Commission Directive 2006/128/EC of 8 December 2006 amending and correcting Directive 95/31/EC laying down specific criteria of purity concerning sweeteners for use in foodstuffs   (Text with EEA relevance)
Date: 2006-12-08
Institutions: European Commission
Subjects: food inspection, food standard, foodstuff, foodstuffs legislation, sweetener

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COMMISSION DIRECTIVE 2006/128/EC

of 8 December 2006

amending and correcting Directive 95/31/EC laying down specific criteria of purity concerning
sweeteners for use in foodstuffs

(Text with EEA relevance)

THE COMMISSION OF THE EUROPEAN COMMUNITIES,

Having regard to the Treaty
Community,

establishing the European

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
intended for human consumption (1),
foodstuffs
and in
particular Article 3(3)(a) thereof,

the laws of

After consulting the Scientific Committee on Food and the
European Food Safety Authority (EFSA),

Whereas:

(1)

(2)

(3)

(4)

Directive 94/35/EC of the European Parliament and of
the Council of 30 June 1994 on sweeteners for use in
foodstuffs (2), lists those substances which may be used
as sweeteners in foodstuffs.

Commission Directive 95/31/EC of 5 July 1995 laying
down specific criteria of purity concerning sweeteners for
use in foodstuffs (3), sets out the purity criteria for the
sweeteners listed in Directive 94/35/EC.

It
is necessary to adopt specific criteria for E 968
erythritol, a new food additive authorised by Directive
2006/52/EC of
the
Council of 5 July 2006 amending Directive 95/2/EC on
food additives other than colours and sweeteners and
Directive 94/35/EC on sweeteners for use in foodstuffs.

the European Parliament and of

A number of language versions of Directive 95/31/EC
contain some errors regarding the following substances:
E 954 saccharin and its Na, K and Ca salts, E 955
sucralose, E 962 salt of aspartame-acesulfame, E 965 (i)
maltitol, E 966 lactitol. Those errors need to be
is necessary to take into
corrected.
account the specifications and analytical techniques for
additives as set out in the Codex Alimentarius as drafted

In addition it

(1) OJ L 40, 11.2.1989, p. 27. Directive as last amended by Regulation
(EC) No 1882/2003 of the European Parliament and of the Council
(OJ L 284, 31.10.2003, p. 1).

(2) OJ L 237, 10.9.1994, p. 3. Directive as last amended by Directive

2006/52/EC (OJ L 204, 26.7.2006, p. 10).

(3) OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive

2004/46/EC (OJ L 114, 21.4.2004, p. 15).

by the Joint FAO/WHO Expert Committee on Food
Additives (JECFA). In particular where appropriate, the
specific purity criteria have been adapted to reflect the
limits for individual heavy metals of interest. For reasons
of clarity the whole text concerning those substances
should be replaced.

EFSA in its
scientific opinion of 19 April 2006
concluded that the composition of maltitol syrup based
on a new production method will be similar to that of
the existing product and will be in accordance with the
existing specification. It is therefore necessary to amend
the definition of E 965 (ii) maltitol syrup set out in
Directive 95/31/EC for E 965 by including that new
production method.

Directive 95/31/EC should therefore be amended and
corrected accordingly.

The measures provided for
accordance with
Committee on the Food Chain and Animal Health,

in this Directive are in
Standing
the

opinion

the

of

(5)

(6)

(7)

HAS ADOPTED THIS DIRECTIVE:

Article 1

The Annex to Directive 95/31/EC is amended and corrected in
accordance with the Annex to this Directive.

Article 2

1. Member States shall bring into force the laws, regulations
and administrative provisions necessary to comply with this
Directive by 15 February 2008 at
the latest. They shall
forthwith communicate to the Commission the text of those
provisions and a correlation table between those provisions and
this Directive.

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.

2. Member States shall communicate to the Commission the
text of the main provisions of national law which they adopt in
the field covered by this Directive.

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

Article 3

This Directive is addressed to the Member States.

Article 4

Done at Brussels, 8 December 2006.

For the Commission

Markos KYPRIANOU
Member of the Commission

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ANNEX

The Annex to Directive 95/31/EC is amended and corrected as follows:

1. The following text concerning E 968 erythritol is inserted after E 967 xylitol:

‘E 968 ERYTHRITOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

Meso-erythritol, tetrahydroxybutane, erythrite

Obtained by fermentation of carbohydrate source by safe and
suitable food grade osmophilic yeasts such as Moniliella pollinis
or Trichosporonoides megachilensis,
followed by purification and
drying

1,2,3,4-Butanetetrol

205-737-3

C4H10O4

122,12

Not less than 99 % after drying

White, odourless, non-hygroscopic, heat-stable crystals with a
sweetness of approximately 60-80 % that of sucrose.

Freely soluble in water, slightly soluble in ethanol, insoluble in
diethyl ether.

