1996L0077 — EN — 20.06.2001 — 003.001 — 1
This document is meant purely as a 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
Nopage date
►M1Commission Directive 98/86/EC of 11 November 1998 L 334 1 9.12.1998
►M2Commission Directive 2000/63/EC of 5 October 2000 L 277 1 30.10.2000
►M3Commission Directive 2001/30/EC of 2 May 2001 L 146 1 31.5.2001
▼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)
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 foodadditives 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 otherthan colours and 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 ofpurity for preservatives authorized for use in foodstuffs intended forhuman 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
human consumption(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Whereas Directives 65/66/EEC and 78/664/EEC should be repealed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 ofthe Scientific Committee for Food, or if different from those mentionedin this Directive, should be submitted for evaluation by the Scientific
Committee for Food 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 toin Article 3 (3) (a) o f Directive 89/107/
EEC for food additives other than colours and sweeteners, as mentionedin Directive 95/2/EC, are set out in the Annex hereto.1996L0077 — EN — 20.06.2001 — 003.001 — 2
(1) OJ NoL 40, 11. 2. 1989, p. 27.
(2) OJ NoL 237, 10. 9. 1994, p. 1.
(3) OJ NoL 61, 18. 3. 1995, p. 1.
(4) OJ No22, 9. 2. 1965, p. 373.
(5) OJ NoL 352, 13. 12. 1986, p. 45.
(6) OJ NoL 223, 14. 8. 1978, p. 30.
(7) OJ NoL 297, 23. 10. 1982, p. 31.
▼M1
Article 2
The purity criteria referred toin Article 1 replace the purity criteria set
out in Directives 65/66/EEC, 78/663/EEC and 78/664/EEC.
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 atthe time of their official publication. The procedure for such referenceshall be adopted by Member 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 tothe Member States.1996L0077 — EN — 20.06.2001 — 003.001 — 3
▼B
▼B
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 90 minutes at 105 ºC
Identification
A. Melting range Between 133 ºC and 135 ºC, after vacuum drying for
four hours in a sulphuric acid desiccator
B. Spectrometry An isopropanol solution (1 in 4 000000) shows
absorbance maximum at 254 ± 2 nm
C. Positive test for double bonds
D. Sublimation point 80 ºC
Purity
Water content Not more than 0,5 % (Karl Fischer method)
Sulphated ash Not more than 0,2 %Aldehydes Not more than 0,1 % (as formaldehyde)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 202 POTASSIUM SORBATE
Definition
Chemical name Potassium sorbate
Potassium (E,E)-2,4-hexadienoatePotassium 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 ºC
Identification
A. Melting range of sorbic acid isolated
by acidification and not recrystallized
133 ºC to135 ºC after vacuum drying in
a sulphuric acid desiccator
B. Positive tests for potassium and for
double bonds1996L0077 — EN — 20.06.2001 — 003.001 — 4
▼B
Purity
Loss on drying Not more than 1,0 % (105 ºC, 3h)
Acidity or alkalinity Not more than about 1,0 % (as sorbic acid or K2CO3)
Aldehydes Not more than 0,1 %, calculated as formaldehyde
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 203 CALCIUM SORBATEDefinition
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 ºC for 90 minutes
Identification
A. Melting range of sorbic acid isolated
by acidification and not recrystallized
133 ºC to135 ºC after vacuum drying in
a sulphuric acid desiccator
B. Positive tests for calcium and for
double bonds
Purity
Loss on drying Not more than 2,0 %, determined by vacuum drying for
four hours in a sulphuric acid desiccator
Aldehydes Not more than 0,1 % (as formaldehyde)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 210 BENZOIC ACID
Definition
Chemical name Benzoic acid
Benzenecarboxylic acidPhenylcarboxylic acid
Einecs 200-618-2
Chemical formula C
7H6O2
Molecular weight 122,12
Assay Content not less than 99,5 % on the anhydrous basis
Description White crystalline powder1996L0077 — EN — 20.06.2001 — 003.001 — 5
▼B
Identification
A. Melting range 121,5 ºC to123,5 ºCB. Positive sublimation test and test for
benzoate
Purity
Loss on drying Not more than 0,5 % after drying for three hours over
sulphuric acid
pH About 4 (solution in water)
Sulphated ash Not more than 0,05 %Chlorinated organic compounds Not more than 0,07 % expressed as chloride corre-
sponding 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 tothe nearest mg, in the heated
solution, and titrate with 0,1 N KMnO4to 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 a reference liquid containing 0,2
ml of cobalt chloride TSC (1), 0,3 ml of ferric chloride
TSC(2), 0,1 ml of copper sulphate TSC(3)and 4,4 ml of
water
Polycyclic acids On fractional acidification of a neutralized solution of
benzoic acid, the first precipitate must not have a
different melting point from that of the benzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 211 SODIUM BENZOATE
Definition
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 C7H5O2Na, after drying at 105 ºC
for four hours
Description A white, almost odourless, crystalline powder or
granules
Identification
A. Solubility Freely soluble in water, sparingly soluble in ethanol
B. Melting range for benzoic acid Melting range of benzoic acid isolated by acidification
and not recrystallized 121,5 ºC to 123,5 ºC, after drying
in a sulphuric acid desiccator
C. Positive tests for benzoate and for
sodium1996L0077 — EN — 20.06.2001 — 003.001 — 6
▼B
Purity
Loss on drying Not more than 1,5 % after drying at 105 ºC 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 KMnO4in drops, until the
pink colour persists for 30 seconds. Dissolve 1 g of the
sample, weighed tothe nearest mg, in the heated
solution, and titrate with 0,1 N KMnO4to 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 range from that of benzoic acid
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corre-
sponding 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 NaOH or 0,1 N HCl
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 212 POTASSIUM BENZOATEDefinition
Chemical name Potassium benzoate
Potassium salt of benzenecarboxylic acidPotassium salt of phenylcarboxylic acid
Einecs 209-481-3
Chemical formula C
7H5KO2·3H2O
Molecular weight 214,27
Assay Content not less than 99 % C7H5O2K after drying at
105 ºC toco nstant weight
Description White crystalline powder
Identification
A. Melting range of benzoic acid
isolated by acidification and not
recrystallized 121,5 ºC to123,5 ºC,
after vacuum drying in a sulphuric acid
desiccator
B. Positive tests for benzoate and for
potassium
Purity
Loss on drying Not more than 26,5 %, determined by drying at 105 ºC
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corre-
sponding 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 KMnO4in drops, until the
pink colour persists for 30 seconds. Dissolve 1 g of the
sample, weighed tothe nearest mg, in the heated
solution, and titrate with 0,1 N KMnO4to a pink colour
that persists for 15 seconds. Not more than 0,5 ml
should be required1996L0077 — EN — 20.06.2001 — 003.001 — 7
▼B
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 range from that of benzoic acid
Degree of acidity or alkalinity Neutralization of 1 g of potassium benzoate, in the
presence of phenolphthalein, must not require more
than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
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 213 CALCIUM BENZOATE
Synonyms Monocalcium benzoate
Definition
Chemical name Calcium benzoate
Calcium dibenzoate
Einecs 218-235-4
Chemical formula Anhydrous: C
14H10O4Ca
Monohydrate: C14H10O4Ca·H2O
Trihydrate: C14H10O4CA·3H2O
Molecular weight Anhydrous: 282,31
Monohydrate: 300,32
Trihydrate: 336,36
Assay Content not less than 99 % after drying at 105 ºC
Description White or colourless crystals, or white powder
Identification
A. Melting range of benzoic acid
isolated by acidification and not
recrystallized 121,5 ºC to123,5 ºC,
after vacuum drying in a sulphuric acid
desiccator
B. Positive tests for benzoate and for
calcium
Purity
Loss on drying Not more than 17,5 % determined by drying at 105 ºC
toco nstant weight
Water insoluble matter Not more than 0,3 %
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corre-
sponding 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 KMnO4in drops, until the
pink colour persists for 30 seconds. Dissolve 1 g of the
sample, weighed tothe nearest mg, in the heated
solution, and titrate with 0,1 N KMnO4to a pink colour
that persists for 15 seconds. Not more than 0,5 ml
should be required1996L0077 — EN — 20.06.2001 — 003.001 — 8
▼B
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 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
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 NaOH or 0,1 N HCl
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 214 ETHYL p-HYDROXYBENZOATE
Synonyms Ethylparaben
Ethylp-oxybenzoate
Definition
Chemical name Ethyl-p-hydroxybenzoate
Ethyl ester of p-hydroxybenzoic acid
Einecs 204-399-4
Chemical formula C9H10O3
Molecular weight 166,8
Assay Content not less than 99,5 % after drying for two hours
at 80 ºC
Description Almost odourless, small, colourless crystals or a white,
crystalline powder
Identification
A. Melting range 115 ºC to118 ºC
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by
acidification and not recrystallized: 213 ºC to 217 ºC,
after vacuum drying in a sulphuric acid desiccator
C. Positive test for alcohol
Purity
Loss on drying Not more than 0,5 % after drying for two hours at 80 ºCSulphated ash Not more than 0,05 %
p-Hydroxybenzoic acid and salicylic
acidNot more than 0,35 % expressed as p-hydroxybenzoic
acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 9
▼B
E 215 SODIUM ETHYL p-HYDROXYBENZOATE
Definition
Chemical name Sodium ethyl p-hydroxybenzoate
Sodium compound of the ethyl ester of p-hydroxyben-
zoic acid
Einecs 252-487-6
Chemical formula C9H9O3Na
Molecular weight 188,8
Assay Content of ethylester of p-hydroxybenzoic acid not less
than 83 % on the anhydrous basis
Description White, crystalline hygroscopic powder
Identification
A. Melting range 115 ºC to118 ºC, after vacuum drying in a sulphuric
acid desiccator
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from
the sample is 213 ºC to217 ºC
C. Positive test for sodiumD. 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 to39 %p-Hydroxybenzoic acid and salicylic
acidNot 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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 216PROPYL p-HYDROXYBENZOATE
Synonyms Propylparaben
Propylp-oxybenzoate
Definition
Chemical name Propylp-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 ºC
Description Almost odourless, small, colourless crystals or a white,
crystalline powder
Identification
A. Melting range 95 ºC to 97 ºC after drying for two hours at 80 ºCB. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from
the sample is 213 ºC to217 ºC1996L0077 — EN — 20.06.2001 — 003.001 — 10
▼B
Purity
Loss on drying Not more than 0,5 % after drying for two hours at 80 ºC
Sulphated ash Not more than 0,05 %
p-Hydroxybenzoic acid and salicylic
acidNot more than 0,35 % expressed as p-hydroxybenzoic
acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 217 SODIUM PROPYL p-HYDROXYBENZOATE
Definition
Chemical name Sodium n-propyl p-hydroxybenzoate
Sodium compound of the n-propylester of p-hydro-
xybenzoic acid
Einecs 252-488-1
Chemical formula C
10H11O3Na
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
acidification and not recrystallized:
94 ºC to97 ºC, after vacuum drying in a
sulphuric acid desiccator
B. Positive test for sodium
C. pH of a 0,1 % aqueous solution must
be between 9,8 and 10,2
Purity
Loss on drying Not more than 5 %, determined by vacuum drying in a
sulphuric acid desiccator
Sulphated ash 34 to36 %p-Hydroxybenzoic acid and salicylic
acidNot more than 0,35 % expressed as p-hydroxybenzoic
acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 218 METHYL p-HYDROXYBENZOATE
Synonyms Methylparaben
Methyl-p-oxybenzoate
Definition
Chemical name Methylp-hydroxybenzoate
Methyl ester of p-hydroxybenzoic acid
Einecs 243-171-5
Chemical formula C
8H8O31996L0077 — EN — 20.06.2001 — 003.001 — 11
▼B
Molecular weight 152,15
Assay Content not less than 99 % after drying for two hours at
80 ºC
Description Almost odourless, small colourless crystals or white
crystalline powder
Identification
A. Melting range 125 ºC to128 ºCB. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from
the sample is 213 ºC to217 ºC after drying fo r two
hours at 80 ºC
Purity
Loss on drying Notmorethan0,5%,afterdryingfortwohoursat80ºCSulphated ash Not more than 0,05 %
p-Hydroxybenzoic acid and salicylic
acidNot 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 219 SODIUM METHYL p-HYDROXYBENZOATE
Definition
Chemical name Sodium methyl p-hydroxybenzoate
Sodium compound of the methylester of p-hydroxy-
benzoic acid
Chemical formula C
8H7O3Na
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
acidifyingwithhydrochloricacida10%
(w/v) aqueous solution of the sodium
derivative of methyl p-hydroxybenzoate
(using litmus paper as indicator) shall,
when washed with water and dried at
80 ºC for two hours, have a melting
range of 125 ºC to 128 ºC
B. Positive test for sodium
C. pH of a 0,1 % solution in carbon
dioxide free water, not less than 9,7 and
not more than 10,3
Purity
Water content Not more than 5 % (Karl Fischer method)
Sulphated ash 40 % to 44,5 % on the anhydrous basisp-Hydroxybenzoic acid and salicylic
acidNot 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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 12
▼B
E 220 SULPHUR DIOXIDE
Definition
Chemical name Sulphur dioxide
Sulphurous acid anhydride
Einecs 231-195-2
Chemical formula SO2
Molecular weight 64,07
Assay Content not less than 99 %
Description Colourless, non-flammable gas with strong pungent
suffocating odour
Identification
A. Positive test for sulphurous
substances
Purity
Water content Not more than 0,05 %
Non-volatile residue Not more than 0,01 %
Sulphur trioxide Not more than 0,1 %
Selenium Not more than 10 mg/kg
Other gases not normally present in the
airNotrace
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 221 SODIUM SULPHITE
Definition
Chemical name Sodium sulphite (anhydrous or heptahydrate)
Einecs 231-821-4
Chemical formula Anhydrous: Na2SO3
Heptahydrate: Na2SO37H2O
Molecular weight Anhydrous: 126,04
Heptahydrate: 252,16
Assay Anhydrous: Not less than 95 % of Na2SO3and
not less than 48 % of SO2
Heptahydrate: Not less than 48 % of Na2SO3and
not less than 24 % of SO2
Description White crystalline powder or colourless crystals
Identification
A. Positive tests for sulphite and for
sodium
B. pH of a 10 % solution (anhydrous) or
a 20 % solution (heptahydrate) between
8,5 and 11,5
Purity
Thiosulphate Not more than 0,1 % based on the SO2content1996L0077 — EN — 20.06.2001 — 003.001 — 13
▼B
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
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 222 SODIUM BISULPHITE
Definition
Chemical name Sodium bisulphite
Sodium hydrogen sulphite
Einecs 231-921-4
Chemical formula NaHSO
3in aqueous solution
Molecular weight 104,06
Assay Content not less than 32 % w/w NaHSO3
Description A clear, colourless to yellow solution
Identification
A. Positive tests for sulphite and for
sodium
B. pH of a 10 % aqueous solution
between 2,5 and 5,5
Purity
Iron Not more than 50 mg/kg of Na2SO3based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 223 SODIUM METABISULPHITE
Synonyms Pyrosulphite
Sodium pyrosulphite
Definition
Chemical name Sodium disulphite
Disodium pentaoxodisulphate
Einecs 231-673-0
Chemical formula Na2S2O5
Molecular weight 190,11
Assay Content not less than 95 % Na2S2O5and not less than
6 4%ofS O2
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 5,51996L0077 — EN — 20.06.2001 — 003.001 — 14
▼B
Purity
Thiosulphate Not more than 0,1 % based on the SO2content
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 224 POTASSIUM METABISULPHITESynonyms Potassium pyrosulphite
Definition
Chemical name Potassium disulphite
Potassium pentaoxo disulphate
Einecs 240-795-3
Chemical formula K
2S2O5
Molecular weight 222,33
Assay Content not less than 90 % of K2S2O5and not less than
51,8 % of SO2, the remainder being composed almost
entirely of potassium sulphate
Description Colourless crystals or white crystalline powder
Identification
A. Positive tests for sulphite and for
potassium
Purity
Thiosulphate Not more than 0,1 % based on the SO2content
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
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 226CALCIUM SULPHITEDefinition
Chemical name Calcium sulphite
Einecs 218-235-4
Chemical formula CaSO
3·2H2O
Molecular weight 156,17
Assay Content not less than 95 % of CaSO3·2H2O and not less
than 39 % of SO2
Description White crystals or white crystalline powder
Identification
A. Positive tests for sulphite and for
calcium1996L0077 — EN — 20.06.2001 — 003.001 — 15
▼B
Purity
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 227 CALCIUM BISULPHITE
Definition
Chemical name Calcium bisulphite
Calcium hydrogen sulphite
Einecs 237-423-7
Chemical formula Ca(HSO
3)2
Molecular weight 202,22
Assay 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/
v) of calcium dioxide corresponding to 10 to 14 % (w/
v) of calcium bisulphite [Ca(HSO3)2]
Description Clear greenish-yellow aqueous solution having a
distinct odour of sulphur dioxide
Identification
A. Positive tests for sulphite and for
calcium
Purity
Iron Not more than 50 mg/kg based on the SO2content
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 228 POTASSIUM BISULPHITE
Definition
Chemical name Potassium bisulphite
Potassium hydrogen sulphite
Einecs 231-870-1
Chemical formula KHSO
3in aqueous solution
Molecular weight 120,17
Assay Content not less than 280 g KHSO3per litre (or 150 g
SO2per 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 SO2content1996L0077 — EN — 20.06.2001 — 003.001 — 16
▼B
Selenium Not more than 10 mg/kg based on the SO2content
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 230 BIPHENYLSynonyms Diphenyl
Definition
Chemical name 1,1′-biphenyl
Phenylbenzene
Einecs 202-163-5
Chemical formula C
12H10
Molecular weight 154,20
Assay Content not less than 99,8 %
Description White or pale yellow to amber crystalline solid having
a characteristic odour
Identification
A. Melting range 68,5 ºC to70,5 ºC
B. Distillation range It distils completely within a 2,5 ºC range between
252,5 ºC and 257,5 ºC
Purity
Benzene Not more than 10 mg/kg
Aromatic amines Not more than 2 mg/kg (as aniline)Phenol derivatives Not more than 5 mg/kg (as phenol)
Readily 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 liquid containing 0,2
ml of cobalt chloride TSC, 0,3 ml of ferric chloride
TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of
water
Terphenyl and higher polyphenyl deri-
vativesNot more than 0,2 %
Polycyclic aromatic hydrocarbons Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/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 170,201996L0077 — EN — 20.06.2001 — 003.001 — 17
▼B
Assay Content not less than 99 %
Description White or slightly yellowish crystalline powder
Identification
A. Melting range 56 ºC to58 ºCB. 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 232 SODIUM ORTHOPHENYLPHENOL
Synonyms 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 C12H9ONa·4H2O
Description White or slightly yellowish crystalline powder
Identification
A. Positive tests for phenolate and for
sodium
B. Melting range of orthophenylphenol
isolated by acidification and not
recrystallized derived from the sample
56 ºC to58 ºC after drying in a
sulphuric acid desiccator
C. pH of a 2 % aqueous solution must
be between 11,1 and 11,8
Purity
Diphenylether Not more than 0,3 %p-phenylphenol Not more than 0,1 %
1-naphthol Not more than 0,01 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 18
▼B
E 233 THIABENDAZOLE
Definition
Chemical name 4-(2-benzimidazolyl)thiazole
2-(4-thiazolyl)-1H-benzimidazole
Einecs 1205-725-8
Chemical formula C10H7N3S
Molecular weight 201,26
Assay Content not less than 98 % on the anhydrous basis
Description White, or almost white, odourless powder
Identification
A. Melting range 296 ºC to303 ºC
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/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 234 NISIN
Definition Nisin consists of several closely related polypeptides
produced by natural strains of Streptococcus lactis ,
Lancefield group N
Einecs 215-807-5
Chemical formula 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 ºC to103 ºC
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 19
▼B
E 235 NATAMYCIN
Synonyms Pimaricin
Definition Natamycin is a fungicide of the polyene macrolide
group, and is produced by natural strains of Strepto-
myces natalensis orofStreptococcus lactis
Einecs 231-683-5
Chemical formula C33H47O13N
Molecular weight 665,74
Assay Content not less than 95 % on the anhydrous basis
Description White tocreamy-white crystalline po wder
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 intopale red after a few minutes
B. Spectrometry A 0,0005 % w/v solution in 1 % methanolic acetic acid
solution has absorption maxima at about 290 nm, 303
nm and 318 nm, a shoulder at about 280 nm and
exhibits minima at about 250nm, 295,5nm and 311 nm
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 rotation /C11½/C13820
D= + 250 º to + 295 º (a 1 % w/v solution in
glacial acetic acid, at 20 ºC and calculated
with reference tothe dried material)
Purity
Loss on drying Not more than 8 % (over P2O5, in vacuum at 60 ºC to
constant weight)
Sulphated ash Not more than 0,5 %
Arsenic Not more than 3 mg/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 viable
countNot 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, hexamethy-
lenetetramine
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 powder1996L0077 — EN — 20.06.2001 — 003.001 — 20
▼B
Identification
A. Positive tests for formaldehyde and
for ammonia
B. Sublimation point approximately
260 ºC
Purity
Loss on drying Not more than 0,5 % after drying at 105 ºC in vacuum
over P2O5for 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 ClAmmonium salts Not detectable
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 242 DIMETHYL DICARBONATESynonyms DMDC
Dimethyl pyrocarbonate
Definition
Einecs 224-859-8
Chemical name Dimethyl dicarbonate
Pyrocarbonic acid dimethyl ester
Chemical formula C
4H6O5
Molecular weight 134,09
Assay Content not less than 99,8 %
Description Colourless liquid, decomposes in aqueous solution. It is
corrosive to skin and eyes and toxic by inhalation and
ingestion
Identification
A. Decomposition After dilution positive tests for CO2and methanol
B. Melting point
Boiling point17 ºC
172 ºC with decomposition
C. Density 20 ºC Approximately 1,25 g/cm3
D. Infrared spectrum Maxima at 1 156 and 1 832 cm−1
Purity
Dimethyl carbonate Not more than 0,2 %
Chlorine, total Not more than 3 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 21
▼B
E 249 POTASSIUM NITRITE
Definition
Chemical name Potassium nitrite
Einecs 231-832-4
Chemical formula KNO2
Molecular weight 85,11
Assay Content not less than 95 % on the anhydrous basis (4)
Description White or slightly yellow, deliquescent granules
Identification
A. Positive tests for nitrite and for
potassium
B. pH of a 5 % solution: not less than
6,0 and not more than 9,0
Purity
Loss on drying Not more than 3 % after drying for four hours over
silica gel
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 250 SODIUM NITRITEDefinition
Chemical name Sodium nitrite
Einecs 231-555-9
Chemical formula NaNO
2
Molecular weight 69,00
Assay Content not less than 97 % on the anhydrous basis (4)
Description White crystalline powder or yellowish lumps
Identification
A. Positive tests for nitrite and for
sodium
Purity
Loss on drying Not more than 0,25 % after drying over silica gel for
four hours
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 251 SODIUM NITRATESynonyms Chile saltpetre
Cubic or soda nitre
Definition
Chemical name Sodium nitrate1996L0077 — EN — 20.06.2001 — 003.001 — 22
▼B
Einecs 231-554-3
Chemical formula NaNO3
Molecular weight 85,00
Assay Content not less than 99 % after drying at 105 ºC for
four hours
Description White crystalline, slightly hygroscopic powder
Identification
A. Positive tests for nitrate and for
sodium
B. pH of a 5 % solution Not less than 5,5 and more than 8,3
C. Melting point: ± 308 ºC
Purity
Loss on drying Not more than 2 % after drying at 105 ºC for four hours
Nitrites Not more than 30 mg/kg expressed as NaNO2
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 252 POTASSIUM NITRATE
Synonyms 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 ºC for four hoursNitrites Not more than 20 mg/kg expressed as KNO
2
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 260 ACETIC ACID
Definition
Chemical name Acetic acid
Ethanoic acid1996L0077 — EN — 20.06.2001 — 003.001 — 23
▼B
Einecs 200-580-7
Chemical formula C2H4O2
Molecular weight 60,05
Assay Content not less than 99,8 %
Description Clear, colourless liquid having a pungent, characteristic
odour
Identification
A. Boiling point 118 ºC at 760 mm pressure (of mercury)B. Specific gravity About 1,049C. A one in three solution gives positive
tests for acetate
D. Solidification point Not lower than 14,5 ºC
Purity
Non-volatile residue Not more than 100 mg/kgFormic 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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 261 POTASSIUM ACETATEDefinition
Chemical name Potassium acetate
Einecs 204-822-2
Chemical formula C
2H3O2K
Molecular weight 98,14
Assay Content not less than 99 % on the anhydrous basis
Description Colourless, deliquescent crystals or a white crystalline
powder, odourless or with a faint acetic odour
Identification
A. pH of a 5 % aqueous solution Not less than 7,5 and not more than 9,0B. Positive tests for acetate and for
potassium
Purity
Loss on drying Not more than 8 % after drying at 150 ºC 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/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 24
▼B
E 262 (i) SODIUM ACETATE
Definition
Chemical name Sodium acetate
Einecs 204-823-8
Chemical formula C2H3NaO2·nH2O( n=0or3 )
Molecular weight Anhydrous: 82,03
Trihydrate: 136,08
Assay Content (for both of anhydrous and trihydrate form) not
less than 98,5 % on the anhydrous basis
Description Anhydrous: White, odourless, granular, hygro-
scopic powder
Trihydrate: Colourless, transparent crystals or
a granular crystalline powder,
odourless or with a faint, acetic
odour. Effloresces in warm, dry air
Identification
A. pH of a 1 % aqueous solution Not less than 8,0 and not more than 9,5B. Positive tests for acetate and for
sodium
Purity
Loss on drying Anhydrous: Not more than 2 % (120 ºC, 4
hours)
Trihydrate: Between 36 and 42 % (120 ºC, 4
hours)
Formic acid, formates and other
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/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
4H7NaO4·nH2O( n=0or3 )
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 5,0B. Positive tests for acetate and for
sodium
Purity
Water content Not more than 2 % (Karl Fischer method)1996L0077 — EN — 20.06.2001 — 003.001 — 25
▼B
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 263 CALCIUM ACETATE
Definition
Chemical name Calcium acetate
Einecs 200-540-9
Chemical formula Anhydrous: C
4H6O4Ca
Monohydrate: C4H6O4Ca·H2O
Molecular weight Anhydrous: 158,17
Monohydrate: 176,18
Assay Content not less than 98 % on the anhydrous basis
Description Anhydrous calcium acetate is a white, hygroscopic,
bulky, crystalline solid with a slightly bitter taste. A
slight odour of acetic acid may be present. The
