1996L0077 — EN — 17.11.2002 — 004.001 — 1
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
►B COMMISSIONDIRECTIVE96/77/EC
of2December 1996
layingdownspecific puritycriteria onfoodadditivesotherthancoloursandsweeteners
(TextwithEEArelevance)
(OJ L 339, 30.12.1996, p. 1)
Amended by:
Official Journal
No page 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
►M4Commission Directive 2002/82/EC of 15 October 2002 L 292 1 28.10.2002
▼B
COMMISSIONDIRECTIVE96/77/EC
of2December 1996
laying down specific purity criteria on food additives other than
coloursandsweeteners
(TextwithEEArelevance)
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 concerningfood additives authorized for use in foodstuffs intended for human
consumption(
1), as amended by European Parliament and Council
Directive 94/34/EC(2), and in particular Article 3 (3) (a) thereof,
After consulting the Scientific Committee for Food,
Whereas it is necessary to establish purity criteria for all additives
other than colours and sweeteners mentioned in European Parliament
and Council Directive 95/2/EC of 20 February 1995 on food additivesother than 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 criteriaof purity 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Whereas Directives 65/66/EEC and 78/664/EEC should be repealed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 Addi-tives (Jecfa);
Whereas food additives, if prepared by production methods or starting
materials significantly different from those included in the evaluationof the Scientific Committee for Food, or if different from thosementioned in 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 to in Article 3 (3) (a) of Directive 89/107/
EEC for food additives other than colours and sweeteners, asmentioned in Directive 95/2/EC, are set out in the Annex hereto.1996L0077 — EN — 17.11.2002 — 004.001 — 2
(1) OJ No L 40, 11. 2. 1989, p. 27.
(2) OJ No L 237, 10. 9. 1994, p. 1.
(3) OJ No L 61, 18. 3. 1995, p. 1.
(4) OJ No 22, 9. 2. 1965, p. 373.
(5) OJ No L 352, 13. 12. 1986, p. 45.
(6) OJ No L 223, 14. 8. 1978, p. 30.
(7) OJ No L 297, 23. 10. 1982, p. 31.
▼M1
Article 2
The purity criteria referred to in Article 1 replace the purity criteria set
out in Directives 65/66/EEC, 78/663/EEC and 78/664/EEC.
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 Commissionthereof.
When Member States adopt these provisions, these shall contain a
reference to this Directive or shall be accompanied by such referenceat the time of their official publication. The procedure for such refer-ence shall 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 to the Member States.1996L0077 — EN — 17.11.2002 — 004.001 — 3
▼B
▼B
ANNEX
E200SORBICACID
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 absor-
bance maximum at 254 ± 2 nm
C. Positive test for double bondsD. 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E202POTASSIUMSORBATE
Definition
Chemical name Potassium sorbate
Potassium (E,E)-2,4-hexadienoate
Potassium salt of trans, trans 2,4-hexadienoic acid
Einecs 246-376-1
Chemical formula 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 to 135 ºC after
vacuum drying in a sulphuric acid
desiccator
B. Positive tests for potassium and for
double bonds1996L0077 — EN — 17.11.2002 — 004.001 — 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 K
2CO3)
Aldehydes Not more than 0,1 %, calculated 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/kg
E203CALCIUMSORBATE
Definition
Chemical name Calcium sorbate
Calcium salts of trans, trans-2,4-hexadienoic acid
Einecs 231-321-6
Chemical formula C
12H14O4Ca
Molecular weight 262,32
Assay Content not less than 98 % on the dried basis
Description Fine white crystalline powder not showing any change
in colour after heating at 105 ºC for 90 minutes
Identification
A. Melting range of sorbic acid
isolated by acidification and not
recrystallized 133 ºC to 135 ºC after
vacuum drying in a sulphuric acid
desiccator
B. Positive tests for calcium and for
double bonds
Purity
Loss on drying Not more than 2,0 %, determined by vacuum drying
for four hours in a sulphuric acid desiccator
Aldehydes Not more than 0,1 % (as formaldehyde)Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E210BENZOICACID
Definition
Chemical name Benzoic acid
Benzenecarboxylic acid
Phenylcarboxylic 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 — 17.11.2002 — 004.001 — 5
▼B
Identification
A. Melting range 121,5 ºC to 123,5 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 to the 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
E211SODIUMBENZOATE
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 gran-
ules
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 — 17.11.2002 — 004.001 — 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 to the 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E212POTASSIUMBENZOATE
Definition
Chemical name Potassium benzoate
Potassium salt of benzenecarboxylic acid
Potassium 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 to constant weight
Description White crystalline powder
Identification
A. Melting range of benzoic acid
isolated by acidification and not
recrystallized 121,5 ºC to 123,5 ºC,
after vacuum drying in a sulphuric acid
desiccator
B. Positive tests for benzoate and for
potassium
Purity
Loss on drying Not more than 26,5 %, determined by drying at 105 ºC
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, 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 to the 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 — 17.11.2002 — 004.001 — 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
E213CALCIUMBENZOATESynonyms 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 to 123,5 ºC,
after vacuum drying in a sulphuric acid
desiccator
B. Positive tests for benzoate and for
calcium
Purity
Loss on drying Not more than 17,5 % determined by drying at 105 ºC
to constant weight
Water insoluble matter Not more than 0,3 %
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, 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 to the 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 — 17.11.2002 — 004.001 — 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/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E214ETHYL p-HYDROXYBENZOATE
Synonyms Ethylparaben
Ethylp-oxybenzoate
Definition
Chemical name Ethyl-p-hydroxybenzoate
Ethyl ester of p-hydroxybenzoic acid
Einecs 204-399-4
Chemical formula C
9H10O3
Molecular weight 166,8
Assay Content not less than 99,5 % after drying for two
hours at 80 ºC
Description Almost odourless, small, colourless crystals or a white,
crystalline powder
Identification
A. Melting range 115 ºC to 118 ºCB. 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 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 9
▼B
E215SODIUMETHYL 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 to 118 ºC, after vacuum drying in a sulphuric
acid desiccator
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from
the sample is 213 ºC to 217 ºC
C. Positive test for 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 to 39 %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
E216PROPYL p-HYDROXYBENZOATE
Synonyms Propylparaben
Propylp-oxybenzoate
Definition
Chemical name Propylp-hydroxybenzoate
n-Propylp-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 to 217 ºC1996L0077 — EN — 17.11.2002 — 004.001 — 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E217SODIUMPROPYL p-HYDROXYBENZOATE
Definition
Chemical name Sodium n-propyl p-hydroxybenzoate
Sodium compound of the n-propylester of p-hydroxy-
benzoic 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 to 97 ºC, after vacuum drying in
a sulphuric acid desiccator
B. Positive test for sodiumC. pH of a 0,1 % aqueous solution
must be between 9,8 and 10,2
Purity
Loss on drying Not more than 5 %, determined by vacuum drying in a
sulphuric acid desiccator
Sulphated ash 34 to 36 %p-Hydroxybenzoic acid and salicylic
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
E218METHYL p-HYDROXYBENZOATE
Synonyms Methylparaben
Methyl-p-oxybenzoate
Definition
Chemical name Methylp-hydroxybenzoate
Methyl ester of p-hydroxybenzoic acid
Einecs 243-171-51996L0077 — EN — 17.11.2002 — 004.001 — 11
▼B
Chemical formula C8H8O3
Molecular weight 152,15
Assay Content not less than 99 % after drying for two hours
at 80 ºC
Description Almost odourless, small colourless crystals or white
crystalline powder
Identification
A. Melting range 125 ºC to 128 ºC
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from
the sample is 213 ºC to 217 ºC after drying for two
hours at 80 ºC
Purity
Loss on drying Not more than 0,5 %, after drying for two hours at
80 ºC
Sulphated ash Not more than 0,05 %p-Hydroxybenzoic acid and salicylic
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
E219SODIUMMETHYL 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
acidifying with hydrochloric acid a
10 % (w/v) aqueous solution of the
sodium derivative of methyl p-hydro-
xybenzoate (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 to128 ºC
B. Positive test for sodiumC. pH of a 0,1 % solution in carbon
dioxide free water, not less than 9,7
and not more than 10,3
Purity
Water content Not more than 5 % (Karl Fischer method)
Sulphated ash 40 % to 44,5 % on the anhydrous basis
p-Hydroxybenzoic acid and salicylic
acidNot more than 0,35 % expressed as p-hydroxybenzoic
acid
Arsenic Not more than 3 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 12
▼B
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E220SULPHURDIOXIDEDefinition
Chemical name Sulphur dioxide
Sulphurous acid anhydride
Einecs 231-195-2
Chemical formula SO
2
Molecular weight 64,07
Assay Content not less than 99 %
Description Colourless, non-flammable gas with strong pungent
suffocating odour
Identification
A. Positive test for sulphurous
substances
Purity
Water content Not more than 0,05 %
Non-volatile residue Not more than 0,01 %Sulphur trioxide Not more than 0,1 %
Selenium Not more than 10 mg/kg
Other gases not normally present in the
airNo trace
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E221SODIUMSULPHITEDefinition
Chemical name Sodium sulphite (anhydrous or heptahydrate)
Einecs 231-821-4
Chemical formula Anhydrous: Na
2SO3
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 11,51996L0077 — EN — 17.11.2002 — 004.001 — 13
▼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/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E222SODIUMBISULPHITEDefinition
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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E223SODIUMMETABISULPHITE
Synonyms Pyrosulphite
Sodium pyrosulphite
Definition
Chemical name Sodium disulphite
Disodium pentaoxodisulphate
Einecs 231-673-0
Chemical formula Na
2S2O5
Molecular weight 190,11
Assay Content not less than 95 % Na2S2O5and not less than
6 4%o fS O2
Description White crystals or crystalline powder1996L0077 — EN — 17.11.2002 — 004.001 — 14
▼B
Identification
A. Positive tests for sulphite and for
sodium
B. pH of a 10 % aqueous solution
between 4,0 and 5,5
Purity
Thiosulphate Not more than 0,1 % based on the 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
E224POTASSIUMMETABISULPHITESynonyms 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
E226CALCIUMSULPHITEDefinition
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 SO21996L0077 — EN — 17.11.2002 — 004.001 — 15
▼B
Description White crystals or white crystalline powder
Identification
A. Positive tests for sulphite and for
calcium
Purity
Iron Not more than 50 mg/kg based on the 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
E227CALCIUMBISULPHITEDefinition
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/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E228POTASSIUMBISULPHITEDefinition
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 solution1996L0077 — EN — 17.11.2002 — 004.001 — 16
▼B
Identification
A. Positive tests for sulphite and for
potassium
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/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
E230BIPHENYL
Synonyms Diphenyl
Definition
Chemical name 1,1′-biphenyl
Phenylbenzene
Einecs 202-163-5
Chemical formula C12H10
Molecular weight 154,20
Assay Content not less than 99,8 %
Description White or pale yellow to amber crystalline solid having
a characteristic odour
Identification
A. Melting range 68,5 ºC to 70,5 ºCB. 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/kgAromatic amines Not more than 2 mg/kg (as aniline)
Phenol derivatives Not more than 5 mg/kg (as phenol)
Readily carbonizable substances Cold solution of 0,5 g of biphenyl in 5 ml of 94,5 to
95,5 % sulphuric acid must not show a stronger
colouring than that of a reference 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/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E231ORTHOPHENYLPHENOL
Synonyms Orthoxenol1996L0077 — EN — 17.11.2002 — 004.001 — 17
▼B
Definition
Chemical name (1,1'-Biphenyl)-2-ol
2-Hydroxydiphenyl
o-Hydroxydiphenyl
Einecs 201-993-5
Chemical formula C12H10O
Molecular weight 170,20
Assay Content not less than 99 %
Description White or slightly yellowish crystalline powder
Identification
A. Melting range 56 ºC to 58 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
E232SODIUMORTHOPHENYLPHENOLSynonyms 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 to 58 ºC after drying in a
sulphuric acid desiccator
C. pH of a 2 % aqueous solution must
be between 11,1 and 11,8
Purity
Diphenylether Not more than 0,3 %p-phenylphenol Not more than 0,1 %
1-naphthol Not more than 0,01 %1996L0077 — EN — 17.11.2002 — 004.001 — 18
▼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
E233THIABENDAZOLEDefinition
Chemical name 4-(2-benzimidazolyl)thiazole
2-(4-thiazolyl)-1H-benzimidazole
Einecs 1205-725-8
Chemical formula C
10H7N3S
Molecular weight 201,26
Assay Content not less than 98 % on the anhydrous basis
Description White, or almost white, odourless powder
Identification
A. Melting range 296 ºC to 303 ºCB. Spectrometry Absorption maxima in 0,1 N HCl (0,0005 % w/v) at
302 nm, 258 nm and 243 nm
E
1%
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 0,53
Ratio of absorption 258 nm/302 nm = 0,14 to 0,18
Purity
Water content Not more than 0,5 % (Karl Fischer method)Sulphated ash Not more than 0,2 %
Selenium Not more than 3 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E234NISINDefinition Nisin consists of several closely related polypeptides
produced by natural strains of Streptococcus lactis ,
Lancefield groupN
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 to 103 ºC
Arsenic Not more than 1 mg/kgLead Not more than 5 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 19
▼B
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E235NATAMYCINSynonyms Pimaricin
Definition Natamycin is a fungicide of the polyene macrolide
group, and is produced by natural strains of Strepto-
myces natalensis or ofStreptococcus lactis
Einecs 231-683-5
Chemical formula C
33H47O13N
Molecular weight 665,74
Assay Content not less than 95 % on the anhydrous basis
Description White to creamy-white crystalline powder
Identification
A. Colour reactions On adding a few crystals of natamycin on a spot plate,
to a dropof:
— concentrated hydrochloric acid, a blue colour
develops,
— concentrated phosphoric acid, a green colour
develops,
which changes into pale red after a few minutes
B. Spectrometry A 0,0005 % w/v solution in 1 % methanolic acetic
acid solution has absorption maxima at about 290 nm,
303 nm and 318 nm, a shoulder at about 280 nm and
exhibits minima at about 250 nm, 295,5 nm and 311
nm
C. pH 5,5 to 7,5 (1 % w/v solution in previously neutralized
mixture of 20 parts dimethylformamide and 80 parts
of water)
D. Specific rotation α½/C13820
D= + 250 º to + 295 º (a 1 % w/v solution in
glacial acetic acid, at 20 ºC and calculated
with reference to the dried material)
Purity
Loss on drying Not more than 8 % (over P2O5, in vacuum at 60 ºC to
constant weight)
Sulphated ash Not more than 0,5 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgMicrobiological criteria: total viable
countNot more than 100/g
E239HEXAMETHYLENETETRAMINE
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 140,191996L0077 — EN — 17.11.2002 — 004.001 — 20
▼B
Assay Content not less than 99 % on the anhydrous basis
Description Colourless or white crystalline powder
Identification
A. Positive tests for formaldehyde and
for ammonia
B. Sublimation point approximately
260 ºC
Purity
Loss on drying Not more than 0,5 % after drying at 105 ºC in vacuum
over P2O5for two hours
Sulphated ash Not more than 0,05 %
Sulphates Not more than 0,005 % expressed as SO4
Chlorides Not more than 0,005 % expressed as Cl
Ammonium salts Not detectable
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E242DIMETHYLDICARBONATESynonyms 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/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 — 17.11.2002 — 004.001 — 21
▼B
E249POTASSIUMNITRITE
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
E250SODIUMNITRITEDefinition
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
E251SODIUMNITRATESynonyms Chile saltpetre
Cubic or soda nitre
Definition
Chemical name Sodium nitrate1996L0077 — EN — 17.11.2002 — 004.001 — 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 8,3C. 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 NaNO
2
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E252POTASSIUMNITRATE
Synonyms Chile saltpetre
Cubic or soda nitre
Definition
Chemical name Potassium nitrate
Einecs 231-818-8
Chemical formula KNO3
Molecular weight 101,11
Assay Content not less than 99 % on the anhydrous basis
Description White crystalline powder or transparent prisms having
a cooling, saline, pungent taste
Identification
A. Positive tests for nitrate and for
potassium
B. pH of a 5 % solution Not less than 4,5 and not more than 8,5
Purity
Loss on drying Not more than 1 % after drying at 105 ºC for four
hours
Nitrites Not more than 20 mg/kg expressed as KNO2
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 23
▼B
E260ACETICACID
Definition
Chemical name Acetic acid
Ethanoic acid
Einecs 200-580-7
Chemical formula C2H4O2
Molecular weight 60,05
Assay Content not less than 99,8 %
Description Clear, colourless liquid having a pungent, character-
istic odour
Identification
A. Boiling point 118 ºC at 760 mm pressure (of mercury)
B. Specific gravity About 1,049
C. A one in three solution gives posi-
tive tests for acetate
D. Solidification point Not lower than 14,5 ºC
Purity
Non-volatile residue Not more than 100 mg/kg
Formic acid, formates and other
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
E261POTASSIUMACETATEDefinition
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
hours
Formic acid, formates and other
oxidizable substancesNot more than 1 000 mg/kg expressed as formic acid1996L0077 — EN — 17.11.2002 — 004.001 — 24
▼B
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
E262(i)SODIUMACETATEDefinition
Chemical name Sodium acetate
Einecs 204-823-8
Chemical formula C
2H3NaO2·nH2O( n=0o r3 )
Molecular weight Anhydrous: 82,03
Trihydrate: 136,08
Assay Content (for both of anhydrous and trihydrate form)
not less than 98,5 % on the anhydrous basis
Description Anhydrous: White, odourless, granular, 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 9,5
B. Positive tests for acetate and for
sodium
Purity
Loss on drying Anhydrous: Not more than 2 % (120 ºC, 4
hours)
Trihydrate: Between 36 and 42 % (120 ºC, 4
hours)
Formic acid, formates and other
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
E262(ii)SODIUMDIACETATE
Definition 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=0o r3 )
Molecular weight 142,09 (anhydrous)
Assay Content 39 to 41 % of free acetic acid and 58 to 60 %
of sodium acetate
Description White, hygroscopic crystalline solid with an acetic
odour
Identification
A. pH of a 10 % aqueous solution Not less than 4,5 and not more than 5,01996L0077 — EN — 17.11.2002 — 004.001 — 25
▼B
B. Positive tests for acetate and for
sodium
Purity
Water content Not more than 2 % (Karl Fischer method)Formic acid, formates and other
oxidizable substancesNot more than 1 000 mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E263CALCIUMACETATEDefinition
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 mono-
hydrate 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/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E270LACTICACIDDefinition
Chemical name Lactic acid
2-Hydroxypropionic acid
1-Hydroxyethane-1-carboxylic acid
Einecs 200-018-0
Chemical formula C
3H6O3
Molecular weight 90,08
Assay Content not less than 76 % and not more than 84 %1996L0077 — EN — 17.11.2002 — 004.001 — 26
▼B
Description Colourless or yellowish, nearly odourless, syrupy
liquid with an acid taste, consisting of a mixture of
lactic acid (C3H6O3) and lactic acid lactate (C6H10O5).
