Commission Directive 2002/82/EC of 15 October 2002 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
Date: 2002-10-15
Institutions: European Commission
Subjects: approximation of laws, consumer protection, food additive, foodstuffs legislation, human nutrition

28.10.2002

EN

Official Journal of the European Communities

L 292/1

I

(Acts whose publication is obligatory)

COMMISSION DIRECTIVE 2002/82/EC

of 15 October 2002

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
Community,

Having regard to Council Directive 89/107/EEC of 21
December 1988 on the approximation of
the
Member States concerning food additives authorised for use in
foodstuffs intended for human consumption (1), as amended
by Directive 94/34/EC of the European Parliament and of the
Council (2) and in particular Article 3(3)(a) thereof,

the laws of

(4)

(5)

(6)

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).

Directive 96/77/EC should therefore be
accordingly.

amended

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

After consulting the Scientific Committee on Food,

HAS ADOPTED THIS DIRECTIVE:

Whereas:

Article 1

(1)

(2)

(3)

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), lists those substances which
may be used as additives other
than colours and
sweeteners in foodstuffs.

Commission Directive 96/77/EC (5), as last amended by
Directive 2001/30/EC (6) sets out the purity criteria for
and sweeteners
the
mentioned in Directive 95/2/EC.

additives other

than colours

It is necessary to adapt to technical progress existing
in Directive 96/77/EC and to
purity criteria set out
establish new purity criteria for those food additives for
which these were failing.

(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 146, 31.5.2001, p. 1.

The Annex to Directive 96/77/EC is amended as set out in the
Annex to this Directive.

Article 2

Member States shall bring into force the laws, regulations and
administrative provisions necessary to comply with this
Directive by 31 August 2003 at the latest. They shall forthwith
inform the Commission thereof.

these provisions,

When Member States adopt
these shall
contain a reference to this Directive or shall be accompanied
by such reference at the occasion of their official publication.
Member States shall determine how such reference is to be
made.

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.

L 292/2

EN

Official Journal of the European Communities

28.10.2002

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 15 October 2002.

For the Commission

David BYRNE

Member of the Commission

28.10.2002

EN

Official Journal of the European Communities

L 292/3

The Annex to Directive 96/77/EC is amended as follows:

ANNEX

(1) The text concerning E 338 Phosphoric acid, E 339 (i) Monosodium Phosphate, E 339 (ii) Disodium Phosphate, E 339 (iii) Trisodium Phosphate,
E 340 (i) Monopotassium Phosphate, E 340 (ii) Dipotassium Phosphate, E 340 (iii) Tripotassium Phosphate, E 341 (i) Monocalcium Phosphate,
E 341 (ii) Dicalcium Phosphate, E 341 (iii) Tricalcium Phosphate, E 450 (i) Disodium Diphosphate, E 450 (ii) Trisodium Diphosphate, E 450 (iii)
Tetrasodium Diphosphate, E 450 (v) Tetrapotassium Diphosphate, E 450 (vi) Dicalcium Diphosphate, E 450 (vii) Calcium Dihydrogen
Diphosphate, E 451 (i) Pentasodium Triphosphate and E 451 (ii) Pentapotassium Triphosphate, E 452 (i) Sodium Polyphosphate, E 452 (ii)
Potassium Polyphosphate and E 452 (iv) Calcium Polyphosphate is replaced by the following:

(cid:145)E 338 PHOSPHORIC ACID

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for acid and for phosphate

Purity

Volatile acids

Chlorides

Nitrates

Sulphates

Fluoride

Arsenic

Cadmium

Lead

Mercury

Note:

This specification refers to a 75 % aqueous solution.

Orthophosphoric acid

Monophosphoric acid

Phosphoric acid

231-633-2

H3PO4

98,00

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

Clear, colourless, viscous liquid

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

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

Not more than 5 mg/kg (as NaNO3)

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

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/4

EN

Official Journal of the European Communities

28.10.2002

E 339 (i) MONOSODIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Monosodium monophosphate

Acid monosodium monophosphate

Monosodium orthophosphate

Monobasic sodium phosphate

Sodium dihydrogen monophosphate

Sodium dihydrogen monophosphate

231-449-2

Anhydrous: NaH2PO4
Monohydrate: NaH2PO4 • H2O
Dihydrate: NaH2PO4 • 2H2O

Anhydrous: 119,98

Monohydrate: 138,00

Dihydrate: 156,01

After drying at 60 (cid:176)C for one hour and then at 105 (cid:176)C for four hours,
contains not less than 97 % of NaH2PO4

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

A white odourless, slightly deliquescent powder, crystals or granules

A. Positive tests for sodium and for phosphate

B.

