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"B COMMISSION DIRECTIVE 96/77/EC
of 2 December 1996
laying down specific purity criteria on food additives other than colours and sweeteners
(Text with EEA relevance)
(OJ L 339, 30.12.1996, p. 1)
Amended by:
Official Journal
No page date
"M1 Commission Directive 98/86/EC of 11 November 1998 L 334 1 9.12.19981996L0077 — EN — 29.12.1998 — 001.001 — 1
COMMISSION DIRECTIVE 96/77/EC
of 2 December 1996
laying down specific purity criteria on food additives other than colours
and sweeteners
(Text with EEA relevance)
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
authorized for use in foodstuffs intended for human consumption (1), as
amended by European Parliament and Council Directive 94/34/EC (2), and in
particular Article 3 (3) (a) thereof,
After consulting the Scientific Committee for Food,
Whereas 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 coloursand sweeteners (
3);
Whereas it is necessary to replace the purity criteria set out in Council
Directive 65/66/EEC of 26 January 1965 laying down specific criteria of
purity for preservatives authorized for use in foodstuffs intended for human
consumption (4), as last amended by Directive 86/604/EEC (5);
Whereas it is necessary to replace the purity criteria set out in Council
Directive 78/664/EEC of 25 July 1978 laying down specific criteria of purity
for antioxidants which may be used in foodstuffs intended for humanconsumption (
6), as amended by Directive 82/712/EEC (7);
Whereas Directives 65/66/EEC and 78/664/EEC should be repealed
accordingly;
Whereas it is necessary to take into acount 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);
Whereas food additives, if prepared by production methods or starting
materials significantly different from those included in the evaluation of the
Scientific Committee for Food, or if different from those mentioned in this
Directive, should be submitted for evaluation by the Scientific Committee forFood for the purposes of a full evaluation with emphasis on the purity criteria;
Whereas, the measures provided for in this Directive are in accordance with
the opinion of the Standing Committee for Foodstuffs,
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 Directive95/2/EC, are set out in the Annex hereto.
Article 2
The purity criteria referred to in Article 1 replace the purity criteria set out in
Directives 65/66/EEC, 78/663/EEC and 78/664/EEC.!B
(1) OJ No L 40, 11. 2. 1989, p. 27.
(2) OJ No L 237, 10. 9. 1994, p. 1.
(3) OJ No L 61, 18. 3. 1995, p. 1.
(4) OJ No 22, 9. 2. 1965, p. 373.
(5) OJ No L 352, 13. 12. 1986, p. 45.
(6) OJ No L 223, 14. 8. 1978, p. 30.
(7) OJ No L 297, 23. 10. 1982, p. 31.!M11996L0077 — EN — 29.12.1998 — 001.001 — 2
Article 3
1. Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this Directive before 1
July 1997. They shall immediately inform the Commission thereof.
When Member States adopt these provisions, these shall contain a reference
to this Directive or shall be accompanied by such reference at the time of their
official publication. The procedure for such reference shall be adopted byMember States.
2. 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.
Article 4
This Directive shall enter into force on the 20th day following that of its
publication in the Official Journal of the European Communities .
Article 5
This Directive is addressed to the Member States.!B1996L0077 — EN — 29.12.1998 — 001.001 — 3
ANNEX
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 90minutes at 105 °C
Identification
A. Melting range Between 133 °C and 135 °C, 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 bondsD. Sublimation point 80 °C
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/kgLead 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 SORBATEDefinition
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 C
6H7O2K
Molecular weight 150,22
Assay Content not less than 99 % on the dried basis
Description White crystalline powder showing no change in colour after heating for
90 minutes at 105 °C
Identification
A. Melting range of sorbic acid isolated by
acidification and not recrystallized 133 °C to135 °C after vacuum drying in a sulphuricacid desiccator!
B1996L0077 — EN — 29.12.1998 — 001.001 — 4
B. Positive tests for potassium and for double
bonds
Purity
Loss on drying Not more than 1,0 % (105 °C, 3h)Acidity or alkalinity Not more than about 1,0 % (as sorbic acid or K
2CO 3)
Aldehydes Not more than 0,1 %, calculated as formaldehyde
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury 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 C
12H14O4Ca
Molecular weight 262,32
Assay Content not less than 98 % on the dried basis
Description Fine white crystalline powder not showing any change in colour after
heating at 105 °C for 90 minutes
Identification
A. Melting range of sorbic acid isolated by
acidification and not recrystallized 133 °C to135 °C after vacuum drying in a sulphuricacid 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/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 210 BENZOIC ACIDDefinition
Chemical name Benzoic acid
Benzenecarboxylic acidPhenylcarboxylic acid
Einecs 200-618-2
Chemical formula C
7H6O2!B1996L0077 — EN — 29.12.1998 — 001.001 — 5
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 °C to 123,5 °C
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 oxidizable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and
add 0,1 N KMnO
4in drops, until the pink colour persists for 30 seconds.
Dissolve 1 g of the sample, weighed to the nearest mg, in the heatedsolution, and titrate with 0,1 N KMnO
4to a pink colour that persists for
15 seconds. Not more than 0,5 ml should be required
Readily carbonizable 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 areference liquid containing 0,2 ml of cobalt chloride TSC (
1), 0,3 ml of
ferric chloride TSC (2), 0,1 ml of copper sulphate TSC (3)and 4,4 ml of
water
Polycyclic acids On fractional acidification of a neutralized solution of benzoic acid, the
first precipitate must not have a different melting point from that of thebenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 211 SODIUM BENZOATEDefinition
Chemical name Sodium benzoate
Sodium salt of benzenecarboxylic acidSodium salt of phenylcarboxylic acid
Einecs 208-534-8
Chemical formula C
7H5O2Na
Molecular weight 144,11
Assay Not less than 99 % of C 7H5O2Na, after drying at 105 °C 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
recrystallized 121,5 °C to 123,5 °C, after drying in a sulphuric aciddesiccator
C. Positive tests for benzoate and for sodium
Purity
Loss on drying Not more than 1,5 % after drying at 105 °C for four hours!
B1996L0077 — EN — 29.12.1998 — 001.001 — 6
Readily oxidizable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and
add 0,1 N KMnO 4in 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 KMnO 4to a pink colour that persists for
15 seconds. Not more than 0,5 ml should be required
Polycyclic acids On fractional acidification of a (neutralized) solution of sodium
benzoate, the first precipitate must not have a different melting rangefrom 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 Neutralization of 1 g of sodium benzoate, in the presence of
phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOHor 0,1 N HCl
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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 C
7H5KO 2.3H2O
Molecular weight 214,27
Assay Content not less than 99 % C 7H5O2K after drying at 105 °C to constant
weight
Description White crystalline powder
Identification
A. Melting range of benzoic acid isolated by
acidification and not recrystallized 121,5 °C
to 123,5 °C, after vacuum drying in asulphuric acid desiccator
B. Positive tests for benzoate and for potassium
Purity
Loss on drying Not more than 26,5 %, determined by drying at 105 °CChlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 %
expressed as monochlorobenzoic acid
Readily oxidizable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and
add 0,1 N KMnO
4in drops, until the pink colour persists for 30 seconds.
Dissolve 1 g of the sample, weighed to the nearest mg, in the heatedsolution, and titrate with 0,1 N KMnO
4to a pink colour that persists for
15 seconds. Not more than 0,5 ml should be required
Readily carbonizable 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 liquidcontaining 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 (neutralized) solution of potassium
benzoate, the first precipitate must not have a different melting range
from that of benzoic acid
Degree of acidity or alkalinity Neutralization of 1 g of potassium benzoate, in the presence of
phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or0,1 N HCl!
B1996L0077 — EN — 29.12.1998 — 001.001 — 7
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 BENZOATESynonyms Monocalcium benzoate
Definition
Chemical name Calcium benzoate
Calcium dibenzoate
Einecs 218-235-4
Chemical formula Anhydrous: C
14H10O4Ca
Monohydrate: C 14H10O4Ca.H2O
Trihydrate: C 14H10O4CA.3H2O
Molecular weight Anhydrous: 282,31
Monohydrate: 300,32Trihydrate: 336,36
Assay Content not less than 99 % after drying at 105 °C
Description White or colourless crystals, or white powder
Identification
A. Melting range of benzoic acid isolated by
acidification and not recrystallized 121,5 °Cto 123,5 °C, after vacuum drying in asulphuric acid desiccator
B. Positive tests for benzoate and for calcium
Purity
Loss on drying Not more than 17,5 % determined by drying at 105 °C to constant weightWater 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 oxidizable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and
add 0,1 N KMnO
4in 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 KMnO 4to a pink colour that persists for
15 seconds. Not more than 0,5 ml should be required
Readily carbonizable 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 liquidcontaining 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 (neutralized) solution of calcium
benzoate, the first precipitate must not be a different melting rangefrom that of benzoic acid
Degree of acidity or alkalinity Neutralization 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/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 8
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 °C
Description Almost odourless, small, colourless crystals or a white, crystalline
powder
Identification
A. Melting range 115 °C to 118 °C
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by acidification and not
recrystallized: 213 °C to 217 °C, after vacuum drying in a sulphuric aciddesiccator
C. Positive test for alcohol
Purity
Loss on drying Not more than 0,5 % after drying for two hours at 80 °CSulphated 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/kgLead 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 C
9H9O3Na
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 °C to 118 °C, after vacuum drying in a sulphuric acid desiccatorB. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is
213 °C to 217 °C!
