This document is meant purely as documentation tool and the institutions do not assume any liability for its contents
"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 9.12.1998
"M2 Commission Directive 2000/63/EC of 5 October 2000 L 277 1 30.10.20001996L0077 — EN — 19.11.2000 — 002.001 — 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Whereas Directives 65/66/EEC and 78/664/EEC should be repealed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 — 19.11.2000 — 002.001 — 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 — 19.11.2000 — 002.001 — 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 °Cto 135 °C after vacuum drying in a sulphuricacid desiccator!
B1996L0077 — EN — 19.11.2000 — 002.001 — 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 °Cto 135 °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 — 19.11.2000 — 002.001 — 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 ben-
zoate
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 ethanolB. 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 acid
desiccator
C. Positive tests for benzoate and for sodium!
B1996L0077 — EN — 19.11.2000 — 002.001 — 6
Purity
Loss on drying Not more than 1,5 % after drying at 105 °C for four hours
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
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/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 212 POTASSIUM BENZOATEDefinition
Chemical name Potassium benzoate
Potassium salt of benzenecarboxylic acidPotassium 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 °Cto 123,5 °C, after vacuum drying in a
sulphuric acid desiccator
B. Positive tests for benzoate and for potassium
Purity
Loss on drying Not more than 26,5 %, determined by drying at 105 °C
Chlorinated 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 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 A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric
acid must not show a stronger colouring than that of a reference liquid
containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC,
0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids On fractional acidification of a (neutralized) solution of potassium
benzoate, the first precipitate must not have a different melting rangefrom that of benzoic acid!
B1996L0077 — EN — 19.11.2000 — 002.001 — 7
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
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 213 CALCIUM BENZOATE
Synonyms 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: 300,32
Trihydrate: 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 a
sulphuric acid desiccator
B. Positive tests for benzoate and for calcium
Purity
Loss on drying Not more than 17,5 % determined by drying at 105 °C to constant weight
Water insoluble matter Not more than 0,3 %Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 %
expressed as monochlorobenzoic 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 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 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 range
from 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 NaOHor 0,1 N HCl
Fluoride Not more than 10 mg/kg!
B1996L0077 — EN — 19.11.2000 — 002.001 — 8
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 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 °CB. 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 acid
desiccator
C. Positive test for alcohol
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/kgMercury 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 desiccator!B1996L0077 — EN — 19.11.2000 — 002.001 — 9
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is
213 °C to 217 °C
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/kgMercury Not more than 1 mg/kg
Heavy 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 °CB. 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 °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/kgMercury Not more than 1 mg/kg
Heavy 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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 10
Einecs 252-488-1
Chemical formula C10H11O3Na
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 acidifica-
tion and not recrystallized: 94 °C to 97 °C,after vacuum drying in a sulphuric acid
desiccator
B. Positive test for sodiumC. 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/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 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 °CB. 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 °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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 11
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 219 SODIUM METHYL p-HYDROXYBENZOATE
Definition
Chemical name Sodium methyl p-hydroxybenzoate
Sodium compound of the methylester of p-hydroxybenzoic acid
Chemical formula C8H7O3Na
Molecular weight 174,15
Assay Content not less than 99,5 % on the anhydrous basis
Description White, hygroscopic powder
Identification
A. The white precipitate formed by acidifying
with hydrochloric acid a 10 % (w/v) aqueoussolution of the sodium derivative of methylp-hydroxybenzoate (using litmus paper as
indicator) shall, when washed with water
and dried at 80 °C for two hours, have amelting range 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 morethan 10,3
Purity
Water content Not more than 5 % (Karl Fischer method)
Sulphated ash 40 % to 44,5 % on the anhydrous basisp-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 220 SULPHUR DIOXIDEDefinition
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 %!B1996L0077 — EN — 19.11.2000 — 002.001 — 12
Non-volatile residue Not more than 0,01 %
Sulphur trioxide Not more than 0,1 %
Selenium Not more than 10 mg/kg
Other gases not normally present in the air No traceArsenic 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 221 SODIUM SULPHITEDefinition
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 sodium
B. pH of a 10 % solution (anhydrous) or a 20 %
solution (heptahydrate) between 8,5 and11,5
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!B1996L0077 — EN — 19.11.2000 — 002.001 — 13
Assay Content not less than 32 % w/w NaHSO 3
Description A clear, colourless to yellow solution
Identification
A. Positive tests for sulphite and for sodiumB. 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/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 223 SODIUM METABISULPHITE
Synonyms 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 sodium
B. 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/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 224 POTASSIUM METABISULPHITE
Synonyms Potassium pyrosulphite
Definition
Chemical name Potassium disulphite
Potassium pentaoxo disulphate!
B1996L0077 — EN — 19.11.2000 — 002.001 — 14
Einecs 240-795-3
Chemical formula K2S2O5
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/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 226 CALCIUM SULPHITE
Definition
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/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 227 CALCIUM BISULPHITEDefinition
Chemical name Calcium bisulphite
Calcium hydrogen sulphite
Einecs 237-423-7
Chemical formula Ca(HSO
3)2!B1996L0077 — EN — 19.11.2000 — 002.001 — 15
Molecular weight 202,22
Assay 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium
dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite
[Ca(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/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 228 POTASSIUM BISULPHITEDefinition
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/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 230 BIPHENYLSynonyms Diphenyl
Definition
Chemical name 1,1’-biphenyl
Phenylbenzene
Einecs 202-163-5
Chemical formula C
12H10
Molecular weight 154,20!B1996L0077 — EN — 19.11.2000 — 002.001 — 16
Assay Content not less than 99,8 %
Description White or pale yellow to amber crystalline solid having a characteristic
odour
Identification
A. Melting range 68,5 °C to 70,5 °C
B. 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 Absent
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 231 ORTHOPHENYLPHENOLSynonyms Orthoxenol
Definition
Chemical name (1,1’-Biphenyl)-2-ol
2-Hydroxydiphenyl
o-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 °C
B. Positive test for phenolate An ethanolic solution (1 g in 10 ml) produces a green colour on addition
of 10 % ferric chloride solution
Purity
Sulphated ash Not more than 0,05 %
Diphenyl ether Not more than 0,3 %
p-Phenylphenol Not more than 0,1 %
1-Naphthol Not more than 0,01 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg!
B1996L0077 — EN — 19.11.2000 — 002.001 — 17
Heavy metals (as Pb) Not more than 10 mg/kg
E 232 SODIUM ORTHOPHENYLPHENOLSynonyms Sodium orthophenylphenate
Sodium salt of o-phenylphenol
Definition
Chemical name Sodium orthophenylphenol
Einecs 205-055-6
Chemical formula C
12H9ONa.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 sodium
B. Melting range of orthophenylphenol isolated
by acidification and not recrystallized de-rived from the sample 56 °C to 58 °C afterdrying 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/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 233 THIABENDAZOLEDefinition
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!B1996L0077 — EN — 19.11.2000 — 002.001 — 18
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
Purity
Water content Not more than 0,5 % (Karl Fischer method)
Sulphated ash Not more than 0,2 %Selenium Not more than 3 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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/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 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 — 19.11.2000 — 002.001 — 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!B1996L0077 — EN — 19.11.2000 — 002.001 — 20
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 242 DIMETHYL DICARBONATE
Synonyms DMDC
Dimethyl pyrocarbonate
Definition
Einecs 224-859-8
Chemical name Dimethyl dicarbonate
Pyrocarbonic acid dimethyl ester
Chemical formula C4H6O5
Molecular weight 134,09
Assay Content not less than 99,8 %
Description Colourless liquid, decomposes in aqueous solution. It is corrosive to skin
and eyes and toxic by inhalation and ingestion
Identification
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/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
E 249 POTASSIUM NITRITE
Definition
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 potassiumB. pH of a 5 % solution: not less than 6,0 and
not more than 9,0!
B1996L0077 — EN — 19.11.2000 — 002.001 — 21
Purity
Loss on drying Not more than 3 % after drying for four hours over silica gel
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 250 SODIUM NITRITE
Definition
Chemical name Sodium nitrite
Einecs 231-555-9
Chemical formula 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 hours
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 251 SODIUM NITRATE
Synonyms 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 sodiumB. 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!B1996L0077 — EN — 19.11.2000 — 002.001 — 22
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 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/kg
Heavy 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 1,049C. A one in three solution gives positive tests
for acetate
D. Solidification point Not lower than 14,5 °C!
B1996L0077 — EN — 19.11.2000 — 002.001 — 23
Purity
Non-volatile residue Not more than 100 mg/kg
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 colour
does not change to brown within 30 minutes
Arsenic Not more than 1 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 261 POTASSIUM ACETATE
Definition
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 9,0B. Positive tests for acetate and for potassium
Purity
Loss on drying Not more than 8 % after drying at 150 °C for two hoursFormic 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 262 (i) SODIUM ACETATE
Definition
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!B1996L0077 — EN — 19.11.2000 — 002.001 — 24
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
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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 25
Chemical formula Anhydrous: C 4H6O4Ca
Monohydrate: C 4H6O4Ca.H2O
Molecular weight Anhydrous: 158,17
Monohydrate: 176,18
Assay Content not less than 98 % on the anhydrous basis
Description Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline
solid with a slightly bitter taste. A slight odour of acetic acid may bepresent. 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 acid
1-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
Note:
Lactic acid is hygroscopic and when concentratedby boiling, it condenses to form lactic acidlactate, which on dilution and heating hydrolyzesto lactic acid
Identification
A. Positive test for lactate
Purity
Sulphated ash Not more than 0,1 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,25 %Iron Not more than 10 mg/kg!
B1996L0077 — EN — 19.11.2000 — 002.001 — 26
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/kgNote:
This specification refers to a 80 % aqueous
solution; for weaker aqueous solutions, calculatevalues corresponding to their lactic acid content
E 280 PROPIONIC ACID
Definition
Chemical name Propionic acid
Propanoic acid
Einecs 201-176-3
Chemical formula C
3H6O2
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 °C!
B1996L0077 — EN — 19.11.2000 — 002.001 — 27
Water insolubles Not more than 0,1 %
Iron Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 282 CALCIUM PROPIONATE
Definition
Chemical name Calcium propionate
Einecs 223-795-8
Chemical formula C
6H10O4Ca
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 °C
Water insolubles Not more than 0,3 %Iron Not more than 50 mg/kg
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/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 potas-
sium!B1996L0077 — EN — 19.11.2000 — 002.001 — 28
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/kgFluoride 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
E 284 BORIC ACID
Synonyms 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/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 285 SODIUM TETRABORATE (BORAX)Synonyms Sodium borate
Definition
Chemical name Sodium tetraborate
Sodium biborateSodium pyroborate
Anhydrous tetraborate
Einecs 215-540-4
Chemical formula Na
2B4O7
Na2B4O7.10H2O
Molecular weight 201,27!B1996L0077 — EN — 19.11.2000 — 002.001 — 29
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/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 290 CARBON DIOXIDE
Synonyms Carbonic acid gas
Dry ice (solid form)Carbonic anhydride
Definition
Chemical name Carbon dioxide
Einecs 204-696-9
Chemical formula 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 compressed
solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added
substances, such as propylene glycol or mineral oil, as binders
Identification
A. Precipitation
(Precipitate formation)When a stream of the sample is passed through a solution of barium
hydroxide, a white precipitate is produced which dissolves with
effervescence in dilute acetic acid
Purity
Acidity 915 ml of gas bubbled through 50 ml of freshly boiled water must not
render the latter more acid to methylorange than is 50 ml freshly boiled
water to which has been added 1 ml of hydrochloric acid (0,01 N)
Reducing substances, hydrogen phosphide and
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 ACID
Definition
Chemical name L-ascorbic acid
Ascorbic acid
2,3-Didehydro-L-threo-hexono-1,4-lactone
3-Keto-L-gulofuranolactone
Einecs 200-066-2
Chemical formula C
6H8O6!B1996L0077 — EN — 19.11.2000 — 002.001 — 30
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 decomposition
B. Positive tests for ascorbic acid
Purity
Loss on drying Not more than 0,4 % after drying in a vacuum desiccator over sulphuric
acid for 24 hours
Sulphated ash Not more than 0,1 %Specific rotation 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/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 301 SODIUM ASCORBATE
Definition
Chemical name Sodium ascorbate
Sodium L-ascorbate
2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate
3-Keto-L-gulofurano-lactone sodium enolate
Einecs 205-126-1
Chemical formula 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/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 — 19.11.2000 — 002.001 — 31
E 302 CALCIUM ASCORBATE
Definition
Chemical name Calcium ascorbate dihydrate
Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Einecs 227-261-5
Chemical formula C12H14O12Ca.2H2O
Molecular weight 426,35
Assay Content not less than 98 % on a volatile matter-free basis
Description White to slightly pale greyish-yellow odourless crystalline powder
Identification
A. Positive tests for ascorbate and for calcium
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Specific rotation 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/C138
20
Dbetween + 21 ° and + 24 ° (5 % w/v in methanol solution)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg!B1996L0077 — EN — 19.11.2000 — 002.001 — 32
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 304 (ii) ASCORBYL STEARATEDefinition
Chemical name Ascorbyl stearate
L-ascorbyl stearate2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate6-stearoyl-3-keto-L-gulofuranolactone
Einecs 246-944-9
Chemical formula C
24H42O7
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/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 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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 33
E 307 ALPHA-TOCOPHEROL
Synonyms dl-α-Tocopherol
Definition
Chemical name dl-5,7,8-Trimethyltocol
dl-2,5,7,8-tetramethyl-2-(4 ’,8’,12’-trimethyltridecyl)-6-chromanol
Einecs 200-412-2
Chemical formula C29H50O2
Molecular weight 430,71
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 etherB. Spectrophotometry In absolute ethanol the maximum absorption is about 292 nm
Purity
Refractive index n
20
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-TOCOPHEROLSynonyms 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 %!B1996L0077 — EN — 19.11.2000 — 002.001 — 34
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 309 DELTA-TOCOPHEROLDefinition
Chemical name 2,8-dimethyl-2-(4 ’,8’,12’-trimethyltridecyl)-6-chromanol
Einecs 204-299-0
Chemical formula C
27H46O2
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/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 310 PROPYL GALLATE
Definition
Chemical name Propyl gallate
Propyl ester of gallic acid
n-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs 204-498-2
Chemical formula 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 %!B1996L0077 — EN — 19.11.2000 — 002.001 — 35
Free acid Not more than 0,5 % (as gallic acid)
Chlorinated organic compound Not more than 100 mg/kg (as C1)
Specific absorption E1%
1c min ethanol E1%
1c m(275 nm) not less than 485 and not more than 520
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 311 OCTYL GALLATEDefinition
Chemical name Octyl gallate
Octyl ester of gallic acid
n-octyl ester of 3,4,5-trihydroxybenzoic acid
Einecs 213-853-0
Chemical formula C
15H22O5
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!B1996L0077 — EN — 19.11.2000 — 002.001 — 36
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 %Free acid Not more than 0,5 % (as gallic acid)
Chlorinated organic compound Not more than 100 mg/kg (as Cl)
Specific absorption E
1%
1c min ethanol E1%
1c m(275 nm) not less than 300 and not more than 325
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kgHeavy 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 acidD-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 reac-
tion
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 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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 37
E 316 SODIUM ERYTHORBATE
Synonyms Sodium isoascorbate
Definition
Chemical name Sodium isoascorbate
Sodium D-isoascorbic acidSodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone
3-keto-D-gulofurano-lactone sodium enolate monohydrate
Einecs 228-973-9
Chemical formula C
6H7O6Na.H2O
Molecular weight 216,13
Assay Content not less than 98 % after drying in a vacuum desiccator over
sulphuric acid for 24 hours expressed on the monohydrate basis
Description White crystalline solid
Identification
A. Solubility tests Freely soluble in water, very slightly soluble in ethanol
B. Positive test for ascorbic acid/colour reac-
tion
C. Positive test for sodium
Purity
Loss on drying Not more than 0,25 % after drying in a vacuum desiccator over sulphuric
acid for 24 hours
Specific rotation α½/C13825
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 remainclear
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 320 BUTYLATED HYDROXYANISOLE (BHA)Synonyms BHA
Definition
Chemical names 3-Tertiary-butyl-4-hydroxyanisole
A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-
hydroxyanisole
EINECS 246-563-8
Chemical formula
C
11H16O2
Formula weight 180,25
Assay Content not less than 98,5 % of C11H16O2and not less than 85 % of 3-
tertiary-butyl-4-hydroxyanisole isomer!B
!M21996L0077 — EN — 19.11.2000 — 002.001 — 38
Description White or slightly yellow crystals or waxy solid with a slight aromatic