monohydrate may be needles, granules or powder
Identification
A. pH of a 10 % aqueous solution Not less than 6,0 and not more than 9,0B. Positive tests for acetate and for
calcium
Purity
Loss on drying Not more than 11 % after drying (155 ºC to constant
weight, for the monohydrate)
Water insoluble matter Not more than 0,3 %
Formic acid, formates and other
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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 270 LACTIC ACIDDefinition
Chemical name Lactic acid
2-Hydroxypropionic acid1-Hydroxyethane-1-carboxylic acid
Einecs 200-018-0
Chemical formula C
3H6O3
Molecular weight 90,08
Assay Content not less than 76 % and not more than 84 %
Description Colourless or yellowish, nearly odourless, syrupy liquid
with an acid taste, consisting of a mixture of lactic acid
(C3H6O3) and lactic acid lactate (C6H10O5). It is obtained
by the lactic fermentation of sugars or is prepared
synthetically1996L0077 — EN — 20.06.2001 — 003.001 — 26
▼B
Note:
Lactic acid is hygroscopic and when
concentrated by boiling, it condenses to
form lactic acid lactate, which on
dilution and heating hydrolyzes to lactic
acid
Identification
A. Positive test for lactate
Purity
Sulphated ash Not more than 0,1 %Chloride Not more than 0,2 %Sulphate Not more than 0,25 %Iron Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgNote:
This specification refers to a 80 %
aqueous solution; for weaker aqueous
solutions, calculate values corre-
sponding 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 ºCB. Distillation range 138,5 ºC to 142,5 ºC
Purity
Non-volatile residue Not more than 0,01 % when dried at 140 ºC to constant
weight
Aldehydes Not more than 0,1 % expressed as formaldehyde
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 27
▼B
E 281 SODIUM PROPIONATE
Definition
Chemical name Sodium propionate
Sodium propanoate
Einecs 205-290-4
Chemical formula C3H5O2Na
Molecular weight 96,06
Assay Content not less than 99 % after drying for two hours at
105 ºC
Description White crystalline hygroscopic powder, or a fine white
powder
Identification
A. Positive tests for propionate and for
sodium
B. pH of a 10 % aqueous solution Not less than 7,5 and not more than 10,5
Purity
Loss on drying Not more than 4 % determined by drying for two hours
at 105 ºC
Water insolubles Not more than 0,1 %
Iron Not more than 50 mg/kg
Arsenic Not more than 3 mg/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 282 CALCIUM PROPIONATEDefinition
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 ºC
Description White crystalline powder
Identification
A. Positive tests for propionate and for
calcium
B. pH of a 10 % aqueous solution Between 6,0 and 9,0
Purity
Loss on drying Not more than 4 %, determined by drying for two hours
at 105 ºC
Water insolubles Not more than 0,3 %
Iron Not more than 50 mg/kgFluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 28
▼B
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 283 POTASSIUM PROPIONATE
Definition
Chemical name Potassium propionate
Potassium propanoate
Einecs 206-323-5
Chemical formula C3H5KO2
Molecular weight 112,17
Assay Content not less than 99 % after drying for two hours at
105 ºC
Description White crystalline powder
Identification
A. Positive tests for propionate and for
potassium
Purity
Loss on drying Not more than 4 %, determined by drying for two hours
at 105 ºC
Water-insoluble substances Not more than 0,3 %Iron Not more than 30 mg/kgFluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 284 BORIC ACID
Synonyms Boracic acid
Orthoboric acid
Borofax
Definition
Einecs 233-139-2
Chemical formula H
3BO3
Molecular weight 61,84
Assay Content not less than 99,5 %
Description Colourless, odourless, transparent crystals or white
granules or powder; slightly unctuous to the touch;
occurs in nature as the mineral sassolite
Identification
A. Melting point At approximately 171 ºC
B. Burns with a nice green flame
C. pH of a 3,3 % aqueous solution Between 3,8 and 4,8
Purity
Peroxides No colour develops with added KI-solutionArsenic Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 29
▼B
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 285 SODIUM TETRABORATE (BORAX)Synonyms Sodium borate
Definition
Chemical name Sodium tetraborate
Sodium biborate
Sodium pyroborateAnhydrous tetraborate
Einecs 215-540-4
Chemical formula Na
2B4O7
Na2B4O7·10H2O
Molecular weight 201,27
Description Powder or glass-like plates becoming opaque on
exposure to air; slowly soluble in water
Identification
A. Melting range Between 171 ºC and 175 ºC with decomposition
Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 290 CARBON DIOXIDE
Synonyms Carbonic acid gas
Dry ice (solid form)
Carbonic anhydride
Definition
Chemical name Carbon dioxide
Einecs 204-696-9
Chemical formula CO2
Molecular weight 44,01
Assay Content not less than 99 % v/v on the gaseous basis
Description A colourless gas under normal environmental condi-
tions with a slight pungent odour. Commercial carbon
dioxide is shipped and handled as a liquid 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 acid1996L0077 — EN — 20.06.2001 — 003.001 — 30
▼B
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 phos-
phide and sulphide915 ml of gas bubbled through 25 ml of ammoniacal
silver nitrate reagent towhich has been added 3 ml o f
ammonia must not cause clouding or blackening of this
solution
Carbon monoxide Not more than 10 µl/l
Oil content Not more than 0,1 mg/l
E 300 ASCORBIC ACID
Definition
Chemical name L-ascorbic acid
Ascorbic acid2,3-Didehydro-L-threo-hexono-1,4-lactone
3-Keto-L-gulofuranolactone
Einecs 200-066-2
Chemical formula C
6H8O6
Molecular weight 176,13
Assay Ascorbic acid, after drying in a vacuum desiccator over
sulphuric acid for 24 hours, contains not less than 99 %
ofC6H8O6
Description White to pale yellow, odourless crystalline solid
Identification
A. Melting range Between 189 ºC and 193 ºC with decomposition
B. Positive tests for ascorbic acid
Purity
Loss on drying Not more than 0,4 % after drying in a vacuum
desiccator over sulphuric acid for 24 hours
Sulphated ash Not more than 0,1 %Specific rotation /C11½/C138
20
Dbetween + 20,5 º and + 21,5 º (10 % w/v
aqueous solution)
pH of a 2 % aqueous solution Between 2,4 and 2,8
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 301 SODIUM ASCORBATE
Definition
Chemical name Sodium ascorbate
Sodium L-ascorbate2,3-Didehydro-L-threo-hexono-1,4-lactone sodium
enolate
3-Keto-L-gulofurano-lactone sodium enolate
Einecs 205-126-1
Chemical formula C
6H7O6Na1996L0077 — EN — 20.06.2001 — 003.001 — 31
▼B
Molecular weight 198,11
Assay Sodium ascorbate, after drying in a vacuum desiccator
over sulphuric acid for 24 hours, contains not less than
9 9%ofC6H7O6Na
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 /C11½/C13820
Dbetween + 103 º and + 106 º (10 % w/v aqueous
solution)
pH of 10 % aqueous solution Between 6,5 and 8,0
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 302 CALCIUM ASCORBATE
Definition
Chemical name Calcium ascorbate dihydrate
Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-
lactone dihydrate
Einecs 227-261-5
Chemical formula C12H14O12Ca·2H2O
Molecular weight 426,35
Assay Content not less than 98 % on a volatile matter-free
basis
Description White to slightly pale greyish-yellow odourless crystal-
line powder
Identification
A. Positive tests for ascorbate and for
calcium
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Specific rotation /C11½/C13820
Dbetween + 95 º and + 97 º (5 % w/v aqueous
solution)
pH of 10 % aqueous solution Between 6,0 and 7,5
Volatile matter Not more than 0,3 % determined by drying at room
temperature for 24 hours in a desiccator containing
sulphuric acid or phosphorus pentoxide
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 32
▼B
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 ºC and 117 ºC
Purity
Loss on drying Not more than 2,0 % after drying in a vacuum oven at
56 ºC and 60 ºC for one hour
Sulphated ash Not more than 0,1 %
Specific rotation /C11½/C13820
Dbetween + 21 º and + 24 º (5 % w/v in methanol
solution)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 304 (ii) ASCORBYL STEARATE
Definition
Chemical name Ascorbyl stearate
L-ascorbyl stearate2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate
6-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 ºC
Purity
Loss on drying Not more than 2,0 % after drying in a vacuum oven at
56 ºC to 60 ºC for one hour
Sulphated ash Not more than 0,1 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 33
▼B
E 306TOCOPHEROL-RICH EXTRACT
Definition Product obtained by the vacuum steam distillation of
edible vegetable oil products, comprising concentrated
tocopherols and tocotrienols
Contains tocopherols such as d- α-, d- β-, d- γ- and d- ς-
tocopherols
Molecular weight 430,71 (d- α-tocopherol)
Assay Content not less than 34 % of total tocopherols
Description Brownish red to red, clear, viscous oil having a mild,
characteristic odour and taste. May show a slight
separation of wax-like constituents in microcrystalline
form
Identification
A. By suitable gas liquid chromato-
graphic method
B. Solubility tests Insoluble in water. Soluble in ethanol. Miscible in ether
Purity
Sulphated ash Not more than 0,1 %
Specific rotation /C11½/C13820
Dnot less than + 20 º
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 307 ALPHA-TOCOPHEROL
Synonyms dl-α-Tocopherol
Definition
Chemical name dl-5,7,8-Trimethyltocol
dl-2,5,7,8-tetramethyl-2-(4 ′,8′,12′-trimethyltridecyl)-6-
chromanol
Einecs 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
toair o r light
Identification
A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in
ether
B. Spectrophotometry In absolute ethanol the maximum absorption is about
292 nm
Purity
Refractive index n20
D1,503 — 1,507
Specific absorption E1%
1c min ethanol E1%1c m(292 nm) 72—76
(0,01 g in 200 ml of absolute ethanol)
Sulphated ash Not more than 0,1 %
Specific rotation /C11½/C13820
D0 º ± 0,05 º (1 in 10 solution in chloroform)1996L0077 — EN — 20.06.2001 — 003.001 — 34
▼B
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 308 GAMMA-TOCOPHEROLSynonyms dl-γ-Tocopherol
Definition
Chemical name 2,7,8-trimethyl-2-(4 ′,8′,12′-trimethyltridecyl)-6-chro-
manol
Einecs 231-523-4
Chemical formula C
28H48O2
Molecular weight 416,69
Assay Content not less than 97 %
Description Clear, viscous, pale yellow oil which oxidizes and
darkens on exposure to air or light
Identification
A. Spectrometry Maximum absorptions in absolute ethanol at about 298
nm and 257 nm
Purity
Specific absorption E1%
1c min ethanol E1%1c m(298 nm) between 91 and 97
E1%
1c m(257 nm) between 5,0 and 8,0
Refractive index n20
D1,503—1,507
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 309 DELTA-TOCOPHEROLDefinition
Chemical name 2,8-dimethyl-2-(4 ′,8′,12′-trimethyltridecyl)-6-chro-
manol
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 %1996L0077 — EN — 20.06.2001 — 003.001 — 35
▼B
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 310 PROPYL GALLATEDefinition
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 ºC and 150 ºC after drying at 110 ºC for
four hours
Purity
Loss on drying Not more than 1,0 % (110 ºC, four hours)
Sulphated ash Not more than 0,1 %
Free acid Not more than 0,5 % (as gallic acid)Chlorinated organic compound Not more than 100 mg/kg (as C1)
Specific absorption E
1%
1c min ethanol E1%1c m(275 nm) not less than 485 and not more than
520
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 311 OCTYL GALLATEDefinition
Chemical name Octyl gallate
Octyl ester of gallic acidn-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 ºC for six
hours
Description White to creamy-white odourless solid
Identification
A. Solubility tests Insoluble in water, freely soluble in ethanol, ether and
propane-1,2-diol1996L0077 — EN — 20.06.2001 — 003.001 — 36
▼B
B. Melting range Between 99 ºC and 102 ºC after drying at 90 ºC for six
hours
Purity
Loss on drying Not more than 0,5 % (90 ºC, six hours)Sulphated ash Not more than 0,05 %Free acid Not more than 0,5 % (as gallic acid)
Chlorinated organic compound Not more than 100 mg/kg (as C1)
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/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 312 DODECYL GALLATE
Synonyms Lauryl gallate
Definition
Chemical name Dodecyl gallate
n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic
acid
Dodecyl ester of gallic acid
Einecs 214-620-6
Chemical formula C
19H30O5
Molecular weight 338,45
Assay Content not less than 98 % after drying at 90 ºC for six
hours
Description White or creamy-white odourless solid
Identification
A. Solubility tests Insoluble in water, freely soluble in ethanol and ether
B. Melting range Between 95 ºC and 98 ºC after drying at 90 ºC for six
hours
Purity
Loss on drying Not more than 0,5 % (90 ºC, six hours)Sulphated ash Not more than 0,05 %
Free acid Not more than 0,5 % (as gallic acid)
Chlorinated organic compound Not more than 100 mg/kg (as Cl)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/kgLead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 30 mg/kg
E 315 ERYTHORBIC ACID
Synonyms Isoascorbic acid
D-araboascorbic acid1996L0077 — EN — 20.06.2001 — 003.001 — 37
▼B
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 ºC to 172 ºC with decomposition
B. Positive test for ascorbic acid/colour
reaction
Purity
Loss on drying Not more than 0,4 % after drying under reduced
pressure on silica gel for 3 hours
Sulphated ash Not more than 0,3 %
Specific rotation /C11½/C13825
D10 % (w/v) aqueous solution between − 16,5 º
to− 18,0 º
Oxalate To a solution of 1 g in 10 ml of water add 2 drops of
glacial acetic acid and 5 ml of 10 % calcium acetate
solution. The solution should remain clear
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 316SODIUM 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 monohy-
drate
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 ethanolB. Positive test for ascorbic acid/colour
reaction
C. Positive test for sodium1996L0077 — EN — 20.06.2001 — 003.001 — 38
▼B
Purity
Loss on drying Not more than 0,25 % after drying in a vacuum
desiccator over sulphuric acid for 24 hours
Specific rotation /C11½/C13825
D10 % (w/v) aqueous solution between + 95 º
and + 98 º
pH of a 10 % aqueous solution 5,5 to 8,0Oxalate To a solution of 1 g in 10 ml of water add 2 drops of
glacial acetic acid and 5 ml of 10 % calcium acetate
solution. The solution should remain clear
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy 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 C 11H16O2and not less
than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer
Description White or slightly yellow crystals or waxy solid with a
slight aromatic smell
Identification
A. Solubility Insoluble in water, freely soluble in ethanol
B. Melting range Between 48oC and 63oC
C. Colour reaction Passes test for phenol groups
Purity
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25oC
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/kgLead Not more than 5 mg/kgMercury 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-ditertiarybutylphenol1996L0077 — EN — 20.06.2001 — 003.001 — 39
▼M2
▼B
▼B
Einecs 204-881-4
Chemical formula C15H24O
Molecular weight 220,36
Assay Content not less than 99 %
Description White, crystalline or flaked solid, odourless or having a
characteristic faint aromatic odour
Identification
A. Solubility tests Insoluble in water and propane- 1,2-diol
Freely soluble in ethanol
B. Melting point At 70 ºC
C. Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm
layer of a 1 in 100000 solution in dehydrated ethanol
exhibits a maximum only at 278 nm
Purity
Sulphated ash Not more than 0,005 %
Phenolic impurities Not more than 0,5 %
Specific absorption E1%
1c min ethanol E1%1c m(278 nm) not less than 81 and not more than 88
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 322 LECITHINS
Synonyms Phosphatides
Phospholipids
Definition Lecithins are mixtures or fractions of phosphatides
obtained by physical procedures from animal or
vegetable foodstuffs; they also include hydrolysed
products obtained through the use of harmless and
appropriate enzymes. The final product must not show
any signs of residual enzyme activity
The lecithins may be slightly bleached in aqueous
medium by means of hydrogen peroxide. This oxida-
tion must not chemically modify the lecithin
phosphatides
Einecs 232-307-2
Assay — Lecithins: not less than 60,0 % of substances
insoluble in acetone
— Hydrolysed lecithins: not less than 56,0 % of
substances insoluble in acetone
Description — Lecithins: brown liquid or viscous semi-liquid or
powder
— Hydrolysed lecithins: light brown to brown viscous
liquid or paste
Identification
A. Positive tests for choline, for phos-
phorus and fatty acids
B. Test for hydrolysed lecithin Toa800mlbeakeradd500mlofwater(30ºC—35ºC).
Then slowly add 50 ml of the sample with constant
stirring. Hydrolysed lecithin will form a homogeneousemulsion. Non-hydrolysed lecithin will form a distinct
mass of about 50 g1996L0077 — EN — 20.06.2001 — 003.001 — 40
▼B
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 ºC
for one hour
Toluene-insoluble matter Not more than 0,3 %Acid value — Lecithins: not more than 35 mg of potassium
hydroxide per gram
— Hydrolysed lecithins: not more than 45 mg of
potassium hydroxide per gram
Peroxide value Equal to or less than 10
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 325 SODIUM LACTATEDefinition
Chemical name Sodium lactate
Sodium 2-hydroxypropanoate
Einecs 200-772-0
Chemical formula C
3H5NaO3
Molecular weight 112,06 (anhydrous)
Assay Content not less than 57 % and not more than 66 %
Description Colourless, transparent, liquid
Odourless, or with a slight, characteristic odour
Identification
A. Positive test for lactate
B. Positive test for potassium
Purity
Acidity Not more than 0,5 % after drying expressed as lactic
acid
pH of a 20 % aqueous solution 6,5 to 7,5
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/kgReducing substances No reduction of Fehling's solution
Note:
This specification refers to a 60 %
aqueous solution
E 326POTASSIUM LACTATE
Definition
Cheminal name Potassium lactate
Potassium 2-hydroxypropanoate
Einecs 213-631-3
Chemical formula C
3H5O3K
Molecular weight 128,17 (anhydrous)1996L0077 — EN — 20.06.2001 — 003.001 — 41
▼B
Assay Content not less than 57 % and not more than 66 %
Description Slightly viscous, almost odourless clear liquid. Odour-
less, or with a slight, characteristic odour
Identification
A. Ignition Ignite potassium lactate solution to an ash. The ash is
alkaline, and an effervescence occurs when acid is
added
B. Colour reaction Overlay 2 ml of potassium lactate solution on 5 ml of a
1 in 100 solution of catechol in sulphuric acid. A deep
red colour is produced at the zone of contact
C. Positive tests for potassium and for
lactate
Purity
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy 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
E 327 CALCIUM LACTATE
Definition
Chemical name Calcium dilactate
Calcium dilactate hydrate2-Hydroxypropanoic acid calcium salt
Einecs 212-406-7
Chemical formula (C
3H5O2)2Ca·nH2O (n = 0—5)
Molecular weight 218,22 (anhydrous)
Assay Content not less than 98 % on the anhydrous basis
Description Almost odourless, white crystalline powder or granules
Identification
A. Positive tests for lactate and for
calcium
B. Solubility tests Soluble in water and practically insoluble in ethanol
Purity
Loss on drying Determined by drying at 120 ºC for four hours:
— anhydrous: not more than 3,0 %
— with 1 molecule of water: not more than 8,0 %— with 3 molecules of water: not more than 20,0 %— with 4,5 molecules of water: not more than 27,0 %
Acidity Not more than 0,5 % of the dry matter expressed as
lactic acid
Fluoride Not more than 30 mg/kg (expressed as fluorine)1996L0077 — EN — 20.06.2001 — 003.001 — 42
▼B
pH of a 5 % solution Between 6,0 and 8,0
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury 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 ACIDDefinition
Chemical name Citric acid
2-Hydroxy-1,2,3-propanetricarboxylic acid
β-Hydroxytricarballytic acid
Einecs 201-069-1
Chemical formula (a) C
6H8O7(anhydrous)
(b) C6H8O7·H2O (monohydrate)
Molecular weight (a) 192,13 (anhydrous)
(b) 210,15 (monohydrate)
Assay Citric acid may be anhydrous or it may contain 1
molecule of water. Citric acid contains not less than
99,5 % of C6H8O7, calculated on the anhydrous basis
Description Citric acid is a white or colourless, odourless, crystal-
line solid, having a strongly acid taste. The
monohydrate effloresces in dry air
Identification
A. Solubility tests Very soluble in water; freely soluble in ethanol; soluble
in ether
Purity
Water content Anhydrous citric acid contains not more than 0,5 %
water; citric acid monohydrate contains not more than
8,8 % water (Karl Fischer method)
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 ºCArsenic 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/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 ºC in the
dark for one hour. Not more than a pale 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-propanetricar-
boxylic acid1996L0077 — EN — 20.06.2001 — 003.001 — 43
▼B
Chemical formula (a) C6H7O7Na (anhydrous)
(b) C6H7O7Na·H2O (monohydrate)
Molecular weight (a) 214,11 (anhydrous)
(b) 232,23 (monohydrate)
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A. Positive tests for citrate and for
sodium
Purity
Loss on drying Determined by drying at 180 ºC for four hours:
— anhydrous: not more than 1,0 %
— monohydrate: not more than 8,8 %
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 1 % aqueous solution Between 3,5 and 3,8Arsenic Not more than 1 mg/kgLead Not more than 1 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E 331 (ii) DISODIUM CITRATE
Synonyms Disodium citrate
Dibasic sodium citrate
Definition
Chemical name Disodium citrate
Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic
acid
Disodium salt of citric acid with 1,5 molecules of water
Einecs 205-623-3
Chemical formula C
6H6O7Na2·1,5H2O
Molecular weight 263,11
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A. Positive tests for citrate and for
sodium
Purity
Loss on drying Not more than 13,0 % by drying at 180 ºC for four
hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 1 % aqueous solution Between 4,9 and 5,2
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 44
▼B
E 331 (iii) TRISODIUM CITRATE
Synonyms Trisodium citrate
Tribasic sodium citrate
Definition
Chemical name Trisodium citrate
Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic
acid
Trisodium salt of citric acid, in anhydrous, dihydrate or
pentahydrate form
Einecs 200-675-3
Chemical formula Anhydrous: C6H5O7Na3
Hydrated: C6H5O7Na3·nH2O( n=2or5 )
Molecular weight 258,07 (anhydrous)
Assay Not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A. Positive tests for citrate and for
sodium
Purity
Loss on drying Determined by drying at 180 ºC for four hours:
— anhydrous: not more than 1,0 %
— dihydrate: not more than 13,5 %
— pentahydrate: not more than 30,3 %
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 5 % aqueous solution Between 7,5 and 9,0
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E 332 (i) MONOPOTASSIUM CITRATE
Synonyms Monopotassium citrate
Monobasic potassium citrate
Definition
Chemical name Monopotassium citrate
Monopotassium salt of 2-hydroxy-1,2,3-propanetricar-
boxylic acid
Anhydrous monopotassium salt of citric acid
Einecs 212-753-4
Chemical formula C6H7O7K
Molecular weight 230,21
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent
crystals1996L0077 — EN — 20.06.2001 — 003.001 — 45
▼B
Identification
A. Positive tests for citrate and for
potassium
Purity
Loss on drying Not more than 1,0 % determined by drying at 180 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 1 % aqueous solution Between 3,5 and 3,8
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E 332 (ii) TRIPOTASSIUM CITRATE
Synonyms Tripotassium citrate
Tribasic potassium citrate
Definition
Chemical name Tripotassium citrate
Tripotassium salt of 2-hydroxy-1,2,3-propanetricar-
boxylic acid
Monohydrated tripotassium salt of citric acid
Einecs 212-755-5
Chemical formula C6H5O7K3·H2O
Molecular weight 324,42
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent
crystals
Identification
A. Positive tests for citrate and for
potassium
Purity
Loss on drying Not more than 6,0 % determined by drying at 180 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 5 % aqueous solution Between 7,5 and 9,0
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kgMercury 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 citrate1996L0077 — EN — 20.06.2001 — 003.001 — 46
▼B
Definition
Chemical name Monocalcium citrate
Monocalcium salt of 2-hydroxy-1,2,3-propanetricar-
boxylic acid
Monohydrate monocalcium salt of citric acid
Chemical formula (C6H7O7)2Ca·H2O
Molecular weight 440,32
Assay Content not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification
A. Positive tests for citrate and for
calcium
Purity
Loss on drying Not more than 7,0 % determined by drying at 180 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 1 % aqueous solution Between 3,2 and 3,5
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N
hydrochloric acid must not liberate more than a few
isolated bubbles
E 333 (ii) DICALCIUM CITRATESynonyms Dicalcium citrate
Dibasic calcium citrate
Definition
Chemical name Dicalcium citrate
Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic
acid
Trihydrated dicalcium salt of citric acid
Chemical formula (C
6H7O7)2Ca2·3H2O
Molecular weight 530,42
Assay Not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification
A. Positive tests for citrate and for
calcium
Purity
Loss on drying Not more than 20,0 % determined by drying at 180 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Fluoride Not more than 30 mg/kg (expressed as fluorine)1996L0077 — EN — 20.06.2001 — 003.001 — 47
▼B
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/kgCarbonates 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-propanetricar-
boxylic 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 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Fluoride Not more than 30 mg/kg (expressed as fluorine)Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy 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 ACID
Definition
Chemical name L-tartaric acid
L-2,3-dihydroxybutanedioic acid
d-α,β-dihydroxysuccinic acid
Einecs 201-766-0
Chemical formula C
4H6O6
Molecular weight 150,09
Assay Content not less than 99,5 % on the anhydrous basis
Description Colourless or translucent crystalline solid or white
crystalline powder1996L0077 — EN — 20.06.2001 — 003.001 — 48
▼B
Identification
A. Melting range Between 168 ºC and 170 ºC
B. Positive test for tartrate
Purity
Loss on drying Not more than 0,5 % (over P2O5, three hours)
Sulphated ash Not more than 1 000 mg/kg after calcination at 800 ±
25 ºC
Specific optical rotation of a 20 % w/v
aqueous solution/C11½/C13820
Dbetween + 11,5 º and + 13,5 º
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
E 335 (i) MONOSODIUM TARTRATE
Synonyms Monosodium salt of L-(+)-tartaric acid
Definition
Chemical name Monosodium salt of L-2,3-dihydroxybutanedioic acid
Monohydrated monosodium salt of L-(+)-tartaric acid
Chemical formula 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 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 335 (ii) DISODIUM TARTRATEDefinition
Chemical name Disodium L-tartrate
Disodium (+)-tartrateDisodium (+)-2,3-dihydroxybutanedioic acid
Dihydrated disodium salt of L-(+)-tartaric acid
Einecs 212-773-3
Chemical formula C
4H4O6Na2·2H2O
Molecular weight 230,8
Assay Content not less than 99 % on the anhydrous basis1996L0077 — EN — 20.06.2001 — 003.001 — 49
▼B
