Commission Directive 2000/63/EC of 5 October 2000 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance.)
Date: 2000-10-05
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuffs legislation, human nutrition

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I

(Acts whose publication is obligatory)

COMMISSION DIRECTIVE 2000/63/EC

of 5 October 2000

amending Directive 96/77/EC laying down specific purity criteria on food additives other than
colours and sweeteners

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty establishing the European Com-
munity,

regard

Having
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), as amended
by Directive of the European Parliament and of the Council
94/34/EC (2) and in particular Article 3(3)(a) thereof,

After consulting the Scientific Committee for Food,

(3)

(4)

(5)

Whereas:

It is necessary, in the light of technical development, to
amend the purity criteria set out in Directive 96/77/EC
for butylated hydroxyanisole (BHA). It is consequently
necessary to adapt that Directive.

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).

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

(1)

(2)

It is necessary to establish purity criteria for all additives
other than colours and sweeteners mentioned in Direc-
tive 95/2/EC of the European Parliament and of the
Council of 20 February 1995 on food additives other
than colours and sweeteners (3), as last amended by
Directive 98/72/EC (4).

Commission Directive 96/77/EC of 2 December 1996
laying down specific purity criteria on food additives
other than colours and sweeteners (5), as amended by
Directive 98/86/EC (6) set out purity criteria for a
number of food additives. This Directive should now be
completed with purity criteria for the remaining food
additives mentioned in Directive 95/2/EC.

(1) OJ L 40, 11.2.1989, p. 27.
(2) OJ L 237, 10.9.1994, p. 1.
(3) OJ L 61, 18.3.1995, p. 1.
(4) OJ L 295, 4.11.1998, p. 18.
(5) OJ L 339, 30.12.1996, p. 1.
(6) OJ L 334, 9.12.1998, p. 1.

(6)

The measures provided for in this Directive are in
accordance with the opinion of the Standing Committee
on Foodstuffs,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 96/77/EC shall be amended as follows:

1.

2.

In the Annex, the text concerning E 320 — butylated
hydroxyanisole (BHA) shall be replaced by the text in
Annex I to this Directive.

In the Annex, the text of Annex II to this Directive shall
be added.

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Article 2

Article 3

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive before 31 March 2001. They shall
immediately
inform the Commission thereof.

2. When Member States adopt these provisions, these shall
contain a reference to this Directive or shall be accompanied
by such reference at the time of their official publication. The
procedure for such reference shall be adopted by Member
States.

3.
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.

This Directive shall enter into force on the twentieth day
following its publication in the Official Journal of the European
Communities.

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 5 October 2000.

For the Commission

David BYRNE

Member of the Commission

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‘E 320 BUTYLATED HYDROXYANISOLE (BHA)

Synonyms

Definition

Chemical names

EINECS

Chemical formula

Formula weight

Assay

Description

Identification

A. Solubility

B. Melting range

C. Colour reaction

Purity

Sulphated ash

Phenolic impurities

1%
Specific absorption E 1cm

1%
Specific absorption E 1cm

Arsenic

Lead

Mercury

ANNEX I

BHA

3-Tertiary-butyl-4-hydroxyanisole

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

246-563-8

C11H16O2

180,25

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

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

Insoluble in water, freely soluble in ethanol

Between 48 ºC and 63 ºC

Passes test for phenol groups

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

Not more than 0,5 %

1%
E 1cm

1%
E 1cm

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

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg’

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‘POLYETHYLENEGLYCOL 6000

Synonyms

Definition

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

ANNEX II

PEG 6000

Macrogol 6000

Polyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-
CH)-OH corresponding to an average relative molecular mass of approximately 6 000

(C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight
of 6000, about 140)

5 600 - 7 000

Not less than 90,0 % and not more than 110,0 %

A white or almost white solid with a waxy or paraffin-like appearance

Very soluble in water and in methylene chloride

Practically insoluble in alcohol, in ether and in fatty and mineral oils

B. Melting range

Between 55 °C and 61 °C

Purity

Viscosity

Hydroxyl value

Sulphated ash

Ethylene oxide

Arsenic

Lead

E 296 MALIC ACID

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Between 0,220 and 0,275 kgm-1s-1 at 20 °C

Between 16 and 22

Not more than 0,2 %

Not more than 1 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

DL-Malic acid, pomalous acid

DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid

230-022-8

C4H6O5

134,09

Content not less than 99,0 %

White or nearly white crystalline powder or granules

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Identification

A. Melting range between 127 °C and 132 °C

B. Positive test for malate

C. Solutions of this substance are optically

inactive in all concentrations

Purity

Sulphated ash

Fumaric acid

Maleic acid

Arsenic

Lead

Mercury

E 297 FUMARIC ACID

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 0,1 %

Not more than 1,0 %

Not more than 0,05 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

203-743-0

C4H4O4

116,07

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

White crystalline powder or granules

A. Melting range

286 °C - 302 °C (closed capillary, rapid heating)

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

dicarboxylic acid

C. pH of a 0,05 % solution at 25 °C

3,0 – 3,2

Purity

Loss on drying

Sulphated ash

Maleic acid

Arsenic

Lead

Mercury

Not more than 0,5 % (120 °C, 4h)

Not more than 0,1 %

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 343(i) MONOMAGNESIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Magnesiumdihydrogenphosphate

Magnesiumphosphate, monobasic

Monomagnesium orthophosphate

Monomagnesiumdihydrogenmonophosphate

236-004-6

Mg(H2PO4)2 · nH2O (where n = 0 to 4)

218,30 (anhydrous)

Not less than 51,0 % after ignition

White, odourless, crystalline powder, slightly soluble in water

A. Positive test for magnesium and for phos-

phate

B. MgO content

Not less than 21,5 % after ignition

Purity

Fluoride

Arsenic

Lead

Cadmium

Mercury

E 343(ii) DIMAGNESIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Not more than 10 mg/kg (as fluorine)

Not more than 3 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Magnesiumhydrogenphosphate

Magnesiumphosphate, dibasic

Dimagnesium orthophosphate

Secondary magnesiumphosphate

Dimagnesiummonohydrogenmonophosphate

231-823-5

MgHPO4 · nH2O (where n = 0 - 3)

120,30 (anhydrous)

