer

    Description

    White or slightly yellow flakes or waxy solid with a slight aromatic smell

    Identification

    Solubility

    Insoluble in water, freely soluble in ethanol

    Melting range

    Between 48 °C and 63 °C

    Colour reaction

    Passes test for phenol groups

    Purity

    Sulphated ash

    Not more than 0,05 % after calcination at 800 ± 25 °C

    Phenolic impurities

    Not more than 0,5 %

    Specific absorption

    image

    (290 nm) not less than 190 and not more than 210

    image

    (228 nm) not less than 326 and not more than 345

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 321 BUTYLATED HYDROXYTOLUENE (BHT)



    Synonyms

    BHT

    Definition

    Einecs

    204-881-4

    Chemical name

    2,6-Ditertiary-butyl-p-cresol; 4-Methyl-2,6-ditertiarybutylphenol

    Chemical formula

    C15H24O

    Molecular weight

    220,36

    Assay

    Content not less than 99 %

    Description

    White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour

    Identification

    Solubility

    Insoluble in water and propane- 1,2-diol

    Freely soluble in ethanol

    Melting point

    At 70 °C

    Spectrometry

    The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm

    Purity

    Sulphated ash

    Not more than 0,005 %

    Phenolic impurities

    Not more than 0,5 %

    Specific absorption in ethanol

    image

    (278 nm) not less than 81 and not more than 88

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 322 LECITHINS



    Synonyms

    Phosphatides; Phospholipids

    Definition

    Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity

    The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides

    Einecs

    232-307-2

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Lecithins: not less than 60,0 % of substances insoluble in acetone

    Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone

    Description

    Lecithins: brown liquid or viscous semi-liquid or powder

    Hydrolysed lecithins: light brown to brown viscous liquid or paste

    Identification

    Test for choline

    Passes test

    Test for phosphorus

    Passes test

    Test for fatty acids

    Passes test

    Test for hydrolysed lecithin

    To a 800 ml beaker add 500 ml of water (30-35 °C). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g

    Purity

    Loss on drying

    Not more than 2,0 % (105 °C, 1 hour)

    Toluene-insoluble matter

    Not more than 0,3 %

    Acid value

    Lecithins: not more than 35 mg of potassium hydroxide per gram

    Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram

    Peroxide value

    Equal to or less than 10

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 325 SODIUM LACTATE



    Synonyms

     

    Definition

    Einecs

    200-772-0

    Chemical name

    Sodium lactate; Sodium 2-hydroxypropanoate

    Chemical formula

    C3H5NaO3

    Molecular weight

    112,06 (anhydrous)

    Assay

    Content not less than 57 % and not more than 66 %

    Description

    Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour

    Identification

    Test for lactate

    Passes test

    ▼M3

    Test for sodium

    Passes test

    ▼B

    pH

    6,5 to 7,5 (20 % aqueous solution)

    Purity

    Acidity

    Not more than 0,5 % after drying expressed as lactic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Reducing substances

    No reduction of Fehling's solution

    Note: This specification refers to a 60 % aqueous solution

    E 326 POTASSIUM LACTATE



    Synonyms

     

    Definition

    Einecs

    213-631-3

    Cheminal name

    Potassium lactate; Potassium 2-hydroxypropanoate

    Chemical formula

    C3H5O3K

    Molecular weight

    128,17 (anhydrous)

    Assay

    Content not less than 57 % and not more than 66 %

    Description

    Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour

    Identification

    Ignition

    Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added

    Colour reaction

    Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact

    Test for potassium

    Passes test

    Test for lactate

    Passes test

    Purity

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Acidity

    Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required

    Reducing substances

    No reduction of Fehling's solution

    Note: This specification refers to a 60 % aqueous solution

    E 327 CALCIUM LACTATE



    Synonyms

     

    Definition

    Einecs

    212-406-7

    Chemical name

    Calcium dilactate; Calcium dilactate hydrate; 2-Hydroxypropanoic acid calcium salt

    Chemical formula

    (C3H5O2)2 Ca·nH2O (n = 0 - 5)

    Molecular weight

    218,22 (anhydrous)

    Assay

    Content not less than 98 % on the anhydrous basis

    Description

    Almost odourless, white crystalline powder or granules

    Identification

    Test for lactate

    Passes test

    Test for calcium

    Passes test

    Solubility

    Soluble in water and practically insoluble in ethanol

    pH

    Between 6,0 and 8,0 (5 % solution)

    Purity

    Loss on drying

    anhydrous: not more than 3,0 % (120 °C, 4 hours)

    with 1 molecule of water: not more than 8,0 % (120 °C, 4 hours)

    with 3 molecules of water: not more than 20,0 % (120 °C, 4 hours)

    with 4,5 molecules of water: not more than 27,0 % (120 °C, 4 hours)

    Acidity

    Not more than 0,5 % of the dry matter expressed as lactic acid

    Fluoride

    Not more than 30 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Reducing substances

    No reduction of Fehling's solution

    E 330 CITRIC ACID



    Synonyms

     

    Definition

    Citric acid is produced from lemon or pineapple juice, by fermentation of carbohydrate solutions or other suitable media using Candida spp. or non-toxicogenic strains of Aspergillus niger

    Einecs

    201-069-1

    Chemical name

    Citric acid; 2-Hydroxy-1,2,3-propanetricarboxylic acid; β-Hydroxytricarballylic acid

    Chemical formula

    (a)  C6H8O7 (anhydrous)

    (b)  C6H8O7·H2O (monohydrate)

    Molecular weight

    (a)  192,13 (anhydrous)

    (b)  210,15 (monohydrate)

    Assay

    Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis

    Description

    Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air

    Identification

    Solubility

    Very soluble in water; freely soluble in ethanol; soluble in ether

    Purity

    Water content

    Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)

    Sulphated ash

    Not more than 0,05 % after calcination at 800 ± 25 °C

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 0,5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Oxalates

    Not more than 100 mg/kg, expressed as oxalic acid, after drying

    Readily carbonisable substances

    Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 °C in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)

    E 331 (i) MONOSODIUM CITRATE



    Synonyms

    Monobasic sodium citrate

    Definition

    Einecs

    242-734-6

    Chemical name

    Monosodium citrate; Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

    Chemical formula

    (a)  C6H7O7Na (anhydrous)

    (b)  C6H7O7Na·H2O (monohydrate)

    Molecular weight

    (a)  214,11 (anhydrous)

    (b)  232,23 (monohydrate)

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Crystalline white powder or colourless crystals

    Identification

    Test for citrate

    Passes test

    Test for sodium

    Passes test

    pH

    Between 3,5 and 3,8 (1 % aqueous solution)

    Purity

    Loss on drying

    anhydrous: not more than 1,0 % (140 °C, 0,5 hour)

    monohydrate: not more than 8,8 % (180 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg expressed as oxalic acid, after drying

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 331 (ii) DISODIUM CITRATE



    Synonyms

    Dibasic sodium citrate

    Definition

    Einecs

    205-623-3

    Chemical name

    Disodium citrate; Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Disodium salt of citric acid with 1,5 molecules of water

    Chemical formula

    C6H6O7Na2·1,5H2O

    Molecular weight

    263,11

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Crystalline white powder or colourless crystals

    Identification

    Test for citrate

    Passes test

    Test for sodium

    Passes test

    pH

    Between 4,9 and 5,2 (1 % aqueous solution)

    Purity

    Loss on drying

    Not more than 13,0 % (180 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg expressed as oxalic acid, after drying

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 331 (iii) TRISODIUM CITRATE



    Synonyms

    Tribasic sodium citrate

    Definition

    Einecs

    200-675-3

    Chemical name

    Trisodium citrate; Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form

    Chemical formula

    Anhydrous: C6H5O7Na3

    Hydrated: C6H5O7Na3·nH2O (n = 2 or 5)

    Molecular weight

    258,07 (anhydrous)

    294,10 (hydrated n = 2)

    348,16 (hydrated n = 5)

    Assay

    Not less than 99 % on the anhydrous basis

    Description

    Crystalline white powder or colourless crystals

    Identification

    Test for citrate

    Passes test

    Test for sodium

    Passes test

    pH

    Between 7,5 and 9,0 (5 % aqueous solution)

    Purity

    Loss of drying

    Anhydrous: not more than 1,0 % (180 °C, 18 hours)

    Dihydrate: 10,0 to 13,0 % (180 °C, 18 hours)

    Pentahydrate: not more than 30,3 % (180 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg expressed as oxalic acid, after drying

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 332 (i) MONOPOTASSIUM CITRATE



    Synonyms

    Monobasic potassium citrate

    Definition

    Einecs

    212-753-4

    Chemical name

    Monopotassium citrate; Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Anhydrous monopotassium salt of citric acid

    Chemical formula

    C6H7O7K

    Molecular weight

    230,21

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    White, hygroscopic, granular powder or transparent crystals

    Identification

    Test for citrate

    Passes test

    Test for potassium

    Passes test

    pH

    Between 3,5 and 3,8 (1 % aqueous solution)

    Purity

    Loss on drying

    Not more than 1,0 % (180 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg expressed as oxalic acid, after drying

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 332 (ii) TRIPOTASSIUM CITRATE



    Synonyms

    Tribasic potassium citrate

    Definition

    Einecs

    212-755-5

    Chemical name

    Tripotassium citrate; Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Monohydrated tripotassium salt of citric acid

    Chemical formula

    C6H5O7K3·H2O

    Molecular weight

    324,42

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    White, hygroscopic, granular powder or transparent crystals

    Identification

    Test for citrate

    Passes test

    Test for potassium

    Passes test

    pH

    Between 7,5 and 9,0 (5 % aqueous solution)

    Purity

    Loss on drying

    Not more than 6,0 % (180 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 333 (i) MONOCALCIUM CITRATE



    Synonyms

    Monobasic calcium citrate

    Definition

    Einecs

     

    Chemical name

    Monocalcium citrate; Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Monohydrate monocalcium salt of citric acid

    Chemical formula

    (C6H7O7)2Ca·H2O

    Molecular weight

    440,32

    Assay

    Content not less than 97,5 % on the anhydrous basis

    Description

    Fine white powder

    Identification

    Test for citrate

    Passes test

    Test for calcium

    Passes test

    pH

    Between 3,2 and 3,5 (1 % aqueous solution)

    Purity

    Loss on drying

    Not more than 7,0 % (180 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Fluoride

    Not more than 30 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Aluminium

    Not more than 30 mg/kg (only if added to food for infants and young children)

    Not more than 200 mg/kg (for all uses except food for infants and young children)

    Carbonates

    Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

    E 333 (ii) DICALCIUM CITRATE



    Synonyms

    Dibasic calcium citrate

    Definition

    Einecs

     

    Chemical name

    Dicalcium citrate; Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Trihydrated dicalcium salt of citric acid

    Chemical formula

    (C6H7O7)2Ca2·3H2O

    Molecular weight

    530,42

    Assay

    Not less than 97,5 % on the anhydrous basis

    Description

    Fine white powder

    Identification

    Test for citrate

    Passes test

    Test for calcium

    Passes test

    Purity

    Loss on drying

    Not more than 20,0 % (180 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Fluoride

    Not more than 30 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Aluminium

    Not more than 30 mg/kg (only if added to food for infants and young children)

    Not more than 200 mg/kg (for all uses except food for infants and young children)

    Carbonates

    Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

    E 333 (iii) TRICALCIUM CITRATE



    Synonyms

    Tribasic calcium citrate

    Definition

    Einecs

    212-391-7

    Chemical name

    Tricalcium citrate; Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Tetrahydrated tricalcium salt of citric acid

    Chemical formula

    (C6H6O7)2Ca3·4H2O

    Molecular weight

    570,51

    Assay

    Not less than 97,5 % on the anhydrous basis

    Description

    Fine white powder

    Identification

    Test for citrate

    Passes test

    Test for calcium

    Passes test

    Purity

    Loss on drying

    Not more than 14,0 % (180 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Fluoride

    Not more than 30 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Aluminium

    Not more than 30 mg/kg (only if added to food for infants and young children)

    Not more than 200 mg/kg (for all uses except food for infants and young children)

    Carbonates

    Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles

    E 334 L(+)-TARTARIC ACID, TARTARIC ACID



    Synonyms

     

    Definition

    Einecs

    201-766-0

    Chemical name

    L-tartaric acid; L-2,3-dihydroxybutanedioic acid; d-α,β-dihydroxysuccinic acid

    Chemical formula

    C4H6O6

    Molecular weight

    150,09

    Assay

    Content not less than 99,5 % on the anhydrous basis

    Description

    Colourless or translucent crystalline solid or white crystalline powder

    Identification

    Melting range

    Between 168 °C and 170 °C

    Test for tartrate

    Passes test

    Specific rotation

    [α]D 20 between + 11,5° and + 13,5° (20 % w/v aqueous solution)

    Purity

    Loss on drying

    Not more than 0,5 % (over P2O5, 3 hours)

    Sulphated ash

    Not more than 1 000  mg/kg (after calcination at 800 ± 25 °C)

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Oxalates

    Not more than 100 mg/kg expressed as oxalic acid, after drying

    E 335 (i) MONOSODIUM TARTRATE



    Synonyms

    Monosodium salt of L-(+)-tartaric acid

    Definition

    Einecs

     

    Chemical name

    Monosodium salt of L-2,3-dihydroxybutanedioic acid; Monohydrated monosodium salt of L-(+)-tartaric acid

    Chemical formula

    C4H5O6Na·H2O

    Molecular weight

    194,05

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Transparent colourless crystals

    Identification

    Test for tartrate

    Passes test

    Test for sodium

    Passes test

    Purity

    Loss on drying

    Not more than 10,0 % (105 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 335 (ii) DISODIUM TARTRATE



    Synonyms

     

    Definition

    Einecs

    212-773-3

    Chemical name

    Disodium L-tartrate; Disodium (+)-tartrate; Disodium salt of (+)-2,3-dihydroxybutanedioic acid; Dihydrated disodium salt of L-(+)-tartaric acid

    Chemical formula

    C4H4O6Na2·2H2O

    Molecular weight

    230,8

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Transparent, colourless crystals

    Identification

    Test for tartrate

    Passes test

    Test for sodium

    Passes test

    Solubility

    1 gram is insoluble in 3 ml of water. Insoluble in ethanol

    pH

    Between 7,0 and 7,5 (1 % aqueous solution)

    Purity

    Loss on drying

    Not more than 17,0 % (150 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 336 (i) MONOPOTASSIUM TARTRATE



    Synonyms

    Monobasic potassium tartrate

    Definition

    Einecs

     

    Chemical name

    Anhydrous monopotassium salt of L-(+)-tartaric acid; Monopotassium salt of L-2,3-dihydroxybutanedioic acid

    Chemical formula

    C4H5O6K

    Molecular weight

    188,16

    Assay

    Content not less than 98 % on the anhydrous basis

    Description

    White crystalline or granulated powder

    Identification

    Test for tartrate

    Passes test

    Test for potassium

    Passes test

    Melting point

    230 °C

    pH

    3,4 (1 % aqueous solution)

    Purity

    Loss on drying

    Not more than 1,0 % (105 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 336 (ii) DIPOTASSIUM TARTRATE



    Synonyms

    Dibasic potassium tartrate

    Definition

    Einecs

    213-067-8

    Chemical name

    Dipotassium salt of L-2,3-dihydroxybutanedioic acid; Dipotassium salt with half a molecule of water of L-(+)-tartaric acid

    Chemical formula

    C4H4O6K2·½H2O

    Molecular weight

    235,2

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    White crystalline or granulated powder

    Identification

    Test for tartrate

    Passes test

    Test for potassium

    Passes test

    pH

    Between 7,0 and 9,0 (1 % aqueous solution)

    Purity

    Loss on drying

    Not more than 4,0 % (150 °C, 4 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 337 POTASSIUM SODIUM TARTRATE



    Synonyms

    Potassium sodium L-(+)-tartrate; Rochelle salt; Seignette salt

    Definition

    Einecs

    206-156-8

    Chemical name

    Potassium sodium salt of L-2,3-dihydroxybutanedioic acid; Potassium sodium L-(+)-tartrate

    Chemical formula

    C4H4O6KNa·4H2O

    Molecular weight

    282,23

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Colourless crystals or white crystalline powder

    Identification

    Test for tartrate

    Passes test

    Test for potassium

    Passes test

    Test for sodium

    Passes test

    Solubility

    1 gram is soluble in 1 ml of water, insoluble in ethanol

    Melting range

    70-80 °C

    pH

    Between 6,5 and 8,5 (1 % aqueous solution)

    Purity

    Loss on drying

    Not more than 26,0 % and not less than 21,0 % (150 °C, 3 hours)

    Oxalates

    Not more than 100 mg/kg (expressed as oxalic acid, after drying)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 338 PHOSPHORIC ACID



    Synonyms

    Orthophosphoric acid; Monophosphoric acid

    Definition

    Einecs

    231-633-2

    Chemical name

    Phosphoric acid

    Chemical formula

    H3PO4

    Molecular weight

    98,00

    Assay

    Content not less than 67,0 % and not more than 85,7 %. Phosphoric acid is commercially available as an aqueous solution at variable concentrations.

    Description

    Clear, colourless, viscous liquid

    Identification

    Test for acid

    Passes test

    Test for phosphate

    Passes test

    Purity

    Volatile acids

    Not more than 10 mg/kg (as acetic acid)

    Chlorides

    Not more than 200 mg/kg (expressed as chlorine)

    Nitrates

    Not more than 5 mg/kg (as NaNO3)

    Sulphates

    Not more than 1 500  mg/kg (as CaSO4)

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Note: This specification refers to a 75 % aqueous solution

    E 339 (i) MONOSODIUM PHOSPHATE



    Synonyms

    Monosodium monophosphate; Acid monosodium monophosphate; Monosodium orthophosphate; Monobasic sodium phosphate; Sodium dihydrogen monophosphate

    Definition

    Einecs

    231-449-2

    Chemical name

    Sodium dihydrogen monophosphate

    Chemical formula

    Anhydrous: NaH2PO4

    Monohydrate: NaH2PO4 · H2O

    Dihydrate: NaH2PO4 · 2H2O

    Molecular weight

    Anhydrous: 119,98

    Monohydrate: 138,00

    Dihydrate: 156,01

    Assay

    After drying at 60 °C for one hour and then at 105 °C for four hours, contains not less than 97 % of NaH2PO4

    P2O5 content between 58,0 % and 60,0 % on the anhydrous basis

    Description

    A white odourless, slightly deliquescent powder, crystals or granules

    Identification

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Freely soluble in water. Insoluble in ethanol or ether

    pH

    Between 4,1 and 5,0 (1 % solution)

    Purity

    Loss on drying

    The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, the dihydrate not more than 25 % (60 °C, 1 hour then 105 °C, 4 hours)

    Water insoluble matter

    Not more than 0,2 % on the anhydrous basis

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 339 (ii) DISODIUM PHOSPHATE



    Synonyms

    Disodium monophosphate; Secondary sodium phosphate; Disodium orthophosphate;

    Definition

    Einecs

    231-448-7

    Chemical name

    Disodium hydrogen monophosphate; Disodium hydrogen orthophosphate

    Chemical formula

    Anhydrous:Na2HPO4

    Hydrate: Na2HPO4 · nH2O (n = 2, 7 or 12)

    Molecular weight

    141,98 (anhydrous)

    Assay

    After drying at 40 °C for three hours and subsequently at 105 °C for five hours, contains not less than 98 % of Na2HPO4

    P2O5 content between 49 % and 51 % on the anhydrous basis

    Description

    Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals

    Identification

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Freely soluble in water. Insoluble in ethanol

    pH

    Between 8,4 and 9,6 (1 % solution)

    Purity

    Loss on drying

    The anhydrous salt loses not more than 5,0 %, the dihydrate not more than 22,0 %, the heptahydrate not more than 50,0 %, the dodecahydrate not more than 61,0 % (40 °C, 3 hours then 105 °C, 5 hours)

    Water insoluble matter

    Not more than 0,2 % on the anhydrous basis

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 339 (iii) TRISODIUM PHOSPHATE



    Synonyms

    Sodium phosphate; Tribasic sodium phosphate; Trisodium orthophosphate

    Definition

    Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains ¼ molecule of NaOH

    Einecs

    231-509-8

    Chemical name

    Trisodium monophosphate; Trisodium phosphate; Trisodium orthophosphate

    Chemical formula

    Anhydrous: Na3PO4

    Hydrated: Na3PO4 nH2O (n = 1/2, 1, 6, 8, or 12)

    Molecular weight

    163,94 (anhydrous)

    Assay

    Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4 calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4 calculated on the ignited basis

    P2O5 content between 40,5 % and 43,5 % on the anhydrous basis

    Description

    White odourless crystals, granules or crystalline powder

    Identification

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Freely soluble in water. Insoluble in ethanol

    pH

    Between 11,5 and 12,5 (1 % solution)

    Purity

    Loss on ignition

    When dried at 120 °C for two hours and then ignited at about 800 °C for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %

    Water insoluble matter

    Not more than 0,2 % on the anhydrous basis

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 340 (i) MONOPOTASSIUM PHOSPHATE



    Synonyms

    Monobasic potassium phosphate; Monopotassium monophosphate; Mono potassium orthophosphate

    Definition

    Einecs

    231-913-4

    Chemical name

    Potassium dihydrogen phosphate; Monopotassium dihydrogen orthophosphate; Monopotassium dihydrogen monophosphate

    Chemical formula

    KH2PO4

    Molecular weight

    136,09

    Assay

    Content not less than 98,0 % after drying at 105 °C for four hours

    P2O5 content between 51,0 % and 53,0 % on the anhydrous basis

    Description

    Odourless, colourless crystals or white granular or crystalline powder

    Identification

    Test for potassium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Freely soluble in water. Insoluble in ethanol

    pH

    Between 4,2 and 4,8 (1 % solution)

    Purity

    Loss on drying

    Not more than 2,0 % (105 °C, 4 hours)

    Water insoluble matter

    Not more than 0,2 % on the anhydrous basis

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 340 (ii) DIPOTASSIUM PHOSPHATE



    Synonyms

    Dipotassium monophosphate; Secondary potassium phosphate; Dipotassium orthophosphate; Dibasic potassium phosphate

    Definition

    Einecs

    231-834-5

    Chemical name

    Dipotassium hydrogen monophosphate; Dipotassium hydrogen phosphate; Dipotassium hydrogen orthophosphate

    Chemical formula

    K2HPO4

    Molecular weight

    174,18

    Assay

    Content not less than 98 % after drying at 105 °C for four hours

    P2O5 content between 40,3 % and 41,5 % on the anhydrous basis

    Description

    Colourless or white granular powder, crystals or masses; deliquescent substance, hygroscopic

    Identification

    Test for potassium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Freely soluble in water. Insoluble in ethanol

    pH

    Between 8,7 and 9,4 (1 % solution)

    Purity

    Loss on drying

    Not more than 2,0 % (105 °C, 4 hours)

    Water insoluble matter

    Not more than 0,2 % (on the anhydrous basis)

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 340 (iii) TRIPOTASSIUM PHOSPHATE



    Synonyms

    Tribasic potassium phosphate; Tripotassium orthophosphate

    Definition

    Einecs

    231-907-1

    Chemical name

    Tripotassium monophosphate; Tripotassium phosphate; Tripotassium orthophosphate

    Chemical formula

    Anhydrous: K3PO4

    Hydrated: K3PO4 · nH2O (n = 1 or 3)

    Molecular weight

    212,27 (anhydrous)

    Assay

    Content not less than 97 % calculated on the ignited basis

    P2O5 content between 30,5 % and 34,0 % on the ignited basis

    Description

    Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate

    Identification

    Test for potassium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Freely soluble in water. Insoluble in ethanol

    pH

    Between 11,5 and 12,3 (1 % solution)

    Purity

    Loss on ignition

    Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 % (determined by drying at 105 °C for one hour and then ignite at about 800 °C ± 25 °C for 30 minutes)

    Water insoluble matter

    Not more than 0,2 % (on the anhydrous basis)

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 341 (i) MONOCALCIUM PHOSPHATE



    Synonyms

    Monobasic calcium phosphate; Monocalcium orthophosphate

    Definition

    Einecs

    231-837-1

    Chemical name

    Calcium dihydrogen phosphate

    Chemical formula

    Anhydrous: Ca(H2PO4)2

    Monohydrate: Ca(H2PO4)2 · H2O

    Molecular weight

    234,05 (anhydrous)

    252,08 (monohydrate)

    Assay

    Content not less than 95 % on the dried basis

    P2O5 content between 55,5 % and 61,1 % on the anhydrous basis

    Description

    Granular powder or white, deliquescent crystals or granules

    Identification

    Test for calcium

    Passes test

    Test for phosphate

    Passes test

    CaO content

    Between 23,0 % and 27,5 % (anhydrous)

    Between 19,0 % and 24,8 % (monohydrate)

    Purity

    Loss on drying

    Anhydrous: not more than 14 % (105 °C, 4 hours)

    Monohydrate: not more than 17,5 % (105 °C, 4 hours)

    Loss on ignition

    Anhydrous: not more than 17,5 % (after ignition at 800 °C ± 25 °C for 30 minutes)

    Monohydrate: not more than 25,0 % (determined by drying at 105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes)

    Fluoride

    Not more than 30 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Aluminium

    Not more than 70 mg/kg (only if added to food for infants and young children)

    Not more than 200 mg/kg (for all uses except food for infants and young children)

    E 341 (ii) DICALCIUM PHOSPHATE



    Synonyms

    Dibasic calcium phosphate; Dicalcium orthophosphate

    Definition

    Einecs

    231-826-1

    Chemical name

    Calcium monohydrogen phosphate; Calcium hydrogen orthophosphate; Secondary calcium phosphate

    Chemical formula

    Anhydrous: CaHPO4

    Dihydrate: CaHPO4 · 2H2O

    Molecular weight

    136,06 (anhydrous)

    172,09 (dihydrate)

    Assay

    Dicalcium phosphate, after drying at 200 °C for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4

    P2O5 content between 50,0 % and 52,5 % on the anhydrous basis

    Description

    White crystals or granules, granular powder or powder

    Identification

    Test for calcium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Sparingly soluble in water. Insoluble in ethanol

    Purity

    Loss on ignition

    Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 °C ± 25 °C for 30 minutes

    Fluoride

    Not more than 50 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Aluminium

    Not more than 100 mg/kg for the anhydrous form and not more than 80 mg/kg for the dihydrated form (only if added to food for infants and young children)

    Not more than 600 mg/kg for the anhydrous form and not more than 500 mg/kg for the dihydrated form (for all uses except food for infants and young children). This applies until 31 March 2015.

    Not more than 200 mg/kg for the anhydrous form and the dihydrated form (for all uses except food for infants and young children). This applies from 1 April 2015.

    E 341 (iii) TRICALCIUM PHOSPHATE



    Synonyms

    Calcium phosphate, tribasic; Calcium orthophosphate; Pentacalcium hydroxy monophosphate; Calcium hydroxyapatite

    Definition

    Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO·3P2O5 ·H2O

    Einecs

    235-330-6 (Pentacalcium hydroxy monophosphate)

    231-840-8 (Calcium orthophosphate)

    Chemical name

    Pentacalcium hydroxy monophosphate; Tricalcium monophosphate

    Chemical formula

    Ca5(PO4)3 ·OH or Ca3(PO4)2

    Molecular weight

    502 or 310

    Assay

    Content not less than 90 % calculated on the ignited basis

    P2O5 content between 38,5 % and 48,0 % on the anhydrous basis

    Description

    A white, odourless powder which is stable in air

    Identification

    Test for calcium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Practically insoluble in water; insoluble in ethanol, soluble in dilute hydrochloric and nitric acid

    Purity

    Loss on ignition

    Not more than 8 % after ignition at 800 °C ± 25 °C for 0,5 hour

    Fluoride

    Not more than 50 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Aluminium

    Not more than 150 mg/kg (only if added to food for infants and young children)

    Not more than 500 mg/kg (for all uses except food for infants and young children). This applies until 31 March 2015

    Not more than 200 mg/kg (for all uses except food for infants and young children). This applies from 1 April 2015.

