# Official Journal L 253/20 S

| | ISSN 1725-2555 |
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| Official Journal
  of the European Union | L 253 |
| | |
| English edition | Legislation | Volume 5120 September 2008 |

ISSN 1725-2555

Official Journal

of the European Union

L 253

English edition

Legislation

Volume 5120 September 2008

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| Contents | | I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory | page |
| --- | --- | --- | --- |
| | | DIRECTIVES |
| | * | Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Codified version) (
  1
  ) | 1 |

Contents

I   Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

page

DIRECTIVES

*

Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Codified version) (
  1
  )

(Codified version) (
  1

1

| | | |
| --- | --- | --- |
| | * | Note to the reader (see page 3 of the cover) | s3 |

*

Note to the reader (see page 3 of the cover)

s3

| | |
| --- | --- |
| | (1)   Text with EEA relevance |

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(1)   Text with EEA relevance

1

| EN | Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.
  The titles of all other Acts are printed in bold type and preceded by an asterisk. |
| --- | --- |

EN

Acts whose titles are printed in light type are those relating to day-to-day management of agricultural matters, and are generally valid for a limited period.

The titles of all other Acts are printed in bold type and preceded by an asterisk.

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I Acts adopted under the EC Treaty/Euratom Treaty whose publication is obligatory

DIRECTIVES

| 20.9.2008 | EN | Official Journal of the European Union | L 253/1 |
| --- | --- | --- | --- |

20.9.2008

EN

Official Journal of the European Union

L 253/1

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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. |
| --- | --- |

(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). |
| --- | --- |

(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). |
| --- | --- |

(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. |
| --- | --- |

(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. |
| --- | --- |

(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, |
| --- | --- |

(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.

Done at Brussels, 27 August 2008.

For the Commission

The President

José Manuel BARROSO

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(1)  
  OJ L 40, 11.2.1989, p. 27.

1

(2)  
  OJ L 339, 30.12.1996, p. 1.

2

(3)  See Annex II, part A.

3

(4)  
  OJ L 61, 18.3.1995, p. 1.

4

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ANNEX I

Ethylene oxide may not be used for sterilising purposes in food additives.

E 170 (i) CALCIUM CARBONATE

Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC (1).

E 200 SORBIC ACID

| Definition | |
| --- | --- |
| Chemical name | Sorbic acid |
| 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 |

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 |
| --- | --- |

B.

Spectrometry

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

| C. | Positive test for double bonds |
| --- | --- |

C.

Positive test for double bonds

| D. | Sublimation point |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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

121,5  oC to 123,5  oC

| B. | Positive sublimation test and test for benzoate |
| --- | --- |

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

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 |

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 |
| --- | --- |

B.

Melting range for benzoic acid

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

| C. | Positive tests for benzoate and for sodium |
| --- | --- |

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 121,5  oC to 123,5  oC, after vacuum drying in a sulphuric acid desiccator |

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 121,5  oC to 123,5  oC, after vacuum drying in a sulphuric acid desiccator

| B. | Positive tests for benzoate and for potassium |
| --- | --- |

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 121,5  oC to 123,5  oC, after vacuum drying in a sulphuric acid desiccator |

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 121,5  oC to 123,5  oC, after vacuum drying in a sulphuric acid desiccator

| B. | Positive tests for benzoate and for calcium |
| --- | --- |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

C.

Positive test for sodium

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

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

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 |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |

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 |

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 |

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

E 230 BIPHENYL

| Synonyms | Diphenyl |
| --- | --- |
| Definition | |
| Chemical name | 1,1′-biphenyl |
| Phenylbenzene |
| Einecs | 202-163-5 |
| Chemical formula | C12H10 |
| Molecular weight | 154,20 |
| Assay | Content not less than 99,8  % |
| Description | White or pale yellow to amber crystalline solid having a characteristic odour |
| Identification | |
| A. | Melting range |

Synonyms

Diphenyl

Definition

Chemical name

1,1′-biphenyl

Phenylbenzene

Einecs

202-163-5

Chemical formula

C12H10

Molecular weight

154,20

Assay

Content not less than 99,8  %

Description

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

Identification

A.

Melting range

68,5  oC to 70,5  oC

| B. | Distillation range |
| --- | --- |

B.

Distillation range

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

Purity

Benzene

Not more than 10 mg/kg

Aromatic amines

Not more than 2 mg/kg (as aniline)

Phenol derivatives

Not more than 5 mg/kg (as phenol)

Readily carbonisable substances

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

Terphenyl and higher polyphenyl derivatives

Not more than 0,2  %

Polycyclic aromatic hydrocarbons

Absent

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 231 ORTHOPHENYLPHENOL

| Synonyms | Orthoxenol |
| --- | --- |
| Definition | |
| Chemical name | (1,1'-Biphenyl)-2-ol |
| 2-Hydroxydiphenyl |
| o-Hydroxydiphenyl |
| Einecs | 201-993-5 |
| Chemical formula | C12H10O |
| Molecular weight | 170,20 |
| Assay | Content not less than 99 % |
| Description | White or slightly yellowish crystalline powder |
| Identification | |
| A. | Melting range |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

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

E 233 THIABENDAZOLE

| Definition | |
| --- | --- |
| Chemical name | 4-(2-benzimidazolyl)thiazole |
| 2-(4-thiazolyl)-1H-benzimidazole |
| Einecs | 205-725-8 |
| Chemical formula | C10H7N3S |
| Molecular weight | 201,26 |
| Assay | Content not less than 98 % on the anhydrous basis |
| Description | White, or almost white, odourless powder |
| Identification | |
| A. | Melting range |

Definition

Chemical name

4-(2-benzimidazolyl)thiazole

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

Einecs

205-725-8

Chemical formula

C10H7N3S

Molecular weight

201,26

Assay

Content not less than 98 % on the anhydrous basis

Description

White, or almost white, odourless powder

Identification

A.

Melting range

296 oC to 303 oC

| B. | Spectrometry |
| --- | --- |

B.

Spectrometry

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

Formula

Formula

Formula

Ratio of absorption 243 nm/302 nm = 0,47 to 0,53

Ratio of absorption 258 nm/302 nm = 0,14 to 0,18

Purity

Water content

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

Sulphated ash

Not more than 0,2  %

Selenium

Not more than 3 mg/kg

Arsenic

Not more than 3 mg/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 234 NISIN

| Definition | Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N |
| --- | --- |
| Einecs | 215-807-5 |
| Chemical formula | C143H230N42O37S7 |
| Molecular weight | 3 354 ,12 |
| Assay | Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 % |
| Description | White powder |
| Purity | |
| Loss on drying | Not more than 3 % when dried to constant weight at 102 oC to 103 oC |
| Arsenic | Not more than 1 mg/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 |

Definition

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

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 solids and a minimum sodium chloride content of 50 %

Description

White powder

Purity

Loss on drying

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

Arsenic

Not more than 1 mg/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 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 |

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 hydrochloric acid, a blue colour develops,

| — | concentrated phosphoric acid, a green colour develops, |
| --- | --- |

—

concentrated phosphoric acid, a green colour develops,

which changes into pale red after a few minutes

| B. | Spectrometry |
| --- | --- |

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 |
| --- | --- |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Melting point

17 oC

Boiling point

172 oC with decomposition

| C. | Density 20 oC |
| --- | --- |

C.

Density 20 oC

Approximately 1,25 g/cm3

| D. | Infrared spectrum |
| --- | --- |

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 (5) |
| Description | White or slightly yellow, deliquescent granules |
| Identification | |
| A. | Positive tests for nitrite and for potassium |

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 (5)

Description

White or slightly yellow, deliquescent granules

Identification

A.

Positive tests for nitrite and for potassium

| B. | pH of a 5 % solution: |
| --- | --- |

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

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 (6) |
| Description | White crystalline powder or yellowish lumps |
| Identification | |
| A. | Positive tests for nitrite and for sodium |

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 (6)

Description

White crystalline powder or yellowish lumps

Identification

A.

Positive tests for nitrite and for sodium

Purity

Loss on drying

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 251 SODIUM NITRATE

1.   SOLID SODIUM NITRATE

| Synonyms | Chile saltpetre |
| --- | --- |
| Cubic or soda nitre |
| Definition | |
| Chemical name | Sodium nitrate |
| Einecs | 231-554-3 |
| Chemical formula | 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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Specific gravity

About 1,049

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

C.

A one in three solution gives positive tests for acetate

| D. | Solidification point |
| --- | --- |

D.

Solidification point

Not lower than 14,5  oC

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |

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 |
| --- | --- |

B.

Distillation range

138,5  oC to 142,5  oC

Purity

Non-volatile residue

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

Aldehydes

Not more than 0,1  % expressed as formaldehyde

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |

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 |
| --- | --- |

B.

Burns with a nice green flame

| C. | pH of a 3,3  % aqueous solution |
| --- | --- |

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 |

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) |

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

Oil content

Not more than 0,1  mg/l

E 296 MALIC ACID

| Synonyms | DL-Malic acid, pomalous acid |
| --- | --- |
| Definition | |
| Chemical name | DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid |
| Einecs | 230-022-8 |
| Chemical formula | 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 |

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 |
| --- | --- |

B.

Positive test for malate

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

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 |

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 |
| --- | --- |

B.

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

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

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 |

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 |
| --- | --- |

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

pH of a 2 % aqueous solution

Between 2,4 and 2,8

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 301 SODIUM ASCORBATE

| Definition | |
| --- | --- |
| Chemical name | Sodium ascorbate |
| Sodium L-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 |

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 |

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 |

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 |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Spectro-photometry

In absolute ethanol the maximum absorption is about 292 nm

Purity

Refractive index

n D
  201,503 -1,507

Formula

Formula
  (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±0,05 o (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 |

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

Formula

Formula

Formula

Refractive index

Formula

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 |

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

Formula

Formula

Formula

Refractive index

Formula

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 |

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 |
| --- | --- |

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)

Formula

Formula

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 |

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 |
| --- | --- |

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)

Formula

Formula

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 |

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 |
| --- | --- |

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)

Formula

Formula

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 |

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 |
| --- | --- |

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 -16,5 o to -18,0 o

Oxalate

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

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 |

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 |
| --- | --- |

B.

Positive test for ascorbic acid/colour reaction

| C. | Positive test for sodium |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Melting point

Not less than 126,5  oC

| C. | Phenolics |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Melting range

Between 48 °C and 63 °C

| C. | Colour reaction |
| --- | --- |

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  %

Formula

Formula

Formula

Formula

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 |

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 |
| --- | --- |

B.

Melting point

At 70 oC

| C. | Absorbance maximum |
| --- | --- |

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  %

Formula

Formula

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 |

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 |
| --- | --- |

—

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

Description

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

—

Lecithins: brown liquid or viscous semi-liquid or powder

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

—

Hydrolysed lecithins: light brown to brown viscous liquid or paste

Identification

| A. | Positive tests for choline, for phosphorus and fatty acids |
| --- | --- |

A.

Positive tests for choline, for phosphorus and fatty acids

| B. | Test for hydrolysed lecithin |
| --- | --- |

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 |
| --- | --- |

—

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

| — | Hydrolysed lecithins: not more than 45 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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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  % |
| --- | --- |

—

anhydrous: not more than 3,0  %

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

—

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

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

—

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

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

—

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) |

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) |
| --- | --- |

(b)

C6H8O7·H2O (monohydrate)

Molecular weight

| (a) | 192,13 (anhydrous) |
| --- | --- |

(a)

192,13 (anhydrous)

| (b) | 210,15 (monohydrate) |
| --- | --- |

(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 |
| --- | --- |

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) |

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) |
| --- | --- |

(b)

C6H7O7Na· H2O (monohydrate)

Molecular weight

| (a) | 214,11 (anhydrous) |
| --- | --- |

(a)

214,11 (anhydrous)

| (b) | 232,23 (monohydrate) |
| --- | --- |

(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 |
| --- | --- |

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  % |
| --- | --- |

—

anhydrous: not more than 1,0  %

| — | monohydrate: not more than 8,8  % |
| --- | --- |

—

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 |

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 |

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: |
| --- | --- |

—

anhydrous:

not more than 1,0  %

| — | dihydrate: |
| --- | --- |

—

dihydrate:

not more than 13,5  %

| — | pentahydrate: |
| --- | --- |

—

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 |

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 |

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 |

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 |

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 |

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 |

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 |
| --- | --- |

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 +11,5 o and +13,5 o

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 |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |

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 |
| --- | --- |

B.

Solubility tests

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

| C. | Melting range |
| --- | --- |

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 |

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 |

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 |
| --- | --- |

B.

Solubility

Freely soluble in water. Insoluble in ethanol or ether

| C. | pH of a 1 % solution |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Solubility

Freely soluble in water. Insoluble in ethanol

| C. | pH of a 1 % solution |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Solubility

Freely soluble in water. Insoluble in ethanol

| C. | pH of a 1 % solution |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Solubility

Freely soluble in water. Insoluble in ethanol

| C. | pH of a 1 % solution |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Solubility

Freely soluble in water. Insoluble in ethanol

| C. | pH of a 1 % solution |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Solubility

Freely soluble in water. Insoluble in ethanol

| C. | pH of a 1 % solution |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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: |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Azo dye formation

Positive

| C. | Solubility |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Azo dye formation

Positive

| C. | Solubility |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |

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 |
| --- | --- |

B.

Specific rotation [α]20
  D

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

| C. | pH of a 5 % slurry |
| --- | --- |

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 |

Definition

Chemical name

Hexanedioic acid, 1,4-butanedicarboxylic acid

Einecs

204-673-3

Chemical formula

C6H10O4

Molecular weight

146,14

Assay

Content not less than 99,6  %

Description

White odourless crystals or crystalline powder

Identification

A.

Melting range

151,5  oC-154,0  oC

| B. | Solubility |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Solubility

Approximately 50 g/100 ml water (20 oC)

| C. | Positive test for sodium |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Solubility

Approximately 60 g/100 ml water (20 oC)

| C. | Positive test for potassium |
| --- | --- |

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 |

Definition

Chemical name

Butanedioic acid

Einecs

203-740-4

Chemical formula

C4H6O4

Molecular weight

118,09

Assay

Content no less than 99,0  %

Description

Colourless or white, odourless crystals

Identification

A.

Melting range

Between 185,0  oC and 190,0  oC

Purity

Residue on ignition

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Chelating activity to metal ions positive

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

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

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 (calculted on equivalent weight basis of 200) |
| Description | Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless |
| Identification | |
| A. | Solubility |

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 (calculted on equivalent weight basis of 200)

Description

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

Identification

A.

Solubility

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

| B. | Calcium chloride precipitation test |
| --- | --- |

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 |
| --- | --- |

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 |
| --- | --- |

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 oC, 4 hours)

Sulphated ash

Not more than 8 % on the anhydrous basis

Sodium hydroxide (1 M solution)

Not more than 2 % on the anhydrous basis insoluble matter

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Negative in 5 g

Salmonella spp.

Negative in 10 g

E 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 | |
| A. | Positive test for sodium and alginic acid |

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

A.

Positive test for sodium and alginic acid

Purity

Loss on drying

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

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Negative in 5 g

Salmonella spp.

Negative in 10 g

E 402 POTASSIUM ALGINATE

| Definition | |
| --- | --- |
| Chemical name | Potassium salt of alginic acid |
| Chemical formula | (C6H7KO6)n |
| Molecular weight | 10 000 -600 000 (typical average) |
| Assay | Yields, on the anhydrous basis, not less than 16,5  % and not more than 19,5  % of carbon dioxide corresponding to not less than 89,2  % and not more than 105,5  % of potassium alginate (calculated on an equivalent weight basis of 238) |
| Description | Nearly odourless, white to yellowish fibrous or granular powder |
| Identification | |
| A. | Positive test for potassium and for alginic acid |

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

A.

Positive test for potassium and for alginic acid

Purity

Loss on drying

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

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Negative in 5 g

Salmonella spp.

Negative in 10 g

E 403 AMMONIUM 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 | |
| A. | Positive test for ammonium and alginic acid |

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

A.

Positive test for ammonium and alginic acid

Purity

Loss on drying

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

Sulphated ash

Not more than 7 % on the dried basis

Water-insoluble matter

Not more than 2 % on the anhydrous basis

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

Not more than 20 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Negative in 5 g

Salmonella spp.

Negative in 10 g

E 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 | |
| A. | Positive test for calcium and alginic acid |

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

A.

Positive test for calcium and alginic acid

Purity

Loss on drying

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Negative in 5 g

Salmonella spp.

Negative in 10 g

E 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 | |
| A. | Positive test for 1,2-propanediol and alginic acid after hydrolysis |

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

A.

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

Purity

Loss on drying

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

Total propane-1,2-diol content

Not less than 15 % and not more than 45 %

Free propane-1,2-diol content

Not more than 15 %

Water-insoluble matter

Not more than 2 % on the anhydrous basis

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 500 colonies per gram

E. coli

Negative in 5 g

Salmonella spp.

Negative in 10 g

E 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 |

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

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, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded |
| Einecs | 232-524-2 |
| Description | Yellowish to colourless, coarse to fine powder which is practically odourless |
| Identification | |
| A. | Positive tests for galactose, for anhydrogalactose and for sulphate |

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, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded

Einecs

232-524-2

Description

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

Identification

A.

Positive tests for galactose, for anhydrogalactose and for sulphate

Purity

Methanol, ethanol propane-2-ol content

Not more than 0,1  % singly or in combination

Viscosity of a 1,5  % solution at 75 oC

Not less than 5 mPa.s

Loss on drying

Not more than 12 % (105 oC, 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 oC

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 1 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

Negative in 5 g

Salmonella spp.

Negative 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 consists chiefly of the potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded |
| Description | Tan to yellowish, coarse to fine powder which is practically odourless |
| Identification | |
| A. | Positive tests for galactose, for anhydrogalactose and for sulphate |

Synonyms

PES (acronym for processed eucheuma seaweed)

Definition

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

Description

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

Identification

A.

Positive tests for galactose, for anhydrogalactose and for sulphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Forms cloudy viscous suspensions in water. Insoluble in ethanol

Purity

Methanol, ethanol, propane-2-ol content

Not more than 0,1  % singly or in combination

Viscosity of a 1,5  % solution at 75 oC

Not less than 5 mPa.s

Loss on drying

Not more than 12 % (105 oC, 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 oC

Acid-insoluble ash

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

Acid-insoluble matter

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

Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)

Not more than 5 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Total plate count

Not more than 5 000 colonies per gram

Yeast and moulds

Not more than 300 colonies per gram

E. coli

Negative in 5 g

Salmonella spp.

Negative in 10 g

E 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 |

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 |
| --- | --- |

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 |
| --- | --- |

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

E 412 GUAR GUM

| Synonyms | Gum cyamopsis |
| --- | --- |
| Guar flour |
| Definition | Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan |
| Einecs | 232-536-0 |
| Molecular weight | 50 000 -8 000 000 |
| Assay | Galactomannan content not less than 75 % |
| Description | A white to yellowish-white, nearly odourless powder |
| Identification | |
| A. | Positive tests for galactose and for mannose |

Synonyms

Gum cyamopsis

Guar flour

Definition

Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan

Einecs

232-536-0

Molecular weight

50 000 -8 000 000

Assay

Galactomannan content not less than 75 %

Description

A white to yellowish-white, nearly odourless powder

Identification

A.

Positive tests for galactose and for mannose

| B. | Solubility |
| --- | --- |

B.

Solubility

Soluble in cold water

Purity

Loss on drying

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

Ash

Not more than 1,5  % determined at 800 oC

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)

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 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 |

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 |

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 |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 (7).

E 420(ii) SORBITOL SYRUP

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

E 421 MANNITOL

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

E 422 GLYCEROL

| Synonyms | Glycerin |
| --- | --- |
| Glycerine |
| Definition | |
| Chemical names | 1,2,3-propanetriol |
| Glycerol |
| Trihydroxypropane |
| Einecs | 200-289-5 |
| 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 |

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) |
| --- | --- |

B.

Specific gravity (25/25 oC)

Not less than 1,257

| C. | Refractive index [n]D20 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

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) |
| --- | --- |

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 |

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 |
| --- | --- |

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) |
| --- | --- |

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

| Definition | Soybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction |
| --- | --- |
| Chemical names | Water soluble soybean polysaccharides |
| Water soluble soybean fibre |
| Assay | Not less than 74 % carbohydrate |
| Description | Free flowing spray-dried white powder |
| Identification | |
| A. | Solubility pH of 1 % solution |

Definition

Soybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction

Chemical names

Water soluble soybean polysaccharides

Water soluble soybean fibre

Assay

Not less than 74 % carbohydrate

Description

Free flowing spray-dried white powder

Identification

A.

Solubility pH of 1 % solution

Soluble in hot and cold water without gel formation

5,5 ±1,5

| B. | Viscosity of 10 % solution |
| --- | --- |

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

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 |

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 |
| --- | --- |

B.

Congealing range

39 oC-44 oC

| C. | Infrared absorption spectrum |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

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 |

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 |
| --- | --- |

B.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated polyol

Purity

Water

Not more than 3 % (Karl Fischer method)

Acid value

Not more than 2

Saponification value

Not less than 41 and not more than 52

Hydroxyl value

Not less than 90 and not more than 107

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 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)

| Synonyms | Polysorbate 60 |
| --- | --- |
| Polyoxyethylene (20) sorbitan monostearate |
| Definition | A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides |
| Assay | Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis |
| Description | A lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint characteristic odour |
| Identification | |
| A. | Solubility |

Synonyms

Polysorbate 60

Polyoxyethylene (20) sorbitan monostearate

Definition

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

Assay

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

Description

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

Identification

A.

Solubility

Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils

| B. | Infrared absorption spectrum |
| --- | --- |

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 81 and not more than 96

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 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)

| Synonyms | Polysorbate 65 |
| --- | --- |
| Polyoxyethylene (20) sorbitan tristearate |
| Definition | A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides |
| Assay | Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis |
| Description | A tan-coloured, waxy solid at 25 oC with a faint characteristic odour |
| Identification | |
| A. | Solubility |

Synonyms

Polysorbate 65

Polyoxyethylene (20) sorbitan tristearate

Definition

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

Assay

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

Description

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

Identification

A.

Solubility

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

| B. | Congealing range |
| --- | --- |

B.

Congealing range

29-33 oC

| C. | Infrared absorption spectrum |
| --- | --- |

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 2

Saponification value

Not less than 88 and not more than 98

Hydroxyl value

Not less than 40 and not more than 60

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 440 (i) PECTIN

| Definition | Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol |
| --- | --- |
| Einecs | 232-553-0 |
| Assay | Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol |
| Description | White, light yellow, light grey or light brown powder |
| Identification | |
| A. | Solubility |

Definition

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

Einecs

232-553-0

Assay

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

Description

White, light yellow, light grey or light brown powder

Identification

A.

Solubility

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

Purity

Loss on drying

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

Acid insoluble ash

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

Sulphur dioxide

Not more than 50 mg/kg on the anhydrous basis

Nitrogen content

Not more than 1,0  % after washing with acid and ethanol

Free methanol, ethanol and propane-2-ol

Not more than 1 %, singly or in combination, on the anhydrous basis

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 440 (ii) AMIDATED PECTIN

| Definition | Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate natural strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol |
| --- | --- |
| Assay | Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol |
| Description | White, light yellow, light greyish or light brownish powder |
| Identification | |
| A. | Solubility |

Definition

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

Assay

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

Description

White, light yellow, light greyish or light brownish powder

Identification

A.

Solubility

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

Purity

Loss on drying

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

Acid-insoluble ash

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

Degree of amidation

Not more than 25 % of total carboxyl groups

Sulphur dioxide residue

Not more than 50 mg/kg on the anhydrous basis

Nitrogen content

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

Free methanol, ethanol and propane-2-ol

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

Arsenic

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 442 AMMONIUM PHOSPHATIDES

| Synonyms | Ammonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glycerides |
| --- | --- |
| Definition | A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides |
| Assay | The phosphorus content is not less than 3 % and not more than 3,4  % by weight; the ammonium content is not less than 1,2  % and not more than 1,5  % (calculated as N) |
| Description | Unctuous semi-solid |
| Identification | |
| A. | Solubility |

Synonyms

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

Definition

A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides

Assay

The phosphorus content is not less than 3 % and not more than 3,4  % by weight; the ammonium content is not less than 1,2  % and not more than 1,5  % (calculated as N)

Description

Unctuous semi-solid

Identification

A.

Solubility

Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone

| B. | Positive tests for glycerol, for fatty acid and for phosphate |
| --- | --- |

B.

Positive tests for glycerol, for fatty acid and for phosphate

Purity

Petroleum ether insoluble matter

Not more than 2,5  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 444 SUCROSE ACETATE ISOBUTYRATE

| Synonyms | SAIB |
| --- | --- |
| Definition | Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6 |
| Einecs | 204-771-6 |
| Chemical name | Sucrose diacetate hexaisobutyrate |
| Chemical formulae | C40H62O19 |
| Molecular weight | 832-856 (approximate), C40H62O19: 846,9 |
| Assay | Content not less than 98,8  % and not more than 101,9  % of C40H62O19 |
| Description | A pale straw-coloured liquid, clear and free of sediment and having a bland odour |
| Identification | |
| A. | Solubility |

Synonyms

SAIB

Definition

Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6

Einecs

204-771-6

Chemical name

Sucrose diacetate hexaisobutyrate

Chemical formulae

C40H62O19

Molecular weight

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

Assay

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

Description

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

Identification

A.

Solubility

Insoluble in water. Soluble in most organic solvents

| B. | Refractive index |
| --- | --- |

B.

