Commission Directive 2001/30/EC of 2 May 2001 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
Date: 2001-05-02
Institutions: European Commission
Subjects: consumer protection, food additive, food colouring, product quality, sweetener

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I

(Acts whose publication is obligatory)

COMMISSION DIRECTIVE 2001/30/EC

of 2 May 2001

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,

HAS ADOPTED THIS DIRECTIVE:

Article 1

Directive 96/77/EC is hereby amended as follows:

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

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 1 June 2002 at the latest. They shall forthwith
inform the Commission thereof.

2. When Member States adopt those provisions, they shall
contain a reference to this Directive or be accompanied by
such a reference on the occasion of their official publication.
Member States shall determine how such reference is to be
made.

3.
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.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 2 May 2001.

For the Commission

David BYRNE

Member of the Commission

Having regard to the Treaty establishing the European
Community,

Having regard to Council Directive 89/107/EEC of 21
the
December 1988 on the approximation of
Member States concerning food additives authorised for use
as
in foodstuffs
amended by Directive 94/34/EC of the European Parliament
and of the Council (2) and in particular Article 3(3)(a) thereof,

for human consumption (1),

the laws of

intended

After consulting Scientific Committee on Food,

Whereas:

(1) It is necessary to establish purity criteria for all additives
other than colours and sweeteners mentioned in Directive
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 2001/5/EC (4).

(2) Commission Directive 96/77/EC of 2 December 1996
laying down specific purity criteria on food additives
other than colours and sweeteners (5), as last amended by
Directive 2000/63/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.

(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) The measures provided for

in this Directive are in
accordance with the opinion of the Standing Committee
for Foodstuffs,

(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 55, 24.2.2001, p. 59.
(5) OJ L 339, 30.12.1996, p. 1.
(6) OJ L 227, 30.10.2000, p. 1.

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E 170 (i) CALCIUM CARBONATE

ANNEX

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/45/EC laying down
specific purity criteria concerning colours for use in foodstuffs (1).

(1) OJ L 226, 22.9.1995, p. 13.

E 353 METATARTARIC ACID

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

A.

B.

Purity

Arsenic

Lead

Mercury

E 354 CALCIUM TARTRATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Ditartaric acid

Metatartaric acid

C4H6O6

Not less than 99,5 %

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

Very soluble in water and ethanol.

Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated
sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 (cid:176)C, an intense
violet coloration appears

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L-Calcium tartrate

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

C4H4CaO6 (cid:25) 2H2O

224,18

Not less than 98,0 %

Fine crystalline powder with a white or off-white colour

A. Slightly

soluble

Solubility
in
approximately 0,01 g/100 ml water (20 (cid:176)C).
Sparingly soluble in ethanol. Slightly soluble
in diethyl ether. Soluble in acids

water.

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B. Specific rotation [Æ]20D

+7,0(cid:176) to +7,4(cid:176) (0,1 % in a 1N de HCl solution)

C. pH of a 5 % slurry

Between 6,0 and 9,0

Purity

Sulphates (as H2SO4)

Arsenic

Lead

Mercury

E 356 SODIUM ADIPATE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Melting range

B. Solubility

C. Positive test for sodium

Purity

Water

Arsenic

Lead

Mercury

E 357 POTASSIUM ADIPATE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Not more than 1 g/kg

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Sodium adipate

231-293-5

C6H8Na2O4

190,11

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

White odourless crystals or crystalline powder

151 (cid:176)C-152 (cid:176)C (for adipic acid)

Approximately 50 g/100 ml water (20 (cid:176)C)

Not more than 3 % (Karl Fischer)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Potassium adipate

242-838-1

C6H8K2O4

222,32

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

White odourless crystals or crystalline powder

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Identification

A. Melting range

B. Solubility

C. Positive test for potassium

Purity

Water

Arsenic

Lead

Mercury

151 (cid:176)C-152 (cid:176)C (for adipic acid)

Approximately 60 g/100 ml water (20 (cid:176)C)

Not more than 3 % (Karl Fischer)

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

E 420(i) SORBITOL

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs (1).

E 420(ii) SORBITOL SYRUP

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

E 421 MANNITOL

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

(1) OJ L 178, 28.7.1995, p. 1.

