I
(Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory)
DIRECTIVES
COMMISSION DIRECTIVE 2008/84/EC
of 27 August 2008
laying down specific purity criteria on food additives other than colours and sweeteners
(Text with EEA relevance)
(Codified version)
THE COMMISSION OF THE EUROPEAN COMMUNITIES,
Having regard to the Treaty establishing the European Commu-
nity,
Having regard to Council Directive 89/107/EEC of 21 December
1988 on the approximation of the laws of the Member Statesconcerning food additives authorised for use in foodstuffsintended for human consumption (
1), and in particular Article 3
(3)(a) thereof,
Whereas:
(1) Commission Directive 96/77/EC of 2 December 1996
laying down specific purity criteria on food additives other
than colours and sweeteners (2) has been substantially
amended several times (3). In the interests of clarity and
rationality the said Directive should be codified.
(2) It is necessary to establish purity criteria for all additives
other than colours and sweeteners mentioned in European
Parliament and Council Directive 95/2/EC of 20 February1995 on food additives other than colours and sweet-eners (
4).
(3) It is necessary to take into account the specifications and
analytical techniques for additives as set out in the Codex
Alimentarius as drafted by the Joint FAO/WHO Expert
Committee on Food Additives (JECFA).(4) Food additives prepared by production methods or starting
materials significantly different from those evaluated by the
Scientific Committee for Food or different from thosementioned in this Directive should be submitted for safetyevaluation by the European Food Safety Authority withemphasis on the purity criteria.
(5) The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health.
(6) This Directive should be without prejudice to the
obligations of the Member States relating to the time-limits
for transposition into national law of the Directives set outin Annex II, part B,
HAS ADOPTED THIS DIRECTIVE:
Article 1
The purity criteria referred to in Article 3(3)(a) of Directive 89/
107/EEC for food additives other than colours and sweeteners, as
mentioned in Directive 95/2/EC, are set out in Annex I to this
Directive.
Article 2
Directive 96/77/EC, as amended by the Directives listed in
Annex II, part A, is repealed, without prejudice to the obligationsof the Member States relating to the time-limits for transpositioninto national law set out in Annex II, part B.20.9.2008 EN Official Journal of the European Union L 253/1
(1) OJ L 40, 11.2.1989, p. 27.
(2) OJ L 339, 30.12.1996, p. 1.
(3) See Annex II, part A.
(4) OJ L 61, 18.3.1995, p. 1.References to the repealed Directive shall be construed as
references to this Directive and shall be read in accordance withthe correlation table in Annex III.
Article 3
This Directive shall enter into force on the 20th day following its
publication in the Official Journal of the European Union.Article 4
This Directive is addressed to the Member States.
Done at Brussels, 27 August 2008.
For the Commission
The President
José Manuel BARROSOL 253/2 EN Official Journal of the European Union 20.9.2008ANNEX I
Ethylene oxide may not be used for sterilising purposes in food additives.
E 170 (i) CALCIUM CARBONATE
Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC (1).
E 200 SORBIC ACID
Definition
Chemical name Sorbic acid
Trans, trans-2,4-hexadienoic acid
Einecs 203-768-7
Chemical formula C 6H8O2
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 105oC
Identification
A. Melting range Between 133oC and 135oC, after vacuum drying for four hours in a
sulphuric acid desiccator
B. Spectrometry An isopropanol solution (1 in 4 000 000) shows absorbance maximum
at 254 ± 2 nm
C. Positive test for double bondsD. Sublimation point 80
oC
Purity
Water content Not more than 0,5 % (Karl Fischer method)
Sulphated ash Not more than 0,2 %
Aldehydes Not more than 0,1 % (as formaldehyde)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 202 POTASSIUM SORBATE
Definition
Chemical name Potassium sorbate
Potassium (E, E)-2,4-hexadienoatePotassium salt of trans, trans 2,4-hexadienoic acid
Einecs 246-376-1
Chemical formula C
6H7O2K
Molecular weight 150,22
Assay Content not less than 99 % on the dried basis20.9.2008 EN Official Journal of the European Union L 253/3
(1) OJ L 226, 22.9.1995, p. 1.Description White crystalline powder showing no change in colour after heating for
90 minutes at 105oC
Identification
A. Melting range of sorbic acid isolated
by acidification and not recrystallised
133oC to 135oC after vacuum
drying in a sulphuric acid desiccator
B. Positive tests for potassium and for
double bonds
Purity
Loss on drying Not more than 1,0 % (105oC, 3h)
Acidity or alkalinity Not more than about 1,0 % (as sorbic acid or K 2CO 3)
Aldehydes Not more than 0,1 %, calculated as formaldehyde
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 203 CALCIUM SORBATE
Definition
Chemical name Calcium sorbate
Calcium salts of trans, trans-2,4-hexadienoic acid
Einecs 231-321-6
Chemical formula C
12H14O4Ca
Molecular weight 262,32Assay Content not less than 98 % on the dried basis
Description Fine white crystalline powder not showing any change in colour after
heating at 105
oC for 90 minutes
Identification
A. Melting range of sorbic acid isolated
by acidification and not recrystallised
133oC to 135oC 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/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/kgL 253/4 EN Official Journal of the European Union 20.9.2008E 210 BENZOIC ACID
Definition
Chemical name Benzoic acid
Benzenecarboxylic acidPhenylcarboxylic acid
Einecs 200-618-2Chemical formula C
7H6O2
Molecular weight 122,12Assay Content not less than 99,5 % on the anhydrous basis
Description White crystalline powder
Identification
A. Melting range 121,5
oC to 123,5oC
B. Positive sublimation test and test for
benzoate
Purity
Loss on drying Not more than 0,5 % after drying for three hours over sulphuric acidpH About 4 (solution in water)Sulphated ash Not more than 0,05 %Chlorinated organic compounds Not more than 0,07 % expressed as chloride corresponding to 0,3 %
expressed as monochlorobenzoic acid
Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point
and add 0,1 N KMnO
4in drops, until the pink colour persists for
30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in
the heated solution, and titrate with 0,1 N KMnO 4to a pink colour that
persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 %
sulphuric acid must not show a stronger colouring than that of a
reference liquid containing 0,2 ml of cobalt chloride TSC (2), 0,3 ml of
ferric chloride TSC (3), 0,1 ml of copper sulphate TSC (4) and 4,4 ml of
water
Polycyclic acids On fractional acidification of a neutralised solution of benzoic acid, the
first precipitate must not have a different melting point from that of the
benzoic acid
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
(2) Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl 2·6H 2O in a sufficient quantity of a mixture of 25 ml hydrochloric
acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml
of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to
cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine
with sodium thiosulphate (0,1 N) in the presence of starch TS (*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of
CoCl 2·6H 2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a
solution containing 59,5 mg of CoCl 2·6H 2O per ml.
(3) Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and
975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine
solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then
titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (*). 1 ml of sodium thiosulphate (0,1 N)
corresponds to 27,03 mg of FeCl 3·6H 2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/
water to give a solution containing 45,0 mg of FeCl 3·6H 2O per ml.
(4) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO 4·5H 2O in a sufficient quantity of a mixture of 25 ml of
hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing
250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium
thiosulphate (0,1 N) in the presence of starch TS (*). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO 4·5H 2O. Adjust
final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing
62,4 mg of CuSO 4·5H 2O per ml.
(*) Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient
quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be
freshly prepared.20.9.2008 EN Official Journal of the European Union L 253/5E 211 SODIUM BENZOATE
Definition
Chemical name Sodium benzoate
Sodium salt of benzenecarboxylic acidSodium salt of phenylcarboxylic acid
Einecs 208-534-8Chemical formula C
7H5O2Na
Molecular weight 144,11
Assay Not less than 99 % of C 7H5O2Na, after drying at 105oC for four hours
Description A white, almost odourless, crystalline powder or granules
Identification
A. Solubility Freely soluble in water, sparingly soluble in ethanol
B. Melting range for benzoic acid Melting range of benzoic acid isolated by acidification and not
recrystallised 121,5oC to 123,5oC, after drying in a sulphuric acid
desiccator
C. Positive tests for benzoate and for
sodium
Purity
Loss on drying Not more than 1,5 % after drying at 105oC for four hours
Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point
and add 0,1 N KMnO 4in drops, until the pink colour persists for
30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in
the heated solution, and titrate with 0,1 N KMnO 4to a pink colour that
persists for 15 seconds. Not more than 0,5 ml should be required
Polycyclic acids On fractional acidification of a (neutralised) solution of sodium
benzoate, the first precipitate must not have a different melting range
from that of benzoic acid
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 %
expressed as monochlorobenzoic acid
Degree of acidity or alkalinity Neutralisation of 1 g of sodium benzoate, in the presence of
phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH
or 0,1 N HCl
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 212 POTASSIUM BENZOATE
Definition
Chemical name Potassium benzoate
Potassium salt of benzenecarboxylic acid
Potassium salt of phenylcarboxylic acid
Einecs 209-481-3Chemical formula C
7H5KO 2·3H 2O
Molecular weight 214,27
Assay Content not less than 99 % C 7H5KO 2after drying at 105oC to constant
weight
Description White crystalline powderL 253/6 EN Official Journal of the European Union 20.9.2008Identification
A. Melting range of benzoic acid iso-
lated by acidification and not recrys-
tallised 121,5oC to 123,5oC, 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 105oC
Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 %
expressed as monochlorobenzoic acid
Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point
and add 0,1 N KMnO 4in drops, until the pink colour persists for
30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in
the heated solution, and titrate with 0,1 N KMnO 4to a pink colour that
persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 %
sulphuric acid must not show a stronger colouring than that of a
reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of
ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids On fractional acidification of a (neutralised) solution of potassium
benzoate, the first precipitate must not have a different melting range
from that of benzoic acid
Degree of acidity or alkalinity Neutralisation of 1 g of potassium benzoate, in the presence of
phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or
0,1 N HCl
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 213 CALCIUM BENZOATE
Synonyms Monocalcium benzoate
Definition
Chemical name Calcium benzoate
Calcium dibenzoate
Einecs 218-235-4
Chemical formula Anhydrous: C
14H10O4Ca
Monohydrate: C 14H10O4Ca·H2O
Trihydrate: C 14H10O4Ca·3H 2O
Molecular weight Anhydrous: 282,31
Monohydrate: 300,32Trihydrate: 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 iso-
lated by acidification and not recrys-
tallised 121,5oC to 123,5oC, after
vacuum drying in a sulphuric acid
desiccator
B. Positive tests for benzoate and for
calcium20.9.2008 EN Official Journal of the European Union L 253/7Purity
Loss on drying Not more than 17,5 % determined by drying at 105oC to constant
weight
Water insoluble matter Not more than 0,3 %Chlorinated organic compounds Not more than 0,06 % expressed as chloride, corresponding to 0,25 %
expressed as monochlorobenzoic acids
Readily oxidisable substances Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point
and add 0,1 N KMnO
4in drops, until the pink colour persists for
30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in
the heated solution, and titrate with 0,1 N KMnO 4to a pink colour that
persists for 15 seconds. Not more than 0,5 ml should be required
Readily carbonisable substances Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 %
sulphuric acid must not show a stronger colouring than that of a
reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of
ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
Polycyclic acids On fractional acidification of a (neutralised) solution of calcium
benzoate, the first precipitate must not be a different melting range
from that of benzoic acid
Degree of acidity or alkalinity Neutralisation of 1 g of calcium benzoate, in the presence of
phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH
or 0,1 N HCl
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 214 ETHYL p-HYDROXYBENZOATE
Synonyms Ethylparaben
Ethyl p-oxybenzoate
Definition
Chemical name Ethyl-p-hydroxybenzoate
Ethyl ester of p-hydroxybenzoic acid
Einecs 204-399-4
Chemical formula C
9H10O3
Molecular weight 166,8
Assay Content not less than 99,5 % after drying for two hours at 80oC
Description Almost odourless, small, colourless crystals or a white, crystalline
powder
Identification
A. Melting range 115oC to 118oC
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid isolated by acidification and not
recrystallised: 213oC to 217oC, 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 80oC
Sulphated ash Not more than 0,05 %
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgL 253/8 EN Official Journal of the European Union 20.9.2008Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 215 SODIUM ETHYL p-HYDROXYBENZOATE
Definition
Chemical name Sodium ethyl p-hydroxybenzoate
Sodium compound of the ethyl ester of p-hydroxybenzoic acid
Einecs 252-487-6
Chemical formula C 9H9O3Na
Molecular weight 188,8
Assay Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the
anhydrous basis
Description White, crystalline hygroscopic powder
Identification
A. Melting range 115oC to 118oC, 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
213oC to 217oC
C. Positive test for sodium
D. pH of a 0,1 % aqueous solution must
be between 9,9 and 10,3
Purity
Loss on drying Not more than 5 %, determined by vacuum drying in a sulphuric acid
desiccator
Sulphated ash 37 to 39 %
p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 218 METHYL p-HYDROXYBENZOATE
Synonyms Methylparaben
Methyl-p-oxybenzoate
Definition
Chemical name Methyl p-hydroxybenzoate
Methyl ester of p-hydroxybenzoic acid
Einecs 243-171-5
Chemical formula C
8H8O3
Molecular weight 152,15
Assay Content not less than 99 % after drying for two hours at 80oC
Description Almost odourless, small colourless crystals or white crystalline powder20.9.2008 EN Official Journal of the European Union L 253/9Identification
A. Melting range 125oC to 128oC
B. Positive test for p-hydroxybenzoate Melting range of p-hydroxybenzoic acid derived from the sample is
213oC to 217oC after drying for two hours at 80oC
Purity
Loss on drying Not more than 0,5 %, after drying for two hours at 80oC
Sulphated ash Not more than 0,05 %p-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 219 SODIUM METHYL p-HYDROXYBENZOATE
Definition
Chemical name Sodium methyl p-hydroxybenzoate
Sodium compound of the methylester of p-hydroxybenzoic acid
Chemical formula C
8H7O3Na
Molecular weight 174,15Assay 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 of125
oC to 128oC
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 basisp-Hydroxybenzoic acid and salicylic acid Not more than 0,35 % expressed as p-hydroxybenzoic acid
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgL 253/10 EN Official Journal of the European Union 20.9.2008E 220 SULPHUR DIOXIDE
Definition
Chemical name Sulphur dioxide
Sulphurous acid anhydride
Einecs 231-195-2
Chemical formula SO 2
Molecular weight 64,07Assay Content not less than 99 %
Description Colourless, non-flammable gas with strong pungent suffocating odour
Identification
A. Positive test for sulphurous sub-
stances
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/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 221 SODIUM SULPHITE
Definition
Chemical name Sodium sulphite (anhydrous or heptahydrate)
Einecs 231-821-4
Chemical formula Anhydrous: Na
2SO 3
Heptahydrate: Na 2SO 37H 2O
Molecular weight Anhydrous: 126,04
Heptahydrate: 252,16
Assay Anhydrous: Not less than 95 % of Na 2SO 3and not less than
48 % of SO 2
Heptahydrate: Not less than 48 % of Na 2SO 3and not less than
24 % of SO 2
Description White crystalline powder or colourless crystals
Identification
A. Positive tests for sulphite and for
sodium
B. pH of a 10 % solution (anhydrous) or
a 20 % solution (heptahydrate)
between 8,5 and 11,520.9.2008 EN Official Journal of the European Union L 253/11Purity
Thiosulphate Not more than 0,1 % based on the SO 2content
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 222 SODIUM BISULPHITE
Definition
Chemical name Sodium bisulphite
Sodium hydrogen sulphite
Einecs 231-921-4Chemical formula NaHSO
3in aqueous solution
Molecular weight 104,06
Assay Content not less than 32 % w/w NaHSO 3
Description A clear, colourless to yellow solution
Identification
A. Positive tests for sulphite and for
sodium
B. pH of a 10 % aqueous solution
between 2,5 and 5,5
Purity
Iron Not more than 50 mg/kg of Na 2SO 3based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 223 SODIUM METABISULPHITE
Synonyms Pyrosulphite
Sodium pyrosulphite
Definition
Chemical name Sodium disulphite
Disodium pentaoxodisulphate
Einecs 231-673-0Chemical formula Na
2S2O5
Molecular weight 190,11Assay Content not less than 95 % Na
2S2O5and not less than 64 % of SO 2
Description White crystals or crystalline powder
Identification
A. Positive tests for sulphite and for
sodiumL 253/12 EN Official Journal of the European Union 20.9.2008B. pH of a 10 % aqueous solution
between 4,0 and 5,5
Purity
Thiosulphate Not more than 0,1 % based on the SO 2content
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 224 POTASSIUM METABISULPHITE
Synonyms Potassium pyrosulphite
Definition
Chemical name Potassium disulphite
Potassium pentaoxo disulphate
Einecs 240-795-3Chemical formula K
2S2O5
Molecular weight 222,33Assay Content not less than 90 % of K
2S2O5and not less than 51,8 % of SO 2,
the remainder being composed almost entirely of potassium sulphate
Description Colourless crystals or white crystalline powder
Identification
A. Positive tests for sulphite and for
potassium
Purity
Thiosulphate Not more than 0,1 % based on the SO 2content
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 226 CALCIUM SULPHITE
Definition
Chemical name Calcium sulphite
Einecs 218-235-4
Chemical formula CaSO
3·2H 2O
Molecular weight 156,17
Assay Content not less than 95 % of CaSO 3·2H 2O and not less than 39 % of
SO 2
Description White crystals or white crystalline powder
Identification
A. Positive tests for sulphite and for
calcium20.9.2008 EN Official Journal of the European Union L 253/13Purity
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 227 CALCIUM BISULPHITE
Definition
Chemical name Calcium bisulphite
Calcium hydrogen sulphite
Einecs 237-423-7
Chemical formula Ca(HSO
3)2
Molecular weight 202,22
Assay 6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium
dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite
[Ca(HSO 3)2]
Description Clear greenish-yellow aqueous solution having a distinct odour of
sulphur dioxide
Identification
A. Positive tests for sulphite and for
calcium
Purity
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2content
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 228 POTASSIUM BISULPHITE
Definition
Chemical name Potassium bisulphite
Potassium hydrogen sulphite
Einecs 231-870-1Chemical formula KHSO
3in aqueous solution
Molecular weight 120,17
Assay Content not less than 280 g KHSO 3per litre (or 150 g SO 2per litre)
Description Clear colourless aqueous solution
Identification
A. Positive tests for sulphite and for
potassium
Purity
Iron Not more than 50 mg/kg based on the SO 2content
Selenium Not more than 10 mg/kg based on the SO 2contentL 253/14 EN Official Journal of the European Union 20.9.2008Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 230 BIPHENYL
Synonyms Diphenyl
Definition
Chemical name 1,1′-biphenyl
Phenylbenzene
Einecs 202-163-5
Chemical formula C 12H10
Molecular weight 154,20
Assay Content not less than 99,8 %
Description White or pale yellow to amber crystalline solid having a characteristic
odour
Identification
A. Melting range 68,5oC to 70,5oC
B. Distillation range It distils completely within a 2,5oC range between 252,5oC and
257,5oC
Purity
Benzene Not more than 10 mg/kg
Aromatic amines Not more than 2 mg/kg (as aniline)
Phenol derivatives Not more than 5 mg/kg (as phenol)Readily carbonisable substances Cold solution of 0,5 g of biphenyl in 5 ml of 94,5 to 95,5 % sulphuric
acid must not show a stronger colouring than that of a reference liquid
containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC,
0,1 ml of copper sulphate TSC and 4,4 ml of water
Terphenyl and higher polyphenyl deriva-
tivesNot more than 0,2 %
Polycyclic aromatic hydrocarbons Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 231 ORTHOPHENYLPHENOL
Synonyms Orthoxenol
Definition
Chemical name (1,1'-Biphenyl)-2-ol
2-Hydroxydiphenyl
o-Hydroxydiphenyl
Einecs 201-993-5Chemical formula C
12H10O
Molecular weight 170,20
Assay Content not less than 99 %
Description White or slightly yellowish crystalline powder20.9.2008 EN Official Journal of the European Union L 253/15Identification
A. Melting range 56oC to 58oC
B. Positive test for phenolate An ethanolic solution (1 g in 10 ml) produces a green colour on
addition of 10 % ferric chloride solution
Purity
Sulphated ash Not more than 0,05 %
Diphenyl ether Not more than 0,3 %p-Phenylphenol Not more than 0,1 %
1-Naphthol Not more than 0,01 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 232 SODIUM ORTHOPHENYLPHENOL
Synonyms Sodium orthophenylphenate
Sodium salt of
o-phenylphenol
Definition
Chemical name Sodium orthophenylphenol
Einecs 205-055-6
Chemical formula C 12H9ONa· 4H 2O
Molecular weight 264,26
Assay Content not less than 97 % of C 12H9ONa· 4H 2O
Description White or slightly yellowish crystalline powder
Identification
A. Positive tests for phenolate and for
sodium
B. Melting range of orthophenylphenol
isolated by acidification and not
recrystallised derived from the sam-
ple 56oC to 58oC after drying in a
sulphuric acid desiccator
C. pH of a 2 % aqueous solution must
be between 11,1 and 11,8
Purity
Diphenylether Not more than 0,3 %
p-phenylphenol Not more than 0,1 %1-naphthol Not more than 0,01 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 233 THIABENDAZOLE
Definition
Chemical name 4-(2-benzimidazolyl)thiazole
2-(4-thiazolyl)-1H-benzimidazoleL 253/16 EN Official Journal of the European Union 20.9.2008Einecs 205-725-8
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 296oC to 303oC
B. Spectrometry Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm
and 243 nm
E1%
1cmat 302 nm ± 2 nm: approximately 1 230
E1%
1cmat 258 nm ± 2 nm: approximately 200
E1%
1cmat 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/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 234 NISIN
Definition Nisin consists of several closely related polypeptides produced by natural
strains of Streptococcus lactis, Lancefield group N
Einecs 215-807-5
Chemical formula C
143H230N42O37S7
Molecular weight 3 354 ,12
Assay Nisin concentrate contains not less than 900 units per mg in a mixture
of non-fat milk solids and a minimum sodium chloride content of 50 %
Description White powder
Purity
Loss on drying Not more than 3 % when dried to constant weight at 102oC to 103oC
Arsenic Not more than 1 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 235 NATAMYCIN
Synonyms Pimaricin
Definition Natamycin is a fungicide of the polyene macrolide group, and is
produced by natural strains of Streptomyces natalensis or of Streptococcus
lactis20.9.2008 EN Official Journal of the European Union L 253/17Einecs 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 drop of:
—concentrated hydrochloric acid, a blue colour develops,
—concentrated phosphoric acid, a green colour develops,
which changes into pale red after a few minutes
B. Spectrometry A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has
absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder
at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and
311 nm
C. pH 5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of
20 parts dimethylformamide and 80 parts of water)
D. Specific rotation [α] D20= + 250oto + 295o(a 1 % w/v solution in glacial acetic acid, at
20oC and calculated with reference to the dried material)
Purity
Loss on drying Not more than 8 % (over P 2O5, in vacuum at 60oC to constant weight)
Sulphated ash 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
Heavy metals (as Pb) Not more than 10 mg/kg
Microbiological criteria: total viable count Not more than 100/g
E 239 HEXAMETHYLENE TETRAMINE
Synonyms Hexamine
Methenamine
Definition
Chemical name 1,3,5,7-Tetraazatricyclo [3.3.1.1
3,7]-decane, hexamethylenetetramine
Einecs 202-905-8
Chemical formula C 6H12N4
Molecular weight 140,19
Assay Content not less than 99 % on the anhydrous basis
Description Colourless or white crystalline powder
Identification
A. Positive tests for formaldehyde and
for ammonia
B. Sublimation point approximately
260oC
Purity
Loss on drying Not more than 0,5 % after drying at 105oC in vacuum over P 2O5for
two hours
Sulphated ash Not more than 0,05 %
Sulphates Not more than 0,005 % expressed as SO 4L 253/18 EN Official Journal of the European Union 20.9.2008Chlorides 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
E 242 DIMETHYL DICARBONATE
Synonyms DMDC
Dimethyl pyrocarbonate
Definition
Chemical name Dimethyl dicarbonate
Pyrocarbonic acid dimethyl ester
Einecs 224-859-8
Chemical formula C
4H6O5
Molecular weight 134,09
Assay Content not less than 99,8 %
Description Colourless liquid, decomposes in aqueous solution. It is corrosive to skin
and eyes and toxic by inhalation and ingestion
Identification
A. Decomposition After dilution positive tests for CO 2and methanol
B. Melting point 17oC
Boiling point 172oC with decomposition
C. Density 20oC Approximately 1,25 g/cm3
D. Infrared spectrum Maxima at 1 156 and 1 832 cm−1
Purity
Dimethyl carbonate Not more than 0,2 %Chlorine, total Not more than 3 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 249 POTASSIUM NITRITE
Definition
Chemical name Potassium nitrite
Einecs 231-832-4
Chemical formula KNO
2
Molecular weight 85,11
Assay Content not less than 95 % on the anhydrous basis (5)
Description White or slightly yellow, deliquescent granules20.9.2008 EN Official Journal of the European Union L 253/19
(5) When labelled ‘for food use ’, nitrite may only be sold in a mixture with salt or a salt substitute.Identification
A. Positive tests for nitrite and for
potassium
B. pH of a 5 % solution: Not less than 6,0 and not more than 9,0
Purity
Loss on drying Not more than 3 % after drying for four hours over silica gel
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 250 SODIUM NITRITE
Definition
Chemical name Sodium nitrite
Einecs 231-555-9
Chemical formula NaNO
2
Molecular weight 69,00
Assay Content not less than 97 % on the anhydrous basis (6)
Description White crystalline powder or yellowish lumps
Identification
A. Positive tests for nitrite and for
sodium
Purity
Loss on drying Not more than 0,25 % after drying over silica gel for four hours
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 251 SODIUM NITRATE
1. SOLID SODIUM NITRATE
Synonyms Chile saltpetre
Cubic or soda nitre
Definition
Chemical name Sodium nitrate
Einecs 231-554-3
Chemical formula NaNO
3
Molecular weight 85,00
Assay Content not less than 99 % after drying
Description White crystalline, slightly hygroscopic powderL 253/20 EN Official Journal of the European Union 20.9.2008
(6) When labelled ‘for food use ’, nitrite may only be sold in a mixture with salt or a salt substitute.Identification
A. Positive tests for nitrate and for
sodium
B. pH of a 5 % solution Not less than 5,5 and more than 8,3
Purity
Loss on drying Not more than 2 % after drying at 105oC 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
E 251 SODIUM NITRATE
2. LIQUID SODIUM NITRATE
Definition Liquid sodium nitrate is an aqueous solution of sodium nitrate as the
direct result of the chemical reaction between sodium hydroxide and
nitric acid in stoechiometric amounts, without subsequent crystal-
lisation. Standardised forms prepared from liquid sodium nitrate
meeting these specifications may contain nitric acid in excessiveamounts, if clearly stated or labelled.
