Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Codified version) (Text with EEA relevance)
Date: 2008-08-27
Institutions: European Commission
Subjects: codification of EU law, food additive, food safety, foodstuff, health control, human nutrition, product quality

20.9.2008

EN

Official Journal of the European Union

L 253/1

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 States
concerning food additives authorised for use in foodstuffs
intended 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)

(3)

It is necessary to establish purity criteria for all additives
other than colours and sweeteners mentioned in European
Parliament and Council Directive 95/2/EC of 20 February
1995 on food additives other than colours and sweet-
eners (4).

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)

(5)

(6)

Food additives prepared by production methods or starting
materials significantly different from those evaluated by the
Scientific Committee for Food or different
from those
mentioned in this Directive should be submitted for safety
evaluation by the European Food Safety Authority with
emphasis on the purity criteria.

The measures provided for
in this Directive are in
accordance with the opinion of the Standing Committee
on the Food Chain and Animal Health.

should be without prejudice

This Directive
to the
obligations of the Member States relating to the time-limits
for transposition into national law of the Directives set out
in 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

(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.

Directive 96/77/EC, as amended by the Directives listed in
Annex II, part A, is repealed, without prejudice to the obligations
of the Member States relating to the time-limits for transposition
into national law set out in Annex II, part B.

L 253/2

EN

Official Journal of the European Union

20.9.2008

References to the repealed Directive shall be construed as
references to this Directive and shall be read in accordance with
the correlation table in Annex III.

Article 4

This Directive is addressed to the Member States.

Article 3

Done at Brussels, 27 August 2008.

This Directive shall enter into force on the 20th day following its
publication in the Official Journal of the European Union.

For the Commission

The President

José Manuel BARROSO

20.9.2008

EN

Official Journal of the European Union

L 253/3

ANNEX 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

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range

B. Spectrometry

Trans, trans-2,4-hexadienoic acid

203-768-7

C6H8O2

112,12

Content not less than 99 % on the anhydrous basis

Colourless needles or white free flowing powder, having a slight
characteristic odour and showing no change in colour after heating for
90 minutes at 105 oC

Between 133 oC and 135 oC, after vacuum drying for four hours in a
sulphuric acid desiccator

An isopropanol solution (1 in 4 000 000) shows absorbance maximum
at 254 ± 2 nm

C. Positive test for double bonds

D. Sublimation point

80 oC

Purity

Water content

Sulphated ash

Aldehydes

Arsenic

Lead

Mercury

Not more than 0,5 % (Karl Fischer method)

Not more than 0,2 %

Not more than 0,1 % (as formaldehyde)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 202 POTASSIUM SORBATE

Definition

Chemical name

Potassium sorbate

Einecs

Chemical formula

Molecular weight

Assay

(1) OJ L 226, 22.9.1995, p. 1.

Potassium (E, E)-2,4-hexadienoate

Potassium salt of trans, trans 2,4-hexadienoic acid

246-376-1

C6H7O2K

150,22

Content not less than 99 % on the dried basis

L 253/4

EN

Official Journal of the European Union

20.9.2008

Description

Identification

A. Melting range of sorbic acid isolated
by acidification and not recrystallised
133 oC to 135 oC after vacuum
drying in a sulphuric acid desiccator

B. Positive tests for potassium and for

double bonds

Purity

Loss on drying

Acidity or alkalinity

Aldehydes

Arsenic

Lead

Mercury

White crystalline powder showing no change in colour after heating for
90 minutes at 105 oC

Not more than 1,0 % (105 oC, 3h)

Not more than about 1,0 % (as sorbic acid or K2CO3)

Not more than 0,1 %, calculated as formaldehyde

Not more than 3 mg/kg

Not more than 5 mg/kg

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

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range of sorbic acid isolated
by acidification and not recrystallised
133 oC to 135 oC after vacuum
drying in a sulphuric acid desiccator

B. Positive tests for calcium and for

double bonds

Purity

Loss on drying

Aldehydes

Fluoride

Arsenic

Lead

Mercury

231-321-6

C12H14O4Ca

262,32

Content not less than 98 % on the dried basis

Fine white crystalline powder not showing any change in colour after
heating at 105 oC for 90 minutes

Not more than 2,0 %, determined by vacuum drying for four hours in a
sulphuric acid desiccator

Not more than 0,1 % (as formaldehyde)

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/5

E 210 BENZOIC ACID

Definition

Chemical name

Benzoic acid

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Benzenecarboxylic acid

Phenylcarboxylic acid

200-618-2

C7H6O2

122,12

Content not less than 99,5 % on the anhydrous basis

White crystalline powder

A. Melting range

121,5 oC to 123,5 oC

B. Positive sublimation test and test for

benzoate

Purity

Loss on drying

pH

Sulphated ash

Not more than 0,5 % after drying for three hours over sulphuric acid

About 4 (solution in water)

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

Readily carbonisable substances

Polycyclic acids

Arsenic

Lead

Mercury

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point
and add 0,1 N KMnO4 in 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 KMnO4 to a pink colour that
persists for 15 seconds. Not more than 0,5 ml should be required

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

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

(2) Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric
acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml
of iodine solution, add 5 ml of 3 % 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
CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a
solution containing 59,5 mg of CoCl2·6H2O per ml.

(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 FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/
water to give a solution containing 45,0 mg of FeCl3·6H2O per ml.

(4) Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of
hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing
250 ml of iodine solution, add 40 ml of water, 4 ml of acetic 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 CuSO4·5H2O. Adjust
final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing
62,4 mg of CuSO4·5H2O per ml.

(*) Starch TS: triturate 0,5 g starch (potato starch, maize starch 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.

L 253/6

EN

Official Journal of the European Union

20.9.2008

E 211 SODIUM BENZOATE

Definition

Chemical name

Sodium benzoate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium salt of benzenecarboxylic acid

Sodium salt of phenylcarboxylic acid

208-534-8

C7H5O2Na

144,11

Not less than 99 % of C7H5O2Na, after drying at 105 oC for four hours

A white, almost odourless, crystalline powder or granules

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 121,5 oC to 123,5 oC, 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 105 oC for four hours

Readily oxidisable substances

Polycyclic acids

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point
and add 0,1 N KMnO4 in 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 KMnO4 to a pink colour that
persists for 15 seconds. Not more than 0,5 ml should be required

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
in the presence of
phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH
or 0,1 N HCl

sodium benzoate,

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

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

Einecs

Chemical formula

Molecular weight

Assay

Potassium salt of benzenecarboxylic acid

Potassium salt of phenylcarboxylic acid

209-481-3

C7H5KO2·3H2O

214,27

Content not less than 99 % C7H5KO2 after drying at 105 oC to constant
weight

Description

White crystalline powder

20.9.2008

EN

Official Journal of the European Union

L 253/7

Identification

A. Melting range of benzoic acid iso-
lated by acidification and not recrys-
tallised 121,5 oC to 123,5 oC, after
vacuum drying in a sulphuric acid
desiccator

B. Positive tests for benzoate and for

potassium

Purity

Loss on drying

Not more than 26,5 %, determined by drying at 105 oC

Chlorinated organic compounds

Readily oxidisable substances

Readily carbonisable substances

Polycyclic acids

Degree of acidity or alkalinity

Not more than 0,06 % expressed as chloride, corresponding to 0,25 %
expressed as monochlorobenzoic acid

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point
and add 0,1 N KMnO4 in 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 KMnO4 to a pink colour that
persists for 15 seconds. Not more than 0,5 ml should be required

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

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

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Monocalcium benzoate

Calcium benzoate

Calcium dibenzoate

218-235-4

Anhydrous:

C14H10O4Ca

Monohydrate:

C14H10O4Ca· H2O

Trihydrate:

Anhydrous:

Monohydrate:

Trihydrate:

C14H10O4Ca· 3H2O

282,31

300,32

336,36

Content not less than 99 % after drying at 105 oC

White or colourless crystals, or white powder

E 213 CALCIUM BENZOATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range of benzoic acid iso-
lated by acidification and not recrys-
tallised 121,5 oC to 123,5 oC, after
vacuum drying in a sulphuric acid
desiccator

B. Positive tests for benzoate and for

calcium

L 253/8

EN

Official Journal of the European Union

20.9.2008

Purity

Loss on drying

Not more than 17,5 % determined by drying at 105 oC to constant
weight

Water insoluble matter

Not more than 0,3 %

Chlorinated organic compounds

Readily oxidisable substances

Readily carbonisable substances

Polycyclic acids

Degree of acidity or alkalinity

Not more than 0,06 % expressed as chloride, corresponding to 0,25 %
expressed as monochlorobenzoic acids

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point
and add 0,1 N KMnO4 in 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 KMnO4 to a pink colour that
persists for 15 seconds. Not more than 0,5 ml should be required

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

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

in the presence of
Neutralisation of 1 g of calcium benzoate,
phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH
or 0,1 N HCl

Fluoride

Arsenic

Lead

Mercury

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 214 ETHYL p-HYDROXYBENZOATE

Synonyms

Definition

Ethylparaben

Ethyl p-oxybenzoate

Chemical name

Ethyl-p-hydroxybenzoate

Ethyl ester of p-hydroxybenzoic acid

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

204-399-4

C9H10O3

166,8

Content not less than 99,5 % after drying for two hours at 80 oC

Almost odourless, small, colourless crystals or a white, crystalline
powder

A. Melting range

115 oC to 118 oC

B. Positive test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid isolated by acidification and not
recrystallised: 213 oC to 217 oC, after vacuum drying in a sulphuric acid
desiccator

C. Positive test for alcohol

Purity

Loss on drying

Sulphated ash

Not more than 0,5 % after drying for two hours at 80 oC

Not more than 0,05 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Lead

Not more than 3 mg/kg

Not more than 5 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/9

Mercury

Heavy metals (as Pb)

Not more than 1 mg/kg

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

Chemical formula

Molecular weight

Assay

Description

Identification

252-487-6

C9H9O3Na

188,8

Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the
anhydrous basis

White, crystalline hygroscopic powder

A. Melting range

115 oC to 118 oC, after vacuum drying in a sulphuric acid desiccator

B. Positive test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid derived from the sample is
213 oC to 217 oC

C. Positive test for sodium

D. pH of a 0,1 % aqueous solution must

be between 9,9 and 10,3

Purity

Loss on drying

Sulphated ash

Not more than 5 %, determined by vacuum drying in a sulphuric acid
desiccator

37 to 39 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 218 METHYL p-HYDROXYBENZOATE

Synonyms

Definition

Methylparaben

Methyl-p-oxybenzoate

Chemical name

Methyl p-hydroxybenzoate

Methyl ester of p-hydroxybenzoic acid

Einecs

Chemical formula

Molecular weight

Assay

Description

243-171-5

C8H8O3

152,15

Content not less than 99 % after drying for two hours at 80 oC

Almost odourless, small colourless crystals or white crystalline powder

L 253/10

EN

Official Journal of the European Union

20.9.2008

Identification

A. Melting range

125 oC to 128 oC

B. Positive test for p-hydroxybenzoate

Melting range of p-hydroxybenzoic acid derived from the sample is
213 oC to 217 oC after drying for two hours at 80 oC

Purity

Loss on drying

Sulphated ash

Not more than 0,5 %, after drying for two hours at 80 oC

Not more than 0,05 %

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

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

Molecular weight

C8H7O3Na

174,15

Assay

Description

Identification

Content not less than 99,5 % on the anhydrous basis

White, hygroscopic powder

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
and dried at 80 oC for
water
two hours, have a melting range of
125 oC to 128 oC

B. Positive test for sodium

C. pH of a 0,1 % solution in carbon
dioxide free water, not less than 9,7
and not more than 10,3

Purity

Water content

Sulphated ash

Not more than 5 % (Karl Fischer method)

40 % to 44,5 % on the anhydrous basis

p-Hydroxybenzoic acid and salicylic acid

Not more than 0,35 % expressed as p-hydroxybenzoic acid

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/11

E 220 SULPHUR DIOXIDE

Definition

Chemical name

Sulphur dioxide

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sulphurous acid anhydride

231-195-2

SO2

64,07

Content not less than 99 %

Colourless, non-flammable gas with strong pungent suffocating odour

A. Positive test
stances

for

sulphurous

sub-

Purity

Water content

Non-volatile residue

Sulphur trioxide

Selenium

Not more than 0,05 %

Not more than 0,01 %

Not more than 0,1 %

Not more than 10 mg/kg

Other gases not normally present in the
air

No trace

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 221 SODIUM SULPHITE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sulphite and for

sodium

B. pH of a 10 % solution (anhydrous) or
(heptahydrate)

20 % solution
a
between 8,5 and 11,5

Sodium sulphite (anhydrous or heptahydrate)

231-821-4

Anhydrous:

Na2SO3

Heptahydrate:

Na2SO37H2O

Anhydrous:

Heptahydrate:

Anhydrous:

Heptahydrate:

126,04

252,16

Not less than 95 % of Na2SO3 and not less than
48 % of SO2

Not less than 48 % of Na2SO3 and not less than
24 % of SO2

White crystalline powder or colourless crystals

L 253/12

EN

Official Journal of the European Union

20.9.2008

Purity

Thiosulphate

Iron

Selenium

Arsenic

Lead

Mercury

Not more than 0,1 % based on the SO2 content

Not more than 50 mg/kg based on the SO2 content

Not more than 10 mg/kg based on the SO2 content

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 222 SODIUM BISULPHITE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sulphite and for

sodium

B. pH of a 10 % aqueous
between 2,5 and 5,5

solution

Purity

Iron

Selenium

Arsenic

Lead

Mercury

Sodium bisulphite

Sodium hydrogen sulphite

231-921-4

NaHSO3 in aqueous solution

104,06

Content not less than 32 % w/w NaHSO3

A clear, colourless to yellow solution

Not more than 50 mg/kg of Na2SO3 based on the SO2 content

Not more than 10 mg/kg based on the SO2 content

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 223 SODIUM METABISULPHITE

Synonyms

Definition

Pyrosulphite

Sodium pyrosulphite

Chemical name

Sodium disulphite

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sulphite and for

sodium

Disodium pentaoxodisulphate

231-673-0

Na2S2O5

190,11

Content not less than 95 % Na2S2O5 and not less than 64 % of SO2

White crystals or crystalline powder

20.9.2008

EN

Official Journal of the European Union

L 253/13

B. pH of a 10 % aqueous
between 4,0 and 5,5

solution

Purity

Thiosulphate

Iron

Selenium

Arsenic

Lead

Mercury

Not more than 0,1 % based on the SO2 content

Not more than 50 mg/kg based on the SO2 content

Not more than 10 mg/kg based on the SO2 content

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 224 POTASSIUM METABISULPHITE

Synonyms

Definition

Potassium pyrosulphite

Chemical name

Potassium disulphite

Potassium pentaoxo disulphate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sulphite and for

potassium

Purity

Thiosulphate

Iron

Selenium

Arsenic

Lead

Mercury

240-795-3

K2S2O5

222,33

Content not less than 90 % of K2S2O5 and not less than 51,8 % of SO2,
the remainder being composed almost entirely of potassium sulphate

Colourless crystals or white crystalline powder

Not more than 0,1 % based on the SO2 content

Not more than 50 mg/kg based on the SO2 content

Not more than 10 mg/kg based on the SO2 content

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 226 CALCIUM SULPHITE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sulphite and for

calcium

Calcium sulphite

218-235-4

CaSO3·2H2O

156,17

Content not less than 95 % of CaSO3·2H2O and not less than 39 % of
SO2

White crystals or white crystalline powder

L 253/14

EN

Official Journal of the European Union

20.9.2008

Purity

Iron

Selenium

Arsenic

Lead

Mercury

Not more than 50 mg/kg based on the SO2 content

Not more than 10 mg/kg based on the SO2 content

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 227 CALCIUM BISULPHITE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sulphite and for

calcium

Purity

Iron

Selenium

Arsenic

Lead

Mercury

Calcium bisulphite

Calcium hydrogen sulphite

237-423-7

Ca(HSO3)2

202,22

6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium
dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite
[Ca(HSO3)2]

Clear greenish-yellow aqueous solution having a distinct odour of
sulphur dioxide

Not more than 50 mg/kg based on the SO2 content

Not more than 10 mg/kg based on the SO2 content

Not more than 3 mg/kg

Not more than 5 mg/kg

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

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sulphite and for

potassium

Purity

Iron

Selenium

Potassium hydrogen sulphite

231-870-1

KHSO3 in aqueous solution

120,17

Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)

Clear colourless aqueous solution

Not more than 50 mg/kg based on the SO2 content

Not more than 10 mg/kg based on the SO2 content

20.9.2008

EN

Official Journal of the European Union

L 253/15

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 230 BIPHENYL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range

B. Distillation range

Purity

Benzene

Aromatic amines

Phenol derivatives

Diphenyl

1,1′-biphenyl

Phenylbenzene

202-163-5

C12H10

154,20

Content not less than 99,8 %

White or pale yellow to amber crystalline solid having a characteristic
odour

68,5 oC to 70,5 oC

It distils completely within a 2,5 oC range between 252,5 oC and
257,5 oC

Not more than 10 mg/kg

Not more than 2 mg/kg (as aniline)

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-
tives

Not more than 0,2 %

Polycyclic aromatic hydrocarbons

Absent

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 231 ORTHOPHENYLPHENOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Orthoxenol

(1,1'-Biphenyl)-2-ol

2-Hydroxydiphenyl

o-Hydroxydiphenyl

201-993-5

C12H10O

170,20

Content not less than 99 %

White or slightly yellowish crystalline powder

L 253/16

EN

Official Journal of the European Union

20.9.2008

Identification

A. Melting range

56 oC to 58 oC

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

Diphenyl ether

p-Phenylphenol

1-Naphthol

Arsenic

Lead

Mercury

Not more than 0,05 %

Not more than 0,3 %

Not more than 0,1 %

Not more than 0,01 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 232 SODIUM ORTHOPHENYLPHENOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium orthophenylphenate

Sodium salt ofo-phenylphenol

Sodium orthophenylphenol

205-055-6

C12H9ONa· 4H2O

264,26

Content not less than 97 % of C12H9ONa· 4H2O

White or slightly yellowish crystalline powder

A. Positive tests for phenolate and for

sodium

B. Melting range of orthophenylphenol
isolated by acidification and not
recrystallised derived from the sam-
ple 56 oC to 58 oC after drying in a
sulphuric acid desiccator

C. pH of a 2 % aqueous solution must

be between 11,1 and 11,8

Purity

Diphenylether

p-phenylphenol

1-naphthol

Arsenic

Lead

Mercury

Not more than 0,3 %

Not more than 0,1 %

Not more than 0,01 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 233 THIABENDAZOLE

Definition

Chemical name

4-(2-benzimidazolyl)thiazole

2-(4-thiazolyl)-1H-benzimidazole

20.9.2008

EN

Official Journal of the European Union

L 253/17

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range

B. Spectrometry

Purity

Water content

Sulphated ash

Selenium

Arsenic

Lead

Mercury

205-725-8

C10H7N3S

201,26

Content not less than 98 % on the anhydrous basis

White, or almost white, odourless powder

296 oC to 303 oC

Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm
and 243 nm

E 1%

1cmat 302 nm ± 2 nm: approximately 1 230

E 1%

1cmat 258 nm ± 2 nm: approximately 200

E 1%

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

Not more than 0,5 % (Karl Fischer method)

Not more than 0,2 %

Not more than 3 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 234 NISIN

Definition

Einecs

Chemical formula

Molecular weight

Assay

Description

Purity

Nisin consists of several closely related polypeptides produced by natural
strains of Streptococcus lactis, Lancefield group N

215-807-5

C143H230N42O37S7

3 354 ,12

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 %

White powder

Loss on drying

Not more than 3 % when dried to constant weight at 102 oC to 103 oC

Arsenic

Lead

Mercury

Not more than 1 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 235 NATAMYCIN

Synonyms

Definition

Pimaricin

Natamycin is a fungicide of
the polyene macrolide group, and is
produced by natural strains of Streptomyces natalensis or of Streptococcus
lactis

L 253/18

EN

Official Journal of the European Union

20.9.2008

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

231-683-5

C33H47O13N

665,74

Content not less than 95 % on the anhydrous basis

White to creamy-white crystalline powder

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

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

5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of
20 parts dimethylformamide and 80 parts of water)

20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at

[α]D
20 oC and calculated with reference to the dried material)

Not more than 8 % (over P2O5, in vacuum at 60 oC to constant weight)

Not more than 0,5 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

B. Spectrometry

C. pH

D. Specific rotation

Purity

Loss on drying

Sulphated ash

Arsenic

Lead

Mercury

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

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for formaldehyde and

point

approximately

for ammonia

B. Sublimation
260 oC

Purity

Loss on drying

Sulphated ash

Sulphates

Hexamine

Methenamine

1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine

202-905-8

C6H12N4

140,19

Content not less than 99 % on the anhydrous basis

Colourless or white crystalline powder

Not more than 0,5 % after drying at 105 oC in vacuum over P2O5 for
two hours

Not more than 0,05 %

Not more than 0,005 % expressed as SO4

20.9.2008

EN

Official Journal of the European Union

L 253/19

Chlorides

Ammonium salts

Arsenic

Lead

Mercury

Not more than 0,005 % expressed as Cl

Not detectable

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 242 DIMETHYL DICARBONATE

Synonyms

Definition

DMDC

Dimethyl pyrocarbonate

Chemical name

Dimethyl dicarbonate

Pyrocarbonic acid dimethyl ester

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Decomposition

B. Melting point

Boiling point

C. Density 20 oC

224-859-8

C4H6O5

134,09

Content not less than 99,8 %

Colourless liquid, decomposes in aqueous solution. It is corrosive to skin
and eyes and toxic by inhalation and ingestion

After dilution positive tests for CO2 and methanol

17 oC

172 oC with decomposition

Approximately 1,25 g/cm3

D.

Infrared spectrum

Maxima at 1 156 and 1 832 cm− 1

Purity

Dimethyl carbonate

Chlorine, total

Arsenic

Lead

Mercury

Not more than 0,2 %

Not more than 3 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 249 POTASSIUM NITRITE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Potassium nitrite

231-832-4

KNO2

85,11

Content not less than 95 % on the anhydrous basis (5)

White or slightly yellow, deliquescent granules

(5) When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.

L 253/20

EN

Official Journal of the European Union

20.9.2008

Identification

A. Positive tests
potassium

for nitrite and for

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 250 SODIUM NITRITE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests
sodium

for nitrite and for

Purity

Sodium nitrite

231-555-9

NaNO2

69,00

Content not less than 97 % on the anhydrous basis (6)

White crystalline powder or yellowish lumps

Loss on drying

Not more than 0,25 % after drying over silica gel for four hours

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

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

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Chile saltpetre

Cubic or soda nitre

Sodium nitrate

231-554-3

NaNO3

85,00

Content not less than 99 % after drying

White crystalline, slightly hygroscopic powder

(6) When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.

20.9.2008

EN

Official Journal of the European Union

L 253/21

Identification

A. Positive tests
sodium

for nitrate and for

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 105 oC for four hours

Nitrites

Arsenic

Lead

Mercury

Not more than 30 mg/kg expressed as NaNO2

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 251 SODIUM NITRATE

2. LIQUID SODIUM NITRATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

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 excessive
amounts, if clearly stated or labelled.