Solubility

Freely soluble in water. Insoluble in ethanol or ether

C. pH of a 1 % solution

Between 4,1 and 5,0

Purity

Loss on drying

The anhydrous salt loses not more than 2,0 %, the monohydrate not
more than 15,0 %, and the dihydrate not more than 25 % when dried
first at 60 (cid:176)C for one hour, then at 105 (cid:176)C for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/5

E 339 (ii) DISODIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Disodium monophosphate

Secondary sodium phosphate

Disodium orthophosphate

Acid disodium phosphate

Disodium hydrogen monophosphate

Disodium hydrogen orthophosphate

231-448-7

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

141,98 (anhydrous)

After drying at 40 (cid:176)C for three hours and subsequently at 105 (cid:176)C for
five hours, contains not less than 98 % of Na2HPO4

Between 49 % and 51 % on the anhydrous basis

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

Identification

A. Positive tests for sodium and for phosphate

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C. pH of a 1 % solution

Between 8,4 and 9,6

Purity

Loss on drying

When dried at 40 (cid:176)C for three hours and then at 105(cid:176)C for five hours,
the losses in weight are as follows: anhydrous not more than 5,0 %,
dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %,
dodecahydrate not more than 61,0 %

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/6

EN

Official Journal of the European Communities

28.10.2002

E 339 (iii) TRISODIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Sodium phosphate

Tribasic sodium phosphate

Trisodium orthophosphate

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

Trisodium monophosphate

Trisodium phosphate

Trisodium orthophosphate

231-509-8

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

163,94 (anhydrous)

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

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

White odourless crystals, granules or crystalline powder

A. Positive tests for sodium and for phosphate

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C. pH of a 1 % solution

Between 11,5 and 12,5

Purity

Loss on ignition

When dried at 120 (cid:176)C for two hours and then ignited at about 800 (cid:176)C
for 30 minutes, the losses in weight are as follows: anhydrous not
more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate:
between 45,0 % and 58,0 %

Water insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/7

E 340 (i) MONOPOTASSIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Monobasic potassium phosphate

Monopotassium monophosphate

Potassium orthophosphate

Potassium dihydrogen phosphate

Monopotassium dihydrogen orthophosphate

Monopotassium dihydrogen monophosphate

231-913-4

KH2PO4

136,09

Content not less than 98,0 % after drying at 105 (cid:176)C for four hours

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

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

A. Positive tests for potassium and for phosphate

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C. pH of a 1 % solution

Between 4,2 and 4,8

Purity

Loss on drying

Not more than 2,0 % determined by drying at 105 (cid:176)C for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/8

EN

Official Journal of the European Communities

28.10.2002

E 340 (ii) DIPOTASSIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Dipotassium monophosphate

Secondary potassium phosphate

Dipotassium acid phosphate

Dipotassium orthophosphate

Dibasic potassium phosphate

Dipotassium hydrogen monophosphate

Dipotassium hydrogen phosphate

Dipotassium hydrogen orthophosphate

231-834-5

K2HPO4

174,18

Content not less than 98 % after drying at 105(cid:176)C for four hours

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

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

A. Positive tests for potassium and for phosphate

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C. pH of a 1 % solution

Between 8,7 and 9,4

Purity

Loss on drying

Not more than 2,0 % determined by drying at 105 (cid:176)C for four hours

Water-insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/9

E 340 (iii) TRIPOTASSIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Potassium phosphate

Tribasic potassium phosphate

Tripotassium orthophosphate

Tripotassium monophosphate

Tripotassium phosphate

Tripotassium orthophosphate

231-907-1

Anhydrous: K3PO4
Hydrated: K3PO4 • nH2O (n = 1 or 3)

212,27 (anhydrous)

Content not less than 97 % calculated on the ignited basis

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

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

A. Positive tests for potassium and for phosphate

B.