B1996L0077 — EN — 29.12.1998 — 001.001 — 9
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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 216 PROPYL p-HYDROXYBENZOATE
Synonyms Propylparaben
Propyl p-oxybenzoate
Definition
Chemical name Propyl p-hydroxybenzoate
n-Propyl p-hydroxybenzoic acid
Einecs 202-307-7
Chemical formula C
10H12O3
Molecular weight 180,21
Assay Content not less than 99,5 % after drying for two hours at 80 °C
Description Almost odourless, small, colourless crystals or a white, crystalline
powder
Identification
A. Melting range 95 °C to 97 °C after drying for two hours at 80 °C
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is
213 °C to 217 °C
Purity
Loss on drying Not more than 0,5 % after drying for two hours at 80 °C
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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 217 SODIUM PROPYL p-HYDROXYBENZOATE
Definition
Chemical name Sodium n-propyl p-hydroxybenzoate
Sodium compound of the n-propylester of p-hydroxybenzoic acid
Einecs 252-488-1
Chemical formula C
10H11O3Na!B1996L0077 — EN — 29.12.1998 — 001.001 — 10
Molecular weight 202,21
Assay Content of the propyl ester of p-hydroxybenzoic acid not less than 85 %
on the anhydrous basis
Description White, or almost white, crystalline hygroscopic powder
Identification
A. Melting range of ester isolated by acidifi-
cation and not recrystallized: 94 °C to 97 °C,after vacuum drying in a sulphuric aciddesiccator
B. Positive test for sodium
C. pH of a 0,1 % aqueous solution must be
between 9,8 and 10,2
Purity
Loss on drying Not more than 5 %, determined by vacuum drying in a sulphuric acid
desiccator
Sulphated ash 34 to 36 %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/kgMercury Not more than 1 mg/kgHeavy 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 C
8H8O3
Molecular weight 152,15
Assay Content not less than 99 % after drying for two hours at 80 °C
Description Almost odourless, small colourless crystals or white crystalline powder
Identification
A. Melting range 125 °C to 128 °C
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is
213 °C to 217 °C after drying for two hours at 80 °C
Purity
Loss on drying Not more than 0,5 %, after drying for two hours at 80 °C
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/kgHeavy metals (as Pb) Not more than 10 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 11
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 methylp-hydroxybenzoate (using litmus paper as
indicator) shall, when washed with water anddried at 80 °C for two hours, have a meltingrange of 125 °C to 128 °C
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 than10,3
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/kgLead Not more than 5 mg/kgMercury 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 SO
2
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 %!B1996L0077 — EN — 29.12.1998 — 001.001 — 12
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/kgMercury 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: Na
2SO3
Heptahydrate: Na 2SO37H2O
Molecular weight Anhydrous: 126,04
Heptahydrate: 252,16
Assay Anhydrous: Not less than 95 % of Na 2SO3and not less than 48 %
of SO 2
Heptahydrate: Not less than 48 % of Na 2SO3and not less than 24 %
of SO 2
Description White crystalline powder or colourless crystals
Identification
A. Positive tests for sulphite and for sodiumB. 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 SO
2content
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kgLead 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 BISULPHITEDefinition
Chemical name Sodium bisulphite
Sodium hydrogen sulphite
Einecs 231-921-4
Chemical formula NaHSO
3in aqueous solution
Molecular weight 104,06
Assay Content not less than 32 % w/w NaHSO 3
Description A clear, colourless to yellow solution!B1996L0077 — EN — 29.12.1998 — 001.001 — 13
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 Na 2SO3based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kgLead 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 METABISULPHITESynonyms Pyrosulphite
Sodium pyrosulphite
Definition
Chemical name Sodium disulphite
Disodium pentaoxodisulphate
Einecs 231-673-0
Chemical formula Na
2S2O5
Molecular weight 190,11
Assay Content not less than 95 % Na 2S2O5and not less than 64 % of SO 2
Description White crystals or crystalline powder
Identification
A. Positive tests for sulphite and for sodiumB. pH of a 10 % aqueous solution between 4,0
and 5,5
Purity
Thiosulphate Not more than 0,1 % based on the SO
2content
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kgLead 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 METABISULPHITESynonyms Potassium pyrosulphite
Definition
Chemical name Potassium disulphite
Potassium pentaoxo disulphate
Einecs 240-795-3
Chemical formula K
2S2O5!B1996L0077 — EN — 29.12.1998 — 001.001 — 14
Molecular weight 222,33
Assay Content not less than 90 % of K 2S2O5and not less than 51,8 % of SO 2,
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 SO 2content
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kgLead 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 SULPHITEDefinition
Chemical name Calcium sulphite
Einecs 218-235-4
Chemical formula CaSO
3.2H2O
Molecular weight 156,17
Assay Content not less than 95 % of CaSO 3.2H2O 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 SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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(HSO
3)2
Molecular weight 202,22!B1996L0077 — EN — 29.12.1998 — 001.001 — 15
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(HSO
3)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 SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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 KHSO
3in aqueous solution
Molecular weight 120,17
Assay Content not less than 280 g KHSO 3per litre (or 150 g SO 2per 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 SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kgLead 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 C
12H10
Molecular weight 154,20
Assay Content not less than 99,8 %!B1996L0077 — EN — 29.12.1998 — 001.001 — 16
Description White or pale yellow to amber crystalline solid having a characteristic
odour
Identification
A. Melting range 68,5 °C to 70,5 °CB. Distillation range It distils completely within a 2,5 °C range between 252,5 °C and 257,5 °C
Purity
Benzene Not more than 10 mg/kgAromatic amines Not more than 2 mg/kg (as aniline)Phenol derivatives Not more than 5 mg/kg (as phenol)
Readily carbonizable 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 liquidcontaining 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 AbsentArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 231 ORTHOPHENYLPHENOLSynonyms Orthoxenol
Definition
Chemical name (1,1’-Biphenyl)-2-ol
2-Hydroxydiphenylo-Hydroxydiphenyl
Einecs 201-993-5
Chemical formula C
12H10O
Molecular weight 170,20
Assay Content not less than 99 %
Description White or slightly yellowish crystalline powder
Identification
A. Melting range 56 °C to 58 °CB. 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/kgHeavy metals (as Pb) Not more than 10 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 17
E 232 SODIUM ORTHOPHENYLPHENOL
Synonyms Sodium orthophenylphenate
Sodium salt of o-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 C 12H9ONa.4H2O
Description White or slightly yellowish crystalline powder
Identification
A. Positive tests for phenolate and for sodiumB. Melting range of orthophenylphenol isolated
by acidification and not recrystallized derived
from the sample 56 °C to 58 °C 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/kgLead Not more than 5 mg/kgMercury 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 1205-725-8
Chemical formula C
10H7N3S
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 °C to 303 °C
B. Spectrometry Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and
243 nm
E1%
1c mat 302 nm ± 2 nm: approximately 1 230
E1%
1c mat 258 nm ± 2 nm: approximately 200
E1%
1c mat 243 nm ± 2 nm: approximately 620
Ratio of absorption 243 nm/302 nm = 0,47 to 0,53Ratio of absorption 258 nm/302 nm = 0,14 to 0,18!
B1996L0077 — EN — 29.12.1998 — 001.001 — 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/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 234 NISINDefinition Nisin consists of several closely related polypeptides produced by
natural strains of Streptococcus lactis , Lancefield group N
Einecs 215-807-5
Chemical formula C
143H230N42O37S7
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 °C to 103 °C
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kgMercury 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 Strepto-
coccus lactis
Einecs 231-683-5
Chemical formula C
33H47O13N
Molecular weight 665,74
Assay Content not less than 95 % on the anhydrous basis
Description White to creamy-white crystalline powder!B1996L0077 — EN — 29.12.1998 — 001.001 — 19
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 atabout 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311nm
C. pH 5,5 to 7,5 (1 % w/v solution in previously neutralized mixture of 20 parts
dimethylformamide and 80 parts of water)
D. Specific rotationα½/C138
20
D= + 250 ° to + 295 ° (a 1 % w/v solution in glacial acetic acid, at
20 °C and calculated with reference to the dried material)
Purity
Loss on drying Not more than 8 % (over P 2O5, in vacuum at 60 °C to constant weight)
Sulphated ash Not more than 0,5 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy 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 [3.3.1.1
3,7]-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 °C
Purity
Loss on drying Not more than 0,5 % after drying at 105 °C in vacuum over P 2O5for two
hours
Sulphated ash Not more than 0,05 %
Sulphates Not more than 0,005 % expressed as SO 4
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!B1996L0077 — EN — 29.12.1998 — 001.001 — 20
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 242 DIMETHYL DICARBONATESynonyms DMDC
Dimethyl pyrocarbonate
Definition
Einecs 224-859-8
Chemical name Dimethyl dicarbonate
Pyrocarbonic acid dimethyl ester
Chemical formula C
4H6O5
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 CO 2and methanol
B. Melting point
Boiling point17 °C
172 °C with decomposition
C. Density 20 °C 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/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 249 POTASSIUM NITRITEDefinition
Chemical name Potassium nitrite
Einecs 231-832-4
Chemical formula KNO
2
Molecular weight 85,11
Assay Content not less than 95 % on the anhydrous basis (4)
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!B1996L0077 — EN — 29.12.1998 — 001.001 — 21
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 NITRITEDefinition
Chemical name Sodium nitrite
Einecs 231-555-9
Chemical formula NaNO
2
Molecular weight 69,00
Assay Content not less than 97 % on the anhydrous basis (4)
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 hoursArsenic Not more than 3 mg/kgLead 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 NITRATESynonyms Chile saltpetre
Cubic or soda nitre
Definition
Chemical name Sodium nitrate
Einecs 231-554-3
Chemical formula NaNO
3
Molecular weight 85,00
Assay Content not less than 99 % after drying at 105 °C for four hours
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
C. Melting point: ± 308 °C
Purity
Loss on drying Not more than 2 % after drying at 105 °C for four hours
Nitrites Not more than 30 mg/kg expressed as NaNO 2
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg!B1996L0077 — EN — 29.12.1998 — 001.001 — 22
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 252 POTASSIUM NITRATESynonyms Chile saltpetre
Cubic or soda nitre
Definition
Chemical name Potassium nitrate
Einecs 231-818-8
Chemical formula KNO
3
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 °C for four hours
Nitrites Not more than 20 mg/kg expressed as KNO 2
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 260 ACETIC ACIDDefinition
Chemical name Acetic acid
Ethanoic acid
Einecs 200-580-7
Chemical formula C
2H4O2
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 °C 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 °C
Purity
Non-volatile residue Not more than 100 mg/kg!B1996L0077 — EN — 29.12.1998 — 001.001 — 23
Formic acid, formates and other oxidizable
substancesNot more than 1 000 mg/kg expressed as formic acid
Readily oxidizable 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 colourdoes 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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 261 POTASSIUM ACETATEDefinition
Chemical name Potassium acetate
Einecs 204-822-2
Chemical formula C
2H3O2K
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 °C for two hours
Formic acid, formates and other oxidizable
substancesNot 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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 262 (i) SODIUM ACETATEDefinition
Chemical name Sodium acetate
Einecs 204-823-8
Chemical formula C
2H3NaO 2.nH2O( n=0o r3 )
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 crystal-
line powder, odourless or with a faint, acetic odour.