It is obtained by the lactic fermentation of sugars or
is prepared synthetically
Note:
Lactic acid is hygroscopic and when
concentrated by boiling, it condenses to
form lactic acid lactate, which on dilu-
tion and heating hydrolyzes to lactic
acid
Identification
A. Positive test for lactate
Purity
Sulphated ash Not more than 0,1 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,25 %Iron Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Note:
This specification refers to a 80 %
aqueous solution; for weaker aqueous
solutions, calculate values corre-
sponding to their lactic acid content
E280PROPIONICACID
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 ºC
B. Distillation range 138,5 ºC to 142,5 ºC
Purity
Non-volatile residue Not more than 0,01 % when dried at 140 ºC to
constant weight
Aldehydes Not more than 0,1 % expressed as formaldehyde
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 27
▼B
E281SODIUMPROPIONATE
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
E282CALCIUMPROPIONATEDefinition
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 — 17.11.2002 — 004.001 — 28
▼B
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E283POTASSIUMPROPIONATE
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
E284BORICACID
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 — 17.11.2002 — 004.001 — 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
E285SODIUMTETRABORATE(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 expo-
sure 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
E290CARBONDIOXIDE
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 pressur-
ized 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 solu-
tion of barium hydroxide, a white precipitate is
produced which dissolves with effervescence in dilute
acetic acid1996L0077 — EN — 17.11.2002 — 004.001 — 30
▼B
Purity
Acidity 915 ml of gas bubbled through 50 ml of freshly boiled
water must not render the latter more acid to methylor-
ange 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 to which has been added 3 ml of
ammonia must not cause clouding or blackening of
this solution
Carbon monoxide Not more than 10 µl/l
Oil content Not more than 0,1 mg/l
E300ASCORBICACIDDefinition
Chemical name L-ascorbic acid
Ascorbic acid
2,3-Didehydro-L-threo-hexono-1,4-lactone
3-Keto-L-gulofuranolactone
Einecs 200-066-2
Chemical formula C
6H8O6
Molecular weight 176,13
Assay Ascorbic acid, after drying in a vacuum desiccator
over sulphuric acid for 24 hours, contains not less
than 99 % of C6H8O6
Description White to pale yellow, odourless crystalline solid
Identification
A. Melting range Between 189 ºC and 193 ºC with decomposition
B. Positive tests for ascorbic acid
Purity
Loss on drying Not more than 0,4 % after drying in a vacuum desic-
cator over sulphuric acid for 24 hours
Sulphated ash Not more than 0,1 %Specific rotation α½/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 2,8Arsenic 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
E301SODIUMASCORBATEDefinition
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 — 17.11.2002 — 004.001 — 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%o fC6H7O6Na
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 desic-
cator over sulphuric acid for 24 hours
Specific rotation α½/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
E302CALCIUMASCORBATE
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 crys-
talline powder
Identification
A. Positive tests for ascorbate and for
calcium
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Specific rotation α½/C13820
Dbetween + 95 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 — 17.11.2002 — 004.001 — 32
▼B
E304(i)ASCORBYLPALMITATE
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 α½/C138
20
Dbetween + 21 º and + 24 º (5 % w/v in
methanol solution)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E304(ii)ASCORBYLSTEARATEDefinition
Chemical name Ascorbyl stearate
L-ascorbyl stearate
2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate6-stearoyl-3-keto-L-gulofuranolactone
Einecs 246-944-9
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/kgMercury Not more than 1 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 33
▼B
Heavy metals (as Pb) Not more than 10 mg/kg
E306TOCOPHEROL-RICHEXTRACT
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 α½/C13820
Dnot less than + 20 º
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
E307ALPHA-TOCOPHEROLSynonyms dl-α-Tocopherol
Definition
Chemical name dl-5,7,8-Trimethyltocol
dl-2,5,7,8-tetramethyl-2-(4 ′,8′,12′-trimethyltridecyl)-6-
chromanol
Einecs 200-412-2
Chemical formula C
29H50O2
Molecular weight 430,71
Assay Content not less than 96 %
Description Slightly yellow to amber, nearly odourless, clear,
viscous oil which oxidizes and darkens on exposure
to air or light
Identification
A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible
in ether
B. Spectrophotometry In absolute ethanol the maximum absorption is about
292 nm
Purity
Refractive index n20
D1,503 — 1,507
Specific absorption E1%
1c min ethanol E1%1c m(292 nm) 72—76
(0,01 g in 200 ml of absolute ethanol)
Sulphated ash Not more than 0,1 %1996L0077 — EN — 17.11.2002 — 004.001 — 34
▼B
Specific rotation α½/C13820
D0 º ± 0,05 º (1 in 10 solution in chloroform)
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
E308GAMMA-TOCOPHEROL
Synonyms 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E309DELTA-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—1,5041996L0077 — EN — 17.11.2002 — 004.001 — 35
▼B
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E310PROPYLGALLATEDefinition
Chemical name Propyl gallate
Propyl ester of gallic acidn-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs 204-498-2
Chemical formula C
10H12O5
Molecular weight 212,20
Assay Content not less than 98 % on the anhydrous basis
Description White to creamy-white, crystalline, odourless solid
Identification
A. Solubility tests Slightly soluble in water, freely soluble in ethanol,
ether and propane-1,2-diol
B. Melting range Between 146 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/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E311OCTYLGALLATEDefinition
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 — 17.11.2002 — 004.001 — 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
E312DODECYLGALLATE
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
E315ERYTHORBICACID
Synonyms Isoascorbic acid
D-araboascorbic acid1996L0077 — EN — 17.11.2002 — 004.001 — 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 pres-
sure on silica gel for 3 hours
Sulphated ash Not more than 0,3 %
Specific rotation α½/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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E316SODIUMERYTHORBATESynonyms Sodium isoascorbate
Definition
Chemical name Sodium isoascorbate
Sodium D-isoascorbic acid
Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-
lactone
3-keto-D-gulofurano-lactone sodium enolate 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
ethanol
B. Positive test for ascorbic acid/colour
reaction
C. Positive test for sodium1996L0077 — EN — 17.11.2002 — 004.001 — 38
▼B
Purity
Loss on drying Not more than 0,25 % after drying in a vacuum desic-
cator over sulphuric acid for 24 hours
Specific rotation α½/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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E320BUTYLATEDHYDROXYANISOLE(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 ethanolB. Melting range Between 48
oC 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 E
1%
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
E321BUTYLATEDHYDROXYTOLUENE(BHT)
Synonyms BHT1996L0077 — EN — 17.11.2002 — 004.001 — 39
▼M2
▼B
▼B
Definition
Chemical name 2,6-Ditertiary-butyl- p-cresol
4-Methyl-2,6-ditertiarybutylphenol
Einecs 204-881-4
Chemical formula C15H24O
Molecular weight 220,36
Assay Content not less than 99 %
Description White, crystalline or flaked solid, odourless or having
a characteristic faint aromatic odour
Identification
A. Solubility tests Insoluble in water and propane- 1,2-diol
Freely soluble in ethanol
B. Melting point At 70 ºCC. Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm
layer of a 1 in 100000 solution in dehydrated ethanolexhibits a maximum only at 278 nm
Purity
Sulphated ash Not more than 0,005 %
Phenolic impurities Not more than 0,5 %Specific absorption E
1%
1c min ethanol E1%1c m(278 nm) not less than 81 and not more than 88
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E322LECITHINS
Synonyms Phosphatides
Phospholipids
Definition Lecithins are mixtures or fractions of phosphatides
obtained by physical procedures from animal or vege-
table 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 inso-
luble 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 acids1996L0077 — EN — 17.11.2002 — 004.001 — 40
▼B
B. Test for hydrolysed lecithin To a 800 ml beaker add 500 ml of water
(30 ºC—35 ºC). Then slowly add 50 ml of the sample
with constant stirring. Hydrolysed lecithin will form a
homogeneous emulsion. Non-hydrolysed lecithin will
form a distinct mass of about 50 g
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 ºC
for one hour
Toluene-insoluble matter Not more than 0,3 %
Acid value — Lecithins: not more than 35 mg of potassium
hydroxide per gram
— Hydrolysed lecithins: not more than 45 mg of
potassium hydroxide per gram
Peroxide value Equal to or less than 10
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E325SODIUMLACTATEDefinition
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 lactateB. 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/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Reducing substances No reduction of Fehling's solution
Note:
This specification refers to a 60 %
aqueous solution
E326POTASSIUMLACTATE
Definition
Cheminal name Potassium lactate
Potassium 2-hydroxypropanoate1996L0077 — EN — 17.11.2002 — 004.001 — 41
▼B
Einecs 213-631-3
Chemical formula C3H5O3K
Molecular weight 128,17 (anhydrous)
Assay Content not less than 57 % and not more than 66 %
Description Slightly viscous, almost odourless clear liquid. 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
deepred colour is p roduced at the zone of contact
C. Positive tests for potassium and for
lactate
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/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 reduc-
tion of Fehling's solution
Note:
This specification refers to a 60 %
aqueous solution
E327CALCIUMLACTATE
Definition
Chemical name Calcium dilactate
Calcium dilactate hydrate
2-Hydroxypropanoic acid calcium salt
Einecs 212-406-7
Chemical formula (C
3H5O2)2Ca·nH2O (n = 0—5)
Molecular weight 218,22 (anhydrous)
Assay Content not less than 98 % on the anhydrous basis
Description Almost odourless, white crystalline powder or granules
Identification
A. Positive tests for lactate and for
calcium
B. Solubility tests Soluble in water and practically insoluble in ethanol
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 %1996L0077 — EN — 17.11.2002 — 004.001 — 42
▼B
Acidity Not more than 0,5 % of the dry matter expressed as
lactic acid
Fluoride Not more than 30 mg/kg (expressed as fluorine)pH of a 5 % solution Between 6,0 and 8,0
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Reducing substances No reduction of Fehling's solution
E330CITRICACIDDefinition
Chemical name Citric acid
2-Hydroxy-1,2,3-propanetricarboxylic acidβ-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/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
Oxalates Not more than 100 mg/kg, expressed as oxalic acid,
after drying
Readily carbonizable substances Heat 1 g of powdered sample with 10 ml of 98 %
minimum sulphuric acid in a water bath at 90 ºC in
the dark for one hour. Not more than a pale brown
colour should be produced (Matching Fluid K)
E331(i)MONOSODIUMCITRATESynonyms Monosodium citrate
Monobasic sodium citrate1996L0077 — EN — 17.11.2002 — 004.001 — 43
▼B
Definition
Chemical name Monosodium citrate
Monosodium salt of 2-hydroxy-1,2,3-propanetricar-
boxylic acid
Chemical formula (a) C6H7O7Na (anhydrous)
(b) C6H7O7Na·H2O (monohydrate)
Molecular weight (a) 214,11 (anhydrous)
(b) 232,23 (monohydrate)
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A. Positive tests for citrate and for
sodium
Purity
Loss on drying Determined by drying at 180 ºC for four hours:
— anhydrous: not more than 1,0 %
— monohydrate: not more than 8,8 %
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 1 % aqueous solution Between 3,5 and 3,8Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E331(ii)DISODIUMCITRATESynonyms 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 5,21996L0077 — EN — 17.11.2002 — 004.001 — 44
▼B
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/kg
E331(iii) TRISODIUMCITRATE
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: C
6H5O7Na3
Hydrated: C6H5O7Na3·nH2O( n=2o r5 )
Molecular weight 258,07 (anhydrous)
Assay Not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A. Positive tests for citrate and for
sodium
Purity
Loss on drying Determined by drying at 180 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 9,0Arsenic 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
E332(i)MONOPOTASSIUMCITRATESynonyms 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 C
6H7O7K
Molecular weight 230,211996L0077 — EN — 17.11.2002 — 004.001 — 45
▼B
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent
crystals
Identification
A. Positive tests for citrate and for
potassium
Purity
Loss on drying Not more than 1,0 % determined by drying at 180 ºC
for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid,
after drying
pH of a 1 % aqueous solution Between 3,5 and 3,8Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E332(ii)TRIPOTASSIUMCITRATE
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 C
6H5O7K3·H2O
Molecular weight 324,42
Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent
crystals
Identification
A. Positive tests for citrate and for
potassium
Purity
Loss on drying Not more than 6,0 % determined by drying at 180 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/kgLead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E333(i)MONOCALCIUMCITRATE
Synonyms Monocalcium citrate
Monobasic calcium citrate1996L0077 — EN — 17.11.2002 — 004.001 — 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 hydro-
chloric acid must not liberate more than a few isolated
bubbles
E333(ii)DICALCIUMCITRATESynonyms Dicalcium citrate
Dibasic calcium citrate
Definition
Chemical name Dicalcium citrate
Dicalcium salt of 2-hydroxy-1,2,3-propanetricar-
boxylic 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 — 17.11.2002 — 004.001 — 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 hydro-
chloric acid must not liberate more than a few isolated
bubbles
E333(iii) TRICALCIUMCITRATE
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 hydro-
chloric acid must not liberate more than a few isolated
bubbles
E334L(+)-TARTARICACID
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 — 17.11.2002 — 004.001 — 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 solutionα½/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
E335(i)MONOSODIUMTARTRATE
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
E335(ii)DISODIUMTARTRATEDefinition
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 — 17.11.2002 — 004.001 — 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
E336(i)MONOPOTASSIUMTARTRATESynonyms 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
E336(ii)DIPOTASSIUMTARTRATESynonyms 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 — 17.11.2002 — 004.001 — 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
E337POTASSIUMSODIUMTARTRATESynonyms 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 % deter-
mined 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 — 17.11.2002 — 004.001 — 51
▼M4
E338PHOSPHORICACID
Synonyms Orthophosphoric acid
Monophosphoric acid
Definition
Chemical name Phosphoric acid
Einecs 231-633-2
Chemical formula H3PO4
Molecular weight 98,00
Assay Phosphoric acid is commercially available as an
aqueous solution at variable concentrations. Content
not less than 67,0 % and not more than 85,7 %.
Description Clear, colourless, viscous liquid
Identification
A. Positive tests for acid and for phos-
phate
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 1 500 mg/kg (as CaSO4)
Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kg
Note:
This specification refers to a 75 %
aqueous solution.
