Commission Directive 2003/95/EC of 27 October 2003 amending Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
Date: 2003-10-27
Institutions: European Commission
Subjects: consumer protection, food additive, foodstuffs legislation, human nutrition, product quality

31.10.2003

EN

Official Journal of the European Union

L 283/71

COMMISSION DIRECTIVE 2003/95/EC

of 27 October 2003

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:

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 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

After consulting the Scientific Committee on Food,

Whereas:

(1)

(2)

(3)

(4)

(5)

(6)

(7)

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), lays down a list of 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 2002/82/EC (6), sets out the purity criteria for
the additives mentioned in Directive 95/2/EC.

The Scientific Committee on Food concluded in its
opinion of 6 May 2002 that the presence of ethylene
oxide should be brought below the detection limit.
Consequently,
the existing
the relevant criterion of
purity criteria set out in Directive 96/77/EC needs to be
adapted.

It is necessary to adapt to technical progress the existing
purity criteria for E 251 sodium nitrate and E 459 beta-
cyclodextrin.

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

techniques for additives as set out

Directive 96/77/EC should therefore be amended accord-
ingly.

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

Article 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 Direc-
tive by 1 November 2004 at the latest. They shall forthwith
inform the Commission thereof.

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

Article 3

Products put on the market or labelled before 1 November
2004 which do not comply with this Directive may be
marketed until stocks are exhausted.

Article 4

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

Article 5

This Directive is addressed to the Member States.

Done at Brussels, 27 October 2003.

For the Commission

David BYRNE

Member of the Commission

(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 292, 28.10.2002, p. 1.

L 283/72

EN

Official Journal of the European Union

31.10.2003

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

1. The text concerning E 251 sodium nitrate is replaced by the following:

ANNEX

‘E 251 SODIUM NITRATE

1. SOLID SODIUM NITRATE

Synonyms

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

Chile saltpetre

Cubic or soda nitre

Sodium nitrate

231-554-3
NaNO3
85,00

Content not less than 99 % after drying

White crystalline, slightly hygroscopic powder

A. Positive tests for nitrate and for sodium

B. pH of a 5 % solution

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

Purity

Loss on drying

Nitrites

Arsenic

Lead

Mercury

E 251 SODIUM NITRATE

2. LIQUID SODIUM NITRATE

Definition

Chemical name

EINECS

Chemical formula

Molecular weight

Assay

Description

Identification

A. Positive tests for nitrate and for sodium

B. pH

Purity

Free nitric acid

Nitrites

Arsenic

Lead

Mercury

This specification refers to a 35 % aqueous solu-
tion.’

Not more than 2 % after drying at 105 °C for four hours
Not more than 30 mg/kg expressed as NaNO2
Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

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

Sodium nitrate

231-554-3
NaNO3
85,00
Content between 33,5 % and 40,0 % of NaNO3
Clear colourless liquid

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

Not more than 0,01 %
Not more than 10 mg/kg expressed as NaNO2
Not more than 1 mg/kg

Not more than 1 mg/kg

Not more than 0,3 mg/kg

31.10.2003

EN

Official Journal of the European Union

L 283/73

2. The text concerning E 431 Polyoxyethylene (40) stearate, E 432 Polyoxyethylene sorbitan monolaurate (Polysorbate
20), E 433 Polyoxyethylene sorbitan monooleate (Polysorbate 80), E 434 Polyoxyethylene sorbitan monopalmitate
(Polysorbate 40), E 435 Polyoxyethylene sorbitan monostearate (Polysorbate 60) and E 436 Polyoxyethylene sorbitan
tristearate (Polysorbate 65) is replaced by the following:

‘E 431 POLYOXYETHYLENE (40) STEARATE

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polyoxyl (40) stearate

polyoxyethylene (40) monostearate

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

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

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

Soluble in water, ethanol, methanol and ethyl acetate. Inso-
luble in mineral oil

B. Congealing range

39 °C — 44 °C

C.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated
polyol

Purity

Water

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 1

Saponification value

Not less than 25 and not more than 35

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 27 and not more than 40

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

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 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

B.