Effloresces in warm, dry air!B1996L0077 — EN — 29.12.1998 — 001.001 — 24
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 °C, 4 hours)
Trihydrate: Between 36 and 42 % (120 °C, 4 hours)
Formic acid, formates and other oxidizable
substancesNot 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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 262 (ii) SODIUM DIACETATEDefinition Sodium diacetate is a molecular compound of sodium acetate and acetic
acid
Chemical name Sodium hydrogen diacetate
Einecs 204-814-9
Chemical formula C
4H7NaO 4.nH2O( n=0o r3 )
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 oxidizable
substancesNot 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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 263 CALCIUM ACETATEDefinition
Chemical name Calcium acetate
Einecs 200-540-9
Chemical formula Anhydrous: C
4H6O4Ca
Monohydrate: C 4H6O4Ca.H2O
Molecular weight Anhydrous: 158,17
Monohydrate: 176,18!B1996L0077 — EN — 29.12.1998 — 001.001 — 25
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 °C to constant weight, for the
monohydrate)
Water insoluble matter Not more than 0,3 %
Formic acid, formates and other oxidizable
substancesNot more than 1 000 mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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 acid1-Hydroxyethane-1-carboxylic acid
Einecs 200-018-0
Chemical formula C
3H6O3
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 (C 3H6O3) and lactic acid
lactate (C 6H10O5). It is obtained by the lactic fermentation of sugars or is
prepared synthetically
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/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 26
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 °C
B. Distillation range 138,5 °C to 142,5 °C
Purity
Non-volatile residue Not more than 0,01 % when dried at 140 °C to constant weight
Aldehydes Not more than 0,1 % expressed as formaldehydeArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 281 SODIUM PROPIONATEDefinition
Chemical name Sodium propionate
Sodium propanoate
Einecs 205-290-4
Chemical formula C
3H5O2Na
Molecular weight 96,06
Assay Content not less than 99 % after drying for two hours at 105 °C
Description White crystalline hygroscopic powder, or a fine white powder
Identification
A. Positive tests for propionate and for sodiumB. 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 °CWater insolubles Not more than 0,1 %
Iron Not more than 50 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 27
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 °C
Description White crystalline powder
Identification
A. Positive tests for propionate and for calciumB. 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 °CWater insolubles Not more than 0,3 %
Iron Not more than 50 mg/kg
Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kgLead 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 PROPIONATEDefinition
Chemical name Potassium propionate
Potassium propanoate
Einecs 206-323-5
Chemical formula C
3H5KO 2
Molecular weight 112,17
Assay Content not less than 99 % after drying for two hours at 105 °C
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 °C
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/kgLead Not more than 5 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 28
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 284 BORIC ACIDSynonyms Boracic acid
Orthoboric acidBorofax
Definition
Einecs 233-139-2
Chemical formula H
3BO 3
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 °C
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/kgMercury 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 Na
2B4O7
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 °C and 175 °C with decomposition
Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kgLead Not more than 5 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 29
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 290 CARBON DIOXIDESynonyms Carbonic acid gas
Dry ice (solid form)Carbonic anhydride
Definition
Chemical name Carbon dioxide
Einecs 204-696-9
Chemical formula CO
2
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 aliquid in pressurized cylinders or bulk storage systems, or in compressedsolid blocks of ‘dry ice’. Solid (dry ice) forms usually contain addedsubstances, 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 witheffervescence 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 boiledwater to which has been added 1 ml of hydrochloric acid (0,01 N)
Reducing substances, hydrogen phosphide and
sulphide915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate
reagent to which has been added 3 ml of ammonia must not causeclouding or blackening of this solution
Carbon monoxide Not more than 10 µl/l
Oil content Not more than 0,1 mg/l
E 300 ASCORBIC ACIDDefinition
Chemical name L-ascorbic acid
Ascorbic acid2,3-Didehydro-L-threo-hexono-1,4-lactone3-Keto-L-gulofuranolactone
Einecs 200-066-2
Chemical formula C
6H8O6
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 C 6H8O6
Description White to pale yellow, odourless crystalline solid
Identification
A. Melting range Between 189 °C and 193 °C with decompositionB. Positive tests for ascorbic acid!
B1996L0077 — EN — 29.12.1998 — 001.001 — 30
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 α½/C138
20
Dbetween + 20,5 ° and + 21,5 ° (10 % w/v aqueous solution)
pH of a 2 % aqueous solution Between 2,4 and 2,8
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury 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 enolate3-Keto-L-gulofurano-lactone sodium enolate
Einecs 205-126-1
Chemical formula C
6H7O6Na
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 C 6H7O6Na
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 α½/C13820
Dbetween + 103 ° and + 106 ° (10 % w/v aqueous solution)
pH of 10 % aqueous solution Between 6,5 and 8,0Arsenic Not more than 3 mg/kgLead 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 ASCORBATEDefinition
Chemical name Calcium ascorbate dihydrate
Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Einecs 227-261-5
Chemical formula C
12H14O12Ca.2H2O
Molecular weight 426,35
Assay Content not less than 98 % on a volatile matter-free basis!B1996L0077 — EN — 29.12.1998 — 001.001 — 31
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 α½/C13820
Dbetween + 95 ° and + 97 ° (5 % w/v aqueous solution)
pH of 10 % aqueous solution Between 6,0 and 7,5V olatile 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/kgMercury 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-palmitate6-palmitoyl-3-keto-L-gulofuranolactone
Einecs 205-305-4
Chemical formula C
22H38O7
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 °C and 117 °C
Purity
Loss on drying Not more than 2,0 % after drying in a vacuum oven at 56 °C and 60 °C
for one hour
Sulphated ash Not more than 0,1 %
Specific rotation α½/C13820
Dbetween + 21 ° and + 24 ° (5 % w/v in methanol solution)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury 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-stearate6-stearoyl-3-keto-L-gulofuranolactone
Einecs 246-944-9!
B1996L0077 — EN — 29.12.1998 — 001.001 — 32
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 °C
Purity
Loss on drying Not more than 2,0 % after drying in a vacuum oven at 56 °C to 60 °C for
one hour
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kgLead 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 EXTRACTDefinition Product obtained by the vacuum steam distillation of edible vegetable oil
products, comprising concentrated tocopherols and tocotrienols
Contains tocopherols such as d- α-,d-/betatwo-,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 inmicrocrystalline 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 α½/C138
20
Dnot less than + 20 °
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 307 ALPHA-TOCOPHEROLSynonyms 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 200-412-2
Chemical formula C
29H50O2
Molecular weight 430,71!B1996L0077 — EN — 29.12.1998 — 001.001 — 33
Assay Content not less than 96 %
Description Slightly yellow to amber, nearly odourless, clear, viscous oil which
oxidizes and darkens on exposure to air or light
Identification
A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in ether
B. Spectrophotometry In absolute ethanol the maximum absorption is about 292 nm
Purity
Refractive index n20
D1,503 — 1,507
Specific absorption E1%
1c min ethanolE1%
1c m(292 nm) 72—76
(0,01 g in 200 ml of absolute ethanol)
Sulphated ash Not more than 0,1 %
Specific rotation α½/C13820
D0 ° ± 0,05 ° (1 in 10 solution in chloroform)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 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 C
28H48O2
Molecular weight 416,69
Assay Content not less than 97 %
Description Clear, viscous, pale yellow oil which oxidizes and darkens on exposure
to air or light
Identification
A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity
Specific absorption E1%
1c min ethanol E1%
1c m(298 nm) between 91 and 97
E1%
1c m(257 nm) between 5,0 and 8,0
Refractive index n20
D1,503—1,507
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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!
B1996L0077 — EN — 29.12.1998 — 001.001 — 34
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 oxidizes and darkens
on exposure to air or light
Identification
A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
Purity
Specific absorption E1%
1c min ethanol E1%
1c m(298 nm) between 89 and 95
E1%
1c m(257 nm) between 3,0 and 6,0
Refractive index n20
D1,500—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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 310 PROPYL GALLATEDefinition
Chemical name Propyl gallate
Propyl ester of gallic acidn-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs 204-498-2
Chemical formula C
10H12O5
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 °C and 150 °C after drying at 110 °C for four hours
Purity
Loss on drying Not more than 1,0 % (110 °C, 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)Specific absorption E
1%
1c min ethanol E1%
1c m(275 nm) not less than 485 and not more than 520
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 35
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 °C 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 °C and 102 °C after drying at 90 °C for six hours
Purity
Loss on drying Not more than 0,5 % (90 °C, 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)
Specific absorption E
1%
1c min ethanol E1%
1c m(275 nm) not less than 375 and not more than 390
Arsenic Not more than 3 mg/kgLead 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 GALLATESynonyms Lauryl gallate
Definition
Chemical name Dodecyl gallate
n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acidDodecyl ester of gallic acid
Einecs 214-620-6
Chemical formula C
19H30O5
Molecular weight 338,45
Assay Content not less than 98 % after drying at 90 °C for six hours
Description White or creamy-white odourless solid
Identification
A. Solubility tests Insoluble in water, freely soluble in ethanol and ether
B. Melting range Between 95 °C and 98 °C after drying at 90 °C for six hours
Purity
Loss on drying Not more than 0,5 % (90 °C, six hours)
Sulphated ash Not more than 0,05 %!B1996L0077 — EN — 29.12.1998 — 001.001 — 36
Free acid Not more than 0,5 % (as gallic acid)
Chlorinated organic compound Not more than 100 mg/kg (as Cl)
Specific absorption E1%
1c min ethanol E1%
1c m(275 nm) not less than 300 and not more than 325
Arsenic Not more than 3 mg/kgLead 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 ACIDSynonyms 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 C
6H8O6
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 °C to 172 °C with decompositionB. 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 α½/C138
25
D10 % (w/v) aqueous solution between − 16,5 ° to − 18,0 °
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 remainclear
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 316 SODIUM ERYTHORBATESynonyms Sodium isoascorbate
Definition
Chemical name Sodium isoascorbate
Sodium D-isoascorbic acid
Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone3-keto-D-gulofurano-lactone sodium enolate monohydrate
Einecs 228-973-9!
B1996L0077 — EN — 29.12.1998 — 001.001 — 37
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 ethanolB. Positive test for ascorbic acid/colour reactionC. 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 α½/C138
25
D10 % (w/v) aqueous solution between + 95 ° and + 98 °
pH of a 10 % aqueous solution 5,5 to 8,0Oxalate 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 320 BUTYLATED HYDROXYANISOLE (BHA)
Synonyms BHA
Definition
Chemical name 3-Tertiary-butyl-4-hydroxyanisole
A mixture of 2-tertiarybutyl-4-hydroxyanisole and 3-tertiarybutyl-
4-hydroxyanisole
Einecs 246-563-8
Chemical formula C
11H16O2
Molecular weight 180,25
Assay Content not less than 98,5 % of C 11H16O2and 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 tests Insoluble in water
B. Melting range Between 48 °C and 55 °C
Purity
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 °C
Phenolic impurities Not more than 0,5 %
Specific absorption E1%
1c min ethanol E1%
1c m(290 nm) not less than 190 and not more than 210
E1%
1c m(228 nm) not less than 326 and not more than 345
Arsenic Not more than 3 mg/kg!B1996L0077 — EN — 29.12.1998 — 001.001 — 38
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 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 °CC. 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 %
Specific absorption E
1%
1c min ethanol E1%
1c m(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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 322 LECITHINSSynonyms Phosphatides
Phospholipids
Definition Lecithins are mixtures or fractions of phosphatides obtained by physical
procedures from animal or vegetable foodstuffs; they also includehydrolysed products obtained through the use of harmless andappropriate 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!
B1996L0077 — EN — 29.12.1998 — 001.001 — 39
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 °C—35 °C). Then slowly
add 50 ml of the sample with constant stirring. Hydrolysed lecithin willform a homogeneous emulsion. Non-hydrolysed lecithin will form adistinct mass of about 50 g
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 °C for one hourToluene-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/kgLead 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 LACTATEDefinition
Chemical name Sodium lactate
Sodium 2-hydroxypropanoate
Einecs 200-772-0
Chemical formula C
3H5NaO 3
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 potassium
Purity
Acidity Not more than 0,5 % after drying expressed as lactic acid
pH of a 20 % aqueous solution 6,5 to 7,5Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgReducing substances No reduction of Fehling’ s solution!