E339(i)MONOSODIUMPHOSPHATESynonyms Monosodium monophosphate
Acid monosodium monophosphateMonosodium orthophosphateMonobasic sodium phosphate
Sodium dihydrogen monophosphate
Definition
Chemical name Sodium dihydrogen monophosphate
Einecs 231-449-2
Chemical formula Anhydrous: NaH
2PO4
Monohydrate: NaH2PO4·H2O
Dihydrate: NaH2PO4·2 H2O
Molecular weight Anhydrous: 119,98
Monohydrate: 138,00Dihydrate: 156,01
Assay After drying at 60 ºC for one hour and then at 105 ºC
for four hours, contains not less than 97 % of
NaH
2PO41996L0077 — EN — 17.11.2002 — 004.001 — 52
▼M4
P2O5content Between 58,0 % and 60,0 % on the anhydrous basis
Description A white odourless, slightly deliquescent powder, crys-
tals or granules
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Freely soluble in water. Insoluble in ethanol or ether
C. pH of a 1 % solution Between 4,1 and 5,0
Purity
Loss on drying The anhydrous salt loses not more than 2,0 %, the
monohydrate not more than 15,0 %, and the dihydrate
not more than 25 % when dried first at 60 ºC for one
hour, then at 105 ºC for four hours
Water-insoluble substances Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E339(ii)DISODIUMPHOSPHATESynonyms Disodium monophosphate
Secondary sodium phosphateDisodium orthophosphateAcid disodium phosphate
Definition
Chemical name Disodium hydrogen monophosphate
Disodium hydrogen orthophosphate
Einecs 231-448-7
Chemical formula Anhydrous: Na
2HPO4
Hydrat: Na2HPO4·n H2O (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
P2O5content Between 49 % and 51 % on the anhydrous basis
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 dode-
cahydrate: white, efflorescent, odourless powder or
crystals
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Freely soluble in water. Insoluble in ethanol
C. pH of a 1 % solution Between 8,4 and 9,61996L0077 — EN — 17.11.2002 — 004.001 — 53
▼M4
Purity
Loss on drying When dried at 40 ºC for three hours and then at 105ºC
for five hours, the losses in weight are as follows:
anhydrous not more than 5,0 %, dihydrate not more
than 22,0 %, heptahydrate not more than 50,0 %,
dodecahydrate not more than 61,0 %
Water-insoluble substances Not more than 0,2 % on the anhydrous basisFluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kgLead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E339(iii) TRISODIUMPHOSPHATESynonyms Sodium phosphate
Tribasic sodium phosphate
Trisodium orthophosphate
Definition Trisodium phosphate is obtained from aqueous solu-
tions and crystallises in the anhydrous form and with
1/2, 1, 6, 8 or 12 H
2O. The dodecahydrate always
crystallises from aqueous solutions with an excess of
sodium hydroxide. It contains ¼ molecule of NaOH
Chemical name Trisodium monophosphate
Trisodium phosphateTrisodium orthophosphate
Einecs 231-509-8
Chemical formula Anhydrous: Na
3PO4
Hydrated: Na3PO4·n H2O (n = 1/2, 1, 6, 8, or 12)
Molecular weight 163,94 (anhydrous)
Assay Sodium phosphate anhydrous and the hydrated forms,
with the exception of the dodecahydrate, contain not
less than 97,0 % of Na3PO4calculated on the dried
basis.Sodium phosphate dodecahydrate contains not
less than 92,0 % of Na3PO4calculated on the ignited
basis
P2O5content Between 40,5 % and 43,5 % on the anhydrous basis
Description White odourless crystals, granules or crystalline
powder
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Freely soluble in water. Insoluble in ethanolC. pH of a 1 % solution Between 11,5 and 12,5
Purity
Loss on ignition When dried at 120 ºC for two hours and then ignited
at about 800 ºC for 30 minutes, the losses in weight
are as follows: anhydrous not more than 2,0 %, mono-
hydrate 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)Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 54
▼M4
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E340(i)MONOPOTASSIUMPHOSPHATESynonyms Monobasic potassium phosphate
Monopotassium monophosphate
Potassium orthophosphate
Definition
Chemical name Potassium dihydrogen phosphate
Monopotassium dihydrogen orthophosphate
Monopotassium dihydrogen monophosphate
Einecs 231-913-4
Chemical formula KH
2PO4
Molecular weight 136,09
Assay Content not less than 98,0 % after drying at 105 ºC for
four hours
P2O5content Between 51,0 % and 53,0 % on the anhydrous basis
Description Odourless, colourless crystals or white granular or
crystalline powder, hygroscopic
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility Freely soluble in water. Insoluble in ethanolC. pH of a 1 % solution Between 4,2 and 4,8
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 ºC
for four hours
Water-insoluble substances Not more than 0,2 % on the anhydrous basisFluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kgLead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E340(ii)DIPOTASSIUMPHOSPHATESynonyms Dipotassium monophosphate
Secondary potassium phosphate
Dipotassium acid phosphateDipotassium orthophosphateDibasic potassium phosphate
Definition
Chemical name Dipotassium hydrogen monophosphate
Dipotassium hydrogen phosphateDipotassium hydrogen orthophosphate
Einecs 231-834-5
Chemical formula K
2HPO4
Molecular weight 174,181996L0077 — EN — 17.11.2002 — 004.001 — 55
▼M4
Assay Content not less than 98 % after drying at 105ºC for
four hours
P2O5content Between 40,3 % and 41,5 % on the anhydrous basis
Description Colourless or white granular powder, crystals or
masses; deliquescent substance
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility Freely soluble in water. Insoluble in ethanolC. pH of a 1 % solution Between 8,7 and 9,4
Purity
Loss on drying Not more than 2,0 % determined by drying at 105 ºC
for four hours
Water-insoluble substances Not more than 0,2 % on the anhydrous basisFluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E340(iii) TRIPOTASSIUMPHOSPHATESynonyms 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·n H2O( n=1o r3 )
Molecular weight 212,27 (anhydrous)
Assay Content not less than 97 % calculated on the ignited
basis
P2O5content Between 30,5 % and 33,0 % 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 Freely soluble in water. Insoluble in ethanol
C. pH of a 1 % solution Between 11,5 and 12,3
Purity
Loss on ignition Anhydrous: not more than 3,0 %; hydrated: not more
than 23,0 %. Determined by drying at 105 ºC for one
hour and then ignite at about 800 ºC ± 25 ºC for 30
minutes
Water insoluble substances Not more than 0,2 % on the anhydrous basis1996L0077 — EN — 17.11.2002 — 004.001 — 56
▼M4
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E341(i)MONOCALCIUMPHOSPHATE
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
P2O5content Between 55,5 % and 61,1 % on the anhydrous basis
Description Granular powder or white, deliquescent crystals or
granules
Identification
A. Positive tests for calcium and for
phosphate
B. CaO content Between 23,0 % and 27,5 % (anhydrous)
Between 19,0 % and 24,8 % (monohydrate)
Purity
Loss on drying Not more than 14 % determined by drying at 105 ºC
for four hours (anhydrous)
Not more than 17,5 % determined by drying at 60 ºC
for one hour, then at 105 ºC for four hours (monohy-
drate)
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/kgCadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E341(ii)DICALCIUMPHOSPHATESynonyms Dibasic calcium phosphate
Dicalcium orthophosphate
Definition
Chemical name Calcium monohydrogen phosphate
Calcium hydrogen orthophosphate
Secondary calcium phosphate1996L0077 — EN — 17.11.2002 — 004.001 — 57
▼M4
Einecs 231-826-1
Chemical formula Anhydrous: CaHPO4
Dihydrate: CaHPO4·2 H2O
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
P2O5content Between 50,0 % and 52,5 % on the anhydrous basis
Description White crystals or granules, granular powder or powder
Identification
A. Positive tests for calcium and for
phosphate
B. Solubility tests Sparingly soluble in water. Insoluble in ethanol
Purity
Loss on ignition Not more than 8,5 % (anhydrous), or 26,5 % (dihy-
drate) after ignition at 800 ºC ± 25 ºC for 30 minutes
Fluoride Not more than 50 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kgLead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E341(iii) TRICALCIUMPHOSPHATESynonyms Calcium phosphate, tribasic
Calcium orthophosphate
Pentacalcium hydroxy monophosphate
Calcium hydroxyapatite
Definition Tricalcium phosphate consists of a variable mixture of
calcium phosphates obtained from neutralisation of
phosphoric acid with calcium hydroxide and having
the approximate composition of 10CaO · 3P
2O5·H2O
Chemical name Pentacalcium hydroxy monophosphate
Tricalcium monophosphate
Einecs 235-330-6(Pentacalcium hydroxy monophosphate)
231-840-8(Calcium orthophosphate)
Chemical formula Ca5(PO4)3·O Ho rC a3(PO4)2
Molecular weight 502 or 310
Assay Content not less than 90 % calculated on the ignited
basis
P2O5content Between 38,5 % and 48,0 % on the anhydrous basis
Description A white, odourless powder which is stable in air
Identification
A. Positive tests for calcium and for
phosphate
B. Solubility Practically insoluble in water; insoluble in etanol,
soluble in dilute hydrochloric and nitric acid
Purity
Loss on ignition Not more than 8 % after ignition at 800 ºC ± 25 ºC, to
constant weight1996L0077 — EN — 17.11.2002 — 004.001 — 58
▼M4
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kgLead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E385CALCIUMDISODIUMETHYLENEDIAMINETETRAACETATE
Synonyms Calcium disodium EDTA
Calcium disodium edetate
Definition
Chemical name N,N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate]
[(4-)-O,O ′,O
N,ON]calciate(2)-disodium
Calcium disodium ethylenediaminetetra acetate
Calcium disodium (ethylenedinitrilo)tetra acetate
Einecs 200-529-9
Chemical formula C10H12O8CaN2Na2·2H2O
Molecular weight 410,31
Assay Content not less than 97 % on the anhydrous basis
Description White, odourless crystalline granules or white to
nearly white powder, slightly hygroscopic
Identification
A. Positive tests for sodium and for
calcium
B. Chelating activity to metal ions
positive
C. pH of a 1 % solution between 6,5
and 7,5
Purity
Water content 5 to 13 % (Karl Fischer method)Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Ethylene oxide may not be used for sterilising purposes in food additives
E400ALGINICACIDDefinition 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)1996L0077 — EN — 17.11.2002 — 004.001 — 59
▼B
▼M1
▼M1
Description Alginic acid occurs in filamentous, grainy, granular
and powdered forms. It is a white to yellowish brown
and nearly odourless
Identification
A. Solubility Insoluble in water and organic solvents, slowly soluble
in solutions of sodium carbonate, sodium hydroxide
and trisodium phosphate
B. Calcium chloride precipitation test To a 0,5 % solution of the sample in 1 M sodium
hydroxide solution, add one fifth of its volume of a
2,5 % solution of calcium chloride. A voluminous,
gelatinous precipitate is formed. This test distinguishes
alginic acid from acacia gum, sodium carboxymethyl
cellulose, carboxymethyl starch, carrageenan, gelatin,
gum ghatti, karaya gum, locust bean gum, methyl
cellulose and tragacanth gum
C. Ammonium sulphate precipitation
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 N sodium
hydroxide and add 1 ml of acid ferric sulphate solu-
tion. 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 basisSodium hydroxide (1 M solution) Not more than 2 % on the anhydrous basis insoluble
matter
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/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 5 000 colonies per gramYeast and moulds Not more than 500 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E401SODIUMALGINATEDefinition
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 gran-
ular powder1996L0077 — EN — 17.11.2002 — 004.001 — 60
▼M1
Identification
A. Positive test for sodium and alginic
acid
Purity
Loss on drying Not more than 15 % (105 ºC, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/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
E402POTASSIUMALGINATE
Definition
Chemical name Potassium salt of alginic acid
Chemical formula (C
6H7KO6)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 corre-
sponding 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 gran-
ular powder
Identification
A. Positive test for potassium and for
alginic acid
Purity
Loss on drying Not more than 15 % (105 ºC, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E403AMMONIUMALGINATEDefinition
Chemical name Ammonium salt of alginic acid1996L0077 — EN — 17.11.2002 — 004.001 — 61
▼M1
Chemical formula (C6H11NO6)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 powder
Identification
A. Positive test for ammonium and
alginic acid
Purity
Loss on drying Not more than 15 % (105 ºC, 4 hours)Sulphated ash Not more than 7 % on the dried basisWater-insoluble matter Not more than 2 % on the anhydrous basisArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/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
E404CALCIUMALGINATE
Synonyms 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 gran-
ular 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/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 — 17.11.2002 — 004.001 — 62
▼M1
Total plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E405PROPANE-1,2-DIOLALGINATE
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 (C
9H14O7)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 gramYeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E406AGARSynonyms Gelose
Japan agar
Bengal, Ceylon, Chinese or Japanese isinglass
Layor Carang1996L0077 — EN — 17.11.2002 — 004.001 — 63
▼M1
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 undSphaero-
coccaceae and related red algae of the class
Rhodophyceae
Einecs 232-658-1
Assay The threshold gel concentration should not be higher
than 0,25 %
Description Agar is odourless or has a slight characteristic odour.
Unground agar usually occurs in bundles consisting
of thin, membranous, agglutinated strips, or in cut,
flaked or granulated forms. It may be light yellowish-
orange, yellowish-grey to pale yellow, or colourless. It
is tough when damp, brittle when dry. Powdered agar
is white to yellowish-white or pale yellow. When
examined in water under a microscope, the agar
appears granular and somewhat filamentous. A few
fragments of the spicules of sponges and a few frus-
tules of diatoms may be present. In chloral hydrate
solution, the powdered agar appears more transparent
than in water, more or less granular, striated, angular
and occasionally contains frustules of diatoms. Gel
strength may be standardised by the addition of
dextrose and maltodextrines or sucrose
Identification
A. Solubility Insoluble in cold water; soluble in boiling water
Purity
Loss on drying Not more than 22 % (105 ºC, 5 hours)Ash Not more than 6,5 % on the anhydrous basis deter-
mined 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 solu-
tion. 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 solu-
tion 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/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/kg1996L0077 — EN — 17.11.2002 — 004.001 — 64
▼M1
E407CARRAGEENAN
Synonyms 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 fasti-
giata)
— Carrageenan (from Chondrus andGigartina spp.)
Definition Carrageenan is obtained by aqueous extraction of
natural strains of seaweeds of Gigartinaceae ,Solieria-
ceae,Hypneaceae andFurcellariaceae , families of the
classRhodophyceae (red seaweeds). No organic preci-
pitant 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. Carrageenanshall not be hydrolysed or otherwise chemically
degraded
Einecs 232-524-2
Description Yellowish to colourless, coarse to fine powder which
is practically odourless
Identification
A. Positive tests for galactose, for
anhydrogalactose and for sulphate
Purity
Methanol, ethanol propane-2-ol content Not more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75 ºC Not less than 5 mPa.s
Loss on drying Not more than 12 % (105 ºC, 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 % deter-
mined 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/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 300 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E407aPROCESSEDEUCHEUMASEAWEED
Synonyms PES (acronym for processed eucheuma seaweed)1996L0077 — EN — 17.11.2002 — 004.001 — 65
▼M1
Definition Processed eucheuma seaweed is obtained by aqueous
alkaline (KOH) treatment of the natural strains of
seaweedsEucheuma cottonii undEucheuma spinosum ,
of the class Rhodophyceae (red seaweeds) to remove
impurities and by fresh water washing and drying to
obtain the product. Further purification may be
achieved by washing with methanol, ethanol or
propane-2-ol and drying. The product consists chiefly
of the potassium salts of polysaccharide sulphate esters
which, on hydrolysis, yield galactose and 3,6-anhydro-
galactose. Sodium, calcium and magnesium salts of
the polysaccharide sulphate esters are present in lesser
amounts. Upto 15 % algal cellulose is also p resent in
the product. The carrageenan in processed eucheuma
seaweed shall not be hydrolysed or otherwise chemi-
cally degraded
Description Tan to yellowish, coarse to fine powder which is prac-
tically 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
contentNot more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75 ºC Not less than 5 mPa.s
Loss on drying Not more than 12 % (105 ºC, 4 hours)
Sulphate Not less than 15 % and not more than 40 % on the
dried basis (as SO4)
Ash Not less than 1 % and not more than 40 % determined
on the dried basis at 550 ºC
Acid-insoluble ash Not more than 1 % on the dried basis (insoluble in
10 % hydrochloric acid)
Acid-insoluble matter Not less than 8 % and not more than 15 % on the
dried basis (insoluble in 1 % v/v sulphuric acid)
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 mould Not more than 300 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E410LOCUSTBEANGUMSynonyms 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 0000001996L0077 — EN — 17.11.2002 — 004.001 — 66
▼M1
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, sepa-
rated or slightly interspaced. Their brown contents are
much less regularly formed in guar gum. Guar gum
shows close groups of round to pear shaped cells.
Their contents are yellow to brown
C. Solubility Soluble in hot water, insoluble in ethanol
Purity
Loss on drying Not more than 15 % (105 ºC, 5 hours)
Ash Not more than 1,2 % determined at 800 ºC
Protein (N × 6,25) Not more than 7 %Acid-insoluble matter Not more than 4 %
Starch Not detectable by the following method: to a 1 in 10
solution of the sample add a few drops of iodine solu-
tion. No blue colour is produced
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Ethanol and propane-2-ol Not more than 1 %, single or in combination
E412GUARGUMSynonyms 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 galac-
tomannan
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 ºC1996L0077 — EN — 17.11.2002 — 004.001 — 67
▼M1
Acid-insoluble matter Not more than 7 %
Protein (N × 6,25) Not more than 10 %Starch Not detectable by the following method: to a 1 in 10
solution of the sample add a few drops of iodine solu-
tion. (No blue colour is produced)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E413TRAGACANTH
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 (galactoara-
bans and acidic polysaccharides) which, on hydrolysis,
yield galacturonic acid, galactose, arabinose, xylose
and fucose. Small amounts of rhamnose and of
glucose (derived from traces of starch and/or cellulose)
may also be present
Molecular weight Approximately 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 to 3 cm in
length. It is white to pale yellow in colour but some
pieces may have a red tinge. The pieces are horny in
texture, with a short fracture. It is odourless and solu-
tions have an insipid mucilaginous taste. Powdered
tragacanth is white to pale yellow or pinkish brown
(pale tan) in colour
Identification
A. Solubility 1 g of the sample in 50 ml of water swells to form a
smooth, stiff, opalescent mucilage; insoluble in ethanol
and does not swell in 60 % (w/v) aqueous ethanol
Purity
Negative test for Karaya gum Boil 1 g with 20 ml of water until a mucilage is
formed. Add 5 ml of hydrochloric acid and again boil
the mixture for five minutes. No permanent pink or
red colour develops
Loss on drying Not more than 16 % (105 ºC, 5 hours)
Total ash Not more than 4 %
Acid insoluble ash Not more than 0,5 %Acid insoluble matter Not more than 2 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Salmonella spp. Negative in 10 g
E. coli Negative in 5 g1996L0077 — EN — 17.11.2002 — 004.001 — 68
▼M1
E414ACACIAGUM
Synonyms Gum arabic
Definition Acacia gum is a dried exudation obtained from the
stems and branches of natural strains of Acacia
senegal(L) Willdenow or closely related species of
Acacia (family Leguminosae ). It consists mainly of
high molecular weight polysaccharides and their
calcium, magnesium and potassium salts, which on
hydrolysis yield arabinose, galactose, rhamnose and
glucuronic acid
Molecular weight Approximately 350000
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 frag-
ments. 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 dropof iodine solution. No bluish or reddish
colours are produced
Tannin To 10 ml of a 1 in 50 solution add about 0,1 ml of
ferric chloride solution (9 g FeCl
3.6H2O made upto
100 ml with water). No blackish colouration or
blackish precipitate is formed
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kgHydrolysis products Mannose, xylose and galacturonic acid are absent
(determined by chromatography)
Salmonella spp. Negative in 10 g
E. coli Negative in 5 g
E415XANTHANGUMDefinition 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 0000001996L0077 — EN — 17.11.2002 — 004.001 — 69
▼M1
Einecs 234-394-2
Assay Yields, on dried basis, not less than 4,2 % and not
more than 5 % of CO2corresponding 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)
Total ash Not more than 16 % on the anhydrous basis deter-
mined 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/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 300 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
Xanthomonas campestris Viable cells absent
E416KARAYA-GUMSynonyms Katilo
KadayaGumsterculia
Sterculia
Karaya, gum karayaKullo
Kuterra
Definition Karaya gum is a dried exudation from the stems and
branches of natural strains of: Sterculia urens
Roxburgh and other species of Sterculia (familySter-
culiaceae ) or fromCochlospermumgossypium A.P. De
Candolle or other species of Cochlospermum (family
Bixaceae). It consists mainly of high molecular weight
acetylated polysaccharides, which on hydrolysis yield
galactose, rhamnose, and galacturonic acid, together
with minor amounts of glucuronic acid
Einecs 232-539-4
Description Karaya gum occurs in tears of variable size and in
broken irregular pieces having a characteristic semi-
crystalline appearance. It is pale yellow to pinkish
brown in colour, translucent and horny. Powdered
karaya gum is a pale grey to pinkish brown. The gum
has a distinctive odour of acetic acid
Identification
A. Solubility Insoluble in ethanol
B. Swelling in ethanol solution Karaya gum swells in 60 % ethanol distinguishing it
from other gums1996L0077 — EN — 17.11.2002 — 004.001 — 70
▼M1
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/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/kgSalmonella spp. Negative in 10 g
E. coli Negative in 5 g
E417TARAGUMDefinition Tara gum is obtained by grinding the endosperm of
the seeds of natural strains of Caesalpinia spinosa
(familyLeguminosae ). It consists chiefly of polysac-
charides of high molecular weight composed mainly
of galactomannans. The principal component consists
of a linear chain of (1-4)- β-D-mannopyranose units
with α-D-galactopyranose units attached by (1-6)
linkages. The ratio of mannose to galactose in tara
gum is 3:1. (In locust bean gum this ratio is 4:1 and
in guar gum 2:1)
Einecs 254-409-6
Description A white to white-yellow odourless powder
Identification
A. Solubility Soluble in water
Insoluble in ethanol
B. Gel formation To an aqueous solution of the sample add small
amounts of sodium borate. A gel is formed
Purity
Loss on drying Not more than 15 %Ash Not more than 1,5 %Acid insoluble matter Not more than 2 %Protein Not more than 3,5 % (factor N 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/kg1996L0077 — EN — 17.11.2002 — 004.001 — 71
▼M1
E418GELLANGUM
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 polysac-
charide is principally composed of a tetrasaccharide
repeating unit of one rhamnose, one glucuronic acid,
and two glucoses, and substituted with acyl (glyceryl
and acetyl) groups as the O-glycosidically linked
esters. The glucuronic acid is neutralised to a mixed
potassium, sodium, calcium, and magnesium salt
Einecs 275-117-5
Molecular weight Approximately 500000
Assay Yields, on the dried basis, not less than 3,3 % and not
more than 6,8 % of CO2
Description An off-white powder
Identification
A. Solubility Soluble in water, forming a viscous solution.
Insoluble in ethanol
Purity
Loss on drying Not more than 15 % after drying (105 ºC, 2½ hours)
Nitrogen Not more than 3 %
Propane-2-ol Not more than 750 mg/kgArsenic Not more than 3 mg/kgLead Not more than 2 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 gramYeast and mould Not more than 400 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E422GLYCEROLSynonyms 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 anhy-
drous basis
Description Clear, colourless hygroscopic syrupy liquid with not
more than a slight characteristic odour, which is
neither harsh nor disagreeable1996L0077 — EN — 17.11.2002 — 004.001 — 72
▼M1
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 ºCButanetriols Not more than 0,2 %
Acrolein, glucose and ammonium
compoundsHeat a mixture of 5 ml of glycerol and 5 ml of potas-
sium hydroxide solution (1 in 10) at 60 ºC for five
minutes. It neither becomes yellow nor emits an odour
of ammonia
Fatty acids and esters Not more than 0,1 % calculated as butyric acid
Chlorinated compounds Not more than 30 mg/kg (as chlorine)
Arsenic Not more than 3 mg/kgLead Not more than 2 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E431POLYOXYETHYLENE(40)STEARATESynonyms Polyoxyl (40) stearate, polyoxyethylene (40) mono-
stearate
Definition A mixture of the mono-and diesters of edible commer-
cial 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 polyox-
yethylated 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/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 — 17.11.2002 — 004.001 — 73
▼M1
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E432POLYOXYETHYLENESORBITANMONOLAURATE(POLYSORBATE20)
Synonyms Polysorbate 20
Polyoxyethylene (20) sorbitan monolaurate
Definition A mixture of the partial esters of sorbitol and its
mono- and dianhydrides with edible commercial lauric
acid and condensed with approximately 20 moles of
ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 70 % of oxyethylene groups,
equivalent to not less than 97,3 % of polyoxyethylene
(20) sorbitan monolaurate on the anhydrous basis
Description A lemon to amber-coloured oily liquid at 25 ºC with a
faint characteristic odour
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and
dioxane.
