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Document 02008L0084-20101110

Consolidated text: 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)

ELI: http://data.europa.eu/eli/dir/2008/84/2010-11-10

2008L0084 — EN — 10.11.2010 — 002.001


This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents

►B

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)

(OJ L 253, 20.9.2008, p.1)

Amended by:

 

 

Official Journal

  No

page

date

►M1

COMMISSION DIRECTIVE 2009/10/EC Text with EEA relevance of 13 February 2009

  L 44

62

14.2.2009

►M2

COMMISSION DIRECTIVE 2010/67/EU Text with EEA relevance of 20 October 2010

  L 277

17

21.10.2010




▼B

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 Community,

Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives 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)

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 sweeteners ( 4 ).

(3)

It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).

(4)

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

(5)

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

(6)

This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set 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

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.

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 3

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

Article 4

This Directive is addressed to the Member States.




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 ( 5 ).

E 200 SORBIC ACID



Definition

 

Chemical name

Sorbic acid

Trans, trans-2,4-hexadienoic acid

Einecs

203-768-7

Chemical formula

C6H8O2

Molecular weight

112,12

Assay

Content not less than 99 % on the anhydrous basis

Description

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

Identification

 

A.  Melting range

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

B.  Spectrometry

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

C.  Positive test for double bonds

 

D.  Sublimation point

80 oC

Purity

 

Water content

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

Sulphated ash

Not more than 0,2 %

Aldehydes

Not more than 0,1 % (as formaldehyde)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 202 POTASSIUM SORBATE



Definition

 

Chemical name

Potassium sorbate

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

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

Einecs

246-376-1

Chemical formula

C6H7O2K

Molecular weight

150,22

Assay

Content not less than 99 % on the dried basis

Description

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

Identification

 

A.  Melting range of sorbic acid isolated by acidification and not 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

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

Acidity or alkalinity

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

Aldehydes

Not more than 0,1 %, calculated as formaldehyde

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 203 CALCIUM SORBATE



Definition

 

Chemical name

Calcium sorbate

Calcium salts of trans, trans-2,4-hexadienoic acid

Einecs

231-321-6

Chemical formula

C12H14O4Ca

Molecular weight

262,32

Assay

Content not less than 98 % on the dried basis

Description

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

Identification

 

A.  Melting range of sorbic acid isolated by acidification and not 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

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

Aldehydes

Not more than 0,1 % (as formaldehyde)

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 210 BENZOIC ACID



Definition

 

Chemical name

Benzoic acid

Benzenecarboxylic acid

Phenylcarboxylic acid

Einecs

200-618-2

Chemical formula

C7H6O2

Molecular weight

122,12

Assay

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

Description

White crystalline powder

Identification

 

A.  Melting range

121,5oC to 123,5oC

B.  Positive sublimation test and test for benzoate

 

Purity

 

Loss on drying

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

pH

About 4 (solution in water)

Sulphated ash

Not more than 0,05 %

Chlorinated organic compounds

Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid

Readily oxidisable substances

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

Readily carbonisable substances

A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (2), 0,3 ml of ferric chloride TSC (3), 0,1 ml of copper sulphate TSC (4) and 4,4 ml of water

Polycyclic acids

On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

(1)   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.

(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). 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). 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). 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.

E 211 SODIUM BENZOATE



Definition

 

Chemical name

Sodium benzoate

Sodium salt of benzenecarboxylic acid

Sodium salt of phenylcarboxylic acid

Einecs

208-534-8

Chemical formula

C7H5O2Na

Molecular weight

144,11

Assay

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

Description

A white, almost odourless, crystalline powder or granules

Identification

 

A.  Solubility

Freely soluble in water, sparingly soluble in ethanol

B.  Melting range for benzoic acid

Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after drying in a sulphuric acid desiccator

C.  Positive tests for benzoate and for sodium

 

Purity

 

Loss on drying

Not more than 1,5 % after drying at 105 oC for four hours

Readily oxidisable substances

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N 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

Polycyclic acids

On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

Chlorinated organic compounds

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

Degree of acidity or alkalinity

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 212 POTASSIUM BENZOATE



Definition

 

Chemical name

Potassium benzoate

Potassium salt of benzenecarboxylic acid

Potassium salt of phenylcarboxylic acid

Einecs

209-481-3

Chemical formula

C7H5KO2·3H2O

Molecular weight

214,27

Assay

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

Description

White crystalline powder

Identification

 

A.  Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator

 

B.  Positive tests for benzoate and for potassium

 

Purity

 

Loss on drying

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

Chlorinated organic compounds

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

Readily oxidisable substances

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N 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

Readily carbonisable substances

A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

Polycyclic acids

On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid

Degree of acidity or alkalinity

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 213 CALCIUM BENZOATE



Synonyms

Monocalcium benzoate

Definition

 

Chemical name

Calcium benzoate

Calcium dibenzoate

Einecs

218-235-4

Chemical formula

Anhydrous:

C14H10O4Ca

Monohydrate:

C14H10O4Ca· H2O

Trihydrate:

C14H10O4Ca· 3H2O

Molecular weight

Anhydrous:

282,31

Monohydrate:

300,32

Trihydrate:

336,36

Assay

Content not less than 99 % after drying at 105 oC

Description

White or colourless crystals, or white powder

Identification

 

A.  Melting range of benzoic acid isolated by acidification and not recrystallised 121,5oC to 123,5oC, after vacuum drying in a sulphuric acid desiccator

 

B.  Positive tests for benzoate and for calcium

 

Purity

 

Loss on drying

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

Water insoluble matter

Not more than 0,3 %

Chlorinated organic compounds

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

Readily oxidisable substances

Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N 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

Readily carbonisable substances

Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water

Polycyclic acids

On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid

Degree of acidity or alkalinity

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

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 214 ETHYL p-HYDROXYBENZOATE



Synonyms

Ethylparaben

Ethyl p-oxybenzoate

Definition

 

Chemical name

Ethyl-p-hydroxybenzoate

Ethyl ester of p-hydroxybenzoic acid

Einecs

204-399-4

Chemical formula

C9H10O3

Molecular weight

166,8

Assay

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

Description

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

Identification

 

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

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

Sulphated ash

Not more than 0,05 %

p-Hydroxybenzoic acid and salicylic acid

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 215 SODIUM ETHYL p-HYDROXYBENZOATE



Definition

 

Chemical name

Sodium ethyl p-hydroxybenzoate

Sodium compound of the ethyl ester of p-hydroxybenzoic acid

Einecs

252-487-6

Chemical formula

C9H9O3Na

Molecular weight

188,8

Assay

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

Description

White, crystalline hygroscopic powder

Identification

 

A.  Melting range

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

B.  Positive test for p-hydroxybenzoate

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

C.  Positive test for sodium

 

D.  pH of a 0,1 % aqueous solution must be between 9,9 and 10,3

 

Purity

 

Loss on drying

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

Sulphated ash

37 to 39 %

p-Hydroxybenzoic acid and salicylic acid

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 218 METHYL p-HYDROXYBENZOATE



Synonyms

Methylparaben

Methyl-p-oxybenzoate

Definition

 

Chemical name

Methyl p-hydroxybenzoate

Methyl ester of p-hydroxybenzoic acid

Einecs

243-171-5

Chemical formula

C8H8O3

Molecular weight

152,15

Assay

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

Description

Almost odourless, small colourless crystals or white crystalline powder

Identification

 

A.  Melting range

125 oC to 128 oC

B.  Positive test for p-hydroxybenzoate

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

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,05 %

p-Hydroxybenzoic acid and salicylic acid

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 219 SODIUM METHYL p-HYDROXYBENZOATE



Definition

 

Chemical name

Sodium methyl p-hydroxybenzoate

Sodium compound of the methylester of p-hydroxybenzoic acid

Chemical formula

C8H7O3Na

Molecular weight

174,15

Assay

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

Description

White, hygroscopic powder

Identification

 

A.  The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 oC for two hours, have a melting range of 125 oC to 128 oC

 

B.  Positive test for sodium

 

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

 

Purity

 

Water content

Not more than 5 % (Karl Fischer method)

Sulphated ash

40 % to 44,5 % on the anhydrous basis

p-Hydroxybenzoic acid and salicylic acid

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 220 SULPHUR DIOXIDE



Definition

 

Chemical name

Sulphur dioxide

Sulphurous acid anhydride

Einecs

231-195-2

Chemical formula

SO2

Molecular weight

64,07

Assay

Content not less than 99 %

Description

Colourless, non-flammable gas with strong pungent suffocating odour

Identification

 

A.  Positive test for sulphurous substances

 

Purity

 

Water content

Not more than 0,05 %

Non-volatile residue

Not more than 0,01 %

Sulphur trioxide

Not more than 0,1 %

Selenium

Not more than 10 mg/kg

Other gases not normally present in the air

No trace

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 221 SODIUM SULPHITE



Definition

 

Chemical name

Sodium sulphite (anhydrous or heptahydrate)

Einecs

231-821-4

Chemical formula

Anhydrous:

Na2SO3

Heptahydrate:

Na2SO37H2O

Molecular weight

Anhydrous:

126,04

Heptahydrate:

252,16

Assay

Anhydrous:

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

Heptahydrate:

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

Description

White crystalline powder or colourless crystals

Identification

 

A.  Positive tests for sulphite and for sodium

 

B.  pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5

 

Purity

 

Thiosulphate

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

Iron

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

Selenium

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 222 SODIUM BISULPHITE



Definition

 

Chemical name

Sodium bisulphite

Sodium hydrogen sulphite

Einecs

231-921-4

Chemical formula

NaHSO3 in aqueous solution

Molecular weight

104,06

Assay

Content not less than 32 % w/w NaHSO3

Description

A clear, colourless to yellow solution

Identification

 

A.  Positive tests for sulphite and for sodium

 

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

 

Purity

 

Iron

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

Selenium

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 223 SODIUM METABISULPHITE



Synonyms

Pyrosulphite

Sodium pyrosulphite

Definition

 

Chemical name

Sodium disulphite

Disodium pentaoxodisulphate

Einecs

231-673-0

Chemical formula

Na2S2O5

Molecular weight

190,11

Assay

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

Description

White crystals or crystalline powder

Identification

 

A.  Positive tests for sulphite and for sodium

 

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

 

Purity

 

Thiosulphate

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

Iron

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

Selenium

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 224 POTASSIUM METABISULPHITE



Synonyms

Potassium pyrosulphite

Definition

 