B1996L0077 — EN — 29.12.1998 — 001.001 — 40
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/kgMercury 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. Notmore than 0,2 ml should be required
Reducing substances Potassium lactate solution shall not cause any reduction of Fehling’ s
solution
E 327 CALCIUM LACTATE
Definition
Chemical name Calcium dilactate
Calcium dilactate hydrate
2-Hydroxypropanoic acid calcium salt
Einecs 212-406-7
Chemical formula (C
3H5O2)2Ca.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!B1996L0077 — EN — 29.12.1998 — 001.001 — 41
Purity
Loss on drying Determined by drying at 120 °C 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 8,0Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy 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
/betatwo-Hydroxytricarballytic acid
Einecs 201-069-1
Chemical formula (a) C
6H8O7(anhydrous)
(b) C 6H8O7.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 C 6H8O7, 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 °CArsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
Oxalates Not more than 100 mg/kg, expressed as oxalic acid, after drying
Readily carbonizable substances Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric
acid in a water bath at 90 °C in the dark for one hour. Not more than apale brown colour should be produced (Matching Fluid K)!
B1996L0077 — EN — 29.12.1998 — 001.001 — 42
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) C 6H7O7Na (anhydrous)
(b) C 6H7O7Na.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 °C 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 dryingpH of a 1 % aqueous solution Between 3,5 and 3,8
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kgMercury 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 C
6H6O7Na2.1,5H2O
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 °C for four hoursOxalates Not more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 1 % aqueous solution Between 4,9 and 5,2!
B1996L0077 — EN — 29.12.1998 — 001.001 — 43
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 CITRATESynonyms Trisodium citrate
Tribasic sodium citrate
Definition
Chemical name Trisodium citrate
Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTrisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate
form
Einecs 200-675-3
Chemical formula Anhydrous: C
6H5O7Na3
Hydrated: C 6H5O7Na3.nH2O( n=2o r5 )
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 °C for four hours:
— anhydrous: not more than 1,0 %— dihydrate: not more than 13,5 %
— pentahy-
drate: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/kgLead 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 C
6H7O7K
Molecular weight 230,21!B1996L0077 — EN — 29.12.1998 — 001.001 — 44
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 °C for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 1 % aqueous solution Between 3,5 and 3,8
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kgMercury 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 C
6H5O7K3.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 °C for four hoursOxalates 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/kgLead Not more than 1 mg/kgMercury 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!
B1996L0077 — EN — 29.12.1998 — 001.001 — 45
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 °C 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 3,5Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kgMercury 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 CITRATESynonyms 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 (C
6H7O7)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 °C for four hoursOxalates 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/kgLead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kgCarbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not
liberate more than a few isolated bubbles!
B1996L0077 — EN — 29.12.1998 — 001.001 — 46
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 °C for four hoursOxalates 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/kgLead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kgCarbonates 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 ACIDDefinition
Chemical name L-tartaric acid
L-2,3-dihydroxybutanedioic acidd-α,/betatwo-dihydroxysuccinic acid
Einecs 201-766-0
Chemical formula C
4H6O6
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 °C and 170 °CB. Positive test for tartrate
Purity
Loss on drying Not more than 0,5 % (over P
2O5, three hours)
Sulphated ash Not more than 1 000 mg/kg after calcination at 800 ± 25 °C
Specific optical rotation of a 20 % w/v aqueous
solutionα½/C13820
Dbetween + 11,5 ° and + 13,5 °!B1996L0077 — EN — 29.12.1998 — 001.001 — 47
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 TARTRATESynonyms 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 C
4H5O6Na.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 °C for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after dryingArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 335 (ii) DISODIUM TARTRATEDefinition
Chemical name Disodium L-tartrate
Disodium (+)-tartrateDisodium (+)-2,3-dihydroxybutanedioic acid
Dihydrated disodium salt of L-(+)-tartaric acid
Einecs 212-773-3
Chemical formula C
4H4O6Na2.2H2O
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 °C 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!B1996L0077 — EN — 29.12.1998 — 001.001 — 48
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 TARTRATESynonyms Monobasic potassium tartrate
Definition
Chemical name Anhydrous monopotassium salt of L-(+)-tartaric acid
Monopotassium salt of L-2,3-dihydroxybutanedioic acid
Chemical formula C
4H5O6K
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 potassiumB. Melting point 230 °C
Purity
pH of a 1 % aqueous solution 3,4Loss on drying Not more than 1,0 % determined by drying at 105 °C for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury 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 C
4H4O6K2.1⁄2H2O
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 °C for four hours!B1996L0077 — EN — 29.12.1998 — 001.001 — 49
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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 337 POTASSIUM SODIUM TARTRATESynonyms 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 C
4H4O6KNa.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 °C
Purity
Loss on drying Not more than 26,0 % and not less than 21,0 % determined by drying at
150 °C for three hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after dryingpH of 1 % aqueous solution Between 6,5 and 8,5
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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 H
3PO4
Molecular weight 98,00
Assay Content not less than 71 % and not more than 83 %
Description Clear, colourless, viscous liquid!B1996L0077 — EN — 29.12.1998 — 001.001 — 50
Identification
A. Positive tests for acid and for phosphate
Purity
V olatile 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 NaNO
3)
Sulphates Not more than 1500 mg/kg (as CaSO 4)
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 339 (i) MONOSODIUM PHOSPHATE
Synonyms Monosodium monophosphate
Acid monosodium monophosphate
Monosodium orthophosphateMonobasic sodium phosphate
Definition
Chemical name Sodium dihydrogen monophosphate
Einecs 231-449-2
Chemical formula Anhydrous: NaH
2PO4
Monohydrate: NaH 2PO4.H2O
Dihydrate: NaH 2PO4.2H2O
Molecular weight Anhydrous: 119,98
Monohydrate: 138,00
Dihydrate: 156,01
Assay After drying at 6,0 °C for one hour and then at 105 °C for four hours,
contains not less than 97 % of NaH 2PO4
Description A white odourless, slightly deliquescent powder, crystals or granules
Identification
A. Positive tests for sodium and for phosphateB. Solubility tests Freely soluble in water. Insoluble in ethanol, ether or chloroform
C. P
2O5content Between 58,0% and 60,0%
Purity
Loss on drying The anhydrous salt loses no more than 2,0 %, the monohydrate no more
than 15,0 %, and the dihydrate no more than 25 % when dried first at
60 °C for one hour, then at 105 °C for four hours
Water-insoluble substances Not more than 0,2 % on the anhydrous basisFluoride Not more than 10 mg/kg (expressed as fluorine)pH of a 1 % aqueous solution Between 4,1 and 5,0
Arsenic Not more than 3 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 51
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 339 (ii) DISODIUM PHOSPHATE
Synonyms Disodium monophosphate
Secondary sodium phosphateDisodium orthophosphateAcid disodium phosphate
Definition
Chemical name Disodium hydrogen monophosphate
Disodium hydrogen orthophosphate
Einecs 231-448-7
Chemical formula Anhydrous: Na
2HPO 4
Hydrated: Na 2HPO 4.nH2O (n = 2, 7 or 12)
Molecular weight 141,98 (anhydrous)
Assay After drying at 40 °C for three hours and subsequently at 105 °C for five
hours, contains not less than 98 % of Na 2HPO 4
Description Anhydrous disodium hydrogen phosphate is a white, hygroscopic,
odourless powder. Hydrated forms available include the dihydrate: awhite 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 tests Freely soluble in water. Insoluble in ethanol
C. P
2O5content Between 49 % and 51 % (anhydrous)
Purity
Loss on drying When dried at 40 °C for three hours and then at 105 °C 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)
pH of a 1,0 % aqueous solution Between 8,4 and 9,6Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 339 (iii) TRISODIUM PHOSPHATESynonyms Sodium phosphate
Tribasic sodium phosphate
Trisodium orthophosphate
Definition
Chemical name Trisodium monophosphate
Trisodium phosphate
Trisodium orthophosphate!
B1996L0077 — EN — 29.12.1998 — 001.001 — 52
Einecs 231-509-8
Chemical formula Anhydrous: Na 3PO4
Hydrated: Na 3PO4.nH2O (n = 0,5, 1 or 12)
Molecular weight 163,94 (anhydrous)
Assay Sodium phosphate anhydrous, and also the hemi- and monohydrates,
contains not less than 97,0 % of Na 3PO4, calculated on the dried basis.
Sodium phosphate dodecahydrate contains not less than 92,0 % ofNa
3PO4, calculated on the ignited basis
Description White odourless crystals, granules or a crystalline powder. Hydrated
forms available include hemi- and monohydrates, hexahydrate, octahy-drate, decahydrate and dodecahydrate. The dodecahydrate contains
1⁄4
molecule of sodium hydroxide
Identification
A. Positive tests for sodium and for phosphate
B. Solubility tests Freely soluble in water. Insoluble in ethanol
C. P 2O5content Between 40,5 % and 43,5 % (anhydrous)
Purity
Loss on ignition When dried at 120 °C for two hours and then ignited at about 800 °C for
30 minutes, the losses in weight are as follows: anhydrous not more than2,0 %, monohydrate: not more than 11,0 %, dodecahydrate: between45,0 % 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)
pH of a 1,0 % aqueous solution Between 11,5 and 12,5Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 340 (i) MONOPOTASSIUM PHOSPHATESynonyms Monobasic potassium phosphate
Monopotassium monophosphate
Potassium acid phosphate
Potassium orthophosphate
Definition
Chemical name Potassium dihydrogen phosphate
Monopotassium dihydrogen orthophosphate
Monopotassium dihydrogen monophosphate
Einecs 231-913-4
Chemical formula KH
2PO4
Molecular weight 136,09
Assay Content not less than 98,0 % after drying at 105 °C for four hours
Description Odourless, colourless crystals or white granular or crystalline powder,
hygroscopic
Identification
A. Positive tests for potassium and for phosphate
B. Solubility tests Freely soluble in water. Insoluble in ethanol!B1996L0077 — EN — 29.12.1998 — 001.001 — 53
C. P 2O5content Between 51,0 % and 53,0 %
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 °C for four hours
Water-insoluble substances Not more than 0,2 % on the anhydrous basisFluoride Not more than 10 mg/kg (expressed as fluorine)
pH of a 1 % aqueous solution Between 4,2 and 4,8
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 340 (ii) DIPOTASSIUM PHOSPHATESynonyms Dipotassium monophosphate
Secondary potassium phosphate
Dipotassium acid phosphateDipotassium orthophosphateDibasic potassium phosphate
Definition
Chemical name Dipotassium hydrogen monophosphate
Dipotassium hydrogen phosphateDipotassium hydrogen orthophosphate
Einecs 231-834-5
Chemical formula K
2HPO 4
Molecular weight 174,18
Assay Content not less than 98 % after drying at 105 °C for four hours
Description Colourless or white granular powder, crystals or masses; deliquescent
substance
Identification
A. Positive tests for potassium and for phosphateB. Solubility tests Freely soluble in water. Insoluble in ethanol
C. P
2O5content Between 40,3 % and 41,5 %
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 °C 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)pH of a 1 % aqueous solution Between 8,7 and 9,4Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 54
E 340 (iii) TRIPOTASSIUM PHOSPHATE
Synonyms Potassium phosphate
Tribasic potassium phosphateTripotassium orthophosphate
Definition
Chemical name Tripotassium monophosphate
Tripotassium phosphate
Tripotassium orthophosphate
Einecs 231-907-1
Chemical formula Anhydrous: K
3PO4
Hydrated: K 3PO4.nH2O( n=1o r3 )
Molecular weight 212,27 (anhydrous)
Assay Content not less than 97 % calculated 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 tests Freely soluble in water. Insoluble in ethanolC. P
2O5content Between 30,5 % and 33,0 % (anhydrous on ignited basis)
Purity
Loss on ignition Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %.