Solubility

Freely soluble in water. Insoluble in ethanol

C. pH of a 1 % solution

Between 11,5 and 12,3

Purity

Loss on ignition

Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %.
Determined by drying at 105 (cid:176)C for one hour and then ignite at about
800 (cid:176)C – 25 (cid:176)C for 30 minutes

Water insoluble substances

Not more than 0,2 % on the anhydrous basis

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/10

EN

Official Journal of the European Communities

28.10.2002

E 341 (i) MONOCALCIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

A. Positive tests for calcium and for phosphate

B. CaO content

Purity

Loss on drying

Loss on ignition

Fluoride

Arsenic

Cadmium

Lead

Mercury

Monobasic calcium phosphate

Monocalcium orthophosphate

Calcium dihydrogen phosphate

231-837-1

Anhydrous: Ca(H2PO4)2
Monohydrate: Ca(H2PO4)2 • H2O

234,05 (anhydrous)

252,08 (monohydrate)

Content not less than 95 % on the dried basis

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

Granular powder or white, deliquescent crystals or granules

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

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

Not more than 14 % determined by drying at 105 (cid:176)C for four hours
(anhydrous)

Not more than 17,5 % determined by drying at 60 (cid:176)C for one hour,
then at 105 (cid:176)C for four hours (monohydrate)

Not more than 17,5 % after ignition at 800 (cid:176)C – 25 (cid:176)C for 30 minutes
(anhydrous)

Not more than 25,0 % determined by drying at 105 (cid:176)C for one hour,
then ignite at 800 (cid:176)C – 25 (cid:176)C for 30 minutes (monohydrate)

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/11

E 341 (ii) DICALCIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Dibasic calcium phosphate

Dicalcium orthophosphate

Calcium monohydrogen phosphate

Calcium hydrogen orthophosphate

Secondary calcium phosphate

231-826-1

Anhydrous: CaHPO4
Dihydrate: CaHPO4 • 2H2O

136,06 (anhydrous)

172,09 (dihydrate)

Dicalcium phosphate, after drying at 200 (cid:176)C for three hours, contains
not less than 98 % and not more than the equivalent of 102 % of
CaHPO4

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

White crystals or granules, granular powder or powder

A. Positive tests for calcium and for phosphate

B.

Solubility tests

Sparingly soluble in water. Insoluble in ethanol

Purity

Loss on ignition

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition
at 800 (cid:176)C – 25 (cid:176)C for 30 minutes

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/12

EN

Official Journal of the European Communities

28.10.2002

E 341 (iii) TRICALCIUM PHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

A. Positive tests for calcium and for phosphate

B.

Solubility

Purity

Loss on ignition

Fluoride

Arsenic

Cadmium

Lead

Mercury

Calcium phosphate, tribasic

Calcium orthophosphate

Pentacalcium hydroxy monophosphate

Calcium hydroxyapatite

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

Pentacalcium hydroxy monophosphate

Tricalcium monophosphate

235-330-6 (Pentacalcium hydroxy monophosphate)

231-840-8 (Calcium orthophosphate)

Ca5(PO4)3 • OH or Ca3(PO4)2

502 or 310

Content not less than 90 % calculated on the ignited basis

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

A white, odourless powder which is stable in air

Practically insoluble in water; insoluble in etanol, soluble in dilute
hydrochloric and nitric acid

Not more than 8 % after ignition at 800 (cid:176)C – 25 (cid:176)C, to constant
weight

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/13

E 450 (i) DISODIUM DIPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 Content

Description

Identification

Disodium dihydrogen diphosphate

Disodium dihydrogen pyrophosphate

Sodium acid pyrophosphate

Disodium pyrophosphate

Disodium dihydrogen diphosphate

231-835-0

Na2H2P2O7

221,94

Content not less than 95 % of disodium diphosphate.

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

White powder or grains

A. Positive tests for sodium and for phosphate

B.

Solubility

Soluble in water

C. pH of a 1 % solution

Between 3,7 and 5,0

Purity

Loss on drying

Water-insoluble matter

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 0,5 % (105 (cid:176)C, four hours)

Not more than 1 %

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/14

EN

Official Journal of the European Communities

28.10.2002

E 450 (ii) TRISODIUM DIPHOSPHATE

Synonyms

Definition

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Acid trisodium pyrophosphate

Trisodium monohydrogen diphosphate

238-735-6

Monohydrate: Na3HP2O7 • H2O
Anhydrous: Na3HP2O7

Monohydrate: 261,95

Anhydrous: 243,93

Content not less than 95 % on the anhydrous basis

Not less than 57 % and not more than 59 %

White powder or grains, occurs anhydrous or as a monohydrate

A. Positive tests for sodium and for phosphate

B.