Insoluble in mineral oil and petroleum ether
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyox-
yethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 40 and not more than 50Hydroxyl value Not less than 96 and not more than 108
1,4-Dioxane Not more than 5 mg/kg
Free ethylene oxide Not more than 1 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E433POLYOXYETHYLENESORBITANMONOOLEATE(POLYSORBATE80)
Synonyms Polysorbate 80
Polyoxyethylene (20) sorbitan monooleate
Definition A mixture of the partial esters of sorbitol and its
mono- and dianhydrides with edible commercial oleic
acid and condensed with approximately 20 moles of
ethylene oxide per mole of sorbitol and its anhydrides
Assay Content not less than 65 % of oxyethylene groups,
equivalent to not less than 96,5 % of polyoxyethylene
(20) sorbitan monooleate on the anhydrous basis
Description A lemon to amber-coloured oily liquid at 25 ºC with a
faint characteristic odour
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and
toluene.
Insoluble in mineral oil and petroleum ether1996L0077 — EN — 17.11.2002 — 004.001 — 74
▼M1
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyox-
yethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2
Saponification value Not less than 45 and not more than 55
Hydroxyl value Not less than 65 and not more than 80
1,4-Dioxane Not more than 5 mg/kg
Free ethylene oxide Not more than 1 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E434POLYOXYETHYLENESORBITANMONOPALMITATE(POLYSORBATE40)
Synonyms Polysorbate 40
Polyoxyethylene (20) sorbitan monopalmitate
Definition A mixture of the partial esters of sorbitol and its
mono- and dianhydrides with edible commercial
palmitic acid and condensed with approximately 20
moles of ethylene oxide per mole of sorbitol and its
anhydrides
Assay Content not less than 66 % of oxyethylene groups,
equivalent to not less than 97 % of polyoxyethylene
(20) sorbitan monopalmitate on the anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at
25 ºC with a faint characteristic odour
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and
acetone.
Insoluble in mineral oil
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyox-
yethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2
Saponification value Not less than 41 and not more than 52
Hydroxyl value Not less than 90 and not more than 1071,4-Dioxane Not more than 5 mg/kg
Free ethylene oxide Not more than 1 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 75
▼M1
E435POLYOXYETHYLENESORBITANMONOSTEARATE(POLYSORBATE60)
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 polyox-
yethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 45 and not more than 55
Hydroxyl value Not less than 81 and not more than 96
1,4-Dioxane Not more than 5 mg/kg
Free ethylene oxide Not more than 1 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E436POLYOXYETHYLENESORBITANTRISTEARATE(POLYSORBATE65)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 char-
acteristic 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 polyox-
yethylated polyol
C. Congealing range 29-33 ºC1996L0077 — EN — 17.11.2002 — 004.001 — 76
▼M1
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2
Saponification value Not less than 88 and not more than 98
Hydroxyl value Not less than 40 and not more than 601,4-Dioxane Not more than 5 mg/kg
Free ethylene oxide Not more than 1 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E440(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 extrac-
tion 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 solu-
tion. 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/kg1996L0077 — EN — 17.11.2002 — 004.001 — 77
▼M1
E440(ii)AMIDATEDPECTIN
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 solu-
tion. 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 groupsSulphur dioxide residue Not more than 50 mg/kg on the anhydrous basisNitrogen content Not more than 2,5 % after washing with acid and
ethanol
Free methanol, ethanol and propane-2-
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
E442AMMONIUMPHOSPHATIDESSynonyms 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 % (calcu-
lated 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 phosphate1996L0077 — EN — 17.11.2002 — 004.001 — 78
▼M1
Purity
Petroleum ether insoluble matter Not more than 2,5 %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
E444SUCROSEACETATEISOBUTYRATESynonyms 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 Content not less than 98,8 % and not more than
101,9 % of C40H62O19
Description A pale straw-coloured liquid, clear and free of sedi-
ment and having a bland odour
Identification
A. Solubility Insoluble in water. Soluble in most organic solventsB. Refractive index n ½/C138
40
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/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgLead Not more than 3 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E445GLYCEROLESTERSOFWOODROSINSynonyms Ester gum1996L0077 — EN — 17.11.2002 — 004.001 — 79
▼M1
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
of C20H30O2, chiefly abietic acid. The substance is puri-
fied 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 ºCAcid value Not less than 3 and not more than 9
Hydroxyl value Not less than 15 and not more than 45
Arsenic Not more than 3 mg/kgLead Not more than 2 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgTest for absence of tall oil rosin
(sulphur test)When sulphur-containing organic compounds are
heated in the presence of sodium formate, the sulphur
is converted to hydrogen sulphide which can readily
be detected by the use of lead acetate paper. A posi-
tive test indicates the use of tall oil rosin instead of
wood rosin
E450(i)DISODIUMDIPHOSPHATE
Synonyms Disodium dihydrogen diphosphate
Disodium dihydrogen pyrophosphateSodium acid pyrophosphate
Disodium pyrophosphate
Definition
Chemical name Disodium dihydrogen diphosphate
Einecs 231-835-0
Chemical formula Na
2H2P2O7
Molecular weight 221,94
Assay Content not less than 95 % of disodium diphosphate.
P2O5Content Not less than 63,0 % and not more than 64,5 %
Description White powder or grains1996L0077 — EN — 17.11.2002 — 004.001 — 80
▼M4
▼M4
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Soluble in waterC. pH of a 1 % solution Between 3,7 and 5,0
Purity
Loss on drying Not more than 0,5 % (105 ºC, four hours)Water-insoluble matter Not more than 1 %Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kgLead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E450(ii)TRISODIUMDIPHOSPHATESynonyms 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
P2O5content Not less than 57 % and not more than 59 %
Description White powder or grains, occurs anhydrous or as a
monohydrate
Identification
A. Positive tests for sodium and for
phosphate
B. Soluble in water
C. pH of a 1 % solution Between 6,7 and 7,5
Purity
Loss on ignition Not more than 4,5 % on the anhydrous compound
Not more than 11,5 % on the monohydrous basis
Loss on drying Not more than 0,5 % (105 ºC, four hours)
Water-insoluble matter Not more than 0,2 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kgLead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E450(iii) TETRASODIUMDIPHOSPHATE
Synonyms Tetrasodium pyrophosphate
Sodium pyrophosphate1996L0077 — EN — 17.11.2002 — 004.001 — 81
▼M4
Definition
Chemical name Tetrasodium diphosphate
Einecs 231-767-1
Chemical formula Anhydrous: Na4P2O7
Decahydrate: Na4P2O7· 10H2O
Molecular weight Anhydrous: 265,94
Decahydrate: 446,09
Assay Content not less than 95 % of Na4P2O7on the ignited
basis
P2O5content Not less than 52,5 % and not more than 54,0 %
Description Colourless or white crystals, or a white crystalline or
granular powder. The decahydrate effloresces slightly
in dry air
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Soluble in water. Insoluble in ethanolC. pH of a 1 % solution Between 9,8 and 10,8
Purity
Loss on ignition Not more than 0,5 % for the anhydrous salt, not less
than 38 % and not more than 42 % for the decahy-
drate, 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/kgCadmium Not more than 1 mg/kgLead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E450(v)TETRAPOTASSIUMDIPHOSPHATESynonyms Potassium pyrophosphate
Tetrapotassium pyrophosphate
Definition
Chemical name Tetrapotassium diphosphate
Einecs 230-785-7
Chemical formula K
4P2O7
Molecular weight 330,34 (anhydrous)
Assay Content not less than 95 % on the ignited basis
P2O5content Not less than 42,0 % and not more than 43,7 % on the
anhydrous basis
Description Colourless crystals or white, very hygroscopic powder
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility Soluble in water, insoluble in ethanolC. pH of a 1 % solution Between 10,0 and 10,81996L0077 — EN — 17.11.2002 — 004.001 — 82
▼M4
Purity
Loss on ignition Not more than 2 % after drying at 105 ºC for four
hours and then ignition at 550 ºC for 30 minutes
Water-insoluble substances Not more than 0,2 %Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E450(vi)DICALCIUMDIPHOSPHATE
Synonyms 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 %
P2O5content Not less than 55 % and not more than 56 %
Description A fine, white, odourless powder
Identification
A. Positive tests for calcium and for
phosphate
B. Solubility Insoluble in water. Soluble in dilute hydrochloric and
nitric acids
C. pH of a 10 % suspension in water Between 5,5 and 7,0
Purity
Loss on ignition Not more than 1,5 % at 800 ºC ± 25 ºC for 30 minutesFluoride Not more than 50 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E450(vii)CALCIUMDIHYDROGENDIPHOSPHATE
Synonyms Acid calcium pyrophosphate
Monocalcium dihydrogen pyrophosphate
Definition
Chemical name Calcium dihydrogen diphosphate
Einecs 238-933-2
Chemical formula CaH
2P2O7
Molecular weight 215,97
Assay Content not less than 90 % on the anhydrous basis
P2O5content Not less than 61 % and not more than 64 %
Description White crystals or powder1996L0077 — EN — 17.11.2002 — 004.001 — 83
▼M4
Identification
A. Positive tests for calcium and for
phosphate
Purity
Acid-insoluble matter Not more than 0,4 %Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kgLead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E451(i)PENTASODIUMTRIPHOSPHATESynonyms Pentasodium tripolyphosphate
Sodium tripolyphosphate
Definition
Chemical name Pentasodium triphosphate
Einecs 231-838-7
Chemical formula Na
5O10P3·n H2O( n=0o r6 )
Molecular weight 367,86
Assay Content not less than 85,0 % (anhydrous) or 65,0 %
(hexahydrate)
P2O5content Not less than 56 % and not more than 59 % (anhy-
drous) or not less than 43 % and not more than 45 %(hexahydrate)
Description White, slightly hygroscopic granules or powder
Identification
A. Solubility Freely soluble in water. Insoluble in ethanolB. Positive tests for sodium and for
phosphate
C. pH of a 1 % solution Between 9,1 and 10,2
Purity
Loss on drying Anhydrous: Not more than 0,7 % (105 ºC, one hour)
Hexahydrate: Not more than 23,5 % (60 ºC, one hour,
followed by drying at 105 ºC, four hours)
Water-insoluble substances Not more than 0,1 %Higher polyphosphates Not more than 1 %Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kgLead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E451(ii)PENTAPOTASSIUMTRIPHOSPHATESynonyms Pentapotassium tripolyphosphate
Potassium triphosphate
Potassium tripolyphosphate1996L0077 — EN — 17.11.2002 — 004.001 — 84
▼M4
Definition
Chemical name Pentapotassium triphosphate
Pentapotassium tripolyphosphate
Einecs 237-574-9
Chemical formula K5O10P3
Molecular weight 448,42
Assay Content not less than 85 % on the anhydrous basis
P2O5content Not less than 46,5 % and not more than 48 %
Description White, very hygroscopic powder or granules
Identification
A. Solubility Very soluble in water
B. Positive tests for potassium and for
phosphate
C. pH of a 1 % solution Between 9,2 and 10,5
Purity
Loss on ignition Not more than 0,4 % (after drying at 105 ºC, four
hours, followed by ignition at 550 ºC, 30 minutes)
Water-insoluble matter Not more than 2 %Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kgLead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E452(i)SODIUMPOLYPHOSPHATE1. SOLUBLE POLYPHOSPHATESynonyms Sodium hexametaphosphate
Sodium tetrapolyphosphate
Graham's salt
Sodium polyphosphates, glassySodium polymetaphosphateSodium 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)x
where x ≥2, terminated by Na2PO4groups. These
substances are usually identified by their Na2O/P2O5ratio or their P2O5content. The Na2O/P2O5ratios vary
from about 1,3 for sodium tetrapolyphosphate,
where x = approximately 4; to about 1,1 for Graham's
salt, commonly called sodium hexametaphosphate,
where x = 13 to 18; and to about 1,0 for the higher
molecular weight sodium polyphosphates, where x = 20
to 100 or more. The pH of their solutions varies from
3,0 to 9,0
Chemical name Sodium polyphosphate
Einecs 272-808-3
Chemical formula Heterogenous mixtures of sodium salts of linear
condensed polyphosphoric acids of general formula
H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight (102)n1996L0077 — EN — 17.11.2002 — 004.001 — 85
▼M4
AssayP2O5content Not less than 60 % and not more than 71 % on the
ignited basis
Description Colourless or white, transparent platelets, granules, or
powders
Identification
A. Solubility Very soluble in waterB. Positive tests for sodium and for
phosphate
C. pH of a 1 % solution Between 3,0 and 9,0
Purity
Loss on ignition Not more than 1 %Water-insoluble matter Not more than 0,1 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
2. INSOLUBLE POLYPHOSPHATE
Synonyms Insoluble sodium metaphosphate
Maddrell's salt
Insoluble sodium polyphosphate, IMP
Definition Insoluble sodium metaphosphate is a high molecular
weight sodium polyphosphate composed of two long
metaphosphate chains (NaPO
3)xthat spiral in opposite
directions about a common axis. The Na2O/P2O5ratio
is about 1,0. The pH of 1 in 3 suspension in water is
about 6,5
Chemical name Sodium polyphosphate
Einecs 272-808-3
Chemical formula Heterogenous mixtures of sodium salts of linear
condensed polyphosphoric acids of general formula
H(n + 2)PnO(3n + 1)where ‘n’ is not less than 2
Molecular weight (102)n
P2O5content Not less than 68,7 % and not more than 70,0 %
Description White crystalline powder
Identification
A. Solubility Insoluble in water, soluble in mineral acids and in
solutions of potassium and ammonium (but not
sodium) chlorides
B. Positive tests for sodium and for
phosphate
C. pH of 1 in 3 suspension in water About 6,5
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 86
▼M4
E452(ii)POTASSIUMPOLYPHOSPHATE
Synonyms Potassium metaphosphate
Potassium polymetaphosphateKurrol salt
Definition
Chemical name Potassium polyphosphate
Einecs 232-212-6
Chemical formula (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 (118)n
P2O5content Not less than 53,5 % and not more than 61,5 % on the
ignited basis
Description Fine white powder or crystals or colourless glassy
platelets
Identification
A. Solubility 1 g dissolves in 100 ml of a 1 in 25 solution of sodium
acetate
B. Positive tests for potassium and for
phosphate
C. pH of a 1 % suspension Not more than 7,8
Purity
Loss on ignition Not more than 2 % (105 ºC, four hours followed by
ignition at 550 ºC, 30 minutes)
Cyclic phosphate Not more than 8 % on P2O5content
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E452(iv)CALCIUMPOLYPHOSPHATESynonyms Calcium metaphosphate
Calcium polymetaphosphate
Definition
Chemical name Calcium polyphosphate
Einecs 236-769-6
Chemical formula (CaP
2O6)n
Heterogenous mixtures of calcium salts of condensed
polyphosphoric acids of general formula H(n + 2)PnO(n + 1)where ‘n’ is not less than 2
Molecular weight (198)n
P2O5content Not less than 71 % and not more than 73 % on the
ignited basis
Description Odourless, colourless crystals or white powder1996L0077 — EN — 17.11.2002 — 004.001 — 87
▼M4
Identification
A. Solubility Usually sparingly soluble in water. Soluble in acid
medium
B. Positive tests for calcium and for
phosphate
C. CaO content 27 to 29,5 %
Purity
Loss on ignition Not more than 2 % (105 ºC, four hours followed by
ignition at 550 ºC, 30 minutes)
Cyclic phosphate Not more than 8 % on P2O5content
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kgCadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E460(i)MICROCRISTALLINECELLULOSE
Synonyms Cellulose gel
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 polymeri-
sation is typically less than 400
Chemical name Cellulose
Einecs 232-674-9
Chemical formula (C
6H10O5)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 spectroscopy
D. Suspension test Mix 30 g of the sample with 270 ml of water in a
high-speed (12 000 rpm) power blender for 5 minutes.
The resultant mixture will be either a free-following
suspension or a heavy, lumpy suspension which flows
poorly, if at all, settles only slightly and contains many
trapped air bubbles. If a free-flowing suspension is
obtained, transfer 100 ml into a 100-ml graduated
cylinder and allow to stand for 1 hour. The solids
settles and a supernatant liquid appears
Purity
Loss on drying Not more than 7 % (105 ºC, 3 hours)
Water-soluble matter Not more than 0,24%
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC1996L0077 — EN — 17.11.2002 — 004.001 — 88
▼M1
▼M1
pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and
7,5
Starch Not detectable
To 20 ml of the dispersion obtained in identification,
test D, add a few drops of iodine solution and mix.
No purplish to blue or blue colour should be produced
Particle size Not less than 5 µm (not more than 10 % of particles of
less than 5 µm)
Carboxyl groups Not more than 1 %Arsenic Not more than 3 mg/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
E460(ii)POWDEREDCELLULOSEDefinition Purified, mechanically disintegrated celluslose
prepared by processing alpha-cellulose obtained as a
pulp from natural strains of fibrous plant materials
Chemical name Cellulose
Linear polymer of 1:4 linked glucose residues
Einecs 232-674-9
Chemical formula (C
6H10O5)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 (12 000 rpm) power blender for 5 minutes.