smell
Identification
A. Solubility Insoluble in water, freely soluble in ethanolB. Melting range Between 48 .
oC and 63 .oC
C. Colour reaction Passes test for phenol groups
Purity
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 .oC
Phenolic impurities Not more than 0,5 %
Specific absorption E1%
1cm E1%1cm(290 nm) not less than 190 and not more than 210
Specific absorption E1%
1cm E1%1cm(228 nm) not less than 326 and not more than 345
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 321 BUTYLATED HYDROXYTOLUENE (BHT)Synonyms BHT
Definition
Chemical name 2,6-Ditertiary-butyl- p-cresol
4-Methyl-2,6-ditertiarybutylphenol
Einecs 204-881-4
Chemical formula C
15H24O
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 °C
C. Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in
100 000 solution in dehydrated ethanol exhibits a maximum only at 278nm
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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg!
M2
!B1996L0077 — EN — 19.11.2000 — 002.001 — 39
E 322 LECITHINS
Synonyms Phosphatides
Phospholipids
Definition Lecithins are mixtures or fractions of phosphatides obtained by physical
procedures from animal or vegetable foodstuffs; they also include
hydrolysed products obtained through the use of harmless andappropriate enzymes. The final product must not show any signs ofresidual enzyme activity
The lecithins may be slightly bleached in aqueous medium by means of
hydrogen peroxide. This oxidation must not chemically modify thelecithin phosphatides
Einecs 232-307-2
Assay — Lecithins: not less than 60,0 % of substances insoluble in acetone
— Hydrolysed lecithins: not less than 56,0 % of substances insoluble
in acetone
Description — Lecithins: brown liquid or viscous semi-liquid or powder
— Hydrolysed lecithins: light brown to brown viscous liquid or paste
Identification
A. Positive tests for choline, for phosphorus
and fatty acids
B. Test for hydrolysed lecithin To a 800 ml beaker add 500 ml of water (30 °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 hour
Toluene-insoluble matter Not more than 0,3 %Acid value — Lecithins: not more than 35 mg of potassium hydroxide per gram
— Hydrolysed lecithins: not more than 45 mg of potassium hydroxide
per gram
Peroxide value Equal to or less than 10
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 325 SODIUM LACTATE
Definition
Chemical name Sodium lactate
Sodium 2-hydroxypropanoate
Einecs 200-772-0
Chemical formula 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!B1996L0077 — EN — 19.11.2000 — 002.001 — 40
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/kg
Reducing substances No reduction of Fehling’ s solution
Note:
This specification refers to a 60 % aqueoussolution
E 326 POTASSIUM LACTATEDefinition
Cheminal name Potassium lactate
Potassium 2-hydroxypropanoate
Einecs 213-631-3
Chemical formula C
3H5O3K
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 zoneof contact
C. Positive tests for potassium and for lactate
Purity
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/kgAcidity Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops
of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not
more than 0,2 ml should be required
Reducing substances Potassium lactate solution shall not cause any reduction of Fehling’ s
solution
Note:
This specification refers to a 60 % aqueous
solution!
B1996L0077 — EN — 19.11.2000 — 002.001 — 41
E 327 CALCIUM LACTATE
Definition
Chemical name Calcium dilactate
Calcium dilactate hydrate
2-Hydroxypropanoic acid calcium salt
Einecs 212-406-7
Chemical formula (C3H5O2)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
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!B1996L0077 — EN — 19.11.2000 — 002.001 — 42
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/kgOxalates 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)
E 331 (i) MONOSODIUM CITRATESynonyms 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 drying
pH of a 1 % aqueous solution Between 3,5 and 3,8
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 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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 43
Chemical formula C6H6O7Na2.1,5H2O
Molecular weight 263,11
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A. Positive tests for citrate and for sodium
Purity
Loss on drying Not more than 13,0 % by drying at 180 °C for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 4,9 and 5,2Arsenic 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
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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 44
Heavy metals (as Pb) Not more than 5 mg/kg
E 332 (i) MONOPOTASSIUM CITRATESynonyms Monopotassium citrate
Monobasic potassium citrate
Definition
Chemical name Monopotassium citrate
Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidAnhydrous monopotassium salt of citric acid
Einecs 212-753-4
Chemical formula C
6H7O7K
Molecular weight 230,21
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent crystals
Identification
A. Positive tests for citrate and for potassium
Purity
Loss on drying Not more than 1,0 % determined by drying at 180 °C for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 3,5 and 3,8Arsenic 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
E 332 (ii) TRIPOTASSIUM CITRATESynonyms Tripotassium citrate
Tribasic potassium citrate
Definition
Chemical name Tripotassium citrate
Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidMonohydrated 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 hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 5 % aqueous solution Between 7,5 and 9,0!
B1996L0077 — EN — 19.11.2000 — 002.001 — 45
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E 333 (i) MONOCALCIUM CITRATESynonyms Monocalcium citrate
Monobasic calcium citrate
Definition
Chemical name Monocalcium citrate
Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidMonohydrate monocalcium salt of citric acid
Chemical formula (C
6H7O7)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 hoursOxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 3,2 and 3,5
Fluoride Not more than 30 mg/kg (expressed as fluorine)Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not
liberate more than a few isolated bubbles
E 333 (ii) DICALCIUM CITRATE
Synonyms Dicalcium citrate
Dibasic calcium citrate
Definition
Chemical name Dicalcium citrate
Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Trihydrated dicalcium salt of citric acid
Chemical formula (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!B1996L0077 — EN — 19.11.2000 — 002.001 — 46
Purity
Loss on drying Not more than 20,0 % determined by drying at 180 °C for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
Fluoride Not more than 30 mg/kg (expressed as fluorine)Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not
liberate more than a few isolated bubbles
E 333 (iii) TRICALCIUM CITRATE
Synonyms Tricalcium citrate
Tribasic calcium citrate
Definition
Chemical name Tricalcium citrate
Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Tetrahydrated tricalcium salt of citric acid
Einecs 212-391-7
Chemical formula (C
6H6O7)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!B1996L0077 — EN — 19.11.2000 — 002.001 — 47
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 °
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!B1996L0077 — EN — 19.11.2000 — 002.001 — 48
Assay Content not less than 99 % on the anhydrous basis
Description Transparent, colourless crystals
Identification
A. Positive tests for tartrate and for sodiumB. 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 hoursOxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 7,0 and 7,5
Arsenic Not more than 3 mg/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 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 potassium
B. Melting point 230 °C
Purity
pH of a 1 % aqueous solution 3,4
Loss on drying Not more than 1,0 % determined by drying at 105 °C for four hoursOxalates 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/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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 49
Chemical formula C4H4O6K2.1⁄2H2O
Molecular weight 235,2
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline or granulated powder
Identification
A. Positive tests for tartrate and for potassium
Purity
pH of a 1 % aqueous solution Between 7,0 and 9,0
Loss on drying Not more than 4,0 % determined by drying at 150 °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 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 drying
pH of 1 % aqueous solution Between 6,5 and 8,5Arsenic 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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 50
E 338 PHOSPHORIC ACID
Synonyms Orthophosphoric acid
Monophosphoric acid
Definition
Chemical name Phosphoric acid
Einecs 231-633-2
Chemical formula H3PO4
Molecular weight 98,00
Assay Content not less than 71 % and not more than 83 %
Description Clear, colourless, viscous liquid
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/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgNote:
This specification refers to a 75 % aqueous
solution
E 339 (i) MONOSODIUM PHOSPHATE
Synonyms Monosodium monophosphate
Acid monosodium monophosphateMonosodium 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: 138,00Dihydrate: 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!B1996L0077 — EN — 19.11.2000 — 002.001 — 51
Identification
A. Positive tests for sodium and for phosphate
B. 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 at60 °C for one hour, then 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 4,1 and 5,0Arsenic 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
E 339 (ii) DISODIUM PHOSPHATESynonyms Disodium monophosphate
Secondary sodium phosphate
Disodium orthophosphate
Acid disodium phosphate
Definition
Chemical name Disodium hydrogen monophosphate
Disodium hydrogen orthophosphate
Einecs 231-448-7
Chemical formula Anhydrous: 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: a
white crystalline, odourless solid; the heptahydrate: white, odourless,efflorescent crystals or granular powder; and the dodecahydrate: white,efflorescent, odourless powder or crystals
Identification
A. Positive tests for sodium and for phosphate
B. Solubility tests Freely soluble in water. Insoluble in ethanolC. 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 9,6!
B1996L0077 — EN — 19.11.2000 — 002.001 — 52
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 339 (iii) TRISODIUM PHOSPHATESynonyms Sodium phosphate
Tribasic sodium phosphate
Trisodium orthophosphate
Definition
Chemical name Trisodium monophosphate
Trisodium phosphate
Trisodium orthophosphate
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 ethanolC. 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 12,5
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 340 (i) MONOPOTASSIUM PHOSPHATE
Synonyms Monobasic potassium phosphate
Monopotassium monophosphatePotassium acid phosphate
Potassium orthophosphate!
B1996L0077 — EN — 19.11.2000 — 002.001 — 53
Definition
Chemical name Potassium dihydrogen phosphate
Monopotassium dihydrogen orthophosphateMonopotassium 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 phos-
phate
B. Solubility tests Freely soluble in water. Insoluble in ethanol
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 orthophosphate
Dibasic 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 phos-
phate
B. Solubility tests Freely soluble in water. Insoluble in ethanol
C. P 2O5content Between 40,3 % and 41,5 %!B1996L0077 — EN — 19.11.2000 — 002.001 — 54
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 9,4
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 340 (iii) TRIPOTASSIUM PHOSPHATE
Synonyms Potassium phosphate
Tribasic potassium phosphateTripotassium orthophosphate
Definition
Chemical name Tripotassium monophosphate
Tripotassium phosphateTripotassium 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 phos-
phate
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!
B1996L0077 — EN — 19.11.2000 — 002.001 — 55
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
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/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 341 (ii) DICALCIUM PHOSPHATE
Synonyms Dibasic calcium phosphate
Dicalcium orthophosphate
Definition
Chemical name Calcium monohydrogen phosphate
Calcium hydrogen orthophosphate
Secondary calcium phosphate
Einecs 231-826-1
Chemical formula Anhydrous: 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!B1996L0077 — EN — 19.11.2000 — 002.001 — 56
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/kg
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 341 (iii) TRICALCIUM PHOSPHATE
Synonyms 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 phosphateB. 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/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 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!B1996L0077 — EN — 19.11.2000 — 002.001 — 57
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 positiveC. pH of a 1 % solution between 6,5 and 7,5
Purity
Water content 5 to 13 % (Karl Fischer method)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury 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 ACID
Definition Linear glycuronoglycan consisting mainly of /betatwo-(1-4) linked D-
mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring
form. Hydrophilic colloidal carbohydrate extracted by the use of dilute
alkali from natural strains of various species of brown seaweeds
(Phaeophyceae )
Einecs 232-680-1
Chemical formula (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 distinguishes
alginic acid from acacia gum, sodium carboxymethyl cellulose,
carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum,locust bean gum, methyl cellulose and tragacanth gum
C. Ammonium sulphate precipitation test To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add
one half of its volume of a saturated solution of ammonium sulphate. 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 finally
becomes deep purple
Purity
pH of a 3 % suspension Between 2,0 and 3,5!
B
!M11996L0077 — EN — 19.11.2000 — 002.001 — 58
Loss on drying Not more than 15 % (105 °C, 4 hours)
Sulphated ash Not more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution) 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/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 401 SODIUM ALGINATE
Definition
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 basisof 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 basisArsenic 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 ALGINATE
Definition
Chemical name Potassium salt of alginic acid
Chemical formula (C
6H7KO 6)n!M11996L0077 — EN — 19.11.2000 — 002.001 — 59
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
Purity
Loss on drying Not more than 15 % (105 °C, 4 hours)
Water-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 (as Pb) 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 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 morethan 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 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 Not more than 20 mg/kgTotal plate count Not more than 5 000 colonies per gram!
M11996L0077 — EN — 19.11.2000 — 002.001 — 60
Y 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 ALGINATE
Synonyms Calcium salt of alginate
Definition
Chemical name Calcium salt of alginic acid
Chemical formula (C6H7Ca1/2O6)n
Molecular weight 10 000-600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and not more than 21
% carbon dioxide corresponding to not less than 89,6 % and not morethan 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/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 gramY 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 ALGINATE
Synonyms Hydroxypropyl alginate
1,2-propanediol ester of alginic acidPropylene 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!M11996L0077 — EN — 19.11.2000 — 002.001 — 61
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 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 (as Pb) 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 406 AGARSynonyms Gelose
Japan agar
Bengal, Ceylon, Chinese or Japanese isinglassLayor Carang
Definition
Chemical name Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-
galactose units. On about every tenth D-galactopyranose unit one of the
hydroxyl groups is esterified with sulphuric acid which is neutralised bycalcium, magnesium, potassium or sodium. It is extracted from certainnatural 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 when
damp, brittle when dry. Powdered agar is white to yellowish-white orpale yellow. When examined in water under a microscope, the agarappears 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 transparent
than in water, more or less granular, striated, angular and occasionally
contains frustules of diatoms. Gel strength may be standardised by theaddition 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 °C!