Sodium nitrate

231-554-3

NaNO3

85,00

Content between 33,5 % and 40,0 % of NaNO3

Clear colourless liquid

A. Positive tests
sodium

for nitrate and for

B. pH

Purity

Not less than 1,5 and not more than 3,5

Free nitric acid

Not more than 0,01 %

Nitrites

Arsenic

Lead

Mercury

Not more than 10 mg/kg expressed as NaNO2

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 0,3 mg/kg

specification refers

This
aqueous solution

to a 35 %

E 252 POTASSIUM NITRATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Chile saltpetre

Cubic or soda nitre

Potassium nitrate

231-818-8

KNO3

101,11

Content not less than 99 % on the anhydrous basis

L 253/22

EN

Official Journal of the European Union

20.9.2008

Description

Identification

White crystalline powder or transparent prisms having a cooling, saline,
pungent taste

A. Positive tests
potassium

for nitrate and for

B. pH of a 5 % solution

Not less than 4,5 and not more than 8,5

Purity

Loss on drying

Not more than 1 % after drying at 105 oC for four hours

Nitrites

Arsenic

Lead

Mercury

Not more than 20 mg/kg expressed as KNO2

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 260 ACETIC ACID

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Acetic acid

Ethanoic acid

200-580-7

C2H4O2

60,05

Content not less than 99,8 %

Clear, colourless liquid having a pungent, characteristic odour

A. Boiling point

B. Specific gravity

118 oC at 760 mm pressure (of mercury)

About 1,049

C. A one in three solution gives positive

tests for acetate

D. Solidification point

Not lower than 14,5 oC

Purity

Non-volatile residue

Not more than 100 mg/kg

Formic acid, formates and other oxidisa-
ble substances

Readily oxidisable substances

Not more than 1 000 mg/kg expressed as formic acid

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

Lead

Mercury

Not more than 1 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 261 POTASSIUM ACETATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Potassium acetate

204-822-2

C2H3O2K

98,14

20.9.2008

EN

Official Journal of the European Union

L 253/23

Assay

Description

Identification

Content not less than 99 % on the anhydrous basis

Colourless, deliquescent crystals or a white crystalline powder, odourless
or with a faint acetic odour

A. pH of a 5 % aqueous solution

Not less than 7,5 and not more than 9,0

B. Positive tests
potassium

for acetate and for

Purity

Loss on drying

Not more than 8 % after drying at 150 oC for two hours

Formic acid, formates and other oxidisa-
ble substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 262 (i) SODIUM ACETATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium acetate

204-823-8

C2H3NaO2·nH2O (n = 0 or 3)

Anhydrous:

Trihydrate:

82,03

136,08

Content (for both of anhydrous and trihydrate form) not less than
98,5 % on the anhydrous basis

Anhydrous:

Trihydrate:

White, odourless, granular, hygroscopic powder

Colourless,
transparent crystals or a granular
crystalline powder, odourless or with a faint,
acetic odour. Effloresces in warm, dry air

A. pH of a 1 % aqueous solution

Not less than 8,0 and not more than 9,5

B. Positive tests
sodium

for acetate and for

Purity

Loss on drying

Formic acid, formates and other oxidisa-
ble substances

Anhydrous:

Trihydrate:

Not more than 2 % (120 oC, 4 hours)

Between 36 and 42 % (120 oC, 4 hours)

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

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 diacetate

L 253/24

EN

Official Journal of the European Union

20.9.2008

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

204-814-9

C4H7NaO4·nH2O (n = 0 or 3)

142,09 (anhydrous)

Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate

White, hygroscopic crystalline solid with an acetic odour

A. pH of a 10 % aqueous solution

Not less than 4,5 and not more than 5,0

B. Positive tests
sodium

for acetate and for

Purity

Water content

Not more than 2 % (Karl Fischer method)

Formic acid, formates and other oxidisa-
ble substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 263 CALCIUM ACETATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium acetate

200-540-9

Anhydrous:

C4H6O4Ca

Monohydrate:

C4H6O4Ca· H2O

Anhydrous:

Monohydrate:

158,17

176,18

Content not less than 98 % on the anhydrous basis

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

A. pH of a 10 % aqueous solution

Not less than 6,0 and not more than 9,0

B. Positive tests
calcium

for acetate and for

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 substances

Not more than 1 000 mg/kg expressed as formic acid

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/25

E 270 LACTIC ACID

Definition

Chemical name

Lactic acid

2-Hydroxypropionic acid

1-Hydroxyethane-1-carboxylic acid

Einecs

Chemical formula

Molecular weight

200-018-0

C3H6O3

90,08

Assay

Description

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

Chloride

Sulphate

Iron

Arsenic

Lead

Mercury

Content not less than 76 % and not more than 84 %

Colourless or yellowish, nearly odourless, syrupy liquid with an acid
taste, consisting of a mixture of lactic acid (C3H6O3) and lactic acid
lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is
prepared synthetically

Not more than 0,1 %

Not more than 0,2 %

Not more than 0,25 %

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Note:

specification refers

to a 80 %
This
aqueous solution;
for weaker aqueous
solutions, calculate values corresponding
to their lactic acid content

E 280 PROPIONIC ACID

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Propionic acid

Propanoic acid

201-176-3

C3H6O2

74,08

Content not less than 99,5 %

Colourless or slightly yellowish, oily liquid with a slightly pungent odour

L 253/26

EN

Official Journal of the European Union

20.9.2008

Indentification

A. Melting point

B. Distillation range

Purity

− 22 oC

138,5 oC to 142,5 oC

Non-volatile residue

Not more than 0,01 % when dried at 140 oC to constant weight

Aldehydes

Arsenic

Lead

Mercury

Not more than 0,1 % expressed as formaldehyde

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 281 SODIUM PROPIONATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium propionate

Sodium propanoate

205-290-4

C3H5O2Na

96,06

Content not less than 99 % after drying for two hours at 105 oC

White crystalline hygroscopic powder, or a fine white powder

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

Water insolubles

Iron

Arsenic

Lead

Mercury

Not more than 4 % determined by drying for two hours at 105 oC

Not more than 0,1 %

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 282 CALCIUM PROPIONATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium propionate

223-795-8

C6H10O4Ca

186,22

Content not less than 99 %, after drying for two hours at 105 oC

White crystalline powder

A. Positive tests for propionate and for

calcium

B. pH of a 10 % aqueous solution

Between 6,0 and 9,0

20.9.2008

EN

Official Journal of the European Union

L 253/27

Purity

Loss on drying

Water insolubles

Iron

Fluoride

Arsenic

Lead

Mercury

Not more than 4 %, determined by drying for two hours at 105 oC

Not more than 0,3 %

Not more than 50 mg/kg

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 283 POTASSIUM PROPIONATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for propionate and for

potassium

Purity

Potassium propionate

Potassium propanoate

206-323-5

C3H5KO2

112,17

Content not less than 99 % after drying for two hours at 105 oC

White crystalline powder

Loss on drying

Not more than 4 %, determined by drying for two hours at 105 oC

Water-insoluble substances

Not more than 0,3 %

Iron

Fluoride

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 284 BORIC ACID

Synonyms

Definition

Einecs

Chemical formula

Molecular weight

Assay

Description

Boracic acid

Orthoboric acid

Borofax

233-139-2

H3BO3

61,84

Content not less than 99,5 %

Colourless, odourless, transparent crystals or white granules or powder;
slightly unctuous to the touch; occurs in nature as the mineral sassolite

L 253/28

EN

Official Journal of the European Union

20.9.2008

Identification

A. Melting point

At approximately 171 oC

B. Burns with a nice green flame

C. pH of a 3,3 % aqueous solution

Between 3,8 and 4,8

Purity

Peroxides

Arsenic

Lead

Mercury

No colour develops with added KI-solution

Not more than 1 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 285 SODIUM TETRABORATE (BORAX)

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Description

Identification

Sodium borate

Sodium tetraborate

Sodium biborate

Sodium pyroborate

Anhydrous tetraborate

215-540-4

Na2B4O7

Na2B4O7·10H2O

201,27

Powder or glass-like plates becoming opaque on exposure to air; slowly
soluble in water

A. Melting range

Between 171 oC and 175 oC with decomposition

Purity

Peroxides

Arsenic

Lead

Mercury

No colour develops with added KI-solution

Not more than 1 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 290 CARBON DIOXIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Carbonic acid gas

Dry ice (solid form)

Carbonic anhydride

Carbon dioxide

204-696-9

CO2

44,01

Content not less than 99 % v/v on the gaseous basis

20.9.2008

EN

Official Journal of the European Union

L 253/29

Description

Identification

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

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 sulphide

915 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

Oil content

Not more than 10 μl/l

Not more than 0,1 mg/l

E 296 MALIC ACID

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range between 127 oC and

132 oC

B. Positive test for malate

C. Solutions of this substance are opti-
cally inactive in all concentrations

Purity

Sulphated ash

Fumaric acid

Maleic acid

Arsenic

Lead

Mercury

E 297 FUMARIC ACID

Definition

Chemical name

Einecs

Chemical formula

DL-Malic acid, pomalous acid

DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid

230-022-8

C4H6O5

134,09

Content not less than 99,0 %

White or nearly white crystalline powder or granules

Not more than 0,1 %

Not more than 1,0 %

Not more than 0,05 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid

203-743-0

C4H4O4

L 253/30

EN

Official Journal of the European Union

20.9.2008

Molecular weight

116,07

Assay

Description

Identification

Content not less than 99,0 % on the anhydrous basis

White crystalline powder or granules

A. Melting range

286 oC-302 oC (closed capillary, rapid heating)

B. Positive tests for double bonds and

for 1,2-dicarboxylic acid

C. pH of a 0,05 % solution at 25 oC

3,0-3,2

Purity

Loss on drying

Sulphated ash

Maleic acid

Arsenic

Lead

Mercury

E 300 ASCORBIC ACID

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 0,5 % (120 oC, 4h)

Not more than 0,1 %

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L-ascorbic acid

Ascorbic acid

2,3-Didehydro-L-threo-hexono-1,4-lactone

3-Keto-L-gulofuranolactone

200-066-2

C6H8O6

176,13

Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for
24 hours, contains not less than 99 % of C6H8O6

White to pale yellow, odourless crystalline solid

A. Melting range

Between 189 oC and 193 oC with decomposition

B. Positive tests for ascorbic acid

Purity

Loss on drying

Sulphated ash

Specific rotation

Not more than 0,4 % after drying in a vacuum desiccator over sulphuric
acid for 24 hours

Not more than 0,1 %

[α]D

20 between + 20,5o and + 21,5o (10 % w/v aqueous solution)

pH of a 2 % aqueous solution

Between 2,4 and 2,8

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/31

E 301 SODIUM ASCORBATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium ascorbate

Sodium L-ascorbate

2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate

3-Keto-L-gulofurano-lactone sodium enolate

205-126-1

C6H7O6Na

198,11

Sodium ascorbate, after drying in a vacuum desiccator over sulphuric
acid for 24 hours, contains not less than 99 % of C6H7O6Na

White or almost white, odourless crystalline solid which darkens on
exposure to light

A. Positive tests for ascorbate and for

sodium

Purity

Loss on drying

Specific rotation

Not more than 0,25 % after drying in a vacuum desiccator over
sulphuric acid for 24 hours

[α]D

20 between + 103o and + 106o (10 % w/v aqueous solution)

pH of 10 % aqueous solution

Between 6,5 and 8,0

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 302 CALCIUM ASCORBATE

Definition

Chemical name

Calcium ascorbate dihydrate

Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for ascorbate and for

calcium

Purity

Fluoride

Specific rotation

227-261-5

C12H14O12Ca· 2H2O

426,35

Content not less than 98 % on a volatile matter-free basis

White to slightly pale greyish-yellow odourless crystalline powder

Not more than 10 mg/kg (expressed as fluorine)

[α]D

20 between + 95o and + 97o (5 % w/v aqueous solution)

pH of 10 % aqueous solution

Between 6,0 and 7,5

Volatile matter

Arsenic

Lead

Mercury

Not more than 0,3 % determined by drying at room temperature for
24 hours in a desiccator containing sulphuric acid or phosphorus
pentoxide

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

L 253/32

EN

Official Journal of the European Union

20.9.2008

E 304 (i) ASCORBYL PALMITATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Ascorbyl palmitate

L-ascorbyl palmitate

2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate

6-palmitoyl-3-keto-L-gulofuranolactone

205-305-4

C22H38O7

414,55

Content not less than 98 % on the dried basis

White or yellowish-white solid with a citrus-like odour

A. Melting range

Between 107 oC and 117 oC

Purity

Loss on drying

Sulphated ash

Specific rotation

Arsenic

Lead

Mercury

Not more than 2,0 % after drying in a vacuum oven at 56 oC and 60 oC
for one hour

Not more than 0,1 %

[α]D

20 between + 21o and + 24o (5 % w/v in methanol solution)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 304 (ii) ASCORBYL STEARATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Ascorbyl stearate

L-ascorbyl stearate

2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate

6-stearoyl-3-keto-L-gulofuranolactone

246-944-9

C24H42O7

442,6

Content not less than 98 %

White or yellowish, white solid with a citrus-like odour

A. Melting point

About 116 oC

Purity

Loss on drying

Sulphated ash

Arsenic

Lead

Mercury

Not more than 2,0 % after drying in a vacuum oven at 56 oC to 60 oC
for one hour

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/33

E 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

Description

Identification

Content not less than 34 % of total tocopherols

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

A. By suitable gas
graphic method

liquid chromato-

B. Solubility tests

Insoluble in water. Soluble in ethanol. Miscible in ether

Purity

Sulphated ash

Specific rotation

Arsenic

Lead

Mercury

Not more than 0,1 %

[α]D

20 not less than + 20o

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 307 ALPHA-TOCOPHEROL

Synonyms

Definition

DL-α-Tocopherol

Chemical name

DL-5,7,8-Trimethyltocol

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

233-466-0

C29H50O2

430,71

Content not less than 96 %

Slightly yellow to amber, nearly odourless, clear, viscous oil which
oxidises and darkens on exposure to air or light

A. Solubility tests

Insoluble in water, freely soluble in ethanol, miscible in ether

B. Spectro-photometry

In absolute ethanol the maximum absorption is about 292 nm

Purity

Refractive index

n D

20 1,503-1,507

Specific absorption E 1%

1cm in ethanol

E 1%

1cm(292 nm) 72-76

Sulphated ash

Specific rotation

Lead

(0,01 g in 200 ml of absolute ethanol)

Not more than 0,1 %

[α]D

25 0o ± 0,05o (1 in 10 solution in chloroform)

Not more than 2 mg/kg

L 253/34

EN

Official Journal of the European Union

20.9.2008

E 308 GAMMA-TOCOPHEROL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Spectrometry

Purity

dl-γ-Tocopherol

2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

231-523-4

C28H48O2

416,69

Content not less than 97 %

Clear, viscous, pale yellow oil which oxidises and darkens on exposure to
air or light

Maximum absorptions in absolute ethanol at about 298 nm and
257 nm

Specific absorption E 1%

1cm in ethanol

E 1%

1cm(298 nm) between 91 and 97

E 1%

1cm(257 nm) between 5,0 and 8,0

Refractive index

Sulphated ash

Arsenic

Lead

Mercury

½n(cid:138)20

D 1,503-1,507

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 309 DELTA-TOCOPHEROL

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Spectrometry

Purity

2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol

204-299-0

C27H46O2

402,7

Content not less than 97 %

Clear, viscous, pale yellowish or orange oil which oxidises and darkens
on exposure to air or light

Maximum absorptions in absolute ethanol at about 298 nm and
257 nm

Specific absorption E 1%

1cm in ethanol

E 1%

1cm(298 nm) between 89 and 95

E 1%

1cm(257 nm) between 3,0 and 6,0

Refractive index

Sulphated ash

Arsenic

Lead

Mercury

n D

20 1,500-1,504

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/35

E 310 PROPYL GALLATE

Definition

Chemical name

Propyl gallate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Propyl ester of gallic acid

n-propyl ester of 3,4,5-trihydroxybenzoic acid

204-498-2

C10H12O5

212,20

Content not less than 98 % on the anhydrous basis

White to creamy-white, crystalline, odourless solid

A. Solubility tests

Slightly soluble in water, freely soluble in ethanol, ether and propane-
1,2-diol

B. Melting range

Between 146 oC and 150 oC after drying at 110 oC for four hours

Purity

Loss on drying

Sulphated ash

Free acid

Not more than 1,0 % (110 oC, four hours)

Not more than 0,1 %

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as C1)

Specific absorption E 1%

1cm in ethanol

E 1%

1cm(275 nm) not less than 485 and not more than 520

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 311 OCTYL GALLATE

Definition

Chemical name

Octyl gallate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility tests

B. Melting range

Purity

Loss on drying

Sulphated ash

Free acid

Octyl ester of gallic acid

n-octyl ester of 3,4,5-trihydroxybenzoic acid

213-853-0

C15H22O5

282,34

Content not less than 98 % after drying at 90 oC for six hours

White to creamy-white odourless solid

Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol

Between 99 oC and 102 oC after drying at 90 oC for six hours

Not more than 0,5 % (90 oC, six hours)

Not more than 0,05 %

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as C1)

Specific absorption E 1%

1cm in ethanol

E 1%

1cm(275 nm) not less than 375 and not more than 390

L 253/36

EN

Official Journal of the European Union

20.9.2008

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 312 DODECYL GALLATE

Synonyms

Definition

Lauryl gallate

Chemical name

Dodecyl gallate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility tests

B. Melting range

Purity

Loss on drying

Sulphated ash

Free acid

n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid

Dodecyl ester of gallic acid

214-620-6

C19H30O5

338,45

Content not less than 98 % after drying at 90 oC for six hours

White or creamy-white odourless solid

Insoluble in water, freely soluble in ethanol and ether

Between 95 oC and 98 oC after drying at 90 oC for six hours

Not more than 0,5 % (90 oC, six hours)

Not more than 0,05 %

Not more than 0,5 % (as gallic acid)

Chlorinated organic compound

Not more than 100 mg/kg (as Cl)

Specific absorption E 1%

1cm in ethanol

E 1%

1cm(275 nm) not less than 300 and not more than 325

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

Not more than 30 mg/kg

E 315 ERYTHORBIC ACID

Synonyms

Definition

Isoascorbic acid

D-Araboascorbic acid

Chemical name

D-Erythro-hex-2-enoic acid γ-lactone

Einecs

Chemical formula

Molecular weight

Assay

Description

Isoascorbic acid

D-Isoascorbic acid

201-928-0

C6H8O6

176,13

Content not less than 98 % on the anhydrous basis

White to slightly yellow crystalline solid which darkens gradually on
exposure to light

20.9.2008

EN

Official Journal of the European Union

L 253/37

Identification

A. Melting range

About 164 oC to 172 oC with decomposition

B. Positive test for ascorbic acid/colour

reaction

Purity

Loss on drying

Sulphated ash

Specific rotation

Oxalate

Not more than 0,4 % after drying under reduced pressure on silica gel
for 3 hours

Not more than 0,3 %

[α]10 % (w/v) aqueous solution between − 16,5o to − 18,0o

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

Definition

Sodium isoascorbate

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

228-973-9

C6H7O6Na· H2O

216,13

Content not less than 98 % after drying in a vacuum desiccator over
sulphuric acid for 24 hours expressed on the monohydrate basis

White crystalline solid

Einecs

Chemical formula

Molecular weight

Assay

Description

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 + 95o and + 98o

pH of a 10 % aqueous solution

5,5 to 8,0

Oxalate

Arsenic

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

L 253/38

EN

Official Journal of the European Union

20.9.2008

E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)

Synonyms

Definition

TBHQ

Chemical names

Tert-butyl-1,4-benzenediol

2-(1,1-Dimethylethyl)-1,4-benzenediol

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Melting point

C. Phenolics

Purity

217-752-2

C10H14O2

166,22

Content not less than 99 % of C10H14O2

White crystalline solid having a characteristic odour

Practically insoluble in water; soluble in ethanol

Not less than 126,5 oC

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

Tertiary-Butyl-p-benzoquinone

Not more than 0,2 %

2,5-Di-tertiary-butyl hydroquinone

Not more than 0,2 %

Hydroxyquinone

Toluene

Lead

Not more than 0,1 %

Not more than 25 mg/kg

Not more than 2 mg/kg

E 320 BUTYLATED HYDROXYANISOLE (BHA)

Synonyms

Definition

BHA

Chemical names

3-Tertiary-butyl-4-hydroxyanisole

A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-
hydroxyanisole

Einecs

Chemical formula

Formula weight

Assay

Description

Identification

A. Solubility

B. Melting range

C. Colour reaction

Purity

Sulphated ash

Phenolic impurities

Specific absorptionE 1%
1cm
Specific absorptionE 1%
1cm

Arsenic

Lead

Mercury

246-563-8

C11H16O2

180,25

Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-
tertiary-butyl-4-hydroxyanisole isomer

White or slightly yellow crystals or waxy solid with a slight aromatic
smell

Insoluble in water, freely soluble in ethanol

Between 48 °C and 63 °C

Passes test for phenol groups

Not more than 0,05 % after calcination at 800 ± 25 °C

Not more than 0,5 %

E 1%

1cm (290 nm) not less than 190 and not more than 210

E 1%

1cm (228 nm) not less than 326 and not more than 345

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/39

E 321 BUTYLATED HYDROXYTOLUENE (BHT)

Synonyms

Definition

BHT

Chemical name

2,6-Ditertiary-butyl-p-cresol

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

4-Methyl-2,6-ditertiarybutylphenol

204-881-4

C15H24O

220,36

Content not less than 99 %

White, crystalline or flaked solid, odourless or having a characteristic
faint aromatic odour

A. Solubility tests

Insoluble in water and propane- 1,2-diol

B. Melting point

At 70 oC

Freely soluble in ethanol

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

Phenolic impurities

Not more than 0,005 %

Not more than 0,5 %

Specific absorption E1%

1cm in ethanol

E 1%

1cm (278 nm) not less than 81 and not more than 88

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 322 LECITHINS

Synonyms

Definition

Einecs

Assay

Phosphatides

Phospholipids

Lecithins are mixtures or fractions of phosphatides obtained by physical
they also include
procedures from animal or vegetable foodstuffs;
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 must
not chemically modify the lecithin phosphatides

232-307-2

— 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-35 oC). Then slowly add
50 ml of the sample with constant stirring. Hydrolysed lecithin will form
a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct
mass of about 50 g

L 253/40

EN

Official Journal of the European Union

20.9.2008

Purity

Loss on drying

Not more than 2,0 % determined by drying at 105 oC for one hour

Toluene-insoluble matter

Not more than 0,3 %

Acid value

— Lecithins: not more than 35 mg of potassium hydroxide per gram

— Hydrolysed lecithins: not more than 45 mg of potassium hydroxide

Peroxide value

Arsenic

Lead

Mercury

per gram

Equal to or less than 10

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 325 SODIUM LACTATE

Definition

Chemical name

Sodium lactate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for lactate

B. Positive test for sodium

Purity

Acidity

Sodium 2-hydroxypropanoate

200-772-0

C3H5NaO3

112,06 (anhydrous)

Content not less than 57 % and not more than 66 %

Colourless, transparent, liquid. Odourless, or with a slight, characteristic
odour

Not more than 0,5 % after drying expressed as lactic acid

pH of a 20 % aqueous solution

6,5 to 7,5

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Reducing substances

Note:

specification refers

This
aqueous solution

to a 60 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

No reduction of Fehling's solution

E 326 POTASSIUM LACTATE

Definition

Cheminal name

Potassium lactate

Einecs

Chemical formula

Molecular weight

Assay

Potassium 2-hydroxypropanoate

213-631-3

C3H5O3K

128,17 (anhydrous)

Content not less than 57 % and not more than 66 %

20.9.2008

EN

Official Journal of the European Union

L 253/41

Description

Identification

A.

Ignition

B. Colour reaction

Slightly viscous, almost odourless clear liquid. Odourless, or with a
slight, characteristic odour

Ignite potassium lactate solution to an ash. The ash is alkaline, and an
effervescence occurs when acid is added

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Acidity

Reducing substances

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

Potassium lactate solution shall not cause any reduction of Fehling's
solution

Note:

specification refers

This
aqueous solution

to a 60 %

E 327 CALCIUM LACTATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests
calcium

B. Solubility tests

Purity

Calcium dilactate

Calcium dilactate hydrate

2-Hydroxypropanoic acid calcium salt

212-406-7

(C3H5O2)2 Ca· nH2O (n = 0-5)

218,22 (anhydrous)

Content not less than 98 % on the anhydrous basis

Almost odourless, white crystalline powder or granules

for

lactate and for

Soluble in water and practically insoluble in ethanol

Loss on drying

Determined by drying at 120 oC for four hours:

— anhydrous: not more than 3,0 %

— with 1 molecule of water: not more than 8,0 %

— with 3 molecules of water: not more than 20,0 %

— with 4,5 molecules of water: not more than 27,0 %

Not more than 0,5 % of the dry matter expressed as lactic acid

Not more than 30 mg/kg (expressed as fluorine)

Between 6,0 and 8,0

Not more than 3 mg/kg

Not more than 5 mg/kg

Acidity

Fluoride

pH of a 5 % solution

Arsenic

Lead

L 253/42

EN

Official Journal of the European Union

20.9.2008

Mercury

Heavy metals (as Pb)

Reducing substances

Not more than 1 mg/kg

Not more than 10 mg/kg

No reduction of Fehling's solution

E 330 CITRIC ACID

Definition

Chemical name

Citric acid

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

2-Hydroxy-1,2,3-propanetricarboxylic acid

β-Hydroxytricarballytic acid

201-069-1

(a) C6H8O7 (anhydrous)

(b) C6H8O7·H2O (monohydrate)

(a) 192,13 (anhydrous)

(b) 210,15 (monohydrate)

Citric acid may be anhydrous or it may contain 1 molecule of water.
Citric acid contains not less than 99,5 % of C6H8O7, calculated on the
anhydrous basis

Citric acid is a white or colourless, odourless, crystalline solid, having a
strongly acid taste. The monohydrate effloresces in dry air

A. Solubility tests

Very soluble in water; freely soluble in ethanol; soluble in ether

Purity

Water content

Sulphated ash

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Oxalates

Readily carbonisable substances

Anhydrous citric acid contains not more than 0,5 % water; citric acid
monohydrate contains not more than 8,8 % water (Karl Fischer method)

Not more than 0,05 % after calcination at 800 ± 25 oC

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

Not more than 100 mg/kg, expressed as oxalic acid, after drying

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

Definition

Chemical name

Monosodium citrate

Monobasic sodium citrate

Chemical formula

(a) C6H7O7Na (anhydrous)

Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Molecular weight

Assay

Description

(b) C6H7O7Na· H2O (monohydrate)

(a) 214,11 (anhydrous)

(b) 232,23 (monohydrate)

Content not less than 99 % on the anhydrous basis

Crystalline white powder or colourless crystals

20.9.2008

EN

Official Journal of the European Union

L 253/43

Identification

A. Positive tests
sodium

for citrate and for

Purity

Loss on drying

Determined by drying at 180 oC for four hours:

— anhydrous: not more than 1,0 %

— monohydrate: not more than 8,8 %

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 3,5 and 3,8

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

E 331 (ii) DISODIUM CITRATE

Synonyms

Definition

Disodium citrate

Dibasic sodium citrate

Chemical name

Disodium citrate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests
sodium

for citrate and for

Purity

Loss on drying

Oxalates

Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Disodium salt of citric acid with 1,5 molecules of water

205-623-3

C6H6O7Na2·1,5H2O

263,11

Content not less than 99 % on the anhydrous basis

Crystalline white powder or colourless crystals

Not more than 13,0 % by drying at 180 oC for four hours

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 4,9 and 5,2

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

E 331 (iii) TRISODIUM CITRATE

Synonyms

Definition

Trisodium citrate

Tribasic sodium citrate

Chemical name

Trisodium citrate

Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate
form

L 253/44

EN

Official Journal of the European Union

20.9.2008

Einecs

Chemical formula

200-675-3

Anhydrous:

Hydrated:

C6H5O7Na3

C6H5O7Na3·nH2O (n = 2 or 5)

Molecular weight

258,07 (anhydrous)

Assay

Description

Identification

A. Positive tests
sodium

for citrate and for

Purity

Not less than 99 % on the anhydrous basis

Crystalline white powder or colourless crystals

Loss on drying

Determined by drying at 180 oC for four hours:

— anhydrous:

not more than 1,0 %

— dihydrate:

not more than 13,5 %

— pentahydrate:

not more than 30,3 %

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 5 % aqueous solution

Between 7,5 and 9,0

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

E 332 (i) MONOPOTASSIUM CITRATE

Synonyms

Monopotassium citrate

Definition

Chemical name

Monopotassium citrate

Monobasic potassium citrate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests
potassium

for citrate and for

Purity

Loss on drying

Oxalates

Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Anhydrous monopotassium salt of citric acid

212-753-4

C6H7O7K

230,21

Content not less than 99 % on the anhydrous basis

White, hygroscopic, granular powder or transparent crystals

Not more than 1,0 % determined by drying at 180 oC for four hours

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 3,5 and 3,8

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/45

E 332 (ii) TRIPOTASSIUM CITRATE

Synonyms

Definition

Tripotassium citrate

Tribasic potassium citrate

Chemical name

Tripotassium citrate

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests
potassium

for citrate and for

Purity

Loss on drying

Oxalates

Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Monohydrated tripotassium salt of citric acid

212-755-5

C6H5O7K3·H2O

324,42

Content not less than 99 % on the anhydrous basis

White, hygroscopic, granular powder or transparent crystals

Not more than 6,0 % determined by drying at 180 oC for four hours

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

Lead

Mercury

Heavy metals (as Pb)

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

E 333 (i) MONOCALCIUM CITRATE

Synonyms

Definition

Monocalcium citrate

Monobasic calcium citrate

Chemical name

Monocalcium citrate

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests
calcium

for citrate and for

Purity

Loss on drying

Oxalates

Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Monohydrate monocalcium salt of citric acid

(C6H7O7)2Ca· H2O

440,32

Content not less than 97,5 % on the anhydrous basis

Fine white powder

Not more than 7,0 % determined by drying at 180 oC for four hours

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of a 1 % aqueous solution

Between 3,2 and 3,5

Fluoride

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Carbonates

Not more than 30 mg/kg (expressed as fluorine)

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must
not liberate more than a few isolated bubbles