Soluble in water

C. pH of a 1 % solution

Between 6,7 and 7,5

Purity

Loss on ignition

Loss on drying

Water-insoluble matter

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 4,5 % on the anhydrous compound

Not more than 11,5 % on the monohydrous basis

Not more than 0,5 % (105 (cid:176)C, four hours)

Not more than 0,2 %

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/15

E 450 (iii) TETRASODIUM DIPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Tetrasodium pyrophosphate

Sodium pyrophosphate

Tetrasodium diphosphate

231-767-1

Anhydrous: Na4P2O7
Decahydrate: Na4P2O7 • 10H2O

Anhydrous: 265,94

Decahydrate: 446,09

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

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

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

A. Positive tests for sodium and for phosphate

B.

Solubility

Soluble in water. Insoluble in ethanol

C. pH of a 1 % solution

Between 9,8 and 10,8

Purity

Loss on ignition

Not more than 0,5 % for the anhydrous salt, not less than 38 % and
not more than 42 % for the decahydrate, in both cases determined
after drying at 105 (cid:176)C for four hours, followed by ignition at 550 (cid:176)C
for 30 minutes

Water-insoluble matter

Not more than 0,2 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/16

EN

Official Journal of the European Communities

28.10.2002

E 450 (v) TETRAPOTASSIUM DIPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Potassium pyrophosphate

Tetrapotassium pyrophosphate

Tetrapotassium diphosphate

230-785-7

K4P2O7

330,34 (anhydrous)

Content not less than 95 % on the ignited basis

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

Colourless crystals or white, very hygroscopic powder

A. Positive tests for potassium and for phosphate

B.

Solubility

Soluble in water, insoluble in ethanol

C. pH of a 1 % solution

Between 10,0 and 10,8

Purity

Loss on ignition

Not more than 2 % after drying at 105 (cid:176)C for four hours and then
ignition at 550 (cid:176)C for 30 minutes

Water-insoluble substances

Not more than 0,2 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/17

E 450 (vi) DICALCIUM DIPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Calcium pyrophosphate

Dicalcium diphosphate

Dicalcium pyrophosphate

232-221-5

Ca2P2O7

254,12

Content not less than 96 %

Not less than 55 % and not more than 56 %

A fine, white, odourless powder

A. Positive tests for calcium and for phosphate

B.

Solubility

Insoluble in water. Soluble in dilute hydrochloric and nitric acids

C. pH of a 10 % suspension in water

Between 5,5 and 7,0

Purity

Loss on ignition

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 1,5 % at 800 (cid:176)C – 25 (cid:176)C for 30 minutes

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/18

EN

Official Journal of the European Communities

28.10.2002

E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

Acid calcium pyrophosphate

Monocalcium dihydrogen pyrophosphate

Calcium dihydrogen diphosphate

238-933-2

CaH2P2O7

215,97

Content not less than 90 % on the anhydrous basis

Not less than 61 % and not more than 64 %

White crystals or powder

A. Positive tests for calcium and for phosphate

Purity

Acid-insoluble matter

Not more than 0,4 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/19

E 451 (i) PENTASODIUM TRIPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

A. Solubility

Pentasodium tripolyphosphate

Sodium tripolyphosphate

Pentasodium triphosphate

231-838-7

Na5O10P3 • nH2O (n = 0 or 6)

367,86

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

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

White, slightly hygroscopic granules or powder

Freely soluble in water. Insoluble in ethanol

B.

Positive tests for sodium and for phosphate

C. pH of a 1 % solution

Between 9,1 and 10,2

Purity

Loss on drying

Anhydrous: Not more than 0,7 % (105 (cid:176)C, one hour)

Hexahydrate: Not more than 23,5 % (60 (cid:176)C, one hour, followed by
drying at 105 (cid:176)C, four hours)

Water-insoluble substances

Higher polyphosphates

Not more than 0,1 %

Not more than 1 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/20

EN

Official Journal of the European Communities

28.10.2002

E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

P2O5 content

Description

Identification

A. Solubility

Pentapotassium tripolyphosphate

Potassium triphosphate

Potassium tripolyphosphate

Pentapotassium triphosphate

Pentapotassium tripolyphosphate

237-574-9

K5O10P3

448,42

Content not less than 85 % on the anhydrous basis

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

White, very hygroscopic powder or granules

Very soluble in water

B.