Chemical name Sodium nitrate
Einecs 231-554-3Chemical formula NaNO
3
Molecular weight 85,00Assay Content between 33,5 % and 40,0 % of NaNO
3
Description Clear colourless liquid
Identification
A. Positive tests for nitrate and for
sodium
B. pH Not less than 1,5 and not more than 3,5
Purity
Free nitric acid Not more than 0,01 %
Nitrites Not more than 10 mg/kg expressed as NaNO 2
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 0,3 mg/kgThis specification refers to a 35 %
aqueous solution
E 252 POTASSIUM NITRATE
Synonyms Chile saltpetre
Cubic or soda nitre
Definition
Chemical name Potassium nitrateEinecs 231-818-8
Chemical formula KNO
3
Molecular weight 101,11
Assay Content not less than 99 % on the anhydrous basis20.9.2008 EN Official Journal of the European Union L 253/21Description 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 105oC for four hours
Nitrites Not more than 20 mg/kg expressed as KNO 2
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 260 ACETIC ACID
Definition
Chemical name Acetic acid
Ethanoic acid
Einecs 200-580-7
Chemical formula C
2H4O2
Molecular weight 60,05
Assay Content not less than 99,8 %
Description Clear, colourless liquid having a pungent, characteristic odour
Identification
A. Boiling point 118oC at 760 mm pressure (of mercury)
B. Specific gravity About 1,049
C. A one in three solution gives positive
tests for acetate
D. Solidification point Not lower than 14,5oC
Purity
Non-volatile residue Not more than 100 mg/kg
Formic acid, formates and other oxidisa-
ble substancesNot more than 1 000 mg/kg expressed as formic acid
Readily oxidisable substances Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of
water and add 0,1 ml of 0,1 N potassium permanganate. The pink
colour does not change to brown within 30 minutes
Arsenic Not more than 1 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 261 POTASSIUM ACETATE
Definition
Chemical name Potassium acetate
Einecs 204-822-2
Chemical formula C
2H3O2K
Molecular weight 98,14L 253/22 EN Official Journal of the European Union 20.9.2008Assay Content not less than 99 % on the anhydrous basis
Description Colourless, deliquescent crystals or a white crystalline powder, odourless
or with a faint acetic odour
Identification
A. pH of a 5 % aqueous solution Not less than 7,5 and not more than 9,0
B. Positive tests for acetate and for
potassium
Purity
Loss on drying Not more than 8 % after drying at 150oC for two hours
Formic acid, formates and other oxidisa-
ble 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/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 262 (i) SODIUM ACETATE
Definition
Chemical name Sodium acetate
Einecs 204-823-8
Chemical formula C 2H3NaO 2·nH 2O (n = 0 or 3)
Molecular weight Anhydrous: 82,03
Trihydrate: 136,08
Assay Content (for both of anhydrous and trihydrate form) not less than
98,5 % on the anhydrous basis
Description Anhydrous: White, odourless, granular, hygroscopic powder
Trihydrate: Colourless, transparent crystals or a granular
crystalline powder, odourless or with a faint,
acetic odour. Effloresces in warm, dry air
Identification
A. pH of a 1 % aqueous solution Not less than 8,0 and not more than 9,5
B. Positive tests for acetate and for
sodium
Purity
Loss on drying Anhydrous: Not more than 2 % (120oC, 4 hours)
Trihydrate: Between 36 and 42 % (120oC, 4 hours)
Formic acid, formates and other oxidisa-
ble substancesNot more than 1 000 mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 262 (ii) SODIUM DIACETATE
Definition Sodium diacetate is a molecular compound of sodium acetate and acetic
acid
Chemical name Sodium hydrogen diacetate20.9.2008 EN Official Journal of the European Union L 253/23Einecs 204-814-9
Chemical formula C 4H7NaO 4·nH 2O (n = 0 or 3)
Molecular weight 142,09 (anhydrous)
Assay Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate
Description White, hygroscopic crystalline solid with an acetic odour
Identification
A. pH of a 10 % aqueous solution Not less than 4,5 and not more than 5,0B. Positive tests for acetate and for
sodium
Purity
Water content Not more than 2 % (Karl Fischer method)
Formic acid, formates and other oxidisa-
ble substancesNot more than 1 000 mg/kg expressed as formic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 263 CALCIUM ACETATE
Definition
Chemical name Calcium acetateEinecs 200-540-9Chemical formula Anhydrous: C
4H6O4Ca
Monohydrate: C 4H6O4Ca·H2O
Molecular weight Anhydrous: 158,17
Monohydrate: 176,18
Assay Content not less than 98 % on the anhydrous basis
Description Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline
solid with a slightly bitter taste. A slight odour of acetic acid may be
present. The monohydrate may be needles, granules or powder
Identification
A. pH of a 10 % aqueous solution Not less than 6,0 and not more than 9,0B. Positive tests for acetate and for
calcium
Purity
Loss on drying Not more than 11 % after drying (155
oC to constant weight, for the
monohydrate)
Water insoluble matter Not more than 0,3 %Formic acid, formates and other oxidisa-
ble 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/kgL 253/24 EN Official Journal of the European Union 20.9.2008E 270 LACTIC ACID
Definition
Chemical name Lactic acid
2-Hydroxypropionic acid
1-Hydroxyethane-1-carboxylic acid
Einecs 200-018-0Chemical formula C
3H6O3
Molecular weight 90,08Assay Content not less than 76 % and not more than 84 %
Description Colourless or yellowish, nearly odourless, syrupy liquid with an acid
taste, consisting of a mixture of lactic acid (C
3H6O3) and lactic acid
lactate (C 6H10O5). It is obtained by the lactic fermentation of sugars or is
prepared synthetically
Note:
Lactic acid is hygroscopic and when
concentrated by boiling, it condenses to
form lactic acid lactate, which on dilution
and heating hydrolyzes to lactic acid
Identification
A. Positive test for lactate
Purity
Sulphated ash Not more than 0,1 %
Chloride Not more than 0,2 %Sulphate Not more than 0,25 %
Iron Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Note:
This specification refers to a 80 %
aqueous solution; for weaker aqueous
solutions, calculate values corresponding
to their lactic acid content
E 280 PROPIONIC ACID
Definition
Chemical name Propionic acid
Propanoic acid
Einecs 201-176-3
Chemical formula C
3H6O2
Molecular weight 74,08
Assay Content not less than 99,5 %
Description Colourless or slightly yellowish, oily liquid with a slightly pungent odour20.9.2008 EN Official Journal of the European Union L 253/25Indentification
A. Melting point −22oC
B. Distillation range 138,5oC to 142,5oC
Purity
Non-volatile residue Not more than 0,01 % when dried at 140oC to constant weight
Aldehydes Not more than 0,1 % expressed as formaldehyde
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 281 SODIUM PROPIONATE
Definition
Chemical name Sodium propionate
Sodium propanoate
Einecs 205-290-4Chemical formula C
3H5O2Na
Molecular weight 96,06
Assay Content not less than 99 % after drying for two hours at 105oC
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 105oC
Water insolubles Not more than 0,1 %
Iron Not more than 50 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 282 CALCIUM PROPIONATE
Definition
Chemical name Calcium propionate
Einecs 223-795-8
Chemical formula C
6H10O4Ca
Molecular weight 186,22
Assay Content not less than 99 %, after drying for two hours at 105oC
Description White crystalline powder
Identification
A. Positive tests for propionate and for
calcium
B. pH of a 10 % aqueous solution Between 6,0 and 9,0L 253/26 EN Official Journal of the European Union 20.9.2008Purity
Loss on drying Not more than 4 %, determined by drying for two hours at 105oC
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/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 283 POTASSIUM PROPIONATE
Definition
Chemical name Potassium propionate
Potassium propanoate
Einecs 206-323-5Chemical formula C
3H5KO 2
Molecular weight 112,17Assay 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 105oC
Water-insoluble substances Not more than 0,3 %
Iron Not more than 30 mg/kgFluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 284 BORIC ACID
Synonyms Boracic acid
Orthoboric acid
Borofax
Definition
Einecs 233-139-2
Chemical formula H
3BO 3
Molecular weight 61,84
Assay Content not less than 99,5 %
Description Colourless, odourless, transparent crystals or white granules or powder;
slightly unctuous to the touch; occurs in nature as the mineral sassolite20.9.2008 EN Official Journal of the European Union L 253/27Identification
A. Melting point At approximately 171oC
B. Burns with a nice green flame
C. pH of a 3,3 % aqueous solution Between 3,8 and 4,8
Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 285 SODIUM TETRABORATE (BORAX)
Synonyms Sodium borate
Definition
Chemical name Sodium tetraborate
Sodium biborate
Sodium pyroborate
Anhydrous tetraborate
Einecs 215-540-4
Chemical formula Na
2B4O7
Na2B4O7·10H 2O
Molecular weight 201,27
Description Powder or glass-like plates becoming opaque on exposure to air; slowly
soluble in water
Identification
A. Melting range Between 171oC and 175oC with decomposition
Purity
Peroxides No colour develops with added KI-solution
Arsenic Not more than 1 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 290 CARBON DIOXIDE
Synonyms Carbonic acid gas
Dry ice (solid form)Carbonic anhydride
Definition
Chemical name Carbon dioxideEinecs 204-696-9
Chemical formula CO
2
Molecular weight 44,01
Assay Content not less than 99 % v/v on the gaseous basisL 253/28 EN Official Journal of the European Union 20.9.2008Description A colourless gas under normal environmental conditions with a slight
pungent odour. Commercial carbon dioxide is shipped and handled as a
liquid in pressurised cylinders or bulk storage systems, or in compressed
solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added
substances, such as propylene glycol or mineral oil, as binders
Identification
A. Precipitation (Precipitate formation) When a stream of the sample is passed through a solution of barium
hydroxide, a white precipitate is produced which dissolves with
effervescence in dilute acetic acid
Purity
Acidity 915 ml of gas bubbled through 50 ml of freshly boiled water must not
render the latter more acid to methylorange than is 50 ml freshly boiled
water to which has been added 1 ml of hydrochloric acid (0,01 N)
Reducing substances, hydrogen 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
E 296 MALIC ACID
Synonyms DL-Malic acid, pomalous acid
Definition
Chemical name DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid
Einecs 230-022-8
Chemical formula C 4H6O5
Molecular weight 134,09
Assay Content not less than 99,0 %
Description White or nearly white crystalline powder or granules
Identification
A. Melting range between 127oC and
132oC
B. Positive test for malate
C. Solutions of this substance are opti-
cally inactive in all concentrations
Purity
Sulphated ash Not more than 0,1 %Fumaric acid Not more than 1,0 %
Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 297 FUMARIC ACID
Definition
Chemical name Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid
Einecs 203-743-0
Chemical formula C
4H4O420.9.2008 EN Official Journal of the European Union L 253/29Molecular weight 116,07
Assay Content not less than 99,0 % on the anhydrous basis
Description White crystalline powder or granules
Identification
A. Melting range 286oC-302oC (closed capillary, rapid heating)
B. Positive tests for double bonds and
for 1,2-dicarboxylic acid
C. pH of a 0,05 % solution at 25oC 3,0-3,2
Purity
Loss on drying Not more than 0,5 % (120oC, 4h)
Sulphated ash Not more than 0,1 %
Maleic acid Not more than 0,1 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 300 ASCORBIC ACID
Definition
Chemical name L-ascorbic acid
Ascorbic acid2,3-Didehydro-L-threo-hexono-1,4-lactone3-Keto-L-gulofuranolactone
Einecs 200-066-2Chemical formula C
6H8O6
Molecular weight 176,13
Assay Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for
24 hours, contains not less than 99 % of C 6H8O6
Description White to pale yellow, odourless crystalline solid
Identification
A. Melting range Between 189oC and 193oC with decomposition
B. Positive tests for ascorbic acid
Purity
Loss on drying Not more than 0,4 % after drying in a vacuum desiccator over sulphuric
acid for 24 hours
Sulphated ash Not more than 0,1 %Specific rotation [α]
D20between + 20,5oand + 21,5o(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/kgL 253/30 EN Official Journal of the European Union 20.9.2008E 301 SODIUM ASCORBATE
Definition
Chemical name Sodium ascorbate
Sodium L-ascorbate
2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate3-Keto-L-gulofurano-lactone sodium enolate
Einecs 205-126-1
Chemical formula C
6H7O6Na
Molecular weight 198,11
Assay Sodium ascorbate, after drying in a vacuum desiccator over sulphuric
acid for 24 hours, contains not less than 99 % of C 6H7O6Na
Description White or almost white, odourless crystalline solid which darkens on
exposure to light
Identification
A. Positive tests for ascorbate and for
sodium
Purity
Loss on drying Not more than 0,25 % after drying in a vacuum desiccator over
sulphuric acid for 24 hours
Specific rotation [α] D20between + 103oand + 106o(10 % w/v aqueous solution)
pH of 10 % aqueous solution Between 6,5 and 8,0Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 302 CALCIUM ASCORBATE
Definition
Chemical name Calcium ascorbate dihydrate
Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
Einecs 227-261-5Chemical formula C
12H14O12Ca·2H 2O
Molecular weight 426,35
Assay Content not less than 98 % on a volatile matter-free basis
Description White to slightly pale greyish-yellow odourless crystalline powder
Identification
A. Positive tests for ascorbate and for
calcium
Purity
Fluoride Not more than 10 mg/kg (expressed as fluorine)
Specific rotation [α] D20between + 95oand + 97o(5 % w/v aqueous solution)
pH of 10 % aqueous solution Between 6,0 and 7,5Volatile 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/kg20.9.2008 EN Official Journal of the European Union L 253/31E 304 (i) ASCORBYL PALMITATE
Definition
Chemical name Ascorbyl palmitate
L-ascorbyl palmitate2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate
6-palmitoyl-3-keto-L-gulofuranolactone
Einecs 205-305-4Chemical 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 107oC and 117oC
Purity
Loss on drying Not more than 2,0 % after drying in a vacuum oven at 56oC and 60oC
for one hour
Sulphated ash Not more than 0,1 %
Specific rotation [α] D20between + 21oand + 24o(5 % w/v in methanol solution)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 304 (ii) ASCORBYL STEARATE
Definition
Chemical name Ascorbyl stearate
L-ascorbyl stearate2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate
6-stearoyl-3-keto-L-gulofuranolactone
Einecs 246-944-9Chemical 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 116oC
Purity
Loss on drying Not more than 2,0 % after drying in a vacuum oven at 56oC to 60oC
for one hour
Sulphated ash Not more than 0,1 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgL 253/32 EN Official Journal of the European Union 20.9.2008E 306 TOCOPHEROL-RICH EXTRACT
Definition Product obtained by the vacuum steam distillation of edible vegetable oil
products, comprising concentrated tocopherols and tocotrienols
Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols
Molecular weight 430,71 (d-α-tocopherol)Assay Content not less than 34 % of total tocopherols
Description Brownish red to red, clear, viscous oil having a mild, characteristic odour
and taste. May show a slight separation of wax-like constituents in
microcrystalline form
Identification
A. By suitable gas liquid 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 [α]
D20not less than + 20o
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 307 ALPHA-TOCOPHEROL
Synonyms DL-α-Tocopherol
Definition
Chemical name DL-5,7,8-Trimethyltocol
DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs 233-466-0
Chemical formula C
29H50O2
Molecular weight 430,71Assay Content not less than 96 %
Description Slightly yellow to amber, nearly odourless, clear, viscous oil which
oxidises and darkens on exposure to air or light
Identification
A. Solubility tests Insoluble in water, freely soluble in ethanol, miscible in etherB. Spectro-photometry In absolute ethanol the maximum absorption is about 292 nm
Purity
Refractive index n
D201,503-1,507
Specific absorption E1%
1cmin ethanol E1%1cm(292 nm) 72-76
(0,01 g in 200 ml of absolute ethanol)
Sulphated ash Not more than 0,1 %
Specific rotation [α] D250o± 0,05o(1 in 10 solution in chloroform)
Lead Not more than 2 mg/kg20.9.2008 EN Official Journal of the European Union L 253/33E 308 GAMMA-TOCOPHEROL
Synonyms dl-γ-Tocopherol
Definition
Chemical name 2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs 231-523-4
Chemical formula C 28H48O2
Molecular weight 416,69Assay Content not less than 97 %
Description Clear, viscous, pale yellow oil which oxidises and darkens on exposure to
air or light
Identification
A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and
257 nm
Purity
Specific absorption E
1%
1cmin ethanol E1%1cm(298 nm) between 91 and 97
E1%
1cm(257 nm) between 5,0 and 8,0
Refractive index ½n20
D1,503-1,507
Sulphated ash Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 309 DELTA-TOCOPHEROL
Definition
Chemical name 2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
Einecs 204-299-0
Chemical formula C
27H46O2
Molecular weight 402,7Assay Content not less than 97 %
Description Clear, viscous, pale yellowish or orange oil which oxidises and darkens
on exposure to air or light
Identification
A. Spectrometry Maximum absorptions in absolute ethanol at about 298 nm and
257 nm
Purity
Specific absorption E
1%
1cmin ethanol E1%1cm(298 nm) between 89 and 95
E1%
1cm(257 nm) between 3,0 and 6,0
Refractive index nD
201,500-1,504
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/kgL 253/34 EN Official Journal of the European Union 20.9.2008E 310 PROPYL GALLATE
Definition
Chemical name Propyl gallate
Propyl ester of gallic acid
n-propyl ester of 3,4,5-trihydroxybenzoic acid
Einecs 204-498-2Chemical formula C
10H12O5
Molecular weight 212,20Assay 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 150oC after drying at 110oC for four hours
Purity
Loss on drying Not more than 1,0 % (110oC, 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 E1%
1cmin ethanol E1%1cm(275 nm) not less than 485 and not more than 520
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 311 OCTYL GALLATE
Definition
Chemical name Octyl gallate
Octyl ester of gallic acid
n-octyl ester of 3,4,5-trihydroxybenzoic acid
Einecs 213-853-0Chemical formula C
15H22O5
Molecular weight 282,34Assay Content not less than 98 % after drying at 90
oC for six hours
Description White to creamy-white odourless solid
Identification
A. Solubility tests Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol
B. Melting range Between 99oC and 102oC after drying at 90oC for six hours
Purity
Loss on drying Not more than 0,5 % (90oC, 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%
1cmin ethanol E1%1cm(275 nm) not less than 375 and not more than 39020.9.2008 EN Official Journal of the European Union L 253/35Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 312 DODECYL GALLATE
Synonyms Lauryl gallate
Definition
Chemical name Dodecyl gallate
n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid
Dodecyl ester of gallic acid
Einecs 214-620-6
Chemical formula C 19H30O5
Molecular weight 338,45
Assay Content not less than 98 % after drying at 90oC 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 95oC and 98oC after drying at 90oC for six hours
Purity
Loss on drying Not more than 0,5 % (90oC, 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%
1cmin ethanol E1%1cm(275 nm) not less than 300 and not more than 325
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 30 mg/kg
E 315 ERYTHORBIC ACID
Synonyms Isoascorbic acid
D-Araboascorbic acid
Definition
Chemical name D-Erythro-hex-2-enoic acid γ-lactone
Isoascorbic 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 lightL 253/36 EN Official Journal of the European Union 20.9.2008Identification
A. Melting range About 164oC to 172oC with decomposition
B. Positive test for ascorbic acid/colour
reaction
Purity
Loss on drying Not more than 0,4 % after drying under reduced pressure on silica gel
for 3 hours
Sulphated ash Not more than 0,3 %
Specific rotation [α]10 % (w/v) aqueous solution between −16,5oto−18,0o
Oxalate To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid
and 5 ml of 10 % calcium acetate solution. The solution should remain
clear
Lead Not more than 2 mg/kg
E 316 SODIUM ERYTHORBATE
Synonyms Sodium isoascorbate
Definition
Chemical name Sodium isoascorbate
Sodium D-isoascorbic acid
Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone
3-keto-D-gulofurano-lactone sodium enolate monohydrate
Einecs 228-973-9
Chemical formula 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 sodium
Purity
Loss on drying Not more than 0,25 % after drying in a vacuum desiccator over
sulphuric acid for 24 hours
Specific rotation [α]10 % (w/v) aqueous solution between + 95oand + 98o
pH of a 10 % aqueous solution 5,5 to 8,0Oxalate To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid
and 5 ml of 10 % calcium acetate solution. The solution should remain
clear
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg20.9.2008 EN Official Journal of the European Union L 253/37E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)
Synonyms TBHQ
Definition
Chemical names Tert-butyl-1,4-benzenediol
2-(1,1-Dimethylethyl)-1,4-benzenediol
Einecs 217-752-2
Chemical formula C 10H14O2
Molecular weight 166,22Assay Content not less than 99 % of C
10H14O2
Description White crystalline solid having a characteristic odour
Identification
A. Solubility Practically insoluble in water; soluble in ethanol
B. Melting point Not less than 126,5oC
C. Phenolics Dissolve about 5 mg of the sample in 10 ml of methanol and add
10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is
produced
Purity
Tertiary-Butyl-p-benzoquinone Not more than 0,2 %2,5-Di-tertiary-butyl hydroquinone Not more than 0,2 %Hydroxyquinone Not more than 0,1 %
Toluene Not more than 25 mg/kg
Lead Not more than 2 mg/kg
E 320 BUTYLATED HYDROXYANISOLE (BHA)
Synonyms BHA
Definition
Chemical names 3-Tertiary-butyl-4-hydroxyanisole
A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-
hydroxyanisole
Einecs 246-563-8Chemical formula C
11H16O2
Formula weight 180,25Assay 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 °C and 63 °CC. Colour reaction Passes test for phenol groups
Purity
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25 °CPhenolic impurities Not more than 0,5 %
Specific absorptionE
1%
1cm E1%1cm(290 nm) not less than 190 and not more than 210
Specific absorptionE1%
1cm E1%1cm(228 nm) not less than 326 and not more than 345
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgL 253/38 EN Official Journal of the European Union 20.9.2008E 321 BUTYLATED HYDROXYTOLUENE (BHT)
Synonyms BHT
Definition
Chemical name 2,6-Ditertiary-butyl-p-cresol
4-Methyl-2,6-ditertiarybutylphenol
Einecs 204-881-4Chemical formula C
15H24O
Molecular weight 220,36Assay Content not less than 99 %
Description White, crystalline or flaked solid, odourless or having a characteristic
faint aromatic odour
Identification
A. Solubility tests Insoluble in water and propane- 1,2-diol
Freely soluble in ethanol
B. Melting point At 70
oC
C. Absorbance maximum The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in
100 000 solution in dehydrated ethanol exhibits a maximum only at
278 nm
Purity
Sulphated ash Not more than 0,005 %Phenolic impurities Not more than 0,5 %
Specific absorption E
1%
1cmin ethanol E1%1cm(278 nm) not less than 81 and not more than 88
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 322 LECITHINS
Synonyms Phosphatides
Phospholipids
Definition Lecithins are mixtures or fractions of phosphatides obtained by physical
procedures from animal or vegetable foodstuffs; they also include
hydrolysed products obtained through the use of harmless and
appropriate enzymes. The final product must not show any signs of
residual enzyme activity The lecithins may be slightly bleached in
aqueous medium by means of hydrogen peroxide. This oxidation mustnot chemically modify the lecithin phosphatides
Einecs 232-307-2Assay —Lecithins: not less than 60,0 % of substances insoluble in acetone
—Hydrolysed lecithins: not less than 56,0 % of substances insoluble in
acetone
Description —Lecithins: brown liquid or viscous semi-liquid or powder
—Hydrolysed lecithins: light brown to brown viscous liquid or paste
Identification
A. Positive tests for choline, for phos-
phorus and fatty acids
B. Test for hydrolysed lecithin To a 800 ml beaker add 500 ml of water (30
oC-35oC). 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 g20.9.2008 EN Official Journal of the European Union L 253/39Purity
Loss on drying Not more than 2,0 % determined by drying at 105oC 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 10Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 325 SODIUM LACTATE
Definition
Chemical name Sodium lactate
Sodium 2-hydroxypropanoate
Einecs 200-772-0
Chemical formula C
3H5NaO 3
Molecular weight 112,06 (anhydrous)Assay Content not less than 57 % and not more than 66 %
Description Colourless, transparent, liquid. Odourless, or with a slight, characteristic
odour
Identification
A. Positive test for lactate
B. Positive test for sodium
Purity
Acidity Not more than 0,5 % after drying expressed as lactic acid
pH of a 20 % aqueous solution 6,5 to 7,5
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgReducing substances No reduction of Fehling's solution
Note:
This specification refers to a 60 %
aqueous solution
E 326 POTASSIUM LACTATE
Definition
Cheminal name Potassium lactate
Potassium 2-hydroxypropanoate
Einecs 213-631-3
Chemical formula C
3H5O3K
Molecular weight 128,17 (anhydrous)
Assay Content not less than 57 % and not more than 66 %L 253/40 EN Official Journal of the European Union 20.9.2008Description Slightly viscous, almost odourless clear liquid. Odourless, or with a
slight, characteristic odour
Identification
A. Ignition Ignite potassium lactate solution to an ash. The ash is alkaline, and an
effervescence occurs when acid is added
B. Colour reaction Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100
solution of catechol in sulphuric acid. A deep red colour is produced at
the zone of contact
C. Positive tests for potassium and for
lactate
Purity
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgAcidity Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops
of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not
more than 0,2 ml should be required
Reducing substances Potassium lactate solution shall not cause any reduction of Fehling's
solution
Note:
This specification refers to a 60 %
aqueous solution
E 327 CALCIUM LACTATE
Definition
Chemical name Calcium dilactate
Calcium dilactate hydrate
2-Hydroxypropanoic acid calcium salt
Einecs 212-406-7
Chemical formula (C
3H5O2)2Ca·nH 2O (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 120oC for four hours:
—anhydrous: not more than 3,0 %
—with 1 molecule of water: not more than 8,0 %
—with 3 molecules of water: not more than 20,0 %
—with 4,5 molecules of water: not more than 27,0 %
Acidity Not more than 0,5 % of the dry matter expressed as lactic acid
Fluoride Not more than 30 mg/kg (expressed as fluorine)
pH of a 5 % solution Between 6,0 and 8,0Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg20.9.2008 EN Official Journal of the European Union L 253/41Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Reducing substances No reduction of Fehling's solution
E 330 CITRIC ACID
Definition
Chemical name Citric acid
2-Hydroxy-1,2,3-propanetricarboxylic acid
β-Hydroxytricarballytic acid
Einecs 201-069-1Chemical formula (a) C
6H8O7(anhydrous)
(b) C 6H8O7·H2O (monohydrate)
Molecular weight (a) 192,13 (anhydrous)
(b) 210,15 (monohydrate)
Assay Citric acid may be anhydrous or it may contain 1 molecule of water.