    E 343 (i) MONOMAGNESIUM PHOSPHATE



    Synonyms

    Magnesiumdihydrogenphosphate; Magnesiumphosphate, monobasic; Monomagnesium orthophosphate

    Definition

    Einecs

    236-004-6

    Chemical name

    Monomagnesiumdihydrogenmonophosphate

    Chemical formula

    Mg(H2PO4)2 nH2O (where n = 0 to 4)

    Molecular weight

    218,30 (anhydrous)

    Assay

    Not less than 51,0 % after ignition calculated as P2O5 at the ignited basis (800 °C ± 25 °C for 30 minutes)

    Description

    White, odourless, crystalline powder, slightly soluble in water

    Identification

    Test for magnesium

    Passes test

    Test for phosphate

    Passes test

    MgO content

    Not less than 21,5 % after ignition or at an anhydrous basis (105 °C, 4 hours)

    Purity

    Fluoride

    Not more than 10 mg/kg (as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 343 (ii) DIMAGNESIUM PHOSPHATE



    Synonyms

    Magnesiumhydrogenphosphate; Magnesiumphosphate, dibasic; Dimagnesium orthophosphate; Secondary magnesiumphosphate

    Definition

    Einecs

    231-823-5

    Chemical name

    Dimagnesiummonohydrogenmonophosphate

    Chemical formula

    MgHPO4 · nH2O (where n = 0-3)

    Molecular weight

    120,30 (anhydrous)

    Assay

    Not less than 96 % after ignition (800 °C ± 25 °C for 30 minutes)

    Description

    White, odourless, crystalline powder, slightly soluble in water

    Identification

    Test for magnesium

    Passes test

    Test for phosphate

    Passes test

    MgO content

    Not less than 33,0 % calculated on the anhydrous basis (105 °C, 4 hours)

    Purity

    Fluoride

    Not more than 10 mg/kg (as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 350 (i) SODIUM MALATE



    Synonyms

    Sodium salt of malic acid

    Definition

    Einecs

     

    Chemical name

    Disodium DL-malate; disodium salt of hydroxybutanedioic acid

    Chemical formula

    Hemihydrate: C4H4Na2O5 ½ H2O

    Trihydrate: C4H4Na2O5 3H2O

    Molecular weight

    Hemihydrate: 187,05

    Trihydrate: 232,10

    Assay

    Content not less than 98,0 % on the anhydrous basis

    Description

    White crystalline powder or lumps

    Identification

    Test for 1,2-dicarboxylic acid

    Passes test

    Test for sodium

    Passes test

    Azo dye formation

    Positive

    Solubility

    Freely soluble in water

    Purity

    Loss on drying

    Hemihydrate: Not more than 7,0 % (130 °C, 4 hours)

    Trihydrate: 20,5-23,5 % (130 °C, 4 hours)

    Alkalinity

    Not more than 0,2 % as Na2CO3

    Fumaric acid

    Not more than 1,0 %

    Maleic acid

    Not more than 0,05 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 350 (ii) SODIUM HYDROGEN MALATE



    Synonyms

    Monosodium salt of DL-malic acid

    Definition

    Einecs

     

    Chemical name

    Monosodium DL-malate; monosodium 2-DL-hydroxy succinate

    Chemical formula

    C4H5NaO5

    Molecular weight

    156,07

    Assay

    Content not less than 99,0 % on the anhydrous basis

    Description

    White powder

    Identification

    Test for 1,2-dicarboxylic acid

    Passes test

    Test for sodium

    Passes test

    Azo dye formation

    Positive

    Purity

    Loss on drying

    Not more than 2,0 % (110 °C, 3 hours)

    Maleic acid

    Not more than 0,05 %

    Fumaric acid

    Not more than 1,0 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 351 POTASSIUM MALATE



    Synonyms

    Potassium salt of malic acid

    Definition

    Einecs

     

    Chemical name

    Dipotassium DL-malate; dipotassium salt of hydroxybutanedioic acid

    Chemical formula

    C4H4K2O5

    Molecular weight

    210,27

    Assay

    Content not less than 59,5 %

    Description

    Colourless or almost colourless aqueous solution

    Identification

    Test for 1,2-dicarboxylic acid

    Passes test

    Test for potassium

    Passes test

    Azo dye formation

    Positive

    Purity

    Alkalinity

    Not more than 0,2 % as K2CO3

    Fumaric acid

    Not more than 1,0 %

    Maleic acid

    Not more than 0,05 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 352 (i) CALCIUM MALATE



    Synonyms

    Calcium salt of malic acid

    Definition

    Einecs

     

    Chemical name

    Calcium DL-malate; calcium-α-hydroxysuccinate; calcium salt of hydroxybutanedioic acid

    Chemical formula

    C4H5CaO5

    Molecular weight

    172,14

    Assay

    Content not less than 97,5 % on the anhydrous basis

    Description

    White powder

    Identification

    Test for malate

    Passes test

    Test 1,2-dicarboxylic acid

    Passes test

    Test for calcium

    Passes test

    Azo dye formation

    Positive

    Solubility

    Slightly soluble in water

    Purity

    Loss on drying

    Not more than 2 % (100 °C, 3 hours)

    Alkalinity

    Not more than 0,2 % as CaCO3

    Maleic acid

    Not more than 0,05 %

    Fumaric acid

    Not more than 1,0 %

    Fluoride

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 352 (ii) CALCIUM HYDROGEN MALATE



    Synonyms

    Monocalcium salt of DL-malic acid

    Definition

    Einecs

     

    Chemical name

    Monocalcium DL-malate; monocalcium 2-DL-hydroxysuccinate

    Chemical formula

    (C4H5O5)2Ca

    Molecular weight

     

    Assay

    Content not less than 97,5 % on the anhydrous basis

    Description

    White powder

    Identification

    Test for 1,2-dicarboxylic acid

    Passes test

    Test for calcium

    Passes test

    Azo dye formation

    Positive

    Purity

    Loss on drying

    Not more than 2,0 % (110 °C, 3 hours)

    Maleic acid

    Not more than 0,05 %

    Fumaric acid

    Not more than 1,0 %

    Fluoride

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 353 METATARTARIC ACID



    Synonyms

    Ditartaric acid

    Definition

    Einecs

     

    Chemical name

    Metatartaric acid

    Chemical formula

    C4H6O6

    Molecular weight

     

    Assay

    Not less than 99,5 %

    Description

    Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel

    Identification

    Solubility

    Very soluble in water and ethanol

    Identification test

    Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulphuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 °C, an intense violet coloration appears

    Purity

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 354 CALCIUM TARTRATE



    Synonyms

    L-Calcium tartrate

    Definition

    Einecs

     

    Chemical name

    Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate

    Chemical formula

    C4H4CaO6 · 2H2O

    Molecular weight

    224,18

    Assay

    Not less than 98,0 %

    Description

    Fine crystalline powder with a white or off-white colour

    Identification

    Solubility

    Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 °C). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids

    Specific rotation

    [α]D 20 + 7,0° to + 7,4° (0,1 % in a 1N HCl solution)

    pH

    Between 6,0 and 9,0 (5 % slurry)

    Purity

    Sulphates

    Not more than 1 g/kg (as H2SO4)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 355 ADIPIC ACID



    Synonyms

     

    Definition

    Einecs

    204-673-3

    Chemical name

    Hexanedioic acid; 1,4-butanedicarboxylic acid

    Chemical formula

    C6H10O4

    Molecular weight

    146,14

    Assay

    Content not less than 99,6 %

    Description

    White odourless crystals or crystalline powder

    Identification

    Melting range

    151,5-154,0 °C

    Solubility

    Slightly soluble in water. Freely soluble in ethanol

    Purity

    Water

    Not more than 0,2 % (Karl Fischer method)

    Sulphated ash

    Not more than 20 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 356 SODIUM ADIPATE



    Synonyms

     

    Definition

    Einecs

    231-293-5

    Chemical name

    Sodium adipate

    Chemical formula

    C6H8Na2O4

    Molecular weight

    190,11

    Assay

    Content not less than 99,0 % (on anhydrous basis)

    Description

    White odourless crystals or crystalline powder

    Identification

    Melting range

    151-152 °C (for adipic acid)

    Solubility

    Approximately 50 g/100 ml water (20 °C)

    Test for sodium

    Passes test

    Purity

    Water content

    Not more than 3 % (Karl Fischer)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 357 POTASSIUM ADIPATE



    Synonyms

     

    Definition

    Einecs

    242-838-1

    Chemical name

    Potassium adipate

    Chemical formula

    C6H8K2O4

    Molecular weight

    222,32

    Assay

    Content not less than 99,0 % (on anhydrous basis)

    Description

    White odourless crystals or crystalline powder

    Identification

    Melting range

    151-152 °C (for adipic acid)

    Solubility

    Approximately 60 g/100 ml water (20 °C)

    Test for potassium

    Passes test

    Purity

    Water

    Not more than 3 % (Karl Fischer)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 363 SUCCINIC ACID



    Synonyms

     

    Definition

    Einecs

    203-740-4

    Chemical name

    Butanedioic acid

    Chemical formula

    C4H6O4

    Molecular weight

    118,09

    Assay

    Content no less than 99,0 %

    Description

    Colourless or white, odourless crystals

    Identification

    Melting range

    185,0-190,0 °C

    Purity

    Residue on ignition

    Not more than 0,025 % (800 °C, 15 min)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 380 TRIAMMONIUM CITRATE



    Synonyms

    Tribasic ammonium citrate

    Definition

    Einecs

    222-394-5

    Chemical name

    Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid

    Chemical formula

    C6H17N3O7

    Molecular weight

    243,22

    Assay

    Content not less than 97,0 %

    Description

    White to off-white crystals or powder

    Identification

    Test for ammonium

    Passes test

    Test for citrate

    Passes test

    Solubility

    Freely soluble in water

    Purity

    Oxalate

    Not more than 0,04 % (as oxalic acid)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE



    Synonyms

    Calcium disodium EDTA; Calcium disodium edetate

    Definition

    Einecs

    200-529-9

    Chemical name

    N,N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium; Calcium disodium ethylenediaminetetra acetate; Calcium disodium (ethylenedinitrilo)tetra acetate

    Chemical formula

    C10H12O8CaN2Na2·2H2O

    Molecular weight

    410,31

    Assay

    Content not less than 97 % on the anhydrous basis

    Description

    White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic

    Identification

    Test for sodium

    Passes test

    Test for calcium

    Passes test

    Chelating activity to metal ions

    Positive

    pH

    Between 6,5 and 7,5 (1 % solution)

    Purity

    Water content

    5 to 13 % (Karl Fischer method)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 392 EXTRACTS OF ROSEMARY



    Synonyms

    Extract of rosemary leaf (antioxidant)

    Definition

    Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification.

    Einecs

    283-291-9

    Chemical name

    Rosemary extract (Rosmarinus officinalis)

    Description

    Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardised.

    Identification

    Reference antioxidative compounds: phenolic diterpenes

    Carnosic acid (C20H28O4) and Carnosol (C20H26O4)

    (which comprise not less than 90 % of the total phenolic diterpenes)

    Reference key volatiles

    Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, Verbenone

    Density

    > 0,25 g/ml

    Solubility

    Insoluble in water

    Purity

    Loss of drying

    < 5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    1 —    Extracts of rosemary produced from dried rosemary leaves by acetone extraction.



    Description

    Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid.

    Identification

    Content of reference antioxidative compounds

    ≥ 10 % w/w, expressed as the total of carnosic acid and carnosol

    Antioxidant/Volatiles — Ratio

    (Total % w/w of carnosic acid and carnosol) ≥ 15

    (% w/w of reference key volatiles)*

    (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)

    Purity

    Residual solvents

    Acetone: Not more than 500 mg/kg

    2 —    Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide.



    Description

    Extracts of rosemary produced from dried rosemary leaves extracted by means of supercritical carbon dioxide with a small amount of ethanol as entrainer.

    Identification

    Content of reference antioxidative compounds

    ≥ 13 % w/w, expressed as the total of carnosic acid and carnosol

    Antioxidant/Volatiles – Ratio

    (Total % w/w of carnosic acid and carnosol) ≥ 15

    (% w/w of reference key volatiles)*

    (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)

    Purity

    Residual solvents

    Ethanol: not more than 2 %

    3 —    Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary.



    Description

    Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The extracts may be further purified, for example by treatment with active carbon and/or molecular distillation. The extracts may be suspended in suitable and approved carriers or spray dried.

    Identification

    Content of reference antioxidative compounds

    ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol

    Antioxidant/Volatiles – Ratio

    (Total % w/w of carnosic acid and carnosol) ≥ 15

    (% w/w of reference key volatiles)*

    (* as a percentage of total volatiles in the extract, measured by Gas Chromatography – Mass Spectrometry Detection, ‘GC-MSD’)

    Purity

    Residual solvents

    Ethanol: not more than 500 mg/kg

    4 —    Extracts of rosemary decolourised and deodorised, obtained by a two-step extraction using hexane and ethanol.



    Description

    Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/or molecular distillation. They may be suspended in suitable and approved carriers or spray dried.

    Identification

    Content of reference antioxidative compounds

    ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol

    Antioxidant/Volatiles – Ratio

    (Total % w/w of carnosic acid and carnosol) ≥ 15

    (% w/w of reference key volatiles)*

    (* as a percentage of total volatiles in the extract, measured by Gas Chromatography – Mass Spectrometry Detection, ‘GC-MSD’)

    Purity

    Residual solvents

    Hexane: not more than 25 mg/kg

    Ethanol: not more than 500 mg/kg

    E 400 ALGINIC ACID



    Synonyms

     

    Definition

    Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from strains of various species of brown seaweeds (Phaeophyceae)

    Einecs

    232-680-1

    Chemical name

     

    Chemical formula

    (C6H8O6)n

    Molecular weight

    10 000 -600 000 (typical average)

    Assay

    Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on equivalent weight basis of 200)

    Description

    Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless

    Identification

    Solubility

    Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate

    Calcium chloride precipitation test

    To a 0,5 % solution of the sample in 1 M sodium hydroxide solution add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum.

    Ammonium sulphate precipitation test

    To a 0,5 % solution of the sample in 1 M sodium hydroxide solution add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch.

    Colour reaction

    Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes a cherry-red colour develops that finally becomes deep purple.

    pH

    Between 2,0 and 3,5 (3 % suspension)

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 4 hours)

    Sulphated ash

    Not more than 8 % on the anhydrous basis

    Sodium hydroxide (1 M solution) insoluble matter

    Not more than 2 % on the anhydrous basis

    Formaldehyde

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 500 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    E 401 SODIUM ALGINATE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Sodium salt of alginic acid

    Chemical formula

    (C6H7NaO6)n

    Molecular weight

    10 000 -600 000 (typical average)

    Assay

    Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)

    Description

    Nearly odourless, white to yellowish fibrous or granular powder

    Identification

    Test for sodium

    Passes test

    Test for alginic acid

    Passes test

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 4 hours)

    Water insoluble matter

    Not more than 2 % on the anhydrous basis

    Formaldehyde

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 500 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    E 402 POTASSIUM ALGINATE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Potassium salt of alginic acid

    Chemical formula

    (C6H7KO6)n

    Molecular weight

    10 000 -600 000 (typical average)

    Assay

    Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)

    Description

    Nearly odourless, white to yellowish fibrous or granular powder

    Identification

    Test for potassium

    Passes test

    Test for alginic acid

    Passes test

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 4 hours)

    Water insoluble matter

    Not more than 2 % on the anhydrous basis

    Formaldehyde

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 500 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    E 403 AMMONIUM ALGINATE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Ammonium salt of alginic acid

    Chemical formula

    (C6H11NO6)n

    Molecular weight

    10 000 -600 000 (typical average)

    Assay

    Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)

    Description

    White to yellowish fibrous or granular powder

    Identification

    Test for ammonium

    Passes test

    Test for alginic acid

    Passes test

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 4 hours)

    Sulphated ash

    Not more than 7 % on the dried basis

    Water insoluble matter

    Not more than 2 % on the anhydrous basis

    Formaldehyde

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 500 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    E 404 CALCIUM ALGINATE



    Synonyms

    Calcium salt of alginate

    Definition

    Einecs

     

    Chemical name

    Calcium salt of alginic acid

    Chemical formula

    (C6H7Ca1/2O6)n

    Molecular weight

    10 000 -600 000 (typical average)

    Assay

    Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)

    Description

    Nearly odourless, white to yellowish fibrous or granular powder

    Identification

    Test for calcium

    Passes test

    Test for alginic acid

    Passes test

    Purity

    Loss on drying

    Not more than 15,0 % (105 °C, 4 hours)

    Formaldehyde

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 500 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    E 405 PROPANE-1,2-DIOL ALGINATE



    Synonyms

    Hydroxypropyl alginate; 1,2-Propanediol ester of alginic acid; Propylene glycol alginate

    Definition

    Einecs

     

    Chemical name

    1,2-Propanediol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule

    Chemical formula

    (C9H14O7)n (esterified)

    Molecular weight

    10 000 -600 000 (typical average)

    Assay

    Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of carbon dioxide (CO2)

    Description

    Nearly odourless, white to yellowish brown fibrous or granular powder

    Identification

    Test for 1,2-propanediol

    Passes test (after hydrolysis)

    Test for alginic acid

    Passes test (after hydrolysis)

    Purity

    Loss on drying

    Not more than 20 % (105 °C, 4 hours)

    Total propane-1,2-diol content

    Not less than 15 % and not more than 45 %

    Free propane-1,2-diol content

    Not more than 15 %

    Water insoluble matter

    Not more than 2 % on the anhydrous basis

    Formaldehyde

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 500 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    E 406 AGAR



    Synonyms

    Gelose; Kanten, Bengal, Ceylon, Chinese or Japanese isinglass; Layor Carang

    Definition

    Agar is a hydrophilic colloidal polysaccharide consisting mainly of galactose units with a regular alternation of L and D isomeric forms. These hexoses are alternately linked with alpha-1,3 and beta-1,4 bonds in the copolymer. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain strains of marine algae of the families Gelidiaceae and Gracilariaceae and relevant red algae of the class Rhodophyceae

    Einecs

    232-658-1

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    The threshold gel concentration should not be higher than 0,25 %

    Description

    Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, agar powder appears more transparent. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose

    Identification

    Solubility

    Insoluble in cold water; soluble in boiling water

    Purity

    Loss on drying

    Not more than 22 % (105 °C, 5 hours)

    Ash

    Not more than 6,5 % on the anhydrous basis determined at 550 °C

    Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)

    Not more than 0,5 % determined at 550 °C on the anhydrous basis

    Insoluble matter (after stirring for 10 minutes in hot water)

    Not more than 1,0 %

    Starch

    Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced

    Gelatin and other proteins

    Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 °C. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes

    Water absorption

    Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 °C for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 300 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 5 g

    E 407 CARRAGEENAN



    Synonyms

    Products of commerce are sold under different names such as:

    Irish moss gelose; Eucheuman (from Eucheuma spp.); Iridophycan (from Iridaea spp.); Hypnean (from Hypnea spp.); Furcellaran or Danish agar (from Furcellaria fastigiata); Carrageenan (from Chondrus and Gigartina spp.)

    Definition

    Carrageenan is obtained by extraction with water or dilute aqueous alkali of strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds).

    Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysacharide. These hexoses are alternately linked α-1,3 and β-1,4 in the copolymer.

    The prevalent polysaccharides in carrageenan are designated as kappa, iota, lambda depending on the number of sulphate by repeating unit (i.e. 1,2,3 sulphate). Between kappa and iota there is a continuum of intermediate compositions differing in number of sulphates per repeat units between 1 and 2.

    During the process, no organic precipitant shall be used other than methanol, ethanol and propan-2-ol.

    The wording carrageenan is reserved for the non hydrolysed or otherwise chemically degraded polymer.

    Formaldehyde may be present as an adventitious impurity up to a maximum of 5 mg/kg.

    Einecs

    232-524-2

    Chemical name

    Sulphate esters of polygalactose

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Yellowish to colourless, coarse to fine powder which is practically odourless

    Identification

    Test for galactose

    Passes test

    Test for anhydrogalactose

    Passes test

    Test for sulphate

    Passes test

    Solubility

    Soluble in hot water; insoluble in alcohol for a 1,5 % dilution

    Purity

    Solvent residues

    Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in combination

    Viscosity

    Not less than 5 mPa.s (1,5 % solution at 75 °C)

    Loss on drying

    Not more than 12 % (105 °C, 4 hours)

    Sulphates

    Not less than 15 % and not more than 40 % on the dried basis (as SO4)

    Ash

    Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C

    Acid-insoluble ash

    Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)

    Acid-insoluble matter

    Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid)

    Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)

    Not more than 5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 2 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 300 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    E 407a PROCESSED EUCHEUMA SEAWEED



    Synonyms

    PES (acronym for processed eucheuma seaweed). The PES obtained from Euchema cottonii is generally called kappa PES and the PES from Euchema spinosum iota PES.

    Definition

    Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment at high temperature of the strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) followed by fresh water washing to remove impurities and drying to obtain the product. Further purification may be achieved by washing with an alcohol. The alcohols authorised are restricted to methanol, ethanol or propan-2-ol. The product consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysaccharide. Up to 15 % algal cellulose is also present in the product. The wording processed eucheuma seaweed is reserved to the non hydrolysed or otherwise chemically degraded polymer. Formaldehyde may be present up to a maximum of 5 mg/kg.

    Description

    Tan to yellowish, coarse to fine powder which is practically odourless

    Identification

    Test for galactose

    Passes test

    Test for anhydrogalactose

    Passes test

    Test for sulphate

    Passes test

    Solubility

    Forms cloudy viscous suspensions in water. Insoluble in ethanol for a 1,5 % solution.

    Purity

    Solvent residues

    Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in combination

    Viscosity

    Not less than 5 mPa.s (1,5 % solution at 75 °C)

    Loss on drying

    Not more than 12 % (105 °C, 4 hours)

    Sulphate

    Not less than 15 % and not more than 40 % on the dried basis (as SO4)

    Ash

    Not less than 15 % and not more than 40 % determined on the dried basis at 550 °C

    Acid-insoluble ash

    Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)

    Acid-insoluble matter

    Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)

    Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)

    Not more than 5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 2 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 300 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    E 410 LOCUST BEAN GUM



    Synonyms

    Carob bean gum; Algaroba gum

    Definition

    Locust bean gum is the ground endosperm of the seeds of the strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan

    Einecs

    232-541-5

    Chemical name

     

    Chemical formula

     

    Molecular weight

    50 000 -3 000 000

    Assay

    Galactomannan content not less than 75 %

    Description

    White to yellowish-white, nearly odourless powder

    Identification

    Test for galactose

    Passes test

    Test for mannose

    Passes test

    Microscopic examination

    Place some ground sample in an aqueous solution containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed than in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown

    Solubility

    Soluble in hot water, insoluble in ethanol

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 5 hours)

    Ash

    Not more than 1,2 % determined at 800 °C

    Protein (N × 6,25)

    Not more than 7 %

    Acid-insoluble matter

    Not more than 4 %

    Starch

    Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Ethanol and propan-2-ol

    Not more than 1 %, single or in combination

    E 412 GUAR GUM



    Synonyms

    Gum cyamopsis; Guar flour

    Definition

    Guar gum is the ground endosperm of the seeds of strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan. The gum may be partially hydrolysed by either heat treatment, mild acid or alcaline oxidative treatment for viscosity adjustment.

    Einecs

    232-536-0

    Chemical name

     

    Chemical formula

     

    Molecular weight

    50 000 -8 000 000

    Assay

    Galactomannan content not less than 75 %

    Description

    A white to yellowish-white, nearly odourless powder

    Identification

    Test for galactose

    Passes test

    Test for mannose

    Passes test

    Solubility

    Soluble in cold water

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 5 hours)

    Ash

    Not more than 5,5 % determined at 800 °C

    Acid-insoluble matter

    Not more than 7 %

    Protein

    Not more than 10 % (factor N x 6,25)

    Starch

    Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. (No blue colour is produced)

    Organic peroxides

    Not more than 0,7 meq active oxygen/kg sample

    Furfural

    Not more than 1 mg/kg

    Pentachlorophenol

    Not more than 0,01 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 413 TRAGACANTH



    Synonyms

    Tragacanth gum; Tragant

    Definition

    Tragacanth is a dried exudation obtained from the stems and branches of strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present

    Einecs

    232-252-5

    Chemical name

     

    Chemical formula

     

    Molecular weight

    Approximately 800 000

    Assay

     

    Description

    Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour

    Identification

    Solubility

    1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol

    Purity

    Test for Karaya gum

    Negative. Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops

    Loss on drying

    Not more than 16 % (105 °C, 5 hours)

    Total ash

    Not more than 4 %

    Acid insoluble ash

    Not more than 0,5 %

    Acid insoluble matter

    Not more than 2 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Salmonella spp.

    Absent in 10 g

    Escherichia coli

    Absent in 5 g

    E 414 ACACIA GUM



    Synonyms

    Gum arabic

    Definition

    Acacia gum is a dried exudation obtained from the stems and branches of strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid

    Einecs

    232-519-5

    Chemical name

     

    Chemical formula

     

    Molecular weight

    Approximately 350 000

    Assay

     

    Description

    Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.

    Identification

    Solubility

    1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol

    Purity

    Loss on drying

    Not more than 17 % (105 °C, 5 hours) for granular and not more than 10 % (105 °C, 4 hours) for spray-dried material

    Total ash

    Not more than 4 %

    Acid insoluble ash

    Not more than 0,5 %

    Acid insoluble matter

    Not more than 1 %

    Starch or dextrin

    Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced

    Tannin

    To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Hydrolysis products

    Mannose, xylose and galacturonic acid are absent (determined by chromatography)

    Microbiological criteria

    Salmonella spp.

    Absent in 10 g

    Escherichia coli

    Absent in 5 g

    E 415 XANTHAN GUM



    Synonyms

     

    Definition

    Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with strains of Xanthomonas campestris, purified by recovery with ethanol or propan-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral

    Einecs

    234-394-2

    Chemical name

     

    Chemical formula

     

    Molecular weight

    Approximately 1 000 000

    Assay

    Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum

    Description

    Cream-coloured powder

    Identification

    Solubility

    Soluble in water. Insoluble in ethanol

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 2,5 hours)

    Total ash

    Not more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C for four hours

    Pyruvic acid

    Not less than 1,5 %

    Nitrogen

    Not more than 1,5 %

    Ethanol and propan-2-ol

    Not more than 500 mg/kg singly or in combination

    Lead

    Not more than 2 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colonies per gram

    Yeast and moulds

    Not more than 300 colonies per gram

    Escherichia coli

    Absent in 5 g

    Salmonella spp.

    Absent in 10 g

    Xanthomonas campestris

    Viable cells absent in 1 g

    E 416 KARAYA-GUM



    Synonyms

    Katilo; Kadaya; Gum sterculia; Sterculia; Karaya, gum karaya; Kullo; Kuterra

    Definition

    Karaya gum is a dried exudation from the stems and branches of strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid

    Einecs

    232-539-4

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid

    Identification

    Solubility

    Insoluble in ethanol

    Swelling in ethanol solution

    Karaya gum swells in 60 % ethanol distinguishing it from other gums

    Purity

    Loss on drying

    Not more than 20 % (105 °C, 5 hours)

    Total ash

    Not more than 8 %

    Acid insoluble ash

    Not more than 1 %

    Acid insoluble matter

    Not more than 3 %

    Volatile acid

    Not less than 10 % (as acetic acid)

    Starch

    Not detectable

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Salmonella spp.

    Absent in 10 g

    Escherichia coli

    Absent in 5 g

    E 417 TARA GUM



    Definition

    Tara gum is obtained by grinding the endosperm of the seeds of strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)

    Einecs

    254-409-6

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    A white to white-yellow odourless powder

    Identification

    Solubility

    Soluble in water, insoluble in ethanol

    Gel formation

    To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed

    Purity

    Loss on drying

    Not more than 15 %

    Ash

    Not more than 1,5 %

    Acid insoluble matter

    Not more than 2 %

    Protein

    Not more than 3,5 % (factor N x 5,7)

    Starch

    Not detectable

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 418 GELLAN GUM



    Synonyms

     

    Definition

    Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by strains of Pseudomonas elodea, purified by recovery with propan-2-ol or ethanol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt

    Einecs

    275-117-5

    Chemical name

     

    Chemical formula

     

    Molecular weight

    Approximately 500 000

    Assay

    Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2

    Description

    An off-white powder

    Identification

    Solubility

    Soluble in water, forming a viscous solution.

    Insoluble in ethanol

    Purity

    Loss on drying

    Not more than 15 % after drying (105 °C, 2,5 hours)

    Nitrogen

    Not more than 3 %

    Propan-2-ol

    Not more than 750 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 10 000 colonies per gram

    Yeast and moulds

    Not more than 400 colonies per gram

    Escherichia coli

    Negative in 5 g

    Salmonella spp.

    Negative in 10 g

    E 420 (i) SORBITOL



    Synonyms

    D-glucitol; D-sorbitol

    Definition

    Sorbitol is obtained by hydrogenation of D-glucose. It is mainly composed of D-sorbitol. According to the level of D-glucose, the part of the products which is not D-sorbitol is composed of related substances such as mannitol, iditol, maltitol.

    Einecs

    200-061-5

    Chemical name

    D-glucitol

    Chemical formula

    C6H14O6

    Molecular weight

    182,2

    Assay

    Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis (glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer).

    Description

    White hygroscopic powder, crystalline powder, flakes or granules.

    Appearance of the aqueous solution:

    The solution is clear.

    Identification

    Solubility

    Very soluble in water, slightly soluble in ethanol

    Melting range

    88 to 102 °C

    Sorbitol monobenzylidene derivative

    To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C

    ▼M4

    Purity

    Water content

    Not more than 1,5 % (Karl Fischer Method)

    Conductivity

    Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

    Reducing sugars

    Not more than 0,3 % (expressed as glucose on dry weight basis)

    Total sugars

    Not more than 1 % (expressed as glucose on dry weight basis)

    Nickel

    Not more than 2 mg/kg (expressed on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    ▼B

    E 420 (ii) SORBITOL SYRUP



    Synonyms

    D-glucitol syrup

    Definition

    Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides.

    The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present (glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer)

    Einecs

    270-337-8

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis

    Description

    Clear and colourless aqueous solution

    Identification

    Solubility

    Miscible with water, with glycerol, and with propane-1,2-diol

    Sorbitol monobenzylidene derivative

    To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C

    ▼M4

    Purity

    Water content

    Not more than 31 % (Karl Fischer Method)

    Conductivity

    Not more than 10 μS/cm (on the product as such) at temperature 20 °C

    Reducing sugars

    Not more than 0,3 % (expressed as glucose on dry weight basis)

    Nickel

    Not more than 2 mg/kg (expressed on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    E 421 (i) MANNITOL BY HYDROGENATION

    ▼B

    (i)   MANNITOL



    Synonyms

    D-mannitol

    ▼M4

    Definition

    Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose.

    The product contains min. 96 % mannitol. The part of the product which is not mannitol is mainly composed of sorbitol (2 % max), maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D-Glucopyranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-D- Glucopyranosyl-D-Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0,1 % of each.

    ▼B

    Einecs

    200-711-8

    Chemical name

    D-mannitol

    Chemical formula

    C6H14O6

    Molecular weight

    182,2

    Assay

    Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis

    Description

    White, odourless, crystalline powder

    Identification

    Solubility

    Soluble in water, very slightly soluble in ethanol, practically insoluble in ether

    Melting range

    Between 164 and 169 °C

    Infrared absorption spectrometry

    Comparison with a reference standard e.g. EP or USP

    Specific rotation

    [α]D 20 + 23° to + 25° (borate solution)

    pH

    Between 5 and 8. Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH

    ▼M4

    Purity

    Water content

    Not more than 0,5 % (Karl Fischer Method)

    Conductivity

    Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

    Reducing sugars

    Not more than 0,3 % (expressed as glucose)

    Total sugars

    Not more than 1 % (expressed as glucose)

    Nickel

    Not more than 2 mg/kg

    Lead

    Not more than 1 mg/kg

    ▼B

    (ii)   MANNITOL MANUFACTURED BY FERMENTATION



    Synonyms

    D-mannitol

    Definition

    Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii. The part of the product which is not mannitol is mainly composed of sorbitol, maltitol and isomalt.

    Einecs

    200-711-8

    Chemical name

    D-mannitol

    Chemical formula

    C6H14O6

    Molecular weight

    182,2

    Assay

    Not less than 99 % on the dried basis

    Description

    White, odourless crystalline powder

    Identification

    Solubility

    Soluble in water, very slightly soluble in ethanol, practically insoluble in ether

    Melting range

    Between 164 and 169 °C

    Infrared absorption spectrometry

    Comparison with a reference standard e.g. EP or USP

    Specific rotation

    [α]D 20 + 23° to + 25° (borate solution)

    pH

    Between 5 and 8

    Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH

    ▼M4

    Purity

    Arabitol

    Not more than 0,3 %

    Water content

    Not more than 0,5 % (Karl Fischer Method)

    Conductivity

    Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

    Reducing sugars

    Not more than 0,3 % (expressed as glucose)

    Total sugars

    Not more than 1 % (expressed as glucose)

    Lead

    Not more than 1 mg/kg

    ▼B

    Microbiological criteria

    Aerobic mesophilic bacteria

    Not more than 1 000 colonies per gram

    Coliforms

    Absent in 10 g

    Salmonella spp.

    Absent in 25 g

    Escherichia coli

    Absent in 10 g

    Staphylococcus aureus

    Absent in 10 g

    Pseudomonas aeruginosa

    Absent in 10 g

    Moulds

    Not more than 100 colonies per gram

    Yeasts

    Not more than 100 colonies per gram

    E 422 GLYCEROL



    Synonyms

    Glycerin; Glycerine

    Definition

    Einecs

    200-289-5

    Chemical name

    1,2,3-propanetriol; Glycerol; Trihydroxypropane

    Chemical formula

    C3H8O3

    Molecular weight

    92,10

    Assay

    Content not less than 98 % of glycerol on the anhydrous basis

    Description

    Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable

    Identification

    Acrolein formation on heating

    Heat a few drops of the sample in a test tube with about 0,5 g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved

    Specific gravity (25 °C/25 °C)

    Not less than 1,257

    Refractive index

    [n]D 20 between 1,471 and 1,474

    Purity

    Water content

    Not more than 5 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,01 % determined at 800 ± 25 °C

    Butanetriols

    Not more than 0,2 %

    Acrolein, glucose and ammonium compounds

    Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60 °C for five minutes. It neither becomes yellow nor emits an odour of ammonia

    Fatty acids and esters

    Not more than 0,1 % calculated as butyric acid

    Chlorinated compounds

    Not more than 30 mg/kg (as chlorine)

    3-Monochloropropane-1,2-diol (3-MCPD)

    Not more than 0,1 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    ▼M7

    E 423 OCTENYL SUCCINIC ACID MODIFIED GUM ARABIC



    Synonyms

    Gum arabic hydrogen octenylbutandioate; Gum arabic hydrogen octenylsuccinate; OSA modified gum arabic; OSA modified gum acacia

    Definition

    Octenyl succinic acid modified gum arabic is produced by esterifying gum arabic (Acacia seyal), or gum arabic (Acacia senegal) in aqueous solution with not more than 3 % of octenyl succinic acid anhydride. It is subsequently spray dried.

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Weight Average Molecular Weight

    Fraction (i): 3,105 g/mol

    Fraction (ii) 1,106 g/mol

    Assay

     

    Description

    Off-white to light tan, free flowing powder

    Identification

    Viscosity of a 5 % solution at 25 °C

    Not more than 30 mPa.s.