M11996L0077 — EN — 19.11.2000 — 002.001 — 62
Acid-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
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.sLoss 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)!M11996L0077 — EN — 19.11.2000 — 002.001 — 63
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/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 gramY 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 WEEDSynonyms 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 the
product. Further purification may be achieved by washing withmethanol, ethanol or propane-2-ol and drying. The product consistschiefly of the potassium salts of polysaccharide sulphate esters which, onhydrolysis, 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 hydrolysed
or 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.sLoss 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/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 — 19.11.2000 — 002.001 — 64
Y east and mould Not more than 300 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 410 LOCUST BEAN GUM
Synonyms Carob bean gum
Algaroba gum
Definition Locust bean gum is the ground endosperm of the seeds of the natural
strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae ).
Consists mainly of a high molecular weight hydrocolloidal polysacchar-ide, composed of galactopyranose and mannopyranose units combinedthrough glycosidic linkages, which may be described chemically asgalactomannan
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 mannoseB. Microscopic examination Place some ground sample in an aqueous solution containing 0,5 %
iodine and 1 % potassium iodide on a glass slide and examine under
microscope. Locust bean gum contains long stretched tubiform cells,separated or slightly interspaced. Their brown contents are much lessregularly 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 °C
Protein (N × 6,25) Not more than 7 %
Acid-insoluble matter Not more than 4 %Starch Not detectable by the following method: to a 1 in 10 solution of the
sample add a few drops of iodine solution. No blue colour is produced
Arsenic Not more than 3 mg/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 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 polysacchar-
ide composed of galactopyranose and mannopyranose units combined
through glycosidic linkages, which may be described chemically asgalactomannan!
M11996L0077 — EN — 19.11.2000 — 002.001 — 65
Einecs 232-536-0
Molecular weight 50 000—8 000 000
Assay Galactomannan content not less than 75 %
Description A white to yellowish-white, nearly odourless powder
Identification
A. Positive tests for galactose and for mannose
B. Solubility Soluble in cold water
Purity
Loss on drying Not more than 15 % (105 °C, 5 hours)
Ash Not more than 1,5 % determined at 800 °CAcid-insoluble matter Not more than 7 %
Protein (N × 6,25) Not more than 10 %
Starch Not detectable by the following method: to a 1 in 10 solution of the
sample add a few drops of iodine solution. (No blue colour is produced)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 413 TRAGACANTH
Synonyms Tragacanth gum
Tragant
Definition Tragacanth is a dried exudation obtained from the stems and branches of
natural strains of Astragalus gummifer Labillardiere and other Asiatic
species of Astragalus (family Leguminosae ). It consists mainly of high
molecular weight polysaccharides (galactoarabans and acidic 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 pieces
may have a red tinge. The pieces are horny in texture, with a short
fracture. It is odourless and solutions have an insipid mucilaginous taste.Powdered tragacanth is white to pale yellow or pinkish brown (pale tan)in colour
Identification
A. Solubility 1 g of the sample in 50 ml of water swells to form a smooth, stiff,
opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol
Purity
Negative test for Karaya gum Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of
hydrochloric acid and again boil the mixture for five minutes. Nopermanent pink or red colour develops
Loss on drying Not more than 16 % (105 °C, 5 hours)
Total ash Not more than 4 %!
M11996L0077 — EN — 19.11.2000 — 002.001 — 66
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/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kgSalmonella spp. Negative in 10 g
E. coli Negative in 5 g
E 414 ACACIA GUM
Synonyms Gum arabic
Definition Acacia gum is a dried exudation obtained from the stems and branches
of natural strains of Acacia senegal (L) Willdenow or closely related
species of Acacia (family Leguminosae ). It consists mainly of high
molecular weight polysaccharides and their calcium, magnesium 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 mixed
with darker fragments. It is also available in the form of white to
yellowish-white flakes, granules, powder or spray-dried material.
Identification
A. Solubility 1 g dissolves in 2 ml of cold water forming a solution which flows
readily and is acid to litmus, insoluble in ethanol
Purity
Loss on drying Not more than 17 % (105 °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/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kgHydrolysis products Mannose, xylose and galacturonic acid are absent (determined by
chromatography)
Salmonella spp. Negative in 10 g
E. coli Negative in 5 g!
M11996L0077 — EN — 19.11.2000 — 002.001 — 67
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
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/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 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 karayaKulloKuterra
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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 68
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. Powdered
karaya gum is a pale grey to pinkish brown. The gum has a distinctive
odour of acetic acid
Identification
A. Solubility Insoluble in ethanol
B. Swelling in ethanol solution Karaya gum swells in 60 % ethanol distinguishing it from other gums
Purity
Loss on drying Not more than 20 % (105 °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/kgHeavy 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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 69
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 418 GELLAN GUM
Definition Gellan gum is a high molecular weight polysaccharide gum produced by
a pure culture fermentation of a carbohydrate by natural strains of
Pseudomonas elodea , purified by recovery with isopropyl alcohol, dried,
and milled. The high molecular weight polysaccharide is 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 glucuronicacid 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 YCEROLSynonyms Glycerin
Glycerine
Definition
Chemical names 1,2,3-propanetriol
GlycerolTrihydroxypropane
Einecs 200-289-5
Chemical formula C
3H8O3
Molecular weight 92,10
Assay Content not less than 98 % of glycerol on the anhydrous basis!M11996L0077 — EN — 19.11.2000 — 002.001 — 70
Description Clear, colourless hygroscopic syrupy liquid with not more than a slight
characteristic odour, which is neither harsh nor disagreeable
Identification
A. Acrolein formation on heating Heat a few drops of the sample in a test tube with about 0,5 g of
potassium bisulphate. The characteristic pungent vapours of acrolein areevolved
B. Specific gravity (25/25 °C) Not less than 1,257
C. 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 yellow
nor emits an odour of ammonia
Fatty acids and esters Not more than 0,1 % calculated as butyric acidChlorinated compounds Not more than 30 mg/kg (as chlorine)
Arsenic Not more than 3 mg/kg
Lead 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 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 ofabout 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 °C
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 1
Saponification value Not less than 25 and not more than 35Hydroxyl value Not less than 27 and not more than 40
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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 71
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 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 the
anhydrous 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 2
Saponification value Not less than 40 and not more than 50Hydroxyl value Not less than 96 and not more than 108
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 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 the
anhydrous basis
Description A lemon to amber-coloured oily liquid at 25 °C with a faint
characteristic odour!
M11996L0077 — EN — 19.11.2000 — 002.001 — 72
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and toluene.
Insoluble in mineral oil and petroleum ether
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2
Saponification value Not less than 45 and not more than 55
Hydroxyl value Not less than 65 and not more than 801,4-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/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 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 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, ethanol, methanol, ethyl acetate and acetone.
Insoluble in mineral oil
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 41 and not more than 52Hydroxyl value Not less than 90 and not more than 1071,4-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/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg!
M11996L0077 — EN — 19.11.2000 — 002.001 — 73
Heavy metals (as Pb) Not more than 10 mg/kg
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 approximately20 moles of ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 65 % of oxyethylene groups, equivalent to not less
than 97 % of polyoxyethylene (20) sorbitan monostearate on the
anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at 25 °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 2
Saponification value Not less than 45 and not more than 55
Hydroxyl value Not less than 81 and not more than 961,4-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
Cadmium Not more than 1 mg/kgHeavy 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 anhydrousbasis
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 polyol
C. Congealing range 29-33 °C!
M11996L0077 — EN — 19.11.2000 — 002.001 — 74
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 88 and not more than 98Hydroxyl value Not less than 40 and not more than 60
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 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. Noorganic precipitant shall be used other than methanol, ethanol andpropane-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 basis
Nitrogen content Not more than 1,0 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol Not more than 1 %, singly or in combination, on the anhydrous 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 (as Pb) Not more than 20 mg/kg!
M11996L0077 — EN — 19.11.2000 — 002.001 — 75
E 440 (ii) AMIDATED PECTIN
Definition Amidated pectin consists mainly of the partial methyl esters and amides
of polygalacturonic acid and their ammonium, sodium, potassium and
calcium salts. It is obtained by extraction in an aqueous medium 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 andpropane-2-ol
Assay Content not less than 65 % of galacturonic acid on the ash-free and
anhydrous basis after washing with acid and alcohol
Description White, light yellow, light greyish or light brownish powder
Identification
A. Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in
ethanol
Purity
Loss on drying Not more than 12 % (105 °C, 2 hours)
Acid-insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)Degree of amidation Not more than 25 % of total carboxyl groups
Sulphur dioxide residue Not more than 50 mg/kg on the anhydrous basis
Nitrogen content Not more than 2,5 % after washing with acid and ethanolFree methanol, ethanol and propane-2-ol Not more than 1 % single or in combination, on a volatile matter-free
basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/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 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 ortwo or three glyceride moieties may be attached to phosphorus.Moreover, two phosphorus esters may be linked together as phosphatidyl
phosphatides
Assay The phosphorus content is not less than 3 % and not more than 3,4 % by
weight; the ammonium content is not less than 1,2 % and not more than1,5 % (calculated as N)
Description Unctuous semi-solid
Identification
A. Solubility Soluble in fats. Insoluble in water. Partially soluble in ethanol and in
acetone
B. Positive tests for glycerol, for fatty acid and
for phosphate
Purity
Petroleum ether insoluble matter Not more than 2,5 %
Arsenic Not more than 3 mg/kg!
M11996L0077 — EN — 19.11.2000 — 002.001 — 76
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 444 SUCROSE ACETATE ISOBUTYRATESynonyms 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 to
butyrate 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 solvents
B. Refractive index n½/C13840
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 0,2Saponification value Not less than 524 and not more than 540
Arsenic Not more than 3 mg/kg
Mercury Not more than 1 mg/kgCadmium 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 stumpsfollowed 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 of
approximately 90 % resin acids and 10 % neutrals (non-acidic
compounds). The resin acid fraction is a complex mixture of isomericditerpenoid 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!M11996L0077 — EN — 19.11.2000 — 002.001 — 77
Identification
A. Solubility Insoluble in water, soluble in acetone
B. Infrared absorption spectrum Characteristic of the compound
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 9Hydroxyl value Not less than 15 and not more than 45
Arsenic Not more than 3 mg/kg
Lead 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 DIPHOSPHATE
Synonyms Disodium dihydrogen diphosphate
Disodium dihydrogen pyrophosphateSodium acid pyrophosphate
Definition
Chemical name Disodium dihydrogen diphosphate
Einecs
231-835-0
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 5,0Loss 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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 78
Heavy metals (as Pb) Not more than 20 mg/kg
E 450 (ii) TRISODIUM DIPHOSPHATESynonyms 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/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 (iii) TETRASODIUM DIPHOSPHATESynonyms Tetrasodium pyrophosphate
Sodium pyrophosphate
Definition
Chemical name Tetrasodium diphosphate
Einecs
231-767-1Chemical 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 — 19.11.2000 — 002.001 — 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 phos-
phate
B. Solubility Soluble in water, insoluble in ethanol
Purity
pH of a 1 % solution Between 10,0 and 10,8
Loss 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/kg
Cadmium Not more than 1 mg/kg!
M11996L0077 — EN — 19.11.2000 — 002.001 — 80
Heavy metals (as Pb) Not more than 20 mg/kg
E 450 (vi) DICALCIUM DIPHOSPHATESynonyms Calcium pyrophosphate
Definition
Chemical name Dicalcium diphosphate
Dicalcium pyrophosphate
Einecs 232-221-5
Chemical formula Ca
2P2O7
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 phosphate
B. Solubility Insoluble in water. Soluble in dilute hydrochloric and nitric acids
Purity
pH of a 10 % suspension in water Between 5,5 and 7,0
Loss on ignition Not more than 1,5 % at 800 ± 25 °C for 30 minutes
Fluoride Not more than 50 mg/kg expressed as fluorineArsenic 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 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE
Synonyms 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!M11996L0077 — EN — 19.11.2000 — 002.001 — 81
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
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/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 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!M11996L0077 — EN — 19.11.2000 — 002.001 — 82
Molecular weight 448,42
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 waterB. Positive tests for potassium and for phos-
phate
C. 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/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 (i) SODIUM POL YPHOSPHATE1. SOLUBLE POL YPHOSPHATE
Synonyms Sodium hexametaphosphate
Sodium tetrapolyphosphate
Graham’ s salt
Sodium polyphosphates, glassySodium polymetaphosphate
Sodium metaphosphate
Definition Soluble sodium polyphosphates are obtained by fusion and subsequent
chilling of sodium orthophosphates. These compounds are a classconsisting 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 molecularweight 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 polypho-
sphoric 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 water!M11996L0077 — EN — 19.11.2000 — 002.001 — 83
B. Positive tests for sodium and for phosphate
C. pH of a 1 % solution Between 3,0 and 9,0
Purity
Loss on ignition Not more than 1 %Water insoluble matter Not more than 0,1 %
Fluoride Not more than 10 mg/kg
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
2. INSOLUBLE POL YPHOSPHATE
Synonyms 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 phosphate
C. pH of a 1 in 3 suspension in water About 6,5
Purity
Fluoride Not more than 10 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 10 mg/kg
E 452 (ii) POTASSIUM POLYPHOSPHATESynonyms Potassium metaphosphate
Potassium polymetaphosphate
Kurrol salt!
M11996L0077 — EN — 19.11.2000 — 002.001 — 84
Definition
Chemical name Potassium polyphosphate
Einecs 232-212-6
Chemical formulae (KPO 3)n
Heterogenous mixtures of potassium 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 (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 phos-
phate
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 POLYPHOSPHATESSynonyms 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 %!
M11996L0077 — EN — 19.11.2000 — 002.001 — 85
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
Fluoride Not more than 30 mg/kg
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
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 in
phosphoric acid and heat for 30 minutes, A red colour is produced
C. To be identified by IR spectroscopyD. 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 %!
M11996L0077 — EN — 19.11.2000 — 002.001 — 86
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 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 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 1,0 %Sulphated ash Not more than 0,3 % 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 B, add a few
drops of iodine solution and mix. No purplish to blue or blue colourshould be produced
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
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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 87
Chemical name Methyl ether of cellulose
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 °CpH 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 463 HYDROXYPROPYL CELLULOSESynonyms 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 2-
CHOHCH 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!M11996L0077 — EN — 19.11.2000 — 002.001 — 88
B. Gas chromatography Determine the substituents by gas chromotography
Purity
Loss on drying Not more than 10 % (105 °C, 3 hours)
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °CpH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Propylene chlorohydrins Not more than 0,1 mg/kg
Arsenic Not more than 3 mg/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 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 8,0Propylene chlorohydrins Not more than 0,1 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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 89
Heavy metals (as Pb) Not more than 20 mg/kg
E 465 ETHYL METHYL CELLULOSESynonyms 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/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 466 SODIUM CARBOXY METHYL CELLULOSESynonyms Carboxy methyl cellulose
CMC
NaCMC
Sodium CMCCellulose gum
Definition Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl
ether of cellulose, the cellulose being obtained directly from natural
strains of fibrous plant material
Chemical name Sodium salt of the carboxymethyl ether of cellulose!