Not less than 96 % after ignition

White, odourless, crystalline powder, slightly soluble in water

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Identification

A. Positive test for magnesium and for phos-

phate

B. MgO content:

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

Purity

Fluoride

Arsenic

Lead

Cadmium

Mercury

E 350 (i) SODIUM MALATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 10 mg/kg (as fluorine)

Not more than 3 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Sodium salt of malic acid

Disodium DL-malate, disodium salt of hydroxybutanedioic acid

Hemihydrate: C4H4Na2O5 · 1/2 H2O
Trihydrate: C4H4Na2O5 · 3H2O

Hemihydrate: 187,05

Trihydrate: 232,10

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

White crystalline powder or lumps

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

for sodium

B. Azo dye formation

Positive

C. Solubility

Purity

Loss on drying

Alkalinity

Fumaric acid

Maleic acid

Arsenic

Lead

Mercury

Freely soluble in water

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

Not more than 0,2 % as Na2CO3

Not more than 1,0 %

Not more than 0,05 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 350 (ii) SODIUM HYDROGEN MALATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Monosodium salt of DL-malic acid

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

C4H5NaO5

156,07

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

White powder

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

for sodium

B. Azo dye formation

Positive

Purity

Loss on drying

Maleic acid

Fumaric acid

Arsenic

Lead

Mercury

E 351 POTASSIUM MALATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 2,0 % (110 °C, 3h)

Not more than 0,05 %

Not more than 1,0 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Potassium salt of malic acid

Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid

C4H4K2O5

210,27

Content not less than 59,5 %

Colourless or almost colourless aqueous solution

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

for potassium

B. Azo dye formation

Positive

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Purity

Alkalinity

Fumaric acid

Maleic acid

Arsenic

Lead

Mercury

E 352 (i) CALCIUM MALATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 0,2 % as K2CO3

Not more than 1,0 %

Not more than 0,05 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Calcium salt of malic acid

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

C4H5CaO5

172,14

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

White powder

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

acid and for calcium

B. Azo dye formation

Positive

C. Solubility

Purity

Loss on drying

Alkalinity

Maleic acid

Fumaric acid

Fluoride

Arsenic

Lead

Mercury

Slightly soluble in water

Not more than 2 % (100 °C, 3h)

Not more than 0,2 % as CaCO3

Not more than 0,05 %

Not more than 1,0 %

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 352 (ii) CALCIUM HYDROGEN MALATE

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

Monocalcium salt of DL-malic acid

Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate

(C4H5O5)2Ca

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

White powder

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

for calcium

B. Azo dye formation

Positive

Purity

Loss on drying

Maleic acid

Fumaric acid

Fluoride

Arsenic

Lead

Mercury

E 355 ADIPIC ACID

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range

B. Solubility

Not more than 2,0 % (110 °C, 3h)

Not more than 0,05 %

Not more than 1,0 %

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Hexanedioic acid, 1,4-butanedicarboxylic acid

204-673-3

C6H10O4

146,14

Content not less than 99,6 %

White odourless crystals or crystalline powder

151,5-154,0 °C

Slightly soluble in water. Freely soluble in ethanol

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Purity

Water

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

Sulphated ash

Not more than 20 mg/kg

Arsenic

Lead

Mercury

E 363 SUCCINIC ACID

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Butanedioic acid

203-740-4

C4H6O4

118,09

Content no less than 99,0 %

Colourless or white, odourless crystals

A. Melting range

Between 185,0 °C and 190,0 °C

Purity

Residue on ignition

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

Arsenic

Lead

Mercury

E 380 TRIAMMONIUM CITRATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Tribasic ammonium citrate

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

222-394-5

C6H17N3O7

243,22

Content not less than 97,0 %

White to off-white crystals or powder

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Identification

A. Positive tests for ammonium and for citrate

B. Solubility

Purity

Oxalate

Arsenic

Lead

Mercury

E 452(iii) SODIUM CALCIUM POLYPHOSPHATE

Synonym

Definition

Chemical name

EINECS

Chemical formula

Assay

Description

Identification

Freely soluble in water

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Sodium calcium polyphosphate, glassy

Sodium calcium polyphosphate

233-782-9

(NaPO3)n CaO where n is typically 5

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

White glassy crystals, spheres

A. pH of a 1 % m/m slurry

Approximately 5 to 7

B. CaO content

7 %-15 % m/m

Purity

Fluoride

Arsenic

Lead

Cadmium

Mercury

E 459 BETA-CYCLODEXTRIN

Definition

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of 7 Æ-1,4-linked D-
glucopyranosyl units. The product is manufactured by the action of the enzyme
cycloglycosyltransferase (CGTase) obtained from Bacillus circulans on partially hydrolysed
starch

Chemical name

EINECS

Chemical formula

Cycloheptaamylose

231-493-2

(C6H10O5)7

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Molecular weight

1135

Assay

Description

Identification

A. Solubility

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

Virtually odourless, white or almost white crystalline solid

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

B. Specific rotation

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

C.

Infrared absorption

The infrared absorption spectrum of a potassium bromide dispersion of the test substance
corresponds with that of a reference standard

Purity

Water

Not more than 14 % (Karl Fischer method)

Other cyclodextrins

Not more than 2 % on an anhydrous basis

Residual
ethylene)

solvents

(toluene

and trichloro-

Not more than 1 mg/kg for each solvent

Reducing substances (as glucose)

Not more than 1 %

Sulphated ash

Not more than 0,1 %

Arsenic

Lead

Not more than 1 mg/kg

Not more than 1 mg/kg

E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE

Synonyms

Cross-linked carboxymethyl cellulose

Cross-linked CMC

Cross-linked sodium CMC

Cross-linked cellulose gum

Definition

Chemical name

Chemical formula

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

Sodium salt of the cross-linked carboxymethyl ether cellulose

The polymers containing substituted anhydroglucose units with the general formula:

C6H7O2(OR1) (OR2)(OR3)
where R1, R2 and R3 may be any of the following:
— H

— CH2COONa
— CH2COOH

Description

Slightly hygroscopic, white to off white, odourless powder

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Identification

A.

B.

C.