The resultant mixture will be either a free-flowing
suspension or a heavy, lumpy suspension which flows
poorly, if at all, settles only slightly and contains many
trapped air bubbles. If a free-flowing suspension is
obtained, transfer 100 ml into a 100-ml graduated
cylinder and allow to stand for 1 hour. The solids
settles and a supernatant liquid appears
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 ºCpH 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/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 89
▼M1
Particle size Not less than 5 µm (not more than 10 % of particles of
less than 5 µm)
E461METHYLCELLULOSESynonyms 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
powder
Identification
A. Solubility Swelling in water, producing a clear to opalescent,
viscous, colloidal solution.
Insoluble in ehtanol, ether and chloroform.
Soluble in glacial acetic acid
Purity
Loss on drying Not more than 10 % (105 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 8,0Arsenic 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
E463HYDROXYPROPYLCELLULOSE
Synonyms Cellulose hydroxypropyl ether
Definition Hydroxypropylcellulose is cellulose obtained directly
from natural strains of fibrous plant material and
partially etherified with hydroxypropyl groups
Chemical name Hydroxypropyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units
with the following general formula:
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 0000001996L0077 — EN — 17.11.2002 — 004.001 — 90
▼M1
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/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E464HYDROXYPROPYLMETHYLCELLULOSEDefinition 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 substitu-
tion
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)1996L0077 — EN — 17.11.2002 — 004.001 — 91
▼M1
Sulphated ash Not more than 1,5 % for products with viscosities of
50 mPa.s or above
Not more than 3 % for products with viscosities below
50 mPa.s
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0Propylene chlorohydrins Not more than 0,1 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E465ETHYLMETHYLCELLULOSE
Synonyms Methylethylcellulose
Definition Ethyl methyl cellulose is cellulose obtained directly
from natural strains of fibrous plant material and
partially etherified with methyl and ethyl groups
Chemical name Ethyl methyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units
with the following general formula:
C
6H7O2(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/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 92
▼M1
E466SODIUMCARBOXYMETHYLCELLULOSE
Synonyms Carboxy methyl cellulose
CMC
NaCMCSodium CMCCellulose gum
Definition Carboxy methyl cellulose is the partial sodium salt of
a carboxymethyl ether of cellulose, the cellulose being
obtained directly from 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 %
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. Inso-
luble 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/kg1996L0077 — EN — 17.11.2002 — 004.001 — 93
▼M1
Heavy metals (as Pb) Not more than 20 mg/kg
Total glycolate Not more than 0,4 %, calculated as sodium glycolate
on the anhydrous basis
Sodium Not more than 12,4 % on the anhydrous basis
E470aSODIUM,POTASSIUMANDCALCIUMSALTSOFFATTYACIDS
Definition Sodium, potassium and calcium salts of fatty acids
occurring in food oils and fats, these salts being
obtained either from edible fats and oils or from
distilled food fatty acids
Assay Content on the anhydrous basis not less than 95 %
Description White or creamy white light powders, flakes or semi-
solids
Identification
A. Solubility Sodium and potassium salts: soluble in water and
ethanol calcium salts: insoluble in water, ethanol and
ether
B. Positive tests for cations and for
fatty acids
Purity
Sodium Not less than 9 % and not more than 14 % expressed
as Na2O
Potassium Not less than 13 % and not more than 21,5 %
expressed as K2O
Calcium Not less than 8,5 % and not more than 13 % expressed
as CaO
Unsaponifiable matter Not more than 2 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Free alkali Not more than 0,1 % expressed as NaOH
Matter insoluble in alcohol Not more than 0,2 % (sodium and potassium salts
only)
E470bMAGNESIUMSALTSOFFATTYACIDS
Definition Magnesium salts of fatty acids occurring in foods oils
and fats, these salts being obtained either from edible
fats and oils or from distilled food fatty acids
Assay Content on the anhydrous basis not less than 95 %
Description White or creamy-white light powders, flakes or semi-
solids
Identification
A. Solubility Insoluble in water, partially soluble in ethanol and
ether
B. Positive tests for magnesium and for
fatty acids
Purity
Magnesium Not less than 6,5 % and not more than 11 % expressed
as MgO1996L0077 — EN — 17.11.2002 — 004.001 — 94
▼M1
Free alkali Not more than 0,1 % expressed as MgO
Unsaponifiable matter Not more than 2 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E471MONO-ANDDIGLYCERIDESOFFATTYACIDS
Synonyms Glyceryl monostearate
Glyceryl monopalmitate
Glyceryl monooleate, etc.
Monostearin, monopalmitin, monoolein, etc.GMS (for glyceryl monostearate)
Definition Mono- and diglycerides of fatty acids consist of
mixtures of glycerol mono-, di- and triesters of fatty
acids occurring in food oils and fats. They may
contain small amounts of free fatty acids and glycerol
Assay Content of mono- and diesters: not less than 70 %
Description The product varies from a pale yellow to pale brown
oily liquid to a white or slightly off-white hard waxy
solid. The solids may be in the form of flakes,
powders or small beads
Identification
A. Infrared spectrum Characteristic of a partial fatty acid ester of a polyol
B. Positive tests for glycerol and for
fatty acids
C. Solubility Insoluble in water, soluble in ethanol and toluene
Purity
Water content Not more than 2 % (Karl Fischer method)
Acid value Not more than 6
Free glycerol Not more than 7 %
Polyglycerols Not more than 4 % diglycerol and not more than 1 %
higher polyglycerols both based on total glycerol
content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total glycerol Not less than 16 % and not more than 33 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
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 — 17.11.2002 — 004.001 — 95
▼M1
E472aACETICACIDESTERSOFMONO-ANDDIGLYCERIDESOFFATTYACIDS
Synonyms Acetic acid esters of mono- and diglycerides
AcetoglyceridesAcetylated mono- and diglycerides
Acetic and fatty acid esters of glycerol
Definition Esters of glycerol with acetic and fatty acids occurring
in food fats and oils. They may contain small amounts
of free glycerol, free fatty acids, free acetic acid and
free glycerides
Description Clear, mobile liquids to solids, from white to pale
yellow in colour
Identification
A. Positive tests for glycerol, for fatty
acids and for acetic acid
B. Solubility Insoluble in water. Soluble in ethanol
Purity
Acids other than acetic and fatty acids Not detectableFree glycerol Not more than 2 %Arsenic Not more than 3 mg/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 acetic acid Not less than 9 % and not more than 32 %Free fatty acids (and acetic acid) Not more than 3 % estimated as oleic acidTotal 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)
E472bLACTICACIDESTERSOFMONO-ANDDIGLYCERIDESOFFATTYACIDSSynonyms 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 detectableFree glycerol Not more than 2 %Arsenic Not more than 3 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 96
▼M1
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/kgTotal lactic acid Not less than 13 % and not more than 45 %
Free fatty acids (and lactic acid) Not more than 3 % estimated as oleic acid
Total glycerol Not less than 13 % and not more than 30 %Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
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)
E472cCITRICACIDESTERSOFMONO-ANDDIGLYCERIDESOFFATTYACIDSSynonyms Citric acid esters of mono- and diglycerides
Citroglycerides
Mono- and diglycerides of fatty acids esterified with
citric acid
Definition Esters of glycerol with citric acid and fatty acids
occurring in food oils and fats. They may contain
small amounts of free glycerol, free fatty acids, free
citric acid and free glycerides. They may be partially
or wholly neutralised with sodium hydroxide or with
potassium hydroxide
Description Yellowish or light brown liquids to waxy solids or
semi-solids
Identification
A. Positive tests for glycerol, for fatty
acids and for citric acid
B. Solubility Insoluble in cold water
Dispersible in hot water
Soluble in oils and fatsInsoluble in cold ethanol
Purity
Acids other than citric and fatty acids Not detectable
Free glycerol Not more than 2 %Total glycerol Not less than 8 % and not more than 33 %Total citric acid Not less than 13 % and not more than 50 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
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 10 mg/kg
Free fatty acids Not more than 3 % estimated as oleic acid
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids,
however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E472dTARTARICACIDESTERSOFMONO-ANDDIGLYCERIDESOFFATTYACIDSSynonyms Tartaric acid esters of mono- and diglycerides
Mono- and diglycerides of fatty acids esterified with
tartaric acid1996L0077 — EN — 17.11.2002 — 004.001 — 97
▼M1
Definition Esters of glycerol with tartaric acid and fatty acids
occurring in food fats and oils. They may contain
small amounts of free glycerol, free fatty acids, free
tartaric acid and free glycerides
Description Sticky viscous yellowish liquids to hard yellow waxes
Identification
A. Positive tests for glycerol, for fatty
acids and for tartaric acid
Purity
Acids other than tartaric and fatty acids Not detectable
Free glycerol Not more than 2 %
Total glycerol Not less than 12 % and not more than 29 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total tartaric acid Not less than 15 % and not more than 50 %
Free fatty acids Not more than 3 % estimated as oleic acid
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
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)
E472eMONO-ANDDIACETYLTARTARICACIDESTERSOFMONO-ANDDIGLYCER-
IDESOFFATTYACIDS
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 ºC
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 98
▼M1
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Total tartaric acid Not less than 10 % and not more than 40 %
Total acetic acid Not less than 8 % and not more than 32 %Free fatty acids Not more than 3 % estimated as oleic acid
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)
E472fMIXEDACETICANDTARTARICACIDESTERSOFMONO-ANDDIGLYCER-
IDESOFFATTYACIDS
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 glycer-
ides. May contain mono- and diacetyltartaric esters of
mono- and diglycerides of fatty acids
Description Sticky liquids to solids, from white to pale-yellow in
colour
Identification
A. Positive tests for glycerol, for fatty
acids, for tartaric acid and for acetic
acid
Purity
Acids other than acetic, tartaric and
fatty 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Total 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)
E473SUCROSEESTERSOFFATTYACIDS
Synonyms Sucroesters
Sugar esters
Definition Essentially the mono-, di- and triesters of sucrose with
fatty acids occurring in food fats and oils. They may
be prepared from sucrose and the methyl and ethyl
esters of food fatty acids or by extraction from sucro-
glycerides. 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 prepara-
tion
Assay Content not less than 80 %1996L0077 — EN — 17.11.2002 — 004.001 — 99
▼M1
Description Stiff gels, soft solids or white to slightly greyish-white
powders
Identification
A. Positive tests for sugar for fatty
acids
B. Solubility Sparingly soluble in water
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25 ºC
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Methanol Not more than 10 mg/kg
Dimethylsulphoxide Not more than 2 mg/kg
Dimethylformamide Not more than 1 mg/kg
2-methyl-1-propanol Not more than 10 mg/kgEthyl acetate/C148/C147/C147/C147/C147/C147/C147/C149/C147/C147/C147/C147/C147/C147/C150Not 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)
E474SUCROGLYCERIDESSynonyms 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, dimethylfor-
mamide, ethyl acetate, 2-methyl-1-propanol and
propane-2-ol
Assay Content not less than 40 % and not more than 60 % of
sucrose fatty acid esters
Description Soft solid masses, stiff gels or white to off-white
powders
Identification
A. Positive tests for sugar and for fatty
acids
B. Solubility Insoluble in cold water
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25 ºC
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 100
▼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 10 mg/kgMethanol Not more than 10 mg/kgDimethylformamide Not more than 1 mg/kg2-methyl-1-propanol/C148/C147/C147/C147/C149/C147/C147/C147/C150Not more than 10 mg/kg, single or in combinationCyclohexane
Ethyl acetate/C148/C147/C147/C147/C149/C147/C147/C147/C150Not 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)
E475POLYGLYCEROLESTERSOFFATTYACIDS
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 poly-
glycerols equal to or higher than heptaglycerol
Assay Content of total fatty acid ester not less than 90 %
Description Light yellow to amber, oily to very viscous liquids;
light tan to medium brown, plastic or soft solids; and
light tan to brown, hard, waxy solids
Identification
A. Positive tests for glycerol, for poly-
glycerols and for fatty acids
B. Solubility The esters range from very hydrophilic to very lipo-
philic, but as a class tend to be dispersible in water
and soluble in organic solvents and oils
Purity
Sulphated ash Not more than 0,5 % determined at 800 ± 25 ºC
Acids other than fatty acids Not detectable
Free fatty acids Not more than 6 % estimated as oleic acidTotal glycerol and polyglycerol Not less than 18 % and not more than 60 %Free glycerol and polyglycerol Not more than 7 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids,
however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate)
E476POLYGLYCEROLPOLYRICINOLEATE
Synonyms Glycerol esters of condensed castor oil fatty acids
Polyglycerol esters of polycondensed fatty acids from
castor oil
Polyglycerol esters of interesterified ricinoleic acid
PGPR1996L0077 — EN — 17.11.2002 — 004.001 — 101
▼M1
Definition Polyglycerol polyricinoleate is prepared by the esterifi-
cation 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 100Acid value Not more than 6Arsenic 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 10 mg/kg
E477PROPANE-1,2-DIOLESTERSOFFATTYACIDS
Synonyms Propylene glycol esters of fatty acids
Definition Consists of mixtures of propane-1,2-diol mono- and
diesters of fatty acids occurring in food fats and oils.
The alcohol moiety is exclusively propane-1,2-diol
together with dimer and traces of trimer. Organic acids
other than food fatty acids are absent.