M11996L0077 — EN — 19.11.2000 — 002.001 — 90
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C6H7O2(OR 1)(OR 2)(OR 3), where R 1,R 2R3each may be one of the
following:
—H
—C H 2COONa
—C H 2COOH
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 ethanolB. Foam test A 0,1 % solution of the sample is shaken vigorously. No layer of foam
appears. (This test permits the distinction of sodium carboxymethyl
cellulose from other cellulose ethers)
C. Precipitate formation To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of
copper sulphate or of aluminium sulphate. A precipitate appears. (Thistest permits the distinction of sodium carboxymethyl cellulose fromother cellulose ethers and from gelatine, locust bean gum and
tragacanth)
D. Colour reaction Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water,
while stirring to produce an uniform dispersion. Continue the 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 so
that it forms a lower layer. A red-purple colour develops at the interface
Purity
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups (-
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 8,5Arsenic 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 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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 91
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
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 acidArsenic 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
Free alkali Not more than 0,1 % expressed as NaOHMatter 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 ether
B. Positive tests for magnesium and for fatty
acids
Purity
Magnesium Not less than 6,5 % and not more than 11 % expressed as MgO
Free alkali Not more than 0,1 % expressed as MgOUnsaponifiable 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/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 471 MONO- AND DIGL YCERIDES OF FATTY ACIDSSynonyms Glyceryl monostearate
Glyceryl monopalmitate
Glyceryl monooleate, etc.Monostearin, monopalmitin, monoolein, etc.GMS (for glyceryl monostearate)
Definition Mono- and diglycerides of fatty acids consist of mixtures of glycerol
mono-, di- and triesters of fatty acids occurring in food oils and fats.They may contain small amounts of free fatty acids and glycerol!
M11996L0077 — EN — 19.11.2000 — 002.001 — 92
Assay Content of mono- and diesters: not less than 70 %
Description The product varies from a pale yellow to pale brown oily liquid to a
white or slightly off-white hard waxy solid. The solids may be in the
form of flakes, powders or small beads
Identification
A. Infrared spectrum Characteristic of a partial fatty acid ester of a polyol
B. Positive tests for glycerol and for fatty acids
C. Solubility Insoluble in water, soluble in ethanol and toluene
Purity
Water content Not more than 2 % (Karl Fischer method)
Acid value Not more than 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/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg!
M11996L0077 — EN — 19.11.2000 — 002.001 — 93
Total acetic acid Not less than 9 % and not more than 32 %
Free fatty acids (and acetic acid) Not more than 3 % estimated as oleic acid
Total glycerol Not less than 14 % and not more than 31 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °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 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 fatty
acids, 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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 94
B. Solubility Insoluble in cold water
Dispersible in hot waterSoluble in oils and fats
Insoluble in cold ethanol
Purity
Acids other than citric and fatty acids Not detectableFree 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/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
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 d TARTARIC ACID ESTERS OF MONO- AND DIGL YCERIDES OF FATTY ACIDS
Synonyms Tartaric acid esters of mono- and diglycerides
Mono- and diglycerides of fatty acids esterified with tartaric acid
Definition Esters of glycerol with tartaric acid and fatty acids occurring in food fats
and oils. They may contain small amounts of free glycerol, free fatty
acids, free tartaric acid and free glycerides
Description Sticky viscous yellowish liquids to hard yellow waxes
Identification
A. Positive tests for glycerol, for fatty acids and
for tartaric acid
Purity
Acids other than tartaric and fatty acids Not detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 12 % and not more than 29 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Total tartaric acid Not less than 15 % and not more than 50 %
Free fatty acids Not more than 3 % estimated as oleic acidSulphated 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)!
M11996L0077 — EN — 19.11.2000 — 002.001 — 95
E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGL YCERIDES OF FATTY ACIDS
Synonyms Diacetyltartaric acid esters of mono- and diglycerides
Mono-and diglycerides of fatty acids esterified with mono- and
diacetyltartaric acid
Diacetyltartaric and fatty acid esters of glycerol
Definition Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained
from tartaric acid) and fatty acids occurring in food fats and oils. They
may contain small amounts of free glycerol, free fatty acids, free tartaricand acetic acids and their combinations, and free glycerides. Containsalso 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 detectableFree 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 °CArsenic 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 tartaric acid Not less than 10 % and not more than 40 %
Total acetic acid Not less than 8 % and not more than 32 %Free fatty acids Not more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND 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 of
fatty acids
Description Sticky liquids to solids, from white to pale-yellow in colour
Identification
A. Positive tests for glycerol, for fatty acids, for
tartaric acid and for acetic acid
Purity
Acids other than acetic, tartaric and fatty acids Not detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 12 % and not more than 27 %!
M11996L0077 — EN — 19.11.2000 — 002.001 — 96
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
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 10 mg/kg
Total acetic acid Not less than 10 % and not more than 20 %Total tartaric acid Not less than 20 % and not more than 40 %
Free fatty acids Not more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 473 SUCROSE ESTERS OF FATTY ACIDSSynonyms 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 andthe methyl and ethyl esters of food fatty acids or by extraction fromsucroglycerides. No organic solvent other than dimethylsulphoxide,dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol,
propylene glycol and methyl ethyl ketone may be used for their
preparation
Assay Content not less than 80 %
Description Stiff gels, soft solids or white to slightly greyish-white powders
Identification
A. Positive tests for sugar for fatty acidsB. Solubility Sparingly soluble in water
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25 °C
Free sugar Not more than 5 %Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 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/kgMethanol Not more than 10 mg/kgDimethylsulphoxide Not more than 2 mg/kg
Dimethylformamide Not more than 1 mg/kg
2-methyl-1-propanol Not more than 10 mg/kgEthyl acetate Not more than 350 mg/kg, singly or in combination
Propane-2-ol
Propylene glycolMethyl ethyl ketone Not more than 10 mg/kg!
M11996L0077 — EN — 19.11.2000 — 002.001 — 97
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
Definition Sucroglycerides are produced by reacting sucrose with an edible fat or
oil to produce a mixture of essentially mono-, di- and triesters of sucrose
and fatty acids together with residual mono-, di- and triglycerides from
fat or oil. No organic solvents shall be used in their preparation otherthan cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propa-nol 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 combination
Cyclohexane
Ethyl acetate Not more than 350 mg/kg, single or in combinationPropane-2-ol
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may
be present up to a maximum level of 6 % (expressed as sodium oleate)
E 475 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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 98
Identification
A. Positive tests for glycerol, for polyglycerols
and for fatty acids
B. Solubility The esters range from very hydrophilic to very lipophilic, but as a class
tend to be dispersible in water and soluble in organic solvents and oils
Purity
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
Acids other than fatty acids Not detectableFree fatty acids Not more than 6 % estimated as oleic acid
Total glycerol and polyglycerol Not less than 18 % and not more than 60 %
Free glycerol and polyglycerol Not more than 7 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy 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 POLYRICINOLEATESynonyms Glycerol esters of condensed castor oil fatty acids
Polyglycerol esters of polycondensed fatty acids from castor oil
Polyglycerol 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 % of
polyglycerols equal to or higher than heptaglycerol
Hydroxyl value Not less than 80 and not more than 100Acid value Not more than 6
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 — 19.11.2000 — 002.001 — 99
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.
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 °C
Acids other than fatty acids Not detectable
Free fatty acids Not more than 6 % estimated as oleic acidTotal 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/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 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 °C
of 10 % of thermally oxidised soya bean oil and 90 % mono- and
diglycerides of food fatty acids. Soya bean oil is exclusively made fromnatural 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 °C
Free fatty acids Not more than 1,5 % estimated as oleic acid
Free glycerol Not more than 2 %Total fatty acids 83—90 %
Total glycerol 16—22 %!
M11996L0077 — EN — 19.11.2000 — 002.001 — 100
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 3Epoxides Not more than 0,03 % oxirane oxygen
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 481 SODIUM STEAROYL-2-LACTYLATE
Synonyms Sodium stearoyl lactylate
Sodium stearoyl lactate
Definition A mixture of the sodium salts of stearoyl lactylic acids and its polymers
and minor amounts of sodium salts of other related acids, manufactured
by the reaction of stearic acid and lactic acid. Other food fatty acids 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 190Acid 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/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 482 CALCIUM STEAROYL-2-LACTYLATESynonyms Calcium stearoyl lactate!
M11996L0077 — EN — 19.11.2000 — 002.001 — 101
Definition A mixture of the calcium salts of stearoyl lactylic acids and its polymers
and minor amounts of calcium salts of other related acids, manufacturedby the reaction of stearic acid and lactic acid. Other food fatty acids may
also be present, free or esterified, due to their presence in the stearic acid
used
Chemical name Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Einecs 227-335-7
Chemical formula C
42H78O8Ca
C38H70O8Ca
Description White or slightly yellowish powder or brittle solid with a characteristic
odour
Identification
A. Positive tests for calcium, for fatty acids and
for lactid acid
B. Solubility Slightly soluble in hot water
Purity
Calcium Not less than 1 % and not more than 5,2 %
Ester value Not less than 125 and not more than 190
Total lactic acid Not less than 15 % and not more than 40 %Acid value Not less than 50 and not more than 130
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/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 483 STEARYL TARTRATESynonyms Stearyl palmityl tartrate
Definition Product of the esterification of tartaric acid with commercial stearyl
alcohol, which consists essentially of stearyl and palmityl alcohols. Itconsists 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 tartare
B. Melting range Between 67 °C and 77 °C. After saponification the saturated long chain
fatty alcohols have a melting range of 49 °C to 55 °C
Purity
Hydroxyl value Not less than 200 and not more than 220
Acid value Not more than 5,6!M11996L0077 — EN — 19.11.2000 — 002.001 — 102
Total tartaric acid content Not less than 18 % and not more than 35 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 °C
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/kgUnsaponifiable matter Not less than 77 % and not more than 83 %
Iodine value Not more than 4 (Wijs)
E 491 SORBITAN MONOSTEARATE
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial stearic acid
Einecs 215-664-9
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and
isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a
slight characteristic odour
Identification
A. Solubility Soluble at temperatures above its melting point in toluene, dioxane,
carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in
petroleum ether and acetone; insoluble in cold water but dispersible in
warm water; soluble with haze at temperatures above 50 °C in mineraloil and ethyl acetate
B. Congealing range 50—52 °C
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 10Saponification 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 TRISTEARATEDefinition 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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 103
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 anddioxane; insoluble in water, methanol and ethanol
B. Congealing range 47—50 °C
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 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 358
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!
M11996L0077 — EN — 19.11.2000 — 002.001 — 104
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
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 160Hydroxyl value Not less than 193 and not more than 210
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 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 warmwater
B. Congealing range 45—47 °C
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of polyol
Purity
Water Not more than 2 % (Karl Fischer method)!
M11996L0077 — EN — 19.11.2000 — 002.001 — 105
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/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 508 POTASSIUM CHLORIDE
Synonyms Sylvine
Sylvite
Definition
Chemical name Potassium chloride
Einecs 231-211-8
Chemical formulae KCl
Molecular weight 74,56
Assay Content not less than 99 % on the dried basis
Description Colourless, elongated, prismatic or cubital crystals or white granular
powder.
Odourless
Identification
A. Solubility Freely soluble in water. Insoluble in ethanol
B. Positive tests for potassium and for chloride
Purity
Loss on drying Not more than 1 % (105 °C, 2 hours)
Sodium Negative testArsenic 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 579 FERROUS GLUCONATE
Definition
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!M11996L0077 — EN — 19.11.2000 — 002.001 — 106
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 ethanolB. 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
Purity
Loss on drying Not more than 10 % (105 °C, 16 hours)
Oxalic acid Not detectableIron (Fe III) 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
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 lactateC. 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/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg!
M11996L0077 — EN — 19.11.2000 — 002.001 — 107
E 1105 L YSOZYME
Synonyms Lysozyme hydrochloride
Muramidase
Definition Lysozyme is a linear polypeptide obtained from hens’ egg whites
consisting of 129 amino acids. It possesses enzymatic activity in its
ability to hydrolyse the /betatwo(1-4) linkages between N-acetylmuramic acid
and N-acetylglucosamine in the outer membranes of bacterial species, inparticular gram-positive organisms. Is usually obtained as the hydro-chloride
Chemical name Enzyme Commission (EC) No: 3.2.1.17
Einecs 232-620-4
Molecular weight About 14 000
Assay Content not less than 950 mg/g on the anhydrous basis
Description White, odourless powder having a slightly sweet taste
Identification
A. Isoelectric point 10,7
B. pH of a 2 % aqueous solution between 3,0
and 3,6
C. Absorption maximum of an aqueous solu-
tion (25 mg/100 ml) at 281 nm, a minimum
at 252 nm
Purity
Water content Not more than 6,0 % (Karl Fischer method) (powder form only)
Residue on ignition Not more than 1,5 %
Nitrogen Not less than 16,8 % and not more than 17,8 %Arsenic Not more than 1 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Microbiological criteria
Total bacterial count Not more than 5 × 10
4col/g
Salmonellae Absent in 25 g
Staphylococcus aureus Absent in 1 g
Escherichia coli Absent in 1 g
POLYETHYLENEGL YCOL 6000SynonymsPEG 6000
Macrogol 6000
Definition Polyethylene glycol 6000 is a mixture of polymers with the general
formulaH/C0OCH
2/C0CH ðÞ /C0OH corresponding to an average
relative molecular mass of approximately 6 000
Chemical formula C2H4O ðÞnH2O(n = number of ethylene oxide units corresponding to a
molecular weight of 6000, about 140)!B
!M21996L0077 — EN — 19.11.2000 — 002.001 — 108
Molecular weight 5 600 - 7 000
Assay Not less than 90,0 % and not more than 110,0 %
Description A white or almost white solid with a waxy or paraffin-like appearance
Identification
A. Solubility Very soluble in water and in methylene chloride
Practically insoluble in alcohol, in ether and in fatty and mineral oils
B. Melting range Between 55 °C and 61 °C
Purity
Viscosity Between 0,220 and 0,275 kgm-1s-1at 20 °C
Hydroxyl value Between 16 and 22
Sulphated ash Not more than 0,2 %
Ethylene oxide Not more than 1 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
E 296 MALIC ACID
Synonyms DL-Malic acid, pomalous acid
Definition
Chemical name DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid
EINECS 230-022-8
Chemical formula C
4H6O5
Molecular weight 134,09
Assay Content not less than 99,0 %
Description White or nearly white crystalline powder or granules
Identification
A. Melting range between 127 °C and 132 °C
B. Positive test for malate
C. Solutions of this substance are optically
inactive in all concentrations
Purity
Sulphated ash Not more than 0,1 %
Fumaric acid Not more than 1,0 %
Maleic acid Not more than 0,05 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 297 FUMARIC ACID
Definition
Chemical name Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid
EINECS 203-743-0
Chemical formula C
4H4O4!M21996L0077 — EN — 19.11.2000 — 002.001 — 109
Molecular weight 116,07
Assay Content not less than 99,0 % on the anhydrous basis
Description White crystalline powder or granules
Identification
A. Melting range 286 °C - 302 °C (closed capillary, rapid heating)
B. Positive tests for double bonds and for 1,2-
dicarboxylic acid
C. pH of a 0,05 % solution at 25 °C 3,0 – 3,2
Purity
Loss on drying Not more than 0,5 % (120 °C, 4h)
Sulphated ash Not more than 0,1 %Maleic acid Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 343(i) MONOMAGNESIUM PHOSPHATESynonyms Magnesiumdihydrogenphosphate
Magnesiumphosphate, monobasic
Monomagnesium orthophosphate
Definition
Chemical name Monomagnesiumdihydrogenmonophosphate
EINECS 236-004-6
Chemical formula Mg H
2PO4 ðÞ2/C1nH2O(where n = 0 to 4)
Molecular weight 218,30 (anhydrous)
Assay Not less than 51,0 % after ignition
Description White, odourless, crystalline powder, slightly soluble in water
Identification
A. Positive test for magnesium and for phos-
phate
B. MgO content Not less than 21,5 % after ignition
Purity
Fluoride Not more than 10 mg/kg (as fluorine)
Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kgCadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 343(ii) DIMAGNESIUM PHOSPHATE
Synonyms Magnesiumhydrogenphosphate
Magnesiumphosphate, dibasicDimagnesium orthophosphate
Secondary magnesiumphosphate!