Description Transparent, colourless crystals
Identification
A. Positive tests for tartrate and for
sodium
B. Solubility tests 1 gram is insoluble in 3 ml of water. Insoluble in
ethanol
Purity
Loss on drying Not more than 17,0 % determined by drying at 150 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 1 % aqueous solution Between 7,0 and 7,5Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy 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 ºC
Purity
pH of a 1 % aqueous solution 3,4Loss on drying Not more than 1,0 % determined by drying at 105 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Arsenic Not more than 3 mg/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(ii) DIPOTASSIUM TARTRATESynonyms 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 acid1996L0077 — EN — 20.06.2001 — 003.001 — 50
▼B
Einecs 213-067-8
Chemical formula C4H4O6K2·½H2O
Molecular weight 235,2
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline or granulated powder
Identification
A. Positive tests for tartrate and for
potassium
Purity
pH of a 1 % aqueous solution Between 7,0 and 9,0Loss on drying Not more than 4,0 % determined by drying at 150 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/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 potas-
sium and for sodium
B. Solubility tests 1 gram is soluble in 1 ml of water, insoluble in ethanolC. Melting range Between 70 and 80 ºC
Purity
Loss on drying Not more than 26,0 % and not less than 21,0 %
determined by drying at 150 ºC for three hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of 1 % aqueous solution Between 6,5 and 8,5
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 51
▼B
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
Volatile acids Not more than 10 mg/kg (as acetic acid)Chlorides Not more than 200 mg/kg (expressed as chlorine)Nitrates Not more than 5 mg/kg (as NaNO
3)
Sulphates Not more than 1500mg/kg (as CaSO4)
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Note:
This specification refers to a 75 %
aqueous solution
E 339 (i) MONOSODIUM PHOSPHATE
Synonyms Monosodium monophosphate
Acid monosodium monophosphate
Monosodium orthophosphateMonobasic sodium phosphate
Definition
Chemical name Sodium dihydrogen monophosphate
Einecs 231-449-2
Chemical formula Anhydrous: NaH
2PO4
Monohydrate: NaH2PO4·H2O
Dihydrate: NaH2PO4·2H2O
Molecular weight Anhydrous: 119,98
Monohydrate: 138,00
Dihydrate: 156,01
Assay After drying at 6,0 ºC for one hour and then at 105 ºC
for four hours, contains not less than 97 % of NaH2PO4
Description A white odourless, slightly deliquescent powder,
crystals or granules1996L0077 — EN — 20.06.2001 — 003.001 — 52
▼B
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility tests Freely soluble in water. Insoluble in ethanol, ether or
chloroform
C. P2O5content Between 58,0% and 60,0%
Purity
Loss on drying The anhydrous salt loses no more than 2,0 %, the
monohydrate no more than 15,0 %, and the dihydrate
no more than 25 % when dried first at 60 ºC for one
hour, then at 105 ºC for four hours
Water-insoluble substances Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)pH of a 1 % aqueous solution Between 4,1 and 5,0
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 339 (ii) DISODIUM PHOSPHATE
Synonyms Disodium monophosphate
Secondary sodium phosphate
Disodium orthophosphateAcid disodium phosphate
Definition
Chemical name Disodium hydrogen monophosphate
Disodium hydrogen orthophosphate
Einecs 231-448-7
Chemical formula Anhydrous: Na
2HPO4
Hydrated: Na2HPO4·nH2O (n = 2, 7 or 12)
Molecular weight 141,98 (anhydrous)
Assay After drying at 40 ºC for three hours and subsequently
at 105 ºC for five hours, contains not less than 98 % of
Na2HPO4
Description Anhydrous disodium hydrogen phosphate is a white,
hygroscopic, odourless powder. Hydrated forms avail-
able 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 ºC for three hours and then at 105 ºC
for five hours, the losses in weight are as follows:
anhydrous not more than 5,0 %, dihydrate not more
than 22,0 %, heptahydrate not more than 50,0 %,
dodecahydrate not more than 61,0 %1996L0077 — EN — 20.06.2001 — 003.001 — 53
▼B
Water-insoluble substances Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)pH of a 1,0 % aqueous solution Between 8,4 and 9,6Arsenic Not more than 3 mg/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 339 (iii) TRISODIUM PHOSPHATESynonyms Sodium phosphate
Tribasic sodium phosphate
Trisodium orthophosphate
Definition
Chemical name Trisodium monophosphate
Trisodium phosphateTrisodium orthophosphate
Einecs 231-509-8
Chemical formula Anhydrous: Na
3PO4
Hydrated: Na3PO4·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 Na3PO4,
calculated on the dried basis. Sodium phosphate
dodecahydrate contains not less than 92,0 % of
Na3PO4, calculated on the ignited basis
Description White odourless crystals, granules or a crystalline
powder. Hydrated forms available include hemi- and
monohydrates, hexahydrate, octahydrate, decahydrate
and dodecahydrate. The dodecahydrate contains ¼
molecule of sodium hydroxide
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility tests Freely soluble in water. Insoluble in ethanol
C. P2O5content Between 40,5 % and 43,5 % (anhydrous)
Purity
Loss on ignition When dried at 120 ºC for two hours and then ignited at
about 800 ºC for 30 minutes, the losses in weight are as
follows: anhydrous not more than 2,0 %, monohydrate:
not more than 11,0 %, dodecahydrate: between 45,0 %
and 58,0 %
Water-insoluble substances Not more than 0,2 % on the anhydrous basisFluoride 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/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 54
▼B
E 340 (i) MONOPOTASSIUM PHOSPHATE
Synonyms Monobasic potassium phosphate
Monopotassium monophosphate
Potassium acid phosphate
Potassium orthophosphate
Definition
Chemical name Potassium dihydrogen phosphate
Monopotassium dihydrogen orthophosphate
Monopotassium dihydrogen monophosphate
Einecs 231-913-4
Chemical formula KH2PO4
Molecular weight 136,09
Assay Content not less than 98,0 % after drying at 105 ºC for
four hours
Description Odourless, colourless crystals or white granular or
crystalline powder, hygroscopic
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility tests Freely soluble in water. Insoluble in ethanolC. P
2O5content Between 51,0 % and 53,0 %
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 ºC
for four hours
Water-insoluble substances Not more than 0,2 % on the anhydrous 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/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 340 (ii) DIPOTASSIUM PHOSPHATE
Synonyms Dipotassium monophosphate
Secondary potassium phosphateDipotassium acid phosphate
Dipotassium orthophosphate
Dibasic potassium phosphate
Definition
Chemical name Dipotassium hydrogen monophosphate
Dipotassium hydrogen phosphate
Dipotassium hydrogen orthophosphate
Einecs 231-834-5
Chemical formula K
2HPO4
Molecular weight 174,18
Assay Content not less than 98 % after drying at 105 ºC for
four hours1996L0077 — EN — 20.06.2001 — 003.001 — 55
▼B
Description Colourless or white granular powder, crystals or
masses; deliquescent substance
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility tests Freely soluble in water. Insoluble in ethanol
C. P2O5content Between 40,3 % and 41,5 %
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 ºC
for four hours
Water-insoluble substances Not more than 0,2 % on the anhydrous basisFluoride 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/kg
Mercury 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 phosphate
Tripotassium orthophosphate
Definition
Chemical name Tripotassium monophosphate
Tripotassium phosphateTripotassium orthophosphate
Einecs 231-907-1
Chemical formula Anhydrous: K
3PO4
Hydrated: K3PO4·nH2O( n=1or3 )
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 mono-
hydrate and trihydrate
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility tests Freely soluble in water. Insoluble in ethanol
C. P2O5content 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 ºC for one
hour and then ignite at about 800 ºC ± 25 ºC for 30
minutes
Water-insoluble substances Not more than 0,2 % on the anhydrous basisFluoride Not more than 10 mg/kg (expressed as fluorine)
pH of a 1 % aqueous solution Between 11,5 and 12,31996L0077 — EN — 20.06.2001 — 003.001 — 56
▼B
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 341 (i) MONOCALCIUM PHOSPHATE
Synonyms Monobasic calcium phosphate
Monocalcium orthophosphate
Definition
Chemical name Calcium dihydrogen phosphate
Einecs 231-837-1
Chemical formula Anhydrous: Ca(H
2PO4)2
Monohydrate: Ca(H2PO4)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. P2O5content 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 ºC for
four hours (anhydrous)
Not more than 17,5 % determined by drying at 60 ºC
for one hour, then at 105 ºC for four hours
(monohydrate)
Loss on ignition Not more than 17,5 % after ignition at 800 ºC ± 25 ºC
for 30 minutes (anhydrous)
Not more than 25,0 % determined by drying at 105 ºC
for one hour, then ignite at 800 ºC ± 25 ºC for 30
minutes (monohydrate)
Fluoride Not more than 30 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 341 (ii) DICALCIUM PHOSPHATESynonyms Dibasic calcium phosphate
Dicalcium orthophosphate
Definition
Chemical name Calcium monohydrogen phosphate
Calcium hydrogen orthophosphate
Secondary calcium phosphate
Einecs 231-826-11996L0077 — EN — 20.06.2001 — 003.001 — 57
▼B
Chemical formula Anhydrous: CaHPO4
Dihydrate: CaHPO4·2H2O
Molecular weight 136,06 (anhydrous)
172,09 (dihydrate)
Assay Dicalcium phosphate, after drying at 200 ºC for three
hours, contains not less than 98 % and not more than
the equivalent of 102 % of CaHPO4
Description White crystals or granules, granular powder or powder
Identification
A. Positive tests for calcium and for
phosphate
B. Solubility tests Sparingly soluble in water. Insoluble in ethanol
C. P2O5content 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 ºC ± 25 ºC for 30
minutes
Fluoride Not more than 50 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 341 (iii) TRICALCIUM PHOSPHATESynonyms Calcium phosphate, tribasic
Calcium orthophosphate
Definition
Chemical name Tricalcium monophosphate
Einecs 231-840-8
Chemical formula Ca
3(PO4)2
Molecular weight 310,17
Assay Not less than 90 % calculated on the ignited basis
Description A white, odourless and tasteless powder which is stable
in air
Identification
A. Positive tests for calcium and for
phosphate
B. Solubility tests Practically insoluble in water; insoluble in ethanol,
soluble in dilute hydrochloric and nitric acid
C. P2O5content Between 38,5 % and 48,0 % (anhydrous)
Purity
Loss on ignition Not more than 8 % after ignition at 800 ºC ± 25 ºC, to
constant weight
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 58
▼B
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
Synonyms Calcium disodium EDTA
Calcium disodium edetate
Definition
Chemical name N,N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate]
[(4-)-O,O ′,ON,ON]calciate(2)-disodium
Calcium disodium ethylenediaminetetra acetate
Calcium disodium (ethylenedinitrilo)tetra acetate
Einecs 200-529-9
Chemical formula C10H12O8CaN2Na2·2H2O
Molecular weight 410,31
Assay Content not less than 97 % on the anhydrous basis
Description White, odourless crystalline granules or white to nearly
white powder, slightly hygroscopic
Identification
A. Positive tests for sodium and for
calcium
B. Chelating activity tometal io ns
positive
C. pH of a 1 % solution between 6,5
and 7,5
Purity
Water content 5 to 13 % (Karl Fischer method)Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Ethylene oxide may not be used for sterilising purposes in food additives
E 400 ALGINIC ACIDDefinition Linear glycuronoglycan consisting mainly of β-(1-4)
linked D-mannuronic and α-(1-4) linked L-guluronic
acid units in pyranose ring form. Hydrophilic colloidal
carbohydrate extracted by the use of dilute alkali from
natural strains of various species of brown seaweeds
(Phaeophyceae )
Einecs 232-680-1
Chemical formula (C
6H8O6)n
Molecular weight 10000—600000 (typical average)
Assay Alginic acid yields, on the anhydrous basis, not less
than 20 % and not more than 23 % of carbon dioxide
(CO2), equivalent to not less than 91 % and not more
than 104,5 % of alginic acid (C6H8O6)n(calculted on
equivalent weight basis of 200)
Description Alginic acid occurs in filamentous, grainy, granular and
powdered forms. It is a white to yellowish brown and
nearly odourless
Identification
A. Solubility Insoluble in water and organic solvents, slowly soluble
in solutions of sodium carbonate, sodium hydroxide
and trisodium phosphate1996L0077 — EN — 20.06.2001 — 003.001 — 59
▼M1
▼M1
B. Calcium chloride precipitation test To a 0,5 % solution of the sample in 1 M sodium
hydroxide solution, add one fifth of its volume of a
2,5 % solution of calcium chloride. A voluminous,
gelatinous precipitate is formed. This test distinguishes
alginic acid from acacia gum, sodium carboxymethyl
cellulose, carboxymethyl starch, carrageenan, gelatin,
gum ghatti, karaya gum, locust bean gum, methyl
cellulose and tragacanth gum
C. Ammonium sulphate precipitation
testTo a 0,5 % solution of the sample in 1 M sodium
hydroxide solution, add one half of its volume of a
saturated solution of ammonium sulphate. No precipi-
tate 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 Nsodium hydroxide and
add 1 ml of acid ferric sulphate solution. Within 5
minutes, a cherry-red colour develops that finally
becomes deep purple
Purity
pH of a 3 % suspension Between 2,0 and 3,5Loss on drying Not more than 15 % (105 ºC, 4 hours)
Sulphated ash Not more than 8 % on the anhydrous basis
Sodium hydroxide (1 M solution) Not more than 2 % on the anhydrous basis insoluble
matter
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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 gramYeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 401 SODIUM ALGINATEDefinition
Chemical name Sodium salt of alginic acid
Chemical formula (C
6H7NaO6)n
Molecular weight 10000-600000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and
not more than 21 % of carbon dioxide corresponding to
not less than 90,8 % and not more than 106,0 % of
sodium alginate (calculated on equivalent weight basis
of 222)
Description Nearly odourless, white to yellowish fibrous or granular
powder
Identification
A. Positive test for sodium and alginic
acid
Purity
Loss on drying Not more than 15 % (105 ºC, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basis1996L0077 — EN — 20.06.2001 — 003.001 — 60
▼M1
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 402 POTASSIUM ALGINATE
Definition
Chemical name Potassium salt of alginic acid
Chemical formula (C6H7KO6)n
Molecular weight 10000-600000 (typical average)
Assay Yields, on the anhydrous basis, not less than 16,5 %
and not more than 19,5 % of carbon dioxide
corresponding to not less than 89,2 % and not more
than 105,5 % of potassium alginate (calculated on an
equivalent weight basis of 238)
Description Nearly odourless, white to yellowish fibrous or granular
powder
Identification
A. Positive test for potassium and for
alginic acid
Purity
Loss on drying Not more than 15 % (105 ºC, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basisArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 403 AMMONIUM ALGINATEDefinition
Chemical name Ammonium salt of alginic acid
Chemical formula (C
6H11NO6)n
Molecular weight 10000-600000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and
not more than 21 % of carbon dioxide corresponding to
not less than 88,7 % and not more than 103,6 %
ammonium alginate (calculated on an equivalent
weight basis of 217)
Description White to yellowish fibrous or granular powder1996L0077 — EN — 20.06.2001 — 003.001 — 61
▼M1
Identification
A. Positive test for ammonium and
alginic acid
Purity
Loss on drying Not more than 15 % (105 ºC, 4 hours)
Sulphated ash Not more than 7 % on the dried basisWater-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 Not more than 20 mg/kgTotal plate count Not more than 5 000 colonies per gramYeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 404 CALCIUM ALGINATESynonyms Calcium salt of alginate
Definition
Chemical name Calcium salt of alginic acid
Chemical formula (C
6H7Ca1/2O6)n
Molecular weight 10000-600000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and
not more than 21 % carbon dioxide corresponding to
not less than 89,6 % and not more than 104,5 % of
calcium alginate (calculated on an equivalent weight
basis of 219)
Description Nearly odourless, white to yellowish fibrous or granular
powder
Identification
A. Positive test for calcium and alginic
acid
Purity
Loss on drying Not more than 15,0 % (105 ºC, 4 hours)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kgTotal plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g1996L0077 — EN — 20.06.2001 — 003.001 — 62
▼M1
E 405 PROPANE-1,2-DIOL ALGINATE
Synonyms Hydroxypropyl alginate
1,2-propanediol ester of alginic acid
Propylene glycol alginate
Definition
Chemical name Propane-1,2-diol ester of alginic acid; varies in
composition according to its degree of esterification
and the percentage of free and neutralised carboxyl
groups in the molecule
Chemical formula (C9H14O7)n
(esterified)
Molecular weight 10000—600000 (typical average)
Assay Yields, on the anhydrous basis, not less than 16 % and
not more than 20 % of CO2of carbon dioxide
Description Nearly odourless, white to yellowish brown fibrous or
granular powder
Identification
A. Positive test for 1,2-propanediol and
alginic acid after hydrolysis
Purity
Loss on drying Not more than 20 % (105 ºC, 4 hours)Total propane-1,2-diol content Not less than 15 % and not more than 45 %
Free propane-1,2-diol content Not more than 15 %
Water-insoluble matter Not more than 2 % on the anhydrous 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/kgTotal plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 406AGAR
Synonyms Gelose
Japan agar
Bengal, Ceylon, Chinese or Japanese isinglass
Layor Carang
Definition
Chemical name Agar is a hydrophilic colloidal polysaccharide
consisting mainly of D-galactose units. On about every
tenth D-galactopyranose unit one of the hydroxyl
groups is esterified with sulphuric acid which is
neutralised by calcium, magnesium, potassium or
sodium. It is extracted from certain natural strains of
marine algae of the families Gelidiaceae undSphaer-
ococcaceae and related red algae of the class
Rhodophyceae
Einecs 232-658-11996L0077 — EN — 20.06.2001 — 003.001 — 63
▼M1
Assay The threshold gel concentration should not be higher
than 0,25 %
Description Agar is odourless or has a slight characteristic odour.
Unground agar usually occurs in bundles consisting of
thin, membranous, agglutinated strips, or in cut, flaked
or granulated forms. It may be light yellowish-orange,
yellowish-grey to pale yellow, or colourless. It is tough
when damp, brittle when dry. Powdered agar is white to
yellowish-white or pale yellow. When examined in
water under a microscope, the agar appears granular
and somewhat filamentous. A few fragments of the
spicules of sponges and a few frustules of diatoms may
be present. In chloral hydrate solution, the powdered
agar appears more transparent than in water, more or
less granular, striated, angular and occasionally
contains frustules of diatoms. Gel strength may be
standardised by the addition of dextrose and maltodex-
trines or sucrose
Identification
A. Solubility Insoluble in cold water; soluble in boiling water
Purity
Loss on drying Not more than 22 % (105 ºC, 5 hours)Ash Not more than 6,5 % on the anhydrous basis
determined at 550 ºC
Acid-insoluble ash (insoluble in
approximately 3N Hydrochloric acid)Not more than 0,5 % determined at 550 ºC on the
anhydrous basis
Insoluble matter (in hot water) Not more than 1,0 %
Starch Not detectable by the following method: to a 1 in 10
solution of the sample add a few drops of iodine
solution. No blue colour is produced
Gelatin and other proteins Dissolve about 1 g of agar in 100 ml of boiling water
and allow to cool of about 50 ºC. To 5 ml of the
solution add 5 ml of trinitrophenol solution (1 g of
anhydrous trinitrophenol/100 ml of hot water). No
turbidity appears within 10 minutes
Water absorption Place 5 g to agar in a 100 ml graduated cylinder, fill to
the mark with water, mix and allow to stand at about 25
ºC for 24 hours. Pour the contents of the cylinder
through moistened glass wool, allowing the water to
drain into a second 100 ml graduated cylinder. Not
more than 75 ml of water is obtained
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium 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 Hypneaspp.)
— Furcellaran or Danish agar (from Furcellaria
fastigiata )
— Carrageenan (from Chondrus andGigartina spp.)1996L0077 — EN — 20.06.2001 — 003.001 — 64
▼M1
Definition Carrageenan is obtained by aqueous extraction of
natural strains of seaweeds of Gigartinaceae ,Solier-
iaceae,Hypneaceae andFurcellariaceae , families of
the class Rhodophyceae (red seaweeds). Noo rganic
precipitant shall be used other than methanol, ethanol
and propane-2-ol. Carrageenan consists chiefly of the
potassium, sodium, magnesium and calcium salts of
polysaccharide sulphate esters which, on hydrolysis,
yield galactose and 3,6-anhydrogalactose. Carrageenan
shall not be hydrolysed or otherwise chemically
degraded
Einecs 232-524-2
Description Yellowish to colourless, coarse to fine powder which is
practically odourless
Identification
A. Positive tests for galactose, for
anhydrogalactose and for sulphate
Purity
Methanol, ethanol propane-2-ol content Not more than 0,1 % singly or in combinationViscosity of a 1,5 % solution at 75 ºC Not less than 5 mPa.s
Loss on drying Not more than 12 % (105 ºC, 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 ºC
Acid-insoluble ash Not more than 1 % on the anhydrous basis (insoluble in
10 % hydrochloric acid)
Acid-insoluble matter Not more than 2 % on the anhydrous basis (insoluble in
1 % v/v sulphuric acid)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kgTotal plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 300 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 407a PROCESSED EUCHEUMA SEAWEEDSynonyms 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 undEucheuma spinosum ,
of the class Rhodophyceae (red seaweeds) toremo ve
impurities and by fresh water washing and drying to
obtain the product. Further purification may be
achieved by washing with methanol, ethanol or
propane-2-ol and drying. The product consists chiefly
of the potassium salts of polysaccharide sulphate esters
which, on hydrolysis, yield galactose and 3,6-anhydro-
galactose. Sodium, calcium and magnesium salts of the
polysaccharide sulphate esters are present in lesser
amounts. Up to 15 % algal cellulose is also present in
the product. The carrageenan in processed eucheuma
seaweed shall not be hydrolysed or otherwise chemi-
cally degraded1996L0077 — EN — 20.06.2001 — 003.001 — 65
▼M1
Description Tan to yellowish, coarse to fine powder which is
practically odourless
Identification
A. Positive tests for galactose, for
anhydrogalactose and for sulphate
B. Solubility Forms cloudy viscous suspensions in water. Insoluble
in ethanol
Purity
Methanol, ethanol, propane-2-ol content Not more than 0,1 % singly or in combinationViscosity of a 1,5 % solution at 75 ºC Not less than 5 mPa.s
Loss on drying Not more than 12 % (105 ºC, 4 hours)
Sulphate Not less than 15 % and not more than 40 % onthe dried
basis (as SO
4)
Ash Not less than 1 % and not more than 40 % determined
on the dried basis at 550 ºC
Acid-insoluble ash Notmore than 1%onthe dried basis(insoluble in10%
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/kgMercury Not more than 1 mg/kgCadmium 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
Yeast and mould Not more than 300 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 410 LOCUST BEAN GUMSynonyms Carob bean gum
Algaroba gum
Definition Locust bean gum is the ground endosperm of the seeds
of the natural strains of carob tree, Cerationia siliqua
(L.) Taub. (family Leguminosae ). Consists mainly of a
high molecular weight hydrocolloidal polysaccharide,
composed of galactopyranose and mannopyranose units
combined through glycosidic linkages, which may be
described chemically as galactomannan
Molecular weight 50000—3 000000
Einecs 232-541-5
Assay Galactomannan content not less than 75 %
Description White to yellowish-white, nearly odourless powder
Identification
A. Positive tests for galactose mannose
B. Microscopic examination Place some ground sample in an aqueous solution
containing 0,5 % iodine and 1 % potassium iodide on a
glass slide and examine under microscope. Locust bean
gum contains long stretched tubiform cells, separated or
slightly interspaced. Their brown contents are much
less regularly formed in guar gum. Guar gum shows
close groups of round to pear shaped cells. Their
contents are yellow to brown1996L0077 — EN — 20.06.2001 — 003.001 — 66
▼M1
C. Solubility Soluble in hot water, insoluble in ethanol
Purity
Loss on drying Not more than 15 % (105 ºC, 5 hours)
Ash Not more than 1,2 % determined at 800 ºC
Protein (N × 6,25) Not more than 7 %Acid-insoluble matter Not more than 4 %Starch Not detectable by the following method: to a 1 in 10
solution of the sample add a few drops of iodine
solution. No blue colour is produced
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Ethanol and propane-2-ol Not more than 1 %, single or in combination
E 412 GUAR GUMSynonyms Gum cyamopsis
Guar flour
Definition Guar gum is the ground endosperm of the seeds of
natural strains of the guar plant, Cyamopsis tetragono-
lobus(L.) Taub. (family Leguminosae ). Consists
mainly of a high molecular weight hydrocolloidal
polysaccharide composed of galactopyranose and
mannopyranose units combined through glycosidic
linkages, which may be described chemically as
galactomannan
Einecs 232-536-0
Molecular weight 50000—8 000000
Assay Galactomannan content not less than 75 %
Description A white to yellowish-white, nearly odourless powder
Identification
A. Positive tests for galactose and for
mannose
B. Solubility Soluble in cold water
Purity
Loss on drying Not more than 15 % (105 ºC, 5 hours)Ash Not more than 1,5 % determined at 800 ºCAcid-insoluble matter Not more than 7 %
Protein (N × 6,25) Not more than 10 %
Starch Not detectable by the following method: to a 1 in 10
solution of the sample add a few drops of iodine
solution. (No blue colour is produced)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 67
▼M1
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 (familyLeguminosae ). It consists mainly of
high molecular weight polysaccharides (galactoarabans
and acidic polysaccharides) which, on hydrolysis, yield
galacturonic acid, galactose, arabinose, xylose and
fucose. Small amounts of rhamnose and of glucose
(derived from traces of starch and/or cellulose) may
alsobe present
Molecular weight Approximately 8 000000
Einecs 232-252-5
Description Unground Tragacanth gum occurs as flattened, lamel-
lated, straight or curved fragments or as spirally twisted
pieces 0,5-2,5 mm thick and up to3 cm in length. It is
white to pale yellow in colour but some pieces may
have a red tinge. The pieces are horny in texture, with a
short fracture. It is odourless and solutions have an
insipid mucilaginous taste. Powdered tragacanth is
white to pale yellow or pinkish brown (pale tan) in
colour
Identification
A. Solubility 1 g of the sample in 50 ml of water swells to form a
smooth, stiff, opalescent mucilage; insoluble in ethanol
and does not swell in 60 % (w/v) aqueous ethanol
Purity
Negative test for Karaya gum Boil 1 g with 20 ml of water until a mucilage is formed.