Assay Content of total fatty acid ester not less than 85 %
Description Clear liquids or waxy white flakes, beads or solids
having a bland odour
Identification
A. Positive tests for propylene glycol
and for fatty acids
Purity
Sulphated ash Not more than 0,5 % determined at 800 ± 25 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/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 — 17.11.2002 — 004.001 — 102
▼M1
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)
E479bTHERMALLYOXIDISEDSOYABEANOILINTERACTEDWITHMONO-AND
DIGLYCERIDESOFFATTYACIDS
Synonyms TOSOM
Definition Thermally oxidised soya bean oil interacted with
mono- and diglycerides of fatty acids is a complex
mixture of esters of glycerol and fatty acids found in
edible fat and fatty acids from thermally oxidised
soya bean oil. It is produced by interaction and deso-
dorisation 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 acidFree glycerol Not more than 2 %
Total fatty acids 83—90 %
Total glycerol 16—22 %
Fatty acid methyl esters, not forming
adduct with ureaNot more than 9 % of total fatty acid methyl esters
Fatty acids, insoluble in petroleum
etherNot more than 2 % of total fatty acids
Peroxide value Not more than 3
Epoxides 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/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E481SODIUMSTEAROYL-2-LACTYLATE
Synonyms Sodium stearoyl lactylate
Sodium stearoyl lactate
Definition A mixture of the sodium salts of stearoyl lactylic acids
and its polymers and minor amounts of sodium salts of
other related acids, manufactured by the reaction of
stearic acid and lactic acid. Other food fatty acids
may also be present, free or esterified, due to their
presence in the stearic acid used
Chemical names Sodium di-2-stearoyl lactate
Sodium di(2-stearoyloxy)propionate
Einecs 246-929-7
Chemical formula
(major components)C
21H39O4Na
C19H35O4Na
Description White or slightly yellowish powder or brittle solid
with a characteristic odour1996L0077 — EN — 17.11.2002 — 004.001 — 103
▼M1
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/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
E482CALCIUMSTEAROYL-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 reac-
tion of stearic acid and lactic acid. Other food fatty
acids may also be present, free or esterified, due to
their presence in the stearic acid used
Chemical name Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Einecs 227-335-7
Chemical formula C
42H78O8Ca
C38H70O8Ca
Description White or slightly yellowish powder or brittle solid
with a characteristic odour
Identification
A. Positive tests for calcium, for fatty
acids and for lactid acid
B. Solubility Slightly soluble in hot water
Purity
Calcium Not less than 1 % and not more than 5,2 %Ester value Not less than 125 and not more than 190Total lactic acid Not less than 15 % and not more than 40 %Acid value Not less than 50 and not more than 130Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E483STEARYLTARTRATESynonyms Stearyl palmityl tartrate1996L0077 — EN — 17.11.2002 — 004.001 — 104
▼M1
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 C38H74O6to C40H78O6
Molecular weight 627 to 655
Assay Content of total ester not less than 90 % corresponding
to an ester value of not less than 163 and not more
than 180
Description Cream-coloured unctuous solid (at 25 ºC)
Identification
A. Positive tests for 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 220
Acid 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/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Unsaponifiable matter Not less than 77 % and not more than 83 %Iodine value Not more than 4 (Wijs)
E491SORBITANMONOSTEARATE
Definition A mixture of the partial esters of sorbitol and its anhy-
drides with edible, commercial stearic acid
Einecs 215-664-9
Assay Content not less than 95 % of a mixture of sorbitol,
sorbitan, and isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or a
hard, waxy solid with a slight characteristic odour
Identification
A. Solubility Soluble at temperatures above its melting point in
toluene, dioxane, carbon tetrachloride, ether, methanol,
ethanol and aniline; insoluble in petroleum ether and
acetone; insoluble in cold water but dispersible in
warm water; soluble with haze at temperatures above
50 ºC in mineral oil and ethyl acetate
B. Congealing range 50—52 ºC
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %1996L0077 — EN — 17.11.2002 — 004.001 — 105
▼M1
Acid value Not more than 10
Saponification value Not less than 147 and not more than 157
Hydroxyl value Not less than 235 and not more than 260
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E492SORBITANTRISTEARATEDefinition A mixture of the partial esters of sorbitol and its anhy-
drides 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; inso-
luble in water, methanol and ethanol
B. Congealing range 47—50 ºC
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 15
Saponification value Not less than 176 and not more than 188Hydroxyl value Not less than 66 and not more than 80
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E493SORBITANMONOLAURATE
Definition A mixture of the partial esters of sorbitol and its anhy-
drides with edible, commercial lauric acid
Einecs 215-663-3
Assay Content not less than 95 % of a mixture of sorbitol,
sorbitan, and isosorbide esters
Description Amber-coloured oily viscous liquid, light cream to
tan-coloured beads or flakes or a hard, waxy solid
with a slight odour
Identification
A. Solubility Dispersible in hot and cold water
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol1996L0077 — EN — 17.11.2002 — 004.001 — 106
▼M1
Purity
Water Not more than 2 % (Karl Fischer method)Sulphated ash Not more than 0,5 %Acid value Not more than 7
Saponification value Not less than 155 and not more than 170
Hydroxyl value Not less than 330 and not more than 358Arsenic 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
E494SORBITANMONOOLEATE
Definition A mixture of the partial esters of sorbitol and its anhy-
drides 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 odour
Identification
A. Solubility Soluble at temperatures above its melting point in
ethanol, ether, ethyl acetate, aniline, toluene, dioxane,
petroleum ether and carbon tetrachloride. Insoluble in
cold water, dispersible in warm water
B. Iodine value The residue of oleic acid, obtained from the saponifi-
cation of the sorbitan monoleate in assay, has a iodine
value between 80 and 100
Purity
Water Not more than 2 % (Karl Fischer method)Sulphated ash Not more than 0,5 %
Acid value Not more than 8
Saponification value Not less than 145 and not more than 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
E495SORBITANMONOPALMITATE
Synonyms Sorbitan palmitate
Definition A mixture of the partial esters of sorbitol and its anhy-
drides with edible, commercial palmitic acid
Einecs 247-568-8
Assay Content not less than 95 % of a mixture of sorbitol,
sorbitan, and isosorbide esters1996L0077 — EN — 17.11.2002 — 004.001 — 107
▼M1
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 tetra-
chloride. 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/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
E508POTASSIUMCHLORIDE
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/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 — 17.11.2002 — 004.001 — 108
▼M1
E579FERROUSGLUCONATE
Definition
Chemical name Ferrous di-D-gluconate dihydrate
Iron(II) di-gluconate dihydrate
Einecs 206-076-3
Chemical formulae C12H22FeO14·2H2O
Molecular weight 482,17
Assay Content not less than 95 % on the dried basis
Description Pale greenish-yellow to yellowish-grey powder or
granules, which may have a faint odour of burnt sugar
Identification
A. Solubility Soluble with slight heating in water. Practically inso-
luble in ethanol
B. Positive test for ferrous ion
C. 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 detectable
Iron (Fe III) Not more than 2 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Reducing substances Not more than 0,5 % expressed as glucose
E585FERROUSLACTATESynonyms Iron(II) lactate
Iron(II) 2-hydroxy propanoatePropanoic acid, 2-hydroxy-iron(2 +) salt (2:1)
Definition
Chemical name Ferrous 2-hydroxy propanoate
Einecs 227-608-0
Chemical formulae C
6H10FeO6·xH2O( x=2o r3 )
Molecular weight 270,02 (dihydrate)
288,03 (trihydrate)
Assay Content not less than 96 % on the dried basis
Description Greenish-white crystals or light green powder having a
characteristic smell
Identification
A. Solubility Soluble in water. Practically insoluble in ethanol
B. Positive test for ferrous ion and for
lactate
C. pH of a 2 % solution Between 4 and 61996L0077 — EN — 17.11.2002 — 004.001 — 109
▼M1
Purity
Loss on drying Not more than 18 % (100 ºC, under vacuum, approxi-
mately 700 mm Hg)
Iron (Fe III) Not more than 0,6 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E650ZINCACETATE
Synonyms Acetic acid, zinc salt, dihydrate
Definition
Chemical name Zinc acetate dihydrate
Chemical formula C
4H6O4Zn · 2H2O
Molecular weight 219,51
Assay Content not less than 98 % and not more than 102 %
of C4H6O4Zn · 2H2O
Description Colourless crystals or fine, off-white powder
Identification
A. Positive tests for acetate and for
zinc
B. pH of a 5 % solution Between 6,0 and 8,0
Purity
Insoluble matter Not more than 0,005 %
Chlorides Not more than 50 mg/kgSulphates Not more than 100 mg/kg
Alkalines and alkaline earths Not more than 0,2 %
Organic volatile impurities Passes test
Iron Not more than 50 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 20 mg/kg
Cadmium Not more than 5 mg/kg
E943aBUTANESynonyms n-Butane
Definition
Chemical name Butane
Chemical formula CH
3CH2CH2CH3
Molecular weight 58,12
Assay Content not less than 96 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
A. Vapour pressure 108,935 kPa at 20 ºC1996L0077 — EN — 17.11.2002 — 004.001 — 110
▼M4
▼M4
Purity
Methane Not more than 0,15 % v/v
Ethane Not more than 0,5 % v/v
Propane Not more than 1,5 % v/v
Isobutane Not more than 3,0 % v/v
1,3-butadiene Not more than 0,1 % v/v
Moisture Not more than 0,005 %
E943bISOBUTANE
Synonyms 2-methyl propane
Definition
Chemical name 2-methyl propane
Chemical formula (CH3)2CH CH3
Molecular weight 58,12
Assay Content not less than 94 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
A. Vapour pressure 205,465 kPa at 20 ºC
Purity
Methane Not more than 0,15 % v/v
Ethane Not more than 0,5 % v/v
Propane Not more than 2,0 % v/v
n-Butane Not more than 4,0 % v/v
1,3-butadiene Not more than 0,1 % v/v
Moisture Not more than 0,005 %
E944PROPANE
Definition
Chemical name Propane
Chemical formula CH3CH2CH3
Molecular weight 44,09
Assay Content not less than 95 %
Description Colourless gas or liquid with mild, characteristic odour
Identification
A. Vapour pressure 732,910 kPa at 20 ºC
Purity
Methane Not more than 0,15 % v/v
Ethane Not more than 1,5 % v/v
Isobutane Not more than 2,0 % v/v
n-Butane Not more than 1,0 % v/v
1,3-butadiene Not more than 0,1 % v/v
Moisture Not more than 0,005 %1996L0077 — EN — 17.11.2002 — 004.001 — 111
▼M4
E949HYDROGEN
Definition
Chemical name Hydrogen
Einecs 215-605-7
Chemical formula H2
Molecular weight 2
Assay Content not less than 99,9 %
Description Colourless, odourless, highly flammable gas
Purity
Water Not more than 0,005 % v/v
Oxygen Not more than 0,001 % v/v
Nitrogen Not more than 0,75 % v/v
E1105LYSOZYME
Synonyms Lysozyme hydrochloride
Muramidase
Definition Lysozyme is a linear polypeptide obtained from hens'
egg whites consisting of 129 amino acids. It possesses
enzymatic activity in its ability to hydrolyse the β(1-4)
linkages between N-acetylmuramic acid and N-acetyl-
glucosamine 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 taste
Identification
A. Isoelectric point 10,7
B. pH of a 2 % aqueous solution
between 3,0 and 3,6
C. Absorption maximum of an aqueous
solution (25 mg/100 ml) at 281 nm, a
minimum at 252 nm
Purity
Water content Not more than 6,0 % (Karl Fischer method) (powder
form only)
Residue on ignition Not more than 1,5 %
Nitrogen Not less than 16,8 % and not more than 17,8 %Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Microbiological criteria
Total bacterial count Not more than 5 × 10
4col/g
Salmonellae Absent in 25 g1996L0077 — EN — 17.11.2002 — 004.001 — 112
▼B
▼B
Staphylococcus aureus Absent in 1 g
Escherichia coli Absent in 1 g
E1201POLYVINYLPYRROLIDONE
Synonyms Povidone
PVPSoluble polyvinylpyrrolidone
Definition
Chemical name Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-
ethylene]
Chemical formula (C
6H9NO)n
Molecular weight Not less than 25000
Assay Content not less than 11,5 % and not more than 12,8 %
of nitrogen (N) on the anhydrous basis
Description White or nearly white powder
Identification
A. Solubility Soluble in water and in ethanol. Insoluble in etherB. pH of a 5 % solution Between 3,0 and 7,0
Purity
Water Not more than 5 % (Karl Fischer)
Total ash Not more than 0,1 %Aldehyde Not more than 500 mg/kg (as acetaldehyde)
Free-N-vinylpyrrolidone Not more than 10 mg/kg
Hydrazine Not more than 1 mg/kgLead Not more than 5 mg/kg
E1202POLYVINYLPOLYPYRROLIDONE
Synonyms Crospovidone
Cross linked polyvidone
Insoluble polyvinylpyrrolidone
Definition Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrro-
lidinyl)-ethylene], cross linked in a random fashion. It
is produced by the polymerisation of N-vinyl-2-pyrro-
lidone in the presence of either caustic catalyst or N,N'-divinyl-imidazolidone. Due to its insolubility in all
common solvents the molecular weight range is not
amenable to analytical determination
Chemical name Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-
ethylene]
Chemical formula (C
6H9NO)n
Assay Content not less than 11 % and not more than 12,8 %
nitrogen (N) on the anhydrous basis
Description A white hygroscopic powder with a faint, non-objec-
tionable odour
Identification
A. Solubility Insoluble in water, ethanol and ether
B. pH of a 1 % suspension in water Between 5,0 and 8,0
Purity
Water Not more than 6 % (Karl Fischer)1996L0077 — EN — 17.11.2002 — 004.001 — 113
▼M4
▼M4
Sulphated ash Not more than 0,4 %
Water-soluble matter Not more than 1 %
Free-N-vinylpyrrolidone Not more than 10 mg/kg
Free-N,N'-divinyl-imidazolidone Not more than 2 mg/kgLead Not more than 5 mg/kg
POLYETHYLENEGLYCOL6000
Synonyms PEG 6000
Macrogol 6000
Definition Polyethylene glycol 6000 is a mixture of polymers
with the general formula H- OCH
2-CH ðÞ -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/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
E296MALICACIDSynonyms DL-Malic acid, pomalous acid
Definition
Chemical name DL-Malic acid, hydroxybutanedioic acid, hydroxysuc-
cinic acid
EINECS 230-022-8
Chemical formula C
4H6O5
Molecular weight 134,09
Assay Content not less than 99,0 %
Description White or nearly white crystalline powder or granules
Identification
A. Melting range between 127 ºC and
132 ºC
B. Positive test for malate
C. Solutions of this substance are opti-
cally inactive in all concentrations1996L0077 — EN — 17.11.2002 — 004.001 — 114
▼M2
▼M2
Purity
Sulphated ash Not more than 0,1 %Fumaric acid Not more than 1,0 %
Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E297FUMARICACID
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/kgMercury Not more than 1 mg/kg
E343(i)MONOMAGNESIUMPHOSPHATE
Synonyms Magnesiumdihydrogenphosphate
Magnesiumphosphate, monobasic
Monomagnesium orthophosphate
Definition
Chemical name Monomagnesiumdihydrogenmonophosphate
EINECS 236-004-6
Chemical formula Mg H
2PO4 ðÞ2/C1nH2O (where n = 0 to 4)
Molecular weight 218,30 (anhydrous)
Assay Not less than 51,0 % after ignition
Description White, odourless, crystalline powder, slightly soluble
in water
Identification
A. Positive test for magnesium and for
phosphate
B. MgO content Not less than 21,5 % after ignition1996L0077 — EN — 17.11.2002 — 004.001 — 115
▼M2
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
E343(ii)DIMAGNESIUMPHOSPHATESynonyms Magnesiumhydrogenphosphate
Magnesiumphosphate, dibasic
Dimagnesium orthophosphate
Secondary 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/kgMercury Not more than 1 mg/kg
E350(i)SODIUMMALATESynonyms Sodium salt of malic acid
Definition
Chemical name Disodium DL-malate, disodium salt of hydroxybutane-
dioic acid
Chemical formula Hemihydrate: C
4H4Na2O5/C1½H2O
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 Positive1996L0077 — EN — 17.11.2002 — 004.001 — 116
▼M2
C. Solubility Freely soluble in water
Purity
Loss on drying Not more than 7,0 % (130 ºC, 4h) for the hemihydrate,
or 20,5 % - 23,5 % (130 ºC, 4h) for the trihydrate
Alkalinity Not more than 0,2 % as 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/kgMercury Not more than 1 mg/kg
E350(ii)SODIUMHYDROGENMALATESynonyms 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E351POTASSIUMMALATESynonyms Potassium salt of malic acid
Definition
Chemical name Dipotassium DL-malate, dipotassium salt of hydroxy-
butanedioic acid
Chemical formula C
4H4K2O5
Molecular weight 210,27
Assay Content not less than 59,5 %
Description Colourless or almost colourless aqueous solution
Identification
A. Positive tests for 1,2-dicarboxylic
acid and for potassium
B. Azo dye formation Positive1996L0077 — EN — 17.11.2002 — 004.001 — 117
▼M2
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/kg
Mercury Not more than 1 mg/kg
E352(i)CALCIUMMALATE
Synonyms 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/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E352(ii)CALCIUMHYDROGENMALATESynonyms 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 Positive1996L0077 — EN — 17.11.2002 — 004.001 — 118
▼M2
Purity
Loss on drying Not more than 2,0 % (110 ºC, 3h)
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E355ADIPICACID
Definition
Chemical name Hexanedioic acid, 1,4-butanedicarboxylic acid
EINECS 204-673-3
Chemical formula C6H10O4
Molecular weight 146,14
Assay Content not less than 99,6 %
Description White odourless crystals or crystalline powder
Identification
A. Melting range 151,5-154,0 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/kg
E363SUCCINICACIDDefinition
Chemical name Butanedioic acid
EINECS 203-740-4
Chemical formula C
4H6O4
Molecular weight 118,09
Assay Content no less than 99,0 %
Description Colourless or white, odourless crystals
Identification
A. Melting range Between 185,0 ºC and 190,0 ºC
Purity
Residue on ignition Not more than 0,025 % (800 ºC, 15 min)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 119
▼M2
E380TRIAMMONIUMCITRATE
Synonyms Tribasic ammonium citrate
Definition
Chemical name Triammonium salt of 2-hydroxypropan-1,2,3-tricar-
boxylic acid
EINECS 222-394-5
Chemical formula C6H17N3O7
Molecular weight 243,22
Assay Content not less than 97,0 %
Description White to off-white crystals or powder
Identification
A. Positive tests for ammonium and
for citrate
B. Solubility Freely soluble in water
Purity
Oxalate Not more than 0,04 % (as oxalic acid)Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E452(iii)SODIUMCALCIUMPOLYPHOSPHATESynonym 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 2O5
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/kgArsenic Not more than 3 mg/kgLead Not more than 4 mg/kgCadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E459BETA-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 Cycloheptaamylose1996L0077 — EN — 17.11.2002 — 004.001 — 120
▼M2
EINECS 231-493-2
Chemical formula C6H10O5 ðÞ7
Molecular weight 1135
Assay Content not less than 98,0 % of C 6H10O5 ðÞ7on an
anhydrous basis
Description Virtually odourless, white or almost white crystalline
solid
Identification
A. Solubility Sparingly soluble in water; freely soluble in hot water;
slightly soluble in ethanol
B. Specific rotation [ α]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 basis
Residual 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
E468CROSS-LINKEDSODIUMCARBOXYMETHYL-
CELLULOSE
Synonyms Cross-linked carboxymethyl cellulose
Cross-linked CMC
Cross-linked sodium CMC
Cross-linked cellulose gum
Definition Cross-linked sodium carboxymethyl cellulose is the
sodium salt of thermally cross-linked partly O-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:
C
6H7O2OR1 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 mass1996L0077 — EN — 17.11.2002 — 004.001 — 121
▼M2
B. Shake 1 g with 50 ml of water. Transfer 1 ml of the
mixture to a test tube, add 1 ml water and 0,05 ml of
freshly prepared 40 g/l solution of alpha-naphthol in
methanol. Incline the test tube and add carefully 2 ml
of sulphuric acid down the side so that it forms a
lower layer. A reddish-violet colour develops at the
interface
C. It gives the reaction of sodium
Purity
Loss on drying Not more than 6 % (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 basisArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgCadmium Not more than 1 mg/kgMercury Not more than 1 mg/kg
E469ENZYMATICALLYHYDROLYSEDCARBOXY-
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 (formerlyT. reesei)
Chemical name Carboxymethyl cellulose, sodium, partially enzymati-
cally hydrolysed
Chemical formula Sodium salts of polymers containing substituted anhy-
droglucose units with the general formula:
C
6H7O2OHðÞxOCH2COONa ðÞyhi
n
where n is the degree of polymerisation
x = 1,50 to 2,80
y = 0,2 to 1,50
x+y=3 , 0(y = degree of substitution)
Formula weight 178,14 where y = 0,20
282,18 where y = 1,50
Macromolecules: Not less than 800 (n about 4)
Assay Not less than 99,5 %, including mono- and 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 ethanolB. 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 gums1996L0077 — EN — 17.11.2002 — 004.001 — 122
▼M2
C. Precipitate formation To 5 ml of a 0,5 % solution of the sample add 5 ml of
a 5 % solution of copper or aluminium sulphate. A
precipitate appears. This test distinguishes sodium
carboxymethyl cellulose, whether hydrolysed or not,
from other cellulose ethers and from gelatine, carob
bean gum and tragacanth gum
D. Colour reaction Add 0,5 g of the powdered sample to 50 ml of water,
while stirring to produce a uniform dispersion.
Continue the stirring until a clear solution is produced.