Positive tests for potassium and for phosphate

C. pH of a 1 % solution

Between 9,2 and 10,5

Purity

Loss on ignition

Not more than 0,4 % (after drying at 105 (cid:176)C, four hours, followed by
ignition at 550 (cid:176)C, 30 minutes)

Water-insoluble matter

Not more than 2 %

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/21

E 452 (i) SODIUM POLYPHOSPHATE

1. SOLUBLE POLYPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay P2O5 content

Description

Identification

A. Solubility

Sodium hexametaphosphate

Sodium tetrapolyphosphate

Graham’s salt

Sodium polyphosphates, glassy

Sodium polymetaphosphate

Sodium metaphosphate

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

Sodium polyphosphate

272-808-3

Heterogenous mixtures of sodium salts of linear condensed
polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where (cid:145)n(cid:146) is
not less than 2

(102)n

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

Colourless or white, transparent platelets, granules, or powders

Very soluble in water

B.

Positive tests for sodium and for phosphate

C. pH of a 1 % solution

Between 3,0 and 9,0

Purity

Loss on ignition

Water-insoluble matter

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 1 %

Not more than 0,1 %

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/22

EN

Official Journal of the European Communities

28.10.2002

2. INSOLUBLE POLYPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

P2O5 content

Description

Identification

A. Solubility

Insoluble sodium metaphosphate

Maddrell’s salt

Insoluble sodium polyphosphate, IMP

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

Sodium polyphosphate

272-808-3

Heterogenous mixtures of sodium salts of linear condensed
polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where (cid:145)n(cid:146) is
not less than 2

(102)n

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

White crystalline powder

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

B.

Positive tests for sodium and for phosphate

C. pH of 1 in 3 suspension in water

About 6,5

Purity

Fluoride

Arsenic

Cadmium

Lead

Mercury

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

28.10.2002

EN

Official Journal of the European Communities

L 292/23

E 452 (ii) POTASSIUM POLYPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

P2O5 content

Description

Identification

A. Solubility

Potassium metaphosphate

Potassium polymetaphosphate

Kurrol salt

Potassium polyphosphate

232-212-6

(KPO3)n
Heterogenous mixtures of potassium salts of linear condensed
polyphosphoric acids of general formula H(n + 2)PnO(3n + 1)where (cid:145)n(cid:146) is
not less than 2

(118)n

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

Fine white powder or crystals or colourless glassy platelets

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

B.

Positive tests for potassium and for phosphate

C. pH of a 1 % suspension

Not more than 7,8

Purity

Loss on ignition

Cyclic phosphate

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 2 % (105 (cid:176)C, four hours followed by ignition at
550 (cid:176)C, 30 minutes)

Not more than 8 % on P2O5 content

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg

L 292/24

EN

Official Journal of the European Communities

28.10.2002

E 452 (iv) CALCIUM POLYPHOSPHATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

P2O5 content

Description

Identification

A. Solubility

Calcium metaphosphate

Calcium polymetaphosphate

Calcium polyphosphate

236-769-6

(CaP2O6)n
Heterogenous mixtures of calcium salts of condensed polyphosphoric
acids of general formula H(n + 2)PnO(n + 1) where (cid:145)n(cid:146) is not less than 2

(198)n

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

Odourless, colourless crystals or white powder

Usually sparingly soluble in water. Soluble in acid medium

B.

Positive tests for calcium and for phosphate

C. CaO content

27 to 29,5 %

Purity

Loss on ignition

Cyclic phosphate

Fluoride

Arsenic

Cadmium

Lead

Mercury

Not more than 2 % (105 (cid:176)C, four hours followed by ignition at
550 (cid:176)C, 30 minutes)

Not more than 8 % on P2O5 content

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

Not more than 3 mg/kg

Not more than 1 mg/kg

Not more than 4 mg/kg

Not more than 1 mg/kg(cid:146)

28.10.2002

EN

Official Journal of the European Communities

L 292/25

(2) The following text relating to E 650 Zinc acetate, E 943a Butane, E 943b Isobutane, E 944 Propane, E 949 Hydrogen, E 1201

Polyvinylpyrrolidone and E 1202 Polyvinylpolypyrrolidone is added:

(cid:145)E 650 ZINC ACETATE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Acetic acid, zinc salt, dihydrate