Citric acid contains not less than 99,5 % of C 6H8O7, calculated on the
anhydrous basis
Description Citric acid is a white or colourless, odourless, crystalline solid, having a
strongly acid taste. The monohydrate effloresces in dry air
Identification
A. Solubility tests Very soluble in water; freely soluble in ethanol; soluble in ether
Purity
Water content Anhydrous citric acid contains not more than 0,5 % water; citric acid
monohydrate contains not more than 8,8 % water (Karl Fischer method)
Sulphated ash Not more than 0,05 % after calcination at 800 ± 25oC
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/kgOxalates Not more than 100 mg/kg, expressed as oxalic acid, after drying
Readily carbonisable substances Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric
acid in a water bath at 90
oC in the dark for one hour. Not more than a
pale brown colour should be produced (Matching Fluid K)
E 331 (i) MONOSODIUM CITRATE
Synonyms Monosodium citrate
Monobasic sodium citrate
Definition
Chemical name Monosodium citrate
Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Chemical formula (a) C 6H7O7Na (anhydrous)
(b) C 6H7O7Na·H2O (monohydrate)
Molecular weight (a) 214,11 (anhydrous)
(b) 232,23 (monohydrate)
Assay Content not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystalsL 253/42 EN Official Journal of the European Union 20.9.2008Identification
A. Positive tests for citrate and for
sodium
Purity
Loss on drying Determined by drying at 180oC for four hours:
—anhydrous: not more than 1,0 %
—monohydrate: not more than 8,8 %
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 3,5 and 3,8Arsenic Not more than 1 mg/kgLead Not more than 1 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E 331 (ii) DISODIUM CITRATE
Synonyms Disodium citrate
Dibasic sodium citrate
Definition
Chemical name Disodium citrate
Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Disodium salt of citric acid with 1,5 molecules of water
Einecs 205-623-3Chemical formula C
6H6O7Na2·1,5H 2O
Molecular weight 263,11Assay 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 dryingpH of a 1 % aqueous solution Between 4,9 and 5,2
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kgMercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E 331 (iii) TRISODIUM CITRATE
Synonyms Trisodium citrate
Tribasic sodium citrate
Definition
Chemical name Trisodium citrate
Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTrisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate
form20.9.2008 EN Official Journal of the European Union L 253/43Einecs 200-675-3
Chemical formula Anhydrous: C 6H5O7Na3
Hydrated: C 6H5O7Na3·nH 2O (n = 2 or 5)
Molecular weight 258,07 (anhydrous)Assay Not less than 99 % on the anhydrous basis
Description Crystalline white powder or colourless crystals
Identification
A. Positive tests for citrate and for
sodium
Purity
Loss on drying Determined by drying at 180
oC for four hours:
—anhydrous: not more than 1,0 %
—dihydrate: not more than 13,5 %
—pentahydrate: not more than 30,3 %
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution Between 7,5 and 9,0Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E 332 (i) MONOPOTASSIUM CITRATE
Synonyms Monopotassium citrate
Monobasic potassium citrate
Definition
Chemical name Monopotassium citrate
Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Anhydrous monopotassium salt of citric acid
Einecs 212-753-4
Chemical formula C
6H7O7K
Molecular weight 230,21Assay 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/kg
Heavy metals (as Pb) Not more than 5 mg/kgL 253/44 EN Official Journal of the European Union 20.9.2008E 332 (ii) TRIPOTASSIUM CITRATE
Synonyms Tripotassium citrate
Tribasic potassium citrate
Definition
Chemical name Tripotassium citrate
Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Monohydrated tripotassium salt of citric acid
Einecs 212-755-5
Chemical formula C 6H5O7K3·H2O
Molecular weight 324,42Assay Content not less than 99 % on the anhydrous basis
Description White, hygroscopic, granular powder or transparent crystals
Identification
A. Positive tests for citrate and for
potassium
Purity
Loss on drying Not more than 6,0 % determined by drying at 180
oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 5 % aqueous solution Between 7,5 and 9,0
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E 333 (i) MONOCALCIUM CITRATE
Synonyms Monocalcium citrate
Monobasic calcium citrate
Definition
Chemical name Monocalcium citrate
Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
Monohydrate monocalcium salt of citric acid
Chemical formula (C
6H7O7)2Ca·H2O
Molecular weight 440,32
Assay Content not less than 97,5 % on the anhydrous basis
Description Fine white powder
Identification
A. Positive tests for citrate and for
calcium
Purity
Loss on drying Not more than 7,0 % determined by drying at 180oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after dryingpH of a 1 % aqueous solution Between 3,2 and 3,5
Fluoride Not more than 30 mg/kg (expressed as fluorine)
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must
not liberate more than a few isolated bubbles20.9.2008 EN Official Journal of the European Union L 253/45E 333 (ii) DICALCIUM CITRATE
Synonyms Dicalcium citrate
Dibasic calcium citrate
Definition
Chemical name Dicalcium citrate
Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTrihydrated dicalcium salt of citric acid
Chemical formula (C
6H7O7)2Ca2·3H 2O
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 180oC 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/kgLead Not more than 1 mg/kgMercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
Carbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must
not liberate more than a few isolated bubbles
E 333 (iii) TRICALCIUM CITRATE
Synonyms Tricalcium citrate
Tribasic calcium citrate
Definition
Chemical name Tricalcium citrate
Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acidTetrahydrated tricalcium salt of citric acid
Einecs 212-391-7
Chemical formula (C
6H6O7)2Ca3·4H 2O
Molecular weight 570,51Assay 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/kgLead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kgCarbonates Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must
not liberate more than a few isolated bubblesL 253/46 EN Official Journal of the European Union 20.9.2008E 334 L(+)-TARTARIC ACID
Definition
Chemical name L-tartaric acid
L-2,3-dihydroxybutanedioic acidd-α, β-dihydroxysuccinic acid
Einecs 201-766-0
Chemical formula C
4H6O6
Molecular weight 150,09Assay Content not less than 99,5 % on the anhydrous basis
Description Colourless or translucent crystalline solid or white crystalline powder
Identification
A. Melting range Between 168
oC and 170oC
B. Positive test for tartrate
Purity
Loss on drying Not more than 0,5 % (over P 2O5, three hours)
Sulphated ash Not more than 1 000 mg/kg after calcination at 800 ± 25oC
Specific optical rotation of a 20 % w/v
aqueous solution[α]20Dbetween + 11,5oand + 13,5o
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgOxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
E 335 (i) MONOSODIUM TARTRATE
Synonyms Monosodium salt of L-(+)-tartaric acid
Definition
Chemical name Monosodium salt of L-2,3-dihydroxybutanedioic acid
Monohydrated monosodium salt of L-(+)-tartaric acid
Chemical formula C
4H5O6Na·H2O
Molecular weight 194,05
Assay Content not less than 99 % on the anhydrous basis
Description Transparent colourless crystals
Identification
A. Positive tests for tartrate and for
sodium
Purity
Loss on drying Not more than 10,0 % determined by drying at 105oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after dryingArsenic 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/kg20.9.2008 EN Official Journal of the European Union L 253/47E 335 (ii) DISODIUM TARTRATE
Definition
Chemical name Disodium L-tartrate
Disodium (+)-tartrate
Disodium (+)-2,3-dihydroxybutanedioic acid
Dihydrated disodium salt of L-(+)-tartaric acid
Einecs 212-773-3Chemical formula C
4H4O6Na2·2H 2O
Molecular weight 230,8
Assay Content not less than 99 % on the anhydrous basis
Description Transparent, colourless crystals
Identification
A. Positive tests for tartrate and for
sodium
B. Solubility tests 1 gram is insoluble in 3 ml of water. Insoluble in ethanol
Purity
Loss on drying Not more than 17,0 % determined by drying at 150oC for four hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of a 1 % aqueous solution Between 7,0 and 7,5
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 336 (i) MONOPOTASSIUM TARTRATE
Synonyms Monobasic potassium tartrate
Definition
Chemical name Anhydrous monopotassium salt of L-(+)-tartaric acid
Monopotassium salt of L-2,3-dihydroxybutanedioic acid
Chemical formula 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 230oC
Purity
pH of a 1 % aqueous solution 3,4
Loss on drying Not more than 1,0 % determined by drying at 105oC 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/kgL 253/48 EN Official Journal of the European Union 20.9.2008E 336 (ii) DIPOTASSIUM TARTRATE
Synonyms Dibasic potassium tartrate
Definition
Chemical name Dipotassium salt of L-2,3-dihydroxybutanedioic acid
Dipotassium salt with half a molecule of water of L-(+)-tartaric acid
Einecs 213-067-8
Chemical formula C 4H4O6K2·1/2H 2O
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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 337 POTASSIUM SODIUM TARTRATE
Synonyms Potassium sodium L-(+)-tartrate
Rochelle salt
Seignette salt
Definition
Chemical name Potassium sodium salt of L-2,3-dihydroxybutanedioic acid
Potassium sodium L-(+)-tartrate
Einecs 206-156-8
Chemical formula C
4H4O6KNa· 4H 2O
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 ethanol
C. Melting range Between 70 and 80oC
Purity
Loss on drying Not more than 26,0 % and not less than 21,0 % determined by drying at
150oC for three hours
Oxalates Not more than 100 mg/kg expressed as oxalic acid, after drying
pH of 1 % aqueous solution Between 6,5 and 8,5
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg20.9.2008 EN Official Journal of the European Union L 253/49Mercury Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 338 PHOSPHORIC ACID
Synonyms Orthophosphoric acid
Monophosphoric acid
Definition
Chemical name Phosphoric acid
Einecs 231-633-2Chemical formula H
3PO 4
Molecular weight 98,00Assay 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 CaSO 4)
Fluoride 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/kgNote:
This specification refers to a 75 %
aqueous solution
E 339 (i) MONOSODIUM PHOSPHATE
Synonyms Monosodium monophosphate
Acid monosodium monophosphate
Monosodium orthophosphate
Monobasic sodium phosphateSodium dihydrogen monophosphate
Definition
Chemical name Sodium dihydrogen monophosphateEinecs 231-449-2
Chemical formula Anhydrous: NaH
2PO 4
Monohydrate: NaH 2PO 4·H2O
Dihydrate: NaH 2PO 4·2H 2OL 253/50 EN Official Journal of the European Union 20.9.2008Molecular weight Anhydrous: 119,98
Monohydrate: 138,00
Dihydrate: 156,01
Assay After drying at 60oC for one hour and then at 105oC for four hours,
contains not less than 97 % of NaH 2PO 4
P2O5content Between 58,0 % and 60,0 % on the anhydrous basis
Description A white odourless, slightly deliquescent powder, crystals or granules
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Freely soluble in water. Insoluble in ethanol or ether
C. pH of a 1 % solution Between 4,1 and 5,0
Purity
Loss on drying The anhydrous salt loses not more than 2,0 %, the monohydrate not
more than 15,0 %, and the dihydrate not more than 25 % when driedfirst at 60
oC for one hour, then at 105oC 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/kgLead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E 339 (ii) DISODIUM PHOSPHATE
Synonyms Disodium monophosphate
Secondary sodium phosphate
Disodium orthophosphate
Acid disodium phosphate
Definition
Chemical name Disodium hydrogen monophosphate
Disodium hydrogen orthophosphate
Einecs 231-448-7
Chemical formula Anhydrous: Na
2HPO 4
Hydrat: Na 2HPO 4·nH 2O (n = 2,7 or 12)
Molecular weight 141,98 (anhydrous)
Assay After drying at 40oC for three hours and subsequently at 105oC for
five hours, contains not less than 98 % of Na 2HPO 4
P2O5content Between 49 % and 51 % on the anhydrous basis
Description Anhydrous disodium hydrogen phosphate is a white, hygroscopic,
odourless powder. Hydrated forms available include the dihydrate: a
white crystalline, odourless solid; the heptahydrate: white, odourless,
efflorescent crystals or granular powder; and the dodecahydrate: white,
efflorescent, odourless powder or crystals
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Freely soluble in water. Insoluble in ethanolC. pH of a 1 % solution Between 8,4 and 9,620.9.2008 EN Official Journal of the European Union L 253/51Purity
Loss on drying When dried at 40oC 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/kg
Cadmium Not more than 1 mg/kgLead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E 339 (iii) TRISODIUM PHOSPHATE
Synonyms Sodium phosphate
Tribasic sodium phosphate
Trisodium orthophosphate
Definition Trisodium phosphate is obtained from aqueous solutions and crystallises
in the anhydrous form and with 1/2, 1, 6, 8 or 12 H
2O. The
dodecahydrate always crystallises from aqueous solutions with an excess
of sodium hydroxide. It contains 1/4 molecule of NaOH
Chemical name Trisodium monophosphate
Trisodium phosphate
Trisodium orthophosphate
Einecs 231-509-8Chemical formula Anhydrous: Na
3PO 4
Hydrated: Na 3PO 4·nH 2O (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 Na
3PO 4
calculated on the dried basis. Sodium phosphate dodecahydrate containsnot less than 92,0 % of Na
3PO 4calculated 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 800oC
for 30 minutes, the losses in weight are as follows: anhydrous not more
than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate:between 45,0 % and 58,0 %
Water insoluble substances Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kgL 253/52 EN Official Journal of the European Union 20.9.2008E 340 (i) MONOPOTASSIUM PHOSPHATE
Synonyms Monobasic potassium phosphate
Monopotassium monophosphate
Potassium orthophosphate
Definition
Chemical name Potassium dihydrogen phosphate
Monopotassium dihydrogen orthophosphate
Monopotassium dihydrogen monophosphate
Einecs 231-913-4
Chemical formula KH 2PO 4
Molecular weight 136,09
Assay Content not less than 98,0 % after drying at 105oC 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 ethanol
C. pH of a 1 % solution Between 4,2 and 4,8
Purity
Loss on drying Not more than 2,0 % determined by drying at 105oC 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/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E 340 (ii) DIPOTASSIUM PHOSPHATE
Synonyms Dipotassium monophosphate
Secondary potassium phosphate
Dipotassium acid phosphateDipotassium orthophosphate
Dibasic potassium phosphate
Definition
Chemical name Dipotassium hydrogen monophosphate
Dipotassium hydrogen phosphate
Dipotassium hydrogen orthophosphate
Einecs 231-834-5
Chemical formula K
2HPO 4
Molecular weight 174,18
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
substance20.9.2008 EN Official Journal of the European Union L 253/53Identification
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 basis
Fluoride 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
E 340 (iii) TRIPOTASSIUM PHOSPHATE
Synonyms Potassium phosphate
Tribasic potassium phosphate
Tripotassium orthophosphate
Definition
Chemical name Tripotassium monophosphate
Tripotassium phosphate
Tripotassium orthophosphate
Einecs 231-907-1
Chemical formula Anhydrous: K
3PO 4
Hydrated: K 3PO 4·nH 2O (n = 1 or 3)
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 monohydrate and trihydrate
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility Freely soluble in water. Insoluble in ethanol
C. pH of a 1 % solution Between 11,5 and 12,3
Purity
Loss on ignition Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %.
Determined by drying at 105oC for one hour and then ignite at about
800oC ± 25oC for 30 minutes
Water insoluble substances Not more than 0,2 % on the anhydrous basis
Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kgL 253/54 EN Official Journal of the European Union 20.9.2008E 341 (i) MONOCALCIUM PHOSPHATE
Synonyms Monobasic calcium phosphate
Monocalcium orthophosphate
Definition
Chemical name Calcium dihydrogen phosphateEinecs 231-837-1
Chemical formula Anhydrous: Ca(H
2PO 4)2
Monohydrate: Ca(H 2PO 4)2·H2O
Molecular weight 234,05 (anhydrous)
252,08 (monohydrate)
Assay Content not less than 95 % on the dried basisP
2O5content 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 105oC for four hours
(anhydrous)
Not more than 17,5 % determined by drying at 60oC for one hour, then
at 105oC for four hours (monohydrate)
Loss on ignition Not more than 17,5 % after ignition at 800oC ± 25oC for 30 minutes
(anhydrous)
Not more than 25,0 % determined by drying at 105oC for one hour,
then ignite at 800oC ± 25oC 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
E 341 (ii) DICALCIUM PHOSPHATE
Synonyms Dibasic calcium phosphate
Dicalcium orthophosphate
Definition
Chemical name Calcium monohydrogen phosphate
Calcium hydrogen orthophosphate
Secondary calcium phosphate
Einecs 231-826-1Chemical formula Anhydrous: CaHPO
4
Dihydrate: CaHPO 4·2H 2O
Molecular weight 136,06 (anhydrous)
172,09 (dihydrate)
Assay Dicalcium phosphate, after drying at 200oC for three hours, contains
not less than 98 % and not more than the equivalent of 102 % of
CaHPO 4
P2O5content Between 50,0 % and 52,5 % on the anhydrous basis
Description White crystals or granules, granular powder or powder20.9.2008 EN Official Journal of the European Union L 253/55Identification
A. Positive tests for calcium and for
phosphate
B. Solubility tests Sparingly soluble in water. Insoluble in ethanol
Purity
Loss on ignition Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at
800oC ± 25oC for 30 minutes
Fluoride Not more than 50 mg/kg (expressed as fluorine)
Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E 341 (iii) TRICALCIUM PHOSPHATE
Synonyms Calcium phosphate, tribasic
Calcium orthophosphatePentacalcium hydroxy monophosphateCalcium 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 Ca 5(PO 4)3·OH or Ca 3(PO 4)2
Molecular weight 502 or 310
Assay Content not less than 90 % calculated on the ignited basisP2O5 content Between 38,5 % and 48,0 % on the anhydrous basis
Description A white, odourless powder which is stable in air
Identification
A. Positive tests for calcium and for
phosphate
B. Solubility Practically insoluble in water; insoluble in ethanol soluble in dilute
hydrochloric and nitric acid
Purity
Loss on ignition Not more than 8 % after ignition at 800
oC ± 25oC, to constant weight
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/kgL 253/56 EN Official Journal of the European Union 20.9.2008E 343(i) MONOMAGNESIUM PHOSPHATE
Synonyms Magnesiumdihydrogenphosphate
Magnesiumphosphate, monobasic
Monomagnesium orthophosphate
Definition
Chemical name Monomagnesiumdihydrogenmonophosphate
Einecs 236-004-6Chemical formula Mg(H
2PO 4)2·nH 2O (where n = 0 to 4)
Molecular weight 218,30 (anhydrous)
Assay Not less than 51,0 % after ignition
Description White, odourless, crystalline powder, slightly soluble in water
Identification
A. Positive test for magnesium and for
phosphate
B. MgO content Not less than 21,5 % after ignition
Purity
Fluoride Not more than 10 mg/kg (as fluorine)
Arsenic Not more than 3 mg/kgLead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 343(ii) DIMAGNESIUM PHOSPHATE
Synonyms Magnesiumhydrogenphosphate
Magnesiumphosphate, dibasic
Dimagnesium orthophosphateSecondary magnesiumphosphate
Definition
Chemical name Dimagnesiummonohydrogenmonophosphate
Einecs 231-823-5Chemical formula MgHPO
4·nH 2O (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/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/57E 350 (i) SODIUM MALATE
Synonyms Sodium salt of malic acid
Definition
Chemical name Disodium DL-malate, disodium salt of hydroxybutanedioic acid
Chemical formula Hemihydrate: C 4H4Na2O5·1/2 H 2O
Trihydrate: C 4H4Na2O5·3H 2O
Molecular weight Hemihydrate: 187,05
Trihydrate: 232,10
Assay Content not less than 98,0 % on the anhydrous basis
Description White crystalline powder or lumps
Identification
A. Positive tests for 1,2-dicarboxylic
acid and for sodium
B. Azo dye formation Positive
C. Solubility Freely soluble in water
Purity
Loss on drying Not more than 7,0 % (130oC, 4h) for the hemihydrate, or 20,5 %-
23,5 % (130oC, 4h) for the trihydrate
Alkalinity Not more than 0,2 % as Na 2CO 3
Fumaric acid Not more than 1,0 %Maleic acid Not more than 0,05 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 350 (ii) SODIUM HYDROGEN MALATE
Synonyms Monosodium salt of DL-malic acid
Definition
Chemical name Monosodium DL-malate, monosodium 2-DL-hydroxy succinate
Chemical formula C
4H5NaO 5
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 % (110oC, 3h)
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgL 253/58 EN Official Journal of the European Union 20.9.2008E 351 POTASSIUM MALATE
Synonyms Potassium salt of malic acid
Definition
Chemical name Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acidChemical formula C
4H4K2O5
Molecular weight 210,27Assay Content not less than 59,5 %
Description Colourless or almost colourless aqueous solution
Identification
A. Positive tests for 1,2-dicarboxylic
acid and for potassium
B. Azo dye formation Positive
Purity
Alkalinity Not more than 0,2 % as K
2CO 3
Fumaric acid Not more than 1,0 %Maleic acid Not more than 0,05 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 352 (i) CALCIUM MALATE
Synonyms Calcium salt of malic acid
Definition
Chemical name Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydro-
xybutanedioic acid
Chemical formula C
4H5CaO 5
Molecular weight 172,14Assay Content not less than 97,5 % on the anhydrous basis
Description White powder
Identification
A. Positive tests for malate, 1,2-dicar-
boxylic acid and for calcium
B. Azo dye formation PositiveC. Solubility Slightly soluble in water
Purity
Loss on drying Not more than 2 % (100
oC, 3h)
Alkalinity Not more than 0,2 % as CaCO 3
Maleic acid Not more than 0,05 %Fumaric acid Not more than 1,0 %Fluoride Not more than 30 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/59E 352 (ii) CALCIUM HYDROGEN MALATE
Synonyms Monocalcium salt of DL-malic acid
Definition
Chemical name Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate
Chemical formula (C 4H5O5)2Ca
Assay Content not less than 97,5 % on the anhydrous basis
Description White powder
Identification
A. Positive tests for 1,2-dicarboxylic
acid and for calcium
B. Azo dye formation Positive
Purity
Loss on drying Not more than 2,0 % (110oC, 3h)
Maleic acid Not more than 0,05 %
Fumaric acid Not more than 1,0 %
Fluoride Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 353 METATARTARIC ACID
Synonyms Ditartaric acid
Definition
Chemical name Metatartaric acid
Chemical formula C
4H6O6
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 ethanolB. Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of
concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent.
When heated to 150
oC, an intense violet coloration appears
Purity
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 354 CALCIUM TARTRATE
Synonyms L-Calcium tartrate
Definition
Chemical name Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate
Chemical formula C
4H4CaO 6·2H 2O
Molecular weight 224,18
Assay Not less than 98,0 %L 253/60 EN Official Journal of the European Union 20.9.2008Description 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 + 7,0oto + 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 H 2SO 4) Not more than 1 g/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 355 ADIPIC ACID
Definition
Chemical name Hexanedioic acid, 1,4-butanedicarboxylic acidEinecs 204-673-3
Chemical formula C
6H10O4
Molecular weight 146,14
Assay Content not less than 99,6 %
Description White odourless crystals or crystalline powder
Identification
A. Melting range 151,5oC-154,0oC
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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 356 SODIUM ADIPATE
Definition
Chemical name Sodium adipate
Einecs 231-293-5
Chemical formula C
6H8Na2O4
Molecular weight 190,11
Assay Content not less than 99,0 % (on anhydrous basis)
Description White odourless crystals or crystalline powder
Identification
A. Melting range 151oC-152oC (for adipic acid)
B. Solubility Approximately 50 g/100 ml water (20oC)
C. Positive test for sodium20.9.2008 EN Official Journal of the European Union L 253/61Purity
Water Not more than 3 % (Karl Fischer)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 357 POTASSIUM ADIPATE
Definition
Chemical name Potassium adipateEinecs 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 151oC-152oC (for adipic acid)
B. Solubility Approximately 60 g/100 ml water (20oC)
C. Positive test for potassium
Purity
Water Not more than 3 % (Karl Fischer)Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 363 SUCCINIC ACID
Definition
Chemical name Butanedioic acidEinecs 203-740-4Chemical formula C
4H6O4
Molecular weight 118,09Assay Content no less than 99,0 %
Description Colourless or white, odourless crystals
Identification
A. Melting range Between 185,0
oC and 190,0oC
Purity
Residue on ignition Not more than 0,025 % (800oC, 15 min)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgL 253/62 EN Official Journal of the European Union 20.9.2008E 380 TRIAMMONIUM CITRATE
Synonyms Tribasic ammonium citrate
Definition
Chemical name Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acidEinecs 222-394-5
Chemical formula C
6H17N3O7
Molecular weight 243,22
Assay Content not less than 97,0 %
Description White to off-white crystals or powder
Identification
A. Positive tests for ammonium and for
citrate
B. Solubility Freely soluble in water
Purity
Oxalate Not more than 0,04 % (as oxalic acid)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
Synonyms Calcium disodium EDTA
Calcium disodium edetate
Definition
Chemical name N, N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,O
N,ON]
calciate(2)-disodium
Calcium disodium ethylenediaminetetra acetate Calcium disodium
(ethylenedinitrilo)tetra acetate
Einecs 200-529-9
Chemical formula C 10H12O8CaN 2Na2·2H 2O
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/kg20.9.2008 EN Official Journal of the European Union L 253/63E 400 ALGINIC ACID
Definition Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuro-
nic 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 232-680-1Chemical formula (C
6H8O6)n
Molecular weight 10 000-600 000 (typical average)Assay Alginic acid yields, on the anhydrous basis, not less than 20 % and not
more than 23 % of carbon dioxide (CO
2), equivalent to not less than
91 % and not more than 104,5 % of alginic acid (C 6H8O6)n(calculted on
equivalent weight basis of 200)
Description Alginic acid occurs in filamentous, grainy, granular and powdered forms.
It is a white to yellowish brown and nearly odourless
Identification
A. Solubility Insoluble in water and organic solvents, slowly soluble in solutions of
sodium carbonate, sodium hydroxide and trisodium phosphate
B. Calcium chloride precipitation test To a 0,5 % solution of the sample in 1 M sodium hydroxide solution,
add one fifth of its volume of a 2,5 % solution of calcium chloride. 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 ammoniumsulphate. No precipitate is formed. This test distinguishes alginic acid
from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified
pectin, gelatin, locust bean gum, methyl cellulose and starch
D. Colour reaction Dissolve as completely as possible 0,01 g of the sample by shaking with
0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate
solution. Within 5 minutes, a cherry-red colour develops that finally
becomes deep purple
Purity
pH of a 3 % suspension Between 2,0 and 3,5Loss 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 matterArsenic 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 gramYeast and moulds Not more than 500 colonies per gramE. coli Negative in 5 g
Salmonella spp. Negative in 10 gL 253/64 EN Official Journal of the European Union 20.9.2008E 401 SODIUM ALGINATE
Definition
Chemical name Sodium salt of alginic acid
Chemical formula (C 6H7NaO 6)n
Molecular weight 10 000-600 000 (typical average)Assay Yields, on the anhydrous basis, not less than 18 % and not more than
21 % of carbon dioxide corresponding to not less than 90,8 % and not
more than 106,0 % of sodium alginate (calculated on equivalent weight
basis of 222)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
A. Positive test for sodium and alginic
acid
Purity
Loss on drying Not more than 15 % (105
oC, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basisArsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kgTotal plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 402 POTASSIUM ALGINATE
Definition
Chemical name Potassium salt of alginic acid
Chemical formula (C
6H7KO 6)n
Molecular weight 10 000-600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 16,5 % and not more than
19,5 % of carbon dioxide corresponding to not less than 89,2 % and not
more than 105,5 % of potassium alginate (calculated on an equivalent
weight basis of 238)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
A. Positive test for potassium and for
alginic acid
Purity
Loss on drying Not more than 15 % (105oC, 4 hours)
Water-insoluble matter Not more than 2 % on the anhydrous basisArsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kgTotal plate count Not more than 5 000 colonies per gram20.9.2008 EN Official Journal of the European Union L 253/65Yeast and moulds Not more than 500 colonies per gram
E.coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 403 AMMONIUM ALGINATE
Definition
Chemical name Ammonium salt of alginic acid
Chemical formula (C 6H11NO 6)n
Molecular weight 10 000 —600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and not more than
21 % of carbon dioxide corresponding to not less than 88,7 % and not
more than 103,6 % ammonium alginate (calculated on an equivalent
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 % (105oC, 4 hours)
Sulphated ash Not more than 7 % on the dried basis
Water-insoluble matter Not more than 2 % on the anhydrous basisArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals Not more than 20 mg/kg
Total plate count Not more than 5 000 colonies per gramYeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 404 CALCIUM ALGINATE
Synonyms Calcium salt of alginate
Definition
Chemical name Calcium salt of alginic acid
Chemical formula (C
6H7Ca1/2O6)n
Molecular weight 10 000-600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 18 % and not more than
21 % carbon dioxide corresponding to not less than 89,6 % and not
more than 104,5 % of calcium alginate (calculated on an equivalent
weight basis of 219)
Description Nearly odourless, white to yellowish fibrous or granular powder
Identification
A. Positive test for calcium and alginic
acid
Purity
Loss on drying Not more than 15,0 % (105oC, 4 hours)
Arsenic Not more than 3 mg/kgL 253/66 EN Official Journal of the European Union 20.9.2008Lead 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/kgTotal plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 500 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 405 PROPANE-1,2-DIOL ALGINATE
Synonyms Hydroxypropyl alginate
1,2-propanediol ester of alginic acid
Propylene glycol alginate
Definition
Chemical name Propane-1,2-diol ester of alginic acid; varies in composition according to
its degree of esterification and the percentage of free and neutralised
carboxyl groups in the molecule
Chemical formula (C
9H14O7)n(esterified)
Molecular weight 10 000-600 000 (typical average)
Assay Yields, on the anhydrous basis, not less than 16 % and not more than
20 % of CO 2of carbon dioxide
Description Nearly odourless, white to yellowish brown fibrous or granular powder
Identification
A. Positive test for 1,2-propanediol and
alginic acid after hydrolysis
Purity
Loss on drying Not more than 20 % (105oC, 4 hours)
Total propane-1,2-diol content Not less than 15 % and not more than 45 %
Free propane-1,2-diol content Not more than 15 %Water-insoluble matter Not more than 2 % on the anhydrous basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/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 g20.9.2008 EN Official Journal of the European Union L 253/67E 406 AGAR
Synonyms Gelose
Japan agarBengal, Ceylon, Chinese or Japanese isinglass
Layor Carang
Definition
Chemical name Agar is a hydrophilic colloidal polysaccharide consisting mainly of
D-galactose units. On about every tenth D-galactopyranose unit one of
the hydroxyl groups is esterified with sulphuric acid which is neutralised
by calcium, magnesium, potassium or sodium. It is extracted from
certain natural strains of marine algae of the families Gelidiaceae and
Sphaerococcaceae and related red algae of the class Rhodophyceae
Einecs 232-658-1Assay The threshold gel concentration should not be higher than 0,25 %
Description Agar is odourless or has a slight characteristic odour. Unground agar
usually occurs in bundles consisting of thin, membranous, agglutinated
strips, or in cut, flaked or granulated forms. It may be light yellowish-
orange, yellowish-grey to pale yellow, or colourless. It is tough when
damp, brittle when dry. Powdered agar is white to yellowish-white or
pale yellow. When examined in water under a microscope, the agar
appears granular and somewhat filamentous. A few fragments of the
spicules of sponges and a few frustules of diatoms may be present. In
chloral hydrate solution, the powdered agar appears more transparentthan in water, more or less granular, striated, angular and occasionally
contains frustules of diatoms. Gel strength may be standardised by the
addition of dextrose and maltodextrines or sucrose
Identification
A. Solubility Insoluble in cold water; soluble in boiling water
Purity
Loss on drying Not more than 22 % (105
oC, 5 hours)
Ash Not more than 6,5 % on the anhydrous basis determined at 550oC
Acid-insoluble ash (insoluble in approxi-
mately 3N Hydrochloric acid)Not more than 0,5 % determined at 550oC on the anhydrous basis
Insoluble matter (in hot water) Not more than 1,0 %
Starch Not detectable by the following method: to a 1 in 10 solution of the
sample add a few drops of iodine solution. No blue colour is produced
Gelatin and other proteins Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool
of about 50oC. To 5 ml of the solution add 5 ml of trinitrophenol
solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No
turbidity appears within 10 minutes
Water absorption Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with
water, mix and allow to stand at about 25oC for 24 hours. Pour the
contents of the cylinder through moistened glass wool, allowing the
water to drain into a second 100 ml graduated cylinder. Not more than
75 ml of water is obtained
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kgL 253/68 EN Official Journal of the European Union 20.9.2008E 407 CARRAGEENAN
Synonyms Products of commerce are sold under different names such as:
Irish moss geloseEucheuman (from Eucheuma spp.)
Iridophycan (from Iridaea spp.)
Hypnean (from Hypnea spp.)
Furcellaran or Danish agar (from Furcellaria fastigiata)
Carrageenan (from Chondrus and Gigartina spp.)