Dilute 1 ml of the solution with 1 ml of water in a
small test tube. Add 5 drops of 1-naphthol TS. Incline
the tube, and carefully introduce down the side of the
tube 2 ml of sulphuric acid so that it forms a lower
layer. A red-purple colour develops at the interface
E. Viscosity (60 % solids) Not less than 2,500 kgm-1s-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
E500(i)SODIUMCARBONATE
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 anhy-
drous basis
Description Colourless crystals or white, granular or crystalline
powder
The anhydrous form is hygroscopic, the decahydrate
efflorescent
Identification
A. Positive tests for sodium and for
carbonate
B. Solubility Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 2 % (anhydrous), 15 % (monohydrate)
or 55 %-65 % (decahydrate) (70 ºC raising gradually
to 300 ºC, to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 123
▼M2
E500(ii)SODIUMHYDROGENCARBONATE
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 8,6C. Solubility Soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 0,25 % (over silica gel, 4h)Ammonium salts No odour of ammonia detectable after heatingArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E500(iii)SODIUMSESQUICARBONATEDefinition
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
carbonate
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/kgMercury Not more than 1 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 124
▼M2
E501(i)POTASSIUMCARBONATE
Definition
Chemical name Potassium carbonate
EINECS 209-529-3
Chemical formula K2CO3/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
E501(ii)POTASSIUMHYDROGENCARBONATESynonyms Potassium bicarbonate, acid potassium carbonate
Definition
Chemical name Potassium hydrogen carbonate
EINECS 206-059-0
Chemical formula KHCO
3
Molecular weight 100,11
Assay Content not less than 99,0 % and not more than
101,0 % 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E503(i)AMMONIUMCARBONATE
Definition Ammonium carbonate consists of ammonium carba-
mate, ammonium carbonate and ammonium hydrogen
carbonate in varying proportions
Chemical name Ammonium carbonate1996L0077 — EN — 17.11.2002 — 004.001 — 125
▼M2
EINECS 233-786-0
Chemical formula CH6N2O2;CH8N2O3and 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 %
of NH3
Description White powder or hard, white or translucent masses or
crystals. Becomes opaque on exposure to air and is
finally converted into white porous lumps or powder
(of ammonium bicarbonate) due to loss of ammonia
and carbon dioxide
Identification
A. Positive tests for ammonium and
for carbonate
B. pH of a 5 % solution about 8,6
C. Solubility Soluble in water
Purity
Non-volatile matter Not more than 500 mg/kgChlorides Not more than 30 mg/kgSulphate Not more than 30 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E503(ii)AMMONIUMHYDROGENCARBONATE
Synonyms 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/kgSulphate Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E507HYDROCHLORICACIDSynonyms Hydrogen chloride, muriatic acid1996L0077 — EN — 17.11.2002 — 004.001 — 126
▼M2
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/kg
Arsenic Not more than 1 mg/kgLead Not more than 1 mg/kgMercury Not more than 1 mg/kg
E509CALCIUMCHLORIDEDefinition
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
chloride
B. Solubility Anhydrous calcium chloride: freely soluble in water
and ethanol
Dihydrate: freely soluble in water, soluble in ethanol
Hexahydrate: very soluble in water and ethanol
Purity
Magnesium and alkali salts Not more than 5 % on the anhydrous basis1996L0077 — EN — 17.11.2002 — 004.001 — 127
▼M2
Fluoride Not more than 40 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E511MAGNESIUMCHLORIDEDefinition
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 crys-
tals
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/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E512STANNOUSCHLORIDESynonyms Tin chloride, tin dichloride
Definition
Chemical name Stannous chloride dihydrate
EINECS 231-868-0
Chemical formula SnCl
2/C12H2O
Molecular weight 225,63
Assay Content not less than 98,0 %
Description Colourless or white crystals
May have a slight odour of hydrochloric acid
Identification
A. Positive tests for tin (II) and for
chloride
B. Solubility Water: soluble in less than its own weight of water,
but it forms an insoluble basic salt with excess water
Ethanol: soluble
Purity
Sulphate Not more than 30 mg/kgArsenic Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Lead Not more than 5 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 128
▼M2
E513SULPHURICACID
Synonyms Oil of vitriol, dihydrogen sulphate
Definition
Chemical name Sulphuric acid
EINECS 231-639-5
Chemical formula H2SO4
Molecular weight 98,07
Assay Sulphuric acid is commercially available in varying
concentrations. The concentrated form contains not
less than 96,0 %
Description Clear, colourless or slightly brown, very corrosive oily
liquid
Identification
A. Positive tests for acid and for
sulphate
B. Solubility Miscible with water, with generation of much heat,
also with ethanol
Purity
Ash Not more than 0,02 %Reducing matter Not more than 40 mg/kg (as 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
E514(i)SODIUMSULPHATE
Definition
Chemical name Sodium sulphate
Chemical formula Na
2SO4/C1nH2O (n = 0 or 10)
Molecular weight 142,04 (anhydrous)
322,04 (decahydrate)
Assay Content not less than 99,0 % on the anhydrous basis
Description Colourless crystals or a fine, white, crystalline powder
The decahydrate is efflorescent
Identification
A. Positive tests for sodium and for
sulphate
B. Acidity of a 5 % solution: neutral
or slightly alkaline to litmus paper
Purity
Loss on drying Not more than 1,0 % (anhydrous) or not more than
57 % (decahydrate) at 130oC
Selenium Not more than 30 mg/kg1996L0077 — EN — 17.11.2002 — 004.001 — 129
▼M2
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E514(ii)SODIUMHYDROGENSULPHATESynonyms 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
E515(i)POTASSIUMSULPHATEDefinition
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 8,5C. Solubility Freely soluble in water, insoluble in ethanol
Purity
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E515(ii)POTASSIUMHYDROGENSULPHATEDefinitionSynonyms Potassium bisulphate, potassium acid sulphate1996L0077 — EN — 17.11.2002 — 004.001 — 130
▼M2
Chemical name Potassium hydrogen sulphate
Chemical formula KHSO 4
Molecular weight 136,17
Assay Content not less than 99 %
Melting point 197 ºC
Description White deliquescent crystals, pieces or granules
Identification
A. Positive test for potassiumB. 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
E516CALCIUMSULPHATESynonyms Gypsum, selenite, anhydrite
Definition
Chemical name Calcium sulphate
EINECS 231-900-3
Chemical formula CaSO
4/C1nH2O( n=0o r2 )
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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E517AMMONIUMSULPHATE
Definition
Chemical name Ammonium sulphate
EINECS 231-984-1
Chemical formula NH
4 ðÞ2SO4
Molecular weight 132,141996L0077 — EN — 17.11.2002 — 004.001 — 131
▼M2
Assay Content not less than 99,0 % and not more than
100,5 %
Description White powder, shining plates or crystalline fragments
Identification
A. Positive tests for ammonium and
for sulphate
B. Solubility Freely soluble in water, insoluble in ethanol
Purity
Loss on ignition Not more than 0,25 %Selenium Not more than 30 mg/kgLead Not more than 5 mg/kg
E520ALUMINIUMSULPHATESynonyms Alum
Definition
Chemical name Aluminium sulphate
EINECS 233-135-0
Chemical formula Al
2SO4 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/kgFluoride Not more than 30 mg/kgArsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E521ALUMINIUMSODIUMSULPHATE
Synonyms Soda alum, sodium alum
Definition
Chemical name Aluminium sodium sulphate
EINECS 233-277-3
Chemical formula AlNa SO
4 ðÞ2/C1nH2O( n=0o r1 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 powder1996L0077 — EN — 17.11.2002 — 004.001 — 132
▼M2
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/kg
Mercury Not more than 1 mg/kg
E522ALUMINIUMPOTASSIUMSULPHATESynonyms 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 heating
Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E523ALUMINIUMAMMONIUMSULPHATESynonyms Ammonium alum
Definition
Chemical name Aluminium ammonium sulphate
EINECS 232-055-3
Chemical formula AlNH
4SO4 ðÞ2/C112 H2O
Molecular weight 453,321996L0077 — EN — 17.11.2002 — 004.001 — 133
▼M2
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
E524SODIUMHYDROXIDE
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/kg
Mercury Not more than 1 mg/kg
E525POTASSIUMHYDROXIDE
Synonyms Caustic potash
Definition
Chemical name Potassium hydroxide
EINECS 215-181-3
Chemical formula KOH1996L0077 — EN — 17.11.2002 — 004.001 — 134
▼M2
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
E526CALCIUMHYDROXIDESynonyms 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/kg
E527AMMONIUMHYDROXIDESynonyms Aqua ammonia, strong ammonia solution
Definition
Chemical name Ammonium hydroxide
Chemical formula NH
4OH
Molecular weight 35,05
Assay Content not less than 27 % of NH 31996L0077 — EN — 17.11.2002 — 004.001 — 135
▼M2
Description Clear, colourless solution, having an exceedingly
pungent, characteristic odour
Identification
A. Positive tests for ammonia
Purity
Non-volatile matter Not more than 0,02 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
E528MAGNESIUMHYDROXIDE
Definition
Chemical name Magnesium hydroxide
EINECS 215-170-3
Chemical formula Mg OH ðÞ2
Molecular weight 58,32
Assay Content not less than 95,0 % on the anhydrous basis
Description Odourless, white bulky powder
Identification
A. Positive test for magnesium and for
alkali
B. Solubility Practically insoluble in water and in ethanol
Purity
Loss on drying Not more than 2,0 % (105 ºC, 2h)
Loss on ignition Not more than 33 % (800 ºC to constant weight)
Calcium oxide Not more than 1,5 %Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
E529CALCIUMOXIDE
Synonyms Burnt lime
Definition
Chemical name Calcium oxide
EINECS 215-138-9
Chemical formula CaO
Molecular weight 56,08
Assay Content not less than 95,0 % on the ignited basis
Description Odourless, hard, white or greyish white masses of
granules, or white to greyish powder
Identification
A. Positive test for alkali and for
calcium
B. Heat is generated on moistening the
sample with water
C. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble
in glycerol1996L0077 — EN — 17.11.2002 — 004.001 — 136
▼M2
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/kgMagnesium and alkali salts Not more than 1,5 %
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
E530MAGNESIUMOXIDE
Definition
Chemical name Magnesium oxide
EINECS 215-171-9
Chemical formula MgO
Molecular weight 40,31
Assay Content not less than 98,0 % on the ignited basis
Description A very bulky, white powder known as light magne-
sium oxide or a relative dense, white powder known
as heavy magnesium oxide. 5 g of light magnesium
oxide occupy a volume of 40 to 50 ml, while 5 g of
heavy magnesium oxide occupy a volume of 10 to
20 ml
Identification
A. Positive test for alkali and for
magnesium
B. Solubility Practically insoluble in water. Insoluble in ethanol
Purity
Loss on ignition Not more than 5,0 % (ca 800 ºC to constant weight)
Calcium oxide Not more than 1,5 %Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
E535SODIUMFERROCYANIDE
Synonyms 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 %
Description Yellow crystals or crystalline powder
Identification
A. Positive test for sodium and for
ferrocyanide
Purity
Free moisture Not more than 1,0 %1996L0077 — EN — 17.11.2002 — 004.001 — 137
▼M2
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
E536POTASSIUMFERROCYANIDESynonyms Yellow prussiate of potash, potassium hexacyanofer-
rate
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 detectableLead Not more than 5 mg/kg
E538CALCIUMFERROCYANIDE
Synonyms 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 powder
Identification
A. Positive test for calcium and for
ferrocyanide
Purity
Free moisture Not more than 1,0 %Water insoluble matter Not more than 0,03 %Chloride Not more than 0,2 %1996L0077 — EN — 17.11.2002 — 004.001 — 138
▼M2
Sulphate Not more than 0,1 %
Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
E541SODIUMALUMINIUMPHOSPHATE,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 to litmus
C. Solubility Insoluble in water. Soluble in hydrochloric acid
Purity
Loss on ignition 19,5 % - 21,0 % (A) } (750 ºC - 800 ºC, 2h)
15 % - 16 % (B) } (750 ºC - 800 ºC, 2h)
Fluoride Not more than 25 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 4 mg/kgCadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E551SILICONDIOXIDESynonyms Silica, silicium dioxide
Definition Silicon dioxide is an amorphous substance, which is
produced synthetically by either a vapour-phase hydro-
lysis 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 SiO
2 ðÞn
Molecular weight 60,08 (SiO 2)
Assay Content after ignition not less than 99,0 % (fumed
silica) or 94,0 % (hydrated forms)1996L0077 — EN — 17.11.2002 — 004.001 — 139
▼M2
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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E552CALCIUMSILICATEDefinition 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 %Fluoride Not more than 50 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E553a(i)MAGNESIUMSILICATEDefinition 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 basis1996L0077 — EN — 17.11.2002 — 004.001 — 140
▼M2
Description Very fine, white, odourless powder, free from gritti-
ness
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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E553a(ii)MAGNESIUMTRISILICATEDefinition
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/kg
E570FATTYACIDSDefinition Linear fatty acids, caprylic acid (C
8), capric acid
(C10), laurinc acid (C 12), myristic acid (C 14), palmitic
acid (C 16), 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 (C 16), octadecanoic acid (C 18), 9-octadecenoic
acid (C 18:1)
Assay Not less than 98 % by chromatography
Description A colourless liquid or white solid obtained from oils
and fats1996L0077 — EN — 17.11.2002 — 004.001 — 141
▼M2
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/kgMercury Not more than 1 mg/kg
E574GLUCONICACIDSynonyms 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/kgSulphate Not more than 240 mg/kgSulphite Not more than 20 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E575GLUCONO-DELTA-LACTONESynonyms Gluconolactone, GDL, D-gluconic acid delta-lactone,
delta-gluconolactone
Definition Glucono-delta-lactone is the cyclic 1,5-intramolecular
ester of D-gluconic acid. In aqueous media it is hydro-
lysed 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 C
6H10O6
Molecular weight 178,14
Assay Content not less than 99,0 % on the anhydrous basis
Description Fine, white, nearly odourless, crystalline powder1996L0077 — EN — 17.11.2002 — 004.001 — 142
▼M2
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
E576SODIUMGLUCONATESynonyms Sodium salt of D-gluconic acid
Definition
Chemical name Sodium D-gluconate
EINECS 208-407-7
Chemical formula C
6H11NaO7(anhydrous)
Molecular weight 218,14
Assay Content not less than 98,0 %
Description White to tan, granular to fine, crystalline powder
Identification
A. Positive test for sodium and for
gluconate
B. Solubility Very soluble in water. Sparingly soluble in ethanol
C. pH of a 10 % solution Between 6,5 and 7,5
Purity
Reducing matter Not more than 1,0 % (as D-glucose)
Lead Not more than 2 mg/kg
E577POTASSIUMGLUCONATE
Synonyms Potassium salt of D-gluconic acid
Definition
Chemical name Potassium D-gluconate
EINECS 206-074-2
Chemical formula C6H11KO7(anhydrous)
C6H11KO7/C1H2O (monohydrate)
Molecular weight 234,25 (anhydrous)
252,26 (monohydrate)
Assay Content not less than 97,0 % and not more than
103,0 % on dried basis
Description Odourless, free flowing white to yellowish white, crys-
talline powder or granules
Identification
A. Positive test for potassium and for
gluconate
B. pH of a 10 % solution Between 7,0 and 8,31996L0077 — EN — 17.11.2002 — 004.001 — 143
▼M2
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
E578CALCIUMGLUCONATESynonyms 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
E640GLYCINEANDITSSODIUMSALTSynonyms(gly) Aminoacetic acid, glycocoll
(Na salt) Sodium glycinate
Definition
Chemical name (gly) Aminoacetic acid
(Na salt) Sodium glycinate
Chemical formula (gly) C
2H5NO2
(Na salt) C2H5NO2Na
EINECS (gly) 200-272-2(Na salt) 227-842-3
Molecular weight (gly) 75,07
(Na salt) 98
Assay Content not less than 98,5 % on the anhydrous basis
Description White crystals or crystalline powder1996L0077 — EN — 17.11.2002 — 004.001 — 144
▼M2
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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E900DIMETHYLPOLYSILOXANESynonyms 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-Si- O-Si CH 3 ðÞ2/C2/C3
n-O-Si CH 3 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 0,977B. Refractive index n ½/C138
D25Between 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/kgMercury Not more than 1 mg/kg
E901BEESWAX
Synonyms White wax, yellow wax
Definition Yellow bees wax is the wax obtained by melting the
walls of the honeycomb made by the honey bee, Apis
mellifera L. , with hot water and removing foreign
matter
White beeswax is obtained by bleaching yellow
beeswax
EINECS 232-383-7 (beeswax)
Description Yellowish white (white form) or yellowish to greyish
brown (yellow form) pieces or plates with a fine-
grained and non-crystalline fracture, having an agree-
able, honey-like odour1996L0077 — EN — 17.11.2002 — 004.001 — 145
▼M2
Identification
A. Melting range Between 62 ºC and 65 ºCB. Specific gravity About 0,96C. 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 24Saponification value 87-104Peroxide value Not more than 5Glycerol 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E902CANDELILLAWAXDefinition Candelilla wax is a purified wax obtained from the
leaves of the candelilla plant, Euphorbia antisyphili-
tica
EINECS 232-347-0
Description Hard, yellowish brown, opaque to translucent wax
Identification
A. Specific gravity About 0,983B. Melting range Between 68,5 ºC and 72,5 ºCC. Solubility Insoluble in water
Soluble in chloroform and toluene
Purity
Acid value Not less than 12 and not more than 22Saponification value Not less than 43 and not more than 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/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E903CARNAUBAWAXDefinition 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 fracture1996L0077 — EN — 17.11.2002 — 004.001 — 146
▼M2
Identification
A. Specific gravity About 0,997B. Melting range Between 82 ºC and 86 ºCC. Solubility Insoluble in water
Partly soluble in boiling ethanolSoluble 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 88
Unsaponifiable 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
E904SHELLACSynonyms 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
E920L-CYSTEINEDefinition L-cysteine hydrochloride or hydrochloride monohy-
drate. Human hair may not be used as a source for
this substance
EINECS 200-157-7 (anhydrous)
Chemical formula C
3H7NO2S/C1HCl /C1nH20 (where n = 0 or 1)
Molecular weight 157,62 (anhydrous)
Assay Content not less than 98,0 % and not more than
101,5 % on the anhydrous basis
Description White powder or colourless crystals
Identification
A. Solubility Freely soluble in water and in ethanol1996L0077 — EN — 17.11.2002 — 004.001 — 147
▼M2
B. Melting range Anhydrous form melts at about 175 ºC
C. Specific rotation α½/C13820
D: between + 5,0º and + 8,0º or
α½/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/kgArsenic Not more than 1,5 mg/kg
Lead Not more than 5 mg/kg
E927bCARBAMIDE
Synonyms 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 to 135 ºC
Purity
Loss on drying Not more than 1,0 % (105 ºC, 1h)
Sulphated ash Not more than 0,1 %
Ethanol-insoluble matter Not more than 0,04 %Alkalinity Passes testAmmonium-ion Not more than 500 mg/kgBiuret Not more than 0,1 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
E938ARGONDefinition
Chemical name Argon
EINECS 231-147-0
Chemical formula Ar
Molecular weight 40
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas1996L0077 — EN — 17.11.2002 — 004.001 — 148
▼M2
Purity
Water Not more than 0,05 %
Methane and other hydrocarbons
calculated as methaneNot more than 100 µl/l
E939HELIUM
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
E941NITROGEN
Definition
Chemical name Nitrogen
EINECS 231-783-9
Chemical formula N2
Molecular weight 28
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %
Carbon monoxide Not more than 10 µl/l
Methane and other hydrocarbons
calculated as methaneNot more than 100 µl/l
Nitrogen dioxide and nitrogen oxide Not more than 10 µl/l
Oxygen Not more than 1 %
E942NITROUSOXIDE
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/l1996L0077 — EN — 17.11.2002 — 004.001 — 149
▼M2
Nitrogen dioxide and nitrogen oxide Not more than 10 µl/l
E948OXYGEN
Definition
Chemical name Oxygen
EINECS 231-956-9
Chemical formula O2
Molecular weight 32
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %
Methane and other hydrocarbons
calculated as methaneNot more than 100 µl/l
E999QUILLAIAEXTRACT
Synonyms Soapbark extract, Quillay bark extract, Panama bark
extract, Quillai extract, Murillo bark extract, China
bark extract
Definition Quillaia extract is obtained by aqueous extraction of
Quillai saponaria Molina , or other Quillaia species,
trees of the family Rosaceae . It contains a number of
triterpenoid saponins consisting of glycosides of quil-
laic acid. Some sugars including glucose, galactose,
arabinose, xylose, and rhamnose are also present,
along with tannin, calcium oxalate and other minor
components
Description Quillaia extract in the powder form is light brown with
a pink tinge. It is also available as an aqueous solution
Identification
A. pH of a 2,5 % solution Between 4,5 and 5,5
Purity
Water Not more than 6,0 % (Karl Fischer method) (powder
form only)
Arsenic Not more than 2 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E1103INVERTASEDefinition Invertase is produced from Saccharomyces cerevisiae
Systematic name β-D-Fructofuranoside fructohydrolase
Enzyme Commission No EC 3.2.1.26
EINECS 232-615-7