Refractive index

[n]40
  D: 1,4492 -1,4504

| C. | Specific gravity |
| --- | --- |

C.

Specific gravity

[d]25
  D: 1,141 -1,151

Purity

Triacetin

Not more than 0,1  %

Acid value

Not more than 0,2

Saponification value

Not less than 524 and not more than 540

Arsenic

Not more than 3 mg/kg

Lead

Not more than 3 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 5 mg/kg

E 445 GLYCEROL ESTERS OF WOOD ROSIN

| Synonyms | Ester gum |
| --- | --- |
| Definition | A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation |
| Description | Hard, yellow to pale amber-coloured solid |
| Identification | |
| A. | Solubility |

Synonyms

Ester gum

Definition

A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation

Description

Hard, yellow to pale amber-coloured solid

Identification

A.

Solubility

Insoluble in water, soluble in acetone

| B. | Infrared absorption spectrum |
| --- | --- |

B.

Infrared absorption spectrum

Characteristic of the compound

Purity

Specific gravity of solution

[d]20
  25 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boilding point 175,5 -176 oC, d20
  4: 0,84 )

Ring and ball softening range

Between 82 oC and 90 oC

Acid value

Not less than 3 and not more than 9

Hydroxyl value

Not less than 15 and not more than 45

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 10 mg/kg

Test for absence of tall oil rosin (sulphur test)

When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin

E 450 (i) DISODIUM DIPHOSPHATE

| Synonyms | Disodium dihydrogen diphosphate |
| --- | --- |
| Disodium dihydrogen pyrophosphate |
| Sodium acid pyrophosphate |
| Disodium pyrophosphate |
| Definition | |
| Chemical name | Disodium dihydrogen diphosphate |
| Einecs | 231-835-0 |
| Chemical formula | Na2H2P2O7 |
| Molecular weight | 221,94 |
| Assay | Content not less than 95 % of disodium diphosphate |
| P2O5 Content | Not less than 63,0  % and not more than 64,5  % |
| Description | White powder or grains |
| Identification | |
| A. | Positive tests for sodium and for phosphate |

Synonyms

Disodium dihydrogen diphosphate

Disodium dihydrogen pyrophosphate

Sodium acid pyrophosphate

Disodium pyrophosphate

Definition

Chemical name

Disodium dihydrogen diphosphate

Einecs

231-835-0

Chemical formula

Na2H2P2O7

Molecular weight

221,94

Assay

Content not less than 95 % of disodium diphosphate

P2O5 Content

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

Description

White powder or grains

Identification

A.

Positive tests for sodium and for phosphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Soluble in water

| C. | pH of a 1 % solution |
| --- | --- |

C.

pH of a 1 % solution

Between 3,7 and 5,0

Purity

Loss on drying

Not more than 0,5  % (105 oC, four hours)

Water-insoluble matter

Not more than 1 %

Fluoride

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 450 (ii) TRISODIUM DIPHOSPHATE

| Synonyms | Acid trisodium pyrophosphate |
| --- | --- |
| Trisodium monohydrogen diphosphate |
| Definition | |
| Einecs | 238-735-6 |
| Chemical formula | Monohydrate: Na3HP2O7 · H2O |
| Anhydrous: Na3HP2O7 |
| Molecular weight | Monohydrate: 261,95 |
| Anhydrous: 243,93 |
| Assay | Content not less than 95 % on the anhydrous basis |
| P2O5 content | Not less than 57 % and not more than 59 % |
| Description | White powder or grains, occurs anhydrous or as a monohydrate |
| Identification | |
| A. | Positive tests for sodium and for phosphate |

Synonyms

Acid trisodium pyrophosphate

Trisodium monohydrogen diphosphate

Definition

Einecs

238-735-6

Chemical formula

Monohydrate: Na3HP2O7 · H2O

Anhydrous: Na3HP2O7

Molecular weight

Monohydrate: 261,95

Anhydrous: 243,93

Assay

Content not less than 95 % on the anhydrous basis

P2O5 content

Not less than 57 % and not more than 59 %

Description

White powder or grains, occurs anhydrous or as a monohydrate

Identification

A.

Positive tests for sodium and for phosphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Soluble in water

| C. | pH of a 1 % solution |
| --- | --- |

C.

pH of a 1 % solution

Between 6,7 and 7,5

Purity

Loss on ignition

Not more than 4,5  % on the anhydrous compound

Not more than 11,5  % on the monohydrous basis

Loss on drying

Not more than 0,5  % (105 oC, four hours)

Water-insoluble matter

Not more than 0,2  %

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 450 (iii) TETRASODIUM DIPHOSPHATE

| Synonyms | Tetrasodium pyrophosphate |
| --- | --- |
| Sodium pyrophosphate |
| Definition | |
| Chemical name | Tetrasodium diphosphate |
| Einecs | 231-767-1 |
| Chemical formula | Anhydrous: Na4P2O7 |
| Decahydrate: Na4P2O7 · 10H2O |
| Molecular weight | Anhydrous: 265,94 |
| Decahydrate: 446,09 |
| Assay | Content not less than 95 % of Na4P2O7 on the ignited basis |
| P2O5 content | Not less than 52,5  % and not more than 54,0  % |
| Description | Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air |
| Identification | |
| A. | Positive tests for sodium and for phosphate |

Synonyms

Tetrasodium pyrophosphate

Sodium pyrophosphate

Definition

Chemical name

Tetrasodium diphosphate

Einecs

231-767-1

Chemical formula

Anhydrous: Na4P2O7

Decahydrate: Na4P2O7 · 10H2O

Molecular weight

Anhydrous: 265,94

Decahydrate: 446,09

Assay

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

P2O5 content

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

Description

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

Identification

A.

Positive tests for sodium and for phosphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Soluble in water. Insoluble in ethanol

| C. | pH of a 1 % solution |
| --- | --- |

C.

pH of a 1 % solution

Between 9,8 and 10,8

Purity

Loss on ignition

Not more than 0,5  % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate, in both cases determined after drying at 105 oC for four hours, followed by ignition at 550 oC for 30 minutes

Water-insoluble matter

Not more than 0,2  %

Fluoride

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 450 (v) TETRAPOTASSIUM DIPHOSPHATE

| Synonyms | Potassium pyrophosphate |
| --- | --- |
| Tetrapotassium pyrophosphate |
| Definition | |
| Chemical name | Tetrapotassium diphosphate |
| Einecs | 230-785-7 |
| Chemical formula | K4P2O7 |
| Molecular weight | 330,34 (anhydrous) |
| Assay | Content not less than 95 % on the ignited basis |
| P2O5 content | Not less than 42,0  % and not more than 43,7  % on the anhydrous basis |
| Description | Colourless crystals or white, very hygroscopic powder |
| Identification | |
| A. | Positive tests for potassium and for phosphate |

Synonyms

Potassium pyrophosphate

Tetrapotassium pyrophosphate

Definition

Chemical name

Tetrapotassium diphosphate

Einecs

230-785-7

Chemical formula

K4P2O7

Molecular weight

330,34 (anhydrous)

Assay

Content not less than 95 % on the ignited basis

P2O5 content

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

Description

Colourless crystals or white, very hygroscopic powder

Identification

A.

Positive tests for potassium and for phosphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Soluble in water, insoluble in ethanol

| C. | pH of a 1 % solution |
| --- | --- |

C.

pH of a 1 % solution

Between 10,0 and 10,8

Purity

Loss on ignition

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

Water-insoluble substances

Not more than 0,2  %

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 450 (vi) DICALCIUM DIPHOSPHATE

| Synonyms | Calcium pyrophosphate |
| --- | --- |
| Definition | |
| Chemical name | Dicalcium diphosphate |
| Dicalcium pyrophosphate |
| Einecs | 232-221-5 |
| Chemical formula | Ca2P2O7 |
| Molecular weight | 254,12 |
| Assay | Content not less than 96 % |
| P2O5 content | Not less than 55 % and not more than 56 % |
| Description | A fine, white, odourless powder |
| Identification | |
| A. | Positive tests for calcium and for phosphate |

Synonyms

Calcium pyrophosphate

Definition

Chemical name

Dicalcium diphosphate

Dicalcium pyrophosphate

Einecs

232-221-5

Chemical formula

Ca2P2O7

Molecular weight

254,12

Assay

Content not less than 96 %

P2O5 content

Not less than 55 % and not more than 56 %

Description

A fine, white, odourless powder

Identification

A.

Positive tests for calcium and for phosphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Insoluble in water. Soluble in dilute hydrochloric and nitric acids

| C. | pH of a 10 % suspension in water |
| --- | --- |

C.

pH of a 10 % suspension in water

Between 5,5 and 7,0

Purity

Loss on ignition

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

Fluoride

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 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE

| Synonyms | Acid calcium pyrophosphate |
| --- | --- |
| Monocalcium dihydrogen pyrophosphate |
| Definition | |
| Chemical name | Calcium dihydrogen diphosphate |
| Einecs | 238-933-2 |
| Chemical formula | CaH2P2O7 |
| Molecular weight | 215,97 |
| Assay | Content not less than 90 % on the anhydrous basis |
| P2O5 content | Not less than 61 % and not more than 64 % |
| Description | White crystals or powder |
| Identification | |
| A. | Positive tests for calcium and for phosphate |

Synonyms

Acid calcium pyrophosphate

Monocalcium dihydrogen pyrophosphate

Definition

Chemical name

Calcium dihydrogen diphosphate

Einecs

238-933-2

Chemical formula

CaH2P2O7

Molecular weight

215,97

Assay

Content not less than 90 % on the anhydrous basis

P2O5 content

Not less than 61 % and not more than 64 %

Description

White crystals or powder

Identification

A.

Positive tests for calcium and for phosphate

Purity

Acid-insoluble matter

Not more than 0,4  %

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 451 (i) PENTASODIUM TRIPHOSPHATE

| Synonyms | Pentasodium tripolyphosphate |
| --- | --- |
| Sodium tripolyphosphate |
| Definition | |
| Chemical name | Pentasodium triphosphate |
| Einecs | 231-838-7 |
| Chemical formula | Na5O10P3 · nH2O (n = 0 or 6) |
| Molecular weight | 367,86 |
| Assay | Content not less than 85,0  % (anhydrous) or 65,0  % (hexahydrate) |
| P2O5 content | Not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate) |
| Description | White, slightly hygroscopic granules or powder |
| Identification | |
| A. | Solubility |

Synonyms

Pentasodium tripolyphosphate

Sodium tripolyphosphate

Definition

Chemical name

Pentasodium triphosphate

Einecs

231-838-7

Chemical formula

Na5O10P3 · nH2O (n = 0 or 6)

Molecular weight

367,86

Assay

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

P2O5 content

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

Description

White, slightly hygroscopic granules or powder

Identification

A.

Solubility

Freely soluble in water. Insoluble in ethanol

| B. | Positive tests for sodium and for phosphate |
| --- | --- |

B.

Positive tests for sodium and for phosphate

| C. | pH of a 1 % solution |
| --- | --- |

C.

pH of a 1 % solution

Between 9,1 and 10,2

Purity

Loss on drying

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

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

Water-insoluble substances

Not more than 0,1  %

Higher polyphosphates

Not more than 1 %

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE

| Synonyms | Pentapotassium tripolyphosphate |
| --- | --- |
| Potassium triphosphate |
| Potassium tripolyphosphate |
| Definition | |
| Chemical name | Pentapotassium triphosphate |
| Pentapotassium tripolyphosphate |
| Einecs | 237-574-9 |
| Chemical formula | K5O10P3 |
| Molecular weight | 448,42 |
| Assay | Content not less than 85 % on the anhydrous basis |
| P2O5 content | Not less than 46,5  % and not more than 48 % |
| Description | White, very hygroscopic powder or granules |
| Identification | |
| A. | Solubility |

Synonyms

Pentapotassium tripolyphosphate

Potassium triphosphate

Potassium tripolyphosphate

Definition

Chemical name

Pentapotassium triphosphate

Pentapotassium tripolyphosphate

Einecs

237-574-9

Chemical formula

K5O10P3

Molecular weight

448,42

Assay

Content not less than 85 % on the anhydrous basis

P2O5 content

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

Description

White, very hygroscopic powder or granules

Identification

A.

Solubility

Very soluble in water

| B. | Positive tests for potassium and for phosphate |
| --- | --- |

B.

Positive tests for potassium and for phosphate

| C. | pH of a 1 % solution |
| --- | --- |

C.

pH of a 1 % solution

Between 9,2 and 10,5

Purity

Loss on ignition

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

Water-insoluble matter

Not more than 2 %

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 452 (i) SODIUM POLYPHOSPHATE

1.   SOLUBLE POLYPHOSPHATE

| Synonyms | Sodium hexametaphosphate |
| --- | --- |
| Sodium tetrapolyphosphate |
| Graham's salt |
| Sodium polyphosphates, glassy |
| Sodium polymetaphosphate |
| Sodium metaphosphate |
| Definition | Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)x where x ≥ 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0 |
| Chemical name | Sodium polyphosphate |
| Einecs | 272-808-3 |
| Chemical formula | Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2 |
| Molecular weight | (102)n |
| Assay P2O5 content | Not less than 60 % and not more than 71 % on the ignited basis |
| Description | Colourless or white, transparent platelets, granules, or powders |
| Identification | |
| A. | Solubility |

Synonyms

Sodium hexametaphosphate

Sodium tetrapolyphosphate

Graham's salt

Sodium polyphosphates, glassy

Sodium polymetaphosphate

Sodium metaphosphate

Definition

Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)x where x ≥ 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0

Chemical name

Sodium polyphosphate

Einecs

272-808-3

Chemical formula

Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

Molecular weight

(102)n

Assay P2O5 content

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

Description

Colourless or white, transparent platelets, granules, or powders

Identification

A.

Solubility

Very soluble in water

| B. | Positive tests for sodium and for phosphate |
| --- | --- |

B.

Positive tests for sodium and for phosphate

| C. | pH of a 1 % solution |
| --- | --- |

C.

pH of a 1 % solution

Between 3,0 and 9,0

Purity

Loss on ignition

Not more than 1 %

Water-insoluble matter

Not more than 0,1  %

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

2.   INSOLUBLE POLYPHOSPHATE

| Synonyms | Insoluble sodium metaphosphate |
| --- | --- |
| Maddrell's salt |
| Insoluble sodium polyphosphate, IMP |
| Definition | Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0 . The pH of 1 in 3 suspension in water is about 6,5 |
| Chemical name | Sodium polyphosphate |
| Einecs | 272-808-3 |
| Chemical formula | Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2 |
| Molecular weight | (102)n |
| P2O5 content | Not less than 68,7  % and not more than 70,0  % |
| Description | White crystalline powder |
| Identification | |
| A. | Solubility |

Synonyms

Insoluble sodium metaphosphate

Maddrell's salt

Insoluble sodium polyphosphate, IMP

Definition

Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0 . The pH of 1 in 3 suspension in water is about 6,5

Chemical name

Sodium polyphosphate

Einecs

272-808-3

Chemical formula

Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

Molecular weight

(102)n

P2O5 content

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

Description

White crystalline powder

Identification

A.

Solubility

Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides

| B. | Positive tests for sodium and for phosphate |
| --- | --- |

B.

Positive tests for sodium and for phosphate

| C. | pH of 1 in 3 suspension in water |
| --- | --- |

C.

pH of 1 in 3 suspension in water

About 6,5

Purity

Fluoride

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

Arsenic

Not more than 3 mg/kg

Cadmium

Not more than 1 mg/kg

Lead

Not more than 4 mg/kg

Mercury

Not more than 1 mg/kg

E 452 (ii) POTASSIUM POLYPHOSPHATE

| Synonyms | Potassium metaphosphate |
| --- | --- |
| Potassium polymetaphosphate |
| Kurrol salt |
| Definition | |
| Chemical name | Potassium polyphosphate |
| Einecs | 232-212-6 |
| Chemical formula | (KPO3)n |
| Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2 |
| Molecular weight | (118)n |
| P2O5 content | Not less than 53,5  % and not more than 61,5  % on the ignited basis |
| Description | Fine white powder or crystals or colourless glassy platelets |
| Identification | |
| A. | Solubility |

Synonyms

Potassium metaphosphate

Potassium polymetaphosphate

Kurrol salt

Definition

Chemical name

Potassium polyphosphate

Einecs

232-212-6

Chemical formula

(KPO3)n

Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2

Molecular weight

(118)n

P2O5 content

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

Description

Fine white powder or crystals or colourless glassy platelets

Identification

A.

Solubility

1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate

| B. | Positive tests for potassium and for phosphate |
| --- | --- |

B.

Positive tests for potassium and for phosphate

| C. | pH of a 1 % suspension |
| --- | --- |

C.

pH of a 1 % suspension

Not more than 7,8

Purity

Loss on ignition

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

Cyclic phosphate

Not more than 8 % on P2O5 content

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 452(iii) SODIUM CALCIUM POLYPHOSPHATE

| Synonym | Sodium calcium polyphosphate, glassy |
| --- | --- |
| Definition | |
| Chemical name | Sodium calcium polyphosphate |
| Einecs | 233-782-9 |
| Chemical formula | (NaPO3)n CaO where n is typically 5 |
| Assay | Not less than 61 % and not more than 69 % as P2O5 |
| Description | White glassy crystals, spheres |
| Identification | |
| A. | pH of a 1 % m/m slurry |

Synonym

Sodium calcium polyphosphate, glassy

Definition

Chemical name

Sodium calcium polyphosphate

Einecs

233-782-9

Chemical formula

(NaPO3)n CaO where n is typically 5

Assay

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

Description

White glassy crystals, spheres

Identification

A.

pH of a 1 % m/m slurry

Approximately 5 to 7

| B. | CaO content |
| --- | --- |

B.

CaO content

7 %-15 % m/m

Purity

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 4 mg/kg

Cadmium

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 452 (iv) CALCIUM POLYPHOSPHATE

| Synonyms | Calcium metaphosphate |
| --- | --- |
| Calcium polymetaphosphate |
| Definition | |
| Chemical name | Calcium polyphosphate |
| Einecs | 236-769-6 |
| Chemical formula | (CaP2O6)n |
| Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where ‘n’ is not less than 2 |
| Molecular weight | (198)n |
| P2O5 content | Not less than 71 % and not more than 73 % on the ignited basis |
| Description | Odourless, colourless crystals or white powder |
| Identification | |
| A. | Solubility |

Synonyms

Calcium metaphosphate

Calcium polymetaphosphate

Definition

Chemical name

Calcium polyphosphate

Einecs

236-769-6

Chemical formula

(CaP2O6)n

Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where ‘n’ is not less than 2

Molecular weight

(198)n

P2O5 content

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

Description

Odourless, colourless crystals or white powder

Identification

A.

Solubility

Usually sparingly soluble in water. Soluble in acid medium

| B. | Positive tests for calcium and for phosphate |
| --- | --- |

B.

Positive tests for calcium and for phosphate

| C. | CaO content |
| --- | --- |

C.

CaO content

27 to 29,5  %

Purity

Loss on ignition

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

Cyclic phosphate

Not more than 8 % on P2O5 content

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 459 BETA-CYCLODEXTRIN

| Definition | Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch |
| --- | --- |
| Chemical name | Cycloheptaamylose |
| Einecs | 231-493-2 |
| Chemical formula | (C6H10O5)7 |
| Molecular weight | 1 135 |
| Assay | Content not less than 98,0  % of (C6H10O5)7 on an anhydrous basis |
| Description | Virtually odourless white or almost white crystalline solid |
| Identification | |
| A. | Solubility |

Definition

Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch

Chemical name

Cycloheptaamylose

Einecs

231-493-2

Chemical formula

(C6H10O5)7

Molecular weight

1 135

Assay

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

Description

Virtually odourless white or almost white crystalline solid

Identification

A.

Solubility

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

| B. | Specific rotation |
| --- | --- |

B.

Specific rotation

[α]25
  D: + 160o to + 164o (1 % solution)

Purity

Water

Not more than 14 % (Karl Fischer method)

Other cyclodextrins

Not more than 2 % on an anhydrous basis

Residual solvents (toluene and trichloroethylene)

Not more than 1 mg/kg for each solvent

Sulphated ash

Not more than 0,1  %

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

E 460 (i) MICROCRISTALLINE CELLULOSE

| Synonyms | Cellulose gel |
| --- | --- |
| Definition | Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400 |
| Chemical name | Cellulose |
| Einecs | 232-674-9 |
| Chemical formula | (C6H10O5)n |
| Molecular weight | About 36 000 |
| Assay | Not less than 97 % calculated as cellulose on the anhydrous basis |
| Description | A fine white or almost white odourless powder |
| Identification | |
| A. | Solubility |

Synonyms

Cellulose gel

Definition

Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400

Chemical name

Cellulose

Einecs

232-674-9

Chemical formula

(C6H10O5)n

Molecular weight

About 36 000

Assay

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

Description

A fine white or almost white odourless powder

Identification

A.

Solubility

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

| B. | Colour reaction |
| --- | --- |

B.

Colour reaction

To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes. A red colour is produced

| C. | To be identified by IR spectroscopy |
| --- | --- |

C.

To be identified by IR spectroscopy

| D. | Suspension test |
| --- | --- |

D.

Suspension test

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

Purity

Loss on drying

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

Water-soluble matter

Not more than 0,24  %

Sulphated ash

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

pH of a 10 % suspension in water

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

Starch

Not detectable

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

Particle size

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

Carboxyl groups

Not more than 1 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 460 (ii) POWDERED CELLULOSE

| Definition | Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials |
| --- | --- |
| Chemical name | Cellulose |
| Linear polymer of 1:4 linked glucose residues |
| Einecs | 232-674-9 |
| Chemical formula | (C6H10O5)n |
| Molecular weight | (162)n (n is predominantly 1 000 and greater) |
| Assay | Content not less than 92 % |
| Description | A white, odourless powder |
| Identification | |
| A. | Solubility |

Definition

Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials

Chemical name

Cellulose

Linear polymer of 1:4 linked glucose residues

Einecs

232-674-9

Chemical formula

(C6H10O5)n

Molecular weight

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

Assay

Content not less than 92 %

Description

A white, odourless powder

Identification

A.

Solubility

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

| B. | Suspension test |
| --- | --- |

B.

Suspension test

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

Purity

Loss on drying

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

Water-soluble matter

Not more than 1,0  %

Sulphated ash

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

pH of a 10 % suspension in water

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

Starch

Not detectable

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Particle size

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

E 461 METHYL CELLULOSE

| Synonyms | Cellulose methyl ether |
| --- | --- |
| Definition | Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups |
| Chemical name | Methyl ether of cellulose |
| Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula: |
| C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:






  — | H |

Synonyms

Cellulose methyl ether

Definition

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

Chemical name

Methyl ether of cellulose

Chemical formula

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

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

—

H

| — | CH3 |
| --- | --- |

—

CH3

| — | or CH2CH3 |
| --- | --- |

—

or CH2CH3

Molecular weight

From about 20 000 to 380 000

Assay

Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)

Description

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

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

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

Insoluble in ethanol, ether and chloroform.

Soluble in glacial acetic acid

Purity

Loss on drying

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

Sulphated ash

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

pH of a 1 % colloidal solution

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

E 462 ETHYL CELLULOSE

| Synonyms | Cellulose ethyl ether |
| --- | --- |
| Definition | Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups |
| Chemical name | Ethyl ether of cellulose |
| Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula: |
| C6H7O2(OR1)(OR2) where R1 and R2 may be any of the following:






  — | H |

Synonyms

Cellulose ethyl ether

Definition

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

Chemical name

Ethyl ether of cellulose

Chemical formula

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

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

—

H

| — | CH2CH3 |
| --- | --- |

—

CH2CH3

Assay

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

Description

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

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate

| B. | Film forming test |
| --- | --- |

B.

Film forming test

Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable

Purity

Loss on drying

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

Sulphated ash

Not more than 0,4  %

pH of a 1 % colloidal solution

Neutral to litmus

Arsenic

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

E 463 HYDROXYPROPYL CELLULOSE

| Synonyms | Cellulose hydroxypropyl ether |
| --- | --- |
| Definition | Hydroxypropylcellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with hydroxypropyl groups |
| Chemical name | Hydroxypropyl ether of cellulose |
| Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula: |
| C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following:






  — | H |

Synonyms

Cellulose hydroxypropyl ether

Definition

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

Chemical name

Hydroxypropyl ether of cellulose

Chemical formula

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

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

—

H

| — | CH2CHOHCH3 |
| --- | --- |

—

CH2CHOHCH3

| — | CH2CHO(CH2CHOHCH3)CH3 |
| --- | --- |

—

CH2CHO(CH2CHOHCH3)CH3

| — | CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3 |
| --- | --- |

—

CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3

Molecular weight

From about 30 000 to 1 000 000

Assay

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

Description

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

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

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

| B. | Gas chromatography |
| --- | --- |

B.

Gas chromatography

Determine the substituents by gas chromotography

Purity

Loss on drying

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

Sulphated ash

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

pH of a 1 % colloidal solution

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

Propylene chlorohydrins

Not more than 0,1  mg/kg

Arsenic

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 464 HYDROXYPROPYL METHYL CELLULOSE

| Definition | Hydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution |
| --- | --- |
| Chemical name | 2-Hydroxypropyl ether of methylcellulose |
| Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula: |
| C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:






  — | H |

Definition

Hydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution

Chemical name

2-Hydroxypropyl ether of methylcellulose

Chemical formula

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

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

—

H

| — | CH3 |
| --- | --- |

—

CH3

| — | CH2CHOHCH3 |
| --- | --- |

—

CH2CHOHCH3

| — | CH2CHO (CH2CHOHCH3) CH3 |
| --- | --- |

—

CH2CHO (CH2CHOHCH3) CH3

| — | CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3 |
| --- | --- |

—

CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3

Molecular weight

From about 13 000 to 200 000

Assay

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

Description

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

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

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

| B. | Gas chromatography |
| --- | --- |

B.