Purity

Loss on drying

Water solubles

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

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

It gives the reaction of sodium

Not more than 6 % (105 ºC, 3h)

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 %

Sodium content

Arsenic

Lead

Cadmium

Mercury

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

Not more than 12,4 % on anhydrous basis

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE

Synonyms

Definition

Chemical name

Chemical formula

Formula weight

Sodium carboxymethyl cellulose, enzymatically hydrolysed

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

Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed

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

[C6H7O2(OH)x(OCH2COONa)y]n
where n is the degree of polymerisation

x = 1,50 to 2,80

y = 0,2 to 1,50

x + y = 3,0

(y = degree of substitution)

178,14 where y = 0,20

282,18 where y = 1,50

Macromolecules: Not less than 800 (n about 4)

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Assay

Description

Identification

A. Solubility

B. Foam test

C. Precipitate formation

D. Colour reaction

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

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

Soluble in water, insoluble in ethanol

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

To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of 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

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

E. Viscosity (60 % solids)

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

Purity

Loss on drying

Not more than 12 % (105 °C 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 500(i) SODIUM CARBONATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Soda ash

Sodium carbonate

207-838-8

Na2CO3 · nH2O (n = 0, 1 or 10)

106,00 (anhydrous)

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

Colourless crystals or white, granular or crystalline powder

The anhydrous form is hygroscopic, the decahydrate efflorescent

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Identification

A. Positive tests for sodium and for carbonate

B. Solubility

Freely soluble in water. Insoluble in ethanol

Purity

Loss on drying

Arsenic

Lead

Mercury

E 500(ii) SODIUM HYDROGEN CARBONATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

Sodium hydrogen carbonate

205-633-8

NaHCO3

84,01

Content not less than 99 % on the anhydrous basis

Colourless or white crystalline masses or crystalline powder

A. Positive tests for sodium and for carbonate

B. pH of a 1 % solution

Between 8,0 and 8,6

C. Solubility

Soluble in water. Insoluble in ethanol

Purity

Loss on drying

Ammonium salts

Arsenic

Lead

Mercury

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

No odour of ammonia detectable after heating

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 500(iii) SODIUM SESQUICARBONATE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium monohydrogen dicarbonate

208-580-9

Na2(CO)3 · NaHCO3 · 2H2O

226,03

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

White flakes, crystals or crystalline powder

A. Positive tests for sodium and for carbonate

B. Solubility

Purity

Freely soluble in water

Sodium chloride

Not more than 0,5 %

Iron

Arsenic

Lead

Mercury

E 501(i) POTASSIUM CARBONATE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 20 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Potassium carbonate

209-529-3

K2CO3 · nH2O (n = 0 or 1,5)

138,21 (anhydrous)

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

White, very deliquescent powder.

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

A. Positive tests for potassium and for car-

bonate

B. Solubility

Very soluble in water. Insoluble in ethanol

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Purity

Loss on drying

Arsenic

Lead

Mercury

E 501(ii) POTASSIUM HYDROGEN CARBONATE

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium bicarbonate, acid potassium carbonate

Potassium hydrogen carbonate

206-059-0

KHCO3

100,11

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

Colourless crystals or white powder or granules

A. Positive tests for potassium and for car-

bonate

B. Solubility

Purity

Loss on drying

Arsenic

Lead

Mercury

E 503(i) AMMONIUM CARBONATE

Freely soluble in water. Insoluble in ethanol

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

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

Ammonium carbonate

233-786-0

CH6N2O2, CH8N2O3 and CH5NO3

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

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

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

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Identification

A. Positive tests for ammonium and for car-

bonate

B. pH of a 5 % solution about 8,6

C. Solubility

Purity

Soluble in water

Non-volatile matter

Not more than 500 mg/kg

Chlorides

Sulphate

Arsenic

Lead

Mercury

E 503(ii) AMMONIUM HYDROGEN CARBONATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Ammonium bicarbonate

Ammonium hydrogen carbonate

213-911-5

CH5NO3

79,06

Content not less than 99,0 %

White crystals or crystalline powder

A. Positive tests for ammonium and for car-

bonate

B. pH of a 5 % solution about 8,0

C. Solubility

Purity

Freely soluble in water. Insoluble in ethanol

Non-volatile matter

Not more than 500 mg/kg

Chlorides

Sulphate

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 507 HYDROCHLORIC ACID

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Hydrogen chloride, muriatic acid

Hydrochloric acid

231-595-7

HCl

36,46

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

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

A. Positive tests for acid and for chloride

B. Solubility

Purity

Soluble in water and in ethanol

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

Reducing substances

Oxidising substances

Sulphate

Iron

Arsenic

Lead

Mercury

E 509 CALCIUM CHLORIDE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Not more than 0,5 %

Not more than 70 mg/kg (as SO2)

Not more than 30 mg/kg (as Cl2)

Not more than 0,5 %

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Calcium chloride

233-140-8

CaCl2 · nH2O (n = 0,2 or 6)

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

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

White, odourless, hygroscopic powder or deliquescent crystals

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Identification

A. Positive tests for calcium and for chloride

B. Solubility

Anhydrous calcium chloride: freely soluble in water and ethanol

Dihydrate: freely soluble in water, soluble in ethanol

Hexahydrate: very soluble in water and ethanol

Purity

Magnesium and alkali salts

Not more than 5 % on the anhydrous basis

Fluoride

Arsenic

Lead

Mercury

E 511 MAGNESIUM CHLORIDE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Not more than 40 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

Magnesium chloride

232-094-6

MgCl2 · 6H2O

203,30

Content not less than 99,0 %

Colourless, odourless, very deliquescent flakes or crystals

tests

for magnesium and for

Very soluble in water, freely soluble in ethanol

Assay

Description

Identification

A. Positive
chloride

B. Solubility

Purity

Ammonium

Arsenic

Lead

Mercury

E 512 STANNOUS CHLORIDE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

Tin chloride, tin dichloride

Stannous chloride dihydrate

231-868-0

SnCl2 · 2H2O

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Molecular weight

Assay

Description

Identification

225,63

Content not less than 98,0 %

Colourless or white crystals

May have a slight odour of hydrochloric acid

A. Positive tests for tin (II) and for chloride

B. Solubility

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

Purity

Sulphate

Arsenic

Mercury

Lead

E 513 SULPHURIC ACID

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Ethanol: soluble

Not more than 30 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

Oil of vitriol, dihydrogen sulphate

Sulphuric acid

231-639-5

H2SO4

98,07

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

Clear, colourless or slightly brown, very corrosive oily liquid

A. Positive tests for acid and for sulphate

B. Solubility

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

Purity

Ash

Reducing matter

Nitrate

Not more than 0,02 %

Not more than 40 mg/kg (as SO2)