L 253/46

EN

Official Journal of the European Union

20.9.2008

E 333 (ii) DICALCIUM CITRATE

Synonyms

Definition

Dicalcium citrate

Dibasic calcium citrate

Chemical name

Dicalcium citrate

Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Trihydrated dicalcium salt of citric acid

Chemical formula

Molecular weight

(C6H7O7)2Ca2·3H2O

530,42

Assay

Description

Identification

A. Positive tests
calcium

for citrate and for

Purity

Not less than 97,5 % on the anhydrous basis

Fine white powder

Loss on drying

Not more than 20,0 % determined by drying at 180 oC for four hours

Oxalates

Fluoride

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Carbonates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Not more than 30 mg/kg (expressed as fluorine)

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

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

Definition

Tricalcium citrate

Tribasic calcium citrate

Chemical name

Tricalcium citrate

Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid

Tetrahydrated tricalcium salt of citric acid

212-391-7

(C6H6O7)2Ca3·4H2O

570,51

Not less than 97,5 % on the anhydrous basis

Fine white powder

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests
calcium

for citrate and for

Purity

Loss on drying

Not more than 14,0 % determined by drying at 180 oC for four hours

Oxalates

Fluoride

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Carbonates

Not more than 100 mg/kg expressed as oxalic acid, after drying

Not more than 30 mg/kg (expressed as fluorine)

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must
not liberate more than a few isolated bubbles

20.9.2008

EN

Official Journal of the European Union

L 253/47

E 334 L(+)-TARTARIC ACID

Definition

Chemical name

L-tartaric acid

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

L-2,3-dihydroxybutanedioic acid

d-α, β-dihydroxysuccinic acid

201-766-0

C4H6O6

150,09

Content not less than 99,5 % on the anhydrous basis

Colourless or translucent crystalline solid or white crystalline powder

A. Melting range

Between 168 oC and 170 oC

B. Positive test for tartrate

Purity

Loss on drying

Sulphated ash

Not more than 0,5 % (over P2O5, three hours)

Not more than 1 000 mg/kg after calcination at 800 ± 25 oC

Specific optical rotation of a 20 % w/v
aqueous solution

[α] 20

D between + 11,5o and + 13,5o

Lead

Mercury

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Oxalates

Not more than 100 mg/kg expressed as oxalic acid, after drying

E 335 (i) MONOSODIUM TARTRATE

Synonyms

Definition

Monosodium salt of L-(+)-tartaric acid

Chemical name

Monosodium salt of L-2,3-dihydroxybutanedioic acid

Monohydrated monosodium salt of L-(+)-tartaric acid

Chemical formula

Molecular weight

C4H5O6Na· H2O

194,05

Content not less than 99 % on the anhydrous basis

Transparent colourless crystals

Assay

Description

Identification

A. Positive tests for

sodium

tartrate and for

Purity

Loss on drying

Not more than 10,0 % determined by drying at 105 oC for four hours

Oxalates

Arsenic

Lead

Mercury

Not more than 100 mg/kg expressed as oxalic acid, after drying

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

L 253/48

EN

Official Journal of the European Union

20.9.2008

E 335 (ii) DISODIUM TARTRATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Disodium L-tartrate

Disodium (+)-tartrate

Disodium (+)-2,3-dihydroxybutanedioic acid

Dihydrated disodium salt of L-(+)-tartaric acid

212-773-3

C4H4O6Na2·2H2O

230,8

Content not less than 99 % on the anhydrous basis

Transparent, colourless crystals

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

Oxalates

Not more than 17,0 % determined by drying at 150 oC for four hours

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 336 (i) MONOPOTASSIUM TARTRATE

Synonyms

Definition

Monobasic potassium tartrate

Chemical name

Anhydrous monopotassium salt of L-(+)-tartaric acid

Monopotassium salt of L-2,3-dihydroxybutanedioic acid

Chemical formula

Molecular weight

C4H5O6K

188,16

Assay

Description

Identification

Content not less than 98 % on the anhydrous basis

White crystalline or granulated powder

A. Positive tests for

tartrate and for

potassium

B. Melting point

Purity

230 oC

pH of a 1 % aqueous solution

3,4

Loss on drying

Not more than 1,0 % determined by drying at 105 oC for four hours

Oxalates

Arsenic

Lead

Mercury

Not more than 100 mg/kg expressed as oxalic acid, after drying

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/49

E 336 (ii) DIPOTASSIUM TARTRATE

Synonyms

Definition

Dibasic potassium tartrate

Chemical name

Dipotassium salt of L-2,3-dihydroxybutanedioic acid

Dipotassium salt with half a molecule of water of L-(+)-tartaric acid

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for

tartrate and for

potassium

Purity

213-067-8

C4H4O6K2·1/2H2O

235,2

Content not less than 99 % on the anhydrous basis

White crystalline or granulated powder

pH of a 1 % aqueous solution

Between 7,0 and 9,0

Loss on drying

Not more than 4,0 % determined by drying at 150 oC for four hours

Oxalates

Arsenic

Lead

Mercury

Not more than 100 mg/kg expressed as oxalic acid, after drying

Not more than 3 mg/kg

Not more than 5 mg/kg

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

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium sodium L-(+)-tartrate

206-156-8

C4H4O6KNa· 4H2O

282,23

Content not less than 99 % on the anhydrous basis

Colourless crystals or white crystalline powder

A. Positive tests for tartrate, for potas-

sium and for sodium

B. Solubility tests

C. Melting range

Purity

Loss on drying

Oxalates

1 gram is soluble in 1 ml of water, insoluble in ethanol

Between 70 and 80 oC

Not more than 26,0 % and not less than 21,0 % determined by drying at
150 oC for three hours

Not more than 100 mg/kg expressed as oxalic acid, after drying

pH of 1 % aqueous solution

Between 6,5 and 8,5

Arsenic

Lead

Not more than 3 mg/kg

Not more than 5 mg/kg

L 253/50

EN

Official Journal of the European Union

20.9.2008

Mercury

Heavy metals (as Pb)

Not more than 1 mg/kg

Not more than 10 mg/kg

E 338 PHOSPHORIC ACID

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for acid and for phos-

phate

Purity

Volatile acids

Chlorides

Nitrates

Sulphates

Fluoride

Arsenic

Cadmium

Lead

Mercury

Note:

specification refers

This
aqueous solution

to a 75 %

E 339 (i) MONOSODIUM PHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Orthophosphoric acid

Monophosphoric acid

Phosphoric acid

231-633-2

H3PO4

98,00

Phosphoric acid is commercially available as an aqueous solution at
variable concentrations. Content not less than 67,0 % and not more
than 85,7 %.

Clear, colourless, viscous liquid

Not more than 10 mg/kg (as acetic acid)

Not more than 200 mg/kg (expressed as chlorine)

Not more than 5 mg/kg (as NaNO3)

Not more than 1 500 mg/kg (as CaSO4)

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Monosodium monophosphate

Acid monosodium monophosphate

Monosodium orthophosphate

Monobasic sodium phosphate

Sodium dihydrogen monophosphate

Sodium dihydrogen monophosphate

231-449-2

Anhydrous: NaH2PO4

Monohydrate: NaH2PO4 · H2O

Dihydrate: NaH2PO4 · 2H2O

20.9.2008

EN

Official Journal of the European Union

L 253/51

Molecular weight

Assay

P2O5 content

Description

Identification

Anhydrous: 119,98

Monohydrate: 138,00

Dihydrate: 156,01

After drying at 60 oC for one hour and then at 105 oC for four hours,
contains not less than 97 % of NaH2PO4

Between 58,0 % and 60,0 % on the anhydrous basis

A white odourless, slightly deliquescent powder, crystals or granules

A. Positive tests for sodium and for

phosphate

B. Solubility

Freely soluble in water. Insoluble in ethanol or ether

C. pH of a 1 % solution

Between 4,1 and 5,0

Purity

Loss on drying

The anhydrous salt loses not more than 2,0 %, the monohydrate not
more than 15,0 %, and the dihydrate not more than 25 % when dried
first at 60 oC for one hour, then at 105 oC for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 339 (ii) DISODIUM PHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Disodium monophosphate

Secondary sodium phosphate

Disodium orthophosphate

Acid disodium phosphate

Disodium hydrogen monophosphate

Disodium hydrogen orthophosphate

231-448-7

Anhydrous: Na2HPO4

Hydrat: Na2HPO4 · nH2O (n = 2,7 or 12)

141,98 (anhydrous)

After drying at 40 oC for three hours and subsequently at 105 oC for
five hours, contains not less than 98 % of Na2HPO4

Between 49 % and 51 % on the anhydrous basis

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 ethanol

C. pH of a 1 % solution

Between 8,4 and 9,6

L 253/52

EN

Official Journal of the European Union

20.9.2008

Purity

Loss on drying

When dried at 40 oC for three hours and then at 105 oC for five hours,
the losses in weight are as follows: anhydrous not more than 5,0 %,
dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %,
dodecahydrate not more than 61,0 %

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 339 (iii) TRISODIUM PHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Sodium phosphate

Tribasic sodium phosphate

Trisodium orthophosphate

Trisodium phosphate is obtained from aqueous solutions and crystallises
in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The
dodecahydrate always crystallises from aqueous solutions with an excess
of sodium hydroxide. It contains 1/4 molecule of NaOH

Trisodium monophosphate

Trisodium phosphate

Trisodium orthophosphate

231-509-8

Anhydrous: Na3PO4

Hydrated: Na3PO4 · nH2O (n = 1/2, 1, 6, 8, or 12)

163,94 (anhydrous)

Sodium phosphate anhydrous and the hydrated forms, with the
exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4
calculated on the dried basis. Sodium phosphate dodecahydrate contains
not less than 92,0 % of Na3PO4 calculated on the ignited basis

Between 40,5 % and 43,5 % on the anhydrous basis

White odourless crystals, granules or crystalline powder

A. Positive tests for sodium and for

phosphate

B. Solubility

Freely soluble in water. Insoluble in ethanol

C. pH of a 1 % solution

Between 11,5 and 12,5

Purity

Loss on ignition

When dried at 120 oC for two hours and then ignited at about 800 oC
for 30 minutes, the losses in weight are as follows: anhydrous not more
than 2,0 %, 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

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/53

E 340 (i) MONOPOTASSIUM PHOSPHATE

Synonyms

Definition

Monobasic potassium phosphate

Monopotassium monophosphate

Potassium orthophosphate

Chemical name

Potassium dihydrogen phosphate

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Monopotassium dihydrogen orthophosphate

Monopotassium dihydrogen monophosphate

231-913-4

KH2PO4

136,09

Content not less than 98,0 % after drying at 105 oC for four hours

Between 51,0 % and 53,0 % on the anhydrous basis

Odourless, colourless crystals or white granular or crystalline powder,
hygroscopic

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 105 oC for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 340 (ii) DIPOTASSIUM PHOSPHATE

Synonyms

Definition

Dipotassium monophosphate

Secondary potassium phosphate

Dipotassium acid phosphate

Dipotassium orthophosphate

Dibasic potassium phosphate

Chemical name

Dipotassium hydrogen monophosphate

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Dipotassium hydrogen phosphate

Dipotassium hydrogen orthophosphate

231-834-5

K2HPO4

174,18

Content not less than 98 % after drying at 105 oC for four hours

Between 40,3 % and 41,5 % on the anhydrous basis

Colourless or white granular powder, crystals or masses; deliquescent
substance

L 253/54

EN

Official Journal of the European Union

20.9.2008

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 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

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 340 (iii) TRIPOTASSIUM PHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Potassium phosphate

Tribasic potassium phosphate

Tripotassium orthophosphate

Tripotassium monophosphate

Tripotassium phosphate

Tripotassium orthophosphate

231-907-1

Anhydrous: K3PO4

Hydrated: K3PO4 · nH2O (n = 1 or 3)

212,27 (anhydrous)

Content not less than 97 % calculated on the ignited basis

Between 30,5 % and 33,0 % on the ignited basis

Colourless or white, odourless hygroscopic crystals or granules.
Hydrated forms available include the monohydrate and trihydrate

A. Positive tests for potassium and for

phosphate

B. Solubility

Freely soluble in water. Insoluble in ethanol

C. pH of a 1 % solution

Between 11,5 and 12,3

Purity

Loss on ignition

Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %.
Determined by drying at 105 oC for one hour and then ignite at about
800 oC ± 25 oC for 30 minutes

Water insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/55

E 341 (i) MONOCALCIUM PHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Monobasic calcium phosphate

Monocalcium orthophosphate

Calcium dihydrogen phosphate

231-837-1

Anhydrous: Ca(H2PO4)2

Monohydrate: Ca(H2PO4)2 · H2O

234,05 (anhydrous)

252,08 (monohydrate)

Content not less than 95 % on the dried basis

Between 55,5 % and 61,1 % on the anhydrous basis

Granular powder or white, deliquescent crystals or granules

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

Loss on ignition

Fluoride

Arsenic

Cadmium

Lead

Mercury

E 341 (ii) DICALCIUM PHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Not more than 14 % determined by drying at 105 oC for four hours
(anhydrous)

Not more than 17,5 % determined by drying at 60 oC for one hour, then
at 105 oC for four hours (monohydrate)

Not more than 17,5 % after ignition at 800 oC ± 25 oC for 30 minutes
(anhydrous)

Not more than 25,0 % determined by drying at 105 oC for one hour,
then ignite at 800 oC ± 25 oC for 30 minutes (monohydrate)

Not more than 30 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Dibasic calcium phosphate

Dicalcium orthophosphate

Calcium monohydrogen phosphate

Calcium hydrogen orthophosphate

Secondary calcium phosphate

231-826-1

Anhydrous: CaHPO4

Dihydrate: CaHPO4 · 2H2O

136,06 (anhydrous)

172,09 (dihydrate)

Dicalcium phosphate, after drying at 200 oC for three hours, contains
not less than 98 % and not more than the equivalent of 102 % of
CaHPO4

P2O5 content

Description

Between 50,0 % and 52,5 % on the anhydrous basis

White crystals or granules, granular powder or powder

L 253/56

EN

Official Journal of the European Union

20.9.2008

Identification

A. Positive tests for calcium and for

phosphate

B. Solubility tests

Purity

Loss on ignition

Fluoride

Arsenic

Cadmium

Lead

Mercury

Sparingly soluble in water. Insoluble in ethanol

Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at
800 oC ± 25 oC for 30 minutes

Not more than 50 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 341 (iii) TRICALCIUM PHOSPHATE

Synonyms

Definition

Calcium phosphate, tribasic

Calcium orthophosphate

Pentacalcium hydroxy monophosphate

Calcium hydroxyapatite

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
· 3P2O5 · H2O

Chemical name

Pentacalcium hydroxy monophosphate

Tricalcium monophosphate

Einecs

235-330-6 (Pentacalcium hydroxy monophosphate)

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

A. Positive tests for calcium and for

phosphate

B. Solubility

Purity

231-840-8 (Calcium orthophosphate)

Ca5(PO4)3· OH or Ca3(PO4)2

502 or 310

Content not less than 90 % calculated on the ignited basis

Between 38,5 % and 48,0 % on the anhydrous basis

A white, odourless powder which is stable in air

Practically insoluble in water;
hydrochloric and nitric acid

insoluble in ethanol soluble in dilute

Loss on ignition

Not more than 8 % after ignition at 800 oC ± 25 oC, to constant weight

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 50 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/57

E 343(i) MONOMAGNESIUM PHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Magnesiumdihydrogenphosphate

Magnesiumphosphate, monobasic

Monomagnesium orthophosphate

Monomagnesiumdihydrogenmonophosphate

236-004-6

Mg(H2PO4)2 · nH2O (where n = 0 to 4)

218,30 (anhydrous)

Not less than 51,0 % after ignition

White, odourless, crystalline powder, slightly soluble in water

A. Positive test for magnesium and for

phosphate

B. MgO content

Purity

Fluoride

Arsenic

Lead

Cadmium

Mercury

Not less than 21,5 % after ignition

Not more than 10 mg/kg (as fluorine)

Not more than 3 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 343(ii) DIMAGNESIUM PHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Magnesiumhydrogenphosphate

Magnesiumphosphate, dibasic

Dimagnesium orthophosphate

Secondary magnesiumphosphate

Dimagnesiummonohydrogenmonophosphate

231-823-5

MgHPO4 · nH2O (where n = 0-3)

120,30 (anhydrous)

Not less than 96 % after ignition

White, odourless, crystalline powder, slightly soluble in water

A. Positive test for magnesium and for

phosphate

B. MgO content:

Not less than 33,0 % calculated on an anhydrous basis

Purity

Fluoride

Arsenic

Lead

Cadmium

Mercury

Not more than 10 mg/kg (as fluorine)

Not more than 3 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

L 253/58

EN

Official Journal of the European Union

20.9.2008

E 350 (i) SODIUM MALATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium salt of malic acid

Disodium DL-malate, disodium salt of hydroxybutanedioic acid

Hemihydrate: C4H4Na2O5 · 1/2 H2O

Trihydrate: C4H4Na2O5 · 3H2O

Hemihydrate: 187,05

Trihydrate: 232,10

Content not less than 98,0 % on the anhydrous basis

White crystalline powder or lumps

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

Alkalinity

Fumaric acid

Maleic acid

Arsenic

Lead

Mercury

Not more than 7,0 % (130 oC, 4h) for the hemihydrate, or 20,5 %-
23,5 % (130 oC, 4h) for the trihydrate

Not more than 0,2 % as Na2CO3

Not more than 1,0 %

Not more than 0,05 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 350 (ii) SODIUM HYDROGEN MALATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Monosodium salt of DL-malic acid

Monosodium DL-malate, monosodium 2-DL-hydroxy succinate

C4H5NaO5

156,07

Content not less than 99,0 % on the anhydrous basis

White powder

A. Positive

tests

for 1,2-dicarboxylic

acid and for sodium

B. Azo dye formation

Positive

Purity

Loss on drying

Maleic acid

Fumaric acid

Arsenic

Lead

Mercury

Not more than 2,0 % (110 oC, 3h)

Not more than 0,05 %

Not more than 1,0 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/59

E 351 POTASSIUM MALATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium salt of malic acid

Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid

C4H4K2O5

210,27

Content not less than 59,5 %

Colourless or almost colourless aqueous solution

A. Positive

tests
acid and for potassium

for 1,2-dicarboxylic

B. Azo dye formation

Positive

Purity

Alkalinity

Fumaric acid

Maleic acid

Arsenic

Lead

Mercury

E 352 (i) CALCIUM MALATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 0,2 % as K2CO3

Not more than 1,0 %

Not more than 0,05 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Calcium salt of malic acid

Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydro-
xybutanedioic acid

C4H5CaO5

172,14

Content not less than 97,5 % on the anhydrous basis

White powder

A. Positive tests for malate, 1,2-dicar-

boxylic acid and for calcium

B. Azo dye formation

Positive

C. Solubility

Slightly soluble in water

Purity

Loss on drying

Alkalinity

Maleic acid

Fumaric acid

Fluoride

Arsenic

Lead

Mercury

Not more than 2 % (100 oC, 3h)

Not more than 0,2 % as CaCO3

Not more than 0,05 %

Not more than 1,0 %

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L 253/60

EN

Official Journal of the European Union

20.9.2008

E 352 (ii) CALCIUM HYDROGEN MALATE

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

Monocalcium salt of DL-malic acid

Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate

(C4H5O5)2Ca

Content not less than 97,5 % on the anhydrous basis

White powder

A. Positive

tests

for 1,2-dicarboxylic

acid and for calcium

B. Azo dye formation

Positive

Purity

Loss on drying

Maleic acid

Fumaric acid

Fluoride

Arsenic

Lead

Mercury

E 353 METATARTARIC ACID

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

A.

B.

Purity

Arsenic

Lead

Mercury

E 354 CALCIUM TARTRATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Not more than 2,0 % (110 oC, 3h)

Not more than 0,05 %

Not more than 1,0 %

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Ditartaric acid

Metatartaric acid

C4H6O6

Not less than 99,5 %

Crystalline or powder form with a white or yellowish colour. Very
deliquescent with a faint odour of caramel

Very soluble in water and ethanol

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L-Calcium tartrate

Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate

C4H4CaO6 · 2H2O

224,18

Not less than 98,0 %

20.9.2008

EN

Official Journal of the European Union

L 253/61

Fine crystalline powder with a white or off-white colour

Description

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]20

D

+ 7,0o to + 7,4o (0,1 % in a 1N de HCl solution)

C. pH of a 5 % slurry

Between 6,0 and 9,0

Purity

Sulphates (as H2SO4)

Arsenic

Lead

Mercury

Not more than 1 g/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 355 ADIPIC ACID

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range

B. Solubility

Purity

Water

Sulphated ash

Arsenic

Lead

Mercury

E 356 SODIUM ADIPATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range

B. Solubility

C. Positive test for sodium

Hexanedioic acid, 1,4-butanedicarboxylic acid

204-673-3

C6H10O4

146,14

Content not less than 99,6 %

White odourless crystals or crystalline powder

151,5 oC-154,0 oC

Slightly soluble in water. Freely soluble in ethanol

Not more than 0,2 % (Karl Fischer method)

Not more than 20 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Sodium adipate

231-293-5

C6H8Na2O4

190,11

Content not less than 99,0 % (on anhydrous basis)

White odourless crystals or crystalline powder

151 oC-152 oC (for adipic acid)

Approximately 50 g/100 ml water (20 oC)

L 253/62

EN

Official Journal of the European Union

20.9.2008

Purity

Water

Arsenic

Lead

Mercury

Not more than 3 % (Karl Fischer)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 357 POTASSIUM ADIPATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium adipate

242-838-1

C6H8K2O4

222,32

Content not less than 99,0 % (on anhydrous basis)

White odourless crystals or crystalline powder

A. Melting range

B. Solubility

C. Positive test for potassium

151 oC-152 oC (for adipic acid)

Approximately 60 g/100 ml water (20 oC)

Purity

Water

Arsenic

Lead

Mercury

E 363 SUCCINIC ACID

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 3 % (Karl Fischer)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Butanedioic acid

203-740-4

C4H6O4

118,09

Content no less than 99,0 %

Colourless or white, odourless crystals

A. Melting range

Between 185,0 oC and 190,0 oC

Purity

Residue on ignition

Not more than 0,025 % (800 oC, 15 min)

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/63

E 380 TRIAMMONIUM CITRATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for ammonium and for

citrate

B. Solubility

Purity

Oxalate

Arsenic

Lead

Mercury

Tribasic ammonium citrate

Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid

222-394-5

C6H17N3O7

243,22

Content not less than 97,0 %

White to off-white crystals or powder

Freely soluble in water

Not more than 0,04 % (as oxalic acid)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium disodium EDTA

Calcium disodium edetate

N, N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]
calciate(2)-disodium

Calcium disodium ethylenediaminetetra acetate Calcium disodium
(ethylenedinitrilo)tetra acetate

200-529-9

C10H12O8CaN2Na2·2H2O

410,31

Content not less than 97 % on the anhydrous basis

White, odourless crystalline granules or white to nearly white powder,
slightly hygroscopic

A. Positive tests for sodium and for

calcium

B. Chelating activity to metal

positive

ions

C. pH of a 1 % solution between 6,5

and 7,5

Purity

Water content

5 to 13 % (Karl Fischer method)

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

L 253/64

EN

Official Journal of the European Union

20.9.2008

E 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

Chemical formula

232-680-1

(C6H8O6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Description

Identification

A. Solubility

B. Calcium chloride precipitation test

C. Ammonium sulphate precipitation

test

D. Colour reaction

Purity

Alginic acid yields, on the anhydrous basis, not less than 20 % and not
more than 23 % of carbon dioxide (CO2), equivalent to not less than
91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on
equivalent weight basis of 200)

Alginic acid occurs in filamentous, grainy, granular and powdered forms.
It is a white to yellowish brown and nearly odourless

Insoluble in water and organic solvents, slowly soluble in solutions of
sodium carbonate, sodium hydroxide and trisodium phosphate

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

To a 0,5 % solution of the sample in 1 M sodium hydroxide solution,
add one half of its volume of a saturated solution of ammonium
sulphate. 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

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

pH of a 3 % suspension

Between 2,0 and 3,5

Loss on drying

Sulphated ash

Not more than 15 % (105 oC, 4 hours)

Not more than 8 % on the anhydrous basis

Sodium hydroxide (1 M solution)

Not more than 2 % on the anhydrous basis insoluble matter

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Salmonella spp.

Negative in 5 g

Negative in 10 g

20.9.2008

EN

Official Journal of the European Union

L 253/65

E 401 SODIUM ALGINATE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for sodium and alginic

acid

Purity

Sodium salt of alginic acid

(C6H7NaO6)n

10 000-600 000 (typical average)

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)

Nearly odourless, white to yellowish fibrous or granular powder

Loss on drying

Not more than 15 % (105 oC, 4 hours)

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Yeast and moulds

E. coli

Salmonella spp.

Not more than 5 000 colonies per gram

Not more than 500 colonies per gram

Negative in 5 g

Negative in 10 g

E 402 POTASSIUM ALGINATE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for potassium and for

alginic acid

Purity

Potassium salt of alginic acid

(C6H7KO6)n

10 000-600 000 (typical average)

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)

Nearly odourless, white to yellowish fibrous or granular powder

Loss on drying

Not more than 15 % (105 oC, 4 hours)

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Total plate count

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 20 mg/kg

Not more than 5 000 colonies per gram

L 253/66

EN

Official Journal of the European Union

20.9.2008

Yeast and moulds

E. coli

Salmonella spp.

Not more than 500 colonies per gram

Negative in 5 g

Negative in 10 g

E 403 AMMONIUM ALGINATE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Ammonium salt of alginic acid

(C6H11NO6)n

10 000 — 600 000 (typical average)

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)

White to yellowish fibrous or granular powder

A. Positive test

for ammonium and

alginic acid

Purity

Loss on drying

Sulphated ash

Not more than 15 % (105 oC, 4 hours)

Not more than 7 % on the dried basis

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Arsenic

Lead

Mercury

Cadmium

Heavy metals

Total plate count

Yeast and moulds

E. coli

Salmonella spp.

E 404 CALCIUM ALGINATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 20 mg/kg

Not more than 5 000 colonies per gram

Not more than 500 colonies per gram

Negative in 5 g

Negative in 10 g

Calcium salt of alginate

Calcium salt of alginic acid

(C6H7Ca1/2O6)n

10 000-600 000 (typical average)

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)

Nearly odourless, white to yellowish fibrous or granular powder

A. Positive test for calcium and alginic

acid

Purity

Loss on drying

Arsenic

Not more than 15,0 % (105 oC, 4 hours)

Not more than 3 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/67

Lead

Mercury

Cadmium

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Yeast and moulds

E. coli

Salmonella spp.