Gas chromatography

Determine the substituents by gas chromatography

Purity

Loss on drying

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

Sulphated ash

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

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

pH of a 1 % colloidal solution

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

Propylene chlorohydrins

Not more than 0,1  mg/kg

Arsenic

Not more than 3 mg/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 465 ETHYL METHYL CELLULOSE

| Synonyms | Methylethylcellulose |
| --- | --- |
| Definition | Ethyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groups |
| Chemical name | Ethyl methyl ether of cellulose |
| Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula: |
| C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:






  — | H |

Synonyms

Methylethylcellulose

Definition

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

Chemical name

Ethyl methyl ether of cellulose

Chemical formula

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

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

—

H

| — | CH3 |
| --- | --- |

—

CH3

| — | CH2CH3 |
| --- | --- |

—

CH2CH3

Molecular weight

From about 30 000 to 40 000

Assay

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

Description

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

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

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

Purity

Loss on drying

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

Sulphated ash

Not more than 0,6  %

pH of a 1 % colloidal solution

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

Arsenic

Not more than 3 mg/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 466 SODIUM CARBOXY METHYL CELLULOSE

| Synonyms | Carboxy methyl cellulose |
| --- | --- |
| CMC |
| NaCMC |
| Sodium CMC |
| Cellulose gum |
| Definition | Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material |
| Chemical name | Sodium salt of the carboxymethyl ether of cellulose |
| Chemical formula | The polymers contain substituted anhydroglucose units with the following general formula: |
| C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:






  — | H |

Synonyms

Carboxy methyl cellulose

CMC

NaCMC

Sodium CMC

Cellulose gum

Definition

Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material

Chemical name

Sodium salt of the carboxymethyl ether of cellulose

Chemical formula

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

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

—

H

| — | CH2COONa |
| --- | --- |

—

CH2COONa

| — | CH2COOH |
| --- | --- |

—

CH2COOH

Molecular weight

Higher than approximately 17 000 (degree of polymerisation approximately 100)

Assay

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

Description

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

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Yields a viscous colloidal solution with water. Insoluble in ethanol

| B. | Foam test |
| --- | --- |

B.

Foam test

A 0,1  % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers)

| C. | Precipitate formation |
| --- | --- |

C.

Precipitate formation

To 5 ml of a 0,5  % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)

| D. | Colour reaction |
| --- | --- |

D.

Colour reaction

Add 0,5  g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:

To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface

Purity

Degree of substitution

Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit

Loss on drying

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

pH of a 1 % colloidal solution

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 20 mg/kg

Total glycolate

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

Sodium

Not more than 12,4  % on the anhydrous basis

E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE

| Synonyms | Cross-linked carboxymethyl cellulose |
| --- | --- |
| Cross-linked CMC |
| Cross-linked sodium CMC |
| Cross-linked cellulose gum |
| Definition | Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose |
| Chemical name | Sodium salt of the cross-linked carboxymethyl ether cellulose |
| Chemical formula | The polymers containing substituted anhydroglucose units with the general formula: |
| C6H7O2(OR1)(OR2)(OR3) |
| where R1, R2 and R3 may be any of the following:






  — | H |

Synonyms

Cross-linked carboxymethyl cellulose

Cross-linked CMC

Cross-linked sodium CMC

Cross-linked cellulose gum

Definition

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

Chemical name

Sodium salt of the cross-linked carboxymethyl ether cellulose

Chemical formula

The polymers containing substituted anhydroglucose units with the general formula:

C6H7O2(OR1)(OR2)(OR3)

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

—

H

| — | CH2COONa |
| --- | --- |

—

CH2COONa

| — | CH2COOH |
| --- | --- |

—

CH2COOH

Description

Slightly hygroscopic, white to off white, odourless powder

Identification

A.

Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass

B.

Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05  ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface

C.

It gives the reaction of sodium

Purity

Loss on drying

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

Water solubles

Not more than 10 %

Degree of substitution

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

pH of 1 %

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

Sodium content

Not more than 12,4  % on anhydrous basis

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Cadmium

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE

| Synonyms | Sodium carboxymethyl cellulose, enzymatically hydrolysed |
| --- | --- |
| Definition | Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei) |
| Chemical name | Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed |
| Chemical formula | Sodium salts of polymers containing substituted anhydroglucose units with the general formula: |
| [C6H7O2(OH)x(OCH2COONa)y]n |
| where n is the degree of polymerisation |
| x = 1,50 to 2,80 |
| y = 0,2 to 1,50 |
| x + y = 3,0 |
| (y = degree of substitution) |
| Formula weight | 178,14 where y = 0,20 |
| 282,18 where y = 1,50 |
| Macromolecules: Not less than 800 (n about 4) |
| Assay | Not less than 99,5  %, including mono- and disaccharides, on the dried basis |
| Description | White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder |
| Identification | |
| A. | Solubility |

Synonyms

Sodium carboxymethyl cellulose, enzymatically hydrolysed

Definition

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

Chemical name

Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed

Chemical formula

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

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

where n is the degree of polymerisation

x = 1,50 to 2,80

y = 0,2 to 1,50

x + y = 3,0

(y = degree of substitution)

Formula weight

178,14 where y = 0,20

282,18 where y = 1,50

Macromolecules: Not less than 800 (n about 4)

Assay

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

Description

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

Identification

A.

Solubility

Soluble in water, insoluble in ethanol

| B. | Foam test |
| --- | --- |

B.

Foam test

Vigorously shake a 0,1  % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums

| C. | Precipitate formation |
| --- | --- |

C.

Precipitate formation

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

| D. | Colour reaction |
| --- | --- |

D.

Colour reaction

Add 0,5  g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface

| E. | Viscosity (60 % solids) |
| --- | --- |

E.

Viscosity (60 % solids)

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

Purity

Loss on drying

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

Degree of substitution

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

pH of a 1 % colloidal solution

Not less than 6,0 and not more than 8,5

Sodium chloride and sodium glycolate

Not more than 0,5  % singly or in combination

Residual enzyme activity

Passes test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose

Lead

Not more than 3 mg/kg

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

| Definition | Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids |
| --- | --- |
| Assay | Content on the anhydrous basis not less than 95 % |
| Description | White or creamy white light powders, flakes or semi-solids |
| Identification | |
| A. | Solubility |

Definition

Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids

Assay

Content on the anhydrous basis not less than 95 %

Description

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

Identification

A.

Solubility

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

insoluble in water, ethanol and ether

| B. | Positive tests for cations and for fatty acids |
| --- | --- |

B.

Positive tests for cations and for fatty acids

Purity

Sodium

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

Potassium

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

Calcium

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

Unsaponifiable matter

Not more than 2 %

Free fatty acids

Not more than 3 % estimated as oleic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Free alkali

Not more than 0,1  % expressed as NaOH

Matter insoluble in alcohol

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

E 470b MAGNESIUM SALTS OF FATTY ACIDS

| Definition | Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids |
| --- | --- |
| Assay | Content on the anhydrous basis not less than 95 % |
| Description | White or creamy-white light powders, flakes or semi-solids |
| Identification | |
| A. | Solubility |

Definition

Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids

Assay

Content on the anhydrous basis not less than 95 %

Description

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

Identification

A.

Solubility

Insoluble in water, partially soluble in ethanol and ether

| B. | Positive tests for magnesium and for fatty acids |
| --- | --- |

B.

Positive tests for magnesium and for fatty acids

Purity

Magnesium

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

Free alkali

Not more than 0,1  % expressed as MgO

Unsaponifiable matter

Not more than 2 %

Free fatty acids

Not more than 3 % estimated as oleic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS

| Synonyms | Glyceryl monostearate |
| --- | --- |
| Glyceryl monopalmitate |
| Glyceryl monooleate, etc. |
| Monostearin, monopalmitin, monoolein, etc. |
| GMS (for glyceryl monostearate) |
| Definition | Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol |
| Assay | Content of mono- and diesters: not less than 70 % |
| Description | The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads |
| Identification | |
| A. | Infrared spectrum |

Synonyms

Glyceryl monostearate

Glyceryl monopalmitate

Glyceryl monooleate, etc.

Monostearin, monopalmitin, monoolein, etc.

GMS (for glyceryl monostearate)

Definition

Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol

Assay

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

Description

The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads

Identification

A.

Infrared spectrum

Characteristic of a partial fatty acid ester of a polyol

| B. | Positive tests for glycerol and for fatty acids |
| --- | --- |

B.

Positive tests for glycerol and for fatty acids

| C. | Solubility |
| --- | --- |

C.

Solubility

Insoluble in water, soluble in ethanol and toluene

Purity

Water content

Not more than 2 % (Karl Fischer method)

Acid value

Not more than 6

Free glycerol

Not more than 7 %

Polyglycerols

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Total glycerol

Not less than 16 % and not more than 33 %

Sulphated ash

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

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

| Synonyms | Acetic acid esters of mono- and diglycerides |
| --- | --- |
| Acetoglycerides |
| Acetylated mono- and diglycerides |
| Acetic and fatty acid esters of glycerol |
| Definition | Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides |
| Description | Clear, mobile liquids to solids, from white to pale yellow in colour |
| Identification | |
| A. | Positive tests for glycerol, for fatty acids and for acetic acid |

Synonyms

Acetic acid esters of mono- and diglycerides

Acetoglycerides

Acetylated mono- and diglycerides

Acetic and fatty acid esters of glycerol

Definition

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

Description

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

Identification

A.

Positive tests for glycerol, for fatty acids and for acetic acid

| B. | Solubility |
| --- | --- |

B.

Solubility

Insoluble in water. Soluble in ethanol

Purity

Acids other than acetic and fatty acids

Not detectable

Free glycerol

Not more than 2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Total acetic acid

Not less than 9 % and not more than 32 %

Free fatty acids (and acetic acid)

Not more than 3 % estimated as oleic acid

Total glycerol

Not less than 14 % and not more than 31 %

Sulphated ash

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

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

| Synonyms | Lactic acid esters of mono- and diglycerides |
| --- | --- |
| Lactoglycerides |
| Mono- and diglycerides of fatty acids esterified with lactic acid |
| Definition | Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides |
| Description | Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour |
| Identification | |
| A. | Positive tests for glycerol, for fatty acids and for lactic acid |

Synonyms

Lactic acid esters of mono- and diglycerides

Lactoglycerides

Mono- and diglycerides of fatty acids esterified with lactic acid

Definition

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

Description

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

Identification

A.

Positive tests for glycerol, for fatty acids and for lactic acid

| B. | Solubility |
| --- | --- |

B.

Solubility

Insoluble in cold water but dispersible in hot water

Purity

Acids other than lactic and fatty acids

Not detectable

Free glycerol

Not more than 2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Total lactic acid

Not less than 13 % and not more than 45 %

Free fatty acids (and lactic acid)

Not more than 3 % estimated as oleic acid

Total glycerol

Not less than 13 % and not more than 30 %

Sulphated ash

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

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

| Synonyms | Citrem |
| --- | --- |
| Citric acid esters of mono- and diglycerides |
| Citroglycerides |
| Mono- and diglycerides of fatty acids esterified with citric acid |
| Definition | Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide |
| Description | Yellowish or light brown liquids to waxy solids or semi-solids |
| Identification | |
| A. | Positive tests for glycerol, for fatty acids and for citric acid |

Synonyms

Citrem

Citric acid esters of mono- and diglycerides

Citroglycerides

Mono- and diglycerides of fatty acids esterified with citric acid

Definition

Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide

Description

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

Identification

A.

Positive tests for glycerol, for fatty acids and for citric acid

| B. | Solubility |
| --- | --- |

B.

Solubility

Insoluble in cold water

Dispersible in hot water

Soluble in oils and fats

Insoluble in cold ethanol

Purity

Acids other than citric and fatty acids

Not detectable

Free glycerol

Not more than 2 %

Total glycerol

Not less than 8 % and not more than 33 %

Total citric acid

Not less than 13 % and not more than 50 %

Sulphated ash (determined at 800 ± 25 oC)

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

Partially or wholly neutralised products: not more than 10 %

Lead

Not more than 2 mg/kg

Free fatty acids

Not more than 3 % estimated as oleic acid

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

| Synonyms | Tartaric acid esters of mono- and diglycerides |
| --- | --- |
| Mono- and diglycerides of fatty acids esterified with tartaric acid |
| Definition | Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides |
| Description | Sticky viscous yellowish liquids to hard yellow waxes |
| Identification | |
| A. | Positive tests for glycerol, for fatty acids and for tartaric acid |

Synonyms

Tartaric acid esters of mono- and diglycerides

Mono- and diglycerides of fatty acids esterified with tartaric acid

Definition

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

Description

Sticky viscous yellowish liquids to hard yellow waxes

Identification

A.

Positive tests for glycerol, for fatty acids and for tartaric acid

Purity

Acids other than tartaric and fatty acids

Not detectable

Free glycerol

Not more than 2 %

Total glycerol

Not less than 12 % and not more than 29 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Total tartaric acid

Not less than 15 % and not more than 50 %

Free fatty acids

Not more than 3 % estimated as oleic acid

Sulphated ash

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

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

| Synonyms | Diacetyltartaric acid esters of mono- and diglycerides |
| --- | --- |
| Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid |
| Diacetyltartaric and fatty acid esters of glycerol |
| Definition | Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids |
| Description | Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid |
| Identification | |
| A. | Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid |

Synonyms

Diacetyltartaric acid esters of mono- and diglycerides

Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid

Diacetyltartaric and fatty acid esters of glycerol

Definition

Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids

Description

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

Identification

A.

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

Purity

Acids other than acetic, tartaric and fatty acids

Not detectable

Free glycerol

Not more than 2 %

Total glycerol

Not less than 11 % and not more than 28 %

Sulphated ash

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Total tartaric acid

Not less than 10 % and not more than 40 %

Total acetic acid

Not less than 8 % and not more than 32 %

Free fatty acids

Not more than 3 % estimated as oleic acid

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS

| Synonyms | Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid |
| --- | --- |
| Definition | Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids |
| Description | Sticky liquids to solids, from white to pale-yellow in colour |
| Identification | |
| A. | Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid |

Synonyms

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

Definition

Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids

Description

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

Identification

A.

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

Purity

Acids other than acetic, tartaric and fatty acids

Not detectable

Free glycerol

Not more than 2 %

Total glycerol

Not less than 12 % and not more than 27 %

Sulphated ash

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Total acetic acid

Not less than 10 % and not more than 20 %

Total tartaric acid

Not less than 20 % and not more than 40 %

Free fatty acids

Not more than 3 % estimated as oleic acid

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 473 SUCROSE ESTERS OF FATTY ACIDS

| Synonyms | Sucroesters |
| --- | --- |
| Sugar esters |
| Definition | Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation |
| Assay | Content not less than 80 % |
| Description | Stiff gels, soft solids or white to slightly greyish-white powders |
| Identification | |
| A. | Positive tests for sugar for fatty acids |

Synonyms

Sucroesters

Sugar esters

Definition

Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation

Assay

Content not less than 80 %

Description

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

Identification

A.

Positive tests for sugar for fatty acids

| B. | Solubility |
| --- | --- |

B.

Solubility

Sparingly soluble in water

Soluble in ethanol

Purity

Sulphated ash

Not more than 2 % determined at 800 ± 25 oC

Free sugar

Not more than 5 %

Free fatty acids

Not more than 3 % estimated as oleic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Methanol

Not more than 10 mg/kg

Dimethylsulphoxide

Not more than 2 mg/kg

Dimethylformamide

Not more than 1 mg/kg

2-methyl-1-propanol

Not more than 10 mg/kg

Ethylacetate

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

Propane-2-ol

Prolyleneglycol

Methyl ethyl ketone

Not more than 10 mg/kg

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 474 SUCROGLYCERIDES

| Synonyms | Sugar glycerides |
| --- | --- |
| Definition | Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-ol |
| Assay | Content not less than 40 % and not more than 60 % of sucrose fatty acid esters |
| Description | Soft solid masses, stiff gels or white to off-white powders |
| Identification | |
| A. | Positive tests for sugar and for fatty acids |

Synonyms

Sugar glycerides

Definition

Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-ol

Assay

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

Description

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

Identification

A.

Positive tests for sugar and for fatty acids

| B. | Solubility |
| --- | --- |

B.

Solubility

Insoluble in cold water

Soluble in ethanol

Purity

Sulphated ash

Not more than 2 % determined at 800 ± 25 oC

Free sugar

Not more than 5 %

Free fatty acids

Not more than 3 % estimated as oleic acid

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Methanol

Not more than 10 mg/kg

Dimethylformamide

Not more than 1 mg/kg

2-methyl-1-propanol

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

Cyclohexane

Ethylacetate

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

Propane-2-ol

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS

| Synonyms | Polyglycerol fatty acid esters |
| --- | --- |
| Polyglycerin esters of fatty acid esters |
| Definition | Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol |
| Assay | Content of total fatty acid ester not less than 90 % |
| Description | Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids |
| Identification | |
| A. | Positive tests for glycerol, for polyglycerols and for fatty acids |

Synonyms

Polyglycerol fatty acid esters

Polyglycerin esters of fatty acid esters

Definition

Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol

Assay

Content of total fatty acid ester not less than 90 %

Description

Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids

Identification

A.

Positive tests for glycerol, for polyglycerols and for fatty acids

| B. | Solubility |
| --- | --- |

B.

Solubility

The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils

Purity

Sulphated ash

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

Acids other than fatty acids

Not detectable

Free fatty acids

Not more than 6 % estimated as oleic acid

Total glycerol and polyglycerol

Not less than 18 % and not more than 60 %

Free glycerol and polyglycerol

Not more than 7 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

E 476 POLYGLYCEROL POLYRICINOLEATE

| Synonyms | Glycerol esters of condensed castor oil fatty acids |
| --- | --- |
| Polyglycerol esters of polycondensed fatty acids from castor oil |
| Polyglycerol esters of interesterified ricinoleic acid |
| PGPR |
| Definition | Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids |
| Description | Clear, highly viscous liquid |
| Identification | |
| A. | Solubility |

Synonyms

Glycerol esters of condensed castor oil fatty acids

Polyglycerol esters of polycondensed fatty acids from castor oil

Polyglycerol esters of interesterified ricinoleic acid

PGPR

Definition

Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids

Description

Clear, highly viscous liquid

Identification

A.

Solubility

Insoluble in water and in ethanol.

Soluble in ether, hydrocarbons and halogenated hydrocarbons

| B. | Positive tests for glycerol, polyglycerol and for ricinoleic acid |
| --- | --- |

B.

Positive tests for glycerol, polyglycerol and for ricinoleic acid

| C. | Refractive index [n]65 |
| --- | --- |

C.

Refractive index [n]65

Between 1,4630 and 1,4665

Purity

Polyglycerols

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

Hydroxyl value

Not less than 80 and not more than 100

Acid value

Not more than 6

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS

| Synonyms | Propylene glycol esters of fatty acids |
| --- | --- |
| Definition | Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent |
| Assay | Content of total fatty acid ester not less than 85 % |
| Description | Clear liquids or waxy white flakes, beads or solids having a bland odour |
| Identification | |
| A. | Positive tests for propylene glycol and for fatty acids |

Synonyms

Propylene glycol esters of fatty acids

Definition

Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent

Assay

Content of total fatty acid ester not less than 85 %

Description

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

Identification

A.

Positive tests for propylene glycol and for fatty acids

Purity

Sulphated ash

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

Acids other than fatty acids

Not detectable

Free fatty acids

Not more than 6 % estimated as oleic acid

Total propane-1,2-diol

Not less than 11 % and not more than 31 %

Free propane-1,2-diol

Not more than 5 %

Dimer and trimer of propylene glycol

Not more than 0,5  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

| Note: | Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate). |
| --- | --- |

Note:

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

| Synonyms | TOSOM |
| --- | --- |
| Definition | Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130 oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans |
| Description | Pale yellow to light brown a waxy or solid consistency |
| Identification | |
| A. | Solubility |

Synonyms

TOSOM

Definition

Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130 oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans

Description

Pale yellow to light brown a waxy or solid consistency

Identification

A.

Solubility

Insoluble in water. Soluble in hot oil or fat

Purity

Melting range

55-65 oC

Free fatty acids

Not more than 1,5  % estimated as oleic acid

Free glycerol

Not more than 2 %

Total fatty acids

83-90 %

Total glycerol

16-22 %

Fatty acid methyl esters, not forming adduct with urea

Not more than 9 % of total fatty acid methyl esters

Fatty acids, insoluble in petroleum ether

Not more than 2 % of total fatty acids

Peroxide value

Not more than 3

Epoxides

Not more than 0,03  % oxirane oxygen

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 481 SODIUM STEAROYL-2-LACTYLATE

| Synonyms | Sodium stearoyl lactylate |
| --- | --- |
| Sodium stearoyl lactate |
| Definition | A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used |
| Chemical names | Sodium di-2-stearoyl lactate |
| Sodium di(2-stearoyloxy)propionate |
| Einecs | 246-929-7 |
| Chemical formula (major components) | C21H39O4Na |
| C19H35O4Na |
| Description | White or slightly yellowish powder or brittle solid with a characteristic odour |
| Identification | |
| A. | Positive tests for sodium, for fatty acids and for lactic acid |

Synonyms

Sodium stearoyl lactylate

Sodium stearoyl lactate

Definition

A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used

Chemical names

Sodium di-2-stearoyl lactate

Sodium di(2-stearoyloxy)propionate

Einecs

246-929-7

Chemical formula (major components)

C21H39O4Na

C19H35O4Na

Description

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

Identification

A.

Positive tests for sodium, for fatty acids and for lactic acid

| B. | Solubility |
| --- | --- |

B.

Solubility

Insoluble in water. Soluble in ethanol

Purity

Sodium

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

Ester value

Not less than 90 and not more than 190

Acid value

Not less than 60 and not more than 130

Total lactic acid

Not less than 15 % and not more than 40 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 482 CALCIUM STEAROYL-2-LACTYLATE

| Synonyms | Calcium stearoyl lactate |
| --- | --- |
| Definition | A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used |
| Chemical name | Calcium di-2-stearoyl lactate |
| Calcium di(2-stearoyloxy)propionate |
| Einecs | 227-335-7 |
| Chemical formula | C42H78O8Ca |
| C38H70O8Ca |
| Description | White or slightly yellowish powder or brittle solid with a characteristic odour |
| Identification | |
| A. | Positive tests for calcium, for fatty acids and for lactid acid |

Synonyms

Calcium stearoyl lactate

Definition

A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used

Chemical name

Calcium di-2-stearoyl lactate

Calcium di(2-stearoyloxy)propionate

Einecs

227-335-7

Chemical formula

C42H78O8Ca

C38H70O8Ca

Description

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

Identification

A.

Positive tests for calcium, for fatty acids and for lactid acid

| B. | Solubility |
| --- | --- |

B.

Solubility

Slightly soluble in hot water

Purity

Calcium

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

Ester value

Not less than 125 and not more than 190

Total lactic acid

Not less than 15 % and not more than 40 %

Acid value

Not less than 50 and not more than 130

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 483 STEARYL TARTRATE

| Synonyms | Stearyl palmityl tartrate |
| --- | --- |
| Definition | Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials |
| Chemical name | Distearyl tartrate |
| Dipalmityl tartrate |
| Chemical formula | C38H74O6 to C40H78O6 |
| Molecular weight | 627 to 655 |
| Assay | Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180 |
| Description | Cream-coloured unctuous solid (at 25 oC) |
| Identification | |
| A. | Positive tests for tartare |

Synonyms

Stearyl palmityl tartrate

Definition

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

Chemical name

Distearyl tartrate

Dipalmityl tartrate

Chemical formula

C38H74O6 to C40H78O6

Molecular weight

627 to 655

Assay

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

Description

Cream-coloured unctuous solid (at 25 oC)

Identification

A.

Positive tests for tartare

| B. | Melting range |
| --- | --- |

B.

Melting range

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

Purity

Hydroxyl value

Not less than 200 and not more than 220

Acid value

Not more than 5,6

Total tartaric acid content

Not less than 18 % and not more than 35 %

Sulphated ash

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Unsaponifiable matter

Not less than 77 % and not more than 83 %

Iodine value

Not more than 4 (Wijs method)

E 491 SORBITAN MONOSTEARATE

| Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid |
| --- | --- |
| Einecs | 215-664-9 |
| Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters |
| Description | Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour |
| Identification | |
| A. | Solubility |

Definition

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

Einecs

215-664-9

Assay

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

Description

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

Identification

A.

Solubility

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

| B. | Congealing range |
| --- | --- |

B.

Congealing range

50-52 oC

| C. | Infrared absorption spectrum |
| --- | --- |

C.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyol

Purity

Water

Not more than 2 % (Karl Fischer method)

Sulphated ash

Not more than 0,5  %

Acid value

Not more than 10

Saponification value

Not less than 147 and not more than 157

Hydroxyl value

Not less than 235 and not more than 260

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 492 SORBITAN TRISTEARATE

| Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid |
| --- | --- |
| Einecs | 247-891-4 |
| Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters |
| Description | Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour |
| Identification | |
| A. | Solubility |

Definition

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

Einecs

247-891-4

Assay

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

Description

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

Identification

A.

Solubility

Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol

| B. | Congealing range |
| --- | --- |

B.