M21996L0077 — EN — 19.11.2000 — 002.001 — 110
Definition
Chemical name Dimagnesiummonohydrogenmonophosphate
EINECS 231-823-5
Chemical formula MgHPO 4/C1nH2O(where n = 0 - 3)
Molecular weight 120,30 (anhydrous)
Assay Not less than 96 % after ignition
Description White, odourless, crystalline powder, slightly soluble in water
Identification
A. Positive test for magnesium and for phos-
phate
B. MgO content: Not less than 33,0 % calculated on an anhydrous basis
Purity
Fluoride Not more than 10 mg/kg (as fluorine)
Arsenic Not more than 3 mg/kgLead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 350 (i) SODIUM MALATESynonyms Sodium salt of malic acid
Definition
Chemical name Disodium DL-malate, disodium salt of hydroxybutanedioic acid
Chemical formula Hemihydrate: C
4H4Na2O5/C12H2OTrihydrate:
C4H4Na2O5/C13H2O
Molecular weight Hemihydrate: 187,05
Trihydrate: 232,10
Assay Content not less than 98,0 % on the anhydrous basis
Description White crystalline powder or lumps
Identification
A. Positive tests for 1,2-dicarboxylic acid and
for sodium
B. Azo dye formation Positive
C. Solubility Freely soluble in water
Purity
Loss on drying Not more than 7,0 % (130 °C, 4h) for the hemihydrate, or 20,5 % -
23,5 % (130 °C, 4h) for the trihydrate
Alkalinity Not more than 0,2 % as Na2CO3
Fumaric acid Not more than 1,0 %
Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 111
E 350 (ii) SODIUM HYDROGEN MALATE
Synonyms Monosodium salt of DL-malic acid
Definition
Chemical name Monosodium DL-malate, monosodium 2-DL-hydroxy succinate
Chemical formula C4H5NaO5
Molecular weight 156,07
Assay Content not less than 99,0 % on the anhydrous basis
Description White powder
Identification
A. Positive tests for 1,2-dicarboxylic acid and
for sodium
B. Azo dye formation Positive
Purity
Loss on drying Not more than 2,0 % (110 °C, 3h)Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 351 POTASSIUM MALATE
Synonyms Potassium salt of malic acid
Definition
Chemical name Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid
Chemical formula C
4H4K2O5
Molecular weight 210,27
Assay Content not less than 59,5 %
Description Colourless or almost colourless aqueous solution
Identification
A. Positive tests for 1,2-dicarboxylic acid and
for potassium
B. Azo dye formation Positive
Purity
Alkalinity Not more than 0,2 % as K2CO3
Fumaric acid Not more than 1,0 %
Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 112
E 352 (i) CALCIUM MALATE
Synonyms Calcium salt of malic acid
Definition
Chemical name Calcium DL-malate, calcium- α-hydroxysuccinate, calcium salt of
hydroxybutanedioic acid
Chemical formula C4H5CaO5
Molecular weight 172,14
Assay Content not less than 97,5 % on the anhydrous basis
Description White powder
Identification
A. Positive tests for malate, 1,2-dicarboxylic
acid and for calcium
B. Azo dye formation Positive
C. Solubility Slightly soluble in water
Purity
Loss on drying Not more than 2 % (100 °C, 3h)
Alkalinity Not more than 0,2 % as CaCO3
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 352 (ii) CALCIUM HYDROGEN MALATE
Synonyms Monocalcium salt of DL-malic acid
Definition
Chemical name Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate
Chemical formula C
4H5O5 ðÞ2Ca
Assay Content not less than 97,5 % on the anhydrous basis
Description White powder
Identification
A. Positive tests for 1,2-dicarboxylic acid and
for calcium
B. Azo dye formation Positive
Purity
Loss on drying Not more than 2,0 % (110 °C, 3h)
Maleic acid Not more than 0,05 %Fumaric acid Not more than 1,0 %
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 113
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 355 ADIPIC ACIDDefinition
Chemical name Hexanedioic acid, 1,4-butanedicarboxylic acid
EINECS 204-673-3
Chemical formula C
6H10O4
Molecular weight 146,14
Assay Content not less than 99,6 %
Description White odourless crystals or crystalline powder
Identification
A. Melting range 151,5-154,0 °C
B. Solubility Slightly soluble in water. Freely soluble in ethanol
Purity
Water Not more than 0,2 % (Karl Fischer method)
Sulphated ash Not more than 20 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 363 SUCCINIC ACID
Definition
Chemical name Butanedioic acid
EINECS 203-740-4
Chemical formula C
4H6O4
Molecular weight 118,09
Assay Content no less than 99,0 %
Description Colourless or white, odourless crystals
Identification
A. Melting range Between 185,0 °C and 190,0 °C
Purity
Residue on ignition Not more than 0,025 % (800 °C, 15 min)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 380 TRIAMMONIUM CITRATE
Synonyms Tribasic ammonium citrate
Definition
Chemical name Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid!
M21996L0077 — EN — 19.11.2000 — 002.001 — 114
EINECS 222-394-5
Chemical formula C6H17N3O7
Molecular weight 243,22
Assay Content not less than 97,0 %
Description White to off-white crystals or powder
Identification
A. Positive tests for ammonium and for citrateB. Solubility Freely soluble in water
Purity
Oxalate Not more than 0,04 % (as oxalic acid)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 452(iii) SODIUM CALCIUM POLYPHOSPHATESynonym Sodium calcium polyphosphate, glassy
Definition
Chemical name Sodium calcium polyphosphate
EINECS 233-782-9
Chemical formula NaPO
3 ðÞnCaO where n is typically 5
Assay Not less than 61 % and not more than 69 % as P2O5
Description White glassy crystals, spheres
Identification
A. pH of a 1 % m/m slurry Approximately 5 to 7B. CaO content 7 %-15 % m/m
Purity
Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kgMercury Not more than 1 mg/kg
E 459 BETA-CYCLODEXTRINDefinition Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of 7 α-
1,4-linked D-glucopyranosyl units. The product is manufactured by the
action of the enzyme cycloglycosyltransferase (CGTase) obtained fromBacillus circulans on partially hydrolysed starch
Chemical name Cycloheptaamylose
EINECS 231-493-2
Chemical formula C
6H10O5 ðÞ7
Molecular weight 1135
Assay Content not less than 98,0 % of C6H10O5 ðÞ7on an anhydrous basis!M21996L0077 — EN — 19.11.2000 — 002.001 — 115
Description Virtually odourless, white or almost white crystalline solid
Identification
A. Solubility Sparingly soluble in water; freely soluble in hot water; slightly soluble in
ethanol
B. Specific rotation [ α]25D: + 160.oto + 164.o(1 % solution)
C. Infrared absorption The infrared absorption spectrum of a potassium bromide dispersion of
the test substance corresponds with that of a reference standard
Purity
Water Not more than 14 % (Karl Fischer method)
Other cyclodextrins Not more than 2 % on an anhydrous basis
Residual solvents (toluene and trichloroethylene) Not more than 1 mg/kg for each solventReducing substances (as glucose) Not more than 1 %
Sulphated ash Not more than 0,1 %
Arsenic Not more than 1 mg/kgLead Not more than 1 mg/kg
E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSESynonyms Cross-linked carboxymethyl cellulose
Cross-linked CMC
Cross-linked sodium CMC
Cross-linked cellulose gum
Definition Cross-linked sodium carboxymethyl cellulose is the sodium salt of
thermally cross-linked partly O-carboxymethylated cellulose
Chemical name Sodium salt of the cross-linked carboxymethyl ether cellulose
Chemical formula The polymers containing substituted anhydroglucose units with the
general formula:
C
6H7O2OR1 ðÞOR2 ðÞOR3 ðÞ whereR1,R2and
R3
may be any of the following:
—H
—CH2COONa
—CH2COOH
Description Slightly hygroscopic, white to off white, odourless powder
Identification
A. Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue
and allow to settle. The substance to be examined absorbs the methyleneblue and settles as a blue, fibrous mass
B. Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube,
add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of
sulphuric acid down the side so that it forms a lower layer. A reddish-
violet colour develops at the interface
C. It gives the reaction of sodium
Purity
Loss on drying Not more than 6 % (105 .
oC, 3h)
Water solubles Not more than 10 %
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups per
anhydroglucose unit
pH of 1 % Not less than 5,0 and not more than 7,0!M21996L0077 — EN — 19.11.2000 — 002.001 — 116
Sodium content Not more than 12,4 % on anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Cadmium Not more than 1 mg/kgMercury Not more than 1 mg/kg
E 469 ENZYMATICALL Y HYDROL YSED CARBOXYMETHYLCELLULOSESynonyms Sodium carboxymethyl cellulose, enzymatically hydrolysed
Definition Enzymatically hydrolysed carboxymethylcellulose is obtained from
carboxymethylcellulose by enzymatic digestion with a cellulase
produced by Trichoderma longibrachiatum (formerly T. reesei )
Chemical name Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed
Chemical formula Sodium salts of polymers containing substituted anhydroglucose units
with the general formula:
C
6H7O2OHðÞxOCH2COONa ðÞyhi
nwhere n is the degree of poly-
merisation
x = 1,50 to 2,80y = 0,2 to 1,50x+y=3 , 0
(y = degree of substitution)
Formula weight 178,14 where y = 0,20
282,18 where y = 1,50
Macromolecules: Not less than 800 (n about 4)
Assay Not less than 99,5 %, including mono- and disaccharides, on the dried
basis
Description White or slightly yellowish or greyish, odourless, slightly hygroscopic
granular or fibrous powder
Identification
A. Solubility Soluble in water, insoluble in ethanol
B. Foam test Vigorously shake a 0,1 % solution of the sample. No layer of foam
appears. This test distinguishes sodium carboxymethyl cellulose,whether hydrolysed or not, from other cellulose ethers and fromalginates and natural gums
C. Precipitate formation To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of
copper or aluminium sulphate. A precipitate appears. This testdistinguishes sodium carboxymethyl cellulose, whether hydrolysed ornot, from other cellulose ethers and from gelatine, carob bean gum andtragacanth gum
D. Colour reaction Add 0,5 g of the powdered sample to 50 ml of water, while stirring to
produce a uniform dispersion. Continue the stirring until a clear solutionis produced. Dilute 1 ml of the solution with 1 ml of water in a small testtube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefullyintroduce down the side of the tube 2 ml of sulphuric acid so that it formsa lower layer. A red-purple colour develops at the interface
E. Viscosity (60 % solids) Not less than 2,500 kgm
-1s-1at 25 °C corresponding to an average
molecule weight of 5 000 D
Purity
Loss on drying Not more than 12 % (105 °C to constant weight)
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups per
anhydroglucose unit on the dried basis
pH of a 1 % colloidal solution Not less than 6,0 and not more than 8,5
Sodium chloride and sodium glycolate Not more than 0,5 % singly or in combination
Residual enzyme activity Passes test. No change in viscosity of test solution occurs, which
indicates hydrolysis of the sodium carboxymethyl cellulose!M21996L0077 — EN — 19.11.2000 — 002.001 — 117
Lead Not more than 3 mg/kg
E 500(i) SODIUM CARBONATESynonyms Soda ash
Definition
Chemical name Sodium carbonate
EINECS 207-838-8
Chemical formula Na
2CO3/C1nH2O(n = 0, 1 or 10)
Molecular weight 106,00 (anhydrous)
Assay Content not less than 99 % of Na2CO3on the anhydrous basis
Description Colourless crystals or white, granular or crystalline powder
The anhydrous form is hygroscopic, the decahydrate efflorescent
Identification
A. Positive tests for sodium and for carbonate
B. Solubility Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 %
(decahydrate) (70 °C raising gradually to 300 °C, to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 500(ii) SODIUM HYDROGEN CARBONATESynonyms Sodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking
soda
Definition
Chemical name Sodium hydrogen carbonate
EINECS 205-633-8
Chemical formulaNaHCO
3
Molecular weight 84,01
Assay Content not less than 99 % on the anhydrous basis
Description Colourless or white crystalline masses or crystalline powder
Identification
A. Positive tests for sodium and for carbonate
B. pH of a 1 % solution Between 8,0 and 8,6
C. Solubility Soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 0,25 % (over silica gel, 4h)
Ammonium salts No odour of ammonia detectable after heatingArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 118
Mercury Not more than 1 mg/kg
E 500(iii) SODIUM SESQUICARBONATEDefinition
Chemical name Sodium monohydrogen dicarbonate
EINECS 208-580-9
Chemical formula Na
2COðÞ3/C1NaHCO 3/C12H2O
Molecular weight 226,03
Assay Content between 35,0 % and 38,6 % of NaHCO 3and between 46,4 %
and 50,0 % of Na2CO3
Description White flakes, crystals or crystalline powder
Identification
A. Positive tests for sodium and for carbonate
B. Solubility Freely soluble in water
Purity
Sodium chloride Not more than 0,5 %
Iron Not more than 20 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 501(i) POTASSIUM CARBONATE
Definition
Chemical name Potassium carbonate
EINECS 209-529-3
Chemical formula K
2CO3/C1nH2O(n = 0 or 1,5)
Molecular weight 138,21 (anhydrous)
Assay Content not less than 99,0 % on the anhydrous basis
Description White, very deliquescent powder.