Add 5 ml of hydrochloric acid and again boil the
mixture for five minutes. No permanent pink or red
colour develops
Loss on drying Not more than 16 % (105 ºC, 5 hours)Total ash Not more than 4 %Acid insoluble ash Not more than 0,5 %Acid insoluble matter Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kgSalmonella spp. Negative in 10 g
E. coli Negative in 5 g
E 414 ACACIA GUMSynonyms Gum arabic
Definition Acacia gum is a dried exudation obtained from the
stems and branches of natural strains of Acacia senegal
(L) Willdenow or closely related species of Acacia
(familyLeguminosae ). It consists mainly of high
molecular weight polysaccharides and their calcium,
magnesium and potassium salts, which on hydrolysis
yield arabinose, galactose, rhamnose and glucuronic
acid
Molecular weight Approximately 3500001996L0077 — EN — 20.06.2001 — 003.001 — 68
▼M1
Einecs 232-519-5
Description Unground acacia gum occurs as white or yellowish-
white spheroidal tears of varying sizes or as angular
fragments and is sometimes mixed with darker
fragments. It is also available in the form of white to
yellowish-white flakes, granules, powder or spray-dried
material.
Identification
A. Solubility 1 g dissolves in 2 ml of cold water forming a solution
which flows readily and is acid to litmus, insoluble in
ethanol
Purity
Loss on drying Not more than 17 % (105 ºC, 5 hours) for granular and
not more than 10 % (105 ºC, 4 hours) for spray-dried
material
Total ash Not more than 4 %Acid insoluble ash Not more than 0,5 %
Acid insoluble matter Not more than 1 %
Starch or dextrin Boil a 1 in 50 solution of the gum and cool. To 5 ml
add 1 drop of iodine solution. No bluish or reddish
colours are produced
Tannin To 10ml of a 1 in 50solution add about 0,1 ml of ferric
chloride solution (9 g FeCl
3.6H2O made up to100 ml
with water). No blackish colouration or blackish
precipitate is formed
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Hydrolysis products Mannose, xylose and galacturonic acid are absent
(determined by chromatography)
Salmonella spp. Negative in 10 g
E. coli Negative in 5 g
E 415 XANTHAN GUMDefinition Xanthan gum is a high molecular weight polysac-
charide gum produced by a pure-culture fermentation
of a carbohydrate with natural strains of Xanthomonas
campestris , purified by recovery with ethanol or
propane-2-ol, dried and milled. It contains D-glucose
and D-mannose as the dominant hexose units, along
with D-glucuronic acid and pyruvic acid, and is
prepared as the sodium, potassium or calcium salt. Its
solutions are neutral
Molecular weight Approximately 1 000000
Einecs 234-394-2
Assay Yields, on dried basis, not less than 4,2 % and not more
than 5 % of CO
2corresponding to between 91 % and
108 % of xanthan gum
Description Cream-coloured powder
Identification
A. Solubility Soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 15 % (105 ºC, 2½ hours)1996L0077 — EN — 20.06.2001 — 003.001 — 69
▼M1
Total ash Not more than 16 % on the anhydrous basis determined
at 650 ºC after drying at 105 ºC for four hours
Pyruvic acid Not less than 1,5 %Nitrogen Not more than 1,5 %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/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kgTotal plate count Not more than 10000 colonies per gram
Yeast 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 416KARAYA-GUM
Synonyms Katilo
KadayaGumsterculia
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 (familySterculiaceae )or
fromCochlospermum gossypium A.P. De Candolle or
other species of Cochlospermum (familyBixaceae). It
consists mainly of high molecular weight acetylated
polysaccharides, which on hydrolysis yield galactose,
rhamnose, and galacturonic acid, together with minor
amounts of glucuronic acid
Einecs 232-539-4
Description Karaya gum occurs in tears of variable size and in
broken irregular pieces having a characteristic semi-
crystalline appearance. It is pale yellow to pinkish
brown in colour, translucent and horny. Powdered
karaya gum is a pale grey topinkish bro wn. The gum
has a distinctive odour of acetic acid
Identification
A. Solubility Insoluble in ethanolB. Swelling in ethanol solution Karaya gum swells in 60 % ethanol distinguishing it
from other gums
Purity
Loss on drying Not more than 20 % (105 ºC, 5 hours)Total ash Not more than 8 %Acid insoluble ash Not more than 1 %
Acid insoluble matter Not more than 3 %
Volatile acid Not less than 10 % (as acetic acid)Starch Not detectableArsenic Not more than 3 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 70
▼M1
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/kgSalmonella spp. Negative in 10 g
E. coli Negative in 5 g
E 417 TARA GUM
Definition Tara gum is obtained by grinding the endosperm of the
seeds of natural strains of Caesalpinia spinosa (family
Leguminosae ). It consists chiefly of polysaccharides of
high molecular weight composed mainly of galacto-
mannans. The principal component consists of a linear
chain of (1-4)- β-D-mannopyranose units with α-D-
galactopyranose units attached by (1-6) linkages. The
ratio of mannose to galactose in tara gum is 3:1. (In
locust bean gum this ratio is 4:1 and in guar gum 2:1)
Einecs 254-409-6
Description A white to white-yellow odourless powder
Identification
A. Solubility Soluble in water
Insoluble in ethanol
B. Gel formation To an aqueous solution of the sample add small
amounts of sodium borate. A gel is formed
Purity
Loss on drying Not more than 15 %Ash Not more than 1,5 %Acid insoluble matter Not more than 2 %Protein Not more than 3,5 % (factor N x 5,7)
Starch Not detectable
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 418 GELLAN GUM
Definition Gellan gum is a high molecular weight polysaccharide
gum produced by a pure culture fermentation of a
carbohydrate by natural strains of Pseudomonas elodea ,
purified by recovery with isopropyl alcohol, dried, and
milled. The high molecular weight polysaccharide is
principally composed of a tetrasaccharide repeating
unit of one rhamnose, one glucuronic acid, and two
glucoses, and substituted withacyl (glyceryl and acetyl)
groups as the O-glycosidically linked esters. The
glucuronic acid is neutralised to a mixed potassium,
sodium, calcium, and magnesium salt
Einecs 275-117-5
Molecular weight Approximately 500000
Assay Yields, on the dried basis, not less than 3,3 % and not
more than 6,8 % of CO
2
Description An off-white powder1996L0077 — EN — 20.06.2001 — 003.001 — 71
▼M1
Identification
A. Solubility Soluble in water, forming a viscous solution.
Insoluble in ethanol
Purity
Loss on drying Not more than 15 % after drying (105 ºC, 2½ hours)
Nitrogen Not more than 3 %
Propane-2-ol Not more than 750 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/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 10000 colonies per gram
Yeast and mould Not more than 400 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 422 GLYCEROL
Synonyms 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
Description Clear, colourless hygroscopic syrupy liquid with not
more than a slight characteristic odour, which is neither
harsh nor disagreeable
Identification
A. Acrolein formation on heating Heat a few drops of the sample in a test tube with about
0,5 g of potassium bisulphate. The characteristic
pungent vapours of acrolein are evolved
B. Specific gravity (25/25 ºC) Not less than 1,257
C. Refractive index [n]D20Between 1,471 and 1,474
Purity
Water Not more than 5 % (Karl Fischer method)
Sulphated ash Not more than 0,01 % determined at 800 ± 25 ºC
Butanetriols Not more than 0,2 %
Acrolein, glucose and ammonium
compoundsHeat a mixture of 5 ml of glycerol and 5 ml of
potassium hydroxide solution (1 in 10) at 60 ºC for five
minutes. It neither becomes yellow nor emits an odour
of ammonia
Fatty acids and esters Not more than 0,1 % calculated as butyric acid
Chlorinated compounds Not more than 30 mg/kg (as chlorine)1996L0077 — EN — 20.06.2001 — 003.001 — 72
▼M1
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E 431 POLYOXYETHYLENE (40) STEARATE
Synonyms Polyoxyl (40) stearate, polyoxyethylene (40) mono-
stearate
Definition A mixture of the mono-and diesters of edible
commercial stearic acid and mixed polyoxyethylene
diols (having an average polymer length of about 40
oxyethylene units) together with free polyol
Assay Content not less than 97,5 % on the anhydrous basis
Description Cream-coloured flakes or waxy solid at 25 ºC with a
faint odour
Identification
A. Solubility Soluble in water, ethanol, methanol and ethyl acetate
Insoluble in mineral oil
B. Congealing range 39-44 ºC
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a
polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 1Saponification value Not less than 25 and not more than 35
Hydroxyl value Not less than 27 and not more than 40
1,4-Dioxane Not more than 5 mg/kgFree ethylene oxide Not more than 1 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)
Synonyms Polysorbate 20
Polyoxyethylene (20) sorbitan monolaurate
Definition A mixture of the partial esters of sorbitol and its mono-
and dianhydrides with edible commercial lauric acid
and condensed with approximately 20 moles of
ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 70 % of oxyethylene groups,
equivalent to not less than 97,3 % of polyoxyethylene
(20) sorbitan monolaurate on the anhydrous basis
Description A lemon to amber-coloured oily liquid at 25 ºC with a
faint characteristic odour1996L0077 — EN — 20.06.2001 — 003.001 — 73
▼M1
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 1081,4-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/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)
Synonyms Polysorbate 80
Polyoxyethylene (20) sorbitan monooleate
Definition A mixture of the partial esters of sorbitol and its mono-
and dianhydrides with edible commercial oleic acid andcondensed with approximately 20 moles of ethylene
oxide per mole of sorbitol and its anhydrides
Assay Content not less than 65 % of oxyethylene groups,
equivalent to not less than 96,5 % of polyoxyethylene
(20) sorbitan monooleate on the anhydrous basis
Description A lemon to amber-coloured oily liquid at 25 ºC with a
faint characteristic odour
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and
toluene.
Insoluble in mineral oil and petroleum ether
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a
polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2Saponification value Not less than 45 and not more than 55
Hydroxyl value Not less than 65 and not more than 80
1,4-Dioxane Not more than 5 mg/kgFree ethylene oxide Not more than 1 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 74
▼M1
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)Synonyms Polysorbate 40 Polyoxyethylene (20) sorbitan mono-
palmitate
Definition A mixture of the partial esters of sorbitol and its mono-
and dianhydrides with edible commercial palmitic acid
and condensed with approximately 20 moles of
ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 66 % of oxyethylene groups,
equivalent to not less than 97 % of polyoxyethylene
(20) sorbitan monopalmitate on the anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at
25 ºC with a faint characteristic odour
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and
acetone.
Insoluble in mineral oil
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a
polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 41 and not more than 52Hydroxyl value Not less than 90 and not more than 1071,4-Dioxane Not more than 5 mg/kgFree ethylene oxide Not more than 1 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)Synonyms Polysorbate 60
Polyoxyethylene (20) sorbitan monostearate
Definition A mixture of the partial esters of sorbitol and its mono-
and dianhydrides with edible commercial stearic acid
and condensed with approximately 20 moles of
ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 65 % of oxyethylene groups,
equivalent to not less than 97 % of polyoxyethylene
(20) sorbitan monostearate on the anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at
25 ºC with a faint characteristic odour
Identification
A. Solubility Soluble in water, ethyl acetate and toluene. Insoluble in
mineral oil and vegetable oils
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a
polyoxyethylated polyol1996L0077 — EN — 20.06.2001 — 003.001 — 75
▼M1
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2Saponification value Not less than 45 and not more than 55Hydroxyl value Not less than 81 and not more than 961,4-Dioxane Not more than 5 mg/kgFree ethylene oxide Not more than 1 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 436POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 6 5)Synonyms Polysorbate 65
Polyoxyethylene (20) sorbitan tristearate
Definition A mixture of the partial esters of sorbitol and its mono-
and dianhydrides with edible commercial stearic acid
and condensed with approximately 20 moles of
ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 46 % of oxyethylene groups,
equivalent to not less than 96 % of polyoxyethylene
(20) sorbitan tristearate on the anhydrous basis
Description A tan-coloured, waxy solid at 25 ºC with a faint
characteristic odour
Identification
A. Solubility Dispersible in water. Soluble in mineral oil, 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 ºC
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2Saponification value Not less than 88 and not more than 98Hydroxyl value Not less than 40 and not more than 601,4-Dioxane Not more than 5 mg/kgFree ethylene oxide Not more than 1 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 76
▼M1
E 440 (i) PECTIN
Definition Pectin consists mainly of the partial methyl esters of
polygalacturonic acid and their ammonium, sodium,
potassium and calcium salts. It is obtained by extraction
in an aqueous medium of natural strains of appropriate
edible plant material, usually citrus fruits or apples. No
organic precipitant shall be used other than methanol,
ethanol and propane-2-ol
Einecs 232-553-0
Assay Content not less than 65 % of galacturonic acid on the
ash-free and anhydrous basis after washing with acid
and alcohol
Description White, light yellow, light grey or light brown powder
Identification
A. Solubility Soluble in water forming a colloidal, opalescent
solution. Insoluble in ethanol
Purity
Loss on drying Not more than 12 % (105 ºC, 2 hours)Acid insoluble ash Not more than 1 % (insoluble in approximately 3N
hydrochloric acid)
Sulphur dioxide Not more than 50 mg/kg on the anhydrous basis
Nitrogen content Not more than 1,0 % after washing with acid and
ethanol
Free methanol, ethanol and propane-2-
olNot more than 1 %, singly or in combination, on the
anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 440 (ii) AMIDATED PECTIN
Definition Amidated pectin consists mainly of the partial methyl
esters and amides of polygalacturonic acid and their
ammonium, sodium, potassium and calcium salts. It is
obtained by extraction in an aqueous medium of
appropriate natural strains of edible plant material,
usually citrus fruits or apples and treatment with
ammonia under alkaline conditions. No organic preci-
pitant shall be used other than methanol, ethanol and
propane-2-ol
Assay Content not less than 65 % of galacturonic acid on the
ash-free and anhydrous basis after washing with acid
and alcohol
Description White, light yellow, light greyish or light brownish
powder
Identification
A. Solubility Soluble in water forming a colloidal, opalescent
solution. Insoluble in ethanol
Purity
Loss on drying Not more than 12 % (105 ºC, 2 hours)
Acid-insoluble ash Not more than 1 % (insoluble in approximately 3N
hydrochloric acid)
Degree of amidation Not more than 25 % of total carboxyl groups1996L0077 — EN — 20.06.2001 — 003.001 — 77
▼M1
Sulphur dioxide residue Not more than 50 mg/kg on the anhydrous basis
Nitrogen content Not more than 2,5 % after washing with acid and
ethanol
Free methanol, ethanol and propane-2-
olNot more than 1 % single or in combination, on a
volatile matter-free basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 442 AMMONIUM PHOSPHATIDES
Synonyms Ammonium salts of phosphatidic acid, mixed ammo-
nium salts of phoshorylated glycerides
Definition A mixture of the ammonium compounds of phospha-
tidic acids derived from edible fat and oil (usually
partially hardened rapeseed oil). One or two or three
glyceride moieties may be attached to phosphorus.
Moreover, two phosphorus esters may be linked
together as phosphatidyl phosphatides
Assay The phosphorus content is not less than 3 % and not
more than 3,4 % by weight; the ammonium content is
not less than 1,2 % and not more than 1,5 % (calculated
as N)
Description Unctuous semi-solid
Identification
A. Solubility Soluble in fats. Insoluble in water. Partially soluble in
ethanol and in acetone
B. Positive tests for glycerol, for fatty
acid and for phosphate
Purity
Petroleum ether insoluble matter Not more than 2,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/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 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 and isobutyric
anhydride, followed by distillation. The mixture
contains all possible combinations of esters in which
the molar ratio of acetate to butyrate is about 2:6
Einecs 204-771-6
Chemical name Sucrose diacetate hexaisobutyrate
Chemical formulae C
40H62O19
Molecular weight 832-856 (approximate), C40H62O19: 846,9
Assay Contentnotlessthan98,8%andnotmore than101,9%
ofC40H62O19
Description A pale straw-coloured liquid, clear and free of sediment
and having a bland odour1996L0077 — EN — 20.06.2001 — 003.001 — 78
▼M1
Identification
A. Solubility Insoluble in water. Soluble in most organic solvents
B. Refractive index n ½/C13840
D: 1,4492 - 1,4504
C. Specific gravity d ½/C13825
D: 1,141 - 1,151
Purity
Triacetin Not more than 0,1 %
Acid value Not more than 0,2
Saponification value Not less than 524 and not more than 540Arsenic Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgLead Not more than 3 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E 445 GLYCEROL ESTERS OF WOOD ROSINSynonyms Ester gum
Definition A complex mixture of tri- and diglycerol esters of resin
acids from wood rosin. The rosin is obtained by the
solvent extraction of aged pine stumps followed by a
liquid-liquid solvent refining process. Excluded from
these specifications are substances derived from gum
rosin, and exudate of living pine trees, and substances
derived from tall oil rosin, a by-product of kraft (paper)
pulp processing. The final product is composed of
approximately 90 % resin acids and 10 % neutrals
(non-acidic compounds). The resin acid fraction is a
complex mixture of isomeric diterpenoid monocar-
boxylic acids having the empirical molecular formula
ofC
20H30O2, chiefly abietic acid. The substance is
purified by steam stripping or by countercurrent steam
distillation
Description Hard, yellow to pale amber-coloured solid
Identification
A. Solubility Insoluble in water, soluble in acetone
B. Infrared absorption spectrum Characteristic of the compound
Purity
Specific gravity of solution d ½/C13820
25not less than 0,935 when determined in a 50 %
solution in d-limonene (97 %, boilding point 175,5-176
ºC, d20
4: 0,84)
Ring and ball softening range Between 82 ºC and 90 ºC
Acid value Not less than 3 and not more than 9
Hydroxyl value Not less than 15 and not more than 45Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Test for absence of tall oil rosin
(sulphur test)When sulphur-containing organic compounds are
heated in the presence of sodium formate, the sulphur
is converted to hydrogen sulphide which can readily be
detected bythe useof lead acetate paper. Apositive test
indicates the use of tall oil rosin instead of wood rosin1996L0077 — EN — 20.06.2001 — 003.001 — 79
▼M1
E 450 (i) DISODIUM DIPHOSPHATE
Synonyms Disodium dihydrogen diphosphate
Disodium dihydrogen pyrophosphateSodium acid pyrophosphate
Definition
Chemical name Disodium dihydrogen diphosphate
Einecs231-835-0Chemical 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 P2O5
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 ºC, 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 450 (ii) TRISODIUM DIPHOSPHATE
Synonyms Acid trisodium pyrophosphate
Trisodium monohydrogen diphosphate
Definition
Einecs 238-735-6
Chemical formula Monohydrate: Na
3HP2O7·H2O
Anhydrous: Na3HP2O7
Molecular weight Monohydrate: 261,95
Anhydrous: 243,93
Assay Content not less than 95 % on the anhydrous basis and
not lessthan 57 % and not more than 59% expressed as
P2O5
Description White powder or grains, occurs anhydrous or as a
monohydrate
Identification
A. Positive tests for sodium and for
phosphate
B. Soluble in water1996L0077 — EN — 20.06.2001 — 003.001 — 80
▼M1
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 ºC, 4 hours)
Water-insoluble matter Not more than 0,2 %Fluoride Not more than 10 mg/kg expressed as fluorine
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 450 (iii) TETRASODIUM DIPHOSPHATE
Synonyms Tetrasodium pyrophosphate
Sodium pyrophosphate
Definition
Chemical name Tetrasodium diphosphate
Einecs
231-767-1
Chemical formula Anhydrous: Na
4P2O7
Decahydrate: Na4P2O7·10 H2O
Molecular weight Anhydrous: 265,94
Decahydrate: 446,09
Assay Content not less than 95 % of Na4P2O7, in the ignited
basis and not less than 52,5 % and not more than 54 %
expressed as P2O5
Description Colourless or white crystals, or a white crystalline or
granular powder. The decahydrate effloresces slightly
in dry air
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Soluble in water. Insoluble in ethanol
Purity
pH of a 1 % solution Between 9,8 and 10,8
Loss on ignition Not more than 0,5 % for the anhydrous salt, not less
than 38 % and not more than 42 % for the decahydrate,
in both cases determined after drying at 105 ºC for four
hours, followed by ignition at 550 ºC for 30 minutes
Water-insoluble matter Not more than 0,2 %Fluoride Not more than 10 mg/kg expressed as fluorine
Arsenic Not more than 3 mg/kg
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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 81
▼M1
E 450 (v) TETRAPOTASSIUM DIPHOSPHATE
Synonyms Potassium pyrophosphate
Tetrapotassium pyrophosphate
Definition
Chemical name Tetrapotassium diphosphate
Einecs 230-785-7
Chemical formula K4P2O7
Molecular weight 330,34 (anhydrous)
Assay Content not less than 95 % on the ignited basis and not
less than 42 % and not more than 43,7 % expressed as
P2O5
Description Colourless crystals or white, very hygroscopic powder
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility Soluble in water, insoluble in ethanol
Purity
pH of a 1 % solution Between 10,0 and 10,8Loss on ignition Not more than 2 % after drying at 105 ºC for 4 hours
then ignition at 550 ºC for 30 minutes
Water-insoluble matter Not more than 0,2 %
Fluoride Not more than 10 mg/kg expressed as fluorine
Arsenic Not more than 3 mg/kg
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 (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 P2O5
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 7,01996L0077 — EN — 20.06.2001 — 003.001 — 82
▼M1
Loss on ignition Not more than 1,5 % at 800 ± 25 ºC for 30 minutes
Fluoride Not more than 50 mg/kg expressed as fluorine
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATESynonyms Acid calcium pyrophosphate
Monocalcium dihydrogen pyrophosphate
Definition
Chemical name Calcium dihydrogen diphosphate
Einecs 238-933-2
Chemical formula CaH
2P2O7
Molecular weight 215,97
Assay Content not less than 90 % on the anhydrous basis and
not lessthan 61 % and not more than 64% expressed as
P2O5
Description White crystals or powder
Identification
A. Positive tests for calcium and for
phosphate
Purity
Acid-insoluble matter Not more than 0,4 %
Fluoride Not more than 30 mg/kg expressed as fluorine
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 451 (i) PENTASODIUM TRIPHOSPHATE
Synonyms Pentasodium tripolyphosphate
Sodium tripolyphosphate
Definition
Chemical name Pentasodium triphosphate
Einecs 231-838-7
Chemical formulae Na
5O10P3·xH2O( x=0or6 )
Molecular weight 367,86
Assay Content not less than 85 %
Content in P2O5not 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 powder1996L0077 — EN — 20.06.2001 — 003.001 — 83
▼M1
Identification
A. Solubility Freely soluble in water.
Insoluble in ethanol
B. Positive tests for sodium and for
phosphate
C. pH of a 1 % solution Between 9,1 and 10,2
Purity
Loss on drying Anhydrous: Not more than 0,7 % (105 ºC, 1 hour)
Hexahydrate: Not more than 23,5 % (60 ºC, 1 hour,
followed by drying at 105 ºC, 4 hours)
Water insoluble matter Not more than 0,1 %Higher polyphosphates Not more than 1 %Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATESynonyms Pentapotassium tripolyphosphate
Potassium triphosphatePotassium tripolyphosphate
Definition
Chemical name Pentapotassium triphosphate
Pentapotassium tripolyphosphate
Einecs 237-574-9
Chemical formulae K
5O10P3
Molecular weight 448,42
Assay Content not less than 85 % on the dried basis
Content in P2O5not 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
phosphate
C. pH of a 1 % solution Between 9,2 and 10,5
Purity
Loss on ignition Not more than 0,4 % (105 ºC, 4 hours, followed by
ignition at 550 ºC, 30 minutes)
Water insoluble matter Not more than 2 %Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 84
▼M1
Heavy metals (as Pb) Not more than 20 mg/kg
E 452 (i) SODIUM POLYPHOSPHATE1.SOLUBLE POLYPHOSPHATE
Synonyms Sodium hexametaphosphate
Sodium tetrapolyphosphate
Graham's saltSodium polyphosphates, glassySodium polymetaphosphate
Sodium metaphosphate
Definition Soluble sodium polyphosphates are obtained by fusion
and subsequent chilling of sodium orthophosphates.
These compounds are a class consisting of several
amorphous, water-soluble polyphosphates composed of
linear chains of metaphosphate units, (NaPO
3)xwhere x
≥2, terminated by Na2PO4groups. These substances
are usually identified by their Na2O/P2O5ratioo r their
P2O5content. The Na2O/P2O5ratios vary from about 1,3
for sodium tetrapolyphosphate, where x = approxi-
mately 4; to about 1,1 for Graham's salt, commonly
called sodium hexametaphosphate, where x = 13 to 18;
and to about 1,0 for the higher molecular weight
sodium polyphosphates, where x = 20 to 100 or more.