Chemical name

Potassium disulphite

Potassium pentaoxo disulphate

Einecs

240-795-3

Chemical formula

K2S2O5

Molecular weight

222,33

Assay

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

Description

Colourless crystals or white crystalline powder

Identification

 

A.  Positive tests for sulphite and for potassium

 

Purity

 

Thiosulphate

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

Iron

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

Selenium

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 226 CALCIUM SULPHITE



Definition

 

Chemical name

Calcium sulphite

Einecs

218-235-4

Chemical formula

CaSO3·2H2O

Molecular weight

156,17

Assay

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

Description

White crystals or white crystalline powder

Identification

 

A.  Positive tests for sulphite and for calcium

 

Purity

 

Iron

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

Selenium

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 227 CALCIUM BISULPHITE



Definition

 

Chemical name

Calcium bisulphite

Calcium hydrogen sulphite

Einecs

237-423-7

Chemical formula

Ca(HSO3)2

Molecular weight

202,22

Assay

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

Description

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

Identification

 

A.  Positive tests for sulphite and for calcium

 

Purity

 

Iron

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

Selenium

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 228 POTASSIUM BISULPHITE



Definition

 

Chemical name

Potassium bisulphite

Potassium hydrogen sulphite

Einecs

231-870-1

Chemical formula

KHSO3 in aqueous solution

Molecular weight

120,17

Assay

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

Description

Clear colourless aqueous solution

Identification

 

A.  Positive tests for sulphite and for potassium

 

Purity

 

Iron

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

Selenium

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

▼M1 —————

▼B

E 231 ORTHOPHENYLPHENOL



Synonyms

Orthoxenol

Definition

 

Chemical name

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

2-Hydroxydiphenyl

o-Hydroxydiphenyl

Einecs

201-993-5

Chemical formula

C12H10O

Molecular weight

170,20

Assay

Content not less than 99 %

Description

White or slightly yellowish crystalline powder

Identification

 

A.  Melting range

56 oC to 58 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

Not more than 0,05 %

Diphenyl ether

Not more than 0,3 %

p-Phenylphenol

Not more than 0,1 %

1-Naphthol

Not more than 0,01 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 232 SODIUM ORTHOPHENYLPHENOL



Synonyms

Sodium orthophenylphenate

Sodium salt ofo-phenylphenol

Definition

 

Chemical name

Sodium orthophenylphenol

Einecs

205-055-6

Chemical formula

C12H9ONa· 4H2O

Molecular weight

264,26

Assay

Content not less than 97 % of C12H9ONa· 4H2O

Description

White or slightly yellowish crystalline powder

Identification

 

A.  Positive tests for phenolate and for sodium

 

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

 

C.  pH of a 2 % aqueous solution must be between 11,1 and 11,8

 

Purity

 

Diphenylether

Not more than 0,3 %

p-phenylphenol

Not more than 0,1 %

1-naphthol

Not more than 0,01 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

▼M1 —————

▼M1

E 234 NISIN



Definition

Nisin consists of several closely related polypeptides produced during the fermentation of a milk or sugar medium by certain natural strains of Lactococcus lactis subsp.lactis

Einecs

215-807-5

Chemical formula

C143H230N42O37S7

Molecular weight

3 354,12

Assay

Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk proteins or fermented solids and a minimum sodium chloride content of 50 %

Description

White powder

Purity

Loss on drying

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

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

▼B

E 235 NATAMYCIN



Synonyms

Pimaricin

Definition

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

Einecs

231-683-5

Chemical formula

C33H47O13N

Molecular weight

665,74

Assay

Content not less than 95 % on the anhydrous basis

Description

White to creamy-white crystalline powder

Identification

 

A.  Colour reactions

On adding a few crystals of natamycin on a spot plate, to a drop of:

— concentrated hydrochloric acid, a blue colour develops,

— concentrated phosphoric acid, a green colour develops,

which changes into pale red after a few minutes

B.  Spectrometry

A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm

C.  pH

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

D.  Specific rotation

[α]D 20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at 20 oC and calculated with reference to the dried material)

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,5 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Microbiological criteria: total viable count

Not more than 100/g

E 239 HEXAMETHYLENE TETRAMINE



Synonyms

Hexamine

Methenamine

Definition

 

Chemical name

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

Einecs

202-905-8

Chemical formula

C6H12N4

Molecular weight

140,19

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless or white crystalline powder

Identification

 

A.  Positive tests for formaldehyde and for ammonia

 

B.  Sublimation point approximately 260 oC

 

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,05 %

Sulphates

Not more than 0,005 % expressed as SO4

Chlorides

Not more than 0,005 % expressed as Cl

Ammonium salts

Not detectable

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 242 DIMETHYL DICARBONATE



Synonyms

DMDC

Dimethyl pyrocarbonate

Definition

 

Chemical name

Dimethyl dicarbonate

Pyrocarbonic acid dimethyl ester

Einecs

224-859-8

Chemical formula

C4H6O5

Molecular weight

134,09

Assay

Content not less than 99,8 %

Description

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

Identification

 

A.  Decomposition

After dilution positive tests for CO2 and methanol

B.  Melting point

17 oC

Boiling point

172 oC with decomposition

C.  Density 20 oC

Approximately 1,25 g/cm3

D.  Infrared spectrum

Maxima at 1 156 and 1 832 cm- 1

Purity

 

Dimethyl carbonate

Not more than 0,2 %

Chlorine, total

Not more than 3 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 249 POTASSIUM NITRITE



Definition

 

Chemical name

Potassium nitrite

Einecs

231-832-4

Chemical formula

KNO2

Molecular weight

85,11

Assay

Content not less than 95 % on the anhydrous basis (1)

Description

White or slightly yellow, deliquescent granules

Identification

 

A.  Positive tests for nitrite and for potassium

 

B.  pH of a 5 % solution:

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

Purity

 

Loss on drying

Not more than 3 % after drying for four hours over silica gel

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

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

E 250 SODIUM NITRITE



Definition

 

Chemical name

Sodium nitrite

Einecs

231-555-9

Chemical formula

NaNO2

Molecular weight

69,00

Assay

Content not less than 97 % on the anhydrous basis (1)

Description

White crystalline powder or yellowish lumps

Identification

 

A.  Positive tests for nitrite and for sodium

 

Purity

 

Loss on drying

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

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

E 251 SODIUM NITRATE

1.   SOLID SODIUM NITRATE



Synonyms

Chile saltpetre

Cubic or soda nitre

Definition

 

Chemical name

Sodium nitrate

Einecs

231-554-3

Chemical formula

NaNO3

Molecular weight

85,00

Assay

Content not less than 99 % after drying

Description

White crystalline, slightly hygroscopic powder

Identification

 

A.  Positive tests for nitrate and for sodium

 

B.  pH of a 5 % solution

Not less than 5,5 and more than 8,3

Purity

 

Loss on drying

Not more than 2 % after drying at 105 oC for four hours

Nitrites

Not more than 30 mg/kg expressed as NaNO2

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 251 SODIUM NITRATE

2.   LIQUID SODIUM NITRATE



Definition

Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.

Chemical name

Sodium nitrate

Einecs

231-554-3

Chemical formula

NaNO3

Molecular weight

85,00

Assay

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

Description

Clear colourless liquid

Identification

 

A.  Positive tests for nitrate and for sodium

 

B.  pH

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

Purity

 

Free nitric acid

Not more than 0,01 %

Nitrites

Not more than 10 mg/kg expressed as NaNO2

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 0,3 mg/kg

This specification refers to a 35 % aqueous solution

 

E 252 POTASSIUM NITRATE



Synonyms

Chile saltpetre

Cubic or soda nitre

Definition

 

Chemical name

Potassium nitrate

Einecs

231-818-8

Chemical formula

KNO3

Molecular weight

101,11

Assay

Content not less than 99 % on the anhydrous basis

Description

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

Identification

 

A.  Positive tests for nitrate and for potassium

 

B.  pH of a 5 % solution

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

Purity

 

Loss on drying

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

Nitrites

Not more than 20 mg/kg expressed as KNO2

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 260 ACETIC ACID



Definition

 

Chemical name

Acetic acid

Ethanoic acid

Einecs

200-580-7

Chemical formula

C2H4O2

Molecular weight

60,05

Assay

Content not less than 99,8 %

Description

Clear, colourless liquid having a pungent, characteristic odour

Identification

 

A.  Boiling point

118 oC at 760 mm pressure (of mercury)

B.  Specific gravity

About 1,049

C.  A one in three solution gives positive tests for acetate

 

D.  Solidification point

Not lower than 14,5oC

Purity

 

Non-volatile residue

Not more than 100 mg/kg

Formic acid, formates and other oxidisable substances

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

Readily oxidisable substances

Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 261 POTASSIUM ACETATE



Definition

 

Chemical name

Potassium acetate

Einecs

204-822-2

Chemical formula

C2H3O2K

Molecular weight

98,14

Assay

Content not less than 99 % on the anhydrous basis

Description

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

Identification

 

A.  pH of a 5 % aqueous solution

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

B.  Positive tests for acetate and for potassium

 

Purity

 

Loss on drying

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

Formic acid, formates and other oxidisable substances

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 262 (i) SODIUM ACETATE



Definition

 

Chemical name

Sodium acetate

Einecs

204-823-8

Chemical formula

C2H3NaO2·nH2O (n = 0 or 3)

Molecular weight

Anhydrous:

82,03

Trihydrate:

136,08

Assay

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

Description

Anhydrous:

White, odourless, granular, hygroscopic powder

Trihydrate:

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

Identification

 

A.  pH of a 1 % aqueous solution

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

B.  Positive tests for acetate and for sodium

 

Purity

 

Loss on drying

Anhydrous:

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

Trihydrate:

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

Formic acid, formates and other oxidisable substances

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 262 (ii) SODIUM DIACETATE



Definition

Sodium diacetate is a molecular compound of sodium acetate and acetic acid

Chemical name

Sodium hydrogen diacetate

Einecs

204-814-9

Chemical formula

C4H7NaO4·nH2O (n = 0 or 3)

Molecular weight

142,09 (anhydrous)

Assay

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

Description

White, hygroscopic crystalline solid with an acetic odour

Identification

 

A.  pH of a 10 % aqueous solution

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

B.  Positive tests for acetate and for sodium

 

Purity

 

Water content

Not more than 2 % (Karl Fischer method)

Formic acid, formates and other oxidisable substances

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 263 CALCIUM ACETATE



Definition

 

Chemical name

Calcium acetate

Einecs

200-540-9

Chemical formula

Anhydrous:

C4H6O4Ca

Monohydrate:

C4H6O4Ca· H2O

Molecular weight

Anhydrous:

158,17

Monohydrate:

176,18

Assay

Content not less than 98 % on the anhydrous basis

Description

Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder

Identification

 

A.  pH of a 10 % aqueous solution

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

B.  Positive tests for acetate and for calcium

 

Purity

 

Loss on drying

Not more than 11 % after drying (155 oC to constant weight, for the monohydrate)

Water insoluble matter

Not more than 0,3 %

Formic acid, formates and other oxidisable substances

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 270 LACTIC ACID



Definition

 

Chemical name

Lactic acid

2-Hydroxypropionic acid

1-Hydroxyethane-1-carboxylic acid

Einecs

200-018-0

Chemical formula

C3H6O3

Molecular weight

90,08

Assay

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

Description

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

Note:

Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid

 

Identification

 

A.  Positive test for lactate

 

Purity

 

Sulphated ash

Not more than 0,1 %

Chloride

Not more than 0,2 %

Sulphate

Not more than 0,25 %

Iron

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Note:

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

 

E 280 PROPIONIC ACID



Definition

 

Chemical name

Propionic acid

Propanoic acid

Einecs

201-176-3

Chemical formula

C3H6O2

Molecular weight

74,08

Assay

Content not less than 99,5 %

Description

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

Indentification

 

A.  Melting point

- 22 oC

B.  Distillation range

138,5oC to 142,5oC

Purity

 

Non-volatile residue

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

Aldehydes

Not more than 0,1 % expressed as formaldehyde

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 281 SODIUM PROPIONATE



Definition

 

Chemical name

Sodium propionate

Sodium propanoate

Einecs

205-290-4

Chemical formula

C3H5O2Na

Molecular weight

96,06

Assay

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

Description

White crystalline hygroscopic powder, or a fine white powder

Identification

 

A.  Positive tests for propionate and for sodium

 

B.  pH of a 10 % aqueous solution

Not less than 7,5 and not more than 10,5

Purity

 

Loss on drying

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

Water insolubles

Not more than 0,1 %

Iron

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 282 CALCIUM PROPIONATE



Definition

 

Chemical name

Calcium propionate

Einecs

223-795-8

Chemical formula

C6H10O4Ca

Molecular weight

186,22

Assay

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

Description

White crystalline powder

Identification

 

A.  Positive tests for propionate and for calcium

 

B.  pH of a 10 % aqueous solution

Between 6,0 and 9,0

Purity

 

Loss on drying

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

Water insolubles

Not more than 0,3 %

Iron

Not more than 50 mg/kg

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 283 POTASSIUM PROPIONATE



Definition

 

Chemical name

Potassium propionate

Potassium propanoate

Einecs

206-323-5

Chemical formula

C3H5KO2

Molecular weight

112,17

Assay

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

Description

White crystalline powder

Identification

 

A.  Positive tests for propionate and for potassium

 

Purity

 

Loss on drying

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

Water-insoluble substances

Not more than 0,3 %

Iron

Not more than 30 mg/kg

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 284 BORIC ACID



Synonyms

Boracic acid

Orthoboric acid

Borofax

Definition

 

Einecs

233-139-2

Chemical formula

H3BO3

Molecular weight

61,84

Assay

Content not less than 99,5 %

Description

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

Identification

 

A.  Melting point

At approximately 171 oC

B.  Burns with a nice green flame

 

C.  pH of a 3,3 % aqueous solution

Between 3,8 and 4,8

Purity

 

Peroxides

No colour develops with added KI-solution

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 285 SODIUM TETRABORATE (BORAX)



Synonyms

Sodium borate

Definition

 

Chemical name

Sodium tetraborate

Sodium biborate

Sodium pyroborate

Anhydrous tetraborate

Einecs

215-540-4

Chemical formula

Na2B4O7

Na2B4O7·10H2O

Molecular weight

201,27

Description

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

Identification

 

A.  Melting range

Between 171 oC and 175 oC with decomposition

Purity

 

Peroxides

No colour develops with added KI-solution

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 290 CARBON DIOXIDE



Synonyms

Carbonic acid gas

Dry ice (solid form)

Carbonic anhydride

Definition

 

Chemical name

Carbon dioxide

Einecs

204-696-9

Chemical formula

CO2

Molecular weight

44,01

Assay

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

Description

A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders

Identification

 

A.  Precipitation (Precipitate formation)

When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid

Purity

 

Acidity

915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)

Reducing substances, hydrogen phosphide 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

Not more than 10 μl/l

▼M2

Oil content

Not more than 5 mg/kg

▼B

E 296 MALIC ACID



Synonyms

DL-Malic acid, pomalous acid

Definition

 

Chemical name

DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid

Einecs

230-022-8

Chemical formula

C4H6O5

Molecular weight

134,09

Assay

Content not less than 99,0 %

Description

White or nearly white crystalline powder or granules

Identification

 

A.  Melting range between 127 oC and 132 oC

 

B.  Positive test for malate

 

C.  Solutions of this substance are optically inactive in all concentrations

 

Purity

 

Sulphated ash

Not more than 0,1 %

Fumaric acid

Not more than 1,0 %

Maleic acid

Not more than 0,05 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 297 FUMARIC ACID



Definition

 

Chemical name

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

Einecs

203-743-0

Chemical formula

C4H4O4

Molecular weight

116,07

Assay

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

Description

White crystalline powder or granules

Identification

 

A.  Melting range

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

B.  Positive tests for double bonds and for 1,2-dicarboxylic acid

 

C.  pH of a 0,05 % solution at 25 oC

3,0-3,2

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,1 %

Maleic acid

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 300 ASCORBIC ACID



Definition

 

Chemical name

L-ascorbic acid

Ascorbic acid

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

3-Keto-L-gulofuranolactone

Einecs

200-066-2

Chemical formula

C6H8O6

Molecular weight

176,13

Assay

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

Description

White to pale yellow, odourless crystalline solid

Identification

 

A.  Melting range

Between 189 oC and 193 oC with decomposition

B.  Positive tests for ascorbic acid

 

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,1 %

Specific rotation

[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

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 301 SODIUM ASCORBATE



Definition

 

Chemical name

Sodium ascorbate

Sodium L-ascorbate

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

3-Keto-L-gulofurano-lactone sodium enolate

Einecs

205-126-1

Chemical formula

C6H7O6Na

Molecular weight

198,11

Assay

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

Description

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

Identification

 

A.  Positive tests for ascorbate and for sodium

 

Purity

 

Loss on drying

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

Specific rotation

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

pH of 10 % aqueous solution

Between 6,5 and 8,0

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 302 CALCIUM ASCORBATE



Definition

 

Chemical name

Calcium ascorbate dihydrate

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

Einecs

227-261-5

Chemical formula

C12H14O12Ca· 2H2O

Molecular weight

426,35

Assay

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

Description

White to slightly pale greyish-yellow odourless crystalline powder

Identification

 

A.  Positive tests for ascorbate and for calcium

 

Purity

 

Fluoride

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

Specific rotation

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

pH of 10 % aqueous solution

Between 6,0 and 7,5

Volatile matter

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 304 (i) ASCORBYL PALMITATE



Definition

 

Chemical name

Ascorbyl palmitate

L-ascorbyl palmitate

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

6-palmitoyl-3-keto-L-gulofuranolactone

Einecs

205-305-4

Chemical formula

C22H38O7

Molecular weight

414,55

Assay

Content not less than 98 % on the dried basis

Description

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

Identification

 

A.  Melting range

Between 107 oC and 117 oC

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,1 %

Specific rotation

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 304 (ii) ASCORBYL STEARATE



Definition

 

Chemical name

Ascorbyl stearate

L-ascorbyl stearate

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

6-stearoyl-3-keto-L-gulofuranolactone

Einecs

246-944-9

Chemical formula

C24H42O7

Molecular weight

442,6

Assay

Content not less than 98 %

Description

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

Identification

 

A.  Melting point

About 116 oC

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

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

Content not less than 34 % of total tocopherols

Description

Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form

Identification

 

A.  By suitable gas liquid chromatographic method

 

B.  Solubility tests

Insoluble in water. Soluble in ethanol. Miscible in ether

Purity

 

Sulphated ash

Not more than 0,1 %

Specific rotation

[α]D 20 not less than + 20o

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 307 ALPHA-TOCOPHEROL



Synonyms

DL-α-Tocopherol

Definition

 

Chemical name

DL-5,7,8-Trimethyltocol

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

Einecs

233-466-0

Chemical formula

C29H50O2

Molecular weight

430,71

Assay

Content not less than 96 %

Description

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

Identification

 

A.  Solubility tests

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

B.  Spectro-photometry

In absolute ethanol the maximum absorption is about 292 nm

Purity

 

Refractive index

n D 201,503-1,507

Specific absorption

image

in ethanol

image

(292 nm) 72-76

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

Sulphated ash

Not more than 0,1 %

Specific rotation

[α]D 25 0o ± 0,05o (1 in 10 solution in chloroform)

Lead

Not more than 2 mg/kg

E 308 GAMMA-TOCOPHEROL



Synonyms

dl-γ-Tocopherol

Definition

 

Chemical name

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

Einecs

231-523-4

Chemical formula

C28H48O2

Molecular weight

416,69

Assay

Content not less than 97 %

Description

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

Identification

 

A.  Spectrometry

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

Purity

 
Specific absorption

image

in ethanol

image

(298 nm) between 91 and 97

image

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

Refractive index

image

1,503-1,507

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 309 DELTA-TOCOPHEROL



Definition

 

Chemical name

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

Einecs

204-299-0

Chemical formula

C27H46O2

Molecular weight

402,7

Assay

Content not less than 97 %

Description

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

Identification

 

A.  Spectrometry

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

Purity

 
Specific absorption

image

in ethanol

image

(298 nm) between 89 and 95

image

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

Refractive index

image

1,500-1,504

Sulphated ash

Not more than 0,1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 310 PROPYL GALLATE



Definition

 

Chemical name

Propyl gallate

Propyl ester of gallic acid

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

Einecs

204-498-2

Chemical formula

C10H12O5

Molecular weight

212,20

Assay

Content not less than 98 % on the anhydrous basis

Description

White to creamy-white, crystalline, odourless solid

Identification

 

A.  Solubility tests

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

B.  Melting range

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

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,1 %

Free acid

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

Chlorinated organic compound

Not more than 100 mg/kg (as C1)

Specific absorption

image

in ethanol

image

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 311 OCTYL GALLATE



Definition

 