    Precipitation reaction

    Forms flocculent precipitate in lead sub-acetate solution (TS)

    Solubility

    Freely soluble in water; insoluble in ethanol

    pH for a 5 % aqueous solution

    3,5 to 6,5

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 5 h)

    Degree of esterification

    Not more than 0,6 %

    Total ash

    Not more than 10 % (530 °C)

    Acid-insoluble ash

    Not more than 0,5 %

    Water insoluble matter

    Not more than 1,0 %

    Test for starch or dextrine

    Boil a 1 in 50 aqueous solution of the sample, add about 0,1 ml iodine TS. No bluish or reddish colour should be produced.

    Test for tannin-bearing gums

    To 10 ml of a 1 in 50 aqueous solution of the sample add about 0,1 ml ferric chloride TS. No blackish coloration or blackish precipitate should be formed.

    Residual octenyl succinic acid

    Not more than 0,3 %

    Lead

    Not more than 2 mg/kg

    Microbiological criteria

    Salmonella sp.

    Absent in 25 g

    Escherichia coli

    Absent in 1 g

    ▼B

    E 425 (i) KONJAC GUM



    Synonyms

     

    Definition

    Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac. The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

    The main component, glucomannan, has an average molecular weight of 200 000 to 2 000 000

    Assay

    Not less than 75 % carbohydrate

    Description

    A white to cream to light tan powder

    Identification

    Solubility

    Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0

    Gel formation

    Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms

    Formation of heat-stable gel

    Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed

    Purity

    Loss on drying

    Not more than 12 % (105 °C, 5 hours)

    Starch

    Not more than 3 %

    Protein

    Not more than 3 % (factor N × 5,7)

    Viscosity (1 % solution)

    Not less than 3 kgm– 1s– 1 at 25 °C

    Ether-soluble material

    Not more than 0,1 %

    Total ash

    Not more than 5,0 % (800 °C, 3 to 4 hours)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Microbiological criteria

    Salmonella spp.

    Absent in 12,5 g

    Escherichia coli

    Absent in 5 g

    E 425 (ii) KONJAC GLUCOMANNAN



    Synonyms

     

    Definition

    Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

    500 000 to 2 000 000

    Assay

    Total dietary fibre: not less than 95 % on a dry weight basis

    Description

    White to slightly brownish fine particle size, free flowing and odourless powder

    Identification

    Solubility

    Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mechanical agitation

    Formation of heat-stable gel

    Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed

    Purity

    Loss on drying

    Not more than 8 % (105 °C, 3 hours)

    Starch

    Not more than 1 %

    Viscosity (1 % solution)

    Not less than 20 kgm– 1s– 1 at 25 °C

    Protein

    Not more than 1,5 % (N × 5,7)

    Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample

    Ether-soluble material

    Not more than 0,5 %

    Sulphite (as SO2)

    Not more than 4 mg/kg

    Chloride

    Not more than 0,02 %

    50 % Alcohol-soluble material

    Not more than 2,0 %

    Total ash

    Not more than 2,0 % (800 °C, 3 to 4 hours)

    Lead

    Not more than 1 mg/kg

    Microbiological criteria

    Salmonella spp.

    Absent in 12,5 g

    Escherichia coli

    Absent in 5 g

    E 426 SOYBEAN HEMICELLULOSE



    Synonyms

     

    Definition

    Soybean Hemicellulose is a refined water-soluble polysaccharide obtained from strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol

    Einecs

     

    Chemical name

    Water soluble soybean polysaccharides; Water soluble soybean fibre

    Chemical formula

     

    Molecular weight

     

    Assay

    Not less than 74 % carbohydrate

    Description

    Free flowing white or yellowish white powder

    Identification

    Solubility

    Soluble in hot and cold water without gel formation

    pH

    5,5 ± 1,5 (1% solution)

    Purity

    Loss on drying

    Not more than 7 % (105 °C, 4 hours)

    Protein

    Not more than 14 %

    Viscosity

    Not more than 200 mPa.s (10 % solution)

    Total ash

    Not more than 9,5 % (600 °C, 4 hours)

    Arsenic

    Not more than 2 mg/kg

    Ethanol

    Not more than 2%

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 3 000 colonies per gram

    Yeast and moulds

    Not more than 100 colonies per gram

    Escherichia coli

    Absent in 10 g

    E 427 CASSIA GUM



    Synonyms

     

    Definition

    Cassia gum is the ground purified endosperm of the seeds of Cassia tora and Cassia obtusifoli (Leguminosae) containing less than 0,05 % of Cassia occidentalis. It consists mainly of high molecular weight polysaccharides composed primarily of a linear chain of 1,4-β-D-mannopyranose units linked with 1,6-α-D-galactopyranose units. The ratio of mannose to galactose is about 5:1.

    In the manufacture the seeds are dehusked and degermed by thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with propan-2-ol.

    Assay

    Not less than 75 % of Galactomannan

    Description

    Pale yellow to off-white, odourless powder

    Identification

    Solubility

    Insoluble in ethanol. Disperses well in cold water forming a colloidal solution.

    Gel formation with borate

    To an aqueous dispersion of the sample add sufficient sodium borate test solution (TS) to raise the pH to above 9; a gel is formed.

    Gel formation with xanthan gum

    Weigh 1,5 g of the sample and 1,5 g of xanthan gum and blend them. Add this blend (with rapid stirring) into 300 ml water at 80 °C in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the temperature above 60 °C during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h.

    A firm, viscoelastic gel forms after the temperature drops below 40 °C, but no such gel forms in a 1 % control solution of cassia gum or xanthan gum alone prepared in a similar manner.

    Viscosity

    Less than 500 mPa.s (25 °C, 2h, 1 % solution) corresponding to an average molecular weight of 200 000 -300 000 Da

    Purity

    Acid insoluble matter

    Not more than 2,0 %

    pH

    5,5-8 (1 % aqueous solution)

    Crude fat

    Not more than 1 %

    Protein

    Not more than 7 %

    Total ash

    Not more than 1,2 %

    Loss on drying

    Not more than 12 % (5h, 105 °C)

    Total anthraquinones

    Not more than 0,5 mg/kg(detection limit)

    Solvent residues

    Not more than 750 mg/kg Propan-2-ol

    Lead

    Not more than 1 mg/kg

    Microbiological criteria

    Total plate count

    Not more than 5 000 colony forming units per gram

    Yeast and moulds

    Not more than 100 colony forming units per gram

    Salmonella spp.

    Absent in 25 g

    Escherichia coli

    Absent in 1 g

    E 431 POLYOXYETHYLENE (40) STEARATE



    Synonyms

    Polyoxyl (40) stearate; Polyoxyethylene (40) monostearate

    Definition

    A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 97,5 % on the anhydrous basis

    Description

    Cream-coloured flakes or waxy solid at 25 °C with a faint odour

    Identification

    Solubility

    Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil

    Congealing range

    39-44 °C

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

    Purity

    Water content

    Not more than 3 % (Karl Fischer method)

    Acid value

    Not more than 1

    Saponification value

    Not less than 25 and not more than 35

    Hydroxyl value

    Not less than 27 and not more than 40

    1,4-Dioxane

    Not more than 5 mg/kg

    Ethylene oxide

    Not more than 0,2 mg/kg

    Ethylene glycols (mono- and di-)

    Not more than 0,25 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)



    Synonyms

    Polysorbate 20; Polyoxyethylene (20) sorbitan monolaurate

    Definition

    A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis

    Description

    A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour

    Identification

    Solubility

    Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

    Purity

    Water content

    Not more than 3 % (Karl Fischer method)

    Acid value

    Not more than 2

    Saponification value

    Not less than 40 and not more than 50

    Hydroxyl value

    Not less than 96 and not more than 108

    1,4-dioxane

    Not more than 5 mg/kg

    Ethylene oxide

    Not more than 0,2 mg/kg

    Ethylene glycols (mono- and di-)

    Not more than 0,25 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)



    Synonyms

    Polysorbate 80; Polyoxyethylene (20) sorbitan monooleate

    Definition

    A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis

    Description

    A lemon to amber-coloured oily liquid at 25 °C with a faint characteristic odour

    Identification

    Solubility

    Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

    Purity

    Water content

    Not more than 3 % (Karl Fischer method)

    Acid value

    Not more than 2

    Saponification value

    Not less than 45 and not more than 55

    Hydroxyl value

    Not less than 65 and not more than 80

    1,4-dioxane

    Not more than 5 mg/kg

    Ethylene oxide

    Not more than 0,2 mg/kg

    Ethylene glycols (mono- and di-)

    Not more than 0,25 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)



    Synonyms

    Polysorbate 40; Polyoxyethylene (20) sorbitan monopalmitate

    Definition

    A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis

    Description

    A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour

    Identification

    Solubility

    Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

    Purity

    Water content

    Not more than 3 % (Karl Fischer method)

    Acid value

    Not more than 2

    Saponification value

    Not less than 41 and not more than 52

    Hydroxyl value

    Not less than 90 and not more than 107

    1,4-dioxane

    Not more than 5 mg/kg

    Ethylene oxide

    Not more than 0,2 mg/kg

    Ethylene glycols (mono- and di-)

    Not more than 0,25 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)



    Synonyms

    Polysorbate 60; Polyoxyethylene (20) sorbitan monostearate

    Definition

    A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis

    Description

    A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic odour

    Identification

    Solubility

    Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

    Purity

    Water content

    Not more than 3 % (Karl Fischer method)

    Acid value

    Not more than 2

    Saponification value

    Not less than 45 and not more than 55

    Hydroxyl value

    Not less than 81 and not more than 96

    1,4-dioxane

    Not more than 5 mg/kg

    Ethylene oxide

    Not more than 0,2 mg/kg

    Ethylene glycols (mono- and di-)

    Not more than 0,25 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)



    Synonyms

    Polysorbate 65; Polyoxyethylene (20) sorbitan tristearate

    Definition

    A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis

    Description

    A tan-coloured, waxy solid at 25 °C with a faint characteristic odour

    Identification

    Solubility

    Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol

    Congealing range

    29-33 °C

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

    Purity

    Water content

    Not more than 3 % (Karl Fischer method)

    Acid value

    Not more than 2

    Saponification value

    Not less than 88 and not more than 98

    Hydroxyl value

    Not less than 40 and not more than 60

    1,4-dioxane

    Not more than 5 mg/kg

    Ethylene oxide

    Not more than 0,2 mg/kg

    Ethylene glycols (mono- and di-)

    Not more than 0,25 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 440 (i) PECTIN



    Synonyms

     

    Definition

    Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol

    Einecs

    232-553-0

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol

    Description

    White, light yellow, light grey or light brown powder

    Identification

    Solubility

    Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol

    Purity

    Loss on drying

    Not more than 12 % (105 °C, 2 hours)

    Acid insoluble ash

    Not more than 1 % (insoluble in approximately 3N hydrochloric acid)

    Sulphur dioxide

    Not more than 50 mg/kg on the anhydrous basis

    Nitrogen content

    Not more than 1,0 % after washing with acid and ethanol

    Total insolubles

    Not more than 3 %

    Solvent residues

    Not more than 1 % of free methanol, ethanol and propan-2-ol, singly or in combination, on the volatile matter-free basis

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 440 (ii) AMIDATED PECTIN



    Synonyms

     

    Definition

    Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol

    Description

    White, light yellow, light greyish or light brownish powder

    Identification

    Solubility

    Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol

    Purity

    Loss on drying

    Not more than 12 % (105 °C, 2 hours)

    Acid-insoluble ash

    Not more than 1 % (insoluble in approximately 3N hydrochloric acid)

    Degree of amidation

    Not more than 25 % of total carboxyl groups

    Sulphur dioxide residue

    Not more than 50 mg/kg on the anhydrous basis

    Nitrogen content

    Not more than 2,5 % after washing with acid and ethanol

    Total insolubles:

    Not more than 3 %

    Solvent residues

    Not more than 1 % of methanol, ethanol and propan-2-ol, singly or in combination, on a volatile matter-free basis

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 442 AMMONIUM PHOSPHATIDES



    Synonyms

    Ammonium salts of phosphatidic acid; Mixed ammonium salts of phoshorylated glycerides

    Definition

    A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil. One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N)

    ▼M3

    Description

    Unctuous semi-solid to oily liquid

    ▼B

    Identification

    Solubility

    Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone

    Test for glycerol

    Passes test

    Test fatty acids

    Passes test

    Test for phosphate

    Passes test

    Purity

    Petroleum ether insoluble matter

    Not more than 2,5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 444 SUCROSE ACETATE ISOBUTYRATE



    Synonyms

    SAIB

    Definition

    Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6

    Einecs

    204-771-6

    Chemical name

    Sucrose diacetate hexaisobutyrate

    Chemical formula

    C40H62O19

    Molecular weight

    832-856 (approximate), C40H62O19: 846,9

    Assay

    Content not less than 98,8 % and not more than 101,9 % of C40H62O19

    Description

    A pale straw-coloured liquid, clear and free of sediment and having a bland odour

    Identification

    Solubility

    Insoluble in water. Soluble in most organic solvents

    Refractive index

    [n]D 40: 1,4492-1,4504

    Specific gravity

    [d]25 D: 1,141-1,151

    Purity

    Triacetin

    Not more than 0,1 %

    Acid value

    Not more than 0,2

    Saponification value

    Not less than 524 and not more than 540

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 445 GLYCEROL ESTERS OF WOOD ROSIN



    Synonyms

    Ester gum

    Definition

    A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Hard, yellow to pale amber-coloured solid

    Identification

    Solubility

    Insoluble in water, soluble in acetone

    Infrared absorption spectrum

    Characteristic of the compound

    Purity

    Specific gravity of solution

    [d]20 25 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boiling point 175,5-176 °C, d20 4: 0,84)

    Ring and ball softening range

    Between 82 °C and 90 °C

    Acid value

    Not less than 3 and not more than 9

    Hydroxyl value

    Not less than 15 and not more than 45

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Test for absence of tall oil rosin (sulphur test)

    When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin

    E 450 (i) DISODIUM DIPHOSPHATE



    Synonyms

    Disodium dihydrogen diphosphate; Disodium dihydrogen pyrophosphate; Sodium acid pyrophosphate; Disodium pyrophosphate

    Definition

    Einecs

    231-835-0

    Chemical name

    Disodium dihydrogen diphosphate

    Chemical formula

    Na2H2P2O7

    Molecular weight

    221,94

    Assay

    Content not less than 95 % of disodium diphosphate

    P2O5 content not less than 63,0 % and not more than 64,5 %

    Description

    White powder or grains

    Identification

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Soluble in water

    pH

    Between 3,7 and 5,0 (1 % solution)

    Purity

    Loss on drying

    Not more than 0,5 % (105 °C, 4 hours)

    Water insoluble matter

    Not more than 1 %

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Aluminium

    Not more than 200 mg/kg

    E 450 (ii) TRISODIUM DIPHOSPHATE



    Synonyms

    Trisodium pyrophosphate; Trisodium monohydrogen diphosphate; Trisodium monohydrogen pyrophosphate; Trisodium diphosphate

    Definition

    Einecs

    238-735-6

    Chemical name

     

    Chemical formula

    Monohydrate: Na3HP2O7 · H2O

    Anhydrous: Na3HP2O7

    Molecular weight

    Monohydrate: 261,95

    Anhydrous: 243,93

    Assay

    Content not less than 95 % on the dried basis

    P2O5 content not less than 57 % and not more than 59 %

    Description

    White powder or grains, occurs anhydrous or as a monohydrate

    Identification

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Soluble in water

    pH

    Between 6,7 and 7,5 (1 % solution)

    Purity

    Loss on ignition

    Not more than 4,5 % on the anhydrous compound (450-550 °C).

    Not more than 11,5 % on the monohydrate basis

    Loss on drying

    Not more than 0,5 % (105 °C, 4 hours) for anhydrous

    Not more than 1,0 % (105 °C, 4 hours) for monohdyrate

    Water insoluble matter

    Not more than 0,2 %

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 450 (iii) TETRASODIUM DIPHOSPHATE



    Synonyms

    Tetrasodium pyrophosphate; Tetrasodium disphosphate; Tetrasodium phosphate

    Definition

    Einecs

    231-767-1

    Chemical name

    Tetrasodium diphosphate

    Chemical formula

    Anhydrous: Na4P2O7

    Decahydrate: Na4P2O7 · 10H2O

    Molecular weight

    Anhydrous: 265,94

    Decahydrate: 446,09

    Assay

    Content not less than 95 % of Na4P2O7 on the ignited basis

    P2O5 content not less than 52,5 % and not more than 54,0 %

    Description

    Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air

    Identification

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Soluble in water. Insoluble in ethanol

    pH

    Between 9,8 and 10,8 (1 % solution)

    Purity

    Loss on ignition

    Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate (105 °C, 4 hours then 550 °C, 30 minutes)

    Water insoluble matter

    Not more than 0,2 %

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1mg/kg

    Mercury

    Not more than 1 mg/kg

    E 450 (v) TETRAPOTASSIUM DIPHOSPHATE



    Synonyms

    Tetrapotassium pyrophosphate

    Definition

    Einecs

    230-785-7

    Chemical name

    Tetrapotassium diphosphate

    Chemical formula

    K4P2O7

    Molecular weight

    330,34 (anhydrous)

    Assay

    Content not less than 95 % (800 °C for 0,5 hours)

    P2O5 content not less than 42,0 % and not more than 43,7 % on the anhydrous basis

    Description

    Colourless crystals or white, very hygroscopic powder

    Identification

    Test for potassium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Soluble in water, insoluble in ethanol

    pH

    Between 10,0 and 10,8 (1 % solution)

    Purity

    Loss on ignition

    Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)

    Water insoluble matter

    Not more than 0,2 %

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 450 (vi) DICALCIUM DIPHOSPHATE



    Synonyms

    Calcium pyrophosphate

    Definition

    Einecs

    232-221-5

    Chemical name

    Dicalcium diphosphate

    Dicalcium pyrophosphate

    Chemical formula

    Ca2P2O7

    Molecular weight

    254,12

    Assay

    Content not less than 96 %

    P2O5 content not less than 55 % and not more than 56 %

    Description

    A fine, white, odourless powder

    Identification

    Test for calcium

    Passes test

    Test for phosphate

    Passes test

    Solubility

    Insoluble in water. Soluble in dilute hydrochloric and nitric acids

    pH

    Between 5,5 and 7,0 (10 % suspension in water)

    Purity

    Loss on ignition

    Not more than 1,5 % (800 °C ± 25 °C, 30 minutes

    Fluoride

    Not more than 50 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE



    Synonyms

    Acid calcium pyrophosphate; Monocalcium dihydrogen pyrophosphate

    Definition

    Einecs

    238-933-2

    Chemical name

    Calcium dihydrogen diphosphate

    Chemical formula

    CaH2P2O7

    Molecular weight

    215,97

    Assay

    Content not less than 90 % on the anhydrous basis

    P2O5 content not less than 61 % and not more than 66 %

    Description

    White crystals or powder

    Identification

    Test for calcium

    Passes test

    Test for phosphate

    Passes test

    Purity

    Acid-insoluble matter

    Not more than 0,4 %

    Fluoride

    Not more than 30 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Aluminium

    Not more than 800 mg/kg. This applies until 31 March 2015.

    Not more than 200 mg/kg. This applies from 1 April 2015.

    ▼M10

    E 450 (ix) MAGNESIUM DIHYDROGEN DIPHOSPHATE



    Synonyms

    Acid magnesium pyrophosphate, monomagnesium dihydrogen pyrophosphate; magnesium diphosphate, magnesium pyrophosphate

    Definition

    Magnesium dihydrogen diphosphate is the acidic magnesium salt of diphosphoric acid. It is manufactured by adding an aqueous dispersion of magnesium hydroxide slowly to phosphoric acid, until a molar ratio about 1:2 between Mg and P is reached. The temperature is held under 60 °C during the reaction. About 0,1 % hydrogen peroxide is added to the reaction mixture and the slurry is then heated and milled.

    EINECS

    244-016-8

    Chemical name

    Mono magnesium dihydrogen diphosphate

    Chemical formula

    MgH2P2O7

    Molecular Weight

    200,25

    Assay

    P2O5 content not less than 68,0 % and not more than 70,5 % expressed as P2O5

    MgO content not less than 18,0 % and not more than 20,5 % expressed as MgO

    Description

    White crystals or powder

    Identification

    Solubility

    Slightly soluble in water, practically insoluble in ethanol

    Particle size:

    The average particle size will deviate between 10 and 50 μm

    Purity

    Loss on ignition

    Not more than 12 % (800 °C, 0,5 hours)

    Fluoride

    Not more than 20 mg/kg (expressed as fluorine)

    Aluminium

    Not more than 50 mg/kg

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg.

    Lead

    Not more than 1 mg/kg

    ▼B

    E 451 (i) PENTASODIUM TRIPHOSPHATE



    Synonyms

    Pentasodium tripolyphosphate; Sodium tripolyphosphate

    Definition

    Einecs

    231-838-7

    Chemical name

    Pentasodium triphosphate

    Chemical formula

    Na5O10P3 · nH2O (n = 0 or 6)

    Molecular weight

    367,86

    Assay

    Content not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate)

    P2O5 content not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)

    Description

    White, slightly hygroscopic granules or powder

    Identification

    Solubility

    Freely soluble in water. Insoluble in ethanol

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    pH

    Between 9,1 and 10,2 (1 % solution)

    Purity

    Loss on drying

    Anhydrous: Not more than 0,7 % (105 °C, 1 hour)

    Hexahydrate: Not more than 23,5 % (60 °C, 1 hour, then 105 °C, 4 hours)

    Water insoluble matter

    Not more than 0,1 %

    Higher polyphosphates

    Not more than 1 %

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE



    Synonyms

    Pentapotassium tripolyphosphate; Potassium triphosphate; Potassium tripolyphosphate

    Definition

    Einecs

    237-574-9

    Chemical name

    Pentapotassium triphosphate; Pentapotassium tripolyphosphate

    Chemical formula

    K5O10P3

    Molecular weight

    448,42

    Assay

    Content not less than 85 % on the anhydrous basis

    P2O5 content not less than 46,5 % and not more than 48 %

    Description

    White, very hygroscopic powder or granules

    Identification

    Solubility

    Very soluble in water

    Test for potassium

    Passes test

    Test for phosphate

    Passes test

    pH

    Between 9,2 and 10,5 (1 % solution)

    Purity

    Loss on ignition

    Not more than 0,4 % (105 °C, 4 hours, then 550 °C, 30 minutes)

    Water insoluble matter

    Not more than 2 %

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 452 (i) SODIUM POLYPHOSPHATE

    I.    SOLUBLE POLYPHOSPHATE



    Synonyms

    Sodium hexametaphosphate; Sodium tetrapolyphosphate; Graham's salt; Sodium polyphosphates, glassy; Sodium polymetaphosphate; Sodium metaphosphate

    Definition

    Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)x where x ≥ 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0

    Einecs

    272-808-3

    Chemical name

    Sodium polyphosphate

    Chemical formula

    Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

    Molecular weight

    (102)n

    Assay

    P2O5 content not less than 60 % and not more than 71 % on the ignited basis

    Description

    Colourless or white, transparent platelets, granules, or powders

    Identification

    Solubility

    Very soluble in water

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    pH

    Between 3,0 and 9,0 (1 % solution)

    Purity

    Loss on ignition

    Not more than 1 %

    Water insoluble matter

    Not more than 0,1 %

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    II.    INSOLUBLE POLYPHOSPHATE



    Synonyms

    Insoluble sodium metaphosphate; Maddrell's salt; Insoluble sodium polyphosphate; IMP

    Definition

    Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5

    Einecs

    272-808-3

    Chemical name

    Sodium polyphosphate

    Chemical formula

    Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

    Molecular weight

    (102)n

    Assay

    P2O5 content not less than 68,7 % and not more than 70,0 %

    Description

    White crystalline powder

    Identification

    Solubility

    Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides

    Test for sodium

    Passes test

    Test for phosphate

    Passes test

    pH

    About 6,5 (1 in 3 suspension in water)

    Purity

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 452 (ii) POTASSIUM POLYPHOSPHATE



    Synonyms

    Potassium metaphosphate; Potassium polymetaphosphate; Kurrol salt

    Definition

    Einecs

    232-212-6

    Chemical name

    Potassium polyphosphate

    Chemical formula

    (KPO3)n

    Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

    Molecular weight

    (118)n

    Assay

    P2O5 content not less than 53,5 % and not more than 61,5 % on the ignited basis

    Description

    Fine white powder or crystals or colourless glassy platelets

    Identification

    Solubility

    1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate

    Test for potassium

    Passes test

    Test for phosphate

    Passes test

    pH

    Not more than 7,8 (1 % suspension)

    Purity

    Loss on ignition

    Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)

    Cyclic phosphate

    Not more than 8 % on P2O5 content

    Fluoride

    Not more than 10 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 452(iii) SODIUM CALCIUM POLYPHOSPHATE



    Synonyms

    Sodium calcium polyphosphate, glassy

    Definition

    Einecs

    233-782-9

    Chemical name

    Sodium calcium polyphosphate

    Chemical formula

    (NaPO3)n CaO where n is typically 5

    Molecular weight

     

    Assay

    P2O5 content not less than 61 % and not more than 69 % on the ignited basis

    Description

    White glassy crystals, spheres

    Identification

    pH

    Approximately 5 to 7 (1 % m/m slurry)

    CaO content

    7 % - 15 % m/m

    Purity

    Fluoride

    Not more than 10 mg/kg

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 452 (iv) CALCIUM POLYPHOSPHATE



    Synonyms

    Calcium metaphosphate; Calcium polymetaphosphate

    Definition

    Einecs

    236-769-6

    Chemical name

    Calcium polyphosphate

    Chemical formula

    (CaP2O6)n

    Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where ‘n’ is not less than 2

    Molecular weight

    (198)n

    Assay

    P2O5 content not less than 71 % and not more than 73 % on the ignited basis

    Description

    Odourless, colourless crystals or white powder

    Identification

    Solubility

    Usually sparingly soluble in water. Soluble in acid medium

    Test for calcium

    Passes test

    Test for phosphate

    Passes test

    CaO content

    27 to 29,5 %

    Purity

    Loss on ignition

    Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)

    Cyclic phosphate

    Not more than 8 % (on P2O5 content)

    Fluoride

    Not more than 30 mg/kg (expressed as fluorine)

    Arsenic

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 459 BETA-CYCLODEXTRIN



    Synonyms

     

    Definition

    Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch

    Einecs

    231-493-2

    Chemical name

    Cycloheptaamylose

    Chemical formula

    (C6H10O5)7

    Molecular weight

    1 135

    Assay

    Content not less than 98,0 % of (C6H10O5)7 on an anhydrous basis

    Description

    Virtually odourless white or almost white crystalline solid

    Appearance of the aqueous solution

    Clear and colourless

    Identification

    Solubility

    Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol

    Specific rotation

    [α]D 25 + 160° to + 164° (1 % solution)

    pH value:

    5,0-8,0 (1 % solution)

    Purity

    Water content

    Not more than 14 % (Karl Fischer method)

    Other cyclodextrins

    Not more than 2 % on an anhydrous basis

    Solvent residues

    Not more than 1 mg/kg of each of toluene and trichloroethylene

    Sulphated ash

    Not more than 0,1 %

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    ▼M8

    E 460 (i) MICROCRYSTALLINE CELLULOSE, CELLULOSE GEL



    Synonyms

     

    ▼B

    Definition

    Microcrystalline cellulose is purified, partially depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400

    Einecs

    232-674-9

    Chemical name

    Cellulose

    Chemical formula

    (C6H10O5)n

    Molecular weight

    About 36 000

    Assay

    Not less than 97 % calculated as cellulose on the anhydrous basis

    Particle size

    Not less than 5 μm (not more than 10 % of particles of less than 5 μm)

    Description

    A fine white or almost white odourless powder

    Identification

    Solubility

    Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution

    Colour reaction

    To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes. A red colour is produced

    Infrared absorption spectroscopy

    To be identified

    Suspension test

    Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears

    pH

    The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)

    Purity

    Loss on drying

    Not more than 7 % (105 °C, 3 hours)

    Water soluble matter

    Not more than 0,24 %

    Sulphated ash

    Not more than 0,5 % (800 ± 25 °C)

    Starch

    Not detectable

    To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced

    Carboxyl groups

    Not more than 1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 460 (ii) POWDERED CELLULOSE



    Definition

    Purified, mechanically disintegrated cellulose prepared by processing alpha-cellulose obtained as a pulp from strains of fibrous plant materials

    Einecs

    232-674-9

    Chemical name

    Cellulose; Linear polymer of 1:4 linked glucose residues

    Chemical formula

    (C6H10O5)n

    Molecular weight

    (162)n (n is predominantly 1 000 and greater)

    Assay

    Content not less than 92 %

    Particle size

    Not less than 5 μm (not more than 10 % of particles of less than 5 μm)

    Description

    A white, odourless powder

    Identification

    Solubility

    Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution

    Suspension test

    Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears

    pH

    The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)

    Purity

    Loss on drying

    Not more than 7 % (105 °C, 3 hours)

    Water soluble matter

    Not more than 1,0 %

    Sulphated ash

    Not more than 0,3 % (800 ± 25 °C)

    Starch

    Not detectable

    To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 461 METHYL CELLULOSE



    Synonyms

    Cellulose methyl ether

    Definition

    Methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl groups

    Einecs

     

    Chemical name

    Methyl ether of cellulose

    Chemical formula

    The polymers contain substituted anhydroglucose units with the following general formula:

    C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:

    — H

    — CH3 or

    — CH2CH3

    Molecular weight

    From about 20 000 to 380 000

    Assay

    Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)

    Description

    Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

    Identification

    Solubility

    Swelling in water, producing a clear to opalescent, viscous, colloidal solution.

    Insoluble in ethanol, ether and chloroform.