The pH of their solutions varies between 3,0 and 9,0
Chemical name Sodium polyphosphate
Einecs 272-808-3
Chemical formulae Heterogenous mixtures of sodium salts of linear
condensed polyphosphoric acids of general formula
H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight (102)n
Assay Content in P2O5not less than 60 % and not more than
71 % on the ignited basis
Description Colourless or white, transparent platelets, granules, or
powders
Identification
A. Solubility Very soluble in water
B. Positive tests for sodium and for
phosphate
C. pH of a 1 % solution Between 3,0 and 9,0
Purity
Loss on ignition Not more than 1 %
Water insoluble matter Not more than 0,1 %Fluoride Not more than 10 mg/kg
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
2.INSOLUBLE POLYPHOSPHATE
Synonyms Insoluble sodium metaphosphate
Maddrell's salt
Insoluble sodium polyphosphate, IMP1996L0077 — EN — 20.06.2001 — 003.001 — 85
▼M1
Definition Insoluble sodium metaphosphate is a high molecular
weight sodium polyphosphate composed of two long
metaphosphate chains (NaPO3)xthat spiral in opposite
directions about a common axis. The Na2O/P2O5ratiois
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 polyphosphoric 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 P2O5
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/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 452 (ii) POTASSIUM POLYPHOSPHATE
Synonyms Potassium metaphosphate
Potassium polymetaphosphate
Kurrol salt
Definition
Chemical name Potassium polyphosphate
Einecs 232-212-6
Chemical formulae (KPO
3)n
Heterogenous mixtures of potassium salts of linear
condensed polyphosphoric acids of general formula H(n
+2 )PnO(3n + 1)where′n′is not less than 2
Molecular weight (134)n
Assay Content in P2O5not less than 53,5 % and not more than
61,5 % on the ignited basis
Description Fine white powder or crystals or colourless glassy
platelets
Identification
A. Solubility 1 g dissolves in 100 ml of a 1 in 25 solution of sodium
acetate
B. Positive tests for potassium and for
phosphate
C. pH of a 1 % solution Not more than 7,81996L0077 — EN — 20.06.2001 — 003.001 — 86
▼M1
Purity
Loss on ignition Not more than 2 % (105 ºC, 4 hours followed by
ignition at 550 ºC, 30 minutes)
Water insoluble matter Not more than 0,2 %
Cyclic phosphate Not more than 8 % on P2O5content
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy 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 P2O5not 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
medium
B. Positive tests for calcium and for
phosphate
C. CaO content 27-29,5 %
Purity
Loss on ignition Not more than 2 % (105 ºC, 4 hours followed by
ignition at 550 ºC, 30 minutes)
Cyclic phosphate Not more than 8 % on P2O5content
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
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 460 (i) MICROCRISTALLINE CELLULOSE
Synonyms Cellulose gel1996L0077 — EN — 20.06.2001 — 003.001 — 87
▼M1
Definition Microcrystalline cellulose is purified, partally depoly-
merised cellulose prepared by treating alpha-cellulose,
obtained as a pulp from natural strains of fibrous plant
material, with mineral acids. The degree of polymer-
isation is typically less than 400
Chemical name Cellulose
Einecs 232-674-9
Chemical formula (C6H10O5)n
Molecular weight About 36000
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 (12000 rpm) power blender for 5 minutes. The
resultant mixture will be either a free-following
suspension or a heavy, lumpy suspension which flows
poorly, if at all, settles only slightly and contains many
trapped air bubbles. If a free-flowing suspension is
obtained, transfer 100 ml into a 100-ml graduated
cylinder and allow to stand for 1 hour. The solids
settles and a supernatant liquid appears
Purity
Loss on drying Not more than 7 % (105 ºC, 3 hours)Water-soluble matter Not more than 0,24%
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and 7,5Starch Not detectable
To 20 ml of the dispersion obtained in identification,
test D, add a few drops of iodine solution and mix. No
purplish to blue or blue colour should be produced
Particle size Not less than 5 µm (not more than 10 % of particles of
less than 5 µm)
Carboxyl groups Not more than 1 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 460 (ii) POWDERED CELLULOSEDefinition Purified, mechanically disintegrated celluslose prepared
by processing alpha-cellulose obtained as a pulp from
natural strains of fibrous plant materials
Chemical name Cellulose
Linear polymer of 1:4 linked glucose residues
Einecs 232-674-91996L0077 — EN — 20.06.2001 — 003.001 — 88
▼M1
Chemical formula (C6H10O5)n
Molecular weight (162)n(n is predominantly 1000 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 (12000 rpm) power blender for 5 minutes. The
resultant mixture will be either a free-flowing suspen-
sion 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 intoa 100-ml graduated cylinder and
allow to stand for 1 hour. The solids settles and a
supernatant liquid appears
Purity
Loss on drying Not more than 7 % (105 ºC, 3 hours)
Water-soluble matter Not more than 1,0 %Sulphated ash Not more than 0,3 % determined at 800 ± 25 ºC
pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and 7,5
Starch Not detectable
To 20 ml of the dispersion obtained in identification,
test B, add a few drops of iodine solution and mix. No
purplish to blue or blue colour should be produced
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Particle size Not less than 5 µm (not more than 10 % of particles of
less than 5 µm)
E 461 METHYL CELLULOSE
Synonyms Cellulose methyl ether
Definition Methyl cellulose is cellulose obtained directly from
natural strains of fibrous plant material and partially
etherified with methyl groups
Chemical name Methyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units
with the following general formula:
C
6H7O2(OR1)(OR2)(OR3) where R1,R2,R3each may be
one of the following:
—H
—C H3or
—C H2CH3
Molecular weight From about 20000 to 380000
Assay Content not less than 25 % and not more than 33 % of
methoxyl groups (-OCH3) and not more than 5 % of
hydroxyethoxyl groups (-OCH2CH2OH)
Description Slightly hygroscopic white or slightly yellowish or
greyish odourless and tasteless, granular or fibrous
powder1996L0077 — EN — 20.06.2001 — 003.001 — 89
▼M1
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 ºC, 3 hours)
Sulphated ash Not more than 1,5 % determined at 800 ± 25 ºCpH 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 hydroxypropyl groups
Chemical name Hydroxypropyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units
with the following general formula:
C
6H7O2(OR1)(OR2)(OR3), where R1,R2,R3each may be
one of the following:
—H
—C H2CHOHCH3
—C H2CHO(CH2CHOHCH3)CH3
—C H2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
Molecular weight From about 30000 to 1 000000
Assay Content not less than 80,5 % of hydroxypropoxyl
groups (-OCH2CHOHCH3) equivalent to not more than
4,6 hydroxypropyl groups per anhydroglucose unit on
the anhydrous basis
Description Slightly hygroscopic white or slightly yellowish or
greyish odourless and tasteless, granular or fibrous
powder
Identification
A. Solubility Swelling in water, producing a clear to opalescent,
viscous, colloidal solution. Soluble in ethanol. Inso-
luble in ether
B. Gas chromatography Determine the substituents by gas chromotography
Purity
Loss on drying Not more than 10 % (105 ºC, 3 hours)
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºCpH 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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 90
▼M1
Heavy metals (as Pb) Not more than 20 mg/kg
E 464 HYDROXYPROPYL METHYL CELLULOSEDefinition Hydroxypropyl methyl cellulose is cellulose obtained
directly from natural strains of fibrous plant material
and partially etherified with methyl groups and
containing a small degree of hydroxypropyl substitution
Chemical name 2-Hydroxypropyl ether of methylcellulose
Chemical formula The polymers contain substituted anhydroglucose units
with the following general formula:
C
6H7O2(OR1)(OR2)(OR3), where R1,R2R3each may be
one of the following:
—H
—C H3
—C H2CHOHCH3
—C H2CHO (CH2CHOHCH3)C H3
—C H2CHO[CH2CHO (CH2CHOHCH3)C H3]CH3
Molecular weight From about 13000 to 200000
Assay Content not less than 19 % and not more than 30 %
methoxyl groups (-OCH3) and not less than 3 % and not
more than 12 % hydroxypropoxyl groups (-
OCH2CHOHCH3), on the anhydrous basis
Description Slightly hygroscopic white or slightly yellowish or
greyish odourless and tasteless, granular or fibrous
powder
Identification
A. Solubility Swelling in water, producing a clear to opalescent,
viscous, colloidal solution. Insoluble in ethanol
B. Gas chromatography Determine the substituents by gas chromatography
Purity
Loss on drying Not more than 10 % (105 ºC, 3 hours)
Sulphated ash Not more than 1,5 % for products with viscosities of 50
mPa.s or above
Not more than 3 % for products with viscosities below
50 mPa.s
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Propylene chlorohydrins Not more than 0,1 mg/kg
Arsenic Not more than 3 mg/kgLead 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 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 ethyl groups
Chemical name Ethyl methyl ether of cellulose1996L0077 — EN — 20.06.2001 — 003.001 — 91
▼M1
Chemical formula The polymers contain substituted anhydroglucose units
with the following general formula:
C6H7O2(OR1)(OR2)(OR3), where R1,R2R3each may be
one of the following:
—H
—C H3
—C H2CH3
Molecular weight From about 30000 to 40000
Assay Content on the anhydrous basis not less than 3,5 % and
not more than 6,5 % of methoxyl groups (-OCH3) and
not less than 14,5 % and not more than 19 % of ethoxyl
groups (-OCH2CH3), and not less than 13,2 % and not
more than 19,6 % of total alkoxyl groups, calculated as
methoxyl
Description Slightly hygroscopic white or slightly yellowish or
greyish odourless and tasteless, granular or fibrous
powder
Identification
A. Solubility Swelling in water, producing a clear to opalescent,
viscous, colloidal solution. Soluble in ethanol. Inso-
luble in ether
Purity
Loss on drying Not more than 15 % for the fibrous form, and not more
than 10 % for the powdered form (105 ºC to constant
weight)
Sulphated ash Not more than 0,6 %
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Arsenic Not more than 3 mg/kgLead 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 466 SODIUM CARBOXY METHYL CELLULOSESynonyms Carboxy methyl cellulose
CMC
NaCMCSodium CMC
Cellulose gum
Definition Carboxy methyl cellulose is the partial sodium salt of a
carboxymethyl ether of cellulose, the cellulose being
obtained directly from natural strains of fibrous plant
material
Chemical name Sodium salt of the carboxymethyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units
with the following general formula:
C
6H7O2(OR1)(OR2)(OR3), where R1,R2R3each may be
one of the following:
—H
—C H2COONa
—C H2COOH
Molecular weight Higher than approximately 17000 (degree of polymer-
isation approximately 100)
Assay Content on the anhydrous basis not less than 99,5 %1996L0077 — EN — 20.06.2001 — 003.001 — 92
▼M1
Description Slightly hygroscopic white or slightly yellowish or
greyish odourless and tasteless, granular or fibrous
powder
Identification
A. Solubility Yields a viscous colloidal solution with water.
Insoluble in ethanol
B. Foam test A 0,1 % solution of the sample is shaken vigorously.
No layer of foam appears. (This test permits the
distinction of sodium carboxymethyl cellulose from
other cellulose ethers)
C. Precipitate formation To 5 ml of a 0,5 % solution of the sample, add 5 ml of
5 % solution of copper sulphate or of aluminium
sulphate. A precipitate appears. (This test permits the
distinction of sodium carboxymethyl cellulose from
other cellulose ethers and from gelatine, locust bean
gum and tragacanth)
D. Colour reaction Add 0,5 g powdered carboxy methyl cellulose sodium
to 50 ml of water, while stirring to produce an uniform
dispersion. Continue the stirring until a clear solution is
produced, and use the solution for the following test:
To 1 mg of the sample, diluted with an equal volume of
water, in a small test tube, add 5 drops of 1-naphthol
solution. Incline the test tube, and carefully introduce
down the side of the tube 2 ml of sulphuric acid so that
it forms a lower layer. A red-purple colour develops at
the interface
Purity
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl
groups (-CH2COOH) per anhydroglucose unit
Loss on drying Not more than 12 % (105 ºC to constant weight)
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,5
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Total glycolate Not more than 0,4 %, calculated as sodium glycolate on
the anhydrous basis
Sodium Not more than 12,4 % on the anhydrous basis
E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDSDefinition Sodium, potassium and calcium salts of fatty acids
occurring in food oils and fats, these salts being
obtained either from edible fats and oils or from
distilled food fatty acids
Assay Content on the anhydrous basis not less than 95 %
Description White or creamy white light powders, flakes or semi-
solids
Identification
A. Solubility Sodium and potassium salts: soluble in water and
ethanol calcium salts: insoluble in water, ethanol and
ether
B. Positive tests for cations and for fatty
acids1996L0077 — EN — 20.06.2001 — 003.001 — 93
▼M1
Purity
Sodium Not less than 9 % and not more than 14 % expressed as
Na2O
Potassium Not less than 13 % and not more than 21,5 % expressed
as K2O
Calcium Not less than 8,5 % and not more than 13 % expressed
as CaO
Unsaponifiable matter Not more than 2 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Free alkali Not more than 0,1 % expressed as NaOH
Matter insoluble in alcohol Not more than 0,2 % (sodium and potassium salts only)
E 470b MAGNESIUM SALTS OF FATTY 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 food fatty acids
Assay Content on the anhydrous basis not less than 95 %
Description White or creamy-white light powders, flakes or semi-
solids
Identification
A. Solubility Insoluble in water, partially soluble in ethanol and ether
B. Positive tests for magnesium and for
fatty acids
Purity
Magnesium Not less than 6,5 % and not more than 11 % expressed
as MgO
Free alkali Not more than 0,1 % expressed as MgO
Unsaponifiable matter Not more than 2 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Glyceryl monostearate
Glyceryl monopalmitateGlyceryl monooleate, etc.
Monostearin, monopalmitin, monoolein, etc.
GMS (for glyceryl monostearate)
Definition Mono- and diglycerides of fatty acids consist of
mixtures of glycerol mono-, di- and triesters of fatty
acids occurring in food oils and fats. They may contain
small amounts of free fatty acids and glycerol1996L0077 — EN — 20.06.2001 — 003.001 — 94
▼M1
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 polyolB. 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/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 glycerol Not less than 16 % and not more than 33 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however
these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDSSynonyms Acetic acid esters of mono- and diglycerides
Acetoglycerides
Acetylated mono- and diglyceridesAcetic and fatty acid esters of glycerol
Definition Esters of glycerol with acetic and fatty acids occurring
in food fats and oils. They may contain small amounts
of free glycerol, free fatty acids, free acetic acid and
free glycerides
Description Clear, mobile liquids to solids, from white to pale
yellow in colour
Identification
A. Positive tests for glycerol, for fatty
acids and for acetic acid
B. Solubility Insoluble in water. Soluble in ethanol
Purity
Acids other than acetic and fatty acids Not detectable
Free glycerol Not more than 2 %Arsenic Not more than 3 mg/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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 95
▼M1
Total acetic acid Not less than 9 % and not more than 32 %
Free fatty acids (and acetic acid) Not more than 3 % estimated as oleic acid
Total glycerol Not less than 14 % and not more than 31 %Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however
these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Lactic acid esters of mono- and diglycerides
Lactoglycerides
Mono- and diglycerides of fatty acids esterified with
lactic acid
Definition Esters of glycerol with lactic acid and fatty acids
occurring in food fats and oils. They may contain small
amounts of free glycerol, free fatty acids, free lactic
acid and free glycerides
Description Clear, mobile liquids to waxy solids of variable
consistency, from white to pale yellow in colour
Identification
A. Positive tests for glycerol, for fatty
acids and for lactic acid
B. Solubility Insoluble in cold water but dispersible in hot water
Purity
Acids other than lactic and fatty acids Not detectable
Free glycerol Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total lactic acid Not less than 13 % and not more than 45 %
Free fatty acids (and lactic acid) Not more than 3 % estimated as oleic acidTotal glycerol Not less than 13 % and not more than 30 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however
these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDSSynonyms Citric acid esters of mono- and diglycerides
CitroglyceridesMono- and diglycerides of fatty acids esterified with
citric acid
Definition Esters of glycerol with citric acid and fatty acids
occurring in food oils and fats. They may contain small
amounts of free glycerol, free fatty acids, free citric
acid and free glycerides. They may be partially or
wholly neutralised with sodium hydroxide or with
potassium hydroxide
Description Yellowish or light brown liquids to waxy solids or
semi-solids1996L0077 — EN — 20.06.2001 — 003.001 — 96
▼M1
Identification
A. Positive tests for glycerol, for fatty
acids and for citric acid
B. Solubility Insoluble in cold water
Dispersible in hot water
Soluble in oils and fatsInsoluble 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 ºC
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/kgHeavy metals (as Pb) Not more than 10 mg/kgFree fatty acids Not more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however
these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Tartaric acid esters of mono- and diglycerides
Mono- and diglycerides of fatty acids esterified with
tartaric acid
Definition Esters of glycerol with tartaric acid and fatty acids
occurring in food fats and oils. They may contain small
amounts of free glycerol, free fatty acids, free tartaric
acid and free glycerides
Description Sticky viscous yellowish liquids to hard yellow waxes
Identification
A. Positive tests for glycerol, for fatty
acids and for tartaric acid
Purity
Acids other than tartaric and fatty acids Not detectableFree glycerol Not more than 2 %Total glycerol Not less than 12 % and not more than 29 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgTotal tartaric acid Not less than 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 ºC
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)1996L0077 — EN — 20.06.2001 — 003.001 — 97
▼M1
E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCER-
IDES 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 diacetyltar-
taric acids (obtained from tartaric acid) and fatty acids
occurring in food fats and oils. They may contain small
amounts of free glycerol, free fatty acids, free tartaric
and acetic acids and their combinations, and free
glycerides. Contains also tartaric and acetic esters of
fatty acids
Description Sticky viscous liquids through a fat-like consistency to
yellow waxes which hydrolyse in moist air to liberate
acetic acid
Identification
A. Positive tests for glycerol, for fatty
acids, for tartaric acid and for acetic
acid
Purity
Acids other than acetic, tartaric and
fatty acidsNot detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 11 % and not more than 28 %Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºCArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgTotal tartaric acid Not less than 10 % and not more than 40 %Total acetic acid Not less than 8 % and not more than 32 %
Free fatty acids Not more than 3 % estimated as oleic 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 DIGLYCERIDES
OF FATTY ACIDS
Synonyms Mono- and diglycerides of fatty acids esterified with
acetic acid and tartaric acid
Definition Esters of glycerol with acetic and tartaric acids and
fatty acids occurring in food fats and oils. They may
contain small amounts of free glycerol, free fatty acids,
free tartaric and ecetic acids, and free glycerides. May
contain mono- and diacetyltartaric esters of mono- and
diglycerides of fatty acids
Description Sticky liquids to solids, from white to pale-yellow in
colour
Identification
A. Positive tests for glycerol, for fatty
acids, for tartaric acid and for acetic
acid1996L0077 — EN — 20.06.2001 — 003.001 — 98
▼M1
Purity
Acids other than acetic, tartaric and
fatty acidsNot detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 12 % and not more than 27 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/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 and the methyl and ethyl esters
of food fatty acids or by extraction from sucroglycer-
ides. No organic solvent other than dimethylsulphoxide,
dimethylformamide, ethyl acetate, propane-2-ol, 2-
methyl-1-propanol, propylene glycol and methyl ethyl
ketone may be used for their preparation
Assay Content not less than 80 %
Description Stiff gels, soft solids or white to slightly greyish-white
powders
Identification
A. Positive tests for sugar for fatty acids
B. Solubility Sparingly soluble in water
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25 ºCFree 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/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Methanol 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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 99
▼M1
Ethyl acetate Not more than 350 mg/kg, singly or in combination
Propane-2-ol
Propylene glycol
Methyl ethyl ketone Not more than 10 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however
these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E 474 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 other than cyclohexane, dimethylforma-
mide, ethyl acetate, 2-methyl-1-propanol and propane-
2-ol
Assay Content not less than 40 % and not more than 60 % of
sucrose fatty acid esters
Description Soft solid masses, stiff gels or white to off-white
powders
Identification
A. Positive tests for sugar and for fatty
acids
B. Solubility Insoluble in cold water
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25 ºCFree 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 POLYGLYCEROL ESTERS OF FATTY ACIDS
Synonyms Polyglycerol fatty acid esters
Polyglycerin esters of fatty acid esters
Definition Polyglycerol esters of fatty acids are produced by the
esterification of polyglycerol with food fats and oils or
with fatty acids occurring in foods fats and oils. The
polyglycerol moiety is predominantly di-, tri- and
tetraglycerol and contains not more than 10 % of
polyglycerols equal to or higher than heptaglycerol1996L0077 — EN — 20.06.2001 — 003.001 — 100
▼M1
Assay Content of total fatty acid ester not less than 90 %
Description Light yellow to amber, oily to very viscous liquids;
light tan to medium brown, plastic or soft solids; and
light tan to brown, hard, waxy solids
Identification
A. Positive tests for glycerol, for
polyglycerols and for fatty acids
B. Solubility The esters range from very hydrophilic to very
lipophilic, but as a class tend to be dispersible in water
and soluble in organic solvents and oils
Purity
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºCAcids other than fatty acids Not detectable
Free fatty acids Not more than 6 % estimated as oleic acid
Total glycerol and polyglycerol Not less than 18 % and not more than 60 %Free glycerol and polyglycerol Not more than 7 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium 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 476POLYGLYCEROL 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 ester-
ification 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 hydro-
carbons
B. Positive tests for glycerol, polygly-
cerol and for ricinoleic acid
C. Refractive index [n]
65Between 1,4630 and 1,4665
Purity
Polyglycerols The polyglycerol moiety shall be composed of not less
than 75 % of di-, tri- and tetraglycerols and shall
contain not more than 10 % of polyglycerols equal to or
higher than heptaglycerol
Hydroxyl value Not less than 80 and not more than 100
Acid value Not more than 6Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 101
▼M1
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDSSynonyms Propylene glycol esters of fatty acids
Definition Consists of mixtures of propane-1,2-diol mono- and
diesters of fatty acids occurring in food fats and oils.
The alcohol moiety is exclusively propane-1,2-diol
together with dimer and traces of trimer. Organic acids
other than food fatty acids are absent.
Assay Content of total fatty acid ester not less than 85 %
Description Clear liquids or waxy white flakes, beads or solids
having a bland odour
Identification
A. Positive tests for propylene glycol
and for fatty acids
Purity
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºCAcids other than fatty acids Not detectable
Free fatty acids Not more than 6 % estimated as oleic acid
Total propane-1,2-diol Not less than 11 % and not more than 31 %Free propane-1,2-diol Not more than 5 %Dimer and trimer of propylene glycol Not more than 0,5 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium 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 THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND
DIGLYCERIDES OF FATTY ACIDS
Synonyms TOSOM
Definition Thermally oxidised soyabean oil interacted with mono-
and diglycerides of fatty acids is a complex mixture of
esters of glycerol and fatty acids found in edible fat and
fatty acids from thermally oxidised soya bean oil. It is
produced by interaction and desodorisation under
vacuum at 130 ºC of 10 % of thermally oxidised soya
bean oil and 90 % mono- and diglycerides of food fatty
acids. Soya bean oil is exclusively made from natural
strains of soya beans
Description Pale yellow to light brown a waxy or solid consistency
Identification
A. Solubility Insoluble in water. Soluble in hot oil or fat
Purity
Melting range 55—65 ºC
Free fatty acids Not more than 1,5 % estimated as oleic acid
Free glycerol Not more than 2 %Total fatty acids 83—90 %1996L0077 — EN — 20.06.2001 — 003.001 — 102
▼M1
Total glycerol 16—22 %
Fatty acid methyl esters, not forming
adduct with ureaNot more than 9 % of total fatty acid methyl esters
Fatty acids, insoluble in petroleum ether Not more than 2 % of total fatty acids
Peroxide value Not more than 3Epoxides Not more than 0,03 % oxirane oxygenArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 481 SODIUM STEAROYL-2-LACTYLATESynonyms Sodium stearoyl lactylate
Sodium stearoyl lactate
Definition A mixture of the sodium salts of stearoyl lactylic acids
and its polymers and minor amounts of sodium salts of
other related acids, manufactured by the reaction of
stearic acid and lactic acid. Other food fatty acids may
alsobe present, free o r esterified, due totheir presence
in the stearic acid used
Chemical names Sodium di-2-stearoyl lactate
Sodium di(2-stearoyloxy)propionate
Einecs 246-929-7
Chemical formula
(major components)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 130Total lactic acid Not less than 15 % and not more than 40 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 482 CALCIUM STEAROYL-2-LACTYLATESynonyms Calcium stearoyl lactate
Definition A mixture of the calcium salts of stearoyl lactylic acids
and its polymers and minor amounts of calcium salts of
other related acids, manufactured by the reaction of
stearic acid and lactic acid. Other food fatty acids may
alsobe present, free o r esterified, due totheir presence
in the stearic acid used1996L0077 — EN — 20.06.2001 — 003.001 — 103
▼M1
Chemical name Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Einecs 227-335-7
Chemical formula C42H78O8Ca
C38H70O8Ca
Description White or slightly yellowish powder or brittle solid with
a characteristic odour
Identification
A. Positive tests for calcium, for fatty
acids and for lactid acid
B. Solubility Slightly soluble in hot water
Purity
Calcium Not less than 1 % and not more than 5,2 %Ester value Not less than 125 and not more than 190
Total lactic acid Not less than 15 % and not more than 40 %
Acid value Not less than 50 and not more than 130Arsenic 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 483 STEARYL TARTRATE
Synonyms Stearyl palmityl tartrate
Definition Product of the esterification of tartaric acid with
commercial stearyl alcohol, which consists essentially
of stearyl and palmityl alcohols. It consists mainly of
diester, with minor amounts of monoester and of
unchanged starting materials
Chemical name Distearyl tartrate
Dipalmityl tartrate
Chemical formula C
38H74O6toC40H78O6
Molecular weight 627 to655
Assay Content of total ester not less than 90 % corresponding
to an ester value of not less than 163 and not more than
180
Description Cream-coloured unctuous solid (at 25 ºC)
Identification
A. Positive tests for tartareB. Melting range Between 67 ºC and 77 ºC. After saponification the
saturated long chain fatty alcohols have a melting range
of 49 ºC to 55 ºC
Purity
Hydroxyl value Not less than 200 and not more than 220Acid value Not more than 5,6Total tartaric acid content Not less than 18 % and not more than 35 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 104
▼M1
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Unsaponifiable matter Not less than 77 % and not more than 83 %
Iodine value Not more than 4 (Wijs)
E 491 SORBITAN MONOSTEARATEDefinition A mixture of the partial esters of sorbitol and its
anhydrides with edible, commercial stearic acid
Einecs 215-664-9
Assay Content not less than 95 % of a mixture of sorbitol,
sorbitan, and isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or a hard,
waxy solid with a slight characteristic odour
Identification
A. Solubility Soluble at temperatures above its melting point in
toluene, dioxane, carbon tetrachloride, ether, methanol,
ethanol and aniline; insoluble in petroleum ether and
acetone; insoluble in cold water but dispersible in warm
water; soluble with haze at temperatures above 50 ºC in
mineral oil and ethyl acetate
B. Congealing range 50—52 ºCC. 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 260Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 492 SORBITAN TRISTEARATE
Definition A mixture of the partial esters of sorbitol and its
anhydrides with edible, commercial stearic acid
Einecs 247-891-4
Assay Content not less than 95 % of a mixture of sorbitol,
sorbitan, and isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or hard,
waxy solid with a slight odour
Identification
A. Solubility Slightly soluble in toluene, ether, carbon tetrachloride
and ethyl acetate; dispersible in petroleum ether,
mineral oil, vegetable oils, acetone and dioxane;
insoluble in water, methanol and ethanol
B. Congealing range 47—50 ºCC. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol1996L0077 — EN — 20.06.2001 — 003.001 — 105
▼M1
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 188Hydroxyl value Not less than 66 and not more than 80Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 493 SORBITAN MONOLAURATE
Definition A mixture of the partial esters of sorbitol and its
anhydrides with edible, commercial lauric acid
Einecs 215-663-3
Assay Content not less than 95 % of a mixture of sorbitol,
sorbitan, and isosorbide esters
Description Amber-coloured oily viscous liquid, light cream to tan-
coloured beads or flakes or a hard, waxy solid with a
slight odour
Identification
A. Solubility Dispersible in hot and cold 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 7Saponification value Not less than 155 and not more than 170
Hydroxyl value Not less than 330 and not more than 358
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 494 SORBITAN MONOOLEATEDefinition A mixture of the partial esters of sorbitol and its
anhydrides with edible, commercial oleic acid. Major
constituent is 1,4-sorbitan monooleate. Other constitu-
ents include isosorbide monooleate, sorbitan dioleate
and sorbitan trioleate
Einecs 215-665-4
Assay Content not less than 95 % of a mixture of sorbitol,
sorbitan and isosorbide esters
Description Amber-coloured viscous liquid, light cream to tan-
coloured beads or flakes or a hard, waxy solid with a
slight characteristic odour1996L0077 — EN — 20.06.2001 — 003.001 — 106
▼M1
Identification
A. Solubility Soluble at temperatures above its melting point in
ethanol, ether, ethyl acetate, aniline, toluene, dioxane,
petroleum ether and carbon tetrachloride. Insoluble in
cold water, dispersible in warm water
B. Iodine value The residue of oleic acid, obtained from the saponifica-
tion 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 210Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 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 and carbon tetrachloride.