E 425(i) KONJAC GUM

Definition

Molecular weight

Assay

Description

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 ration of 1,6:1,0, connected by (cid:226)(1-4)-glycosidic bonds.
Shorter side chains are attached through (cid:226)(1-3)-glycosidic bonds, and acetyl groups
occur at random at a ratio of about 1 group per 9 to 19 sugar units

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

Not less than 75 % carbohydrate

A white to cream to light tan powder

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Identification

A. Solubility

B. Gel formation

C. Formation of heat-stable gel

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

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

Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min,
with continuous agitation and then cooling the solution to room temperature. For each g
of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium
carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture
in a water bath to 85 (cid:176)C, and maintain for 2 h without agitation. Under these conditions
a thermally stable gel is formed

D. Viscosity (1 % solution)

Not less than 3 kgm-1s-1 at 25 (cid:176)C

Purity

Loss on drying

Not more than 12 % (105 (cid:176)C, 5 h)

Starch

Protein

Not more than 3 %

Not more than 3 % (N (cid:215) 5,7)

Ether-soluble material

Not more than 0,1 %

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

Total ash

Arsenic

Lead

Salmonella spp.

E. coli

E 425(ii) KONJAC GLUCOMANNAN

Definition

Not more than 5,0 % (800 (cid:176)C, 3 to 4h)

Not more than 3 mg/kg

Not more than 2 mg/kg

Absent in 12,5 g

Absent in 5 g

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 ration of 1,6:1,0, connected by (cid:226)(1-4)-glycosidic
bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is
acetylated

Molecular weight

500 000 to 2 000 000

Assay

Description

Identification

A. Solubility

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

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

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

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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 (cid:176)C, and maintain for 2 h without agitation. Under these conditions
a thermally stable gel is formed

C. Viscosity (1 % solution)

Not less than 20 kgm-1s-1 at 25 (cid:176)C

Purity

Loss on drying

Not more than 8 % (105 (cid:176)C, 3h)

Starch

Protein

Not more than 1 %

Not more than 1,5 % (N (cid:215) 5,7)

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

Ether-soluble material

Not more than 0,5 %

Sulphite (as SO2)

Chloride

Not more than 4 mg/kg

Not more than 0,02 %

50 % Alcohol-soluble

Not more than 2,0 % material

Total ash

Lead

Salmonella spp.

E. coli

Not more than 2,0 % (800 (cid:176)C, 3 to 4h)

Not more than 1 mg/kg

Absent in 12,5 g

Absent in 5 g

E 504(ii) MAGNESIUM HYDROXIDE CARBONATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

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

Magnesium carbonate hydroxide hydrated

235-192-7

4MgCO3Mg(OH)25H2O

485

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

Light, white friable mass or bulky white powder

A. Positive tests for magnesium and for carbonate

B. Solubility

Practically insoluble in water. Insoluble in ethanol

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Purity

Acid insoluble matter

Not more than 0,05 %

Water soluble matter

Not more than 1,0 %

Calcium

Arsenic

Lead

Mercury

E 553b TALC

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Description

Identification

Not more than 1,0 %

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

Talcum

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

Magnesium hydrogen metasilicate

238-877-9

Mg3(Si4O10)(OH)2

379,22

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

A. IR absorption

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

B. X-ray diffraction

Peaks at 9,34 / 4,66 / 3,12 ¯

C. Solubility

Purity

Insoluble in water and ethanol

Loss on drying

Not more than 0,5 % (105 (cid:176)C, 1h)

Acid-soluble matter

Not more than 6 %

Water-soluble matter

Not more than 0,2 %

Acid-soluble iron

Not detectable

Arsenic

Lead

Not more than 10 mg/kg

Not more than 5 mg/kg

E 554 SODIUM ALUMINIUM SILICATE

Synonyms

Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate

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Definition

Chemical name

Assay

Description

Identification

Sodium aluminium silicate

Content on the anhydrous basis:

(cid:151) as SiO2 not less than 66,0 % and not more than 88,0 %

(cid:151) as Al2O3 not less than 5,0 % and not more than 15,0 %

Fine white amorphous powder or beads

A. Positive tests for sodium, for aluminium and

for silicate

B. pH of a 5 % slurry

Between 6,5 and 11,5

Purity

Loss on drying

Loss on ignition

Sodium

Arsenic

Lead

Mercury

E 555 POTASSIUM ALUMINIUM SILICATE

Not more than 8,0 % (105 (cid:176)C, 2h)

Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000 (cid:176)C, constant
weight)

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

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Synonyms

Definition

EINECS

Chemical name

Chemical formulae

Molecular weight

Assay

Description

Identification

A. Solubility

Purity

Loss on drying

Antimony

Zinc

Mica

Natural mica consists of mainly potassium aluminium silicate (muscovite)

310-127-6

Potassium aluminium silicate

KAl2[AlSi3O10](OH)2

398

Content not less than 98 %

Light grey to white crystalline platelets or powder

Insoluble in water, diluted acids and alkali and organic solvents

Not more than 0,5 % (105 (cid:176)C, 2h)

Not more than 20 mg/kg

Not more than 25 mg/kg

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Barium

Chromium

Copper

Nickel

Arsenic

Mercury

Cadmium

Lead

Not more than 25 mg/kg

Not more than 100 mg/kg

Not more than 25 mg/kg

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 2 mg/kg

Not more than 10 mg/kg

E 556 CALCIUM ALUMINIUM SILICATE

Synonyms

Definition

Chemical name

Assay

Description

Identification

A. Positive tests for calcium, for aluminium and

for silicate

Purity

Loss on drying

Loss on ignition

Fluoride

Arsenic

Lead

Mercury

E 558 BENTONITE

Definition

Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate

Calcium aluminium silicate

Content on the anhydrous basis:

(cid:151) as SiO2 not less than 44,0 % and not more than 50,0 %

(cid:151) as Al2O3 not less than 3,0 % and not more than 5,0 %

(cid:151) as CaO not less than 32,0 % and not more than 38,0 %

Fine white, free-flowing powder

Not more than 10,0 % (105 (cid:176)C, 2h)

Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000 (cid:176)C, constant
weight)

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 10 mg/kg

Not more than 1 mg/kg

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

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EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Methylene blue test

215-108-5

(Al, Mg)8(Si4O10) 4(OH)8 (cid:25) 12H2O

819

Montmorillonite content not less than 80 %

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

B. X-Ray diffraction

Characteristic peaks at 12,5/15 A

C.

IR absorption

Peaks at 428/470/530/1 110-1 020/3 750 (cid:151) 3 400 cm-1

Purity

Loss on drying

Not more than 15,0 % (105 (cid:176)C, 2h)

Arsenic

Lead

Not more than 2 mg/kg

Not more than 20 mg/kg

E 559 ALUMINIUM SILICATE (KAOLIN)

Synonyms

Definition

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Kaolin, light or heavy

Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite,
potassium aluminium silicate, feldspar and quartz. Processing should not include calci-
nation

215-286-4 (kaolinite)

Al2Si2O5(OH)4 (kaolinite)

264

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

Silica (SiO2)

Between 45 % and 55 %

Alumina (Al2O3)

Between 30 % and 39 %

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

A. Positive tests for alumina and for silicate

B. X-ray diffraction:

characteristic peaks at 7,18 / 3,58 / 2,38 / 1,78 ¯

C.

IR absorption:

peaks at 3 700 and 3 620 cm-1

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Purity

Loss on ignition

Between 10 and 14 % (1 000 (cid:176)C, constant weight)

Water soluble matter

Not more than 0,3 %

Acid soluble matter

Not more than 2,0 %

Iron

Potassium oxide (K2O)

Carbon

Arsenic

Lead

Mercury

E 620 GLUTAMIC ACID

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 5 %

Not more than 5 %

Not more than 0,5 %

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

L-Glutamic acid, L-Æ-aminoglutaric acid

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

200-293-7

C5H9NO4

147,13

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

White crystals or crystalline powder

A. Positive test for glutamic acid by thin layer

chromatography

B. Specific rotation [Æ]D20

Between + 31,5(cid:176) and + 32,2(cid:176)