Congealing range

47-50 oC

| C. | Infrared absorption spectrum |
| --- | --- |

C.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyol

Purity

Water

Not more than 2 % (Karl Fischer method)

Sulphated ash

Not more than 0,5  %

Acid value

Not more than 15

Saponification value

Not less than 176 and not more than 188

Hydroxyl value

Not less than 66 and not more than 80

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 493 SORBITAN MONOLAURATE

| Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid |
| --- | --- |
| Einecs | 215-663-3 |
| Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters |
| Description | Amber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour |
| Identification | |
| A. | Solubility |

Definition

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

Einecs

215-663-3

Assay

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

Description

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

Identification

A.

Solubility

Dispersible in hot and cold water

| B. | Infrared absorption spectrum |
| --- | --- |

B.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyol

Purity

Water

Not more than 2 % (Karl Fischer method)

Sulphated ash

Not more than 0,5  %

Acid value

Not more than 7

Saponification value

Not less than 155 and not more than 170

Hydroxyl value

Not less than 330 and not more than 358

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 494 SORBITAN MONOOLEATE

| Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate |
| --- | --- |
| Einecs | 215-665-4 |
| Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters |
| Description | Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour |
| Identification | |
| A. | Solubility |

Definition

A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate

Einecs

215-665-4

Assay

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

Description

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

Identification

A.

Solubility

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

| B. | Iodine value |
| --- | --- |

B.

Iodine value

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

Purity

Water

Not more than 2 % (Karl Fischer method)

Sulphated ash

Not more than 0,5  %

Acid value

Not more than 8

Saponification value

Not less than 145 and not more than 160

Hydroxyl value

Not less than 193 and not more than 210

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 495 SORBITAN MONOPALMITATE

| Synonyms | Sorbitan palmitate |
| --- | --- |
| Definition | A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid |
| Einecs | 247-568-8 |
| Assay | Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters |
| Description | Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour |
| Identification | |
| A. | Solubility |

Synonyms

Sorbitan palmitate

Definition

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

Einecs

247-568-8

Assay

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

Description

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

Identification

A.

Solubility

Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water

| B. | Congealing range |
| --- | --- |

B.

Congealing range

45-47 oC

| C. | Infrared absorption spectrum |
| --- | --- |

C.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of polyol

Purity

Water

Not more than 2 % (Karl Fischer method)

Sulphate ash

Not more than 0,5  %

Acid value

Not more than 7,5

Saponification value

Not less than 140 and not more than 150

Hydroxyl value

Not less than 270 and not more than 305

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 500(i) SODIUM CARBONATE

| Synonyms | Soda ash |
| --- | --- |
| Definition | |
| Chemical name | Sodium carbonate |
| Einecs | 207-838-8 |
| Chemical formula | Na2CO3 · nH2O (n = 0, 1 or 10) |
| Molecular weight | 106,00 (anhydrous) |
| Assay | Content not less than 99 % of Na2CO3 on the anhydrous basis |
| Description | Colourless crystals or white, granular or crystalline powder |
| The anhydrous form is hygroscopic, the decahydrate efflorescent |
| Identification | |
| A. | Positive tests for sodium and for carbonate |

Synonyms

Soda ash

Definition

Chemical name

Sodium carbonate

Einecs

207-838-8

Chemical formula

Na2CO3 · nH2O (n = 0, 1 or 10)

Molecular weight

106,00 (anhydrous)

Assay

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

Description

Colourless crystals or white, granular or crystalline powder

The anhydrous form is hygroscopic, the decahydrate efflorescent

Identification

A.

Positive tests for sodium and for carbonate

| B. | Solubility |
| --- | --- |

B.

Solubility

Freely soluble in water. Insoluble in ethanol

Purity

Loss on drying

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 500(ii) SODIUM HYDROGEN CARBONATE

| Synonyms | Sodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking soda |
| --- | --- |
| Definition | |
| Chemical name | Sodium hydrogen carbonate |
| Einecs | 205-633-8 |
| Chemical formula | NaHCO3 |
| Molecular weight | 84,01 |
| Assay | Content not less than 99 % on the anhydrous basis |
| Description | Colourless or white crystalline masses or crystalline powder |
| Identification | |
| A. | Positive tests for sodium and for carbonate |

Synonyms

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

Definition

Chemical name

Sodium hydrogen carbonate

Einecs

205-633-8

Chemical formula

NaHCO3

Molecular weight

84,01

Assay

Content not less than 99 % on the anhydrous basis

Description

Colourless or white crystalline masses or crystalline powder

Identification

A.

Positive tests for sodium and for carbonate

| B. | pH of a 1 % solution |
| --- | --- |

B.

pH of a 1 % solution

Between 8,0 and 8,6

| C. | Solubility |
| --- | --- |

C.

Solubility

Soluble in water. Insoluble in ethanol

Purity

Loss on drying

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

Ammonium salts

No odour of ammonia detectable after heating

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 500(iii) SODIUM SESQUICARBONATE

| Definition | |
| --- | --- |
| Chemical name | Sodium monohydrogen dicarbonate |
| Einecs | 208-580-9 |
| Chemical formula | Na2(CO)3 · NaHCO3 · 2H2O |
| Molecular weight | 226,03 |
| Assay | Content between 35,0  % and 38,6  % of NaHCO3 and between 46,4  % and 50,0  % of Na2CO3 |
| Description | White flakes, crystals or crystalline powder |
| Identification | |
| A. | Positive tests for sodium and for carbonate |

Definition

Chemical name

Sodium monohydrogen dicarbonate

Einecs

208-580-9

Chemical formula

Na2(CO)3 · NaHCO3 · 2H2O

Molecular weight

226,03

Assay

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

Description

White flakes, crystals or crystalline powder

Identification

A.

Positive tests for sodium and for carbonate

| B. | Solubility |
| --- | --- |

B.

Solubility

Freely soluble in water

Purity

Sodium chloride

Not more than 0,5  %

Iron

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 501(i) POTASSIUM CARBONATE

| Definition | |
| --- | --- |
| Chemical name | Potassium carbonate |
| Einecs | 209-529-3 |
| Chemical formula | K2CO3 · nH2O (n = 0 or 1,5 ) |
| Molecular weight | 138,21 (anhydrous) |
| Assay | Content not less than 99,0  % on the anhydrous basis |
| Description | White, very deliquescent powder. |
| The hydrate occurs as small, white, translucent crystals or granules |
| Identification | |
| A. | Positive tests for potassium and for carbonate |

Definition

Chemical name

Potassium carbonate

Einecs

209-529-3

Chemical formula

K2CO3 · nH2O (n = 0 or 1,5 )

Molecular weight

138,21 (anhydrous)

Assay

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

Description

White, very deliquescent powder.

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

Identification

A.

Positive tests for potassium and for carbonate

| B. | Solubility |
| --- | --- |

B.

Solubility

Very soluble in water. Insoluble in ethanol

Purity

Loss on drying

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 501(ii) POTASSIUM HYDROGEN CARBONATE

| Synonyms | Potassium bicarbonate, acid potassium carbonate |
| --- | --- |
| Definition | |
| Chemical name | Potassium hydrogen carbonate |
| Einecs | 206-059-0 |
| Chemical formula | KHCO3 |
| Molecular weight | 100,11 |
| Assay | Content not less than 99,0  % and not more than 101,0  % KHCO3 on the anhydrous basis |
| Description | Colourless crystals or white powder or granules |
| Identification | |
| A. | Positive tests for potassium and for carbonate |

Synonyms

Potassium bicarbonate, acid potassium carbonate

Definition

Chemical name

Potassium hydrogen carbonate

Einecs

206-059-0

Chemical formula

KHCO3

Molecular weight

100,11

Assay

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

Description

Colourless crystals or white powder or granules

Identification

A.

Positive tests for potassium and for carbonate

| B. | Solubility |
| --- | --- |

B.

Solubility

Freely soluble in water. Insoluble in ethanol

Purity

Loss on drying

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 503(i) AMMONIUM CARBONATE

| Definition | Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions |
| --- | --- |
| Chemical name | Ammonium carbonate |
| Einecs | 233-786-0 |
| Chemical formula | CH6N2O2, CH8N2O3 and CH5NO3 |
| Molecular weight | Ammonium carbamate 78,06 ; ammonium carbonate 98,73 ; ammonium hydrogen carbonate 79,06 |
| Assay | Content not less than 30,0  % and not more than 34,0  % of NH3 |
| Description | White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide |
| Identification | |
| A. | Positive tests for ammonium and for carbonate |

Definition

Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions

Chemical name

Ammonium carbonate

Einecs

233-786-0

Chemical formula

CH6N2O2, CH8N2O3 and CH5NO3

Molecular weight

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

Assay

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

Description

White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide

Identification

A.

Positive tests for ammonium and for carbonate

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

about 8,6

| C. | Solubility |
| --- | --- |

C.

Solubility

Soluble in water

Purity

Non-volatile matter

Not more than 500 mg/kg

Chlorides

Not more than 30 mg/kg

Sulphate

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 503(ii) AMMONIUM HYDROGEN CARBONATE

| Synonyms | Ammonium bicarbonate |
| --- | --- |
| Definition | |
| Chemical name | Ammonium hydrogen carbonate |
| Einecs | 213-911-5 |
| Chemical formula | CH5NO3 |
| Molecular weight | 79,06 |
| Assay | Content not less than 99,0  % |
| Description | White crystals or crystalline powder |
| Identification | |
| A. | Positive tests for ammonium and for carbonate |

Synonyms

Ammonium bicarbonate

Definition

Chemical name

Ammonium hydrogen carbonate

Einecs

213-911-5

Chemical formula

CH5NO3

Molecular weight

79,06

Assay

Content not less than 99,0  %

Description

White crystals or crystalline powder

Identification

A.

Positive tests for ammonium and for carbonate

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

about 8,0

| C. | Solubility |
| --- | --- |

C.

Solubility

Freely soluble in water. Insoluble in ethanol

Purity

Non-volatile matter

Not more than 500 mg/kg

Chlorides

Not more than 30 mg/kg

Sulphate

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 504(ii) MAGNESIUM HYDROXIDE CARBONATE

| Synonyms | Magnesium hydrogen carbonate, magnesium subcarbonate (light or heavy), hydrated basic magnesium carbonate, magnesium carbonate hydroxide |
| --- | --- |
| Definition | |
| Chemical name | Magnesium carbonate hydroxide hydrated |
| Einecs | 235-192-7 |
| Chemical formula | 4MgCO3Mg(OH)25H2O |
| Molecular weight | 485 |
| Assay | Mg content not less than 40,0  % and not more than 45,0  % calculated as MgO |
| Description | Light, white friable mass or bulky white powder |
| Identification | |
| A. | Positive tests for magnesium and for carbonate |

Synonyms

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

Definition

Chemical name

Magnesium carbonate hydroxide hydrated

Einecs

235-192-7

Chemical formula

4MgCO3Mg(OH)25H2O

Molecular weight

485

Assay

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

Description

Light, white friable mass or bulky white powder

Identification

A.

Positive tests for magnesium and for carbonate

| B. | Solubility |
| --- | --- |

B.

Solubility

Practically insoluble in water. Insoluble in ethanol

Purity

Acid insoluble matter

Not more than 0,05  %

Water soluble matter

Not more than 1,0  %

Calcium

Not more than 1,0  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

E 507 HYDROCHLORIC ACID

| Synonyms | Hydrogen chloride, muriatic acid |
| --- | --- |
| Definition | |
| Chemical name | Hydrochloric acid |
| Einecs | 231-595-7 |
| Chemical formula | HCl |
| Molecular weight | 36,46 |
| Assay | Hydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0  % HCl |
| Description | Clear, colourless or slightly yellowish, corrosive liquid having a pungent odour |
| Identification | |
| A. | Positive tests for acid and for chloride |

Synonyms

Hydrogen chloride, muriatic acid

Definition

Chemical name

Hydrochloric acid

Einecs

231-595-7

Chemical formula

HCl

Molecular weight

36,46

Assay

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

Description

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

Identification

A.

Positive tests for acid and for chloride

| B. | Solubility |
| --- | --- |

B.

Solubility

Soluble in water and in ethanol

Purity

Total organic compounds

Total organic compounds (non-fluorine containing): not more than 5 mg/kg

Benzene: not more than 0,05  mg/kg

Fluorinated compounds (total): not more than 25 mg/kg

Non-volatile matter

Not more than 0,5  %

Reducing substances

Not more than 70 mg/kg (as SO2)

Oxidising substances

Not more than 30 mg/kg (as Cl2)

Sulphate

Not more than 0,5  %

Iron

Not more than 5 mg/kg

Arsenic

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 508 POTASSIUM CHLORIDE

| Synonyms | Sylvine |
| --- | --- |
| Sylvite |
| Definition | |
| Chemical name | Potassium chloride |
| Einecs | 231-211-8 |
| Chemical formulae | KCl |
| Molecular weight | 74,56 |
| Assay | Content not less than 99 % on the dried basis |
| Description | Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless |
| Identification | |
| A. | Solubility |

Synonyms

Sylvine

Sylvite

Definition

Chemical name

Potassium chloride

Einecs

231-211-8

Chemical formulae

KCl

Molecular weight

74,56

Assay

Content not less than 99 % on the dried basis

Description

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

Identification

A.

Solubility

Freely soluble in water. Insoluble in ethanol

| B. | Positive tests for potassium and for chloride |
| --- | --- |

B.

Positive tests for potassium and for chloride

Purity

Loss on drying

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

Sodium

Negative test

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

E 509 CALCIUM CHLORIDE

| Definition | |
| --- | --- |
| Chemical name | Calcium chloride |
| Einecs | 233-140-8 |
| Chemical formula | CaCl2 · nH2O (n = 0,2 or 6) |
| Molecular weight | 110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate) |
| Assay | Content not less than 93,0  % on the anhydrous basis |
| Description | White, odourless, hygroscopic powder or deliquescent crystals |
| Identification | |
| A. | Positive tests for calcium and for chloride |

Definition

Chemical name

Calcium chloride

Einecs

233-140-8

Chemical formula

CaCl2 · nH2O (n = 0,2 or 6)

Molecular weight

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

Assay

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

Description

White, odourless, hygroscopic powder or deliquescent crystals

Identification

A.

Positive tests for calcium and for chloride

| B. | Solubility |
| --- | --- |

B.

Solubility

Anhydrous calcium chloride: freely soluble in water and ethanol

Dihydrate: freely soluble in water, soluble in ethanol

Hexahydrate: very soluble in water and ethanol

Purity

Magnesium and alkali salts

Not more than 5 % on the anhydrous basis

Fluoride

Not more than 40 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

E 511 MAGNESIUM CHLORIDE

| Definition | |
| --- | --- |
| Chemical name | Magnesium chloride |
| Einecs | 232-094-6 |
| Chemical formula | MgCl2 · 6H2O |
| Molecular weight | 203,30 |
| Assay | Content not less than 99,0  % |
| Description | Colourless, odourless, very deliquescent flakes or crystals |
| Identification | |
| A. | Positive tests for magnesium and for chloride |

Definition

Chemical name

Magnesium chloride

Einecs

232-094-6

Chemical formula

MgCl2 · 6H2O

Molecular weight

203,30

Assay

Content not less than 99,0  %

Description

Colourless, odourless, very deliquescent flakes or crystals

Identification

A.

Positive tests for magnesium and for chloride

| B. | Solubility |
| --- | --- |

B.

Solubility

Very soluble in water, freely soluble in ethanol

Purity

Ammonium

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

E 512 STANNOUS CHLORIDE

| Synonyms | Tin chloride, tin dichloride |
| --- | --- |
| Definition | |
| Chemical name | Stannous chloride dihydrate |
| Einecs | 231-868-0 |
| Chemical formula | SnCl2 · 2H2O |
| Molecular weight | 225,63 |
| Assay | Content not less than 98,0  % |
| Description | Colourless or white crystals |
| May have a slight odour of hydrochloric acid |
| Identification | |
| A. | Positive tests for tin (II) and for chloride |

Synonyms

Tin chloride, tin dichloride

Definition

Chemical name

Stannous chloride dihydrate

Einecs

231-868-0

Chemical formula

SnCl2 · 2H2O

Molecular weight

225,63

Assay

Content not less than 98,0  %

Description

Colourless or white crystals

May have a slight odour of hydrochloric acid

Identification

A.

Positive tests for tin (II) and for chloride

| B. | Solubility |
| --- | --- |

B.

Solubility

Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water

Ethanol: soluble

Purity

Sulphate

Not more than 30 mg/kg

Arsenic

Not more than 2 mg/kg

Mercury

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

E 513 SULPHURIC ACID

| Synonyms | Oil of vitriol, dihydrogen sulphate |
| --- | --- |
| Definition | |
| Chemical name | Sulphuric acid |
| Einecs | 231-639-5 |
| Chemical formula | H2SO4 |
| Molecular weight | 98,07 |
| Assay | Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0  % |
| Description | Clear, colourless or slightly brown, very corrosive oily liquid |
| Identification | |
| A. | Positive tests for acid and for sulphate |

Synonyms

Oil of vitriol, dihydrogen sulphate

Definition

Chemical name

Sulphuric acid

Einecs

231-639-5

Chemical formula

H2SO4

Molecular weight

98,07

Assay

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

Description

Clear, colourless or slightly brown, very corrosive oily liquid

Identification

A.

Positive tests for acid and for sulphate

| B. | Solubility |
| --- | --- |

B.

Solubility

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

Purity

Ash

Not more than 0,02  %

Reducing matter

Not more than 40 mg/kg (as SO2)

Nitrate

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

Chloride

Not more than 50 mg/kg

Iron

Not more than 20 mg/kg

Selenium

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 514(i) SODIUM SULPHATE

| Definition | |
| --- | --- |
| Chemical name | Sodium sulphate |
| Chemical formula | Na2SO4 · nH2O (n = 0 or 10) |
| Molecular weight | 142,04 (anhydrous) |
| 322,04 (decahydrate) |
| Assay | Content not less than 99,0  % on the anhydrous basis |
| Description | Colourless crystals or a fine, white, crystalline powder |
| The decahydrate is efflorescent |
| Identification | |
| A. | Positive tests for sodium and for sulphate |

Definition

Chemical name

Sodium sulphate

Chemical formula

Na2SO4 · nH2O (n = 0 or 10)

Molecular weight

142,04 (anhydrous)

322,04 (decahydrate)

Assay

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

Description

Colourless crystals or a fine, white, crystalline powder

The decahydrate is efflorescent

Identification

A.

Positive tests for sodium and for sulphate

| B. | Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper |
| --- | --- |

B.

Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper

Purity

Loss on drying

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

Selenium

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 514(ii) SODIUM HYDROGEN SULPHATE

| Synonyms | Acid sodium sulphate, sodium bisulphate, nitre cake |
| --- | --- |
| Definition | |
| Chemical name | Sodium hydrogen sulphate |
| Chemical formula | NaHSO4 |
| Molecular weight | 120,06 |
| Assay | Content not less than 95,2  % |
| Description | White, odourless crystals or granules |
| Identification | |
| A. | Positive tests for sodium and for sulphate |

Synonyms

Acid sodium sulphate, sodium bisulphate, nitre cake

Definition

Chemical name

Sodium hydrogen sulphate

Chemical formula

NaHSO4

Molecular weight

120,06

Assay

Content not less than 95,2  %

Description

White, odourless crystals or granules

Identification

A.

Positive tests for sodium and for sulphate

| B. | Solutions are strongly acidic |
| --- | --- |

B.

Solutions are strongly acidic

Purity

Loss on drying

Not more than 0,8  %

Water insoluble

Not more than 0,05  %

Selenium

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 515(i) POTASSIUM SULPHATE

| Definition | |
| --- | --- |
| Chemical name | Potassium sulphate |
| Chemical formula | K2SO4 |
| Molecular weight | 174,25 |
| Assay | Content not less than 99,0  % |
| Description | Colourless or white crystals or crystalline powder |
| Identification | |
| A. | Positive tests for potassium and for sulphate |

Definition

Chemical name

Potassium sulphate

Chemical formula

K2SO4

Molecular weight

174,25

Assay

Content not less than 99,0  %

Description

Colourless or white crystals or crystalline powder

Identification

A.

Positive tests for potassium and for sulphate

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 5,5 and 8,5

| C. | Solubility |
| --- | --- |

C.

Solubility

Freely soluble in water, insoluble in ethanol

Purity

Selenium

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 515(ii) POTASSIUM HYDROGEN SULPHATE

| Definition | |
| --- | --- |
| Synonyms | Potassium bisulphate, potassium acid sulphate |
| Chemical name | Potassium hydrogen sulphate |
| Chemical formula | KHSO4 |
| Molecular weight | 136,17 |
| Assay | Content not less than 99 % |
| Melting point | 197 oC |
| Description | White deliquescent crystals, pieces or granules |
| Identification | |
| A. | Positive test for potassium |

Definition

Synonyms

Potassium bisulphate, potassium acid sulphate

Chemical name

Potassium hydrogen sulphate

Chemical formula

KHSO4

Molecular weight

136,17

Assay

Content not less than 99 %

Melting point

197 oC

Description

White deliquescent crystals, pieces or granules

Identification

A.

Positive test for potassium

| B. | Solubility |
| --- | --- |

B.

Solubility

Freely soluble in water, insoluble in ethanol

Purity

Selenium

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 516 CALCIUM SULPHATE

| Synonyms | Gypsum, selenite, anhydrite |
| --- | --- |
| Definition | |
| Chemical name | Calcium sulphate |
| Einecs | 231-900-3 |
| Chemical formula | CaSO4 · nH2O (n = 0 or 2) |
| Molecular weight | 136,14 (anhydrous), 172,18 (dihydrate) |
| Assay | Content not less than 99,0  % on the anhydrous basis |
| Description | Fine, white to slightly yellowish-white odourless powder |
| Identification | |
| A. | Positive tests for calcium and for sulphate |

Synonyms

Gypsum, selenite, anhydrite

Definition

Chemical name

Calcium sulphate

Einecs

231-900-3

Chemical formula

CaSO4 · nH2O (n = 0 or 2)

Molecular weight

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

Assay

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

Description

Fine, white to slightly yellowish-white odourless powder

Identification

A.

Positive tests for calcium and for sulphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Slightly soluble in water, insoluble in ethanol

Purity

Loss on drying

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

Dihydrate: not more than 23 % (ibid.)

Fluoride

Not more than 30 mg/kg

Selenium

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 517 AMMONIUM SULPHATE

| Definition | |
| --- | --- |
| Chemical name | Ammonium sulphate |
| Einecs | 231-984-1 |
| Chemical formula | (NH4)2SO4 |
| Molecular weight | 132,14 |
| Assay | Content not less than 99,0  % and not more than 100,5  % |
| Description | White powder, shining plates or crystalline fragments |
| Identification | |
| A. | Positive tests for ammonium and for sulphate |

Definition

Chemical name

Ammonium sulphate

Einecs

231-984-1

Chemical formula

(NH4)2SO4

Molecular weight

132,14

Assay

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

Description

White powder, shining plates or crystalline fragments

Identification

A.

Positive tests for ammonium and for sulphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Freely soluble in water, insoluble in ethanol

Purity

Loss on ignition

Not more than 0,25  %

Selenium

Not more than 30 mg/kg

Lead

Not more than 5 mg/kg

E 520 ALUMINIUM SULPHATE

| Synonyms | Alum |
| --- | --- |
| Definition | |
| Chemical name | Aluminium sulphate |
| Einecs | 233-135-0 |
| Chemical formula | Al2(SO4)3 |
| Molecular weight | 342,13 |
| Assay | Content not less than 99,5  % on the ignited basis |
| Description | White powder, shining plates or crystalline fragments |
| Identification | |
| A. | Positive tests for aluminium and for sulphate |

Synonyms

Alum

Definition

Chemical name

Aluminium sulphate

Einecs

233-135-0

Chemical formula

Al2(SO4)3

Molecular weight

342,13

Assay

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

Description

White powder, shining plates or crystalline fragments

Identification

A.

Positive tests for aluminium and for sulphate

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

B.

pH of a 5 % solution 2,9 or above

| C. | Solubility |
| --- | --- |

C.

Solubility

Freely soluble in water, insoluble in ethanol

Purity

Loss on ignition

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

Alkalies and alkaline earths

Not more than 0,4  %

Selenium

Not more than 30 mg/kg

Fluoride

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

E 521 ALUMINIUM SODIUM SULPHATE

| Synonyms | Soda alum, sodium alum |
| --- | --- |
| Definition | |
| Chemical name | Aluminium sodium sulphate |
| Einecs | 233-277-3 |
| Chemical formula | AlNa(SO4)2 · nH2O (n = 0 or 12) |
| Molecular weight | 242,09 (anhydrous) |
| Assay | Content on the anhydrous basis not less than 96,5  % (anhydrous) and 99,5  % (dodecahydrate) |
| Description | Transparent crystals or white crystalline powder |
| Identification | |
| A. | Positive tests for aluminium, for sodium and for sulphate |

Synonyms

Soda alum, sodium alum

Definition

Chemical name

Aluminium sodium sulphate

Einecs

233-277-3

Chemical formula

AlNa(SO4)2 · nH2O (n = 0 or 12)

Molecular weight

242,09 (anhydrous)

Assay

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

Description

Transparent crystals or white crystalline powder

Identification

A.

Positive tests for aluminium, for sodium and for sulphate

| B. | Solubility |
| --- | --- |

B.