Definition Carrageenan is obtained by aqueous extraction of natural strains of
seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae,
families of the class Rhodophyceae (red seaweeds). No organic precipitant
shall be used other than methanol, ethanol and propane-2-ol.
Carrageenan consists chiefly of the potassium, sodium, magnesium
and calcium salts of polysaccharide sulphate esters which, on hydrolysis,
yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be
hydrolysed or otherwise chemically degraded
Einecs 232-524-2
Description Yellowish to colourless, coarse to fine powder which is practically
odourless
Identification
A. Positive tests for galactose, for anhy-
drogalactose and for sulphate
Purity
Methanol, ethanol propane-2-ol content Not more than 0,1 % singly or in combinationViscosity of a 1,5 % solution at 75
oC Not less than 5 mPa.s
Loss on drying Not more than 12 % (105oC, four hours)
Sulphate Not less than 15 % and not more than 40 % on the dried basis (as SO 4)
Ash Not less than 15 % and not more than 40 % determined on the dried
basis at 550oC
Acid-insoluble ash Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric
acid)
Acid-insoluble matter Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric
acid)
Low molecular weight carrageenan
(Molecular weight fraction below
50 kDa)Not more than 5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgTotal plate count Not more than 5 000 colonies per gram
Yeast and moulds Not more than 300 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g20.9.2008 EN Official Journal of the European Union L 253/69E 407a PROCESSED EUCHEUMA SEAWEED
Synonyms PES (acronym for processed eucheuma seaweed)
Definition Processed eucheuma seaweed is obtained by aqueous alkaline (KOH)
treatment of the natural strains of seaweeds Eucheuma cottonii and
Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove
impurities and by fresh water washing and drying to obtain the product.
Further purification may be achieved by washing with methanol, ethanol
or propane-2-ol and drying. The product consists chiefly of the
potassium salts of polysaccharide sulphate esters which, on hydrolysis,
yield galactose and 3,6-anhydrogalactose. Sodium, calcium and
magnesium salts of the polysaccharide sulphate esters are present in
lesser amounts. Up to 15 % algal cellulose is also present in the product.
The carrageenan in processed eucheuma seaweed shall not be hydrolysed
or otherwise chemically degraded
Description Tan to yellowish, coarse to fine powder which is practically odourless
Identification
A. Positive tests for galactose, for anhy-
drogalactose and for sulphate
B. Solubility Forms cloudy viscous suspensions in water. Insoluble in ethanol
Purity
Methanol, ethanol, propane-2-ol content Not more than 0,1 % singly or in combination
Viscosity of a 1,5 % solution at 75oC Not less than 5 mPa.s
Loss on drying Not more than 12 % (105oC, four hours)
Sulphate Not less than 15 % and not more than 40 % on the dried basis (as SO 4)
Ash Not less than 15 % and not more than 40 % determined on the dried
basis at 550oC
Acid-insoluble ash Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric
acid)
Acid-insoluble matter Not less than 8 % and not more than 15 % on the dried basis (insoluble
in 1 % v/v sulphuric acid)
Low molecular weight carrageenan
(Molecular weight fraction below
50 kDa)Not more than 5 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgTotal 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
E 410 LOCUST BEAN GUM
Synonyms Carob bean gum
Algaroba gum
Definition Locust bean gum is the ground endosperm of the seeds of the natural
strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae).
Consists mainly of a high molecular weight hydrocolloidal polysacchar-
ide, composed of galactopyranose and mannopyranose units combined
through glycosidic linkages, which may be described chemically as
galactomannan
Molecular weight 50 000-3 000 000L 253/70 EN Official Journal of the European Union 20.9.2008Einecs 232-541-5
Assay Galactomannan content not less than 75 %
Description White to yellowish-white, nearly odourless powder
Identification
A. Positive tests for galactose mannose
B. Microscopic examination Place some ground sample in an aqueous solution containing 0,5 %
iodine and 1 % potassium iodide on a glass slide and examine undermicroscope. Locust bean gum contains long stretched tubiform cells,
separated or slightly interspaced. Their brown contents are much less
regularly formed in guar gum. Guar gum shows close groups of round 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 800oC
Protein (N × 6,25) Not more than 7 %
Acid-insoluble matter Not more than 4 %Starch Not detectable by the following method: to a 1 in 10 solution of the
sample add a few drops of iodine solution. No blue colour is produced
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Ethanol and propane-2-ol Not more than 1 %, single or in combination
E 412 GUAR GUM
Synonyms Gum cyamopsis
Guar flour
Definition Guar gum is the ground endosperm of the seeds of natural strains of the
guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae).
Consists mainly of a high molecular weight hydrocolloidal polysacchar-
ide composed of galactopyranose and mannopyranose units combinedthrough glycosidic linkages, which may be described chemically as
galactomannan
Einecs 232-536-0
Molecular weight 50 000-8 000 000
Assay Galactomannan content not less than 75 %
Description A white to yellowish-white, nearly odourless powder
Identification
A. Positive tests for galactose and for
mannose
B. Solubility Soluble in cold water
Purity
Loss on drying Not more than 15 % (105
oC, 5 hours)
Ash Not more than 1,5 % determined at 800oC
Acid-insoluble matter Not more than 7 %Protein (N × 6,25) Not more than 10 %20.9.2008 EN Official Journal of the European Union L 253/71Starch Not detectable by the following method: to a 1 in 10 solution of the
sample add a few drops of iodine solution. (No blue colour is produced)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 413 TRAGACANTH
Synonyms Tragacanth gum
Tragant
Definition Tragacanth is a dried exudation obtained from the stems and branches of
natural strains of Astragalus gummifer Labillardiere and other Asiatic
species of Astragalus (family Leguminosae). It consists mainly of high
molecular weight polysaccharides (galactoarabans and acidic polysac-
charides) which, on hydrolysis, yield galacturonic acid, galactose,
arabinose, xylose and fucose. Small amounts of rhamnose and of
glucose (derived from traces of starch and/or cellulose) may also be
present
Molecular weight Approximately 800 000
Einecs 232-252-5
Description Unground Tragacanth gum occurs as flattened, lamellated, straight or
curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up
to 3 cm in length. It is white to pale yellow in colour but some pieces
may have a red tinge. The pieces are horny in texture, with a short
fracture. It is odourless and solutions have an insipid mucilaginous taste.
Powdered tragacanth is white to pale yellow or pinkish brown (pale tan)
in colour
Identification
A. Solubility 1 g of the sample in 50 ml of water swells to form a smooth, stiff,
opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/
v) aqueous ethanol
Purity
Negative test for Karaya gum Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of
hydrochloric acid and again boil the mixture for five minutes. No
permanent pink or red colour develops
Loss on drying Not more than 16 % (105
oC, 5 hours)
Total ash Not more than 4 %
Acid insoluble ash Not more than 0,5 %
Acid insoluble matter Not more than 2 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kgSalmonella spp. Negative in 10 g
E. coli Negative in 5 gL 253/72 EN Official Journal of the European Union 20.9.2008E 414 ACACIA GUM
Synonyms Gum arabic
Definition Acacia gum is a dried exudation obtained from the stems and branches
of natural strains of Acacia senegal (L) Willdenow or closely related
species of Acacia (family Leguminosae). It consists mainly of high
molecular weight polysaccharides and their calcium, magnesium and
potassium salts, which on hydrolysis yield arabinose, galactose,
rhamnose and glucuronic acid
Molecular weight Approximately 350 000
Einecs 232-519-5
Description Unground acacia gum occurs as white or yellowish-white spheroidal
tears of varying sizes or as angular fragments and is sometimes mixed
with darker fragments. It is also available in the form of white to
yellowish-white flakes, granules, powder or spray-dried material.
Identification
A. Solubility 1 g dissolves in 2 ml of cold water forming a solution which flows
readily and is acid to litmus, insoluble in ethanol
Purity
Loss on drying Not more than 17 % (105oC, 5 hours) for granular and not more than
10 % (105oC, 4 hours) for spray-dried material
Total ash Not more than 4 %Acid insoluble ash Not more than 0,5 %
Acid insoluble matter Not more than 1 %
Starch or dextrin Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of
iodine solution. No bluish or reddish colours are produced
Tannin To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride
solution (9 g FeCl
3.6H 2O made up to 100 ml with water). No blackish
colouration or blackish precipitate is formed
Arsenic Not more than 3 mg/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/kgHydrolysis products Mannose, xylose and galacturonic acid are absent (determined by
chromatography)
Salmonella spp. Negative in 10 g
E. coli Negative in 5 g
E 415 XANTHAN GUM
Definition Xanthan gum is a high molecular weight polysaccharide gum produced
by a pure-culture fermentation of a carbohydrate with natural strains of
Xanthomonas campestris, purified by recovery with ethanol or propane-2-
ol, dried and milled. It contains D-glucose and D-mannose as the
dominant hexose units, along with D-glucuronic acid and pyruvic acid,
and is prepared as the sodium, potassium or calcium salt. Its solutions
are neutral
Molecular weight Approximately 1 000 000Einecs 234-394-2
Assay Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO
2
corresponding to between 91 % and 108 % of xanthan gum
Description Cream-coloured powder20.9.2008 EN Official Journal of the European Union L 253/73Identification
A. Solubility Soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 15 % (105oC, 21/2 hours)
Total ash Not more than 16 % on the anhydrous basis determined at 650oC after
drying at 105oC for four hours
Pyruvic acid Not less than 1,5 %Nitrogen Not more than 1,5 %
Ethanol and propan-2-ol Not more than 500 mg/kg singly or in combination
Lead Not more than 2 mg/kgTotal plate count Not more than 5 000 colonies per gram
Yeast and mould Not more than 300 colonies per gram
E. coli Absent in 5 g
Salmonella spp. Absent in 10 g
Xanthomonas campestris Viable cells absent in 1 g
E 416 KARAYA-GUM
Synonyms Katilo
KadayaGum sterculia
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 (family
Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other
species of Cochlospermum (family Bixaceae). It consists mainly of high
molecular weight acetylated polysaccharides, which on hydrolysis yield
galactose, rhamnose, and galacturonic acid, together with minor
amounts of glucuronic acid
Einecs 232-539-4
Description Karaya gum occurs in tears of variable size and in broken irregular pieces
having a characteristic semi-crystalline appearance. It is pale yellow topinkish 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 ethanolB. Swelling in ethanol solution Karaya gum swells in 60 % ethanol distinguishing it from other gums
Purity
Loss on drying Not more than 20 % (105
oC, 5 hours)
Total ash Not more than 8 %
Acid insoluble ash Not more than 1 %
Acid insoluble matter Not more than 3 %Volatile acid Not less than 10 % (as acetic acid)
Starch Not detectable
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgL 253/74 EN Official Journal of the European Union 20.9.2008Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Salmonella spp. Negative in 10 g
E. coli Negative in 5 g
E 417 TARA GUM
Definition Tara gum is obtained by grinding the endosperm of the seeds of natural
strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of
polysaccharides of high molecular weight composed mainly of
galactomannans. The principal component consists of a linear chainof (1-4)-β-D-mannopyranose units with α-D-galactopyranose units
attached by (1-6) linkages. The ratio of mannose to galactose in tara
gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)
Einecs 254-409-6
Description A white to white-yellow odourless powder
Identification
A. Solubility Soluble in water
Insoluble in ethanol
B. Gel formation To an aqueous solution of the sample add small amounts of sodium
borate. A gel is formed
Purity
Loss on drying Not more than 15 %
Ash Not more than 1,5 %Acid insoluble matter Not more than 2 %
Protein Not more than 3,5 % (factor N × 5,7)
Starch Not detectableArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 418 GELLAN GUM
Definition Gellan gum is a high molecular weight polysaccharide gum produced by
a pure culture fermentation of a carbohydrate by natural strains of
Pseudomonas elodea, purified by recovery with isopropyl alcohol, dried,
and milled. The high molecular weight polysaccharide is principally
composed of a tetrasaccharide repeating unit of one rhamnose, one
glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and
acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is
neutralised to a mixed potassium, sodium, calcium, and magnesium salt
Einecs 275-117-5Molecular weight Approximately 500 000
Assay Yields, on the dried basis, not less than 3,3 % and not more than 6,8 %
of CO
2
Description An off-white powder20.9.2008 EN Official Journal of the European Union L 253/75Identification
A. Solubility Soluble in water, forming a viscous solution.
Insoluble in ethanol
Purity
Loss on drying Not more than 15 % after drying (105oC, 21/2 hours)
Nitrogen Not more than 3 %
Propane-2-ol Not more than 750 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
Total plate count Not more than 10 000 colonies per gramYeast and mould Not more than 400 colonies per gram
E. coli Negative in 5 g
Salmonella spp. Negative in 10 g
E 420(i) SORBITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Commission Directive 2008/60/EC (
7).
E 420(ii) SORBITOL SYRUP
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 421 MANNITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 422 GLYCEROL
Synonyms Glycerin
Glycerine
Definition
Chemical names 1,2,3-propanetriol
Glycerol
Trihydroxypropane
Einecs 200-289-5Chemical formula C
3H8O3
Molecular weight 92,10Assay Content not less than 98 % of glycerol on the anhydrous basis
Description Clear, colourless hygroscopic syrupy liquid with not more than a slight
characteristic odour, which is neither harsh nor disagreeableL 253/76 EN Official Journal of the European Union 20.9.2008
(7) OJ L 158, 18.6.2008, p. 17.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 (25/25oC) 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 ± 25oC
Butanetriols Not more than 0,2 %
Acrolein, glucose and ammonium com-
poundsHeat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide
solution (1 in 10) at 60oC for five minutes. It neither becomes yellow
nor emits an odour of ammonia
Fatty acids and esters Not more than 0,1 % calculated as butyric acid
Chlorinated compounds Not more than 30 mg/kg (as chlorine)Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 5 mg/kg
E 425(i) KONJAC GUM
Definition Konjac gum is a water-soluble hydrocolloid obtained from the Konjac
flour by aqueous extraction. Konjac flour is the unpurified raw product
from the root of the perennial plant Amorphophallus konjac. The main
component of Konjac gum is the water-soluble high-molecular-weight
polysaccharide glucomannan, which consists of D-mannose and D-
glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic
bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds,
and acetyl groups occur at random at a ratio of about 1 group per 9 to
19 sugar units
Molecular weight The main component, glucomannan, has an average molecular weight of
200 000 to 2 000 000
Assay Not less than 75 % carbohydrate
Description A white to cream to light tan powder
Identification
A. Solubility Dispersible in hot or cold water forming a highly viscous solution with a
pH between 4,0 and 7,0
B. Gel formation Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the
sample in a test tube, and shake vigorously. A gel forms
C. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a boiling water bath
for 30 min, with continuous agitation and then cooling the solution to
room temperature. For each g of the sample used to prepare 30 g of the
2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully
hydrated sample at ambient temperature. Heat the mixture in a water
bath to 85
oC, and maintain for 2 h without agitation. Under these
conditions a thermally stable gel is formed
D. Viscosity (1 % solution) Not less than 3 kgm-1s-1at 25oC
Purity
Loss on drying Not more than 12 % (105oC, 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 sample20.9.2008 EN Official Journal of the European Union L 253/77Ether-soluble material Not more than 0,1 %
Total ash Not more than 5,0 % (800oC, 3 to 4h)
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kgSalmonella spp. Absent in 12,5 g
E. coli Absent in 5 g
E 425(ii) KONJAC GLUCOMANNAN
Definition Konjac glucomannan is a water-soluble hydrocolloid obtained from
Konjac flour by washing with water-containing ethanol. Konjac flour is
the unpurified raw product from the tuber of the perennial plant
Amorphophallus konjac. The main component is the water-soluble high-
molecular-weight polysaccharide glucomannan, which consists of D-
mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by
β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit.
About each 19th sugar residue is acetylated
Molecular weight 500 000 to 2 000 000
Assay Total dietary fibre: not less than 95 % on a dry weight basis
Description White to slightly brownish fine particle size, free flowing and odourless
powder
Identification
A. Solubility Dispersible in hot or cold water forming a highly viscous solution with a
pH between 5,0 and 7,0. Solubility is increased by heat and mechanical
agitation
B. Formation of heat-stable gel Prepare a 2 % solution of the sample by heating it in a boiling water bath
for 30 min, with continuous agitation and then cooling the solution toroom temperature. For each g of the sample used to prepare 30 g of the
2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully
hydrated sample at ambient temperature. Heat the mixture in a water
bath to 85
oC, and maintain for 2 h without agitation. Under these
conditions a thermally stable gel is formed
C. Viscosity (1 % solution) Not less than 20 kgm-1s-1at 25oC
Purity
Loss on drying Not more than 8 % (105oC, 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 gL 253/78 EN Official Journal of the European Union 20.9.2008E 426 SOYBEAN HEMICELLULOSE
Definition Soybean hemicellulose is a refined water-soluble polysaccharide
obtained from natural strain soybean fibre by hot water extraction
Chemical names Water soluble soybean polysaccharides
Water soluble soybean fibre
Assay Not less than 74 % carbohydrate
Description Free flowing spray-dried white powder
Identification
A. Solubility pH of 1 % solution Soluble in hot and cold water without gel formation
5,5 ± 1,5
B. Viscosity of 10 % solution Not more than 200 mPa.s
Purity
Loss on drying Not more than 7 % (105oC, 4h)
Protein Not more than 14 %
Total ash Not more than 9,5 % (600oC, 4h)
Arsenic Not more than 2 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgStandard plate count Not more than 3 000 colonies per gram
Yeast and mould Not more than 100 colonies per gram
E. coli Negative in 10 g
E 431 POLYOXYETHYLENE (40) STEARATE
Synonyms Polyoxyl (40) stearate
polyoxyethylene (40) monostearate
Definition A mixture of the mono- and diesters of edible commercial stearic acid
and mixed polyoxyethylene diols (having an average polymer length of
about 40 oxyethylene units) together with free polyol
Assay Content not less than 97,5 % on the anhydrous basis
Description Cream-coloured flakes or waxy solid at 25
oC with a faint odour
Identification
A. Solubility Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in
mineral oil
B. Congealing range 39oC-44oC
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 1
Saponification value Not less than 25 and not more than 35
Hydroxyl value Not less than 27 and not more than 40
1,4-Dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg20.9.2008 EN Official Journal of the European Union L 253/79Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)
Synonyms Polysorbate 20
Polyoxyethylene (20) sorbitan monolaurate
Definition A mixture of the partial esters of sorbitol and its mono- and
dianhydrides with edible commercial lauric acid and condensed with
approximately 20 moles of ethylene oxide per mole of sorbitol and its
anhydrides
Assay Content not less than 70 % of oxyethylene groups, equivalent to not less
than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the
anhydrous basis
Description A lemon to amber-coloured oily liquid at 25oC with a faint
characteristic odour
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble
in mineral oil and petroleum ether
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2
Saponification value Not less than 40 and not more than 50
Hydroxyl value Not less than 96 and not more than 1081,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)
Synonyms Polysorbate 80
Polyoxyethylene (20) sorbitan monooleate
Definition A mixture of the partial esters of sorbitol and its mono- and
dianhydrides with edible commercial oleic acid and condensed withapproximately 20 moles of ethylene oxide per mole of sorbitol and its
anhydrides
Assay Content not less than 65 % of oxyethylene groups, equivalent to not less
than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the
anhydrous basis
Description A lemon to amber-coloured oily liquid at 25
oC with a faint
characteristic odour
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble
in mineral oil and petroleum ether
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyolL 253/80 EN Official Journal of the European Union 20.9.2008Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2
Saponification value Not less than 45 and not more than 55Hydroxyl value Not less than 65 and not more than 80
1,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 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
E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)
Synonyms Polysorbate 40
Polyoxyethylene (20) sorbitan monopalmitate
Definition A mixture of the partial esters of sorbitol and its mono- and
dianhydrides with edible commercial palmitic acid and condensed with
approximately 20 moles of ethylene oxide per mole of sorbitol and its
anhydrides
Assay Content not less than 66 % of oxyethylene groups, equivalent to not less
than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the
anhydrous basis
Description A lemon to orange-coloured oily liquid or semi-gel at 25
oC with a faint
characteristic odour
Identification
A. Solubility Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble
in mineral oil
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2
Saponification value Not less than 41 and not more than 52
Hydroxyl value Not less than 90 and not more than 1071,4-dioxane Not more than 5 mg/kg
Ethylene oxide Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)
Synonyms Polysorbate 60
Polyoxyethylene (20) sorbitan monostearate
Definition A mixture of the partial esters of sorbitol and its mono- and
dianhydrides with edible commercial stearic acid and condensed with
approximately 20 moles of ethylene oxide per mole of sorbitol and its
anhydrides20.9.2008 EN Official Journal of the European Union L 253/81Assay 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 25oC with a faint
characteristic odour
Identification
A. Solubility Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and
vegetable oils
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)
Acid value Not more than 2Saponification value Not less than 45 and not more than 55
Hydroxyl value Not less than 81 and not more than 96
1,4-dioxane Not more than 5 mg/kgEthylene oxide Not more than 0,2 mg/kg
Ethylene glycols (mono- and di-) Not more than 0,25 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)
Synonyms Polysorbate 65
Polyoxyethylene (20) sorbitan tristearate
Definition A mixture of the partial esters of sorbitol and its mono- and
dianhydrides with edible commercial stearic acid and condensed with
approximately 20 moles of ethylene oxide per mole of sorbitol and its
anhydrides
Assay Content not less than 46 % of oxyethylene groups, equivalent to not less
than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous
basis
Description A tan-coloured, waxy solid at 25
oC with a faint characteristic odour
Identification
A. Solubility Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether,
acetone, ether, dioxane, ethanol and methanol
B. Congealing range 29-33oC
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
Purity
Water Not more than 3 % (Karl Fischer method)Acid value Not more than 2Saponification value Not less than 88 and not more than 98Hydroxyl value Not less than 40 and not more than 601,4-dioxane Not more than 5 mg/kgEthylene oxide Not more than 0,2 mg/kgEthylene glycols (mono- and di-) Not more than 0,25 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgL 253/82 EN Official Journal of the European Union 20.9.2008E 440 (i) PECTIN
Definition Pectin consists mainly of the partial methyl esters of polygalacturonic
acid and their ammonium, sodium, potassium and calcium salts. It is
obtained by extraction in an aqueous medium of natural strains of
appropriate edible plant material, usually citrus fruits or apples. Noorganic precipitant shall be used other than methanol, ethanol and
propane-2-ol
Einecs 232-553-0
Assay Content not less than 65 % of galacturonic acid on the ash-free and
anhydrous basis after washing with acid and alcohol
Description White, light yellow, light grey or light brown powder
Identification
A. Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in
ethanol
Purity
Loss on drying Not more than 12 % (105
oC, 2 hours)
Acid insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Sulphur dioxide Not more than 50 mg/kg on the anhydrous basisNitrogen content Not more than 1,0 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol Not more than 1 %, singly or in combination, on the anhydrous basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 440 (ii) AMIDATED PECTIN
Definition Amidated pectin consists mainly of the partial methyl esters and amides
of polygalacturonic acid and their ammonium, sodium, potassium and
calcium salts. It is obtained by extraction in an aqueous medium of
appropriate natural strains of edible plant material, usually citrus fruits
or apples and treatment with ammonia under alkaline conditions. No
organic precipitant shall be used other than methanol, ethanol and
propane-2-ol
Assay Content not less than 65 % of galacturonic acid on the ash-free and
anhydrous basis after washing with acid and alcohol
Description White, light yellow, light greyish or light brownish powder
Identification
A. Solubility Soluble in water forming a colloidal, opalescent solution. Insoluble in
ethanol
Purity
Loss on drying Not more than 12 % (105
oC, 2 hours)
Acid-insoluble ash Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
Degree of amidation Not more than 25 % of total carboxyl groups
Sulphur dioxide residue Not more than 50 mg/kg on the anhydrous basisNitrogen content Not more than 2,5 % after washing with acid and ethanol
Free methanol, ethanol and propane-2-ol Not more than 1 % single or in combination, on a volatile matter-free
basis
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/83Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 442 AMMONIUM PHOSPHATIDES
Synonyms Ammonium salts of phosphatidic acid, mixed ammonium salts of
phoshorylated glycerides
Definition A mixture of the ammonium compounds of phosphatidic acids derived
from edible fat and oil (usually partially hardened rapeseed oil). One or
two or three glyceride moieties may be attached to phosphorus.