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

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Chloride

Iron

Selenium

Arsenic

Lead

Mercury

E 514(i) SODIUM SULPHATE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sodium and for sulphate

B. Acidity of a 5 % solution: neutral or slightly

alkaline to litmus paper

Purity

Loss on drying

Selenium

Arsenic

Lead

Mercury

E 514(ii) SODIUM HYDROGEN SULPHATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Not more than 50 mg/kg

Not more than 20 mg/kg

Not more than 20 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Sodium sulphate

Na2SO4 · nH2O (n = 0 or 10)

142,04 (anhydrous)

322,04 (decahydrate)

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

Colourless crystals or a fine, white, crystalline powder

The decahydrate is efflorescent

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

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Acid sodium sulphate, sodium bisulphate, nitre cake

Sodium hydrogen sulphate

NaHSO4

120,06

Content not less than 95,2 %

White, odourless crystals or granules

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Identification

A. Positive tests for sodium and for sulphate

B. Solutions are strongly acidic

Purity

Loss on drying

Water insoluble

Selenium

Arsenic

Lead

Mercury

E 515(i) POTASSIUM SULPHATE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 0,8 %

Not more than 0,05 %

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Potassium sulphate

K2SO4

174,25

Content not less than 99,0 %

Colourless or white crystals or crystalline powder

A. Positive tests for potassium and for sulphate

B. pH of a 5 % solution

Between 5,5 and 8,5

C. Solubility

Purity

Selenium

Arsenic

Lead

Mercury

Freely soluble in water, insoluble in ethanol

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 515(ii) POTASSIUM HYDROGEN SULPHATE

Definition

Synonyms

Chemical name

Potassium bisulphate, potassium acid sulphate

Potassium hydrogen sulphate

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Chemical formula

Molecular weight

Assay

Melting point

Description

Identification

A. Positive test for potassium

B. Solubility

Purity

Selenium

Arsenic

Lead

Mercury

E 516 CALCIUM SULPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for calcium and for sulphate

B. Solubility

Purity

Loss on drying

Fluoride

Selenium

Arsenic

Lead

Mercury

KHSO4

136,17

Content not less than 99 %

197 °C

White deliquescent crystals, pieces or granules

Freely soluble in water, insoluble in ethanol

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Gypsum, selenite, anhydrite

Calcium sulphate

231-900-3

CaSO4 · nH2O (n = 0 or 2)

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

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

Fine, white to slightly yellowish-white odourless powder

Slightly soluble in water, insoluble in ethanol

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

Dihydrate: not more than 23 % (ibid.)

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 517 AMMONIUM SULPHATE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Ammonium sulphate

231-984-1

(NH4)2SO4

132,14

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

White powder, shining plates or crystalline fragments

A. Positive tests for ammonium and for sul-

phate

B. Solubility

Purity

Freely soluble in water, insoluble in ethanol

Loss on ignition

Not more than 0,25 %

Selenium

Lead

Not more than 30 mg/kg

Not more than 5 mg/kg

E 520 ALUMINIUM SULPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Alum

Aluminium sulphate

233-135-0

Al2(SO4)3

342,13

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

White powder, shining plates or crystalline fragments

A. Positive tests for aluminium and for sulphate

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

C. Solubility

Freely soluble in water, insoluble in ethanol

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Purity

Loss on ignition

Not more than 5 % (500 °C, 3h)

Alkalies and alkaline earths

Not more than 0,4 %

Selenium

Fluoride

Arsenic

Lead

Mercury

E 521 ALUMINIUM SODIUM SULPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

Soda alum, sodium alum

Aluminium sodium sulphate

233-277-3

AlNa(SO4)2 · nH2O (n = 0 or 12)

242,09 (anhydrous)

Content on the anhydrous basis not
(dodecahydrate)

less than 96,5 % (anhydrous) and 99,5 %

Transparent crystals or white crystalline powder

A. Positive tests for aluminium, for sodium and

for sulphate

B. Solubility

Purity

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

Loss on drying

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

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

Ammonium salts

No odour of ammonia detectable after heating

Selenium

Fluoride

Arsenic

Lead

Mercury

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 522 ALUMINIUM POTASSIUM SULPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Potassium alum, potash alum

Aluminium potassium sulphate dodecahydrate

233-141-3

AlK(SO4)2 · 12 H2O

474,38

Content not less than 99,5 %

Large, transparent crystals or white crystalline powder

A. Positive tests for aluminium, for potassium

and for sulphate

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

C. Solubility

Purity

Freely soluble in water, insoluble in ethanol

Ammonium salts

No odour of ammonia detectable after heating

Selenium

Fluoride

Arsenic

Lead

Mercury

E 523 ALUMINIUM AMMONIUM SULPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Ammonium alum

Aluminium ammonium sulphate

232-055-3

AlNH4(SO4)2 · 12 H2O

453,32

Content not less than 99,5 %

Large, colourless crystals or white powder

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Identification

A. Positive tests for aluminium, for ammonium

and for sulphate

B. Solubility

Purity

Freely soluble in water, soluble in ethanol

Alkali metals and alkaline earths

Not more than 0,5 %

Selenium

Fluoride

Arsenic

Lead

Mercury

E 524 SODIUM HYDROXIDE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for sodium

B. A 1 % solution is strongly alkaline

C. Solubility

Purity

Not more than 30 mg/kg

Not more than 30 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Caustic soda, lye

Sodium hydroxide

215-185-5

NaOH

40,0

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

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

Very soluble in water. Freely soluble in ethanol

Water insoluble and organic matter

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

Carbonate

Arsenic

Lead

Mercury

Not more than 0,5 % (as Na2CO3)

Not more than 3 mg/kg

Not more than 0,5 mg/kg

Not more than 1 mg/kg

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E 525 POTASSIUM HYDROXIDE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for potassium

B. A 1 % solution is strongly alkaline

C. Solubility

Purity

Caustic potash

Potassium hydroxide

215-181-3

KOH

56,11

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

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

Very soluble in water. Freely soluble in ethanol

Water insoluble matter

A 5 % solution is completely clear and colourless

Carbonate

Arsenic

Lead

Mercury

E 526 CALCIUM HYDROXIDE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Not more than 3,5 % (as K2CO3)