Insoluble in cold water but dispersible in warm water
B. Congealing range 45—47 ºCC. Infrared absorption spectrum Characteristic of a partial fatty acid ester of polyol
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphate ash Not more than 0,5 %
Acid value Not more than 7,5Saponification value Not less than 140 and not more than 150Hydroxyl value Not less than 270 and not more than 305Arsenic 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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 107
▼M1
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 ethanolB. Positive tests for potassium and for
chloride
Purity
Loss on drying Not more than 1 % (105 ºC, 2 hours)Sodium Negative testArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy 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
12H22FeO14·2H2O
Molecular weight 482,17
Assay Content not less than 95 % on the dried basis
Description Pale greenish-yellow to yellowish-grey powder or
granules, which may have a faint odour of burnt sugar
Identification
A. Solubility Soluble with slight heating in water. Practically
insoluble in ethanol
B. Positive test for ferrous ionC. Formation of phenylhydrazine deri-
vative of gluconic acid positive
D. pH of a 10 % solution Between 4 and 5,5
Purity
Loss on drying Not more than 10 % (105 ºC, 16 hours)Oxalic acid Not detectable1996L0077 — EN — 20.06.2001 — 003.001 — 108
▼M1
Iron (Fe III) Not more than 2 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Reducing substances Not more than 0,5 % expressed as glucose
E 585 FERROUS LACTATESynonyms Iron(II) lactate
Iron(II) 2-hydroxy propanoate
Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)
Definition
Chemical name Ferrous 2-hydroxy propanoate
Einecs 227-608-0
Chemical formulae C
6H10FeO6·xH2O( x=2or3 )
Molecular weight 270,02 (dihydrate)
288,03 (trihydrate)
Assay Content not less than 96 % on the dried basis
Description Greenish-white crystals or light green powder having a
characteristic smell
Identification
A. Solubility Soluble in water. Practically insoluble in ethanol
B. Positive test for ferrous ion and for
lactate
C. pH of a 2 % solution Between 4 and 6
Purity
Loss on drying Not more than 18 % (100 ºC, under vacuum,
approximately 700 mm Hg)
Iron (Fe III) Not more than 0,6 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 1105 LYSOZYME
Synonyms Lysozyme hydrochloride
Muramidase
Definition Lysozyme is a linear polypeptide obtained from hens'
egg whites consisting of 129 amino acids. It possesses
enzymatic activity in its ability tohydro lyse the β(1-4)
linkages between N-acetylmuramic acid and N-acet-
ylglucosamine in the outer membranes of bacterial
species, in particular gram-positive organisms. Is
usually obtained as the hydrochloride
Chemical name Enzyme Commission (EC) No: 3.2.1.17
Einecs 232-620-4
Molecular weight About 14000
Assay Content not less than 950 mg/g on the anhydrous basis
Description White, odourless powder having a slightly sweet taste1996L0077 — EN — 20.06.2001 — 003.001 — 109
▼B
▼B
Identification
A. Isoelectric point 10,7
B. pH of a 2 % aqueous solution
between 3,0 and 3,6
C. Absorption maximum of an aqueous
solution (25 mg/100 ml) at 281 nm, a
minimum at 252 nm
Purity
Water content Not more than 6,0 % (Karl Fischer method) (powder
form only)
Residue on ignition Not more than 1,5 %
Nitrogen Not less than 16,8 % and not more than 17,8 %
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Microbiological criteria
Total bacterial count Not more than 5 × 104col/g
Salmonellae Absent in 25 g
Staphylococcus aureus Absent in 1 g
Escherichia coli Absent in 1 g
POLYETHYLENEGLYCOL 6000
Synonyms PEG 6000
Macrogol 6000
Definition Polyethylene glycol 6000 is a mixture of polymers with
the general formula H /C0OCH2/C0CH ðÞ /C0 OH corre-
sponding 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)
Molecular weight 5 600 - 7 000
Assay Not less than 90,0 % and not more than 110,0 %
Description A white or almost white solid with a waxy or paraffin-
like appearance
Identification
A. Solubility Very soluble in water and in methylene chloride
Practically insoluble in alcohol, in ether and in fatty
and mineral oils
B. Melting range Between 55 ºC and 61 ºC
Purity
Viscosity Between 0,220 and 0,275 kgm-1s-1at 20 ºC
Hydroxyl value Between 16 and 22
Sulphated ash Not more than 0,2 %
Ethylene oxide Not more than 1 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 110
▼M2
▼M2
E 296MALIC ACID
Synonyms DL-Malic acid, pomalous acid
Definition
Chemical name DL-Malic acid, hydroxybutanedioic acid, hydroxysuc-
cinic acid
EINECS 230-022-8
Chemical formula C4H6O5
Molecular weight 134,09
Assay Content not less than 99,0 %
Description White or nearly white crystalline powder or granules
Identification
A. Melting range between 127 ºC and
132 ºC
B. Positive test for malate
C. Solutions of this substance are
optically inactive in all concentra-
tions
Purity
Sulphated ash Not more than 0,1 %
Fumaric acid Not more than 1,0 %Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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
Molecular weight 116,07
Assay Content not less than 99,0 % on the anhydrous basis
Description White crystalline powder or granules
Identification
A. Melting range 286 ºC - 302 ºC (closed capillary, rapid heating)
B. Positive tests for double bonds and
for 1,2-dicarboxylic acid
C. pH of a 0,05 % solution at 25 ºC 3,0 - 3,2
Purity
Loss on drying Not more than 0,5 % (120 ºC, 4h)Sulphated ash Not more than 0,1 %
Maleic acid Not more than 0,1 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 111
▼M2
E 343(i) MONOMAGNESIUM PHOSPHATE
Synonyms Magnesiumdihydrogenphosphate
Magnesiumphosphate, monobasicMonomagnesium orthophosphate
Definition
Chemical name Monomagnesiumdihydrogenmonophosphate
EINECS 236-004-6
Chemical formula Mg H
2PO4 ðÞ2/C1nH2O (where n = 0 to4)
Molecular weight 218,30 (anhydrous)
Assay Not less than 51,0 % after ignition
Description White, odourless, crystalline powder, slightly soluble in
water
Identification
A. Positive test for magnesium and for
phosphate
B. MgO content Not less than 21,5 % after ignition
Purity
Fluoride Not more than 10 mg/kg (as fluorine)Arsenic Not more than 3 mg/kgLead Not more than 4 mg/kgCadmium Not more than 1 mg/kgMercury Not more than 1 mg/kg
E 343(ii) DIMAGNESIUM PHOSPHATESynonyms Magnesiumhydrogenphosphate
Magnesiumphosphate, dibasic
Dimagnesium orthophosphateSecondary magnesiumphosphate
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
phosphate
B. MgO content: Not less than 33,0 % calculated on an anhydrous basis
Purity
Fluoride Not more than 10 mg/kg (as fluorine)Arsenic Not more than 3 mg/kgLead Not more than 4 mg/kgCadmium Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 112
▼M2
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 hydroxybutane-
dioic acid
Chemical formula Hemihydrate: C
4H4Na2O5/C1è5 H2O
Trihydrate: C 4H4Na2O5/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 PositiveC. Solubility Freely soluble in water
Purity
Loss on drying Not more than 7,0 % (130 ºC, 4h) for the hemihydrate,
or 20,5 % - 23,5 % (130 ºC, 4h) for the trihydrate
Alkalinity Not more than 0,2 % as Na
2CO3
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 350 (ii) SODIUM HYDROGEN MALATESynonyms Monosodium salt of DL-malic acid
Definition
Chemical name Monosodium DL-malate, monosodium 2-DL-hydroxy
succinate
Chemical formula C
4H5NaO5
Molecular weight 156,07
Assay Content not less than 99,0 % on the anhydrous basis
Description White powder
Identification
A. Positive tests for 1,2-dicarboxylic
acid and for sodium
B. Azo dye formation Positive
Purity
Loss on drying Not more than 2,0 % (110 ºC, 3h)
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %Arsenic Not more than 3 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 113
▼M2
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 351 POTASSIUM MALATE
Synonyms Potassium salt of malic acid
Definition
Chemical name Dipotassium DL-malate, dipotassium salt of hydroxy-
butanedioic acid
Chemical formula C4H4K2O5
Molecular weight 210,27
Assay Content not less than 59,5 %
Description Colourless or almost colourless aqueous solution
Identification
A. Positive tests for 1,2-dicarboxylic
acid and for potassium
B. Azo dye formation Positive
Purity
Alkalinity Not more than 0,2 % as K 2CO3
Fumaric acid Not more than 1,0 %Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 352 (i) CALCIUM MALATESynonyms Calcium salt of malic acid
Definition
Chemical name Calcium DL-malate, calcium- α-hydroxysuccinate,
calcium salt of hydroxybutanedioic acid
Chemical formula C
4H5CaO5
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-dicar-
boxylic acid and for calcium
B. Azo dye formation PositiveC. Solubility Slightly soluble in water
Purity
Loss on drying Not more than 2 % (100 ºC, 3h)Alkalinity Not more than 0,2 % as CaCO
3
Maleic acid Not more than 0,05 %Fumaric acid Not more than 1,0 %Fluoride Not more than 30 mg/kgArsenic Not more than 3 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 114
▼M2
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 352 (ii) CALCIUM HYDROGEN MALATESynonyms Monocalcium salt of DL-malic acid
Definition
Chemical name Monocalcium DL-malate, monocalcium 2-DL-hydro-
xysuccinate
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 ºC, 3h)Maleic acid Not more than 0,05 %Fumaric acid Not more than 1,0 %
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury 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 ºC
B. Solubility Slightly soluble in water. Freely soluble in ethanol
Purity
Water Not more than 0,2 % (Karl Fischer method)Sulphated ash Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 115
▼M2
E 363 SUCCINIC ACID
Definition
Chemical name Butanedioic acid
EINECS 203-740-4
Chemical formula C4H6O4
Molecular weight 118,09
Assay Content no less than 99,0 %
Description Colourless or white, odourless crystals
Identification
A. Melting range Between 185,0 ºC and 190,0 ºC
Purity
Residue on ignition Not more than 0,025 % (800 ºC, 15 min)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury 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-tricar-
boxylic acid
EINECS 222-394-5
Chemical formula C
6H17N3O7
Molecular weight 243,22
Assay Content not less than 97,0 %
Description White to off-white crystals or powder
Identification
A. Positive tests for ammonium and for
citrate
B. Solubility Freely soluble in water
Purity
Oxalate Not more than 0,04 % (as oxalic acid)
Arsenic Not more than 3 mg/kgLead 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 P 2O51996L0077 — EN — 20.06.2001 — 003.001 — 116
▼M2
Description White glassy crystals, spheres
Identification
A. pH of a 1 % m/m slurry Approximately 5 to 7
B. CaO content 7 %-15 % m/m
Purity
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kgCadmium Not more than 1 mg/kg
Mercury 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 C 6H10O5 ðÞ7ona n
anhydrous basis
Description Virtually odourless, white or almost white crystalline
solid
Identification
A. Solubility Sparingly soluble in water; freely soluble in hot water;
slightly soluble in ethanol
B. Specific rotation [ α]25D: + 160oto+ 164o(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 basisResidual solvents (toluene and trichlor-
oethylene)Not more than 1 mg/kg for each solvent
Reducing substances (as glucose) Not more than 1 %
Sulphated ash Not more than 0,1 %
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
E 468 CROSS-LINKED SODIUM CARBOXYMETHYL-
CELLULOSE
Synonyms Cross-linked carboxymethyl cellulose
Cross-linked CMC
Cross-linked sodium CMC
Cross-linked cellulose gum1996L0077 — EN — 20.06.2001 — 003.001 — 117
▼M2
Definition Cross-linked sodium carboxymethyl cellulose is the
sodium salt of thermally cross-linked partly O-carbox-
ymethylated cellulose
Chemical name Sodium salt of the cross-linked carboxymethyl ether
cellulose
Chemical formula The polymers containing substituted anhydroglucose
units with the general formula:
C6H7O2OR1 ðÞOR2 ðÞOR3 ðÞ
where R 1,R2and R3may be any of the following:
—H
—C H 2COONa
—C H 2COOH
Description Slightly hygroscopic, white to off white, odourless
powder
Identification
A. Shake 1 g with 100 ml of a solution containing 4 mg/kg
methylene blue and allow to settle. The substance to be
examined absorbs the methylene blue and settles as a
blue, fibrous mass
B. Shake 1 g with 50 ml of water. Transfer 1 ml of the
mixture toa test tube, add 1 ml water and 0,05 ml o f
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 % (105oC, 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 7,0Sodium content Not more than 12,4 % on anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgCadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 469 ENZYMATICALLY HYDROLYSED CARBOXY-
METHYLCELLULOSE
Synonyms Sodium carboxymethyl cellulose, enzymatically hydro-
lysed
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 enzymati-
cally hydrolysed
Chemical formula Sodium salts of polymers containing substituted
anhydroglucose units with the general formula:
C
6H7O2OHðÞxOCH2COONa ðÞyhi
n
where n is the degree of polymerisation
x = 1,50 to2,80
y = 0,2 to1,50
x+y=3 , 0(y = degree of substitution)1996L0077 — EN — 20.06.2001 — 003.001 — 118
▼M2
Formula weight 178,14 where y = 0,20
282,18 where y = 1,50Macromolecules: Not less than 800 (n about 4)
Assay Not less than 99,5 %, including mono- and disacchar-
ides, on the dried basis
Description White or slightly yellowish or greyish, odourless,
slightly hygroscopic granular or fibrous powder
Identification
A. Solubility Soluble in water, insoluble in ethanol
B. Foam test Vigorously shake a 0,1 % solution of the sample. No
layer of foam appears. This test distinguishes sodium
carboxymethyl cellulose, whether hydrolysed or not,
from other cellulose ethers and from alginates and
natural gums
C. Precipitate formation To 5 ml of a 0,5 % solution of the sample add 5 ml of a
5 % solution of copper or aluminium sulphate. A
precipitate appears. This test distinguishes sodium
carboxymethyl cellulose, whether hydrolysed or not,
from other cellulose ethers and from gelatine, carobbean gum and tragacanth gum
D. Colour reaction Add 0,5 g of the powdered sample to 50 ml of water,
while stirring to produce a uniform dispersion.
Continue the stirring until a clear solution is produced.
Dilute 1 ml of the solution with 1 ml of water in a small
test tube. Add 5 drops of 1-naphthol TS. Incline the
tube, and carefully introduce down the side of the tube
2 ml of sulphuric acid so that it forms a lower layer. A
red-purple colour develops at the interface
E. Viscosity (60 % solids) Not less than 2,500 kgm
-1s-1at 25 ºC corresponding to
an average molecule weight of 5 000 D
Purity
Loss on drying Not more than 12 % (105 ºC to constant weight)
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl
groups per anhydroglucose unit on the dried basis
pH of a 1 % colloidal solution Not less than 6,0 and not more than 8,5
Sodium chloride and sodium glycolate Not more than 0,5 % singly or in combination
Residual enzyme activity Passes test. No change in viscosity of test solution
occurs, which indicates hydrolysis of the sodium
carboxymethyl cellulose
Lead Not more than 3 mg/kg
E 500(i) SODIUM CARBONATE
Synonyms Soda ash
Definition
Chemical name Sodium carbonate
EINECS 207-838-8
Chemical formula Na2CO3/C1nH2O (n = 0, 1 or 10)
Molecular weight 106,00 (anhydrous)
Assay Content not less than 99 % of Na 2CO3on the
anhydrous basis
Description Colourless crystals or white, granular or crystalline
powder
The anhydrous form is hygroscopic, the decahydrate
efflorescent1996L0077 — EN — 20.06.2001 — 003.001 — 119
▼M2
Identification
A. Positive tests for sodium and for
carbonate
B. Solubility Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 2 % (anhydrous), 15 % (monohydrate)
or 55 %-65 % (decahydrate) (70 ºC raising gradually to300 ºC, toco nstant 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 CARBONATE
Synonyms Sodium bicarbonate, sodium acid carbonate, bicarbo-
nate of soda, baking soda
Definition
Chemical name Sodium hydrogen carbonate
EINECS 205-633-8
Chemical formula NaHCO
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 heating
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 500(iii) SODIUM SESQUICARBONATE
Definition
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 Na 2CO3
Description White flakes, crystals or crystalline powder
Identification
A. Positive tests for sodium and for
carbonate1996L0077 — EN — 20.06.2001 — 003.001 — 120
▼M2
B. Solubility Freely soluble in water
Purity
Sodium chloride Not more than 0,5 %
Iron 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 501(i) POTASSIUM CARBONATEDefinition
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
carbonate
B. Solubility Very soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 5 % (anhydrous) or 18 % (hydrate)
(180 ºC, 4h)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 501(ii) POTASSIUM HYDROGEN CARBONATESynonyms Potassium bicarbonate, acid potassium carbonate
Definition
Chemical name Potassium hydrogen carbonate
EINECS 206-059-0
Chemical formula KHCO
3
Molecular weight 100,11
Assay Contentnotlessthan99,0%andnotmore than101,0%
KHCO 3on the anhydrous basis
Description Colourless crystals or white powder or granules
Identification
A. Positive tests for potassium and for
carbonate
B. Solubility Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 0,25 % (over silica gel, 4h)
Arsenic Not more than 3 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 121
▼M2
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 carba-
mate, ammonium carbonate and ammonium hydrogen
carbonate in varying proportions
Chemical name Ammonium carbonate
EINECS 233-786-0
Chemical formula CH6N2O2,C H8N2O3and CH 5NO3
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 %
ofN H3
Description White powder or hard, white or translucent masses or
crystals. Becomes opaque on exposure to air and is
finally converted into white porous lumps or powder
(of ammonium bicarbonate) due to loss of ammonia
and carbon dioxide
Identification
A. Positive tests for ammonium and for
carbonate
B. pH of a 5 % solution about 8,6
C. Solubility Soluble in water
Purity
Non-volatile matter Not more than 500 mg/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 503(ii) AMMONIUM HYDROGEN CARBONATESynonyms Ammonium bicarbonate
Definition
Chemical name Ammonium hydrogen carbonate
EINECS 213-911-5
Chemical formula CH
5NO3
Molecular weight 79,06
Assay Content not less than 99,0 %
Description White crystals or crystalline powder
Identification
A. Positive tests for ammonium and for
carbonate
B. pH of a 5 % solution about 8,0
C. Solubility Freely soluble in water. Insoluble in ethanol
Purity
Non-volatile matter Not more than 500 mg/kgChlorides Not more than 30 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 122
▼M2
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 ACIDSynonyms Hydrogen chloride, muriatic acid
Definition
Chemical name Hydrochloric acid
EINECS 231-595-7
Chemical formula HCl
Molecular weight 36,46
Assay Hydrochloric acid is commercially available in varying
concentrations. Concentrated hydrochloric acid
contains not less than 35,0 % HCl
Description Clear, colourless or slightly yellowish, corrosive liquid
having a pungent odour
Identification
A. Positive tests for acid and for
chloride
B. Solubility Soluble in water and in ethanol
Purity
Total organic compounds Total organic compounds (non-fluorine containing): not
more than 5 mg/kg
Benzene: not more than 0,05 mg/kg
Fluorinated compounds (total): not more than 25 mg/kg
Non-volatile matter Not more than 0,5 %Reducing substances Not more than 70 mg/kg (as SO
2)
Oxidising substances Not more than 30 mg/kg (as Cl 2)
Sulphate Not more than 0,5 %Iron Not more than 5 mg/kgArsenic Not more than 1 mg/kgLead Not more than 1 mg/kgMercury 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 (hexa-
hydrate)
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
chloride1996L0077 — EN — 20.06.2001 — 003.001 — 123
▼M2
B. 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 basisFluoride Not more than 40 mg/kgArsenic Not more than 3 mg/kgLead Not more than 10 mg/kgMercury Not more than 1 mg/kg
E 511 MAGNESIUM CHLORIDEDefinition
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/kgArsenic Not more than 3 mg/kgLead 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: soluble1996L0077 — EN — 20.06.2001 — 003.001 — 124
▼M2
Purity
Sulphate Not more than 30 mg/kgArsenic Not more than 2 mg/kgMercury Not more than 1 mg/kgLead Not more than 5 mg/kg
E 513 SULPHURIC ACIDSynonyms 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
sulphate
B. Solubility Miscible with water, with generation of much heat, also
with ethanol
Purity
Ash Not more than 0,02 %
Reducing matter Not more than 40 mg/kg (as SO 2)
Nitrate Not more than 10 mg/kg (on H 2SO4basis)
Chloride Not more than 50 mg/kgIron Not more than 20 mg/kgSelenium Not more than 20 mg/kgArsenic Not more than 3 mg/kgLead 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=0or1 0 )
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 efflorescent1996L0077 — EN — 20.06.2001 — 003.001 — 125
▼M2
Identification
A. Positive tests for sodium and for
sulphate
B. Acidity of a 5 % solution: neutral or
slightly alkaline tolitmus paper
Purity
Loss on drying Notmorethan1,0%(anhydrous)ornotmorethan57%
(decahydrate) at 130oC
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 514(ii) SODIUM HYDROGEN SULPHATE
Synonyms Acid sodium sulphate, sodium bisulphate, nitre cake
Definition
Chemical name Sodium hydrogen sulphate
Chemical formula 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 515(i) POTASSIUM SULPHATE
Definition
Chemical name Potassium sulphate
Chemical formula 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 ethanol1996L0077 — EN — 20.06.2001 — 003.001 — 126
▼M2
Purity
Selenium Not more than 30 mg/kgArsenic 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 %
Meltingpoint 197 ºC
Description White deliquescent crystals, pieces or granules
Identification
A. Positive test for potassium
B. Solubility Freely soluble in water, insoluble in ethanol
Purity
Selenium Not more than 30 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 516CALCIUM SULPHATESynonyms Gypsum, selenite, anhydrite
Definition
Chemical name Calcium sulphate
EINECS 231-900-3
Chemical formula CaSO
4/C1nH2O( n=0or2 )
Molecular weight 136,14 (anhydrous), 172,18 (dihydrate)
Assay Content not less than 99,0 % on the anhydrous basis
Description Fine, white to slightly yellowish-white odourless
powder
Identification
A. Positive tests for calcium and for
sulphate
B. Solubility Slightly soluble in water, insoluble in ethanol
Purity
Loss on drying Anhydrous: not more than 1,5 % (250 ºC, constant
weight)
Dihydrate: not more than 23 % (ibid.)