Moreover, two phosphorus esters may be linked together as phospha-
tidyl phosphatides
Assay The phosphorus content is not less than 3 % and not more than 3,4 %
by weight; the ammonium content is not less than 1,2 % and not more
than 1,5 % (calculated as N)
Description Unctuous semi-solid
Identification
A. Solubility Soluble in fats. Insoluble in water. Partially soluble in ethanol and in
acetone
B. Positive tests for glycerol, for fatty
acid and for phosphate
Purity
Petroleum ether insoluble matter Not more than 2,5 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 444 SUCROSE ACETATE ISOBUTYRATE
Synonyms SAIB
Definition Sucrose acetate isobutyrate is a mixture of the reaction products formed
by the esterification of food grade sucrose with acetic acid anhydride and
isobutyric anhydride, followed by distillation. The mixture contains all
possible combinations of esters in which the molar ratio of acetate to
butyrate is about 2:6
Einecs 204-771-6
Chemical name Sucrose diacetate hexaisobutyrateChemical formulae C
40H62O19
Molecular weight 832-856 (approximate), C 40H62O19: 846,9
Assay Content not less than 98,8 % and not more than 101,9 % of C 40H62O19
Description A pale straw-coloured liquid, clear and free of sediment and having a
bland odour
Identification
A. Solubility Insoluble in water. Soluble in most organic solvents
B. Refractive index [n]40D: 1,4492-1,4504
C. Specific gravity [d]25D: 1,141-1,151
Purity
Triacetin Not more than 0,1 %
Acid value Not more than 0,2Saponification value Not less than 524 and not more than 540L 253/84 EN Official Journal of the European Union 20.9.2008Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 5 mg/kg
E 445 GLYCEROL ESTERS OF WOOD ROSIN
Synonyms Ester gum
Definition A complex mixture of tri- and diglycerol esters of resin acids from wood
rosin. The rosin is obtained by the solvent extraction of aged pine
stumps followed by a liquid-liquid solvent refining process. Excluded
from these specifications are substances derived from gum rosin, and
exudate of living pine trees, and substances derived from tall oil rosin, a
by-product of kraft (paper) pulp processing. The final product is
composed of approximately 90 % resin acids and 10 % neutrals (non-
acidic compounds). The resin acid fraction is a complex mixture of
isomeric diterpenoid monocarboxylic acids having the empirical
molecular formula of C
20H30O2, chiefly abietic acid. The substance is
purified by steam stripping or by countercurrent steam distillation
Description Hard, yellow to pale amber-coloured solid
Identification
A. Solubility Insoluble in water, soluble in acetone
B. Infrared absorption spectrum Characteristic of the compound
Purity
Specific gravity of solution [d]2025not less than 0,935 when determined in a 50 % solution in
d-limonene (97 %, boilding point 175,5-176oC, d204: 0,84)
Ring and ball softening range Between 82oC and 90oC
Acid value Not less than 3 and not more than 9
Hydroxyl value Not less than 15 and not more than 45Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Test for absence of tall oil rosin (sulphur
test)When sulphur-containing organic compounds are heated in the presence
of sodium formate, the sulphur is converted to hydrogen sulphide which
can readily be detected by the use of lead acetate paper. A positive testindicates the use of tall oil rosin instead of wood rosin
E 450 (i) DISODIUM DIPHOSPHATE
Synonyms Disodium dihydrogen diphosphate
Disodium dihydrogen pyrophosphate
Sodium acid pyrophosphate
Disodium pyrophosphate
Definition
Chemical name Disodium dihydrogen diphosphate
Einecs 231-835-0Chemical formula Na
2H2P2O720.9.2008 EN Official Journal of the European Union L 253/85Molecular 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 grains
Identification
A. Positive tests for sodium and for
phosphate
B. Solubility Soluble in water
C. pH of a 1 % solution Between 3,7 and 5,0
Purity
Loss on drying Not more than 0,5 % (105oC, four hours)
Water-insoluble matter Not more than 1 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E 450 (ii) TRISODIUM DIPHOSPHATE
Synonyms Acid trisodium pyrophosphate
Trisodium monohydrogen diphosphate
Definition
Einecs 238-735-6
Chemical formula Monohydrate: Na
3HP2O7·H2O
Anhydrous: Na 3HP2O7
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. Solubility Soluble in water
C. pH of a 1 % solution Between 6,7 and 7,5
Purity
Loss on ignition Not more than 4,5 % on the anhydrous compound
Not more than 11,5 % on the monohydrous basis
Loss on drying Not more than 0,5 % (105oC, four hours)
Water-insoluble matter Not more than 0,2 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kgL 253/86 EN Official Journal of the European Union 20.9.2008E 450 (iii) TETRASODIUM DIPHOSPHATE
Synonyms Tetrasodium pyrophosphate
Sodium pyrophosphate
Definition
Chemical name Tetrasodium diphosphateEinecs 231-767-1Chemical formula Anhydrous: Na
4P2O7
Decahydrate: Na 4P2O7·10H 2O
Molecular weight Anhydrous: 265,94
Decahydrate: 446,09
Assay Content not less than 95 % of Na 4P2O7on 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 ethanol
C. pH of a 1 % solution Between 9,8 and 10,8
Purity
Loss on ignition Not more than 0,5 % for the anhydrous salt, not less than 38 % and not
more than 42 % for the decahydrate, in both cases determined afterdrying at 105
oC for four hours, followed by ignition at 550oC 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/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E 450 (v) TETRAPOTASSIUM DIPHOSPHATE
Synonyms Potassium pyrophosphate
Tetrapotassium pyrophosphate
Definition
Chemical name Tetrapotassium diphosphate
Einecs 230-785-7
Chemical formula K
4P2O7
Molecular weight 330,34 (anhydrous)Assay Content not less than 95 % on the ignited basis
P
2O5content Not less than 42,0 % and not more than 43,7 % on the anhydrous basis
Description Colourless crystals or white, very hygroscopic powder
Identification
A. Positive tests for potassium and for
phosphate
B. Solubility Soluble in water, insoluble in ethanol
C. pH of a 1 % solution Between 10,0 and 10,820.9.2008 EN Official Journal of the European Union L 253/87Purity
Loss on ignition Not more than 2 % after drying at 105oC for four hours and then
ignition at 550oC 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/kgLead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E 450 (vi) DICALCIUM DIPHOSPHATE
Synonyms Calcium pyrophosphate
Definition
Chemical name Dicalcium diphosphate
Dicalcium pyrophosphate
Einecs 232-221-5
Chemical formula 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 800oC ± 25oC 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/kg
Lead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg
E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE
Synonyms Acid calcium pyrophosphate
Monocalcium dihydrogen pyrophosphate
Definition
Chemical name Calcium dihydrogen diphosphate
Einecs 238-933-2Chemical formula CaH
2P2O7
Molecular weight 215,97Assay Content not less than 90 % on the anhydrous basisP
2O5content Not less than 61 % and not more than 64 %L 253/88 EN Official Journal of the European Union 20.9.2008Description White crystals or powder
Identification
A. Positive tests for calcium and for
phosphate
Purity
Acid-insoluble matter Not more than 0,4 %
Fluoride Not more than 30 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E 451 (i) PENTASODIUM TRIPHOSPHATE
Synonyms Pentasodium tripolyphosphate
Sodium tripolyphosphate
Definition
Chemical name Pentasodium triphosphate
Einecs 231-838-7
Chemical formula Na
5O10P3·nH 2O (n = 0 or 6)
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 % (anhydrous) or not less than
43 % and not more than 45 % (hexahydrate)
Description White, slightly hygroscopic granules or powder
Identification
A. Solubility Freely soluble in water. Insoluble in ethanol
B. Positive tests for sodium and for
phosphate
C. pH of a 1 % solution Between 9,1 and 10,2
Purity
Loss on drying Anhydrous: Not more than 0,7 % (105oC, one hour)
Hexahydrate: Not more than 23,5 % (60oC, one hour, followed by
drying at 105oC, four hours)
Water-insoluble substances Not more than 0,1 %
Higher polyphosphates Not more than 1 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury Not more than 1 mg/kg
E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE
Synonyms Pentapotassium tripolyphosphate
Potassium triphosphatePotassium tripolyphosphate20.9.2008 EN Official Journal of the European Union L 253/89Definition
Chemical name Pentapotassium triphosphate
Pentapotassium tripolyphosphate
Einecs 237-574-9Chemical formula K
5O10P3
Molecular weight 448,42Assay Content not less than 85 % on the anhydrous basisP
2O5content 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 105oC, four hours, followed by
ignition at 550oC, 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
E 452 (i) SODIUM POLYPHOSPHATE
1. SOLUBLE POLYPHOSPHATE
Synonyms Sodium hexametaphosphate
Sodium tetrapolyphosphate
Graham's saltSodium polyphosphates, glassy
Sodium polymetaphosphate
Sodium metaphosphate
Definition Soluble sodium polyphosphates are obtained by fusion and subsequent
chilling of sodium orthophosphates. These compounds are a class
consisting of several amorphous, water-soluble polyphosphates com-
posed of linear chains of metaphosphate units, (NaPO
3)xwhere x ≥2,
terminated by Na 2PO 4groups. These substances are usually identified by
their Na 2O/P 2O5ratio or their P 2O5content. The Na 2O/P 2O5ratios vary
from about 1,3 for sodium tetrapolyphosphate, where x = approximately4; to about 1,1 for Graham's salt, commonly called sodium
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 polypho-
sphoric acids of general formula H
(n + 2) PnO(3n + 1) where ‘n’is not less
than 2
Molecular weight (102) n
Assay P 2O5content Not less than 60 % and not more than 71 % on the ignited basisL 253/90 EN Official Journal of the European Union 20.9.2008Description Colourless or white, transparent platelets, granules, or powders
Identification
A. Solubility Very soluble in water
B. Positive tests for sodium and for
phosphate
C. pH of a 1 % solution Between 3,0 and 9,0
Purity
Loss on ignition Not more than 1 %
Water-insoluble matter Not more than 0,1 %
Fluoride Not more than 10 mg/kg (expressed as fluorine)Arsenic Not more than 3 mg/kg
Cadmium Not more than 1 mg/kg
Lead Not more than 4 mg/kgMercury 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)x
that spiral in opposite directions about a common axis. The Na 2O/P 2O5
ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5
Chemical name Sodium polyphosphateEinecs 272-808-3
Chemical formula Heterogenous mixtures of sodium salts of linear condensed polypho-
sphoric acids of general formula H
(n + 2) PnO(3n + 1) where ‘n’is not less
than 2
Molecular weight (102) n
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/kgLead Not more than 4 mg/kg
Mercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/91E 452 (ii) POTASSIUM POLYPHOSPHATE
Synonyms Potassium metaphosphate
Potassium polymetaphosphate
Kurrol salt
Definition
Chemical name Potassium polyphosphate
Einecs 232-212-6
Chemical formula (KPO 3)n
Heterogenous mixtures of potassium salts of linear condensed polypho-
sphoric acids of general formula H (n + 2) PnO(3n + 1) where ‘n’is not less
than 2
Molecular weight (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 % (105oC, four hours followed by ignition at 550oC,
30 minutes)
Cyclic phosphate Not more than 8 % on P 2O5content
Fluoride 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
E 452(iii) SODIUM CALCIUM POLYPHOSPHATE
Synonym Sodium calcium polyphosphate, glassy
Definition
Chemical name Sodium calcium polyphosphate
Einecs 233-782-9Chemical formula (NaPO
3)nCaO 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/kg
Arsenic Not more than 3 mg/kgLead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kgL 253/92 EN Official Journal of the European Union 20.9.2008E 452 (iv) CALCIUM POLYPHOSPHATE
Synonyms Calcium metaphosphate
Calcium polymetaphosphate
Definition
Chemical name Calcium polyphosphateEinecs 236-769-6Chemical 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 powder
Identification
A. Solubility Usually sparingly soluble in water. Soluble in acid mediumB. 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 550oC,
30 minutes)
Cyclic phosphate Not more than 8 % on P 2O5content
Fluoride Not more than 30 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
E 459 BETA-CYCLODEXTRIN
Definition Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven
α-1,4-linked D-glucopyranosyl units. The product is manufactured by
the action of the enzyme cycloglycosyltransferase (CGTase) obtained
from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus
licheniformis strain SJ1608 on partially hydrolysed starch
Chemical name CycloheptaamyloseEinecs 231-493-2Chemical formula (C
6H10O5)7
Molecular weight 1 135Assay Content not less than 98,0 % of (C
6H10O5)7on 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)
Purity
Water Not more than 14 % (Karl Fischer method)Other cyclodextrins Not more than 2 % on an anhydrous basisResidual solvents (toluene and trichlor-
oethylene)Not more than 1 mg/kg for each solvent20.9.2008 EN Official Journal of the European Union L 253/93Sulphated ash Not more than 0,1 %
Arsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
E 460 (i) MICROCRISTALLINE CELLULOSE
Synonyms Cellulose gel
Definition Microcrystalline cellulose is purified, partally depolymerised cellulose
prepared by treating alpha-cellulose, obtained as a pulp from natural
strains of fibrous plant material, with mineral acids. The degree of
polymerisation is typically less than 400
Chemical name CelluloseEinecs 232-674-9
Chemical formula (C
6H10O5)n
Molecular weight About 36 000
Assay Not less than 97 % calculated as cellulose on the anhydrous basis
Description A fine white or almost white odourless powder
Identification
A. Solubility Insoluble in water, ethanol, ether and dilute mineral acids. Slightly
soluble in sodium hydroxide solution
B. Colour reaction To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water
bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in
phosphoric acid and heat for 30 minutes. A red colour is produced
C. To be identified by IR 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 % (105oC, 3 hours)
Water-soluble matter Not more than 0,24 %Sulphated ash Not more than 0,5 % determined at 800 ± 25
oC
pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and 7,5
Starch Not detectable
To 20 ml of the dispersion obtained in identification, test D, add a few
drops of iodine solution and mix. No purplish to blue or blue colour
should be produced
Particle size Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
Carboxyl groups Not more than 1 %
Arsenic Not more than 3 mg/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/kgL 253/94 EN Official Journal of the European Union 20.9.2008E 460 (ii) POWDERED CELLULOSE
Definition Purified, mechanically disintegrated celluslose prepared by processing
alpha-cellulose obtained as a pulp from natural strains of fibrous plant
materials
Chemical name Cellulose
Linear polymer of 1:4 linked glucose residues
Einecs 232-674-9
Chemical formula (C 6H10O5)n
Molecular weight (162) n(n is predominantly 1 000 and greater)
Assay Content not less than 92 %
Description A white, odourless powder
Identification
A. Solubility Insoluble in water, ethanol, ether and dilute mineral acids. Slightly
soluble in sodium hydroxide solution
B. Suspension test Mix 30 g of the sample with 270 ml of water in a high-speed
(12 000 rpm) power blender for 5 minutes. The resultant mixture will
be either a free-flowing suspension or a heavy, lumpy suspension which
flows poorly, if at all, settles only slightly and contains many trapped air
bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a
100-ml graduated cylinder and allow to stand for 1 hour. The solids
settle and a supernatant liquid appears
Purity
Loss on drying Not more than 7 % (105oC, 3 hours)
Water-soluble matter Not more than 1,0 %
Sulphated ash Not more than 0,3 % determined at 800 ± 25oC
pH of a 10 % suspension in water The pH of the supernatant liquid is between 5,0 and 7,5Starch Not detectable
To 20 ml of the dispersion obtained in identification, test B, add a few
drops of iodine solution and mix. No purplish to blue or blue colour
should be produced
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Particle size Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
E 461 METHYL CELLULOSE
Synonyms Cellulose methyl ether
Definition Methyl cellulose is cellulose obtained directly from natural strains of
fibrous plant material and partially etherified with methyl groups
Chemical name Methyl ether of celluloseChemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR 1)(OR 2)(OR 3) where R 1, R 2, R 3each may be one of the
following:
—H
—CH 3
—or CH 2CH 320.9.2008 EN Official Journal of the European Union L 253/95Molecular weight From about 20 000 to 380 000
Assay Content not less than 25 % and not more than 33 % of methoxyl groups
(-OCH 3) and not more than 5 % of hydroxyethoxyl groups
(-OCH 2CH 2OH)
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder
Identification
A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal
solution.
Insoluble in ethanol, ether and chloroform.
Soluble in glacial acetic acid
Purity
Loss on drying Not more than 10 % (105oC, 3 hours)
Sulphated ash Not more than 1,5 % determined at 800 ± 25oC
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 462 ETHYL CELLULOSE
Synonyms Cellulose ethyl ether
Definition Ethyl cellulose is cellulose obtained directly from fibrous plant material
and partially etherified with ethyl groups
Chemical name Ethyl ether of celluloseChemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR 1)(OR 2) where R 1and R 2may be any of the following:
—H
—CH 2CH 3
Assay Content not less than 44 % and not more than 50 % of ethoxyl groups
(-OC 2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl
groups per anhydroglucose unit)
Description Slightly hygroscopic white to off-white, odourless and tasteless powder
Identification
A. Solubility Practically insoluble in water, in glycerol and in propane-1,2-diol but
soluble in varying proportions in certain organic solvents dependingupon the ethoxyl content. Ethyl cellulose containing less than 46 to
48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl
acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures.
Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely
soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl
acetate
B. Film forming test Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene
ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml
of the solution onto a glass plate and allow the solvent to evaporate. Athick, tough, continuous, clear film remains. The film is flammable
Purity
Loss on drying Not more than 3 % (105
oC, 2 hours)
Sulphated ash Not more than 0,4 %L 253/96 EN Official Journal of the European Union 20.9.2008pH of a 1 % colloidal solution Neutral to litmus
Arsenic Not more than 3 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
E 463 HYDROXYPROPYL CELLULOSE
Synonyms Cellulose hydroxypropyl ether
Definition Hydroxypropylcellulose is cellulose obtained directly from natural
strains of fibrous plant material and partially etherified with
hydroxypropyl groups
Chemical name Hydroxypropyl ether of celluloseChemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR 1)(OR 2)(OR 3), where R 1, R 2, R 3each may be one of the
following:
—H
—CH 2CHOHCH 3
—CH 2CHO(CH 2CHOHCH 3)CH 3
—CH 2CHO[CH 2CHO(CH 2CHOHCH 3)CH 3]CH 3
Molecular weight From about 30 000 to 1 000 000
Assay Content not less than 80,5 % of hydroxypropoxyl groups
(-OCH 2CHOHCH 3) equivalent to not more than 4,6 hydroxypropyl
groups per anhydroglucose unit on the anhydrous basis
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder
Identification
A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal
solution. Soluble in ethanol. Insoluble in ether
B. Gas chromatography Determine the substituents by gas chromotography
Purity
Loss on drying Not more than 10 % (105oC, 3 hours)
Sulphated ash Not more than 0,5 % determined at 800 ± 25oC
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Propylene chlorohydrins Not more than 0,1 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 464 HYDROXYPROPYL METHYL CELLULOSE
Definition Hydroxypropyl methyl cellulose is cellulose obtained directly from
natural strains of fibrous plant material and partially etherified with
methyl groups and containing a small degree of hydroxypropyl
substitution
Chemical name 2-Hydroxypropyl ether of methylcellulose20.9.2008 EN Official Journal of the European Union L 253/97Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C6H7O2(OR 1)(OR 2)(OR 3), where R 1, R 2R3each may be one of the
following:
—H
—CH 3
—CH 2CHOHCH 3
—CH 2CHO (CH 2CHOHCH 3) CH 3
—CH 2CHO[CH 2CHO (CH 2CHOHCH 3) CH 3]CH 3
Molecular weight From about 13 000 to 200 000
Assay Content not less than 19 % and not more than 30 % methoxyl groups
(-OCH 3) and not less than 3 % and not more than 12 % hydro-
xypropoxyl groups (-OCH 2CHOHCH 3), on the anhydrous basis
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder
Identification
A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal
solution. Insoluble in ethanol
B. Gas chromatography Determine the substituents by gas chromatography
Purity
Loss on drying Not more than 10 % (105oC, 3 hours)
Sulphated ash Not more than 1,5 % for products with viscosities of 50 mPa.s or above
Not more than 3 % for products with viscosities below 50 mPa.s
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Propylene chlorohydrins Not more than 0,1 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 20 mg/kg
E 465 ETHYL METHYL CELLULOSE
Synonyms Methylethylcellulose
Definition Ethyl methyl cellulose is cellulose obtained directly from natural strains
of fibrous plant material and partially etherified with methyl and ethyl
groups
Chemical name Ethyl methyl ether of cellulose
Chemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR 1)(OR 2)(OR 3), where R 1, R 2R3each may be one of the
following:
—H
—CH 3
—CH 2CH 3
Molecular weight From about 30 000 to 40 000L 253/98 EN Official Journal of the European Union 20.9.2008Assay Content on the anhydrous basis not less than 3,5 % and not more than
6,5 % of methoxyl groups (-OCH 3) and not less than 14,5 % and not
more than 19 % of ethoxyl groups (-OCH 2CH 3), and not less than
13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as
methoxyl
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder
Identification
A. Solubility Swelling in water, producing a clear to opalescent, viscous, colloidal
solution. Soluble in ethanol. Insoluble in ether
Purity
Loss on drying Not more than 15 % for the fibrous form, and not more than 10 % for
the powdered form (105oC to constant weight)
Sulphated ash Not more than 0,6 %pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,0
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
E 466 SODIUM CARBOXY METHYL CELLULOSE
Synonyms Carboxy methyl cellulose
CMC
NaCMC
Sodium CMCCellulose gum
Definition Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl
ether of cellulose, the cellulose being obtained directly from natural
strains of fibrous plant material
Chemical name Sodium salt of the carboxymethyl ether of celluloseChemical formula The polymers contain substituted anhydroglucose units with the
following general formula:
C
6H7O2(OR 1)(OR 2)(OR 3), where R 1, R 2R3each may be one of the
following:
—H
—CH 2COONa
—CH 2COOH
Molecular weight Higher than approximately 17 000 (degree of polymerisation approxi-
mately 100)
Assay Content on the anhydrous basis not less than 99,5 %
Description Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder
Identification
A. Solubility Yields a viscous colloidal solution with water. Insoluble in ethanolB. Foam test A 0,1 % solution of the sample is shaken vigorously. No layer of foam
appears. (This test permits the distinction of sodium carboxymethyl
cellulose from other cellulose ethers)
C. Precipitate formation To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of
copper sulphate or of aluminium sulphate. A precipitate appears. (This
test permits the distinction of sodium carboxymethyl cellulose from
other cellulose ethers and from gelatine, locust bean gum and
tragacanth)20.9.2008 EN Official Journal of the European Union L 253/99D. 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
(-CH 2COOH) per anhydroglucose unit
Loss on drying Not more than 12 % (105oC to constant weight)
pH of a 1 % colloidal solution Not less than 5,0 and not more than 8,5
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 20 mg/kg
Total glycolate Not more than 0,4 %, calculated as sodium glycolate on the anhydrous
basis
Sodium Not more than 12,4 % on the anhydrous basis
E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE
Synonyms Cross-linked carboxymethyl cellulose
Cross-linked CMC
Cross-linked sodium CMC
Cross-linked cellulose gum
Definition Cross-linked sodium carboxymethyl cellulose is the sodium salt of
thermally cross-linked partly O-carboxymethylated cellulose
Chemical name Sodium salt of the cross-linked carboxymethyl ether cellulose
Chemical formula The polymers containing substituted anhydroglucose units with the
general formula:
C
6H7O2(OR 1)(OR 2)(OR 3)
where R 1, R2and R 3may be any of the following:
—H
—CH 2COONa
—CH 2COOH
Description Slightly hygroscopic, white to off white, odourless powder
Identification
A. Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue
and allow to settle. The substance to be examined absorbs the methylene
blue and settles as a blue, fibrous mass
B. Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture 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 sodiumL 253/100 EN Official Journal of the European Union 20.9.2008Purity
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 7,0
Sodium content Not more than 12,4 % on anhydrous basisArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Cadmium Not more than 1 mg/kgMercury Not more than 1 mg/kg
E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE
Synonyms Sodium carboxymethyl cellulose, enzymatically hydrolysed
Definition Enzymatically hydrolysed carboxymethylcellulose is obtained from
carboxymethylcellulose by enzymatic digestion with a cellulase produced
byTrichoderma longibrachiatum (formerly T. reesei)
Chemical name Carboxymethyl cellulose, sodium, partially enzymatically hydrolysedChemical formula Sodium salts of polymers containing substituted anhydroglucose units
with the general formula:
[C
6H7O2(OH) x(OCH 2COONa) y]n
where n is the degree of polymerisation
x = 1,50 to 2,80
y = 0,2 to 1,50x + y = 3,0
(y = degree of substitution)
Formula weight 178,14 where y = 0,20
282,18 where y = 1,50
Macromolecules: Not less than 800 (n about 4)
Assay Not less than 99,5 %, including mono- and disaccharides, on the dried
basis
Description White or slightly yellowish or greyish, odourless, slightly hygroscopic
granular or fibrous powder
Identification
A. Solubility Soluble in water, insoluble in 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 gums
C. Precipitate formation To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of
copper or aluminium sulphate. A precipitate appears. This test
distinguishes sodium carboxymethyl cellulose, whether hydrolysed or
not, from other cellulose ethers and from gelatine, carob bean gum and
tragacanth gum
D. Colour reaction Add 0,5 g of the powdered sample to 50 ml of water, while stirring to
produce a uniform dispersion. Continue the stirring until a clear solution
is produced. Dilute 1 ml of the solution with 1 ml of water in a small test
tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully
introduce down the side of the tube 2 ml of sulphuric acid so that it
forms a lower layer. A red-purple colour develops at the interface
E. Viscosity (60 % solids) Not less than 2,500 kgm
-1s-1at 25oC corresponding to an average
molecule weight of 5 000 D20.9.2008 EN Official Journal of the European Union L 253/101Purity
Loss on drying Not more than 12 % (105oC to constant weight)
Degree of substitution Not less than 0,2 and not more than 1,5 carboxymethyl groups per
anhydroglucose unit on the dried basis
pH of a 1 % colloidal solution Not less than 6,0 and not more than 8,5
Sodium chloride and sodium glycolate Not more than 0,5 % singly or in combination
Residual enzyme activity Passes test. No change in viscosity of test solution occurs, which
indicates hydrolysis of the sodium carboxymethyl cellulose
Lead Not more than 3 mg/kg
E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS
Definition Sodium, potassium and calcium salts of fatty acids occurring in food oils
and fats, these salts being obtained either from edible fats and oils or
from distilled food fatty acids
Assay Content on the anhydrous basis not less than 95 %
Description White or creamy white light powders, flakes or semi-solids
Identification
A. Solubility Sodium and potassium salts: soluble in water and ethanol calcium salts:
insoluble in water, ethanol and ether
B. Positive tests for cations and for fatty
acids
Purity
Sodium Not less than 9 % and not more than 14 % expressed as Na 2O
Potassium Not less than 13 % and not more than 21,5 % expressed as K 2O
Calcium Not less than 8,5 % and not more than 13 % expressed as CaOUnsaponifiable matter Not more than 2 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Free alkali Not more than 0,1 % expressed as NaOH
Matter insoluble in alcohol Not more than 0,2 % (sodium and potassium salts only)
E 470b MAGNESIUM SALTS OF FATTY ACIDS
Definition Magnesium salts of fatty acids occurring in foods oils and fats, these salts
being obtained either from edible fats and oils or from distilled food
fatty acids
Assay Content on the anhydrous basis not less than 95 %
Description White or creamy-white light powders, flakes or semi-solids
Identification
A. Solubility Insoluble in water, partially soluble in ethanol and ether
B. Positive tests for magnesium and for
fatty acidsL 253/102 EN Official Journal of the European Union 20.9.2008Purity
Magnesium Not less than 6,5 % and not more than 11 % expressed as MgO
Free alkali Not more than 0,1 % expressed as MgO
Unsaponifiable matter Not more than 2 %Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Glyceryl monostearate
Glyceryl monopalmitate
Glyceryl monooleate, etc.
Monostearin, monopalmitin, monoolein, etc.GMS (for glyceryl monostearate)
Definition Mono- and diglycerides of fatty acids consist of mixtures of glycerol
mono-, di- and triesters of fatty acids occurring in food oils and fats.
They may contain small amounts of free fatty acids and glycerol
Assay Content of mono- and diesters: not less than 70 %
Description The product varies from a pale yellow to pale brown oily liquid to a
white or slightly off-white hard waxy solid. The solids may be in the
form of flakes, powders or small beads
Identification
A. Infrared spectrum Characteristic of a partial fatty acid ester of a polyol
B. Positive tests for glycerol and for fatty
acids
C. Solubility Insoluble in water, soluble in ethanol and toluene
Purity
Water content Not more than 2 % (Karl Fischer method)Acid value Not more than 6
Free glycerol Not more than 7 %
Polyglycerols Not more than 4 % diglycerol and not more than 1 % higher
polyglycerols both based on total glycerol content
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Total glycerol Not less than 16 % and not more than 33 %
Sulphated ash Not more than 0,5 % determined at 800 ± 25
oC
Note: 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).20.9.2008 EN Official Journal of the European Union L 253/103E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Acetic acid esters of mono- and diglycerides
Acetoglycerides
Acetylated mono- and diglycerides
Acetic and fatty acid esters of glycerol
Definition Esters of glycerol with acetic and fatty acids occurring in food fats and
oils. They may contain small amounts of free glycerol, free fatty acids,
free acetic acid and free glycerides
Description Clear, mobile liquids to solids, from white to pale yellow in colour
Identification
A. Positive tests for glycerol, for fatty
acids and for acetic acid
B. Solubility Insoluble in water. Soluble in ethanol
Purity
Acids other than acetic and fatty acids Not detectable
Free glycerol Not more than 2 %
Arsenic Not more than 3 mg/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 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
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Lactic acid esters of mono- and diglycerides
Lactoglycerides
Mono- and diglycerides of fatty acids esterified with lactic acid
Definition Esters of glycerol with lactic acid and fatty acids occurring in food fats
and oils. They may contain small amounts of free glycerol, free fatty
acids, free lactic acid and free glycerides
Description Clear, mobile liquids to waxy solids of variable consistency, from white
to pale yellow in colour
Identification
A. Positive tests for glycerol, for fatty
acids and for lactic acid
B. Solubility Insoluble in cold water but dispersible in hot water
Purity
Acids other than lactic and fatty acids Not detectable
Free glycerol Not more than 2 %Arsenic Not more than 3 mg/kgL 253/104 EN Official Journal of the European Union 20.9.2008Lead 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/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
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Citrem
Citric acid esters of mono- and diglycerides
Citroglycerides
Mono- and diglycerides of fatty acids esterified with citric acid
Definition Esters of glycerol with citric acid and fatty acids occurring in food oils
and fats. They may contain small amounts of free glycerol, free fatty
acids, free citric acid and free glycerides. They may be partially or wholly
neutralised with sodium hydroxide or with potassium hydroxide
Description Yellowish or light brown liquids to waxy solids or semi-solids
Identification
A. Positive tests for glycerol, for fatty
acids and for citric acid
B. Solubility Insoluble in cold water
Dispersible in hot water
Soluble in oils and 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 (determined at 800 ± 25oC) Non-neutralised products: not more than 0,5 %Partially or wholly neutralised products: not more than 10 %
Lead Not more than 2 mg/kg
Free fatty acids Not more than 3 % estimated as oleic acid
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Tartaric acid esters of mono- and diglycerides
Mono- and diglycerides of fatty acids esterified with tartaric acid
Definition Esters of glycerol with tartaric acid and fatty acids occurring in food fats
and oils. They may contain small amounts of free glycerol, free fatty
acids, free tartaric acid and free glycerides20.9.2008 EN Official Journal of the European Union L 253/105Description Sticky viscous yellowish liquids to hard yellow waxes
Identification
A. Positive tests for glycerol, for fatty
acids and for tartaric acid
Purity
Acids other than tartaric and fatty acids Not detectable
Free glycerol Not more than 2 %Total glycerol Not less than 12 % and not more than 29 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgTotal tartaric acid Not less than 15 % and not more than 50 %
Free fatty acids Not more than 3 % estimated as oleic acid
Sulphated ash Not more than 0,5 % determined at 800 ± 25
oC
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Diacetyltartaric acid esters of mono- and diglycerides
Mono-and diglycerides of fatty acids esterified with mono- and
diacetyltartaric acid
Diacetyltartaric and fatty acid esters of glycerol
Definition Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained
from tartaric acid) and fatty acids occurring in food fats and oils. They
may contain small amounts of free glycerol, free fatty acids, free tartaric
and acetic acids and their combinations, and free glycerides. Contains
also tartaric and acetic esters of fatty acids
Description Sticky viscous liquids through a fat-like consistency to yellow waxes
which hydrolyse in moist air to liberate acetic acid
Identification
A. Positive tests for glycerol, for fatty
acids, for tartaric acid and for aceticacid
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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgTotal tartaric acid Not less than 10 % and not more than 40 %L 253/106 EN Official Journal of the European Union 20.9.2008Total acetic acid Not less than 8 % and not more than 32 %
Free fatty acids Not more than 3 % estimated as oleic acid
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
Synonyms Mono- and diglycerides of fatty acids esterified with acetic acid and
tartaric acid
Definition Esters of glycerol with acetic and tartaric acids and fatty acids occurring
in food fats and oils. They may contain small amounts of free glycerol,
free fatty acids, free tartaric and ecetic acids, and free glycerides. May
contain mono- and diacetyltartaric esters of mono- and diglycerides of
fatty acids
Description Sticky liquids to solids, from white to pale-yellow in colour
Identification
A. Positive tests for glycerol, for fatty
acids, for tartaric acid and for acetic
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/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kgTotal acetic acid Not less than 10 % and not more than 20 %
Total tartaric acid Not less than 20 % and not more than 40 %
Free fatty acids Not more than 3 % estimated as oleic acid
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 473 SUCROSE ESTERS OF FATTY ACIDS
Synonyms Sucroesters
Sugar esters
Definition Essentially the mono-, di- and triesters of sucrose with fatty acids
occurring in food fats and oils. They may be prepared from sucrose and
the methyl and ethyl esters of food fatty acids or by extraction from
sucroglycerides. No organic solvent other than dimethylsulphoxide,
dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol,
propylene glycol and methyl ethyl ketone may be used for their
preparation
Assay Content not less than 80 %
Description Stiff gels, soft solids or white to slightly greyish-white powders
Identification
A. Positive tests for sugar for fatty acids20.9.2008 EN Official Journal of the European Union L 253/107B. Solubility Sparingly soluble in water
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25oC
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acid
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Methanol Not more than 10 mg/kg
Dimethylsulphoxide Not more than 2 mg/kgDimethylformamide Not more than 1 mg/kg
2-methyl-1-propanol Not more than 10 mg/kg
Ethylacetate
Not more than 350 mg/kg, singly or in combination Propane-2-ol
Prolyleneglycol9
>>=
>>;
Methyl ethyl ketone Not more than 10 mg/kg
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 474 SUCROGLYCERIDES
Synonyms Sugar glycerides
Definition Sucroglycerides are produced by reacting sucrose with an edible fat or oil
to produce a mixture of essentially mono-, di- and triesters of sucrose
and fatty acids together with residual mono-, di- and triglycerides from
fat or oil. No organic solvents shall be used in their preparation other
than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-
propanol and propane-2-ol
Assay Content not less than 40 % and not more than 60 % of sucrose fatty acid
esters
Description Soft solid masses, stiff gels or white to off-white powders
Identification
A. Positive tests for sugar and for fatty
acids
B. Solubility Insoluble in cold water
Soluble in ethanol
Purity
Sulphated ash Not more than 2 % determined at 800 ± 25oC
Free sugar Not more than 5 %
Free fatty acids Not more than 3 % estimated as oleic acidArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Methanol Not more than 10 mg/kg
Dimethylformamide Not more than 1 mg/kgL 253/108 EN Official Journal of the European Union 20.9.20082-methyl-1-propanol
Not more than 10 mg/kg, single or in combination
Cyclohexane)
Ethylacetate
Not more than 350 mg/kg, single or in combination
Propane-2-ol)
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS
Synonyms Polyglycerol fatty acid esters
Polyglycerin esters of fatty acid esters
Definition Polyglycerol esters of fatty acids are produced by the esterification of
polyglycerol with food fats and oils or with fatty acids occurring in foods
fats and oils. The polyglycerol moiety is predominantly di-, tri- and
tetraglycerol and contains not more than 10 % of polyglycerols equal to
or higher than 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 lipophilic, but as a class
tend to be dispersible in water and soluble in organic solvents and oils
Purity
Sulphated ash Not more than 0,5 % determined at 800 ± 25oC
Acids other than fatty acids Not detectable
Free fatty acids Not more than 6 % estimated as oleic acid
Total glycerol and polyglycerol Not less than 18 % and not more than 60 %Free glycerol and polyglycerol Not more than 7 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
Note: Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a
maximum level of 6 % (expressed as sodium oleate).
