Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)(Codified version)
2008/84/EC • 32008L0084
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20.9.2008
EN
Official Journal of the European Union
L 253/1
COMMISSION DIRECTIVE 2008/84/EC
of 27 August 2008
laying down specific purity criteria on food additives other than colours and sweeteners
(Text with EEA relevance)
(Codified version)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Community,
Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
Whereas:
(1)
Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.
(2)
It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (4).
(3)
It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
(4)
Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.
(5)
The measures provided for in this Directive are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health.
(6)
This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, part B,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in Annex I to this Directive.
Article 2
Loading citations...Directive 96/77/EC, as amended by the Directives listed in Annex II, part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law set out in Annex II, part B.
References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.
Article 3
This Directive shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
Article 4
This Directive is addressed to the Member States.
Done at Brussels, 27 August 2008.
For the Commission
The President
José Manuel BARROSO
(1) OJ L 40, 11.2.1989, p. 27.
(2) OJ L 339, 30.12.1996, p. 1.
(3) See Annex II, part A.
(4) OJ L 61, 18.3.1995, p. 1.
ANNEX I
Ethylene oxide may not be used for sterilising purposes in food additives.
E 170 (i) CALCIUM CARBONATE
Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC (1).
E 200 SORBIC ACID
Definition
Chemical name
Sorbic acid
Trans, trans-2,4-hexadienoic acid
Einecs
203-768-7
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 oC
Identification
A.
Melting range
Between 133 oC and 135 oC, after vacuum drying for four hours in a sulphuric acid desiccator
B.
Spectrometry
An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm
C.
Positive test for double bonds
D.
Sublimation point
80 oC
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 202 POTASSIUM SORBATE
Definition
Chemical name
Potassium sorbate
Potassium (E, E)-2,4-hexadienoate
Potassium salt of trans, trans 2,4-hexadienoic acid
Einecs
246-376-1
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 oC
Identification
A.
Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator
B.
Positive tests for potassium and for double bonds
Purity
Loss on drying
Not more than 1,0 % (105 oC, 3h)
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 203 CALCIUM SORBATE
Definition
Chemical name
Calcium sorbate
Calcium salts of trans, trans-2,4-hexadienoic acid
Einecs
231-321-6
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 oC for 90 minutes
Identification
A.
Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator
B.
Positive tests for calcium and for double bonds
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 210 BENZOIC ACID
Definition
Chemical name
Benzoic acid
Benzenecarboxylic acid
Phenylcarboxylic acid
Einecs
200-618-2
Chemical formula
C7H6O2
Molecular weight
122,12
Assay
Content not less than 99,5 % on the anhydrous basis
Description
White crystalline powder
Identification
A.
Melting range
121,5 oC to 123,5 oC
B.
Positive sublimation test and test for benzoate
Purity
Loss on drying
Not more than 0,5 % after drying for three hours over sulphuric acid
pH
About 4 (solution in water)
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 (3), 0,3 ml of ferric chloride TSC (4), 0,1 ml of copper sulphate TSC (5) 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 211 SODIUM BENZOATE
Definition
Chemical name
Sodium benzoate
Sodium salt of benzenecarboxylic acid
Sodium salt of phenylcarboxylic acid
Einecs
208-534-8
Chemical formula
C7H5O2Na
Molecular weight
144,11
Assay
Not less than 99 % of C7H5O2Na, after drying at 105 oC for four hours
Description
A white, almost odourless, crystalline powder or granules
Identification
A.
Solubility
Freely soluble in water, sparingly soluble in ethanol
B.
Melting range for benzoic acid
Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after drying in a sulphuric acid desiccator
C.
Positive tests for benzoate and for sodium
Purity
Loss on drying
Not more than 1,5 % after drying at 105 oC for four 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
Degree of 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 212 POTASSIUM BENZOATE
Definition
Chemical name
Potassium benzoate
Potassium salt of benzenecarboxylic acid
Potassium salt of phenylcarboxylic acid
Einecs
209-481-3
Chemical formula
C7H5KO2·3H2O
Molecular weight
214,27
Assay
Content not less than 99 % C7H5KO2 after drying at 105 oC to constant weight
Description
White crystalline powder
Identification
A.
Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator
B.
Positive tests for benzoate and for potassium
Purity
Loss on drying
Not more than 26,5 %, determined by drying at 105 oC
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
Degree of 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 213 CALCIUM BENZOATE
Synonyms
Monocalcium benzoate
Definition
Chemical name
Calcium benzoate
Calcium dibenzoate
Einecs
218-235-4
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 oC
Description
White or colourless crystals, or white powder
Identification
A.
Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator
B.
Positive tests for benzoate and for calcium
Purity
Loss on drying
Not more than 17,5 % determined by drying at 105 oC 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 acids
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
Degree of 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 214 ETHYL p-HYDROXYBENZOATE
Synonyms
Ethylparaben
Ethyl p-oxybenzoate
Definition
Chemical name
Ethyl-p-hydroxybenzoate
Ethyl ester of p-hydroxybenzoic acid
Einecs
204-399-4
Chemical formula
C9H10O3
Molecular weight
166,8
Assay
Content not less than 99,5 % after drying for two hours at 80 oC
Description
Almost odourless, small, colourless crystals or a white, crystalline powder
Identification
A.
Melting range
115 oC to 118 oC
B.
Positive test for p-hydroxybenzoate
Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 oC to 217 oC, after vacuum drying in a sulphuric acid desiccator
C.
Positive test for alcohol
Purity
Loss on drying
Not more than 0,5 % after drying for two hours at 80 oC
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 215 SODIUM ETHYL p-HYDROXYBENZOATE
Definition
Chemical name
Sodium ethyl p-hydroxybenzoate
Sodium compound of the ethyl ester of p-hydroxybenzoic acid
Einecs
252-487-6
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
A.
Melting range
115 oC to 118 oC, after vacuum drying in a sulphuric acid desiccator
B.
Positive test for p-hydroxybenzoate
Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC
C.
Positive test for sodium
D.
pH of a 0,1 % aqueous solution must be between 9,9 and 10,3
Purity
Loss on drying
Not more than 5 %, determined 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 218 METHYL p-HYDROXYBENZOATE
Synonyms
Methylparaben
Methyl-p-oxybenzoate
Definition
Chemical name
Methyl p-hydroxybenzoate
Methyl ester of p-hydroxybenzoic acid
Einecs
243-171-5
Chemical formula
C8H8O3
Molecular weight
152,15
Assay
Content not less than 99 % after drying for two hours at 80 oC
Description
Almost odourless, small colourless crystals or white crystalline powder
Identification
A.
Melting range
125 oC to 128 oC
B.
Positive test for p-hydroxybenzoate
Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC after drying for two hours at 80 oC
Purity
Loss on drying
Not more than 0,5 %, after drying for two hours at 80 oC
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 219 SODIUM METHYL p-HYDROXYBENZOATE
Definition
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
A.
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 oC for two hours, have a melting range of 125 oC to 128 oC
B.
Positive test for sodium
C.
pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 220 SULPHUR DIOXIDE
Definition
Chemical name
Sulphur dioxide
Sulphurous acid anhydride
Einecs
231-195-2
Chemical formula
SO2
Molecular weight
64,07
Assay
Content not less than 99 %
Description
Colourless, non-flammable gas with strong pungent suffocating odour
Identification
A.
Positive test for sulphurous substances
Purity
Water content
Not more than 0,05 %
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 221 SODIUM SULPHITE
Definition
Chemical name
Sodium sulphite (anhydrous or heptahydrate)
Einecs
231-821-4
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
A.
Positive tests for sulphite and for sodium
B.
pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5
Purity
Thiosulphate
Not more than 0,1 % based on the SO2 content
Iron
Not more than 50 mg/kg based on the SO2 content
Selenium
Not more than 10 mg/kg based on the SO2 content
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 222 SODIUM BISULPHITE
Definition
Chemical name
Sodium bisulphite
Sodium hydrogen sulphite
Einecs
231-921-4
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
A.
Positive tests for sulphite and for sodium
B.
pH of a 10 % aqueous solution between 2,5 and 5,5
Purity
Iron
Not more than 50 mg/kg of Na2SO3 based on the SO2 content
Selenium
Not more than 10 mg/kg based on the SO2 content
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 223 SODIUM METABISULPHITE
Synonyms
Pyrosulphite
Sodium pyrosulphite
Definition
Chemical name
Sodium disulphite
Disodium pentaoxodisulphate
Einecs
231-673-0
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
A.
Positive tests for sulphite and for sodium
B.
pH of a 10 % aqueous solution between 4,0 and 5,5
Purity
Thiosulphate
Not more than 0,1 % based on the SO2 content
Iron
Not more than 50 mg/kg based on the SO2 content
Selenium
Not more than 10 mg/kg based on the SO2 content
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 224 POTASSIUM METABISULPHITE
Synonyms
Potassium pyrosulphite
Definition
Chemical name
Potassium disulphite
Potassium pentaoxo disulphate
Einecs
240-795-3
Chemical formula
K2S2O5
Molecular weight
222,33
Assay
Content not less than 90 % of 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
A.
Positive tests for sulphite and for potassium
Purity
Thiosulphate
Not more than 0,1 % based on the SO2 content
Iron
Not more than 50 mg/kg based on the SO2 content
Selenium
Not more than 10 mg/kg based on the SO2 content
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 226 CALCIUM SULPHITE
Definition
Chemical name
Calcium sulphite
Einecs
218-235-4
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
A.
Positive tests for sulphite and for calcium
Purity
Iron
Not more than 50 mg/kg based on the SO2 content
Selenium
Not more than 10 mg/kg based on the SO2 content
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 227 CALCIUM BISULPHITE
Definition
Chemical name
Calcium bisulphite
Calcium hydrogen sulphite
Einecs
237-423-7
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
A.
Positive tests for sulphite and for calcium
Purity
Iron
Not more than 50 mg/kg based on the SO2 content
Selenium
Not more than 10 mg/kg based on the SO2 content
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 228 POTASSIUM BISULPHITE
Definition
Chemical name
Potassium bisulphite
Potassium hydrogen sulphite
Einecs
231-870-1
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
A.
Positive tests for sulphite and for potassium
Purity
Iron
Not more than 50 mg/kg based on the SO2 content
Selenium
Not more than 10 mg/kg based on the SO2 content
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 230 BIPHENYL
Synonyms
Diphenyl
Definition
Chemical name
1,1′-biphenyl
Phenylbenzene
Einecs
202-163-5
Chemical formula
C12H10
Molecular weight
154,20
Assay
Content not less than 99,8 %
Description
White or pale yellow to amber crystalline solid having a characteristic odour
Identification
A.
Melting range
68,5 oC to 70,5 oC
B.
Distillation range
It distils completely within a 2,5 oC range between 252,5 oC and 257,5 oC
Purity
Benzene
Not more than 10 mg/kg
Aromatic amines
Not more than 2 mg/kg (as aniline)
Phenol derivatives
Not more than 5 mg/kg (as phenol)
Readily carbonisable substances
Cold solution of 0,5 g of biphenyl 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
Terphenyl and higher polyphenyl derivatives
Not more than 0,2 %
Polycyclic aromatic hydrocarbons
Absent
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 231 ORTHOPHENYLPHENOL
Synonyms
Orthoxenol
Definition
Chemical name
(1,1'-Biphenyl)-2-ol
2-Hydroxydiphenyl
o-Hydroxydiphenyl
Einecs
201-993-5
Chemical formula
C12H10O
Molecular weight
170,20
Assay
Content not less than 99 %
Description
White or slightly yellowish crystalline powder
Identification
A.
Melting range
56 oC to 58 oC
B.
Positive test for phenolate
An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution
Purity
Sulphated ash
Not more than 0,05 %
Diphenyl ether
Not more than 0,3 %
p-Phenylphenol
Not more than 0,1 %
1-Naphthol
Not more than 0,01 %
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 232 SODIUM ORTHOPHENYLPHENOL
Synonyms
Sodium orthophenylphenate
Sodium salt ofo-phenylphenol
Definition
Chemical name
Sodium orthophenylphenol
Einecs
205-055-6
Chemical formula
C12H9ONa· 4H2O
Molecular weight
264,26
Assay
Content not less than 97 % of C12H9ONa· 4H2O
Description
White or slightly yellowish crystalline powder
Identification
A.
Positive tests for phenolate and for sodium
B.
Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56 oC to 58 oC after drying in a sulphuric acid desiccator
C.
pH of a 2 % aqueous solution must be between 11,1 and 11,8
Purity
Diphenylether
Not more than 0,3 %
p-phenylphenol
Not more than 0,1 %
1-naphthol
Not more than 0,01 %
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 233 THIABENDAZOLE
Definition
Chemical name
4-(2-benzimidazolyl)thiazole
2-(4-thiazolyl)-1H-benzimidazole
Einecs
205-725-8
Chemical formula
C10H7N3S
Molecular weight
201,26
Assay
Content not less than 98 % on the anhydrous basis
Description
White, or almost white, odourless powder
Identification
A.
Melting range
296 oC to 303 oC
B.
Spectrometry
Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm
at 302 nm ± 2 nm: approximately 1 230
at 258 nm ± 2 nm: approximately 200
at 243 nm ± 2 nm: approximately 620
Ratio of absorption 243 nm/302 nm = 0,47 to 0,53
Ratio of absorption 258 nm/302 nm = 0,14 to 0,18
Purity
Water content
Not more than 0,5 % (Karl Fischer method)
Sulphated ash
Not more than 0,2 %
Selenium
Not more than 3 mg/kg
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 234 NISIN
Definition
Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N
Einecs
215-807-5
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
Purity
Loss on drying
Not more than 3 % when dried to constant weight at 102 oC to 103 oC
Arsenic
Not more than 1 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 235 NATAMYCIN
Synonyms
Pimaricin
Definition
Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis
Einecs
231-683-5
Chemical formula
C33H47O13N
Molecular weight
665,74
Assay
Content not less than 95 % on the anhydrous basis
Description
White to creamy-white crystalline powder
Identification
A.
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
B.
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
C.
pH
5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)
D.
Specific rotation
[α]D 20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at 20 oC and calculated with reference to the dried material)
Purity
Loss on drying
Not more than 8 % (over P2O5, in vacuum at 60 oC to constant weight)
Sulphated ash
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
Heavy metals (as Pb)
Not more than 10 mg/kg
Microbiological criteria: total viable count
Not more than 100/g
E 239 HEXAMETHYLENE TETRAMINE
Synonyms
Hexamine
Methenamine
Definition
Chemical name
1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine
Einecs
202-905-8
Chemical formula
C6H12N4
Molecular weight
140,19
Assay
Content not less than 99 % on the anhydrous basis
Description
Colourless or white crystalline powder
Identification
A.
Positive tests for formaldehyde and for ammonia
B.
Sublimation point approximately 260 oC
Purity
Loss on drying
Not more than 0,5 % after drying at 105 oC in vacuum over P2O5 for two 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 242 DIMETHYL DICARBONATE
Synonyms
DMDC
Dimethyl pyrocarbonate
Definition
Chemical name
Dimethyl dicarbonate
Pyrocarbonic acid dimethyl ester
Einecs
224-859-8
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
A.
Decomposition
After dilution positive tests for CO2 and methanol
B.
Melting point
17 oC
Boiling point
172 oC with decomposition
C.
Density 20 oC
Approximately 1,25 g/cm3
D.
Infrared 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 249 POTASSIUM NITRITE
Definition
Chemical name
Potassium nitrite
Einecs
231-832-4
Chemical formula
KNO2
Molecular weight
85,11
Assay
Content not less than 95 % on the anhydrous basis (6)
Description
White or slightly yellow, deliquescent granules
Identification
A.
Positive tests for nitrite and for potassium
B.
pH of a 5 % solution:
Not less than 6,0 and not more than 9,0
Purity
Loss on drying
Not more than 3 % after drying for four hours over silica gel
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 250 SODIUM NITRITE
Definition
Chemical name
Sodium nitrite
Einecs
231-555-9
Chemical formula
NaNO2
Molecular weight
69,00
Assay
Content not less than 97 % on the anhydrous basis (7)
Description
White crystalline powder or yellowish lumps
Identification
A.
Positive tests for nitrite and for sodium
Purity
Loss on drying
Not more than 0,25 % after drying over silica gel for four hours
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 251 SODIUM NITRATE
1. SOLID SODIUM NITRATE
Synonyms
Chile saltpetre
Cubic or soda nitre
Definition
Chemical name
Sodium nitrate
Einecs
231-554-3
Chemical formula
NaNO3
Molecular weight
85,00
Assay
Content not less than 99 % after drying
Description
White crystalline, slightly hygroscopic powder
Identification
A.
Positive tests for nitrate and for sodium
B.
pH of a 5 % solution
Not less than 5,5 and more than 8,3
Purity
Loss on drying
Not more than 2 % after drying at 105 oC for four hours
Nitrites
Not more than 30 mg/kg expressed as NaNO2
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 251 SODIUM NITRATE
2. LIQUID SODIUM NITRATE
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.
Chemical name
Sodium nitrate
Einecs
231-554-3
Chemical formula
NaNO3
Molecular weight
85,00
Assay
Content between 33,5 % and 40,0 % of NaNO3
Description
Clear colourless liquid
Identification
A.