Determined by drying at 105 °C for one hour and then ignite at about800 °C ± 25 °C 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)pH of a 1 % aqueous solution Between 11,5 and 12,3Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 341 (i) MONOCALCIUM PHOSPHATESynonyms Monobasic calcium phosphate
Monocalcium orthophosphate
Definition
Chemical name Calcium dihydrogen phosphate
Einecs 231-837-1
Chemical formula Anhydrous: Ca(H
2PO4)2
Monohydrate: Ca(H 2PO4)2.H2O
Molecular weight 234,05 (anhydrous)
252,08 (monohydrate)
Assay Content not less than 95 % on the dried basis
Description Granular powder or white, deliquescent crystals or granules!B1996L0077 — EN — 29.12.1998 — 001.001 — 55
Identification
A. Positive tests for calcium and for phosphate
B. P 2O5content Between 55,5 % and 61,1 % (anhydrous)
C. CaO content Between 23,0 % and 27,5 % (anhydrous)
Between 19,0 % and 24,8 % (monohydrate)
Purity
Loss on drying Not less than 14 % determined by drying at 105 °C for four hours
(anhydrous)
Not more than 17,5 % determined by drying at 60 °C for one hour, then
at 105 °C for four hours (monohydrate)
Loss on ignition Not more than 17,5 % after ignition at 800 °C ± 25 °C for 30 minutes
(anhydrous)
Not more than 25,0 % determined by drying at 105 °C for one hour, then
ignite at 800 °C ± 25 °C for 30 minutes (monohydrate)
Fluoride Not more than 30 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 341 (ii) DICALCIUM PHOSPHATESynonyms Dibasic calcium phosphate
Dicalcium orthophosphate
Definition
Chemical name Calcium monohydrogen phosphate
Calcium hydrogen orthophosphateSecondary calcium phosphate
Einecs 231-826-1
Chemical formula Anhydrous: CaHPO
4
Dihydrate: CaHPO 4.2H2O
Molecular weight 136,06 (anhydrous)
172,09 (dihydrate)
Assay Dicalcium phosphate, after drying at 200 °C for three hours, contains not
less than 98 % and not more than the equivalent of 102 % of CaHPO 4
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
C. P 2O5content Between 50,0 % and 52,5 % (anhydrous)
Purity
Loss on ignition Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at
800 °C ± 25 °C for 30 minutes
Fluoride Not more than 50 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg!
B1996L0077 — EN — 29.12.1998 — 001.001 — 56
Heavy metals (as Pb) Not more than 10 mg/kg
E 341 (iii) TRICALCIUM PHOSPHATESynonyms Calcium phosphate, tribasic
Calcium orthophosphate
Definition
Chemical name Tricalcium monophosphate
Einecs 231-840-8
Chemical formula Ca
3(PO 4)2
Molecular weight 310,17
Assay Not less than 90 % calculated on the ignited basis
Description A white, odourless and tasteless powder which is stable in air
Identification
A. Positive tests for calcium and for phosphate
B. Solubility tests Practically insoluble in water; insoluble in ethanol, soluble in dilute
hydrochloric and nitric acid
C. P 2O5content Between 38,5 % and 48,0 % (anhydrous)
Purity
Loss on ignition Not more than 8 % after ignition at 800 °C ± 25 °C, to constant weight
Fluoride Not more than 50 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATESynonyms Calcium disodium EDTA
Calcium disodium edetate
Definition
Chemical name N,N’-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate]
[(4-)-O,O ’,O
N,ON]calciate(2)-disodium
Calcium disodium ethylenediaminetetra acetateCalcium disodium (ethylenedinitrilo)tetra acetate
Einecs 200-529-9
Chemical formula C
10H12O8CaN 2Na2.2H2O
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!B1996L0077 — EN — 29.12.1998 — 001.001 — 57
Purity
Water content 5 to 13 % (Karl Fischer method)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Ethylene oxide may not be used for sterilising purposes in food additives
E 400 ALGINIC ACIDDefinition Linear glycuronoglycan consisting mainly of /betatwo-(1-4) linked D-man-
nuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form.
Hydrophilic colloidal carbohydrate extracted by the use of dilute alkalifrom natural strains of various species of brown seaweeds(Phaeophyceae )
Einecs 232-680-1
Chemical formula (C
6H8O6)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 (CO 2), equivalent to not less than 91
% and not more than 104,5 % of alginic acid (C 6H8O6)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. Avoluminous, gelatinous precipitate is formed. This test distinguishesalginic 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. Noprecipitate 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 sulphatesolution. Within 5 minutes, a cherry-red colour develops that finallybecomes deep purple
Purity
pH of a 3 % suspension Between 2,0 and 3,5Loss on drying Not more than 15 % (105 °C, 4 hours)Sulphated ash Not more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution) Not more than 2 % on the anhydrous basis insoluble matter
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg!
B
!M11996L0077 — EN — 29.12.1998 — 001.001 — 58
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Y east and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 401 SODIUM ALGINATEDefinition
Chemical name Sodium salt of alginic acid
Chemical formula (C
6H7NaO 6)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 °C, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Y east and moulds Not more than 500 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 402 POTASSIUM ALGINATEDefinition
Chemical name Potassium salt of alginic acid
Chemical formula (C
6H7KO 6)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 equivalentweight basis of 238)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
A. Positive test for potassium and for alginic
acid!
M11996L0077 — EN — 29.12.1998 — 001.001 — 59
Purity
Loss on drying Not more than 15 % (105 °C, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Y east and moulds Not more than 500 colonies per gramE. 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 (C
6H11NO 6)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 weightbasis 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 °C, 4 hours)
Sulphated ash Not more than 7 % on the dried basisWater-insoluble matter Not more than 2 % on the anhydrous basisArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gramY east and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 404 CALCIUM ALGINATESynonyms Calcium salt of alginate!
M11996L0077 — EN — 29.12.1998 — 001.001 — 60
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 weightbasis 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 °C, 4 hours)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kgTotal plate count Not more than 5 000 colonies per gram
Y east 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 ALGINATESynonyms 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 neutralisedcarboxyl groups in the molecule
Chemical formula (C
9H14O7)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
%o fC O 2of 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 °C, 4 hours)Total propane-1,2-diol content Not less than 15 % and not more than 45 %Free propane-1,2-diol content Not more than 15 %
Water-insoluble matter Not more than 2 % on the anhydrous basis!
M11996L0077 — EN — 29.12.1998 — 001.001 — 61
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/kgHeavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Y east and moulds Not more than 500 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 406 AGAR
Synonyms Gelose
Japan agarBengal, 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 ofthe 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 und
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, agglutinatedstrips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough whendamp, 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 thespicules of sponges and a few frustules of diatoms may be present. Inchloral hydrate solution, the powdered agar appears more transparentthan in water, more or less granular, striated, angular and occasionallycontains 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 °C, 5 hours)
Ash Not more than 6,5 % on the anhydrous basis determined at 550 °CAcid-insoluble ash (insoluble in approximately
3N Hydrochloric acid)Not more than 0,5 % determined at 550 °C 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 °C. To 5 ml of the solution add 5 ml of trinitrophenol solution(1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidityappears within 10 minutes!
M11996L0077 — EN — 29.12.1998 — 001.001 — 62
Water absorption Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with
water, mix and allow to stand at about 25 °C for 24 hours. Pour thecontents 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 407 CARRAGEENANSynonyms Products of commerce are sold under different names such as:
— Irish moss gelose
— Eucheuman (from Eucheuma spp.)
— Iridophycan (from Irdidaea spp.)
— Hypnean (from Hypnea spp.)
— Furcellaran or Danish agar (from Furcellaria fastigiata )
— Carrageenan (from Chondrus andGigartina spp.)
Definition Carrageenan is obtained by aqueous extraction of natural strains of
seaweeds of Gigartinaceae ,Solieriaceae ,Hypneaceae and Furcellar-
iaceae , 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 andcalcium salts of polysaccharide sulphate esters which, on hydrolysis,yield galactose and 3,6-anhydrogalactose. Carrageenan shall not behydrolysed or otherwise chemically degraded
Einecs 232-524-2
Description Y ellowish to colourless, coarse to fine powder which is practically
odourless
Identification
A. Positive tests for galactose, for anhydroga-
lactose 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 °C Not less than 5 mPa.s
Loss on drying Not more than 12 % (105 °C, 4 hours)Sulphate Not less than 15 % and not more than 40 % on the anhydrous basis (as
SO
4)
Ash Not less than 15 % and not more than 40 % determined on the anhydrous
basis at 550 °C
Acid-insoluble ash Not more than 1 % on the anhydrous basis (insoluble in 10 %
hydrochloric acid)
Acid-insoluble matter Not more than 2 % on the anhydrous basis (insoluble in 1 % v/v
sulphuric acid)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium 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!
M11996L0077 — EN — 29.12.1998 — 001.001 — 63
Y east 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 SEA WEED
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 und
Eucheuma spinosum , of the class Rhodophyceae (red seaweeds) to
remove impurities and by fresh water washing and drying to obtain theproduct. Further purification may be achieved by washing withmethanol, 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, calciumand magnesium salts of the polysaccharide sulphate esters are present inlesser amounts. Up to 15 % algal cellulose is also present in the product.The carrageenan in processed eucheuma seaweed shall not be hydrolysedor otherwise chemically degraded
Description Tan to yellowish, coarse to fine powder which is practically odourless
Identification
A. Positive tests for galactose, for anhydroga-
lactose 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 °C Not less than 5 mPa.s
Loss on drying Not more than 12 % (105 °C, 4 hours)Sulphate Not less than 15 % and not more than 40 % on the dried basis (as SO
4)
Ash Not less than 1 % and not more than 40 % determined on the dried basis
at 550 °C
Acid-insoluble ash Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric
acid)
Acid-insoluble matter Not less than 8 % and not more than 15 % on the dried basis (insoluble in
1 % v/v sulphuric acid)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Y east and mould Not more than 300 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 410 LOCUST BEAN GUM
Synonyms Carob bean gum
Algaroba gum!