E 476 POLYGLYCEROL POLYRICINOLEATE
Synonyms Glycerol esters of condensed castor oil fatty acids
Polyglycerol esters of polycondensed fatty acids from castor oil
Polyglycerol esters of interesterified ricinoleic acidPGPR
Definition Polyglycerol polyricinoleate is prepared by the esterification of
polyglycerol with condensed castor oil fatty acids
Description Clear, highly viscous liquid20.9.2008 EN Official Journal of the European Union L 253/109Identification
A. Solubility Insoluble in water and in ethanol.
Soluble in ether, hydrocarbons and halogenated hydrocarbons
B. Positive tests for glycerol, polygly-
cerol and for ricinoleic acid
C. Refractive index [n]65Between 1,4630 and 1,4665
Purity
Polyglycerols The polyglycerol moiety shall be composed of not less than 75 % of di-,
tri- and tetraglycerols and shall contain not more than 10 % of
polyglycerols equal to or higher than heptaglycerol
Hydroxyl value Not less than 80 and not more than 100
Acid value Not more than 6Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS
Synonyms Propylene glycol esters of fatty acids
Definition Consists of mixtures of propane-1,2-diol mono- and diesters of fatty
acids occurring in food fats and oils. The alcohol moiety is exclusively
propane-1,2-diol together with dimer and traces of trimer. Organic acids
other than food fatty acids are absent
Assay Content of total fatty acid ester not less than 85 %
Description Clear liquids or waxy white flakes, beads or solids having a bland odour
Identification
A. Positive tests for propylene glycol
and for fatty acids
Purity
Sulphated ash Not more than 0,5 % determined at 800 ± 25
oC
Acids other than fatty acids Not detectableFree fatty acids Not more than 6 % estimated as oleic acidTotal propane-1,2-diol Not less than 11 % and not more than 31 %Free propane-1,2-diol Not more than 5 %Dimer and trimer of propylene glycol Not more than 0,5 %Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
Note: 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).L 253/110 EN Official Journal of the European Union 20.9.2008E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF
FATTY ACIDS
Synonyms TOSOM
Definition Thermally oxidised soya bean oil interacted with mono- and diglycerides
of fatty acids is a complex mixture of esters of glycerol and fatty acids
found in edible fat and fatty acids from thermally oxidised soya bean oil.
It is produced by interaction and desodorisation under vacuum at
130oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and
diglycerides of food fatty acids. Soya bean oil is exclusively made fromnatural strains of soya beans
Description Pale yellow to light brown a waxy or solid consistency
Identification
A. Solubility Insoluble in water. Soluble in hot oil or fat
Purity
Melting range 55-65
oC
Free fatty acids Not more than 1,5 % estimated as oleic acid
Free glycerol Not more than 2 %
Total fatty acids 83-90 %
Total glycerol 16-22 %
Fatty acid methyl esters, not forming
adduct with ureaNot more than 9 % of total fatty acid methyl esters
Fatty acids, insoluble in petroleum ether Not more than 2 % of total fatty acids
Peroxide value Not more than 3
Epoxides Not more than 0,03 % oxirane oxygen
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 481 SODIUM STEAROYL-2-LACTYLATE
Synonyms Sodium stearoyl lactylate
Sodium stearoyl lactate
Definition A mixture of the sodium salts of stearoyl lactylic acids and its polymers
and minor amounts of sodium salts of other related acids, manufactured
by the reaction of stearic acid and lactic acid. Other food fatty acids may
also be present, free or esterified, due to their presence in the stearic acid
used
Chemical names Sodium di-2-stearoyl lactate
Sodium di(2-stearoyloxy)propionate
Einecs 246-929-7
Chemical formula (major components) C 21H39O4Na
C19H35O4Na
Description White or slightly yellowish powder or brittle solid with a characteristic
odour
Identification
A. Positive tests for sodium, for fatty
acids and for lactic acid
B. Solubility Insoluble in water. Soluble in ethanol20.9.2008 EN Official Journal of the European Union L 253/111Purity
Sodium Not less than 2,5 % and not more than 5 %
Ester value Not less than 90 and not more than 190
Acid value Not less than 60 and not more than 130Total lactic acid Not less than 15 % and not more than 40 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 482 CALCIUM STEAROYL-2-LACTYLATE
Synonyms Calcium stearoyl lactate
Definition A mixture of the calcium salts of stearoyl lactylic acids and its polymers
and minor amounts of calcium salts of other related acids, manufactured
by the reaction of stearic acid and lactic acid. Other food fatty acids may
also be present, free or esterified, due to their presence in the stearic acid
used
Chemical name Calcium di-2-stearoyl lactate
Calcium di(2-stearoyloxy)propionate
Einecs 227-335-7
Chemical formula 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 130
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 483 STEARYL TARTRATE
Synonyms Stearyl palmityl tartrate
Definition Product of the esterification of tartaric acid with commercial stearyl
alcohol, which consists essentially of stearyl and palmityl alcohols. It
consists mainly of diester, with minor amounts of monoester and of
unchanged starting materials
Chemical name Distearyl tartrate
Dipalmityl tartrateL 253/112 EN Official Journal of the European Union 20.9.2008Chemical formula C 38H74O6to C 40H78O6
Molecular weight 627 to 655
Assay Content of total ester not less than 90 % corresponding to an ester value
of not less than 163 and not more than 180
Description Cream-coloured unctuous solid (at 25oC)
Identification
A. Positive tests for tartareB. Melting range Between 67
oC and 77oC. After saponification the saturated long chain
fatty alcohols have a melting range of 49oC to 55oC
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/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
Unsaponifiable matter Not less than 77 % and not more than 83 %
Iodine value Not more than 4 (Wijs method)
E 491 SORBITAN MONOSTEARATE
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial stearic acid
Einecs 215-664-9Assay 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 50-52oC
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 10Saponification value Not less than 147 and not more than 157
Hydroxyl value Not less than 235 and not more than 260
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/kg20.9.2008 EN Official Journal of the European Union L 253/113E 492 SORBITAN TRISTEARATE
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial stearic acid
Einecs 247-891-4Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and
isosorbide esters
Description Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a
slight odour
Identification
A. Solubility Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate;
dispersible in petroleum ether, mineral oil, vegetable oils, acetone and
dioxane; insoluble in water, methanol and ethanol
B. Congealing range 47-50
oC
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity
Water Not more than 2 % (Karl Fischer method)Sulphated ash Not more than 0,5 %
Acid value Not more than 15
Saponification value Not less than 176 and not more than 188Hydroxyl value Not less than 66 and not more than 80Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kg
E 493 SORBITAN MONOLAURATE
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial lauric acid
Einecs 215-663-3
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and
isosorbide esters
Description Amber-coloured oily viscous liquid, light cream to tan-coloured beads or
flakes or a hard, waxy solid with a slight odour
Identification
A. Solubility Dispersible in hot and cold water
B. Infrared absorption spectrum Characteristic of a partial fatty acid ester of a polyol
Purity
Water Not more than 2 % (Karl Fischer method)Sulphated ash Not more than 0,5 %
Acid value Not more than 7
Saponification value Not less than 155 and not more than 170Hydroxyl value Not less than 330 and not more than 358Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kgHeavy metals (as Pb) Not more than 10 mg/kgL 253/114 EN Official Journal of the European Union 20.9.2008E 494 SORBITAN MONOOLEATE
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial oleic acid. Major constituent is 1,4-sorbitan monooleate.
Other constituents include isosorbide monooleate, sorbitan dioleate and
sorbitan trioleate
Einecs 215-665-4
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan and
isosorbide esters
Description Amber-coloured viscous liquid, light cream to tan-coloured beads or
flakes or a hard, waxy solid with a slight characteristic odour
Identification
A. Solubility Soluble at temperatures above its melting point in ethanol, ether, ethyl
acetate, aniline, toluene, dioxane, petroleum ether and carbon
tetrachloride. Insoluble in cold water, dispersible in warm water
B. Iodine value The residue of oleic acid, obtained from the saponification of the
sorbitan monoleate in assay, has a iodine value between 80 and 100
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphated ash Not more than 0,5 %
Acid value Not more than 8Saponification value Not less than 145 and not more than 160
Hydroxyl value Not less than 193 and not more than 210
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 495 SORBITAN MONOPALMITATE
Synonyms Sorbitan palmitate
Definition A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial palmitic acid
Einecs 247-568-8
Assay Content not less than 95 % of a mixture of sorbitol, sorbitan, and
isosorbide esters
Description Light cream to tan-coloured beads or flakes or a hard, waxy solid with a
slight characteristic odour
Identification
A. Solubility Soluble at temperatures above its melting point in ethanol, methanol,
ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and
carbon tetrachloride. Insoluble in cold water but dispersible in warm
water
B. Congealing range 45-47
oC
C. Infrared absorption spectrum Characteristic of a partial fatty acid ester of polyol
Purity
Water Not more than 2 % (Karl Fischer method)
Sulphate ash Not more than 0,5 %Acid value Not more than 7,5
Saponification value Not less than 140 and not more than 150
Hydroxyl value Not less than 270 and not more than 305
Arsenic Not more than 3 mg/kg20.9.2008 EN Official Journal of the European Union L 253/115Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 500(i) SODIUM CARBONATE
Synonyms Soda ash
Definition
Chemical name Sodium carbonate
Einecs 207-838-8Chemical formula Na
2CO 3·nH 2O (n = 0, 1 or 10)
Molecular weight 106,00 (anhydrous)
Assay Content not less than 99 % of Na 2CO 3on the anhydrous basis
Description Colourless crystals or white, granular or crystalline powder
The anhydrous form is hygroscopic, the decahydrate efflorescent
Identification
A. Positive tests for sodium and for
carbonate
B. Solubility Freely soluble in water. Insoluble in ethanol
Purity
Loss on drying Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 %
(decahydrate) (70oC raising gradually to 300oC, to constant weight)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 500(ii) SODIUM HYDROGEN CARBONATE
Synonyms Sodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking
soda
Definition
Chemical name Sodium hydrogen carbonateEinecs 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 heatingL 253/116 EN Official Journal of the European Union 20.9.2008Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 500(iii) SODIUM SESQUICARBONATE
Definition
Chemical name Sodium monohydrogen dicarbonate
Einecs 208-580-9
Chemical formula Na 2(CO) 3·NaHCO 3·2H 2O
Molecular weight 226,03
Assay Content between 35,0 % and 38,6 % of NaHCO 3and between 46,4 %
and 50,0 % of Na 2CO 3
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/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 501(i) POTASSIUM CARBONATE
Definition
Chemical name Potassium carbonate
Einecs 209-529-3
Chemical formula K
2CO 3·nH 2O (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) (180oC, 4h)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/117E 501(ii) POTASSIUM HYDROGEN CARBONATE
Synonyms Potassium bicarbonate, acid potassium carbonate
Definition
Chemical name Potassium hydrogen carbonateEinecs 206-059-0Chemical 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
E 503(i) AMMONIUM CARBONATE
Definition Ammonium carbonate consists of ammonium carbamate, ammonium
carbonate and ammonium hydrogen carbonate in varying proportions
Chemical name Ammonium carbonate
Einecs 233-786-0
Chemical formula CH
6N2O2, CH 8N2O3and CH 5NO 3
Molecular weight Ammonium carbamate 78,06; ammonium carbonate 98,73; ammo-
nium hydrogen carbonate 79,06
Assay Content not less than 30,0 % and not more than 34,0 % of NH 3
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/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kgL 253/118 EN Official Journal of the European Union 20.9.2008E 503(ii) AMMONIUM HYDROGEN CARBONATE
Synonyms Ammonium bicarbonate
Definition
Chemical name Ammonium hydrogen carbonateEinecs 213-911-5Chemical formula CH
5NO 3
Molecular weight 79,06Assay 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 8,0C. 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
E 504(ii) MAGNESIUM HYDROXIDE CARBONATE
Synonyms Magnesium hydrogen carbonate, magnesium subcarbonate (light or
heavy), hydrated basic magnesium carbonate, magnesium carbonatehydroxide
Definition
Chemical name Magnesium carbonate hydroxide hydratedEinecs 235-192-7Chemical formula 4MgCO
3Mg(OH) 25H 2O
Molecular weight 485Assay Mg content not less than 40,0 % and not more than 45,0 % calculated as
MgO
Description Light, white friable mass or bulky white powder
Identification
A. Positive tests for magnesium and for
carbonate
B. Solubility Practically insoluble in water. Insoluble in ethanol
Purity
Acid insoluble matter Not more than 0,05 %Water soluble matter Not more than 1,0 %Calcium Not more than 1,0 %Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kgMercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/119E 507 HYDROCHLORIC ACID
Synonyms Hydrogen chloride, muriatic acid
Definition
Chemical name Hydrochloric acid
Einecs 231-595-7Chemical 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 chlorideB. Solubility Soluble in water and in ethanol
Purity
Total organic compounds Total organic compounds (non-fluorine containing): not more than
5 mg/kg
Benzene: not more than 0,05 mg/kg
Fluorinated compounds (total): not more than 25 mg/kg
Non-volatile matter Not more than 0,5 %
Reducing substances Not more than 70 mg/kg (as SO
2)
Oxidising substances Not more than 30 mg/kg (as Cl 2)
Sulphate Not more than 0,5 %
Iron Not more than 5 mg/kgArsenic Not more than 1 mg/kg
Lead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 508 POTASSIUM CHLORIDE
Synonyms Sylvine
Sylvite
Definition
Chemical name Potassium chloride
Einecs 231-211-8
Chemical formulae KClMolecular weight 74,56
Assay Content not less than 99 % on the dried basis
Description Colourless, elongated, prismatic or cubital crystals or white granular
powder. Odourless
Identification
A. Solubility Freely soluble in water. Insoluble in ethanol
B. Positive tests for potassium and for
chloride
Purity
Loss on drying Not more than 1 % (105
oC, 2 hours)
Sodium Negative test
Arsenic Not more than 3 mg/kgL 253/120 EN Official Journal of the European Union 20.9.2008Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kg
Heavy metals (as Pb) Not more than 10 mg/kg
E 509 CALCIUM CHLORIDE
Definition
Chemical name Calcium chloride
Einecs 233-140-8Chemical formula CaCl
2·nH 2O (n = 0,2 or 6)
Molecular weight 110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)
Assay Content not less than 93,0 % on the anhydrous basis
Description White, odourless, hygroscopic powder or deliquescent crystals
Identification
A. Positive tests for calcium and for
chloride
B. Solubility Anhydrous calcium chloride: freely soluble in water and ethanol
Dihydrate: freely soluble in water, soluble in ethanolHexahydrate: very soluble in water and ethanol
Purity
Magnesium and alkali salts Not more than 5 % on the anhydrous basis
Fluoride Not more than 40 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E 511 MAGNESIUM CHLORIDE
Definition
Chemical name Magnesium chloride
Einecs 232-094-6Chemical formula MgCl
2·6H 2O
Molecular weight 203,30
Assay Content not less than 99,0 %
Description Colourless, odourless, very deliquescent flakes or crystals
Identification
A. Positive tests for magnesium and for
chloride
B. Solubility Very soluble in water, freely soluble in ethanol
Purity
Ammonium Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kgMercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/121E 512 STANNOUS CHLORIDE
Synonyms Tin chloride, tin dichloride
Definition
Chemical name Stannous chloride dihydrate
Einecs 231-868-0
Chemical formula SnCl 2·2H 2O
Molecular weight 225,63
Assay Content not less than 98,0 %
Description Colourless or white crystals
May have a slight odour of hydrochloric acid
Identification
A. Positive tests for tin (II) and for
chloride
B. Solubility Water: soluble in less than its own weight of water, but it forms an
insoluble basic salt with excess water
Ethanol: soluble
Purity
Sulphate Not more than 30 mg/kg
Arsenic Not more than 2 mg/kg
Mercury Not more than 1 mg/kg
Lead Not more than 5 mg/kg
E 513 SULPHURIC ACID
Synonyms Oil of vitriol, dihydrogen sulphate
Definition
Chemical name Sulphuric acid
Einecs 231-639-5
Chemical formula H 2SO 4
Molecular weight 98,07Assay 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 sul-
phate
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 2SO 4basis)
Chloride Not more than 50 mg/kg
Iron Not more than 20 mg/kg
Selenium Not more than 20 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgL 253/122 EN Official Journal of the European Union 20.9.2008E 514(i) SODIUM SULPHATE
Definition
Chemical name Sodium sulphateChemical formula Na
2SO 4·nH 2O (n = 0 or 10)
Molecular weight 142,04 (anhydrous)
322,04 (decahydrate)
Assay Content not less than 99,0 % on the anhydrous basis
Description Colourless crystals or a fine, white, crystalline powder
The decahydrate is efflorescent
Identification
A. Positive tests for sodium and for
sulphate
B. Acidity of a 5 % solution: neutral or
slightly alkaline to litmus paper
Purity
Loss on drying Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate)
at 130 °C
Selenium Not more than 30 mg/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 514(ii) SODIUM HYDROGEN SULPHATE
Synonyms Acid sodium sulphate, sodium bisulphate, nitre cake
Definition
Chemical name Sodium hydrogen sulphateChemical formula NaHSO
4
Molecular weight 120,06Assay 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/kgArsenic Not more than 3 mg/kgLead Not more than 5 mg/kgMercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/123E 515(i) POTASSIUM SULPHATE
Definition
Chemical name Potassium sulphate
Chemical formula K 2SO 4
Molecular weight 174,25
Assay Content not less than 99,0 %
Description Colourless or white crystals or crystalline powder
Identification
A. Positive tests for potassium and for
sulphate
B. pH of a 5 % solution Between 5,5 and 8,5
C. Solubility Freely soluble in water, insoluble in ethanol
Purity
Selenium Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 515(ii) POTASSIUM HYDROGEN SULPHATE
Definition
Synonyms Potassium bisulphate, potassium acid sulphate
Chemical name Potassium hydrogen sulphate
Chemical formula KHSO
4
Molecular weight 136,17
Assay Content not less than 99 %
Melting point 197oC
Description White deliquescent crystals, pieces or granules
Identification
A. Positive test for potassiumB. Solubility Freely soluble in water, insoluble in ethanol
Purity
Selenium Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 516 CALCIUM SULPHATE
Synonyms Gypsum, selenite, anhydrite
Definition
Chemical name Calcium sulphateEinecs 231-900-3
Chemical formula CaSO
4·nH 2O (n = 0 or 2)
Molecular weight 136,14 (anhydrous), 172,18 (dihydrate)
Assay Content not less than 99,0 % on the anhydrous basisL 253/124 EN Official Journal of the European Union 20.9.2008Description 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 % (250oC, constant weight)
Dihydrate: not more than 23 % (ibid.)
Fluoride Not more than 30 mg/kg
Selenium Not more than 30 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 517 AMMONIUM SULPHATE
Definition
Chemical name Ammonium sulphate
Einecs 231-984-1
Chemical formula (NH
4)2SO 4
Molecular weight 132,14
Assay Content not less than 99,0 % and not more than 100,5 %
Description White powder, shining plates or crystalline fragments
Identification
A. Positive tests for ammonium and for
sulphate
B. Solubility Freely soluble in water, insoluble in ethanol
Purity
Loss on ignition Not more than 0,25 %
Selenium Not more than 30 mg/kgLead Not more than 5 mg/kg
E 520 ALUMINIUM SULPHATE
Synonyms Alum
Definition
Chemical name Aluminium sulphate
Einecs 233-135-0
Chemical formula Al
2(SO 4)3
Molecular weight 342,13
Assay Content not less than 99,5 % on the ignited basis
Description White powder, shining plates or crystalline fragments
Identification
A. Positive tests for aluminium and for
sulphate
B. pH of a 5 % solution 2,9 or above
C. Solubility Freely soluble in water, insoluble in ethanol20.9.2008 EN Official Journal of the European Union L 253/125Purity
Loss on ignition Not more than 5 % (500oC, 3h)
Alkalies and alkaline earths Not more than 0,4 %
Selenium Not more than 30 mg/kgFluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kgMercury Not more than 1 mg/kg
E 521 ALUMINIUM SODIUM SULPHATE
Synonyms Soda alum, sodium alum
Definition
Chemical name Aluminium sodium sulphateEinecs 233-277-3
Chemical formula AlNa(SO
4)2·nH 2O (n = 0 or 12)
Molecular weight 242,09 (anhydrous)
Assay Content on the anhydrous basis not less than 96,5 % (anhydrous) and
99,5 % (dodecahydrate)
Description Transparent crystals or white crystalline powder
Identification
A. Positive tests for aluminium, for
sodium and for sulphate
B. Solubility Dodecahydrate is freely soluble in water. The anhydrous form is slowly
soluble in water. Both forms are insoluble in ethanol
Purity
Loss on drying Anhydrous form: not more than 10,0 % (220oC, 16h)
Dodecahydrate: not more than 47,2 % (50oC-55oC, 1h then 200oC,
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
E 522 ALUMINIUM POTASSIUM SULPHATE
Synonyms Potassium alum, potash alum
Definition
Chemical name Aluminium potassium sulphate dodecahydrate
Einecs 233-141-3Chemical formula AlK(SO
4)2·12 H 2O
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 sulphateL 253/126 EN Official Journal of the European Union 20.9.2008B. 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
E 523 ALUMINIUM AMMONIUM SULPHATE
Synonyms Ammonium alum
Definition
Chemical name Aluminium ammonium sulphateEinecs 232-055-3
Chemical formula AlNH
4(SO 4)2·12 H 2O
Molecular weight 453,32Assay Content not less than 99,5 %
Description Large, colourless crystals or white powder
Identification
A. Positive tests for aluminium, for
ammonium and for sulphate
B. Solubility Freely soluble in water, soluble in ethanol
Purity
Alkali metals and alkaline earths Not more than 0,5 %Selenium Not more than 30 mg/kg
Fluoride Not more than 30 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 524 SODIUM HYDROXIDE
Synonyms Caustic soda, lye
Definition
Chemical name Sodium hydroxide
Einecs 215-185-5
Chemical formula NaOH
Molecular weight 40,0
Assay Content of solid forms not less than 98,0 % of total alkali (as NaOH).
Content of solutions accordingly, based on the stated or labelled
percentage of NaOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms.