Positive tests for nitrate and for sodium
B.
pH
Not less than 1,5 and not more than 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
Chemical name
Potassium nitrate
Einecs
231-818-8
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
A.
Positive tests for nitrate and for potassium
B.
pH of a 5 % solution
Not less than 4,5 and not more than 8,5
Purity
Loss on drying
Not more than 1 % after drying at 105 oC for four hours
Nitrites
Not more than 20 mg/kg expressed as KNO2
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 260 ACETIC ACID
Definition
Chemical name
Acetic acid
Ethanoic acid
Einecs
200-580-7
Chemical formula
C2H4O2
Molecular weight
60,05
Assay
Content not less than 99,8 %
Description
Clear, colourless liquid having a pungent, characteristic odour
Identification
A.
Boiling point
118 oC at 760 mm pressure (of mercury)
B.
Specific gravity
About 1,049
C.
A one in three solution gives positive tests for acetate
D.
Solidification point
Not lower than 14,5 oC
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 261 POTASSIUM ACETATE
Definition
Chemical name
Potassium acetate
Einecs
204-822-2
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
A.
pH of a 5 % aqueous solution
Not less than 7,5 and not more than 9,0
B.
Positive tests for acetate and for potassium
Purity
Loss on drying
Not more than 8 % after drying at 150 oC for two 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 262 (i) SODIUM ACETATE
Definition
Chemical name
Sodium acetate
Einecs
204-823-8
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
A.
pH of a 1 % aqueous solution
Not less than 8,0 and not more than 9,5
B.
Positive tests for acetate and for sodium
Purity
Loss on drying
Anhydrous:
Not more than 2 % (120 oC, 4 hours)
Trihydrate:
Between 36 and 42 % (120 oC, 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 262 (ii) SODIUM DIACETATE
Definition
Sodium diacetate is a molecular compound of sodium acetate and acetic acid
Chemical name
Sodium hydrogen diacetate
Einecs
204-814-9
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
A.
pH of a 10 % aqueous solution
Not less than 4,5 and not more than 5,0
B.
Positive tests for acetate and for sodium
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 263 CALCIUM ACETATE
Definition
Chemical name
Calcium acetate
Einecs
200-540-9
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
A.
pH of a 10 % aqueous solution
Not less than 6,0 and not more than 9,0
B.
Positive tests for acetate and for calcium
Purity
Loss on drying
Not more than 11 % after drying (155 oC 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 270 LACTIC ACID
Definition
Chemical name
Lactic acid
2-Hydroxypropionic acid
1-Hydroxyethane-1-carboxylic acid
Einecs
200-018-0
Chemical formula
C3H6O3
Molecular weight
90,08
Assay
Content not less than 76 % and not more than 84 %
Description
Colourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting 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
Note:
Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid
Identification
A.
Positive test for lactate
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
Definition
Chemical name
Propionic acid
Propanoic acid
Einecs
201-176-3
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
Indentification
A.
Melting point
- 22 oC
B.
Distillation range
138,5 oC to 142,5 oC
Purity
Non-volatile residue
Not more than 0,01 % when dried at 140 oC to constant weight
Aldehydes
Not more than 0,1 % expressed as formaldehyde
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 281 SODIUM PROPIONATE
Definition
Chemical name
Sodium propionate
Sodium propanoate
Einecs
205-290-4
Chemical formula
C3H5O2Na
Molecular weight
96,06
Assay
Content not less than 99 % after drying for two hours at 105 oC
Description
White crystalline hygroscopic powder, or a fine white powder
Identification
A.
Positive tests for propionate and for sodium
B.
pH of a 10 % aqueous solution
Not less than 7,5 and not more than 10,5
Purity
Loss on drying
Not more than 4 % determined by drying for two hours at 105 oC
Water insolubles
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 282 CALCIUM PROPIONATE
Definition
Chemical name
Calcium propionate
Einecs
223-795-8
Chemical formula
C6H10O4Ca
Molecular weight
186,22
Assay
Content not less than 99 %, after drying for two hours at 105 oC
Description
White crystalline powder
Identification
A.
Positive tests for propionate and for calcium
B.
pH of a 10 % aqueous solution
Between 6,0 and 9,0
Purity
Loss on drying
Not more than 4 %, determined by drying for two hours at 105 oC
Water insolubles
Not more than 0,3 %
Iron
Not more than 50 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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 283 POTASSIUM PROPIONATE
Definition
Chemical name
Potassium propionate
Potassium propanoate
Einecs
206-323-5
Chemical formula
C3H5KO2
Molecular weight
112,17
Assay
Content not less than 99 % after drying for two hours at 105 oC
Description
White crystalline powder
Identification
A.
Positive tests for propionate and for potassium
Purity
Loss on drying
Not more than 4 %, determined by drying for two hours at 105 oC
Water-insoluble substances
Not more than 0,3 %
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 284 BORIC ACID
Synonyms
Boracic acid
Orthoboric acid
Borofax
Definition
Einecs
233-139-2
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
A.
Melting point
At approximately 171 oC
B.
Burns with a nice green flame
C.
pH of a 3,3 % aqueous solution
Between 3,8 and 4,8
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 285 SODIUM TETRABORATE (BORAX)
Synonyms
Sodium borate
Definition
Chemical name
Sodium tetraborate
Sodium biborate
Sodium pyroborate
Anhydrous tetraborate
Einecs
215-540-4
Chemical formula
Na2B4O7
Na2B4O7·10H2O
Molecular weight
201,27
Description
Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
Identification
A.
Melting range
Between 171 oC and 175 oC 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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 290 CARBON DIOXIDE
Synonyms
Carbonic acid gas
Dry ice (solid form)
Carbonic anhydride
Definition
Chemical name
Carbon dioxide
Einecs
204-696-9
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
A.
Precipitation (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 0,1 mg/l
E 296 MALIC ACID
Synonyms
DL-Malic acid, pomalous acid
Definition
Chemical name
DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid
Einecs
230-022-8
Chemical formula
C4H6O5
Molecular weight
134,09
Assay
Content not less than 99,0 %
Description
White or nearly white crystalline powder or granules
Identification
A.
Melting range between 127 oC and 132 oC
B.
Positive test for malate
C.
Solutions of this substance are optically inactive in all concentrations
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 297 FUMARIC ACID
Definition
Chemical name
Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid
Einecs
203-743-0
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
A.
Melting range
286 oC-302 oC (closed capillary, rapid heating)
B.
Positive tests for double bonds and for 1,2-dicarboxylic acid
C.
pH of a 0,05 % solution at 25 oC
3,0-3,2
Purity
Loss on drying
Not more than 0,5 % (120 oC, 4h)
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 300 ASCORBIC ACID
Definition
Chemical name
L-ascorbic acid
Ascorbic acid
2,3-Didehydro-L-threo-hexono-1,4-lactone
3-Keto-L-gulofuranolactone
Einecs
200-066-2
Chemical formula
C6H8O6
Molecular weight
176,13
Assay
Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6
Description
White to pale yellow, odourless crystalline solid
Identification
A.
Melting range
Between 189 oC and 193 oC with decomposition
B.
Positive tests for ascorbic acid
Purity
Loss on drying
Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Sulphated ash
Not more than 0,1 %
Specific rotation
[α]D 20 between +20,5o and +21,5o (10 % w/v aqueous solution)
pH of a 2 % aqueous solution
Between 2,4 and 2,8
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 301 SODIUM ASCORBATE
Definition
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
Einecs
205-126-1
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 solid which darkens on exposure to light
Identification
A.
Positive tests for ascorbate and for sodium
Purity
Loss on drying
Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotation
[α]D 20 between + 103o and + 106o (10 % w/v aqueous solution)
pH of 10 % aqueous solution
Between 6,5 and 8,0
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 302 CALCIUM ASCORBATE
Definition
Chemical name
Calcium ascorbate dihydrate
Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Einecs
227-261-5
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
A.
Positive tests for ascorbate and for calcium
Purity
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Specific rotation
[α]D 20 between + 95o and + 97o (5 % w/v aqueous solution)
pH of 10 % aqueous solution
Between 6,0 and 7,5
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 304 (i) ASCORBYL PALMITATE
Definition
Chemical name
Ascorbyl palmitate
L-ascorbyl palmitate
2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate
6-palmitoyl-3-keto-L-gulofuranolactone
Einecs
205-305-4
Chemical formula
C22H38O7
Molecular weight
414,55
Assay
Content not less than 98 % on the dried basis
Description
White or yellowish-white solid with a citrus-like odour
Identification
A.
Melting range
Between 107 oC and 117 oC
Purity
Loss on drying
Not more than 2,0 % after drying in a vacuum oven at 56 oC and 60 oC for one hour
Sulphated ash
Not more than 0,1 %
Specific rotation
[α]D 20 between + 21o and + 24o (5 % w/v in methanol solution)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 304 (ii) ASCORBYL STEARATE
Definition
Chemical name
Ascorbyl stearate
L-ascorbyl stearate
2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate
6-stearoyl-3-keto-L-gulofuranolactone
Einecs
246-944-9
Chemical formula
C24H42O7
Molecular weight
442,6
Assay
Content not less than 98 %
Description
White or yellowish, white solid with a citrus-like odour
Identification
A.
Melting point
About 116 oC
Purity
Loss on drying
Not more than 2,0 % after drying in a vacuum oven at 56 oC to 60 oC for one hour
Sulphated ash
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 306 TOCOPHEROL-RICH EXTRACT
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-ς-tocopherols
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
A.
By suitable gas liquid chromatographic method
B.
Solubility tests
Insoluble in water. Soluble in ethanol. Miscible in ether
Purity
Sulphated ash
Not more than 0,1 %
Specific rotation
[α]D 20 not less than + 20o
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 307 ALPHA-TOCOPHEROL
Synonyms
DL-α-Tocopherol
Definition
Chemical name
DL-5,7,8-Trimethyltocol
DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs
233-466-0
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
A.
Solubility tests
Insoluble in water, freely soluble in ethanol, miscible in ether
B.
Spectro-photometry
In absolute ethanol the maximum absorption is about 292 nm
Purity
Refractive index
n D 201,503-1,507
in ethanol
(292 nm) 72-76
(0,01 g in 200 ml of absolute ethanol)
Sulphated ash
Not more than 0,1 %
Specific rotation
[α]D 25 0o±0,05o (1 in 10 solution in chloroform)
Lead
Not more than 2 mg/kg
E 308 GAMMA-TOCOPHEROL
Synonyms
dl-γ-Tocopherol
Definition
Chemical name
2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs
231-523-4
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
A.
Spectrometry
Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity
in ethanol
(298 nm) between 91 and 97
(257 nm) between 5,0 and 8,0
Refractive index
1,503-1,507
Sulphated ash
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 309 DELTA-TOCOPHEROL
Definition
Chemical name
2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs
204-299-0
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
A.
Spectrometry
Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity
in ethanol
(298 nm) between 89 and 95
(257 nm) between 3,0 and 6,0
Refractive index
1,500-1,504
Sulphated ash
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 310 PROPYL GALLATE
Definition
Chemical name
Propyl gallate
Propyl ester of gallic acid
n-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs
204-498-2
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
A.
Solubility tests
Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol
B.
Melting range
Between 146 oC and 150 oC after drying at 110 oC for four hours
Purity
Loss on drying
Not more than 1,0 % (110 oC, four 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)
in ethanol
(275 nm) not less than 485 and not more than 520
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 311 OCTYL GALLATE
Definition
Chemical name
Octyl gallate
Octyl ester of gallic acid
n-octyl ester of 3,4,5-trihydroxybenzoic acid
Einecs
213-853-0
Chemical formula
C15H22O5
Molecular weight
282,34
Assay
Content not less than 98 % after drying at 90 oC for six hours
Description
White to creamy-white odourless solid
Identification
A.
Solubility tests
Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol
B.
Melting range
Between 99 oC and 102 oC after drying at 90 oC for six hours
Purity
Loss on drying
Not more than 0,5 % (90 oC, six 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)
in ethanol
(275 nm) not less than 375 and not more than 390
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 312 DODECYL GALLATE
Synonyms
Lauryl gallate
Definition
Chemical name
Dodecyl gallate
n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid
Dodecyl ester of gallic acid
Einecs
214-620-6
Chemical formula
C19H30O5
Molecular weight
338,45
Assay
Content not less than 98 % after drying at 90 oC for six hours
Description
White or creamy-white odourless solid
Identification
A.
Solubility tests
Insoluble in water, freely soluble in ethanol and ether
B.
Melting range
Between 95 oC and 98 oC after drying at 90 oC for six hours
Purity
Loss on drying
Not more than 0,5 % (90 oC, six 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)
in ethanol
(275 nm) not less than 300 and not more than 325
Arsenic
Not more than 3 mg/kg
Lead
Not more than 10 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 30 mg/kg
E 315 ERYTHORBIC ACID
Synonyms
Isoascorbic acid
D-Araboascorbic acid
Definition
Chemical name
D-Erythro-hex-2-enoic acid γ-lactone
Isoascorbic acid
D-Isoascorbic acid
Einecs
201-928-0
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
A.
Melting range
About 164 oC to 172 oC with decomposition
B.
Positive test for ascorbic acid/colour reaction
Purity
Loss on drying
Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours
Sulphated ash
Not more than 0,3 %
Specific rotation
[α]10 % (w/v) aqueous solution between -16,5o to -18,0o
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
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
Einecs
228-973-9
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
A.
Solubility tests
Freely soluble in water, very slightly soluble in ethanol
B.
Positive test for ascorbic acid/colour reaction
C.
Positive test for sodium
Purity
Loss on drying
Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
Specific rotation
[α]10 % (w/v) aqueous solution between + 95o and + 98o
pH of a 10 % aqueous solution
5,5 to 8,0
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)
Synonyms
TBHQ
Definition
Chemical names
Tert-butyl-1,4-benzenediol
2-(1,1-Dimethylethyl)-1,4-benzenediol
Einecs
217-752-2
Chemical formula
C10H14O2
Molecular weight
166,22
Assay
Content not less than 99 % of C10H14O2
Description
White crystalline solid having a characteristic odour
Identification
A.
Solubility
Practically insoluble in water; soluble in ethanol
B.
Melting point
Not less than 126,5 oC
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
Chemical names
3-Tertiary-butyl-4-hydroxyanisole
A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole
Einecs
246-563-8
Chemical formula
C11H16O2
Formula 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 crystals or waxy solid with a slight aromatic smell
Identification
A.
Solubility
Insoluble in water, freely soluble in ethanol
B.
Melting range
Between 48 °C and 63 °C
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 %
(290 nm) not less than 190 and not more than 210
(228 nm) not less than 326 and not more than 345
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 321 BUTYLATED HYDROXYTOLUENE (BHT)
Synonyms
BHT
Definition
Chemical name
2,6-Ditertiary-butyl-p-cresol
4-Methyl-2,6-ditertiarybutylphenol
Einecs
204-881-4
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
A.
Solubility tests
Insoluble in water and propane- 1,2-diol
Freely soluble in ethanol
B.
Melting point
At 70 oC
C.
Absorbance maximum
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 %
in ethanol
(278 nm) not less than 81 and not more than 88
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
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
A.
Positive tests for choline, for phosphorus and fatty acids
B.
Test for hydrolysed lecithin
To a 800 ml beaker add 500 ml of water (30 oC-35 oC). 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 % determined by drying at 105 oC for one 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 325 SODIUM LACTATE
Definition
Chemical name
Sodium lactate
Sodium 2-hydroxypropanoate
Einecs
200-772-0
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
A.
Positive test for lactate
B.
Positive test for sodium
Purity
Acidity
Not more than 0,5 % after drying expressed as lactic acid
pH of a 20 % aqueous solution
6,5 to 7,5
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
Reducing substances
No reduction of Fehling's solution
Note:
This specification refers to a 60 % aqueous solution
E 326 POTASSIUM LACTATE
Definition
Cheminal name
Potassium lactate
Potassium 2-hydroxypropanoate
Einecs
213-631-3
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
A.
Ignition
Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added
B.
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
C.
Positive tests for potassium and for lactate
Purity
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
Potassium lactate solution shall not cause any reduction of Fehling's solution
Note:
This specification refers to a 60 % aqueous solution
E 327 CALCIUM LACTATE
Definition
Chemical name
Calcium dilactate
Calcium dilactate hydrate
2-Hydroxypropanoic acid calcium salt
Einecs
212-406-7
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
A.
Positive tests for lactate and for calcium
B.
Solubility tests
Soluble in water and practically insoluble in ethanol
Purity
Loss on drying
Determined by drying at 120 oC for four hours:
—
anhydrous: not more than 3,0 %
—
with 1 molecule of water: not more than 8,0 %
—
with 3 molecules of water: not more than 20,0 %
—
with 4,5 molecules of water: not more than 27,0 %
Acidity
Not more than 0,5 % of the dry matter expressed as lactic acid
Fluoride
Not more than 30 mg/kg (expressed as fluorine)
pH of a 5 % solution
Between 6,0 and 8,0
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
Reducing substances
No reduction of Fehling's solution
E 330 CITRIC ACID
Definition
Chemical name
Citric acid
2-Hydroxy-1,2,3-propanetricarboxylic acid
β-Hydroxytricarballytic acid
Einecs
201-069-1
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
A.
Solubility tests
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 oC
Arsenic
Not more than 1 mg/kg
Lead
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 5 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 oC 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
Monosodium citrate
Monobasic sodium citrate
Definition
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
A.