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

Slaked lime, hydrated lime

Calcium hydroxide

215-137-3

Ca(OH)2

74,09

Content not less than 92,0 %

White powder

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Identification

A. Positive tests for alkali and for calcium

B. Solubility

Purity

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

Acid insoluble ash

Not more than 1,0 %

Magnesium and alkali salts

Not more than 1,0 %

Barium

Fluoride

Arsenic

Lead

E 527 AMMONIUM HYDROXIDE

Not more than 300 mg/kg

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Aqua ammonia, strong ammonia solution

Ammonium hydroxide

NH4OH

35,05

Content not less than 27 % of NH3

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

A. Positive tests for ammonia

Purity

Non-volatile matter

Not more than 0,02 %

Arsenic

Lead

Not more than 3 mg/kg

Not more than 5 mg/kg

E 528 MAGNESIUM HYDROXIDE

Definition

Chemical name

EINECS

Chemical formula

Magnesium hydroxide

215-170-3

Mg(OH)2

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Molecular weight

58,32

Assay

Description

Identification

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

Odourless, white bulky powder

A. Positive test for magnesium and for alkali

B. Solubility

Practically insoluble in water and in ethanol

Purity

Loss on drying

Loss on ignition

Calcium oxide

Arsenic

Lead

E 529 CALCIUM OXIDE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 2,0 % (105 °C, 2h)

Not more than 33 % (800 °C to constant weight)

Not more than 1,5 %

Not more than 3 mg/kg

Not more than 10 mg/kg

Burnt lime

Calcium oxide

215-138-9

CaO

56,08

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

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

A. Positive test for alkali and for calcium

B. Heat is generated on moistening the sample

with water

C. Solubility

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

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Purity

Loss on ignition

Not more than 10,0 % (ca 800 °C 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

Arsenic

Lead

E 530 MAGNESIUM OXIDE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Magnesium oxide

215-171-9

MgO

40,31

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

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

Identification

A. Positive test for alkali and for magnesium

B. Solubility

Practically insoluble in water. Insoluble in ethanol

Purity

Loss on ignition

Calcium oxide

Arsenic

Lead

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

Not more than 1,5 %

Not more than 3 mg/kg

Not more than 10 mg/kg

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E 535 SODIUM FERROCYANIDE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Yellow prussiate of soda, sodium hexacyanoferrate

Sodium ferrocyanide

237-081-9

Na4Fe(CN)6 · 10 H2O

484,1

Content not less than 99,0 %

Yellow crystals or crystalline powder

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

Sulphate

Free cyanide

Ferricyanide

Lead

E 536 POTASSIUM FERROCYANIDE

Not more than 0,2 %

Not more than 0,1 %

Not detectable

Not detectable

Not more than 5 mg/kg

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Yellow prussiate of potash, potassium hexacyanoferrate

Potassium ferrocyanide

237-722-2

K4Fe(CN)6 · 3 H2O

422,4

Content not less than 99,0 %

Lemon yellow crystals

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Identification

A. Positive test for potassium and for ferro-

cyanide

Purity

Free moisture

Not more than 1,0 %

Water insoluble matter

Not more than 0,03 %

Chloride

Sulphate

Free cyanide

Ferricyanide

Lead

E 538 CALCIUM FERROCYANIDE

Not more than 0,2 %

Not more than 0,1 %

Not detectable

Not detectable

Not more than 5 mg/kg

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Yellow prussiate of lime, calcium hexacyanoferrate

Calcium ferrocyanide

215-476-7

Ca2Fe(CN)6 · 12H2O

508,3

Content not less than 99,0 %

Yellow crystals or crystalline powder

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

Sulphate

Free cyanide

Ferricyanide

Lead

Not more than 0,2 %

Not more than 0,1 %

Not detectable

Not detectable

Not more than 5 mg/kg

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E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for sodium, for aluminium and

for phosphate

B. pH

C. Solubility

Purity

Loss on ignition

Fluoride

Arsenic

Lead

Cadmium

Mercury

E 551 SILICON DIOXIDE

Synonyms

Definition

SALP

Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) or

Trisodium dialuminium pentadecahydrogen octaphosphate (B)

232-090-4

NaAl3H14(PO4) 8 · 4H2O (A)
Na3Al2H15(PO4)8 (B)

949,88 (A)

897,82 (B)

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

White odourless powder

Acid to litmus

Insoluble in water. Soluble in hydrochloric acid

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

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

Not more than 25 mg/kg

Not more than 3 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

Silica, silicium dioxide

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

Chemical name

Silicon dioxide

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231-545-4

(SiO2)n

60,08 (SiO2)

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

White, fluffy powder or granules

Hygroscopic

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive test for silica

Purity

Loss on drying

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

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

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

Loss on ignition

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

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

Soluble ionisable salts

Not more than 5,0 % (as Na2SO4)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

Calcium silicate

215-710-8

Content on the anhydrous basis:

— as SiO2 not less than 50 % and not more than 95 %
— as CaO not less than 3 % and not more than 35 %

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

Arsenic

Lead

Mercury

E 552 CALCIUM SILICATE

Definition

Chemical name

EINECS

Assay

Description

Identification

A. Positive test for silicate and for calcium

B. Forms a gel with mineral acids

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Purity

Loss on drying

Loss on ignition

Sodium

Fluoride

Arsenic

Lead

Mercury

E 553a(i) MAGNESIUM SILICATE

Definition

Assay

Description

Identification

Not more than 10 % (105 °C, 2h)

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

Not more than 3 %

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

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

Very fine, white, odourless powder, free from grittiness

A. Positive test for magnesium and for silicate

B. pH of a 10 % slurry

Between 7,0 and 10,8

Purity

Loss on drying

Loss on ignition

Water soluble salts

Free alkali

Fluoride

Arsenic

Lead

Mercury

E 553a(ii) MAGNESIUM TRISILICATE

Definition

Chemical name

Chemical formula

EINECS

Assay

Description

Not more than 15 % (105 °C, 2h)

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

Not more than 3 %

Not more than 1 % (as NaOH)

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Magnesium trisilicate

Mg2Si3O8 · xH2O (approximate composition)

239-076-7

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

Fine, white powder, free from grittiness

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Identification

A. Positive test for magnesium and for silicate

B. pH of a 5 % slurry

Between 6,3 and 9,5

Purity

Loss on ignition

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

Water soluble salts

Not more than 2 %

Free alkali

Fluoride

Arsenic

Lead

Mercury

E 570 FATTY ACIDS

Definition

Chemical name

Assay

Description

Identification

Not more than 1 % (as NaOH)

Not more than 10 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

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

Not less than 98 % by chromatography

A colourless liquid or white solid obtained from oils and fats

A.