Fluoride Not more than 30 mg/kgSelenium Not more than 30 mg/kgArsenic Not more than 3 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 127
▼M2
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 Contentnotlessthan99,0%andnotmore than100,5%
Description White powder, shining plates or crystalline fragments
Identification
A. Positive tests for ammonium and for
sulphate
B. Solubility Freely soluble in water, insoluble in ethanol
Purity
Loss on ignition Not more than 0,25 %
Selenium Not more than 30 mg/kg
Lead Not more than 5 mg/kg
E 520 ALUMINIUM SULPHATE
Synonyms Alum
Definition
Chemical name Aluminium sulphate
EINECS 233-135-0
Chemical formula Al2SO4 ðÞ3
Molecular weight 342,13
Assay Content not less than 99,5 % on the ignited basis
Description White powder, shining plates or crystalline fragments
Identification
A. Positive tests for aluminium and for
sulphate
B. pH of a 5 % solution 2,9 or above
C. Solubility Freely soluble in water, insoluble in ethanol
Purity
Loss on ignition Not more than 5 % (500 ºC, 3h)
Alkalies and alkaline earths Not more than 0,4 %
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kgMercury Not more than 1 mg/kg
E 521 ALUMINIUM SODIUM SULPHATE
Synonyms Soda alum, sodium alum1996L0077 — EN — 20.06.2001 — 003.001 — 128
▼M2
Definition
Chemical name Aluminium sodium sulphate
EINECS 233-277-3
Chemical formula AlNa SO 4 ðÞ2/C1nH2O( n=0or1 2 )
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 anhy-
drous form is slowly soluble in water. Both forms are
insoluble in ethanol
Purity
Loss on drying Anhydrous form: not more than 10,0 % (220 ºC, 16h)
Dodecahydrate: not more than 47,2 % (50 ºC-55 ºC, 1h
then 200 ºC, 16h)
Ammonium salts No odour of ammonia detectable after 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/kgMercury Not more than 1 mg/kg
E 522 ALUMINIUM POTASSIUM SULPHATESynonyms 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/kgFluoride Not more than 30 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 129
▼M2
E 523 ALUMINIUM AMMONIUM SULPHATE
Synonyms Ammonium alum
Definition
Chemical name Aluminium ammonium sulphate
EINECS 232-055-3
Chemical formula AlNH4SO4 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/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 524 SODIUM HYDROXIDE
Synonyms Caustic soda, lye
Definition
Chemical name Sodium hydroxide
EINECS 215-185-5
Chemical formula NaOH
Molecular weight 40,0
Assay Content of solid forms not less than 98,0 % of total
alkali (as NaOH). Content of solutions accordingly,
based on the stated or labelled percentage of NaOH
Description White or nearly white pellets, flakes, sticks, fused
masses or other forms. Solutions are clear or slightly
turbid, colourless or slightly coloured, strongly caustic
and hygroscopic and when exposed to the air they
absorb carbon dioxide, forming sodium carbonate
Identification
A. Positive tests for sodium
B. A 1 % solution is strongly alkaline
C. Solubility Very soluble in water. Freely soluble in ethanol
Purity
Water insoluble and organic matter A 5 % solution is completely clear and colourless to
slightly coloured
Carbonate Not more than 0,5 % (as Na 2CO3)
Arsenic Not more than 3 mg/kg
Lead Not more than 0,5 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 130
▼M2
Mercury 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/kgLead Not more than 10 mg/kgMercury Not more than 1 mg/kg
E 526CALCIUM 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/kgFluoride Not more than 50 mg/kgArsenic Not more than 3 mg/kgLead Not more than 10 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 131
▼M2
E 527 AMMONIUM HYDROXIDE
Synonyms Aqua ammonia, strong ammonia solution
Definition
Chemical name Ammonium hydroxide
Chemical formula NH4OH
Molecular weight 35,05
Assay Content not less than 27 % of NH 3
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/kgLead Not more than 5 mg/kg
E 528 MAGNESIUM HYDROXIDE
Definition
Chemical name Magnesium hydroxide
EINECS 215-170-3
Chemical formula Mg OHðÞ
2
Molecular weight 58,32
Assay Content not less than 95,0 % on the anhydrous basis
Description Odourless, white bulky powder
Identification
A. Positive test for magnesium and for
alkali
B. Solubility Practically insoluble in water and in ethanol
Purity
Loss on drying Not more than 2,0 % (105 ºC, 2h)Loss on ignition Not more than 33 % (800 ºC to constant weight)
Calcium oxide Not more than 1,5 %
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
E 529 CALCIUM OXIDE
Synonyms Burnt lime
Definition
Chemical name Calcium oxide
EINECS 215-138-9
Chemical formula CaO
Molecular weight 56,08
Assay Content not less than 95,0 % on the ignited basis1996L0077 — EN — 20.06.2001 — 003.001 — 132
▼M2
Description Odourless, hard, white or greyish white masses of
granules, or white to greyish powder
Identification
A. Positive test for alkali and for
calcium
B. Heat is generated on moistening the
sample with water
C. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble
in glycerol
Purity
Loss on ignition Not more than 10,0 % (ca 800 ºC to constant weight)Acid insoluble matter Not more than 1,0 %
Barium Not more than 300 mg/kg
Magnesium and alkali salts Not more than 1,5 %Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
E 530 MAGNESIUM OXIDEDefinition
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 knownas heavy
magnesium oxide. 5 g of light magnesium oxide
occupy a volume of 40 to 50 ml, while 5 g of heavy
magnesium oxide occupy a volume of 10 to 20 ml
Identification
A. Positive test for alkali and for
magnesium
B. Solubility Practically insoluble in water. Insoluble in ethanol
Purity
Loss on ignition Not more than 5,0 % (ca 800 ºC to constant weight)Calcium oxide Not more than 1,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
E 535 SODIUM FERROCYANIDESynonyms Yellow prussiate of soda, sodium hexacyanoferrate
Definition
Chemical name Sodium ferrocyanide
EINECS 237-081-9
Chemical formula Na
4Fe CNðÞ6/C110 H2O
Molecular weight 484,1
Assay Content not less than 99,0 %1996L0077 — EN — 20.06.2001 — 003.001 — 133
▼M2
Description Yellow crystals or crystalline powder
Identification
A. Positive test for sodium and for
ferrocyanide
Purity
Free moisture Not more than 1,0 %
Water insoluble matter Not more than 0,03 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %
Free cyanide Not detectable
Ferricyanide Not detectableLead Not more than 5 mg/kg
E 536POTASSIUM FERROCYANIDE
Synonyms Yellow prussiate of potash, potassium hexacyanoferrate
Definition
Chemical name Potassium ferrocyanide
EINECS 237-722-2
Chemical formula K
4Fe CNðÞ6/C13H2O
Molecular weight 422,4
Assay Content not less than 99,0 %
Description Lemon yellow crystals
Identification
A. Positive test for potassium and for
ferrocyanide
Purity
Free moisture Not more than 1,0 %
Water insoluble matter Not more than 0,03 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %
Free cyanide Not detectableFerricyanide Not detectable
Lead Not more than 5 mg/kg
E 538 CALCIUM FERROCYANIDESynonyms Yellow prussiate of lime, calcium hexacyanoferrate
Definition
Chemical name Calcium ferrocyanide
EINECS 215-476-7
Chemical formula Ca
2Fe CNðÞ6/C112H2O
Molecular weight 508,3
Assay Content not less than 99,0 %
Description Yellow crystals or crystalline powder1996L0077 — EN — 20.06.2001 — 003.001 — 134
▼M2
Identification
A. Positive test for calcium and for
ferrocyanide
Purity
Free moisture Not more than 1,0 %
Water insoluble matter Not more than 0,03 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %
Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDICSynonyms SALP
Definition
Chemical name Sodium trialuminium tetradecahydrogen octaphosphate
tetrahydrate (A) or
Trisodium dialuminium pentadecahydrogen octapho-
sphate (B)
EINECS 232-090-4
Chemical formula NaAl
3H14PO4 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 alumi-
nium and for phosphate
B. pH Acid tolitmus
C. Solubility Insoluble in water. Soluble in hydrochloric acid
Purity
Loss on ignition 19,5 % - 21,0 % (A) } (750 ºC - 800 ºC, 2h)
15 % - 16 % (B) } (750 ºC - 800 ºC, 2h)
Fluoride Not more than 25 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 551 SILICON DIOXIDE
Synonyms Silica, silicium dioxide1996L0077 — EN — 20.06.2001 — 003.001 — 135
▼M2
Definition Silicon dioxide is an amorphous substance, which is
produced synthetically by either a vapour-phase
hydrolysis process, yielding fumed silica, or by a wet
process, yielding precipitated silica, silica gel, or
hydrous silica. Fumed silica is produced in essentially
an anhydrous state, whereas the wet-process products
are obtained as hydrates or contain surface absorbed
water
Chemical name Silicon dioxide
EINECS 231-545-4
Chemical formula SiO2 ðÞn
Molecular weight 60,08 (SiO 2)
Assay Content after ignition not less than 99,0 % (fumed
silica) or 94,0 % (hydrated forms)
Description White, fluffy powder or granules
Hygroscopic
Identification
A. Positive test for silica
Purity
Loss on drying Not more than 2,5 % (fumed silica, 105 ºC, 2h)
Not more than 8,0 % (precipitated silica and silica gel,
105 ºC, 2h)
Not more than 70 % (hydrous silica, 105 ºC, 2h)
Loss on ignition Not more than 2,5 % after drying (1 000 ºC, fumed
silica)
Not more than 8,5 % after drying (1 000 ºC, hydrated
forms)
Soluble ionisable salts Not more than 5,0 % (as Na 2SO4)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 552 CALCIUM SILICATE
Definition Calcium silicate is a hydrous or anhydrous silicate with
varying proportions of CaO and SiO 2
Chemical name Calcium silicate
EINECS 215-710-8
Assay Content on the anhydrous basis:
— as SiO 2not less than 50 % and not more than 95 %
— as CaO not less than 3 % and not more than 35 %
Description White to off-white free-flowing powder that remains so
after absorbing relatively large amounts of water or
other liquids
Identification
A. Positive test for silicate and for
calcium
B. Forms a gel with mineral acids
Purity
Loss on drying Not more than 10 % (105 ºC, 2h)
Loss on ignition Not less than 5 % and not more than 14 % (1 000 ºC,
constant weight)
Sodium Not more than 3 %1996L0077 — EN — 20.06.2001 — 003.001 — 136
▼M2
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 553a(i) MAGNESIUM SILICATE
Definition Magnesium silicate is a synthetic compound of which
the molar ratio of magnesium oxide to silicon dioxide is
approximately 2:5
Assay Content not less than 15 % of MgO and not less than
67 % of 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 ºC, 2h)
Loss on ignition Not more than 15 % after drying (1 000 ºC, 20 min)
Water soluble salts Not more than 3 %
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 553a(ii) MAGNESIUM TRISILICATE
Definition
Chemical name Magnesium trisilicate
Chemical formula 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 SiO 2both on the ignited basis
Description Fine, white powder, free from grittiness
Identification
A. Positive test for magnesium and for
silicate
B. pH of a 5 % slurry Between 6,3 and 9,5
Purity
Loss on ignition Not less than 17 % and not more than 34 % (1 000 ºC)
Water soluble salts Not more than 2 %
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 137
▼M2
E 570 FATTY ACIDS
Definition Linear fatty acids, caprylic acid (C 8), capric acid (C 10),
laurinc acid (C 12), myristic acid (C 14), palmitic acid
(C16), stearic acid (C 18), oleic acid (C 18:1)
Chemical name octanoic acid (C 8), decanoic acid (C 10), dodecanoic
acid (C 12), tetradecanoic acid (C 14), hexadecanoic acid
(C16), octadecanoic acid (C 18), 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 identi-
fied 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)
Arsenic Not more than 3 mg/kgLead 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 C
6H12O7(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 deri-
vative positiveCompound formed melts between 196 ºC and 202 ºC
with decomposition
Purity
Residue on ignition Not more than 1,0 %Reducing matter Not more than 0,75 % (as D-glucose)
Chloride Not more than 350 mg/kg
Sulphate Not more than 240 mg/kg
Sulphite Not more than 20 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 575 GLUCONO-DELTA-LACTONE
Synonyms Gluconolactone, GDL, D-gluconic acid delta-lactone,
delta-gluconolactone1996L0077 — EN — 20.06.2001 — 003.001 — 138
▼M2
Definition Glucono-delta-lactone is the cyclic 1,5-intramolecular
ester of D-gluconic acid. In aqueous media it is
hydrolysed to an equilibrium mixture of D-gluconic
acid (55 %-66 %) and the delta- and gamma-lactones
Chemical name D-Glucono-1,5-lactone
EINECS 202-016-5
Chemical formula C6H10O6
Molecular weight 178,14
Assay Content not less than 99,0 % on the anhydrous basis
Description Fine, white, nearly odourless, crystalline powder
Identification
A. Formation of phenylhydrazine deri-
vative of gluconic acid positiveCompound formed melts between 196 ºC and 202 ºC
with decomposition
B. Solubility Freely soluble in water. Sparingly soluble in ethanol
C. Melting point 152 ºC ± 2 ºC
Purity
Water Not more than 1,0 % (Karl Fischer method)Reducing substances Not more than 0,75 % (as D-glucose)
Lead Not more than 2 mg/kg
E 576SODIUM 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 totan, granular tofine, crystalline po wder
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)1996L0077 — EN — 20.06.2001 — 003.001 — 139
▼M2
Molecular weight 234,25 (anhydrous)
252,26 (monohydrate)
Assay Contentnotlessthan97,0%andnotmore than103,0%
on dried basis
Description Odourless, free flowing white to yellowish white,
crystalline powder or granules
Identification
A. Positive test for potassium and for
gluconate
B. pH of a 10 % solution Between 7,0 and 8,3
Purity
Loss on drying Anhydrous: not more than 3,0 % (105 ºC, 4h, vacuum)
Monohydrate: not less than 6 % and not more than
7,5 % (105 ºC, 4h, vacuum)
Reducing substances Not more than 1,0 % (as D-glucose)Lead Not more than 2 mg/kg
E 578 CALCIUM GLUCONATESynonyms Calcium salt of D-gluconic acid
Definition
Chemical name Calcium di-D-gluconate
EINECS 206-075-8
Chemical formula C
12H22CaO14(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
gluconate
B. Solubility Soluble in water, insoluble in ethanolC. pH of a 5 % solution Between 6,0 and 8,0
Purity
Loss on drying Not more than 3,0 % (105 ºC, 16h) (anhydrous)
Not more than 2,0 % (105 ºC, 16h) (monohydrate)
Reducing substances Not more than 1,0 % (as D-glucose)Lead Not more than 2 mg/kg
E 640 GLYCINE AND ITS SODIUM SALTSynonyms (gly) Aminoacetic acid, glycocoll
(Na salt) Sodium glycinate
Definition
Chemical name (gly) Aminoacetic acid
(Na salt) Sodium glycinate1996L0077 — EN — 20.06.2001 — 003.001 — 140
▼M2
Chemical formula (gly) C2H5NO2
(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 ºC, 3h)
(Na salt) Not more than 0,2 % (105 ºC, 3h)
Residue on ignition (gly) Not more than 0,1 %(Na salt) Not more than 0,1 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 900 DIMETHYL POLYSILOXANESynonyms 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 trimethylsi-
loxy end-blocking units of the formula CH 3 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 (25º/25 ºC) Between 0,964 and 0,977
B. Refractive index n ½/C138D25Between 1,400 and 1,405
C. Infrared spectrum characteristic of
the compound
Purity
Loss on drying Not more than 0,5 % (150 ºC, 4h)
Viscosity Not less than 1,00 · 10-4m2s-1at 25 ºC
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 901 BEESWAXSynonyms White wax, yellow wax1996L0077 — EN — 20.06.2001 — 003.001 — 141
▼M2
Definition Yellow bees wax is the wax obtained by melting the
walls of the honeycomb made by the honey bee, Apis
mellifera L. , with hot water and removing foreign
matter
White beeswax is obtained by bleaching yellow
beeswax
EINECS 232-383-7 (beeswax)
Description Yellowish white (white form) or yellowish to greyish
brown (yellow form) pieces or plates with a fine-
grained and non-crystalline fracture, having an agree-
able, honey-like odour
Identification
A. Melting range Between 62 ºC and 65 ºC
B. Specific gravity About 0,96
C. Solubility Insoluble in water
Sparingly soluble in alcohol
Very soluble in chloroform and ether
Purity
Acid value Not less than 17 and not more than 24
Saponification value 87-104
Peroxide value Not more than 5
Glycerol and other polyols Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other
waxesAbsent
Fats, Japan wax, rosin and soaps Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 902 CANDELILLA WAXDefinition Candelilla wax is a purified wax obtained from the
leaves of the candelilla plant, Euphorbia antisyphilitica
EINECS 232-347-0
Description Hard, yellowish brown, opaque to translucent wax
Identification
A. Specific gravity About 0,983
B. Melting range Between 68,5 ºC and 72,5 ºC
C. Solubility Insoluble in water
Soluble in chloroform and toluene
Purity
Acid value Not less than 12 and not more than 22
Saponification value Not less than 43 and not more than 65Glycerol and other polyols Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other
waxesAbsent
Fats, Japan wax, rosin and soaps Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 142
▼M2
E 903 CARNAUBA WAX
Definition Carnauba wax is a purified wax obtained from the leaf
buds and leaves of the Brazilian Mart wax palm,
Copernicia 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 0,997B. Melting range Between 82 ºC and 86 ºCC. Solubility Insoluble in water
Partly soluble in boiling ethanol
Soluble in chloroform and diethyl ether
Purity
Sulphated ash Not more than 0,25 %Acid value Not less than 2 and not more than 7Ester 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 904 SHELLAC
Synonyms Bleached shellac, white shellac
Definition Shellac is the purified and bleached lac, the resinous
secretion of the insect Laccifer (Tachardia) lacca Kerr
(Fam.Coccidae )
EINECS 232-549-9
Description Bleached shellac — off-white, amorphous, granular
resin
Wax-free bleached shellac — light yellow, amorphous,
granular resin
Identification
A. Solubility Insoluble in water; freely (though very slowly) soluble
in alcohol; slightly soluble in acetone
B. Acid value Between 60 and 89
Purity
Loss on drying Not more than 6,0 % (40 ºC, over silica gel, 15h)Rosin 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-CYSTEINE
Definition L-cysteine hydrochloride or hydrochloride monohy-
drate. Human hair may not be used as a source for this
substance
EINECS 200-157-7 (anhydrous)1996L0077 — EN — 20.06.2001 — 003.001 — 143
▼M2
Chemical formula C3H7NO2S/C1HCl /C1nH20 (where n = 0 or 1)
Molecular weight 157,62 (anhydrous)
Assay Contentnotlessthan98,0%andnotmore than101,5%
on the anhydrous basis
Description White powder or colourless crystals
Identification
A. Solubility Freely soluble in water and in ethanol
B. Melting range Anhydrous form melts at about 175 ºC
C. Specific rotation /C11½/C13820
D: between + 5,0º and + 8,0º or
/C11½/C13825
D: between + 4,9º and 7,9º
Purity
Loss on drying Between 8,0 % and 12,0 %
Not more than 2,0 % (anhydrous form)
Residue on ignition Not more than 0,1 %
Ammonium-ion Not more than 200 mg/kg
Arsenic Not more than 1,5 mg/kg
Lead Not more than 5 mg/kg
E 927b 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 producedD. Melting range 132 ºC to135 ºC
Purity
Loss on drying Not more than 1,0 % (105 ºC, 1h)
Sulphated ash Not more than 0,1 %
Ethanol-insoluble matter Not more than 0,04 %
Alkalinity Passes testAmmonium-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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 144
▼M2
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
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 %1996L0077 — EN — 20.06.2001 — 003.001 — 145
▼M2
E 942 NITROUS OXIDE
Definition
Chemical name Nitrous oxide
EINECS 233-032-0
Chemical formula N2O
Molecular weight 44
Assay Not less than 99 %
Description Colourless, non-flammable gas, sweetish odour
Purity
Water Not more than 0,05 %Carbon monoxide Not more than 30 µl/l
Nitrogen dioxide and nitrogen oxide Not more than 10 µl/l
E 948 OXYGENDefinition
Chemical name Oxygen
EINECS 231-956-9
Chemical formula O
2
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, Murillobark 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 . It contains a number of
triterpenoid saponins consisting of glycosides of
quillaic acid. Some sugars including glucose, galactose,
arabinose, xylose, and rhamnose are also present, along
with tannin, calcium oxalate and other minor compo-
nents
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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 146
▼M2
E 1103 INVERTASE
Definition Invertase is produced from Saccharomyces cerevisiae
Systematic name β-D-Fructofuranoside fructohydrolase
Enzyme Commission No EC 3.2.1.26
EINECS 232-615-7
Purity
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgCadmium Not more than 0,5 mg/kgTotal bacterial count Not more than 50000/gSalmonella spp. Absent by test in 25 g
Coliforms Not more than 30/gE. coli Absent by test in 25 g
E 1200 POLYDEXTROSE
Synonyms Modified polydextroses
Definition Randomly bonded glucose polymers with some sorbitol
end-groups, and with citric acid or phosphoric acid
residues attached to the polymers by mono or diester
bonds. They are obtained by melting and condensation
of the ingredients and consist of approximately 90 parts
D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1
part phosphoric acid. The 1,6-glucosidic linkage
predominates in the polymers but other linkages are
present. The products contain small quantities of free
glucose, sorbitol, levoglucosan (1,6-anhydro-D-
glucose) and citric acid and may be neutralised with
any food grade base and/or decolorised and deionised
for further purification. The products may also be
partially hydrogenated with Raney nickel catalyst to
reduce residual glucose. Polydextrose-N is neutralised
polydextrose
Assay Content not less than 90 % of polymer on the ash free
and anhydrous basis
Description White to light tan-coloured solid. Polydextroses
dissolve in water to give a clear, colourless to straw
coloured solution
Identification
A. Positive tests for sugar and for
reducing sugar
B. pH of a 10 % solution Between 2,5 and 7,0 for polydextrose
Between 5,0 and 6,0 for polydextrose-N
Purity
Water Not more than 4,0 % (Karl Fischer method)Sulphated ash Not more than 0,3 % (polydextrose)
Not more than 2,0 % (polydextrose N)
Nickel Not more than 2 mg/kg for hydrogenated polydextroses1,6-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 22,0001996L0077 — EN — 20.06.2001 — 003.001 — 147
▼M2
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 STARCH
Definition Oxidised starch is starch treated with sodium hypo-
chlorite
Description White or nearly white powder or granules or (if
pregelatinised) flakes, amorphous powder or coarse
particles
Identification
A. If not pregelatinised: by micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Carboxyl groups Not more than 1,1 %Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1410 MONOSTARCH 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 micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato 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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 148
▼M2
Lead Not more than 2 mg/kg
Mercury 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 micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1413 PHOSPHATED DISTARCH PHOSPHATEDefinition Phosphated distarch phosphate is starch having under-
gone a combination of treatments as described for
monostarch phosphate and for distarch phosphate
Description White or nearly white powder or granules or (if
pregelatinised) flakes, amorphous powder or coarse
particles
Identification
A. If not pregelatinised: by micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato 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/kg1996L0077 — EN — 20.06.2001 — 003.001 — 149
▼M2
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1414 ACETYLATED DISTARCH PHOSPHATE
Definition Acetylated distarch phosphate is starch cross-linked
with sodium trimetaphosphate or phosphorus
oxychloride and esterified by acetic anhydride or vinyl
acetate
Description White or nearly white powder or granules or (if
pregelatinised) flakes, amorphous powder or coarse
particles
Identification
A. If not pregelatinised: by micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %Residual phosphate Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 % (as P) for other starches
Vinyl acetate Not more than 0,1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1420 ACETYLATED 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 micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %
Vinyl acetate Not more than 0,1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 150
▼M2
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 1422 ACETYLATED DISTARCH ADIPATE
Definition
Acetylated distarch adipate is starch cross-linked with
adipic anhydride and esterified with acetic anhydride
Description White or nearly white powder or granules or (if
pregelatinised) flakes, amorphous powder or coarse
particles
Identification
A. If not pregelatinised: by micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %Adipate groups Not more than 0,135 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kgMercury Not more than 0,1 mg/kg
E 1440 HYDROXYPROPYL STARCH
Definition Hydroxypropyl starch is starch etherified with propy-
lene oxide
Description White or nearly white powder or granules or (if
pregelatinised) flakes, amorphous powder or coarse
particles
Identification
A. If not pregelatinised: by micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups Not more than 7,0 %1996L0077 — EN — 20.06.2001 — 003.001 — 151
▼M2
Propylene chlorohydrin Not more than 1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/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 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 micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups Not more than 7,0 %
Residual phosphate Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 (as P) for other starches
Propylene chlorohydrin Not more than 1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1450 STARCH SODIUM OCTENYL 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 micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)1996L0077 — EN — 20.06.2001 — 003.001 — 152
▼M2
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/kgMercury 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 micro-
scopic observation
B. Iodine staining positive (dark blue
to light red colour)
Purity(all values expressed on an
anhydrous basis except for loss on
drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Carboxyl groups Not more than 1,3 %Acetyl groups Not more than 2,5 %Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kgMercury Not more than 0,1 mg/kg
E 1505 TRIETHYL CITRATE
Synonyms 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 %1996L0077 — EN — 20.06.2001 — 003.001 — 153
▼M2
Description Odourless, practically colourless, oily liquid
Identification
A. Specific gravity d 2525: 1,135-1,139
B. Refractive index n ½/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/kg
Lead Not more than 5 mg/kg
E 1518 GLYCERYL 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
glycerol
B. Refractive index Between 1,429 and 1,431 at 25 ºC
C. Specific gravity (25 ºC/25 ºC) Between 1,154 and 1,158D. Boiling range Between 258º and 270 ºC
Purity
Water Not more than 0,2 % (Karl Fischer method)
Sulphated ash Not more than 0,02 % (as citric acid)Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
E 1520 PROPANE-1,2-DIOL
Synonyms Propylene glycol
Definition
Chemical names 1,2-dihydroxypropane
EINECS 200-338-0
Chemical formula C
3H8O2
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 acetoneB. Specific gravity d
2020: 1,035-1,0401996L0077 — EN — 20.06.2001 — 003.001 — 154
▼M2
C. Refractive index n ½/C13820D: 1,431-1,433
Purity
Distillation range 99 % v/v distils between 185 ºC-189 ºC
Sulphated ash Not more than 0,07 %Water Not more than 1,0 % (Karl Fischer method)Lead Not more than 5 mg/kg
(1) Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a
mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of thissolution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and20 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 CoCl2·6H2O per ml.
(2) Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of
hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-
bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the
mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodiumthiosulphate (0,1 N) in the presence of starch TS(*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mgof 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 FeCl3·6H2O per ml.
(3) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a
mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of thissolution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acidand 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starchTS (*). 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 CuSO4·5H2O per ml.
(*) Starch TS: triturate 0,5 g starch (potato starch, maize starch of soluble starch) with 5 ml of water; to the resulting
paste add a sufficient quantity of water to give a total volume of 100 ml, strirring all the time. Boil for a fewminutes, allow to cool, filter. The starch must be freshly prepared.
(
4) When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.
E 170 (i) CALCIUM CARBONATE
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/45/
EC laying down specific purity criteria concerning colours for use in foodstuffs(1).
E 353 METATARTARIC ACID
Synonyms Ditartaric acid
Definition
Chemical name Metatartaric acid
Chemical formula C4H6O6
Assay Not less than 99,5 %
Description Crystalline or powder form with a white or yellowish
colour. Very deliquescent with a faint odour of caramel
Identification
A. Very soluble in water and ethanol.B. Place a sample of 1 to 10 mg of this substance in a test
tube with 2 ml of concentrated sulfuric acid and 2 drops
of sulpho-resorcinol reagent. When heated to 150 ºC, an
intense violet coloration appears
Purity
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 155
(1) OJ L 226, 22.9.1995, p. 13.▼B
▼M3
▼M3
E 354 CALCIUM TARTRATE
Synonyms L-Calcium tartrate
Definition
Chemical name Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate
Chemical formula C4H4CaO6·2 H2O
Molecular weight 224,18
Assay Not less than 98,0 %
Description Fine crystalline powder with a white or off-white colour
Identification
A. Slightly soluble in water. Solubility
approximately 0,01 g/100 ml water
(20 ºC). Sparingly soluble in
ethanol. Slightly soluble in diethylether. Soluble in acids
B. Specific rotation [ α]
20D +7,0º to +7,4º (0,1 % in a 1N de HCl solution)
C. pH of a 5 % slurry Between 6,0 and 9,0
Purity
Sulphates (as H2SO4) Not more than 1 g/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 356SODIUM ADIPATE
Definition
Chemical name Sodium adipate
EINECS 231-293-5
Chemical formula C
6H8Na2O4
Molecular weight 190,11
Assay Content not less than 99,0 % (on anhydrous basis)
Description White odourless crystals or crystalline powder
Identification
A. Melting range 151 ºC-152 ºC (for adipic acid)
B. Solubility Approximately 50 g/100 ml water (20 ºC)C. Positive test for sodium
Purity
Water Not more than 3 % (Karl Fischer)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 357 POTASSIUM ADIPATE
Definition
Chemical name Potassium adipate
EINECS 242-838-1
Chemical formula C
6H8K2O4
Molecular weight 222,32
Assay Content not less than 99,0 % (on anhydrous basis)1996L0077 — EN — 20.06.2001 — 003.001 — 156
▼M3
Description White odourless crystals or crystalline powder
Identification
A. Melting range 151 ºC-152 ºC (for adipic acid)
B. Solubility Approximately 60 g/100 ml water (20 ºC)
C. Positive test for potassium
Purity
Water Not more than 3 % (Karl Fischer)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 420(i) SORBITOL
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs(
1).