Positive tests for citrate and for sodium
Purity
Loss on drying
Determined by drying at 180 oC for four hours:
—
anhydrous: not more than 1,0 %
—
monohydrate: not more than 8,8 %
Oxalates
Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution
Between 3,5 and 3,8
Arsenic
Not more than 1 mg/kg
Lead
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 5 mg/kg
E 331 (ii) DISODIUM CITRATE
Synonyms
Disodium citrate
Dibasic sodium citrate
Definition
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
Einecs
205-623-3
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
A.
Positive tests for citrate and for sodium
Purity
Loss on drying
Not more than 13,0 % by drying at 180 oC for four hours
Oxalates
Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution
Between 4,9 and 5,2
Arsenic
Not more than 1 mg/kg
Lead
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 5 mg/kg
E 331 (iii) TRISODIUM CITRATE
Synonyms
Trisodium citrate
Tribasic sodium citrate
Definition
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
Einecs
200-675-3
Chemical formula
Anhydrous:
C6H5O7Na3
Hydrated:
C6H5O7Na3·nH2O (n = 2 or 5)
Molecular weight
258,07 (anhydrous)
Assay
Not less than 99 % on the anhydrous basis
Description
Crystalline white powder or colourless crystals
Identification
A.
Positive tests for citrate and for sodium
Purity
Loss on drying
Determined by drying at 180 oC for four hours:
—
anhydrous:
not more than 1,0 %
—
dihydrate:
not more than 13,5 %
—
pentahydrate:
not more than 30,3 %
Oxalates
Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution
Between 7,5 and 9,0
Arsenic
Not more than 1 mg/kg
Lead
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 5 mg/kg
E 332 (i) MONOPOTASSIUM CITRATE
Synonyms
Monopotassium citrate
Monobasic potassium citrate
Definition
Chemical name
Monopotassium citrate
Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Anhydrous monopotassium salt of citric acid
Einecs
212-753-4
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
A.
Positive tests for citrate and for potassium
Purity
Loss on drying
Not more than 1,0 % determined by drying at 180 oC for four hours
Oxalates
Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution
Between 3,5 and 3,8
Arsenic
Not more than 1 mg/kg
Lead
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 5 mg/kg
E 332 (ii) TRIPOTASSIUM CITRATE
Synonyms
Tripotassium citrate
Tribasic potassium citrate
Definition
Chemical name
Tripotassium citrate
Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Monohydrated tripotassium salt of citric acid
Einecs
212-755-5
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
A.
Positive tests for citrate and for potassium
Purity
Loss on drying
Not more than 6,0 % determined by drying at 180 oC for four hours
Oxalates
Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution
Between 7,5 and 9,0
Arsenic
Not more than 1 mg/kg
Lead
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 5 mg/kg
E 333 (i) MONOCALCIUM CITRATE
Synonyms
Monocalcium citrate
Monobasic calcium citrate
Definition
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
A.
Positive tests for citrate and for calcium
Purity
Loss on drying
Not more than 7,0 % determined by drying at 180 oC for four hours
Oxalates
Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution
Between 3,2 and 3,5
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
Heavy metals (as Pb)
Not more than 5 mg/kg
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
Dicalcium citrate
Dibasic calcium citrate
Definition
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
A.
Positive tests for citrate and for calcium
Purity
Loss on drying
Not more than 20,0 % determined by drying at 180 oC for four 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
Heavy metals (as Pb)
Not more than 5 mg/kg
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
Tricalcium citrate
Tribasic calcium citrate
Definition
Chemical name
Tricalcium citrate
Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Tetrahydrated tricalcium salt of citric acid
Einecs
212-391-7
Chemical formula
(C6H6O7)2Ca3·4H2O
Molecular weight
570,51
Assay
Not less than 97,5 % on the anhydrous basis
Description
Fine white powder
Identification
A.
Positive tests for citrate and for calcium
Purity
Loss on drying
Not more than 14,0 % determined by drying at 180 oC for four 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
Heavy metals (as Pb)
Not more than 5 mg/kg
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
Definition
Chemical name
L-tartaric acid
L-2,3-dihydroxybutanedioic acid
d-α, β-dihydroxysuccinic acid
Einecs
201-766-0
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
A.
Melting range
Between 168 oC and 170 oC
B.
Positive test for tartrate
Purity
Loss on drying
Not more than 0,5 % (over P2O5, three hours)
Sulphated ash
Not more than 1 000 mg/kg after calcination at 800 ± 25 oC
Specific optical rotation of a 20 % w/v aqueous solution
[α] 20 D between +11,5o and +13,5o
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
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
A.
Positive tests for tartrate and for sodium
Purity
Loss on drying
Not more than 10,0 % determined by drying at 105 oC for four 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 335 (ii) DISODIUM TARTRATE
Definition
Chemical name
Disodium L-tartrate
Disodium (+)-tartrate
Disodium (+)-2,3-dihydroxybutanedioic acid
Dihydrated disodium salt of L-(+)-tartaric acid
Einecs
212-773-3
Chemical formula
C4H4O6Na2·2H2O
Molecular weight
230,8
Assay
Content not less than 99 % on the anhydrous basis
Description
Transparent, colourless crystals
Identification
A.
Positive tests for tartrate and for sodium
B.
Solubility tests
1 gram is insoluble in 3 ml of water. Insoluble in ethanol
Purity
Loss on drying
Not more than 17,0 % determined by drying at 150 oC for four hours
Oxalates
Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution
Between 7,0 and 7,5
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 336 (i) MONOPOTASSIUM TARTRATE
Synonyms
Monobasic potassium tartrate
Definition
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
A.
Positive tests for tartrate and for potassium
B.
Melting point
230 oC
Purity
pH of a 1 % aqueous solution
3,4
Loss on drying
Not more than 1,0 % determined by drying at 105 oC for four 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 336 (ii) DIPOTASSIUM TARTRATE
Synonyms
Dibasic potassium tartrate
Definition
Chemical name
Dipotassium salt of L-2,3-dihydroxybutanedioic acid
Dipotassium salt with half a molecule of water of L-(+)-tartaric acid
Einecs
213-067-8
Chemical formula
C4H4O6K2·1/2H2O
Molecular weight
235,2
Assay
Content not less than 99 % on the anhydrous basis
Description
White crystalline or granulated powder
Identification
A.
Positive tests for tartrate and for potassium
Purity
pH of a 1 % aqueous solution
Between 7,0 and 9,0
Loss on drying
Not more than 4,0 % determined by drying at 150 oC for four 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 337 POTASSIUM SODIUM TARTRATE
Synonyms
Potassium sodium L-(+)-tartrate
Rochelle salt
Seignette salt
Definition
Chemical name
Potassium sodium salt of L-2,3-dihydroxybutanedioic acid
Potassium sodium L-(+)-tartrate
Einecs
206-156-8
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
A.
Positive tests for tartrate, for potassium and for sodium
B.
Solubility tests
1 gram is soluble in 1 ml of water, insoluble in ethanol
C.
Melting range
Between 70 and 80 oC
Purity
Loss on drying
Not more than 26,0 % and not less than 21,0 % determined by drying at 150 oC for three hours
Oxalates
Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of 1 % aqueous solution
Between 6,5 and 8,5
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 338 PHOSPHORIC ACID
Synonyms
Orthophosphoric acid
Monophosphoric acid
Definition
Chemical name
Phosphoric acid
Einecs
231-633-2
Chemical formula
H3PO4
Molecular weight
98,00
Assay
Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %.
Description
Clear, colourless, viscous liquid
Identification
A.
Positive tests for acid and for phosphate
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 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 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
Chemical name
Sodium dihydrogen monophosphate
Einecs
231-449-2
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 oC for one hour and then at 105 oC 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
A.
Positive tests for sodium and for phosphate
B.
Solubility
Freely soluble in water. Insoluble in ethanol or ether
C.
pH of a 1 % solution
Between 4,1 and 5,0
Purity
Loss on drying
The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, and the dihydrate not more than 25 % when dried first at 60 oC for one hour, then at 105 oC for four hours
Water-insoluble substances
Not more than 0,2 % on the anhydrous basis
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 339 (ii) DISODIUM PHOSPHATE
Synonyms
Disodium monophosphate
Secondary sodium phosphate
Disodium orthophosphate
Acid disodium phosphate
Definition
Chemical name
Disodium hydrogen monophosphate
Disodium hydrogen orthophosphate
Einecs
231-448-7
Chemical formula
Anhydrous: Na2HPO4
Hydrat: Na2HPO4 · nH2O (n = 2,7 or 12)
Molecular weight
141,98 (anhydrous)
Assay
After drying at 40 oC for three hours and subsequently at 105 oC 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
A.
Positive tests for sodium and for phosphate
B.
Solubility
Freely soluble in water. Insoluble in ethanol
C.
pH of a 1 % solution
Between 8,4 and 9,6
Purity
Loss on drying
When dried at 40 oC for three hours and then at 105 oC for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 %
Water-insoluble substances
Not more than 0,2 % on the anhydrous basis
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 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 1/4 molecule of NaOH
Chemical name
Trisodium monophosphate
Trisodium phosphate
Trisodium orthophosphate
Einecs
231-509-8
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
A.
Positive tests for sodium and for phosphate
B.
Solubility
Freely soluble in water. Insoluble in ethanol
C.
pH of a 1 % solution
Between 11,5 and 12,5
Purity
Loss on ignition
When dried at 120 oC for two hours and then ignited at about 800 oC 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 substances
Not more than 0,2 % on the anhydrous basis
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 340 (i) MONOPOTASSIUM PHOSPHATE
Synonyms
Monobasic potassium phosphate
Monopotassium monophosphate
Potassium orthophosphate
Definition
Chemical name
Potassium dihydrogen phosphate
Monopotassium dihydrogen orthophosphate
Monopotassium dihydrogen monophosphate
Einecs
231-913-4
Chemical formula
KH2PO4
Molecular weight
136,09
Assay
Content not less than 98,0 % after drying at 105 oC 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, hygroscopic
Identification
A.
Positive tests for potassium and for phosphate
B.
Solubility
Freely soluble in water. Insoluble in ethanol
C.
pH of a 1 % solution
Between 4,2 and 4,8
Purity
Loss on drying
Not more than 2,0 % determined by drying at 105 oC for four hours
Water-insoluble substances
Not more than 0,2 % on the anhydrous basis
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 340 (ii) DIPOTASSIUM PHOSPHATE
Synonyms
Dipotassium monophosphate
Secondary potassium phosphate
Dipotassium acid phosphate
Dipotassium orthophosphate
Dibasic potassium phosphate
Definition
Chemical name
Dipotassium hydrogen monophosphate
Dipotassium hydrogen phosphate
Dipotassium hydrogen orthophosphate
Einecs
231-834-5
Chemical formula
K2HPO4
Molecular weight
174,18
Assay
Content not less than 98 % after drying at 105 oC 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
Identification
A.
Positive tests for potassium and for phosphate
B.
Solubility
Freely soluble in water. Insoluble in ethanol
C.
pH of a 1 % solution
Between 8,7 and 9,4
Purity
Loss on drying
Not more than 2,0 % determined by drying at 105 oC for four hours
Water-insoluble substances
Not more than 0,2 % on the anhydrous basis
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 340 (iii) TRIPOTASSIUM PHOSPHATE
Synonyms
Potassium phosphate
Tribasic potassium phosphate
Tripotassium orthophosphate
Definition
Chemical name
Tripotassium monophosphate
Tripotassium phosphate
Tripotassium orthophosphate
Einecs
231-907-1
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 33,0 % on the ignited basis
Description
Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate
Identification
A.
Positive tests for potassium and for phosphate
B.
Solubility
Freely soluble in water. Insoluble in ethanol
C.
pH of a 1 % solution
Between 11,5 and 12,3
Purity
Loss on ignition
Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 oC for one hour and then ignite at about 800 oC ± 25 oC for 30 minutes
Water insoluble substances
Not more than 0,2 % on the anhydrous basis
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 341 (i) MONOCALCIUM PHOSPHATE
Synonyms
Monobasic calcium phosphate
Monocalcium orthophosphate
Definition
Chemical name
Calcium dihydrogen phosphate
Einecs
231-837-1
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
A.
Positive tests for calcium and for phosphate
B.
CaO content
Between 23,0 % and 27,5 % (anhydrous)
Between 19,0 % and 24,8 % (monohydrate)
Purity
Loss on drying
Not more than 14 % determined by drying at 105 oC for four hours (anhydrous)
Not more than 17,5 % determined by drying at 60 oC for one hour, then at 105 oC for four hours (monohydrate)
Loss on ignition
Not more than 17,5 % after ignition at 800 oC ± 25 oC for 30 minutes (anhydrous)
Not more than 25,0 % determined by drying at 105 oC for one hour, then ignite at 800 oC ± 25 oC for 30 minutes (monohydrate)
Fluoride
Not more than 30 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 341 (ii) DICALCIUM PHOSPHATE
Synonyms
Dibasic calcium phosphate
Dicalcium orthophosphate
Definition
Chemical name
Calcium monohydrogen phosphate
Calcium hydrogen orthophosphate
Secondary calcium phosphate
Einecs
231-826-1
Chemical formula
Anhydrous: CaHPO4
Dihydrate: CaHPO4 · 2H2O
Molecular weight
136,06 (anhydrous)
172,09 (dihydrate)
Assay
Dicalcium phosphate, after drying at 200 oC 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
A.
Positive tests for calcium and for phosphate
B.
Solubility tests
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 oC ± 25 oC for 30 minutes
Fluoride
Not more than 50 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
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
Chemical name
Pentacalcium hydroxy monophosphate
Tricalcium monophosphate
Einecs
235-330-6 (Pentacalcium hydroxy monophosphate)
231-840-8 (Calcium orthophosphate)
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
A.
Positive tests for calcium and for phosphate
B.
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 oC ± 25 oC, to constant weight
Fluoride
Not more than 50 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 343(i) MONOMAGNESIUM PHOSPHATE
Synonyms
Magnesiumdihydrogenphosphate
Magnesiumphosphate, monobasic
Monomagnesium orthophosphate
Definition
Chemical name
Monomagnesiumdihydrogenmonophosphate
Einecs
236-004-6
Chemical formula
Mg(H2PO4)2 · nH2O (where n = 0 to 4)
Molecular weight
218,30 (anhydrous)
Assay
Not less than 51,0 % after ignition
Description
White, odourless, crystalline powder, slightly soluble in water
Identification
A.
Positive test for magnesium and for phosphate
B.
MgO content
Not less than 21,5 % after ignition
Purity
Fluoride
Not more than 10 mg/kg (as fluorine)
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 343(ii) DIMAGNESIUM PHOSPHATE
Synonyms
Magnesiumhydrogenphosphate
Magnesiumphosphate, dibasic
Dimagnesium orthophosphate
Secondary magnesiumphosphate
Definition
Chemical name
Dimagnesiummonohydrogenmonophosphate
Einecs
231-823-5
Chemical formula
MgHPO4 · nH2O (where n = 0-3)
Molecular weight
120,30 (anhydrous)
Assay
Not less than 96 % after ignition
Description
White, odourless, crystalline powder, slightly soluble in water
Identification
A.
Positive test for magnesium and for phosphate
B.
MgO content:
Not less than 33,0 % calculated on an anhydrous basis
Purity
Fluoride
Not more than 10 mg/kg (as fluorine)
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 350 (i) SODIUM MALATE
Synonyms
Sodium salt of malic acid
Definition
Chemical name
Disodium DL-malate, disodium salt of hydroxybutanedioic acid
Chemical formula
Hemihydrate: C4H4Na2O5 · 1/2 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
A.
Positive tests for 1,2-dicarboxylic acid and for sodium
B.
Azo dye formation
Positive
C.
Solubility
Freely soluble in water
Purity
Loss on drying
Not more than 7,0 % (130 oC, 4h) for the hemihydrate, or 20,5 %-23,5 % (130 oC, 4h) for the trihydrate
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 350 (ii) SODIUM HYDROGEN MALATE
Synonyms
Monosodium salt of DL-malic acid
Definition
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
A.
Positive tests for 1,2-dicarboxylic acid and for sodium
B.
Azo dye formation
Positive
Purity
Loss on drying
Not more than 2,0 % (110 oC, 3h)
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 351 POTASSIUM MALATE
Synonyms
Potassium salt of malic acid
Definition
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
A.
Positive tests for 1,2-dicarboxylic acid and for potassium
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 352 (i) CALCIUM MALATE
Synonyms
Calcium salt of malic acid
Definition
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
A.
Positive tests for malate, 1,2-dicarboxylic acid and for calcium
B.
Azo dye formation
Positive
C.
Solubility
Slightly soluble in water
Purity
Loss on drying
Not more than 2 % (100 oC, 3h)
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 352 (ii) CALCIUM HYDROGEN MALATE
Synonyms
Monocalcium salt of DL-malic acid
Definition
Chemical name
Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate
Chemical formula
(C4H5O5)2Ca
Assay
Content not less than 97,5 % on the anhydrous basis
Description
White powder
Identification
A.
Positive tests for 1,2-dicarboxylic acid and for calcium
B.
Azo dye formation
Positive
Purity
Loss on drying
Not more than 2,0 % (110 oC, 3h)
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 353 METATARTARIC ACID
Synonyms
Ditartaric acid
Definition
Chemical name
Metatartaric acid
Chemical formula
C4H6O6
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
A.