Not more than 5 000 colonies per gram

Not more than 500 colonies per gram

Negative in 5 g

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

Chemical formula

Molecular weight

Assay

Description

Identification

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

(C9H14O7)n (esterified)

10 000-600 000 (typical average)

Yields, on the anhydrous basis, not less than 16 % and not more than
20 % of CO2 of carbon dioxide

Nearly odourless, white to yellowish brown fibrous or granular powder

A. Positive test for 1,2-propanediol and

alginic acid after hydrolysis

Purity

Loss on drying

Not more than 20 % (105 oC, 4 hours)

Total propane-1,2-diol content

Not less than 15 % and not more than 45 %

Free propane-1,2-diol content

Not more than 15 %

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Yeast and moulds

E. coli

Salmonella spp.

Not more than 5 000 colonies per gram

Not more than 500 colonies per gram

Negative in 5 g

Negative in 10 g

L 253/68

EN

Official Journal of the European Union

20.9.2008

E 406 AGAR

Synonyms

Definition

Chemical name

Einecs

Assay

Description

Gelose

Japan agar

Bengal, Ceylon, Chinese or Japanese isinglass

Layor Carang

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

232-658-1

The threshold gel concentration should not be higher than 0,25 %

Agar is odourless or has a slight characteristic odour. Unground agar
usually occurs in bundles consisting of thin, membranous, agglutinated
strips, or in cut, flaked or granulated forms. It may be light yellowish-
orange, yellowish-grey to pale yellow, or colourless. It is tough when
damp, brittle when dry. Powdered agar is white to yellowish-white or
pale yellow. When examined in water under a microscope, the agar
appears granular and somewhat filamentous. A few fragments of the
spicules of sponges and a few frustules of diatoms may be present. In
chloral hydrate solution, the powdered agar appears more transparent
than in water, more or less granular, striated, angular and occasionally
contains frustules of diatoms. Gel strength may be standardised by the
addition of dextrose and maltodextrines or sucrose

Identification

A. Solubility

Insoluble in cold water; soluble in boiling water

Purity

Loss on drying

Ash

Not more than 22 % (105 oC, 5 hours)

Not more than 6,5 % on the anhydrous basis determined at 550 oC

Acid-insoluble ash (insoluble in approxi-
mately 3N Hydrochloric acid)

Not more than 0,5 % determined at 550 oC on the anhydrous basis

Insoluble matter (in hot water)

Not more than 1,0 %

Starch

Not detectable by the following method: to a 1 in 10 solution of the
sample add a few drops of iodine solution. No blue colour is produced

Gelatin and other proteins

Water absorption

Arsenic

Lead

Mercury

Cadmium

Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool
of about 50 oC. To 5 ml of the solution add 5 ml of trinitrophenol
solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No
turbidity appears within 10 minutes

Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with
water, mix and allow to stand at about 25 oC for 24 hours. Pour the
contents of the cylinder through moistened glass wool, allowing the
water to drain into a second 100 ml graduated cylinder. Not more than
75 ml of water is obtained

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/69

E 407 CARRAGEENAN

Synonyms

Products of commerce are sold under different names such as:

Irish moss gelose

Eucheuman (from Eucheuma spp.)

Iridophycan (from Iridaea spp.)

Hypnean (from Hypnea spp.)

Furcellaran or Danish agar (from Furcellaria fastigiata)

Carrageenan (from Chondrus and Gigartina spp.)

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

232-524-2

Yellowish to colourless, coarse to fine powder which is practically
odourless

Definition

Einecs

Description

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 combination

Viscosity of a 1,5 % solution at 75 oC

Not less than 5 mPa.s

Loss on drying

Not more than 12 % (105 oC, four hours)

Sulphate

Ash

Acid-insoluble ash

Acid-insoluble matter

Not less than 15 % and not more than 40 % on the dried basis (as SO4)

Not less than 15 % and not more than 40 % determined on the dried
basis at 550 oC

Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric
acid)

Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric
acid)

Low molecular weight
(Molecular
50 kDa)

weight

carrageenan
below

fraction

Arsenic

Lead

Mercury

Cadmium

Total plate count

Yeast and moulds

E. coli

Salmonella spp.

Not more than 5 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 000 colonies per gram

Not more than 300 colonies per gram

Negative in 5 g

Negative in 10 g

L 253/70

EN

Official Journal of the European Union

20.9.2008

E 407a PROCESSED EUCHEUMA SEAWEED

Synonyms

Definition

Description

Identification

A. Positive tests for galactose, for anhy-

drogalactose and for sulphate

PES (acronym for processed eucheuma seaweed)

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
calcium and
and 3,6-anhydrogalactose. Sodium,
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

Tan to yellowish, coarse to fine powder which is practically odourless

B. Solubility

Forms cloudy viscous suspensions in water. Insoluble in ethanol

Purity

Methanol, ethanol, propane-2-ol content

Not more than 0,1 % singly or in combination

Viscosity of a 1,5 % solution at 75 oC

Not less than 5 mPa.s

Loss on drying

Sulphate

Ash

Acid-insoluble ash

Acid-insoluble matter

Not more than 12 % (105 oC, four hours)

Not less than 15 % and not more than 40 % on the dried basis (as SO4)

Not less than 15 % and not more than 40 % determined on the dried
basis at 550 oC

Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric
acid)

Not less than 8 % and not more than 15 % on the dried basis (insoluble
in 1 % v/v sulphuric acid)

Low molecular weight
(Molecular
50 kDa)

weight

carrageenan
below

fraction

Arsenic

Lead

Mercury

Cadmium

Total plate count

Yeast and moulds

E. coli

Salmonella spp.

E 410 LOCUST BEAN GUM

Synonyms

Definition

Not more than 5 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 000 colonies per gram

Not more than 300 colonies per gram

Negative in 5 g

Negative in 10 g

Carob bean gum

Algaroba gum

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

50 000-3 000 000

20.9.2008

EN

Official Journal of the European Union

L 253/71

Einecs

Assay

Description

Identification

A. Positive tests for galactose mannose

B. Microscopic examination

232-541-5

Galactomannan content not less than 75 %

White to yellowish-white, nearly odourless powder

Place some ground sample in an aqueous solution containing 0,5 %
iodine and 1 % potassium iodide on a glass slide and examine under
microscope. Locust bean gum contains long stretched tubiform cells,
separated or slightly interspaced. Their brown contents are much less
regularly formed in guar gum. Guar gum shows close groups of round to
pear shaped cells. Their contents are yellow to brown

C. Solubility

Soluble in hot water, insoluble in ethanol

Purity

Loss on drying

Ash

Protein (N × 6,25)

Acid-insoluble matter

Starch

Arsenic

Lead

Mercury

Cadmium

Not more than 15 % (105 oC, 5 hours)

Not more than 1,2 % determined at 800 oC

Not more than 7 %

Not more than 4 %

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Ethanol and propane-2-ol

Not more than 1 %, single or in combination

E 412 GUAR GUM

Synonyms

Definition

Einecs

Molecular weight

Assay

Description

Identification

Gum cyamopsis

Guar flour

Guar gum is the ground endosperm of the seeds of natural strains of the
guar plant, Cyamopsis tetragonolobus
(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

(L.) Taub.

232-536-0

50 000-8 000 000

Galactomannan content not less than 75 %

A white to yellowish-white, nearly odourless powder

A. Positive tests for galactose and for

mannose

B. Solubility

Soluble in cold water

Purity

Loss on drying

Ash

Acid-insoluble matter

Protein (N × 6,25)

Not more than 15 % (105 oC, 5 hours)

Not more than 1,5 % determined at 800 oC

Not more than 7 %

Not more than 10 %

L 253/72

EN

Official Journal of the European Union

20.9.2008

Starch

Arsenic

Lead

Mercury

Cadmium

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)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

E 413 TRAGACANTH

Synonyms

Definition

Tragacanth gum

Tragant

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

Description

Identification

A. Solubility

Purity

Negative test for Karaya gum

232-252-5

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

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

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

Total ash

Acid insoluble ash

Not more than 16 % (105 oC, 5 hours)

Not more than 4 %

Not more than 0,5 %

Acid insoluble matter

Not more than 2 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Salmonella spp.

E. coli

Negative in 10 g

Negative in 5 g

20.9.2008

EN

Official Journal of the European Union

L 253/73

E 414 ACACIA GUM

Synonyms

Definition

Gum arabic

Acacia gum is a dried exudation obtained from the stems and branches
of natural strains of Acacia senegal (L) Willdenow or closely related
It consists mainly of high
species of Acacia (family Leguminosae).
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

Description

Identification

A. Solubility

Purity

Loss on drying

Total ash

Acid insoluble ash

Acid insoluble matter

Starch or dextrin

Tannin

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Hydrolysis products

Salmonella spp.

E. coli

E 415 XANTHAN GUM

Definition

232-519-5

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.

1 g dissolves in 2 ml of cold water forming a solution which flows
readily and is acid to litmus, insoluble in ethanol

Not more than 17 % (105 oC, 5 hours) for granular and not more than
10 % (105 oC, 4 hours) for spray-dried material

Not more than 4 %

Not more than 0,5 %

Not more than 1 %

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

To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride
solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish
colouration or blackish precipitate is formed

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 20 mg/kg

Mannose, xylose and galacturonic acid are absent
chromatography)

(determined by

Negative in 10 g

Negative in 5 g

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 1 000 000

Einecs

Assay

234-394-2

Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2
corresponding to between 91 % and 108 % of xanthan gum

Description

Cream-coloured powder

L 253/74

EN

Official Journal of the European Union

20.9.2008

Identification

A. Solubility

Purity

Loss on drying

Total ash

Pyruvic acid

Nitrogen

Soluble in water. Insoluble in ethanol

Not more than 15 % (105 oC, 21/2 hours)

Not more than 16 % on the anhydrous basis determined at 650 oC after
drying at 105 oC for four hours

Not less than 1,5 %

Not more than 1,5 %

Ethanol and propan-2-ol

Not more than 500 mg/kg singly or in combination

Lead

Total plate count

Yeast and mould

E. coli

Salmonella spp.

Not more than 2 mg/kg

Not more than 5 000 colonies per gram

Not more than 300 colonies per gram

Absent in 5 g

Absent in 10 g

Xanthomonas campestris

Viable cells absent in 1 g

E 416 KARAYA-GUM

Synonyms

Definition

Einecs

Description

Katilo

Kadaya

Gum sterculia

Sterculia

Karaya, gum karaya

Kullo

Kuterra

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,
together with minor
amounts of glucuronic acid

rhamnose, and galacturonic acid,

232-539-4

Karaya gum occurs in tears of variable size and in broken irregular pieces
having a characteristic semi-crystalline appearance. It is pale yellow to
pinkish brown in colour, translucent and horny. Powdered karaya gum is
a pale grey to pinkish brown. The gum has a distinctive odour of acetic
acid

Identification

A. Solubility

Insoluble in ethanol

B. Swelling in ethanol solution

Karaya gum swells in 60 % ethanol distinguishing it from other gums

Purity

Loss on drying

Total ash

Acid insoluble ash

Acid insoluble matter

Volatile acid

Starch

Arsenic

Lead

Not more than 20 % (105 oC, 5 hours)

Not more than 8 %

Not more than 1 %

Not more than 3 %

Not less than 10 % (as acetic acid)

Not detectable

Not more than 3 mg/kg

Not more than 5 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/75

Mercury

Cadmium

Heavy metals (as Pb)

Salmonella spp.

E. coli

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 20 mg/kg

Negative in 10 g

Negative in 5 g

E 417 TARA GUM

Definition

Einecs

Description

Identification

A. Solubility

B. Gel formation

Purity

Loss on drying

Ash

Acid insoluble matter

Protein

Starch

Arsenic

Lead

Mercury

Cadmium

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 chain
of
(1-4)-β-D-mannopyranose units with α-D-galactopyranose units
attached by (1-6) linkages. The ratio of mannose to galactose in tara
gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)

254-409-6

A white to white-yellow odourless powder

Soluble in water

Insoluble in ethanol

To an aqueous solution of the sample add small amounts of sodium
borate. A gel is formed

Not more than 15 %

Not more than 1,5 %

Not more than 2 %

Not more than 3,5 % (factor N × 5,7)

Not detectable

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

E 418 GELLAN GUM

Definition

Einecs

Molecular weight

Assay

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

275-117-5

Approximately 500 000

Yields, on the dried basis, not less than 3,3 % and not more than 6,8 %
of CO2

Description

An off-white powder

L 253/76

EN

Official Journal of the European Union

20.9.2008

Identification

A. Solubility

Purity

Loss on drying

Nitrogen

Propane-2-ol

Arsenic

Lead

Mercury

Cadmium

Soluble in water, forming a viscous solution.

Insoluble in ethanol

Not more than 15 % after drying (105 oC, 21/2 hours)

Not more than 3 %

Not more than 750 mg/kg

Not more than 3 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Yeast and mould

E. coli

Salmonella spp.

Not more than 10 000 colonies per gram

Not more than 400 colonies per gram

Negative in 5 g

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

Definition

Chemical names

Einecs

Chemical formula

Molecular weight

Assay

Description

(7) OJ L 158, 18.6.2008, p. 17.

Glycerin

Glycerine

1,2,3-propanetriol

Glycerol

Trihydroxypropane

200-289-5

C3H8O3

92,10

Content not less than 98 % of glycerol on the anhydrous basis

Clear, colourless hygroscopic syrupy liquid with not more than a slight
characteristic odour, which is neither harsh nor disagreeable

20.9.2008

EN

Official Journal of the European Union

L 253/77

Identification

A. Acrolein formation on heating

Heat a few drops of the sample in a test tube with about 0,5 g of
potassium bisulphate. The characteristic pungent vapours of acrolein are
evolved

B. Specific gravity (25/25 oC)

Not less than 1,257

C. Refractive index [n]D20

Between 1,471 and 1,474

Purity

Water

Sulphated ash

Butanetriols

Not more than 5 % (Karl Fischer method)

Not more than 0,01 % determined at 800 ± 25 oC

Not more than 0,2 %

Acrolein, glucose and ammonium com-
pounds

Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide
solution (1 in 10) at 60 oC for five minutes. It neither becomes yellow
nor emits an odour of ammonia

Fatty acids and esters

Not more than 0,1 % calculated as butyric acid

Chlorinated compounds

Not more than 30 mg/kg (as chlorine)

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Not more than 3 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

E 425(i) KONJAC GUM

Definition

Molecular weight

Assay

Description

Identification

A. Solubility

B. Gel formation

C.

Formation of heat-stable gel

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

The main component, glucomannan, has an average molecular weight of
200 000 to 2 000 000

Not less than 75 % carbohydrate

A white to cream to light tan powder

Dispersible in hot or cold water forming a highly viscous solution with a
pH between 4,0 and 7,0

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

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-1 at 25 oC

Purity

Loss on drying

Not more than 12 % (105 oC, 5 h)

Starch

Protein

Not more than 3 %

Not more than 3 % (N × 5,7)

Determine nitrogen by Kjeldahl method. The percentage of nitrogen in
the sample multiplied by 5,7 gives the percent of protein in the sample

L 253/78

EN

Official Journal of the European Union

20.9.2008

Ether-soluble material

Not more than 0,1 %

Total ash

Arsenic

Lead

Salmonella spp.

E. coli

Not more than 5,0 % (800 oC, 3 to 4h)

Not more than 3 mg/kg

Not more than 2 mg/kg

Absent in 12,5 g

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

Description

Identification

A. Solubility

B.

Formation of heat-stable gel

Total dietary fibre: not less than 95 % on a dry weight basis

White to slightly brownish fine particle size, free flowing and odourless
powder

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

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

C. Viscosity (1 % solution)

Not less than 20 kgm-1s-1 at 25 oC

Purity

Loss on drying

Not more than 8 % (105 oC, 3h)

Starch

Protein

Not more than 1 %

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 SO2)

Chloride

Not more than 4 mg/kg

Not more than 0,02 %

50 % Alcohol-soluble

Not more than 2,0 % material

Total ash

Lead

Salmonella spp.

E. coli

Not more than 2,0 % (800 oC, 3 to 4h)

Not more than 1 mg/kg

Absent in 12,5 g

Absent in 5 g

20.9.2008

EN

Official Journal of the European Union

L 253/79

E 426 SOYBEAN HEMICELLULOSE

Definition

Soybean hemicellulose
obtained from natural strain soybean fibre by hot water extraction

refined water-soluble polysaccharide

is

a

Chemical names

Water soluble soybean polysaccharides

Assay

Description

Identification

Water soluble soybean fibre

Not less than 74 % carbohydrate

Free flowing spray-dried white powder

A. Solubility pH of 1 % solution

Soluble in hot and cold water without gel formation

B. Viscosity of 10 % solution

Not more than 200 mPa.s

5,5 ± 1,5

Purity

Loss on drying

Not more than 7 % (105 oC, 4h)

Protein

Total ash

Arsenic

Lead

Mercury

Cadmium

Standard plate count

Yeast and mould

E. coli

Not more than 14 %

Not more than 9,5 % (600 oC, 4h)

Not more than 2 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 3 000 colonies per gram

Not more than 100 colonies per gram

Negative in 10 g

E 431 POLYOXYETHYLENE (40) STEARATE

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polyoxyl (40) stearate

polyoxyethylene (40) monostearate

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

Content not less than 97,5 % on the anhydrous basis

Cream-coloured flakes or waxy solid at 25 oC with a faint odour

Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in
mineral oil

B. Congealing range

39 oC-44 oC

C.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

Purity

Water

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 1

Saponification value

Not less than 25 and not more than 35

Hydroxyl value

1,4-Dioxane

Ethylene oxide

Not less than 27 and not more than 40

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Not more than 3 mg/kg

L 253/80

EN

Official Journal of the European Union

20.9.2008

Lead

Mercury

Cadmium

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polysorbate 20

Polyoxyethylene (20) sorbitan monolaurate

the partial esters of sorbitol and its mono- and
A mixture of
dianhydrides with edible commercial lauric acid and condensed with
approximately 20 moles of ethylene oxide per mole of sorbitol and its
anhydrides

Content not less than 70 % of oxyethylene groups, equivalent to not less
than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the
anhydrous basis

A lemon to amber-coloured oily liquid at 25 oC with a faint
characteristic odour

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

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 40 and not more than 50

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 96 and not more than 108

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polysorbate 80

Polyoxyethylene (20) sorbitan monooleate

A mixture of
the partial esters of sorbitol and its mono- and
dianhydrides with edible commercial oleic acid and condensed with
approximately 20 moles of ethylene oxide per mole of sorbitol and its
anhydrides

Content not less than 65 % of oxyethylene groups, equivalent to not less
than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the
anhydrous basis

A lemon to amber-coloured oily liquid at 25 oC with a faint
characteristic odour

Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble
in mineral oil and petroleum ether

B.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

20.9.2008

EN

Official Journal of the European Union

L 253/81

Purity

Water

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 45 and not more than 55

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 65 and not more than 80

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polysorbate 40

Polyoxyethylene (20) sorbitan monopalmitate

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

Content not less than 66 % of oxyethylene groups, equivalent to not less
than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the
anhydrous basis

A lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint
characteristic odour

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

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 41 and not more than 52

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 90 and not more than 107

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)

Synonyms

Definition

Polysorbate 60

Polyoxyethylene (20) sorbitan monostearate

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

L 253/82

EN

Official Journal of the European Union

20.9.2008

Assay

Description

Identification

A. Solubility

Content not less than 65 % of oxyethylene groups, equivalent to not less
than 97 % of polyoxyethylene (20) sorbitan monostearate on the
anhydrous basis

A lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint
characteristic odour

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

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 45 and not more than 55

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 81 and not more than 96

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polysorbate 65

Polyoxyethylene (20) sorbitan tristearate

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

Content not less than 46 % of oxyethylene groups, equivalent to not less
than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous
basis

A tan-coloured, waxy solid at 25 oC with a faint characteristic odour

Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether,
acetone, ether, dioxane, ethanol and methanol

B. Congealing range

29-33 oC

C.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

Purity

Water

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 88 and not more than 98

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 40 and not more than 60

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/83

E 440 (i) PECTIN

Definition

Einecs

Assay

Description

Identification

A. Solubility

Purity

Loss on drying

Acid insoluble ash

Sulphur dioxide

Nitrogen content

Pectin consists mainly of the partial methyl esters of polygalacturonic
acid and their ammonium, sodium, potassium and calcium salts. It is
obtained by extraction in an aqueous medium of natural strains of
appropriate edible plant material, usually citrus fruits or apples. No
organic precipitant shall be used other than methanol, ethanol and
propane-2-ol

232-553-0

Content not less than 65 % of galacturonic acid on the ash-free and
anhydrous basis after washing with acid and alcohol

White, light yellow, light grey or light brown powder

Soluble in water forming a colloidal, opalescent solution. Insoluble in
ethanol

Not more than 12 % (105 oC, 2 hours)

Not more than 1 % (insoluble in approximately 3N hydrochloric acid)

Not more than 50 mg/kg on the anhydrous basis

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

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

E 440 (ii) AMIDATED PECTIN

Definition

Assay

Description

Identification

A. Solubility

Purity

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

Content not less than 65 % of galacturonic acid on the ash-free and
anhydrous basis after washing with acid and alcohol

White, light yellow, light greyish or light brownish powder

Soluble in water forming a colloidal, opalescent solution. Insoluble in
ethanol

Loss on drying

Acid-insoluble ash

Degree of amidation

Not more than 12 % (105 oC, 2 hours)

Not more than 1 % (insoluble in approximately 3N hydrochloric acid)

Not more than 25 % of total carboxyl groups

Sulphur dioxide residue

Not more than 50 mg/kg on the anhydrous basis

Nitrogen content

Not more than 2,5 % after washing with acid and ethanol

Free methanol, ethanol and propane-2-ol

Not more than 1 % single or in combination, on a volatile matter-free
basis

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L 253/84

EN

Official Journal of the European Union

20.9.2008

Cadmium

Heavy metals (as Pb)

Not more than 1 mg/kg

Not more than 20 mg/kg

E 442 AMMONIUM PHOSPHATIDES

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Ammonium salts of phosphatidic acid, mixed ammonium salts of
phoshorylated glycerides

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

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)

Unctuous semi-solid

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

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 444 SUCROSE ACETATE ISOBUTYRATE

Synonyms

Definition

Einecs

Chemical name

Chemical formulae

Molecular weight

Assay

Description

Identification

A. Solubility

B. Refractive index

C. Specific gravity

Purity

Triacetin

Acid value

SAIB

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

204-771-6

Sucrose diacetate hexaisobutyrate

C40H62O19

832-856 (approximate), C40H62O19: 846,9

Content not less than 98,8 % and not more than 101,9 % of C40H62O19

A pale straw-coloured liquid, clear and free of sediment and having a
bland odour

Insoluble in water. Soluble in most organic solvents

[n]40

D: 1,4492-1,4504

[d]25

D: 1,141-1,151

Not more than 0,1 %

Not more than 0,2

Saponification value

Not less than 524 and not more than 540

20.9.2008

EN

Official Journal of the European Union

L 253/85

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Not more than 3 mg/kg

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

E 445 GLYCEROL ESTERS OF WOOD ROSIN

Synonyms

Definition

Description

Identification

Ester gum

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
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 C20H30O2, chiefly abietic acid. The substance is
purified by steam stripping or by countercurrent steam distillation

(paper) pulp processing. The final product

Hard, yellow to pale amber-coloured solid

A. Solubility

Insoluble in water, soluble in acetone

B.