The hydrate occurs as small, white, translucent crystals or granules
Identification
A. Positive tests for potassium and for carbo-
nate
B. Solubility Very soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 5 % (anhydrous) or 18 % (hydrate) (180 °C, 4h)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 501(ii) POTASSIUM HYDROGEN CARBONATE
Synonyms Potassium bicarbonate, acid potassium carbonate!
M21996L0077 — EN — 19.11.2000 — 002.001 — 119
Definition
Chemical name Potassium hydrogen carbonate
EINECS 206-059-0
Chemical formula KHCO3
Molecular weight 100,11
Assay Content not less than 99,0 % and not more than 101,0 % KHCO3on the
anhydrous basis
Description Colourless crystals or white powder or granules
Identification
A. Positive tests for potassium and for carbo-
nate
B. Solubility Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 0,25 % (over silica gel, 4h)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 503(i) AMMONIUM CARBONATE
Definition Ammonium carbonate consists of ammonium carbamate, ammonium
carbonate and ammonium hydrogen carbonate in varying proportions
Chemical name Ammonium carbonate
EINECS 233-786-0
Chemical formula CH
6N2O2,CH8N2O3andCH5NO3
Molecular weight Ammonium carbamate 78,06; ammonium carbonate 98,73; ammonium
hydrogen carbonate 79,06
Assay Content not less than 30,0 % and not more than 34,0 % of NH3
Description White powder or hard, white or translucent masses or crystals. Becomes
opaque on exposure to air and is finally converted into white porouslumps or powder (of ammonium bicarbonate) due to loss of ammoniaand carbon dioxide
Identification
A. Positive tests for ammonium and for carbo-
nate
B. pH of a 5 % solution about 8,6
C. Solubility Soluble in water
Purity
Non-volatile matter Not more than 500 mg/kg
Chlorides Not more than 30 mg/kgSulphate Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 120
E 503(ii) AMMONIUM HYDROGEN CARBONATE
Synonyms Ammonium bicarbonate
Definition
Chemical name Ammonium hydrogen carbonate
EINECS 213-911-5
Chemical formula CH5NO3
Molecular weight 79,06
Assay Content not less than 99,0 %
Description White crystals or crystalline powder
Identification
A. Positive tests for ammonium and for carbo-
nate
B. pH of a 5 % solution about 8,0
C. Solubility Freely soluble in water. Insoluble in ethanol
Purity
Non-volatile matter Not more than 500 mg/kgChlorides Not more than 30 mg/kg
Sulphate Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 507 HYDROCHLORIC ACID
Synonyms Hydrogen chloride, muriatic acid
Definition
Chemical name Hydrochloric acid
EINECS 231-595-7
Chemical formula HCl
Molecular weight 36,46
Assay Hydrochloric acid is commercially available in varying concentrations.
Concentrated hydrochloric acid contains not less than 35,0 % HCl
Description Clear, colourless or slightly yellowish, corrosive liquid having a pungent
odour
Identification
A. Positive tests for acid and for chloride
B. Solubility Soluble in water and in ethanol
Purity
Total organic compounds Total organic compounds (non-fluorine containing): not more than 5 mg/
kg
Benzene: not more than 0,05 mg/kgFluorinated compounds (total): not more than 25 mg/kg
Non-volatile matter Not more than 0,5 %
Reducing substances Not more than 70 mg/kg (as SO
2)!M21996L0077 — EN — 19.11.2000 — 002.001 — 121
Oxidising substances Not more than 30 mg/kg (as Cl2)
Sulphate Not more than 0,5 %
Iron Not more than 5 mg/kg
Arsenic Not more than 1 mg/kgLead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 509 CALCIUM CHLORIDE
Definition
Chemical name Calcium chloride
EINECS 233-140-8
Chemical formula CaCl
2/C1nH2O(n = 0,2 or 6)
Molecular weight 110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)
Assay Content not less than 93,0 % on the anhydrous basis
Description White, odourless, hygroscopic powder or deliquescent crystals
Identification
A. Positive tests for calcium and for chlorideB. Solubility Anhydrous calcium chloride: freely soluble in water and ethanol
Dihydrate: freely soluble in water, soluble in ethanolHexahydrate: very soluble in water and ethanol
Purity
Magnesium and alkali salts Not more than 5 % on the anhydrous basis
Fluoride Not more than 40 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E 511 MAGNESIUM CHLORIDE
Definition
Chemical name Magnesium chloride
EINECS 232-094-6
Chemical formula MgCl
2/C16H2O
Molecular weight 203,30
Assay Content not less than 99,0 %
Description Colourless, odourless, very deliquescent flakes or crystals
Identification
A. Positive tests for magnesium and for chloride
B. Solubility Very soluble in water, freely soluble in ethanol
Purity
Ammonium Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg!M21996L0077 — EN — 19.11.2000 — 002.001 — 122
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E 512 STANNOUS CHLORIDESynonyms Tin chloride, tin dichloride
Definition
Chemical name Stannous chloride dihydrate
EINECS 231-868-0
Chemical formula SnCl
2/C12H2O
Molecular weight 225,63
Assay Content not less than 98,0 %
Description Colourless or white crystals
May have a slight odour of hydrochloric acid
Identification
A. Positive tests for tin (II) and for chloride
B. Solubility Water: soluble in less than its own weight of water, but it forms an
insoluble basic salt with excess water
Ethanol: soluble
Purity
Sulphate Not more than 30 mg/kg
Arsenic Not more than 2 mg/kg
Mercury Not more than 1 mg/kgLead Not more than 5 mg/kg
E 513 SULPHURIC ACID
Synonyms Oil of vitriol, dihydrogen sulphate
Definition
Chemical name Sulphuric acid
EINECS 231-639-5
Chemical formula H
2SO4
Molecular weight 98,07
Assay Sulphuric acid is commercially available in varying concentrations. The
concentrated form contains not less than 96,0 %
Description Clear, colourless or slightly brown, very corrosive oily liquid
Identification
A. Positive tests for acid and for sulphateB. Solubility Miscible with water, with generation of much heat, also with ethanol
Purity
Ash Not more than 0,02 %Reducing matter Not more than 40 mg/kg (as SO
2)
Nitrate Not more than 10 mg/kg (on H2SO4basis)
Chloride Not more than 50 mg/kg!M21996L0077 — EN — 19.11.2000 — 002.001 — 123
Iron Not more than 20 mg/kg
Selenium Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 514(i) SODIUM SULPHATEDefinition
Chemical name Sodium sulphate
Chemical formula Na
2SO4/C1nH2O(n = 0 or 10)
Molecular weight 142,04 (anhydrous)
322,04 (decahydrate)
Assay Content not less than 99,0 % on the anhydrous basis
Description Colourless crystals or a fine, white, crystalline powder
The decahydrate is efflorescent
Identification
A. Positive tests for sodium and for sulphate
B. Acidity of a 5 % solution: neutral or slightly
alkaline to litmus paper
Purity
Loss on drying Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at
130 .oC
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 514(ii) SODIUM HYDROGEN SULPHATE
Synonyms Acid sodium sulphate, sodium bisulphate, nitre cake
Definition
Chemical name Sodium hydrogen sulphate
Chemical formula NaHSO
4
Molecular weight 120,06
Assay Content not less than 95,2 %
Description White, odourless crystals or granules
Identification
A. Positive tests for sodium and for sulphate
B. Solutions are strongly acidic
Purity
Loss on drying Not more than 0,8 %Water insoluble Not more than 0,05 %
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 124
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 515(i) POTASSIUM SULPHATEDefinition
Chemical name Potassium sulphate
Chemical formula K
2SO4
Molecular weight 174,25
Assay Content not less than 99,0 %
Description Colourless or white crystals or crystalline powder
Identification
A. Positive tests for potassium and for sulphate
B. pH of a 5 % solution Between 5,5 and 8,5
C. Solubility Freely soluble in water, insoluble in ethanol
Purity
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 515(ii) POTASSIUM HYDROGEN SULPHATEDefinition
Synonyms Potassium bisulphate, potassium acid sulphate
Chemical name Potassium hydrogen sulphate
Chemical formula KHSO
4
Molecular weight 136,17
Assay Content not less than 99 %
Melting point 197 °C
Description White deliquescent crystals, pieces or granules
Identification
A. Positive test for potassiumB. Solubility Freely soluble in water, insoluble in ethanol
Purity
Selenium Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 516 CALCIUM SULPHATE
Synonyms Gypsum, selenite, anhydrite!
M21996L0077 — EN — 19.11.2000 — 002.001 — 125
Definition
Chemical name Calcium sulphate
EINECS 231-900-3
Chemical formula CaSO4/C1nH2O(n = 0 or 2)
Molecular weight 136,14 (anhydrous), 172,18 (dihydrate)
Assay Content not less than 99,0 % on the anhydrous basis
Description Fine, white to slightly yellowish-white odourless powder
Identification
A. Positive tests for calcium and for sulphate
B. Solubility Slightly soluble in water, insoluble in ethanol
Purity
Loss on drying Anhydrous: not more than 1,5 % (250 °C, constant weight)
Dihydrate: not more than 23 % (ibid.)
Fluoride Not more than 30 mg/kg
Selenium Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 517 AMMONIUM SULPHATEDefinition
Chemical name Ammonium sulphate
EINECS 231-984-1
Chemical formula NH
4 ðÞ2SO4
Molecular weight 132,14
Assay Content not less than 99,0 % and not more than 100,5 %
Description White powder, shining plates or crystalline fragments
Identification
A. Positive tests for ammonium and for sulphateB. Solubility Freely soluble in water, insoluble in ethanol
Purity
Loss on ignition Not more than 0,25 %Selenium Not more than 30 mg/kg
Lead Not more than 5 mg/kg
E 520 ALUMINIUM SULPHATE
Synonyms Alum
Definition
Chemical name Aluminium sulphate
EINECS 233-135-0
Chemical formula Al
2SO4 ðÞ3!M21996L0077 — EN — 19.11.2000 — 002.001 — 126
Molecular weight 342,13
Assay Content not less than 99,5 % on the ignited basis
Description White powder, shining plates or crystalline fragments
Identification
A. Positive tests for aluminium and for sulphate
B. pH of a 5 % solution 2,9 or above
C. Solubility Freely soluble in water, insoluble in ethanol
Purity
Loss on ignition Not more than 5 % (500 °C, 3h)Alkalies and alkaline earths Not more than 0,4 %
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E 521 ALUMINIUM SODIUM SULPHATE
Synonyms Soda alum, sodium alum
Definition
Chemical name Aluminium sodium sulphate
EINECS 233-277-3
Chemical formula AlNa SO
4 ðÞ2/C1nH2O(n = 0 or 12)
Molecular weight 242,09 (anhydrous)
Assay Content on the anhydrous basis not less than 96,5 % (anhydrous) and
99,5 % (dodecahydrate)
Description Transparent crystals or white crystalline powder
Identification
A. Positive tests for aluminium, for sodium and
for sulphate
B. Solubility Dodecahydrate is freely soluble in water. The anhydrous form is slowly
soluble in water. Both forms are insoluble in ethanol
Purity
Loss on drying Anhydrous form: not more than 10,0 % (220 °C, 16h)
Dodecahydrate: not more than 47,2 % (50 °C-55 °C, 1h then 200 °C,
16h)
Ammonium salts No odour of ammonia detectable after heatingSelenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 127
E 522 ALUMINIUM POTASSIUM SULPHATE
Synonyms Potassium alum, potash alum
Definition
Chemical name Aluminium potassium sulphate dodecahydrate
EINECS 233-141-3
Chemical formula AlK SO 4 ðÞ2/C112 H2O
Molecular weight 474,38
Assay Content not less than 99,5 %
Description Large, transparent crystals or white crystalline powder
Identification
A. Positive tests for aluminium, for potassium
and for sulphate
B. pH of a 10 % solution between 3,0 and 4,0
C. Solubility Freely soluble in water, insoluble in ethanol
Purity
Ammonium salts No odour of ammonia detectable after heatingSelenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 523 ALUMINIUM AMMONIUM SULPHATE
Synonyms Ammonium alum
Definition
Chemical name Aluminium ammonium sulphate
EINECS 232-055-3
Chemical formula AlNH
4SO4 ðÞ2/C112 H2O
Molecular weight 453,32
Assay Content not less than 99,5 %
Description Large, colourless crystals or white powder
Identification
A. Positive tests for aluminium, for ammonium
and for sulphate
B. Solubility Freely soluble in water, soluble in ethanol
Purity
Alkali metals and alkaline earths Not more than 0,5 %Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 128
Mercury Not more than 1 mg/kg
E 524 SODIUM HYDROXIDESynonyms Caustic soda, lye
Definition
Chemical name Sodium hydroxide
EINECS 215-185-5
Chemical formula NaOH
Molecular weight 40,0
Assay Content of solid forms not less than 98,0 % of total alkali (as NaOH).
Content of solutions accordingly, based on the stated or labelledpercentage of NaOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms.