Very soluble in water and ethanol
B.
Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 oC, an intense violet coloration appears
Purity
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 354 CALCIUM TARTRATE
Synonyms
L-Calcium tartrate
Definition
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
A.
Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
B.
Specific rotation [α]20 D
+7,0o to +7,4o (0,1 % in a 1N de HCl solution)
C.
pH of a 5 % slurry
Between 6,0 and 9,0
Purity
Sulphates (as H2SO4)
Not more than 1 g/kg
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 355 ADIPIC ACID
Definition
Chemical name
Hexanedioic acid, 1,4-butanedicarboxylic acid
Einecs
204-673-3
Chemical formula
C6H10O4
Molecular weight
146,14
Assay
Content not less than 99,6 %
Description
White odourless crystals or crystalline powder
Identification
A.
Melting range
151,5 oC-154,0 oC
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 356 SODIUM ADIPATE
Definition
Chemical name
Sodium adipate
Einecs
231-293-5
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
A.
Melting range
151 oC-152 oC (for adipic acid)
B.
Solubility
Approximately 50 g/100 ml water (20 oC)
C.
Positive test for sodium
Purity
Water
Not more than 3 % (Karl Fischer)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 357 POTASSIUM ADIPATE
Definition
Chemical name
Potassium adipate
Einecs
242-838-1
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
A.
Melting range
151 oC-152 oC (for adipic acid)
B.
Solubility
Approximately 60 g/100 ml water (20 oC)
C.
Positive test for potassium
Purity
Water
Not more than 3 % (Karl Fischer)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 363 SUCCINIC ACID
Definition
Chemical name
Butanedioic acid
Einecs
203-740-4
Chemical formula
C4H6O4
Molecular weight
118,09
Assay
Content no less than 99,0 %
Description
Colourless or white, odourless crystals
Identification
A.
Melting range
Between 185,0 oC and 190,0 oC
Purity
Residue on ignition
Not more than 0,025 % (800 oC, 15 min)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 380 TRIAMMONIUM CITRATE
Synonyms
Tribasic ammonium citrate
Definition
Chemical name
Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid
Einecs
222-394-5
Chemical formula
C6H17N3O7
Molecular weight
243,22
Assay
Content not less than 97,0 %
Description
White to off-white crystals or powder
Identification
A.
Positive tests for ammonium and for citrate
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
Synonyms
Calcium disodium EDTA
Calcium disodium edetate
Definition
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
Einecs
200-529-9
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
A.
Positive tests for sodium and for calcium
B.
Chelating activity to metal ions positive
C.
pH of a 1 % solution between 6,5 and 7,5
Purity
Water content
5 to 13 % (Karl Fischer method)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 400 ALGINIC ACID
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 natural strains of various species of brown seaweeds (Phaeophyceae)
Einecs
232-680-1
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
A.
Solubility
Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate
B.
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
C.
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
D.
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
Purity
pH of a 3 % suspension
Between 2,0 and 3,5
Loss on drying
Not more than 15 % (105 oC, 4 hours)
Sulphated ash
Not more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution)
Not more than 2 % on the anhydrous basis insoluble matter
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
Heavy metals (as Pb)
Not more than 20 mg/kg
Total plate count
Not more than 5 000 colonies per gram
Yeast and moulds
Not more than 500 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative in 10 g
E 401 SODIUM ALGINATE
Definition
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
A.
Positive test for sodium and alginic acid
Purity
Loss on drying
Not more than 15 % (105 oC, 4 hours)
Water-insoluble matter
Not more than 2 % 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
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 20 mg/kg
Total plate count
Not more than 5 000 colonies per gram
Yeast and moulds
Not more than 500 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative in 10 g
E 402 POTASSIUM ALGINATE
Definition
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
A.
Positive test for potassium and for alginic acid
Purity
Loss on drying
Not more than 15 % (105 oC, 4 hours)
Water-insoluble matter
Not more than 2 % 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
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 20 mg/kg
Total plate count
Not more than 5 000 colonies per gram
Yeast and moulds
Not more than 500 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative in 10 g
E 403 AMMONIUM ALGINATE
Definition
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
A.
Positive test for ammonium and alginic acid
Purity
Loss on drying
Not more than 15 % (105 oC, 4 hours)
Sulphated ash
Not more than 7 % on the dried basis
Water-insoluble matter
Not more than 2 % 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
Cadmium
Not more than 1 mg/kg
Heavy metals
Not more than 20 mg/kg
Total plate count
Not more than 5 000 colonies per gram
Yeast and moulds
Not more than 500 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative in 10 g
E 404 CALCIUM ALGINATE
Synonyms
Calcium salt of alginate
Definition
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
A.
Positive test for calcium and alginic acid
Purity
Loss on drying
Not more than 15,0 % (105 oC, 4 hours)
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
Heavy metals (as Pb)
Not more than 20 mg/kg
Total plate count
Not more than 5 000 colonies per gram
Yeast and moulds
Not more than 500 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative in 10 g
E 405 PROPANE-1,2-DIOL ALGINATE
Synonyms
Hydroxypropyl alginate
1,2-propanediol ester of alginic acid
Propylene glycol alginate
Definition
Chemical name
Propane-1,2-diol 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 CO2 of carbon dioxide
Description
Nearly odourless, white to yellowish brown fibrous or granular powder
Identification
A.
Positive test for 1,2-propanediol and alginic acid after hydrolysis
Purity
Loss on drying
Not more than 20 % (105 oC, 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
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
Heavy metals (as Pb)
Not more than 20 mg/kg
Total plate count
Not more than 5 000 colonies per gram
Yeast and moulds
Not more than 500 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative in 10 g
E 406 AGAR
Synonyms
Gelose
Japan agar
Bengal, Ceylon, Chinese or Japanese isinglass
Layor Carang
Definition
Chemical name
Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. 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 natural strains of marine algae of the families Gelidiaceae and Sphaerococcaceae and related red algae of the class Rhodophyceae
Einecs
232-658-1
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, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. 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
A.
Solubility
Insoluble in cold water; soluble in boiling water
Purity
Loss on drying
Not more than 22 % (105 oC, 5 hours)
Ash
Not more than 6,5 % on the anhydrous basis determined at 550 oC
Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)
Not more than 0,5 % determined at 550 oC on the anhydrous basis
Insoluble matter (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 oC. 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 oC 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
Heavy metals (as Pb)
Not more than 20 mg/kg
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 aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded
Einecs
232-524-2
Description
Yellowish to colourless, coarse to fine powder which is practically odourless
Identification
A.
Positive tests for galactose, for anhydrogalactose and for sulphate
Purity
Methanol, ethanol propane-2-ol content
Not more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75 oC
Not less than 5 mPa.s
Loss on drying
Not more than 12 % (105 oC, four 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 oC
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 1 mg/kg
Total plate count
Not more than 5 000 colonies per gram
Yeast and moulds
Not more than 300 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative in 10 g
E 407a PROCESSED EUCHEUMA SEAWEED
Synonyms
PES (acronym for processed eucheuma seaweed)
Definition
Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consists chiefly of the potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded
Description
Tan to yellowish, coarse to fine powder which is practically odourless
Identification
A.
Positive tests for galactose, for anhydrogalactose and for sulphate
B.
Solubility
Forms cloudy viscous suspensions in water. Insoluble in ethanol
Purity
Methanol, ethanol, propane-2-ol content
Not more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75 oC
Not less than 5 mPa.s
Loss on drying
Not more than 12 % (105 oC, four 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 oC
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 1 mg/kg
Total plate count
Not more than 5 000 colonies per gram
Yeast and moulds
Not more than 300 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative 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 natural 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
Molecular weight
50 000-3 000 000
Einecs
232-541-5
Assay
Galactomannan content not less than 75 %
Description
White to yellowish-white, nearly odourless powder
Identification
A.
Positive tests for galactose mannose
B.
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 in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
C.
Solubility
Soluble in hot water, insoluble in ethanol
Purity
Loss on drying
Not more than 15 % (105 oC, 5 hours)
Ash
Not more than 1,2 % determined at 800 oC
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 20 mg/kg
Ethanol and propane-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 natural 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
Einecs
232-536-0
Molecular weight
50 000-8 000 000
Assay
Galactomannan content not less than 75 %
Description
A white to yellowish-white, nearly odourless powder
Identification
A.
Positive tests for galactose and for mannose
B.
Solubility
Soluble in cold water
Purity
Loss on drying
Not more than 15 % (105 oC, 5 hours)
Ash
Not more than 1,5 % determined at 800 oC
Acid-insoluble matter
Not more than 7 %
Protein (N × 6,25)
Not more than 10 %
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 20 mg/kg
E 413 TRAGACANTH
Synonyms
Tragacanth gum
Tragant
Definition
Tragacanth is a dried exudation obtained from the stems and branches of natural 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
Molecular weight
Approximately 800 000
Einecs
232-252-5
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
A.
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
Negative test for Karaya gum
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 oC, 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 20 mg/kg
Salmonella spp.
Negative in 10 g
E. coli
Negative in 5 g
E 414 ACACIA GUM
Synonyms
Gum arabic
Definition
Acacia gum is a dried exudation obtained from the stems and branches of natural 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
Molecular weight
Approximately 350 000
Einecs
232-519-5
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
A.
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 oC, 5 hours) for granular and not more than 10 % (105 oC, 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 20 mg/kg
Hydrolysis products
Mannose, xylose and galacturonic acid are absent (determined by chromatography)
Salmonella spp.
Negative in 10 g
E. coli
Negative in 5 g
E 415 XANTHAN GUM
Definition
Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains of Xanthomonas campestris, purified by recovery with ethanol or propane-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
Molecular weight
Approximately 1 000 000
Einecs
234-394-2
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
A.
Solubility
Soluble in water. Insoluble in ethanol
Purity
Loss on drying
Not more than 15 % (105 oC, 21/2 hours)
Total ash
Not more than 16 % on the anhydrous basis determined at 650 oC after drying at 105 oC 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
Total plate count
Not more than 5 000 colonies per gram
Yeast and mould
Not more than 300 colonies per gram
E. 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 natural 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
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
A.
Solubility
Insoluble in ethanol
B.
Swelling in ethanol solution
Karaya gum swells in 60 % ethanol distinguishing it from other gums
Purity
Loss on drying
Not more than 20 % (105 oC, 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 20 mg/kg
Salmonella spp.
Negative in 10 g
E. coli
Negative in 5 g
E 417 TARA GUM
Definition
Tara gum is obtained by grinding the endosperm of the seeds of natural 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
Description
A white to white-yellow odourless powder
Identification
A.
Solubility
Soluble in water
Insoluble in ethanol
B.
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 × 5,7)
Starch
Not detectable
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
Heavy metals (as Pb)
Not more than 20 mg/kg
E 418 GELLAN GUM
Definition
Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains of Pseudomonas elodea, purified by recovery with isopropyl alcohol, 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
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
A.
Solubility
Soluble in water, forming a viscous solution.
Insoluble in ethanol
Purity
Loss on drying
Not more than 15 % after drying (105 oC, 21/2 hours)
Nitrogen
Not more than 3 %
Propane-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
Heavy metals (as Pb)
Not more than 20 mg/kg
Total plate count
Not more than 10 000 colonies per gram
Yeast and mould
Not more than 400 colonies per gram
E. coli
Negative in 5 g
Salmonella spp.
Negative in 10 g
E 420(i) SORBITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Commission Directive 2008/60/EC (8).
E 420(ii) SORBITOL SYRUP
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 421 MANNITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 422 GLYCEROL
Synonyms
Glycerin
Glycerine
Definition
Chemical names
1,2,3-propanetriol
Glycerol
Trihydroxypropane
Einecs
200-289-5
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
A.
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
B.
Specific gravity (25/25 oC)
Not less than 1,257
C.
Refractive index [n]D20
Between 1,471 and 1,474
Purity
Water
Not more than 5 % (Karl Fischer method)
Sulphated ash
Not more than 0,01 % determined at 800 ± 25 oC
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 oC 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)
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
Heavy metals (as Pb)
Not more than 5 mg/kg
E 425(i) KONJAC GUM
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
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
A.
Solubility
Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0
B.
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
C.
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 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
D.
Viscosity (1 % solution)
Not less than 3 kgm-1s-1 at 25 oC
Purity
Loss on drying
Not more than 12 % (105 oC, 5 h)
Starch
Not more than 3 %
Protein
Not more than 3 % (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 0,1 %
Total ash
Not more than 5,0 % (800 oC, 3 to 4h)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 2 mg/kg
Salmonella spp.
Absent in 12,5 g
E. coli
Absent in 5 g
E 425(ii) KONJAC GLUCOMANNAN
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
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
A.
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
B.
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 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
C.
Viscosity (1 % solution)
Not less than 20 kgm-1s-1 at 25 oC
Purity
Loss on drying
Not more than 8 % (105 oC, 3h)
Starch
Not more than 1 %
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
Not more than 2,0 % material
Total ash
Not more than 2,0 % (800 oC, 3 to 4h)
Lead
Not more than 1 mg/kg
Salmonella spp.
Absent in 12,5 g
E. coli
Absent in 5 g
E 426 SOYBEAN HEMICELLULOSE
Definition
Soybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction
Chemical names
Water soluble soybean polysaccharides
Water soluble soybean fibre
Assay
Not less than 74 % carbohydrate
Description
Free flowing spray-dried white powder
Identification
A.
Solubility pH of 1 % solution
Soluble in hot and cold water without gel formation
5,5±1,5
B.
Viscosity of 10 % solution
Not more than 200 mPa.s
Purity
Loss on drying
Not more than 7 % (105 oC, 4h)
Protein
Not more than 14 %
Total ash
Not more than 9,5 % (600 oC, 4h)
Arsenic
Not more than 2 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Standard plate count
Not more than 3 000 colonies per gram
Yeast and mould
Not more than 100 colonies per gram
E. coli
Negative in 10 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
Assay
Content not less than 97,5 % on the anhydrous basis
Description
Cream-coloured flakes or waxy solid at 25 oC with a faint odour
Identification
A.
Solubility
Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil
B.
Congealing range
39 oC-44 oC
C.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water
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 5 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
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 oC with a faint characteristic odour
Identification
A.
Solubility
Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether
B.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water
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 5 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
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 oC with a faint characteristic odour
Identification
A.
Solubility
Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
B.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water
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 5 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
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 oC with a faint characteristic odour
Identification
A.
Solubility
Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
B.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water
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 5 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
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 oC with a faint characteristic odour
Identification
A.
Solubility
Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
B.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water
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 5 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
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 oC with a faint characteristic odour
Identification
A.
Solubility
Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol
B.
Congealing range
29-33 oC
C.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
E 440 (i) PECTIN
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 natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
Einecs
232-553-0
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
A.
Solubility
Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Purity
Loss on drying
Not more than 12 % (105 oC, 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
Free methanol, ethanol and propane-2-ol
Not more than 1 %, singly or in combination, 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
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 20 mg/kg
E 440 (ii) AMIDATED PECTIN
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 natural 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 propane-2-ol
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
A.
Solubility
Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
Purity
Loss on drying
Not more than 12 % (105 oC, 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
Free methanol, ethanol and propane-2-ol
Not more than 1 % single 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
Heavy metals (as Pb)
Not more than 20 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 (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
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)
Description
Unctuous semi-solid
Identification
A.
Solubility
Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
B.
Positive tests for glycerol, for fatty acid and for phosphate
Purity
Petroleum ether insoluble matter
Not more than 2,5 %
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 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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 formulae
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
A.
Solubility
Insoluble in water. Soluble in most organic solvents
B.
Refractive index
[n]40 D: 1,4492-1,4504
C.
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 3 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 5 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
Description
Hard, yellow to pale amber-coloured solid
Identification
A.
Solubility
Insoluble in water, soluble in acetone
B.
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 %, boilding point 175,5-176 oC, d20 4: 0,84)
Ring and ball softening range
Between 82 oC and 90 oC
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
Heavy metals (as Pb)
Not more than 10 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
Chemical name
Disodium dihydrogen diphosphate
Einecs
231-835-0
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
A.
Positive tests for sodium and for phosphate
B.
Solubility
Soluble in water
C.
pH of a 1 % solution
Between 3,7 and 5,0
Purity
Loss on drying
Not more than 0,5 % (105 oC, four hours)
Water-insoluble matter
Not more than 1 %
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 450 (ii) TRISODIUM DIPHOSPHATE
Synonyms
Acid trisodium pyrophosphate
Trisodium monohydrogen diphosphate
Definition
Einecs
238-735-6
Chemical formula
Monohydrate: Na3HP2O7 · H2O
Anhydrous: Na3HP2O7
Molecular weight
Monohydrate: 261,95
Anhydrous: 243,93
Assay
Content not less than 95 % on the anhydrous basis
P2O5 content
Not less than 57 % and not more than 59 %
Description
White powder or grains, occurs anhydrous or as a monohydrate
Identification
A.
Positive tests for sodium and for phosphate
B.