Infrared absorption spectrum

Characteristic of the compound

Purity

Specific gravity of solution

25 not less than 0,935 when determined in a 50 % solution in

[d]20
d-limonene (97 %, boilding point 175,5-176 oC, d20

4: 0,84)

Ring and ball softening range

Between 82 oC and 90 oC

Acid value

Hydroxyl value

Arsenic

Lead

Mercury

Cadmium

Not less than 3 and not more than 9

Not less than 15 and not more than 45

Not more than 3 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

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 test
indicates the use of tall oil rosin instead of wood rosin

E 450 (i) DISODIUM DIPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Disodium dihydrogen diphosphate

Disodium dihydrogen pyrophosphate

Sodium acid pyrophosphate

Disodium pyrophosphate

Disodium dihydrogen diphosphate

231-835-0

Na2H2P2O7

L 253/86

EN

Official Journal of the European Union

20.9.2008

Molecular weight

Assay

P2O5 Content

Description

Identification

221,94

Content not less than 95 % of disodium diphosphate

Not less than 63,0 % and not more than 64,5 %

White powder or grains

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 % (105 oC, four hours)

Water-insoluble matter

Not more than 1 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 450 (ii) TRISODIUM DIPHOSPHATE

Synonyms

Definition

Einecs

Acid trisodium pyrophosphate

Trisodium monohydrogen diphosphate

238-735-6

Chemical formula

Monohydrate: Na3HP2O7 · H2O

Molecular weight

Assay

P2O5 content

Description

Identification

Anhydrous: Na3HP2O7

Monohydrate: 261,95

Anhydrous: 243,93

Content not less than 95 % on the anhydrous basis

Not less than 57 % and not more than 59 %

White powder or grains, occurs anhydrous or as a monohydrate

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 % (105 oC, four hours)

Water-insoluble matter

Not more than 0,2 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/87

E 450 (iii) TETRASODIUM DIPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Tetrasodium pyrophosphate

Sodium pyrophosphate

Tetrasodium diphosphate

231-767-1

Anhydrous: Na4P2O7

Decahydrate: Na4P2O7 · 10H2O

Anhydrous: 265,94

Decahydrate: 446,09

Content not less than 95 % of Na4P2O7 on the ignited basis

Not less than 52,5 % and not more than 54,0 %

Colourless or white crystals, or a white crystalline or granular powder.
The decahydrate effloresces slightly in dry air

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 after
drying at 105 oC for four hours, followed by ignition at 550 oC for
30 minutes

Water-insoluble matter

Not more than 0,2 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 450 (v) TETRAPOTASSIUM DIPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Potassium pyrophosphate

Tetrapotassium pyrophosphate

Tetrapotassium diphosphate

230-785-7

K4P2O7

330,34 (anhydrous)

Content not less than 95 % on the ignited basis

Not less than 42,0 % and not more than 43,7 % on the anhydrous basis

Colourless crystals or white, very hygroscopic powder

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 10,8

L 253/88

EN

Official Journal of the European Union

20.9.2008

Purity

Loss on ignition

Not more than 2 % after drying at 105 oC for four hours and then
ignition at 550 oC for 30 minutes

Water-insoluble substances

Not more than 0,2 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 450 (vi) DICALCIUM DIPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Calcium pyrophosphate

Dicalcium diphosphate

Dicalcium pyrophosphate

232-221-5

Ca2P2O7

254,12

Content not less than 96 %

Not less than 55 % and not more than 56 %

A fine, white, odourless powder

A. Positive tests for calcium and for

phosphate

B. Solubility

Insoluble in water. Soluble in dilute hydrochloric and nitric acids

C. pH of a 10 % suspension in water

Between 5,5 and 7,0

Purity

Loss on ignition

Not more than 1,5 % at 800 oC ± 25 oC for 30 minutes

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 50 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Acid calcium pyrophosphate

Monocalcium dihydrogen pyrophosphate

Calcium dihydrogen diphosphate

238-933-2

CaH2P2O7

215,97

Content not less than 90 % on the anhydrous basis

Not less than 61 % and not more than 64 %

20.9.2008

EN

Official Journal of the European Union

L 253/89

Description

Identification

A. Positive tests for calcium and for

phosphate

Purity

White crystals or powder

Acid-insoluble matter

Not more than 0,4 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 30 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 451 (i) PENTASODIUM TRIPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Pentasodium tripolyphosphate

Sodium tripolyphosphate

Pentasodium triphosphate

231-838-7

Na5O10P3 · nH2O (n = 0 or 6)

367,86

Content not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate)

Not less than 56 % and not more than 59 % (anhydrous) or not less than
43 % and not more than 45 % (hexahydrate)

White, slightly hygroscopic granules or powder

A. Solubility

Freely soluble in water. Insoluble in ethanol

B. Positive tests for sodium and for

phosphate

C. pH of a 1 % solution

Between 9,1 and 10,2

Purity

Loss on drying

Anhydrous: Not more than 0,7 % (105 oC, one hour)

Hexahydrate: Not more than 23,5 % (60 oC, one hour, followed by
drying at 105 oC, four hours)

Water-insoluble substances

Not more than 0,1 %

Higher polyphosphates

Not more than 1 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE

Synonyms

Pentapotassium tripolyphosphate

Potassium triphosphate

Potassium tripolyphosphate

L 253/90

EN

Official Journal of the European Union

20.9.2008

Definition

Chemical name

Pentapotassium triphosphate

Pentapotassium tripolyphosphate

Einecs

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

237-574-9

K5O10P3

448,42

Content not less than 85 % on the anhydrous basis

Not less than 46,5 % and not more than 48 %

White, very hygroscopic powder or granules

A. Solubility

Very soluble in water

B. Positive tests for potassium and for

phosphate

C. pH of a 1 % solution

Between 9,2 and 10,5

Purity

Loss on ignition

Not more than 0,4 % (after drying at 105 oC, four hours, followed by
ignition at 550 oC, 30 minutes)

Water-insoluble matter

Not more than 2 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 452 (i) SODIUM POLYPHOSPHATE

1. SOLUBLE POLYPHOSPHATE

Synonyms

Definition

Sodium hexametaphosphate

Sodium tetrapolyphosphate

Graham's salt

Sodium polyphosphates, glassy

Sodium polymetaphosphate

Sodium metaphosphate

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, (NaPO3)x where x ≥ 2,
terminated by Na2PO4 groups. These substances are usually identified by
their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary
from about 1,3 for sodium tetrapolyphosphate, where x = approximately
4;
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

to about 1,1 for Graham's

salt,

Chemical name

Einecs

Chemical formula

Molecular weight

Assay P2O5 content

Sodium polyphosphate

272-808-3

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

(102)n

Not less than 60 % and not more than 71 % on the ignited basis

20.9.2008

EN

Official Journal of the European Union

L 253/91

Description

Identification

Colourless or white, transparent platelets, granules, or powders

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

Water-insoluble matter

Not more than 1 %

Not more than 0,1 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

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 (NaPO3)x
that spiral in opposite directions about a common axis. The Na2O/P2O5
ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5

Chemical name

Sodium polyphosphate

Einecs

Chemical formula

Molecular weight

P2O5 content

Description

Identification

A. Solubility

272-808-3

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

(102)n

Not less than 68,7 % and not more than 70,0 %

White crystalline powder

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

Arsenic

Cadmium

Lead

Mercury

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 253/92

EN

Official Journal of the European Union

20.9.2008

E 452 (ii) POTASSIUM POLYPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

P2O5 content

Description

Identification

Potassium metaphosphate

Potassium polymetaphosphate

Kurrol salt

Potassium polyphosphate

232-212-6

(KPO3)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

(118)n

Not less than 53,5 % and not more than 61,5 % on the ignited basis

Fine white powder or crystals or colourless glassy platelets

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

Cyclic phosphate

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 2 % (105 oC, four hours followed by ignition at 550 oC,
30 minutes)

Not more than 8 % on P2O5 content

Not more than 10 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

E 452(iii) SODIUM CALCIUM POLYPHOSPHATE

Synonym

Definition

Chemical name

Einecs

Chemical formula

Assay

Description

Identification

Sodium calcium polyphosphate, glassy

Sodium calcium polyphosphate

233-782-9

(NaPO3)n CaO where n is typically 5

Not less than 61 % and not more than 69 % as P2O5

White glassy crystals, spheres

A. pH of a 1 % m/m slurry

Approximately 5 to 7

B. CaO content

7 %-15 % m/m

Purity

Fluoride

Arsenic

Lead

Cadmium

Mercury

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/93

E 452 (iv) CALCIUM POLYPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

P2O5 content

Description

Identification

Calcium metaphosphate

Calcium polymetaphosphate

Calcium polyphosphate

236-769-6

(CaP2O6)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

(198)n

Not less than 71 % and not more than 73 % on the ignited basis

Odourless, colourless crystals or white powder

A. Solubility

Usually sparingly soluble in water. Soluble in acid medium

B. Positive tests for calcium and for

phosphate

C. CaO content

Purity

Loss on ignition

Cyclic phosphate

Fluoride

Arsenic

Cadmium

Lead

Mercury

E 459 BETA-CYCLODEXTRIN

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

27 to 29,5 %

Not more than 2 % (105 oC, four hours followed by ignition at 550 oC,
30 minutes)

Not more than 8 % on P2O5 content

Not more than 30 mg/kg (expressed as fluorine)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

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

Cycloheptaamylose

231-493-2

(C6H10O5)7

1 135

Content not less than 98,0 % of (C6H10O5)7 on an anhydrous basis

Virtually odourless white or almost white crystalline solid

Sparingly soluble in water; freely soluble in hot water; slightly soluble in
ethanol

B. Specific rotation

[α]25

D: + 160o to + 164o (1 % solution)

Purity

Water

Not more than 14 % (Karl Fischer method)

Other cyclodextrins

Not more than 2 % on an anhydrous basis

Residual solvents (toluene and trichlor-
oethylene)

Not more than 1 mg/kg for each solvent

L 253/94

EN

Official Journal of the European Union

20.9.2008

Sulphated ash

Arsenic

Lead

Not more than 0,1 %

Not more than 1 mg/kg

Not more than 1 mg/kg

E 460 (i) MICROCRISTALLINE CELLULOSE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Colour reaction

C. To be identified by IR spectroscopy

D. Suspension test

Cellulose gel

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

Cellulose

232-674-9

(C6H10O5)n

About 36 000

Not less than 97 % calculated as cellulose on the anhydrous basis

A fine white or almost white odourless powder

Insoluble in water, ethanol, ether and dilute mineral acids. Slightly
soluble in sodium hydroxide solution

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

Mix 30 g of
the sample with 270 ml of water in a high-speed
(12 000 rpm) power blender for 5 minutes. The resultant mixture will
be either a free-following suspension or a heavy,
lumpy suspension
which flows poorly, if at all, settles only slightly and contains many
trapped air bubbles. If a free-flowing suspension is obtained, transfer
100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour.
The solids settles and a supernatant liquid appears

Purity

Loss on drying

Not more than 7 % (105 oC, 3 hours)

Water-soluble matter

Not more than 0,24 %

Sulphated ash

Not more than 0,5 % determined at 800 ± 25 oC

pH of a 10 % suspension in water

The pH of the supernatant liquid is between 5,0 and 7,5

Starch

Not detectable

Particle size

Carboxyl groups

Arsenic

Lead

Mercury

Cadmium

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

Not less than 5 μm (not more than 10 % of particles of less than 5 μm)

Not more than 1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/95

E 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

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Suspension test

Purity

Loss on drying

Water-soluble matter

Sulphated ash

Linear polymer of 1:4 linked glucose residues

232-674-9

(C6H10O5)n

(162)n (n is predominantly 1 000 and greater)

Content not less than 92 %

A white, odourless powder

Insoluble in water, ethanol, ether and dilute mineral acids. Slightly
soluble in sodium hydroxide solution

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

Not more than 7 % (105 oC, 3 hours)

Not more than 1,0 %

Not more than 0,3 % determined at 800 ± 25 oC

pH of a 10 % suspension in water

The pH of the supernatant liquid is between 5,0 and 7,5

Starch

Not detectable

To 20 ml of the dispersion obtained in identification, test B, add a few
drops of iodine solution and mix. No purplish to blue or blue colour
should be produced

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

Definition

Chemical name

Chemical formula

Cellulose methyl ether

Methyl cellulose is cellulose obtained directly from natural strains of
fibrous plant material and partially etherified with methyl groups

Methyl ether of cellulose

The polymers contain substituted anhydroglucose units with the
following general formula:

C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the
following:

— H

— CH3

— or CH2CH3

L 253/96

EN

Official Journal of the European Union

20.9.2008

Molecular weight

Assay

Description

Identification

A. Solubility

Purity

Loss on drying

Sulphated ash

From about 20 000 to 380 000

Content not less than 25 % and not more than 33 % of methoxyl groups
(-OCH3)
groups
(-OCH2CH2OH)

than 5 % of hydroxyethoxyl

and not more

Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder

Swelling in water, producing a clear to opalescent, viscous, colloidal
solution.

Insoluble in ethanol, ether and chloroform.

Soluble in glacial acetic acid

Not more than 10 % (105 oC, 3 hours)

Not more than 1,5 % determined at 800 ± 25 oC

pH of a 1 % colloidal solution

Not less than 5,0 and not more than 8,0

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

E 462 ETHYL CELLULOSE

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

A. Solubility

B.

Film forming test

Purity

Loss on drying

Sulphated ash

Cellulose ethyl ether

Ethyl cellulose is cellulose obtained directly from fibrous plant material
and partially etherified with ethyl groups

Ethyl ether of cellulose

The polymers contain substituted anhydroglucose units with the
following general formula:

C6H7O2(OR1)(OR2) where R1 and R2 may be any of the following:

— H

— CH2CH3

Content not less than 44 % and not more than 50 % of ethoxyl groups
(-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl
groups per anhydroglucose unit)

Slightly hygroscopic white to off-white, odourless and tasteless powder

Practically insoluble in water, in glycerol and in propane-1,2-diol but
soluble in varying proportions in certain organic solvents depending
upon 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

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. A
thick, tough, continuous, clear film remains. The film is flammable

Not more than 3 % (105 oC, 2 hours)

Not more than 0,4 %

20.9.2008

EN

Official Journal of the European Union

L 253/97

pH of a 1 % colloidal solution

Neutral to litmus

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 463 HYDROXYPROPYL CELLULOSE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

Cellulose hydroxypropyl ether

Hydroxypropylcellulose is cellulose obtained directly from natural
strains of
and partially etherified with
hydroxypropyl groups

fibrous plant material

Hydroxypropyl ether of cellulose

The polymers contain substituted anhydroglucose units with the
following general formula:

C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the
following:

— H

— CH2CHOHCH3

— CH2CHO(CH2CHOHCH3)CH3

— CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3

From about 30 000 to 1 000 000

not

groups
80,5 % of
Content
(-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl
groups per anhydroglucose unit on the anhydrous basis

hydroxypropoxyl

than

less

Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder

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

Sulphated ash

Not more than 10 % (105 oC, 3 hours)

Not more than 0,5 % determined at 800 ± 25 oC

pH of a 1 % colloidal solution

Not less than 5,0 and not more than 8,0

Propylene chlorohydrins

Not more than 0,1 mg/kg

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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 methylcellulose

L 253/98

EN

Official Journal of the European Union

20.9.2008

Chemical formula

The polymers contain substituted anhydroglucose units with the
following general formula:

C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the
following:

— H

— CH3

— CH2CHOHCH3

— CH2CHO (CH2CHOHCH3) CH3

— CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3

From about 13 000 to 200 000

Content not less than 19 % and not more than 30 % methoxyl groups
(-OCH3) and not
less than 3 % and not more than 12 % hydro-
xypropoxyl groups (-OCH2CHOHCH3), on the anhydrous basis

Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder

Swelling in water, producing a clear to opalescent, viscous, colloidal
solution. Insoluble in ethanol

Molecular weight

Assay

Description

Identification

A. Solubility

B. Gas chromatography

Determine the substituents by gas chromatography

Purity

Loss on drying

Sulphated ash

Not more than 10 % (105 oC, 3 hours)

Not more than 1,5 % for products with viscosities of 50 mPa.s or above

Not more than 3 % for products with viscosities below 50 mPa.s

pH of a 1 % colloidal solution

Not less than 5,0 and not more than 8,0

Propylene chlorohydrins

Not more than 0,1 mg/kg

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

E 465 ETHYL METHYL CELLULOSE

Synonyms

Definition

Chemical name

Chemical formula

Methylethylcellulose

Ethyl methyl cellulose is cellulose obtained directly from natural strains
of fibrous plant material and partially etherified with methyl and ethyl
groups

Ethyl methyl ether of cellulose

The polymers contain substituted anhydroglucose units with the
following general formula:

C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the
following:

— H

— CH3

— CH2CH3

Molecular weight

From about 30 000 to 40 000

20.9.2008

EN

Official Journal of the European Union

L 253/99

Assay

Description

Identification

A. Solubility

Purity

Loss on drying

Sulphated ash

Content on the anhydrous basis not less than 3,5 % and not more than
6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not
more than 19 % of ethoxyl groups (-OCH2CH3), and not less than
13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as
methoxyl

Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder

Swelling in water, producing a clear to opalescent, viscous, colloidal
solution. Soluble in ethanol. Insoluble in ether

Not more than 15 % for the fibrous form, and not more than 10 % for
the powdered form (105 oC to constant weight)

Not more than 0,6 %

pH of a 1 % colloidal solution

Not less than 5,0 and not more than 8,0

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

E 466 SODIUM CARBOXY METHYL CELLULOSE

Synonyms

Carboxy methyl cellulose

CMC

NaCMC

Sodium CMC

Cellulose gum

Definition

Chemical name

Chemical formula

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

Sodium salt of the carboxymethyl ether of cellulose

The polymers contain substituted anhydroglucose units with the
following general formula:

C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the
following:

Molecular weight

Assay

Description

Identification

A. Solubility

B.

Foam test

C. Precipitate formation

— H

— CH2COONa

— CH2COOH

Higher than approximately 17 000 (degree of polymerisation approxi-
mately 100)

Content on the anhydrous basis not less than 99,5 %

Slightly hygroscopic white or slightly yellowish or greyish odourless and
tasteless, granular or fibrous powder

Yields a viscous colloidal solution with water. Insoluble in ethanol

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)

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
locust bean gum and
other cellulose ethers and from gelatine,
tragacanth)

L 253/100

EN

Official Journal of the European Union

20.9.2008

D. Colour reaction

Purity

Degree of substitution

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

less than 0,2 and not more than 1,5 carboxymethyl groups

Not
(-CH2COOH) per anhydroglucose unit

Loss on drying

Not more than 12 % (105 oC to constant weight)

pH of a 1 % colloidal solution

Not less than 5,0 and not more than 8,5

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total glycolate

Sodium

Not more than 0,4 %, calculated as sodium glycolate on the anhydrous
basis

Not more than 12,4 % on the anhydrous basis

E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE

Synonyms

Cross-linked carboxymethyl cellulose

Definition

Chemical name

Chemical formula

Description

Identification

A.

B.

C.

Cross-linked CMC

Cross-linked sodium CMC

Cross-linked cellulose gum

Cross-linked sodium carboxymethyl cellulose is the sodium salt of
thermally cross-linked partly O-carboxymethylated cellulose

Sodium salt of the cross-linked carboxymethyl ether cellulose

The polymers containing substituted anhydroglucose units with the
general formula:

C6H7O2(OR1)(OR2)(OR3)

where R1, R2 and R3 may be any of the following:

— H

— CH2COONa

— CH2COOH

Slightly hygroscopic, white to off white, odourless powder

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

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

It gives the reaction of sodium

20.9.2008

EN

Official Journal of the European Union

L 253/101

Purity

Loss on drying

Water solubles

Degree of substitution

pH of 1 %

Sodium content

Arsenic

Lead

Cadmium

Mercury

Not more than 6 % (105 oC, 3h)

Not more than 10 %

Not less than 0,2 and not more than 1,5 carboxymethyl groups per
anhydroglucose unit

Not less than 5,0 and not more than 7,0

Not more than 12,4 % on anhydrous basis

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE

Synonyms

Definition

Chemical name

Chemical formula

Formula weight

Assay

Description

Identification

A. Solubility

B.

Foam test

C. Precipitate formation

D. Colour reaction

E. Viscosity (60 % solids)

Sodium carboxymethyl cellulose, enzymatically hydrolysed

Enzymatically hydrolysed carboxymethylcellulose is obtained from
carboxymethylcellulose by enzymatic digestion with a cellulase produced
by Trichoderma longibrachiatum (formerly T. reesei)

Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed

Sodium salts of polymers containing substituted anhydroglucose units
with the general formula:

[C6H7O2(OH)x(OCH2COONa)y]n

where n is the degree of polymerisation

x = 1,50 to 2,80

y = 0,2 to 1,50

x + y = 3,0

(y = degree of substitution)

178,14 where y = 0,20

282,18 where y = 1,50

Macromolecules: Not less than 800 (n about 4)

Not less than 99,5 %, including mono- and disaccharides, on the dried
basis

White or slightly yellowish or greyish, odourless, slightly hygroscopic
granular or fibrous powder

Soluble in water, insoluble in ethanol

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

To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of
test
copper or aluminium sulphate. A precipitate appears. This
distinguishes sodium carboxymethyl cellulose, whether hydrolysed or
not, from other cellulose ethers and from gelatine, carob bean gum and
tragacanth gum

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

Not less than 2,500 kgm-1s-1 at 25 oC corresponding to an average
molecule weight of 5 000 D

L 253/102

EN

Official Journal of the European Union

20.9.2008

Purity

Loss on drying

Degree of substitution

Not more than 12 % (105 oC to constant weight)

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
indicates hydrolysis of the sodium carboxymethyl cellulose

test solution occurs, which

Lead

Not more than 3 mg/kg

E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS

Definition

Assay

Description

Identification

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

Content on the anhydrous basis not less than 95 %

White or creamy white light powders, flakes or semi-solids

A. Solubility

Sodium and potassium salts: soluble in water and ethanol calcium salts:

B. Positive tests for cations and for fatty

insoluble in water, ethanol and ether

acids

Purity

Sodium

Potassium

Calcium

Not less than 9 % and not more than 14 % expressed as Na2O

Not less than 13 % and not more than 21,5 % expressed as K2O

Not less than 8,5 % and not more than 13 % expressed as CaO

Unsaponifiable matter

Not more than 2 %

Free fatty acids

Not more than 3 % estimated as oleic acid

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Free alkali

Not more than 0,1 % expressed as NaOH

Matter insoluble in alcohol

Not more than 0,2 % (sodium and potassium salts only)

E 470b MAGNESIUM SALTS OF FATTY ACIDS

Definition

Assay

Description

Identification

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

Content on the anhydrous basis not less than 95 %

White or creamy-white light powders, flakes or semi-solids

A. Solubility

Insoluble in water, partially soluble in ethanol and ether

B. Positive tests for magnesium and for

fatty acids

20.9.2008

EN

Official Journal of the European Union

L 253/103

Purity

Magnesium

Free alkali

Not less than 6,5 % and not more than 11 % expressed as MgO

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

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

Definition

Assay

Description

Identification

Glyceryl monostearate

Glyceryl monopalmitate

Glyceryl monooleate, etc.

Monostearin, monopalmitin, monoolein, etc.

GMS (for glyceryl monostearate)

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

Content of mono- and diesters: not less than 70 %

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

A.

Infrared spectrum

Characteristic of a partial fatty acid ester of a polyol

B. Positive tests for glycerol and for fatty

acids

C. Solubility

Purity

Water content

Acid value

Free glycerol

Polyglycerols

Arsenic

Lead

Mercury

Cadmium

Insoluble in water, soluble in ethanol and toluene

Not more than 2 % (Karl Fischer method)

Not more than 6

Not more than 7 %

Not more than 4 % diglycerol and not more than 1 % higher
polyglycerols both based on total glycerol content

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Total glycerol

Sulphated ash

Not less than 16 % and not more than 33 %

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).

L 253/104

EN

Official Journal of the European Union

20.9.2008

E 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

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

Clear, mobile liquids to solids, from white to pale yellow in colour

Definition

Description

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

Arsenic

Lead

Mercury

Cadmium

Not more than 2 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy 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 acid

Total glycerol

Sulphated ash

Not less than 14 % and not more than 31 %

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

Definition

Description

Identification

Lactoglycerides

Mono- and diglycerides of fatty acids esterified with lactic acid

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

Clear, mobile liquids to waxy solids of variable consistency, from white
to pale yellow in colour

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

Arsenic

Not more than 2 %

Not more than 3 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/105

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Total lactic acid

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

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

Sulphated ash

Not less than 13 % and not more than 30 %

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

Definition

Description

Identification

A. Positive tests for glycerol, for fatty

acids and for citric acid

B. Solubility

Citric acid esters of mono- and diglycerides

Citroglycerides

Mono- and diglycerides of fatty acids esterified with citric acid

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

Yellowish or light brown liquids to waxy solids or semi-solids

Insoluble in cold water

Dispersible in hot water

Soluble in oils and fats

Insoluble in cold ethanol

Purity

Acids other than citric and fatty acids

Not detectable

Free glycerol

Total glycerol

Total citric acid

Not more than 2 %

Not less than 8 % and not more than 33 %

Not less than 13 % and not more than 50 %

Sulphated ash (determined at 800 ± 25 oC)

Non-neutralised products: not more than 0,5 %

Lead

Free fatty acids

Not more than 2 mg/kg

Not more than 3 % estimated as oleic acid

Partially or wholly neutralised products: not more than 10 %

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

Definition

Tartaric acid esters of mono- and diglycerides

Mono- and diglycerides of fatty acids esterified with tartaric acid

Esters of glycerol with tartaric acid and fatty acids occurring in food fats
and oils. They may contain small amounts of free glycerol, free fatty
acids, free tartaric acid and free glycerides

L 253/106

EN

Official Journal of the European Union

20.9.2008

Description

Identification

Sticky viscous yellowish liquids to hard yellow waxes

A. Positive tests for glycerol, for fatty

acids and for tartaric acid

Purity

Acids other than tartaric and fatty acids

Not detectable

Free glycerol

Total glycerol

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Total tartaric acid

Free fatty acids

Sulphated ash

Not more than 2 %

Not less than 12 % and not more than 29 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

Not less than 15 % and not more than 50 %

Not more than 3 % estimated as oleic acid

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

Definition

Description

Identification

Mono-and diglycerides of
diacetyltartaric acid

fatty acids esterified with mono- and

Diacetyltartaric and fatty acid esters of glycerol

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

Sticky viscous liquids through a fat-like consistency to yellow waxes
which hydrolyse in moist air to liberate acetic acid

A. Positive tests for glycerol, for fatty
acids, for tartaric acid and for acetic
acid

Purity

Acids other than acetic, tartaric and fatty
acids

Not detectable

Free glycerol

Total glycerol

Sulphated ash

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Total tartaric acid

Not more than 2 %

Not less than 11 % and not more than 28 %

Not more than 0,5 % determined at 800 ± 25 oC

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

Not less than 10 % and not more than 40 %

20.9.2008

EN

Official Journal of the European Union

L 253/107

Total acetic acid

Free fatty acids

Not less than 8 % and not more than 32 %

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

Definition

Description

Identification

Mono- and diglycerides of fatty acids esterified with acetic acid and
tartaric acid

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

Sticky liquids to solids, from white to pale-yellow in colour

A. Positive tests for glycerol, for fatty
acids, for tartaric acid and for acetic
acid

Purity

Acids other than acetic, tartaric and fatty
acids

Not detectable

Free glycerol

Total glycerol

Sulphated ash

Arsenic

Lead

Mercury

Cadmium

Not more than 2 %

Not less than 12 % and not more than 27 %

Not more than 0,5 % determined at 800 ± 25 oC

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Total acetic acid

Total tartaric acid

Free fatty acids

Not less than 10 % and not more than 20 %

Not less than 20 % and not more than 40 %

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

Definition

Assay

Description

Identification

A. Positive tests for sugar for fatty acids

Sucroesters

Sugar esters

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

Content not less than 80 %

Stiff gels, soft solids or white to slightly greyish-white powders

L 253/108

EN

Official Journal of the European Union

20.9.2008

B. Solubility

Purity

Sulphated ash

Free sugar

Free fatty acids

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Methanol

Dimethylsulphoxide

Dimethylformamide

2-methyl-1-propanol

Ethylacetate

Propane-2-ol

Prolyleneglycol

Sparingly soluble in water

Soluble in ethanol

Not more than 2 % determined at 800 ± 25 oC

Not more than 5 %

Not more than 3 % estimated as oleic acid

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

Not more than 10 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

9
>>=

>>;

Not more than 350 mg/kg, singly or in combination

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

Definition

Assay

Description

Identification

Sugar glycerides

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

Content not less than 40 % and not more than 60 % of sucrose fatty acid
esters

Soft solid masses, stiff gels or white to off-white powders

A. Positive tests for sugar and for fatty

acids

B. Solubility

Insoluble in cold water

Soluble in ethanol

Purity

Sulphated ash

Free sugar

Free fatty acids

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Methanol

Dimethylformamide

Not more than 2 % determined at 800 ± 25 oC

Not more than 5 %

Not more than 3 % estimated as oleic acid

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/109

2-methyl-1-propanol

Cyclohexane

Ethylacetate

Propane-2-ol

)

)

Not more than 10 mg/kg, single or in combination

Not more than 350 mg/kg, single or in combination

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

Definition

Assay

Description

Identification

Polyglycerol fatty acid esters

Polyglycerin esters of fatty acid esters

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

Content of total fatty acid ester not less than 90 %

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

A. Positive tests for glycerol, for poly-

glycerols and for fatty acids

B. Solubility

Purity

Sulphated ash

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

Not more than 0,5 % determined at 800 ± 25 oC

Acids other than fatty acids

Not detectable

Free fatty acids

Not more than 6 % estimated as oleic acid

Total glycerol and polyglycerol

Not less than 18 % and not more than 60 %

Free glycerol and polyglycerol

Not more than 7 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

Definition

Description

Polyglycerol esters of polycondensed fatty acids from castor oil

Polyglycerol esters of interesterified ricinoleic acid

PGPR

Polyglycerol polyricinoleate
polyglycerol with condensed castor oil fatty acids

is prepared by the

esterification of

Clear, highly viscous liquid

L 253/110

EN

Official Journal of the European Union

20.9.2008

Identification

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]65

Between 1,4630 and 1,4665

Purity

Polyglycerols

The polyglycerol moiety shall be composed of not less than 75 % of di-,
tri- and tetraglycerols and shall contain not more than 10 % of
polyglycerols equal to or higher than heptaglycerol

Hydroxyl value

Not less than 80 and not more than 100

Acid value

Arsenic

Lead

Mercury

Cadmium

Not more than 6

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

Definition

Assay

Description

Identification

Propylene glycol esters of fatty acids

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

Content of total fatty acid ester not less than 85 %

Clear liquids or waxy white flakes, beads or solids having a bland odour

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 detectable

Free fatty acids

Not more than 6 % estimated as oleic acid

Total propane-1,2-diol

Not less than 11 % and not more than 31 %

Free propane-1,2-diol

Not more than 5 %

Dimer and trimer of propylene glycol

Not more than 0,5 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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).