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Cadmium Not more than 0,5 mg/kg
Total bacterial count Not more than 50000/g
Salmonella spp. Absent by test in 25 g1996L0077 — EN — 17.11.2002 — 004.001 — 150
▼M2
Coliforms Not more than 30/g
E. coli Absent by test in 25 g
E1200POLYDEXTROSESynonyms 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 approxi-
mately 90 parts D-glucose, 10 parts sorbitol and 1 part
citric acid or 0,1 part phosphoric acid. The 1,6-gluco-
sidic linkage predominates in the polymers but other
linkages are present. The products contain small quan-
tities of free glucose, sorbitol, levoglucosan (1,6-
anhydro-D-glucose) and citric acid and may be neutra-
lised with any food grade base and/or decolorised and
deionised for further purification. The products may
also be partially hydrogenated with Raney nickel cata-
lyst 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 polydex-
troses
1,6-Anhydro-D-glucose Not more than 4,0 % on the ash-free and the dried
basis
Glucose and sorbitol Not more than 6,0 % combined on the ash-free and the
dried basis; glucose and sorbitol are determined sepa-
rately
Molecular weight limit Negative test for polymers of molecular weight greater
than 22,000
5-Hydroxymethylfurfural Not more than 0,1 % (polydextrose)
Not more than 0,05 % (polydextrose-N)
Lead Not more than 0,5 mg/kg
E1404OXIDISEDSTARCH
Definition Oxidised starch is starch treated with sodium hypo-
chlorite
Description White or nearly white powder or granules or (if prege-
latinised) flakes, amorphous powder or coarse particles1996L0077 — EN — 17.11.2002 — 004.001 — 151
▼M2
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 anhy-
drous 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
E1410MONOSTARCHPHOSPHATE
Definition Monostarch phosphate is starch esterified with ortho-
phosphoric acid, or sodium or potassium ortho-phos-
phate or sodium tripolyphosphate
Description White or nearly white powder or granules or (if prege-
latinised) 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 anhy-
drous basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E1412DISTARCHPHOSPHATE
Definition Distarch phosphate is starch cross-linked with sodium
trimetaphosphate or phosphorus oxychloride
Description White or nearly white powder or granules or (if prege-
latinised) flakes, amorphous powder or coarse particles1996L0077 — EN — 17.11.2002 — 004.001 — 152
▼M2
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 anhy-
drous basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starchNot more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kgMercury Not more than 0,1 mg/kg
E1413PHOSPHATEDDISTARCHPHOSPHATEDefinition 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 prege-
latinised) 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 anhy-
drous 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
E1414ACETYLATEDDISTARCHPHOSPHATE
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 prege-
latinised) flakes, amorphous powder or coarse particles1996L0077 — EN — 17.11.2002 — 004.001 — 153
▼M2
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 anhy-
drous 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/kgLead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E1420ACETYLATEDSTARCHSynonyms Starch acetate
Definition Acetylated starch is starch esterified with acetic anhy-
dride or vinyl acetate
Description White or nearly white powder or granules or (if prege-
latinised) 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 anhy-
drous basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %
Vinyl acetate Not more than 0,1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E1422ACETYLATEDDISTARCHADIPATEDefinition Acetylated distarch adipate is starch cross-linked with
adipic anhydride and esterified with acetic anhydride1996L0077 — EN — 17.11.2002 — 004.001 — 154
▼M2
Description White or nearly white powder or granules or (if prege-
latinised) 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 anhy-
drous 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 %
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
E1440HYDROXYPROPYLSTARCH
Definition Hydroxypropyl starch is starch etherified with propy-
lene oxide
Description White or nearly white powder or granules or (if prege-
latinised) 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 anhy-
drous basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups Not more than 7,0 %Propylene chlorohydrin Not more than 1 mg/kgSulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E1442HYDROXYPROPYLDISTARCHPHOSPHATEDefinition 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 prege-
latinised) flakes, amorphous powder or coarse particles1996L0077 — EN — 17.11.2002 — 004.001 — 155
▼M2
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 anhy-
drous basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups Not more than 7,0 %Residual phosphate Not more than 0,14 % (as P) for wheat or potato
starch
Not more than 0,04 (as P) for other starches
Propylene chlorohydrin Not more than 1 mg/kgSulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches,
unless otherwise specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kgMercury Not more than 0,1 mg/kg
E1450STARCHSODIUMOCTENYLSUCCINATESynonyms SSOS
Definition Starch sodium octenyl succinate is starch esterified
with octenylsuccinic anhydride
Description White or nearly white powder or granules or (if prege-
latinised) 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 anhy-
drous 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
E1451ACETYLATEDOXIDISEDSTARCHDefinition Acetylated oxidised starch is starch treated with
sodium hypochlorite followed by esterification with
acetic anhydride1996L0077 — EN — 17.11.2002 — 004.001 — 156
▼M2
Description White or nearly white powder or granules or (if prege-
latinised) 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 anhy-
drous 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
E1505TRIETHYLCITRATESynonyms Ethyl citrate
Definition
Chemical name Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
EINECS 201-070-7
Chemical formula C
12H20O7
Molecular weight 276,29
Assay Content not less than 99,0 %
Description Odourless, practically colourless, oily liquid
Identification
A. Specific gravity 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
E1518GLYCERYLTRIACETATE
Synonyms Triacetin
Definition
Chemical name Glyceryl triacetate
EINECS 203-051-9
Chemical formula C
9H14O6
Molecular weight 218,211996L0077 — EN — 17.11.2002 — 004.001 — 157
▼M2
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 ºCC. Specific gravity (25 ºC/25 ºC) Between 1,154 and 1,158
D. 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
E1520PROPANE-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 acetone
B. Specific gravity d 2020: 1,035-1,040
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 this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogenperoxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g ofpotassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate theliberated 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 around-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide;
leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with
sodium thiosulphate (0,1 N) in the presence of starch TS (*). 1 ml of sodium thiosulphate (0,1 N) correspondsto 27,03 mg of FeCl
3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydro-
chloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml.
(3) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a
mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this
solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acidand 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence ofstarch TS (*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO
4·5H2O. Adjust final volume
of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution
containing 62,4 mg of CuSO4·5H2O per ml.1996L0077 — EN — 17.11.2002 — 004.001 — 158
▼B
▼B
(*) 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 few minutes, 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.
E170(i)CALCIUMCARBONATE
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).
E353METATARTARICACID
Synonyms Ditartaric acid
Definition
Chemical name Metatartaric acid
Chemical formula C4H6O6
Assay Not less than 99,5 %
Description Crystalline or powder form with a white or yellowish
colour. Very deliquescent with a faint odour of caramel
Identification
A. Very soluble in water and ethanol.
B. Place a sample of 1 to 10 mg of this substance in a test
tube with 2 ml of concentrated sulfuric acid and 2 drops
of sulpho-resorcinol reagent. When heated to 150 ºC, an
intense violet coloration appears
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E354CALCIUMTARTRATE
Synonyms L-Calcium tartrate
Definition
Chemical name Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate
Chemical formula C
4H4CaO6·2 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 diethyl
ether. 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/kg1996L0077 — EN — 17.11.2002 — 004.001 — 159
(1) OJ L 226, 22.9.1995, p. 13.▼M3
▼M3
Mercury Not more than 1 mg/kg
E356SODIUMADIPATE
Definition
Chemical name Sodium adipate
EINECS 231-293-5
Chemical formula C6H8Na2O4
Molecular weight 190,11
Assay Content not less than 99,0 % (on anhydrous basis)
Description White odourless crystals or crystalline powder
Identification
A. Melting range 151 ºC-152 ºC (for adipic acid)B. Solubility Approximately 50 g/100 ml water (20 ºC)
C. Positive test for sodium
Purity
Water Not more than 3 % (Karl Fischer)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E357POTASSIUMADIPATE
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)
Description White odourless crystals or crystalline powder
Identification
A. Melting range 151 ºC-152 ºC (for adipic acid)B. Solubility Approximately 60 g/100 ml water (20 ºC)
C. Positive test for potassium
Purity
Water Not more than 3 % (Karl Fischer)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E420(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).
E420(ii)SORBITOLSYRUP
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 — 17.11.2002 — 004.001 — 160
(1) OJ L 178, 28.7.1995, p. 1.
▼M3
E421MANNITOL
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.
E425(i)KONJACGUM
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 groupp er 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 to cream to light tan powder
Identification
A. Solubility Dispersible in hot or cold water forming a highly
viscous solution with a pH between 4,0 and 7,0
B. Gel formation Add 5 ml of a 4 % sodium borate solution to a 1 %
solution of the sample in a test tube, and shake vigor-
ously. A gel forms
C. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a
boiling water bath for 30 min, with continuous agitation
and then cooling the solution to room temperature. For
each g of the sample used to prepare 30 g of the 2 %
solution, add 1 ml of 10 % potassium carbonate solution
to the fully hydrated sample at ambient temperature.Heat the mixture in a water bath to 85 ºC, and maintain
for 2 h without agitation. Under these conditions a ther-
mally stable gel is formed
D. Viscosity (1 % solution) Not less than 3 kgm
-1s-1at 25 ºC
Purity
Loss on drying Not more than 12 % (105 ºC, 5 h)Starch Not more than 3 %
Protein Not more than 3 % (N × 5,7)
Determine nitrogen by Kjeldahl method. The percentage
of nitrogen in the sample multiplied by 5,7 gives the
percent of protein in the sample
Ether-soluble material Not more than 0,1 %
Total ash Not more than 5,0 % (800 ºC, 3 to 4h)Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Salmonella spp. Absent in 12,5 g
E. coli Absent in 5 g
E425(ii)KONJACGLUCOMANNAN
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 gluco-
mannan, 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 acetylated1996L0077 — EN — 17.11.2002 — 004.001 — 161
▼M3
Molecular weight 500000 to 2000 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. Solubi-
lity is increased by heat and mechanical agitation
B. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a
boiling water bath for 30 min, with continuous agitation
and then cooling the solution to room temperature. For
each g of the sample used to prepare 30 g of the 2 %
solution, add 1 ml of 10 % potassium carbonate solution
to the fully hydrated sample at ambient temperature.
Heat the mixture in a water bath to 85 ºC, and maintain
for 2 h without agitation. Under these conditions a ther-
mally 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)Lead Not more than 1 mg/kgSalmonella spp. Absent in 12,5 g
E. coli Absent in 5 g
E504(ii)MAGNESIUMHYDROXIDECARBONATE
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 4MgCO
3Mg(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 %1996L0077 — EN — 17.11.2002 — 004.001 — 162
▼M3
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
E553bTALC
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 to the touch
Identification
A. IR absorption Characteristic peaks at 3 677, 1 018 and 669 cm-1
B. X-ray diffraction Peaks at 9,34/4,66/3,12 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 %Acid-soluble iron Not detectable
Arsenic Not more than 10 mg/kg
Lead Not more than 5 mg/kg
E554SODIUMALUMINIUMSILICATE
Synonyms Sodium silicoaluminate, sodium aluminosilicate, alumi-
nium sodium silicate
Definition
Chemical name Sodium aluminium silicate
Assay Content on the anhydrous basis:
— as SiO
2not less than 66,0 % and not more than
88,0 %
—a sA l2O3not less than 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)1996L0077 — EN — 17.11.2002 — 004.001 — 163
▼M3
Sodium Not less than 5 % and not more than 8,5 % (as Na2O) on
the anhydrous basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E555POTASSIUMALUMINIUMSILICATE
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/kgArsenic Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 2 mg/kgLead Not more than 10 mg/kg
E556CALCIUMALUMINIUMSILICATE
Synonyms Calcium aluminosilicate, calcium silicoaluminate, alumi-
nium calcium silicate
Definition
Chemical name Calcium aluminium silicate
Assay Content on the anhydrous basis:
— as SiO
2not less than 44,0 % and not more than
50,0 %
—a sA l2O3not less than 3,0 % and not more than 5,0 %
— as CaO not less than 32,0 % and not more than
38,0 %
Description Fine white, free-flowing powder
Identification
A. Positive tests for calcium, for
aluminium and for silicate
Purity
Loss on drying Not more than 10,0 % (105 ºC, 2h)1996L0077 — EN — 17.11.2002 — 004.001 — 164
▼M3
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/kgArsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E558BENTONITE
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 natu-
rally 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 bento-
nite: 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 gran-
ules. The structure of bentonite allows it to absorb
water in its structure and on its external surface (swel-
ling properties)
Identification
A. Methylene blue test
B. X-Ray diffraction Characteristic peaks at 12,5/15 AC. 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/kgLead Not more than 20 mg/kg
E559ALUMINIUMSILICATE(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 Al
2Si2O5(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 upof loose aggregations of randomly oriented
stacks of kaolinite flakes or of individual hexagonal
flakes
Identification
A. Positive tests for alumina and for
silicate1996L0077 — EN — 17.11.2002 — 004.001 — 165
▼M3
B. X-ray diffraction: characteristic peaks at 7,18/3,58/2,38/1,78 Å
C. 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
E620GLUTAMICACID
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 chromatography
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
E621MONOSODIUMGLUTAMATE
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 basis1996L0077 — EN — 17.11.2002 — 004.001 — 166
▼M3
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
E622MONOPOTASSIUMGLUTAMATE
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
powder
Identification
A. Positive test for potassium
B. Positive test for glutamic acid by
thin-layer chromatography
C. Specific rotation [ α]D20Between + 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
E623CALCIUMDIGLUTAMATE
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)1996L0077 — EN — 17.11.2002 — 004.001 — 167
▼M3
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 Not more than 19,0 % (for calcium diglutamate with
x = 4) (Karl Fischer)
Chloride Not more than 0,2 %Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg
E624MONOAMMONIUMGLUTAMATE
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 basis
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
E625MAGNESIUMDIGLUTAMATE
Synonyms Magnesium glutamate
Definition
Chemical name Monomagnesium di-L-glutamate tetrahydrate
EINECS 242-413-0
Chemical formula C
10H16MgN2O8·4 H2O1996L0077 — EN — 17.11.2002 — 004.001 — 168
▼M3
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
E626GUANYLICACID
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 basis
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 chromatography
Lead Not more than 2 mg/kg
E627DISODIUMGUANYLATE
Synonyms Sodium guanylate, sodium 5'-guanylate
Definition
Chemical name Disodium guanosine-5'-monophosphate
EINECS 221-849-5
Chemical formula C10H12N5Na2O8P·xH2O (x = ca. 7)
Molecular weight 407,19 (anhydrous)
Assay Content not less than 97,0 % on the anhydrous basis1996L0077 — EN — 17.11.2002 — 004.001 — 169
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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 chromatographyLead Not more than 2 mg/kg
E628DIPOTASSIUMGUANYLATE
Synonyms Potassium guanylate, potassium 5'-guanylate
Definition
Chemical name Dipotassium guanosine-5'-monophosphate
EINECS 226-914-1
Chemical formula C
10H12K2N5O8P
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 8,5
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N
HCl at 256 nm
Purity
Loss on drying Not more than 5 % (120 ºC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E629CALCIUMGUANYLATE
Synonyms Calcium 5'-guanylate
Definition
Chemical name Calcium guanosine-5'-monophosphate
Chemical formula C10H12CaN5O8P·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 nm1996L0077 — EN — 17.11.2002 — 004.001 — 170
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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
E630INOSINICACID
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 chromatographyLead Not more than 2 mg/kg
E631DISODIUMINOSINATE
Synonyms Sodium inosinate, sodium 5'-inosinate
Definition
Chemical name Disodium inosine-5'-monophosphate
EINECS 225-146-4
Chemical formula C
10H11N4Na2O8P·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 chromatographyLead Not more than 2 mg/kg
E632DIPOTASSIUMINOSINATE
Synonyms Potassium inosinate, potassium 5'-inosinate1996L0077 — EN — 17.11.2002 — 004.001 — 171
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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 chromatography
Lead Not more than 2 mg/kg
E633CALCIUMINOSINATE
Synonyms Calcium 5'-inosinate
Definition
Chemical name Calcium inosine-5'-monophosphate
Chemical formula C10H11CaN4O8P·n H2O
Molecular weight 386,19 (anhydrous)
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for calcium
B. pH of a 0,05 % solution Between 7,0 and 8,0C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N
HCl at 250 nm
Purity
Water Not more than 23,0 % (Karl Fischer)Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E634CALCIUM5'-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 powder1996L0077 — EN — 17.11.2002 — 004.001 — 172
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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
E635DISODIUM5'-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 8,5
Purity
Water Not more than 26,0 % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatographyLead Not more than 2 mg/kg
E905MICROCRYSTALLINEWAX
Synonyms Petroleum wax
Definition Microcrystalline wax is a refined mixture of solid, satu-
rated 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
D1001,434-1,448
Purity
Molecular weight Average not less than 500
Viscosity at 100 ºC Not less than 1,1 · 10-5m2s-1
Residue on ignition Not more than 0,1 %
Carbon number at 5 % distillation
pointNot 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/kg1996L0077 — EN — 17.11.2002 — 004.001 — 173
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Polycyclic aromatic compounds The polycyclic aromatic hydrocarbons, obtained by
extraction with dimethyl sulfoxide, shall meet the
following ultraviolet absorbency limits:
nm Maximum absorbance per cm path length
280-289 0,15
290-299 0,12300-359 0,08360-400 0,02
E912MONTANACIDESTERS
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. Dropp oint Greater than 77 ºC
Purity
Acid value Not more than 40Glycerol Not more than 1 % (by gas chromatography)
Other polyols Not more than 1 % (by gas chromatography)
Other wax types Not detectable (by differential scanning calorimetry and/
or infrared spectroscopy)
Arsenic Not more than 2 mg/kg
Chromium Not more than 3 mg/kgLead Not more than 2 mg/kg
E914OXIDISEDPOLYETHYLENEWAX
Definition Polar reaction products from mild oxidation of polyethy-
lene
Chemical name Oxidised polyethylene
Description Almost white flakes, powder, granules or pellets
Identification
A. Density (20 ºC) Between 0,92 and 1,05
B. Dropp oint Greater than 95 ºC
Purity
Acid value Not more than 70Viscosity 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/kgLead Not more than 2 mg/kg
E950ACESULFAMEK
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 — 17.11.2002 — 004.001 — 174
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E951ASPARTAME
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.
E953ISOMALT
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 sweet-
eners for use in foodstuffs.
E957THAUMATIN
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.
E959NEOHESPERIDINEDIHYDROCHALCONE
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.
E965(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.
E965(ii)MALTITOLSYRUP
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.
E966LACTITOL
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.
E967XYLITOL
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 — 17.11.2002 — 004.001 — 175