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

Purity

Residue on ignition

Not more than 0,1 %

Unsaponifiable matter

Not more than 1,5 %

Water

Arsenic

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

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E 574 GLUCONIC ACID

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

D-gluconic acid, dextronic acid

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

Gluconic acid

C6H12O7 (gluconic acid)

196,2

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

Colourless to light yellow, clear syrupy liquid

A. Formation of phenylhydrazine derivative

Compound formed melts between 196 °C and 202 °C with decomposition

positive

Purity

Residue on ignition

Not more than 1,0 %

Reducing matter

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

Chloride

Sulphate

Sulphite

Arsenic

Lead

Mercury

E 575 GLUCONO-DELTA-LACTONE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Not more than 350 mg/kg

Not more than 240 mg/kg

Not more than 20 mg/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

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

D-Glucono-1,5-lactone

202-016-5

C6H10O6

178,14

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

Fine, white, nearly odourless, crystalline powder

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Identification

A. Formation of phenylhydrazine derivative of

Compound formed melts between 196 °C and 202 °C with decomposition

gluconic acid positive

B. Solubility

C. Melting point

Purity

Water

Freely soluble in water. Sparingly soluble in ethanol

152 °C ± 2 °C

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

Reducing substances

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

Lead

Not more than 2 mg/kg

E 576 SODIUM GLUCONATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium salt of D-gluconic acid

Sodium D-gluconate

208-407-7

C6H11NaO7 (anhydrous)

218,14

Content not less than 98,0 %

White to tan, granular to fine, crystalline powder

A. Positive test for sodium and for gluconate

B. Solubility

Very soluble in water. Sparingly soluble in ethanol

C. pH of a 10 % solution

Between 6,5 and 7,5

Purity

Reducing matter

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

Lead

Not more than 2 mg/kg

E 577 POTASSIUM GLUCONATE

Synonyms

Definition

Potassium salt of D-gluconic acid

Chemical name

Potassium D-gluconate

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EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

206-074-2

C6H11KO7 (anhydrous)
C6H11KO7 · H2O (monohydrate)

234,25 (anhydrous)

252,26 (monohydrate)

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

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

A. Positive test for potassium and for gluconate

B. pH of a 10 % solution

Between 7,0 and 8,3

Purity

Loss on drying

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

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

Reducing substances

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

Lead

Not more than 2 mg/kg

E 578 CALCIUM GLUCONATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium salt of D-gluconic acid

Calcium di-D-gluconate

206-075-8

C12H22CaO14 (anhydrous)
C12H22CaO14 · H2O (monohydrate)

430,38 (anhydrous form)

448,39 (monohydrate)

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

Odourless, white crystalline granules or powder, stable in air

A. Positive test for calcium and for gluconate

B. Solubility

Soluble in water, insoluble in ethanol

C. pH of a 5 % solution

Between 6,0 and 8,0

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Purity

Loss on drying

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

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

Reducing substances

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

Lead

Not more than 2 mg/kg

E 640 GLYCINE AND ITS SODIUM SALT

Synonyms (gly)

Aminoacetic acid, glycocoll

(Na salt)

Definition

Chemical name (gly)

(Na salt)

Chemical formula (gly)

(Na salt)

EINECS (gly)

(Na salt)

Molecular weight (gly)

(Na salt)

Assay

Description

Identification

Sodium glycinate

Aminoacetic acid

Sodium glycinate

C2H5NO2

C2H5NO2 Na

200-272-2

227-842-3

75,07

98

Content not less than 98,5 % on the anhydrous basis

White crystals or crystalline powder

A. Positive test for aminoacid (gly and Na salt)

B. Positive test for sodium (Na salt)

Purity

Loss on drying (gly)

Not more than 0,2 % (105 °C, 3h)

(Na salt)

Not more than 0,2 % (105 °C, 3h)

Residue on ignition (gly)

Not more than 0,1 %

(Na salt)

Arsenic

Lead

Mercury

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 900 DIMETHYL POLYSILOXANE

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone

Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing
repeating units of the formula (CH3)2 SiO and stablised with trimethylsiloxy end-blocking
units of the formula (CH3)3 SiO

Siloxanes and silicones, di-methyl

(CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3

Content of total silicon not less than 37,3 % and not more than 38,5 %

Clear, colourless, viscous liquid

A. Specific gravity (25°/25 °C)

Between 0,964 and 0,977

B. Refractive index [n]D

25

Between 1,400 and 1,405

C.

Infrared spectrum characteristic of the com-
pound

Purity

Loss on drying

Viscosity

Arsenic

Lead

Mercury

E 901 BEESWAX

Synonyms

Definition

EINECS

Description

Identification

A. Melting range

B. Specific gravity

C. Solubility

Not more than 0,5 % (150 °C, 4h)

Not less than 1,00 · 10-4 m2s-1 at 25 °C

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

White wax, yellow wax

Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by
the honey bee, Apis mellifera L., with hot water and removing foreign matter
White beeswax is obtained by bleaching yellow beeswax

232-383-7 (beeswax)

Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or
plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like
odour

Between 62 °C and 65 °C

About 0,96

Insoluble in water

Sparingly soluble in alcohol

Very soluble in chloroform and ether

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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

Lead

Mercury

E 902 CANDELILLA WAX

Definition

EINECS

Description

Identification

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia
antisyphilitica

232-347-0

Hard, yellowish brown, opaque to translucent wax

A. Specific gravity

About 0,983

B. Melting range

C. Solubility

Purity

Acid value

Between 68,5 °C and 72,5 °C

Insoluble in water

Soluble in chloroform and toluene

Not less than 12 and not more than 22

Saponification value

Not less than 43 and not more than 65

Glycerol and other polyols

Not more than 0,5 % (as glycerol)