20.9.2008

EN

Official Journal of the European Union

L 253/111

E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF
FATTY ACIDS

Synonyms

Definition

Description

Identification

TOSOM

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
130 oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and
diglycerides of food fatty acids. Soya bean oil is exclusively made from
natural strains of soya beans

Pale yellow to light brown a waxy or solid consistency

A. Solubility

Insoluble in water. Soluble in hot oil or fat

Purity

Melting range

Free fatty acids

Free glycerol

Total fatty acids

Total glycerol

55-65 oC

Not more than 1,5 % estimated as oleic acid

Not more than 2 %

83-90 %

16-22 %

Fatty acid methyl esters, not
adduct with urea

forming

Not 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

Arsenic

Lead

Mercury

Cadmium

Not more than 0,03 % oxirane oxygen

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 481 SODIUM STEAROYL-2-LACTYLATE

Synonyms

Definition

Sodium stearoyl lactylate

Sodium stearoyl lactate

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

Chemical formula (major components)

246-929-7

C21H39O4Na

C19H35O4Na

Description

Identification

White or slightly yellowish powder or brittle solid with a characteristic
odour

A. Positive tests for sodium, for fatty

acids and for lactic acid

B. Solubility

Insoluble in water. Soluble in ethanol

L 253/112

EN

Official Journal of the European Union

20.9.2008

Purity

Sodium

Ester value

Acid value

Not less than 2,5 % and not more than 5 %

Not less than 90 and not more than 190

Not less than 60 and not more than 130

Total lactic acid

Not less than 15 % and not more than 40 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 482 CALCIUM STEAROYL-2-LACTYLATE

Synonyms

Definition

Calcium stearoyl lactate

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

Chemical formula

Description

Identification

227-335-7

C42H78O8Ca

C38H70O8Ca

White or slightly yellowish powder or brittle solid with a characteristic
odour

A. Positive tests for calcium, for fatty

acids and for lactid acid

B. Solubility

Slightly soluble in hot water

Purity

Calcium

Ester value

Total lactic acid

Acid value

Arsenic

Lead

Mercury

Cadmium

Not less than 1 % and not more than 5,2 %

Not less than 125 and not more than 190

Not less than 15 % and not more than 40 %

Not less than 50 and not more than 130

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 483 STEARYL TARTRATE

Synonyms

Definition

Stearyl palmityl tartrate

Product of the esterification of tartaric acid with commercial stearyl
alcohol, which consists essentially of stearyl and palmityl alcohols. It
consists mainly of diester, with minor amounts of monoester and of
unchanged starting materials

Chemical name

Distearyl tartrate

Dipalmityl tartrate

20.9.2008

EN

Official Journal of the European Union

L 253/113

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for tartare

B. Melting range

Purity

Hydroxyl value

Acid value

C38H74O6 to C40H78O6

627 to 655

Content of total ester not less than 90 % corresponding to an ester value
of not less than 163 and not more than 180

Cream-coloured unctuous solid (at 25 oC)

Between 67 oC and 77 oC. After saponification the saturated long chain
fatty alcohols have a melting range of 49 oC to 55 oC

Not less than 200 and not more than 220

Not more than 5,6

Total tartaric acid content

Not less than 18 % and not more than 35 %

Sulphated ash

Not more than 0,5 % determined at 800 ± 25 oC

Arsenic

Lead

Mercury

Cadmium

Heavy metals (as Pb)

Unsaponifiable matter

Iodine value

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

Not less than 77 % and not more than 83 %

Not more than 4 (Wijs method)

E 491 SORBITAN MONOSTEARATE

Definition

Einecs

Assay

Description

Identification

A. Solubility

A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial stearic acid

215-664-9

Content not less than 95 % of a mixture of sorbitol, sorbitan, and
isosorbide esters

Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a
slight characteristic odour

Soluble at temperatures above its melting point in toluene, dioxane,
carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in
petroleum ether and acetone; insoluble in cold water but dispersible in
warm water; soluble with haze at temperatures above 50 oC in mineral
oil and ethyl acetate

B. Congealing range

50-52 oC

C.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyol

Purity

Water

Sulphated ash

Acid value

Saponification value

Hydroxyl value

Arsenic

Lead

Mercury

Cadmium

Not more than 2 % (Karl Fischer method)

Not more than 0,5 %

Not more than 10

Not less than 147 and not more than 157

Not less than 235 and not more than 260

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

L 253/114

EN

Official Journal of the European Union

20.9.2008

E 492 SORBITAN TRISTEARATE

Definition

Einecs

Assay

Description

Identification

A. Solubility

A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial stearic acid

247-891-4

Content not less than 95 % of a mixture of sorbitol, sorbitan, and
isosorbide esters

Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a
slight odour

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

Sulphated ash

Acid value

Saponification value

Hydroxyl value

Arsenic

Lead

Mercury

Cadmium

Not more than 2 % (Karl Fischer method)

Not more than 0,5 %

Not more than 15

Not less than 176 and not more than 188

Not less than 66 and not more than 80

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 493 SORBITAN MONOLAURATE

Definition

Einecs

Assay

Description

Identification

A. Solubility

A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial lauric acid

215-663-3

Content not less than 95 % of a mixture of sorbitol, sorbitan, and
isosorbide esters

Amber-coloured oily viscous liquid, light cream to tan-coloured beads or
flakes or a hard, waxy solid with a slight odour

Dispersible in hot and cold water

B.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyol

Purity

Water

Sulphated ash

Acid value

Saponification value

Hydroxyl value

Arsenic

Lead

Mercury

Cadmium

Not more than 2 % (Karl Fischer method)

Not more than 0,5 %

Not more than 7

Not less than 155 and not more than 170

Not less than 330 and not more than 358

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/115

E 494 SORBITAN MONOOLEATE

Definition

Einecs

Assay

Description

Identification

A. Solubility

B.

Iodine value

Purity

Water

Sulphated ash

Acid value

Saponification value

Hydroxyl value

Arsenic

Lead

Mercury

Cadmium

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

215-665-4

Content not less than 95 % of a mixture of sorbitol, sorbitan and
isosorbide esters

Amber-coloured viscous liquid, light cream to tan-coloured beads or
flakes or a hard, waxy solid with a slight characteristic odour

Soluble at temperatures above its melting point in ethanol, ether, ethyl
acetate,
and carbon
tetrachloride. Insoluble in cold water, dispersible in warm water

toluene, dioxane, petroleum ether

aniline,

The residue of oleic acid, obtained from the saponification of the
sorbitan monoleate in assay, has a iodine value between 80 and 100

Not more than 2 % (Karl Fischer method)

Not more than 0,5 %

Not more than 8

Not less than 145 and not more than 160

Not less than 193 and not more than 210

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 495 SORBITAN MONOPALMITATE

Synonyms

Definition

Einecs

Assay

Description

Identification

A. Solubility

Sorbitan palmitate

A mixture of the partial esters of sorbitol and its anhydrides with edible,
commercial palmitic acid

247-568-8

Content not less than 95 % of a mixture of sorbitol, sorbitan, and
isosorbide esters

Light cream to tan-coloured beads or flakes or a hard, waxy solid with a
slight characteristic odour

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

Sulphate ash

Acid value

Not more than 2 % (Karl Fischer method)

Not more than 0,5 %

Not more than 7,5

Saponification value

Not less than 140 and not more than 150

Hydroxyl value

Arsenic

Not less than 270 and not more than 305

Not more than 3 mg/kg

L 253/116

EN

Official Journal of the European Union

20.9.2008

Lead

Mercury

Cadmium

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 500(i) SODIUM CARBONATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sodium and for

carbonate

B. Solubility

Purity

Loss on drying

Arsenic

Lead

Mercury

Soda ash

Sodium carbonate

207-838-8

Na2CO3 · nH2O (n = 0, 1 or 10)

106,00 (anhydrous)

Content not less than 99 % of Na2CO3 on the anhydrous basis

Colourless crystals or white, granular or crystalline powder

The anhydrous form is hygroscopic, the decahydrate efflorescent

Freely soluble in water. Insoluble in ethanol

Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 %
(decahydrate) (70 oC raising gradually to 300 oC, to constant weight)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 500(ii) SODIUM HYDROGEN CARBONATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking
soda

Sodium hydrogen carbonate

205-633-8

NaHCO3

84,01

Content not less than 99 % on the anhydrous basis

Colourless or white crystalline masses or crystalline powder

A. Positive tests for sodium and for

carbonate

B. pH of a 1 % solution

Between 8,0 and 8,6

C. Solubility

Soluble in water. Insoluble in ethanol

Purity

Loss on drying

Ammonium salts

Not more than 0,25 % (over silica gel, 4h)

No odour of ammonia detectable after heating

20.9.2008

EN

Official Journal of the European Union

L 253/117

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 500(iii) SODIUM SESQUICARBONATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium monohydrogen dicarbonate

208-580-9

Na2(CO)3 · NaHCO3 · 2H2O

226,03

Content between 35,0 % and 38,6 % of NaHCO3 and between 46,4 %
and 50,0 % of Na2CO3

White flakes, crystals or crystalline powder

A. Positive tests for sodium and for

carbonate

B. Solubility

Purity

Sodium chloride

Iron

Arsenic

Lead

Mercury

Freely soluble in water

Not more than 0,5 %

Not more than 20 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 501(i) POTASSIUM CARBONATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium carbonate

209-529-3

K2CO3 · nH2O (n = 0 or 1,5)

138,21 (anhydrous)

Content not less than 99,0 % on the anhydrous basis

White, very deliquescent powder.

The hydrate occurs as small, white, translucent crystals or granules

A. Positive tests for potassium and for

carbonate

B. Solubility

Very soluble in water. Insoluble in ethanol

Purity

Loss on drying

Not more than 5 % (anhydrous) or 18 % (hydrate) (180 oC, 4h)

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L 253/118

EN

Official Journal of the European Union

20.9.2008

E 501(ii) POTASSIUM HYDROGEN CARBONATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium bicarbonate, acid potassium carbonate

Potassium hydrogen carbonate

206-059-0

KHCO3

100,11

Content not less than 99,0 % and not more than 101,0 % KHCO3 on the
anhydrous basis

Colourless crystals or white powder or granules

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

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

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Ammonium carbonate

233-786-0

CH6N2O2, CH8N2O3 and CH5NO3

Ammonium carbamate 78,06; ammonium carbonate 98,73; ammo-
nium hydrogen carbonate 79,06

Content not less than 30,0 % and not more than 34,0 % of NH3

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

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/kg

Chlorides

Sulphate

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/119

E 503(ii) AMMONIUM HYDROGEN CARBONATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Ammonium bicarbonate

Ammonium hydrogen carbonate

213-911-5

CH5NO3

79,06

Content not less than 99,0 %

White crystals or crystalline powder

A. Positive tests for ammonium and for

carbonate

B. pH of a 5 % solution

about 8,0

C. Solubility

Freely soluble in water. Insoluble in ethanol

Purity

Non-volatile matter

Not more than 500 mg/kg

Chlorides

Sulphate

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 504(ii) MAGNESIUM HYDROXIDE CARBONATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Magnesium hydrogen carbonate, magnesium subcarbonate (light or
heavy), hydrated basic magnesium carbonate, magnesium carbonate
hydroxide

Magnesium carbonate hydroxide hydrated

235-192-7

4MgCO3Mg(OH)25H2O

485

Mg content not less than 40,0 % and not more than 45,0 % calculated as
MgO

Light, white friable mass or bulky white powder

A. Positive tests for magnesium and for

carbonate

B. Solubility

Practically insoluble in water. Insoluble in ethanol

Purity

Acid insoluble matter

Water soluble matter

Calcium

Arsenic

Lead

Mercury

Not more than 0,05 %

Not more than 1,0 %

Not more than 1,0 %

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

L 253/120

EN

Official Journal of the European Union

20.9.2008

E 507 HYDROCHLORIC ACID

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Hydrogen chloride, muriatic acid

Hydrochloric acid

231-595-7

HCl

36,46

Hydrochloric acid is commercially available in varying concentrations.
Concentrated hydrochloric acid contains not less than 35,0 % HCl

Clear, colourless or slightly yellowish, corrosive liquid having a pungent
odour

A. Positive tests for acid and for chloride

B. Solubility

Soluble in water and in ethanol

Purity

Total organic compounds

Non-volatile matter

Reducing substances

Oxidising substances

Sulphate

Iron

Arsenic

Lead

Mercury

E 508 POTASSIUM CHLORIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formulae

Molecular weight

Assay

Description

Identification

A. Solubility

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

Not more than 0,5 %

Not more than 70 mg/kg (as SO2)

Not more than 30 mg/kg (as Cl2)

Not more than 0,5 %

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Sylvine

Sylvite

Potassium chloride

231-211-8

KCl

74,56

Content not less than 99 % on the dried basis

Colourless, elongated, prismatic or cubital crystals or white granular
powder. Odourless

Freely soluble in water. Insoluble in ethanol

B. Positive tests for potassium and for

chloride

Purity

Loss on drying

Sodium

Arsenic

Not more than 1 % (105 oC, 2 hours)

Negative test

Not more than 3 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/121

Lead

Mercury

Cadmium

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 509 CALCIUM CHLORIDE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium chloride

233-140-8

CaCl2 · nH2O (n = 0,2 or 6)

110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)

Content not less than 93,0 % on the anhydrous basis

White, odourless, hygroscopic powder or deliquescent crystals

A. Positive tests for calcium and for

chloride

B. Solubility

Anhydrous calcium chloride: freely soluble in water and ethanol

Dihydrate: freely soluble in water, soluble in ethanol

Hexahydrate: very soluble in water and ethanol

Purity

Magnesium and alkali salts

Not more than 5 % on the anhydrous basis

Fluoride

Arsenic

Lead

Mercury

Not more than 40 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

E 511 MAGNESIUM CHLORIDE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Magnesium chloride

232-094-6

MgCl2 · 6H2O

203,30

Content not less than 99,0 %

Colourless, odourless, very deliquescent flakes or crystals

A. Positive tests for magnesium and for

chloride

B. Solubility

Very soluble in water, freely soluble in ethanol

Purity

Ammonium

Arsenic

Lead

Mercury

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

L 253/122

EN

Official Journal of the European Union

20.9.2008

E 512 STANNOUS CHLORIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Tin chloride, tin dichloride

Stannous chloride dihydrate

231-868-0

SnCl2 · 2H2O

225,63

Content not less than 98,0 %

Colourless or white crystals

May have a slight odour of hydrochloric acid

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

Purity

Sulphate

Arsenic

Mercury

Lead

E 513 SULPHURIC ACID

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Ethanol: soluble

Not more than 30 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

Oil of vitriol, dihydrogen sulphate

Sulphuric acid

231-639-5

H2SO4

98,07

Sulphuric acid is commercially available in varying concentrations. The
concentrated form contains not less than 96,0 %

Clear, colourless or slightly brown, very corrosive oily liquid

A. Positive tests for acid and for sul-

phate

B. Solubility

Purity

Ash

Miscible with water, with generation of much heat, also with ethanol

Not more than 0,02 %

Reducing matter

Not more than 40 mg/kg (as SO2)

Nitrate

Chloride

Iron

Selenium

Arsenic

Lead

Mercury

Not more than 10 mg/kg (on H2SO4 basis)

Not more than 50 mg/kg

Not more than 20 mg/kg

Not more than 20 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/123

E 514(i) SODIUM SULPHATE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

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

Selenium

Arsenic

Lead

Mercury

E 514(ii) SODIUM HYDROGEN SULPHATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium sulphate

Na2SO4 · nH2O (n = 0 or 10)

142,04 (anhydrous)

322,04 (decahydrate)

Content not less than 99,0 % on the anhydrous basis

Colourless crystals or a fine, white, crystalline powder

The decahydrate is efflorescent

Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate)
at 130 °C

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Acid sodium sulphate, sodium bisulphate, nitre cake

Sodium hydrogen sulphate

NaHSO4

120,06

Content not less than 95,2 %

White, odourless crystals or granules

A. Positive tests for sodium and for

sulphate

B. Solutions are strongly acidic

Purity

Loss on drying

Water insoluble

Selenium

Arsenic

Lead

Mercury

Not more than 0,8 %

Not more than 0,05 %

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L 253/124

EN

Official Journal of the European Union

20.9.2008

E 515(i) POTASSIUM SULPHATE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium sulphate

K2SO4

174,25

Content not less than 99,0 %

Colourless or white crystals or crystalline powder

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

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 515(ii) POTASSIUM HYDROGEN SULPHATE

Definition

Synonyms

Chemical name

Chemical formula

Molecular weight

Assay

Melting point

Description

Identification

Potassium bisulphate, potassium acid sulphate

Potassium hydrogen sulphate

KHSO4

136,17

Content not less than 99 %

197 oC

White deliquescent crystals, pieces or granules

A. Positive test for potassium

B. Solubility

Freely soluble in water, insoluble in ethanol

Purity

Selenium

Arsenic

Lead

Mercury

E 516 CALCIUM SULPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Gypsum, selenite, anhydrite

Calcium sulphate

231-900-3

CaSO4 · nH2O (n = 0 or 2)

136,14 (anhydrous), 172,18 (dihydrate)

Content not less than 99,0 % on the anhydrous basis

20.9.2008

EN

Official Journal of the European Union

L 253/125

Description

Identification

A. Positive tests for calcium and for

sulphate

Fine, white to slightly yellowish-white odourless powder

B. Solubility

Slightly soluble in water, insoluble in ethanol

Purity

Loss on drying

Anhydrous: not more than 1,5 % (250 oC, constant weight)

Fluoride

Selenium

Arsenic

Lead

Mercury

Dihydrate: not more than 23 % (ibid.)

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 517 AMMONIUM SULPHATE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for ammonium and for

sulphate

B. Solubility

Purity

Loss on ignition

Selenium

Lead

E 520 ALUMINIUM SULPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for aluminium and for

sulphate

B. pH of a 5 % solution 2,9 or above

Ammonium sulphate

231-984-1

(NH4)2SO4

132,14

Content not less than 99,0 % and not more than 100,5 %

White powder, shining plates or crystalline fragments

Freely soluble in water, insoluble in ethanol

Not more than 0,25 %

Not more than 30 mg/kg

Not more than 5 mg/kg

Alum

Aluminium sulphate

233-135-0

Al2(SO4)3

342,13

Content not less than 99,5 % on the ignited basis

White powder, shining plates or crystalline fragments

C. Solubility

Freely soluble in water, insoluble in ethanol

L 253/126

EN

Official Journal of the European Union

20.9.2008

Purity

Loss on ignition

Not more than 5 % (500 oC, 3h)

Alkalies and alkaline earths

Not more than 0,4 %

Selenium

Fluoride

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

E 521 ALUMINIUM SODIUM SULPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests

for aluminium,

sodium and for sulphate

B. Solubility

Purity

Soda alum, sodium alum

Aluminium sodium sulphate

233-277-3

AlNa(SO4)2 · nH2O (n = 0 or 12)

242,09 (anhydrous)

Content on the anhydrous basis not less than 96,5 % (anhydrous) and
99,5 % (dodecahydrate)

Transparent crystals or white crystalline powder

for

Dodecahydrate is freely soluble in water. The anhydrous form is slowly
soluble in water. Both forms are insoluble in ethanol

Loss on drying

Anhydrous form: not more than 10,0 % (220 oC, 16h)

Dodecahydrate: not more than 47,2 % (50 oC-55 oC, 1h then 200 oC,
16h)

Ammonium salts

No odour of ammonia detectable after heating

Selenium

Fluoride

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 522 ALUMINIUM POTASSIUM SULPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests

for aluminium,

potassium and for sulphate

Potassium alum, potash alum

Aluminium potassium sulphate dodecahydrate

233-141-3

AlK(SO4)2 · 12 H2O

474,38

Content not less than 99,5 %

Large, transparent crystals or white crystalline powder

for

20.9.2008

EN

Official Journal of the European Union

L 253/127

B. pH of a 10 % solution between 3,0

and 4,0

C. Solubility

Freely soluble in water, insoluble in ethanol

Purity

Ammonium salts

No odour of ammonia detectable after heating

Selenium

Fluoride

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 523 ALUMINIUM AMMONIUM SULPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Ammonium alum

Aluminium ammonium sulphate

232-055-3

AlNH4(SO4)2 · 12 H2O

453,32

Content not less than 99,5 %

Large, colourless crystals or white powder

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

Fluoride

Arsenic

Lead

Mercury

E 524 SODIUM HYDROXIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Caustic soda, lye

Sodium hydroxide

215-185-5

NaOH

40,0

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

White or nearly white pellets, flakes, sticks, fused masses or other forms.
Solutions are clear or slightly turbid, colourless or slightly coloured,
strongly caustic and hygroscopic and when exposed to the air they
absorb carbon dioxide, forming sodium carbonate

L 253/128

EN

Official Journal of the European Union

20.9.2008

Identification

A. Positive tests for sodium

B. A 1 % solution is strongly alkaline

C. Solubility

Very soluble in water. Freely soluble in ethanol

Purity

Water insoluble and organic matter

A 5 % solution is completely clear and colourless to slightly coloured

Carbonate

Arsenic

Lead

Mercury

Not more than 0,5 % (as Na2CO3)

Not more than 3 mg/kg

Not more than 0,5 mg/kg

Not more than 1 mg/kg

E 525 POTASSIUM HYDROXIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Caustic potash

Potassium hydroxide

215-181-3

KOH

56,11

Content not less than 85,0 % of alkali calculated as KOH

White or nearly white pellets, flakes, sticks, fused masses or other forms

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

Arsenic

Lead

Mercury

Not more than 3,5 % (as K2CO3)

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

E 526 CALCIUM HYDROXIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Slaked lime, hydrated lime

Calcium hydroxide

215-137-3

Ca(OH)2

74,09

Content not less than 92,0 %

20.9.2008

EN

Official Journal of the European Union

L 253/129

Description

Identification

A. Positive
calcium

B. Solubility

Purity

White powder

tests

for alkali and for

Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol

Acid insoluble ash

Magnesium and alkali salts

Barium

Fluoride

Arsenic

Lead

Not more than 1,0 %

Not more than 1,0 %

Not more than 300 mg/kg

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

E 527 AMMONIUM HYDROXIDE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Aqua ammonia, strong ammonia solution

Ammonium hydroxide

NH4OH

35,05

Content not less than 27 % of NH3

Clear, colourless solution, having an exceedingly pungent, characteristic
odour

A. Positive tests for ammonia

Purity

Non-volatile matter

Arsenic

Lead

Not more than 0,02 %

Not more than 3 mg/kg

Not more than 5 mg/kg

E 528 MAGNESIUM HYDROXIDE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Magnesium hydroxide

215-170-3

Mg(OH)2

58,32

Content not less than 95,0 % on the anhydrous basis

Odourless, white bulky powder

A. Positive test for magnesium and for

alkali

B. Solubility

Practically insoluble in water and in ethanol

L 253/130

EN

Official Journal of the European Union

20.9.2008

Purity

Loss on drying

Loss on ignition

Calcium oxide

Arsenic

Lead

E 529 CALCIUM OXIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 2,0 % (105 oC, 2h)

Not more than 33 % (800 oC to constant weight)

Not more than 1,5 %

Not more than 3 mg/kg

Not more than 10 mg/kg

Burnt lime

Calcium oxide

215-138-9

CaO

56,08

Content not less than 95,0 % on the ignited basis

Odourless, hard, white or greyish white masses of granules, or white to
greyish powder

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

Acid insoluble matter

Barium

Not more than 10,0 % (ca 800 oC to constant weight)

Not more than 1,0 %

Not more than 300 mg/kg

Magnesium and alkali salts

Not more than 1,5 %

Fluoride

Arsenic

Lead

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

E 530 MAGNESIUM OXIDE

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Magnesium oxide

215-171-9

MgO

40,31

Content not less than 98,0 % on the ignited basis

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

A. Positive

test

for

alkali

and for

magnesium

B. Solubility

Practically insoluble in water. Insoluble in ethanol

20.9.2008

EN

Official Journal of the European Union

L 253/131

Purity

Loss on ignition

Calcium oxide

Arsenic

Lead

Not more than 5,0 % (ca 800 oC to constant weight)

Not more than 1,5 %

Not more than 3 mg/kg

Not more than 10 mg/kg

E 535 SODIUM FERROCYANIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test
ferrocyanide

for

sodium and for

Purity

Free moisture

Water insoluble matter

Chloride

Sulphate

Free cyanide

Ferricyanide

Lead

E 536 POTASSIUM FERROCYANIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Yellow prussiate of soda, sodium hexacyanoferrate

Sodium ferrocyanide

237-081-9

Na4Fe(CN)6 · 10 H2O

484,1

Content not less than 99,0 %

Yellow crystals or crystalline powder

Not more than 1,0 %

Not more than 0,03 %

Not more than 0,2 %

Not more than 0,1 %

Not detectable

Not detectable

Not more than 5 mg/kg

Yellow prussiate of potash, potassium hexacyanoferrate

Potassium ferrocyanide

237-722-2

K4Fe(CN)6· 3 H2O

422,4

Content not less than 99,0 %

Lemon yellow crystals

A. Positive test for potassium and for

ferrocyanide

Purity

Free moisture

Water insoluble matter

Chloride

Sulphate

Free cyanide

Not more than 1,0 %

Not more than 0,03 %

Not more than 0,2 %

Not more than 0,1 %

Not detectable

L 253/132

EN

Official Journal of the European Union

20.9.2008

Ferricyanide

Lead

Not detectable

Not more than 5 mg/kg

E 538 CALCIUM FERROCYANIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test
ferrocyanide

for calcium and for

Purity

Free moisture

Water insoluble matter

Chloride

Sulphate

Free cyanide

Ferricyanide

Lead

Yellow prussiate of lime, calcium hexacyanoferrate

Calcium ferrocyanide

215-476-7

Ca2Fe(CN)6 · 12H2O

508,3

Content not less than 99,0 %

Yellow crystals or crystalline powder

Not more than 1,0 %

Not more than 0,03 %

Not more than 0,2 %

Not more than 0,1 %

Not detectable

Not detectable

Not more than 5 mg/kg

E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

SALP

Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A)
or

Trisodium dialuminium pentadecahydrogen octaphosphate (B)

232-090-4

NaAl3H14(PO4)8 · 4H2O (A)

Na3Al2H15(PO4)8 (B)

949,88 (A)

897,82 (B)

Content not less than 95,0 % (both forms)

White odourless powder

A. Positive test for sodium, for alumi-

nium and for phosphate

B. pH

C. Solubility

Purity

Acid to litmus

Insoluble in water. Soluble in hydrochloric acid

Loss on ignition

19,5 %-21,0 % (A) } (750 oC-800 oC, 2h)

15 %-16 % (B) } (750 oC-800 oC, 2h)

Fluoride

Not more than 25 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/133

Arsenic

Lead

Cadmium

Mercury

Not more than 3 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 551 SILICON DIOXIDE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Silica, silicium dioxide

Silicon dioxide is an amorphous
substance, which is produced
synthetically by either a vapour-phase hydrolysis process, yielding
fumed silica, or by a wet process, yielding precipitated silica, silica gel, or
hydrous silica. Fumed silica is produced in essentially an anhydrous state,
whereas the wet-process products are obtained as hydrates or contain
surface absorbed water

Silicon dioxide

231-545-4

(SiO2)n

60,08 (SiO2)

Content after ignition not less than 99,0 % (fumed silica) or 94,0 %
(hydrated forms)

Description

White, fluffy powder or granules

Hygroscopic

Identification

A. Positive test for silica

Purity

Loss on drying

Not more than 2,5 % (fumed silica, 105 oC, 2h)

Not more than 8,0 % (precipitated silica and silica gel, 105 oC, 2h)

Not more than 70 % (hydrous silica, 105 oC, 2h)

Loss on ignition

Not more than 2,5 % after drying (1 000 oC, fumed silica)

Not more than 8,5 % after drying (1 000 oC, hydrated forms)

Soluble ionisable salts

Not more than 5,0 % (as Na2SO4)

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 552 CALCIUM SILICATE

Definition

Chemical name

Einecs

Assay

Description

Calcium silicate is a hydrous or anhydrous silicate with varying
proportions of CaO and SiO2

Calcium silicate

215-710-8

Content on the anhydrous basis:

— as SiO2 not less than 50 % and not more than 95 %

— as CaO not less than 3 % and not more than 35 %

White to off-white free-flowing powder that remains so after absorbing
relatively large amounts of water or other liquids

L 253/134

EN

Official Journal of the European Union

20.9.2008

Identification

A. Positive test
calcium

for

silicate and for

B.