Chemical name

Octyl gallate

Octyl ester of gallic acid

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

Einecs

213-853-0

Chemical formula

C15H22O5

Molecular weight

282,34

Assay

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

Description

White to creamy-white odourless solid

Identification

 

A.  Solubility tests

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

B.  Melting range

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

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,05 %

Free acid

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

Chlorinated organic compound

Not more than 100 mg/kg (as C1)

Specific absorption

image

in ethanol

image

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 312 DODECYL GALLATE



Synonyms

Lauryl gallate

Definition

 

Chemical name

Dodecyl gallate

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

Dodecyl ester of gallic acid

Einecs

214-620-6

Chemical formula

C19H30O5

Molecular weight

338,45

Assay

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

Description

White or creamy-white odourless solid

Identification

 

A.  Solubility tests

Insoluble in water, freely soluble in ethanol and ether

B.  Melting range

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

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,05 %

Free acid

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

Chlorinated organic compound

Not more than 100 mg/kg (as Cl)

Specific absorption

image

in ethanol

image

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 30 mg/kg

E 315 ERYTHORBIC ACID



Synonyms

Isoascorbic acid

D-Araboascorbic acid

Definition

 

Chemical name

D-Erythro-hex-2-enoic acid γ-lactone

Isoascorbic acid

D-Isoascorbic acid

Einecs

201-928-0

Chemical formula

C6H8O6

Molecular weight

176,13

Assay

Content not less than 98 % on the anhydrous basis

Description

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

Identification

 

A.  Melting range

About 164 oC to 172 oC with decomposition

B.  Positive test for ascorbic acid/colour reaction

 

Purity

 

Loss on drying

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

Sulphated ash

Not more than 0,3 %

Specific rotation

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

Oxalate

To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear

Lead

Not more than 2 mg/kg

E 316 SODIUM ERYTHORBATE



Synonyms

Sodium isoascorbate

Definition

 

Chemical name

Sodium isoascorbate

Sodium D-isoascorbic acid

Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone

3-keto-D-gulofurano-lactone sodium enolate monohydrate

Einecs

228-973-9

Chemical formula

C6H7O6Na· H2O

Molecular weight

216,13

Assay

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

Description

White crystalline solid

Identification

 

A.  Solubility tests

Freely soluble in water, very slightly soluble in ethanol

B.  Positive test for ascorbic acid/colour reaction

 

C.  Positive test for sodium

 

Purity

 

Loss on drying

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

Specific rotation

[α]10 % (w/v) aqueous solution between + 95o and + 98o

pH of a 10 % aqueous solution

5,5 to 8,0

Oxalate

To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)



Synonyms

TBHQ

Definition

 

Chemical names

Tert-butyl-1,4-benzenediol

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

Einecs

217-752-2

Chemical formula

C10H14O2

Molecular weight

166,22

Assay

Content not less than 99 % of C10H14O2

Description

White crystalline solid having a characteristic odour

Identification

 

A.  Solubility

Practically insoluble in water; soluble in ethanol

B.  Melting point

Not less than 126,5oC

C.  Phenolics

Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced

Purity

 

Tertiary-Butyl-p-benzoquinone

Not more than 0,2 %

2,5-Di-tertiary-butyl hydroquinone

Not more than 0,2 %

Hydroxyquinone

Not more than 0,1 %

Toluene

Not more than 25 mg/kg

Lead

Not more than 2 mg/kg

E 320 BUTYLATED HYDROXYANISOLE (BHA)



Synonyms

BHA

Definition

 

Chemical names

3-Tertiary-butyl-4-hydroxyanisole

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

Einecs

246-563-8

Chemical formula

C11H16O2

Formula weight

180,25

Assay

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

Description

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

Identification

 

A.  Solubility

Insoluble in water, freely soluble in ethanol

B.  Melting range

Between 48 °C and 63 °C

C.  Colour reaction

Passes test for phenol groups

Purity

 

Sulphated ash

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

Phenolic impurities

Not more than 0,5 %

Specific absorption

image

image

(290 nm) not less than 190 and not more than 210
Specific absorption

image

image

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 321 BUTYLATED HYDROXYTOLUENE (BHT)



Synonyms

BHT

Definition

 

Chemical name

2,6-Ditertiary-butyl-p-cresol

4-Methyl-2,6-ditertiarybutylphenol

Einecs

204-881-4

Chemical formula

C15H24O

Molecular weight

220,36

Assay

Content not less than 99 %

Description

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

Identification

 

A.  Solubility tests

Insoluble in water and propane- 1,2-diol

Freely soluble in ethanol

B.  Melting point

At 70 oC

C.  Absorbance maximum

The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm

Purity

 

Sulphated ash

Not more than 0,005 %

Phenolic impurities

Not more than 0,5 %

Specific absorption

image

in ethanol

image

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 322 LECITHINS



Synonyms

Phosphatides

Phospholipids

Definition

Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides

Einecs

232-307-2

Assay

— Lecithins: not less than 60,0 % of substances insoluble in acetone

— Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone

Description

— Lecithins: brown liquid or viscous semi-liquid or powder

— Hydrolysed lecithins: light brown to brown viscous liquid or paste

Identification

 

A.  Positive tests for choline, for phosphorus 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

Purity

 

Loss on drying

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

Toluene-insoluble matter

Not more than 0,3 %

Acid value

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

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

Peroxide value

Equal to or less than 10

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 325 SODIUM LACTATE



Definition

 

Chemical name

Sodium lactate

Sodium 2-hydroxypropanoate

Einecs

200-772-0

Chemical formula

C3H5NaO3

Molecular weight

112,06 (anhydrous)

Assay

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

Description

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

Identification

 

A.  Positive test for lactate

 

B.  Positive test for sodium

 

Purity

 

Acidity

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

pH of a 20 % aqueous solution

6,5 to 7,5

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Reducing substances

No reduction of Fehling's solution

Note:

This specification refers to a 60 % aqueous solution

 

E 326 POTASSIUM LACTATE



Definition

 

Cheminal name

Potassium lactate

Potassium 2-hydroxypropanoate

Einecs

213-631-3

Chemical formula

C3H5O3K

Molecular weight

128,17 (anhydrous)

Assay

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

Description

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

Identification

 

A.  Ignition

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

B.  Colour reaction

Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact

C.  Positive tests for potassium and for lactate

 

Purity

 

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Acidity

Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required

Reducing substances

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

Note:

This specification refers to a 60 % aqueous solution

 

E 327 CALCIUM LACTATE



Definition

 

Chemical name

Calcium dilactate

Calcium dilactate hydrate

2-Hydroxypropanoic acid calcium salt

Einecs

212-406-7

Chemical formula

(C3H5O2)2 Ca· nH2O (n = 0-5)

Molecular weight

218,22 (anhydrous)

Assay

Content not less than 98 % on the anhydrous basis

Description

Almost odourless, white crystalline powder or granules

Identification

 

A.  Positive tests for lactate and for calcium

 

B.  Solubility tests

Soluble in water and practically insoluble in ethanol

Purity

 

Loss on drying

Determined by drying at 120 oC for four hours:

— anhydrous: not more than 3,0 %

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

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

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

Acidity

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

Fluoride

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

pH of a 5 % solution

Between 6,0 and 8,0

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Reducing substances

No reduction of Fehling's solution

E 330 CITRIC ACID



Definition

 

Chemical name

Citric acid

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

β-Hydroxytricarballytic acid

Einecs

201-069-1

Chemical formula

(a)  C6H8O7 (anhydrous)

(b)  C6H8O7·H2O (monohydrate)

Molecular weight

(a)  192,13 (anhydrous)

(b)  210,15 (monohydrate)

Assay

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

Description

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

Identification

 

A.  Solubility tests

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

Purity

 

Water content

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

Sulphated ash

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

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

Oxalates

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

Readily carbonisable substances

Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 oC in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)

E 331 (i) MONOSODIUM CITRATE



Synonyms

Monosodium citrate

Monobasic sodium citrate

Definition

 

Chemical name

Monosodium citrate

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

Chemical formula

(a)  C6H7O7Na (anhydrous)

(b)  C6H7O7Na· H2O (monohydrate)

Molecular weight

(a)  214,11 (anhydrous)

(b)  232,23 (monohydrate)

Assay

Content not less than 99 % on the anhydrous basis

Description

Crystalline white powder or colourless crystals

Identification

 

A.  Positive tests for citrate and for sodium

 

Purity

 

Loss on drying

Determined by drying at 180 oC for four hours:

— anhydrous: not more than 1,0 %

— monohydrate: not more than 8,8 %

Oxalates

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

pH of a 1 % aqueous solution

Between 3,5 and 3,8

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 331 (ii) DISODIUM CITRATE



Synonyms

Disodium citrate

Dibasic sodium citrate

Definition

 

Chemical name

Disodium citrate

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

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

Einecs

205-623-3

Chemical formula

C6H6O7Na2·1,5H2O

Molecular weight

263,11

Assay

Content not less than 99 % on the anhydrous basis

Description

Crystalline white powder or colourless crystals

Identification

 

A.  Positive tests for citrate and for sodium

 

Purity

 

Loss on drying

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

Oxalates

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

pH of a 1 % aqueous solution

Between 4,9 and 5,2

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 331 (iii) TRISODIUM CITRATE



Synonyms

Trisodium citrate

Tribasic sodium citrate

Definition

 

Chemical name

Trisodium citrate

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

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

Einecs

200-675-3

Chemical formula

Anhydrous:

C6H5O7Na3

Hydrated:

C6H5O7Na3·nH2O (n = 2 or 5)

Molecular weight

258,07 (anhydrous)

Assay

Not less than 99 % on the anhydrous basis

Description

Crystalline white powder or colourless crystals

Identification

 

A.  Positive tests for citrate and for sodium

 

Purity

 

Loss on drying

Determined by drying at 180 oC for four hours:

— anhydrous:

not more than 1,0 %

— dihydrate:

not more than 13,5 %

— pentahydrate:

not more than 30,3 %

Oxalates

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

pH of a 5 % aqueous solution

Between 7,5 and 9,0

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 332 (i) MONOPOTASSIUM CITRATE



Synonyms

Monopotassium citrate

Monobasic potassium citrate

Definition

 

Chemical name

Monopotassium citrate

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

Anhydrous monopotassium salt of citric acid

Einecs

212-753-4

Chemical formula

C6H7O7K

Molecular weight

230,21

Assay

Content not less than 99 % on the anhydrous basis

Description

White, hygroscopic, granular powder or transparent crystals

Identification

 