Solubility
Soluble in water
C.
pH of a 1 % solution
Between 6,7 and 7,5
Purity
Loss on ignition
Not more than 4,5 % on the anhydrous compound
Not more than 11,5 % on the monohydrous basis
Loss on drying
Not more than 0,5 % (105 oC, four hours)
Water-insoluble matter
Not more than 0,2 %
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 450 (iii) TETRASODIUM DIPHOSPHATE
Synonyms
Tetrasodium pyrophosphate
Sodium pyrophosphate
Definition
Chemical name
Tetrasodium diphosphate
Einecs
231-767-1
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
A.
Positive tests for sodium and for phosphate
B.
Solubility
Soluble in water. Insoluble in ethanol
C.
pH of a 1 % solution
Between 9,8 and 10,8
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, in both cases determined after drying at 105 oC for four hours, followed by ignition at 550 oC for 30 minutes
Water-insoluble matter
Not more than 0,2 %
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 450 (v) TETRAPOTASSIUM DIPHOSPHATE
Synonyms
Potassium pyrophosphate
Tetrapotassium pyrophosphate
Definition
Chemical name
Tetrapotassium diphosphate
Einecs
230-785-7
Chemical formula
K4P2O7
Molecular weight
330,34 (anhydrous)
Assay
Content not less than 95 % on the ignited basis
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
A.
Positive tests for potassium and for phosphate
B.
Solubility
Soluble in water, insoluble in ethanol
C.
pH of a 1 % solution
Between 10,0 and 10,8
Purity
Loss on ignition
Not more than 2 % after drying at 105 oC for four hours and then ignition at 550 oC for 30 minutes
Water-insoluble substances
Not more than 0,2 %
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 450 (vi) DICALCIUM DIPHOSPHATE
Synonyms
Calcium pyrophosphate
Definition
Chemical name
Dicalcium diphosphate
Dicalcium pyrophosphate
Einecs
232-221-5
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
A.
Positive tests for calcium and for phosphate
B.
Solubility
Insoluble in water. Soluble in dilute hydrochloric and nitric acids
C.
pH of a 10 % suspension in water
Between 5,5 and 7,0
Purity
Loss on ignition
Not more than 1,5 % at 800 oC ± 25 oC for 30 minutes
Fluoride
Not more than 50 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE
Synonyms
Acid calcium pyrophosphate
Monocalcium dihydrogen pyrophosphate
Definition
Chemical name
Calcium dihydrogen diphosphate
Einecs
238-933-2
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 64 %
Description
White crystals or powder
Identification
A.
Positive tests for calcium and for phosphate
Purity
Acid-insoluble matter
Not more than 0,4 %
Fluoride
Not more than 30 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 451 (i) PENTASODIUM TRIPHOSPHATE
Synonyms
Pentasodium tripolyphosphate
Sodium tripolyphosphate
Definition
Chemical name
Pentasodium triphosphate
Einecs
231-838-7
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
A.
Solubility
Freely soluble in water. Insoluble in ethanol
B.
Positive tests for sodium and for phosphate
C.
pH of a 1 % solution
Between 9,1 and 10,2
Purity
Loss on drying
Anhydrous: Not more than 0,7 % (105 oC, one hour)
Hexahydrate: Not more than 23,5 % (60 oC, one hour, followed by drying at 105 oC, four hours)
Water-insoluble substances
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 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE
Synonyms
Pentapotassium tripolyphosphate
Potassium triphosphate
Potassium tripolyphosphate
Definition
Chemical name
Pentapotassium triphosphate
Pentapotassium tripolyphosphate
Einecs
237-574-9
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
A.
Solubility
Very soluble in water
B.
Positive tests for potassium and for phosphate
C.
pH of a 1 % solution
Between 9,2 and 10,5
Purity
Loss on ignition
Not more than 0,4 % (after drying at 105 oC, four hours, followed by ignition at 550 oC, 30 minutes)
Water-insoluble matter
Not more than 2 %
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 452 (i) SODIUM POLYPHOSPHATE
1. 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
Chemical name
Sodium polyphosphate
Einecs
272-808-3
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
A.
Solubility
Very soluble in water
B.
Positive tests for sodium and for phosphate
C.
pH of a 1 % solution
Between 3,0 and 9,0
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 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
2. 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
Chemical name
Sodium polyphosphate
Einecs
272-808-3
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
P2O5 content
Not less than 68,7 % and not more than 70,0 %
Description
White crystalline powder
Identification
A.
Solubility
Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides
B.
Positive tests for sodium and for phosphate
C.
pH of 1 in 3 suspension in water
About 6,5
Purity
Fluoride
Not more than 10 mg/kg (expressed as fluorine)
Arsenic
Not more than 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 452 (ii) POTASSIUM POLYPHOSPHATE
Synonyms
Potassium metaphosphate
Potassium polymetaphosphate
Kurrol salt
Definition
Chemical name
Potassium polyphosphate
Einecs
232-212-6
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
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
A.
Solubility
1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate
B.
Positive tests for potassium and for phosphate
C.
pH of a 1 % suspension
Not more than 7,8
Purity
Loss on ignition
Not more than 2 % (105 oC, four hours followed by ignition at 550 oC, 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 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 452(iii) SODIUM CALCIUM POLYPHOSPHATE
Synonym
Sodium calcium polyphosphate, glassy
Definition
Chemical name
Sodium calcium polyphosphate
Einecs
233-782-9
Chemical formula
(NaPO3)n CaO where n is typically 5
Assay
Not less than 61 % and not more than 69 % as P2O5
Description
White glassy crystals, spheres
Identification
A.
pH of a 1 % m/m slurry
Approximately 5 to 7
B.
CaO content
7 %-15 % m/m
Purity
Fluoride
Not more than 10 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 452 (iv) CALCIUM POLYPHOSPHATE
Synonyms
Calcium metaphosphate
Calcium polymetaphosphate
Definition
Chemical name
Calcium polyphosphate
Einecs
236-769-6
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
P2O5 content
Not less than 71 % and not more than 73 % on the ignited basis
Description
Odourless, colourless crystals or white powder
Identification
A.
Solubility
Usually sparingly soluble in water. Soluble in acid medium
B.
Positive tests for calcium and for phosphate
C.
CaO content
27 to 29,5 %
Purity
Loss on ignition
Not more than 2 % (105 oC, four hours followed by ignition at 550 oC, 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 3 mg/kg
Cadmium
Not more than 1 mg/kg
Lead
Not more than 4 mg/kg
Mercury
Not more than 1 mg/kg
E 459 BETA-CYCLODEXTRIN
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
Chemical name
Cycloheptaamylose
Einecs
231-493-2
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
Identification
A.
Solubility
Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
B.
Specific rotation
[α]25 D: + 160o to + 164o (1 % solution)
Purity
Water
Not more than 14 % (Karl Fischer method)
Other cyclodextrins
Not more than 2 % on an anhydrous basis
Residual solvents (toluene and trichloroethylene)
Not more than 1 mg/kg for each solvent
Sulphated ash
Not more than 0,1 %
Arsenic
Not more than 1 mg/kg
Lead
Not more than 1 mg/kg
E 460 (i) MICROCRISTALLINE CELLULOSE
Synonyms
Cellulose gel
Definition
Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400
Chemical name
Cellulose
Einecs
232-674-9
Chemical formula
(C6H10O5)n
Molecular weight
About 36 000
Assay
Not less than 97 % calculated as cellulose on the anhydrous basis
Description
A fine white or almost white odourless powder
Identification
A.
Solubility
Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
B.
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
C.
To be identified by IR spectroscopy
D.
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
Purity
Loss on drying
Not more than 7 % (105 oC, 3 hours)
Water-soluble matter
Not more than 0,24 %
Sulphated ash
Not more than 0,5 % determined at 800 ± 25 oC
pH of a 10 % suspension in water
The pH of the supernatant liquid is between 5,0 and 7,5
Starch
Not detectable
To 20 ml of the dispersion obtained in identification, test D, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
Particle size
Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
Carboxyl groups
Not more than 1 %
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 460 (ii) POWDERED CELLULOSE
Definition
Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials
Chemical name
Cellulose
Linear polymer of 1:4 linked glucose residues
Einecs
232-674-9
Chemical formula
(C6H10O5)n
Molecular weight
(162)n (n is predominantly 1 000 and greater)
Assay
Content not less than 92 %
Description
A white, odourless powder
Identification
A.
Solubility
Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
B.
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 settle and a supernatant liquid appears
Purity
Loss on drying
Not more than 7 % (105 oC, 3 hours)
Water-soluble matter
Not more than 1,0 %
Sulphated ash
Not more than 0,3 % determined at 800 ± 25 oC
pH of a 10 % suspension in water
The pH of the supernatant liquid is between 5,0 and 7,5
Starch
Not detectable
To 20 ml of the dispersion obtained in identification, test B, 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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
Particle size
Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
E 461 METHYL CELLULOSE
Synonyms
Cellulose methyl ether
Definition
Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups
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
A.
Solubility
Swelling in water, producing a clear to opalescent, viscous, colloidal solution.
Insoluble in ethanol, ether and chloroform.
Soluble in glacial acetic acid
Purity
Loss on drying
Not more than 10 % (105 oC, 3 hours)
Sulphated ash
Not more than 1,5 % determined at 800 ± 25 oC
pH of a 1 % colloidal solution
Not less than 5,0 and not more than 8,0
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
Heavy metals (as Pb)
Not more than 20 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
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
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
A.
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
B.
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
Purity
Loss on drying
Not more than 3 % (105 oC, 2 hours)
Sulphated ash
Not more than 0,4 %
pH of a 1 % colloidal solution
Neutral to litmus
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 natural strains of fibrous plant material and partially etherified with hydroxypropyl groups
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 less 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
A.
Solubility
Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
B.
Gas chromatography
Determine the substituents by gas chromotography
Purity
Loss on drying
Not more than 10 % (105 oC, 3 hours)
Sulphated ash
Not more than 0,5 % determined at 800 ± 25 oC
pH of a 1 % colloidal solution
Not less than 5,0 and not more than 8,0
Propylene chlorohydrins
Not more than 0,1 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
Heavy metals (as Pb)
Not more than 20 mg/kg
E 464 HYDROXYPROPYL METHYL CELLULOSE
Definition
Hydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution
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
A.
Solubility
Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol
B.
Gas chromatography
Determine the substituents by gas chromatography
Purity
Loss on drying
Not more than 10 % (105 oC, 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
pH of a 1 % colloidal solution
Not less than 5,0 and not more than 8,0
Propylene chlorohydrins
Not more than 0,1 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
Heavy metals (as Pb)
Not more than 20 mg/kg
E 465 ETHYL METHYL CELLULOSE
Synonyms
Methylethylcellulose
Definition
Ethyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groups
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
A.
Solubility
Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
Purity
Loss on drying
Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 oC to constant weight)
Sulphated ash
Not more than 0,6 %
pH of a 1 % colloidal solution
Not less than 5,0 and not more than 8,0
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
Heavy metals (as Pb)
Not more than 20 mg/kg
E 466 SODIUM CARBOXY METHYL CELLULOSE
Synonyms
Carboxy methyl cellulose
CMC
NaCMC
Sodium CMC
Cellulose gum
Definition
Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material
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
A.
Solubility
Yields a viscous colloidal solution with water. Insoluble in ethanol
B.
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)
C.
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)
D.
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
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 oC to constant weight)
pH of a 1 % colloidal solution
Not less than 5,0 and not more than 8,5
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 1 mg/kg
Heavy metals (as Pb)
Not more than 20 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
Synonyms
Cross-linked carboxymethyl cellulose
Cross-linked CMC
Cross-linked sodium CMC
Cross-linked cellulose gum
Definition
Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose
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
Description
Slightly hygroscopic, white to off white, odourless powder
Identification
A.
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
B.
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
C.
It gives the reaction of sodium
Purity
Loss on drying
Not more than 6 % (105 oC, 3h)
Water solubles
Not more than 10 %
Degree of substitution
Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit
pH of 1 %
Not less than 5,0 and not more than 7,0
Sodium content
Not more than 12,4 % on anhydrous basis
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Cadmium
Not more than 1 mg/kg
Mercury
Not more than 1 mg/kg
E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE
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)
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)
Formula 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
A.
Solubility
Soluble in water, insoluble in ethanol
B.
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
C.
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
D.
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
E.
Viscosity (60 % solids)
Not less than 2,500 kgm-1s-1 at 25 oC corresponding to an average molecule weight of 5 000 D
Purity
Loss on drying
Not more than 12 % (105 oC 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
pH of a 1 % colloidal solution
Not less than 6,0 and not more than 8,5
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
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
Assay
Content on the anhydrous basis not less than 95 %
Description
White or creamy white light powders, flakes or semi-solids
Identification
A.
Solubility
Sodium and potassium salts: soluble in water and ethanol calcium salts:
insoluble in water, ethanol and ether
B.
Positive tests for cations and for fatty acids
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
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
Assay
Content on the anhydrous basis not less than 95 %
Description
White or creamy-white light powders, flakes or semi-solids
Identification
A.
Solubility
Insoluble in water, partially soluble in ethanol and ether
B.
Positive tests for magnesium and for fatty acids
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
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
A.
Infrared spectrum
Characteristic of a partial fatty acid ester of a polyol
B.
Positive tests for glycerol and for fatty acids
C.
Solubility
Insoluble in water, soluble in ethanol and toluene
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
Total glycerol
Not less than 16 % and not more than 33 %
Sulphated ash
Not more than 0,5 % determined at 800 ± 25 oC
Note:
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
Description
Clear, mobile liquids to solids, from white to pale yellow in colour
Identification
A.
Positive tests for glycerol, for fatty acids and for acetic acid
B.
Solubility
Insoluble in water. Soluble in ethanol
Purity
Acids other than acetic and fatty acids
Not detectable
Free glycerol
Not more than 2 %
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
Heavy metals (as Pb)
Not more than 10 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 oC
Note:
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
A.
Positive tests for glycerol, for fatty acids and for lactic acid
B.
Solubility
Insoluble in cold water but dispersible in hot water
Purity
Acids other than lactic and fatty acids
Not detectable
Free glycerol
Not more than 2 %
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
Heavy metals (as Pb)
Not more than 10 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 % determined at 800 ± 25 oC
Note:
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 hydroxide or with potassium hydroxide
Description
Yellowish or light brown liquids to waxy solids or semi-solids
Identification
A.
Positive tests for glycerol, for fatty acids and for citric acid
B.
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
Not detectable
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 (determined at 800 ± 25 oC)
Non-neutralised products: not more than 0,5 %
Partially or wholly neutralised products: not more than 10 %
Lead
Not more than 2 mg/kg
Free fatty acids
Not more than 3 % estimated as oleic acid
Note:
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
Description
Sticky viscous yellowish liquids to hard yellow waxes
Identification
A.
Positive tests for glycerol, for fatty acids and for tartaric acid
Purity
Acids other than tartaric and fatty acids
Not detectable
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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 % determined at 800 ± 25 oC
Note:
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
Mixted 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
Description
Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
Identification
A.
Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Purity
Acids other than acetic, tartaric and fatty acids
Not detectable
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 oC
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
Heavy metals (as Pb)
Not more than 10 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 %
Free fatty acids
Not more than 3 % estimated as oleic acid
Note:
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 ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
Description
Sticky liquids to solids, from white to pale-yellow in colour
Identification
A.
Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
Purity
Acids other than acetic, tartaric and fatty acids
Not detectable
Free glycerol
Not more than 2 %
Total glycerol
Not less than 12 % and not more than 27 %
Sulphated ash
Not more than 0,5 % determined at 800 ± 25 oC
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
Heavy metals (as Pb)
Not more than 10 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
Note:
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 and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation
Assay
Content not less than 80 %
Description
Stiff gels, soft solids or white to slightly greyish-white powders
Identification
A.
Positive tests for sugar for fatty acids
B.
Solubility
Sparingly soluble in water
Soluble in ethanol
Purity
Sulphated ash
Not more than 2 % determined at 800 ± 25 oC
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
Ethylacetate
Not more than 350 mg/kg, singly or in combination
Propane-2-ol
Prolyleneglycol
Methyl ethyl ketone
Not more than 10 mg/kg
Note:
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 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 propane-2-ol
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
A.
Positive tests for sugar and for fatty acids
B.
Solubility
Insoluble in cold water
Soluble in ethanol
Purity
Sulphated ash
Not more than 2 % determined at 800 ± 25 oC
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
Methanol
Not more than 10 mg/kg
Dimethylformamide
Not more than 1 mg/kg
2-methyl-1-propanol
Not more than 10 mg/kg, single or in combination
Cyclohexane
Ethylacetate
Not more than 350 mg/kg, single or in combination
Propane-2-ol
Note:
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
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
A.
Positive tests for glycerol, for polyglycerols and for fatty acids
B.
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 % determined at 800 ± 25 oC
Acids other than fatty acids
Not detectable
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
Note:
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
Description
Clear, highly viscous liquid
Identification
A.
Solubility
Insoluble in water and in ethanol.
Soluble in ether, hydrocarbons and halogenated hydrocarbons
B.
Positive tests for glycerol, polyglycerol and for ricinoleic acid
C.
Refractive index [n]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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
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
A.
Positive tests for propylene glycol and for fatty acids
Purity
Sulphated ash
Not more than 0,5 % determined at 800 ± 25 oC
Acids other than fatty acids
Not detectable
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
Note:
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 desodorisation under vacuum at 130 oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans
Description
Pale yellow to light brown a waxy or solid consistency
Identification
A.