M11996L0077 — EN — 29.12.1998 — 001.001 — 64
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 polysac-
charide, composed of galactopyranose and mannopyranose units
combined through glycosidic linkages, which may be describedchemically 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 undermicroscope. 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 topear 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 °C, 5 hours)Ash Not more than 1,2 % determined at 800 °CProtein (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/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kgEthanol and propane-2-ol Not more than 1 %, single or in combination
E 412 GUAR GUMSynonyms 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 polysac-charide composed of galactopyranose and mannopyranose unitscombined 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!
M11996L0077 — EN — 29.12.1998 — 001.001 — 65
Purity
Loss on drying Not more than 15 % (105 °C, 5 hours)
Ash Not more than 1,5 % determined at 800 °C
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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 413 TRAGACANTHSynonyms 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 polysac-
charides) 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 8 000 000
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 upto 3 cm in length. It is white to pale yellow in colour but some piecesmay 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 °C, 5 hours)Total ash Not more than 4 %
Acid insoluble ash Not more than 0,5 %
Acid insoluble matter Not more than 2 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 66
Salmonella spp. Negative in 10 g
E. coli Negative in 5 g
E 414 ACACIA GUMSynonyms 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 andpotassium 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 mixedwith 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 °C, 5 hours) for granular and not more than 10
% (105 °C, 4 hours) for spray-dried material
Total ash Not more than 4 %
Acid insoluble ash Not more than 0,5 %
Acid insoluble matter Not more than 1 %Starch or dextrin Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine
solution. No bluish or reddish colours are produced
Tannin To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution
(9 g FeCl
3.6H 2O 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/kgCadmium 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 thedominant hexose units, along with D-glucuronic acid and pyruvic acid,and is prepared as the sodium, potassium or calcium salt. Its solutionsare neutral
Molecular weight Approximately 1 000 000!
M11996L0077 — EN — 29.12.1998 — 001.001 — 67
Einecs 234-394-2
Assay Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO 2
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 °C, 21⁄2hours)
Total ash Not more than 16 % on the anhydrous basis determined at 650 °C after
drying at 105 °C for four hours
Pyruvic acid Not less than 1,5 %Nitrogen Not more than 1,5 %
Propane-2-ol Not more than 500 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kgTotal plate count Not more than 10 000 colonies per gram
Y east and mould Not more than 300 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
Xanthomonas campestris Viable cells absent
E 416 KARAYA-GUM
Synonyms Katilo
KadayaGum sterculia
Sterculia
Karaya, gum karaya
KulloKuterra
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 paleyellow to pinkish brown in colour, translucent and horny. Powderedkaraya gum is a pale grey to pinkish brown. The gum has a distinctiveodour of acetic acid
Identification
A. Solubility Insoluble in ethanolB. Swelling in ethanol solution Karaya gum swells in 60 % ethanol distinguishing it from other gums!
M11996L0077 — EN — 29.12.1998 — 001.001 — 68
Purity
Loss on drying Not more than 20 % (105 °C, 5 hours)
Total ash Not more than 8 %
Acid insoluble ash Not more than 1 %Acid insoluble matter Not more than 3 %
V olatile acid Not less than 10 % (as acetic acid)
Starch Not detectableArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium 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 GUMDefinition 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 ofgalactomannans. The principal component consists of a linear chain of(1-4)- /betatwo-D-mannopyranose units with α-D-galactopyranose units at-
tached 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 x 5,7)Starch Not detectableArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 69
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 principallycomposed of a tetrasaccharide repeating unit of one rhamnose, oneglucuronic acid, and two glucoses, and substituted with acyl (glyceryland 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
CO
2
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 °C, 21⁄2hours)
Nitrogen Not more than 3 %
Propane-2-ol Not more than 750 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 10 000 colonies per gram
Y east and mould Not more than 400 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 422 GL YCEROL
Synonyms Glycerin
Glycerine
Definition
Chemical names 1,2,3-propanetriol
Glycerol
Trihydroxypropane
Einecs 200-289-5
Chemical formula C
3H8O3
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!M11996L0077 — EN — 29.12.1998 — 001.001 — 70
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 °C) Not less than 1,257C. Refractive index [n]D
20 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 °C
Butanetriols Not more than 0,2 %
Acrolein, glucose and ammonium compounds Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide
solution (1 in 10) at 60 °C for five minutes. It neither becomes yellownor 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/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E 431 POLYOXYETHYLENE (40) STEARATESynonyms 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 °C with a faint odour
Identification
A. Solubility Soluble in water, ethanol, methanol and ethyl acetate
Insoluble in mineral oil
B. Congealing range 39-44 °CC. 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 401,4-Dioxane Not more than 5 mg/kg
Free ethylene oxide Not more than 1 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 71
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POL YSORBATE 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 approximately20 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 theanhydrous basis
Description A lemon to amber-coloured oily liquid at 25 °C 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 2Saponification 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/kgFree ethylene oxide Not more than 1 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POL YSORBATE 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 20moles 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 theanhydrous basis
Description A lemon to amber-coloured oily liquid at 25 °C 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!
M11996L0077 — EN — 29.12.1998 — 001.001 — 72
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 55Hydroxyl value Not less than 65 and not more than 80
1,4-Dioxane Not more than 5 mg/kg
Free ethylene oxide Not more than 1 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POL YSORBATE 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 approximately20 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 °C 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 2Saponification 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/kgFree ethylene oxide Not more than 1 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 73
E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POL YSORBATE 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 theanhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at 25 °C 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 2Saponification 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/kgFree ethylene oxide Not more than 1 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POL YSORBATE 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 approximately20 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 °C with a faint characteristic odour
Identification
A. Solubility Dispersible in water. Soluble in mineral oil, vegetable oils, petroleum
ether, acetone, ether, dioxane, ethanol and methanol
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyolC. Congealing range 29-33 °C
Purity
Water Not more than 3 % (Karl Fischer method)!
M11996L0077 — EN — 29.12.1998 — 001.001 — 74
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/kgFree ethylene oxide Not more than 1 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 440 (i) PECTINDefinition Pectin consists mainly of the partial methyl esters of polygalacturonic
acid and their ammonium, sodium, potassium and calcium salts. It isobtained by extraction in an aqueous medium of natural strains ofappropriate 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 °C, 2 hours)
Acid insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Sulphur dioxide Not more than 50 mg/kg on the anhydrous basisNitrogen content Not more than 1,0 % after washing with acid and ethanolFree 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/kgMercury 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 PECTINDefinition Amidated pectin consists mainly of the partial methyl esters and amides
of polygalacturonic acid and their ammonium, sodium, potassium andcalcium salts. It is obtained by extraction in an aqueous medium ofappropriate natural strains of edible plant material, usually citrus fruits orapples and treatment with ammonia under alkaline conditions. Noorganic precipitant shall be used other than methanol, ethanol and
propane-2-ol!
M11996L0077 — EN — 29.12.1998 — 001.001 — 75
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 °C, 2 hours)Acid-insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Degree of amidation Not more than 25 % of total carboxyl groups
Sulphur dioxide residue Not more than 50 mg/kg on the anhydrous basisNitrogen 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 442 AMMONIUM PHOSPHATIDESSynonyms 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 phosphatidylphosphatides
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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 76
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 andisobutyric anhydride, followed by distillation. The mixture contains allpossible combinations of esters in which the molar ratio of acetate tobutyrate is about 2:6
Einecs 204-771-6
Chemical name Sucrose diacetate hexaisobutyrate
Chemical formulae C
40H62O19
Molecular weight 832-856 (approximate), C 40H62O19: 846,9
Assay Content not less than 98,8 % and not more than 101,9 % of C 40H62O19
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 solventsB. Refractive index n½/C138
40
D: 1,4492 - 1,4504
C. Specific gravity d½/C13825
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 540Arsenic Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgLead Not more than 3 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E 445 GL YCEROL 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 thesespecifications are substances derived from gum rosin, and exudate ofliving pine trees, and substances derived from tall oil rosin, a by-productof kraft (paper) pulp processing. The final product is composed ofapproximately 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 molecularformula of C
20H30O2, 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 acetoneB. Infrared absorption spectrum Characteristic of the compound!