A.  Positive tests for citrate and for potassium

 

Purity

 

Loss on drying

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

Oxalates

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

pH of a 1 % aqueous solution

Between 3,5 and 3,8

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 332 (ii) TRIPOTASSIUM CITRATE



Synonyms

Tripotassium citrate

Tribasic potassium citrate

Definition

 

Chemical name

Tripotassium citrate

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

Monohydrated tripotassium salt of citric acid

Einecs

212-755-5

Chemical formula

C6H5O7K3·H2O

Molecular weight

324,42

Assay

Content not less than 99 % on the anhydrous basis

Description

White, hygroscopic, granular powder or transparent crystals

Identification

 

A.  Positive tests for citrate and for potassium

 

Purity

 

Loss on drying

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

Oxalates

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

pH of a 5 % aqueous solution

Between 7,5 and 9,0

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 333 (i) MONOCALCIUM CITRATE



Synonyms

Monocalcium citrate

Monobasic calcium citrate

Definition

 

Chemical name

Monocalcium citrate

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

Monohydrate monocalcium salt of citric acid

Chemical formula

(C6H7O7)2Ca· H2O

Molecular weight

440,32

Assay

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

Description

Fine white powder

Identification

 

A.  Positive tests for citrate and for calcium

 

Purity

 

Loss on drying

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

Oxalates

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

pH of a 1 % aqueous solution

Between 3,2 and 3,5

Fluoride

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

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

Carbonates

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

E 333 (ii) DICALCIUM CITRATE



Synonyms

Dicalcium citrate

Dibasic calcium citrate

Definition

 

Chemical name

Dicalcium citrate

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

Trihydrated dicalcium salt of citric acid

Chemical formula

(C6H7O7)2Ca2·3H2O

Molecular weight

530,42

Assay

Not less than 97,5 % on the anhydrous basis

Description

Fine white powder

Identification

 

A.  Positive tests for citrate and for calcium

 

Purity

 

Loss on drying

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

Oxalates

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

Fluoride

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

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

Carbonates

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

E 333 (iii) TRICALCIUM CITRATE



Synonyms

Tricalcium citrate

Tribasic calcium citrate

Definition

 

Chemical name

Tricalcium citrate

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

Tetrahydrated tricalcium salt of citric acid

Einecs

212-391-7

Chemical formula

(C6H6O7)2Ca3·4H2O

Molecular weight

570,51

Assay

Not less than 97,5 % on the anhydrous basis

Description

Fine white powder

Identification

 

A.  Positive tests for citrate and for calcium

 

Purity

 

Loss on drying

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

Oxalates

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

Fluoride

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

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

Carbonates

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

E 334 L(+)-TARTARIC ACID



Definition

 

Chemical name

L-tartaric acid

L-2,3-dihydroxybutanedioic acid

d-α, β-dihydroxysuccinic acid

Einecs

201-766-0

Chemical formula

C4H6O6

Molecular weight

150,09

Assay

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

Description

Colourless or translucent crystalline solid or white crystalline powder

Identification

 

A.  Melting range

Between 168 oC and 170 oC

B.  Positive test for tartrate

 

Purity

 

Loss on drying

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

Sulphated ash

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

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

[α] 20 D between + 11,5o and + 13,5o

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Oxalates

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

E 335 (i) MONOSODIUM TARTRATE



Synonyms

Monosodium salt of L-(+)-tartaric acid

Definition

 

Chemical name

Monosodium salt of L-2,3-dihydroxybutanedioic acid

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

Chemical formula

C4H5O6Na· H2O

Molecular weight

194,05

Assay

Content not less than 99 % on the anhydrous basis

Description

Transparent colourless crystals

Identification

 

A.  Positive tests for tartrate and for sodium

 

Purity

 

Loss on drying

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

Oxalates

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 335 (ii) DISODIUM TARTRATE



Definition

 

Chemical name

Disodium L-tartrate

Disodium (+)-tartrate

Disodium (+)-2,3-dihydroxybutanedioic acid

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

Einecs

212-773-3

Chemical formula

C4H4O6Na2·2H2O

Molecular weight

230,8

Assay

Content not less than 99 % on the anhydrous basis

Description

Transparent, colourless crystals

Identification

 

A.  Positive tests for tartrate and for sodium

 

B.  Solubility tests

1 gram is insoluble in 3 ml of water. Insoluble in ethanol

Purity

 

Loss on drying

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

Oxalates

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

pH of a 1 % aqueous solution

Between 7,0 and 7,5

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 336 (i) MONOPOTASSIUM TARTRATE



Synonyms

Monobasic potassium tartrate

Definition

 

Chemical name

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

Monopotassium salt of L-2,3-dihydroxybutanedioic acid

Chemical formula

C4H5O6K

Molecular weight

188,16

Assay

Content not less than 98 % on the anhydrous basis

Description

White crystalline or granulated powder

Identification

 

A.  Positive tests for tartrate and for potassium

 

B.  Melting point

230 oC

Purity

 

pH of a 1 % aqueous solution

3,4

Loss on drying

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

Oxalates

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 336 (ii) DIPOTASSIUM TARTRATE



Synonyms

Dibasic potassium tartrate

Definition

 

Chemical name

Dipotassium salt of L-2,3-dihydroxybutanedioic acid

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

Einecs

213-067-8

Chemical formula

C4H4O6K2·1/2H2O

Molecular weight

235,2

Assay

Content not less than 99 % on the anhydrous basis

Description

White crystalline or granulated powder

Identification

 

A.  Positive tests for tartrate and for potassium

 

Purity

 

pH of a 1 % aqueous solution

Between 7,0 and 9,0

Loss on drying

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

Oxalates

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 337 POTASSIUM SODIUM TARTRATE



Synonyms

Potassium sodium L-(+)-tartrate

Rochelle salt

Seignette salt

Definition

 

Chemical name

Potassium sodium salt of L-2,3-dihydroxybutanedioic acid

Potassium sodium L-(+)-tartrate

Einecs

206-156-8

Chemical formula

C4H4O6KNa· 4H2O

Molecular weight

282,23

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless crystals or white crystalline powder

Identification

 

A.  Positive tests for tartrate, for potassium and for sodium

 

B.  Solubility tests

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

C.  Melting range

Between 70 and 80 oC

Purity

 

Loss on drying

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

Oxalates

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

pH of 1 % aqueous solution

Between 6,5 and 8,5

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 338 PHOSPHORIC ACID



Synonyms

Orthophosphoric acid

Monophosphoric acid

Definition

 

Chemical name

Phosphoric acid

Einecs

231-633-2

Chemical formula

H3PO4

Molecular weight

98,00

Assay

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

Description

Clear, colourless, viscous liquid

Identification

 

A.  Positive tests for acid and for phosphate

 

Purity

 

Volatile acids

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

Chlorides

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

Nitrates

Not more than 5 mg/kg (as NaNO3)

Sulphates

Not more than 1 500 mg/kg (as CaSO4)

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

Note:

This specification refers to a 75 % aqueous solution

 

E 339 (i) MONOSODIUM PHOSPHATE



Synonyms

Monosodium monophosphate

Acid monosodium monophosphate

Monosodium orthophosphate

Monobasic sodium phosphate

Sodium dihydrogen monophosphate

Definition

 

Chemical name

Sodium dihydrogen monophosphate

Einecs

231-449-2

Chemical formula

Anhydrous: NaH2PO4

Monohydrate: NaH2PO4 · H2O

Dihydrate: NaH2PO4 · 2H2O

Molecular weight

Anhydrous: 119,98

Monohydrate: 138,00

Dihydrate: 156,01

Assay

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

P2O5 content

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

Description

A white odourless, slightly deliquescent powder, crystals or granules

Identification

 

A.  Positive tests for sodium and for phosphate

 

B.  Solubility

Freely soluble in water. Insoluble in ethanol or ether

C.  pH of a 1 % solution

Between 4,1 and 5,0

Purity

 

Loss on drying

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

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 339 (ii) DISODIUM PHOSPHATE



Synonyms

Disodium monophosphate

Secondary sodium phosphate

Disodium orthophosphate

Acid disodium phosphate

Definition

 

Chemical name

Disodium hydrogen monophosphate

Disodium hydrogen orthophosphate

Einecs

231-448-7

Chemical formula

Anhydrous: Na2HPO4

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

Molecular weight

141,98 (anhydrous)

Assay

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

P2O5 content

Between 49 % and 51 % on the anhydrous basis

Description

Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals

Identification

 

A.  Positive tests for sodium and for phosphate

 

B.  Solubility

Freely soluble in water. Insoluble in ethanol

C.  pH of a 1 % solution

Between 8,4 and 9,6

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

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 339 (iii) TRISODIUM PHOSPHATE



Synonyms

Sodium phosphate

Tribasic sodium phosphate

Trisodium orthophosphate

Definition

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

Chemical name

Trisodium monophosphate

Trisodium phosphate

Trisodium orthophosphate

Einecs

231-509-8

Chemical formula

Anhydrous: Na3PO4

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

Molecular weight

163,94 (anhydrous)

Assay

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

P2O5 content

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

Description

White odourless crystals, granules or crystalline powder

Identification

 

A.  Positive tests for sodium and for phosphate

 

B.  Solubility

Freely soluble in water. Insoluble in 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

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 340 (i) MONOPOTASSIUM PHOSPHATE



Synonyms

Monobasic potassium phosphate

Monopotassium monophosphate

Potassium orthophosphate

Definition

 

Chemical name

Potassium dihydrogen phosphate

Monopotassium dihydrogen orthophosphate

Monopotassium dihydrogen monophosphate

Einecs

231-913-4

Chemical formula

KH2PO4

Molecular weight

136,09

Assay

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

P2O5 content

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

Description

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

Identification

 

A.  Positive tests for potassium and for phosphate

 

B.  Solubility

Freely soluble in water. Insoluble in ethanol

C.  pH of a 1 % solution

Between 4,2 and 4,8

Purity

 

Loss on drying

Not more than 2,0 % determined by drying at 105 oC for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 340 (ii) DIPOTASSIUM PHOSPHATE



Synonyms

Dipotassium monophosphate

Secondary potassium phosphate

Dipotassium acid phosphate

Dipotassium orthophosphate

Dibasic potassium phosphate

Definition

 

Chemical name

Dipotassium hydrogen monophosphate

Dipotassium hydrogen phosphate

Dipotassium hydrogen orthophosphate

Einecs

231-834-5

Chemical formula

K2HPO4

Molecular weight

174,18

Assay

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

P2O5 content

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

Description

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

Identification

 