    Soluble in glacial acetic acid

    pH

    Not less than 5,0 and not more than 8,0 (1 % colloidal solution)

    Purity

    Loss on drying

    Not more than 10 % (105 °C, 3 hours)

    Sulphated ash

    Not more than 1,5 % (800 ± 25 °C)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 462 ETHYL CELLULOSE



    Synonyms

    Cellulose ethyl ether

    Definition

    Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups

    Einecs

     

    Chemical name

    Ethyl ether of cellulose

    Chemical formula

    The polymers contain substituted anhydroglucose units with the following general formula:

    C6H7O2(OR1)(OR2) where R1 and R2 may be any of the following:

    — H

    — CH2CH3

    Molecular weight

     

    Assay

    Content not less than 44 % and not more than 50 % of ethoxyl groups (-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)

    Description

    Slightly hygroscopic white to off-white, odourless and tasteless powder

    Identification

    Solubility

    Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate

    Film forming test

    Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable

    pH

    Neutral to litmus (1 % colloidal solution)

    Purity

    Loss on drying

    Not more than 3 % (105 °C, 2 hours)

    Sulphated ash

    Not more than 0,4 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 463 HYDROXYPROPYL CELLULOSE



    Synonyms

    Cellulose hydroxypropyl ether

    Definition

    Hydroxypropylcellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with hydroxypropyl groups

    Einecs

     

    Chemical name

    Hydroxypropyl ether of cellulose

    Chemical formula

    The polymers contain substituted anhydroglucose units with the following general formula:

    C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following:

    — H

    — CH2CHOHCH3

    — CH2CHO(CH2CHOHCH3)CH3

    — CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3

    Molecular weight

    From about 30 000 to 1 000 000

    Assay

    Content not more than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis

    Description

    Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

    Identification

    Solubility

    Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether

    Gas chromatography

    Determine the substituents by gas chromotography

    pH

    Not less than 5,0 and not more than 8,0 (1 % colloidal solution)

    Purity

    Loss on drying

    Not more than 10 % (105 °C, 3 hours)

    Sulphated ash

    Not more than 0,5 % determined at 800 ± 25 °C

    Propylene chlorohydrins

    Not more than 0,1 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 464 HYDROXYPROPYL METHYL CELLULOSE



    Synonyms

     

    Definition

    Hydroxypropyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution

    Einecs

     

    Chemical name

    2-Hydroxypropyl ether of methylcellulose

    Chemical formula

    The polymers contain substituted anhydroglucose units with the following general formula:

    C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following:

    — H

    — CH3

    — CH2CHOHCH3

    — CH2CHO (CH2CHOHCH3) CH3

    — CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3

    Molecular weight

    From about 13 000 to 200 000

    Assay

    Content not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and not less than 3 % and not more than 12 % hydroxypropoxyl groups (-OCH2CHOHCH3), on the anhydrous basis

    Description

    Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

    Identification

    Solubility

    Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol

    Gas chromatography

    Determine the substituents by gas chromatography

    pH

    Not less than 5,0 and not more than 8,0 (1 % colloidal solution)

    Purity

    Loss on drying

    Not more than 10 % (105 °C, 3 hours)

    Sulphated ash

    Not more than 1,5 % for products with viscosities of 50 mPa.s or above

    Not more than 3 % for products with viscosities below 50 mPa.s

    Propylene chlorohydrins

    Not more than 0,1 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 465 ETHYL METHYL CELLULOSE



    Synonyms

    Methylethylcellulose

    Definition

    Ethyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl and ethyl groups

    Einecs

     

    Chemical name

    Ethyl methyl ether of cellulose

    Chemical formula

    The polymers contain substituted anhydroglucose units with the following general formula:

    C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following:

    — H

    — CH3

    — CH2CH3

    Molecular weight

    From about 30 000 to 40 000

    Assay

    Content on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl

    Description

    Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

    Identification

    Solubility

    Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether

    pH

    Not less than 5,0 and not more than 8,0 (1 % colloidal solution)

    Purity

    Loss on drying

    Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 °C to constant weight)

    Sulphated ash

    Not more than 0,6 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    ▼M8

    E 466 SODIUM CARBOXY METHYL CELLULOSE, CELLULOSE GUM



    Synonyms

    NaCMC; Sodium CMC

    Definition

    Sodium carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from strains of fibrous plant material

    ▼B

    Einecs

     

    Chemical name

    Sodium salt of the carboxymethyl ether of cellulose

    Chemical formula

    The polymers contain substituted anhydroglucose units with the following general formula:

    C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following:

    — H

    — CH2COONa

    — CH2COOH

    Molecular weight

    Higher than approximately 17 000 (degree of polymerisation approximately 100)

    Assay

    Content on the anhydrous basis not less than 99,5 %

    Description

    Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder

    Identification

    Solubility

    Yields a viscous colloidal solution with water. Insoluble in ethanol

    Foam test

    A 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers)

    Precipitate formation

    To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)

    Colour reaction

    Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:

    To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface

    pH

    Not less than 5,0 and not more than 8,5 (1 % colloidal solution)

    Purity

    Degree of substitution

    Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit

    Loss on drying

    Not more than 12 % (105 °C to constant weight)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total glycolate

    Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis

    Sodium

    Not more than 12,4 % on the anhydrous basis

    E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE, CROSS-LINKED CELLULOSE GUM



    Synonyms

    Cross-linked carboxymethyl cellulose; Cross-linked CMC; Cross-linked sodium CMC;

    Definition

    Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose

    Einecs

     

    Chemical name

    Sodium salt of the cross-linked carboxymethyl ether cellulose

    Chemical formula

    The polymers containing substituted anhydroglucose units with the general formula:

    C6H7O2(OR1)(OR2)(OR3) where R1, R2 and R3 may be any of the following:

    — H

    — CH2COONa

    — CH2COOH

    Molecular weight

     

    Assay

     

    Description

    Slightly hygroscopic, white to off white, odourless powder

    Identification

    Precipitate formation

    Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass

    Colour reaction

    Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface

    Test for sodium

    Passes test

    pH

    Not less than 5,0 and not more than 7,0 (1 % solution)

    Purity

    Loss on drying

    Not more than 6 % (105 °C, 3 hours)

    Water soluble matter

    Not more than 10 %

    Degree of substitution

    Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit

    Sodium content

    Not more than 12,4 % on anhydrous basis

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE, ENZYMATICALLY HYDROLISED CELLULOSE GUM



    Synonyms

    Sodium carboxymethyl cellulose, enzymatically hydrolysed

    Definition

    Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei)

    Einecs

     

    Chemical name

    Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed

    Chemical formula

    Sodium salts of polymers containing substituted anhydroglucose units with the general formula:

    [C6H7O2(OH)x(OCH2COONa)y]n

    where n is the degree of polymerisation

    x = 1,50 to 2,80

    y = 0,2 to 1,50

    x + y = 3,0

    (y = degree of substitution)

    Molecular weight

    178,14 where y = 0,20

    282,18 where y = 1,50

    Macromolecules: Not less than 800 (n about 4)

    Assay

    Not less than 99,5 %, including mono- and disaccharides, on the dried basis

    Description

    White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder

    Identification

    Solubility

    Soluble in water, insoluble in ethanol

    Foam test

    Vigorously shake a 0,1 % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums

    Precipitate formation

    To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum

    Colour reaction

    Add 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface

    Viscosity (60 % solids)

    Not less than 2 500 kgm– 1s– 1 at 25 °C corresponding to an average molecule weight of 5 000 Da

    pH

    Not less than 6,0 and not more than 8,5 (1 % colloidal solution)

    Purity

    Loss on drying

    Not more than 12 % (105 °C to constant weight)

    Degree of substitution

    Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis

    Sodium chloride and sodium glycolate

    Not more than 0,5 % singly or in combination

    Residual enzyme activity

    Passes test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose

    Lead

    Not more than 3 mg/kg

    E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS



    Synonyms

     

    Definition

    Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids.

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content on the anhydrous basis not less than 95 % (105 °C till a constant weight)

    Description

    White or creamy white light powders, flakes or semi-solids

    Identification

    Solubility

    Sodium and potassium salts: soluble in water and ethanol. Calcium salts: insoluble in water, ethanol and ether

    Test for cations

    Passes test

    Test for fatty acids

    Passes test

    Purity

    Sodium

    Not less than 9 % and not more than 14 % expressed as Na2O

    Potassium

    Not less than 13 % and not more than 21,5 % expressed as K2O

    Calcium

    Not less than 8,5 % and not more than 13 % expressed as CaO

    Unsaponifiable matter

    Not more than 2 %

    Free fatty acids

    Not more than 3 % estimated as oleic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Free alkali

    Not more than 0,1 % expressed as NaOH

    Matter insoluble in alcohol

    Not more than 0,2 % (sodium and potassium salts only)

    E 470b MAGNESIUM SALTS OF FATTY ACIDS



    Synonyms

     

    Definition

    Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content on the anhydrous basis not less than 95 % (105 °C till a constant weight)

    Description

    White or creamy-white light powders, flakes or semi-solids

    Identification

    Solubility

    Insoluble in water, partially soluble in ethanol and ether

    Test for magnesium

    Passes test

    Test for fatty acids

    Passes test

    Purity

    Magnesium

    Not less than 6,5 % and not more than 11 % expressed as MgO

    Free alkali

    Not more than 0,1 % expressed as MgO

    Unsaponifiable matter

    Not more than 2 %

    Free fatty acids

    Not more than 3 % estimated as oleic acid

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS



    Synonyms

    Glyceryl monostearate; Glyceryl monopalmitate; Glyceryl monooleate, etc.; Monostearin; Monopalmitin; Monoolein, etc.; GMS (for glyceryl monostearate)

    Definition

    Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content of mono- and diesters: not less than 70 %

    Description

    The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads

    Identification

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyol

    Test for glycerol

    Passes test

    Test for fatty acids

    Passes test

    Solubility

    Insoluble in water, soluble in ethanol and toluene at 50 °C

    Purity

    Water content

    Not more than 2 % (Karl Fischer method)

    Acid value

    Not more than 6

    Free glycerol

    Not more than 7 %

    Polyglycerols

    Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total glycerol

    Not less than 16 % and not more than 33 %

    Sulphated ash

    Not more than 0,5 % determined at 800 ± 25 °C

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS



    Synonyms

    Acetic acid esters of mono- and diglycerides; Acetoglycerides; Acetylated mono- and diglycerides; Acetic and fatty acid esters of glycerol

    Definition

    Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Clear, mobile liquids to solids, from white to pale yellow in colour

    Identification

    Test for glycerol

    Passes test

    Test for fatty acids

    Passes test

    Test for acetic acid

    Passes test

    Solubility

    Insoluble in water. Soluble in ethanol

    Purity

    Acids other than acetic and fatty acids

    Less than 1 %

    Free glycerol

    Not more than 2 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total acetic acid

    Not less than 9 % and not more than 32 %

    Free fatty acids (and acetic acid)

    Not more than 3 % estimated as oleic acid

    Total glycerol

    Not less than 14 % and not more than 31 %

    Sulphated ash

    Not more than 0,5 % determined at 800 ± 25 °C

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS



    Synonyms

    Lactic acid esters of mono- and diglycerides; Lactoglycerides; Mono- and diglycerides of fatty acids esterified with lactic acid

    Definition

    Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides

    Description

    Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour

    Identification

    Test for glycerol,

    Passes test

    Test for fatty acids

    Passes test

    Test for lactic acid

    Passes test

    Solubility

    Insoluble in cold water but dispersible in hot water

    Purity

    Acids other than lactic and fatty acids

    Less than 1 %

    Free glycerol

    Not more than 2 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total lactic acid

    Not less than 13 % and not more than 45 %

    Free fatty acids (and lactic acid)

    Not more than 3 % estimated as oleic acid

    Total glycerol

    Not less than 13 % and not more than 30 %

    Sulphated ash

    Not more than 0,5 % (800 ± 25 °C)

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS



    Synonyms

    Citrem; Citric acid esters of mono- and diglycerides; Citroglycerides; Mono- and diglycerides of fatty acids esterified with citric acid

    Definition

    Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium, potassium or calcium salts suitable for the purpose and authorised as food additives according to this Regulation.

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Yellowish or light brown liquids to waxy solids or semi-solids

    Identification

    Test for glycerol

    Passes test

    Test for fatty acids

    Passes test

    Test for citric acid

    Passes test

    Solubility

    Insoluble in cold water, dispersible in hot water, soluble in oils and fats, insoluble in cold ethanol

    Purity

    Acids other than citric and fatty acids

    Less than 1 %

    Free glycerol

    Not more than 2 %

    Total glycerol

    Not less than 8 % and not more than 33 %

    Total citric acid

    Not less than 13 % and not more than 50 %

    Sulphated ash

    Non-neutralised products: not more than 0,5 % (800 ± 25 °C)

    Partially or wholly neutralised products: not more than 10 % (800 ± 25 °C)

    Lead

    Not more than 2 mg/kg

    Acid value

    Not more than 130

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS



    Synonyms

    Tartaric acid esters of mono- and diglycerides; Mono- and diglycerides of fatty acids esterified with tartaric acid

    Definition

    Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Sticky viscous yellowish liquids to hard yellow waxes

    Identification

    Test for glycerol

    Passes test

    Test for fatty acids

    Passes test

    Test for tartaric acid

    Passes test

    Purity

    Acids other than tartaric and fatty acids

    Less than 1,0 %

    Free glycerol

    Not more than 2 %

    Total glycerol

    Not less than 12 % and not more than 29 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total tartaric acid

    Not less than 15 % and not more than 50 %

    Free fatty acids

    Not more than 3 % estimated as oleic acid

    Sulphated ash

    Not more than 0,5 % (800 ± 25 °C)

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS



    Synonyms

    Diacetyltartaric acid esters of mono- and diglycerides; Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid; Diacetyltartaric and fatty acid esters of glycerol

    Definition

    Mixed esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid

    Identification

    Test for glycerol

    Passes test

    Test for fatty acids

    Passes test

    Test for tartaric acid

    Passes test

    Test for acetic acid

    Passes test

    Purity

    Acids other than acetic, tartaric and fatty acids

    Less than 1 %

    Free glycerol

    Not more than 2 %

    Total glycerol

    Not less than 11 % and not more than 28 %

    Sulphated ash

    Not more than 0,5 % determined at 800 ± 25 °C

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total tartaric acid

    Not less than 10 % and not more than 40 %

    Total acetic acid

    Not less than 8 % and not more than 32 %

    Acid value

    Not less than 40 and not more than 130

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS



    Synonyms

    Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid

    Definition

    Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Sticky liquids to solids, from white to pale-yellow in colour

    Identification

    Test for glycerol

    Passes test

    Test for fatty acids

    Passes test

    Test for tartaric acid

    Passes test

    Test for acetic acid

    Passes test

    Purity

    Acids other than acetic, tartaric and fatty acids

    Less than 1,0 %

    Free glycerol

    Not more than 2 %

    Total glycerol

    Not less than 12 % and not more than 27 %

    Sulphated ash

    Not more than 0,5 % (800 ± 25 °C)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Total acetic acid

    Not less than 10 % and not more than 20 %

    Total tartaric acid

    Not less than 20 % and not more than 40 %

    Free fatty acids

    Not more than 3 % estimated as oleic acid

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 473 SUCROSE ESTERS OF FATTY ACIDS



    Synonyms

    Sucroesters; Sugar esters

    Definition

    Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl, ethyl and vinyl esters of food fatty acids (including lauric acid) or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propan-2-ol, 2-methyl-1-propanol, propylene glycol, methyl ethyl ketone and supercritical carbondioxide may be used for their preparation. p-methoxy phenol can be used as a stabiliser during the manufacturing procedure.

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 80 %

    Description

    Stiff gels, soft solids or white to slightly greyish-white powders

    Identification

    Test for sugar

    Passes test

    Test for fatty acids

    Passes test

    Solubility

    Sparingly soluble in water, soluble in ethanol

    Purity

    Sulphated ash

    Not more than 2 % (800 ± 25 °C)

    Free sugar

    Not more than 5 %

    Free fatty acids

    Not more than 3 % estimated as oleic acid

    p-methoxy-phenol

    Not more than 100 μg/kg

    Acetaldehyde

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Methanol

    Not more than 10 mg/kg

    Dimethylsulphoxide

    Not more than 2 mg/kg

    Dimethylformamide

    Not more than 1 mg/kg

    2-methyl-1-propanol

    Not more than 10 mg/kg

    Ethyl acetate

    right accolade Not more than 350 mg/kg, singly or in combination

    Propan-2-ol

    Propylene glycol

    Methyl ethyl ketone

    Not more than 10 mg/kg

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 474 SUCROGLYCERIDES



    Synonyms

    Sugar glycerides

    Definition

    Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids (including lauric acid) together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propan-2-ol

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 40 % and not more than 60 % of sucrose fatty acid esters

    Description

    Soft solid masses, stiff gels or white to off-white powders

    Identification

    Test for sugar

    Passes test

    Test for fatty acids

    Passes test

    Solubility

    Insoluble in cold water, soluble in ethanol

    Purity

    Sulphated ash

    Not more than 2 % (800 ± 25 °C)

    Free sugar

    Not more than 5 %

    Free fatty acids

    Not more than 3 % (estimated as oleic acid)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Methanol

    Not more than 10 mg/kg

    Dimethylformamide

    Not more than 1 mg/kg

    2-Methyl-1-propanol

    right accolade Not more than 10 mg/kg, single or in combination

    Cyclohexane

    Ethyl acetate

    right accolade Not more than 350 mg/kg, single or in combination

    Propan-2-ol

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS



    Synonyms

    Polyglycerol fatty acid esters; Polyglycerin esters of fatty acid esters

    Definition

    Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content of total fatty acid ester not less than 90 %

    Description

    Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids

    Identification

    Test for glycerol,

    Passes test

    Test for polyglycerols

    Passes test

    Test for fatty acids

    Passes test

    Solubility

    The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils

    Purity

    Sulphated ash

    Not more than 0,5 % (800 ± 25 °C)

    Acids other than fatty acids

    Less than 1 %

    Free fatty acids

    Not more than 6 % estimated as oleic acid

    Total glycerol and polyglycerol

    Not less than 18 % and not more than 60 %

    Free glycerol and polyglycerol

    Not more than 7 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 476 POLYGLYCEROL POLYRICINOLEATE



    Synonyms

    Glycerol esters of condensed castor oil fatty acids; Polyglycerol esters of polycondensed fatty acids from castor oil; Polyglycerol esters of interesterified ricinoleic acid; PGPR

    Definition

    Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Clear, highly viscous liquid

    Identification

    Solubility

    Insoluble in water and in ethanol; soluble in ether, hydrocarbons and halogenated hydrocarbons

    Test for glycerol

    Passes test

    Test for polyglycerol

    Passes test

    Test for ricinoleic acid

    Passes test

    Refractive index

    [n]D 65 between 1,4630 and 1,4665

    Purity

    Polyglycerols

    The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol

    Hydroxyl value

    Not less than 80 and not more than 100

    Acid value

    Not more than 6

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS



    Synonyms

    Propylene glycol esters of fatty acids

    Definition

    Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content of total fatty acid ester not less than 85 %

    Description

    Clear liquids or waxy white flakes, beads or solids having a bland odour

    Identification

    Test for propylene glycol

    Passes test

    Test for fatty acids

    Passes test

    Purity

    Sulphated ash

    Not more than 0,5 % (800 ± 25 °C)

    Acids other than fatty acids

    Less than 1 %

    Free fatty acids

    Not more than 6 % estimated as oleic acid

    Total propane-1,2-diol

    Not less than 11 % and not more than 31 %

    Free propane-1,2-diol

    Not more than 5 %

    Dimer and trimer of propylene glycol

    Not more than 0,5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)

    E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS



    Synonyms

    TOSOM

    Definition

    Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and deodorisation under vacuum at 130 °C of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from strains of soya beans

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Pale yellow to light brown a waxy or solid consistency

    Identification

    Solubility

    Insoluble in water. Soluble in hot oil or fat

    Purity

    Melting range

    55-65 °C

    Free fatty acids

    Not more than 1,5 % estimated as oleic acid

    Free glycerol

    Not more than 2 %

    Total fatty acids

    83-90 %

    Total glycerol

    16-22 %

    Fatty acid methyl esters, not forming adduct with urea

    Not more than 9 % of total fatty acid methyl esters

    Fatty acids, insoluble in petroleum ether

    Not more than 2 % of total fatty acids

    Peroxide value

    Not more than 3

    Epoxides

    Not more than 0,03 % oxirane oxygen

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 481 SODIUM STEAROYL-2-LACTYLATE



    Synonyms

    Sodium stearoyl lactylate; Sodium stearoyl lactate

    Definition

    A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used

    Einecs

    246-929-7

    Chemical name

    Sodium di-2-stearoyl lactate

    Sodium di(2-stearoyloxy)propionate

    Chemical formula

    C21H39O4Na; C19H35O4Na (major components)

    Molecular weight

     

    Assay

     

    Description

    White or slightly yellowish powder or brittle solid with a characteristic odour

    Identification

    Test for sodium

    Passes test

    Test for fatty acids

    Passes test

    Test for lactic acid

    Passes test

    Solubility

    Insoluble in water. Soluble in ethanol

    Purity

    Sodium

    Not less than 2,5 % and not more than 5 %

    Ester value

    Not less than 90 and not more than 190

    Acid value

    Not less than 60 and not more than 130

    Total lactic acid

    Not less than 15 % and not more than 40 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 482 CALCIUM STEAROYL-2-LACTYLATE



    Synonyms

    Calcium stearoyl lactate

    Definition

    A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used

    Einecs

    227-335-7

    Chemical name

    Calcium di-2-stearoyl lactate

    Calcium di(2-stearoyloxy)propionate

    Chemical formula

    C42H78O8Ca; C38H70O8Ca, C40H74O8Ca (major components)

    Molecular weight

     

    Assay

     

    Description

    White or slightly yellowish powder or brittle solid with a characteristic odour

    Identification

    Test for calcium

    Passes test

    Test for fatty acids

    Passes test

    Test for lactid acid

    Passes test

    Solubility

    Slightly soluble in hot water

    Purity

    Calcium

    Not less than 1 % and not more than 5,2 %

    Ester value

    Not less than 125 and not more than 190

    Total lactic acid

    Not less than 15 % and not more than 40 %

    Acid value

    Not less than 50 and not more than 130

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 483 STEARYL TARTRATE



    Synonyms

    Stearyl palmityl tartrate

    Definition

    Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials

    Einecs

     

    Chemical name

    Distearyl tartrate

    Dipalmityl tartrate

    Stearylpalmityl tartrate

    Chemical formula

    C40H78O6 (Distearyl tartrate)

    C36H70O6 (Dipalmityl tartrate)

    C38H74O6 (Stearylpalmityl tartrate)

    Molecular weight

    655 (Distearyl tartrate)

    599 (Dipalmityl tartrate)

    627 (Stearylpalmityl tartrate)

    Assay

    Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180

    Description

    Cream-coloured unctuous solid (at 25 °C)

    Identification

    Test for tartrate

    Passes test

    Melting range

    Between 67 °C and 77 °C. After saponification the saturated long chain fatty alcohols have a melting range of 49 °C to 55 °C

    Purity

    Hydroxyl value

    Not less than 200 and not more than 220

    Acid value

    Not more than 5,6

    Total tartaric acid

    Not less than 18 % and not more than 35 %

    Sulphated ash

    Not more than 0,5 % (800 ± 25 °C)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Unsaponifiable matter

    Not less than 77 % and not more than 83 %

    Iodine value

    Not more than 4 (Wijs method)

    E 491 SORBITAN MONOSTEARATE



    Synonyms

     

    Definition

    A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid

    Einecs

    215-664-9

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters

    Description

    Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour

    Identification

    Solubility

    Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 °C in mineral oil and ethyl acetate

    Congealing range

    50-52 °C

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyol

    Purity

    Water content

    Not more than 2 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,5 %

    Acid value

    Not more than 10

    Saponification value

    Not less than 147 and not more than 157

    Hydroxyl value

    Not less than 235 and not more than 260

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 492 SORBITAN TRISTEARATE



    Synonyms

     

    Definition

    A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid

    Einecs

    247-891-4

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters

    Description

    Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour

    Identification

    Solubility

    Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol

    Congealing range

    47-50 °C

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyol

    Purity

    Water content

    Not more than 2 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,5 %

    Acid value

    Not more than 15

    Saponification value

    Not less than 176 and not more than 188

    Hydroxyl value

    Not less than 66 and not more than 80

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 493 SORBITAN MONOLAURATE



    Synonyms

     

    Definition

    A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid

    Einecs

    215-663-3

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters

    Description

    Amber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour

    Identification

    Solubility

    Dispersible in hot and cold water

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of a polyol

    Purity

    Water content

    Not more than 2 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,5 %

    Acid value

    Not more than 7

    Saponification value

    Not less than 155 and not more than 170

    Hydroxyl value

    Not less than 330 and not more than 358

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 494 SORBITAN MONOOLEATE



    Synonyms

     

    Definition

    A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate

    Einecs

    215-665-4

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters

    Description

    Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour

    Identification

    Solubility

    Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetra-chloride. Insoluble in cold water, dispersible in warm water

    Iodine value

    The residue of oleic acid, obtained from the saponification of the sorbitan monooleate in assay, has a iodine value between 80 and 100

    Purity

    Water content

    Not more than 2 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,5 %

    Acid value

    Not more than 8

    Saponification value

    Not less than 145 and not more than 160

    Hydroxyl value

    Not less than 193 and not more than 210

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 495 SORBITAN MONOPALMITATE



    Synonyms

    Sorbitan palmitate

    Definition

    A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid

    Einecs

    247-568-8

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters

    Description

    Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour

    Identification

    Solubility

    Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water

    Congealing range

    45-47 °C

    Infrared absorption spectrum

    Characteristic of a partial fatty acid ester of polyol

    Purity

    Water content

    Not more than 2 % (Karl Fischer method)

    Sulphate ash

    Not more than 0,5 %

    Acid value

    Not more than 7,5

    Saponification value

    Not less than 140 and not more than 150

    Hydroxyl value

    Not less than 270 and not more than 305

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    ▼M5

    E 499 STIGMASTEROL-RICH PLANT STEROLS



    Synonyms

     

    Definition

    Stigmasterol-rich plant sterols are derived from soybeans and are a chemically defined simple mixture that comprises not less than 95 % of plant sterols (stigmasterol, β-sitosterol, campesterol and brassicasterol), with stigmasterol representing not less than 85 % of the stigmasterol-rich plant sterols.

    Einecs

     

    Chemical name

     

    Stigmasterol

    (3S,8S,9S,10R,13R,14S,17R)-17-(5-ethyl-6-methyl-hept-3-en-2-yl)-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol

    β-Sitosterol

    (3S,8S,9S,10R,13R,14S,17R)-17-[(2S,5S)-5-ethyl-6-methylheptan-2-yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol

    Campesterol

    (3S,8S,9S,10R,13R,14S,17R)-17-(5,6-dimethylheptan-2-yl)-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol

    Brassicasterol

    (3S,8S,9S,10R,13R,14S,17R)-17-[(E,2R,5R)-5,6-dimethylhept-3-en-2-yl]-10,13-dimethyl-2,3,4,7,8,9,11,12,14,15,16,17-dodecahydro-1Hcyclopenta[a]phenanthren-3-ol

    Chemical formula

     

    Stigmasterol

    C29H48O

    β-Sitosterol

    C29H50O

    Campesterol

    C28H48O

    Brassicasterol

    C28H46O

    Molecular weight

     

    Stigmasterol

    412,6 g/mol

    β-Sitosterol

    414,7 g/mol

    Campesterol

    400,6 g/mol

    Brassicasterol

    398,6 g/mol

    Assay (products containing only free sterols and stanols)

    Content not less than 95 % on a total free sterol/stanol basis on the anhydrous basis

    Description

    Free-flowing, white to off-white powders, pills or pastilles; colourless to pale yellow liquids

    Identification

     

    Solubility

    Practically insoluble in water. Phytosterols and phytostanols are soluble in acetone and ethyl acetate.

    Stigmasterol content

    Not less than 85 % (w/w)

    Other plant sterols/stanols: either singularly or in combination including Brassicasterol, campestanol, campesterol, Δ-7-campesterol, cholesterol, chlerosterol, sitostanol and β-sitosterol.

    Not more than 15 % (w/w)

    Purity

     

    Total Ash

    Not more than 0,1 %

    Residual Solvents

    Ethanol: Not more than 5 000  mg/kg

    Methanol: Not more than 50 mg/kg

    Water content

    Not more than 4 % (Karl Fischer method)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 1 mg/kg

    Microbiological criteria

     

    Total plate count

    Not more than 1 000 CFU/g

    Yeasts

    Not more than 100 CFU/g

    Moulds

    Not more than 100 CFU/g

    Escherichia coli

    Not more than 10 CFU/g

    Salmonella spp.

    Absent in 25 g

    ▼B

    E 500 (i) SODIUM CARBONATE



    Synonyms

    Soda ash

    Definition

    Einecs

    207-838-8

    Chemical name

    Sodium carbonate

    Chemical formula

    Na2CO3 · nH2O (n = 0, 1 or 10)

    Molecular weight

    106,00 (anhydrous)

    Assay

    Content not less than 99 % of Na2CO3 on the anhydrous basis

    Description

    Colourless crystals or white, granular or crystalline powder

    The anhydrous form is hygroscopic, the decahydrate efflorescent

    Identification

    Test for sodium

    Passes test

    Test for carbonate

    Passes test

    Solubility

    Freely soluble in water. Insoluble in ethanol

    Purity

    Loss on drying

    Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 °C raising gradually to 300 °C, to constant weight)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 500 (ii) SODIUM HYDROGEN CARBONATE



    Synonyms

    Sodium bicarbonate; sodium acid carbonate; Bicarbonate of soda; Baking soda

    Definition

    Einecs

    205-633-8

    Chemical name

    Sodium hydrogen carbonate

    Chemical formula

    NaHCO3

    Molecular weight

    84,01

    Assay

    Content not less than 99 % on the anhydrous basis

    Description

    Colourless or white crystalline masses or crystalline powder

    Identification

    Test for sodium

    Passes test

    Test for carbonate

    Passes test

    pH

    Between 8,0 and 8,6 (1 % solution)

    Solubility

    Soluble in water. Insoluble in ethanol

    Purity

    Loss on drying

    Not more than 0,25 % (over silica gel, 4 hours)

    Ammonium salts

    No odour of ammonia detectable after heating

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 500 (iii) SODIUM SESQUICARBONATE



    Synonyms

     

    Definition

    Einecs

    208-580-9

    Chemical name

    Sodium monohydrogen dicarbonate

    Chemical formula

    Na2CO3 · NaHCO3 · 2H2O

    Molecular weight

    226,03

    Assay

    Content between 35,0 % and 38,6 % of NaHCO3 and between 46,4 % and 50,0 % of Na2CO3

    Description

    White flakes, crystals or crystalline powder

    Identification

    Test for sodium

    Passes test

    Test for carbonate

    Passes test

    Solubility

    Freely soluble in water

    Purity

    Sodium chloride

    Not more than 0,5 %

    Iron

    Not more than 20 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 501 (i) POTASSIUM CARBONATE



    Synonyms

     

    Definition

    Einecs

    209-529-3

    Chemical name

    Potassium carbonate

    Chemical formula

    K2CO3 · nH2O (n = 0 or 1,5)

    Molecular weight

    138,21 (anhydrous)

    Assay

    Content not less than 99,0 % on the anhydrous basis

    Description

    White, very deliquescent powder.

    The hydrate occurs as small, white, translucent crystals or granules

    Identification

    Test for potassium

    Passes test

    Test for carbonate

    Passes test

    Solubility

    Very soluble in water. Insoluble in ethanol

    Purity

    Loss on drying

    Not more than 5 % (anhydrous) or 18 % (hydrate) (180 °C, 4 hours)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 501 (ii) POTASSIUM HYDROGEN CARBONATE



    Synonyms

    Potassium bicarbonate; Acid potassium carbonate

    Definition

    Einecs

    206-059-0

    Chemical name

    Potassium hydrogen carbonate

    Chemical formula

    KHCO3

    Molecular weight

    100,11

    Assay

    Content not less than 99,0 % and not more than 101,0 % KHCO3 on the anhydrous basis

    Description

    Colourless crystals or white powder or granules

    Identification

    Test for potassium

    Passes test

    Test for carbonate

    Passes test

    Solubility

    Freely soluble in water. Insoluble in ethanol

    Purity

    Loss on drying

    Not more than 0,25 % (over silica gel, 4 hours)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 503 (i) AMMONIUM CARBONATE



    Synonyms

     

    Definition

    Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions

    Einecs

    233-786-0

    Chemical name

    Ammonium carbonate

    Chemical formula

    CH6N2O2, CH8N2O3 and CH5NO3

    Molecular weight

    Ammonium carbamate 78,06; ammonium carbonate 98,73; ammonium hydrogen carbonate 79,06

    Assay

    Content not less than 30,0 % and not more than 34,0 % of NH3

    Description

    White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide

    Identification

    Test for ammonium

    Passes test

    Test for carbonate

    Passes test

    pH

    About 8,6 (5 % solution)

    Solubility

    Soluble in water

    Purity

    Non-volatile matter

    Not more than 500 mg/kg

    Chlorides

    Not more than 30 mg/kg

    Sulphate

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 503 (ii) AMMONIUM HYDROGEN CARBONATE



    Synonyms

    Ammonium bicarbonate

    Definition

    Einecs

    213-911-5

    Chemical name

    Ammonium hydrogen carbonate

    Chemical formula

    CH5NO3

    Molecular weight

    79,06

    Assay

    Content not less than 99,0 %

    Description

    White crystals or crystalline powder

    Identification

    Test for ammonium

    Passes test

    Test for carbonate

    Passes test

    pH

    About 8,0 (5 % solution)

    Solubility

    Freely soluble in water. Insoluble in ethanol

    Purity

    Non-volatile matter

    Not more than 500 mg/kg

    Chlorides

    Not more than 30 mg/kg

    Sulphate

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 504 (i) MAGNESIUM CARBONATE



    Synonyms

    Hydromagnesite

    Definition

    Magnesium carbonate is a basic hydrated or a monohydrated magnesium carbonate or a mixture of the two.