Solutions are clear or slightly turbid, colourless or slightly coloured,
strongly caustic and hygroscopic and when exposed to the air they
absorb carbon dioxide, forming sodium carbonate
Identification
A. Positive tests for sodium
B. A 1 % solution is strongly alkaline
C. Solubility Very soluble in water. Freely soluble in ethanol
Purity
Water insoluble and organic matter A 5 % solution is completely clear and colourless to slightly colouredCarbonate Not more than 0,5 % (as Na
2CO3)
Arsenic Not more than 3 mg/kg
Lead Not more than 0,5 mg/kgMercury Not more than 1 mg/kg
E 525 POTASSIUM HYDROXIDESynonyms Caustic potash
Definition
Chemical name Potassium hydroxide
EINECS 215-181-3
Chemical formula KOH
Molecular weight 56,11
Assay Content not less than 85,0 % of alkali calculated as KOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms
Identification
A. Positive tests for potassium
B. A 1 % solution is strongly alkaline
C. Solubility Very soluble in water. Freely soluble in ethanol
Purity
Water insoluble matter A 5 % solution is completely clear and colourless
Carbonate Not more than 3,5 % (as K
2CO3)
Arsenic Not more than 3 mg/kg!M21996L0077 — EN — 19.11.2000 — 002.001 — 129
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E 526 CALCIUM HYDROXIDESynonyms Slaked lime, hydrated lime
Definition
Chemical name Calcium hydroxide
EINECS 215-137-3
Chemical formula Ca OHðÞ
2
Molecular weight 74,09
Assay Content not less than 92,0 %
Description White powder
Identification
A.Positive tests for alkali and for calcium
B. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Acid insoluble ash Not more than 1,0 %Magnesium and alkali salts Not more than 1,0 %Barium Not more than 300 mg/kg
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
E 527 AMMONIUM HYDROXIDESynonyms Aqua ammonia, strong ammonia solution
Definition
Chemical name Ammonium hydroxide
Chemical formula NH
4OH
Molecular weight 35,05
Assay Content not less than 27 % of NH3
Description Clear, colourless solution, having an exceedingly pungent, characteristic
odour
Identification
A. Positive tests for ammonia
Purity
Non-volatile matter Not more than 0,02 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg!M21996L0077 — EN — 19.11.2000 — 002.001 — 130
E 528 MAGNESIUM HYDROXIDE
Definition
Chemical name Magnesium hydroxide
EINECS 215-170-3
Chemical formula Mg OHðÞ2
Molecular weight 58,32
Assay Content not less than 95,0 % on the anhydrous basis
Description Odourless, white bulky powder
Identification
A. Positive test for magnesium and for alkaliB. Solubility Practically insoluble in water and in ethanol
Purity
Loss on drying Not more than 2,0 % (105 °C, 2h)Loss on ignition Not more than 33 % (800 °C to constant weight)
Calcium oxide Not more than 1,5 %
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
E 529 CALCIUM OXIDESynonyms Burnt lime
Definition
Chemical name Calcium oxide
EINECS 215-138-9
Chemical formula CaO
Molecular weight 56,08
Assay Content not less than 95,0 % on the ignited basis
Description Odourless, hard, white or greyish white masses of granules, or white to
greyish powder
Identification
A. Positive test for alkali and for calcium
B. Heat is generated on moistening the sample
with water
C. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Loss on ignition Not more than 10,0 % (ca 800 °C to constant weight)
Acid insoluble matter Not more than 1,0 %Barium Not more than 300 mg/kgMagnesium and alkali salts Not more than 1,5 %
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 131
E 530 MAGNESIUM OXIDE
Definition
Chemical name Magnesium oxide
EINECS 215-171-9
Chemical formula MgO
Molecular weight 40,31
Assay Content not less than 98,0 % on the ignited basis
Description A very bulky, white powder known as light magnesium oxide or a
relative dense, white powder known as heavy magnesium oxide. 5 g of
light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of
heavy magnesium oxide occupy a volume of 10 to 20 ml
Identification
A. Positive test for alkali and for magnesium
B. Solubility Practically insoluble in water. Insoluble in ethanol
Purity
Loss on ignition Not more than 5,0 % (ca 800 °C to constant weight)
Calcium oxide Not more than 1,5 %
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
E 535 SODIUM FERROCYANIDESynonyms Y ellow prussiate of soda, sodium hexacyanoferrate
Definition
Chemical name Sodium ferrocyanide
EINECS 237-081-9
Chemical formula Na
4FeC NðÞ6/C110 H2O
Molecular weight 484,1
Assay Content not less than 99,0 %
Description Y ellow crystals or crystalline powder
Identification
A. Positive test for sodium and for ferrocyanide
Purity
Free moisture Not more than 1,0 %
Water insoluble matter Not more than 0,03 %
Chloride Not more than 0,2 %Sulphate Not more than 0,1 %
Free cyanide Not detectable
Ferricyanide Not detectableLead Not more than 5 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 132
E 536 POTASSIUM FERROCYANIDE
Synonyms Y ellow prussiate of potash, potassium hexacyanoferrate
Definition
Chemical name Potassium ferrocyanide
EINECS 237-722-2
Chemical formula K4FeC NðÞ6/C13H2O
Molecular weight 422,4
Assay Content not less than 99,0 %
Description Lemon yellow crystals
Identification
A. Positive test for potassium and for ferrocya-
nide
Purity
Free moisture Not more than 1,0 %Water insoluble matter Not more than 0,03 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
E 538 CALCIUM FERROCYANIDESynonyms Y ellow prussiate of lime, calcium hexacyanoferrate
Definition
Chemical name Calcium ferrocyanide
EINECS 215-476-7
Chemical formula Ca
2FeC NðÞ6/C112H2O
Molecular weight 508,3
Assay Content not less than 99,0 %
Description Y ellow crystals or crystalline powder
Identification
A. Positive test for calcium and for ferrocyanide
Purity
Free moisture Not more than 1,0 %Water insoluble matter Not more than 0,03 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 133
E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC
Synonyms SALP
Definition
Chemical name Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A)
or
Trisodium dialuminium pentadecahydrogen octaphosphate (B)
EINECS 232-090-4
Chemical formula NaAl3H14PO4 ðÞ8/C14H2O(A)
Na3Al2H15PO4 ðÞ8(B)
Molecular weight 949,88 (A)
897,82 (B)
Assay Content not less than 95,0 % (both forms)
Description White odourless powder
Identification
A. Positive test for sodium, for aluminium and
for phosphate
B. pH Acid to litmusC. Solubility Insoluble in water. Soluble in hydrochloric acid
Purity
Loss on ignition 19,5 % - 21,0 % (A) } (750 °C - 800 °C, 2h)
15 % - 16 % (B) } (750 °C - 800 °C, 2h)
Fluoride Not more than 25 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kgMercury Not more than 1 mg/kg
E 551 SILICON DIOXIDESynonyms Silica, silicium dioxide
Definition Silicon dioxide is an amorphous substance, which is produced
synthetically by either a vapour-phase hydrolysis process, yielding
fumed silica, or by a wet process, yielding precipitated silica, silica gel,
or hydrous silica. Fumed silica is produced in essentially an anhydrousstate, whereas the wet-process products are obtained as hydrates orcontain surface absorbed water
Chemical name Silicon dioxide
EINECS 231-545-4
Chemical formula SiO
2 ðÞn
Molecular weight 60,08 (SiO2)
Assay Content after ignition not less than 99,0 % (fumed silica) or 94,0 %
(hydrated forms)
Description White, fluffy powder or granules
Hygroscopic
Identification
A. Positive test for silica!M21996L0077 — EN — 19.11.2000 — 002.001 — 134
Purity
Loss on drying Not more than 2,5 % (fumed silica, 105 °C, 2h)
Not more than 8,0 % (precipitated silica and silica gel, 105 °C, 2h)Not more than 70 % (hydrous silica, 105 °C, 2h)
Loss on ignition Not more than 2,5 % after drying (1 000 °C, fumed silica)
Not more than 8,5 % after drying (1 000 °C, hydrated forms)
Soluble ionisable salts Not more than 5,0 % (as Na
2SO4)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 552 CALCIUM SILICATEDefinition Calcium silicate is a hydrous or anhydrous silicate with varying
proportions of CaO and SiO
2
Chemical name Calcium silicate
EINECS 215-710-8
Assay Content on the anhydrous basis:
—a sSiO2not less than 50 % and not more than 95 %
— as CaO not less than 3 % and not more than 35 %
Description White to off-white free-flowing powder that remains so after absorbing
relatively large amounts of water or other liquids
Identification
A. Positive test for silicate and for calcium
B. Forms a gel with mineral acids
Purity
Loss on drying Not more than 10 % (105 °C, 2h)
Loss on ignition Not less than 5 % and not more than 14 % (1 000 °C, constant weight)
Sodium Not more than 3 %Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 553a(i) MAGNESIUM SILICATEDefinition Magnesium silicate is a synthetic compound of which the molar ratio of
magnesium oxide to silicon dioxide is approximately 2:5
Assay Content not less than 15 % of MgO and not less than 67 % of SiO
2on
the ignited basis
Description Very fine, white, odourless powder, free from grittiness
Identification
A. Positive test for magnesium and for silicate
B. pH of a 10 % slurry Between 7,0 and 10,8
Purity
Loss on drying Not more than 15 % (105 °C, 2h)
Loss on ignition Not more than 15 % after drying (1 000 °C, 20 min)!M21996L0077 — EN — 19.11.2000 — 002.001 — 135
Water soluble salts Not more than 3 %
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 553a(ii) MAGNESIUM TRISILICA TE
Definition
Chemical name Magnesium trisilicate
Chemical formula Mg
2Si3O8/C1xH2O(approximate composition)
EINECS 239-076-7
Assay Content not less than 29,0 % of MgO and not less than 65,0 % of SiO2
both on the ignited basis
Description Fine, white powder, free from grittiness
Identification
A. Positive test for magnesium and for silicate
B. pH of a 5 % slurry Between 6,3 and 9,5
Purity
Loss on ignition Not less than 17 % and not more than 34 % (1 000 °C)
Water soluble salts Not more than 2 %Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 570 FATTY ACIDS
Definition Linear fatty acids, caprylic acid ( C
8), capric acid ( C10), laurinc acid
(C12), myristic acid ( C14), palmitic acid ( C16), stearic acid ( C18), oleic
acid (C18:1)
Chemical name octanoic acid ( C8), decanoic acid ( C10), dodecanoic acid ( C12),
tetradecanoic acid ( C14), hexadecanoic acid ( C16), octadecanoic acid
(C18), 9-octadecenoic acid ( C18:1)
Assay Not less than 98 % by chromatography
Description A colourless liquid or white solid obtained from oils and fats
Identification
A. Individual fatty acids can be identified by
acid value, iodine value, gas chromatography
and molecular weight
Purity
Residue on ignition Not more than 0,1 %
Unsaponifiable matter Not more than 1,5 %
Water Not more than 0,2 % (Karl Fischer method)!M21996L0077 — EN — 19.11.2000 — 002.001 — 136
Arsenic Not more than 3 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 574 GLUCONIC ACID
Synonyms D-gluconic acid, dextronic acid
Definition Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-
lactone
Chemical name Gluconic acid
Chemical formula C6H12O7(gluconic acid)
Molecular weight 196,2
Assay Content not less than 50,0 % (as gluconic acid)
Description Colourless to light yellow, clear syrupy liquid
Identification
A. Formation of phenylhydrazine derivative
positiveCompound formed melts between 196 °C and 202 °C with decomposi-
tion
Purity
Residue on ignition Not more than 1,0 %Reducing matter Not more than 0,75 % (as D-glucose)Chloride Not more than 350 mg/kg
Sulphate Not more than 240 mg/kg
Sulphite Not more than 20 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 575 GLUCONO-DELTA-LACTONESynonyms Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolac-
tone
Definition Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of
D-gluconic acid. In aqueous media it is hydrolysed to an equilibriummixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-
lactones
Chemical name D-Glucono-1,5-lactone
EINECS 202-016-5
Chemical formula C
6H10O6
Molecular weight 178,14
Assay Content not less than 99,0 % on the anhydrous basis
Description Fine, white, nearly odourless, crystalline powder
Identification
A. Formation of phenylhydrazine derivative of
gluconic acid positiveCompound formed melts between 196 °C and 202 °C with decomposi-
tion
B. Solubility Freely soluble in water. Sparingly soluble in ethanol
C. Melting point 152 °C ± 2 °C!M21996L0077 — EN — 19.11.2000 — 002.001 — 137
Purity
Water Not more than 1,0 % (Karl Fischer method)
Reducing substances Not more than 0,75 % (as D-glucose)
Lead Not more than 2 mg/kg
E 576 SODIUM GLUCONATESynonyms Sodium salt of D-gluconic acid
Definition
Chemical name Sodium D-gluconate
EINECS 208-407-7
Chemical formula C
6H11NaO7(anhydrous)
Molecular weight 218,14
Assay Content not less than 98,0 %
Description White to tan, granular to fine, crystalline powder
Identification
A. Positive test for sodium and for gluconate
B. Solubility Very soluble in water. Sparingly soluble in ethanolC. pH of a 10 % solution Between 6,5 and 7,5
Purity
Reducing matter Not more than 1,0 % (as D-glucose)
Lead Not more than 2 mg/kg
E 577 POTASSIUM GLUCONATESynonyms Potassium salt of D-gluconic acid
Definition
Chemical name Potassium D-gluconate
EINECS 206-074-2
Chemical formula C
6H11KO7(anhydrous)
C6H11KO7/C1H2O(monohydrate)
Molecular weight 234,25 (anhydrous)
252,26 (monohydrate)
Assay Content not less than 97,0 % and not more than 103,0 % on dried basis
Description Odourless, free flowing white to yellowish white, crystalline powder or
granules
Identification
A. Positive test for potassium and for gluconate
B. pH of a 10 % solution Between 7,0 and 8,3
Purity
Loss on drying Anhydrous: not more than 3,0 % (105 °C, 4h, vacuum)
Monohydrate: not less than 6 % and not more than 7,5 % (105 °C, 4h,
vacuum)
Reducing substances Not more than 1,0 % (as D-glucose)
Lead Not more than 2 mg/kg!M21996L0077 — EN — 19.11.2000 — 002.001 — 138
E 578 CALCIUM GLUCONATE
Synonyms Calcium salt of D-gluconic acid
Definition
Chemical name Calcium di-D-gluconate
EINECS 206-075-8
Chemical formula C12H22CaO14(anhydrous)
C12H22CaO14/C1H2O(monohydrate)
Molecular weight 430,38 (anhydrous form)
448,39 (monohydrate)
Assay Content not less than 98,0 % and not more than 102 % on the anhydrous
and monohydrate basis
Description Odourless, white crystalline granules or powder, stable in air
Identification
A. Positive test for calcium and for gluconateB. Solubility Soluble in water, insoluble in ethanol
C. pH of a 5 % solution Between 6,0 and 8,0
Purity
Loss on drying Not more than 3,0 % (105 °C, 16h) (anhydrous)
Not more than 2,0 % (105 °C, 16h) (monohydrate)
Reducing substances Not more than 1,0 % (as D-glucose)
Lead Not more than 2 mg/kg
E 640 GL YCINE AND ITS SODIUM SALT
Synonyms (gly) Aminoacetic acid, glycocoll
(Na salt) Sodium glycinate
Definition
Chemical name (gly) Aminoacetic acid
(Na salt) Sodium glycinate
Chemical formula (gly) C
2H5NO2
(Na salt) C2H5NO2Na
EINECS (gly) 200-272-2
(Na salt) 227-842-3
Molecular weight (gly) 75,07
(Na salt) 98
Assay Content not less than 98,5 % on the anhydrous basis#
Description White crystals or crystalline powder#
Identification
A. Positive test for aminoacid (gly and Na salt)
B. Positive test for sodium (Na salt)
Purity
Loss on drying (gly) Not more than 0,2 % (105 °C, 3h)!M21996L0077 — EN — 19.11.2000 — 002.001 — 139
(Na salt) Not more than 0,2 % (105 °C, 3h)
Residue on ignition (gly) Not more than 0,1 %
(Na salt) 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
E 900 DIMETHYL POLYSILOXANE
Synonyms Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone
Definition Dimethylpolysiloxane is a mixture of fully methylated linear siloxane
polymers containing repeating units of the formula CH
3 ðÞ2SiO and
stablised with trimethylsiloxy end-blocking units of the formula
CH3 ðÞ3SiO
Chemical name Siloxanes and silicones, di-methyl
Chemical formula CH3 ðÞ3/C0Si/C0O/C0Si CH3 ðÞ2/C2/C3
n/C0O/C0Si CH3 ðÞ3
Assay Content of total silicon not less than 37,3 % and not more than 38,5 %
Description Clear, colourless, viscous liquid
Identification
A. Specific gravity (25°/25 °C) Between 0,964 and 0,977B. Refractive index n½/C138
D25Between 1,400 and 1,405
C. Infrared spectrum characteristic of the com-
pound
Purity
Loss on drying Not more than 0,5 % (150 °C, 4h)
Viscosity Not less than 1,00.10-4m2s-1at 25 °C
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 901 BEESW AX
Synonyms White wax, yellow wax
Definition Y ellow bees wax is the wax obtained by melting the walls of the
honeycomb made by the honey bee, Apis mellifera L. , with hot water and
removing foreign matter
White beeswax is obtained by bleaching yellow beeswax
EINECS 232-383-7 (beeswax)
Description Y ellowish white (white form) or yellowish to greyish brown (yellow
form) pieces or plates with a fine-grained and non-crystalline fracture,
having an agreeable, honey-like odour
Identification
A. Melting range Between 62 °C and 65 °C
B. Specific gravity About 0,96
C. Solubility Insoluble in water
Sparingly soluble in alcohol
Very soluble in chloroform and ether!