A.  Positive tests for potassium and for phosphate

 

B.  Solubility

Freely soluble in water. Insoluble in 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

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 340 (iii) TRIPOTASSIUM PHOSPHATE



Synonyms

Potassium phosphate

Tribasic potassium phosphate

Tripotassium orthophosphate

Definition

 

Chemical name

Tripotassium monophosphate

Tripotassium phosphate

Tripotassium orthophosphate

Einecs

231-907-1

Chemical formula

Anhydrous: K3PO4

Hydrated: K3PO4 · nH2O (n = 1 or 3)

Molecular weight

212,27 (anhydrous)

Assay

Content not less than 97 % calculated on the ignited basis

P2O5 content

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

Description

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

Identification

 

A.  Positive tests for potassium and for phosphate

 

B.  Solubility

Freely soluble in water. Insoluble in ethanol

C.  pH of a 1 % solution

Between 11,5 and 12,3

Purity

 

Loss on ignition

Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 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

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 341 (i) MONOCALCIUM PHOSPHATE



Synonyms

Monobasic calcium phosphate

Monocalcium orthophosphate

Definition

 

Chemical name

Calcium dihydrogen phosphate

Einecs

231-837-1

Chemical formula

Anhydrous: Ca(H2PO4)2

Monohydrate: Ca(H2PO4)2 · H2O

Molecular weight

234,05 (anhydrous)

252,08 (monohydrate)

Assay

Content not less than 95 % on the dried basis

P2O5 content

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

Description

Granular powder or white, deliquescent crystals or granules

Identification

 

A.  Positive tests for calcium and for phosphate

 

B.  CaO content

Between 23,0 % and 27,5 % (anhydrous)

Between 19,0 % and 24,8 % (monohydrate)

Purity

 

Loss on drying

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

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

Loss on ignition

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

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

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 341 (ii) DICALCIUM PHOSPHATE



Synonyms

Dibasic calcium phosphate

Dicalcium orthophosphate

Definition

 

Chemical name

Calcium monohydrogen phosphate

Calcium hydrogen orthophosphate

Secondary calcium phosphate

Einecs

231-826-1

Chemical formula

Anhydrous: CaHPO4

Dihydrate: CaHPO4 · 2H2O

Molecular weight

136,06 (anhydrous)

172,09 (dihydrate)

Assay

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

P2O5 content

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

Description

White crystals or granules, granular powder or powder

Identification

 

A.  Positive tests for calcium and for phosphate

 

B.  Solubility tests

Sparingly soluble in water. Insoluble in ethanol

Purity

 

Loss on ignition

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

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 341 (iii) TRICALCIUM PHOSPHATE



Synonyms

Calcium phosphate, tribasic

Calcium orthophosphate

Pentacalcium hydroxy monophosphate

Calcium hydroxyapatite

Definition

Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO · 3P2O5 · H2O

Chemical name

Pentacalcium hydroxy monophosphate

Tricalcium monophosphate

Einecs

235-330-6 (Pentacalcium hydroxy monophosphate)

231-840-8 (Calcium orthophosphate)

Chemical formula

Ca5(PO4)3· OH or Ca3(PO4)2

Molecular weight

502 or 310

Assay

Content not less than 90 % calculated on the ignited basis

P2O5 content

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

Description

A white, odourless powder which is stable in air

Identification

 

A.  Positive tests for calcium and for phosphate

 

B.  Solubility

Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acid

Purity

 

Loss on ignition

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

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 343(i) MONOMAGNESIUM PHOSPHATE



Synonyms

Magnesiumdihydrogenphosphate

Magnesiumphosphate, monobasic

Monomagnesium orthophosphate

Definition

 

Chemical name

Monomagnesiumdihydrogenmonophosphate

Einecs

236-004-6

Chemical formula

Mg(H2PO4)2 · nH2O (where n = 0 to 4)

Molecular weight

218,30 (anhydrous)

Assay

Not less than 51,0 % after ignition

Description

White, odourless, crystalline powder, slightly soluble in water

Identification

 

A.  Positive test for magnesium and for phosphate

 

B.  MgO content

Not less than 21,5 % after ignition

Purity

 

Fluoride

Not more than 10 mg/kg (as fluorine)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 4 mg/kg

Cadmium

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 343(ii) DIMAGNESIUM PHOSPHATE



Synonyms

Magnesiumhydrogenphosphate

Magnesiumphosphate, dibasic

Dimagnesium orthophosphate

Secondary magnesiumphosphate

Definition

 

Chemical name

Dimagnesiummonohydrogenmonophosphate

Einecs

231-823-5

Chemical formula

MgHPO4 · nH2O (where n = 0-3)

Molecular weight

120,30 (anhydrous)

Assay

Not less than 96 % after ignition

Description

White, odourless, crystalline powder, slightly soluble in water

Identification

 

A.  Positive test for magnesium and for phosphate

 

B.  MgO content:

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

Purity

 

Fluoride

Not more than 10 mg/kg (as fluorine)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 4 mg/kg

Cadmium

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 350 (i) SODIUM MALATE



Synonyms

Sodium salt of malic acid

Definition

 

Chemical name

Disodium DL-malate, disodium salt of hydroxybutanedioic acid

Chemical formula

Hemihydrate: C4H4Na2O5 · 1/2 H2O

Trihydrate: C4H4Na2O5 · 3H2O

Molecular weight

Hemihydrate: 187,05

Trihydrate: 232,10

Assay

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

Description

White crystalline powder or lumps

Identification

 

A.  Positive tests for 1,2-dicarboxylic acid and for sodium

 

B.  Azo dye formation

Positive

C.  Solubility

Freely soluble in water

Purity

 

Loss on drying

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

Alkalinity

Not more than 0,2 % as Na2CO3

Fumaric acid

Not more than 1,0 %

Maleic acid

Not more than 0,05 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 350 (ii) SODIUM HYDROGEN MALATE



Synonyms

Monosodium salt of DL-malic acid

Definition

 

Chemical name

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

Chemical formula

C4H5NaO5

Molecular weight

156,07

Assay

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

Description

White powder

Identification

 

A.  Positive tests for 1,2-dicarboxylic acid and for sodium

 

B.  Azo dye formation

Positive

Purity

 

Loss on drying

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

Maleic acid

Not more than 0,05 %

Fumaric acid

Not more than 1,0 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 351 POTASSIUM MALATE



Synonyms

Potassium salt of malic acid

Definition

 

Chemical name

Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid

Chemical formula

C4H4K2O5

Molecular weight

210,27

Assay

Content not less than 59,5 %

Description

Colourless or almost colourless aqueous solution

Identification

 

A.  Positive tests for 1,2-dicarboxylic acid and for potassium

 

B.  Azo dye formation

Positive

Purity

 

Alkalinity

Not more than 0,2 % as K2CO3

Fumaric acid

Not more than 1,0 %

Maleic acid

Not more than 0,05 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 352 (i) CALCIUM MALATE



Synonyms

Calcium salt of malic acid

Definition

 

Chemical name

Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid

Chemical formula

C4H5CaO5

Molecular weight

172,14

Assay

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

Description

White powder

Identification

 

A.  Positive tests for malate, 1,2-dicarboxylic acid and for calcium

 

B.  Azo dye formation

Positive

C.  Solubility

Slightly soluble in water

Purity

 

Loss on drying

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

Alkalinity

Not more than 0,2 % as CaCO3

Maleic acid

Not more than 0,05 %

Fumaric acid

Not more than 1,0 %

Fluoride

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 352 (ii) CALCIUM HYDROGEN MALATE



Synonyms

Monocalcium salt of DL-malic acid

Definition

 

Chemical name

Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate

Chemical formula

(C4H5O5)2Ca

Assay

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

Description

White powder

Identification

 

A.  Positive tests for 1,2-dicarboxylic acid and for calcium

 

B.  Azo dye formation

Positive

Purity

 

Loss on drying

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

Maleic acid

Not more than 0,05 %

Fumaric acid

Not more than 1,0 %

Fluoride

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 353 METATARTARIC ACID



Synonyms

Ditartaric acid

Definition

 

Chemical name

Metatartaric acid

Chemical formula

C4H6O6

Assay

Not less than 99,5 %

Description

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

Identification

 

A.

Very soluble in water and ethanol

B.

Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 oC, an intense violet coloration appears

Purity

 

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 354 CALCIUM TARTRATE



Synonyms

L-Calcium tartrate

Definition

 

Chemical name

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

Chemical formula

C4H4CaO6 · 2H2O

Molecular weight

224,18

Assay

Not less than 98,0 %

Description

Fine crystalline powder with a white or off-white colour

Identification

 

A.  Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids

 

B.  Specific rotation [α]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)

Not more than 1 g/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 355 ADIPIC ACID



Definition

 

Chemical name

Hexanedioic acid, 1,4-butanedicarboxylic acid

Einecs

204-673-3

Chemical formula

C6H10O4

Molecular weight

146,14

Assay

Content not less than 99,6 %

Description

White odourless crystals or crystalline powder

Identification

 

A.  Melting range

151,5oC-154,0oC

B.  Solubility

Slightly soluble in water. Freely soluble in ethanol

Purity

 

Water

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

Sulphated ash

Not more than 20 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 356 SODIUM ADIPATE



Definition

 

Chemical name

Sodium adipate

Einecs

231-293-5

Chemical formula

C6H8Na2O4

Molecular weight

190,11

Assay

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

Description

White odourless crystals or crystalline powder

Identification

 

A.  Melting range

151 oC-152 oC (for adipic acid)

B.  Solubility

Approximately 50 g/100 ml water (20 oC)

C.  Positive test for sodium

 

Purity

 

Water

Not more than 3 % (Karl Fischer)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 357 POTASSIUM ADIPATE



Definition

 

Chemical name

Potassium adipate

Einecs

242-838-1

Chemical formula

C6H8K2O4

Molecular weight

222,32

Assay

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

Description

White odourless crystals or crystalline powder

Identification

 

A.  Melting range

151 oC-152 oC (for adipic acid)

B.  Solubility

Approximately 60 g/100 ml water (20 oC)

C.  Positive test for potassium

 

Purity

 

Water

Not more than 3 % (Karl Fischer)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 363 SUCCINIC ACID



Definition

 

Chemical name

Butanedioic acid

Einecs

203-740-4

Chemical formula

C4H6O4

Molecular weight

118,09

Assay

Content no less than 99,0 %

Description

Colourless or white, odourless crystals

Identification

 