Solubility

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

Purity

Loss on drying

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

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

Ammonium salts

No odour of ammonia detectable after heating

Selenium

Not more than 30 mg/kg

Fluoride

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 522 ALUMINIUM POTASSIUM SULPHATE

| Synonyms | Potassium alum, potash alum |
| --- | --- |
| Definition | |
| Chemical name | Aluminium potassium sulphate dodecahydrate |
| Einecs | 233-141-3 |
| Chemical formula | AlK(SO4)2 · 12 H2O |
| Molecular weight | 474,38 |
| Assay | Content not less than 99,5  % |
| Description | Large, transparent crystals or white crystalline powder |
| Identification | |
| A. | Positive tests for aluminium, for potassium and for sulphate |

Synonyms

Potassium alum, potash alum

Definition

Chemical name

Aluminium potassium sulphate dodecahydrate

Einecs

233-141-3

Chemical formula

AlK(SO4)2 · 12 H2O

Molecular weight

474,38

Assay

Content not less than 99,5  %

Description

Large, transparent crystals or white crystalline powder

Identification

A.

Positive tests for aluminium, for potassium and for sulphate

| B. | pH of a 10 % solution between 3,0 and 4,0 |
| --- | --- |

B.

pH of a 10 % solution between 3,0 and 4,0

| C. | Solubility |
| --- | --- |

C.

Solubility

Freely soluble in water, insoluble in ethanol

Purity

Ammonium salts

No odour of ammonia detectable after heating

Selenium

Not more than 30 mg/kg

Fluoride

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 523 ALUMINIUM AMMONIUM SULPHATE

| Synonyms | Ammonium alum |
| --- | --- |
| Definition | |
| Chemical name | Aluminium ammonium sulphate |
| Einecs | 232-055-3 |
| Chemical formula | AlNH4(SO4)2 · 12 H2O |
| Molecular weight | 453,32 |
| Assay | Content not less than 99,5  % |
| Description | Large, colourless crystals or white powder |
| Identification | |
| A. | Positive tests for aluminium, for ammonium and for sulphate |

Synonyms

Ammonium alum

Definition

Chemical name

Aluminium ammonium sulphate

Einecs

232-055-3

Chemical formula

AlNH4(SO4)2 · 12 H2O

Molecular weight

453,32

Assay

Content not less than 99,5  %

Description

Large, colourless crystals or white powder

Identification

A.

Positive tests for aluminium, for ammonium and for sulphate

| B. | Solubility |
| --- | --- |

B.

Solubility

Freely soluble in water, soluble in ethanol

Purity

Alkali metals and alkaline earths

Not more than 0,5  %

Selenium

Not more than 30 mg/kg

Fluoride

Not more than 30 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 524 SODIUM HYDROXIDE

| Synonyms | Caustic soda, lye |
| --- | --- |
| Definition | |
| Chemical name | Sodium hydroxide |
| Einecs | 215-185-5 |
| Chemical formula | NaOH |
| Molecular weight | 40,0 |
| Assay | Content of solid forms not less than 98,0  % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH |
| Description | White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate |
| Identification | |
| A. | Positive tests for sodium |

Synonyms

Caustic soda, lye

Definition

Chemical name

Sodium hydroxide

Einecs

215-185-5

Chemical formula

NaOH

Molecular weight

40,0

Assay

Content of solid forms not less than 98,0  % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH

Description

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

Identification

A.

Positive tests for sodium

| B. | A 1 % solution is strongly alkaline |
| --- | --- |

B.

A 1 % solution is strongly alkaline

| C. | Solubility |
| --- | --- |

C.

Solubility

Very soluble in water. Freely soluble in ethanol

Purity

Water insoluble and organic matter

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

Carbonate

Not more than 0,5  % (as Na2CO3)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 0,5  mg/kg

Mercury

Not more than 1 mg/kg

E 525 POTASSIUM HYDROXIDE

| Synonyms | Caustic potash |
| --- | --- |
| Definition | |
| Chemical name | Potassium hydroxide |
| Einecs | 215-181-3 |
| Chemical formula | KOH |
| Molecular weight | 56,11 |
| Assay | Content not less than 85,0  % of alkali calculated as KOH |
| Description | White or nearly white pellets, flakes, sticks, fused masses or other forms |
| Identification | |
| A. | Positive tests for potassium |

Synonyms

Caustic potash

Definition

Chemical name

Potassium hydroxide

Einecs

215-181-3

Chemical formula

KOH

Molecular weight

56,11

Assay

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

Description

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

Identification

A.

Positive tests for potassium

| B. | A 1 % solution is strongly alkaline |
| --- | --- |

B.

A 1 % solution is strongly alkaline

| C. | Solubility |
| --- | --- |

C.

Solubility

Very soluble in water. Freely soluble in ethanol

Purity

Water insoluble matter

A 5 % solution is completely clear and colourless

Carbonate

Not more than 3,5  % (as K2CO3)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

E 526 CALCIUM HYDROXIDE

| Synonyms | Slaked lime, hydrated lime |
| --- | --- |
| Definition | |
| Chemical name | Calcium hydroxide |
| Einecs | 215-137-3 |
| Chemical formula | Ca(OH)2 |
| Molecular weight | 74,09 |
| Assay | Content not less than 92,0  % |
| Description | White powder |
| Identification | |
| A. | Positive tests for alkali and for calcium |

Synonyms

Slaked lime, hydrated lime

Definition

Chemical name

Calcium hydroxide

Einecs

215-137-3

Chemical formula

Ca(OH)2

Molecular weight

74,09

Assay

Content not less than 92,0  %

Description

White powder

Identification

A.

Positive tests for alkali and for calcium

| B. | Solubility |
| --- | --- |

B.

Solubility

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

Purity

Acid insoluble ash

Not more than 1,0  %

Magnesium and alkali salts

Not more than 1,0  %

Barium

Not more than 300 mg/kg

Fluoride

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

E 527 AMMONIUM HYDROXIDE

| Synonyms | Aqua ammonia, strong ammonia solution |
| --- | --- |
| Definition | |
| Chemical name | Ammonium hydroxide |
| Chemical formula | NH4OH |
| Molecular weight | 35,05 |
| Assay | Content not less than 27 % of NH3 |
| Description | Clear, colourless solution, having an exceedingly pungent, characteristic odour |
| Identification | |
| A. | Positive tests for ammonia |

Synonyms

Aqua ammonia, strong ammonia solution

Definition

Chemical name

Ammonium hydroxide

Chemical formula

NH4OH

Molecular weight

35,05

Assay

Content not less than 27 % of NH3

Description

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

Identification

A.

Positive tests for ammonia

Purity

Non-volatile matter

Not more than 0,02  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

E 528 MAGNESIUM HYDROXIDE

| Definition | |
| --- | --- |
| Chemical name | Magnesium hydroxide |
| Einecs | 215-170-3 |
| Chemical formula | Mg(OH)2 |
| Molecular weight | 58,32 |
| Assay | Content not less than 95,0  % on the anhydrous basis |
| Description | Odourless, white bulky powder |
| Identification | |
| A. | Positive test for magnesium and for alkali |

Definition

Chemical name

Magnesium hydroxide

Einecs

215-170-3

Chemical formula

Mg(OH)2

Molecular weight

58,32

Assay

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

Description

Odourless, white bulky powder

Identification

A.

Positive test for magnesium and for alkali

| B. | Solubility |
| --- | --- |

B.

Solubility

Practically insoluble in water and in ethanol

Purity

Loss on drying

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

Loss on ignition

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

Calcium oxide

Not more than 1,5  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

E 529 CALCIUM OXIDE

| Synonyms | Burnt lime |
| --- | --- |
| Definition | |
| Chemical name | Calcium oxide |
| Einecs | 215-138-9 |
| Chemical formula | CaO |
| Molecular weight | 56,08 |
| Assay | Content not less than 95,0  % on the ignited basis |
| Description | Odourless, hard, white or greyish white masses of granules, or white to greyish powder |
| Identification | |
| A. | Positive test for alkali and for calcium |

Synonyms

Burnt lime

Definition

Chemical name

Calcium oxide

Einecs

215-138-9

Chemical formula

CaO

Molecular weight

56,08

Assay

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

Description

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

Identification

A.

Positive test for alkali and for calcium

| B. | Heat is generated on moistening the sample with water |
| --- | --- |

B.

Heat is generated on moistening the sample with water

| C. | Solubility |
| --- | --- |

C.

Solubility

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

Purity

Loss on ignition

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

Acid insoluble matter

Not more than 1,0  %

Barium

Not more than 300 mg/kg

Magnesium and alkali salts

Not more than 1,5  %

Fluoride

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

E 530 MAGNESIUM OXIDE

| Definition | |
| --- | --- |
| Chemical name | Magnesium oxide |
| Einecs | 215-171-9 |
| Chemical formula | MgO |
| Molecular weight | 40,31 |
| Assay | Content not less than 98,0  % on the ignited basis |
| Description | A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 ml |
| Identification | |
| A. | Positive test for alkali and for magnesium |

Definition

Chemical name

Magnesium oxide

Einecs

215-171-9

Chemical formula

MgO

Molecular weight

40,31

Assay

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

Description

A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 ml

Identification

A.

Positive test for alkali and for magnesium

| B. | Solubility |
| --- | --- |

B.

Solubility

Practically insoluble in water. Insoluble in ethanol

Purity

Loss on ignition

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

Calcium oxide

Not more than 1,5  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

E 535 SODIUM FERROCYANIDE

| Synonyms | Yellow prussiate of soda, sodium hexacyanoferrate |
| --- | --- |
| Definition | |
| Chemical name | Sodium ferrocyanide |
| Einecs | 237-081-9 |
| Chemical formula | Na4Fe(CN)6 · 10 H2O |
| Molecular weight | 484,1 |
| Assay | Content not less than 99,0  % |
| Description | Yellow crystals or crystalline powder |
| Identification | |
| A. | Positive test for sodium and for ferrocyanide |

Synonyms

Yellow prussiate of soda, sodium hexacyanoferrate

Definition

Chemical name

Sodium ferrocyanide

Einecs

237-081-9

Chemical formula

Na4Fe(CN)6 · 10 H2O

Molecular weight

484,1

Assay

Content not less than 99,0  %

Description

Yellow crystals or crystalline powder

Identification

A.

Positive test for sodium and for ferrocyanide

Purity

Free moisture

Not more than 1,0  %

Water insoluble matter

Not more than 0,03  %

Chloride

Not more than 0,2  %

Sulphate

Not more than 0,1  %

Free cyanide

Not detectable

Ferricyanide

Not detectable

Lead

Not more than 5 mg/kg

E 536 POTASSIUM FERROCYANIDE

| Synonyms | Yellow prussiate of potash, potassium hexacyanoferrate |
| --- | --- |
| Definition | |
| Chemical name | Potassium ferrocyanide |
| Einecs | 237-722-2 |
| Chemical formula | K4Fe(CN)6· 3 H2O |
| Molecular weight | 422,4 |
| Assay | Content not less than 99,0  % |
| Description | Lemon yellow crystals |
| Identification | |
| A. | Positive test for potassium and for ferrocyanide |

Synonyms

Yellow prussiate of potash, potassium hexacyanoferrate

Definition

Chemical name

Potassium ferrocyanide

Einecs

237-722-2

Chemical formula

K4Fe(CN)6· 3 H2O

Molecular weight

422,4

Assay

Content not less than 99,0  %

Description

Lemon yellow crystals

Identification

A.

Positive test for potassium and for ferrocyanide

Purity

Free moisture

Not more than 1,0  %

Water insoluble matter

Not more than 0,03  %

Chloride

Not more than 0,2  %

Sulphate

Not more than 0,1  %

Free cyanide

Not detectable

Ferricyanide

Not detectable

Lead

Not more than 5 mg/kg

E 538 CALCIUM FERROCYANIDE

| Synonyms | Yellow prussiate of lime, calcium hexacyanoferrate |
| --- | --- |
| Definition | |
| Chemical name | Calcium ferrocyanide |
| Einecs | 215-476-7 |
| Chemical formula | Ca2Fe(CN)6 · 12H2O |
| Molecular weight | 508,3 |
| Assay | Content not less than 99,0  % |
| Description | Yellow crystals or crystalline powder |
| Identification | |
| A. | Positive test for calcium and for ferrocyanide |

Synonyms

Yellow prussiate of lime, calcium hexacyanoferrate

Definition

Chemical name

Calcium ferrocyanide

Einecs

215-476-7

Chemical formula

Ca2Fe(CN)6 · 12H2O

Molecular weight

508,3

Assay

Content not less than 99,0  %

Description

Yellow crystals or crystalline powder

Identification

A.

Positive test for calcium and for ferrocyanide

Purity

Free moisture

Not more than 1,0  %

Water insoluble matter

Not more than 0,03  %

Chloride

Not more than 0,2  %

Sulphate

Not more than 0,1  %

Free cyanide

Not detectable

Ferricyanide

Not detectable

Lead

Not more than 5 mg/kg

E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC

| Synonyms | SALP |
| --- | --- |
| Definition | |
| Chemical name | Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) or |
| Trisodium dialuminium pentadecahydrogen octaphosphate (B) |
| Einecs | 232-090-4 |
| Chemical formula | NaAl3H14(PO4)8 · 4H2O (A) |
| Na3Al2H15(PO4)8 (B) |
| Molecular weight | 949,88 (A) |
| 897,82 (B) |
| Assay | Content not less than 95,0  % (both forms) |
| Description | White odourless powder |
| Identification | |
| A. | Positive test for sodium, for aluminium and for phosphate |

Synonyms

SALP

Definition

Chemical name

Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) or

Trisodium dialuminium pentadecahydrogen octaphosphate (B)

Einecs

232-090-4

Chemical formula

NaAl3H14(PO4)8 · 4H2O (A)

Na3Al2H15(PO4)8 (B)

Molecular weight

949,88 (A)

897,82 (B)

Assay

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

Description

White odourless powder

Identification

A.

Positive test for sodium, for aluminium and for phosphate

| B. | pH |
| --- | --- |

B.

pH

Acid to litmus

| C. | Solubility |
| --- | --- |

C.

Solubility

Insoluble in water. Soluble in hydrochloric acid

Purity

Loss on ignition

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

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

Fluoride

Not more than 25 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 4 mg/kg

Cadmium

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 551 SILICON DIOXIDE

| Synonyms | Silica, silicium dioxide |
| --- | --- |
| Definition | Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water |
| Chemical name | Silicon dioxide |
| Einecs | 231-545-4 |
| Chemical formula | (SiO2)n |
| Molecular weight | 60,08 (SiO2) |
| Assay | Content after ignition not less than 99,0  % (fumed silica) or 94,0  % (hydrated forms) |
| Description | White, fluffy powder or granules |
| Hygroscopic |
| Identification | |
| A. | Positive test for silica |

Synonyms

Silica, silicium dioxide

Definition

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

Chemical name

Silicon dioxide

Einecs

231-545-4

Chemical formula

(SiO2)n

Molecular weight

60,08 (SiO2)

Assay

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

Description

White, fluffy powder or granules

Hygroscopic

Identification

A.

Positive test for silica

Purity

Loss on drying

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

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

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

Loss on ignition

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

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

Soluble ionisable salts

Not more than 5,0  % (as Na2SO4)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 552 CALCIUM SILICATE

| Definition | Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2 |
| --- | --- |
| Chemical name | Calcium silicate |
| Einecs | 215-710-8 |
| Assay | Content on the anhydrous basis:






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

Definition

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

Chemical name

Calcium silicate

Einecs

215-710-8

Assay

Content on the anhydrous basis:

—

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

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

—

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

Description

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

Identification

| A. | Positive test for silicate and for calcium |
| --- | --- |

A.

Positive test for silicate and for calcium

| B. | Forms a gel with mineral acids |
| --- | --- |

B.

Forms a gel with mineral acids

Purity

Loss on drying

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

Loss on ignition

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

Sodium

Not more than 3 %

Fluoride

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 553a(i) MAGNESIUM SILICATE

| Definition | Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5 |
| --- | --- |
| Assay | Content not less than 15 % of MgO and not less than 67 % of SiO2 on the ignited basis |
| Description | Very fine, white, odourless powder, free from grittiness |
| Identification | |
| A. | Positive test for magnesium and for silicate |

Definition

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

Assay

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

Description

Very fine, white, odourless powder, free from grittiness

Identification

A.

Positive test for magnesium and for silicate

| B. | pH of a 10 % slurry |
| --- | --- |

B.

pH of a 10 % slurry

Between 7,0 and 10,8

Purity

Loss on drying

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

Loss on ignition

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

Water soluble salts

Not more than 3 %

Free alkali

Not more than 1 % (as NaOH)

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 553a(ii) MAGNESIUM TRISILICATE

| Definition | |
| --- | --- |
| Chemical name | Magnesium trisilicate |
| Chemical formula | Mg2Si3O8 · xH2O (approximate composition) |
| Einecs | 239-076-7 |
| Assay | Content not less than 29,0  % of MgO and not less than 65,0  % of SiO2 both on the ignited basis |
| Description | Fine, white powder, free from grittiness |
| Identification | |
| A. | Positive test for magnesium and for silicate |

Definition

Chemical name

Magnesium trisilicate

Chemical formula

Mg2Si3O8 · xH2O (approximate composition)

Einecs

239-076-7

Assay

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

Description

Fine, white powder, free from grittiness

Identification

A.

Positive test for magnesium and for silicate

| B. | pH of a 5 % slurry |
| --- | --- |

B.

pH of a 5 % slurry

Between 6,3 and 9,5

Purity

Loss on ignition

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

Water soluble salts

Not more than 2 %

Free alkali

Not more than 1 % (as NaOH)

Fluoride

Not more than 10 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 553b TALC

| Synonyms | Talcum |
| --- | --- |
| Definition | Naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite |
| Chemical name | Magnesium hydrogen metasilicate |
| Einecs | 238-877-9 |
| Chemical formula | Mg3(Si4O10)(OH)2 |
| Molecular weight | 379,22 |
| Description | Light, homogeneous, white or almost white powder, greasy to the touch |
| Identification | |
| A. | IR absorption |

Synonyms

Talcum

Definition

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

Chemical name

Magnesium hydrogen metasilicate

Einecs

238-877-9

Chemical formula

Mg3(Si4O10)(OH)2

Molecular weight

379,22

Description

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

Identification

A.

IR absorption

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

| B. | X-ray diffraction |
| --- | --- |

B.

X-ray diffraction

Peaks at 9,34 /4,66/3,12 Å

| C. | Solubility |
| --- | --- |

C.

Solubility

Insoluble in water and ethanol

Purity

Loss on drying

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

Acid-soluble matter

Not more than 6 %

Water-soluble matter

Not more than 0,2  %

Acid-soluble iron

Not detectable

Arsenic

Not more than 10 mg/kg

Lead

Not more than 5 mg/kg

E 554 SODIUM ALUMINIUM SILICATE

| Synonyms | Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate |
| --- | --- |
| Definition | |
| Chemical name | Sodium aluminium silicate |
| Assay | Content on the anhydrous basis:






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

Synonyms

Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate

Definition

Chemical name

Sodium aluminium silicate

Assay

Content on the anhydrous basis:

—

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

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

—

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

Description

Fine white amorphous powder or beads

Identification

| A. | Positive tests for sodium, for aluminium and for silicate |
| --- | --- |

A.

Positive tests for sodium, for aluminium and for silicate

| B. | pH of a 5 % slurry |
| --- | --- |

B.

pH of a 5 % slurry

Between 6,5 and 11,5

Purity

Loss on drying

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

Loss on ignition

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

Sodium

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 555 POTASSIUM ALUMINIUM SILICATE

| Synonyms | Mica |
| --- | --- |
| Definition | Natural mica consists of mainly potassium aluminium silicate (muscovite) |
| Einecs | 310-127-6 |
| Chemical name | Potassium aluminium silicate |
| Chemical formulae | KAl2[AlSi3O10](OH)2 |
| Molecular weight | 398 |
| Assay | Content not less than 98 % |
| Description | Light grey to white crystalline platelets or powder |
| Identification | |
| A. | Solubility |

Synonyms

Mica

Definition

Natural mica consists of mainly potassium aluminium silicate (muscovite)

Einecs

310-127-6

Chemical name

Potassium aluminium silicate

Chemical formulae

KAl2[AlSi3O10](OH)2

Molecular weight

398

Assay

Content not less than 98 %

Description

Light grey to white crystalline platelets or powder

Identification

A.

Solubility

Insoluble in water, diluted acids and alkali and organic solvents

Purity

Loss on drying

Not more than 0,5  % (105 oC, 2h)

Antimony

Not more than 20 mg/kg

Zinc

Not more than 25 mg/kg

Barium

Not more than 25 mg/kg

Chromium

Not more than 100 mg/kg

Copper

Not more than 25 mg/kg

Nickel

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 2 mg/kg

Lead

Not more than 10 mg/kg

E 556 CALCIUM ALUMINIUM SILICATE

| Synonyms | Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate |
| --- | --- |
| Definition | |
| Chemical name | Calcium aluminium silicate |
| Assay | Content on the anhydrous basis:






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

Synonyms

Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate

Definition

Chemical name

Calcium aluminium silicate

Assay

Content on the anhydrous basis:

—

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

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

—

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

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

—

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

Description

Fine white, free-flowing powder

Identification

| A. | Positive tests for calcium, for aluminium and for silicate |
| --- | --- |

A.

Positive tests for calcium, for aluminium and for silicate

Purity

Loss on drying

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

Loss on ignition

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

Fluoride

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 10 mg/kg

Mercury

Not more than 1 mg/kg

E 558 BENTONITE

| Definition | Bentonite is a natural clay containing a high proportion of montmorillonite, a native hydrated aluminium silicate in which some aluminium and silicon atoms were naturally replaced by other atoms such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite and acid-activated bentonite |
| --- | --- |
| Einecs | 215-108-5 |
| Chemical formula | (Al, Mg)8(Si4O10) 4(OH)8 · 12H2O |
| Molecular weight | 819 |
| Assay | Montmorillonite content not less than 80 % |
| Description | Very fine, yellowish or greyish white powder or granules. The structure of bentonite allows it to absorb water in its structure and on its external surface (swelling properties) |
| Identification | |
| A. | Methylene blue test |

Definition

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

Einecs

215-108-5

Chemical formula

(Al, Mg)8(Si4O10) 4(OH)8 · 12H2O

Molecular weight

819

Assay

Montmorillonite content not less than 80 %

Description

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

Identification

A.

Methylene blue test

| B. | X-Ray diffraction |
| --- | --- |

B.

X-Ray diffraction

Characteristic peaks at 12,5 /15 A

| C. | IR absorption |
| --- | --- |

C.

IR absorption

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

Purity

Loss on drying

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

Arsenic

Not more than 2 mg/kg

Lead

Not more than 20 mg/kg

E 559 ALUMINIUM SILICATE (KAOLIN)

| Synonyms | Kaolin, light or heavy |
| --- | --- |
| Definition | Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption |
| Einecs | 215-286-4 (kaolinite) |
| Chemical formula | Al2Si2O5(OH)4 (kaolinite) |
| Molecular weight | 264 |
| Assay | Content not less than 90 % (sum of silica and alumina, after ignition) |
| Silica (SiO2) | Between 45 % and 55 % |
| Alumina (Al2O3) | Between 30 % and 39 % |
| Description | Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes |
| Identification | |
| A. | Positive tests for alumina and for silicate |

Synonyms

Kaolin, light or heavy

Definition

Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption

Einecs

215-286-4 (kaolinite)

Chemical formula

Al2Si2O5(OH)4 (kaolinite)

Molecular weight

264

Assay

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

Silica (SiO2)

Between 45 % and 55 %

Alumina (Al2O3)

Between 30 % and 39 %

Description

Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes

Identification

A.

Positive tests for alumina and for silicate

| B. | X-ray diffraction: |
| --- | --- |

B.

X-ray diffraction:

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

| C. | IR absorption: |
| --- | --- |

C.

IR absorption:

Peaks at 3 700 and 3 620 cm-1

Purity

Loss on ignition

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

Water soluble matter

Not more than 0,3  %

Acid soluble matter

Not more than 2 %

Iron

Not more than 5 %

Potassium oxide (K2O)

Not more than 5 %

Carbon

Not more than 0,5  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 570 FATTY ACIDS

| Definition | Linear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1) |
| --- | --- |
| Chemical name | octanoic acid (C8), decanoic acid (C10), dodecanoic acid (C12), tetradecanoic acid (C14), hexadecanoic acid (C16), octadecanoic acid (C18), 9-octadecenoic acid (C18:1) |
| Assay | Not less than 98 % by chromatography |
| Description | A colourless liquid or white solid obtained from oils and fats |
| Identification | |
| A. | Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight |

Definition

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

Chemical name

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

Assay

Not less than 98 % by chromatography

Description

A colourless liquid or white solid obtained from oils and fats

Identification

A.

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

Purity

Residue on ignition

Not more than 0,1  %

Unsaponifiable matter

Not more than 1,5  %

Water

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

Arsenic

Not more than 3 mg/kg

Lead

Not more than 1 mg/kg

Mercury

Not more than 1 mg/kg

E 574 GLUCONIC ACID

| Synonyms | D-gluconic acid, dextronic acid |
| --- | --- |
| Definition | Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone |
| Chemical name | Gluconic acid |
| Chemical formula | C6H12O7 (gluconic acid) |
| Molecular weight | 196,2 |
| Assay | Content not less than 50,0  % (as gluconic acid) |
| Description | Colourless to light yellow, clear syrupy liquid |
| Identification | |
| A. | Formation of phenylhydrazine derivative positive |

Synonyms

D-gluconic acid, dextronic acid

Definition

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

Chemical name

Gluconic acid

Chemical formula

C6H12O7 (gluconic acid)

Molecular weight

196,2

Assay

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

Description

Colourless to light yellow, clear syrupy liquid

Identification

A.