    Einecs

    208-915-9

    Chemical name

    Magnesium carbonate

    Chemical formula

    MgCO3 · nH2O

    Assay

    Not less than 24 % and not more than 26,4 % of Mg

    Description

    Odourless, light, white friable masses or as a bulky white powder

    Identification

    Test for magnesium

    Passes test

    Test for carbonate

    Passes test

    Solubility

    Practically insoluble both in water or ethanol

    Purity

    Acid insoluble matter

    Not more than 0,05 %

    Water soluble matter

    Not more than 1,0 %

    Calcium

    Not more than 0,4 %

    Arsenic

    Not more than 4 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 504 (ii) MAGNESIUM HYDROXIDE CARBONATE



    Synonyms

    Magnesium hydrogen carbonate; Magnesium subcarbonate (light or heavy); Hydrated basic magnesium carbonate; Magnesium carbonate hydroxide

    Definition

    Einecs

    235-192-7

    Chemical name

    Magnesium carbonate hydroxide hydrated

    Chemical formula

    4MgCO3Mg(OH)2 · 5H2O

    Molecular weight

    485

    Assay

    Mg content not less than 40,0 % and not more than 45,0 % calculated as MgO

    Description

    Light, white friable mass or bulky white powder

    Identification

    Test for magnesium

    Passes test

    Test for carbonate

    Passes test

    Solubility

    Practically insoluble in water. Insoluble in ethanol

    Purity

    Acid insoluble matter

    Not more than 0,05 %

    Water soluble matter

    Not more than 1,0 %

    Calcium

    Not more than 1,0 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 507 HYDROCHLORIC ACID



    Synonyms

    Hydrogen chloride; Muriatic acid

    Definition

    Einecs

    231-595-7

    Chemical name

    Hydrochloric acid

    Chemical formula

    HCl

    Molecular weight

    36,46

    Assay

    Hydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0 % HCl

    Description

    Clear, colourless or slightly yellowish, corrosive liquid having a pungent odour

    Identification

    Test for acid

    Passes test

    Test for chloride

    Passes test

    Solubility

    Soluble in water and in ethanol

    Purity

    Total organic compounds

    Total organic compounds (non-fluorine containing): not more than 5 mg/kg

    Benzene: not more than 0,05 mg/kg

    Fluorinated compounds (total): not more than 25 mg/kg

    Non-volatile matter

    Not more than 0,5 %

    Reducing substances

    Not more than 70 mg/kg (as SO2)

    Oxidising substances

    Not more than 30 mg/kg (as Cl2)

    Sulphate

    Not more than 0,5 %

    Iron

    Not more than 5 mg/kg

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 508 POTASSIUM CHLORIDE



    Synonyms

    Sylvine; Sylvite

    Definition

    Einecs

    231-211-8

    Chemical name

    Potassium chloride

    Chemical formula

    KCl

    Molecular weight

    74,56

    Assay

    Content not less than 99 % on the dried basis

    Description

    Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless

    Identification

    Solubility

    Freely soluble in water. Insoluble in ethanol

    Test for potassium

    Passes test

    Test for chloride

    Passes test

    Purity

    Loss on drying

    Not more than 1 % (105 °C, 2 hours)

    Test for sodium

    Negative

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 509 CALCIUM CHLORIDE



    Synonyms

     

    Definition

    Einecs

    233-140-8

    Chemical name

    Calcium chloride

    Chemical formula

    CaCl2 · nH2O (n = 0,2 or 6)

    Molecular weight

    110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)

    Assay

    Content not less than 93,0 % on the anhydrous basis

    Description

    White, odourless, hygroscopic powder or deliquescent crystals

    Identification

    Test for calcium

    Passes test

    Test for chloride

    Passes test

    Solubility

    Soluble in water and in ethanol

    Purity

    Magnesium and alkali salts

    Not more than 5 % on the dried basis (calculated as sulphates)

    Fluoride

    Not more than 40 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 511 MAGNESIUM CHLORIDE



    Synonyms

     

    Definition

    Einecs

    232-094-6

    Chemical name

    Magnesium chloride

    Chemical formula

    MgCl2 · 6H2O

    Molecular weight

    203,30

    Assay

    Content not less than 99,0 %

    Description

    Colourless, odourless, very deliquescent flakes or crystals

    Identification

    Test for magnesium

    Passes test

    Test for chloride

    Passes test

    Solubility

    Very soluble in water, freely soluble in ethanol

    Purity

    Ammonium

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 512 STANNOUS CHLORIDE



    Synonyms

    Tin chloride; Tin dichloride

    Definition

    Einecs

    231-868-0

    Chemical name

    Stannous chloride dihydrate

    Chemical formula

    SnCl2 · 2H2O

    Molecular weight

    225,63

    Assay

    Content not less than 98,0 %

    Description

    Colourless or white crystals

    May have a slight odour of hydrochloric acid

    Identification

    Test for tin (II)

    Passes test

    Test for chloride

    Passes test

    Solubility

    Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water

    Ethanol: soluble

    Purity

    Sulphate

    Not more than 30 mg/kg

    Arsenic

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg

    E 513 SULPHURIC ACID



    Synonyms

    Oil of vitriol; Dihydrogen sulphate

    Definition

    Einecs

    231-639-5

    Chemical name

    Sulphuric acid

    Chemical formula

    H2SO4

    Molecular weight

    98,07

    Assay

    Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 %

    Description

    Clear, colourless or slightly brown, very corrosive oily liquid

    Identification

    Test for acid

    Passes test

    Test for sulphate

    Passes test

    Solubility

    Miscible with water, with generation of much heat, also with ethanol

    Purity

    Ash

    Not more than 0,02 %

    Reducing matter

    Not more than 40 mg/kg (as SO2)

    Nitrate

    Not more than 10 mg/kg (on H2SO4 basis)

    Chloride

    Not more than 50 mg/kg

    Iron

    Not more than 20 mg/kg

    Selenium

    Not more than 20 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 514 (i) SODIUM SULPHATE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Sodium sulphate

    Chemical formula

    Na2SO4 · nH2O (n = 0 or 10)

    Molecular weight

    142,04 (anhydrous)

    322,04 (decahydrate)

    Assay

    Content not less than 99,0 % on the anhydrous basis

    Description

    Colourless crystals or a fine, white, crystalline powder

    The decahydrate is efflorescent

    Identification

    Test for sodium

    Passes test

    Test for sulphate

    Passes test

    pH

    Neutral or slightly alkaline to litmus paper (5 % solution)

    Purity

    Loss on drying

    Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at 130 °C

    Selenium

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 514 (ii) SODIUM HYDROGEN SULPHATE



    Synonyms

    Acid sodium sulphate; Sodium bisulphate; Nitre cake

    Definition

    Chemical name

    Sodium hydrogen sulphate

    Chemical formula

    NaHSO4

    Molecular weight

    120,06

    Assay

    Content not less than 95,2 %

    Description

    White, odourless crystals or granules

    Identification

    Test for sodium

    Passes test

    Test for sulphate

    Passes test

    pH

    Solutions are strongly acidic

    Purity

    Loss on drying

    Not more than 0,8 %

    Water insoluble matter

    Not more than 0,05 %

    Selenium

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 515 (i) POTASSIUM SULPHATE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Potassium sulphate

    Chemical formula

    K2SO4

    Molecular weight

    174,25

    Assay

    Content not less than 99,0 %

    Description

    Colourless or white crystals or crystalline powder

    Identification

    Test for potassium

    Passes test

    Test for sulphate

    Passes test

    pH

    Between 5,5 and 8,5 (5 % solution)

    Solubility

    Freely soluble in water, insoluble in ethanol

    Purity

    Selenium

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 515 (ii) POTASSIUM HYDROGEN SULPHATE



    Synonyms

    Potassium bisulphate; Potassium acid sulphate

    Definition

    Einecs

     

    Chemical name

    Potassium hydrogen sulphate

    Chemical formula

    KHSO4

    Molecular weight

    136,17

    Assay

    Content not less than 99 %

    Description

    White deliquescent crystals, pieces or granules

    Identification

    Melting point

    197  °C

    Test for potassium

    Passes test

    Solubility

    Freely soluble in water, insoluble in ethanol

    Purity

    Selenium

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 516 CALCIUM SULPHATE



    Synonyms

    Gypsum; Selenite; Anhydrite

    Definition

    Einecs

    231-900-3

    Chemical name

    Calcium sulphate

    Chemical formula

    CaSO4 · nH2O (n = 0 or 2)

    Molecular weight

    136,14 (anhydrous), 172,18 (dihydrate)

    Assay

    Content not less than 99,0 % on the anhydrous basis

    Description

    Fine, white to slightly yellowish-white odourless powder

    Identification

    Test for calcium

    Passes test

    Test for sulphate

    Passes test

    Solubility

    Slightly soluble in water, insoluble in ethanol

    Purity

    Loss on drying

    Anhydrous: not more than 1,5 % (250 °C, constant weight)

    Dihydrate: not more than 23 % (250 °C, constant weight)

    Fluoride

    Not more than 30 mg/kg

    Selenium

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 517 AMMONIUM SULPHATE



    Synonyms

     

    Definition

    Einecs

    231-984-1

    Chemical name

    Ammonium sulphate

    Chemical formula

    (NH4)2SO4

    Molecular weight

    132,14

    Assay

    Content not less than 99,0 % and not more than 100,5 %

    Description

    White powder, shining plates or crystalline fragments

    Identification

    Test for ammonium

    Passes test

    Test for sulphate

    Passes test

    Solubility

    Freely soluble in water, insoluble in ethanol

    Purity

    Loss on ignition

    Not more than 0,25 %

    Selenium

    Not more than 30 mg/kg

    Lead

    Not more than 3 mg/kg

    E 520 ALUMINIUM SULPHATE



    Synonyms

    Alum

    Definition

    Einecs

     

    Chemical name

    Aluminium sulphate

    Chemical formula

    Al2(SO4)3

    Molecular weight

    342,13

    Assay

    Content not less than 99,5 % on the ignited basis

    Description

    White powder, shining plates or crystalline fragments

    Identification

    Test for aluminium

    Passes test

    Test for sulphate

    Passes test

    pH

    2,9 or above (5 % solution)

    Solubility

    Freely soluble in water, insoluble in ethanol

    Purity

    Loss on ignition

    Not more than 5 % (500 °C, 3 hours)

    Alkalies and alkaline earths

    Not more than 0,4 %

    Selenium

    Not more than 30 mg/kg

    Fluoride

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 521 ALUMINIUM SODIUM SULPHATE



    Synonyms

    Soda alum; Sodium alum

    Definition

    Einecs

    233-277-3

    Chemical name

    Aluminium sodium sulphate

    Chemical formula

    AlNa(SO4)2 · nH2O (n = 0 or 12)

    Molecular weight

    242,09 (anhydrous)

    Assay

    Content on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate)

    Description

    Transparent crystals or white crystalline powder

    Identification

    Test for aluminium

    Passes test

    Test for sodium

    Passes test

    Test for sulphate

    Passes test

    Solubility

    Dodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanol

    Purity

    Loss on drying

    Anhydrous form: not more than 10,0 % (220 °C, 16 hours)

    Dodecahydrate: not more than 47,2 % (50-55 °C, 1 hour then 200 °C, 16 hours)

    Ammonium salts

    No odour of ammonia detectable after heating

    Selenium

    Not more than 30 mg/kg

    Fluoride

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 522 ALUMINIUM POTASSIUM SULPHATE



    Synonyms

    Potassium alum; Potash alum

    Definition

    Einecs

    233-141-3

    Chemical name

    Aluminium potassium sulphate dodecahydrate

    Chemical formula

    AlK(SO4)2 · 12 H2O

    Molecular weight

    474,38

    Assay

    Content not less than 99,5 %

    Description

    Large, transparent crystals or white crystalline powder

    Identification

    Test for aluminium

    Passes test

    Test for potassium

    Passes test

    Test for sulphate

    Passes test

    pH

    Between 3,0 and 4,0 (10 % solution)

    Solubility

    Freely soluble in water, insoluble in ethanol

    Purity

    Ammonium salts

    No odour of ammonia detectable after heating

    Selenium

    Not more than 30 mg/kg

    Fluoride

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 523 ALUMINIUM AMMONIUM SULPHATE



    Synonyms

    Ammonium alum

    Definition

    Einecs

    232-055-3

    Chemical name

    Aluminium ammonium sulphate

    Chemical formula

    AlNH4(SO4)2 · 12 H2O

    Molecular weight

    453,32

    Assay

    Content not less than 99,5 %

    Description

    Large, colourless crystals or white powder

    Identification

    Test for aluminium

    Passes test

    Test for ammonium

    Passes test

    Test for sulphate

    Passes test

    Solubility

    Freely soluble in water, soluble in ethanol

    Purity

    Alkali metals and alkaline earths

    Not more than 0,5 %

    Selenium

    Not more than 30 mg/kg

    Fluoride

    Not more than 30 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 3 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 524 SODIUM HYDROXIDE



    Synonyms

    Caustic soda; Lye

    Definition

    Einecs

    215-185-5

    Chemical name

    Sodium hydroxide

    Chemical formula

    NaOH

    Molecular weight

    40,0

    Assay

    Content of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH

    Description

    White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate

    Identification

    Test for sodium

    Passes test

    pH

    Strongly alkaline (1 % solution)

    Solubility

    Very soluble in water. Freely soluble in ethanol

    Purity

    Water insoluble and organic matter

    A 5 % solution is completely clear and colourless to slightly coloured

    Carbonate

    Not more than 0,5 % (as Na2CO3)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 0,5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 525 POTASSIUM HYDROXIDE



    Synonyms

    Caustic potash

    Definition

    Einecs

    215-181-3

    Chemical name

    Potassium hydroxide

    Chemical formula

    KOH

    Molecular weight

    56,11

    Assay

    Content not less than 85,0 % of alkali calculated as KOH

    Description

    White or nearly white pellets, flakes, sticks, fused masses or other forms

    Identification

    Test for potassium

    Passes test

    pH

    Strongly alkaline (1 % solution)

    Solubility

    Very soluble in water. Freely soluble in ethanol

    Purity

    Water insoluble matter

    A 5 % solution is completely clear and colourless

    Carbonate

    Not more than 3,5 % (as K2CO3)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 526 CALCIUM HYDROXIDE



    Synonyms

    Slaked lime; Hydrated lime

    Definition

    Einecs

    215-137-3

    Chemical name

    Calcium hydroxide

    Chemical formula

    Ca(OH)2

    Molecular weight

    74,09

    Assay

    Content not less than 92,0 %

    Description

    White powder

    Identification

    Test for alkali

    Passes test

    Test for calcium

    Passes test

    Solubility

    Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

    Purity

    Acid insoluble ash

    Not more than 1,0 %

    Magnesium and alkali salts

    Not more than 2,7 %

    Barium

    Not more than 300 mg/kg

    Fluoride

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    E 527 AMMONIUM HYDROXIDE



    Synonyms

    Aqua ammonia; Strong ammonia solution

    Definition

    Einecs

     

    Chemical name

    Ammonium hydroxide

    Chemical formula

    NH4OH

    Molecular weight

    35,05

    Assay

    Content not less than 27 % of NH3

    Description

    Clear, colourless solution, having an exceedingly pungent, characteristic odour

    Identification

    Test for ammonia

    Passes test

    Purity

    Non-volatile matter

    Not more than 0,02 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    E 528 MAGNESIUM HYDROXIDE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Magnesium hydroxide

    Chemical formula

    Mg(OH)2

    Molecular weight

    58,32

    Assay

    Content not less than 95,0 % on the anhydrous basis

    Description

    Odourless, white bulky powder

    Identification

    Test for magnesium

    Passes test

    Test for alkali

    Passes test

    Solubility

    Practically insoluble in water and in ethanol

    Purity

    Loss on drying

    Not more than 2,0 % (105 °C, 2 hours)

    Loss on ignition

    Not more than 33 % (800 °C to constant weight)

    Calcium oxide

    Not more than 1,5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    E 529 CALCIUM OXIDE



    Synonyms

    Burnt lime

    Definition

    Einecs

    215-138-9

    Chemical name

    Calcium oxide

    Chemical formula

    CaO

    Molecular weight

    56,08

    Assay

    Content not less than 95,0 % on the ignited basis

    Description

    Odourless, hard, white or greyish white masses of granules, or white to greyish powder

    Identification

    Test for alkali

    Passes test

    Test for calcium

    Passes test

    Reaction with water

    Heat is generated on moistening the sample with water

    Solubility

    Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

    Purity

    Loss on ignition

    Not more than 10,0 % (ca. 800 °C to constant weight)

    Acid insoluble matter

    Not more than 1,0 %

    Barium

    Not more than 300 mg/kg

    Magnesium and alkali salts

    Not more than 3,6 %

    Fluoride

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    E 530 MAGNESIUM OXIDE



    Synonyms

     

    Definition

    Einecs

    215-171-9

    Chemical name

    Magnesium oxide

    Chemical formula

    MgO

    Molecular weight

    40,31

    Assay

    Content not less than 98,0 % on the ignited basis

    Description

    A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of at least 33 ml, while 5 g of heavy magnesium oxide occupy a volume of not more than 20 ml

    Identification

    Test for alkali

    Passes test

    Test for magnesium

    Passes test

    Solubility

    Practically insoluble in water. Insoluble in ethanol

    Purity

    Loss on ignition

    Not more than 5,0 % (ca. 800 °C to constant weight)

    Calcium oxide

    Not more than 1,5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    ▼M20

    E 534 IRON TARTRATE



    Synonyms

    Iron meso-tartrate; complexation product of sodium tartrate with iron(III) chloride

    Definition

    Iron tartrate is manufactured by the isomerisation of L-tartrate to an equilibrium mixture of D-, L- and meso-tartrate followed by addition of iron(III) chloride.

    CAS number

    1280193-05-9

    Chemical name

    Iron(III) complexation product of D(+)-, L(-)- and meso-2,3 dihydroxybutanedioic acids

    Chemical formula

    Fe(OH)2 C4H4O6Na

    Molecular weight

    261,93

    Assay

    meso-tartrate

    > 28 %, expressed as the anion on dry basis

    D(-)- and L(+)-tartrate

    > 10 %, expressed as the anion on dry basis

    Iron(III)

    > 8 %, expressed as the anion on dry basis

    Description

    Dark green aqueous solution typically comprising ca 35 % by weight complexation products

    Identification

    Highly soluble in water

     

    Positive tests for tartrate and iron

     

    pH of a 35 % aqueous solution of complexation products between 3,5 and 3,9

    Purity

    Chloride

    Not more than 25 %

    Sodium

    Not more than 23 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Oxalate

    Not more than 1,5 % expressed as oxalate on dry basis

    ▼B

    E 535 SODIUM FERROCYANIDE



    Synonyms

    Yellow prussiate of soda; Sodium hexacyanoferrate

    Definition

    Einecs

    237-081-9

    Chemical name

    Sodium ferrocyanide

    Chemical formula

    Na4Fe(CN)6 · 10 H2O

    Molecular weight

    484,1

    Assay

    Content not less than 99,0 %

    Description

    Yellow crystals or crystalline powder

    Identification

    Test for sodium

    Passes test

    Test for ferrocyanide

    Passes test

    Purity

    Free moisture

    Not more than 1,0 %

    Water insoluble matter

    Not more than 0,03 %

    Chloride

    Not more than 0,2 %

    Sulphate

    Not more than 0,1 %

    Free cyanide

    Not detectable

    Ferricyanide

    Not detectable

    Lead

    Not more than 5 mg/kg

    E 536 POTASSIUM FERROCYANIDE



    Synonyms

    Yellow prussiate of potash; Potassium hexacyanoferrate

    Definition

    Einecs

    237-722-2

    Chemical name

    Potassium ferrocyanide

    Chemical formula

    K4Fe(CN)6 · 3 H2O

    Molecular weight

    422,4

    Assay

    Content not less than 99,0 %

    Description

    Lemon yellow crystals

    Identification

    Test for potassium

    Passes test

    Test for ferrocyanide

    Passes test

    Purity

    Free moisture

    Not more than 1,0 %

    Water insoluble matter

    Not more than 0,03 %

    Chloride

    Not more than 0,2 %

    Sulphate

    Not more than 0,1 %

    Free cyanide

    Not detectable

    Ferricyanide

    Not detectable

    Lead

    Not more than 5 mg/kg

    E 538 CALCIUM FERROCYANIDE



    Synonyms

    Yellow prussiate of lime; Calcium hexacyanoferrate

    Definition

    Einecs

    215-476-7

    Chemical name

    Calcium ferrocyanide

    Chemical formula

    Ca2Fe(CN)6 · 12H2O

    Molecular weight

    508,3

    Assay

    Content not less than 99,0 %

    Description

    Yellow crystals or crystalline powder

    Identification

    Test for calcium

    Passes test

    Test for ferrocyanide

    Passes test

    Purity

    Free moisture

    Not more than 1,0 %

    Water insoluble matter

    Not more than 0,03 %

    Chloride

    Not more than 0,2 %

    Sulphate

    Not more than 0,1 %

    Free cyanide

    Not detectable

    Ferricyanide

    Not detectable

    Lead

    Not more than 5 mg/kg

    E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC



    Synonyms

    SALP

    Definition

    Einecs

    232-090-4

    Chemical name

    Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A); Trisodium dialuminium pentadecahydrogen octaphosphate (B)

    Chemical formula

    NaAl3H14(PO4)8 · 4H2O (A)

    Na3Al2H15(PO4)8 (B)

    Molecular weight

    949,88 (A)

    897,82 (B)

    Assay

    Content not less than 95,0 % (both forms)

    Description

    White odourless powder

    Identification

    Test for sodium

    Passes test

    Test for aluminium

    Passes test

    Test for phosphate

    Passes test

    pH

    Acid to litmus

    Solubility

    Insoluble in water. Soluble in hydrochloric acid

    Purity

    Loss on ignition

    19,5-21,0 % (A) (750-800 °C, 2 hours)

    15-16 % (B) (750-800 °C, 2 hours)

    Fluoride

    Not more than 25 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 4 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 551 SILICON DIOXIDE



    Synonyms

    Silica; Silicium dioxide

    Definition

    Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water

    Einecs

    231-545-4

    Chemical name

    Silicon dioxide

    Chemical formula

    (SiO2)n

    Molecular weight

    60,08 (SiO2)

    Assay

    Content after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms)

    Description

    White, fluffy powder or granules. Hygroscopic

    Identification

    Test for silica

    Positive

    Purity

    Loss on drying

    Not more than 2,5 % (fumed silica, 105 °C, 2 hours)

    Not more than 8,0 % (precipitated silica and silica gel, 105 °C, 2 hours)

    Not more than 70 % (hydrous silica, 105 °C, 2 hours)

    Loss on ignition

    Not more than 2,5 % after drying (1 000  °C, fumed silica)

    Not more than 8,5 % after drying (1 000  °C, hydrated forms)

    Soluble ionisable salts

    Not more than 5,0 % (as Na2SO4)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 552 CALCIUM SILICATE



    Synonyms

     

    Definition

    Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2. The product should be free of asbestos.

    Einecs

    215-710-8

    Chemical name

    Calcium silicate

    Chemical formula

     

    Molecular weight

     

    Assay

    Content on the anhydrous basis:

    — as SiO2 not less than 50 % and not more than 95 %

    — as CaO not less than 3 % and not more than 35 %

    Description

    White to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or other liquids

    Identification

    Test for silicate

    Passes test

    Test for calcium

    Passes test

    Gel formation

    Forms a gel with mineral acids

    Purity

    Loss on drying

    Not more than 10 % (105 °C, 2 hours)

    Loss on ignition

    Not less than 5 % and not more than 14 % (1 000  °C, constant weight)

    Sodium

    Not more than 3 %

    Fluoride

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 553a (i) MAGNESIUM SILICATE



    Synonyms

     

    Definition

    Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 15 % of MgO and not less than 67 % of SiO2 on the ignited basis

    Description

    Very fine, white, odourless powder, free from grittiness

    Identification

    Test for magnesium

    Passes test

    Test for silicate

    Passes test

    pH

    Between 7,0 and 10,8 (10 % slurry)

    Purity

    Loss on drying

    Not more than 15 % (105 °C, 2 hours)

    Loss on ignition

    Not more than 15 % after drying (1 000  °C, 20 min)

    Water soluble salts

    Not more than 3 %

    Free alkali

    Not more than 1 % (as NaOH)

    Fluoride

    Not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 553a (ii) MAGNESIUM TRISILICATE



    Synonyms

     

    Definition

    Einecs

    239-076-7

    Chemical name

    Magnesium trisilicate

    Chemical formula

    Mg2Si3O8 · nH2O (approximate composition)

    Molecular weight

     

    Assay

    Content not less than 29,0 % of MgO and not less than 65,0 % of SiO2 both on the ignited basis

    Description

    Fine, white powder, free from grittiness

    Identification

    Test for magnesium

    Passes test

    Test for silicate

    Passes test

    pH

    Between 6,3 and 9,5 (5 % slurry)

    Purity

    Loss on ignition

    Not less than 17 % and not more than 34 % (1 000  °C)

    Water soluble salts

    Not more than 2 %

    Free alkali

    Not more than 1 % (as NaOH)

    Fluoride

    Not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 553b TALC



    Synonyms

    Talcum

    Definition

    Naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite. The product should be free of asbestos.

    Einecs

    238-877-9

    Chemical name

    Magnesium hydrogen metasilicate

    Chemical formula

    Mg3(Si4O10)(OH)2

    Molecular weight

    379,22

    Assay

     

    Description

    Light, homogeneous, white or almost white powder, greasy to the touch

    Identification

    Infrared absorption spectrum

    Characteristic peaks at 3 677 , 1 018 and 669 cm-1

    X-ray diffraction

    Peaks at 9,34/4,66/3,12 Å

    Solubility

    Insoluble in water and ethanol

    Purity

    Loss on drying

    Not more than 0,5 % (105 °C, 1 hour)

    Acid soluble matter

    Not more than 6 %

    Water soluble matter

    Not more than 0,2 %

    Acid-soluble iron

    Not detectable

    Arsenic

    Not more than 10 mg/kg

    Lead

    Not more than 2 mg/kg

    E 554 SODIUM ALUMINIUM SILICATE



    Synonyms

    Sodium silicoaluminate; Sodium aluminosilicate; Aluminium sodium silicate

    Definition

    Einecs

     

    Chemical name

    Sodium aluminium silicate

    Chemical formula

     

    Molecular weight

     

    Assay

    Content on the anhydrous basis:

    — as SiO2 not less than 66,0 % and not more than 88,0 %

    — as Al2O3 not less than 5,0 % and not more than 15,0 %

    Description

    Fine white amorphous powder or beads

    Identification

    Test for sodium

    Passes test

    Test for aluminium

    Passes test

    Test for silicate

    Passes test

    pH

    Between 6,5 and 11,5 (5 % slurry)

    Purity

    Loss on drying

    Not more than 8,0 % (105 °C, 2 hours)

    Loss on ignition

    Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000  °C to constant weight)

    Sodium

    Not less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous basis

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 555 POTASSIUM ALUMINIUM SILICATE



    Synonyms

    Mica

    Definition

    Natural mica consists of mainly potassium aluminium silicate (muscovite)

    Einecs

    310-127-6

    Chemical name

    Potassium aluminium silicate

    Chemical formula

    KAl2[AlSi3O10](OH)2

    Molecular weight

    398

    Assay

    Content not less than 98 %

    Description

    Light grey to white crystalline platelets or powder

    Identification

    Solubility

    Insoluble in water, diluted acids and alkali and organic solvents

    Purity

    Loss on drying

    Not more than 0,5 % (105 °C, 2 hours)

    Antimony

    Not more than 20 mg/kg

    Zinc

    Not more than 25 mg/kg

    Barium

    Not more than 25 mg/kg

    Chromium

    Not more than 100 mg/kg

    Copper

    Not more than 25 mg/kg

    Nickel

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 2 mg/kg

    Lead

    Not more than 5 mg/kg

    ▼M3

    E 556 CALCIUM ALUMINIUM SILICATE ( 1 )

    ▼B



    Synonyms

    Calcium aluminosilicate; Calcium silicoaluminate; Aluminium calcium silicate

    Definition

    Einecs

     

    Chemical name

    Calcium aluminium silicate

    Chemical formula

     

    Molecular weight

     

    Assay

    Content on the anhydrous basis:

    — as SiO2 not less than 44,0 % and not more than 50,0 %

    — as Al2O3 not less than 3,0 % and not more than 5,0 %

    — as CaO not less than 32,0 % and not more than 38,0 %

    Description

    Fine white, free-flowing powder

    Identification

    Test for calcium

    Passes test

    Test for aluminium

    Passes test

    Test for silicate

    Passes test

    Purity

    Loss on drying

    Not more than 10,0 % (105 °C, 2 hours)

    Loss on ignition

    Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000  °C, constant weight)

    Fluoride

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼M3

    E 559 ALUMINIUM SILICATE (KAOLIN) ( 2 )

    ▼B



    Synonyms

    Kaolin, light or heavy

    Definition

    Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption. The product should be free of asbestos

    Einecs

    215-286-4 (kaolinite)

    Chemical name

     

    Chemical formula

    Al2Si2O5(OH)4 (kaolinite)

    Molecular weight

    264

    Assay

    Content not less than 90 % (sum of silica and alumina, after ignition)

    Silica (SiO2)

    Between 45 % and 55 %

    Alumina (Al2O3)

    Between 30 % and 39 %

    Description

    Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes

    Identification

    Test for alumina

    Passes test

    Test for silicate

    Passes test

    X-ray diffraction

    Characteristic peaks at 7,18/3,58/2,38/1,78 Å

    Infrared absorption spectrum

    Peaks at 3 700 and 3 620  cm-1

    Purity

    Loss on ignition

    Between 10 and 14 % (1 000  °C, constant weight)

    Water soluble matter

    Not more than 0,3 %

    Acid soluble matter

    Not more than 2 %

    Iron

    Not more than 5 %

    Potassium oxide (K2O)

    Not more than 5 %

    Carbon

    Not more than 0,5 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 570 FATTY ACIDS



    Synonyms

     

    Definition

    Linear fatty acids, caprylic acid (C8), capric acid (C10), lauric acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)

    Einecs

     

    Chemical name

    Octanoic acid (C8); decanoic acid (C10); dodecanoic acid (C12); tetradecanoic acid (C14); hexadecanoic acid (C16); octadecanoic acid (C18); 9-octadecenoic acid (C18:1)

    Chemical formula

     

    Molecular weight

     

    Assay

    Not less than 98 % by chromatography

    Description

    A colourless liquid or white solid obtained from oils and fats

    Identification

    Identification test

    Individual fatty acids can be identified by acid value, iodine value, gas chromatography

    Purity

    Residue on ignition

    Not more than 0,1 %

    Unsaponifiable matter

    Not more than 1,5 %

    Water content

    Not more than 0,2 % (Karl Fischer method)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 574 GLUCONIC ACID



    Synonyms

    D-gluconic acid; Dextronic acid

    Definition

    Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone

    Einecs

     

    Chemical name

    Gluconic acid

    Chemical formula

    C6H12O7 (gluconic acid)

    Molecular weight

    196,2

    Assay

    Content not less than 49,0 % (as gluconic acid)

    Description

    Colourless to light yellow, clear syrupy liquid

    Identification

    Formation of phenylhydrazine derivative

    Positive. Compound formed melts between 196 °C and 202 °C with decomposition

    Purity

    Residue on ignition

    Not more than 1,0 % 550 °C +/– 20 °C till disappearance of organic residues (black spots).