Solubility
Insoluble in water. Soluble in hot oil or fat
Purity
Melting range
55-65 oC
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
Chemical names
Sodium di-2-stearoyl lactate
Sodium di(2-stearoyloxy)propionate
Einecs
246-929-7
Chemical formula (major components)
C21H39O4Na
C19H35O4Na
Description
White or slightly yellowish powder or brittle solid with a characteristic odour
Identification
A.
Positive tests for sodium, for fatty acids and for lactic acid
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
Chemical name
Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Einecs
227-335-7
Chemical formula
C42H78O8Ca
C38H70O8Ca
Description
White or slightly yellowish powder or brittle solid with a characteristic odour
Identification
A.
Positive tests for calcium, for fatty acids and for lactid acid
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
Chemical name
Distearyl tartrate
Dipalmityl tartrate
Chemical formula
C38H74O6 to C40H78O6
Molecular weight
627 to 655
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 oC)
Identification
A.
Positive tests for tartare
B.
Melting range
Between 67 oC and 77 oC. After saponification the saturated long chain fatty alcohols have a melting range of 49 oC to 55 oC
Purity
Hydroxyl value
Not less than 200 and not more than 220
Acid value
Not more than 5,6
Total tartaric acid content
Not less than 18 % and not more than 35 %
Sulphated ash
Not more than 0,5 % determined at 800 ± 25 oC
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
Heavy metals (as Pb)
Not more than 10 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
Definition
A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
Einecs
215-664-9
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
A.
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 oC in mineral oil and ethyl acetate
B.
Congealing range
50-52 oC
C.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyol
Purity
Water
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 492 SORBITAN TRISTEARATE
Definition
A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
Einecs
247-891-4
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
A.
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
B.
Congealing range
47-50 oC
C.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyol
Purity
Water
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 493 SORBITAN MONOLAURATE
Definition
A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid
Einecs
215-663-3
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
A.
Solubility
Dispersible in hot and cold water
B.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of a polyol
Purity
Water
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 494 SORBITAN MONOOLEATE
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
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
A.
Solubility
Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water
B.
Iodine value
The residue of oleic acid, obtained from the saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100
Purity
Water
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 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
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
A.
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
B.
Congealing range
45-47 oC
C.
Infrared absorption spectrum
Characteristic of a partial fatty acid ester of polyol
Purity
Water
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 5 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg
Heavy metals (as Pb)
Not more than 10 mg/kg
E 500(i) SODIUM CARBONATE
Synonyms
Soda ash
Definition
Chemical name
Sodium carbonate
Einecs
207-838-8
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
A.
Positive tests for sodium and for carbonate
B.
Solubility
Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying
Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 oC raising gradually to 300 oC, to constant weight)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 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
Chemical name
Sodium hydrogen carbonate
Einecs
205-633-8
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
A.
Positive tests for sodium and for carbonate
B.
pH of a 1 % solution
Between 8,0 and 8,6
C.
Solubility
Soluble in water. Insoluble in ethanol
Purity
Loss on drying
Not more than 0,25 % (over silica gel, 4h)
Ammonium salts
No odour of ammonia detectable after heating
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 500(iii) SODIUM SESQUICARBONATE
Definition
Chemical name
Sodium monohydrogen dicarbonate
Einecs
208-580-9
Chemical formula
Na2(CO)3 · 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
A.
Positive tests for sodium and for carbonate
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 501(i) POTASSIUM CARBONATE
Definition
Chemical name
Potassium carbonate
Einecs
209-529-3
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
A.
Positive tests for potassium and for carbonate
B.
Solubility
Very soluble in water. Insoluble in ethanol
Purity
Loss on drying
Not more than 5 % (anhydrous) or 18 % (hydrate) (180 oC, 4h)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 501(ii) POTASSIUM HYDROGEN CARBONATE
Synonyms
Potassium bicarbonate, acid potassium carbonate
Definition
Chemical name
Potassium hydrogen carbonate
Einecs
206-059-0
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
A.
Positive tests for potassium and for carbonate
B.
Solubility
Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying
Not more than 0,25 % (over silica gel, 4h)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 503(i) AMMONIUM CARBONATE
Definition
Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions
Chemical name
Ammonium carbonate
Einecs
233-786-0
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
A.
Positive tests for ammonium and for carbonate
B.
pH of a 5 % solution
about 8,6
C.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 503(ii) AMMONIUM HYDROGEN CARBONATE
Synonyms
Ammonium bicarbonate
Definition
Chemical name
Ammonium hydrogen carbonate
Einecs
213-911-5
Chemical formula
CH5NO3
Molecular weight
79,06
Assay
Content not less than 99,0 %
Description
White crystals or crystalline powder
Identification
A.
Positive tests for ammonium and for carbonate
B.
pH of a 5 % solution
about 8,0
C.
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 5 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
Chemical name
Magnesium carbonate hydroxide hydrated
Einecs
235-192-7
Chemical formula
4MgCO3Mg(OH)25H2O
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
A.
Positive tests for magnesium and for carbonate
B.
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 10 mg/kg
Mercury
Not more than 1 mg/kg
E 507 HYDROCHLORIC ACID
Synonyms
Hydrogen chloride, muriatic acid
Definition
Chemical name
Hydrochloric acid
Einecs
231-595-7
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
A.
Positive tests for acid and for chloride
B.
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
Chemical name
Potassium chloride
Einecs
231-211-8
Chemical formulae
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
A.
Solubility
Freely soluble in water. Insoluble in ethanol
B.
Positive tests for potassium and for chloride
Purity
Loss on drying
Not more than 1 % (105 oC, 2 hours)
Sodium
Negative test
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
Heavy metals (as Pb)
Not more than 10 mg/kg
E 509 CALCIUM CHLORIDE
Definition
Chemical name
Calcium chloride
Einecs
233-140-8
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
A.
Positive tests for calcium and for chloride
B.
Solubility
Anhydrous calcium chloride: freely soluble in water and ethanol
Dihydrate: freely soluble in water, soluble in ethanol
Hexahydrate: very soluble in water and ethanol
Purity
Magnesium and alkali salts
Not more than 5 % on the anhydrous basis
Fluoride
Not more than 40 mg/kg
Arsenic
Not more than 3 mg/kg
Lead
Not more than 10 mg/kg
Mercury
Not more than 1 mg/kg
E 511 MAGNESIUM CHLORIDE
Definition
Chemical name
Magnesium chloride
Einecs
232-094-6
Chemical formula
MgCl2 · 6H2O
Molecular weight
203,30
Assay
Content not less than 99,0 %
Description
Colourless, odourless, very deliquescent flakes or crystals
Identification
A.
Positive tests for magnesium and for chloride
B.
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 10 mg/kg
Mercury
Not more than 1 mg/kg
E 512 STANNOUS CHLORIDE
Synonyms
Tin chloride, tin dichloride
Definition
Chemical name
Stannous chloride dihydrate
Einecs
231-868-0
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
A.
Positive tests for tin (II) and for chloride
B.
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 5 mg/kg
E 513 SULPHURIC ACID
Synonyms
Oil of vitriol, dihydrogen sulphate
Definition
Chemical name
Sulphuric acid
Einecs
231-639-5
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
A.
Positive tests for acid and for sulphate
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 514(i) SODIUM SULPHATE
Definition
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
A.
Positive tests for sodium and for sulphate
B.
Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper
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 5 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
A.
Positive tests for sodium and for sulphate
B.
Solutions are strongly acidic
Purity
Loss on drying
Not more than 0,8 %
Water insoluble
Not more than 0,05 %
Selenium
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 515(i) POTASSIUM SULPHATE
Definition
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
A.
Positive tests for potassium and for sulphate
B.
pH of a 5 % solution
Between 5,5 and 8,5
C.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 515(ii) POTASSIUM HYDROGEN SULPHATE
Definition
Synonyms
Potassium bisulphate, potassium acid sulphate
Chemical name
Potassium hydrogen sulphate
Chemical formula
KHSO4
Molecular weight
136,17
Assay
Content not less than 99 %
Melting point
197 oC
Description
White deliquescent crystals, pieces or granules
Identification
A.
Positive test for potassium
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 516 CALCIUM SULPHATE
Synonyms
Gypsum, selenite, anhydrite
Definition
Chemical name
Calcium sulphate
Einecs
231-900-3
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
A.
Positive tests for calcium and for sulphate
B.
Solubility
Slightly soluble in water, insoluble in ethanol
Purity
Loss on drying
Anhydrous: not more than 1,5 % (250 oC, constant weight)
Dihydrate: not more than 23 % (ibid.)
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 517 AMMONIUM SULPHATE
Definition
Chemical name
Ammonium sulphate
Einecs
231-984-1
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
A.
Positive tests for ammonium and for sulphate
B.
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 5 mg/kg
E 520 ALUMINIUM SULPHATE
Synonyms
Alum
Definition
Chemical name
Aluminium sulphate
Einecs
233-135-0
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
A.
Positive tests for aluminium and for sulphate
B.
pH of a 5 % solution 2,9 or above
C.
Solubility
Freely soluble in water, insoluble in ethanol
Purity
Loss on ignition
Not more than 5 % (500 oC, 3h)
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 10 mg/kg
Mercury
Not more than 1 mg/kg
E 521 ALUMINIUM SODIUM SULPHATE
Synonyms
Soda alum, sodium alum
Definition
Chemical name
Aluminium sodium sulphate
Einecs
233-277-3
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
A.
Positive tests for aluminium, for sodium and for sulphate
B.
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 oC, 16h)
Dodecahydrate: not more than 47,2 % (50 oC-55 oC, 1h then 200 oC, 16h)
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
Chemical name
Aluminium potassium sulphate dodecahydrate
Einecs
233-141-3
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
A.
Positive tests for aluminium, for potassium and for sulphate
B.
pH of a 10 % solution between 3,0 and 4,0
C.
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
Chemical name
Aluminium ammonium sulphate
Einecs
232-055-3
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
A.
Positive tests for aluminium, for ammonium and for sulphate
B.
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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 524 SODIUM HYDROXIDE
Synonyms
Caustic soda, lye
Definition
Chemical name
Sodium hydroxide
Einecs
215-185-5
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
A.
Positive tests for sodium
B.
A 1 % solution is strongly alkaline
C.
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
Chemical name
Potassium hydroxide
Einecs
215-181-3
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
A.
Positive tests for potassium
B.
A 1 % solution is strongly alkaline
C.
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 10 mg/kg
Mercury
Not more than 1 mg/kg
E 526 CALCIUM HYDROXIDE
Synonyms
Slaked lime, hydrated lime
Definition
Chemical name
Calcium hydroxide
Einecs
215-137-3
Chemical formula
Ca(OH)2
Molecular weight
74,09
Assay
Content not less than 92,0 %
Description
White powder
Identification
A.
Positive tests for alkali and for calcium
B.
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 1,0 %
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 10 mg/kg
E 527 AMMONIUM HYDROXIDE
Synonyms
Aqua ammonia, strong ammonia solution
Definition
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
A.
Positive tests for ammonia
Purity
Non-volatile matter
Not more than 0,02 %
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
E 528 MAGNESIUM HYDROXIDE
Definition
Chemical name
Magnesium hydroxide
Einecs
215-170-3
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
A.
Positive test for magnesium and for alkali
B.
Solubility
Practically insoluble in water and in ethanol
Purity
Loss on drying
Not more than 2,0 % (105 oC, 2h)
Loss on ignition
Not more than 33 % (800 oC to constant weight)
Calcium oxide
Not more than 1,5 %
Arsenic
Not more than 3 mg/kg
Lead
Not more than 10 mg/kg
E 529 CALCIUM OXIDE
Synonyms
Burnt lime
Definition
Chemical name
Calcium oxide
Einecs
215-138-9
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
A.
Positive test for alkali and for calcium
B.
Heat is generated on moistening the sample with water
C.
Solubility
Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Loss on ignition
Not more than 10,0 % (ca 800 oC 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 1,5 %
Fluoride
Not more than 50 mg/kg
Arsenic
Not more than 3 mg/kg
Lead
Not more than 10 mg/kg
E 530 MAGNESIUM OXIDE
Definition
Chemical name
Magnesium oxide
Einecs
215-171-9
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 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 ml
Identification
A.
Positive test for alkali and for magnesium
B.
Solubility
Practically insoluble in water. Insoluble in ethanol
Purity
Loss on ignition
Not more than 5,0 % (ca 800 oC to constant weight)
Calcium oxide
Not more than 1,5 %
Arsenic
Not more than 3 mg/kg
Lead
Not more than 10 mg/kg
E 535 SODIUM FERROCYANIDE
Synonyms
Yellow prussiate of soda, sodium hexacyanoferrate
Definition
Chemical name
Sodium ferrocyanide
Einecs
237-081-9
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
A.
Positive test for sodium and for ferrocyanide
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
Chemical name
Potassium ferrocyanide
Einecs
237-722-2
Chemical formula
K4Fe(CN)6· 3 H2O
Molecular weight
422,4
Assay
Content not less than 99,0 %
Description
Lemon yellow crystals
Identification
A.
Positive test for potassium and for ferrocyanide
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
Chemical name
Calcium ferrocyanide
Einecs
215-476-7
Chemical formula
Ca2Fe(CN)6 · 12H2O
Molecular weight
508,3
Assay
Content not less than 99,0 %
Description
Yellow crystals or crystalline powder
Identification
A.
Positive test for calcium and for ferrocyanide
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
Chemical name
Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) or
Trisodium dialuminium pentadecahydrogen octaphosphate (B)
Einecs
232-090-4
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
A.
Positive test for sodium, for aluminium and for phosphate
B.
pH
Acid to litmus
C.
Solubility
Insoluble in water. Soluble in hydrochloric acid
Purity
Loss on ignition
19,5 %-21,0 % (A) } (750 oC-800 oC, 2h)
15 %-16 % (B) } (750 oC-800 oC, 2h)
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
Chemical name
Silicon dioxide
Einecs
231-545-4
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
A.
Positive test for silica
Purity
Loss on drying
Not more than 2,5 % (fumed silica, 105 oC, 2h)
Not more than 8,0 % (precipitated silica and silica gel, 105 oC, 2h)
Not more than 70 % (hydrous silica, 105 oC, 2h)
Loss on ignition
Not more than 2,5 % after drying (1 000 oC, fumed silica)
Not more than 8,5 % after drying (1 000 oC, 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
Definition
Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2
Chemical name
Calcium silicate
Einecs
215-710-8
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
A.
Positive test for silicate and for calcium
B.
Forms a gel with mineral acids
Purity
Loss on drying
Not more than 10 % (105 oC, 2h)
Loss on ignition
Not less than 5 % and not more than 14 % (1 000 oC, 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 5 mg/kg
Mercury
Not more than 1 mg/kg
E 553a(i) MAGNESIUM SILICATE
Definition
Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
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
A.
Positive test for magnesium and for silicate
B.
pH of a 10 % slurry
Between 7,0 and 10,8
Purity
Loss on drying
Not more than 15 % (105 oC, 2h)
Loss on ignition
Not more than 15 % after drying (1 000 oC, 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
Definition
Chemical name
Magnesium trisilicate
Chemical formula
Mg2Si3O8 · xH2O (approximate composition)
Einecs
239-076-7
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
A.
Positive test for magnesium and for silicate
B.
pH of a 5 % slurry
Between 6,3 and 9,5
Purity
Loss on ignition
Not less than 17 % and not more than 34 % (1 000 oC)
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
Chemical name
Magnesium hydrogen metasilicate
Einecs
238-877-9
Chemical formula
Mg3(Si4O10)(OH)2
Molecular weight
379,22
Description
Light, homogeneous, white or almost white powder, greasy to the touch
Identification
A.
IR absorption
Characteristic peaks at 3 677, 1 018 and 669 cm-1
B.
X-ray diffraction
Peaks at 9,34/4,66/3,12 Å
C.
Solubility
Insoluble in water and ethanol
Purity
Loss on drying
Not more than 0,5 % (105 oC, 1h)
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 5 mg/kg
E 554 SODIUM ALUMINIUM SILICATE
Synonyms
Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate
Definition
Chemical name
Sodium aluminium silicate
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
A.
Positive tests for sodium, for aluminium and for silicate
B.
pH of a 5 % slurry
Between 6,5 and 11,5
Purity
Loss on drying
Not more than 8,0 % (105 oC, 2h)
Loss on ignition
Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000 oC, 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 formulae
KAl2[AlSi3O10](OH)2
Molecular weight
398
Assay
Content not less than 98 %
Description
Light grey to white crystalline platelets or powder
Identification
A.
Solubility
Insoluble in water, diluted acids and alkali and organic solvents
Purity
Loss on drying
Not more than 0,5 % (105 oC, 2h)
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 10 mg/kg
E 556 CALCIUM ALUMINIUM SILICATE
Synonyms
Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate
Definition
Chemical name
Calcium aluminium silicate
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
A.
Positive tests for calcium, for aluminium and for silicate
Purity
Loss on drying
Not more than 10,0 % (105 oC, 2h)
Loss on ignition
Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000 oC, constant weight)
Fluoride
Not more than 50 mg/kg
Arsenic
Not more than 3 mg/kg
Lead
Not more than 10 mg/kg
Mercury
Not more than 1 mg/kg
E 558 BENTONITE
Definition
Bentonite is a natural clay containing a high proportion of montmorillonite, a native hydrated aluminium silicate in which some aluminium and silicon atoms were naturally replaced by other atoms such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite and acid-activated bentonite
Einecs
215-108-5
Chemical formula
(Al, Mg)8(Si4O10) 4(OH)8 · 12H2O
Molecular weight
819
Assay
Montmorillonite content not less than 80 %
Description
Very fine, yellowish or greyish white powder or granules. The structure of bentonite allows it to absorb water in its structure and on its external surface (swelling properties)
Identification
A.