Forms a gel with mineral acids

Purity

Loss on drying

Loss on ignition

Sodium

Fluoride

Arsenic

Lead

Mercury

Not more than 10 % (105 oC, 2h)

Not less than 5 % and not more than 14 % (1 000 oC, constant weight)

Not more than 3 %

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 553a(i) MAGNESIUM SILICATE

Definition

Assay

Description

Identification

Magnesium silicate is a synthetic compound of which the molar ratio of
magnesium oxide to silicon dioxide is approximately 2:5

Content not less than 15 % of MgO and not less than 67 % of SiO2 on
the ignited basis

Very fine, white, odourless powder, free from grittiness

A. Positive test for magnesium and for

silicate

B. pH of a 10 % slurry

Between 7,0 and 10,8

Purity

Loss on drying

Loss on ignition

Water soluble salts

Free alkali

Fluoride

Arsenic

Lead

Mercury

Not more than 15 % (105 oC, 2h)

Not more than 15 % after drying (1 000 oC, 20 min)

Not more than 3 %

Not more than 1 % (as NaOH)

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 553a(ii) MAGNESIUM TRISILICATE

Definition

Chemical name

Chemical formula

Einecs

Assay

Description

Identification

Magnesium trisilicate

Mg2Si3O8 · xH2O (approximate composition)

239-076-7

Content not less than 29,0 % of MgO and not less than 65,0 % of SiO2
both on the ignited basis

Fine, white powder, free from grittiness

A. Positive test for magnesium and for

silicate

B. pH of a 5 % slurry

Between 6,3 and 9,5

20.9.2008

EN

Official Journal of the European Union

L 253/135

Purity

Loss on ignition

Water soluble salts

Free alkali

Fluoride

Arsenic

Lead

Mercury

E 553b TALC

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Description

Identification

A.

IR absorption

B. X-ray diffraction

C. Solubility

Purity

Loss on drying

Acid-soluble matter

Water-soluble matter

Acid-soluble iron

Arsenic

Lead

Not less than 17 % and not more than 34 % (1 000 oC)

Not more than 2 %

Not more than 1 % (as NaOH)

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Talcum

Naturally occurring form of hydrous magnesium silicate containing
varying proportions of such associated minerals as alpha-quartz, calcite,
chlorite, dolomite, magnesite, and phlogopite

Magnesium hydrogen metasilicate

238-877-9

Mg3(Si4O10)(OH)2

379,22

Light, homogeneous, white or almost white powder, greasy to the touch

Characteristic peaks at 3 677, 1 018 and 669 cm-1

Peaks at 9,34/4,66/3,12 Å

Insoluble in water and ethanol

Not more than 0,5 % (105 oC, 1h)

Not more than 6 %

Not more than 0,2 %

Not detectable

Not more than 10 mg/kg

Not more than 5 mg/kg

E 554 SODIUM ALUMINIUM SILICATE

Synonyms

Definition

Chemical name

Assay

Description

Identification

Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium
silicate

Sodium aluminium silicate

Content on the anhydrous basis:

— as SiO2 not less than 66,0 % and not more than 88,0 %

— as Al2O3 not less than 5,0 % and not more than 15,0 %

Fine white amorphous powder or beads

A. Positive tests for sodium, for alumi-

nium and for silicate

B. pH of a 5 % slurry

Between 6,5 and 11,5

L 253/136

EN

Official Journal of the European Union

20.9.2008

Purity

Loss on drying

Loss on ignition

Sodium

Arsenic

Lead

Mercury

Not more than 8,0 % (105 oC, 2h)

Not less than 5,0 % and not more than 11,0 % on the anhydrous basis
(1 000 oC, constant weight)

Not less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous
basis

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 555 POTASSIUM ALUMINIUM SILICATE

Synonyms

Definition

Einecs

Chemical name

Chemical formulae

Molecular weight

Assay

Description

Identification

Mica

Natural mica
(muscovite)

310-127-6

consists of mainly potassium aluminium silicate

Potassium aluminium silicate

KAl2[AlSi3O10](OH)2

398

Content not less than 98 %

Light grey to white crystalline platelets or powder

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

Zinc

Barium

Chromium

Copper

Nickel

Arsenic

Mercury

Cadmium

Lead

Not more than 20 mg/kg

Not more than 25 mg/kg

Not more than 25 mg/kg

Not more than 100 mg/kg

Not more than 25 mg/kg

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 10 mg/kg

E 556 CALCIUM ALUMINIUM SILICATE

Synonyms

Definition

Chemical name

Assay

Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium
silicate

Calcium aluminium silicate

Content on the anhydrous basis:

— as SiO2 not less than 44,0 % and not more than 50,0 %

— as Al2O3 not less than 3,0 % and not more than 5,0 %

— as CaO not less than 32,0 % and not more than 38,0 %

20.9.2008

EN

Official Journal of the European Union

L 253/137

Description

Identification

A. Positive tests for calcium, for alumi-

nium and for silicate

Fine white, free-flowing powder

Purity

Loss on drying

Loss on ignition

Fluoride

Arsenic

Lead

Mercury

E 558 BENTONITE

Definition

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Methylene blue test

B. X-Ray diffraction

C.

IR absorption

Purity

Loss on drying

Arsenic

Lead

Not more than 10,0 % (105 oC, 2h)

Not less than 14,0 % and not more than 18,0 on the anhydrous basis
(1 000 oC, constant weight)

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

is

a natural

Bentonite
clay containing a high proportion of
montmorillonite, a native hydrated aluminium silicate in which some
aluminium and silicon atoms were naturally replaced by other atoms
such as magnesium and iron. Calcium and sodium ions are trapped
between the mineral layers. There are four common types of bentonite:
natural sodium bentonite, natural calcium bentonite, sodium-activated
bentonite and acid-activated bentonite

215-108-5

(Al, Mg)8(Si4O10) 4(OH)8 · 12H2O

819

Montmorillonite content not less than 80 %

Very fine, yellowish or greyish white powder or granules. The structure
of bentonite allows it to absorb water in its structure and on its external
surface (swelling properties)

Characteristic peaks at 12,5/15 A

Peaks at 428/470/530/1 110-1 020/3 750 — 3 400 cm-1

Not more than 15,0 % (105 oC, 2h)

Not more than 2 mg/kg

Not more than 20 mg/kg

E 559 ALUMINIUM SILICATE (KAOLIN)

Synonyms

Definition

Kaolin, light or heavy

is a purified white plastic clay
Aluminium silicate hydrous (kaolin)
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
for human
consumption

injurious to health or unfit

Einecs

Chemical formula

Molecular weight

215-286-4 (kaolinite)

Al2Si2O5(OH)4 (kaolinite)

264

L 253/138

EN

Official Journal of the European Union

20.9.2008

Assay

Content not less than 90 % (sum of silica and alumina, after ignition)

Silica (SiO2)

Between 45 % and 55 %

Alumina (Al2O3)

Between 30 % and 39 %

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

Description

Identification

A. Positive tests for alumina and for

silicate

B. X-ray diffraction:

C.

IR absorption:

Purity

Loss on ignition

Water soluble matter

Acid soluble matter

Iron

Potassium oxide (K2O)

Carbon

Arsenic

Lead

Mercury

E 570 FATTY ACIDS

Definition

Chemical name

Assay

Description

Identification

A.

Individual fatty acids can be identi-
fied by acid value, iodine value, gas
chromatog-raphy
and molecular
weight

Purity

Residue on ignition

Unsaponifiable matter

Water

Arsenic

Lead

Mercury

E 574 GLUCONIC ACID

Synonyms

Definition

Characteristic peaks at 7,18/3,58/2,38/1,78 Å

Peaks at 3 700 and 3 620 cm-1

Between 10 and 14 % (1 000 oC, constant weight)

Not more than 0,3 %

Not more than 2 %

Not more than 5 %

Not more than 5 %

Not more than 0,5 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Linear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12),
myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)

octanoic acid (C8), decanoic acid (C10), dodecanoic acid (C12),
tetradecanoic acid (C14), hexadecanoic acid (C16), octadecanoic acid
(C18), 9-octadecenoic acid (C18:1)

Not less than 98 % by chromatography

A colourless liquid or white solid obtained from oils and fats

Not more than 0,1 %

Not more than 1,5 %

Not more than 0,2 % (Karl Fischer method)

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

D-gluconic acid, dextronic acid

Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-
lactone

Chemical name

Gluconic acid

20.9.2008

EN

Official Journal of the European Union

L 253/139

Chemical formula

Molecular weight

C6H12O7 (gluconic acid)

196,2

Assay

Description

Identification

Content not less than 50,0 % (as gluconic acid)

Colourless to light yellow, clear syrupy liquid

A. Formation of phenylhydrazine deri-

vative positive

Compound formed melts between 196 oC and 202 oC with decom-
position

Purity

Residue on ignition

Reducing matter

Chloride

Sulphate

Sulphite

Arsenic

Lead

Mercury

Not more than 1,0 %

Not more than 0,75 % (as D-glucose)

Not more than 350 mg/kg

Not more than 240 mg/kg

Not more than 20 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 575 GLUCONO-DELTA-LACTONE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolac-
tone

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

D-Glucono-1,5-lactone

202-016-5

C6H10O6

178,14

Content not less than 99,0 % on the anhydrous basis

Fine, white, nearly odourless, crystalline powder

A. Formation of phenylhydrazine deri-
vative of gluconic acid positive

Compound formed melts between 196 oC and 202 oC with decom-
position

B. Solubility

C. Melting point

Purity

Water

Freely soluble in water. Sparingly soluble in ethanol

152 oC ± 2 oC

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

Definition

Chemical name

Einecs

Chemical formula

Sodium salt of D-gluconic acid

Sodium D-gluconate

208-407-7

C6H11NaO7 (anhydrous)

L 253/140

EN

Official Journal of the European Union

20.9.2008

Molecular weight

218,14

Assay

Description

Identification

Content not less than 98,0 %

White to tan, granular to fine, crystalline powder

for

sodium and for

A. Positive test
gluconate

B. Solubility

Very soluble in water. Sparingly soluble in ethanol

C. pH of a 10 % solution

Between 6,5 and 7,5

Purity

Reducing matter

Lead

Not more than 1,0 % (as D-glucose)

Not more than 2 mg/kg

E 577 POTASSIUM GLUCONATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium salt of D-gluconic acid

Potassium D-gluconate

206-074-2

C6H11KO7 (anhydrous)

C6H11KO7 · H2O (monohydrate)

234,25 (anhydrous)

252,26 (monohydrate)

Content not less than 97,0 % and not more than 103,0 % on dried basis

Odourless, free flowing white to yellowish white, crystalline powder or
granules

A. Positive test for potassium and for

gluconate

B. pH of a 10 % solution

Between 7,0 and 8,3

Purity

Loss on drying

Anhydrous: not more than 3,0 % (105 oC, 4h, vacuum)

Monohydrate: not less than 6 % and not more than 7,5 % (105 oC, 4h,
vacuum)

Reducing substances

Not more than 1,0 % (as D-glucose)

Lead

Not more than 2 mg/kg

E 578 CALCIUM GLUCONATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Calcium salt of D-gluconic acid

Calcium di-D-gluconate

206-075-8

C12H22CaO14 (anhydrous)

C12H22CaO14 · H2O (monohydrate)

430,38 (anhydrous form)

448,39 (monohydrate)

20.9.2008

EN

Official Journal of the European Union

L 253/141

Assay

Description

Identification

Content not
anhydrous and monohydrate basis

less than 98,0 % and not more than 102 % on the

Odourless, white crystalline granules or powder, stable in air

for calcium and for

A. Positive test
gluconate

B. Solubility

Soluble in water, insoluble in ethanol

C. pH of a 5 % solution

Between 6,0 and 8,0

Purity

Loss on drying

Not more than 3,0 % (105 oC, 16h) (anhydrous)

Not more than 2,0 % (105 oC, 16h) (monohydrate)

Reducing substances

Not more than 1,0 % (as D-glucose)

Lead

Not more than 2 mg/kg

E 579 FERROUS GLUCONATE

Definition

Chemical name

Einecs

Chemical formulae

Molecular weight

Assay

Description

Identification

A. Solubility

Ferrous di-D-gluconate dihydrate

Iron(II) di-gluconate dihydrate

206-076-3

C12H22FeO14·2H2O

482,17

Content not less than 95 % on the dried basis

Pale greenish-yellow to yellowish-grey powder or granules, which may
have a faint odour of burnt sugar

Soluble with slight heating in water. Practically insoluble in ethanol

B. Positive test for ferrous ion

C.

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

Iron (Fe III)

Arsenic

Lead

Mercury

Cadmium

Not detectable

Not more than 2 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Reducing substances

Not more than 0,5 % expressed as glucose

E 585 FERROUS LACTATE

Synonyms

Iron(II) lactate

Iron(II) 2-hydroxy propanoate

Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)

L 253/142

EN

Official Journal of the European Union

20.9.2008

Definition

Chemical name

Einecs

Chemical formulae

Molecular weight

Assay

Description

Identification

A. Solubility

Ferrous 2-hydroxy propanoate

227-608-0

C6H10FeO6·xH2O (x = 2 or 3)

270,02 (dihydrate)

288,03 (trihydrate)

Content not less than 96 % on the dried basis

Greenish-white crystals or light green powder having a characteristic
smell

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

Iron (Fe III)

Arsenic

Lead

Mercury

Cadmium

E 586 4-HEXYLRESORCINOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Nitric acid test

C. Bromine test

Not more than 18 % (100 oC, under vacuum, approximately 700 mm
Hg)

Not more than 0,6 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

4-Hexyl-1,3-benzenediol

Hexylresorcinol

4-Hexylresorcinol

205-257-4

C12H18O2

197,24

Not less than 98 % on the dried basis

White powder

Freely soluble in ether and acetone; very slightly soluble in water

To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A
light red colour appears

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

Sulphated ash

Not more than 0,05 %

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 blue
colour is produced

Nickel

Lead

Mercury

Not more than 2 mg/kg

Not more than 2 mg/kg

Not more than 3 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/143

E 620 GLUTAMIC ACID

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

L-Glutamic acid, L-α-aminoglutaric acid

L-Glutamic acid, L-2-amino-pentanedioic acid

200-293-7

C5H9NO4

147,13

Content not less than 99,0 % and not more than 101,0 % on the
anhydrous basis

White crystals or crystalline powder

A. Positive test for glutamic acid by thin

layer chromatography

B. Specific rotation [α]D20

Between + 31,5o and + 32,2o

C. pH of a saturated solution

Between 3,0 and 3,5

(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

Purity

Loss on drying

Sulphated ash

Chloride

Not more than 0,2 % (80 oC, 3h)

Not more than 0,2 %

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

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for sodium

Sodium glutamate, MSG

Monosodium L-glutamate monohydrate

205-538-1

C5H8NaNO4 · H2O

187,13

Content not less than 99,0 % and not more than 101,0 % on the
anhydrous basis

White, practically odourless crystals or crystalline powder

B. Positive test

for glutamic acid by

thin-layer chromatography

C. Specific rotation [α]D

20

Between + 24,8o and + 25,3o

(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

D. pH of a 5 % solution

Between 6,7 and 7,2

Purity

Loss on drying

Chloride

Not more than 0,5 % (98 oC, 5h)

Not more than 0,2 %

Pyrrolidone carboxylic acid

Not more than 0,2 %

Lead

Not more than 2 mg/kg

L 253/144

EN

Official Journal of the European Union

20.9.2008

E 622 MONOPOTASSIUM GLUTAMATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for potassium

Potassium glutamate, MPG

Monopotassium L-glutamate monohydrate

243-094-0

C5H8KNO4 · H2O

203,24

Content not less than 99,0 % and not more than 101,0 % on the
anhydrous basis

White, practically odourless crystals or crystalline powder

B. Positive test

for glutamic acid by

thin-layer chromatog-raphy

C. Specific rotation [α]D

20

Between + 22,5o and + 24,0o

(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

D. pH of a 2 % solution

Between 6,7 and 7,3

Purity

Loss on drying

Chloride

Not more than 0,2 % (80 oC, 5h)

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

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for calcium

Calcium glutamate

Monocalcium di-L-glutamate

242-905-5

C10H16CaN2O8 · x H2O (x = 0, 1, 2 or 4)

332,32 (anhydrous)

Content not less than 98,0 % and not more than 102,0 % on the
anhydrous basis

White, practically odourless crystals or crystalline powder

B. Positive test

for glutamic acid by

thin-layer chromatog-raphy

C. Specific rotation [α]D

20

Between + 27,4 and + 29,2 (for calcium diglutamate with x = 4) (10 %
solution (anhydrous basis) in 2N HCl, 200 mm tube)

Purity

Water

Chloride

Not more than 19,0 % (for calcium diglutamate with x = 4) (Karl Fischer)

Not more than 0,2 %

Pyrrolidone carboxylic acid

Not more than 0,2 %

Lead

Not more than 2 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/145

E 624 MONOAMMONIUM GLUTAMATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for ammonium

Ammonium glutamate

Monoammonium L-glutamate monohydrate

231-447-1

C5H12N2O4 · H2O

182,18

Content not less than 99,0 % and not more 101,0 % on the anhydrous
basis

White, practically odourless crystals or crystalline powder

B. Positive test

for glutamic acid by

thin-layer chromatog-raphy

C. Specific rotation [α]D

20

Between + 25,4o and + 26,4o

(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

D. pH of a 5 % solution

Between 6,0 and 7,0

Purity

Loss on drying

Sulphated ash

Not more than 0,5 % (50 oC, 4h)

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

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for magnesium

Magnesium glutamate

Monomagnesium di-L-glutamate tetrahydrate

242-413-0

C10H16MgN2O8 · 4H2O

388,62

Content not less than 95,0 % and not more than 105,0 % on the
anhydrous basis

Odourless, white or off-white crystals or powder

B. Positive test

for glutamic acid by

thin-layer chromatog-raphy

C. Specific rotation [α]D

20

Between + 23,8o and + 24,4o

(10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)

D. pH of a 10 % solution

Between 6,4 and 7,5

Purity

Water

Chloride

Not more than 24 % (Karl Fischer)

Not more than 0,2 %

Pyrrolidone carboxylic acid

Not more than 0,2 %

Lead

Not more than 2 mg/kg

L 253/146

EN

Official Journal of the European Union

20.9.2008

E 626 GUANYLIC ACID

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive

for
organic phosphate

test

Guanylic acid

Guanosine-5'-monophosphoric acid

201-598-8

C10H14N5O8P

363,22

Content not less than 97,0 % on the anhydrous basis

Odourless, colourless or white crystals or white crystalline powder

ribose and for

B. pH of a 0,25 % solution

Between 1,5 and 2,5

C. Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

Purity

Loss on drying

Other nucleotides

Lead

Not more than 1,5 % (120 oC, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

E 627 DISODIUM GUANYLATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium guanylate, sodium 5'-guanylate

Disodium guanosine-5'-monophosphate

221-849-5

C10H12N5Na2O8P· x H2O (x = ca. 7)

407,19 (anhydrous)

Content not less than 97,0 % on the anhydrous basis

Odourless, colourless or white crystals or white crystalline powder

A. Positive test for ribose, for organic

phosphate, and for sodium

B. pH of a 5 % solution

Between 7,0 and 8,5

C. Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm

Purity

Loss on drying

Other nucleotides

Lead

Not more than 25 % (120 oC, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

E 628 DIPOTASSIUM GUANYLATE

Synonyms

Definition

Chemical name

Einecs

Potassium guanylate, potassium 5'-guanylate

Dipotassium guanosine-5'-monophosphate

226-914-1

20.9.2008

EN

Official Journal of the European Union

L 253/147

Chemical formula

Molecular weight

C10H12K2N5O8P

439,40

Assay

Description

Identification

Content not less than 97,0 % on the anhydrous basis

Odourless, colourless or white crystals or white crystalline powder

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

Other nucleotides

Lead

Not more than 5 % (120 oC, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

E 629 CALCIUM GUANYLATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium 5'-guanylate

Calcium guanosine-5'-monophosphate

C10H12CaN5O8P· nH2O

401,20 (anhydrous)

Content not less than 97,0 % on the anhydrous basis

Odourless, white or off-white crystals or powder

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

Other nucleotides

Lead

E 630 INOSINIC ACID

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Not more than 23,0 % (120 oC, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

5'-Inosinic acid

Inosine-5'-monophosphoric acid

205-045-1

C10H13N4O8P

348,21

Content not less than 97,0 % on the anhydrous basis

Odourless, colourless or white crystals or powder

L 253/148

EN

Official Journal of the European Union

20.9.2008

Identification

A. Positive test

for
organic phosphate

ribose, and for

B. pH of a 5 % solution

Between 1,0 and 2,0

C. Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

Purity

Loss on drying

Other nucleotides

Lead

Not more than 3,0 % (120 oC, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

E 631 DISODIUM INOSINATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium inosinate, sodium 5'-inosinate

Disodium inosine-5'-monophosphate

225-146-4

C10H11N4Na2O8P· H2O

392,17 (anhydrous)

Content not less than 97,0 % on the anhydrous basis

Odourless, colourless or white crystals or powder

A. Positive test

for
organic phosphate and for sodium

ribose, and for

B. pH of a 5 % solution

Between 7,0 and 8,5

C. Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

Purity

Water

Other nucleotides

Lead

Not more than 28,5 % (Karl Fischer)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

E 632 DIPOTASSIUM INOSINATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium inosinate, potassium 5'-inosinate

Dipotassium inosine-5'-monophosphate

243-652-3

C10H11K2N4O8P

424,39

Content not less than 97,0 % on the anhydrous basis

Odourless, colourless or white crystals or powder

A. Positive test

ribose, and for
organic phosphate and for potassium

for

B. pH of a 5 % solution

Between 7,0 and 8,5

C. Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

20.9.2008

EN

Official Journal of the European Union

L 253/149

Purity

Water

Other nucleotides

Lead

Not more than 10,0 % (Karl Fischer)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

E 633 CALCIUM INOSINATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium 5'-inosinate

Calcium inosine-5'-monophosphate

C10H11CaN4O8P· nH2O

386,19 (anhydrous)

Content not less than 97,0 % on the anhydrous basis

Odourless, colourless or white crystals or powder

A. Positive test

for
organic phosphate and for calcium

ribose, and for

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

Chemical formula

Assay

Description

Identification

Calcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-
monophosphate and calcium guanosine-5'-monophosphate

C10H11N4CaO8P· nH2O y

C10H12N5CaO8P· nH2O

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

Odourless, white or nearly white crystals or powder

A. Positive test

for
organic phosphate and for calcium

ribose, and for

B. pH of a 0,05 % solution

Between 7,0 and 8,0

Purity

Water

Not more than 23,0 % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

L 253/150

EN

Official Journal of the European Union

20.9.2008

E 635 DISODIUM 5'-RIBONUCLEOTIDE

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

Sodium 5'-ribonucleotide

Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-
5'-monophosphate and disodium guanosine-5'-monophosphate

C10H11N4Na2O8P · nH2O and

C10H12N5Na2O8P· nH2O

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

Odourless, white or nearly white crystals or powder

A. Positive test

for
organic phosphate and for sodium

ribose, and for

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)

(Na salt)

Definition

Chemical name (gly)

(Na salt)

Chemical formula (gly)

(Na salt)

Einecs (gly)

(Na salt)

Molecular weight (gly)

(Na salt)

Assay

Description

Identification

Aminoacetic acid, glycocoll

Sodium glycinate

Aminoacetic acid

Sodium glycinate

C2H5NO2

C2H5NO2 Na

200-272-2

227-842-3

75,07

98

Content not less than 98,5 % on the anhydrous basis

White crystals or crystalline powder

A. Positive test for amino acid (gly and

Na salt)

B. Positive test for sodium (Na salt)

Purity

Loss on drying (gly)

(Na salt)

Residue on ignition (gly)

(Na salt)

Arsenic

Lead

Mercury

Not more than 0,2 % (105 oC, 3h)

Not more than 0,2 % (105 oC, 3h)

Not more than 0,1 %

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/151

E 650 ZINC ACETATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Acetic acid, zinc salt, dihydrate

Zinc acetate dihydrate

C4H6O4 Zn· 2H2O

219,51

Content not less than 98 % and not more than 102 % of C4H6O4 Zn
· 2H2O

Colourless crystals or fine, off-white powder

A. Positive tests for acetate and for zinc

B. pH of a 5 % solution

Between 6,0 and 8,0

Purity

Insoluble matter

Chlorides

Sulphates

Not more than 0,005 %

Not more than 50 mg/kg

Not more than 100 mg/kg

Alkalines and alkaline earths

Not more than 0,2 %

Organic volatile impurities

Passes test

Iron

Arsenic

Lead

Cadmium

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 20 mg/kg

Not more than 5 mg/kg

E 900 DIMETHYL POLYSILOXANE

Synonyms

Definition

Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone

Dimethylpolysiloxane is a mixture of fully methylated linear siloxane
polymers containing repeating units of the formula (CH3)2 SiO and
stablised with trimethylsiloxy end-blocking units of the formula (CH3)3
SiO

Chemical name

Chemical formula

Siloxanes and silicones, di-methyl

(CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3

Assay

Description

Identification

Content of total silicon not less than 37,3 % and not more than 38,5 %

Clear, colourless, viscous liquid

A. Specific gravity (25o/25 oC)

Between 0,964 and 0,977

B. Refractive index [n]D

25

Between 1,400 and 1,405

C.