    Reducing matter

    Not more than 2,0 % (as D-glucose)

    Chloride

    Not more than 350 mg/kg

    Sulphate

    Not more than 240 mg/kg

    Sulphite

    Not more than 20 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 575 GLUCONO-DELTA-LACTONE



    Synonyms

    Gluconolactone; GDL; D-Gluconic acid delta-lactone; Delta-gluconolactone

    Definition

    Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 % - 66 %) and the delta- and gamma-lactones

    Einecs

    202-016-5

    Chemical name

    D-Glucono-1,5-lactone

    Chemical formula

    C6H10O6

    Molecular weight

    178,14

    Assay

    Content not less than 99,0 % on the anhydrous basis

    Description

    Fine, white, nearly odourless, crystalline powder

    Identification

    Formation of phenylhydrazine derivative of gluconic acid

    Positive. Compound formed melts between 196 °C and 202 °C with decomposition

    Solubility

    Freely soluble in water. Sparingly soluble in ethanol

    Purity

    Water content

    Not more than 0,2 % (Karl Fischer method)

    Reducing substances

    Not more than 0,5 % (as D-glucose)

    Lead

    Not more than 1 mg/kg

    E 576 SODIUM GLUCONATE



    Synonyms

    Sodium salt of D-gluconic acid

    Definition

    Manufactured by fermentation or chemical catalytic oxidation

    Einecs

    208-407-7

    Chemical name

    Sodium D-gluconate

    Chemical formula

    C6H11NaO7 (anhydrous)

    Molecular weight

    218,14

    Assay

    Content not less than 99,0 %

    Description

    White to tan, granular to fine, crystalline powder

    Identification

    Test for sodium

    Passes test

    Test for gluconate

    Passes test

    Solubility

    Very soluble in water. Sparingly soluble in ethanol

    pH

    Between 6,5 and 7,5 (10 % solution)

    Purity

    Reducing matter

    Not more than 1,0 % (as D-glucose)

    Lead

    Not more than 1 mg/kg

    E 577 POTASSIUM GLUCONATE



    Synonyms

    Potassium salt of D-gluconic acid

    Definition

    Einecs

    206-074-2

    Chemical name

    Potassium D-gluconate

    Chemical formula

    C6H11KO7 (anhydrous)

    C6H11KO7 · H2O (monohydrate)

    Molecular weight

    234,25 (anhydrous)

    252,26 (monohydrate)

    Assay

    Content not less than 97,0 % and not more than 103,0 % on dried basis

    Description

    Odourless, free flowing white to yellowish white, crystalline powder or granules

    Identification

    Test for potassium

    Passes test

    Test for gluconate

    Passes test

    pH

    Between 7,0 and 8,3 (10 % solution)

    Purity

    Loss on drying

    Anhydrous: not more than 3,0 % (105 °C, 4 hours, vacuum)

    Monohydrate: not less than 6 % and not more than 7,5 % (105 °C, 4 hours, vacuum)

    Reducing substances

    Not more than 1,0 % (as D-glucose)

    Lead

    Not more than 2 mg/kg

    E 578 CALCIUM GLUCONATE



    Synonyms

    Calcium salt of D-gluconic acid

    Definition

    Einecs

    206-075-8

    Chemical name

    Calcium di-D-gluconate

    Chemical formula

    C12H22CaO14 (anhydrous)

    C12H22CaO14 · H2O (monohydrate)

    Molecular weight

    430,38 (anhydrous form)

    448,39 (monohydrate)

    Assay

    anhydrous: Content not less than 98 % and not more than 102 % on the dried basis

    monohydrate: not less than 98 % and not more than 102 % on the ‘as is’ basis.

    Description

    Odourless, white crystalline granules or powder, stable in air

    Identification

    Test for calcium

    Passes test

    Test for gluconate

    Passes test

    Solubility

    Soluble in water, insoluble in ethanol

    pH

    Between 6,0 and 8,0 (5 % solution)

    Purity

    Loss on drying

    Not more than 3,0 % (105 °C, 16 hours) (anhydrous)

    Not more than 2,0 % (105 °C, 16 hours) (monohydrate)

    Reducing substances

    Not more than 1,0 % (as D-glucose)

    Lead

    Not more than 2 mg/kg

    E 579 FERROUS GLUCONATE



    Synonyms

     

    Definition

    Einecs

    206-076-3

    Chemical name

    Ferrous di-D-gluconate dihydrate; Iron(II) di-gluconate dihydrate

    Chemical formula

    C12H22FeO14·2H2O

    Molecular weight

    482,17

    Assay

    Content not less than 95 % on the dried basis

    Description

    Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar

    Identification

    Solubility

    Soluble with slight heating in water. Practically insoluble in ethanol

    Test for ferrous ion

    Passes test

    Formation of phenylhy-drazine derivative of gluconic acid

    Positive

    pH

    Between 4 and 5,5 (10 % solution)

    Purity

    Loss on drying

    Not more than 10 % (105 °C, 16 hours)

    Oxalic acid

    Not detectable

    Iron (Fe III)

    Not more than 2 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    Reducing substances

    Not more than 0,5 % expressed as glucose

    E 585 FERROUS LACTATE



    Synonyms

    Iron(II) lactate; Iron(II) 2-hydroxy propanoate;

    Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)

    Definition

    Einecs

    227-608-0

    Chemical name

    Ferrous 2-hydroxy propanoate

    Chemical formula

    C6H10FeO6· nH2O (n = 2 or 3)

    Molecular weight

    270,02 (dihydrate)

    288,03 (trihydrate)

    Assay

    Content not less than 96 % on the dried basis

    Description

    Greenish-white crystals or light green powder having a characteristic smell

    Identification

    Solubility

    Soluble in water. Practically insoluble in ethanol

    Test for ferrous ion

    Passes test

    Test for lactate

    Passes test

    pH

    Between 4 and 6 (2 % solution)

    Purity

    Loss on drying

    Not more than 18 % (100 °C, under vacuum, approximately 700 mm Hg)

    Iron (Fe III)

    Not more than 0,6 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    E 586 4-HEXYLRESORCINOL



    Synonyms

    4-Hexyl-1,3-benzenediol; Hexylresorcinol

    Definition

    Einecs

    205-257-4

    Chemical name

    4-Hexylresorcinol

    Chemical formula

    C12H18O2

    Molecular weight

    197,24

    Assay

    Not less than 98 % on the dried basis (4 hours at room temperature)

    Description

    White powder

    Identification

    Solubility

    Freely soluble in ether and acetone; very slightly soluble in water

    Nitric acid test

    To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears

    Bromine test

    To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution

    Purity

    Melting range

    62 to 67 °C

    Acidity

    Not more than 0,05 %

    Sulphated ash

    Not more than 0,1 %

    Resorcinol and other phenols

    Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced

    Nickel

    Not more than 2 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 3 mg/kg

    E 620 GLUTAMIC ACID



    Synonyms

    L-Glutamic acid; L-α-Aminoglutaric acid

    Definition

    Einecs

    200-293-7

    Chemical name

    L-Glutamic acid; L-2-amino-pentanedioic acid

    Chemical formula

    C5H9NO4

    Molecular weight

    147,13

    Assay

    Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis

    Solubility

    Sparingly soluble in water; practically insoluble in ethanol or ether

    Description

    White crystals or crystalline powder

    Identification

    Test for glutamic acid (by thin layer chromatography)

    Passes test

    Specific rotation

    [α]D 20 between + 31,5° and + 32,2°

    (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

    pH

    Between 3,0 and 3,5 (saturated solution)

    Purity

    Loss on drying

    Not more than 0,2 % (80 °C, 3 hours)

    Sulphated ash

    Not more than 0,2 %

    Chloride

    Not more than 0,2 %

    Pyrrolidone carboxylic acid

    Not more than 0,2 %

    Arsenic

    Not more than 2,5 mg/kg

    Lead

    Not more than 1 mg/kg

    E 621 MONOSODIUM GLUTAMATE



    Synonyms

    Sodium glutamate; MSG

    Definition

    Einecs

    205-538-1

    Chemical name

    Monosodium L-glutamate monohydrate

    Chemical formula

    C5H8NaNO4 · H2O

    Molecular weight

    187,13

    Assay

    Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis

    Solubility

    Freely soluble in water; practically insoluble in ethanol or ether

    Description

    White, practically odourless crystals or crystalline powder

    Identification

    Test for sodium

    Passes test

    Test for glutamic acid (by thin-layer chromatography)

    Passes test

    Specific rotation

    [α]D 20 between + 24,8° and + 25,3°

    (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

    pH

    Between 6,7 and 7,2 (5 % solution)

    Purity

    Loss on drying

    Not more than 0,5 % (98 °C, 5 hours)

    Chloride

    Not more than 0,2 %

    Pyrrolidone carboxylic acid

    Not more than 0,2 %

    Lead

    Not more than 1 mg/kg

    E 622 MONOPOTASSIUM GLUTAMATE



    Synonyms

    Potassium glutamate; MPG

    Definition

    Einecs

    243-094-0

    Chemical name

    Monopotassium L-glutamate monohydrate

    Chemical formula

    C5H8KNO4 · H2O

    Molecular weight

    203,24

    Assay

    Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis

    Solubility

    Freely soluble in water; practically insoluble in ethanol or ether

    Description

    White, practically odourless crystals or crystalline powder

    Identification

    Test for potassium

    Passes test

    Test for glutamic acid (by thin-layer chromatography)

    Passes test

    Specific rotation

    [α]D 20 between + 22,5° and + 24,0°

    (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

    pH

    Between 6,7 and 7,3 (2 % solution)

    Purity

    Loss on drying

    Not more than 0,2 % (80 °C, 5 hours)

    Chloride

    Not more than 0,2 %

    Pyrrolidone carboxylic acid

    Not more than 0,2 %

    Lead

    Not more than 1 mg/kg

    E 623 CALCIUM DIGLUTAMATE



    Synonyms

    Calcium glutamate

    Definition

    Einecs

    242-905-5

    Chemical name

    Monocalcium di-L-glutamate

    Chemical formula

    C10H16CaN2O8 · nH2O (n = 0, 1, 2 or 4)

    Molecular weight

    332,32 (anhydrous)

    Assay

    Content not less than 98,0 % and not more than 102,0 % on the anhydrous basis

    Solubility

    Freely soluble in water; practically insoluble in ethanol or ether

    Description

    White, practically odourless crystals or crystalline powder

    Identification

    Test for calcium

    Passes test

    Test for glutamic acid (by thin-layer chromatography)

    Passes test

    Specific rotation

    [α]D 20 between + 27,4° and + 29,2° (for calcium diglutamate with n = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

    Purity

    Water content

    Not more than 19,0 % (for calcium diglutamate with n = 4) (Karl Fischer)

    Chloride

    Not more than 0,2 %

    Pyrrolidone carboxylic acid

    Not more than 0,2 %

    Lead

    Not more than 1 mg/kg

    E 624 MONOAMMONIUM GLUTAMATE



    Synonyms

    Ammonium glutamate

    Definition

    Einecs

    231-447-1

    Chemical name

    Monoammonium L-glutamate monohydrate

    Chemical formula

    C5H12N2O4 · H2O

    Molecular weight

    182,18

    Assay

    Content not less than 99,0 % and not more 101,0 % on the anhydrous basis

    Solubility

    Freely soluble in water; practically insoluble in ethanol or ether

    Description

    White, practically odourless crystals or crystalline powder

    Identification

    Test for ammonium

    Passes test

    Test for glutamic acid (by thin-layer chromatography)

    Passes test

    Specific rotation

    [α]D 20 between + 25,4° and + 26,4°

    (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

    pH

    Between 6,0 and 7,0 (5 % solution)

    Purity

    Loss on drying

    Not more than 0,5 % (50 °C, 4 hours)

    Sulphated ash

    Not more than 0,1 %

    Pyrrolidone carboxylic acid

    Not more than 0,2 %

    Lead

    Not more than 1 mg/kg

    E 625 MAGNESIUM DIGLUTAMATE



    Synonyms

    Magnesium glutamate

    Definition

    Einecs

    242-413-0

    Chemical name

    Monomagnesium di-L-glutamate tetrahydrate

    Chemical formula

    C10H16MgN2O8 · 4H2O

    Molecular weight

    388,62

    Assay

    Content not less than 95,0 % and not more than 105,0 % on the anhydrous basis

    Solubility

    Very soluble in water; practically insoluble in ethanol or ether

    Description

    Odourless, white or off-white crystals or powder

    Identification

    Test for magnesium

    Passes test

    Test for glutamic acid (by thin-layer chromatography)

    Passes test

    Specific rotation

    [α]D 20 between + 23,8° and + 24,4°

    (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

    pH

    Between 6,4 and 7,5 (10 % solution)

    Purity

    Water content

    Not more than 24 % (Karl Fischer)

    Chloride

    Not more than 0,2 %

    Pyrrolidone carboxylic acid

    Not more than 0,2 %

    Lead

    Not more than 1 mg/kg

    E 626 GUANYLIC ACID



    Synonyms

    5'-Guanylic acid

    Definition

    Einecs

    201-598-8

    Chemical name

    Guanosine-5'-monophosphoric acid

    Chemical formula

    C10H14N5O8P

    Molecular weight

    363,22

    Assay

    Content not less than 97,0 % on the anhydrous basis

    Solubility

    Slightly soluble in water, practically insoluble in ethanol

    Description

    Odourless, colourless or white crystals or white crystalline powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    pH

    Between 1,5 and 2,5 (0,25 % solution)

    Spectrometry

    Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

    Purity

    Loss on drying

    Not more than 1,5 % (120 °C, 4 hours)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 627 DISODIUM GUANYLATE



    Synonyms

    Sodium guanylate; Sodium 5'-guanylate

    Definition

    ▼M3

    Einecs

    226-914-1

    ▼B

    Chemical name

    Disodium guanosine-5'-monophosphate

    Chemical formula

    C10H12N5Na2O8P · nH2O (n = ca. 7)

    Molecular weight

    407,19 (anhydrous)

    Assay

    Content not less than 97,0 % on the anhydrous basis

    Solubility

    Soluble in water, sparingly soluble in ethanol, practically insoluble in ether

    Description

    Odourless, colourless or white crystals or white crystalline powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    Test for sodium

    Passes test

    pH

    Between 7,0 and 8,5 (5 % solution)

    Spectrometry

    maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

    Purity

    Loss on drying

    Not more than 25 % (120 °C, 4 hours)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 628 DIPOTASSIUM GUANYLATE



    Synonyms

    Potassium guanylate; Potassium 5'-guanylate

    Definition

    ▼M3

    Einecs

    221-849-5

    ▼B

    Chemical name

    Dipotassium guanosine-5'-monophosphate

    Chemical formula

    C10H12K2N5O8P

    Molecular weight

    439,40

    Assay

    Content not less than 97,0 % on the anhydrous basis

    Solubility

    Freely soluble in water, practically insoluble in ethanol

    Description

    Odourless, colourless or white crystals or white crystalline powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    Test for potassium

    Passes test

    pH

    Between 7,0 and 8,5 (5 % solution)

    Spectrometry

    Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

    Purity

    Loss on drying

    Not more than 5 % (120 °C, 4 hours)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 629 CALCIUM GUANYLATE



    Synonyms

    Calcium 5'-guanylate

    Definition

    Einecs

     

    Chemical name

    Calcium guanosine-5'-monophosphate

    Chemical formula

    C10H12CaN5O8P · nH2O

    Molecular weight

    401,20 (anhydrous)

    Assay

    Content not less than 97,0 % on the anhydrous basis

    Solubility

    Sparingly soluble in water

    Description

    Odourless, white or off-white crystals or powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    Test for calcium

    Passes test

    pH

    Between 7,0 and 8,0 (0,05 % solution)

    Spectrometry

    Maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

    Purity

    Loss on drying

    Not more than 23,0 % (120 °C, 4 hours)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 630 INOSINIC ACID



    Synonyms

    5'-Inosinic acid

    Definition

    Einecs

    205-045-1

    Chemical name

    Inosine-5'-monophosphoric acid

    Chemical formula

    C10H13N4O8P

    Molecular weight

    348,21

    Assay

    Content not less than 97,0 % on the anhydrous basis

    Solubility

    Freely soluble in water, slightly soluble in ethanol

    Description

    Odourless, colourless or white crystals or powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    pH

    Between 1,0 and 2,0 (5 % solution)

    Spectrometry

    Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

    Purity

    Loss on drying

    Not more than 3,0 % (120 °C, 4 hours)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 631 DISODIUM INOSINATE



    Synonyms

    Sodium inosinate; Sodium 5'-inosinate

    Definition

    Einecs

    225-146-4

    Chemical name

    Disodium inosine-5'-monophosphate

    Chemical formula

    C10H11N4Na2O8P · H2O

    Molecular weight

    392,17 (anhydrous)

    Assay

    Content not less than 97,0 % on the anhydrous basis

    Solubility

    Soluble in water, sparingly soluble in ethanol, practically insoluble in ether

    Description

    Odourless, colourless or white crystals or powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    Test for sodium

    Passes test

    pH

    Between 7,0 and 8,5

    Spectrometry

    Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

    Purity

    Water content

    Not more than 28,5 % (Karl Fischer)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 632 DIPOTASSIUM INOSINATE



    Synonyms

    Potassium inosinate; Potassium 5'-inosinate

    Definition

    Einecs

    243-652-3

    Chemical name

    Dipotassium inosine-5'-monophosphate

    Chemical formula

    C10H11K2N4O8P

    Molecular weight

    424,39

    Assay

    Content not less than 97,0 % on the anhydrous basis

    Solubility

    Freely soluble in water; practically insoluble in ethanol

    Description

    Odourless, colourless or white crystals or powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    Test for potassium

    Passes test

    pH

    Between 7,0 and 8,5 (5 % solution)

    Spectrometry

    Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

    Purity

    Water content

    Not more than 10,0 % (Karl Fischer)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 633 CALCIUM INOSINATE



    Synonyms

    Calcium 5'-inosinate

    Definition

    Einecs

     

    Chemical name

    Calcium inosine-5'-monophosphate

    Chemical formula

    C10H11CaN4O8P · nH2O

    Molecular weight

    386,19 (anhydrous)

    Assay

    Content not less than 97,0 % on the anhydrous basis

    Solubility

    Sparingly soluble in water

    Description

    Odourless, colourless or white crystals or powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    Test for calcium

    Passes test

    pH

    Between 7,0 and 8,0 (0,05 % solution)

    Spectrometry

    Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

    Purity

    Water content

    Not more than 23,0 % (Karl Fischer)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 634 CALCIUM 5'-RIBONUCLEOTIDE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Calcium 5′-ribonucleotide is essentially a mixture of calcium inosine-5′-monophosphate and calcium guanosine-5′-monophosphate

    Chemical formula

    C10H11N4CaO8P · nH2O

    C10H12N5CaO8P · nH2O

    Molecular weight

     

    Assay

    Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis

    Solubility

    Sparingly soluble in water

    Description

    Odourless, white or nearly white crystals or powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    Test for calcium

    Passes test

    pH

    Between 7,0 and 8,0 (0,05 % solution)

    Purity

    Water content

    Not more than 23,0 % (Karl Fischer)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 635 DISODIUM 5'-RIBONUCLEOTIDE



    Synonyms

    Sodium 5'-ribonucleotide

    Definition

    Einecs

     

    Chemical name

    Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate

    Chemical formula

    C10H11N4O8P · nH2O

    C10H12N5Na2O8P · nH2O

    Molecular weight

     

    Assay

    Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis

    Solubility

    Soluble in water, sparingly soluble in ethanol practically insoluble in ether

    Description

    Odourless, white or nearly white crystals or powder

    Identification

    Test for ribose

    Passes test

    Test for organic phosphate

    Passes test

    Test for sodium

    Passes test

    pH

    Between 7,0 and 8,5 (5 % solution)

    Purity

    Water content

    Not more than 26,0 % (Karl Fischer)

    Other nucleotides

    Not detectable by thin-layer chromatography

    Lead

    Not more than 1 mg/kg

    E 640 GLYCINE AND ITS SODIUM SALT

    (i)   GLYCINE



    Synonyms

    Aminoacetic acid; Glycocoll

    Definition

    Einecs

    200-272-2

    Chemical name

    Aminoacetic acid

    Chemical formula

    C2H5NO2

    Molecular weight

    75,07

    Assay

    Content not less than 98,5 % on the anhydrous basis

    Description

    White crystals or crystalline powder

    Identification

    Test for amino acid

    Passes test

    Purity

    Loss on drying

    Not more than 0,2 % (105 °C, 3 hours)

    Residue on ignition

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    (ii)   SODIUM GLYCINATE



    Synonyms

     

    Definition

    Einecs

    227-842-3

    Chemical name

    Sodium glycinate

    Chemical formula

    C2H5NO2 Na

    Molecular weight

    98

    Assay

    Content not less than 98,5 % on the anhydrous basis

    Description

    White crystals or crystalline powder

    Identification

    Test for amino acid

    Passes test

    Test for sodium

    Passes test

    Purity

    Loss on drying

    Not more than 0,2 % (105 °C, 3 hours)

    Residue on ignition

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼M18

    E 641 L-LEUCINE



    Synonyms

    2-Aminoisobutylacetic acid; L-2-Amino-4-methylvaleric acid; alpha-Aminoisocaproic acid; (S)-2-Amino-4-methylpentanoic acid; L-Leu

    Definition

    Einecs

    200-522-0

    CAS number

    61-90-5

    Chemical name

    L-Leucine; L-2-Amino-4-methylpentanoic acid

    Chemical formula

    C6H13NO2

    Molecular Weight

    131,17

    Assay

    Content not less than 98,5 % and not more than 101,0 % on the anhydrous basis

    Description

    White or almost white crystalline powder or shiny flakes

    Identification

    Solubility

    Soluble in water, acetic acid, dilute HCl and alkaline hydroxides and carbonates; slightly soluble in ethanol

    Specific rotation

    [α]D 20 between + 14,5° and + 16,5°

    (4 % solution (anhydrous basis) in 6N HCl)

    Purity

    Loss on drying

    Not more than 0,5 % (100 °C – 105 °C)

    Sulphated Ash

    Not more than 0,1 %

    Chlorides

    Not more than 200 mg/kg

    Sulphates

    Not more than 300 mg/kg

    Ammonium

    Not more than 200 mg/kg

    Iron

    Not more than 10 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    ▼B

    E 650 ZINC ACETATE



    Synonyms

    Acetic acid, zinc salt, dihydrate

    Definition

    Einecs

     

    Chemical name

    Zinc acetate dihydrate

    Chemical formula

    C4H6O4 Zn · 2H2O

    Molecular weight

    219,51

    Assay

    Content not less than 98 % and not more than 102 % of C4H6O4 Zn · 2H2O

    Description

    Colourless crystals or fine, off-white powder

    Identification

    Test for acetate

    Passes test

    Test for zinc

    Passes test

    pH

    Between 6,0 and 8,0 (5 % solution)

    Purity

    Water insoluble matter

    Not more than 0,005 %

    Chlorides

    Not more than 50 mg/kg

    Sulphates

    Not more than 100 mg/kg

    Alkalines and alkaline earths

    Not more than 0,2 %

    Organic volatile impurities

    Passes test

    Iron

    Not more than 50 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 20 mg/kg

    Cadmium

    Not more than 5 mg/kg

    E 900 DIMETHYL POLYSILOXANE



    Synonyms

    Polydimethyl siloxane; Silicone fluid; Silicone oil; Dimethyl silicone

    Definition

    Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2 SiO and stabilised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO

    Einecs

     

    Chemical name

    Siloxanes and silicones, di-methyl

    Chemical formula

    (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3

    Molecular weight

     

    Assay

    Content of total silicon not less than 37,3 % and not more than 38,5 %

    Description

    Clear, colourless, viscous liquid

    Identification

    Specific gravity (25° C/25 °C)

    Between 0,964 and 0,977

    Refractive index

    [n]D 25 between 1,400 and 1,405

    Infrared absorption spectrum

    The infrared absorption spectrum of a liquid film of the sample between two sodium chloride plates exhibits relative maxima at the same wavelengths as those of a similar preparation of Dimethylpolysiloxane Reference Standard

    Purity

    Loss on drying

    Not more than 0,5 % (150 °C, 4h)

    Viscosity

    Not less than 1,00 · 10– 4 m2s– 1 at 25 °C

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 901 BEESWAX, WHITE AND YELLOW



    Synonyms

    White wax; Yellow wax

    Definition

    Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter

    White beeswax is obtained by bleaching yellow beeswax

    Einecs

    232-383-7

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour

    Identification

    Melting range

    Between 62 °C and 65 °C

    Specific gravity

    About 0,96

    Solubility

    Insoluble in water, sparingly soluble in alcohol, very soluble in chloroform and ether

    Purity

    Acid value

    Not less than 17 and not more than 24

    Saponification value

    87-104

    Peroxide value

    Not more than 5

    Glycerol and other polyols

    Not more than 0,5 % (as glycerol)

    Ceresin, paraffins and certain other waxes

    Transfer 3,0 g of the sample to a 100 ml round-bottomed flask, add 30 ml of a 4% w/v solution of potassium hydroxide in aldehyde-free ethanol and boil gently under a reflux condenser for 2 h. Remove the condenser and immediately insert a thermometer. Place the flask in water at 80 °C and allow to cool, swirling the solution continuously. No precipitate is formed before the temperature reaches 65 °C, although the solution may be opalescent.

    Fats, Japan wax, rosin and soaps

    Boil 1 g of the sample for 30 min with 35 ml of a 1 in 7 solution of sodium hydroxide, maintaining the volume by the occasional addition of water, and cool the mixture. The wax separates and the liquid remains clear. Filter the cold mixture and acidify the filtrate with hydrochloric acid. No precipitate is formed.

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 902 CANDELILLA WAX



    Synonyms

     

    Definition

    Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica

    Einecs

    232-347-0

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Hard, yellowish brown, opaque to translucent wax

    Identification

    Specific gravity

    About 0,98

    Melting range

    Between 68,5 °C and 72,5 °C

    Solubility

    Insoluble in water, soluble in chloroform and toluene

    Purity

    Acid value

    Not less than 12 and not more than 22

    Saponification value

    Not less than 43 and not more than 65

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 903 CARNAUBA WAX



    Synonyms

     

    Definition

    Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia cerifera

    Einecs

    232-399-4

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture

    Identification

    Specific gravity

    About 0,997

    Melting range

    Between 82 °C and 86 °C

    Solubility

    Insoluble in water, partly soluble in boiling ethanol, soluble in chloroform and diethyl ether

    Purity

    Sulphated ash

    Not more than 0,25 %

    Acid value

    Not less than 2 and not more than 7

    Ester value

    Not less than 71 and not more than 88

    Unsaponifiable matter

    Not less than 50 % and not more than 55 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 904 SHELLAC



    Synonyms

    Bleached shellac; White shellac

    Definition

    Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)

    Einecs

    232-549-9

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Bleached shellac — off-white, amorphous, granular resin

    Wax-free bleached shellac — light yellow, amorphous, granular resin

    Identification

    Solubility

    Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone

    Acid value

    Between 60 and 89

    Purity

    Loss on drying

    Not more than 6,0 % (40 °C, over silica gel, 15 hours)

    Rosin

    Absent

    Wax

    Bleached shellac: not more than 5,5 %

    Wax-free bleached shellac: not more than 0,2 %

    Lead

    Not more than 2 mg/kg

    E 905 MICROCRYSTALLINE WAX



    Synonyms

    Petroleum wax; Hydrocarbon wax; Fischer-Tropsch wax; Synthetic wax; Synthetic paraffin

    Definition

    Refined mixtures of solid, saturated hydrocarbons, obtained from petroleum or synthetic feedstocks

    Description

    White to amber, odourless wax

    Identification

    Solubility

    Insoluble in water, very slightly soluble in ethanol

    Refractive index

    [n]D 100 1,434-1,448

    Alternative [n]D 1201,426-1,440

    Purity

    Molecular weight

    Average not less than 500

    Viscosity

    Not less than 1,1 × 10– 5 m2s– 1at 100 °C

    Alternative: Not less than 0,8 × 10– 5 m2s– 1at 120 °C, if solid at 100 °C

    Residue on ignition

    Not more than 0,1 %

    Carbon number at 5 % distillation point

    Not more than 5 % of molecules with carbon number less than 25

    Colour

    Passes test

    Sulphur

    Not more than 0,4 wt %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 3 mg/kg

    Polycyclic aromatic compounds

    Benzo(a)pyrene no more than 50 μg/kg

    E 907 HYDROGENATED POLY-1-DECENE



    Synonyms

    Hydrogenated polydec-1-ene; Hydrogenated poly-alpha-olefin

    Definition

    Einecs

     

    Chemical name

     

    Chemical formula

    C10nH20n+2 where n = 3-6

    Molecular weight

    560 (average)

    Assay

    Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution:

    C30: 13-37 %

    C40: 35-70 %

    C50: 9-25 %

    C60: 1-7 %

    Description

     

    Identification

    Solubility

    Insoluble in water; slightly soluble in ethanol; soluble in toluene

    Burning

    Burns with a bright flame and a paraffin-like characteristic smell

    Viscosity

    Between 5,7 × 10– 6 and 6,1 × 10– 6 m2s– 1 at 100 °C

    Purity

    Compounds with carbon number less than 30

    Not more than 1,5 %

    Readily carbonisable substances

    After 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour

    Nickel

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    ▼M15 —————

    ▼B

    E 914 OXIDISED POLYETHYLENE WAX



    Synonyms

     

    Definition

    Polar reaction products from mild oxidation of polyethylene

    Einecs

     

    Chemical name

    Oxidised polyethylene

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Almost white flakes, powder, granules or pellets

    Identification

    Density

    Between 0,92 and 1,05 (20 °C)

    Drop point

    Greater than 95 °C

    Purity

    Acid value

    Not more than 70

    Viscosity

    Not less than 8,1 · 10– 5 m2s– 1 at 120 °C

    Other wax types

    Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)

    Oxygen

    Not more than 9,5 %

    Chromium

    Not more than 5 mg/kg

    Lead

    Not more than 2 mg/kg

    E 920 L-CYSTEINE



    Synonyms

     

    Definition

    L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance

    Einecs

    200-157-7 (anhydrous)

    Chemical name

     

    Chemical formula

    C3H7NO2S · HCl · nH2O (where n = 0 or 1)

    Molecular weight

    157,62 (anhydrous)

    Assay

    Content not less than 98,0 % and not more than 101,5 % on the anhydrous basis

    Description

    White powder or colourless crystals

    Identification

    Solubility

    Freely soluble in water and in ethanol

    Melting range

    Anhydrous form melts at about 175 °C

    Specific rotation

    [α]D 20: between + 5,0° and + 8,0° or

    [α]D 25: between + 4,9° and 7,9°

    Purity

    Loss on drying

    Between 8,0 % and 12,0 %

    Not more than 2,0 % (anhydrous form)

    Residue on ignition

    Not more than 0,1 %

    Ammonium-ion

    Not more than 200 mg/kg

    Arsenic

    Not more than 1,5 mg/kg

    Lead

    Not more than 5 mg/kg

    E 927b CARBAMIDE



    Synonyms

    Urea

    Definition

    Einecs

    200-315-5

    Chemical name

     

    Chemical formula

    CH4N2O

    Molecular weight

    60,06

    Assay

    Content not less than 99,0 % on the anhydrous basis

    Description

    Colourless to white, prismatic, crystalline powder or small, white pellets

    Identification

    Solubility

    Very soluble in water

    Soluble in ethanol

    Precipitation with nitric acid

    To pass the test a white, crystalline precipitate is formed

    Colour reaction

    To pass the test a reddish-violet colour is produced

    Melting range

    132 °C to 135 °C

    Purity

    Loss on drying

    Not more than 1,0 % (105 °C, 1 hour)

    Sulphated ash

    Not more than 0,1 %

    Ethanol-insoluble matter

    Not more than 0,04 %

    Alkalinity

    Passes test

    Ammonium-ion

    Not more than 500 mg/kg

    Biuret

    Not more than 0,1 %

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    E 938 ARGON



    Synonyms

     