Infrared absorption spectrum

Polysorbate 20

Polyoxyethylene (20) sorbitan monolaurate

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

commercial

lauric

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

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

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

Characteristic of a partial fatty acid ester of a polyoxyethylated
polyol

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Official Journal of the European Union

31.10.2003

Purity

Water

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 40 and not more than 50

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 96 and not more than 108

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

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 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

B.

Infrared absorption spectrum

Purity

Water

Acid value

Polysorbate 80

Polyoxyethylene (20) sorbitan monooleate

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

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

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

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

Characteristic of a partial fatty acid ester of a polyoxyethylated
polyol

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 45 and not more than 55

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 65 and not more than 80

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg

31.10.2003

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Official Journal of the European Union

L 283/75

E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

B.

Infrared absorption spectrum

Purity

Water

Acid value

Polysorbate 40

Polyoxyethylene (20) sorbitan monopalmitate

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

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

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

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

Characteristic of a partial fatty acid ester of a polyoxyethylated
polyol

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 41 and not more than 52

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 90 and not more than 107

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

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 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

B.

Infrared absorption spectrum

Polysorbate 60

Polyoxyethylene (20) sorbitan monostearate

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

commercial

stearic

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

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

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

Insoluble in

Characteristic of a partial fatty acid ester of a polyoxyethylated
polyol

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Official Journal of the European Union

31.10.2003

Purity

Water

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 45 and not more than 55

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 81 and not more than 96

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

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 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polysorbate 65

Polyoxyethylene (20) sorbitan tristearate

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

commercial

stearic

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

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

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

B. Congealing range

29 — 33 °C

C.

Infrared absorption spectrum

Characteristic of a partial fatty acid ester of a polyoxyethylated
polyol

Purity

Water

Acid value

Not more than 3 % (Karl Fischer method)

Not more than 2

Saponification value

Not less than 88 and not more than 98

Hydroxyl value

1,4-dioxane

Ethylene oxide

Not less than 40 and not more than 60

Not more than 5 mg/kg

Not more than 0,2 mg/kg

Ethylene glycols (mono- and di-)

Not more than 0,25 %

Arsenic

Lead

Mercury

Cadmium

Not more than 3 mg/kg

Not more than 5 mg/kg

Not more than 1 mg/kg

Not more than 1 mg/kg’

31.10.2003

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Official Journal of the European Union

L 283/77

3. The text concerning E 459 beta-cyclodextrin is replaced by the following:

‘E 459 BETA-CYCLODEXTRIN

Definition

Chemical name

EINECS
Chemical formula

Molecular weight

Assay

Description
Identification
A. Solubility

B. Specific rotation

Purity

Water
Other cyclodextrins

a

is

cyclic

non-reducing

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

recombinant Bacillus

231-493-2
(C6H10O5)7
1135
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
[α] 25

D: +160 ° to +164 ° (1 % solution)

Not more than 14 % (Karl Fischer method)
Not more than 2 % on an anhydrous basis

Residual solvents (toluene and trichloroethylene)

Not more than 1 mg/kg for each solvent

Sulphated ash
Arsenic

Lead

Not more than 0,1 %
Not more than 1 mg/kg

Not more than 1 mg/kg’

4. The text concerning Polyethylene glycol 6000 is replaced by the following:

‘POLYETHYLENE GLYCOL 6000

Synonyms

Definition

Chemical formula

Molecular weight

Assay
Description

Identification
A. Solubility

B. Melting range

Purity

Viscosity
Hydroxyl value

Sulphated ash

Ethylene oxide
Arsenic

Lead

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 corre-
sponding to a molecular weight of 6 000, 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
Between 55 °C and 61 °C

Between 0,220 and 0,275 kgm-1s-1 at 20 °C
Between 16 and 22

Not more than 0,2 %

Not more than 0,2 mg/kg
Not more than 3 mg/kg

Not more than 5 mg/kg’