A.  Melting range

Between 185,0oC and 190,0oC

Purity

 

Residue on ignition

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 380 TRIAMMONIUM CITRATE



Synonyms

Tribasic ammonium citrate

Definition

 

Chemical name

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

Einecs

222-394-5

Chemical formula

C6H17N3O7

Molecular weight

243,22

Assay

Content not less than 97,0 %

Description

White to off-white crystals or powder

Identification

 

A.  Positive tests for ammonium and for citrate

 

B.  Solubility

Freely soluble in water

Purity

 

Oxalate

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE



Synonyms

Calcium disodium EDTA

Calcium disodium edetate

Definition

 

Chemical name

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

Calcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetate

Einecs

200-529-9

Chemical formula

C10H12O8CaN2Na2·2H2O

Molecular weight

410,31

Assay

Content not less than 97 % on the anhydrous basis

Description

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

Identification

 

A.  Positive tests for sodium and for calcium

 

B.  Chelating activity to metal ions positive

 

C.  pH of a 1 % solution between 6,5 and 7,5

 

Purity

 

Water content

5 to 13 % (Karl Fischer method)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

▼M2

E 392 EXTRACTS OF ROSEMARY



GENERAL SPECIFICATION

Synonym

Extract of rosemary leaf (antioxidant)

Definition

Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification

EINECS

283-291-9

Chemical name

Rosemary extract (Rosmarinus officinalis)

Description

Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardised

Identification

Reference antioxidative compounds: phenolic diterpenes

Carnosic acid (C20H28O4) and Carnosol (C20H26O4) (which comprise not less than 90 % of the total phenolic diterpenes)

Reference key volatiles

Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, Verbenone

Density

> 0,25 g/ml

Solubility

Insoluble in water

Purity

Loss on Drying

< 5 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg



1.  Extracts of rosemary produced from dried rosemary leaves by acetone extraction

Description

Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid

Identification

Content of reference antioxidative compounds

≥ 10 % w/w, expressed as the total of carnosic acid and carnosol

Antioxidant/Volatiles — Ratio

(Total % w/w of carnosic acid and carnosol) ≥ 15

(% w/w of reference key volatiles)*

(* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)

Residual Solvents

Acetone: not more than 500 mg/kg



2.  Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide

Identification

Content of reference antioxidative compounds

≥ 13 % w/w, expressed as the total of carnosic acid and carnosol

Antioxidant/Volatiles — Ratio

(Total % w/w of carnosic acid and carnosol) ≥ 15

(% w/w of reference key volatiles)*

(* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)

Residual Solvents

Ethanol: not more than 2 %



3.  Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary

Identification

Content of reference antioxidative compounds

≥ 5 % w/w, expressed as the total of carnosic acid and carnosol

Antioxidant/Volatiles — Ratio

(Total % w/w of carnosic acid and carnosol) ≥ 15

(% w/w of reference key volatiles)*

(* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)

Residual Solvents

Ethanol: not more than 500 mg/kg



4.  Extracts of rosemary decolourised and deodorised, obtained by a two-step extraction using hexane and ethanol

Identification

Content of reference antioxidative compounds

≥ 5 % w/w, expressed as the total of carnosic acid and carnosol

Antioxidant/Volatiles — Ratio

(Total % w/w of carnosic acid and carnosol) ≥ 15

(% w/w of reference key volatiles)*

(* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)

Residual solvents

Hexane: not more than 25 mg/kg

Ethanol: not more than 500 mg/kg

▼M1

E 400 ALGINIC ACID



Definition

Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)

Einecs

232-680-1

Chemical formula

(C6H8O6)n

Molecular weight

10 000-600 000 (typical average)

Assay

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

Description

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

Identification

A.  Solubility

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

B.  Calcium chloride precipitation test

To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum

C.  Ammonium sulphate precipitation test

To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch

D.  Colour reaction

Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple

Purity

pH of a 3 % suspension

Between 2,0 and 3,5

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Sulphated ash

Not more than 8 % on the anhydrous basis

Sodium hydroxide (1 M solution)

Not more than 2 % on the anhydrous basis insoluble matter

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

E 401 SODIUM ALGINATE



Definition

Chemical name

Sodium salt of alginic acid

Chemical formula

(C6H7NaO6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)

Description

Nearly odourless, white to yellowish fibrous or granular powder

Identification

Positive test for sodium and alginic acid

 

Purity

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

E 402 POTASSIUM ALGINATE



Definition

Chemical name

Potassium salt of alginic acid

Chemical formula

(C6H7KO6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)

Description

Nearly odourless, white to yellowish fibrous or granular powder

Identification

Positive test for potassium and for alginic acid

 

Purity

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

E 403 AMMONIUM ALGINATE



Definition

Chemical name

Ammonium salt of alginic acid

Chemical formula

(C6H11NO6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)

Description

White to yellowish fibrous or granular powder

Identification

Positive test for ammonium and alginic acid

 

Purity

Loss on drying

Not more than 15 % (105 °C, 4 hours)

Sulphated ash

Not more than 7 % on the dried basis

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

E 404 CALCIUM ALGINATE



Synonyms

Calcium salt of alginate

Definition

Chemical name

Calcium salt of alginic acid

Chemical formula

(C6H7Ca1/2O6)n

Molecular weight

10 000-600 000 (typical average)

Assay

Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)

Description

Nearly odourless, white to yellowish fibrous or granular powder

Identification

Positive test for calcium and alginic acid

 

Purity

Loss on drying

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

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

E 405 PROPANE-1,2-DIOL ALGINATE



Synonyms

Hydroxypropyl alginate

1,2-propanediol ester of alginic acid

Propylene glycol alginate

Definition

Chemical name

Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule

Chemical formula

(C9H14O7)n (esterified)

Molecular weight

10 000-600 000 (typical average)

Assay

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

Description

Nearly odourless, white to yellowish brown fibrous or granular powder

Identification

Positive test for 1,2-propanediol and alginic acid after hydrolysis

 

Purity

Loss on drying

Not more than 20 % (105 °C, 4 hours)

Total propane-1,2-diol content

Not less than 15 % and not more than 45 %

Free propane-1,2-diol content

Not more than 15 %

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Formaldehyde

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

▼B

E 406 AGAR



Synonyms

Gelose

Japan agar

Bengal, Ceylon, Chinese or Japanese isinglass

Layor Carang

Definition

 

Chemical name

Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain natural strains of marine algae of the families Gelidiaceae and Sphaerococcaceae and related red algae of the class Rhodophyceae

Einecs

232-658-1

Assay

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

Description

Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, 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

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

Ash

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

Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)

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

Insoluble matter (in hot water)

Not more than 1,0 %

Starch

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

Gelatin and other proteins

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

Water absorption

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

▼M1

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.)

Definition

Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaeceae 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. Formaldehyde may be present as an adventitious impurity up to a maximum level of 5 mg/kg

Einecs

232-524-2

Description

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

Identification

Positive tests for galactose, for anhydrogalactose and for sulphate

 

Purity

Methanol, ethanol, propane-2-ol content

Not more than 0,1 % singly or in combination

Viscosity of a 1,5 % solution at 75 °C

Not less than 5 mPa.s

Loss on drying

Not more than 12 % (105 °C, four hours)

Sulphate

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

Ash

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

Acid-insoluble ash

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

Acid-insoluble matter

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

Low molecular weight carrageenan

(Molecular weight fraction below 50 kDa)

Not more than 5 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 2 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 300 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

E 407a PROCESSED EUCHEUMA SEAWEED



Synonyms

PES (acronym for processed eucheuma seaweed)

Definition

Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consist chiefly of the potassium salt of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded. Formaldehyde may be present as an adventitious impurity up to a maximum level of 5 mg/kg.

Description

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

Identification

A.  Positive tests for galactose, for anhydrogalactose and for sulphate

 

B.  Solubility

Forms cloudy viscous suspensions in water. Insoluble in ethanol

Purity

Methanol, ethanol, propane-2-ol content

Not more than 0,1 % singly or in combination

Viscosity of a 1,5 % solution at 75 °C

Not less than 5 mPa.s

Loss on drying

Not more than 12 % (105 °C, four hours)

Sulphate

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

Ash

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

Acid-insoluble ash

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

Acid-insoluble matter

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

Low molecular weight carrageenan

(Molecular weight fraction below 50 kDa)

Not more than 5 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 2 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 300 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

▼B

E 410 LOCUST BEAN GUM



Synonyms

Carob bean gum

Algaroba gum

Definition

Locust bean gum is the ground endosperm of the seeds of the natural strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan

Molecular weight

50 000-3 000 000

Einecs

232-541-5

Assay

Galactomannan content not less than 75 %

Description

White to yellowish-white, nearly odourless powder

Identification

 

A.  Positive tests for galactose mannose

 

B.  Microscopic examination

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

C.  Solubility

Soluble in hot water, insoluble in ethanol

Purity

 

Loss on drying

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

Ash

Not more than 1,2 % determined at 800 oC

Protein (N × 6,25)

Not more than 7 %

Acid-insoluble matter

Not more than 4 %

Starch

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

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

▼M1

E 412 GUAR GUM



Synonyms

Gum cyamopsis

Guar flour

Definition

Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobur (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as a galactomannan. The gum may be partially hydrolysed by either heat treatment, mild acid or alkaline oxidative treatment for viscosity adjustment.

Einecs

232-536-0

Molecular weight

Consists mainly of a high molecular weight hydrocolloidal polysaccharide (50 000-8 000 000)

Assay

Galactomannan content not less than 75 %

Description

A white to yellowish-white, nearly odourless powder

Identification

A.  Positive tests for galactose and for mannose

 

B.  Solubility

Soluble in cold water

Purity

Loss on drying

Not more than 15 % (105 °C, 5 hours)

Ash

Not more than 5,5 % determined at 800 °C

Acid-insoluble matter

Not more than 7 %

Protein (N × 6,25)

Not more than 10 %

Starch

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

Organic peroxides

Not more than 0,7 meq active oxygen/kg sample

Furfural

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Arsenic

Not more than 3 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

▼B

E 413 TRAGACANTH



Synonyms

Tragacanth gum

Tragant

Definition

Tragacanth is a dried exudation obtained from the stems and branches of natural strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present

Molecular weight

Approximately 800 000

Einecs

232-252-5

Description

Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour

Identification

 

A.  Solubility

1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol

Purity

 

Negative test for Karaya gum

Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops

Loss on drying

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

Total ash

Not more than 4 %

Acid insoluble ash

Not more than 0,5 %

Acid insoluble matter

Not more than 2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Salmonella spp.