    Definition

    Einecs

    231-147-0

    Chemical name

    Argon

    Chemical formula

    Ar

    Atomic weight

    40

    Assay

    Not less than 99 %

    Description

    Colourless, odourless, non-flammable gas

    Identification

     

    Purity

    Water content

    Not more than 0,05 %

    Methane and other hydrocarbons

    Not more than 100 μl/l (calculated as methane)

    E 939 HELIUM



    Synonyms

     

    Definition

    Einecs

    231-168-5

    Chemical name

    Helium

    Chemical formula

    He

    Atomic weight

    4

    Assay

    Not less than 99 %

    Description

    Colourless, odourless, non-flammable gas

    Identification

     

    Purity

    Water content

    Not more than 0,05 %

    Methane and other hydrocarbons

    Not more than 100 μl/l (calculated as methane)

    E 941 NITROGEN



    Synonyms

     

    Definition

    Einecs

    231-783-9

    Chemical name

    Nitrogen

    Chemical formula

    N2

    Molecular weight

    28

    Assay

    Not less than 99 %

    Description

    Colourless, odourless, non-flammable gas

    Identification

     

    Purity

    Water content

    Not more than 0,05 %

    Carbon monoxide

    Not more than 10 μl/l

    Methane and other hydrocarbons

    Not more than 100 μl/l (calculated as methane)

    Nitrogen dioxide and nitrogen oxide

    Not more than 10 μl/l

    Oxygen

    Not more than 1 %

    E 942 NITROUS OXIDE



    Synonyms

     

    Definition

    Einecs

    233-032-0

    Chemical name

    Nitrous oxide

    Chemical formula

    N2O

    Molecular weight

    44

    Assay

    Not less than 99 %

    Description

    Colourless, non-flammable gas, sweetish odour

    Identification

     

    Purity

    Water content

    Not more than 0,05 %

    Carbon monoxide

    Not more than 30 μl/l

    Nitrogen dioxide and nitrogen oxide

    Not more than 10 μl/l

    E 943a BUTANE



    Synonyms

    n-Butane

    Definition

    Einecs

     

    Chemical name

    Butane

    Chemical formula

    CH3CH2CH2CH3

    Molecular weight

    58,12

    Assay

    Content not less than 96 %

    Description

    Colourless gas or liquid with mild, characteristic odour

    Identification

    Vapour pressure

    108,935 kPa at 20 °C

    Purity

    Methane

    Not more than 0,15 % v/v

    Ethane

    Not more than 0,5 % v/v

    Propane

    Not more than 1,5 % v/v

    Isobutane

    Not more than 3,0 % v/v

    1,3-butadiene

    Not more than 0,1 % v/v

    Moisture

    Not more than 0,005 %

    E 943b ISOBUTANE



    Synonyms

    2-Methyl propane

    Definition

    Einecs

     

    Chemical name

    2-methyl propane

    Chemical formula

    (CH3)2CH CH3

    Molecular weight

    58,12

    Assay

    Content not less than 94 %

    Description

    Colourless gas or liquid with mild, characteristic odour

    Identification

    Vapour pressure

    205,465 kPa at 20 °C

    Purity

    Methane

    Not more than 0,15 % v/v

    Ethane

    Not more than 0,5 % v/v

    Propane

    Not more than 2,0 % v/v

    n-Butane

    Not more than 4,0 % v/v

    1,3-butadiene

    Not more than 0,1 % v/v

    Moisture

    Not more than 0,005 %

    E 944 PROPANE



    Synonyms

     

    Definition

    Einecs

     

    Chemical name

    Propane

    Chemical formula

    CH3CH2CH3

    Molecular weight

    44,09

    Assay

    Content not less than 95 %

    Description

    Colourless gas or liquid with mild, characteristic odour

    Identification

    Vapour pressure

    732,910 kPa at 20 °C

    Purity

    Methane

    Not more than 0,15 % v/v

    Ethane

    Not more than 1,5 % v/v

    Isobutane

    Not more than 2,0 % v/v

    n-Butane

    Not more than 1,0 % v/v

    1,3-butadiene

    Not more than 0,1 % v/v

    Moisture

    Not more than 0,005 %

    E 948 OXYGEN



    Synonyms

     

    Definition

    Einecs

    231-956-9

    Chemical name

    Oxygen

    Chemical formula

    O2

    Molecular weight

    32

    Assay

    Not less than 99 %

    Description

    Colourless, odourless, non-flammable gas

    Identification

     

    Purity

    Water content

    Not more than 0,05 %

    Methane and other hydrocarbons

    Not more than 100 μl/l (calculated as methane)

    E 949 HYDROGEN



    Synonyms

     

    Definition

    Einecs

    215-605-7

    Chemical name

    Hydrogen

    Chemical formula

    H2

    Molecular weight

    2

    Assay

    Content not less than 99,9 %

    Description

    Colourless, odourless, highly flammable gas

    Identification

     

    Purity

    Water content

    Not more than 0,005 % v/v

    Oxygen

    Not more than 0,001 % v/v

    Nitrogen

    Not more than 0,07 % v/v

    E 950 ACESULFAME K



    Synonyms

    Acesulfame potassium; Potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one-2,2-dioxide

    Definition

    Einecs

    259-715-3

    Chemical name

    6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt

    Chemical formula

    C4H4KNO4S

    Molecular weight

    201,24

    Assay

    Content not less than 99 % of C4H4KNO4S on the anhydrous basis

    Description

    Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose

    Identification

    Solubility

    Very soluble in water, very slightly soluble in ethanol

    Ultraviolet absorption

    Maximum 227 ± 2 nm for a solution of 10 mg in 1 000  ml of water

    Test for potassium

    Passes test (test the residue obtained by igniting 2 g of the sample)

    Precipitation test

    Add a few drops of a 10 % solution of sodium cobaltnitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced

    Purity

    Loss on drying

    Not more than 1 % (105 °C, 2 hours)

    Organic impurities

    Passes test for 20 mg/kg of UV active components

    Fluoride

    Not more than 3 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 951 ASPARTAME



    Synonyms

    Aspartyl phenylalanine methyl ester

    Definition

    Einecs

    245-261-3

    Chemical name

    N-L-α-Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester

    Chemical formula

    C14H18N2O5

    Molecular weight

    294,31

    Assay

    Not less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis

    Description

    White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose

    Identification

    Solubility

    Slightly soluble in water and in ethanol

    pH

    Between 4,5 and 6,0 (1 in 125 solution)

    Specific rotation

    [α]D 20: + 14,5° to + 16,5°

    Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution

    Purity

    Loss on drying

    Not more than 4,5 % (105 °C, 4 hours)

    Sulphated ash

    Not more than 0,2 % (expressed on dry weight basis)

    Transmittance

    The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    5-Benzyl-3,6-dioxo-2-piperazineacetic acid

    Not more than 1,5 % (expressed on dry weight basis)

    E 952 CYCLAMIC ACID AND ITS Na AND Ca SALTS

    (i)   CYCLAMIC ACID



    Synonyms

    Cyclohexylsulphamic acid; Cyclamate

    Definition

    Einecs

    202-898-1

    Chemical name

    Cyclohexanesulphamic acid; cyclohexylaminosulphonic acid

    Chemical formula

    C6H13NO3S

    Molecular weight

    179,24

    Assay

    Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis

    Description

    A practically colourless, white crystalline powder. Approximately 40 times as sweet as sucrose

    Identification

    Solubility

    Soluble in water and in ethanol

    Precipitation test

    Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.

    Purity

    Loss on drying

    Not more than 1 % (105 °C, 1 hour)

    Selenium

    Not more than 30 mg/kg (expressed as selenium on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Cyclohexylamine

    Not more than 10 mg/kg (expressed on dry weight basis)

    Dicyclohexylamine

    Not more than 1 mg/kg (expressed on dry weight basis)

    Aniline

    Not more than 1 mg/kg (expressed on dry weight basis)

    (ii)   SODIUM CYCLAMATE



    Synonyms

    Cyclamate; Sodium salt of cyclamic acid

    Definition

    Einecs

    205-348-9

    Chemical name

    Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate

    Chemical formula

    C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O

    Molecular weight

    201,22 calculated on the anhydrous form

    237,22 calculated on the hydrated form

    Assay

    Not less than 98 % and not more than 102 % on the dried basis

    Dihydrate form: not less than 84 % on the dried basis

    Description

    White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose

    Identification

    Solubility

    Soluble in water, practically insoluble in ethanol

    Purity

    Loss on drying

    Not more than 1 % (105 °C, 1 hour)

    Not more than 15,2 % (105 °C, 2 hours) for the dihydrate form

    Selenium

    Not more than 30 mg/kg (expressed as selenium on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    Cyclohexylamine

    Not more than 10 mg/kg (expressed on dry weight basis)

    Dicyclohexylamine

    Not more than 1 mg/kg (expressed on dry weight basis)

    Aniline

    Not more than 1 mg/kg (expressed on dry weight basis)

    (iii)   CALCIUM CYCLAMATE



    Synonyms

    Cyclamate; Calcium salt of cyclamic acid

    Definition

    Einecs

    205-349-4

    Chemical name

    Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate

    Chemical formula

    C12H24CaN2O6S2· 2H2O

    Molecular weight

    432,57

    Assay

    Not less than 98 % and not more than 101 % on the dried basis

    Description

    White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose

    Identification

    Solubility

    Soluble in water, sparingly soluble in ethanol

    Purity

    Loss on drying

    Not more than 1 % (105 °C, 1 hour)

    Not more than 8,5 % (140 °C, 4 hours) for the dihydrate form

    Selenium

    Not more than 30 mg/kg (expressed as selenium on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    Cyclohexylamine

    Not more than 10 mg/kg (expressed on dry weight basis)

    Dicyclohexylamine

    Not more than 1 mg/kg (expressed on dry weight basis)

    Aniline

    Not more than 1 mg/kg (expressed on dry weight basis)

    E 953 ISOMALT



    Synonyms

    Hydrogenated isomaltulose.

    Definition

    Manufactured by enzymatic conversion of sucrose with nonviable cells of Protaminobacter rubrum followed by catalytic hydrogenation

    Einecs

     

    Chemical name

    Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides:

    6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and

    1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)

    Chemical formula

    6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O11

    1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O

    Molecular weight

    6-O-α-D-Glucopyranosyl-D-sorbitol: 344,3

    1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,3

    Assay

    Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.

    ▼M4

    Description

    Odourless, white, slightly hygroscopic, crystalline mass or aqueous solution with a minimum concentration of 60 %

    ▼B

    Identification

    Solubility

    Soluble in water, very slightly soluble in ethanol.

    HPLC test

    Comparison with an appropriate reference standard of Isomalt shows that the 2 principal peaks in the chromatogram of the test solution are similar in retention time to the 2 principal peaks in the chromatogram obtained with the reference solution.

    ▼M4

    Purity

    Water content

    Not more than 7 % for solid product (Karl Fischer Method)

    Conductivity

    Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

    D-Mannitol

    Not more than 3 %

    D-Sorbitol

    Not more than 6 %

    Reducing sugars

    Not more than 0,3 % (expressed as glucose on dry weight basis)

    Nickel

    Not more than 2 mg/kg (expressed on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    ▼B

    E 954 SACCHARIN AND ITS Na. K AND Ca SALTS

    (i)   SACCHARIN



    Synonyms

     

    Definition

    Einecs

    201-321-0

    Chemical name

    3-Oxo-2,3dihydrobenzo(d)isothiazol-1,1-dioxide

    Chemical formula

    C7H5NO3S

    Molecular weight

    183,18

    Assay

    Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis

    Description

    White crystals or a white crystalline powder, odourless or with a faint, aromatic odour. Approximately between 300 and 500 times as sweet as sucrose

    Identification

    Solubility

    Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol

    Purity

    Loss on drying

    Not more than 1 % (105 °C, 2 hours)

    Melting range

    226 to 230 °C

    Sulphated ash

    Not more than 0,2 % (expressed on dry weight basis)

    Benzoic and salicylic acid

    To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

    o-Toluenesulphonamide

    Not more than 10 mg/kg (expressed on dry weight basis)

    p-Toluenesulphonamide

    Not more than 10 mg/kg (expressed on dry weight basis)

    Benzoic acid p-sulphonamide

    Not more than 25 mg/kg (expressed on dry weight basis)

    Readily carbonisable substances

    Absent

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Selenium

    Not more than 30 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    (ii)   SODIUM SACCHARIN



    Synonyms

    Saccharin; Sodium salt of saccharin

    Definition

    Einecs

    204-886-1

    Chemical name

    Sodium o-benzosulphimide; sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole; oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate

    Chemical formula

    C7H4NNaO3S·2H2O

    Molecular weight

    241,19

    Assay

    Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis

    Description

    White crystals or a white crystalline efflorescent powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions

    Identification

    Solubility

    Freely soluble in water, sparingly soluble in ethanol

    Purity

    Loss on drying

    Not more than 15 % (120 °C, 4 hours)

    Benzoic and salicylic acid

    To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

    o-Toluenesulphonamide

    Not more than 10 mg/kg (expressed on dry weight basis)

    p-Toluenesulphonamide

    Not more than 10 mg/kg (expressed on dry weight basis)

    Benzoic acid p-sulphonamide

    Not more than 25 mg/kg (expressed on dry weight basis)

    Readily carbonisable substances

    Absent

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Selenium

    Not more than 30 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    (iii)   CALCIUM SACCHARIN



    Synonyms

    Saccharin; Calcium salt of saccharin

    Definition

    Chemical name

    Calcium o-benzosulphimide; calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)

    Einecs

    229-349-9

    Chemical formula

    C14H8CaN2O6S2·3½H2O

    Molecular weight

    467,48

    Assay

    Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis

    Description

    White crystals or a white crystalline powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions

    Identification

    Solubility

    Freely soluble in water, soluble in ethanol

    Purity

    Loss on drying

    Not more than 13,5 % (120 °C, 4 hours)

    Benzoic and salicylic acid

    To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

    o-Toluenesulphonamide

    Not more than 10 mg/kg expressed (on dry weight basis)

    p-Toluenesulphonamide

    Not more than 10 mg/kg expressed (on dry weight basis)

    Benzoic acid p-sulphonamide

    Not more than 25 mg/kg expressed (on dry weight basis)

    Readily carbonisable substances

    Absent

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Selenium

    Not more than 30 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    (iv)   POTASSIUM SACCHARIN



    Synonyms

    Saccharin; Potassium salt of saccharin

    Definition

    Einecs

     

    Chemical name

    Potassium o-benzosulphimide; potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole; potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate

    Chemical formula

    C7H4KNO3S·H2O

    Molecular weight

    239,77

    Assay

    Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis

    Description

    White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose

    Identification

    Solubility

    Freely soluble in water, sparingly soluble in ethanol

    Purity

    Loss on drying

    Not more than 8 % (120 °C, 4 hours)

    Benzoic and salicylic acid

    To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears

    o-Toluenesulphonamide

    Not more than 10 mg/kg (expressed on dry weight basis)

    p-Toluenesulphonamide

    Not more than 10 mg/kg (expressed on dry weight basis)

    Benzoic acid p-sulphonamide

    Not more than 25 mg/kg (expressed on dry weight basis)

    Readily carbonisable substances

    Absent

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Selenium

    Not more than 30 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    E 955 SUCRALOSE



    Synonyms

    4,1’,6’-Trichlorogalactosucrose

    Definition

    Einecs

    259-952-2

    Chemical name

    1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside

    Chemical formula

    C12H19Cl3O8

    Molecular weight

    397,64

    Assay

    Content not less than 98 % and not more than 102 % C12H19Cl3O8 calculated on an anhydrous basis.

    Description

    White to off-white, practically odourless, crystalline powder.

    Identification

    Solubility

    Freely soluble in water, methanol and ethanol

    Slightly soluble in ethyl acetate

    Infrared absorption spectrum

    The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard.

    Thin layer chromatography

    The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0g of sucralose reference standard in 10 ml of methanol.

    Specific rotation

    [α]D 20 + 84,0° to + 87,5° calculated on the anhydrous basis (10 % w/v solution)

    Purity

    Water content

    Not more than 2,0 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,7 %

    Other chlorinated disaccharides

    Not more than 0,5 %

    Chlorinated monosaccharides

    Not more than 0,1 %

    Triphenylphosphine oxide

    Not more than 150 mg/kg

    Methanol

    Not more than 0,1 %

    Lead

    Not more than 1 mg/kg

    E 957 THAUMATIN



    Synonyms

     

    Definition

    Einecs

    258-822-2

    Chemical name

    Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of strains of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material

    Chemical formula

    Polypeptide of 207 amino acids

    Molecular weight

    Thaumatin I 22209

    Thaumatin II 22293

    Assay

    Not less than 15,1 % nitrogen on the dried basis equivalent to not less than 93 % proteins (N × 6,2)

    Description

    Odourless, cream-coloured powder. Approximately 2 000 to 3 000 times as sweet as sucrose

    Identification

    Solubility

    Very soluble in water, insoluble in acetone

    Purity

    Loss on drying

    Not more than 9 % (105 °C to constant weight)

    Carbohydrates

    Not more than 3 % (expressed on dry weight basis)

    Sulphated ash

    Not more than 2 % (expressed on dry weight basis)

    Aluminium

    Not more than 100 mg/kg (expressed on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 3 mg/kg (expressed on dry weight basis)

    Microbiological criteria

    Total aerobic microbial count

    Not more than 1 000 colonies per gram

    Escherichia coli

    Absent in 1 g

    E 959 NEOHESPERIDINE DIHYDROCHALCONE



    Synonyms

    Neohesperidin dihydrochalcone; NHDC; Hesperetin dihydrochalcone-4′-β-neohesperidoside; Neohesperidin DC

    Definition

    It is obtained by catalytic hydrogenation of neohesperidin

    Einecs

    243-978-6

    Chemical name

    2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone.

    Chemical formula

    C28H36O15

    Molecular weight

    612,6

    Assay

    Content not less than 96 % on the dried basis

    Description

    Off-white, odourless, crystalline powder. Approximately between 1 000 and 1 800 times as sweet as sucrose

    Identification

    Solubility

    Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene

    Ultraviolet absorption maximum

    282 to 283 nm for a solution of 2 mg in 100 ml methanol

    Neu's test

    Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced

    Purity

    Loss on drying

    Not more than 11 % (105 °C, 3 hours)

    Sulphated ash

    Not more than 0,2 % (expressed on dry weight basis)

    Arsenic

    Not more than 3 mg/kg expressed on dry weight basis

    Lead

    Not more than 2 mg/kg (expressed on dry weight basis)

    ▼M21

    E 960 STEVIOL GLYCOSIDES



    Synonyms

     

    Definition

    The manufacturing process comprises two main phases: the first involving water extraction of the leaves of the Stevia rebaudiana Bertoni plant and preliminary purification of the extract by employing ion exchange chromatography to yield a steviol glycoside primary extract, and the second involving recrystallisation of the steviol glycosides from methanol or aqueous ethanol resulting in a final product containing not less than 95 % of the below identified 11 related steviol glycosides, in any combination and ratio.

    The additive may contain residues of ion-exchange resins used in the manufacturing process. Several other related steviol glycosides that may be generated as a result of the production process, but do not occur naturally in the Stevia rebaudiana plant have been identified in small amounts (0,10 to 0,37 % w/w).

    Chemical name

    Steviolbioside: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid

    Rubusoside: 13-β-D-glucopyranosyloxykaur-16-en-18-oic acid, β-D-glucopyranosyl ester

    Dulcoside A: 13-[(2-O-α–L-rhamnopyranosyl-β–D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester

    Stevioside: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester

    Rebaudioside A: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D- glucopyranosyl ester

    Rebaudioside B: 13-[(2-O-β–D-glucopyranosyl-3-O-β–D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid

    Rebaudioside C: 13-[(2-O-α–L-rhamnopyranosyl-3-O-β–D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester

    Rebaudioside D: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester

    Rebaudioside E: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, 2-O-β-D-glucopyranosyl-β-D-glucopyranosyl ester

    Rebaudioside F: 13[(2-O-β-D-xylofurananosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester

    Rebaudioside M: 13-[(2-O-β-D-glucopyranosyl-3-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

    Molecular formula

    Trivial name

    Formula

    Conversion factor

    Steviol

    C20 H30 O3

    1,00

    Steviolbioside

    C32 H50 O13

    0,50

    Rubusoside

    C32 H50 O13

    0,50

    Dulcoside A

    C38 H60 O17

    0,40

    Stevioside

    C38 H60 O18

    0,40

    Rebaudioside A

    C44 H70 O23

    0,33

    Rebaudioside B

    C38 H60 O18

    0,40

    Rebaudioside C

    C44 H70 O22

    0,34

    Rebaudioside D

    C50 H80 O28

    0,29

    Rebaudioside E

    C44 H70 O23

    0,33

    Rebaudioside F

    C43 H68 O22

    0,34

    Rebaudioside M

    C56 H90 O33

    0,25

    Molecular weight and CAS No

    Trivial name

    CAS Number

    Molecular weight (g/mol)

    Steviol

     

    318,46

    Steviolbioside

    41093-60-1

    642,73

    Rubusoside

    64849-39-4

    642,73

    Dulcoside A

    64432-06-0

    788,87

    Stevioside

    57817-89-7

    804,88

    Rebaudioside A

    58543-16-1

    967,01

    Rebaudioside B

    58543-17-2

    804,88

    Rebaudioside C

    63550-99-2

    951,02

    Rebaudioside D

    63279-13-0

    1 129,15

    Rebaudioside E

    63279-14-1

    967,01

    Rebaudioside F

    438045-89-7

    936,99

    Rebaudioside M

    1220616-44-3

    1 291,30

    Assay

    Not less than 95 % steviolbioside, rubusoside, dulcoside A, stevioside, rebaudiosides A, B, C, D, E, F and M on the dried basis, in any combination and ratio.

    Description

    White to light yellow powder, approximately between 200 and 350 times sweeter than sucrose (at 5 % sucrose equivalency).

    Identification

    Solubility

    Freely soluble to slightly soluble in water

    pH

    Between 4,5 and 7,0 (1 in 100 solution)

    Purity

    Total ash

    Not more than 1 %

    Loss on drying

    Not more than 6 % (105 °C, 2h)

    Residual solvents

    Not more than 200 mg/kg methanol

    Not more than 5 000  mg/kg ethanol

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 1 mg/kg

    ▼B

    E 961 NEOTAME



    Synonyms

    N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester;

    N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester.

    Definition

    Neotame is manufactured by reaction under hydrogen pressure of aspartame with 3,3,-dimethylbutyraldehyde in methanol in presence of a palladium/carbon catalyst. It is isolated and purified by filtration, where diatomaceous earth may be used. After solvent removal via distillation, neotame is washed with water, isolated by centrifugation and finally vacuum dried.

    CAS Nr.

    165450-17-9

    Chemical name

    N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester

    Chemical formula

    C20H30N2O5

    Molecular weight

    378,47

    Description

    white to off-white powder

    Assay

    Not less than 97,0 % on the dried basis

    Identification

    Solubility

    4,75 % (w/w) at 60 °C in water, soluble in ethanol and ethyl acetate

    Purity

    Water content

    Not more than 5 % (Karl Fischer, sample size 25 ± 5mg)

    pH

    5,0-7,0 (0,5 % aqueous solution)

    Melting range

    81 °C to 84 °C

    N-[(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine

    Not more than 1,5 %

    Lead

    Not more than 1 mg/kg

    E 962 SALT OF ASPARTAME-ACESULFAME



    Synonyms

    Aspartame-acesulfame; Aspartame-acesulfame salt

    Definition

    The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.

    Einecs

     

    Chemical name

    6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid

    Chemical formula

    C18H23O9N3S

    Molecular weight

    457,46

    Assay

    63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis)

    Description

    A white, odourless, crystalline powder

    Identification

    Solubility

    Sparingly soluble water; slightly soluble in ethanol

    Transmittance

    The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022.

    Specific rotation

    [α]D 20 + 14,5° to + 16,5°

    Determine at a concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame

    Purity

    Loss on drying

    Not more than 0,5 % (105 °C, 4 hours)

    5-Benzyl-3,6-dioxo-2-piperazineacetic acid

    Not more than 0,5 %

    Lead

    Not more than 1 mg/kg

    ▼M1

    E 964 POLYGLYCITOL SYRUP



    Synonyms

    Hydrogenated starch hydrolysate, hydrogenated glucose syrup and polyglucitol

    Definition

    A mixture consisting mainly of maltitol and sorbitol and lesser amounts of hydrogenated oligo- and polysaccharides and maltrotriitol. It is manufactured by the catalytic hydrogenation of a mixture of starch hydrolysates consisting of glucose, maltose and higher glucose polymers, similar to the catalytic hydrogenation process used for the manufacture of maltitol syrup. The resulting syrup is desalted by ion exchange and concentrated to the desired level.

    Einecs

     

    Chemical name

    Sorbitol: D-glucitol

    Maltitol: (α)-D-Glucopyranosyl-1,4-D-glucitol

    Chemical formula

    Sorbitol: C6H14O6

    Maltitol: C12H24O11

    Molecular weight

    Sorbitol: 182,2

    Maltitol: 344,3

    Assay

    Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis, not less than 50 % higher molecular weight polyols, not more than 50 % of maltitol and not more than 20 % of sorbitol on the anhydrous basis.

    Description

    Colourless and odourless clear viscous liquid

    Identification

     

    Solubility

    Very soluble in water and slightly soluble in ethanol

    Test for maltitol

    Passes test

    Test for sorbitol

    To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter the crystals and dissolve in 20 ml of boiling water containing 1 g of sodium bicarbonate. Filter the crystals, wash with 5 ml of a water-methanol mixture (1 in 2) and dry in the air. The crystals of the monobenzylidine derivative of sorbitol so obtained melt between 173 and 179 °C.

    Purity

     

    Water content

    Not more than 31 % (Karl Fischer method)

    Chlorides

    Not more than 50 mg/kg

    Sulphates

    Not more than 100 mg/kg

    Reducing sugars

    Not more than 0,3 %

    Nickel

    Not more than 2 mg/kg

    Lead

    Not more than 1 mg/kg

    ▼B

    E 965 (i) MALTITOL



    Synonyms

    D-Maltitol; Hydrogenated maltose

    Definition

    Maltitol is obtained by hydrogenation of D-maltose. It is mainly composed of D-maltitol. It may contain small amounts of sorbitol and related polyhydric alcohols.

    Einecs

    209-567-0

    Chemical name

    (α)-D-Glucopyranosyl-1,4-D-glucitol

    Chemical formula

    C12H24O11

    Molecular weight

    344,3

    Assay

    Content not less than 98 % D-maltitol C12H24O11 on the anhydrous basis

    Description

    White crystalline powder

    Identification

    Solubility

    Very soluble in water, slightly soluble in ethanol

    Melting range

    148 to 151 °C

    Specific rotation

    [α]D 20 + 105,5° to + 108,5° (5 % w/v solution)

    ▼M4

    Purity

    Appearance of the aqueous solution

    The solution is clear and colourless

    Water content

    Not more than 1 % (Karl Fischer Method)

    Conductivity

    Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

    Reducing sugars

    Not more than 0,1 % (expressed as glucose on an anhydrous basis)

    Nickel

    Not more than 2 mg/kg (expressed on anhydrous basis)

    Arsenic

    Not more than 3 mg/kg (expressed on anhydrous basis)

    Lead

    Not more than 1 mg/kg (expressed on anhydrous basis)

    ▼B

    E 965 (ii) MALTITOL SYRUP



    Synonyms

    Hydrogenated high-maltose-glucose syrup; Hydrogenated glucose syrup; Maltitol liquid

    Definition

    A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis

    Description

    Colourless and odourless, clear viscous liquids or white crystalline masses

    Identification

    Solubility

    Very soluble in water, slightly soluble in ethanol

    HPLC test

    Comparison with an appropriate reference standard of Maltitol shows that the principle peak in the chromatogram of the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution (ISO 10504:1998).

    ▼M4

    Purity

    Appearance of the aqueous solution

    The solution is clear and colourless

    Water content

    Not more than 31 % (Karl Fischer Method)

    Conductivity

    Not more than 10 μS/cm (on the product as such) at temperature 20 °C

    Reducing sugars

    Not more than 0,3 % (expressed as glucose on an anhydrous basis)

    Nickel

    Not more than 2 mg/kg

    Lead

    Not more than 1 mg/kg

    ▼B

    E 966 LACTITOL



    Synonyms

    Lactit; Lactositol; Lactobiosit

    Definition

    Lactitol is manufactured via catalytic hydrogenation of lactose

    Einecs

    209-566-5

    Chemical name

    4-O-β-D-Galactopyranosyl-D-glucitol

    Chemical formula

    C12H24O11

    Molecular weight

    344,3

    Assay

    Not less than 95 % on the dry weight basis

    Description

    Crystalline powder or colourless solution. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.

    Identification

    Solubility

    Very soluble in water

    Specific rotation

    [α]D 20 = + 13° to + 16° calculated on the anhydrous basis (10 % w/v aqueous solution)

    Purity

    Water content

    Crystalline products; not more than 10,5 % (Karl Fischer method)

    Other polyols

    Not more than 2,5 % (on the anhydrous basis)

    Reducing sugars

    Not more than 0,2 % (expressed as glucose on dry weight basis)

    Chlorides

    Not more than 100 mg/kg (expressed on dry weight basis)

    Sulphates

    Not more than 200 mg/kg (expressed on dry weight basis)

    Sulphated ash

    Not more than 0,1 % (expressed on dry weight basis)

    Nickel

    Not more than 2 mg/kg (expressed on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    E 967 XYLITOL



    Synonyms

    Xylitol

    Definition

    Xylitol is mainly composed of D-xylitol. The part which is not D-xylitol is composed of related substances such as L-arabinitol, galactitol, mannitol, sorbitol

    Einecs

    201-788-0

    Chemical name

    D-xylitol

    Chemical formula

    C5H12O5

    Molecular weight

    152,2

    Assay

    Not less than 98,5 % as xylitol on the anhydrous basis

    Description

    White, crystalline powder, practically odourless.

    Identification

    Solubility

    Very soluble in water, sparingly soluble in ethanol

    Melting range

    92 to 96 °C

    pH

    5 to 7 (10 % w/v aqueous solution)

    Infrared absorption spectroscopy

    Comparison with a reference standard e.g. EP or USP.

    ▼M4

    Purity

    Water content

    Not more than 1 % (Karl Fischer Method)

    Conductivity

    Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

    Reducing sugars

    Not more than 0,2 % (expressed as glucose on dry weight basis)

    Other polyhydric alcohols

    Not more than 1 % (expressed on dry weight basis)

    Nickel

    Not more than 2 mg/kg (expressed on dry weight basis)

    Arsenic

    Not more than 3 mg/kg (expressed on dry weight basis)

    Lead

    Not more than 1 mg/kg (expressed on dry weight basis)

    ▼B

    E 968 ERYTHRITOL



    Synonyms

    Meso-erythritol; Tetrahydroxybutane; Erythrite

    Definition

    Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Moniliella megachilensis, followed by purification and drying

    Einecs

    205-737-3

    Chemical name

    1,2,3,4-Butanetetrol

    Chemical formula

    C4H10O4

    Molecular weight

    122,12

    Assay

    Not less than 99 % after drying

    Description

    White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.

    Identification

    Solubility

    Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.

    Melting range

    119-123 °C

    ▼M4

    Purity

    Loss on drying

    Not more than 0,2 % (70 °C, 6 hours, in a vacuum desiccator)

    Conductivity

    Not more than 20 μS/cm (on 20 % dry solids solution) at temperature 20 °C

    Reducing substances

    Not more than 0,3 % expressed as D-glucose

    Ribitol and glycerol

    Not more than 0,1 %

    Lead

    Not more than 0,5 mg/kg

    ▼M11

    E 969 ADVANTAME



    Synonyms

     

    Definition

    Advantame (ANS9801) is produced by chemical synthesis in a three-step process; production of the principal manufacturing intermediate, 3-hydroxy-4-methoxycinnamaldehyde (HMCA), followed by hydrogenation to form 3-(3-hydroxy-4-methoxyphenyl) propionaldehyde (HMPA). In the final step, the HMPA methanol solution (filtrate) is combined with aspartame to give the imine that under selective hydrogenation forms advantame. The solution is allowed to crystallise and crude crystals are washed. The product is re-crystallised and crystals are separated, washed and dried.