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

C. pH of a saturated solution

Between 3,0 and 3,5

Purity

Loss on drying

Sulphated ash

Chloride

Not more than 0,2 % (80 (cid:176)C, 3h)

Not more than 0,2 %

Not more than 0,2 %

Pyrrolidone carboxylic acid

Not more than 0,2 %

Lead

Not more than 2 mg/kg

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E 621 MONOSODIUM GLUTAMATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Sodium glutamate, MSG

Monosodium L-glutamate monohydrate

205-538-1

C5H8NaNO4 (cid:25) H2O

187,13

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

White, practically odourless crystals or crystalline powder

A. Positive test for sodium

B. Positive test

for glutamic acid by thin-layer

chromatography

C. Specific rotation [Æ]D20

Between + 24,8(cid:176) and + 25,3(cid:176)

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

D. pH of a 5 % solution

Between 6,7 and 7,2

Purity

Loss on drying

Chloride

Not more than 0,5 % (98 (cid:176)C, 5h)

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

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Potassium glutamate, MPG

Monopotassium L-glutamate monohydrate

243-094-0

C5H8KNO4 (cid:25) H2O

203,24

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

White, practically odourless crystals or crystalline powder

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Identification

A. Positive test for potassium

B. Positive test

for glutamic acid by thin-layer

chromatography

C. Specific rotation [Æ]D20

Between + 22,5(cid:176) and + 24,0(cid:176)

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

D. pH of a 2 % solution

Between 6,7 and 7,3

Purity

Loss on drying

Chloride

Not more than 0,2 % (80 (cid:176)C, 5h)

Not more than 0,2 %

Pyrrolidone carboxylic acid

Not more than 0,2 %

Lead

Not more than 2 mg/kg

E 623 CALCIUM DIGLUTAMATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium glutamate

Monocalcium di-L-glutamate

242-905-5

C10H16CaN2O8 (cid:25) x H2O (x = 0, 1, 2 or 4)

332,32 (anhydrous)

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

White, practically odourless crystals or crystalline powder

A. Positive test for calcium

B. Positive test

for glutamic acid by thin-layer

chromatography

C. Specific rotation [Æ]D20

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

Purity

Water

Chloride

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

Not more than 0,2 %

Pyrrolidone carboxylic acid

Not more than 0,2 %

Lead

Not more than 2 mg/kg

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E 624 MONOAMMONIUM GLUTAMATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Ammonium glutamate

Monoammonium L-glutamate monohydrate

231-447-1

C5H12N2O4 (cid:25) H2O

182,18

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

White, practically odourless crystals or crystalline powder

A. Positive test for ammonium

B. Positive test

for glutamic acid by thin-layer

chromatography

C. Specific rotation [Æ]D20

Between + 25,4(cid:176) and + 26,4(cid:176)

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

D. pH of a 5 % solution

Between 6,0 and 7,0

Purity

Loss on drying

Sulphated ash

Not more than 0,5 % (50 (cid:176)C, 4h)

Not more than 0,1 %

Pyrrolidone carboxylic acid

Not more than 0,2 %

Lead

Not more than 2 mg/kg

E 625 MAGNESIUM DIGLUTAMATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Magnesium glutamate

Monomagnesium di-L-glutamate tetrahydrate

242-413-0

C10H16MgN2O8 (cid:25) 4H2O

388,62

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

Odourless, white or off-white crystals or powder

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Identification

A. Positive test for magnesium

B. Positive test

for glutamic acid by thin-layer

chromatography

C. Specific rotation [Æ]D20

Between + 23,8(cid:176) and + 24,4(cid:176)

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

D. pH of a 10 % solution

Between 6,4 and 7,5

Purity

Water

Chloride

Not more than 24 % (Karl Fischer)

Not more than 0,2 %

Pyrrolidone carboxylic acid

Not more than 0,2 %

Lead

Not more than 2 mg/kg

E 626 GUANYLIC ACID

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Guanylic acid

Guanosine-5’-monophosphoric acid

201-598-8

C10H14N5O8P

363,22

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

Odourless, colourless or white crystals or white crystalline powder

A. Positive

test

for

ribose

and for organic

phosphate

B. pH of a 0,25 % solution

Between 1,5 and 2,5

C. Spectrometry:

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

Purity

Loss on drying

Other nucleotides

Lead

E 627 DISODIUM GUANYLATE

Not more than 1,5 % (120 (cid:176)C, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