Formation of phenylhydrazine derivative positive

Compound formed melts between 196 oC and 202 oC with decomposition

Purity

Residue on ignition

Not more than 1,0  %

Reducing matter

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

Chloride

Not more than 350 mg/kg

Sulphate

Not more than 240 mg/kg

Sulphite

Not more than 20 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 575 GLUCONO-DELTA-LACTONE

| Synonyms | Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolactone |
| --- | --- |
| Definition | Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-lactones |
| Chemical name | D-Glucono-1,5 -lactone |
| Einecs | 202-016-5 |
| Chemical formula | C6H10O6 |
| Molecular weight | 178,14 |
| Assay | Content not less than 99,0  % on the anhydrous basis |
| Description | Fine, white, nearly odourless, crystalline powder |
| Identification | |
| A. | Formation of phenylhydrazine derivative of gluconic acid positive |

Synonyms

Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolactone

Definition

Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-lactones

Chemical name

D-Glucono-1,5 -lactone

Einecs

202-016-5

Chemical formula

C6H10O6

Molecular weight

178,14

Assay

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

Description

Fine, white, nearly odourless, crystalline powder

Identification

A.

Formation of phenylhydrazine derivative of gluconic acid positive

Compound formed melts between 196 oC and 202 oC with decomposition

| B. | Solubility |
| --- | --- |

B.

Solubility

Freely soluble in water. Sparingly soluble in ethanol

| C. | Melting point |
| --- | --- |

C.

Melting point

152 oC ± 2 oC

Purity

Water

Not more than 1,0  % (Karl Fischer method)

Reducing substances

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

Lead

Not more than 2 mg/kg

E 576 SODIUM GLUCONATE

| Synonyms | Sodium salt of D-gluconic acid |
| --- | --- |
| Definition | |
| Chemical name | Sodium D-gluconate |
| Einecs | 208-407-7 |
| Chemical formula | C6H11NaO7 (anhydrous) |
| Molecular weight | 218,14 |
| Assay | Content not less than 98,0  % |
| Description | White to tan, granular to fine, crystalline powder |
| Identification | |
| A. | Positive test for sodium and for gluconate |

Synonyms

Sodium salt of D-gluconic acid

Definition

Chemical name

Sodium D-gluconate

Einecs

208-407-7

Chemical formula

C6H11NaO7 (anhydrous)

Molecular weight

218,14

Assay

Content not less than 98,0  %

Description

White to tan, granular to fine, crystalline powder

Identification

A.

Positive test for sodium and for gluconate

| B. | Solubility |
| --- | --- |

B.

Solubility

Very soluble in water. Sparingly soluble in ethanol

| C. | pH of a 10 % solution |
| --- | --- |

C.

pH of a 10 % solution

Between 6,5 and 7,5

Purity

Reducing matter

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

Lead

Not more than 2 mg/kg

E 577 POTASSIUM GLUCONATE

| Synonyms | Potassium salt of D-gluconic acid |
| --- | --- |
| Definition | |
| Chemical name | Potassium D-gluconate |
| Einecs | 206-074-2 |
| Chemical formula | C6H11KO7 (anhydrous) |
| C6H11KO7 · H2O (monohydrate) |
| Molecular weight | 234,25 (anhydrous) |
| 252,26 (monohydrate) |
| Assay | Content not less than 97,0  % and not more than 103,0  % on dried basis |
| Description | Odourless, free flowing white to yellowish white, crystalline powder or granules |
| Identification | |
| A. | Positive test for potassium and for gluconate |

Synonyms

Potassium salt of D-gluconic acid

Definition

Chemical name

Potassium D-gluconate

Einecs

206-074-2

Chemical formula

C6H11KO7 (anhydrous)

C6H11KO7 · H2O (monohydrate)

Molecular weight

234,25 (anhydrous)

252,26 (monohydrate)

Assay

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

Description

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

Identification

A.

Positive test for potassium and for gluconate

| B. | pH of a 10 % solution |
| --- | --- |

B.

pH of a 10 % solution

Between 7,0 and 8,3

Purity

Loss on drying

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

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

Reducing substances

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

Lead

Not more than 2 mg/kg

E 578 CALCIUM GLUCONATE

| Synonyms | Calcium salt of D-gluconic acid |
| --- | --- |
| Definition | |
| Chemical name | Calcium di-D-gluconate |
| Einecs | 206-075-8 |
| Chemical formula | C12H22CaO14 (anhydrous) |
| C12H22CaO14 · H2O (monohydrate) |
| Molecular weight | 430,38 (anhydrous form) |
| 448,39 (monohydrate) |
| Assay | Content not less than 98,0  % and not more than 102 % on the anhydrous and monohydrate basis |
| Description | Odourless, white crystalline granules or powder, stable in air |
| Identification | |
| A. | Positive test for calcium and for gluconate |

Synonyms

Calcium salt of D-gluconic acid

Definition

Chemical name

Calcium di-D-gluconate

Einecs

206-075-8

Chemical formula

C12H22CaO14 (anhydrous)

C12H22CaO14 · H2O (monohydrate)

Molecular weight

430,38 (anhydrous form)

448,39 (monohydrate)

Assay

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

Description

Odourless, white crystalline granules or powder, stable in air

Identification

A.

Positive test for calcium and for gluconate

| B. | Solubility |
| --- | --- |

B.

Solubility

Soluble in water, insoluble in ethanol

| C. | pH of a 5 % solution |
| --- | --- |

C.

pH of a 5 % solution

Between 6,0 and 8,0

Purity

Loss on drying

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

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

Reducing substances

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

Lead

Not more than 2 mg/kg

E 579 FERROUS GLUCONATE

| Definition | |
| --- | --- |
| Chemical name | Ferrous di-D-gluconate dihydrate |
| Iron(II) di-gluconate dihydrate |
| Einecs | 206-076-3 |
| Chemical formulae | C12H22FeO14·2H2O |
| Molecular weight | 482,17 |
| Assay | Content not less than 95 % on the dried basis |
| Description | Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar |
| Identification | |
| A. | Solubility |

Definition

Chemical name

Ferrous di-D-gluconate dihydrate

Iron(II) di-gluconate dihydrate

Einecs

206-076-3

Chemical formulae

C12H22FeO14·2H2O

Molecular weight

482,17

Assay

Content not less than 95 % on the dried basis

Description

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

Identification

A.

Solubility

Soluble with slight heating in water. Practically insoluble in ethanol

| B. | Positive test for ferrous ion |
| --- | --- |

B.

Positive test for ferrous ion

| C. | Formation of phenylhy-drazine derivative of gluconic acid positive |
| --- | --- |

C.

Formation of phenylhy-drazine derivative of gluconic acid positive

| D. | pH of a 10 % solution |
| --- | --- |

D.

pH of a 10 % solution

Between 4 and 5,5

Purity

Loss on drying

Not more than 10 % (105 oC, 16 hours)

Oxalic acid

Not detectable

Iron (Fe III)

Not more than 2 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

Reducing substances

Not more than 0,5  % expressed as glucose

E 585 FERROUS LACTATE

| Synonyms | Iron(II) lactate |
| --- | --- |
| Iron(II) 2-hydroxy propanoate |
| Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1) |
| Definition | |
| Chemical name | Ferrous 2-hydroxy propanoate |
| Einecs | 227-608-0 |
| Chemical formulae | C6H10FeO6·xH2O (x = 2 or 3) |
| Molecular weight | 270,02 (dihydrate) |
| 288,03 (trihydrate) |
| Assay | Content not less than 96 % on the dried basis |
| Description | Greenish-white crystals or light green powder having a characteristic smell |
| Identification | |
| A. | Solubility |

Synonyms

Iron(II) lactate

Iron(II) 2-hydroxy propanoate

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

Definition

Chemical name

Ferrous 2-hydroxy propanoate

Einecs

227-608-0

Chemical formulae

C6H10FeO6·xH2O (x = 2 or 3)

Molecular weight

270,02 (dihydrate)

288,03 (trihydrate)

Assay

Content not less than 96 % on the dried basis

Description

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

Identification

A.

Solubility

Soluble in water. Practically insoluble in ethanol

| B. | Positive test for ferrous ion and for lactate |
| --- | --- |

B.

Positive test for ferrous ion and for lactate

| C. | pH of a 2 % solution |
| --- | --- |

C.

pH of a 2 % solution

Between 4 and 6

Purity

Loss on drying

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

Iron (Fe III)

Not more than 0,6  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Cadmium

Not more than 1 mg/kg

E 586 4-HEXYLRESORCINOL

| Synonyms | 4-Hexyl-1,3-benzenediol |
| --- | --- |
| Hexylresorcinol |
| Definition | |
| Chemical name | 4-Hexylresorcinol |
| Einecs | 205-257-4 |
| Chemical formula | C12H18O2 |
| Molecular weight | 197,24 |
| Assay | Not less than 98 % on the dried basis |
| Description | White powder |
| Identification | |
| A. | Solubility |

Synonyms

4-Hexyl-1,3-benzenediol

Hexylresorcinol

Definition

Chemical name

4-Hexylresorcinol

Einecs

205-257-4

Chemical formula

C12H18O2

Molecular weight

197,24

Assay

Not less than 98 % on the dried basis

Description

White powder

Identification

A.

Solubility

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

| B. | Nitric acid test |
| --- | --- |

B.

Nitric acid test

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

| C. | Bromine test |
| --- | --- |

C.

Bromine test

To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution

| D. | Melting range |
| --- | --- |

D.

Melting range

62 to 67 oC

Purity

Acidity

Not more than 0,05  %

Sulphated ash

Not more than 0,1  %

Resorcinol and other phenols

Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced

Nickel

Not more than 2 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 3 mg/kg

E 620 GLUTAMIC ACID

| Synonyms | L-Glutamic acid, L-α-aminoglutaric acid |
| --- | --- |
| Definition | |
| Chemical name | L-Glutamic acid, L-2-amino-pentanedioic acid |
| Einecs | 200-293-7 |
| Chemical formula | C5H9NO4 |
| Molecular weight | 147,13 |
| Assay | Content not less than 99,0  % and not more than 101,0  % on the anhydrous basis |
| Description | White crystals or crystalline powder |
| Identification | |
| A. | Positive test for glutamic acid by thin layer chromatography |

Synonyms

L-Glutamic acid, L-α-aminoglutaric acid

Definition

Chemical name

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

Einecs

200-293-7

Chemical formula

C5H9NO4

Molecular weight

147,13

Assay

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

Description

White crystals or crystalline powder

Identification

A.

Positive test for glutamic acid by thin layer chromatography

| B. | Specific rotation [α]D20 |
| --- | --- |

B.

Specific rotation [α]D20

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

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

| C. | pH of a saturated solution |
| --- | --- |

C.

pH of a saturated solution

Between 3,0 and 3,5

Purity

Loss on drying

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

Sulphated ash

Not more than 0,2  %

Chloride

Not more than 0,2  %

Pyrrolidone carboxylic acid

Not more than 0,2  %

Lead

Not more than 2 mg/kg

E 621 MONOSODIUM GLUTAMATE

| Synonyms | Sodium glutamate, MSG |
| --- | --- |
| Definition | |
| Chemical name | Monosodium L-glutamate monohydrate |
| Einecs | 205-538-1 |
| Chemical formula | C5H8NaNO4 · H2O |
| Molecular weight | 187,13 |
| Assay | Content not less than 99,0  % and not more than 101,0  % on the anhydrous basis |
| Description | White, practically odourless crystals or crystalline powder |
| Identification | |
| A. | Positive test for sodium |

Synonyms

Sodium glutamate, MSG

Definition

Chemical name

Monosodium L-glutamate monohydrate

Einecs

205-538-1

Chemical formula

C5H8NaNO4 · H2O

Molecular weight

187,13

Assay

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

Description

White, practically odourless crystals or crystalline powder

Identification

A.

Positive test for sodium

| B. | Positive test for glutamic acid by thin-layer chromatography |
| --- | --- |

B.

Positive test for glutamic acid by thin-layer chromatography

| C. | Specific rotation [α]D
  20 |
| --- | --- |

C.

Specific rotation [α]D
  20

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

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

| D. | pH of a 5 % solution |
| --- | --- |

D.

pH of a 5 % solution

Between 6,7 and 7,2

Purity

Loss on drying

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

Chloride

Not more than 0,2  %

Pyrrolidone carboxylic acid

Not more than 0,2  %

Lead

Not more than 2 mg/kg

E 622 MONOPOTASSIUM GLUTAMATE

| Synonyms | Potassium glutamate, MPG |
| --- | --- |
| Definition | |
| Chemical name | Monopotassium L-glutamate monohydrate |
| Einecs | 243-094-0 |
| Chemical formula | C5H8KNO4 · H2O |
| Molecular weight | 203,24 |
| Assay | Content not less than 99,0  % and not more than 101,0  % on the anhydrous basis |
| Description | White, practically odourless crystals or crystalline powder |
| Identification | |
| A. | Positive test for potassium |

Synonyms

Potassium glutamate, MPG

Definition

Chemical name

Monopotassium L-glutamate monohydrate

Einecs

243-094-0

Chemical formula

C5H8KNO4 · H2O

Molecular weight

203,24

Assay

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

Description

White, practically odourless crystals or crystalline powder

Identification

A.

Positive test for potassium

| B. | Positive test for glutamic acid by thin-layer chromatog-raphy |
| --- | --- |

B.

Positive test for glutamic acid by thin-layer chromatog-raphy

| C. | Specific rotation [α]D
  20 |
| --- | --- |

C.

Specific rotation [α]D
  20

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

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

| D. | pH of a 2 % solution |
| --- | --- |

D.

pH of a 2 % solution

Between 6,7 and 7,3

Purity

Loss on drying

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

Chloride

Not more than 0,2  %

Pyrrolidone carboxylic acid

Not more than 0,2  %

Lead

Not more than 2 mg/kg

E 623 CALCIUM DIGLUTAMATE

| Synonyms | Calcium glutamate |
| --- | --- |
| Definition | |
| Chemical name | Monocalcium di-L-glutamate |
| Einecs | 242-905-5 |
| Chemical formula | C10H16CaN2O8 · x H2O (x = 0, 1, 2 or 4) |
| Molecular weight | 332,32 (anhydrous) |
| Assay | Content not less than 98,0  % and not more than 102,0  % on the anhydrous basis |
| Description | White, practically odourless crystals or crystalline powder |
| Identification | |
| A. | Positive test for calcium |

Synonyms

Calcium glutamate

Definition

Chemical name

Monocalcium di-L-glutamate

Einecs

242-905-5

Chemical formula

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

Molecular weight

332,32 (anhydrous)

Assay

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

Description

White, practically odourless crystals or crystalline powder

Identification

A.

Positive test for calcium

| B. | Positive test for glutamic acid by thin-layer chromatog-raphy |
| --- | --- |

B.

Positive test for glutamic acid by thin-layer chromatog-raphy

| C. | Specific rotation [α]D
  20 |
| --- | --- |

C.

Specific rotation [α]D
  20

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

Purity

Water

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

Chloride

Not more than 0,2  %

Pyrrolidone carboxylic acid

Not more than 0,2  %

Lead

Not more than 2 mg/kg

E 624 MONOAMMONIUM GLUTAMATE

| Synonyms | Ammonium glutamate |
| --- | --- |
| Definition | |
| Chemical name | Monoammonium L-glutamate monohydrate |
| Einecs | 231-447-1 |
| Chemical formula | C5H12N2O4 · H2O |
| Molecular weight | 182,18 |
| Assay | Content not less than 99,0  % and not more 101,0  % on the anhydrous basis |
| Description | White, practically odourless crystals or crystalline powder |
| Identification | |
| A. | Positive test for ammonium |

Synonyms

Ammonium glutamate

Definition

Chemical name

Monoammonium L-glutamate monohydrate

Einecs

231-447-1

Chemical formula

C5H12N2O4 · H2O

Molecular weight

182,18

Assay

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

Description

White, practically odourless crystals or crystalline powder

Identification

A.

Positive test for ammonium

| B. | Positive test for glutamic acid by thin-layer chromatog-raphy |
| --- | --- |

B.

Positive test for glutamic acid by thin-layer chromatog-raphy

| C. | Specific rotation [α]D
  20 |
| --- | --- |

C.

Specific rotation [α]D
  20

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

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

| D. | pH of a 5 % solution |
| --- | --- |

D.

pH of a 5 % solution

Between 6,0 and 7,0

Purity

Loss on drying

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

Sulphated ash

Not more than 0,1  %

Pyrrolidone carboxylic acid

Not more than 0,2  %

Lead

Not more than 2 mg/kg

E 625 MAGNESIUM DIGLUTAMATE

| Synonyms | Magnesium glutamate |
| --- | --- |
| Definition | |
| Chemical name | Monomagnesium di-L-glutamate tetrahydrate |
| Einecs | 242-413-0 |
| Chemical formula | C10H16MgN2O8 · 4H2O |
| Molecular weight | 388,62 |
| Assay | Content not less than 95,0  % and not more than 105,0  % on the anhydrous basis |
| Description | Odourless, white or off-white crystals or powder |
| Identification | |
| A. | Positive test for magnesium |

Synonyms

Magnesium glutamate

Definition

Chemical name

Monomagnesium di-L-glutamate tetrahydrate

Einecs

242-413-0

Chemical formula

C10H16MgN2O8 · 4H2O

Molecular weight

388,62

Assay

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

Description

Odourless, white or off-white crystals or powder

Identification

A.

Positive test for magnesium

| B. | Positive test for glutamic acid by thin-layer chromatog-raphy |
| --- | --- |

B.

Positive test for glutamic acid by thin-layer chromatog-raphy

| C. | Specific rotation [α]D
  20 |
| --- | --- |

C.

Specific rotation [α]D
  20

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

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

| D. | pH of a 10 % solution |
| --- | --- |

D.

pH of a 10 % solution

Between 6,4 and 7,5

Purity

Water

Not more than 24 % (Karl Fischer)

Chloride

Not more than 0,2  %

Pyrrolidone carboxylic acid

Not more than 0,2  %

Lead

Not more than 2 mg/kg

E 626 GUANYLIC ACID

| Synonyms | Guanylic acid |
| --- | --- |
| Definition | |
| Chemical name | Guanosine-5'-monophosphoric acid |
| Einecs | 201-598-8 |
| Chemical formula | C10H14N5O8P |
| Molecular weight | 363,22 |
| Assay | Content not less than 97,0  % on the anhydrous basis |
| Description | Odourless, colourless or white crystals or white crystalline powder |
| Identification | |
| A. | Positive test for ribose and for organic phosphate |

Synonyms

Guanylic acid

Definition

Chemical name

Guanosine-5'-monophosphoric acid

Einecs

201-598-8

Chemical formula

C10H14N5O8P

Molecular weight

363,22

Assay

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

Description

Odourless, colourless or white crystals or white crystalline powder

Identification

A.

Positive test for ribose and for organic phosphate

| B. | pH of a 0,25  % solution |
| --- | --- |

B.

pH of a 0,25  % solution

Between 1,5 and 2,5

| C. | Spectrometry: |
| --- | --- |

C.

Spectrometry:

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

Purity

Loss on drying

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

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 627 DISODIUM GUANYLATE

| Synonyms | Sodium guanylate, sodium 5'-guanylate |
| --- | --- |
| Definition | |
| Chemical name | Disodium guanosine-5'-monophosphate |
| Einecs | 221-849-5 |
| Chemical formula | C10H12N5Na2O8P· x H2O (x = ca. 7) |
| Molecular weight | 407,19 (anhydrous) |
| Assay | Content not less than 97,0  % on the anhydrous basis |
| Description | Odourless, colourless or white crystals or white crystalline powder |
| Identification | |
| A. | Positive test for ribose, for organic phosphate, and for sodium |

Synonyms

Sodium guanylate, sodium 5'-guanylate

Definition

Chemical name

Disodium guanosine-5'-monophosphate

Einecs

221-849-5

Chemical formula

C10H12N5Na2O8P· x H2O (x = ca. 7)

Molecular weight

407,19 (anhydrous)

Assay

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

Description

Odourless, colourless or white crystals or white crystalline powder

Identification

A.

Positive test for ribose, for organic phosphate, and for sodium

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 7,0 and 8,5

| C. | Spectrometry: |
| --- | --- |

C.

Spectrometry:

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

Purity

Loss on drying

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

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 628 DIPOTASSIUM GUANYLATE

| Synonyms | Potassium guanylate, potassium 5'-guanylate |
| --- | --- |
| Definition | |
| Chemical name | Dipotassium guanosine-5'-monophosphate |
| Einecs | 226-914-1 |
| Chemical formula | C10H12K2N5O8P |
| Molecular weight | 439,40 |
| Assay | Content not less than 97,0  % on the anhydrous basis |
| Description | Odourless, colourless or white crystals or white crystalline powder |
| Identification | |
| A. | Positive test for ribose, for organic phosphate, and for potassium |

Synonyms

Potassium guanylate, potassium 5'-guanylate

Definition

Chemical name

Dipotassium guanosine-5'-monophosphate

Einecs

226-914-1

Chemical formula

C10H12K2N5O8P

Molecular weight

439,40

Assay

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

Description

Odourless, colourless or white crystals or white crystalline powder

Identification

A.

Positive test for ribose, for organic phosphate, and for potassium

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 7,0 and 8,5

| C. | Spectrometry: |
| --- | --- |

C.

Spectrometry:

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

Purity

Loss on drying

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

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 629 CALCIUM GUANYLATE

| Synonyms | Calcium 5'-guanylate |
| --- | --- |
| Definition | |
| Chemical name | Calcium guanosine-5'-monophosphate |
| Chemical formula | C10H12CaN5O8P· nH2O |
| Molecular weight | 401,20 (anhydrous) |
| Assay | Content not less than 97,0  % on the anhydrous basis |
| Description | Odourless, white or off-white crystals or powder |
| Identification | |
| A. | Positive test for ribose, for organic phosphate, and for calcium |

Synonyms

Calcium 5'-guanylate

Definition

Chemical name

Calcium guanosine-5'-monophosphate

Chemical formula

C10H12CaN5O8P· nH2O

Molecular weight

401,20 (anhydrous)

Assay

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

Description

Odourless, white or off-white crystals or powder

Identification

A.

Positive test for ribose, for organic phosphate, and for calcium

| B. | pH of a 0,05  % solution |
| --- | --- |

B.

pH of a 0,05  % solution

Between 7,0 and 8,0

| C. | Spectrometry: |
| --- | --- |

C.

Spectrometry:

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

Purity

Loss on drying

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

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 630 INOSINIC ACID

| Synonyms | 5'-Inosinic acid |
| --- | --- |
| Definition | |
| Chemical name | Inosine-5'-monophosphoric acid |
| Einecs | 205-045-1 |
| Chemical formula | C10H13N4O8P |
| Molecular weight | 348,21 |
| Assay | Content not less than 97,0  % on the anhydrous basis |
| Description | Odourless, colourless or white crystals or powder |
| Identification | |
| A. | Positive test for ribose, and for organic phosphate |

Synonyms

5'-Inosinic acid

Definition

Chemical name

Inosine-5'-monophosphoric acid

Einecs

205-045-1

Chemical formula

C10H13N4O8P

Molecular weight

348,21

Assay

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

Description

Odourless, colourless or white crystals or powder

Identification

A.

Positive test for ribose, and for organic phosphate

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 1,0 and 2,0

| C. | Spectrometry: |
| --- | --- |

C.

Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm

Purity

Loss on drying

Not more than 3,0  % (120 oC, 4h)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 631 DISODIUM INOSINATE

| Synonyms | Sodium inosinate, sodium 5'-inosinate |
| --- | --- |
| Definition | |
| Chemical name | Disodium inosine-5'-monophosphate |
| Einecs | 225-146-4 |
| Chemical formula | C10H11N4Na2O8P· H2O |
| Molecular weight | 392,17 (anhydrous) |
| Assay | Content not less than 97,0  % on the anhydrous basis |
| Description | Odourless, colourless or white crystals or powder |
| Identification | |
| A. | Positive test for ribose, and for organic phosphate and for sodium |

Synonyms

Sodium inosinate, sodium 5'-inosinate

Definition

Chemical name

Disodium inosine-5'-monophosphate

Einecs

225-146-4

Chemical formula

C10H11N4Na2O8P· H2O

Molecular weight

392,17 (anhydrous)

Assay

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

Description

Odourless, colourless or white crystals or powder

Identification

A.

Positive test for ribose, and for organic phosphate and for sodium

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 7,0 and 8,5

| C. | Spectrometry: |
| --- | --- |

C.

Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm

Purity

Water

Not more than 28,5  % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 632 DIPOTASSIUM INOSINATE

| Synonyms | Potassium inosinate, potassium 5'-inosinate |
| --- | --- |
| Definition | |
| Chemical name | Dipotassium inosine-5'-monophosphate |
| Einecs | 243-652-3 |
| Chemical formula | C10H11K2N4O8P |
| Molecular weight | 424,39 |
| Assay | Content not less than 97,0  % on the anhydrous basis |
| Description | Odourless, colourless or white crystals or powder |
| Identification | |
| A. | Positive test for ribose, and for organic phosphate and for potassium |

Synonyms

Potassium inosinate, potassium 5'-inosinate

Definition

Chemical name

Dipotassium inosine-5'-monophosphate

Einecs

243-652-3

Chemical formula

C10H11K2N4O8P

Molecular weight

424,39

Assay

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

Description

Odourless, colourless or white crystals or powder

Identification

A.

Positive test for ribose, and for organic phosphate and for potassium

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 7,0 and 8,5

| C. | Spectrometry: |
| --- | --- |

C.

Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm

Purity

Water

Not more than 10,0  % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 633 CALCIUM INOSINATE

| Synonyms | Calcium 5'-inosinate |
| --- | --- |
| Definition | |
| Chemical name | Calcium inosine-5'-monophosphate |
| Chemical formula | C10H11CaN4O8P· nH2O |
| Molecular weight | 386,19 (anhydrous) |
| Assay | Content not less than 97,0  % on the anhydrous basis |
| Description | Odourless, colourless or white crystals or powder |
| Identification | |
| A. | Positive test for ribose, and for organic phosphate and for calcium |

Synonyms

Calcium 5'-inosinate

Definition

Chemical name

Calcium inosine-5'-monophosphate

Chemical formula

C10H11CaN4O8P· nH2O

Molecular weight

386,19 (anhydrous)

Assay

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

Description

Odourless, colourless or white crystals or powder

Identification

A.

Positive test for ribose, and for organic phosphate and for calcium

| B. | pH of a 0,05  % solution |
| --- | --- |

B.

pH of a 0,05  % solution

Between 7,0 and 8,0

| C. | Spectrometry: |
| --- | --- |

C.

Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01 N HCl at 250 nm

Purity

Water

Not more than 23,0  % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 634 CALCIUM 5'-RIBONUCLEOTIDE

| Definition | |
| --- | --- |
| Chemical name | Calcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate |
| Chemical formula | C10H11N4CaO8P· nH2O y |
| C10H12N5CaO8P· nH2O |
| Assay | Content of both major components not less than 97,0  %, and of each component not less than 47,0  % and not more than 53 %, in every case on the anhydrous basis |
| Description | Odourless, white or nearly white crystals or powder |
| Identification | |
| A. | Positive test for ribose, and for organic phosphate and for calcium |

Definition

Chemical name

Calcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate

Chemical formula

C10H11N4CaO8P· nH2O y

C10H12N5CaO8P· nH2O

Assay

Content of both major components not less than 97,0  %, and of each component not less than 47,0  % and not more than 53 %, in every case on the anhydrous basis

Description

Odourless, white or nearly white crystals or powder

Identification

A.

Positive test for ribose, and for organic phosphate and for calcium

| B. | pH of a 0,05  % solution |
| --- | --- |

B.

pH of a 0,05  % solution

Between 7,0 and 8,0

Purity

Water

Not more than 23,0  % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 635 DISODIUM 5'-RIBONUCLEOTIDE

| Synonyms | Sodium 5'-ribonucleotide |
| --- | --- |
| Definition | |
| Chemical name | Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate |
| Chemical formula | C10H11N4Na2O8P · nH2O and |
| C10H12N5Na2O8P· nH2O |
| Assay | Content of both major components not less than 97,0  %, and of each component not less than 47,0  % and not more than 53 %, in every case on the anhydrous basis |
| Description | Odourless, white or nearly white crystals or powder |
| Identification | |
| A. | Positive test for ribose, and for organic phosphate and for sodium |

Synonyms

Sodium 5'-ribonucleotide

Definition

Chemical name

Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate

Chemical formula

C10H11N4Na2O8P · nH2O and

C10H12N5Na2O8P· nH2O

Assay

Content of both major components not less than 97,0  %, and of each component not less than 47,0  % and not more than 53 %, in every case on the anhydrous basis

Description

Odourless, white or nearly white crystals or powder

Identification

A.

Positive test for ribose, and for organic phosphate and for sodium

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 7,0 and 8,5

Purity

Water

Not more than 26,0  % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 640 GLYCINE AND ITS SODIUM SALT

| Synonyms
  (gly) | Aminoacetic acid, glycocoll |
| --- | --- |
| (Na salt) | Sodium glycinate |
| Definition | |
| Chemical name (gly) | Aminoacetic acid |
| (Na salt) | Sodium glycinate |
| Chemical formula (gly) | C2H5NO2 |
| (Na salt) | C2H5NO2 Na |
| Einecs (gly) | 200-272-2 |
| (Na salt) | 227-842-3 |
| Molecular weight (gly) | 75,07 |
| (Na salt) | 98 |
| Assay | Content not less than 98,5  % on the anhydrous basis |
| Description | White crystals or crystalline powder |
| Identification | |
| A. | Positive test for amino acid (gly and Na salt) |

Synonyms
  (gly)

Aminoacetic acid, glycocoll

(Na salt)

Sodium glycinate

Definition

Chemical name (gly)

Aminoacetic acid

(Na salt)

Sodium glycinate

Chemical formula (gly)

C2H5NO2

(Na salt)

C2H5NO2 Na

Einecs (gly)

200-272-2

(Na salt)

227-842-3

Molecular weight (gly)

75,07

(Na salt)

98

Assay

Content not less than 98,5  % on the anhydrous basis

Description

White crystals or crystalline powder

Identification

A.

Positive test for amino acid (gly and Na salt)

| B. | Positive test for sodium (Na salt) |
| --- | --- |

B.

Positive test for sodium (Na salt)

Purity

Loss on drying (gly)

Not more than 0,2  % (105 oC, 3h)

(Na salt)

Not more than 0,2  % (105 oC, 3h)

Residue on ignition (gly)

Not more than 0,1  %

(Na salt)

Not more than 0,1  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 650 ZINC ACETATE

| Synonyms | Acetic acid, zinc salt, dihydrate |
| --- | --- |
| Definition | |
| Chemical name | Zinc acetate dihydrate |
| Chemical formula | C4H6O4 Zn· 2H2O |
| Molecular weight | 219,51 |
| Assay | Content not less than 98 % and not more than 102 % of C4H6O4 Zn · 2H2O |
| Description | Colourless crystals or fine, off-white powder |
| Identification | |
| A. | Positive tests for acetate and for zinc |

Synonyms

Acetic acid, zinc salt, dihydrate

Definition

Chemical name

Zinc acetate dihydrate

Chemical formula

C4H6O4 Zn· 2H2O

Molecular weight

219,51

Assay

Content not less than 98 % and not more than 102 % of C4H6O4 Zn · 2H2O

Description

Colourless crystals or fine, off-white powder

Identification

A.

Positive tests for acetate and for zinc

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 6,0 and 8,0

Purity

Insoluble matter

Not more than 0,005  %

Chlorides

Not more than 50 mg/kg

Sulphates

Not more than 100 mg/kg

Alkalines and alkaline earths

Not more than 0,2  %

Organic volatile impurities

Passes test

Iron

Not more than 50 mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 20 mg/kg

Cadmium

Not more than 5 mg/kg

E 900 DIMETHYL POLYSILOXANE

| Synonyms | Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone |
| --- | --- |
| Definition | Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2 SiO and stablised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO |
| Chemical name | Siloxanes and silicones, di-methyl |
| Chemical formula | (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3 |
| Assay | Content of total silicon not less than 37,3  % and not more than 38,5  % |
| Description | Clear, colourless, viscous liquid |
| Identification | |
| A. | Specific gravity (25o/25 oC) |

Synonyms

Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone

Definition

Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2 SiO and stablised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO

Chemical name

Siloxanes and silicones, di-methyl

Chemical formula

(CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3

Assay

Content of total silicon not less than 37,3  % and not more than 38,5  %

Description

Clear, colourless, viscous liquid

Identification

A.

Specific gravity (25o/25 oC)

Between 0,964 and 0,977

| B. | Refractive index [n]D
  25 |
| --- | --- |

B.

Refractive index [n]D
  25

Between 1,400 and 1,405

| C. | Infrared spectrum characteristic of the compound |
| --- | --- |

C.

Infrared spectrum characteristic of the compound

Purity

Loss on drying

Not more than 0,5  % (150 oC, 4h)

Viscosity

Not less than 1,00 · 10-4 m2s-1 at 25 oC

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 901 BEESWAX

| Synonyms | White wax, yellow wax |
| --- | --- |
| Definition | Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter |
| White beeswax is obtained by bleaching yellow beeswax |
| Einecs | 232-383-7 (beeswax) |
| Description | Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour |
| Identification | |
| A. | Melting range |

Synonyms

White wax, yellow wax

Definition

Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter

White beeswax is obtained by bleaching yellow beeswax

Einecs

232-383-7 (beeswax)

Description

Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour

Identification

A.

Melting range

Between 62 oC and 65 oC

| B. | Specific gravity |
| --- | --- |

B.

Specific gravity

About 0,96

| C. | Solubility |
| --- | --- |

C.

Solubility

Insoluble in water

Sparingly soluble in alcohol

Very soluble in chloroform and ether

Purity

Acid value

Not less than 17 and not more than 24

Saponification value

87-104

Peroxide value

Not more than 5

Glycerol and other polyols

Not more than 0,5  % (as glycerol)

Ceresin, paraffins and certain other waxes

Absent

Fats, Japan wax, rosin and soaps

Absent

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 902 CANDELILLA WAX

| Definition | Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica |
| --- | --- |
| Einecs | 232-347-0 |
| Description | Hard, yellowish brown, opaque to translucent wax |
| Identification | |
| A. | Specific gravity |

Definition

Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica

Einecs

232-347-0

Description

Hard, yellowish brown, opaque to translucent wax

Identification

A.

Specific gravity

About 0,983

| B. | Melting range |
| --- | --- |

B.

Melting range

Between 68,5  oC and 72,5  oC

| C. | Solubility |
| --- | --- |

C.

Solubility

Insoluble in water

Soluble in chloroform and toluene

Purity

Acid value

Not less than 12 and not more than 22

Saponification value

Not less than 43 and not more than 65

Glycerol and other polyols

Not more than 0,5  % (as glycerol)

Ceresin, paraffins and certain other waxes

Absent

Fats, Japan wax, rosin and soaps

Absent

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 903 CARNAUBA WAX

| Definition | Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia cerifera |
| --- | --- |
| Einecs | 232-399-4 |
| Description | Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture |
| Identification | |
| A. | Specific gravity |

Definition

Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia cerifera

Einecs

232-399-4

Description

Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture

Identification

A.

Specific gravity

About 0,997

| B. | Melting range |
| --- | --- |

B.

Melting range

Between 82 oC and 86 oC

| C. | Solubility |
| --- | --- |

C.

Solubility

Insoluble in water

Partly soluble in boiling ethanol

Soluble in chloroform and diethyl ether

Purity

Sulphated ash

Not more than 0,25  %

Acid value

Not less than 2 and not more than 7

Ester value

Not less than 71 and not more than 88

Unsaponifiable matter

Not less than 50 % and not more than 55 %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 904 SHELLAC

| Synonyms | Bleached shellac, white shellac |
| --- | --- |
| Definition | Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae) |
| Einecs | 232-549-9 |
| Description | Bleached shellac — off-white, amorphous, granular resin |
| Wax-free bleached shellac — light yellow, amorphous, granular resin |
| Identification | |
| A. | Solubility |

Synonyms

Bleached shellac, white shellac

Definition

Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)

Einecs

232-549-9

Description

Bleached shellac — off-white, amorphous, granular resin

Wax-free bleached shellac — light yellow, amorphous, granular resin

Identification

A.

Solubility

Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone

| B. | Acid value |
| --- | --- |

B.

Acid value

Between 60 and 89

Purity

Loss on drying

Not more than 6,0  % (40 oC, over silica gel, 15h)

Rosin

Absent

Wax

Bleached shellac: not more than 5,5  %

Wax-free bleached shellac: not more than 0,2  %

Lead

Not more than 2 mg/kg

E 905 MICROCRYSTALLINE WAX

| Synonyms | Petroleum wax |
| --- | --- |
| Definition | Microcrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleum |
| Description | White to amber, odourless wax |
| Identification | |
| A. | Solubility |

Synonyms

Petroleum wax

Definition

Microcrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleum

Description

White to amber, odourless wax

Identification

A.

Solubility

Insoluble in water, very slightly soluble in ethanol

| B. | Refractive Index |
| --- | --- |

B.

Refractive Index

n D
  1001,434 -1,448

Purity

Molecular weight

Average not less than 500

Viscosity at 100 oC

Not less than 1,1 · 10-5 m2s-1

Residue on ignition

Not more than 0,1  %

Carbon number at 5 % distillation point

Not more than 5 % of molecules with carbon number less than 25

Colour

Passes test

Sulphur

Not more than 0,4  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 3 mg/kg

Polycyclic aromatic compounds

The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:

nm

Maximum absorbance per cm path length

280-289

0,15

290-299

0,12

300-359

0,08

360-400

0,02

E 907 HYDROGENATED POLY-1-DECENE

| Synonyms | Hydrogenated polydec-1-ene |
| --- | --- |
| Hydrogenated poly-alpha-olefin |
| Definition | |
| Chemical formula | C10nH20n+2 where n = 3-6 |
| Molecular weight | 560 (average) |
| Assay | Not less than 98,5  % of hydrogenated poly-1-decene, having the following oligomer distribution: |
| C30: 13-37 % |
| C40: 35-70 % |
| C50: 9-25 % |
| C60: 1-7 % |
| Description | |
| Identification | |
| A. | Solubility |

Synonyms

Hydrogenated polydec-1-ene

Hydrogenated poly-alpha-olefin

Definition

Chemical formula

C10nH20n+2 where n = 3-6

Molecular weight

560 (average)

Assay

Not less than 98,5  % of hydrogenated poly-1-decene, having the following oligomer distribution:

C30: 13-37 %

C40: 35-70 %

C50: 9-25 %

C60: 1-7 %

Description

Identification

A.

Solubility

Insoluble in water; slightly soluble in ethanol; soluble in toluene

| B. | Burning |
| --- | --- |

B.

Burning

Burns with a bright flame and a paraffin-like characteristic smell

Purity

Viscosity

Between 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 oC

Compounds with carbon number less than 30

Not more than 1,5  %

Readily carbonisable substances

After 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour

Nickel

Not more than 1 mg/kg

Lead

Not more than 1 mg/kg

E 912 MONTAN ACID ESTERS

| Definition | Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol |
| --- | --- |
| Chemical name | Montan acid esters |
| Description | Almost white to yellowish flakes, powder, granules or pellets |
| Identification | |
| A. | Density (20 oC) |

Definition

Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol

Chemical name

Montan acid esters

Description

Almost white to yellowish flakes, powder, granules or pellets

Identification

A.

Density (20 oC)

Between 0,98 and 1,05

| B. | Drop point |
| --- | --- |

B.

Drop point

Greater than 77 oC

Purity

Acid value

Not more than 40

Glycerol

Not more than 1 % (by gas chromatography)

Other polyols

Not more than 1 % (by gas chromatography)

Other wax types

Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)

Arsenic

Not more than 2 mg/kg

Chromium

Not more than 3 mg/kg

Lead

Not more than 2 mg/kg

E 914 OXIDISED POLYETHYLENE WAX

| Definition | Polar reaction products from mild oxidation of polyethylene |
| --- | --- |
| Chemical name | Oxidised polyethylene |
| Description | Almost white flakes, powder, granules or pellets |
| Identification | |
| A. | Density (20 oC) |

Definition

Polar reaction products from mild oxidation of polyethylene

Chemical name

Oxidised polyethylene

Description

Almost white flakes, powder, granules or pellets

Identification

A.

Density (20 oC)

Between 0,92 and 1,05

| B. | Drop point |
| --- | --- |

B.

Drop point

Greater than 95 oC

Purity

Acid value

Not more than 70

Viscosity at 120 oC

Not less than 8,1 · 10-5 m2s-1

Other wax types

Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)

Oxygen

Not more than 9,5  %

Chromium

Not more than 5 mg/kg

Lead

Not more than 2 mg/kg

E 920 L-CYSTEINE

| Definition | L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance |
| --- | --- |
| Einecs | 200-157-7 (anhydrous) |
| Chemical formula | C3H7NO2S· HCl· n H20 (where n = 0 or 1) |
| Molecular weight | 157,62 (anhydrous) |
| Assay | Content not less than 98,0  % and not more than 101,5  % on the anhydrous basis |
| Description | White powder or colourless crystals |
| Identification | |
| A. | Solubility |

Definition

L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance

Einecs

200-157-7 (anhydrous)

Chemical formula

C3H7NO2S· HCl· n H20 (where n = 0 or 1)

Molecular weight

157,62 (anhydrous)

Assay

Content not less than 98,0  % and not more than 101,5  % on the anhydrous basis

Description

White powder or colourless crystals

Identification

A.

Solubility

Freely soluble in water and in ethanol

| B. | Melting range |
| --- | --- |

B.

Melting range

Anhydrous form melts at about 175 oC

| C. | Specific rotation |
| --- | --- |

C.

Specific rotation

[α]20
  D: between +5,0 o and +8,0 o or

[α]25
  D: between +4,9 o and 7,9 o

Purity

Loss on drying

Between 8,0  % and 12,0  %

Not more than 2,0  % (anhydrous form)

Residue on ignition

Not more than 0,1  %

Ammonium-ion

Not more than 200 mg/kg

Arsenic

Not more than 1,5  mg/kg

Lead

Not more than 5 mg/kg

E 927b CARBAMIDE

| Synonyms | Urea |
| --- | --- |
| Definition | |
| Einecs | 200-315-5 |
| Chemical formula | CH4N2O |
| Molecular weight | 60,06 |
| Assay | Content not less than 99,0  % on the anhydrous basis |
| Description | Colourless to white, prismatic, crystalline powder or small, white pellets |
| Identification | |
| A. | Solubility |

Synonyms

Urea

Definition

Einecs

200-315-5

Chemical formula

CH4N2O

Molecular weight

60,06

Assay

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

Description

Colourless to white, prismatic, crystalline powder or small, white pellets

Identification

A.

Solubility

Very soluble in water

Soluble in ethanol

| B. | Precipitation with nitric acid |
| --- | --- |

B.

Precipitation with nitric acid

To pass the test a white, crystalline precipitate is formed

| C. | Colour reaction |
| --- | --- |

C.

Colour reaction

To pass the test a reddish-violet colour is produced

| D. | Melting range |
| --- | --- |

D.

Melting range

132 oC to 135 oC

Purity

Loss on drying

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

Sulphated ash

Not more than 0,1  %

Ethanol-insoluble matter

Not more than 0,04  %

Alkalinity

Passes test

Ammonium-ion

Not more than 500 mg/kg

Biuret

Not more than 0,1  %

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

E 938 ARGON

| Definition | |
| --- | --- |
| Chemical name | Argon |
| Einecs | 231-147-0 |
| Chemical formula | Ar |
| Molecular weight | 40 |
| Assay | Not less than 99 % |
| Description | Colourless, odourless, non-flammable gas |
| Purity | |
| Water | Not more than 0,05  % |
| Methane and other hydrocarbons calculated as methane | Not more than 100 μl/l |

Definition

Chemical name

Argon

Einecs

231-147-0

Chemical formula

Ar

Molecular weight

40

Assay

Not less than 99 %

Description

Colourless, odourless, non-flammable gas

Purity

Water

Not more than 0,05  %

Methane and other hydrocarbons calculated as methane

Not more than 100 μl/l

E 939 HELIUM

| Definition | |
| --- | --- |
| Chemical name | Helium |
| Einecs | 231-168-5 |
| Chemical formula | He |
| Molecular weight | 4 |
| Assay | Not less than 99 % |
| Description | Colourless, odourless, non-flammable gas |
| Purity | |
| Water | Not more than 0,05  % |
| Methane and other hydrocarbons calculated as methane | Not more than 100 μl/l |

Definition

Chemical name

Helium

Einecs

231-168-5

Chemical formula

He

Molecular weight

4

Assay

Not less than 99 %

Description

Colourless, odourless, non-flammable gas

Purity

Water

Not more than 0,05  %

Methane and other hydrocarbons calculated as methane

Not more than 100 μl/l

E 941 NITROGEN

| Definition | |
| --- | --- |
| Chemical name | Nitrogen |
| Einecs | 231-783-9 |
| Chemical formula | N2 |
| Molecular weight | 28 |
| Assay | Not less than 99 % |
| Description | Colourless, odourless, non-flammable gas |
| Purity | |
| Water | Not more than 0,05  % |
| Carbon monoxide | Not more than 10 μl/l |
| Methane and other hydrocarbons calculated as methane | Not more than 100 μl/l |
| Nitrogen dioxide and nitrogen oxide | Not more than 10 μl/l |
| Oxygen | Not more than 1 % |

Definition

Chemical name

Nitrogen

Einecs

231-783-9

Chemical formula

N2

Molecular weight

28

Assay

Not less than 99 %

Description

Colourless, odourless, non-flammable gas

Purity

Water

Not more than 0,05  %

Carbon monoxide

Not more than 10 μl/l

Methane and other hydrocarbons calculated as methane

Not more than 100 μl/l

Nitrogen dioxide and nitrogen oxide

Not more than 10 μl/l

Oxygen

Not more than 1 %

E 942 NITROUS OXIDE

| Definition | |
| --- | --- |
| Chemical name | Nitrous oxide |
| Einecs | 233-032-0 |
| Chemical formula | N2O |
| Molecular weight | 44 |
| Assay | Not less than 99 % |
| Description | Colourless, non-flammable gas, sweetish odour |
| Purity | |
| Water | Not more than 0,05  % |
| Carbon monoxide | Not more than 30 μl/l |
| Nitrogen dioxide and nitrogen oxide | Not more than 10 μl/l |

Definition

Chemical name

Nitrous oxide

Einecs

233-032-0

Chemical formula

N2O

Molecular weight

44

Assay

Not less than 99 %

Description

Colourless, non-flammable gas, sweetish odour

Purity

Water

Not more than 0,05  %

Carbon monoxide

Not more than 30 μl/l

Nitrogen dioxide and nitrogen oxide

Not more than 10 μl/l

E 943a BUTANE

| Synonyms | n-Butane |
| --- | --- |
| Definition | |
| Chemical name | Butane |
| Chemical formula | CH3CH2CH2CH3 |
| Molecular weight | 58,12 |
| Assay | Content not less than 96 % |
| Description | Colourless gas or liquid with mild, characteristic odour |
| Identification | |
| A. | Vapour pressure |

Synonyms

n-Butane

Definition

Chemical name

Butane

Chemical formula

CH3CH2CH2CH3

Molecular weight

58,12

Assay

Content not less than 96 %

Description

Colourless gas or liquid with mild, characteristic odour

Identification

A.

Vapour pressure

108,935 kPa at 20 oC

Purity

Methane

Not more than 0,15  % v/v

Ethane

Not more than 0,5  % v/v

Propane

Not more than 1,5  % v/v

Isobutane

Not more than 3,0  % v/v

1,3-butadiene

Not more than 0,1  % v/v

Moisture

Not more than 0,005  %

E 943b ISOBUTANE

| Synonyms | 2-methyl propane |
| --- | --- |
| Definition | |
| Chemical name | 2-methyl propane |
| Chemical formula | (CH3)2CH CH3 |
| Molecular weight | 58,12 |
| Assay | Content not less than 94 % |
| Description | Colourless gas or liquid with mild, characteristic odour |
| Identification | |
| A. | Vapour pressure |

Synonyms

2-methyl propane

Definition

Chemical name

2-methyl propane

Chemical formula

(CH3)2CH CH3

Molecular weight

58,12

Assay

Content not less than 94 %

Description

Colourless gas or liquid with mild, characteristic odour

Identification

A.

Vapour pressure

205,465 kPa at 20 oC

Purity

Methane

Not more than 0,15  % v/v

Ethane

Not more than 0,5  % v/v

Propane

Not more than 2,0  % v/v

n-Butane

Not more than 4,0  % v/v

1,3 -butadiene

Not more than 0,1  % v/v

Moisture

Not more than 0,005  %

E 944 PROPANE

| Definition | |
| --- | --- |
| Chemical name | Propane |
| Chemical formula | CH3CH2CH3 |
| Molecular weight | 44,09 |
| Assay | Content not less than 95 % |
| Description | Colourless gas or liquid with mild, characteristic odour |
| Identification | |
| A. | Vapour pressure |

Definition

Chemical name

Propane

Chemical formula

CH3CH2CH3

Molecular weight

44,09

Assay

Content not less than 95 %

Description

Colourless gas or liquid with mild, characteristic odour

Identification

A.