Zinc acetate dihydrate

C4H6O4 Zn • 2H2O

219,51

Content not less than 98 % and not more than 102 %
of C4H6O4 Zn • 2H2O

Colourless crystals or fine, off-white powder

A. Positive tests for acetate and for zinc

B. pH of a 5 % solution

Between 6,0 and 8,0

Purity

Insoluble matter

Chlorides

Sulphates

Alkalines and alkaline earths

Organic volatile impurities

Iron

Arsenic

Lead

Cadmium

E 943a BUTANE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 0,005 %

Not more than 50 mg/kg

Not more than 100 mg/kg

Not more than 0,2 %

Passes test

Not more than 50 mg/kg

Not more than 3 mg/kg

Not more than 20 mg/kg

Not more than 5 mg/kg

n-Butane

Butane

CH3CH2CH2CH3

58,12

Content not less than 96 %

Colourless gas or liquid with mild, characteristic odour

A. Vapour pressure

108,935 kPa at 20 (cid:176)C

Purity

Methane

Ethane

Propane

Not more than 0,15 % v/v

Not more than 0,5 % v/v

Not more than 1,5 % v/v

L 292/26

EN

Official Journal of the European Communities

28.10.2002

Isobutane

1,3-butadiene

Moisture

E 943b ISOBUTANE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 3,0 % v/v

Not more than 0,1 % v/v

Not more than 0,005 %

2-methyl propane

2-methyl propane

(CH3)2CH CH3

58,12

Content not less than 94 %

Colourless gas or liquid with mild, characteristic odour

A. Vapour pressure

205,465 kPa at 20 (cid:176)C

Purity

Methane

Ethane

Propane

n-Butane

1,3-butadiene

Moisture

E 944 PROPANE

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

Not more than 0,15 % v/v

Not more than 0,5 % v/v

Not more than 2,0 % v/v

Not more than 4,0 % v/v

Not more than 0,1 % v/v

Not more than 0,005 %

Propane

CH3CH2CH3

44,09

Content not less than 95 %

Colourless gas or liquid with mild, characteristic odour

A. Vapour pressure

732,910 kPa at 20 (cid:176)C

Purity

Methane

Ethane

Isobutane

n-Butane

1,3-butadiene

Moisture

Not more than 0,15 % v/v

Not more than 1,5 % v/v

Not more than 2,0 % v/v

Not more than 1,0 % v/v

Not more than 0,1 % v/v

Not more than 0,005 %

28.10.2002

EN

Official Journal of the European Communities

L 292/27

E 949 HYDROGEN

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Purity

Water

Oxygen

Nitrogen

E 1201 POLYVINYLPYRROLIDONE

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

Hydrogen

215-605-7

H2

2

Content not less than 99,9 %

Colourless, odourless, highly flammable gas

Not more than 0,005 % v/v

Not more than 0,001 % v/v

Not more than 0,75 % v/v

Povidone

PVP

Soluble polyvinylpyrrolidone

Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

(C6H9NO)n

Not less than 25 000

Content not less than 11,5 % and not more than 12,8 % of nitrogen
(N) on the anhydrous basis

White or nearly white powder

Soluble in water and in ethanol. Insoluble in ether

B. pH of a 5 % solution

Between 3,0 and 7,0

Purity

Water

Total ash

Aldehyde

Free-N-vinylpyrrolidone

Hydrazine

Lead

Not more than 5 % (Karl Fischer)

Not more than 0,1 %

Not more than 500 mg/kg (as acetaldehyde)

Not more than 10 mg/kg

Not more than 1 mg/kg

Not more than 5 mg/kg

L 292/28

EN

Official Journal of the European Communities

28.10.2002

E 1202 POLYVINYLPOLYPYRROLIDONE

Synonyms

Definition

Chemical name

Chemical formula

Assay

Description

Identification

A. Solubility

Crospovidone

Cross linked polyvidone

Insoluble polyvinylpyrrolidone

Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene],
cross linked in a random fashion. It is produced by the polymerisation
of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or
N, N’-divinyl-imidazolidone. Due to its insolubility in all common
solvents the molecular weight range is not amenable to analytical
determination

Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]

(C6H9NO)n

Content not less than 11 % and not more than 12,8 % nitrogen (N) on
the anhydrous basis

A white hygroscopic powder with a faint, non-objectionable odour

Insoluble in water, ethanol and ether

B. pH of a 1 % suspension in water

Between 5,0 and 8,0

Purity

Water

Sulphated ash

Water-soluble matter

Free-N-vinylpyrrolidone

Free-N,N’-divinyl-imidazolidone

Lead

Not more than 6 % (Karl Fischer)

Not more than 0,4 %

Not more than 1 %

Not more than 10 mg/kg

Not more than 2 mg/kg

Not more than 5 mg/kg(cid:146).