Synonyms

Sodium guanylate, sodium 5’-guanylate

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Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Disodium guanosine-5’-monophosphate

221-849-5

C10H12N5Na2O8P (cid:25) x H2O (x = ca. 7)

407,19 (anhydrous)

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

Odourless, colourless or white crystals or white crystalline powder

A. Positive test for ribose, for organic phosphate,

and for sodium

B. pH of a 5 % solution

Between 7,0 and 8,5

C. Spectrometry:

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

Purity

Loss on drying

Other nucleotides

Lead

E 628 DIPOTASSIUM GUANYLATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 25 % (120 (cid:176)C, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

Potassium guanylate, potassium 5’-guanylate

Dipotassium guanosine-5’-monophosphate

226-914-1

C10H12K2N5O8P

439,40

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

Odourless, colourless or white crystals or white crystalline powder

A. Positive test for ribose, for organic phosphate,

and for potassium

B. pH of a 5 % solution

Between 7,0 and 8,5

C. Spectrometry:

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

Purity

Loss on drying

Other nucleotides

Lead

Not more than 5 % (120 (cid:176)C, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

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E 629 CALCIUM GUANYLATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium 5’-guanylate

Calcium guanosine-5’-monophosphate

C10H12CaN5O8P (cid:25) nH2O

401,20 (anhydrous)

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

Odourless, white or off-white crystals or powder

A. Positive test for ribose, for organic phosphate,

and for calcium

B. pH of a 0,05 % solution

Between 7,0 and 8,0

C. Spectrometry:

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

Purity

Loss on drying

Other nucleotides

Lead

E 630 INOSINIC ACID

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 23,0 % (120 (cid:176)C, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

5’-Inosinic acid

Inosine-5’-monophosphoric acid

205-045-1

C10H13N4O8P

348,21

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

Odourless, colourless or white crystals or powder

A. Positive

test

for

ribose, and for organic

phosphate

B. pH of a 5 % solution

Between 1,0 and 2,0

C. Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

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Purity

Loss on drying

Other nucleotides

Lead

E 631 DISODIUM INOSINATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 3,0 % (120 (cid:176)C, 4h)

Not detectable by thin-layer chromatography

Not more than 2 mg/kg

Sodium inosinate, sodium 5’-inosinate

Disodium inosine-5’-monophosphate

225-146-4

C10H11N4Na2O8P (cid:25) H2O

392,17 (anhydrous)

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

Odourless, colourless or white crystals or powder

A. Positive

test

for

ribose, and for organic

phosphate and for sodium

B. pH of a 5 % solution

Between 7,0 and 8,5

C. Spectrometry:

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

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Potassium inosinate, potassium 5’-inosinate

Dipotassium inosine-5’-monophosphate

243-652-3

C10H11K2N4O8P

424,39

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

Odourless, colourless or white crystals or powder

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Identification

A. Positive

test

for

ribose, and for organic

phosphate and for potassium

B. pH of a 5 % solution

Between 7,0 and 8,5

C. Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 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

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Calcium 5’-inosinate

Calcium inosine-5’-monophosphate

C10H11CaN4O8P (cid:25) nH2O

386,19 (anhydrous)

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

Odourless, colourless or white crystals or powder

A. Positive

test

for

ribose, and for organic

phosphate and for calcium

B. pH of a 0,05 % solution

Between 7,0 and 8,0

C. Spectrometry:

maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm

Purity

Water

Not more than 23,0 % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 634 CALCIUM 5’-RIBONUCLEOTIDE

Definition

Chemical name

Chemical formula

Calcium 5’-ribonucleotide is essentially a mixture of calcium inosine-5’-monophosphate
and calcium guanosine-5’-monophosphate

C10H11N4CaO8P (cid:25) nH2O y

C10H12N5CaO8P (cid:25) nH2O

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Assay

Description

Identification

Content of both major components not less than 97,0 %, and of each component not less
than 47,0 % and not more than 53 %, in every case on the anhydrous basis