Vapour pressure

732,910 kPa at 20 oC

Purity

Methane

Not more than 0,15  % v/v

Ethane

Not more than 1,5  % v/v

Isobutane

Not more than 2,0  % v/v

n-Butane

Not more than 1,0  % v/v

1,3-butadiene

Not more than 0,1  % v/v

Moisture

Not more than 0,005  %

E 948 OXYGEN

| Definition | |
| --- | --- |
| Chemical name | Oxygen |
| Einecs | 231-956-9 |
| Chemical formula | O2 |
| Molecular weight | 32 |
| Assay | Not less than 99 % |
| Description | Colourless, odourless, non-flammable gas |
| Purity | |
| Water | Not more than 0,05  % |
| Methane and other hydrocarbons calculated as methane | Not more than 100 μl/l |

Definition

Chemical name

Oxygen

Einecs

231-956-9

Chemical formula

O2

Molecular weight

32

Assay

Not less than 99 %

Description

Colourless, odourless, non-flammable gas

Purity

Water

Not more than 0,05  %

Methane and other hydrocarbons calculated as methane

Not more than 100 μl/l

E 949 HYDROGEN

| Definition | |
| --- | --- |
| Chemical name | Hydrogen |
| Einecs | 215-605-7 |
| Chemical formula | H2 |
| Molecular weight | 2 |
| Assay | Content not less than 99,9  % |
| Description | Colourless, odourless, highly flammable gas |
| Purity | |
| Water | Not more than 0,005  % v/v |
| Oxygen | Not more than 0,001  % v/v |
| Nitrogen | Not more than 0,75  % v/v |

Definition

Chemical name

Hydrogen

Einecs

215-605-7

Chemical formula

H2

Molecular weight

2

Assay

Content not less than 99,9  %

Description

Colourless, odourless, highly flammable gas

Purity

Water

Not more than 0,005  % v/v

Oxygen

Not more than 0,001  % v/v

Nitrogen

Not more than 0,75  % v/v

E 950 ACESULFAME K

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

E 951 ASPARTAME

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

E 953 ISOMALT

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

E 957 THAUMATIN

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

E 959 NEOHESPERIDINE DIHYDROCHALCONE

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

E 965(i) MALTITOL

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

E 965(ii) MALTITOL SYRUP

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

E 966 LACTITOL

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

E 967 XYLITOL

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

E 999 QUILLAIA EXTRACT

| Synonyms | Soapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark extract, China bark extract |
| --- | --- |
| Definition | Quillaia extract is obtained by aqueous extraction of Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components |
| Description | Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution |
| Identification | |
| A. | pH of a 2,5  % solution |

Synonyms

Soapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark extract, China bark extract

Definition

Quillaia extract is obtained by aqueous extraction of Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components

Description

Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution

Identification

A.

pH of a 2,5  % solution

Between 4,5 and 5,5

Purity

Water

Not more than 6,0  % (Karl Fischer method) (powder form only)

Arsenic

Not more than 2 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

E 1103 INVERTASE

| Definition | Invertase is produced from Saccharomyces cerevisiae |
| --- | --- |
| Systematic name | β-D-Fructofuranoside fructohydrolase |
| Enzyme Commission No | EC 3.2.1.26 |
| Einecs | 232-615-7 |
| Purity | |
| Arsenic | Not more than 3 mg/kg |
| Lead | Not more than 5 mg/kg |
| Cadmium | Not more than 0,5  mg/kg |
| Total bacterial count | Not more than 50 000 /g |
| Salmonella spp. | Absent by test in 25 g |
| Coliforms | Not more than 30/g |
| E. coli | Absent by test in 25 g |

Definition

Invertase is produced from Saccharomyces cerevisiae

Systematic name

β-D-Fructofuranoside fructohydrolase

Enzyme Commission No

EC 3.2.1.26

Einecs

232-615-7

Purity

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

Cadmium

Not more than 0,5  mg/kg

Total bacterial count

Not more than 50 000 /g

Salmonella spp.

Absent by test in 25 g

Coliforms

Not more than 30/g

E. coli

Absent by test in 25 g

E 1105 LYSOZYME

| Synonyms | Lysozyme hydrochloride |
| --- | --- |
| Muramidase |
| Definition | Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride |
| Chemical name | Enzyme Commission (EC) No: 3.2.1.17 |
| Einecs | 232-620-4 |
| Molecular weight | About 14 000 |
| Assay | Content not less than 950 mg/g on the anhydrous basis |
| Description | White, odourless powder having a slightly sweet taste |
| Identification | |
| A. | Isoelectric point 10,7 |

Synonyms

Lysozyme hydrochloride

Muramidase

Definition

Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride

Chemical name

Enzyme Commission (EC) No: 3.2.1.17

Einecs

232-620-4

Molecular weight

About 14 000

Assay

Content not less than 950 mg/g on the anhydrous basis

Description

White, odourless powder having a slightly sweet taste

Identification

A.

Isoelectric point 10,7

| B. | pH of a 2 % aqueous solution between 3,0 and 3,6 |
| --- | --- |

B.

pH of a 2 % aqueous solution between 3,0 and 3,6

| C. | Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm |
| --- | --- |

C.

Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm

Purity

Water content

Not more than 6,0  % (Karl Fischer method) (powder form only)

Residue on ignition

Not more than 1,5  %

Nitrogen

Not less than 16,8  % and not more than 17,8  %

Arsenic

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

Mercury

Not more than 1 mg/kg

Heavy metals (as Pb)

Not more than 10 mg/kg

Microbiological criteria

Total bacterial count

Not more than 5 × 104 col/g

Salmonellae

Absent in 25 g

Staphylococcus aureus

Absent in 1 g

Escherichia coli

Absent in 1 g

E 1200 POLYDEXTROSE

| Synonyms | Modified polydextroses |
| --- | --- |
| Definition | Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose |
| Assay | Content not less than 90 % of polymer on the ash free and anhydrous basis |
| Description | White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution |
| Identification | |
| A. | Positive tests for sugar and for reducing sugar |

Synonyms

Modified polydextroses

Definition

Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose

Assay

Content not less than 90 % of polymer on the ash free and anhydrous basis

Description

White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution

Identification

A.

Positive tests for sugar and for reducing sugar

| B. | pH of a 10 % solution |
| --- | --- |

B.

pH of a 10 % solution

Between 2,5 and 7,0 for polydextrose

Between 5,0 and 6,0 for polydextrose-N

Purity

Water

Not more than 4,0  % (Karl Fischer method)

Sulphated ash

Not more than 0,3  % (polydextrose)

Not more than 2,0  % (polydextrose N)

Nickel

Not more than 2 mg/kg for hydrogenated polydextroses

1,6-Anhydro-D-glucose

Not more than 4,0  % on the ash-free and the dried basis

Glucose and sorbitol

Not more than 6,0  % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately

Molecular weight limit

Negative test for polymers of molecular weight greater than 22 000

5-Hydroxy-methylfurfural

Not more than 0,1  % (polydextrose)

Not more than 0,05  % (polydextrose-N)

Lead

Not more than 0,5  mg/kg

E 1201 POLYVINYLPYRROLIDONE

| Synonyms | Povidone |
| --- | --- |
| PVP |
| Soluble polyvinylpyrrolidone |
| Definition | |
| Chemical name | Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene] |
| Chemical formula | (C6H9NO)n |
| Molecular weight | Not less than 25 000 |
| Assay | Content not less than 11,5  % and not more than 12,8  % of nitrogen (N) on the anhydrous basis |
| Description | White or nearly white powder |
| Identification | |
| A. | Solubility |

Synonyms

Povidone

PVP

Soluble polyvinylpyrrolidone

Definition

Chemical name

Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

Chemical formula

(C6H9NO)n

Molecular weight

Not less than 25 000

Assay

Content not less than 11,5  % and not more than 12,8  % of nitrogen (N) on the anhydrous basis

Description

White or nearly white powder

Identification

A.

Solubility

Soluble in water and in ethanol. Insoluble in ether

| B. | pH of a 5 % solution |
| --- | --- |

B.

pH of a 5 % solution

Between 3,0 and 7,0

Purity

Water

Not more than 5 % (Karl Fischer)

Total ash

Not more than 0,1  %

Aldehyde

Not more than 500 mg/kg (as acetaldehyde)

Free-N-vinylpyrrolidone

Not more than 10 mg/kg

Hydrazine

Not more than 1 mg/kg

Lead

Not more than 5 mg/kg

E 1202 POLYVINYLPOLYPYRROLIDONE

| Synonyms | Crospovidone |
| --- | --- |
| Cross linked polyvidone |
| Insoluble polyvinylpyrrolidone |
| Definition | Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination |
| Chemical name | Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene] |
| Chemical formula | (C6H9NO)n |
| Assay | Content not less than 11 % and not more than 12,8  % nitrogen (N) on the anhydrous basis |
| Description | A white hygroscopic powder with a faint, non-objectionable odour |
| Identification | |
| A. | Solubility |

Synonyms

Crospovidone

Cross linked polyvidone

Insoluble polyvinylpyrrolidone

Definition

Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination

Chemical name

Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

Chemical formula

(C6H9NO)n

Assay

Content not less than 11 % and not more than 12,8  % nitrogen (N) on the anhydrous basis

Description

A white hygroscopic powder with a faint, non-objectionable odour

Identification

A.

Solubility

Insoluble in water, ethanol and ether

| B. | pH of a 1 % suspension in water |
| --- | --- |

B.

pH of a 1 % suspension in water

Between 5,0 and 8,0

Purity

Water

Not more than 6 % (Karl Fischer)

Sulphated ash

Not more than 0,4  %

Water-soluble matter

Not more than 1 %

Free-N-vinylpyrrolidone

Not more than 10 mg/kg

Free-N, N'-divinyl-imidazolidone

Not more than 2 mg/kg

Lead

Not more than 5 mg/kg

E 1204 PULLULAN

| Definition | Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography |
| --- | --- |
| Einecs | 232-945-1 |
| Chemical formula | (C6H10O5)x |
| Assay | Not less than 90 % of glucan on the dried basis |
| Description | White to off-white odourless powder |
| Identification | |
| A. | Solubility |

Definition

Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography

Einecs

232-945-1

Chemical formula

(C6H10O5)x

Assay

Not less than 90 % of glucan on the dried basis

Description

White to off-white odourless powder

Identification

A.

Solubility

Soluble in water, practically insoluble in ethanol

| B. | pH of 10 % solution |
| --- | --- |

B.

pH of 10 % solution

5,0 to 7,0

| C. | Precipitation with polyethylene glycol 600 |
| --- | --- |

C.

Precipitation with polyethylene glycol 600

Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed

| D. | Depoly-merisation with pullulanase |
| --- | --- |

D.

Depoly-merisation with pullulanase

Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1  ml pullulanase solution having activity 10 units/g to one test tube, and 0,1  ml water to the other. After incubation at about 25 oC for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution

Purity

Loss on drying

Not more than 6 % (90 oC, pressure not more than 50 mm Hg, 6 h)

Mono-, di- and oligosaccharides

Not more than 10 % expressed as glucose

Viscosity

100 to 180 mm2/s (10 % w/w aqueous solution at 30 oC)

Lead

Not more than 1 mg/kg

Yeast and moulds

Not more than 100 colonies per gram

Coliforms

Absent in 25 g

Salmonella

Absent in 25 g

E 1404 OXIDISED STARCH

| Definition | Oxidised starch is starch treated with sodium hypochlorite |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Oxidised starch is starch treated with sodium hypochlorite

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Carboxyl groups

Not more than 1,1  %

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1410 MONOSTARCH PHOSPHATE

| Definition | Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Residual phosphate

Not more than 0,5  % (as P) for wheat or potato starch

Not more than 0,4  % (as P) for other starches

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1412 DISTARCH PHOSPHATE

| Definition | Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Residual phosphate

Not more than 0,5  % (as P) for wheat or potato starch

Not more than 0,4  % (as P) for other starches

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1413 PHOSPHATED DISTARCH PHOSPHATE

| Definition | Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Residual phosphate

Not more than 0,5  % (as P) for wheat or potato starch

Not more than 0,4  % (as P) for other starches

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1414 ACETYLATED DISTARCH PHOSPHATE

| Definition | Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Acetyl groups

Not more than 2,5  %

Residual phosphate

Not more than 0,14  % (as P) for wheat or potato starch

Not more than 0,04  % (as P) for other starches

Vinyl acetate

Not more than 0,1  mg/kg

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1420 ACETYLATED STARCH

| Synonyms | Starch acetate |
| --- | --- |
| Definition | Acetylated starch is starch esterified with acetic anhydride or vinyl acetate |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Synonyms

Starch acetate

Definition

Acetylated starch is starch esterified with acetic anhydride or vinyl acetate

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Acetyl groups

Not more than 2,5  %

Vinyl acetate

Not more than 0,1  mg/kg

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1422 ACETYLATED DISTARCH ADIPATE

| Definition | Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Acetyl groups

Not more than 2,5  %

Adipate groups

Not more than 0,135  %

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1440 HYDROXYPROPYL STARCH

| Definition | Hydroxypropyl starch is starch etherified with propylene oxide |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Hydroxypropyl starch is starch etherified with propylene oxide

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Hydroxypropyl groups

Not more than 7,0  %

Propylene chlorohydrin

Not more than 1 mg/kg

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE

| Definition | Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Hydroxypropyl groups

Not more than 7,0  %

Residual phosphate

Not more than 0,14  % (as P) for wheat or potato starch

Not more than 0,04 (as P) for other starches

Propylene chlorohydrin

Not more than 1 mg/kg

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1450 STARCH SODIUM OCTENYL SUCCINATE

| Synonyms | SSOS |
| --- | --- |
| Definition | Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Synonyms

SSOS

Definition

Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Octenylsuccinyl groups

Not more than 3 %

Octenylsuccinic acid residue

Not more than 0,3  %

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1451 ACETYLATED OXIDISED STARCH

| Definition | Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride |
| --- | --- |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Definition

Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 15,0  % for cereal starch

Not more than 21,0  % for potato starch

Not more than 18,0  % for other starches

Carboxyl groups

Not more than 1,3  %

Acetyl groups

Not more than 2,5  %

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE

| Synonyms | SAOS |
| --- | --- |
| Definition | Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate |
| Description | White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles |
| Identification | |
| A. | If not pregelatinised: by microscopic observation |

Synonyms

SAOS

Definition

Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate

Description

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles

Identification

A.

If not pregelatinised: by microscopic observation

| B. | Iodine staining positive (dark blue to light red colour) |
| --- | --- |

B.

Iodine staining positive (dark blue to light red colour)

Purity (all values expressed on an anhydrous basis except for loss on drying)

Loss on drying

Not more than 21,0  %

Octenylsuccinyl groups

Not more than 3 %

Octenylsuccinic acid residue

Not more than 0,3  %

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for the other modified starches, unless otherwise specified

Arsenic

Not more than 1 mg/kg

Lead

Not more than 2 mg/kg

Mercury

Not more than 0,1  mg/kg

Aluminium

Not more than 0,3  %

E 1505 TRIETHYL CITRATE

| Synonyms | Ethyl citrate |
| --- | --- |
| Definition | |
| Chemical name | Triethyl-2-hydroxypropan-1,2,3-tricarboxylate |
| Einecs | 201-070-7 |
| Chemical formula | C12H20O7 |
| Molecular weight | 276,29 |
| Assay | Content not less than 99,0  % |
| Description | Odourless, practically colourless, oily liquid |
| Identification | |
| A. | Specific gravity |

Synonyms

Ethyl citrate

Definition

Chemical name

Triethyl-2-hydroxypropan-1,2,3-tricarboxylate

Einecs

201-070-7

Chemical formula

C12H20O7

Molecular weight

276,29

Assay

Content not less than 99,0  %

Description

Odourless, practically colourless, oily liquid

Identification

A.

Specific gravity

d25
  25: 1,135 -1,139

| B. | Refractive index |
| --- | --- |

B.

Refractive index

[n]D
  20: 1,439 -1,441

Purity

Water

Not more than 0,25  % (Karl Fischer method)

Acidity

Not more than 0,02  % (as citric acid)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

E 1517 GLYCERYL DIACETATE

| Synonyms | Diacetin |
| --- | --- |
| Definition | Glyceryl diacetate consist predominantly of a mixture of the 1,2 - and 1,3 -diacetates of glycerol, with minor amounts of the mono- and tri-esters |
| Chemical names | Glyceryl diacetate |
| 1, 2, 3-propanetriol diacetate |
| Chemical formula | C7H12O5 |
| Molecular weight | 176,17 |
| Assay | Not less than 94,0  % |
| Description | Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour |
| Identification | |
| A. | Solubility |

Synonyms

Diacetin

Definition

Glyceryl diacetate consist predominantly of a mixture of the 1,2 - and 1,3 -diacetates of glycerol, with minor amounts of the mono- and tri-esters

Chemical names

Glyceryl diacetate

1, 2, 3-propanetriol diacetate

Chemical formula

C7H12O5

Molecular weight

176,17

Assay

Not less than 94,0  %

Description

Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour

Identification

A.

Solubility

Soluble in water. Miscible with ethanol

| B. | Positive tests for glycerol and acetate |
| --- | --- |

B.

Positive tests for glycerol and acetate

| C. | Specific gravity |
| --- | --- |

C.

Specific gravity

d20
  20: 1,175 -1,195

| D. | Boiling range |
| --- | --- |

D.

Boiling range

Between 259 and 261 oC

Purity

Total ash

Not more than 0,02  %

Acidity

Not more than 0,4  % (as ascetic acid)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

E 1518 GLYCERYL TRIACETATE

| Synonyms | Triacetin |
| --- | --- |
| Definition | |
| Chemical name | Glyceryl triacetate |
| Einecs | 203-051-9 |
| Chemical formula | C9H14O6 |
| Molecular weight | 218,21 |
| Assay | Content not less than 98,0  % |
| Description | Colourless, somewhat oily liquid having a slightly fatty odour |
| Identification | |
| A. | Positive tests for acetate and for glycerol |

Synonyms

Triacetin

Definition

Chemical name

Glyceryl triacetate

Einecs

203-051-9

Chemical formula

C9H14O6

Molecular weight

218,21

Assay

Content not less than 98,0  %

Description

Colourless, somewhat oily liquid having a slightly fatty odour

Identification

A.

Positive tests for acetate and for glycerol

| B. | Refractive index |
| --- | --- |

B.

Refractive index

Between 1,429 and 1,431 at 25 oC

| C. | Specific gravity (25 oC/25 oC) |
| --- | --- |

C.

Specific gravity (25 oC/25 oC)

Between 1,154 and 1,158

| D. | Boiling range |
| --- | --- |

D.

Boiling range

Between 258 and 270 oC

Purity

Water

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

Sulphated ash

Not more than 0,02  % (as citric acid)

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

E 1519 BENZYL ALCOHOL

| Synonyms | Phenylcarbinol |
| --- | --- |
| Phenylmethyl alcohol |
| Benzenemethanol |
| Alpha-hydroxytoluene |
| Definition | |
| Chemical names | Benzyl alcohol |
| Phenylmethanol |
| Chemical formula | C7H8O |
| Molecular weight | 108,14 |
| Assay | Not less than 98,0  % |
| Description | Colourless, clear liquid with a faint, aromatic odour |
| Identification | |
| A. | Solubility |

Synonyms

Phenylcarbinol

Phenylmethyl alcohol

Benzenemethanol

Alpha-hydroxytoluene

Definition

Chemical names

Benzyl alcohol

Phenylmethanol

Chemical formula

C7H8O

Molecular weight

108,14

Assay

Not less than 98,0  %

Description

Colourless, clear liquid with a faint, aromatic odour

Identification

A.

Solubility

Soluble in water, ethanol and ether

| B. | Refractive index |
| --- | --- |

B.

Refractive index

[n]D
  20: 1,538 -1,541

| C. | Specific gravity |
| --- | --- |

C.

Specific gravity

d25
  25: 1,042 -1,047

| D. | Positive test for peroxides |
| --- | --- |

D.

Positive test for peroxides

Purity

Distillation range

Not less than 95 % v/v distils between 202 and 208 oC

Acid value

Not more than 0,5

Aldehydes

Not more than 0,2  % v/v (as bezaldehyde)

Lead

Not more than 5 mg/kg

E 1520 PROPANE-1,2-DIOL

| Synonyms | Propylene glycol |
| --- | --- |
| Definition | |
| Chemical names | 1,2-dihydroxypropane |
| Einecs | 200-338-0 |
| Chemical formula | C3H8O2 |
| Molecular weight | 76,10 |
| Assay | Content not less than 99,5  % on the anhydrous basis |
| Description | Clear, colourless, hygroscopic, viscous liquid |
| Identification | |
| A. | Solubility |

Synonyms

Propylene glycol

Definition

Chemical names

1,2-dihydroxypropane

Einecs

200-338-0

Chemical formula

C3H8O2

Molecular weight

76,10

Assay

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

Description

Clear, colourless, hygroscopic, viscous liquid

Identification

A.

Solubility

Soluble in water, ethanol and acetone

| B. | Specific gravity |
| --- | --- |

B.

Specific gravity

d20
  20: 1,035 -1,040

| C. | Refractive index |
| --- | --- |

C.

Refractive index

[n]20
  D: 1,431 -1,433

Purity

Distillation range

99 % v/v distils between 185 oC-189 oC

Sulphated ash

Not more than 0,07  %

Water

Not more than 1,0  % (Karl Fischer method)

Lead

Not more than 5 mg/kg

POLYETHYLENE GLYCOL 6000

| Synonyms | PEG 6000 |
| --- | --- |
| Macrogol 6000 |
| Definition | Polyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-CH)-OH corresponding to an average relative molecular mass of approximately 6 000 |
| Chemical formula | (C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000 , about 140) |
| Molecular weight | 5 600 -7 000 |
| Assay | Not less than 90,0  % and not more than 110,0  % |
| Description | A white or almost white solid with a waxy or paraffin-like appearance |
| Identification | |
| A. | Solubility |

Synonyms

PEG 6000

Macrogol 6000

Definition

Polyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-CH)-OH corresponding to an average relative molecular mass of approximately 6 000

Chemical formula

(C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000 , about 140)

Molecular weight

5 600 -7 000

Assay

Not less than 90,0  % and not more than 110,0  %

Description

A white or almost white solid with a waxy or paraffin-like appearance

Identification

A.

Solubility

Very soluble in water and in methylene chloride. Practically insoluble in alcohol, in ether and in fatty and mineral oils

| B. | Melting range |
| --- | --- |

B.

Melting range

Between 55 oC and 61 oC

Purity

Viscosity

Between 0,220 and 0,275 kgm-1s-1 at 20 oC

Hydroxyl value

Between 16 and 22

Sulphated ash

Not more than 0,2  %

Ethylene oxide

Not more than 0,2  mg/kg

Arsenic

Not more than 3 mg/kg

Lead

Not more than 5 mg/kg

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

(*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.

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

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

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

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ANNEX II

PART A

Repealed Directive with list of its successive amendments

(referred to in Article 2)

| Commission Directive 96/77/EC | Commission Directive 98/86/EC |
| --- | --- |

Commission Directive 96/77/EC

Commission Directive 98/86/EC

| | Commission Directive 2000/63/EC |
| --- | --- |

Commission Directive 2000/63/EC

| | Commission Directive 2001/30/EC |
| --- | --- |

Commission Directive 2001/30/EC

| | Commission Directive 2002/82/EC |
| --- | --- |

Commission Directive 2002/82/EC

| | Commission Directive 2003/95/EC |
| --- | --- |

Commission Directive 2003/95/EC

| | Commission Directive 2004/45/EC |
| --- | --- |

Commission Directive 2004/45/EC

| | Commission Directive 2006/129/EC |
| --- | --- |

Commission Directive 2006/129/EC

(OJ L 339, 30.12.1996, p. 1)

| | (OJ L 334, 9.12.1998, p. 1) |
| --- | --- |

(OJ L 334, 9.12.1998, p. 1)

| | (OJ L 277, 30.10.2000, p. 1) |
| --- | --- |

(OJ L 277, 30.10.2000, p. 1)

| | (OJ L 146, 31.5.2001, p. 1) |
| --- | --- |

(OJ L 146, 31.5.2001, p. 1)

| | (OJ L 292, 28.10.2002, p. 1) |
| --- | --- |

(OJ L 292, 28.10.2002, p. 1)

| | (OJ L 283, 31.10.2003, p. 71) |
| --- | --- |

(OJ L 283, 31.10.2003, p. 71)

| | (OJ L 113, 20.4.2004, p. 19) |
| --- | --- |

(OJ L 113, 20.4.2004, p. 19)

| | (OJ L 346, 9.12.2006, p. 15) |
| --- | --- |

(OJ L 346, 9.12.2006, p. 15)

PART B

List of time-limits for transposition into national law

(referred to in Article 2)

| Directive | Time-limit for transposition |
| --- | --- |
| 96/77/EC | 1 July 1997 (1) |
| 98/86/EC | 1 July 1999 (2) |
| 2000/63/EC | 31 March 2001 (3) |
| 2001/30/EC | 1 June 2002 (4) |
| 2002/82/EC | 31 August 2003 |
| 2003/95/EC | 1 November 2004 (5) |
| 2004/45/EC | 1 April 2005 (6) |
| 2006/129/EC | 15 February 2008 |

Directive

Time-limit for transposition

96/77/EC

1 July 1997 (1)

98/86/EC

1 July 1999 (2)

2000/63/EC

31 March 2001 (3)

2001/30/EC

1 June 2002 (4)

2002/82/EC

31 August 2003

2003/95/EC

1 November 2004 (5)

2004/45/EC

1 April 2005 (6)

2006/129/EC

15 February 2008

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(1)  According to Article 3(2) of Directive 96/77/EC, products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted.

(2)  According to Article 2(2) of Directive 98/86/EC, products put on the market or labelled before 1 July 1999 which do not comply with this Directive may be marketed until stocks are exhausted.

(3)  According to Article 2(3) of Directive 2000/63/EC, products put on the market or labelled before 31 March 2001 which do not comply with this Directive may be marketed until stocks are exhausted.

(4)  According to Article 2(3) of Directive 2001/30/EC, products put on the market or labelled before 1 June 2002 which do not comply with this Directive may be marketed until stocks are exhausted.

(5)  According to Article 3 of Directive 2003/95/EC, products put on the market or labelled before 1 November 2004 which do not comply with this Directive may be marketed until stocks are exhausted.

(6)  According to Article 3 of Directive 2004/45/EC, products put on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted.

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ANNEX III

Correlation table

| Directive 96/77/EC | This Directive |
| --- | --- |
| Article 1 | Article 1 |
| Article 2 | — |
| Article 3 | — |
| — | Article 2 |
| Article 4 | Article 3 |
| Article 5 | Article 4 |
| Annex | Annex I |
| — | Annex II |
| — | Annex III |

Directive 96/77/EC

This Directive

Article 1

Article 1

Article 2

—

Article 3

—

—

Article 2

Article 4

Article 3

Article 5

Article 4

Annex

Annex I

—

Annex II

—

Annex III

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20.9.2008

| 20.9.2008 | EN | Official Journal of the European Union | L 253/s3 |
| --- | --- | --- | --- |

EN

Official Journal of the European Union

L 253/s3

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NOTE TO THE READER

The institutions have decided no longer to quote in their texts the last amendment to cited acts.

Unless otherwise indicated, references to acts in the texts published here are to the version of those acts currently in force.

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