Solutions are clear or slightly turbid, colourless or slightly coloured,
strongly caustic and hygroscopic and when exposed to the air theyabsorb carbon dioxide, forming sodium carbonate20.9.2008 EN Official Journal of the European Union L 253/127Identification
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 2CO 3)
Arsenic Not more than 3 mg/kg
Lead Not more than 0,5 mg/kg
Mercury Not more than 1 mg/kg
E 525 POTASSIUM HYDROXIDE
Synonyms Caustic potash
Definition
Chemical name Potassium hydroxide
Einecs 215-181-3
Chemical formula KOH
Molecular weight 56,11
Assay Content not less than 85,0 % of alkali calculated as KOH
Description White or nearly white pellets, flakes, sticks, fused masses or other forms
Identification
A. Positive tests for potassium
B. A 1 % solution is strongly alkaline
C. Solubility Very soluble in water. Freely soluble in ethanol
Purity
Water insoluble matter A 5 % solution is completely clear and colourless
Carbonate Not more than 3,5 % (as K 2CO 3)
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E 526 CALCIUM HYDROXIDE
Synonyms Slaked lime, hydrated lime
Definition
Chemical name Calcium hydroxide
Einecs 215-137-3
Chemical formula Ca(OH) 2
Molecular weight 74,09Assay Content not less than 92,0 %L 253/128 EN Official Journal of the European Union 20.9.2008Description White powder
Identification
A. Positive tests for alkali and for
calcium
B. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Acid insoluble ash Not more than 1,0 %Magnesium and alkali salts Not more than 1,0 %
Barium Not more than 300 mg/kg
Fluoride Not more than 50 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
E 527 AMMONIUM HYDROXIDE
Synonyms Aqua ammonia, strong ammonia solution
Definition
Chemical name Ammonium hydroxide
Chemical formula NH
4OH
Molecular weight 35,05Assay Content not less than 27 % of NH
3
Description Clear, colourless solution, having an exceedingly pungent, characteristic
odour
Identification
A. Positive tests for ammonia
Purity
Non-volatile matter Not more than 0,02 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
E 528 MAGNESIUM HYDROXIDE
Definition
Chemical name Magnesium hydroxide
Einecs 215-170-3
Chemical formula Mg(OH) 2
Molecular weight 58,32
Assay Content not less than 95,0 % on the anhydrous basis
Description Odourless, white bulky powder
Identification
A. Positive test for magnesium and for
alkali
B. Solubility Practically insoluble in water and in ethanol20.9.2008 EN Official Journal of the European Union L 253/129Purity
Loss on drying Not more than 2,0 % (105oC, 2h)
Loss on ignition Not more than 33 % (800oC to constant weight)
Calcium oxide Not more than 1,5 %Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
E 529 CALCIUM OXIDE
Synonyms Burnt lime
Definition
Chemical name Calcium oxide
Einecs 215-138-9Chemical formula CaO
Molecular weight 56,08
Assay Content not less than 95,0 % on the ignited basis
Description Odourless, hard, white or greyish white masses of granules, or white to
greyish powder
Identification
A. Positive test for alkali and for calcium
B. Heat is generated on moistening the
sample with water
C. Solubility Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
Purity
Loss on ignition Not more than 10,0 % (ca 800
oC to constant weight)
Acid insoluble matter Not more than 1,0 %
Barium Not more than 300 mg/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
E 530 MAGNESIUM OXIDE
Definition
Chemical name Magnesium oxideEinecs 215-171-9
Chemical formula MgO
Molecular weight 40,31Assay Content not less than 98,0 % on the ignited basis
Description A very bulky, white powder known as light magnesium oxide or a
relative dense, white powder known as heavy magnesium oxide. 5 g of
light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of
heavy magnesium oxide occupy a volume of 10 to 20 ml
Identification
A. Positive test for alkali and for
magnesium
B. Solubility Practically insoluble in water. Insoluble in ethanolL 253/130 EN Official Journal of the European Union 20.9.2008Purity
Loss on ignition Not more than 5,0 % (ca 800oC to constant weight)
Calcium oxide Not more than 1,5 %
Arsenic Not more than 3 mg/kgLead Not more than 10 mg/kg
E 535 SODIUM FERROCYANIDE
Synonyms Yellow prussiate of soda, sodium hexacyanoferrate
Definition
Chemical name Sodium ferrocyanide
Einecs 237-081-9Chemical formula Na
4Fe(CN) 6·10 H 2O
Molecular weight 484,1
Assay Content not less than 99,0 %
Description Yellow crystals or crystalline powder
Identification
A. Positive test for sodium and for
ferrocyanide
Purity
Free moisture Not more than 1,0 %
Water insoluble matter Not more than 0,03 %
Chloride Not more than 0,2 %Sulphate Not more than 0,1 %
Free cyanide Not detectable
Ferricyanide Not detectableLead Not more than 5 mg/kg
E 536 POTASSIUM FERROCYANIDE
Synonyms Yellow prussiate of potash, potassium hexacyanoferrate
Definition
Chemical name Potassium ferrocyanide
Einecs 237-722-2Chemical formula K
4Fe(CN)6· 3 H 2O
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 detectable20.9.2008 EN Official Journal of the European Union L 253/131Ferricyanide Not detectable
Lead Not more than 5 mg/kg
E 538 CALCIUM FERROCYANIDE
Synonyms Yellow prussiate of lime, calcium hexacyanoferrate
Definition
Chemical name Calcium ferrocyanide
Einecs 215-476-7
Chemical formula Ca 2Fe(CN) 6·12H 2O
Molecular weight 508,3
Assay Content not less than 99,0 %
Description Yellow crystals or crystalline powder
Identification
A. Positive test for calcium and for
ferrocyanide
Purity
Free moisture Not more than 1,0 %Water insoluble matter Not more than 0,03 %
Chloride Not more than 0,2 %
Sulphate Not more than 0,1 %Free cyanide Not detectable
Ferricyanide Not detectable
Lead Not more than 5 mg/kg
E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC
Synonyms SALP
Definition
Chemical name Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A)
or
Trisodium dialuminium pentadecahydrogen octaphosphate (B)
Einecs 232-090-4
Chemical formula NaAl
3H14(PO 4)8·4H 2O (A)
Na3Al2H15(PO 4)8(B)
Molecular weight 949,88 (A)
897,82 (B)
Assay Content not less than 95,0 % (both forms)
Description White odourless powder
Identification
A. Positive test for sodium, for 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) } (750oC-800oC, 2h)
15 %-16 % (B) } (750oC-800oC, 2h)
Fluoride Not more than 25 mg/kgL 253/132 EN Official Journal of the European Union 20.9.2008Arsenic Not more than 3 mg/kg
Lead Not more than 4 mg/kg
Cadmium Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 551 SILICON DIOXIDE
Synonyms Silica, silicium dioxide
Definition Silicon dioxide is an amorphous substance, which is produced
synthetically by either a vapour-phase hydrolysis process, yielding
fumed silica, or by a wet process, yielding precipitated silica, silica gel, orhydrous 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 231-545-4Chemical formula (SiO
2)n
Molecular weight 60,08 (SiO 2)
Assay Content after ignition not less than 99,0 % (fumed silica) or 94,0 %
(hydrated forms)
Description White, fluffy powder or granules
Hygroscopic
Identification
A. Positive test for silica
Purity
Loss on drying Not more than 2,5 % (fumed silica, 105oC, 2h)
Not more than 8,0 % (precipitated silica and silica gel, 105oC, 2h)
Not more than 70 % (hydrous silica, 105oC, 2h)
Loss on ignition Not more than 2,5 % after drying (1 000oC, fumed silica)
Not more than 8,5 % after drying (1 000oC, hydrated forms)
Soluble ionisable salts Not more than 5,0 % (as Na 2SO 4)
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 552 CALCIUM SILICATE
Definition Calcium silicate is a hydrous or anhydrous silicate with varying
proportions of CaO and SiO
2
Chemical name Calcium silicate
Einecs 215-710-8
Assay Content on the anhydrous basis:
—as SiO 2not less than 50 % and not more than 95 %
—as CaO not less than 3 % and not more than 35 %
Description White to off-white free-flowing powder that remains so after absorbing
relatively large amounts of water or other liquids20.9.2008 EN Official Journal of the European Union L 253/133Identification
A. Positive test for silicate and for
calcium
B. Forms a gel with mineral acids
Purity
Loss on drying Not more than 10 % (105oC, 2h)
Loss on ignition Not less than 5 % and not more than 14 % (1 000oC, constant weight)
Sodium Not more than 3 %
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 553a(i) MAGNESIUM SILICATE
Definition Magnesium silicate is a synthetic compound of which the molar ratio of
magnesium oxide to silicon dioxide is approximately 2:5
Assay Content not less than 15 % of MgO and not less than 67 % of SiO
2on
the ignited basis
Description Very fine, white, odourless powder, free from grittiness
Identification
A. Positive test for magnesium and for
silicate
B. pH of a 10 % slurry Between 7,0 and 10,8
Purity
Loss on drying Not more than 15 % (105oC, 2h)
Loss on ignition Not more than 15 % after drying (1 000oC, 20 min)
Water soluble salts Not more than 3 %
Free alkali Not more than 1 % (as NaOH)
Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 553a(ii) MAGNESIUM TRISILICATE
Definition
Chemical name Magnesium trisilicate
Chemical formula Mg
2Si3O8·xH2O (approximate composition)
Einecs 239-076-7Assay Content not less than 29,0 % of MgO and not less than 65,0 % of SiO
2
both on the ignited basis
Description Fine, white powder, free from grittiness
Identification
A. Positive test for magnesium and for
silicate
B. pH of a 5 % slurry Between 6,3 and 9,5L 253/134 EN Official Journal of the European Union 20.9.2008Purity
Loss on ignition Not less than 17 % and not more than 34 % (1 000oC)
Water soluble salts Not more than 2 %
Free alkali Not more than 1 % (as NaOH)Fluoride Not more than 10 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 553b TALC
Synonyms Talcum
Definition Naturally occurring form of hydrous magnesium silicate containing
varying proportions of such associated minerals as alpha-quartz, calcite,
chlorite, dolomite, magnesite, and phlogopite
Chemical name Magnesium hydrogen metasilicateEinecs 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 Å
C. Solubility Insoluble in water and ethanol
Purity
Loss on drying Not more than 0,5 % (105oC, 1h)
Acid-soluble matter Not more than 6 %
Water-soluble matter Not more than 0,2 %Acid-soluble iron Not detectable
Arsenic Not more than 10 mg/kg
Lead Not more than 5 mg/kg
E 554 SODIUM ALUMINIUM SILICATE
Synonyms Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium
silicate
Definition
Chemical name Sodium aluminium silicate
Assay Content on the anhydrous basis:
—as SiO
2not less than 66,0 % and not more than 88,0 %
—as Al 2O3not 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 11,520.9.2008 EN Official Journal of the European Union L 253/135Purity
Loss on drying Not more than 8,0 % (105oC, 2h)
Loss on ignition Not less than 5,0 % and not more than 11,0 % on the anhydrous basis
(1 000oC, constant weight)
Sodium Not less than 5 % and not more than 8,5 % (as Na 2O) on the anhydrous
basis
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 555 POTASSIUM ALUMINIUM SILICATE
Synonyms Mica
Definition Natural mica consists of mainly potassium aluminium silicate
(muscovite)
Einecs 310-127-6
Chemical name Potassium aluminium silicateChemical formulae KAl
2[AlSi 3O10](OH) 2
Molecular weight 398Assay 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
E 556 CALCIUM ALUMINIUM SILICATE
Synonyms Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium
silicate
Definition
Chemical name Calcium aluminium silicate
Assay Content on the anhydrous basis:
—as SiO
2not less than 44,0 % and not more than 50,0 %
—as Al 2O3not less than 3,0 % and not more than 5,0 %
—as CaO not less than 32,0 % and not more than 38,0 %L 253/136 EN Official Journal of the European Union 20.9.2008Description Fine white, free-flowing powder
Identification
A. Positive tests for calcium, for alumi-
nium and for silicate
Purity
Loss on drying Not more than 10,0 % (105oC, 2h)
Loss on ignition Not less than 14,0 % and not more than 18,0 on the anhydrous basis
(1 000oC, constant weight)
Fluoride Not more than 50 mg/kg
Arsenic Not more than 3 mg/kg
Lead Not more than 10 mg/kg
Mercury Not more than 1 mg/kg
E 558 BENTONITE
Definition Bentonite is a natural clay containing a high proportion of
montmorillonite, a native hydrated aluminium silicate in which some
aluminium and silicon atoms were naturally replaced by other atomssuch as magnesium and iron. Calcium and sodium ions are trapped
between the mineral layers. There are four common types of bentonite:
natural sodium bentonite, natural calcium bentonite, sodium-activated
bentonite and acid-activated bentonite
Einecs 215-108-5
Chemical formula (Al, Mg)
8(Si4O10)4(OH) 8·12H 2O
Molecular weight 819Assay Montmorillonite content not less than 80 %
Description Very fine, yellowish or greyish white powder or granules. The structure
of bentonite allows it to absorb water in its structure and on its externalsurface (swelling properties)
Identification
A. Methylene blue test
B. X-Ray diffraction Characteristic peaks at 12,5/15 A
C. IR absorption Peaks at 428/470/530/1 110-1 020/3 750 —3 400 cm
-1
Purity
Loss on drying Not more than 15,0 % (105oC, 2h)
Arsenic Not more than 2 mg/kgLead Not more than 20 mg/kg
E 559 ALUMINIUM SILICATE (KAOLIN)
Synonyms Kaolin, light or heavy
Definition Aluminium silicate hydrous (kaolin) is a purified white plastic clay
composed of kaolinite, potassium aluminium silicate, feldspar and
quartz. Processing should not include calcination. The raw kaolinitic clay
used in the production of aluminium silicate shall have a level of dioxin
which does not make it injurious to health or unfit for humanconsumption
Einecs 215-286-4 (kaolinite)
Chemical formula Al
2Si2O5(OH) 4(kaolinite)
Molecular weight 26420.9.2008 EN Official Journal of the European Union L 253/137Assay Content not less than 90 % (sum of silica and alumina, after ignition)
Silica (SiO 2) Between 45 % and 55 %
Alumina (Al 2O3) Between 30 % and 39 %
Description Fine, white or greyish white, unctuous powder. Kaolin is made up of
loose aggregations of randomly oriented stacks of kaolinite flakes or of
individual hexagonal flakes
Identification
A. Positive tests for alumina and for
silicate
B. X-ray diffraction: Characteristic peaks at 7,18/3,58/2,38/1,78 Å
C. IR absorption: Peaks at 3 700 and 3 620 cm-1
Purity
Loss on ignition Between 10 and 14 % (1 000oC, constant weight)
Water soluble matter Not more than 0,3 %
Acid soluble matter Not more than 2 %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/kg
Mercury Not more than 1 mg/kg
E 570 FATTY ACIDS
Definition Linear fatty acids, caprylic acid (C
8), capric acid (C 10), laurinc acid (C 12),
myristic acid (C 14), palmitic acid (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
(C18), 9-octadecenoic acid (C 18:1)
Assay Not less than 98 % by chromatography
Description A colourless liquid or white solid obtained from oils and fats
Identification
A. Individual fatty acids can be identi-
fied by acid value, iodine value, gas
chromatog-raphy and molecular
weight
Purity
Residue on ignition Not more than 0,1 %
Unsaponifiable matter Not more than 1,5 %
Water Not more than 0,2 % (Karl Fischer method)
Arsenic Not more than 3 mg/kgLead Not more than 1 mg/kg
Mercury Not more than 1 mg/kg
E 574 GLUCONIC ACID
Synonyms D-gluconic acid, dextronic acid
Definition Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-
lactone
Chemical name Gluconic acidL 253/138 EN Official Journal of the European Union 20.9.2008Chemical 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 196oC and 202oC with decom-
position
Purity
Residue on ignition Not more than 1,0 %
Reducing matter Not more than 0,75 % (as D-glucose)Chloride Not more than 350 mg/kg
Sulphate Not more than 240 mg/kg
Sulphite Not more than 20 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 575 GLUCONO-DELTA-LACTONE
Synonyms Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolac-
tone
Definition Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-
gluconic acid. In aqueous media it is hydrolysed to an equilibrium
mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-
lactones
Chemical name D-Glucono-1,5-lactoneEinecs 202-016-5
Chemical formula C
6H10O6
Molecular weight 178,14
Assay Content not less than 99,0 % on the anhydrous basis
Description Fine, white, nearly odourless, crystalline powder
Identification
A. Formation of phenylhydrazine deri-
vative of gluconic acid positiveCompound formed melts between 196oC and 202oC with decom-
position
B. Solubility Freely soluble in water. Sparingly soluble in ethanol
C. Melting point 152oC ± 2oC
Purity
Water Not more than 1,0 % (Karl Fischer method)
Reducing substances Not more than 0,75 % (as D-glucose)
Lead Not more than 2 mg/kg
E 576 SODIUM GLUCONATE
Synonyms Sodium salt of D-gluconic acid
Definition
Chemical name Sodium D-gluconate
Einecs 208-407-7
Chemical formula C 6H11NaO 7(anhydrous)20.9.2008 EN Official Journal of the European Union L 253/139Molecular weight 218,14
Assay Content not less than 98,0 %
Description White to tan, granular to fine, crystalline powder
Identification
A. Positive test for sodium and for
gluconate
B. Solubility Very soluble in water. Sparingly soluble in ethanolC. pH of a 10 % solution Between 6,5 and 7,5
Purity
Reducing matter Not more than 1,0 % (as D-glucose)Lead Not more than 2 mg/kg
E 577 POTASSIUM GLUCONATE
Synonyms Potassium salt of D-gluconic acid
Definition
Chemical name Potassium D-gluconate
Einecs 206-074-2Chemical formula C
6H11KO 7(anhydrous)
C6H11KO 7·H2O (monohydrate)
Molecular weight 234,25 (anhydrous)
252,26 (monohydrate)
Assay Content not less than 97,0 % and not more than 103,0 % on dried basis
Description Odourless, free flowing white to yellowish white, crystalline powder or
granules
Identification
A. Positive test for potassium and for
gluconate
B. pH of a 10 % solution Between 7,0 and 8,3
Purity
Loss on drying Anhydrous: not more than 3,0 % (105oC, 4h, vacuum)
Monohydrate: not less than 6 % and not more than 7,5 % (105oC, 4h,
vacuum)
Reducing substances Not more than 1,0 % (as D-glucose)
Lead Not more than 2 mg/kg
E 578 CALCIUM GLUCONATE
Synonyms Calcium salt of D-gluconic acid
Definition
Chemical name Calcium di-D-gluconate
Einecs 206-075-8Chemical formula C
12H22CaO 14(anhydrous)
C12H22CaO 14·H2O (monohydrate)
Molecular weight 430,38 (anhydrous form)
448,39 (monohydrate)L 253/140 EN Official Journal of the European Union 20.9.2008Assay 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 % (105oC, 16h) (monohydrate)
Reducing substances Not more than 1,0 % (as D-glucose)Lead Not more than 2 mg/kg
E 579 FERROUS GLUCONATE
Definition
Chemical name Ferrous di-D-gluconate dihydrate
Iron(II) di-gluconate dihydrate
Einecs 206-076-3
Chemical formulae C
12H22FeO 14·2H 2O
Molecular weight 482,17Assay Content not less than 95 % on the dried basis
Description Pale greenish-yellow to yellowish-grey powder or granules, which may
have a faint odour of burnt sugar
Identification
A. Solubility Soluble with slight heating in water. Practically insoluble in ethanol
B. Positive test for ferrous ionC. Formation of phenylhy-drazine 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/kgLead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
Cadmium Not more than 1 mg/kgReducing substances Not more than 0,5 % expressed as glucose
E 585 FERROUS LACTATE
Synonyms Iron(II) lactate
Iron(II) 2-hydroxy propanoatePropanoic acid, 2-hydroxy-iron(2 +) salt (2:1)20.9.2008 EN Official Journal of the European Union L 253/141Definition
Chemical name Ferrous 2-hydroxy propanoate
Einecs 227-608-0
Chemical formulae C 6H10FeO 6·xH 2O (x = 2 or 3)
Molecular weight 270,02 (dihydrate)
288,03 (trihydrate)
Assay Content not less than 96 % on the dried basis
Description Greenish-white crystals or light green powder having a characteristic
smell
Identification
A. Solubility Soluble in water. Practically insoluble in ethanol
B. Positive test for ferrous ion and for
lactate
C. pH of a 2 % solution Between 4 and 6
Purity
Loss on drying Not more than 18 % (100oC, under vacuum, approximately 700 mm
Hg)
Iron (Fe III) Not more than 0,6 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgCadmium Not more than 1 mg/kg
E 586 4-HEXYLRESORCINOL
Synonyms 4-Hexyl-1,3-benzenediol
Hexylresorcinol
Definition
Chemical name 4-Hexylresorcinol
Einecs 205-257-4Chemical formula C
12H18O2
Molecular weight 197,24Assay Not less than 98 % on the dried basis
Description White powder
Identification
A. Solubility Freely soluble in ether and acetone; very slightly soluble in water
B. Nitric acid test To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A
light red colour appears
C. Bromine test To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A
yellow, flocculent precipitate dissolves producing a yellow solution
D. Melting range 62 to 67
oC
Purity
Acidity Not more than 0,05 %Sulphated ash Not more than 0,1 %
Resorcinol and other phenols Shake about 1 g of the sample with 50 ml of water for a few minutes,
filter, and to the filtrate add 3 drops of ferric chloride TS. No red or bluecolour is produced
Nickel Not more than 2 mg/kg
Lead Not more than 2 mg/kgMercury Not more than 3 mg/kgL 253/142 EN Official Journal of the European Union 20.9.2008E 620 GLUTAMIC ACID
Synonyms L-Glutamic acid, L-α-aminoglutaric acid
Definition
Chemical name L-Glutamic acid, L-2-amino-pentanedioic acid
Einecs 200-293-7
Chemical formula C 5H9NO 4
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 + 31,5oand + 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 % (80oC, 3h)
Sulphated ash Not more than 0,2 %Chloride Not more than 0,2 %
Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg
E 621 MONOSODIUM GLUTAMATE
Synonyms Sodium glutamate, MSG
Definition
Chemical name Monosodium L-glutamate monohydrate
Einecs 205-538-1
Chemical formula C
5H8NaNO 4·H2O
Molecular weight 187,13
Assay Content not less than 99,0 % and not more than 101,0 % on the
anhydrous basis
Description White, practically odourless crystals or crystalline powder
Identification
A. Positive test for sodium
B. Positive test for glutamic acid by
thin-layer chromatography
C. Specific rotation [α] D20Between + 24,8oand + 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 % (98oC, 5h)
Chloride Not more than 0,2 %Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg20.9.2008 EN Official Journal of the European Union L 253/143E 622 MONOPOTASSIUM GLUTAMATE
Synonyms Potassium glutamate, MPG
Definition
Chemical name Monopotassium L-glutamate monohydrateEinecs 243-094-0
Chemical formula C
5H8KNO 4·H2O
Molecular weight 203,24Assay Content not less than 99,0 % and not more than 101,0 % on the
anhydrous basis
Description White, practically odourless crystals or crystalline powder
Identification
A. Positive test for potassium
B. Positive test for glutamic acid by
thin-layer chromatog-raphy
C. Specific rotation [α]
D20Between + 22,5oand + 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 % (80oC, 5h)
Chloride Not more than 0,2 %
Pyrrolidone carboxylic acid Not more than 0,2 %Lead Not more than 2 mg/kg
E 623 CALCIUM DIGLUTAMATE
Synonyms Calcium glutamate
Definition
Chemical name Monocalcium di-L-glutamateEinecs 242-905-5
Chemical formula C
10H16CaN 2O8·x H 2O (x = 0, 1, 2 or 4)
Molecular weight 332,32 (anhydrous)Assay Content not less than 98,0 % and not more than 102,0 % on the
anhydrous basis
Description White, practically odourless crystals or crystalline powder
Identification
A. Positive test for calciumB. Positive test for glutamic acid by
thin-layer chromatog-raphy
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/kgL 253/144 EN Official Journal of the European Union 20.9.2008E 624 MONOAMMONIUM GLUTAMATE
Synonyms Ammonium glutamate
Definition
Chemical name Monoammonium L-glutamate monohydrate
Einecs 231-447-1
Chemical formula C 5H12N2O4·H2O
Molecular weight 182,18Assay 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 ammoniumB. Positive test for glutamic acid by
thin-layer chromatog-raphy
C. Specific rotation [α]
D20Between + 25,4oand + 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 % (50oC, 4h)
Sulphated ash Not more than 0,1 %
Pyrrolidone carboxylic acid Not more than 0,2 %
Lead Not more than 2 mg/kg
E 625 MAGNESIUM DIGLUTAMATE
Synonyms Magnesium glutamate
Definition
Chemical name Monomagnesium di-L-glutamate tetrahydrate
Einecs 242-413-0
Chemical formula C 10H16MgN 2O8·4H 2O
Molecular weight 388,62
Assay Content not less than 95,0 % and not more than 105,0 % on the
anhydrous basis
Description Odourless, white or off-white crystals or powder
Identification
A. Positive test for magnesium
B. Positive test for glutamic acid by
thin-layer chromatog-raphy
C. Specific rotation [α] D20Between + 23,8oand + 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/kg20.9.2008 EN Official Journal of the European Union L 253/145E 626 GUANYLIC ACID
Synonyms Guanylic acid
Definition
Chemical name Guanosine-5'-monophosphoric acid
Einecs 201-598-8Chemical 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 crystalline powder
Identification
A. Positive test for ribose and for
organic phosphate
B. pH of a 0,25 % solution Between 1,5 and 2,5C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Purity
Loss on drying Not more than 1,5 % (120
oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 627 DISODIUM GUANYLATE
Synonyms Sodium guanylate, sodium 5'-guanylate
Definition
Chemical name Disodium guanosine-5'-monophosphateEinecs 221-849-5
Chemical formula C
10H12N5Na2O8P·x H 2O (x = ca. 7)
Molecular weight 407,19 (anhydrous)Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or white crystalline powder
Identification
A. Positive test for ribose, for organic
phosphate, and for sodium
B. pH of a 5 % solution Between 7,0 and 8,5C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Purity
Loss on drying Not more than 25 % (120
oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 628 DIPOTASSIUM GUANYLATE
Synonyms Potassium guanylate, potassium 5'-guanylate
Definition
Chemical name Dipotassium guanosine-5'-monophosphate
Einecs 226-914-1L 253/146 EN Official Journal of the European Union 20.9.2008Chemical 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 crystalline powder
Identification
A. Positive test for ribose, for organic
phosphate, and for potassium
B. pH of a 5 % solution Between 7,0 and 8,5
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Purity
Loss on drying Not more than 5 % (120oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 629 CALCIUM GUANYLATE
Synonyms Calcium 5'-guanylate
Definition
Chemical name Calcium guanosine-5'-monophosphate
Chemical formula C 10H12CaN 5O8P·nH 2O
Molecular weight 401,20 (anhydrous)
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, white or off-white crystals or powder
Identification
A. Positive test for ribose, for organic
phosphate, and for calcium
B. pH of a 0,05 % solution Between 7,0 and 8,0
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
Purity
Loss on drying Not more than 23,0 % (120oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 630 INOSINIC ACID
Synonyms 5'-Inosinic acid
Definition
Chemical name Inosine-5'-monophosphoric acid
Einecs 205-045-1Chemical 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 powder20.9.2008 EN Official Journal of the European Union L 253/147Identification
A. Positive test for ribose, and for
organic phosphate
B. pH of a 5 % solution Between 1,0 and 2,0C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Purity
Loss on drying Not more than 3,0 % (120
oC, 4h)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 631 DISODIUM INOSINATE
Synonyms Sodium inosinate, sodium 5'-inosinate
Definition
Chemical name Disodium inosine-5'-monophosphate
Einecs 225-146-4Chemical 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 8,5C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Purity
Water Not more than 28,5 % (Karl Fischer)Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 632 DIPOTASSIUM INOSINATE
Synonyms Potassium inosinate, potassium 5'-inosinate
Definition
Chemical name Dipotassium inosine-5'-monophosphateEinecs 243-652-3
Chemical formula C
10H11K2N4O8P
Molecular weight 424,39Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for potassium
B. pH of a 5 % solution Between 7,0 and 8,5
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nmL 253/148 EN Official Journal of the European Union 20.9.2008Purity
Water Not more than 10,0 % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 633 CALCIUM INOSINATE
Synonyms Calcium 5'-inosinate
Definition
Chemical name Calcium inosine-5'-monophosphate
Chemical formula C 10H11CaN 4O8P·nH 2O
Molecular weight 386,19 (anhydrous)
Assay Content not less than 97,0 % on the anhydrous basis
Description Odourless, colourless or white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for calcium
B. pH of a 0,05 % solution Between 7,0 and 8,0
C. Spectrometry: maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
Purity
Water Not more than 23,0 % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 634 CALCIUM 5'-RIBONUCLEOTIDE
Definition
Chemical name Calcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-
monophosphate and calcium guanosine-5'-monophosphate
Chemical formula C 10H11N4CaO 8P·nH 2O y
C10H12N5CaO 8P·nH 2O
Assay Content of both major components not less than 97,0 %, and of each
component not less than 47,0 % and not more than 53 %, in every case
on the anhydrous basis
Description Odourless, white or nearly white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for calcium
B. pH of a 0,05 % solution Between 7,0 and 8,0
Purity
Water Not more than 23,0 % (Karl Fischer)
Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg20.9.2008 EN Official Journal of the European Union L 253/149E 635 DISODIUM 5'-RIBONUCLEOTIDE
Synonyms Sodium 5'-ribonucleotide
Definition
Chemical name Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-
5'-monophosphate and disodium guanosine-5'-monophosphate
Chemical formula C 10H11N4Na2O8P·nH 2O and
C10H12N5Na2O8P·nH 2O
Assay Content of both major components not less than 97,0 %, and of each
component not less than 47,0 % and not more than 53 %, in every case
on the anhydrous basis
Description Odourless, white or nearly white crystals or powder
Identification
A. Positive test for ribose, and for
organic phosphate and for sodium
B. pH of a 5 % solution Between 7,0 and 8,5
Purity
Water Not more than 26,0 % (Karl Fischer)Other nucleotides Not detectable by thin-layer chromatography
Lead Not more than 2 mg/kg
E 640 GLYCINE AND ITS SODIUM SALT
Synonyms (gly) Aminoacetic acid, glycocoll
(Na salt) Sodium glycinate
Definition
Chemical name (gly) Aminoacetic acid(Na salt) Sodium glycinate
Chemical formula (gly) C
2H5NO 2
(Na salt) C 2H5NO 2Na
Einecs (gly) 200-272-2
(Na salt) 227-842-3Molecular weight (gly) 75,07
(Na salt) 98
Assay Content not less than 98,5 % on the anhydrous basis