Methylene blue test
B.
X-Ray diffraction
Characteristic peaks at 12,5/15 A
C.
IR absorption
Peaks at 428/470/530/1 110-1 020/3 750 — 3 400 cm-1
Purity
Loss on drying
Not more than 15,0 % (105 oC, 2h)
Arsenic
Not more than 2 mg/kg
Lead
Not more than 20 mg/kg
E 559 ALUMINIUM SILICATE (KAOLIN)
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
Einecs
215-286-4 (kaolinite)
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
A.
Positive tests for alumina and for silicate
B.
X-ray diffraction:
Characteristic peaks at 7,18/3,58/2,38/1,78 Å
C.
IR absorption:
Peaks at 3 700 and 3 620 cm-1
Purity
Loss on ignition
Between 10 and 14 % (1 000 oC, 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
Definition
Linear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)
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)
Assay
Not less than 98 % by chromatography
Description
A colourless liquid or white solid obtained from oils and fats
Identification
A.
Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight
Purity
Residue on ignition
Not more than 0,1 %
Unsaponifiable matter
Not more than 1,5 %
Water
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
Chemical name
Gluconic acid
Chemical formula
C6H12O7 (gluconic acid)
Molecular weight
196,2
Assay
Content not less than 50,0 % (as gluconic acid)
Description
Colourless to light yellow, clear syrupy liquid
Identification
A.
Formation of phenylhydrazine derivative positive
Compound formed melts between 196 oC and 202 oC with decomposition
Purity
Residue on ignition
Not more than 1,0 %
Reducing matter
Not more than 0,75 % (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 5 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
Chemical name
D-Glucono-1,5-lactone
Einecs
202-016-5
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
A.
Formation of phenylhydrazine derivative of gluconic acid positive
Compound formed melts between 196 oC and 202 oC with decomposition
B.
Solubility
Freely soluble in water. Sparingly soluble in ethanol
C.
Melting point
152 oC ± 2 oC
Purity
Water
Not more than 1,0 % (Karl Fischer method)
Reducing substances
Not more than 0,75 % (as D-glucose)
Lead
Not more than 2 mg/kg
E 576 SODIUM GLUCONATE
Synonyms
Sodium salt of D-gluconic acid
Definition
Chemical name
Sodium D-gluconate
Einecs
208-407-7
Chemical formula
C6H11NaO7 (anhydrous)
Molecular weight
218,14
Assay
Content not less than 98,0 %
Description
White to tan, granular to fine, crystalline powder
Identification
A.
Positive test for sodium and for gluconate
B.
Solubility
Very soluble in water. Sparingly soluble in ethanol
C.
pH of a 10 % solution
Between 6,5 and 7,5
Purity
Reducing matter
Not more than 1,0 % (as D-glucose)
Lead
Not more than 2 mg/kg
E 577 POTASSIUM GLUCONATE
Synonyms
Potassium salt of D-gluconic acid
Definition
Chemical name
Potassium D-gluconate
Einecs
206-074-2
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
A.
Positive test for potassium and for gluconate
B.
pH of a 10 % solution
Between 7,0 and 8,3
Purity
Loss on drying
Anhydrous: not more than 3,0 % (105 oC, 4h, vacuum)
Monohydrate: not less than 6 % and not more than 7,5 % (105 oC, 4h, 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
Chemical name
Calcium di-D-gluconate
Einecs
206-075-8
Chemical formula
C12H22CaO14 (anhydrous)
C12H22CaO14 · H2O (monohydrate)
Molecular weight
430,38 (anhydrous form)
448,39 (monohydrate)
Assay
Content not less than 98,0 % and not more than 102 % on the anhydrous and monohydrate basis
Description
Odourless, white crystalline granules or powder, stable in air
Identification
A.
Positive test for calcium and for gluconate
B.
Solubility
Soluble in water, insoluble in ethanol
C.
pH of a 5 % solution
Between 6,0 and 8,0
Purity
Loss on drying
Not more than 3,0 % (105 oC, 16h) (anhydrous)
Not more than 2,0 % (105 oC, 16h) (monohydrate)
Reducing substances
Not more than 1,0 % (as D-glucose)
Lead
Not more than 2 mg/kg
E 579 FERROUS GLUCONATE
Definition
Chemical name
Ferrous di-D-gluconate dihydrate
Iron(II) di-gluconate dihydrate
Einecs
206-076-3
Chemical formulae
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
A.
Solubility
Soluble with slight heating in water. Practically insoluble in ethanol
B.
Positive test for ferrous ion
C.
Formation of phenylhy-drazine derivative of gluconic acid positive
D.
pH of a 10 % solution
Between 4 and 5,5
Purity
Loss on drying
Not more than 10 % (105 oC, 16 hours)
Oxalic acid
Not detectable
Iron (Fe III)
Not more than 2 %
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
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
Chemical name
Ferrous 2-hydroxy propanoate
Einecs
227-608-0
Chemical formulae
C6H10FeO6·xH2O (x = 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
A.
Solubility
Soluble in water. Practically insoluble in ethanol
B.
Positive test for ferrous ion and for lactate
C.
pH of a 2 % solution
Between 4 and 6
Purity
Loss on drying
Not more than 18 % (100 oC, 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 5 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
Chemical name
4-Hexylresorcinol
Einecs
205-257-4
Chemical formula
C12H18O2
Molecular weight
197,24
Assay
Not less than 98 % on the dried basis
Description
White powder
Identification
A.
Solubility
Freely soluble in ether and acetone; very slightly soluble in water
B.
Nitric acid test
To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears
C.
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
D.
Melting range
62 to 67 oC
Purity
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
Chemical name
L-Glutamic acid, L-2-amino-pentanedioic acid
Einecs
200-293-7
Chemical formula
C5H9NO4
Molecular weight
147,13
Assay
Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
Description
White crystals or crystalline powder
Identification
A.
Positive test for glutamic acid by thin layer chromatography
B.
Specific rotation [α]D20
Between +31,5o and +32,2o
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
C.
pH of a saturated solution
Between 3,0 and 3,5
Purity
Loss on drying
Not more than 0,2 % (80 oC, 3h)
Sulphated ash
Not more than 0,2 %
Chloride
Not more than 0,2 %
Pyrrolidone carboxylic acid
Not more than 0,2 %
Lead
Not more than 2 mg/kg
E 621 MONOSODIUM GLUTAMATE
Synonyms
Sodium glutamate, MSG
Definition
Chemical name
Monosodium L-glutamate monohydrate
Einecs
205-538-1
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
Description
White, practically odourless crystals or crystalline powder
Identification
A.
Positive test for sodium
B.
Positive test for glutamic acid by thin-layer chromatography
C.
Specific rotation [α]D 20
Between +24,8o and +25,3o
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.
pH of a 5 % solution
Between 6,7 and 7,2
Purity
Loss on drying
Not more than 0,5 % (98 oC, 5h)
Chloride
Not more than 0,2 %
Pyrrolidone carboxylic acid
Not more than 0,2 %
Lead
Not more than 2 mg/kg
E 622 MONOPOTASSIUM GLUTAMATE
Synonyms
Potassium glutamate, MPG
Definition
Chemical name
Monopotassium L-glutamate monohydrate
Einecs
243-094-0
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
Description
White, practically odourless crystals or crystalline powder
Identification
A.
Positive test for potassium
B.
Positive test for glutamic acid by thin-layer chromatog-raphy
C.
Specific rotation [α]D 20
Between +22,5o and +24,0o
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.
pH of a 2 % solution
Between 6,7 and 7,3
Purity
Loss on drying
Not more than 0,2 % (80 oC, 5h)
Chloride
Not more than 0,2 %
Pyrrolidone carboxylic acid
Not more than 0,2 %
Lead
Not more than 2 mg/kg
E 623 CALCIUM DIGLUTAMATE
Synonyms
Calcium glutamate
Definition
Chemical name
Monocalcium di-L-glutamate
Einecs
242-905-5
Chemical formula
C10H16CaN2O8 · x H2O (x = 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
Description
White, practically odourless crystals or crystalline powder
Identification
A.
Positive test for calcium
B.
Positive test for glutamic acid by thin-layer chromatog-raphy
C.
Specific rotation [α]D 20
Between +27,4 and +29,2 (for calcium diglutamate with x = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
Purity
Water
Not more than 19,0 % (for calcium diglutamate with x = 4) (Karl Fischer)
Chloride
Not more than 0,2 %
Pyrrolidone carboxylic acid
Not more than 0,2 %
Lead
Not more than 2 mg/kg
E 624 MONOAMMONIUM GLUTAMATE
Synonyms
Ammonium glutamate
Definition
Chemical name
Monoammonium L-glutamate monohydrate
Einecs
231-447-1
Chemical formula
C5H12N2O4 · H2O
Molecular weight
182,18
Assay
Content not less than 99,0 % and not more 101,0 % on the anhydrous basis
Description
White, practically odourless crystals or crystalline powder
Identification
A.
Positive test for ammonium
B.
Positive test for glutamic acid by thin-layer chromatog-raphy
C.
Specific rotation [α]D 20
Between +25,4o and +26,4o
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.
pH of a 5 % solution
Between 6,0 and 7,0
Purity
Loss on drying
Not more than 0,5 % (50 oC, 4h)
Sulphated ash
Not more than 0,1 %
Pyrrolidone carboxylic acid
Not more than 0,2 %
Lead
Not more than 2 mg/kg
E 625 MAGNESIUM DIGLUTAMATE
Synonyms
Magnesium glutamate
Definition
Chemical name
Monomagnesium di-L-glutamate tetrahydrate
Einecs
242-413-0
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
Description
Odourless, white or off-white crystals or powder
Identification
A.
Positive test for magnesium
B.
Positive test for glutamic acid by thin-layer chromatog-raphy
C.
Specific rotation [α]D 20
Between +23,8o and +24,4o
(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
D.
pH of a 10 % solution
Between 6,4 and 7,5
Purity
Water
Not more than 24 % (Karl Fischer)
Chloride
Not more than 0,2 %
Pyrrolidone carboxylic acid
Not more than 0,2 %
Lead
Not more than 2 mg/kg
E 626 GUANYLIC ACID
Synonyms
Guanylic acid
Definition
Chemical name
Guanosine-5'-monophosphoric acid
Einecs
201-598-8
Chemical formula
C10H14N5O8P
Molecular weight
363,22
Assay
Content not less than 97,0 % on the anhydrous basis
Description
Odourless, colourless or white crystals or white crystalline powder
Identification
A.
Positive test for ribose and for organic phosphate
B.
pH of a 0,25 % solution
Between 1,5 and 2,5
C.
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 oC, 4h)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 627 DISODIUM GUANYLATE
Synonyms
Sodium guanylate, sodium 5'-guanylate
Definition
Chemical name
Disodium guanosine-5'-monophosphate
Einecs
221-849-5
Chemical formula
C10H12N5Na2O8P· x H2O (x = ca. 7)
Molecular weight
407,19 (anhydrous)
Assay
Content not less than 97,0 % on the anhydrous basis
Description
Odourless, colourless or white crystals or white crystalline powder
Identification
A.
Positive test for ribose, for organic phosphate, and for sodium
B.
pH of a 5 % solution
Between 7,0 and 8,5
C.
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 oC, 4h)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 628 DIPOTASSIUM GUANYLATE
Synonyms
Potassium guanylate, potassium 5'-guanylate
Definition
Chemical name
Dipotassium guanosine-5'-monophosphate
Einecs
226-914-1
Chemical formula
C10H12K2N5O8P
Molecular weight
439,40
Assay
Content not less than 97,0 % on the anhydrous basis
Description
Odourless, colourless or white crystals or white crystalline powder
Identification
A.
Positive test for ribose, for organic phosphate, and for potassium
B.
pH of a 5 % solution
Between 7,0 and 8,5
C.
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 oC, 4h)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 629 CALCIUM GUANYLATE
Synonyms
Calcium 5'-guanylate
Definition
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
Description
Odourless, white or off-white crystals or powder
Identification
A.
Positive test for ribose, for organic phosphate, and for calcium
B.
pH of a 0,05 % solution
Between 7,0 and 8,0
C.
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 oC, 4h)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 630 INOSINIC ACID
Synonyms
5'-Inosinic acid
Definition
Chemical name
Inosine-5'-monophosphoric acid
Einecs
205-045-1
Chemical formula
C10H13N4O8P
Molecular weight
348,21
Assay
Content not less than 97,0 % on the anhydrous basis
Description
Odourless, colourless or white crystals or powder
Identification
A.
Positive test for ribose, and for organic phosphate
B.
pH of a 5 % solution
Between 1,0 and 2,0
C.
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 oC, 4h)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 631 DISODIUM INOSINATE
Synonyms
Sodium inosinate, sodium 5'-inosinate
Definition
Chemical name
Disodium inosine-5'-monophosphate
Einecs
225-146-4
Chemical formula
C10H11N4Na2O8P· H2O
Molecular weight
392,17 (anhydrous)
Assay
Content not less than 97,0 % on the anhydrous basis
Description
Odourless, colourless or white crystals or powder
Identification
A.
Positive test for ribose, and for organic phosphate and for sodium
B.
pH of a 5 % solution
Between 7,0 and 8,5
C.
Spectrometry:
maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Purity
Water
Not more than 28,5 % (Karl Fischer)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 632 DIPOTASSIUM INOSINATE
Synonyms
Potassium inosinate, potassium 5'-inosinate
Definition
Chemical name
Dipotassium inosine-5'-monophosphate
Einecs
243-652-3
Chemical formula
C10H11K2N4O8P
Molecular weight
424,39
Assay
Content not less than 97,0 % on the anhydrous basis
Description
Odourless, colourless or white crystals or powder
Identification
A.
Positive test for ribose, and for organic phosphate and for potassium
B.
pH of a 5 % solution
Between 7,0 and 8,5
C.
Spectrometry:
maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Purity
Water
Not more than 10,0 % (Karl Fischer)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 633 CALCIUM INOSINATE
Synonyms
Calcium 5'-inosinate
Definition
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
Description
Odourless, colourless or white crystals or powder
Identification
A.
Positive test for ribose, and for organic phosphate and for calcium
B.
pH of a 0,05 % solution
Between 7,0 and 8,0
C.
Spectrometry:
maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Purity
Water
Not more than 23,0 % (Karl Fischer)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 634 CALCIUM 5'-RIBONUCLEOTIDE
Definition
Chemical name
Calcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate
Chemical formula
C10H11N4CaO8P· nH2O y
C10H12N5CaO8P· nH2O
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
Description
Odourless, white or nearly white crystals or powder
Identification
A.
Positive test for ribose, and for organic phosphate and for calcium
B.
pH of a 0,05 % solution
Between 7,0 and 8,0
Purity
Water
Not more than 23,0 % (Karl Fischer)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 635 DISODIUM 5'-RIBONUCLEOTIDE
Synonyms
Sodium 5'-ribonucleotide
Definition
Chemical name
Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate
Chemical formula
C10H11N4Na2O8P · nH2O and
C10H12N5Na2O8P· nH2O
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
Description
Odourless, white or nearly white crystals or powder
Identification
A.
Positive test for ribose, and for organic phosphate and for sodium
B.
pH of a 5 % solution
Between 7,0 and 8,5
Purity
Water
Not more than 26,0 % (Karl Fischer)
Other nucleotides
Not detectable by thin-layer chromatography
Lead
Not more than 2 mg/kg
E 640 GLYCINE AND ITS SODIUM SALT
Synonyms (gly)
Aminoacetic acid, glycocoll
(Na salt)
Sodium glycinate
Definition
Chemical name (gly)
Aminoacetic acid
(Na salt)
Sodium glycinate
Chemical formula (gly)
C2H5NO2
(Na salt)
C2H5NO2 Na
Einecs (gly)
200-272-2
(Na salt)
227-842-3
Molecular weight (gly)
75,07
(Na salt)
98
Assay
Content not less than 98,5 % on the anhydrous basis
Description
White crystals or crystalline powder
Identification
A.
Positive test for amino acid (gly and Na salt)
B.
Positive test for sodium (Na salt)
Purity
Loss on drying (gly)
Not more than 0,2 % (105 oC, 3h)
(Na salt)
Not more than 0,2 % (105 oC, 3h)
Residue on ignition (gly)
Not more than 0,1 %
(Na salt)
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
E 650 ZINC ACETATE
Synonyms
Acetic acid, zinc salt, dihydrate
Definition
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
A.
Positive tests for acetate and for zinc
B.
pH of a 5 % solution
Between 6,0 and 8,0
Purity
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 stablised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO
Chemical name
Siloxanes and silicones, di-methyl
Chemical formula
(CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3
Assay
Content of total silicon not less than 37,3 % and not more than 38,5 %
Description
Clear, colourless, viscous liquid
Identification
A.
Specific gravity (25o/25 oC)
Between 0,964 and 0,977
B.
Refractive index [n]D 25
Between 1,400 and 1,405
C.