Infrared spectrum characteristic of
the compound

Purity

Loss on drying

Not more than 0,5 % (150 oC, 4h)

Viscosity

Arsenic

Lead

Mercury

Not less than 1,00 · 10-4 m2s-1 at 25 oC

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L 253/152

EN

Official Journal of the European Union

20.9.2008

E 901 BEESWAX

Synonyms

Definition

Einecs

Description

Identification

A. Melting range

B. Specific gravity

C. Solubility

Purity

Acid value

Saponification value

Peroxide value

White wax, yellow wax

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

232-383-7 (beeswax)

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

Between 62 oC and 65 oC

About 0,96

Insoluble in water

Sparingly soluble in alcohol

Very soluble in chloroform and ether

Not less than 17 and not more than 24

87-104

Not more than 5

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 902 CANDELILLA WAX

Definition

Einecs

Description

Identification

A. Specific gravity

B. Melting range

C. Solubility

Purity

Acid value

Candelilla wax is a purified wax obtained from the leaves of
candelilla plant, Euphorbia antisyphilitica

the

232-347-0

Hard, yellowish brown, opaque to translucent wax

About 0,983

Between 68,5 oC and 72,5 oC

Insoluble in water

Soluble in chloroform and toluene

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

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/153

E 903 CARNAUBA WAX

Definition

Einecs

Description

Identification

A. Specific gravity

B. Melting range

C. Solubility

Purity

Sulphated ash

Acid value

Ester value

Carnauba wax is a purified wax obtained from the leaf buds and leaves of
the Brazilian Mart wax palm, Copernicia cerifera

232-399-4

Light brown to pale yellow powder or flakes or hard and brittle solid
with a resinous fracture

About 0,997

Between 82 oC and 86 oC

Insoluble in water

Partly soluble in boiling ethanol

Soluble in chloroform and diethyl ether

Not more than 0,25 %

Not less than 2 and not more than 7

Not less than 71 and not more than 88

Unsaponifiable matter

Not less than 50 % and not more than 55 %

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 904 SHELLAC

Synonyms

Definition

Einecs

Description

Identification

A. Solubility

Bleached shellac, white shellac

Shellac is the purified and bleached lac, the resinous secretion of the
insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)

232-549-9

Bleached shellac — off-white, amorphous, granular resin

Wax-free bleached shellac — light yellow, amorphous, granular resin

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

Wax

Lead

Absent

Bleached shellac: not more than 5,5 %

Wax-free bleached shellac: not more than 0,2 %

Not more than 2 mg/kg

E 905 MICROCRYSTALLINE WAX

Synonyms

Definition

Description

Petroleum wax

Microcrystalline wax is a refined mixture of solid, saturated hydro-
carbons, mainly branched paraffin, obtained from petroleum

White to amber, odourless wax

L 253/154

EN

Official Journal of the European Union

20.9.2008

Identification

A. Solubility

B. Refractive Index

Purity

Molecular weight

Viscosity at 100 oC

Residue on ignition

Insoluble in water, very slightly soluble in ethanol

n D

100 1,434- 1,448

Average not less than 500

Not less than 1,1 · 10-5 m2s-1

Not more than 0,1 %

Carbon number at 5 % distillation point

Not more than 5 % of molecules with carbon number less than 25

Colour

Sulphur

Arsenic

Lead

Passes test

Not more than 0,4 %

Not more than 3 mg/kg

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

280-289

290-299

300-359

360-400

Maximum absorbance per cm path length

0,15

0,12

0,08

0,02

E 907 HYDROGENATED POLY-1-DECENE

Synonyms

Definition

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Burning

Purity

Viscosity

Hydrogenated polydec-1-ene

Hydrogenated poly-alpha-olefin

C10nH20n+2 where n = 3-6

560 (average)

less than 98,5 % of hydrogenated poly-1-decene, having the

Not
following oligomer distribution:

C30: 13-37 %

C40: 35-70 %

C50: 9-25 %

C60: 1-7 %

Insoluble in water; slightly soluble in ethanol; soluble in toluene

Burns with a bright flame and a paraffin-like characteristic smell

Between 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 oC

Compounds with carbon number less
than 30

Not 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

Lead

Not more than 1 mg/kg

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/155

E 912 MONTAN ACID ESTERS

Definition

Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol
and/or glycerol

Chemical name

Montan acid esters

Description

Identification

A. Density (20 oC)

B. Drop point

Purity

Acid value

Glycerol

Other polyols

Other wax types

Arsenic

Chromium

Lead

Almost white to yellowish flakes, powder, granules or pellets

Between 0,98 and 1,05

Greater than 77 oC

Not more than 40

Not more than 1 % (by gas chromatography)

Not more than 1 % (by gas chromatography)

Not detectable (by differential scanning calorimetry and/or infrared
spectroscopy)

Not more than 2 mg/kg

Not more than 3 mg/kg

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

Identification

A. Density (20 oC)

B. Drop point

Purity

Acid value

Viscosity at 120 oC

Other wax types

Oxygen

Chromium

Lead

E 920 L-CYSTEINE

Definition

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Almost white flakes, powder, granules or pellets

Between 0,92 and 1,05

Greater than 95 oC

Not more than 70

Not less than 8,1 · 10-5 m2s-1

Not detectable (by differential scanning calorimetry and/or infrared
spectroscopy)

Not more than 9,5 %

Not more than 5 mg/kg

Not more than 2 mg/kg

L-cysteine hydrochloride or hydrochloride monohydrate. Human hair
may not be used as a source for this substance

200-157-7 (anhydrous)

C3H7NO2S· HCl· n H20 (where n = 0 or 1)

157,62 (anhydrous)

Content not less than 98,0 % and not more than 101,5 % on the
anhydrous basis

White powder or colourless crystals

A. Solubility

Freely soluble in water and in ethanol

L 253/156

EN

Official Journal of the European Union

20.9.2008

B. Melting range

C. Specific rotation

Purity

Anhydrous form melts at about 175 oC

[α]20

D: between + 5,0o and + 8,0o or

[α]25

D: between + 4,9o and 7,9o

Loss on drying

Between 8,0 % and 12,0 %

Residue on ignition

Ammonium-ion

Arsenic

Lead

Not more than 2,0 % (anhydrous form)

Not more than 0,1 %

Not more than 200 mg/kg

Not more than 1,5 mg/kg

Not more than 5 mg/kg

E 927b CARBAMIDE

Synonyms

Definition

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

Urea

200-315-5

CH4N2O

60,06

Content not less than 99,0 % on the anhydrous basis

Colourless to white, prismatic, crystalline powder or small, white pellets

Very soluble in water

Soluble in ethanol

B. Precipitation with nitric acid

To pass the test a white, crystalline precipitate is formed

C. Colour reaction

D. Melting range

Purity

Loss on drying

Sulphated ash

Ethanol-insoluble matter

Alkalinity

Ammonium-ion

Biuret

Arsenic

Lead

E 938 ARGON

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

To pass the test a reddish-violet colour is produced

132 oC to 135 oC

Not more than 1,0 % (105 oC, 1h)

Not more than 0,1 %

Not more than 0,04 %

Passes test

Not more than 500 mg/kg

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Argon

231-147-0

Ar

40

Not less than 99 %

Colourless, odourless, non-flammable gas

20.9.2008

EN

Official Journal of the European Union

L 253/157

Purity

Water

Methane and other hydrocarbons calcu-
lated as methane

Not more than 0,05 %

Not more than 100 μl/l

E 939 HELIUM

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Methane and other hydrocarbons calcu-
lated as methane

E 941 NITROGEN

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Carbon monoxide

Methane and other hydrocarbons calcu-
lated as methane

Helium

231-168-5

He

4

Not less than 99 %

Colourless, odourless, non-flammable gas

Not more than 0,05 %

Not more than 100 μl/l

Nitrogen

231-783-9

N2

28

Not less than 99 %

Colourless, odourless, non-flammable gas

Not more than 0,05 %

Not more than 10 μl/l

Not 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

Einecs

Chemical formula

Molecular weight

Assay

Description

Nitrous oxide

233-032-0

N2O

44

Not less than 99 %

Colourless, non-flammable gas, sweetish odour

L 253/158

EN

Official Journal of the European Union

20.9.2008

Purity

Water

Carbon monoxide

Not more than 0,05 %

Not more than 30 μl/l

Nitrogen dioxide and nitrogen oxide

Not more than 10 μl/l

E 943a BUTANE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

n-Butane

Butane

CH3CH2CH2CH3

58,12

Content not less than 96 %

Colourless gas or liquid with mild, characteristic odour

A. Vapour pressure

108,935 kPa at 20 oC

Purity

Methane

Ethane

Propane

Isobutane

1,3-butadiene

Moisture

E 943b ISOBUTANE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 0,15 % v/v

Not more than 0,5 % v/v

Not more than 1,5 % v/v

Not more than 3,0 % v/v

Not more than 0,1 % v/v

Not more than 0,005 %

2-methyl propane

2-methyl propane

(CH3)2CH CH3

58,12

Content not less than 94 %

Colourless gas or liquid with mild, characteristic odour

A. Vapour pressure

205,465 kPa at 20 oC

Purity

Methane

Ethane

Propane

n-Butane

1,3-butadiene

Moisture

Not more than 0,15 % v/v

Not more than 0,5 % v/v

Not more than 2,0 % v/v

Not more than 4,0 % v/v

Not more than 0,1 % v/v

Not more than 0,005 %

20.9.2008

EN

Official Journal of the European Union

L 253/159

E 944 PROPANE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Propane

CH3CH2CH3

44,09

Content not less than 95 %

Colourless gas or liquid with mild, characteristic odour

A. Vapour pressure

732,910 kPa at 20 oC

Purity

Methane

Ethane

Isobutane

n-Butane

1,3-butadiene

Moisture

E 948 OXYGEN

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Methane and other hydrocarbons calcu-
lated as methane

E 949 HYDROGEN

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Oxygen

Nitrogen

Not more than 0,15 % v/v

Not more than 1,5 % v/v

Not more than 2,0 % v/v

Not more than 1,0 % v/v

Not more than 0,1 % v/v

Not more than 0,005 %

Oxygen

231-956-9

O2

32

Not less than 99 %

Colourless, odourless, non-flammable gas

Not more than 0,05 %

Not more than 100 μl/l

Hydrogen

215-605-7

H2

2

Content not less than 99,9 %

Colourless, odourless, highly flammable gas

Not more than 0,005 % v/v

Not more than 0,001 % v/v

Not more than 0,75 % v/v

L 253/160

EN

Official Journal of the European Union

20.9.2008

E 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

Definition

Description

Soapbark extract, Quillay bark extract, Panama bark extract, Quillai
extract, Murillo bark extract, China bark extract

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

Quillaia extract in the powder form is light brown with a pink tinge. It is
also available as an aqueous solution

20.9.2008

EN

Official Journal of the European Union

L 253/161

Identification

A. pH of a 2,5 % solution

Between 4,5 and 5,5

Not more than 6,0 % (Karl Fischer method) (powder form only)

Not more than 2 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Purity

Water

Arsenic

Lead

Mercury

E 1103 INVERTASE

Definition

Invertase is produced from Saccharomyces cerevisiae

Systematic name

Enzyme Commission No

Einecs

Purity

Arsenic

Lead

Cadmium

Total bacterial count

Salmonella spp.

Coliforms

E. coli

E 1105 LYSOZYME

Synonyms

Definition

Chemical name

Einecs

Molecular weight

Assay

Description

Identification

A.

Isoelectric point 10,7

B. pH of

a 2 % aqueous

between 3,0 and 3,6

β-D-Fructofuranoside fructohydrolase

EC 3.2.1.26

232-615-7

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 0,5 mg/kg

Not more than 50 000/g

Absent by test in 25 g

Not more than 30/g

Absent by test in 25 g

Lysozyme hydrochloride

Muramidase

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

Enzyme Commission (EC) No: 3.2.1.17

232-620-4

About 14 000

Content not less than 950 mg/g on the anhydrous basis

White, odourless powder having a slightly sweet taste

solution

C. Absorption maximum of an aqueous
solution (25 mg/100 ml) at 281 nm,
a minimum at 252 nm

Purity

Water content

Residue on ignition

Not more than 6,0 % (Karl Fischer method) (powder form only)

Not more than 1,5 %

L 253/162

EN

Official Journal of the European Union

20.9.2008

Nitrogen

Arsenic

Lead

Mercury

Heavy metals (as Pb)

Microbiological criteria

Total bacterial count

Salmonellae

Staphylococcus aureus

Escherichia coli

Not less than 16,8 % and not more than 17,8 %

Not more than 1 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 10 mg/kg

Not more than 5 × 104 col/g

Absent in 25 g

Absent in 1 g

Absent in 1 g

E 1200 POLYDEXTROSE

Synonyms

Definition

Assay

Description

Identification

Modified polydextroses

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

Content not less than 90 % of polymer on the ash free and anhydrous
basis

White to light tan-coloured solid. Polydextroses dissolve in water to give
a clear, colourless to straw coloured solution

A. Positive

tests
reducing sugar

for

sugar and for

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

Sulphated ash

Not more than 4,0 % (Karl Fischer method)

Not more than 0,3 % (polydextrose)

Not more than 2,0 % (polydextrose N)

Nickel

Not more than 2 mg/kg for hydrogenated polydextroses

1,6-Anhydro-D-glucose

Not more than 4,0 % on the ash-free and the dried 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/kg

20.9.2008

EN

Official Journal of the European Union

L 253/163

E 1201 POLYVINYLPYRROLIDONE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Povidone

PVP

Soluble polyvinylpyrrolidone

Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

(C6H9NO)n

Not less than 25 000

Content not less than 11,5 % and not more than 12,8 % of nitrogen (N)
on the anhydrous basis

White or nearly white powder

A. Solubility

Soluble in water and in ethanol. Insoluble in ether

B. pH of a 5 % solution

Between 3,0 and 7,0

Purity

Water

Total ash

Aldehyde

Not more than 5 % (Karl Fischer)

Not more than 0,1 %

Not more than 500 mg/kg (as acetaldehyde)

Free-N-vinylpyrrolidone

Not more than 10 mg/kg

Hydrazine

Lead

Not more than 1 mg/kg

Not more than 5 mg/kg

E 1202 POLYVINYLPOLYPYRROLIDONE

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

Crospovidone

Cross linked polyvidone

Insoluble polyvinylpyrrolidone

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

Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

(C6H9NO)n

Content not less than 11 % and not more than 12,8 % nitrogen (N) on
the anhydrous basis

A white hygroscopic powder with a faint, non-objectionable odour

A. Solubility

Insoluble in water, ethanol and ether

B. pH of a 1 % suspension in water

Between 5,0 and 8,0

Purity

Water

Sulphated ash

Water-soluble matter

Not more than 6 % (Karl Fischer)

Not more than 0,4 %

Not more than 1 %

Free-N-vinylpyrrolidone

Not more than 10 mg/kg

Free-N, N'-divinyl-imidazolidone

Not more than 2 mg/kg

Lead

Not more than 5 mg/kg

L 253/164

EN

Official Journal of the European Union

20.9.2008

E 1204 PULLULAN

Definition

Einecs

Chemical formula

Assay

Description

Identification

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
fungal cells are removed by microfiltration, the filtrate is heat-sterilised
and pigments and other impurities are removed by adsorption and ion
exchange chromatography

the fermentation,

232-945-1

(C6H10O5)x

Not less than 90 % of glucan on the dried basis

White to off-white odourless powder

A. Solubility

Soluble in water, practically insoluble in ethanol

B. pH of 10 % solution

5,0 to 7,0

C. Precipitation with polyethylene gly-

col 600

Add 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 % (90 oC, pressure not more than 50 mm Hg, 6 h)

Mono-, di- and oligosaccharides

Not more than 10 % expressed as glucose

Viscosity

Lead

100 to 180 mm2/s (10 % w/w aqueous solution at 30 oC)

Not more than 1 mg/kg

Yeast and moulds

Not more than 100 colonies per gram

Coliforms

Salmonella

Absent in 25 g

Absent in 25 g

Oxidised starch is starch treated with sodium hypochlorite

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

E 1404 OXIDISED STARCH

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Carboxyl groups

Sulphur dioxide

Arsenic

Lead

Mercury

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 1,1 %

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/165

Monostarch phosphate is starch esterified with ortho-phosphoric acid,
or sodium or potassium ortho-phosphate or sodium tripolyphosphate

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

E 1410 MONOSTARCH PHOSPHATE

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 0,4 % (as P) for other starches

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

Arsenic

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Distarch phosphate is starch cross-linked with sodium trimetaphosphate
or phosphorus oxychloride

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

E 1412 DISTARCH PHOSPHATE

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 0,4 % (as P) for other starches

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

Arsenic

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

L 253/166

EN

Official Journal of the European Union

20.9.2008

E 1413 PHOSPHATED DISTARCH PHOSPHATE

Phosphated distarch phosphate is starch having undergone a combina-
tion of treatments as described for monostarch phosphate and for
distarch phosphate

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 0,4 % (as P) for other starches

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

Arsenic

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1414 ACETYLATED DISTARCH PHOSPHATE

Acetylated distarch phosphate is starch cross-linked with sodium
trimetaphosphate or phosphorus oxychloride and esterified by acetic
anhydride or vinyl acetate

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Acetyl groups

Residual phosphate

Vinyl acetate

Sulphur dioxide

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 2,5 %

Not more than 0,14 % (as P) for wheat or potato starch

Not more than 0,04 % (as P) for other starches

Not more than 0,1 mg/kg

Not more than 50 mg/kg for modified cereal starches

Arsenic

Not more than 1 mg/kg

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

20.9.2008

EN

Official Journal of the European Union

L 253/167

Lead

Mercury

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Starch acetate

Acetylated starch is starch esterified with acetic anhydride or vinyl
acetate

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

E 1420 ACETYLATED STARCH

Synonyms

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Acetyl groups

Vinyl acetate

Sulphur dioxide

Arsenic

Lead

Mercury

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 2,5 %

Not more than 0,1 mg/kg

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Acetylated distarch adipate is starch cross-linked with adipic anhydride
and esterified with acetic anhydride

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

E 1422 ACETYLATED DISTARCH ADIPATE

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Acetyl groups

Adipate groups

Sulphur dioxide

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 2,5 %

Not more than 0,135 %

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

L 253/168

EN

Official Journal of the European Union

20.9.2008

Arsenic

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Hydroxypropyl starch is starch etherified with propylene oxide

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

E 1440 HYDROXYPROPYL STARCH

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Hydroxypropyl groups

Propylene chlorohydrin

Sulphur dioxide

Arsenic

Lead

Mercury

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 7,0 %

Not more than 1 mg/kg

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE

Hydroxypropyl distarch phosphate is starch cross-linked with sodium
trimetaphosphate or phosphorus oxychloride and etherified with
propylene oxide

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Hydroxypropyl groups

Residual phosphate

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 7,0 %

Not more than 0,14 % (as P) for wheat or potato starch

Not more than 0,04 (as P) for other starches

Propylene chlorohydrin

Not more than 1 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/169

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

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1450 STARCH SODIUM OCTENYL SUCCINATE

SSOS

Starch sodium octenyl succinate is starch esterified with octenylsuccinic
anhydride

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

Synonyms

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Acetylated oxidised starch is starch treated with sodium hypochlorite
followed by esterification with acetic anhydride

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

E 1451 ACETYLATED OXIDISED STARCH

Definition

Description

Identification

A.

B.

If not pregelatinised: by microscopic
observation

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 %

L 253/170

EN

Official Journal of the European Union

20.9.2008

Acetyl groups

Sulphur dioxide

Arsenic

Lead

Mercury

Not more than 2,5 %

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise
specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE

Synonyms

Definition

Description

Identification

SAOS

Starch aluminium octenyl succinate is starch esterified with octenylsuc-
cinic anhydride and treated with aluminium sulphate

White or nearly white powder or granules or (if pregelatinised) flakes,
amorphous powder or coarse particles

A.

B.

If not pregelatinised: by microscopic
observation

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

Octenylsuccinyl groups

Not more than 21,0 %

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

Lead

Mercury

Aluminium

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Not more than 0,3 %

E 1505 TRIETHYL CITRATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

Ethyl citrate

Triethyl-2-hydroxypropan-1,2,3-tricarboxylate

201-070-7

C12H20O7

276,29

Content not less than 99,0 %

Odourless, practically colourless, oily liquid

A. Specific gravity

B. Refractive index

d25

25: 1,135-1,139

[n]D

20: 1,439-1,441

Purity

Water

Acidity

Not more than 0,25 % (Karl Fischer method)

Not more than 0,02 % (as citric acid)

20.9.2008

EN

Official Journal of the European Union

L 253/171

Arsenic

Lead

Not more than 3 mg/kg

Not more than 5 mg/kg

E 1517 GLYCERYL DIACETATE

Synonyms

Definition

Diacetin

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

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Positive tests for glycerol and acetate

C. Specific gravity

D. Boiling range

Purity

Total ash

Acidity

Arsenic

Lead

E 1518 GLYCERYL TRIACETATE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

1, 2, 3-propanetriol diacetate

C7H12O5

176,17

Not less than 94,0 %

Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty
odour

Soluble in water. Miscible with ethanol

d20

20: 1,175-1,195

Between 259 and 261 oC

Not more than 0,02 %

Not more than 0,4 % (as ascetic acid)

Not more than 3 mg/kg

Not more than 5 mg/kg

Triacetin

Glyceryl triacetate

203-051-9

C9H14O6

218,21

Content not less than 98,0 %

Colourless, somewhat oily liquid having a slightly fatty odour

A. Positive tests
glycerol

for acetate and for

B. Refractive index

Between 1,429 and 1,431 at 25 oC

C. Specific gravity (25 oC/25 oC)

Between 1,154 and 1,158

D. Boiling range

Between 258 and 270 oC

Purity

Water

Sulphated ash

Arsenic

Lead

Not more than 0,2 % (Karl Fischer method)

Not more than 0,02 % (as citric acid)

Not more than 3 mg/kg

Not more than 5 mg/kg

L 253/172

EN

Official Journal of the European Union

20.9.2008

E 1519 BENZYL ALCOHOL

Synonyms

Definition

Chemical names

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Refractive index

C. Specific gravity

D. Positive test for peroxides

Purity

Phenylcarbinol

Phenylmethyl alcohol

Benzenemethanol

Alpha-hydroxytoluene

Benzyl alcohol

Phenylmethanol

C7H8O

108,14

Not less than 98,0 %

Colourless, clear liquid with a faint, aromatic odour

Soluble in water, ethanol and ether

[n]D20: 1,538-1,541

d25

25: 1,042-1,047

Distillation range

Not less than 95 % v/v distils between 202 and 208 oC

Acid value

Aldehydes

Lead

Not more than 0,5

Not more than 0,2 % v/v (as bezaldehyde)

Not more than 5 mg/kg

E 1520 PROPANE-1,2-DIOL

Synonyms

Definition

Chemical names

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Specific gravity

C. Refractive index

Purity

Distillation range

Sulphated ash

Water

Lead

Propylene glycol

1,2-dihydroxypropane

200-338-0

C3H8O2

76,10

Content not less than 99,5 % on the anhydrous basis

Clear, colourless, hygroscopic, viscous liquid

Soluble in water, ethanol and acetone

d20

20: 1,035-1,040

[n]20

D: 1,431-1,433

99 % v/v distils between 185 oC-189 oC

Not more than 0,07 %

Not more than 1,0 % (Karl Fischer method)

Not more than 5 mg/kg

20.9.2008

EN

Official Journal of the European Union

L 253/173

POLYETHYLENE GLYCOL 6000

Synonyms

Definition

Chemical formula

PEG 6000

Macrogol 6000

Polyethylene glycol 6000 is a mixture of polymers with the general
formula H-(OCH2-CH)-OH corresponding to an average
relative
molecular mass of approximately 6 000

(C2H4O)n H2O (n = number of ethylene oxide units corresponding to a
molecular weight of 6 000, about 140)

Molecular weight

5 600-7 000

Assay

Description

Identification

A. Solubility

Not less than 90,0 % and not more than 110,0 %

A white or almost white solid with a waxy or paraffin-like appearance

Very soluble in water and in methylene chloride. Practically insoluble in
alcohol, in ether and in fatty and mineral oils

B. Melting range

Between 55 oC and 61 oC

Purity

Viscosity

Hydroxyl value

Sulphated ash

Ethylene oxide

Arsenic

Lead

Between 0,220 and 0,275 kgm-1s-1 at 20 oC

Between 16 and 22

Not more than 0,2 %

Not more than 0,2 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

L 253/174

EN

Official Journal of the European Union

20.9.2008

ANNEX II

PART A

Repealed Directive with list of its successive amendments

(referred to in Article 2)

Commission Directive 96/77/EC

(OJ L 339, 30.12.1996, p. 1)

Commission Directive 98/86/EC

(OJ L 334, 9.12.1998, p. 1)

Commission Directive 2000/63/EC

(OJ L 277, 30.10.2000, p. 1)

Commission Directive 2001/30/EC

(OJ L 146, 31.5.2001, p. 1)

Commission Directive 2002/82/EC

(OJ L 292, 28.10.2002, p. 1)

Commission Directive 2003/95/EC

(OJ L 283, 31.10.2003, p. 71)

Commission Directive 2004/45/EC

(OJ L 113, 20.4.2004, p. 19)

Commission Directive 2006/129/EC

(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

98/86/EC

2000/63/EC

2001/30/EC

2002/82/EC

2003/95/EC

2004/45/EC

2006/129/EC

1 July 1997 (1)

1 July 1999 (2)

31 March 2001 (3)

1 June 2002 (4)

31 August 2003

1 November 2004 (5)

1 April 2005 (6)

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

(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.

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.

20.9.2008

EN

Official Journal of the European Union

L 253/175

ANNEX III

Correlation table

Directive 96/77/EC

This Directive

Article 1

Article 2

Article 3

—

Article 4

Article 5

Annex

—

—

Article 1

—

—

Article 2

Article 3

Article 4

Annex I

Annex II

Annex III