M11996L0077 — EN — 29.12.1998 — 001.001 — 77
Purity
Specific gravity of solution d½/C13820
25not less than 0,935 when determined in a 50 % solution in d-
limonene (97 %, boilding point 175,5-176 °C, d204: 0,84)
Ring and ball softening range Between 82 °C and 90 °CAcid 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/kgLead Not more than 2 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgTest 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 testindicates the use of tall oil rosin instead of wood rosin
E 450 (i) DISODIUM DIPHOSPHATESynonyms Disodium dihydrogen diphosphate
Disodium dihydrogen pyrophosphate
Sodium acid pyrophosphate
Definition
Chemical name Disodium dihydrogen diphosphate
Einecs231-835-0
Chemical formula Na
2H2P2O7
Molecular weight 221,94
Assay Content not less than 95 % of disodium diphosphate and not less than 63
% and not more than 64,5 % expressed as P 2O5
Description White powder or grains
Identification
A. Positive tests for sodium and for phosphate
B. Solubility Soluble in water
Purity
pH of a 1 % solution Between 3,7 and 5,0
Loss on drying Not more than 0,5 % (105 °C, 4 hours)
Water-insoluble matter Not more than 1 %Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 78
E 450 (ii) TRISODIUM DIPHOSPHATE
Synonyms Acid trisodium pyrophosphate
Trisodium monohydrogen diphosphate
Definition
Einecs 238-735-6
Chemical formula Monohydrate: Na 3HP2O7.H2O
Anhydrous: Na 3HP2O7
Molecular weight Monohydrate: 261,95
Anhydrous: 243,93
Assay Content not less than 95 % on the anhydrous basis and not less than 57 %
and not more than 59 % expressed as P 2O5
Description White powder or grains, occurs anhydrous or as a monohydrate
Identification
A. Positive tests for sodium and for phosphate
B. Soluble in water
Purity
pH of a 1 % solution Between 6,7 and 7,3
Loss on ignition 4,5 % on the anhydrous compound
11,5 % on the monohydrous basis
Loss on drying Not more than 0,5 % (105 °C, 4 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
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 450 (iii) TETRASODIUM DIPHOSPHATESynonyms Tetrasodium pyrophosphate
Sodium pyrophosphate
Definition
Chemical name Tetrasodium diphosphate
Einecs
231-767-1
Chemical formula Anhydrous: Na
4P2O7
Decahydrate: Na 4P2O7.10H2O
Molecular weight Anhydrous: 265,94
Decahydrate: 446,09
Assay Content not less than 95 % of Na 4P2O7, in the ignited basis and not less
than 52,5 % and not more than 54 % expressed as P 2O5!M11996L0077 — EN — 29.12.1998 — 001.001 — 79
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 phosphateB. Solubility Soluble in water. Insoluble in ethanol
Purity
pH of a 1 % solution Between 9,8 and 10,8Loss 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 afterdrying at 105 °C for four hours, followed by ignition at 550 °C 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
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 450 (v) TETRAPOTASSIUM DIPHOSPHATE
Synonyms Potassium pyrophosphate
Tetrapotassium pyrophosphate
Definition
Chemical name Tetrapotassium diphosphate
Einecs 230-785-7
Chemical formula K
4P2O7
Molecular weight 330,34 (anhydrous)
Assay Content not less than 95 % on the ignited basis and not less than 42 %
and not more than 43,7 % expressed as P 2O5
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
Purity
pH of a 1 % solution Between 10,0 and 10,8Loss on ignition Not more than 2 % after drying at 105 °C for 4 hours then ignition at 550
°C 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
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 80
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 % and not less than 55 % and not more than 56
% expressed as P 2O5
Description A fine, white, odourless powder
Identification
A. Positive tests for calcium and for phosphateB. Solubility Insoluble in water. Soluble in dilute hydrochloric and nitric acids
Purity
pH of a 10 % suspension in water Between 5,5 and 7,0Loss on ignition Not more than 1,5 % at 800 ± 25 °C for 30 minutes
Fluoride Not more than 50 mg/kg expressed as fluorine
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATESynonyms Acid calcium pyrophosphate
Monocalcium dihydrogen pyrophosphate
Definition
Chemical name Calcium dihydrogen diphosphate
Einecs 238-933-2
Chemical formula CaH
2P2O7
Molecular weight 215,97
Assay Content not less than 90 % on the anhydrous basis and not less than 61 %
and not more than 64 % expressed as P 2O5
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!M11996L0077 — EN — 29.12.1998 — 001.001 — 81
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 451 (i) PENTASODIUM TRIPHOSPHATESynonyms Pentasodium tripolyphosphate
Sodium tripolyphosphate
Definition
Chemical name Pentasodium triphosphate
Einecs 231-838-7
Chemical formulae Na
5O10P3.xH2O( x=0o r6 )
Molecular weight 367,86
Assay Content not less than 85 %
Content in P 2O5not less than 56 % and not more than 58 % (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 °C, 1 hour)
Hexahydrate: Not more than 23,5 % (60 °C, 1 hour, followed by drying
at 105 °C, 4 hours)
Water insoluble matter Not more than 0,1 %
Higher polyphosphates Not more than 1 %
Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE
Synonyms Pentapotassium tripolyphosphate
Potassium triphosphatePotassium tripolyphosphate
Definition
Chemical name Pentapotassium triphosphate
Pentapotassium tripolyphosphate
Einecs 237-574-9
Chemical formulae K
5O10P3
Molecular weight 448,42!M11996L0077 — EN — 29.12.1998 — 001.001 — 82
Assay Content not less than 85 % on the dried basis
Content in P 2O5not less than 46,5 % and not more than 48 %
Description White, hygroscopic powder or granules
Identification
A. Solubility Very soluble in water
B. Positive tests for potassium and for phosphateC. pH of a 1 % solution Between 9,2 and 10,5
Purity
Loss on ignition Not more than 0,4 % (105 °C, 4 hours, followed by ignition at 550 °C, 30
minutes)
Water insoluble matter Not more than 2 %
Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 452 (i) SODIUM POL YPHOSPHATE1. SOLUBLE POL YPHOSPHATE
Synonyms Sodium hexametaphosphate
Sodium tetrapolyphosphateGraham’ s saltSodium 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 com-
posed of linear chains of metaphosphate units, (NaPO
3)xwhere x 52,
terminated by Na 2PO4groups. These substances are usually identified by
their Na 2O/P 2O5ratio or their P 2O5content. The Na 2O/P 2O5ratios vary
from about 1,3 for sodium tetrapolyphosphate, where x = approximately4; to about 1,1 for Graham’ s salt, commonly called sodium hexameta-
phosphate, 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 oftheir solutions varies between 3,0 and 9,0
Chemical name Sodium polyphosphate
Einecs 272-808-3
Chemical formulae Heterogenous mixtures of sodium salts of linear condensed polyphos-
phoric acids of general formula H
(n + 2) PnO(3n + 1) where ‘n’ is not less
than 2
Molecular weight (102) n
Assay Content in P 2O5not 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 waterB. Positive tests for sodium and for phosphateC. pH of a 1 % solution Between 3,0 and 9,0!
M11996L0077 — EN — 29.12.1998 — 001.001 — 83
Purity
Loss on ignition Not more than 1 %
Water insoluble matter Not more than 0,1 %
Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
2. INSOLUBLE POL YPHOSPHATESynonyms Insoluble sodium metaphosphateMaddrell’ s salt
Insoluble sodium polyphosphate, IMP
Definition Insoluble sodium metaphosphate is a high molecular weight sodium
polyphosphate composed of two long metaphosphate chains (NaPO
3)x
that spiral in opposite directions about a common axis. The Na 2O/P 2O5
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 formulae Heterogenous mixtures of sodium salts of linear condensed polypho-
sphoric acids of general formula H (n + 2) PnO(3n + 1) where ‘n’ is not less
than 2
Molecular weight (102) n
Assay Not less than 68,7 % and not more than 70 % of P 2O5
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 phosphateC. pH of a 1 in 3 suspension in water About 6,5
Purity
Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 452 (ii) POTASSIUM POLYPHOSPHATE
Synonyms Potassium metaphosphate
Potassium polymetaphosphateKurrol salt
Definition
Chemical name Potassium polyphosphate
Einecs 232-212-6!
M11996L0077 — EN — 29.12.1998 — 001.001 — 84
Chemical formulae (KPO 3)n
Heterogenous mixtures of potassium salts of linear condensed poly-
phosphoric acids of general formula H (n + 2) PnO(3n + 1) where ’n’is not
less than 2
Molecular weight (134) n
Assay Content in P 2O5not 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 acetateB. Positive tests for potassium and for phosphate
C. pH of a 1 % solution Not more than 7,8
Purity
Loss on ignition Not more than 2 % (105 °C, 4 hours followed by ignition at 550 °C, 30
minutes)
Water insoluble matter Not more than 0,2 %
Cyclic phosphate Not more than 8 % on P
2O5content
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 452 (iv) CALCIUM POLYPHOSPHATES
Synonyms Calcium metaphosphate
Calcium polymetaphosphate
Definition
Chemical name Calcium polyphosphate
Einecs 236-769-6
Chemical formulae (CaP
2O6)n
A heterogeneous mixture of calcium salts of condensed polyphosphoric
acids of general formula H (n + 2) PnO(n + 1) where ‘n’ is not less than 2
Molecular weight (198) n
Assay Content in P 2O5not less than 50 % and not more than 71 % on the
ignited basis
Description Odourless, colourless crystals or white powder
Identification
A. Solubility Usually sparingly soluble in water. Soluble in acid mediumB. Positive tests for calcium and for phosphate
C. CaO content 27-29,5 %
Purity
Loss on ignition Not more than 2 % (105 °C, 4 hours followed by ignition at 550 °C, 30
minutes)
Cyclic phosphate Not more than 8 % on P
2O5content!M11996L0077 — EN — 29.12.1998 — 001.001 — 85
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/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 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 naturalstrains of fibrous plant material, with mineral acids. The degree ofpolymerisation is typically less than 400
Chemical name Cellulose
Einecs 232-674-9
Chemical formula (C
6H10O5)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 inphosphoric 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 afree-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 a100-ml graduated cylinder and allow to stand for 1 hour. The solidssettles and a supernatant liquid appears
Purity
Loss on drying Not more than 7 % (105 °C, 3 hours)
Water-soluble matter Not more than 0,24%Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
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 colourshould 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 86
Heavy metals (as Pb) Not more than 10 mg/kg
E 460 (ii) POWDERED CELLULOSEDefinition Purified, mechanically disintegrated celluslose prepared by processing
alpha-cellulose obtained as a pulp from natural strains of fibrous plantmaterials
Chemical name Cellulose
Linear polymer of 1:4 linked glucose residues
Einecs 232-674-9
Chemical formula (C
6H10O5)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 afree-flowing suspension or a heavy, lumpy suspension which flowspoorly, if at all, settles only slightly and contains many trapped airbubbles. 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 °C, 3 hours)
Water-soluble matter Not more than 1,0 %
Sulphated ash Not more than 0,3 % determined at 800 ± 25 °CpH 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy 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!
M11996L0077 — EN — 29.12.1998 — 001.001 — 87
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C6H7O2(OR 1)(OR 2)(OR 3) where R 1,R 2,R 3each may be one of the
following:
—H
—C H 3or
—C H 2CH 3
Molecular weight From about 20 000 to 380 000
Assay Content not less than 25 % and not more than 33 % of methoxyl groups
(-OCH 3) and not more than 5 % of hydroxyethoxyl groups
(-OCH 2CH 2OH)
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 ehtanol, ether and chloroform.Soluble in glacial acetic acid
Purity
Loss on drying Not more than 10 % (105 °C, 3 hours)
Sulphated ash Not more than 1,5 % determined at 800 ± 25 °C
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 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 hydro-xypropyl groups
Chemical name Hydroxypropyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR 1)(OR 2)(OR 3), where R 1,R 2,R 3each may be one of the
following:
—H
—C H 2CHOHCH 3
—C H 2CHO(CH 2CHOHCH 3)CH 3
—C H 2CHO[CH 2CHO(CH 2CHOHCH 3)CH 3]CH 3
Molecular weight From about 30 000 to 1 000 000
Assay Content not less than 80,5 % of hydroxypropoxyl groups
(-OCH 2CHOHCH 3) 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!M11996L0077 — EN — 29.12.1998 — 001.001 — 88
Purity
Loss on drying Not more than 10 % (105 °C, 3 hours)
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0Propylene chlorohydrins Not more than 0,1 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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 CELLULOSEDefinition Hydroxypropyl methyl cellulose is cellulose obtained directly from
natural strains of fibrous plant material and partially etherified withmethyl groups and containing a small degree of hydroxypropylsubstitution
Chemical name 2-Hydroxypropyl ether of methylcellulose
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR 1)(OR 2)(OR 3), where R 1,R 2R3each may be one of the
following:
—H
—C H 3
—C H 2CHOHCH 3
—C H 2CHO (CH 2CHOHCH 3)C H 3
—C H 2CHO[CH 2CHO (CH 2CHOHCH 3)C H 3]CH 3
Molecular weight From about 13 000 to 200 000
Assay Content not less than 19 % and not more than 30 % methoxyl groups (-
OCH 3) and not less than 3 % and not more than 12 % hydroxypropoxyl
groups (-OCH 2CHOHCH 3), 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 °C, 3 hours)Sulphated ash Not more than 1,5 % for products with viscosities of 50 mPa.s or above
Not more than 3 % for products with viscosities below 50 mPa.s
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/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 89
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 ethylgroups
Chemical name Ethyl methyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR 1)(OR 2)(OR 3), where R 1,R 2R3each may be one of the
following:
—H
—C H 3
—C H 2CH 3
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 (-OCH 3) and not less than 14,5 % and not more
than 19 % of ethoxyl groups (-OCH 2CH 3), 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 °C 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/kgMercury 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 CELLULOSESynonyms Carboxy methyl cellulose
CMC
NaCMCSodium CMCCellulose gum
Definition Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl
ether of cellulose, the cellulose being obtained directly from naturalstrains 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:
C
6H7O2(OR 1)(OR 2)(OR 3), where R 1,R 2R3each may be one of the
following:
—H
—C H 2COONa
—C H 2COOH!M11996L0077 — EN — 29.12.1998 — 001.001 — 90
Molecular weight Higher than approximately 17 000 (degree of polymerisation approxi-
mately 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 carboxymethylcellulose 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. (Thistest permits the distinction of sodium carboxymethyl cellulose fromother cellulose ethers and from gelatine, locust bean gum andtragacanth)
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 stirringuntil a clear solution is produced, and use the solution for the followingtest:
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, andcarefully introduce down the side of the tube 2 ml of sulphuric acid sothat 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 (-
CH
2COOH) per anhydroglucose unit
Loss on drying Not more than 12 % (105 °C 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy 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 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDSDefinition Sodium, potassium and calcium salts of fatty acids occurring in food oils
and fats, these salts being obtained either from edible fats and oils orfrom 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 Na
2O
Potassium Not less than 13 % and not more than 21,5 % expressed as K 2O!M11996L0077 — EN — 29.12.1998 — 001.001 — 91
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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy 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 ACIDSDefinition Magnesium salts of fatty acids occurring in foods oils and fats, these
salts being obtained either from edible fats and oils or from distilled foodfatty 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 etherB. 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/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 471 MONO- AND DIGL YCERIDES OF FATTY ACIDS
Synonyms Glyceryl monostearate
Glyceryl monopalmitateGlyceryl 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 theform of flakes, powders or small beads!