    CAS No.

    714229-20-6

    Chemical name

    N-[N-[3-(3-hydroxy-4-methoxyphenyl) propyl]-α-aspartyl]-L-phenylalanine 1-methyl ester, monohydrate (IUPAC);

    L-phenylalanine, N-[3-(3-hydroxy-4-methoxyphenyl)propyl]-L-alpha-aspartyl-, 2-methyl ester, monohydrate (CA)

    Molecular formula

    C24H30N2O7·H2O

    Molecular weight

    476,52 g/mol (monohydrate)

    Assay

    Not less than 97,0 % and not more than 102,0 % on an anhydrous basis

    Description

    White to yellow powder

    Identification

     

    Melting Point

    101,5 °C

    Purity

     

    N-[N-[3-(3-hydroxy-4-methoxyphenyl)propyl-α-aspartyl]-L-phenylalanine (ANS9801-acid)

    Not more than 1,0 %

    Total other related substances

    Not more than 1,5 %

    Residual Solvents

    Isopropyl acetate: Not more than 2 000  mg/kg

    Methyl acetate: Not more than 500 mg/kg

    Methanol: Not more than 500 mg/kg

    2-Propanol: Not more than 500 mg/kg

    Water content

    Not more than 5,0 % (Karl Fischer method)

    Residue on ignition

    Not more than 0,2 %

    Arsenic

    Not more than 2 mg/kg

    Lead

    Not more than 1 mg/kg

    Palladium

    Not more than 5,3 mg/kg

    Platinum

    Not more than 1,7 mg/kg

    ▼B

    E 999 QUILLAIA EXTRACT



    Synonyms

    Soapbark extract; Quillay bark extract; Panama bark extract; Quillai extract; Murillo bark extract; China bark extract

    Definition

    Quillaia extract is obtained by aqueous extraction of Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution

    Identification

    pH

    Between 3,7 and 5,5 (4 % solution)

    Purity

    Water content

    Not more than 6,0 % (Karl Fischer method) (powder form only)

    Arsenic

    Not more than 2 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    E 1103 INVERTASE



    Synonyms

     

    Definition

    Invertase is produced from Saccharomyces cerevisiae

    Einecs

    232-615-7

    Enzyme Commission No

    EC 3.2.1.26

    Systematic name

    β-D-Fructofuranoside fructohydrolase

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

     

    Identification

     

    Purity

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 5 mg/kg

    Cadmium

    Not more than 0,5 mg/kg

    Microbiological criteria

    Total bacterial count

    Not more than 50 000 colonies per gram

    Salmonella spp.

    Absent in 25 g

    Coliforms

    Not more than 30 colonies per gram

    Escherichia coli

    Absent in 25 g

    E 1105 LYSOZYME



    Synonyms

    Lysozyme hydrochloride; Muramidase

    Definition

    Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride

    Einecs

    232-620-4

    Enzyme Commission No

    EC 3.2.1.17

    Chemical name

     

    Chemical formula

     

    Molecular weight

    About 14 000

    Assay

    Content not less than 950 mg/g on the anhydrous basis

    Description

    White, odourless powder having a slightly sweet taste

    Identification

    Isoelectric point

    10,7

    pH

    Between 3,0 and 3,6 (2 % aqueous solution)

    Spectrophotometry

    Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm

    Purity

    Water content

    Not more than 6,0 % (Karl Fischer method) (powder form only)

    Residue on ignition

    Not more than 1,5 %

    Nitrogen

    Not less than 16,8 % and not more than 17,8 %

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 5 mg/kg

    Mercury

    Not more than 1 mg/kg

    Microbiological criteria

    Total bacterial count

    Not more than 5 × 104 colonies per gram

    Salmonella spp.

    Absent in 25 g

    Staphylococcus aureus

    Absent in 1 g

    Escherichia coli

    Absent in 1 g

    E 1200 POLYDEXTROSE



    Synonyms

    Modified polydextroses

    Definition

    Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid and/or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolourised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

    Content not less than 90 % of polymer on the ash free and anhydrous basis

    Description

    White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution

    Identification

    Test for sugar

    Passes test

    Test for reducing sugar

    Passes test

    pH

    Between 2,5 and 7,0 for polydextrose (10 % solution)

    Between 5,0 and 6,0 for polydextrose-N (10 % solution)

    Purity

    Water content

    Not more than 4,0 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,3 % (polydextrose)

    Not more than 2,0 % (polydextrose N)

    Nickel

    Not more than 2 mg/kg for hydrogenated polydextroses

    1,6-Anhydro-D-glucose

    Not more than 4,0 % on the ash-free and the dried basis

    Glucose and sorbitol

    Not more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately

    Molecular weight limit

    Negative test for polymers of molecular weight greater than 22 000

    5-Hydroxy-methylfurfural

    Not more than 0,1 % (polydextrose)

    Not more than 0,05 % (polydextrose-N)

    Lead

    Not more than 0,5 mg/kg

    E 1201 POLYVINYLPYRROLIDONE



    Synonyms

    Povidone; PVP; Soluble polyvinylpyrrolidone

    Definition

    Einecs

     

    Chemical name

    Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

    Chemical formula

    (C6H9NO)n

    Average molecular weight

    Not less than 25 000

    Assay

    Content not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basis

    Description

    White or nearly white powder

    Identification

    Solubility

    Soluble in water and in ethanol. Insoluble in ether

    pH

    Between 3,0 and 7,0 (5 % solution)

    Purity

    Water content

    Not more than 5 % (Karl Fischer)

    Total ash

    Not more than 0,1 %

    Aldehyde

    Not more than 500 mg/kg (as acetaldehyde)

    Free-N-vinylpyrrolidone

    Not more than 10 mg/kg

    Hydrazine

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg

    E 1202 POLYVINYLPOLYPYRROLIDONE



    Synonyms

    Crospovidone; Cross-linked polyvidone; Insoluble polyvinylpyrrolidone

    Definition

    Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination

    Einecs

     

    Chemical name

    Polyvinylpyrrolidone; poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

    Chemical formula

    (C6H9NO)n

    Molecular weight

     

    Assay

    Content not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basis

    Description

    A white hygroscopic powder with a faint, non-objectionable odour

    Identification

    Solubility

    Insoluble in water, ethanol and ether

    pH

    Between 5,0 and 8,0 (1 % suspension in water)

    Purity

    Water content

    Not more than 6 % (Karl Fischer)

    Sulphated ash

    Not more than 0,4 %

    Water-soluble matter

    Not more than 1 %

    Free-N-vinylpyrrolidone

    Not more than 10 mg/kg

    Free-N,N'-divinyl-imidazolidone

    Not more than 2 mg/kg

    Lead

    Not more than 2 mg/kg

    E 1203 POLYVINYL ALCOHOL



    Synonyms

    Vinyl alcohol polymer, PVOH

    Definition

    Polyvinyl alcohol is a synthetic resin prepared by the polymerisation of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characteristics of the product depend on the degree of polymerisation and the degree of hydrolysis.

    Chemical name

    Ethenol homopolymer

    Chemical formula

    (C2H3OR)n where R = H or COCH3

    Description

    Odourless, tasteless, translucent, white or cream-coloured granular powder

    Identification

    ▼M17

    Solubility

    Soluble in water; Practically insoluble or insoluble in ethanol (≥ 99,8 %)

    ▼B

    Precipitation reaction

    Dissolve 0,25 g of the sample in 5 ml of water with warming and let the solution cool to room temperature. The addition of 10 ml of ethanol to this solution leads to a white, turbid or flocculent precipitate.

    Colour reaction

    Dissolve 0,01 g of the sample in 100 ml of water with warming and let the solution cool to room temperature. A blue colour is produced when adding (to 5 ml solution) one drop of iodine test solution (TS) and a few drops of boric acid solution

    Dissolve 0,5 g of the sample in 10 ml of water with warming and let the solution cool to room temperature. A dark red to blue colour is produced after adding one drop of iodine TS to 5 ml of solution.

    Viscosity

    4,8 to 5,8 mPa.s (4 % solution at 20 °C) corresponding to an average molecular weight of 26 000 -30 000 Da

    Purity

    Water insoluble matter

    Not more than 0,1 %

    Ester value

    Between 125 and 153 mg KOH/g

    Degree of hydrolysis

    86,5 to 89,0%

    Acid value

    Not more than 3,0

    Solvent residues

    Not more than 1,0 % Methanol, 1,0 % Methyl acetate

    pH

    5,0 to 6,5 (4 % solution)

    Loss on drying

    Not more than 5,0 % (105 °C, 3 hours)

    Residue in ignition

    Not more than 1,0 %

    Lead

    Not more than 2 mg/kg

    E 1204 PULLULAN



    Synonyms

     

    Definition

    Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography

    Einecs

    232-945-1

    Chemical name

     

    Chemical formula

    (C6H10O5)n

    Molecular weight

     

    Assay

    Not less than 90 % of glucan on the dried basis

    Description

    White to off-white odourless powder

    Identification

    Solubility

    Soluble in water, practically insoluble in ethanol

    pH

    5,0 to 7,0 (10 % solution)

    Precipitation with polyethylene glycol 600

    Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed

    Depolymerisation with pullulanase

    Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 °C for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution

    Viscosity

    100 to 180 mm2/s (10 % w/w aqueous solution at 30 °C)

    Purity

    Loss on drying

    Not more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 hours)

    Mono-, di- and oligosaccharides

    Not more than 10 % expressed as glucose

    Lead

    Not more than 1 mg/kg

    Microbiological criteria

    Yeast and moulds

    Not more than 100 colonies per gram

    Coliforms

    Absent in 25 g

    Salmonella spp.

    Absent in 25 g

    E 1205 BASIC METHACRYLATE COPOLYMER



    Synonyms

    Basic butylated methacrylate copolymer; amino methacrylate copolymer; aminoalkyl methacrylate copolymer E; butyl methacrylate, dimethylaminoethyl methacrylate, methyl methacrylate polymer; butyl methacrylate, methyl methacrylate, dimethylaminoethyl methacrylate polymer

    Definition

    Basic methacrylate copolymer is manufactured by thermic controlled polymerisation of the monomers methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate, dissolved in propan-2-ol) by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The solid polymer is milled (first milling step) and extruded and granulated under vacuum to remove residual volatile components. The granules resulting are commercialised as such or undergo a second milling step (micronisation).

    Chemical name

    Poly(butyl methacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate) 1:2:1

    Chemical formula

    Poly[(CH2:C(CH3)CO2(CH2)2N(CH3)2)-co-(CH2:C(CH3)CO2CH3)-co-(CH2:C(CH3)CO2(CH2)3CH3)]

    Weight average molecular weight estimated by gel permeation chromatography

    Approximately 47 000  g/mol

    Particle size of powder (when used forms a film)

    < 50 μm more than 50 %

    < 0,1 μm 5,1-5,5 %

    Assay

    (according to Ph. Eur. 2.2.20 ‘potentiometric titration’)

    20,8-25,5 % dimethylaminoethyl (DMAE) groups on dry substance

    Description

    Granules are colourless to yellow tinged, the powder is white

    Identification

    Infrared absorption spectroscopy

    To be identified

    Viscosity of a 12,5 % solution in 60:40 (w/w/) propan-2-ol to acetone

    3-6 mPa.s

    Refractive index

    [n]D 20 1,380-1,385

    Solubility

    1 g dissolves in 7 g Methanol, Ethanol, propan-2-ol, dichloromethane, aqueous Hydrochloric acid 1N.

    Not soluble in petroleum ether.

    ▼M6

    Purity

    Loss of drying

    Not more than 2,0 % (105 °C, 3 h)

    Alkali value

    162-198 mg KOH/g of dried substance

    Sulphated ash

    Not more than 0,1 %

    Residual monomers

    Butylmethacrylate < 1 000  mg/kg

    Methyl methacrylate < 1 000  mg/kg

    Dimethylaminoethyl methacrylate < 1 000  mg/kg

    Solvent residues

    propan-2-ol < 0,5 %

    Butanol < 0,5 %

    Methanol < 0,1 %

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 3 mg/kg

    Mercury

    Not more than 0,1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    ▼M6

    E 1206 NEUTRAL METHACRYLATE COPOLYMER



    Synonyms

    Ethyl acrylate methyl methacrylate polymer; Ethyl acrylate, methyl methacrylate polymer; Ethyl acrylate, polymer with methyl methacrylate; Methyl methacrylate, ethyl acrylate polymer; Methyl methacrylate, polymer with ethyl acrylate

    Definition

    Neutral methacrylate copolymer is a fully polymerised copolymer of methyl methacrylate and ethyl acrylate. It is produced using a process of emulsion polymerisation. It is manufactured by redox initiated polymerisation of the monomers ethyl acrylate, methyl methacrylate by using a free radical donor redox initiator system stabilised with polyethylene glycol monostearyl ether and vinylic acid/sodium hydroxide. Residual monomers are removed by means of water vapour distillation.

    CAS No

    9010-88-2

    Chemical name

    Poly(ethylacrylate-co-methyl methacrylate) 2:1

    Chemical formula

    Poly[(CH2:CHCO2CH2CH3)-co-(CH2:C(CH3)CO2CH3)]

    Weight average molecular weight

    Approximately 600 000  g/mol

    Assay/Residue on evaporation

    28,5–31,5 %

    1 g dispersion is dried in an oven for 3 hours at 110 °C.

    Description

    Milky-white dispersion (the commercial form is a 30 % dispersion of the dry substance in water) of low viscosity with a faint characteristic odour.

    Identification

    Infrared absorption spectroscopy

    Characteristic of the compound

    Viscosity

    Max. 50 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry)

    pH-value

    5,5–8,6

    Relative density (at 20 °C)

    1,037–1,047

    Solubility

    The dispersion is miscible with water in any proportion. The polymer and the dispersion are freely soluble in acetone, ethanol and isopropyl alcohol. Not soluble when mixed with 1 N sodium hydroxide in a ratio of 1:2.

    Purity

    Sulphated ash

    Not more than 0,4 % in the dispersion

    Residual monomers

    Total of monomers (sum of methyl methacrylate and ethyl acrylate): not more than 100 mg/kg in the dispersion

    Residual emulsifier

    Polyethylene glycol monostearyl ether (macrogol stearyl ether 20) not more than 0,7 % in the dispersion

    Solvent residues

    Ethanol not more than 0,5 % in the dispersion

    Methanol not more than 0,1 % in the dispersion

    Arsenic

    Not more than 0,3 mg/kg in the dispersion

    Lead

    Not more than 0,9 mg/kg in the dispersion

    Mercury

    Not more than 0,03 mg/kg in the dispersion

    Cadmium

    Not more than 0,3 mg/kg in the dispersion

    E 1207 ANIONIC METHACRYLATE COPOLYMER



    Synonyms

    Methyl acrylate, methyl methacrylate, methacrylic acid polymer; Methacrylic acid, polymer with methyl acrylate and methyl methacrylate

    Definition

    Anionic methacrylate copolymer is a fully polymerised copolymer of methacrylic acid, methyl methacrylate and methyl acrylate. It is manufactured in aqueous medium by emulsion polymerisation of methyl methacrylate, methyl acrylate and methacrylic acid using a free radical initiator stabilised with sodium lauryl sulphate and polyoxyethylene sorbitan monooleate (polysorbate 80). Residual monomers are removed by means of water vapour distillation.

    CAS No

    26936-24-3

    Chemical name

    Poly (methyl acrylate-co-methylmethacrylate-co-methacrylic acid) 7:3:1

    Chemical formula

    Poly[(CH2:CHCO2CH3)-co-(CH2:C(CH3)CO2CH3)-co-(CH2:C(CH3)COOH)]

    Weight average molecular weight

    Approximately 280 000  g/mol

    Assay/Residue on evaporation

    28,5–31,5 %

    1 g of the dispersion is dried in an oven for 5 hours at 110 °C.

    9,2–12,3 % methacrylic acid units on dry substance.

    Description

    Milky-white dispersion (the commercial form is a 30 % dispersion of the dry substance in water) of low viscosity with a faint characteristic odour.

    Identification

    Infrared absorption spectroscopy

    Characteristic of the compound

    Viscosity

    Max. 20 mPa.s, 30 rpm/20 °C (Brookfield viscosimetry)

    pH-value

    2,0–3,5

    Relative density (at 20 °C)

    1,058–1,068

    Solubility

    The dispersion is miscible with water in any proportion. The polymer and the dispersion are freely soluble in acetone, ethanol and isopropyl alcohol. Soluble when mixed with 1 N sodium hydroxide in a ratio of 1:2. Soluble above pH 7,0.

    Purity

    Acid value

    60–80 mg KOH/g of dried substance

    Sulphated ash

    Not more than 0,2 % in the dispersion

    Residual monomers

    Total of monomers (sum of methacrylic acid, methyl methacrylate and methyl acrylate): not more than 100 mg/kg in the dispersion

    Residual emulsifiers

    Sodium lauryl sulphate not more than 0,3 % on the dry substance

    Polysorbate 80 not more than 1,2 % on the dry substance

    Solvent residues

    Methanol not more than 0,1 % in the dispersion

    Arsenic

    Not more than 0,3 mg/kg in the dispersion

    Lead

    Not more than 0,9 mg/kg in the dispersion

    Mercury

    Not more than 0,03 mg/kg in the dispersion

    Cadmium

    Not more than 0,3 mg/kg in the dispersion

    ▼M9

    E 1208 POLYVINYLPYRROLIDONE-VINYL ACETATE COPOLYMER



    Synonyms

    Copolyvidon; copovidone; 1-vinyl-2-pyrrolidone-vinyl acetate copolymer; 2-pyrrolidinone, 1-ethenyl-, polymer with ethenyl acetate

    Definition

    It is produced by free radical copolymerisation of N-vinyl-2-pyrrolidone and vinyl acetate in solution in propan-2-ol, in the presence of initiators.

    Einecs

     

    Chemical name

    Acetic acid, ethenyl ester, polymer with 1-ethenyl-2-pyrrolidinone

    Chemical formula

    (C6H9NO)n.(C4H6O2)m

    Average Viscosity Molecular Weight

    Between 26 000 and 46 000  g/mol.

    Assay

    Nitrogen content 7,0-8,0 %

    Description

    The physical state is described as a white to yellowish-white powder or flakes with an average particle size of 50-130 μm.

    Identification

    Solubility

    Freely soluble in water, ethanol, ethylene chloride and ether.

    Infrared absorption spectroscopy

    To be identified

    European Colour Test (BY Colour)

    Minimum BY5

    K-value (1) (1 % solids in aqueous solution)

    25,2-30,8

    pH value

    3,0-7,0 (10 % aqueous solution)

    Purity

    Vinylacetate component in copolymer

    Not more than 42,0 %

    Free vinyl acetate

    Not more than 5 mg/kg

    Total ash

    Not more than 0,1 %

    Aldehyde

    Not more than 2 000  mg/kg (as acetaldehyde)

    Free-N-vinylpyrrolidone

    Not more than 5 mg/kg

    Hydrazine

    Not more than 0,8 mg/kg

    Peroxide content

    Not more than 400 mg/kg

    Propan-2-ol

    Not more than 150 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    (1)   K-value: dimensionless index, calculated from kinematic viscosity measurements of dilute solutions, used to indicate the likely degree of polymerisation or molecular size of a polymer.

    ▼M13

    E 1209 POLYVINYL ALCOHOL-POLYETHYLENE GLYCOL-GRAFT-COPOLYMER



    Synonyms

    Macrogol poly(vinyl alcohol) grafted co-polymer; poly(ethan-1,2-diol-graft-ethanol); ethenol, polymer with oxirane, graft; oxirane, polymer with ethanol, graft; ethylene oxide-vinyl alcohol graft co-polymer

    Definition

    Polyvinyl alcohol-polyethylene glycol-graft-co-polymer is a synthetic co-polymer that consists of approximately 75 % PVA units and 25 % PEG units.

    CAS number

    96734-39-3

    Chemical name

    Polyvinyl alcohol-polyethylene glycol-graft-co-polymer

    Chemical formula

     

    Weight Average Molecular Weight

    40 000 to 50 000  g/mol

    Description

    White to faintly yellow powder

    Identification

     

    Solubility

    Freely soluble in water and dilute acids and dilute solutions of alkali hydroxides; practically insoluble in ethanol, acetic acid, acetone, and chloroform

    IR Spectrum

    Must comply

    pH value

    5,0-8,0

    Purity

     

    Ester Value

    10 to 75 mg/g KOH

    Dynamic viscosity

    50 to 250 mPa·s

    Loss on drying

    Not more than 5 %

    Sulphated Ash

    Not more than 2 %

    Vinyl Acetate

    Not more than 20 mg/kg

    Acetic acid/Total Acetate

    Not more than 1,5 %

    Ethylene glycol

    Not more than 50 mg/kg

    Diethylene glycol

    Not more than 50 mg/kg

    1,4-Dioxane

    Not more than 10 mg/kg

    Ethylene oxide

    Not more than 0,2 mg/kg

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 1 mg/kg

    Mercury

    Not more than 1 mg/kg

    Cadmium

    Not more than 1 mg/kg

    ▼B

    E 1404 OXIDISED STARCH



    Synonyms

     

    Definition

    Oxidised starch is starch treated with sodium hypochlorite

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Carboxyl groups

    Not more than 1,1 % (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1410 MONOSTARCH PHOSPHATE



    Synonyms

     

    Definition

    Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Residual phosphate

    Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis)

    Not more than 0,4 % (as P) for other starches (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1412 DISTARCH PHOSPHATE



    Synonyms

     

    Definition

    Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Residual phosphate

    Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis)

    Not more than 0,4 % (as P) for other starches (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1413 PHOSPHATED DISTARCH PHOSPHATE



    Synonyms

     

    Definition

    Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Residual phosphate

    Not more than 0,5 % (as P) for wheat or potato starch (on an anhydrous basis)

    Not more than 0,4 % (as P) for other starches (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1414 ACETYLATED DISTARCH PHOSPHATE



    Synonyms

     

    Definition

    Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Acetyl groups

    Not more than 2,5 % (on an anhydrous basis)

    Residual phosphate

    Not more than 0,14 % (as P) for wheat or potato starch (on an anhydrous basis)

    Not more than 0,04 % (as P) for other starches (on an anhydrous basis)

    Vinyl acetate

    Not more than 0,1 mg/kg (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1420 ACETYLATED STARCH



    Synonyms

    Starch acetate

    Definition

    Acetylated starch is starch esterified with acetic anhydride or vinyl acetate

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Acetyl groups

    Not more than 2,5 % (on an anhydrous basis)

    Vinyl acetate

    Not more than 0,1 mg/kg (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1422 ACETYLATED DISTARCH ADIPATE



    Synonyms

     

    Definition

    Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Acetyl groups

    Not more than 2,5 % (on an anhydrous basis)

    Adipate groups

    Not more than 0,135 % (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1440 HYDROXYPROPYL STARCH



    Synonyms

     

    Definition

    Hydroxypropyl starch is starch etherified with propylene oxide

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Hydroxypropyl groups

    Not more than 7,0 % (on an anhydrous basis)

    Propylene chlorohydrin

    Not more than 1 mg/kg (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE



    Synonyms

     

    Definition

    Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Hydroxypropyl groups

    Not more than 7,0 % (on an anhydrous basis)

    Residual phosphate

    Not more than 0,14 % (as P) for wheat or potato starch (on an anhydrous basis)

    Not more than 0,04 % (as P) for other starches (on an anhydrous basis)

    Propylene chlorohydrin

    Not more than 1 mg/kg (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1450 STARCH SODIUM OCTENYL SUCCINATE



    Synonyms

    SSOS

    Definition

    Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Octenylsuccinyl groups

    Not more than 3 % (on an anhydrous basis)

    Octenylsuccinic acid residue

    Not more than 0,3 % (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1451 ACETYLATED OXIDISED STARCH



    Synonyms

     

    Definition

    Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 15,0 % for cereal starch

    Not more than 21,0 % for potato starch

    Not more than 18,0 % for other starches

    Carboxyl groups

    Not more than 1,3 % (on an anhydrous basis)

    Acetyl groups

    Not more than 2,5 % (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE



    Synonyms

     

    Definition

    Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate

    Einecs

     

    Chemical name

     

    Chemical formula

     

    Molecular weight

     

    Assay

     

    Description

    White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

    Identification

    Microscopic observation

    Passes test (if not pregelatinised)

    Iodine staining

    Passes test (dark blue to light red colour)

    Purity

    Loss on drying

    Not more than 21,0 %

    Octenylsuccinyl groups

    Not more than 3 % (on an anhydrous basis)

    Octenylsuccinic acid residue

    Not more than 0,3 % (on an anhydrous basis)

    Sulphur dioxide

    Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)

    Not more than 10 mg/kg for the other modified starches, unless otherwise specified (on an anhydrous basis)

    Arsenic

    Not more than 1 mg/kg

    Lead

    Not more than 2 mg/kg (on an anhydrous basis)

    Mercury

    Not more than 0,1 mg/kg

    Aluminium

    Not more than 0,3 % (on an anhydrous basis)

    E 1505 TRIETHYL CITRATE



    Synonyms

    Ethyl citrate

    Definition

    Einecs

    201-070-7

    Chemical name

    Triethyl-2-hydroxypropan-1,2,3-tricarboxylate

    Chemical formula

    C12H20O7

    Molecular weight

    276,29

    Assay

    Content not less than 99,0 %

    Description

    Odourless, practically colourless, oily liquid

    Identification

    Specific gravity (25° C/25 °C)

    1,135-1,139

    Refractive index

    [n]D 20: 1,439-1,441

    Purity

    Water content

    Not more than 0,25 % (Karl Fischer method)

    Acidity

    Not more than 0,02 % (as citric acid)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    E 1517 GLYCERYL DIACETATE



    Synonyms

    Diacetin

    Definition

    Glyceryl diacetate consist predominantly of a mixture of the 1, 2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters

    Einecs

     

    Chemical name

    Glyceryl diacetate; 1, 2, 3-propanetriol diacetate

    Chemical formula

    C7H12O5

    Molecular weight

    176,17

    Assay

    Not less than 94,0 %

    Description

    Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour

    Identification

    Solubility

    Soluble in water. Miscible with ethanol

    Test for glycerol

    Passes test

    Test for acetate

    Passes test

    Specific gravity (20° C/20 °C)

    1,175-1,195

    Boiling range

    Between 259 and 261 °C

    Purity

    Total ash

    Not more than 0,02 %

    Acidity

    Not more than 0,4 % (as acetic acid)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    E 1518 GLYCERYL TRIACETATE



    Synonyms

    Triacetin

    Definition

    Einecs

    203-051-9

    Chemical name

    Glyceryl triacetate

    Chemical formula

    C9H14O6

    Molecular weight

    218,21

    Assay

    Content not less than 98,0 %

    Description

    Colourless, somewhat oily liquid having a slightly fatty odour

    Identification

    Test for acetate

    Passes test

    Test for glycerol

    Passes test

    Refractive index

    [n]D 25 between 1,429 and 1,431

    Specific gravity (25 °C/25 °C)

    Between 1,154 and 1,158

    Boiling range

    Between 258 and 270 °C

    Purity

    Water content

    Not more than 0,2 % (Karl Fischer method)

    Sulphated ash

    Not more than 0,02 % (as citric acid)

    Arsenic

    Not more than 3 mg/kg

    Lead

    Not more than 2 mg/kg

    E 1519 BENZYL ALCOHOL



    Synonyms

    Phenylcarbinol; Phenylmethyl alcohol; Benzenemethanol; Alpha-hydroxytoluene

    Definition

    Einecs

     

    Chemical name

    Benzyl alcohol; Phenylmethanol

    Chemical formula

    C7H8O

    Molecular weight

    108,14

    Assay

    Not less than 98,0 %

    Description

    Colourless, clear liquid with a faint, aromatic odour

    Identification

    Solubility

    Soluble in water, ethanol and ether

    Refractive index

    [n]D 20 1,538-1,541

    Specific gravity (25° C/25 °C)

    1,042-1,047

    Test for peroxides

    Passes test

    Distillation range

    Not less than 95 % v/v distils between 202 and 208 °C

    Purity

    Acid value

    Not more than 0,5

    Aldehydes

    Not more than 0,2 % v/v (as benzaldehyde)

    Lead

    Not more than 2 mg/kg

    E 1520 PROPANE-1,2-DIOL



    Synonyms

    Propylene glycol

    Definition

    Einecs

    200-338-0

    Chemical name

    1,2-dihydroxypropane

    Chemical formula

    C3H8O2

    Molecular weight

    76,10

    Assay

    Content not less than 99,5 % on the anhydrous basis

    Description

    Clear, colourless, hygroscopic, viscous liquid

    Identification

    Solubility

    Soluble in water, ethanol and acetone

    Specific gravity (20° C/20 °C)

    1,035-1,040

    Refractive index

    [n]D 20: 1,431-1,433

    Purity

    Distillation test

    99,5% of the product distils between 185-189 °C. The remaining 0,5% consists mainly of dimers and traces of trimers from propylene glycol.

    Sulphated ash

    Not more than 0,07 %

    Water content

    Not more than 1,0 % (Karl Fischer method)

    Lead

    Not more than 2 mg/kg

    E 1521 POLYETHYLENE GLYCOL



    Synonyms

    PEG; Macrogol; Polyethylene oxide

    Definition

    Addition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the molecular weight.

    Chemical name

    alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol)

    Chemical formula

    (C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000 , about 140)

    Average molecular weight

    380 to 9 000 Da

    Assay

    PEG 400: Not less than 95 % and not more than 105 %

    PEG 3000: Not less than 90 % and not more than 110 %

    PEG 3350: Not less than 90 % and not more than 110 %

    PEG 4000: Not less than 90 % and not more than 110 %

    PEG 6000:Not less than 90 % and not more than 110 %

    PEG 8000: Not less than 87,5 % and not more than 112,5 %

    Description

    PEG 400 is a clear, viscous, colourless or almost colourless hygroscopic liquid

    PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are white or almost white solids with a waxy or paraffin-like appearance

    Identification

    Melting range

    PEG 400: 4-8 °C

    PEG 3000: 50-56 °C

    PEG 3350: 53-57 °C

    PEG 4000: 53-59 °C

    PEG 6000:55-61 °C

    PEG 8000: 55-62 °C

    Viscosity

    PEG 400: 105 to 130 mPa.s at 20 °C

    PEG 3000: 75 to 100 mPa.s at 20 °C

    PEG 3350: 83 to 120 mPa.s at 20 °C

    PEG 4000: 110 to 170 mPa.s at 20 °C

    PEG 6000: 200 to 270 mPa.s at 20 °C

    PEG 8000: 260 to 510 mPa.s at 20 °C

    For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in water

    Solubility

    PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils

    PEG 3000 and PEG 3350: very soluble in water and in methylene chloride, very slightly soluble in alcohol, practically insoluble in fatty oils and in mineral oils

    PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils.

    Purity

    Hydroxyl value

    PEG 400: 264-300

    PEG 3000: 34-42

    PEG 3350: 30-38

    PEG 4000: 25-32

    PEG 6000: 16-22

    PEG 8000: 12-16

    Sulphated ash

    Not more than 0,2 %

    1,4-Dioxane

    Not more than 10 mg/kg

    Ethylene oxide

    Not more than 0,2 mg/kg

    Ethylene glycol and diethylene glycol

    Total not more than 0,25 % °w/w individually or in combination

    Lead

    Not more than 1 mg/kg



    ( 1 ) Period of application: until 31 January 2014.

    ( 2 ) Period of application: until 31 January 2014.

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