Negative in 10 g

E. coli

Negative in 5 g

E 414 ACACIA GUM



Synonyms

Gum arabic

Definition

Acacia gum is a dried exudation obtained from the stems and branches of natural strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid

Molecular weight

Approximately 350 000

Einecs

232-519-5

Description

Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.

Identification

 

A.  Solubility

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

Purity

 

Loss on drying

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

Total ash

Not more than 4 %

Acid insoluble ash

Not more than 0,5 %

Acid insoluble matter

Not more than 1 %

Starch or dextrin

Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced

Tannin

To 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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Hydrolysis products

Mannose, xylose and galacturonic acid are absent (determined by chromatography)

Salmonella spp.

Negative in 10 g

E. coli

Negative in 5 g

E 415 XANTHAN GUM



Definition

Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains of Xanthomonas campestris, purified by recovery with ethanol or propane-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral

Molecular weight

Approximately 1 000 000

Einecs

234-394-2

Assay

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

Identification

 

A.  Solubility

Soluble in water. Insoluble in ethanol

Purity

 

Loss on drying

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

Total ash

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

Pyruvic acid

Not less than 1,5 %

Nitrogen

Not more than 1,5 %

Ethanol and propan-2-ol

Not more than 500 mg/kg singly or in combination

Lead

Not more than 2 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and mould

Not more than 300 colonies per gram

E. coli

Absent in 5 g

Salmonella spp.

Absent in 10 g

Xanthomonas campestris

Viable cells absent in 1 g

E 416 KARAYA-GUM



Synonyms

Katilo

Kadaya

Gum sterculia

Sterculia

Karaya, gum karaya

Kullo

Kuterra

Definition

Karaya gum is a dried exudation from the stems and branches of natural strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid

Einecs

232-539-4

Description

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

Identification

 

A.  Solubility

Insoluble in ethanol

B.  Swelling in ethanol solution

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

Purity

 

Loss on drying

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

Total ash

Not more than 8 %

Acid insoluble ash

Not more than 1 %

Acid insoluble matter

Not more than 3 %

Volatile acid

Not less than 10 % (as acetic acid)

Starch

Not detectable

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Salmonella spp.

Negative in 10 g

E. coli

Negative in 5 g

E 417 TARA GUM



Definition

Tara gum is obtained by grinding the endosperm of the seeds of natural strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)

Einecs

254-409-6

Description

A white to white-yellow odourless powder

Identification

 

A.  Solubility

Soluble in water

Insoluble in ethanol

B.  Gel formation

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

Purity

 

Loss on drying

Not more than 15 %

Ash

Not more than 1,5 %

Acid insoluble matter

Not more than 2 %

Protein

Not more than 3,5 % (factor N × 5,7)

Starch

Not detectable

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

E 418 GELLAN GUM



Definition

Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains of Pseudomonas elodea, purified by recovery with isopropyl alcohol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt

Einecs

275-117-5

Molecular weight

Approximately 500 000

Assay

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

Description

An off-white powder

Identification

 

A.  Solubility

Soluble in water, forming a viscous solution.

Insoluble in ethanol

Purity

 

Loss on drying

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

Nitrogen

Not more than 3 %

Propane-2-ol

Not more than 750 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Not more than 10 000 colonies per gram

Yeast and mould

Not more than 400 colonies per gram

E. coli

Negative in 5 g

Salmonella spp.

Negative in 10 g

E 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 ( 6 ).

E 420(ii) SORBITOL SYRUP

Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.

E 421 MANNITOL

Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.

E 422 GLYCEROL



Synonyms

Glycerin

Glycerine

Definition

 

Chemical names

1,2,3-propanetriol

Glycerol

Trihydroxypropane

Einecs

200-289-5

Chemical formula

C3H8O3

Molecular weight

92,10

Assay

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

Description

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

Identification

 

A.  Acrolein formation on heating

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

B.  Specific gravity (25/25 oC)

Not less than 1,257

C.  Refractive index [n]D20

Between 1,471 and 1,474

Purity

 

Water

Not more than 5 % (Karl Fischer method)

Sulphated ash

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

Butanetriols

Not more than 0,2 %

Acrolein, glucose and ammonium compounds

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

Fatty acids and esters

Not more than 0,1 % calculated as butyric acid

Chlorinated compounds

Not more than 30 mg/kg (as chlorine)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 425(i) KONJAC GUM



Definition

Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac. The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units

Molecular weight

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

Assay

Not less than 75 % carbohydrate

Description

A white to cream to light tan powder

Identification

 

A.  Solubility

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

B.  Gel formation

Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms

C.  Formation of heat-stable gel

Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed

D.  Viscosity (1 % solution)

Not less than 3 kgm-1s-1 at 25 oC

Purity

 

Loss on drying

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

Starch

Not more than 3 %

Protein

Not more than 3 % (N × 5,7)

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

Ether-soluble material

Not more than 0,1 %

Total ash

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Salmonella spp.

Absent in 12,5 g

E. coli

Absent in 5 g

E 425(ii) KONJAC GLUCOMANNAN



Definition

Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated

Molecular weight

500 000 to 2 000 000

Assay

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

Description

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

Identification

 

A.  Solubility

Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mechanical agitation

B.  Formation of heat-stable gel

Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution 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

Not more than 1 %

Protein

Not more than 1,5 % (N × 5,7)

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

Ether-soluble material

Not more than 0,5 %

Sulphite (as SO2)

Not more than 4 mg/kg

Chloride

Not more than 0,02 %

50 % Alcohol-soluble

Not more than 2,0 % material

Total ash

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

Lead

Not more than 1 mg/kg

Salmonella spp.

Absent in 12,5 g

E. coli

Absent in 5 g

E 426 SOYBEAN HEMICELLULOSE



▼M2

Definition

Soybean Hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol

▼B

Chemical names

Water soluble soybean polysaccharides

Water soluble soybean fibre

Assay

Not less than 74 % carbohydrate

▼M2

Description

Free flowing white or yellowish white powder

▼B

Identification

 

A.  Solubility pH of 1 % solution

Soluble in hot and cold water without gel formation

5,5 ± 1,5

B.  Viscosity of 10 % solution

Not more than 200 mPa.s

Purity

 

Loss on drying

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

Protein

Not more than 14 %

Total ash

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

Arsenic

Not more than 2 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Standard plate count

Not more than 3 000 colonies per gram

Yeast and mould

Not more than 100 colonies per gram

E. coli

Negative in 10 g

▼M2

Ethanol

Not more than 2 %

E 427 CASSIA GUM



Synonyms

 

Definition

Cassia gum is the ground purified endosperm of the seeds of Cassia tora and Cassia obtusifoli (Leguminosae) containing less than 0,05 % of Cassia occidentalis. It consists mainly of high molecular weight polysaccharides composed primarily of a linear chain of 1,4-β-D-mannopyranose units linked with 1,6-α-D-galactopyranose units. The ratio of mannose to galactose is about 5:1

In the manufacture the seeds are dehusked and degermed by thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with isopropanol

Assay

Not less than 75 % of Galactomannan

Description

Pale yellow to off-white, odourless powder

Identification

Solubility

Insoluble in ethanol. Disperses well in cold water forming a colloidal solution

Gel formation with borate

To an aqueous dispersion of the sample add sufficient sodium borate test solution (TS) to raise the pH to above 9; a gel is formed

Gel formation with xanthan gum

Weigh 1,5 g of the sample and 1,5 g of xanthan gum and blend them. Add this blend (with rapid stirring) into 300 ml water at 80 °C in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the temperature above 60 °C during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h

A firm, viscoelastic gel forms after the temperature drops below 40 °C, but no such gel forms in a 1 % control solution of cassia gum or xanthan gum alone prepared in a similar manner

Viscosity

Less than 500 mPa.s (25 °C, 2h, 1 % solution) corresponding to an average molecular weight of 200 000-300 000 D

Purity

Acid insoluble matter

Not more than 2,0 %

pH

5,5-8 (1 % aqueous solution)

Crude fat

Not more than 1 %

Proteins

Not more than 7 %

Total ash

Not more than 1,2 %

Loss on drying

Not more than 12 % (5 h, 105 °C)

Total Anthraquinones

Not more than 0,5 mg/kg (detection limit)

Solvent residues

Not more than 750 mg/kg Isopropyl alcohol

Lead

Not more than 1 mg/kg

Microbiological criteria

Total plate count

Not more than 5 000 colony forming units per gram

Yeast and mould

Not more than 100 colony forming units per gram

Salmonella spp.

Absent in 25 g

E. Coli

Absent in 1 g

▼B

E 431 POLYOXYETHYLENE (40) STEARATE



Synonyms

Polyoxyl (40) stearate

polyoxyethylene (40) monostearate

Definition

A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol

Assay

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

Description

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

Identification

 

A.  Solubility

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

B.  Congealing range

39 oC-44 oC

C.  Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

Purity

 

Water

Not more than 3 % (Karl Fischer method)

Acid value

Not more than 1

Saponification value

Not less than 25 and not more than 35

Hydroxyl value

Not less than 27 and not more than 40

1,4-Dioxane

Not more than 5 mg/kg

Ethylene oxide

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)



Synonyms

Polysorbate 20

Polyoxyethylene (20) sorbitan monolaurate

Definition

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

Assay

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

Description

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

Identification

 

A.  Solubility

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

B.  Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

Purity

 

Water

Not more than 3 % (Karl Fischer method)

Acid value

Not more than 2

Saponification value

Not less than 40 and not more than 50

Hydroxyl value

Not less than 96 and not more than 108

1,4-dioxane

Not more than 5 mg/kg

Ethylene oxide

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)



Synonyms

Polysorbate 80

Polyoxyethylene (20) sorbitan monooleate

Definition

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

Assay

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

Description

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

Identification

 

A.  Solubility

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

B.  Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

Purity

 

Water

Not more than 3 % (Karl Fischer method)

Acid value

Not more than 2

Saponification value

Not less than 45 and not more than 55

Hydroxyl value

Not less than 65 and not more than 80

1,4-dioxane

Not more than 5 mg/kg

Ethylene oxide

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)



Synonyms

Polysorbate 40

Polyoxyethylene (20) sorbitan monopalmitate

Definition

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

Assay

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

Description

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

Identification

 

A.  Solubility

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

B.  Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

Purity

 

Water

Not more than 3 % (Karl Fischer method)

Acid value

Not more than 2

Saponification value

Not less than 41 and not more than 52

Hydroxyl value

Not l