M21996L0077 — EN — 19.11.2000 — 002.001 — 140
Purity
Acid value Not less than 17 and not more than 24
Saponification value 87-104
Peroxide value Not more than 5Glycerol and other polyols Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxes Absent
Fats, Japan wax, rosin and soaps AbsentArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 902 CANDELILLA W AXDefinition Candelilla wax is a purified wax obtained from the leaves of the
candelilla plant, Euphorbia antisyphilitica
EINECS 232-347-0
Description Hard, yellowish brown, opaque to translucent wax
Identification
A. Specific gravity About 0,983B. Melting range Between 68,5 °C and 72,5 °C
C. Solubility Insoluble in water
Soluble in chloroform and toluene
Purity
Acid value Not less than 12 and not more than 22Saponification value Not less than 43 and not more than 65
Glycerol and other polyols Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxes AbsentFats, Japan wax, rosin and soaps Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 903 CARNAUBA W AXDefinition Carnauba wax is a purified wax obtained from the leaf buds and leaves
of the Brazilian Mart wax palm, Copernicia cereferia
EINECS 232-399-4
Description Light brown to pale yellow powder or flakes or hard and brittle solid
with a resinous fracture
Identification
A. Specific gravity About 0,997
B. Melting range Between 82 °C and 86 °C
C. Solubility Insoluble in water
Partly soluble in boiling ethanol
Soluble in chloroform and diethyl ether!
M21996L0077 — EN — 19.11.2000 — 002.001 — 141
Purity
Sulphated ash Not more than 0,25 %
Acid value Not less than 2 and not more than 7
Ester value Not less than 71 and not more than 88Unsaponifiable matter Not less than 50 % and not more than 55 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 904 SHELLACSynonyms Bleached shellac, white shellac
Definition Shellac is the purified and bleached lac, the resinous secretion of the
insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae )
EINECS 232-549-9
Description Bleached shellac — off-white, amorphous, granular resin
Wax-free bleached shellac — light yellow, amorphous, granular resin
Identification
A. Solubility Insoluble in water; freely (though very slowly) soluble in alcohol;
slightly soluble in acetone
B. Acid value Between 60 and 89
Purity
Loss on drying Not more than 6,0 % (40 °C, over silica gel, 15h)
Rosin AbsentWax Bleached shellac: not more than 5,5 %
Wax-free bleached shellac: not more than 0,2 %
Lead Not more than 2 mg/kg
E 920 L-CYSTEINEDefinition L-cysteine hydrochloride or hydrochloride monohydrate. Human hair
may not be used as a source for this substance
EINECS 200-157-7 (anhydrous)
Chemical formula C
3H7NO2S/C1HCl /C1nH20(where n = 0 or 1)
Molecular weight 157,62 (anhydrous)
Assay Content not less than 98,0 % and not more than 101,5 % on the
anhydrous basis
Description White powder or colourless crystals
Identification
A. Solubility Freely soluble in water and in ethanol
B. Melting range Anhydrous form melts at about 175 °C
C. Specific rotation α½/C13820
D: between + 5,0° and + 8,0° or
α½/C13825
D: between + 4,9° and 7,9°
Purity
Loss on drying Between 8,0 % and 12,0 %
Not more than 2,0 % (anhydrous form)!M21996L0077 — EN — 19.11.2000 — 002.001 — 142
Residue on ignition Not more than 0,1 %
Ammonium-ion Not more than 200 mg/kg
Arsenic Not more than 1,5 mg/kg
Lead Not more than 5 mg/kg
E 927b CARBAMIDESynonyms Urea
Definition
EINECS 200-315-5
Chemical formula CH
4N2O
Molecular weight 60,06
Assay Content not less than 99,0 % on the anhydrous basis
Description Colourless to white, prismatic, crystalline powder or small, white pellets
Identification
A. Solubility Very soluble in water
Soluble in ethanol
B. Precipitation with nitric acid To pass the test a white, crystalline precipitate is formed
C. Colour reaction To pass the test a reddish-violet colour is produced
D. Melting range 132 °C to 135 °C
Purity
Loss on drying Not more than 1,0 % (105 °C, 1h)
Sulphated ash Not more than 0,1 %Ethanol-insoluble matter Not more than 0,04 %Alkalinity Passes test
Ammonium-ion Not more than 500 mg/kg
Biuret Not more than 0,1 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
E 938 ARGON
Definition
Chemical name Argon
EINECS 231-147-0
Chemical formula Ar
Molecular weight 40
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %Methane and other hydrocarbons calculated as
methaneNot more than 100 µl/l!
M21996L0077 — EN — 19.11.2000 — 002.001 — 143
E 939 HELIUM
Definition
Chemical name Helium
EINECS 231-168-5
Chemical formula He
Molecular weight 4
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %Methane and other hydrocarbons calculated as
methaneNot more than 100 µl/l
E 941 NITROGEN
Definition
Chemical name Nitrogen
EINECS 231-783-9
Chemical formula N
2
Molecular weight 28
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %
Carbon monoxide Not more than 10 µl/l
Methane and other hydrocarbons calculated as
methaneNot more than 100 µl/l
Nitrogen dioxide and nitrogen oxide Not more than 10 µl/l
Oxygen Not more than 1 %
E 942 NITROUS OXIDEDefinition
Chemical name Nitrous oxide
EINECS 233-032-0
Chemical formula N
2O
Molecular weight 44
Assay Not less than 99 %
Description Colourless, non-flammable gas, sweetish odour
Purity
Water Not more than 0,05 %Carbon monoxide Not more than 30 µl/l
Nitrogen dioxide and nitrogen oxide Not more than 10 µl/l!
M21996L0077 — EN — 19.11.2000 — 002.001 — 144
E 948 OXYGEN
Definition
Chemical name Oxygen
EINECS 231-956-9
Chemical formula O2
Molecular weight 32
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %Methane and other hydrocarbons calculated as
methaneNot more than 100 µl/l
E 999 QUILLAIA EXTRACT
Synonyms Soapbark extract, Quillay bark extract, Panama bark extract, Quillai
extract, Murillo bark extract, China bark extract
Definition Quillaia extract is obtained by aqueous extraction of Quillai saponaria
Molina , or other Quillaia species, trees of the family Rosaceae .I t
contains a number of triterpenoid saponins consisting of glycosides ofquillaic acid. Some sugars including glucose, galactose, arabinose,xylose, and rhamnose are also present, along with tannin, calciumoxalate and other minor components
Description Quillaia extract in the powder form is light brown with a pink tinge. It is
also available as an aqueous solution
Identification
A. pH of a 2,5 % solution Between 4,5 and 5,5
Purity
Water Not more than 6,0 % (Karl Fischer method) (powder form only)Arsenic Not more than 2 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 1103 INVERTASEDefinition Invertase is produced from Saccharomyces cerevisiae
Systematic name /betatwo-D-Fructofuranoside fructohydrolase
Enzyme Commission No EC 3.2.1.26
EINECS 232-615-7
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Cadmium Not more than 0,5 mg/kgTotal bacterial count Not more than 50 000/gSalmonella spp. Absent by test in 25 g
Coliforms Not more than 30/g!
M21996L0077 — EN — 19.11.2000 — 002.001 — 145
E. coli Absent by test in 25 g
E 1200 POLYDEXTROSESynonyms Modified polydextroses
Definition Randomly bonded glucose polymers with some sorbitol end-groups, and
with citric acid or phosphoric acid residues attached to the polymers bymono or diester bonds. They are obtained by melting and condensation
of the ingredients and consist of approximately 90 parts D-glucose, 10
parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages arepresent. The products contain small quantities of free glucose, sorbitol,levoglucosan (1,6-anhydro-D-glucose) and citric acid and may beneutralised with any food grade base and/or decolorised and deionisedfor further purification. The products may also be partially hydrogenated
with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is
neutralised polydextrose
Assay Content not less than 90 % of polymer on the ash free and anhydrous
basis
Description White to light tan-coloured solid. Polydextroses dissolve in water to give
a clear, colourless to straw coloured solution
Identification
A. Positive tests for sugar and for reducing
sugar
B. pH of a 10 % solution Between 2,5 and 7,0 for polydextrose
Between 5,0 and 6,0 for polydextrose-N
Purity
Water Not more than 4,0 % (Karl Fischer method)Sulphated ash Not more than 0,3 % (polydextrose)
Not more than 2,0 % (polydextrose N)
Nickel Not more than 2 mg/kg for hydrogenated polydextroses
1,6-Anhydro-D-glucose Not more than 4,0 % on the ash-free and the dried basisGlucose and sorbitol Not more than 6,0 % combined on the ash-free and the dried basis;
glucose and sorbitol are determined separately
Molecular weight limit Negative test for polymers of molecular weight greater than 22,000
5-Hydroxymethylfurfural Not more than 0,1 % (polydextrose)
Not more than 0,05 % (polydextrose-N)
Lead Not more than 0,5 mg/kg
E 1404 OXIDISED STARCHDefinition Oxidised starch is starch treated with sodium hypochlorite
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Carboxyl groups Not more than 1,1 %!
M21996L0077 — EN — 19.11.2000 — 002.001 — 146
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1410 MONOSTARCH PHOSPHATEDefinition Monostarch phosphate is starch esterified with ortho-phosphoric acid, or
sodium or potassium ortho-phosphate or sodium tripolyphosphate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kgMercury Not more than 0,1 mg/kg
E 1412 DISTARCH PHOSPHATEDefinition Distarch phosphate is starch cross-linked with sodium trimetaphosphate
or phosphorus oxychloride
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 147
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1413 PHOSPHATED DISTARCH PHOSPHATEDefinition Phosphated distarch phosphate is starch having undergone a combination
of treatments as described for monostarch phosphate and for distarchphosphate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1414 ACETYLATED DISTARCH PHOSPHATEDefinition Acetylated distarch phosphate is starch cross-linked with sodium
trimetaphosphate or phosphorus oxychloride and esterified by aceticanhydride or vinyl acetate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %
Residual phosphate Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 % (as P) for other starches
Vinyl acetate Not more than 0,1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 148
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1420 ACETYLATED STARCHSynonyms Starch acetate
Definition Acetylated starch is starch esterified with acetic anhydride or vinyl
acetate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %Vinyl acetate Not more than 0,1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1422 ACETYLATED DISTARCH ADIP ATE
Definition
Acetylated distarch adipate is starch cross-linked with adipic anhydride
and esterified with acetic anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %
Adipate groups Not more than 0,135 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 149
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1440 HYDROXYPROPYL STARCHDefinition Hydroxypropyl starch is starch etherified with propylene oxide
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups Not more than 7,0 %
Propylene chlorohydrin Not more than 1 mg/kgSulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kgMercury Not more than 0,1 mg/kg
E 1442 HYDROXYPROPYL DISTARCH PHOSPHATEDefinition Hydroxypropyl distarch phosphate is starch cross-linked with sodium
trimetaphosphate or phosphorus oxychloride and etherified withpropylene oxide
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups Not more than 7,0 %
Residual phosphate Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 (as P) for other starches
Propylene chlorohydrin Not more than 1 mg/kgSulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 150
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1450 STARCH SODIUM OCTENYL SUCCINATESynonyms SSOS
Definition Starch sodium octenyl succinate is starch esterified with octenylsuccinic
anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Octenylsuccinyl groups Not more than 3 %Octenylsuccinic acid residue Not more than 0,3 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1451 ACETYLATED OXIDISED STARCH
Definition Acetylated oxidised starch is starch treated with sodium hypochlorite
followed by esterification with acetic anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic ob-
servation
B. Iodine staining positive (dark blue to light
red colour)
Purity (all values expressed on an anhydrous basis
except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Carboxyl groups Not more than 1,3 %Acetyl groups Not more than 2,5 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 151
Mercury Not more than 0,1 mg/kg
E 1505 TRIETHYL CITRATESynonyms Ethyl citrate
Definition
Chemical name Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
EINECS 201-070-7
Chemical formula C
12H20O7
Molecular weight 276,29
Assay Content not less than 99,0 %
Description Odourless, practically colourless, oily liquid
Identification
A. Specific gravity d2525: 1,135-1,139
B. Refractive index n½/C138D20: 1,439-1,441
Purity
Water Not more than 0,25 % (Karl Fischer method)
Acidity Not more than 0,02 % (as citric acid)Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
E 1518 GL YCERYL TRIACETATESynonyms Triacetin
Definition
Chemical name Glyceryl triacetate
EINECS 203-051-9
Chemical formula C
9H14O6
Molecular weight 218,21
Assay Content not less than 98,0 %
Description Colourless, somewhat oily liquid having a slightly fatty odour
Identification
A. Positive tests for acetate and for glycerolB. Refractive index Between 1,429 and 1,431 at 25 °C
C. Specific gravity (25 °C/25 °C) Between 1,154 and 1,158
D. Boiling range Between 258° and 270 °C
Purity
Water Not more than 0,2 % (Karl Fischer method)
Sulphated ash Not more than 0,02 % (as citric acid)Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg!
M21996L0077 — EN — 19.11.2000 — 002.001 — 152
E 1520 PROPANE-1,2-DIOL
Synonyms Propylene glycol
Definition
Chemical names 1,2-dihydroxypropane
EINECS 200-338-0
Chemical formula C3H8O2
Molecular weight 76,10
Assay Content not less than 99,5 % on the anhydrous basis
Description Clear, colourless, hygroscopic, viscous liquid
Identification
A. Solubility Soluble in water, ethanol and acetone
B. Specific gravity d2020: 1,035-1,040
C. Refractive index n½/C13820D: 1,431-1,433
Purity
Distillation range 99 % v/v distils between 185 °C-189 °C
Sulphated ash Not more than 0,07 %Water Not more than 1,0 % (Karl Fischer method)Lead Not more than 5 mg/kg
(
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 iodinewith 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.!M21996L0077 — EN — 19.11.2000 — 002.001 — 153