Odourless, white or nearly white crystals or powder

A. Positive

test

for

ribose, and for organic

phosphate and for calcium

B. pH of a 0,05 % solution

Between 7,0 and 8,0

Purity

Water

Not more than 23,0 % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 635 DISODIUM 5’-RIBONUCLEOTIDE

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

Sodium 5’-ribonucleotide

Disodium 5’-ribonucleotide is essentially a mixture of disodium inosine-5’-mono-
phosphate and disodium guanosine-5’-monophosphate

C10H11N4O8P (cid:25) nH2O and

C10H12N5Na2O8P (cid:25) nH2O

Content of both major components not less than 97,0 %, and of each component not less
than 47,0 % and not more than 53 %, in every case on the anhydrous basis

Odourless, white or nearly white crystals or powder

A. Positive

test

for

ribose, and for organic

phosphate and for sodium

B. pH of a 5 % solution

Between 7,0 and 8,5

Purity

Water

Not more than 26,0 % (Karl Fischer)

Other nucleotides

Not detectable by thin-layer chromatography

Lead

Not more than 2 mg/kg

E 905 MICROCRYSTALLINE WAX

Synonyms

Definition

Description

Petroleum wax

Microcrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly
branched paraffin, obtained from petroleum

White to amber, odourless wax

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Identification

A. Solubility

Insoluble in water, very slightly soluble in ethanol

B. Refractive Index

nD100 1,434-1,448

Purity

Molecular weight

Viscosity at 100 (cid:176)C

Residue on ignition

Carbon number at 5 %
distillation point

Colour

Sulphur

Arsenic

Lead

Average not less than 500

Not less than 1,1 (cid:25) 10-5 m2s-1

Not more than 0,1 %

Not more than 5 % of molecules with carbon number less than 25

Passes test

Not more than 0,4 %

Not more than 3 mg/kg

Not more than 3 mg/kg

Polycyclic aromatic compounds

The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide,
shall meet the following ultraviolet absorbency limits:

nm

Maximum absorbance per cm path length

280-289

290-299

300-359

360-400

0,15

0,12

0,08

0,02

E 912 MONTAN ACID ESTERS

Definition

Chemical name

Description

Identification

A. Density (20 (cid:176)C)

B. Drop point

Purity

Acid value

Glycerol

Other polyols

Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol

Montan acid esters

Almost white to yellowish flakes, powder, granules or pellets

Between 0,98 and 1,05

Greater than 77 (cid:176)C

Not more than 40

Not more than 1 % (by gas chromatography)

Not more than 1 % (by gas chromatography)

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Other wax types

Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)

Arsenic

Chromium

Lead

Not more than 2 mg/kg

Not more than 3 mg/kg

Not more than 2 mg/kg

E 914 OXIDISED POLYETHYLENE WAX

Definition

Chemical name

Description

Identification

A. Density (20 (cid:176)C)

B. Drop point

Purity

Acid value

Viscosity at 120 (cid:176)C

Other wax types

Oxygen

Chromium

Lead

Polar reaction products from mild oxidation of polyethylene

Oxidised polyethylene

Almost white flakes, powder, granules or pellets

Between 0,92 and 1,05

Greater than 95 (cid:176)C

Not more than 70

Not less than 8,1 (cid:25) 10-5 m2s-1

Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)

Not more than 9,5 %

Not more than 5 mg/kg

Not more than 2 mg/kg

E 950 ACESULFAME K

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

E 951 ASPARTAME

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

E 953 ISOMALT

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC, as amended
by Directive 98/66/EC, laying down specific criteria of purity concerning sweeteners for use in foodstuffs.

E 957 THAUMATIN

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

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E 959 NEOHESPERIDINE DIHYDROCHALCONE

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

E 965(i) MALTITOL

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

E 965(ii) MALTITOL SYRUP

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

E 966 LACTITOL

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.

E 967 XYLITOL

Purity criteria for this additive are the same as set out for this additive in the Annex to Directive 95/31/EC laying down
specific criteria of purity concerning sweeteners for use in foodstuffs.