Description White crystals or crystalline powder
Identification
A. Positive test for amino acid (gly and
Na salt)
B. Positive test for sodium (Na salt)
Purity
Loss on drying (gly) Not more than 0,2 % (105
oC, 3h)
(Na salt) Not more than 0,2 % (105oC, 3h)
Residue on ignition (gly) Not more than 0,1 %
(Na salt) Not more than 0,1 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgL 253/150 EN Official Journal of the European Union 20.9.2008E 650 ZINC ACETATE
Synonyms Acetic acid, zinc salt, dihydrate
Definition
Chemical name Zinc acetate dihydrateChemical formula C
4H6O4Zn·2H 2O
Molecular weight 219,51
Assay Content not less than 98 % and not more than 102 % of C 4H6O4Zn
·2H 2O
Description Colourless crystals or fine, off-white powder
Identification
A. Positive tests for acetate and for zinc
B. pH of a 5 % solution Between 6,0 and 8,0
Purity
Insoluble matter Not more than 0,005 %
Chlorides Not more than 50 mg/kg
Sulphates Not more than 100 mg/kgAlkalines and alkaline earths Not more than 0,2 %
Organic volatile impurities Passes test
Iron Not more than 50 mg/kgArsenic Not more than 3 mg/kg
Lead Not more than 20 mg/kg
Cadmium Not more than 5 mg/kg
E 900 DIMETHYL POLYSILOXANE
Synonyms Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone
Definition Dimethylpolysiloxane is a mixture of fully methylated linear siloxane
polymers containing repeating units of the formula (CH
3)2SiO and
stablised with trimethylsiloxy end-blocking units of the formula (CH 3)3
SiO
Chemical name Siloxanes and silicones, di-methyl
Chemical formula (CH 3)3-Si-[O-Si(CH 3)2]n-O-Si(CH 3)3
Assay Content of total silicon not less than 37,3 % and not more than 38,5 %
Description Clear, colourless, viscous liquid
Identification
A. Specific gravity (25o/25oC) Between 0,964 and 0,977
B. Refractive index [n] D25Between 1,400 and 1,405
C. Infrared spectrum characteristic of
the compound
Purity
Loss on drying Not more than 0,5 % (150oC, 4h)
Viscosity Not less than 1,00 ·10-4m2s-1at 25oC
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/151E 901 BEESWAX
Synonyms White wax, yellow wax
Definition Yellow bees wax is the wax obtained by melting the walls of the
honeycomb made by the honey bee, Apis mellifera L., with hot water and
removing foreign matter
White beeswax is obtained by bleaching yellow beeswax
Einecs 232-383-7 (beeswax)
Description Yellowish white (white form) or yellowish to greyish brown (yellow
form) pieces or plates with a fine-grained and non-crystalline fracture,
having an agreeable, honey-like odour
Identification
A. Melting range Between 62oC and 65oC
B. Specific gravity About 0,96
C. Solubility Insoluble in water
Sparingly soluble in alcohol
Very soluble in chloroform and ether
Purity
Acid value Not less than 17 and not more than 24
Saponification value 87-104
Peroxide value Not more than 5
Glycerol and other polyols Not more than 0,5 % (as glycerol)
Ceresin, paraffins and certain other waxes AbsentFats, Japan wax, rosin and soaps Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 902 CANDELILLA WAX
Definition Candelilla wax is a purified wax obtained from the leaves of the
candelilla plant, Euphorbia antisyphilitica
Einecs 232-347-0
Description Hard, yellowish brown, opaque to translucent wax
Identification
A. Specific gravity About 0,983
B. Melting range Between 68,5
oC and 72,5oC
C. Solubility Insoluble in water
Soluble in chloroform and toluene
Purity
Acid value Not less than 12 and not more than 22
Saponification value Not less than 43 and not more than 65
Glycerol and other polyols Not more than 0,5 % (as glycerol)Ceresin, paraffins and certain other waxes Absent
Fats, Japan wax, rosin and soaps Absent
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kgL 253/152 EN Official Journal of the European Union 20.9.2008E 903 CARNAUBA WAX
Definition Carnauba wax is a purified wax obtained from the leaf buds and leaves of
the Brazilian Mart wax palm, Copernicia cerifera
Einecs 232-399-4
Description Light brown to pale yellow powder or flakes or hard and brittle solid
with a resinous fracture
Identification
A. Specific gravity About 0,997
B. Melting range Between 82oC and 86oC
C. Solubility Insoluble in water
Partly soluble in boiling ethanol
Soluble in chloroform and diethyl ether
Purity
Sulphated ash Not more than 0,25 %
Acid value Not less than 2 and not more than 7
Ester value Not less than 71 and not more than 88Unsaponifiable matter Not less than 50 % and not more than 55 %
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kgMercury Not more than 1 mg/kg
E 904 SHELLAC
Synonyms Bleached shellac, white shellac
Definition Shellac is the purified and bleached lac, the resinous secretion of the
insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)
Einecs 232-549-9
Description Bleached shellac —off-white, amorphous, granular resin
Wax-free bleached shellac —light yellow, amorphous, granular resin
Identification
A. Solubility Insoluble in water; freely (though very slowly) soluble in alcohol; slightly
soluble in acetone
B. Acid value Between 60 and 89
Purity
Loss on drying Not more than 6,0 % (40
oC, over silica gel, 15h)
Rosin AbsentWax Bleached shellac: not more than 5,5 %
Wax-free bleached shellac: not more than 0,2 %
Lead Not more than 2 mg/kg
E 905 MICROCRYSTALLINE WAX
Synonyms Petroleum wax
Definition Microcrystalline wax is a refined mixture of solid, saturated hydro-
carbons, mainly branched paraffin, obtained from petroleum
Description White to amber, odourless wax20.9.2008 EN Official Journal of the European Union L 253/153Identification
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 100oC Not less than 1,1 ·10-5m2s-1
Residue on ignition Not more than 0,1 %
Carbon number at 5 % distillation point Not more than 5 % of molecules with carbon number less than 25
Colour Passes test
Sulphur Not more than 0,4 %Arsenic Not more than 3 mg/kg
Lead Not more than 3 mg/kg
Polycyclic aromatic compounds The polycyclic aromatic hydrocarbons, obtained by extraction with
dimethyl sulfoxide, shall meet the following ultraviolet absorbency
limits:
nm Maximum absorbance per cm path length
280-289 0,15
290-299 0,12300-359 0,08
360-400 0,02
E 907 HYDROGENATED POLY-1-DECENE
Synonyms Hydrogenated polydec-1-ene
Hydrogenated poly-alpha-olefin
Definition
Chemical formula C
10nH20n+2 where n = 3-6
Molecular weight 560 (average)
Assay Not less than 98,5 % of hydrogenated poly-1-decene, having the
following oligomer distribution:
C30: 13-37 %
C40: 35-70 %
C50: 9-25 %
C60: 1-7 %
DescriptionIdentification
A. Solubility Insoluble in water; slightly soluble in ethanol; soluble in toluene
B. Burning Burns with a bright flame and a paraffin-like characteristic smell
Purity
Viscosity Between 5,7 × 10
-6and 6,1 × 10-6m2s-1at 100oC
Compounds with carbon number less
than 30Not more than 1,5 %
Readily carbonisable substances After 10 minutes shaking in a boiling water bath, a tube of sulphuric
acid with a 5 g sample of hydrogenated poly-1-decene is not darker than
a very slight straw colour
Nickel Not more than 1 mg/kgLead Not more than 1 mg/kgL 253/154 EN Official Journal of the European Union 20.9.2008E 912 MONTAN ACID ESTERS
Definition Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol
and/or glycerol
Chemical name Montan acid esters
Description Almost white to yellowish flakes, powder, granules or pellets
Identification
A. Density (20oC) Between 0,98 and 1,05
B. Drop point Greater than 77oC
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
E 914 OXIDISED POLYETHYLENE WAX
Definition Polar reaction products from mild oxidation of polyethylene
Chemical name Oxidised polyethylene
Description Almost white flakes, powder, granules or pellets
Identification
A. Density (20
oC) Between 0,92 and 1,05
B. Drop point Greater than 95oC
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/kg
Lead Not more than 2 mg/kg
E 920 L-CYSTEINE
Definition L-cysteine hydrochloride or hydrochloride monohydrate. Human hair
may not be used as a source for this substance
Einecs 200-157-7 (anhydrous)Chemical formula C
3H7NO 2S·HCl· n H 20 (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 ethanol20.9.2008 EN Official Journal of the European Union L 253/155B. Melting range Anhydrous form melts at about 175oC
C. Specific rotation [α]20D: between + 5,0oand + 8,0oor
[α]25D: between + 4,9oand 7,9o
Purity
Loss on drying Between 8,0 % and 12,0 %
Not more than 2,0 % (anhydrous form)
Residue on ignition Not more than 0,1 %Ammonium-ion Not more than 200 mg/kg
Arsenic Not more than 1,5 mg/kg
Lead Not more than 5 mg/kg
E 927b CARBAMIDE
Synonyms Urea
Definition
Einecs 200-315-5Chemical 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 formedC. Colour reaction To pass the test a reddish-violet colour is produced
D. Melting range 132
oC to 135oC
Purity
Loss on drying Not more than 1,0 % (105oC, 1h)
Sulphated ash Not more than 0,1 %
Ethanol-insoluble matter Not more than 0,04 %Alkalinity Passes test
Ammonium-ion Not more than 500 mg/kg
Biuret Not more than 0,1 %Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
E 938 ARGON
Definition
Chemical name Argon
Einecs 231-147-0Chemical formula Ar
Molecular weight 40
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gasL 253/156 EN Official Journal of the European Union 20.9.2008Purity
Water Not more than 0,05 %
Methane and other hydrocarbons calcu-
lated as methaneNot more than 100 μl/l
E 939 HELIUM
Definition
Chemical name Helium
Einecs 231-168-5
Chemical formula He
Molecular weight 4
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %Methane and other hydrocarbons calcu-
lated as methaneNot more than 100 μl/l
E 941 NITROGEN
Definition
Chemical name NitrogenEinecs 231-783-9
Chemical formula N
2
Molecular weight 28
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %
Carbon monoxide Not more than 10 μl/l
Methane and other hydrocarbons calcu-
lated as methaneNot more than 100 μl/l
Nitrogen dioxide and nitrogen oxide Not more than 10 μl/l
Oxygen Not more than 1 %
E 942 NITROUS OXIDE
Definition
Chemical name Nitrous oxide
Einecs 233-032-0Chemical formula N
2O
Molecular weight 44
Assay Not less than 99 %
Description Colourless, non-flammable gas, sweetish odour20.9.2008 EN Official Journal of the European Union L 253/157Purity
Water Not more than 0,05 %
Carbon monoxide Not more than 30 μl/l
Nitrogen dioxide and nitrogen oxide Not more than 10 μl/l
E 943a BUTANE
Synonyms n-Butane
Definition
Chemical name Butane
Chemical formula CH 3CH 2CH 2CH 3
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 20oC
Purity
Methane Not more than 0,15 % v/v
Ethane Not more than 0,5 % v/vPropane Not more than 1,5 % v/v
Isobutane Not more than 3,0 % v/v
1,3-butadiene Not more than 0,1 % v/vMoisture Not more than 0,005 %
E 943b ISOBUTANE
Synonyms 2-methyl propane
Definition
Chemical name 2-methyl propaneChemical formula (CH
3)2CH CH 3
Molecular weight 58,12Assay 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/vPropane 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 %L 253/158 EN Official Journal of the European Union 20.9.2008E 944 PROPANE
Definition
Chemical name Propane
Chemical formula CH 3CH 2CH 3
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 20oC
Purity
Methane Not more than 0,15 % v/vEthane Not more than 1,5 % v/v
Isobutane Not more than 2,0 % v/v
n-Butane Not more than 1,0 % v/v1,3-butadiene Not more than 0,1 % v/v
Moisture Not more than 0,005 %
E 948 OXYGEN
Definition
Chemical name OxygenEinecs 231-956-9
Chemical formula O
2
Molecular weight 32
Assay Not less than 99 %
Description Colourless, odourless, non-flammable gas
Purity
Water Not more than 0,05 %
Methane and other hydrocarbons calcu-
lated as methaneNot more than 100 μl/l
E 949 HYDROGEN
Definition
Chemical name Hydrogen
Einecs 215-605-7
Chemical formula H 2
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/v20.9.2008 EN Official Journal of the European Union L 253/159E 950 ACESULFAME K
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 951 ASPARTAME
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 953 ISOMALT
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 957 THAUMATIN
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 959 NEOHESPERIDINE DIHYDROCHALCONE
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 965(i) MALTITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 965(ii) MALTITOL SYRUP
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 966 LACTITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 967 XYLITOL
Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
E 999 QUILLAIA EXTRACT
Synonyms Soapbark extract, Quillay bark extract, Panama bark extract, Quillai
extract, Murillo bark extract, China bark extract
Definition Quillaia extract is obtained by aqueous extraction of Quillaia saponaria
Molina, or other Quillaia species, trees of the family Rosaceae. It contains
a number of triterpenoid saponins consisting of glycosides of quillaic
acid. Some sugars including glucose, galactose, arabinose, xylose, and
rhamnose are also present, along with tannin, calcium oxalate and other
minor components
Description Quillaia extract in the powder form is light brown with a pink tinge. It is
also available as an aqueous solutionL 253/160 EN Official Journal of the European Union 20.9.2008Identification
A. pH of a 2,5 % solution Between 4,5 and 5,5
Purity
Water Not more than 6,0 % (Karl Fischer method) (powder form only)Arsenic Not more than 2 mg/kg
Lead Not more than 5 mg/kg
Mercury Not more than 1 mg/kg
E 1103 INVERTASE
Definition Invertase is produced from Saccharomyces cerevisiae
Systematic name β-D-Fructofuranoside fructohydrolase
Enzyme Commission No EC 3.2.1.26
Einecs 232-615-7
Purity
Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
Cadmium Not more than 0,5 mg/kg
Total bacterial count Not more than 50 000/gSalmonella spp. Absent by test in 25 g
Coliforms Not more than 30/g
E. coli Absent by test in 25 g
E 1105 LYSOZYME
Synonyms Lysozyme hydrochloride
Muramidase
Definition Lysozyme is a linear polypeptide obtained from hens' egg whites
consisting of 129 amino acids. It possesses enzymatic activity in its
ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid
and N-acetylglucosamine in the outer membranes of bacterial species, in
particular gram-positive organisms. Is usually obtained as the hydro-
chloride
Chemical name Enzyme Commission (EC) No: 3.2.1.17
Einecs 232-620-4
Molecular weight About 14 000Assay 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 %20.9.2008 EN Official Journal of the European Union L 253/161Nitrogen 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/kgHeavy metals (as Pb) Not more than 10 mg/kg
Microbiological criteria
Total bacterial count Not more than 5 × 10
4col/g
Salmonellae Absent in 25 g
Staphylococcus aureus Absent in 1 g
Escherichia coli Absent in 1 g
E 1200 POLYDEXTROSE
Synonyms Modified polydextroses
Definition Randomly bonded glucose polymers with some sorbitol end-groups, and
with citric acid or phosphoric acid residues attached to the polymers by
mono or diester bonds. They are obtained by melting and condensation
of the ingredients and consist of approximately 90 parts D-glucose,10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The
1,6-glucosidic linkage predominates in the polymers but other linkages
are present. The products contain small quantities of free glucose,
sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may
be neutralised with any food grade base and/or decolorised and
deionised for further purification. The products may also be partially
hydrogenated with Raney nickel catalyst to reduce residual glucose.
Polydextrose-N is neutralised polydextrose
Assay Content not less than 90 % of polymer on the ash free and anhydrous
basis
Description White to light tan-coloured solid. Polydextroses dissolve in water to give
a clear, colourless to straw coloured solution
Identification
A. Positive tests for sugar and for
reducing sugar
B. pH of a 10 % solution Between 2,5 and 7,0 for polydextrose
Between 5,0 and 6,0 for polydextrose-N
Purity
Water Not more than 4,0 % (Karl Fischer method)
Sulphated ash Not more than 0,3 % (polydextrose)
Not more than 2,0 % (polydextrose N)
Nickel Not more than 2 mg/kg for hydrogenated polydextroses1,6-Anhydro-D-glucose Not more than 4,0 % on the ash-free and the dried basis
Glucose and sorbitol Not more than 6,0 % combined on the ash-free and the dried basis;
glucose and sorbitol are determined separately
Molecular weight limit Negative test for polymers of molecular weight greater than 22 000
5-Hydroxy-methylfurfural Not more than 0,1 % (polydextrose)
Not more than 0,05 % (polydextrose-N)
Lead Not more than 0,5 mg/kgL 253/162 EN Official Journal of the European Union 20.9.2008E 1201 POLYVINYLPYRROLIDONE
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 25 000Assay 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/kgHydrazine Not more than 1 mg/kgLead Not more than 5 mg/kg
E 1202 POLYVINYLPOLYPYRROLIDONE
Synonyms Crospovidone
Cross linked polyvidoneInsoluble polyvinylpyrrolidone
Definition Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene],
cross linked in a random fashion. It is produced by the polymerisation of
N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-
divinyl-imidazolidone. Due to its insolubility in all common solvents the
molecular weight range is not amenable to analytical determination
Chemical name Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
Chemical formula (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-objectionable odour
Identification
A. Solubility Insoluble in water, ethanol and ether
B. pH of a 1 % suspension in water Between 5,0 and 8,0
Purity
Water Not more than 6 % (Karl Fischer)Sulphated ash Not more than 0,4 %Water-soluble matter Not more than 1 %Free-N-vinylpyrrolidone Not more than 10 mg/kgFree-N, N'-divinyl-imidazolidone Not more than 2 mg/kgLead Not more than 5 mg/kg20.9.2008 EN Official Journal of the European Union L 253/163E 1204 PULLULAN
Definition Linear, neutral glucan consisting mainly of maltotriose units connected
by - 1,6 glycosidic bonds. It is produced by fermentation from a food-
grade hydrolysed starch using a non-toxin-producing strain of
Aureobasidium pullulans. After completion of the fermentation, the
fungal cells are removed by microfiltration, the filtrate is heat-sterilised
and pigments and other impurities are removed by adsorption and ion
exchange chromatography
Einecs 232-945-1Chemical formula (C
6H10O5)x
Assay Not less than 90 % of glucan on the dried basis
Description White to off-white odourless powder
Identification
A. Solubility Soluble in water, practically insoluble in ethanol
B. pH of 10 % solution 5,0 to 7,0C. Precipitation with polyethylene gly-
col 600Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution
of pullulan. A white precipitate is formed
D. Depoly-merisation with pullulanase Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add
0,1 ml pullulanase solution having activity 10 units/g to one test tube,
and 0,1 ml water to the other. After incubation at about 25
oC for
20 minutes, the viscosity of the pullulanase-treated solution is visibly
lower than that of the untreated solution
Purity
Loss on drying Not more than 6 % (90oC, pressure not more than 50 mm Hg, 6 h)
Mono-, di- and oligosaccharides Not more than 10 % expressed as glucose
Viscosity 100 to 180 mm2/s (10 % w/w aqueous solution at 30oC)
Lead Not more than 1 mg/kgYeast and moulds Not more than 100 colonies per gram
Coliforms Absent in 25 g
Salmonella Absent in 25 g
E 1404 OXIDISED STARCH
Definition Oxidised starch is starch treated with sodium hypochlorite
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Carboxyl groups Not more than 1,1 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kgL 253/164 EN Official Journal of the European Union 20.9.2008E 1410 MONOSTARCH PHOSPHATE
Definition Monostarch phosphate is starch esterified with ortho-phosphoric acid,
or sodium or potassium ortho-phosphate or sodium tripolyphosphate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1412 DISTARCH PHOSPHATE
Definition Distarch phosphate is starch cross-linked with sodium trimetaphosphate
or phosphorus oxychloride
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg20.9.2008 EN Official Journal of the European Union L 253/165E 1413 PHOSPHATED DISTARCH PHOSPHATE
Definition Phosphated distarch phosphate is starch having undergone a combina-
tion of treatments as described for monostarch phosphate and for
distarch phosphate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Residual phosphate Not more than 0,5 % (as P) for wheat or potato starch
Not more than 0,4 % (as P) for other starches
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1414 ACETYLATED DISTARCH PHOSPHATE
Definition Acetylated distarch phosphate is starch cross-linked with sodium
trimetaphosphate or phosphorus oxychloride and esterified by acetic
anhydride or vinyl acetate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato 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/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/kgL 253/166 EN Official Journal of the European Union 20.9.2008Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1420 ACETYLATED STARCH
Synonyms Starch acetate
Definition Acetylated starch is starch esterified with acetic anhydride or vinyl
acetate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %
Vinyl acetate Not more than 0,1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1422 ACETYLATED DISTARCH ADIPATE
Definition Acetylated distarch adipate is starch cross-linked with adipic anhydride
and esterified with acetic anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Acetyl groups Not more than 2,5 %Adipate groups Not more than 0,135 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified20.9.2008 EN Official Journal of the European Union L 253/167Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1440 HYDROXYPROPYL STARCH
Definition Hydroxypropyl starch is starch etherified with propylene oxide
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups Not more than 7,0 %
Propylene chlorohydrin Not more than 1 mg/kg
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE
Definition Hydroxypropyl distarch phosphate is starch cross-linked with sodium
trimetaphosphate or phosphorus oxychloride and etherified with
propylene oxide
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Hydroxypropyl groups Not more than 7,0 %
Residual phosphate Not more than 0,14 % (as P) for wheat or potato starch
Not more than 0,04 (as P) for other starches
Propylene chlorohydrin Not more than 1 mg/kgL 253/168 EN Official Journal of the European Union 20.9.2008Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1450 STARCH SODIUM OCTENYL SUCCINATE
Synonyms SSOS
Definition Starch sodium octenyl succinate is starch esterified with octenylsuccinic
anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Octenylsuccinyl groups Not more than 3 %Octenylsuccinic acid residue Not more than 0,3 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kgMercury Not more than 0,1 mg/kg
E 1451 ACETYLATED OXIDISED STARCH
Definition Acetylated oxidised starch is starch treated with sodium hypochlorite
followed by esterification with acetic anhydride
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 15,0 % for cereal starch
Not more than 21,0 % for potato starch
Not more than 18,0 % for other starches
Carboxyl groups Not more than 1,3 %20.9.2008 EN Official Journal of the European Union L 253/169Acetyl groups Not more than 2,5 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for other modified starches, unless otherwise
specified
Arsenic Not more than 1 mg/kg
Lead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE
Synonyms SAOS
Definition Starch aluminium octenyl succinate is starch esterified with octenylsuc-
cinic anhydride and treated with aluminium sulphate
Description White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles
Identification
A. If not pregelatinised: by microscopic
observation
B. Iodine staining positive (dark blue to
light red colour)
Purity (all values expressed on an anhydrous
basis except for loss on drying)
Loss on drying Not more than 21,0 %
Octenylsuccinyl groups Not more than 3 %Octenylsuccinic acid residue Not more than 0,3 %
Sulphur dioxide Not more than 50 mg/kg for modified cereal starches
Not more than 10 mg/kg for the other modified starches, unless
otherwise specified
Arsenic Not more than 1 mg/kgLead Not more than 2 mg/kg
Mercury Not more than 0,1 mg/kg
Aluminium Not more than 0,3 %
E 1505 TRIETHYL CITRATE
Synonyms Ethyl citrate
Definition
Chemical name Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
Einecs 201-070-7Chemical formula C
12H20O7
Molecular weight 276,29Assay 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] D20: 1,439-1,441
Purity
Water Not more than 0,25 % (Karl Fischer method)Acidity Not more than 0,02 % (as citric acid)L 253/170 EN Official Journal of the European Union 20.9.2008Arsenic Not more than 3 mg/kg
Lead Not more than 5 mg/kg
E 1517 GLYCERYL DIACETATE
Synonyms Diacetin
Definition Glyceryl diacetate consist predominantly of a mixture of the 1,2- and
1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters
Chemical names Glyceryl diacetate
1, 2, 3-propanetriol diacetate
Chemical formula C
7H12O5
Molecular weight 176,17Assay Not less than 94,0 %
Description Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty
odour
Identification
A. Solubility Soluble in water. Miscible with ethanol
B. Positive tests for glycerol and acetateC. Specific gravity d
2020: 1,175-1,195
D. Boiling range Between 259 and 261oC
Purity
Total ash Not more than 0,02 %
Acidity Not more than 0,4 % (as ascetic acid)
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg
E 1518 GLYCERYL TRIACETATE
Synonyms Triacetin
Definition
Chemical name Glyceryl triacetateEinecs 203-051-9
Chemical formula C
9H14O6
Molecular weight 218,21
Assay Content not less than 98,0 %
Description Colourless, somewhat oily liquid having a slightly fatty odour
Identification
A. Positive tests for acetate and for
glycerol
B. Refractive index Between 1,429 and 1,431 at 25oC
C. Specific gravity (25oC/25oC) Between 1,154 and 1,158
D. Boiling range Between 258 and 270oC
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/kg20.9.2008 EN Official Journal of the European Union L 253/171E 1519 BENZYL ALCOHOL
Synonyms Phenylcarbinol
Phenylmethyl alcohol
Benzenemethanol
Alpha-hydroxytoluene
Definition
Chemical names Benzyl alcohol
Phenylmethanol
Chemical formula C 7H8O
Molecular weight 108,14
Assay Not less than 98,0 %
Description Colourless, clear liquid with a faint, aromatic odour
Identification
A. Solubility Soluble in water, ethanol and ether
B. Refractive index [n]D20: 1,538-1,541
C. Specific gravity d 2525: 1,042-1,047
D. Positive test for peroxides
Purity
Distillation range Not less than 95 % v/v distils between 202 and 208oC
Acid value Not more than 0,5
Aldehydes Not more than 0,2 % v/v (as bezaldehyde)
Lead Not more than 5 mg/kg
E 1520 PROPANE-1,2-DIOL
Synonyms Propylene glycol
Definition
Chemical names 1,2-dihydroxypropane
Einecs 200-338-0
Chemical formula 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]20D: 1,431-1,433
Purity
Distillation range 99 % v/v distils between 185oC-189oC
Sulphated ash Not more than 0,07 %
Water Not more than 1,0 % (Karl Fischer method)
Lead Not more than 5 mg/kgL 253/172 EN Official Journal of the European Union 20.9.2008POLYETHYLENE GLYCOL 6000
Synonyms PEG 6000
Macrogol 6000
Definition Polyethylene glycol 6000 is a mixture of polymers with the general
formula H-(OCH 2-CH)-OH corresponding to an average relative
molecular mass of approximately 6 000
Chemical formula (C 2H4O)nH2O (n = number of ethylene oxide units corresponding to a
molecular weight of 6 000, about 140)
Molecular weight 5 600-7 000
Assay Not less than 90,0 % and not more than 110,0 %
Description A white or almost white solid with a waxy or paraffin-like appearance
Identification
A. Solubility Very soluble in water and in methylene chloride. Practically insoluble in
alcohol, in ether and in fatty and mineral oils
B. Melting range Between 55oC and 61oC
Purity
Viscosity Between 0,220 and 0,275 kgm-1s-1at 20oC
Hydroxyl value Between 16 and 22Sulphated ash Not more than 0,2 %
Ethylene oxide Not more than 0,2 mg/kg
Arsenic Not more than 3 mg/kgLead Not more than 5 mg/kg20.9.2008 EN Official Journal of the European Union L 253/173ANNEX II
PART A
Repealed Directive with list of its successive amendments
(referred to in Article 2)
Commission Directive 96/77/EC
Commission Directive 98/86/EC
Commission Directive 2000/63/ECCommission Directive 2001/30/ECCommission Directive 2002/82/ECCommission Directive 2003/95/ECCommission Directive 2004/45/ECCommission Directive 2006/129/EC(OJ L 339, 30.12.1996, p. 1)
(OJ L 334, 9.12.1998, p. 1)
(OJ L 277, 30.10.2000, p. 1)(OJ L 146, 31.5.2001, p. 1)(OJ L 292, 28.10.2002, p. 1)(OJ L 283, 31.10.2003, p. 71)(OJ L 113, 20.4.2004, p. 19)(OJ L 346, 9.12.2006, p. 15)
PART B
List of time-limits for transposition into national law
(referred to in Article 2)
Directive Time-limit for transposition
96/77/EC 1 July 1997 (1)
98/86/EC 1 July 1999 (2)
2000/63/EC 31 March 2001 (3)
2001/30/EC 1 June 2002 (4)
2002/82/EC 31 August 2003
2003/95/EC 1 November 2004 (5)
2004/45/EC 1 April 2005 (6)
2006/129/EC 15 February 2008
(1) According to Article 3(2) of Directive 96/77/EC, products put on the market or labelled before 1 July 1997 which do not comply with
this Directive may be marketed until stocks are exhausted.
(2) According to Article 2(2) of Directive 98/86/EC, products put on the market or labelled before 1 July 1999 which do not comply with
this Directive may be marketed until stocks are exhausted.
(3) According to Article 2(3) of Directive 2000/63/EC, products put on the market or labelled before 31 March 2001 which do not comply
with this Directive may be marketed until stocks are exhausted.
(4) According to Article 2(3) of Directive 2001/30/EC, products put on the market or labelled before 1 June 2002 which do not comply
with this Directive may be marketed until stocks are exhausted.
(5) According to Article 3 of Directive 2003/95/EC, products put on the market or labelled before 1 November 2004 which do not comply
with this Directive may be marketed until stocks are exhausted.
(6) According to Article 3 of Directive 2004/45/EC, products put on the market or labelled before 1 April 2005 which do not comply with
this Directive may be marketed until stocks are exhausted.L 253/174 EN Official Journal of the European Union 20.9.2008ANNEX III
Correlation table
Directive 96/77/EC This Directive
Article 1 Article 1
Article 2 —
Article 3 —
— Article 2
Article 4 Article 3
Article 5 Article 4Annex Annex I
— Annex II
— Annex III20.9.2008 EN Official Journal of the European Union L 253/175