E 420(ii) SORBITOL SYRUP
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
E 421 MANNITOL
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
E 425(i) KONJAC GUM
Definition Konjac gum is a water-soluble hydrocolloid obtained
from the Konjac flour by aqueous extraction. Konjac
flour is the unpurified raw product from the root of the
perennial plant Amorphophallus konjac The main
component of Konjac gum is the water-soluble high-
molecular-weight polysaccharide glucomannan, which
consists of D-mannose and D-glucose units at a molar
ration of 1,6:1,0, connected by β(1-4)-glycosidic bonds.
Shorter side chains are attached through β(1-3)-glyco-
sidic bonds, and acetyl groups occur at random at a ratio
of about 1 group per 9 to 19 sugar units
Molecular weight The main component, glucomannan, has an average
molecular weight of 200 000 to 2 000000
Assay Not less than 75 % carbohydrate
Description A white tocream tolight tan po wder
Identification
A. Solubility Dispersible in hot or cold water forming a highly viscous
solution with a pH between 4,0 and 7,0
B. Gel formation Add 5 ml of a 4 % sodium borate solution to a 1 %
solution of the sample in a test tube, and shake
vigorously. A gel forms
C. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a
boiling water bath for 30 min, with continuous agitation
and then cooling the solution to room temperature. For
each g of the sample used to prepare 30 g of the 2 %
solution, add 1 ml of 10 % potassium carbonate solution
tothe fully hydrated sample at ambient temperature. Heat
the mixture in a water bath to85 ºC, and maintain fo r 2 h
without agitation. Under these conditions a thermally
stable gel is formed
D. Viscosity (1 % solution) Not less than 3 kgm-1s-1at 25 ºC1996L0077 — EN — 20.06.2001 — 003.001 — 157
(1) OJ L 178, 28.7.1995, p. 1.
▼M3
Purity
Loss on drying Not more than 12 % (105 ºC, 5 h)Starch Not more than 3 %
Protein Not more than 3 % (N × 5,7)
Determine nitrogen by Kjeldahl method. The percentage
of nitrogen in the sample multiplied by 5,7 gives the
percent of protein in the sample
Ether-soluble material Not more than 0,1 %
Total ash Not more than 5,0 % (800 ºC, 3 to 4h)Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Salmonella spp. Absent in 12,5 g
E. coli Absent in 5 g
E 425(ii) KONJAC GLUCOMANNAN
Definition Konjac glucomannan is a water-soluble hydrocolloid
obtained from Konjac flour by washing with water-
containing ethanol. Konjac flour is the unpurified raw
product from the tuber of the perennial plant Amorpho-
phallus konjac . The main component is the water-soluble
high-molecular-weight polysaccharide glucomannan,
which consists of D-mannose and D-glucose units at a
molar ration of 1,6:1,0, connected by β(1-4)-glycosidic
bonds with a branch at about each 50th or 60th unit.
About each 19th sugar residue is acetylated
Molecular weight 500000 to2000 000
Assay Total dietary fibre: not less than 95 % on a dry weight
basis
Description White to slightly brownish fine particle size, free flowing
and odourless powder
Identification
A. Solubility Dispersible in hot or cold water forming a highly viscous
solution with a pH between 5,0 and 7,0. Solubility is
increased by heat and mechanical agitation
B. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a
boiling water bath for 30 min, with continuous agitation
and then cooling the solution to room temperature. For
each g of the sample used to prepare 30 g of the 2 %
solution, add 1 ml of 10 % potassium carbonate solution
tothe fully hydrated sample at ambient temperature. Heatthe mixture in a water bath to85 ºC, and maintain fo r 2 h
without agitation. Under these conditions a thermally
stable gel is formed
C. Viscosity (1 % solution) Not less than 20 kgm
-1s-1at 25 ºC
Purity
Loss on drying Not more than 8 % (105 ºC, 3h)Starch Not more than 1 %
Protein Not more than 1,5 % (N × 5,7)
Determine nitrogen by Kjeldahl method. The percentage
of nitrogen in the sample multiplied by 5,7 gives the
percent of protein in the sample
Ether-soluble material Not more than 0,5 %
Sulphite (as SO
2) Not more than 4 mg/kg
Chloride Not more than 0,02 %
50 % Alcohol-soluble Not more than 2,0 % material
Total ash Not more than 2,0 % (800 ºC, 3 to 4h)1996L0077 — EN — 20.06.2001 — 003.001 — 158
▼M3
Lead Not more than 1 mg/kg
Salmonella spp. Absent in 12,5 g
E. coli Absent in 5 g
E 504(ii) MAGNESIUM HYDROXIDE CARBONATE
Synonyms Magnesium hydrogen carbonate, magnesium subcarbo-
nate (light or heavy), hydrated basic magnesium
carbonate, magnesium carbonate hydroxide
Definition
Chemical name Magnesium carbonate hydroxide hydrated
EINECS 235-192-7
Chemical formula 4MgCO3Mg(OH)25H2O
Molecular weight 485
Assay Mg content not less than 40,0 % and not more than
45,0 % calculated as MgO
Description Light, white friable mass or bulky white powder
Identification
A. Positive tests for magnesium and for
carbonate
B. Solubility Practically insoluble in water. Insoluble in ethanol
Purity
Acid insoluble matter Not more than 0,05 %
Water soluble matter Not more than 1,0 %Calcium Not more than 1,0 %
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kgMercury Not more than 1 mg/kg
E 553b TALC
Synonyms Talcum
Definition Naturally occurring form of hydrous magnesium silicate
containing varying proportions of such associated
minerals as alpha-quartz, calcite, chlorite, dolomite,
magnesite, and phlogopite
Chemical name Magnesium hydrogen metasilicate
EINECS 238-877-9
Chemical formula Mg
3(Si4O10)(OH)2
Molecular weight 379,22
Description Light, homogeneous, white or almost white powder,
greasy tothe to uch
Identification
A. IR absorption Characteristic peaks at 3 677, 1 018 and 669 cm-1
B. X-ray diffraction Peaks at 9,34/4,66/3,12 ÅC. Solubility Insoluble in water and ethanol
Purity
Loss on drying Not more than 0,5 % (105 ºC, 1h)
Acid-soluble matter Not more than 6 %
Water-soluble matter Not more than 0,2 %1996L0077 — EN — 20.06.2001 — 003.001 — 159
▼M3
Acid-soluble iron Not detectable
Arsenic Not more than 10 mg/kg
Lead Not more than 5 mg/kg
E 554 SODIUM ALUMINIUM SILICATE
Synonyms Sodium silicoaluminate, sodium aluminosilicate, alumi-
nium sodium silicate
Definition
Chemical name Sodium aluminium silicate
Assay Content on the anhydrous basis:
— asSiO2notlessthan 66,0%andnotmorethan88,0%
—a s A l2O3not lessthan 5,0%and not more than 15,0%
Description Fine white amorphous powder or beads
Identification
A. Positive tests for sodium, for alumi-
nium and for silicate
B. pH of a 5 % slurry Between 6,5 and 11,5
Purity
Loss on drying Not more than 8,0 % (105 ºC, 2h)Loss on ignition Not less than 5,0 % and not more than 11,0 % on the
anhydrous basis (1 000 ºC, constant weight)
Sodium Not less than 5 % and not more than 8,5 % (as Na
2O) on
the anhydrous basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 555 POTASSIUM ALUMINIUM SILICATE
Synonyms Mica
Definition Natural mica consists of mainly potassium aluminium
silicate (muscovite)
EINECS 310-127-6
Chemical name Potassium aluminium silicate
Chemical formulae KAl
2[AlSi3O10](OH)2
Molecular weight 398
Assay Content not less than 98 %
Description Light grey to white crystalline platelets or powder
Identification
A. Solubility Insoluble in water, diluted acids and alkali and organic
solvents
Purity
Loss on drying Not more than 0,5 % (105 ºC, 2h)Antimony Not more than 20 mg/kg
Zinc Not more than 25 mg/kg
Barium Not more than 25 mg/kgChromium Not more than 100 mg/kg
Copper Not more than 25 mg/kg
Nickel Not more than 50 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 160
▼M3
Arsenic Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 2 mg/kg
Lead Not more than 10 mg/kg
E 556CALCIUM ALUMINIUM SILICATE
Synonyms Calcium aluminosilicate, calcium silicoaluminate, alumi-
nium calcium silicate
Definition
Chemical name Calcium aluminium silicate
Assay Content on the anhydrous basis:
— asSiO2notlessthan 44,0%andnotmorethan50,0%
—a sA l2O3not less than 3,0 % and not more than 5,0 %
— asCaOnotlessthan 32,0%andnotmorethan38,0%
Description Fine white, free-flowing powder
Identification
A. Positive tests for calcium, for alumi-
nium and for silicate
Purity
Loss on drying Not more than 10,0 % (105 ºC, 2h)Loss on ignition Not less than 14,0 % and not more than 18,0 on the
anhydrous basis (1 000 ºC, constant weight)
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kgMercury Not more than 1 mg/kg
E 558 BENTONITE
Definition Bentonite is a natural clay containing a high proportion
of montmorillonite, a native hydrated aluminium silicate
in which some aluminium and silicon atoms were
naturally replaced by other atoms such as magnesium
and iron. Calcium and sodium ions are trapped between
the mineral layers. There are four common types of
bentonite: natural sodium bentonite, natural calcium
bentonite, sodium-activated bentonite and acid-activated
bentonite
EINECS 215-108-5
Chemical formula (Al, Mg)
8(Si4O10)4(OH)8· 12H2O
Molecular weight 819
Assay Montmorillonite content not less than 80 %
Description Very fine, yellowish or greyish white powder or granules.
The structure of bentonite allows it to absorb water in its
structure and on its external surface (swelling properties)
Identification
A. Methylene blue testB. X-Ray diffraction Characteristic peaks at 12,5/15 A
C. IR absorption Peaks at 428/470/530/1 110-1 020/3750 — 3400 cm
-1
Purity
Loss on drying Not more than 15,0 % (105 ºC, 2h)
Arsenic Not more than 2 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 161
▼M3
Lead Not more than 20 mg/kg
E 559 ALUMINIUM SILICATE (KAOLIN)
Synonyms Kaolin, light or heavy
Definition Aluminium silicate hydrous (kaolin) is a purified white
plastic clay composed of kaolinite, potassium aluminium
silicate, feldspar and quartz. Processing should not
include calcination
EINECS 215-286-4 (kaolinite)
Chemical formula Al2Si2O5(OH)4(kaolinite)
Molecular weight 264
Assay Content not less than 90 % (sum of silica and alumina,
after ignition)
Silica (SiO2) Between 45 % and 55 %
Alumina (Al2O3) Between 30 % and 39 %
Description Fine, white or greyish white, unctuous powder. Kaolin is
made up of loose aggregations of randomly oriented
stacks of kaolinite flakes or of individual hexagonal
flakes
Identification
A. Positive tests for alumina and for
silicate
B. X-ray diffraction: characteristic peaks at 7,18/3,58/2,38/1,78 ÅC. IR absorption: peaks at 3 700 and 3620 cm
-1
Purity
Loss on ignition Between 10 and 14 % (1 000 ºC, constant weight)
Water soluble matter Not more than 0,3 %Acid soluble matter Not more than 2,0 %
Iron Not more than 5 %
Potassium oxide (K
2O) Not more than 5 %
Carbon Not more than 0,5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 620 GLUTAMIC ACID
Synonyms L-Glutamic acid, L- α-aminoglutaric acid
Definition
Chemical name L-Glutamic acid, L-2-amino-pentanedioic acid
EINECS 200-293-7
Chemical formula C
5H9NO4
Molecular weight 147,13
Assay Content not less than 99,0 % and not more than 101,0 %
on the anhydrous basis
Description White crystals or crystalline powder
Identification
A. Positive test for glutamic acid by
thin layer chromatography1996L0077 — EN — 20.06.2001 — 003.001 — 162
▼M3
B. Specific rotation [ α]D20Between + 31,5º and + 32,2º
(10 % solution (anhydrous basis) in 2N HCl, 200 mm
tube)
C. pH of a saturated solution Between 3,0 and 3,5
Purity
Loss on drying Not more than 0,2 % (80 ºC, 3h)
Sulphated ash Not more than 0,2 %Chloride Not more than 0,2 %
Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg
E 621 MONOSODIUM GLUTAMATE
Synonyms Sodium glutamate, MSG
Definition
Chemical name Monosodium L-glutamate monohydrate
EINECS 205-538-1
Chemical formula C
5H8NaNO4·H2O
Molecular weight 187,13
Assay Content not less than 99,0 % and not more than 101,0 %
on the anhydrous basis
Description White, practically odourless crystals or crystalline
powder
Identification
A. Positive test for sodium
B. Positive test for glutamic acid by
thin-layer chromatography
C. Specific rotation [ α]D20Between + 24,8º and + 25,3º
(10 % solution (anhydrous basis) in 2N HCl, 200 mm
tube)
D. pH of a 5 % solution Between 6,7 and 7,2
Purity
Loss on drying Not more than 0,5 % (98 ºC, 5h)
Chloride Not more than 0,2 %Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg
E 622 MONOPOTASSIUM GLUTAMATE
Synonyms Potassium glutamate, MPG
Definition
Chemical name Monopotassium L-glutamate monohydrate
EINECS 243-094-0
Chemical formula C
5H8KNO4·H2O
Molecular weight 203,24
Assay Content not less than 99,0 % and not more than 101,0 %
on the anhydrous basis
Description White, practically odourless crystals or crystalline
powder1996L0077 — EN — 20.06.2001 — 003.001 — 163
▼M3
Identification
A. Positive test for potassiumB. Positive test for glutamic acid by
thin-layer chromatography
C. Specific rotation [ α]D
20Between + 22,5º and + 24,0º
(10 % solution (anhydrous basis) in 2N HCl, 200 mm
tube)
D. pH of a 2 % solution Between 6,7 and 7,3
Purity
Loss on drying Not more than 0,2 % (80 ºC, 5h)Chloride Not more than 0,2 %
Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg
E 623 CALCIUM DIGLUTAMATE
Synonyms Calcium glutamate
Definition
Chemical name Monocalcium di-L-glutamate
EINECS 242-905-5
Chemical formula C
10H16CaN2O8·xH2O (x = 0, 1, 2 or 4)
Molecular weight 332,32 (anhydrous)
Assay Content not less than 98,0 % and not more than 102,0 %
on the anhydrous basis
Description White, practically odourless crystals or crystalline
powder
Identification
A. Positive test for calcium
B. Positive test for glutamic acid by
thin-layer chromatography
C. Specific rotation [ α]D20Between + 27,4 and + 29,2 (for calcium diglutamate with
x = 4) (10 % solution (anhydrous basis) in 2N HCl,
200 mm tube)
Purity
Water Notmorethan19,0%(forcalciumdiglutamatewithx=4)
(Karl Fischer)
Chloride Not more than 0,2 %Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg
E 624 MONOAMMONIUM GLUTAMATE
Synonyms Ammonium glutamate
Definition
Chemical name Monoammonium L-glutamate monohydrate
EINECS 231-447-1
Chemical formula C
5H12N2O4·H2O
Molecular weight 182,18
Assay Content not less than 99,0 % and not more 101,0 % on
the anhydrous basis1996L0077 — EN — 20.06.2001 — 003.001 — 164
▼M3
Description White, practically odourless crystals or crystalline
powder
Identification
A. Positive test for ammonium
B. Positive test for glutamic acid by
thin-layer chromatography
C. Specific rotation [ α]D20Between + 25,4º and + 26,4º
(10 % solution (anhydrous basis) in 2N HCl, 200 mm
tube)
D. pH of a 5 % solution Between 6,0 and 7,0
Purity
Loss on drying Not more than 0,5 % (50 ºC, 4h)
Sulphated ash Not more than 0,1 %Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg
E 625 MAGNESIUM DIGLUTAMATE
Synonyms Magnesium glutamate
Definition
Chemical name Monomagnesium di-L-glutamate tetrahydrate
EINECS 242-413-0
Chemical formula C
10H16MgN2O8·4 H2O
Molecular weight 388,62
Assay Content not less than 95,0 % and not more than 105,0 %
on the anhydrous basis
Description Odourless, white or off-white crystals or powder
Identification
A. Positive test for magnesium
B. Positive test for glutamic acid by
thin-layer chromatography
C. Specific rotation [ α]D20Between + 23,8º and + 24,4º
(10 % solution (anhydrous basis) in 2N HCl, 200 mm
tube)
D. pH of a 10 % solution Between 6,4 and 7,5
Purity
Water Not more than 24 % (Karl Fischer)
Chloride Not more than 0,2 %
Pyrrolidone carboxylic acid Not more than 0,2 %Lead Not more than 2 mg/kg
E 626 GUANYLIC ACID
Synonyms Guanylic acid
Definition
Chemical name Guanosine-5'-monophosphoric acid
EINECS 201-598-8
Chemical formula C
10H14N5O8P
Molecular weight 363,22
Assay Content not less than 97,0 % on the anhydrous basis1996L0077 — EN — 20.06.2001 — 003.001 — 165
▼M3
Description Odourless, colourless or white crystals or white crystal-
line powder
Identification
A. Positive test for ribose and for
organic phosphate
B. pH of a 0,25 % solution Between 1,5 and 2,5
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl
at 256 nm
Purity
Loss on drying Not more than 1,5 % (120 ºC, 4h)
Other nucleotides Not detectable by thin-layer chromatographyLead Not more than 2 mg/kg
E 627 DISODIUM GUANYLATE
Synonyms Sodium guanylate, sodium 5'-guanylate
Definition
Chemical name Disodium guanosine-5'-monophosphate
EINECS 221-849-5
Chemical formula C
10H12N5Na2O8P·xH2O (x = ca. 7)
Molecular weight 407,19 (anhydrous)
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or white crystal-
line powder
Identification
A. Positive test for ribose, for organic
phosphate, and for sodium
B. pH of a 5 % solution Between 7,0 and 8,5
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl
at 256 nm
Purity
Loss on drying Not more than 25 % (120 ºC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 628 DIPOTASSIUM GUANYLATE
Synonyms Potassium guanylate, potassium 5'-guanylate
Definition
Chemical name Dipotassium guanosine-5'-monophosphate
EINECS 226-914-1
Chemical formula C10H12K2N5O8P
Molecular weight 439,40
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or white crystal-
line powder
Identification
A. Positive test for ribose, for organic
phosphate, and for potassium
B. pH of a 5 % solution Between 7,0 and 8,51996L0077 — EN — 20.06.2001 — 003.001 — 166
▼M3
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl
at 256 nm
Purity
Loss on drying Not more than 5 % (120 ºC, 4h)
Other nucleotides Not detectable by thin-layer chromatographyLead Not more than 2 mg/kg
E 629 CALCIUM GUANYLATE
Synonyms Calcium 5'-guanylate
Definition
Chemical name Calcium guanosine-5'-monophosphate
Chemical formula C
10H12CaN5O8P·n H2O
Molecular weight 401,20 (anhydrous)
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, white or off-white crystals or powder
Identification
A. Positive test for ribose, for organic
phosphate, and for calcium
B. pH of a 0,05 % solution Between 7,0 and 8,0
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl
at 256 nm
Purity
Loss on drying Not more than 23,0 % (120 ºC, 4h)Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 630 INOSINIC ACID
Synonyms 5'-Inosinic acid
Definition
Chemical name Inosine-5'-monophosphoric acid
EINECS 205-045-1
Chemical formula C
10H13N4O8P
Molecular weight 348,21
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate
B. pH of a 5 % solution Between 1,0 and 2,0
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl
at 250 nm
Purity
Loss on drying Not more than 3,0 % (120 ºC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 167
▼M3
E 631 DISODIUM INOSINATE
Synonyms Sodium inosinate, sodium 5'-inosinate
Definition
Chemical name Disodium inosine-5'-monophosphate
EINECS 225-146-4
Chemical formula C10H11N4Na2O8P·H2O
Molecular weight 392,17 (anhydrous)
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for sodium
B. pH of a 5 % solution Between 7,0 and 8,5
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl
at 250 nm
Purity
Water Not more than 28,5 % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 632 DIPOTASSIUM INOSINATE
Synonyms Potassium inosinate, potassium 5'-inosinate
Definition
Chemical name Dipotassium inosine-5'-monophosphate
EINECS 243-652-3
Chemical formula C10H11K2N4O8P
Molecular weight 424,39
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for potas-
sium
B. pH of a 5 % solution Between 7,0 and 8,5
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl
at 250 nm
Purity
Water Not more than 10,0 % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatographyLead Not more than 2 mg/kg
E 633 CALCIUM INOSINATE
Synonyms Calcium 5'-inosinate
Definition
Chemical name Calcium inosine-5'-monophosphate
Chemical formula C
10H11CaN4O8P·n H2O
Molecular weight 386,19 (anhydrous)1996L0077 — EN — 20.06.2001 — 003.001 — 168
▼M3
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for calcium
B. pH of a 0,05 % solution Between 7,0 and 8,0
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl
at 250 nm
Purity
Water Not more than 23,0 % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatographyLead Not more than 2 mg/kg
E 634 CALCIUM 5'-RIBONUCLEOTIDE
Definition
Chemical name Calcium 5'-ribonucleotide is essentially a mixture of
calcium inosine-5'-monophosphate and calcium guano-
sine-5'-monophosphate
Chemical formula C
10H11N4CaO8P·n H2Oy
C10H12N5CaO8P·n H2O
Assay Content of both major components not less than 97,0 %,
and of each component not less than 47,0 % and not more
than 53 %, in every case on the anhydrous basis
Description Odourless, white or nearly white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for calcium
B. pH of a 0,05 % solution Between 7,0 and 8,0
Purity
Water Not more than 23,0 % (Karl Fischer)Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 635 DISODIUM 5'-RIBONUCLEOTIDE
Synonyms Sodium 5'-ribonucleotide
Definition
Chemical name Disodium 5'-ribonucleotide is essentially a mixture of
disodium inosine-5'-monophosphate and disodium
guanosine-5'-monophosphate
Chemical formula C
10H11N4O8P·n H2O and
C10H12N5Na2O8P·n H2O
Assay Content of both major components not less than 97,0 %,
and of each component not less than 47,0 % and not more
than 53 %, in every case on the anhydrous basis
Description Odourless, white or nearly white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for sodium
B. pH of a 5 % solution Between 7,0 and 8,51996L0077 — EN — 20.06.2001 — 003.001 — 169
▼M3
Purity
Water Not more than 26,0 % (Karl Fischer)Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 905 MICROCRYSTALLINE WAX
Synonyms Petroleum wax
Definition Microcrystalline wax is a refined mixture of solid,
saturated hydrocarbons, mainly branched paraffin,
obtained from petroleum
Description White to amber, odourless wax
Identification
A. Solubility Insoluble in water, very slightly soluble in ethanol
B. Refractive Index n D
1001,434-1,448
Purity
Molecular weight Average not less than 500Viscosity at 100 ºC Not less than 1,1 · 10
-5m2s-1
Residue on ignition Not more than 0,1 %Carbon number at 5 % distillation point Not more than 5 % of molecules with carbon number less
than 25
Colour Passes testSulphur Not more than 0,4 %
Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kgPolycyclic aromatic compounds The polycyclic aromatic hydrocarbons, obtained by
extraction with dimethyl sulfoxide, shall meet the
following ultraviolet absorbency limits:
nm Maximum absorbance per cm path length280-289 0,15
290-299 0,12
300-359 0,08360-400 0,02
E 912 MONTAN ACID ESTERS
Definition Montan acids and/or esters with ethylene glycol and/or
1,3-butanediol and/or glycerol
Chemical name Montan acid esters
Description Almost white to yellowish flakes, powder, granules or
pellets
Identification
A. Density (20 ºC) Between 0,98 and 1,05
B. Drop point Greater than 77 ºC
Purity
Acid value Not more than 40
Glycerol Not more than 1 % (by gas chromatography)
Other polyols Not more than 1 % (by gas chromatography)Other wax types Not detectable (by differential scanning calorimetry and/
or infrared spectroscopy)
Arsenic Not more than 2 mg/kg1996L0077 — EN — 20.06.2001 — 003.001 — 170
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Chromium Not more than 3 mg/kg
Lead Not more than 2 mg/kg
E 914 OXIDISED POLYETHYLENE WAX
Definition Polar reaction products from mild oxidation of poly-
ethylene
Chemical name Oxidised polyethylene
Description Almost white flakes, powder, granules or pellets
Identification
A. Density (20 ºC) Between 0,92 and 1,05
B. Drop point Greater than 95 ºC
Purity
Acid value Not more than 70
Viscosity at 120 ºC Not less than 8,1 · 10-5m2s-1
Other wax types Not detectable (by differential scanning calorimetry and/
or infrared spectroscopy)
Oxygen Not more than 9,5 %Chromium Not more than 5 mg/kg
Lead Not more than 2 mg/kg
E 950 ACESULFAME K
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
E 951 ASPARTAME
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
E 953 ISOMALT
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC, as amended by Directive 98/66/EC, laying down specific criteria of purity concerning sweeteners
for use in foodstuffs.
E 957 THAUMATIN
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
E 959 NEOHESPERIDINE DIHYDROCHALCONE
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
E 965(i) MALTITOL
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
E 965(ii) MALTITOL SYRUP
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.
E 966 LACTITOL
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.1996L0077 — EN — 20.06.2001 — 003.001 — 171
▼M3
E 967 XYLITOL
Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/
EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs.1996L0077 — EN — 20.06.2001 — 003.001 — 172