Infrared spectrum characteristic of the compound
Purity
Loss on drying
Not more than 0,5 % (150 oC, 4h)
Viscosity
Not less than 1,00 · 10-4 m2s-1 at 25 oC
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 901 BEESWAX
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 (beeswax)
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
A.
Melting range
Between 62 oC and 65 oC
B.
Specific gravity
About 0,96
C.
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
Absent
Fats, Japan wax, rosin and soaps
Absent
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 902 CANDELILLA WAX
Definition
Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica
Einecs
232-347-0
Description
Hard, yellowish brown, opaque to translucent wax
Identification
A.
Specific gravity
About 0,983
B.
Melting range
Between 68,5 oC and 72,5 oC
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
Glycerol and other polyols
Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxes
Absent
Fats, Japan wax, rosin and soaps
Absent
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 903 CARNAUBA WAX
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
Description
Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture
Identification
A.
Specific gravity
About 0,997
B.
Melting range
Between 82 oC and 86 oC
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 5 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
Description
Bleached shellac — off-white, amorphous, granular resin
Wax-free bleached shellac — light yellow, amorphous, granular resin
Identification
A.
Solubility
Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone
B.
Acid value
Between 60 and 89
Purity
Loss on drying
Not more than 6,0 % (40 oC, over silica gel, 15h)
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
Definition
Microcrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleum
Description
White to amber, odourless wax
Identification
A.
Solubility
Insoluble in water, very slightly soluble in ethanol
B.
Refractive Index
n D 1001,434-1,448
Purity
Molecular weight
Average not less than 500
Viscosity at 100 oC
Not less than 1,1 · 10-5 m2s-1
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 %
Arsenic
Not more than 3 mg/kg
Lead
Not more than 3 mg/kg
Polycyclic aromatic compounds
The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:
nm
Maximum absorbance per cm path length
280-289
0,15
290-299
0,12
300-359
0,08
360-400
0,02
E 907 HYDROGENATED POLY-1-DECENE
Synonyms
Hydrogenated polydec-1-ene
Hydrogenated poly-alpha-olefin
Definition
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
A.
Solubility
Insoluble in water; slightly soluble in ethanol; soluble in toluene
B.
Burning
Burns with a bright flame and a paraffin-like characteristic smell
Purity
Viscosity
Between 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 oC
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
E 912 MONTAN ACID ESTERS
Definition
Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol
Chemical name
Montan acid esters
Description
Almost white to yellowish flakes, powder, granules or pellets
Identification
A.
Density (20 oC)
Between 0,98 and 1,05
B.
Drop point
Greater than 77 oC
Purity
Acid value
Not more than 40
Glycerol
Not more than 1 % (by gas chromatography)
Other polyols
Not more than 1 % (by gas chromatography)
Other wax types
Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)
Arsenic
Not more than 2 mg/kg
Chromium
Not more than 3 mg/kg
Lead
Not more than 2 mg/kg
E 914 OXIDISED POLYETHYLENE WAX
Definition
Polar reaction products from mild oxidation of polyethylene
Chemical name
Oxidised polyethylene
Description
Almost white flakes, powder, granules or pellets
Identification
A.
Density (20 oC)
Between 0,92 and 1,05
B.
Drop point
Greater than 95 oC
Purity
Acid value
Not more than 70
Viscosity at 120 oC
Not less than 8,1 · 10-5 m2s-1
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
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 formula
C3H7NO2S· HCl· n H20 (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
A.
Solubility
Freely soluble in water and in ethanol
B.
Melting range
Anhydrous form melts at about 175 oC
C.
Specific rotation
[α]20 D: between +5,0o and +8,0o or
[α]25 D: between +4,9o and 7,9o
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 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
A.
Solubility
Very soluble in water
Soluble in ethanol
B.
Precipitation with nitric acid
To pass the test a white, crystalline precipitate is formed
C.
Colour reaction
To pass the test a reddish-violet colour is produced
D.
Melting range
132 oC to 135 oC
Purity
Loss on drying
Not more than 1,0 % (105 oC, 1h)
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 5 mg/kg
E 938 ARGON
Definition
Chemical name
Argon
Einecs
231-147-0
Chemical formula
Ar
Molecular weight
40
Assay
Not less than 99 %
Description
Colourless, odourless, non-flammable gas
Purity
Water
Not more than 0,05 %
Methane and other hydrocarbons calculated as methane
Not more than 100 μl/l
E 939 HELIUM
Definition
Chemical name
Helium
Einecs
231-168-5
Chemical formula
He
Molecular weight
4
Assay
Not less than 99 %
Description
Colourless, odourless, non-flammable gas
Purity
Water
Not more than 0,05 %
Methane and other hydrocarbons calculated as methane
Not more than 100 μl/l
E 941 NITROGEN
Definition
Chemical name
Nitrogen
Einecs
231-783-9
Chemical formula
N2
Molecular weight
28
Assay
Not less than 99 %
Description
Colourless, odourless, non-flammable gas
Purity
Water
Not more than 0,05 %
Carbon monoxide
Not more than 10 μl/l
Methane and other hydrocarbons calculated as methane
Not more than 100 μl/l
Nitrogen dioxide and nitrogen oxide
Not more than 10 μl/l
Oxygen
Not more than 1 %
E 942 NITROUS OXIDE
Definition
Chemical name
Nitrous oxide
Einecs
233-032-0
Chemical formula
N2O
Molecular weight
44
Assay
Not less than 99 %
Description
Colourless, non-flammable gas, sweetish odour
Purity
Water
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
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
A.
Vapour pressure
108,935 kPa at 20 oC
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
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
A.
Vapour pressure
205,465 kPa at 20 oC
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
Definition
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
A.
Vapour pressure
732,910 kPa at 20 oC
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
Definition
Chemical name
Oxygen
Einecs
231-956-9
Chemical formula
O2
Molecular weight
32
Assay
Not less than 99 %
Description
Colourless, odourless, non-flammable gas
Purity
Water
Not more than 0,05 %
Methane and other hydrocarbons calculated as methane
Not more than 100 μl/l
E 949 HYDROGEN
Definition
Chemical name
Hydrogen
Einecs
215-605-7
Chemical formula
H2
Molecular weight
2
Assay
Content not less than 99,9 %
Description
Colourless, odourless, highly flammable gas
Purity
Water
Not more than 0,005 % v/v
Oxygen
Not more than 0,001 % v/v
Nitrogen
Not more than 0,75 % v/v
E 950 ACESULFAME K
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 951 ASPARTAME
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 953 ISOMALT
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 957 THAUMATIN
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 959 NEOHESPERIDINE DIHYDROCHALCONE
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 965(i) MALTITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 965(ii) MALTITOL SYRUP
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 966 LACTITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 967 XYLITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
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
Description
Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution
Identification
A.
pH of a 2,5 % solution
Between 4,5 and 5,5
Purity
Water
Not more than 6,0 % (Karl Fischer method) (powder form only)
Arsenic
Not more than 2 mg/kg
Lead
Not more than 5 mg/kg
Mercury
Not more than 1 mg/kg
E 1103 INVERTASE
Definition
Invertase is produced from Saccharomyces cerevisiae
Systematic name
β-D-Fructofuranoside fructohydrolase
Enzyme Commission No
EC 3.2.1.26
Einecs
232-615-7
Purity
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
Cadmium
Not more than 0,5 mg/kg
Total bacterial count
Not more than 50 000/g
Salmonella spp.
Absent by test in 25 g
Coliforms
Not more than 30/g
E. coli
Absent by test 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
Chemical name
Enzyme Commission (EC) No: 3.2.1.17
Einecs
232-620-4
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
A.
Isoelectric point 10,7
B.
pH of a 2 % aqueous solution between 3,0 and 3,6
C.
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
Heavy metals (as Pb)
Not more than 10 mg/kg
Microbiological criteria
Total bacterial count
Not more than 5 × 104 col/g
Salmonellae
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 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 decolorised 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
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
A.
Positive tests for sugar and for reducing sugar
B.
pH of a 10 % solution
Between 2,5 and 7,0 for polydextrose
Between 5,0 and 6,0 for polydextrose-N
Purity
Water
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
Chemical name
Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula
(C6H9NO)n
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
A.
Solubility
Soluble in water and in ethanol. Insoluble in ether
B.
pH of a 5 % solution
Between 3,0 and 7,0
Purity
Water
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 5 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
Chemical name
Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula
(C6H9NO)n
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
A.
Solubility
Insoluble in water, ethanol and ether
B.
pH of a 1 % suspension in water
Between 5,0 and 8,0
Purity
Water
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 5 mg/kg
E 1204 PULLULAN
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 formula
(C6H10O5)x
Assay
Not less than 90 % of glucan on the dried basis
Description
White to off-white odourless powder
Identification
A.
Solubility
Soluble in water, practically insoluble in ethanol
B.
pH of 10 % solution
5,0 to 7,0
C.
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
D.
Depoly-merisation 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 oC for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution
Purity
Loss on drying
Not more than 6 % (90 oC, pressure not more than 50 mm Hg, 6 h)
Mono-, di- and oligosaccharides
Not more than 10 % expressed as glucose
Viscosity
100 to 180 mm2/s (10 % w/w aqueous solution at 30 oC)
Lead
Not more than 1 mg/kg
Yeast and moulds
Not more than 100 colonies per gram
Coliforms
Absent in 25 g
Salmonella
Absent in 25 g
E 1404 OXIDISED STARCH
Definition
Oxidised starch is starch treated with sodium hypochlorite
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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 %
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1410 MONOSTARCH PHOSPHATE
Definition
Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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
Not more than 0,4 % (as P) for other starches
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1412 DISTARCH PHOSPHATE
Definition
Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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
Not more than 0,4 % (as P) for other starches
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1413 PHOSPHATED DISTARCH PHOSPHATE
Definition
Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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
Not more than 0,4 % (as P) for other starches
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1414 ACETYLATED DISTARCH PHOSPHATE
Definition
Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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 %
Residual phosphate
Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 % (as P) for other starches
Vinyl acetate
Not more than 0,1 mg/kg
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
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
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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 %
Vinyl acetate
Not more than 0,1 mg/kg
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1422 ACETYLATED DISTARCH ADIPATE
Definition
Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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 %
Adipate groups
Not more than 0,135 %
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1440 HYDROXYPROPYL STARCH
Definition
Hydroxypropyl starch is starch etherified with propylene oxide
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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 %
Propylene chlorohydrin
Not more than 1 mg/kg
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE
Definition
Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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 %
Residual phosphate
Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 (as P) for other starches
Propylene chlorohydrin
Not more than 1 mg/kg
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
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
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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 %
Octenylsuccinic acid residue
Not more than 0,3 %
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1451 ACETYLATED OXIDISED STARCH
Definition
Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
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 %
Acetyl groups
Not more than 2,5 %
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE
Synonyms
SAOS
Definition
Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate
Description
White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
Identification
A.
If not pregelatinised: by microscopic observation
B.
Iodine staining positive (dark blue to light red colour)
Purity (all values expressed on an anhydrous basis except for loss on drying)
Loss on drying
Not more than 21,0 %
Octenylsuccinyl groups
Not more than 3 %
Octenylsuccinic acid residue
Not more than 0,3 %
Sulphur dioxide
Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for the other modified starches, unless otherwise specified
Arsenic
Not more than 1 mg/kg
Lead
Not more than 2 mg/kg
Mercury
Not more than 0,1 mg/kg
Aluminium
Not more than 0,3 %
E 1505 TRIETHYL CITRATE
Synonyms
Ethyl citrate
Definition
Chemical name
Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
Einecs
201-070-7
Chemical formula
C12H20O7
Molecular weight
276,29
Assay
Content not less than 99,0 %
Description
Odourless, practically colourless, oily liquid
Identification
A.
Specific gravity
d25 25: 1,135-1,139
B.
Refractive index
[n]D 20: 1,439-1,441
Purity
Water
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 5 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
Chemical names
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
A.
Solubility
Soluble in water. Miscible with ethanol
B.
Positive tests for glycerol and acetate
C.
Specific gravity
d20 20: 1,175-1,195
D.
Boiling range
Between 259 and 261 oC
Purity
Total ash
Not more than 0,02 %
Acidity
Not more than 0,4 % (as ascetic acid)
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
E 1518 GLYCERYL TRIACETATE
Synonyms
Triacetin
Definition
Chemical name
Glyceryl triacetate
Einecs
203-051-9
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
A.
Positive tests for acetate and for glycerol
B.
Refractive index
Between 1,429 and 1,431 at 25 oC
C.
Specific gravity (25 oC/25 oC)
Between 1,154 and 1,158
D.
Boiling range
Between 258 and 270 oC
Purity
Water
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 5 mg/kg
E 1519 BENZYL ALCOHOL
Synonyms
Phenylcarbinol
Phenylmethyl alcohol
Benzenemethanol
Alpha-hydroxytoluene
Definition
Chemical names
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
A.
Solubility
Soluble in water, ethanol and ether
B.
Refractive index
[n]D 20: 1,538-1,541
C.
Specific gravity
d25 25: 1,042-1,047
D.
Positive test for peroxides
Purity
Distillation range
Not less than 95 % v/v distils between 202 and 208 oC
Acid value
Not more than 0,5
Aldehydes
Not more than 0,2 % v/v (as bezaldehyde)
Lead
Not more than 5 mg/kg
E 1520 PROPANE-1,2-DIOL
Synonyms
Propylene glycol
Definition
Chemical names
1,2-dihydroxypropane
Einecs
200-338-0
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
A.
Solubility
Soluble in water, ethanol and acetone
B.
Specific gravity
d20 20: 1,035-1,040
C.
Refractive index
[n]20 D: 1,431-1,433
Purity
Distillation range
99 % v/v distils between 185 oC-189 oC
Sulphated ash
Not more than 0,07 %
Water
Not more than 1,0 % (Karl Fischer method)
Lead
Not more than 5 mg/kg
POLYETHYLENE GLYCOL 6000
Synonyms
PEG 6000
Macrogol 6000
Definition
Polyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-CH)-OH corresponding to an average relative molecular mass of approximately 6 000
Chemical formula
(C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000, about 140)
Molecular weight
5 600-7 000
Assay
Not less than 90,0 % and not more than 110,0 %
Description
A white or almost white solid with a waxy or paraffin-like appearance
Identification
A.
Solubility
Very soluble in water and in methylene chloride. Practically insoluble in alcohol, in ether and in fatty and mineral oils
B.
Melting range
Between 55 oC and 61 oC
Purity
Viscosity
Between 0,220 and 0,275 kgm-1s-1 at 20 oC
Hydroxyl value
Between 16 and 22
Sulphated ash
Not more than 0,2 %
Ethylene oxide
Not more than 0,2 mg/kg
Arsenic
Not more than 3 mg/kg
Lead
Not more than 5 mg/kg
(1) OJ L 226, 22.9.1995, p. 1.
(2) 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.
(3) 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.
(4) 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.
(5) 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 (). 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.
(6) When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.
(7) When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.
(8) OJ L 158, 18.6.2008, p. 17.
ANNEX II
PART A
Repealed Directive with list of its successive amendments
(referred to in Article 2)
Commission Directive 96/77/EC
Commission Directive 98/86/EC
Commission Directive 2000/63/EC
Commission Directive 2001/30/EC
Commission Directive 2002/82/EC
Commission Directive 2003/95/EC
Commission Directive 2004/45/EC
Commission Directive 2006/129/EC
(OJ L 339, 30.12.1996, p. 1)
(OJ L 334, 9.12.1998, p. 1)
(OJ L 277, 30.10.2000, p. 1)
(OJ L 146, 31.5.2001, p. 1)
(OJ L 292, 28.10.2002, p. 1)
(OJ L 283, 31.10.2003, p. 71)
(OJ L 113, 20.4.2004, p. 19)
(OJ L 346, 9.12.2006, p. 15)
PART B
List of time-limits for transposition into national law
(referred to in Article 2)
Directive
Time-limit for transposition
96/77/EC
1 July 1997 (1)
98/86/EC
1 July 1999 (2)
2000/63/EC
31 March 2001 (3)
2001/30/EC
1 June 2002 (4)
2002/82/EC
31 August 2003
2003/95/EC
1 November 2004 (5)
2004/45/EC
1 April 2005 (6)
2006/129/EC
15 February 2008
(1) According to Article 3(2) of Directive 96/77/EC, products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted.
(2) According to Article 2(2) of Directive 98/86/EC, products put on the market or labelled before 1 July 1999 which do not comply with this Directive may be marketed until stocks are exhausted.
(3) According to Article 2(3) of Directive 2000/63/EC, products put on the market or labelled before 31 March 2001 which do not comply with this Directive may be marketed until stocks are exhausted.
(4) According to Article 2(3) of Directive 2001/30/EC, products put on the market or labelled before 1 June 2002 which do not comply with this Directive may be marketed until stocks are exhausted.
(5) According to Article 3 of Directive 2003/95/EC, products put on the market or labelled before 1 November 2004 which do not comply with this Directive may be marketed until stocks are exhausted.
(6) According to Article 3 of Directive 2004/45/EC, products put on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted.
ANNEX III
Correlation table
Directive 96/77/EC
This Directive
Article 1
Article 1
Article 2
—
Article 3
—
—
Article 2
Article 4
Article 3
Article 5
Article 4
Annex
Annex I
—
Annex II
—
Annex III