M11996L0077 — EN — 29.12.1998 — 001.001 — 92
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 6Free 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy 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 °CPurity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 a ACETIC ACID ESTERS OF MONO- AND DIGL YCERIDES OF FATTY ACIDSSynonyms Acetic acid esters of mono- and diglycerides
AcetoglyceridesAcetylated 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 detectableFree glycerol Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgTotal 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 %!
M11996L0077 — EN — 29.12.1998 — 001.001 — 93
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 b LACTIC ACID ESTERS OF MONO- AND DIGL YCERIDES OF FATTY ACIDS
Synonyms Lactic acid esters of mono- and diglycerides
LactoglyceridesMono- 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 fattyacids, 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy 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 acidTotal glycerol Not less than 13 % and not more than 30 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 c CITRIC ACID ESTERS OF MONO- AND DIGL YCERIDES OF FATTY ACIDSSynonyms 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 fattyacids, free citric acid and free glycerides. They may be partially orwholly neutralised with sodium hydroxide or with potassium hydroxide
Description Y ellowish 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 waterSoluble in oils and fatsInsoluble in cold ethanol!
M11996L0077 — EN — 29.12.1998 — 001.001 — 94
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 Not more than 0,5 % determined at 800 ± 25 °C
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Free fatty acids Not more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGL YCERIDES OF FATTY ACIDSSynonyms 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 fattyacids, 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/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgTotal 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 °CPurity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGL YCERIDES OF FATTY ACIDSSynonyms 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!
M11996L0077 — EN — 29.12.1998 — 001.001 — 95
Definition Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained
from tartaric acid) and fatty acids occurring in food fats and oils. Theymay 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 °C
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgTotal 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 acidPurity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGL YCERIDES 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. Maycontain mono- and diacetyltartaric esters of mono- and diglycerides offatty 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 detectableFree 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 °CArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 96
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 acidPurity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 473 SUCROSE ESTERS OF FATTY ACIDS
Synonyms Sucroesters
Sugar esters
Definition Essentially the mono-, di- and triesters of sucrose with fatty acids
occurring in food fats and oils. They may be prepared from sucrose and
the methyl 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 theirpreparation
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 °CFree sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Methanol Not more than 10 mg/kg
Dimethylsulphoxide Not more than 2 mg/kgDimethylformamide Not more than 1 mg/kg
2-methyl-1-propanol Not more than 10 mg/kg
Ethyl acetate Not more than 350 mg/kg, singly or in combinationPropane-2-olPropylene glycol
Methyl ethyl ketone Not more than 10 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 474 SUCROGLYCERIDESSynonyms Sugar glycerides!
M11996L0077 — EN — 29.12.1998 — 001.001 — 97
Definition Sucroglycerides are produced by reacting sucrose with an edible fat or
oil to produce a mixture of essentially mono-, di- and triesters of sucroseand 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-pro-panol 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 °CFree sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Methanol Not more than 10 mg/kg
Dimethylformamide Not more than 1 mg/kg2-methyl-1-propanol Not more than 10 mg/kg, single or in combinationCyclohexane
Ethyl acetate Not more than 350 mg/kg, single or in combination
Propane-2-olPurity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 475 POLYGL YCEROL 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 toor 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!
M11996L0077 — EN — 29.12.1998 — 001.001 — 98
Purity
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
Acids other than fatty acids Not detectable
Free fatty acids Not more than 6 % estimated as oleic acidTotal 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 476 POLYGL YCEROL POLYRICINOLEATE
Synonyms Glycerol esters of condensed castor oil fatty acids
Polyglycerol esters of polycondensed fatty acids from castor oilPolyglycerol esters of interesterified ricinoleic acidPGPR
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 % ofpolyglycerols equal to or higher than heptaglycerol
Hydroxyl value Not less than 80 and not more than 100
Acid value Not more than 6Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium 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 exclusivelypropane-1,2-diol together with dimer and traces of trimer. Organic acidsother than food fatty acids are absent.!
M11996L0077 — EN — 29.12.1998 — 001.001 — 99
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 °CAcids other than fatty acids Not detectableFree 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/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgPurity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 479 b THERMALL Y OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGL YCERIDES 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 acidsfound in edible fat and fatty acids from thermally oxidised soya bean oil.It is produced by interaction and desodorisation under vacuum at 130 °Cof 10 % of thermally oxidised soya bean oil and 90 % mono- anddiglycerides 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 °CFree 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
ureaNot 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!
M11996L0077 — EN — 29.12.1998 — 001.001 — 100
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-LACTYLATESynonyms 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, manufacturedby the reaction of stearic acid and lactic acid. Other food fatty acids mayalso be present, free or esterified, due to their presence in the stearic acidused
Chemical names Sodium di-2-stearoyl lactate
Sodium di(2-stearoyloxy)propionate
Einecs 246-929-7
Chemical formula
(major components)C
21H39O4Na
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/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 482 CALCIUM STEAROYL-2-LACTYLATESynonyms 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 mayalso be present, free or esterified, due to their presence in the stearic acidused
Chemical name Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Einecs 227-335-7
Chemical formula C
42H78O8Ca
C38H70O8Ca!M11996L0077 — EN — 29.12.1998 — 001.001 — 101
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 130Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium 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 ofunchanged starting materials
Chemical name Distearyl tartrate
Dipalmityl tartrate
Chemical formula C
38H74O6to C 40H78O6
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 °C)
Identification
A. Positive tests for tartareB. Melting range Between 67 °C and 77 °C. After saponification the saturated long chain
fatty alcohols have a melting range of 49 °C to 55 °C
Purity
Hydroxyl value Not less than 200 and not more than 220Acid 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 °CArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 102
Unsaponifiable matter Not less than 77 % and not more than 83 %
Iodine value Not more than 4 (Wijs)
E 491 SORBITAN MONOSTEARATEDefinition 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 inpetroleum ether and acetone; insoluble in cold water but dispersible in
warm water; soluble with haze at temperatures above 50 °C in mineral
oil and ethyl acetate
B. Congealing range 50—52 °CC. 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 157Hydroxyl value Not less than 235 and not more than 260
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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 °CC. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol!
M11996L0077 — EN — 29.12.1998 — 001.001 — 103
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 15Saponification 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 493 SORBITAN MONOLAURATEDefinition 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 waterB. 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 170Hydroxyl value Not less than 330 and not more than 358Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium 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 andsorbitan trioleate
Einecs 215-665-4
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan and
isosorbide esters!
M11996L0077 — EN — 29.12.1998 — 001.001 — 104
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 tetra-chloride. 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 8Saponification 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 495 SORBITAN MONOPALMITATESynonyms 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 andcarbon tetrachloride. Insoluble in cold water but dispersible in warm
water
B. Congealing range 45—47 °CC. 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 305Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg!
M11996L0077 — EN — 29.12.1998 — 001.001 — 105
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 508 POTASSIUM CHLORIDESynonyms 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 °C, 2 hours)
Sodium Negative test
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 579 FERROUS GLUCONATEDefinition
Chemical name Ferrous di-D-gluconate dihydrate
Iron(II) di-gluconate dihydrate
Einecs 206-076-3
Chemical formulae C
12H22FeO 14.2H2O
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 phenylhydrazine derivative of
gluconic acid positive
D. pH of a 10 % solution Between 4 and 5,5!M11996L0077 — EN — 29.12.1998 — 001.001 — 106
Purity
Loss on drying Not more than 10 % (105 °C, 16 hours)
Oxalic acid Not detectable
Iron (Fe III) Not more than 2 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium 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 propanoatePropanoic acid, 2-hydroxy-iron(2 +) salt (2:1)
Definition
Chemical name Ferrous 2-hydroxy propanoate
Einecs 227-608-0
Chemical formulae C
6H10FeO 6.xH2O( x=2o r3 )
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 °C, under vacuum, approximately 700 mm Hg)
Iron (Fe III) Not more than 0,6 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
E 1105 L YSOZYMESynonymsLysozyme hydrochloride
Muramidase
Definition Lysozyme is a linear polypeptide obtained from hens’ egg whites
consisting of 129 amino acids. It possesses enzymatic activity in itsability to hydrolyse the /betatwo(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 hydro-
chloride!
M1
!B1996L0077 — EN — 29.12.1998 — 001.001 — 107
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 10,7B. 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 252nm
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/kgMercury 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 × 10
4col/g
Salmonellae Absent in 25 g
Staphylococcus aureus Absent in 1 g
Escherichia coli Absent in 1 g
(1)Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl 2.6H2O 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 CoCl 2.6H2O.
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 CoCl 2.6H2O per ml.
(2)Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975
ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15
ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine
with sodium thiosulphate (0,1 N) in the presence of starch TS (*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of
FeCl 3.6H2O. 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 FeCl 3.6H2O per ml.
(3)Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO 4.5H2O 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 CuSO
4.5H2O. 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 CuSO 4.5H2O
per ml.
(4)When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.
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
This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic
acid content
This specification refers to a 60 % aqueous solution
This specification refers to a 60 % aqueous solution
This specification refers to a 75 % aqueous solution!B1996L0077 — EN — 29.12.1998 — 001.001 — 108