Ceresin, paraffins and certain other waxes

Absent

Fats, Japan wax, rosin and soaps

Absent

Arsenic

Lead

Mercury

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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E 903 CARNAUBA WAX

Definition

EINECS

Description

Identification

A. Specific gravity

B. Melting range

C. Solubility

Purity

Sulphated ash

Acid value

Ester value

Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian
Mart wax palm, Copernicia cereferia

232-399-4

Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous
fracture

About 0,997

Between 82 °C and 86 °C

Insoluble in water

Partly soluble in boiling ethanol

Soluble in chloroform and diethyl ether

Not more than 0,25 %

Not less than 2 and not more than 7

Not less than 71 and not more than 88

Unsaponifiable matter

Not less than 50 % and not more than 55 %

Arsenic

Lead

Mercury

E 904 SHELLAC

Synonyms

Definition

EINECS

Description

Identification

A. Solubility

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Bleached shellac, white shellac

Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer
(Tachardia) lacca Kerr (Fam. Coccidae)

232-549-9

Bleached shellac — off-white, amorphous, granular resin

Wax-free bleached shellac — light yellow, amorphous, granular resin

Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in
acetone

B. Acid value

Between 60 and 89

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Purity

Loss on drying

Rosin

Wax

Lead

E 920 L-CYSTEINE

Definition

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Melting range

C. Specific rotation

Purity

Loss on drying

Residue on ignition

Ammonium-ion

Arsenic

Lead

E 927b CARBAMIDE

Synonyms

Definition

EINECS

Chemical formula

Not more than 6,0 % (40 °C, over silica gel, 15h)

Absent

Bleached shellac: not more than 5,5 %

Wax-free bleached shellac: not more than 0,2 %

Not more than 2 mg/kg

L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used
as a source for this substance

200-157-7 (anhydrous)

C3H7NO2S · HCl · n H20 (where n = 0 or 1)

157,62 (anhydrous)

Content not less than 98,0 % and not more than 101,5 % on the anhydrous basis

White powder or colourless crystals

Freely soluble in water and in ethanol

Anhydrous form melts at about 175 °C

[Æ] 20

D: between + 5,0° and + 8,0° or

[Æ] 25

D: between + 4,9° and 7,9°

Between 8,0 % and 12,0 %

Not more than 2,0 % (anhydrous form)

Not more than 0,1 %

Not more than 200 mg/kg

Not more than 1,5 mg/kg

Not more than 5 mg/kg

Urea

200-315-5

CH4N2O

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Molecular weight

60,06

Assay

Description

Identification

A. Solubility

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

Colourless to white, prismatic, crystalline powder or small, white pellets

Very soluble in water

Soluble in ethanol

B. Precipitation with nitric acid

To pass the test a white, crystalline precipitate is formed

C. Colour reaction

D. Melting range

Purity

Loss on drying

Sulphated ash

To pass the test a reddish-violet colour is produced

132 °C to 135 °C

Not more than 1,0 % (105 °C, 1h)

Not more than 0,1 %

Ethanol-insoluble matter

Not more than 0,04 %

Alkalinity

Ammonium-ion

Biuret

Arsenic

Lead

E 938 ARGON

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Methane and other hydrocarbons calculated as
methane

Passes test

Not more than 500 mg/kg

Not more than 0,1 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Argon

231-147-0

Ar

40

Not less than 99 %

Colourless, odourless, non-flammable gas

Not more than 0,05 %

Not more than 100 (cid:236)l/l

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E 939 HELIUM

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Methane and other hydrocarbons calculated as
methane

E 941 NITROGEN

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Carbon monoxide

Methane and other hydrocarbons calculated as
methane

Helium

231-168-5

He

4

Not less than 99 %

Colourless, odourless, non-flammable gas

Not more than 0,05 %

Not more than 100 (cid:236)l/l

Nitrogen

231-783-9

N2

28

Not less than 99 %

Colourless, odourless, non-flammable gas

Not more than 0,05 %

Not more than 10 (cid:236)l/l

Not more than 100 (cid:236)l/l

Nitrogen dioxide and nitrogen oxide

Not more than 10 (cid:236)l/l

Oxygen

Not more than 1 %

E 942 NITROUS OXIDE

Definition

Chemical name

EINECS

Chemical formula

Nitrous oxide

233-032-0

N2O

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Molecular weight

44

Assay

Description

Purity

Water

Not less than 99 %

Colourless, non-flammable gas, sweetish odour

Not more than 0,05 %

Carbon monoxide

Not more than 30 (cid:236)l/l

Nitrogen dioxide and nitrogen oxide

Not more than 10 (cid:236)l/l

E 948 OXYGEN

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Methane and other hydrocarbons calculated as
methane

E 999 QUILLAIA EXTRACT

Synonyms

Definition

Description

Identification

Oxygen

231-956-9

O2

32

Not less than 99 %

Colourless, odourless, non-flammable gas

Not more than 0,05 %

Not more than 100 (cid:236)l/l

Soapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark
extract, China bark extract

Quillaia extract is obtained by aqueous extraction of Quillai saponaria Molina, or other
Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins
consisting of glycosides of quillaic acid. Some sugars including glucose, galactose,
arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and
other minor components

Quillaia extract in the powder form is light brown with a pink tinge. It is also available
as an aqueous solution

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)

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Arsenic

Lead

Mercury

E 1103 INVERTASE

Definition

Systematic name

Enzyme Commission No

EINECS

Purity

Arsenic

Lead

Cadmium

Not more than 2 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Invertase is produced from Saccharomyces cerevisiae

(cid:226)-D-Fructofuranoside fructohydrolase

EC 3.2.1.26

232-615-7

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 0,5 mg/kg

Total bacterial count

Not more than 50 000/g

Salmonella spp.

Coliforms

E. coli

E 1200 POLYDEXTROSE

Synonyms

Definition

Assay

Description

Identification

Absent by test in 25 g

Not more than 30/g

Absent by test in 25 g

Modified polydextroses

Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid
or phosphoric acid residues attached to the polymers by mono or diester bonds. They
are obtained by melting and condensation of the ingredients and consist of approximately
90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid.
The 1,6-glucosidic linkage predominates in the polymers but other linkages are present.
The products contain small quantities of free glucose, sorbitol,
levoglucosan (1,6-
anhydro-D-glucose) and citric acid and may be neutralised with any food grade base
and/or decolorised and deionised for further purification. The products may also be
partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-
N is neutralised polydextrose

Content not less than 90 % of polymer on the ash free and anhydrous basis

White to light tan-coloured solid. Polydextroses dissolve in water to give a clear,
colourless to straw coloured solution

A. Positive tests for sugar and for reducing

sugar

B. pH of a 10 % solution

Between 2,5 and 7,0 for polydextrose

Between 5,0 and 6,0 for polydextrose-N

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Purity

Water

Sulphated ash

Not more than 4,0 % (Karl Fischer method)

Not more than 0,3 % (polydextrose)

Not more than 2,0 % (polydextrose N)

Nickel

Not more than 2 mg/kg for hydrogenated polydextroses

1,6-Anhydro-D-glucose

Not more than 4,0 % on the ash-free and the dried basis

Glucose and sorbitol

Not more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol
are determined separately

Molecular weight limit

Negative test for polymers of molecular weight greater than 22,000

5-Hydroxymethylfurfural

Not more than 0,1 % (polydextrose)

Not more than 0,05 % (polydextrose-N)

Lead

Not more than 0,5 mg/kg

Oxidised starch is starch treated with sodium hypochlorite

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

E 1404 OXIDISED STARCH

Definition

Description

Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Carboxyl groups

Sulphur dioxide

Arsenic

Lead

Mercury

Not more than 15,0 % for cereal starch

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 1,1 %

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

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E 1410 MONOSTARCH PHOSPHATE

Definition

Description

Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or
potassium ortho-phosphate or sodium tripolyphosphate

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

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

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1412 DISTARCH PHOSPHATE

Definition

Description

Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus
oxychloride

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

Not more than 15,0 % for cereal starch

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

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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

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1413 PHOSPHATED DISTARCH PHOSPHATE

Definition

Description

Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Phosphated distarch phosphate is starch having undergone a combination of treatments
as described for monostarch phosphate and for distarch phosphate

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

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

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1414 ACETYLATED DISTARCH PHOSPHATE

Definition

Description

Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or
phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

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Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Vinyl acetate

Sulphur dioxide

Arsenic

Lead

Mercury

E 1420 ACETYLATED STARCH

Synonyms

Definition

Description

Identification

A.

If not pregelatinised: by microscopic obser-
vation

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 0,04 % (as P) for other starches

Not more than 0,1 mg/kg

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Starch acetate

Acetylated starch is starch esterified with acetic anhydride or vinyl acetate

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

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 %

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Vinyl acetate

Sulphur dioxide

Arsenic

Lead

Mercury

Not more than 0,1 mg/kg

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1422 ACETYLATED DISTARCH ADIPATE

Definition

Description

Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Acetyl groups

Adipate groups

Sulphur dioxide

Arsenic

Lead

Mercury

Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified
with acetic anhydride

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

Not more than 15,0 % for cereal starch

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 2,5 %

Not more than 0,135 %

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1440 HYDROXYPROPYL STARCH

Definition

Description

Hydroxypropyl starch is starch etherified with propylene oxide

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

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Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE

Definition

Description

Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate
or phosphorus oxychloride and etherified with propylene oxide

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

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

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Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Lead

Mercury

E 1450 STARCH SODIUM OCTENYL SUCCINATE

Synonyms

Definition

Description

Identification

A.

If not pregelatinised: by microscopic obser-
vation

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 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

SSOS

Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

Not more than 15,0 % for cereal starch

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Octenylsuccinyl groups

Not more than 3 %

Octenylsuccinic acid residue

Not more than 0,3 %

Sulphur dioxide

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Arsenic

Lead

Mercury

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

E 1451 ACETYLATED OXIDISED STARCH

Definition

Description

Acetylated oxidised starch is starch treated with sodium hypochlorite followed by
esterification with acetic anhydride

White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder
or coarse particles

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Identification

A.

If not pregelatinised: by microscopic obser-
vation

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

Carboxyl groups

Acetyl groups

Sulphur dioxide

Arsenic

Lead

Mercury

E 1505 TRIETHYL CITRATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Specific gravity

B. Refractive index

Purity

Water

Acidity

Arsenic

Lead

Not more than 15,0 % for cereal starch

Not more than 21,0 % for potato starch

Not more than 18,0 % for other starches

Not more than 1,3 %

Not more than 2,5 %

Not more than 50 mg/kg for modified cereal starches

Not more than 10 mg/kg for other modified starches, unless otherwise specified

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 0,1 mg/kg

Ethyl citrate

Triethyl-2-hydroxypropan-1,2,3-tricarboxylate

201-070-7

C12H20O7

276,29

Content not less than 99,0 %

Odourless, practically colourless, oily liquid

d25

25: 1,135-1,139

[n]D20: 1,439-1,441

Not more than 0,25 % (Karl Fischer method)

Not more than 0,02 % (as citric acid)

Not more than 3 mg/kg

Not more than 5 mg/kg

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E 1518 GLYCERYL TRIACETATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Triacetin

Glyceryl triacetate

203-051-9

C9H14O6

218,21

Content not less than 98,0 %

Colourless, somewhat oily liquid having a slightly fatty odour

A. Positive tests for acetate and for glycerol

B. Refractive index

Between 1,429 and 1,431 at 25 °C

C. Specific gravity (25 °C/25 °C)

Between 1,154 and 1,158

D. Boiling range

Between 258° and 270 °C

Purity

Water

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

Sulphated ash

Not more than 0,02 % (as citric acid)

Arsenic

Lead

Not more than 3 mg/kg

Not more than 5 mg/kg

E 1520 PROPANE-1,2-DIOL

Synonyms

Definition

Chemical names

EINECS

Chemical formula

Molecular weight

Assay

Description

Propylene glycol

1,2-dihydroxypropane

200-338-0

C3H8O2

76,10

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

Clear, colourless, hygroscopic, viscous liquid

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Identification

A. Solubility

B. Specific gravity

C. Refractive index

Purity

Distillation range

Sulphated ash

Water

Lead

Soluble in water, ethanol and acetone

d20

20: 1,035-1,040

[n]20D: 1,431-1,433

99 % v/v distils between 185 °C-189 °C

Not more than 0,07 %

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

Not more than 5 mg/kg’