B. Melting range

119-123 °C

Purity

Loss on drying

Sulphated ash

Reducing substances

Ribitol and glycerol

Lead

Not more than 0,2 % (70 °C, six hours, in a vacuum desiccator)

Not more than 0,1 %

Not more than 0,3 % expressed as D-glucose

Not more than 0,1 %

Not more than 0,5 mg/kg’

2. The text concerning E 954 saccharin and its Na, K and Ca salts is replaced by the following:

‘E 954 SACCHARIN AND ITS Na, K AND Ca SALTS

(I) SACCHARIN

Definition

Chemical name

3-Oxo-2,3-dihydrobenzo(d)isothiazol-1,1-dioxide

Einecs

Chemical formula

Relative molecular mass

201-321-0

C7H5NO3S

183,18

Assay

Description

Not less than 99 % and not more than 101 % of C7H5NO3S on
the anhydrous basis

White crystals or a white crystalline powder, odourless or with a
faint, aromatic odour, having a sweet taste, even in very dilute
solutions. Approximately between 300 and 500 times as sweet as
sucrose

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Identification

Solubility

Purity

Loss on drying

Melting range

Sulphated ash

Benzoic and salicylic acid

Slightly soluble in water, soluble in basic solutions, sparingly
soluble in ethanol

Not more than 1 % (105 °C, two hours)

226-230 °C

Not more than 0,2 % expressed on dry weight basis

To 10 ml of a 1 in 20 solution, previously acidified with five
drops of acetic acid, add three drops of an approximately molar
solution of ferric chloride in water. No precipitate or violet colour
appears

o-Toluenesulphonamide

Not more than 10 mg/kg expressed on dry weight basis

p-Toluenesulphonamide

Not more than 10 mg/kg expressed on dry weight basis

Benzoic acid p-sulfonamide

Not more than 25 mg/kg expressed on dry weight basis

Readily carbonisable substances

Absent

Arsenic

Selenium

Lead

Not more than 3 mg/kg expressed on dry weight basis

Not more than 30 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis.

(II) SODIUM SACCHARIN

Synonyms

Definition

Chemical name

Saccharin, sodium salt of saccharin

Sodium o-benzosulphimide,
oxobenzisosulphonazole,
oxobenzisosulphonazole,
sothiazolin-3-one-1,1-dioxide sodium salt dihydrate

sodium salt of 2,3-dihydro-3-
1,2-benzi-

Einecs

Chemical formula

204-886-1

C7H4NNaO3S·2H2O

Relative molecular mass

241,19

Assay

Description

Identification

Solubility

Purity

Not less than 99 % and not more than 101 % of C7H4NNaO3S
on the anhydrous basis

a white

crystals or

efflorescent powder,
White
odourless or with a faint odour, having an intensely sweet
taste, even in very dilute solutions. Approximately between 300
and 500 times as sweet as sucrose in dilute solutions

crystalline

Freely soluble in water, sparingly soluble in ethanol

Loss on drying

Not more than 15 % (120 °C, four hours)

Benzoic and salicylic acid

To 10 ml of a 1 in 20 solution, previously acidified with five
drops of acetic acid, add three drops of an approximately molar
solution of ferric chloride in water. No precipitate or violet colour
appears

o-Toluenesulphonamide

Not more than 10 mg/kg expressed on dry weight basis

p-Toluenesulphonamide

Not more than 10 mg/kg expressed on dry weight basis

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Benzoic acid p-sulphonamide

Not more than 25 mg/kg expressed on dry weight basis

Readily carbonisable substances

Absent

Arsenic

Selenium

Lead

Not more than 3 mg/kg expressed on dry weight basis

Not more than 30 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

(III) CALCIUM SACCHARIN

Synonyms

Definition

Chemical name

Saccharin, calcium salt of saccharin

Calcium o-benzosulphimide,
oxobenzisosulfonazole,
calcium salt hydrate (2:7)

calcium salt of 2,3-dihydro-3-
1,2-benzisothiazolin-3-one-1,1-dioxide

Einecs

Chemical formula

229-349-9

C14H8CaN2O6S2

·31/2H2O

Relative molecular mass

467,48

Assay

Description

Identification

Solubility

Purity

Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis

White crystals or a white crystalline powder, odourless or with a
faint odour, having an intensely sweet taste, even in very dilute
solutions. Approximately between 300 and 500 times as sweet as
sucrose in dilute solutions

Freely soluble in water, soluble in ethanol

Loss on drying

Not more than 13,5 % (120 °C, four hours)

Benzoic and salicylic acid

To 10 ml of a 1 in 20 solution, previously acidified with five
drops of acetic acid, add three drops of an approximately molar
solution of ferric chloride in water. No precipitate or violet colour
appears

o-Toluenesulphonamide

Not more than 10 mg/kg expressed on dry weight basis

p-Toluenesulphonamide

Not more than 10 mg/kg expressed on dry weight basis

Benzoic acid p-sulphonamide

Not more than 25 mg/kg expressed on dry weight basis

Readily carbonisable substances

Absent

Arsenic

Selenium

Lead

Not more than 3 mg/kg expressed on dry weight basis

Not more than 30 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis

(IV) POTASSIUM SACCHARIN

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Saccharin, potassium salt of saccharin

Potassium o-benzosulphimide, potassium salt of 2,3-dihydro-3-
oxobenzisosulphonazole, potassium salt of 1,2-benzisothiazolin-
3-one-1,1-dioxide monohydrate

C7H4KNO3S·H2O

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Relative molecular mass

239,77

Assay

Description

Identification

Solubility

Purity

Not less than 99 % and not more than 101 % of C7H4KNO3S on
the anhydrous basis

White crystals or a white crystalline powder, odourless or with a
faint odour, having an intensely sweet taste, even in very dilute
solutions. Approximately between 300 and 500 times as sweet as
sucrose

Freely soluble in water, sparingly soluble in ethanol

Loss on drying

Not more than 8 % (120 °C, four hours)

Benzoic and salicylic acid

To 10 ml of a 1 in 20 solution, previously acidified with five
drops of acetic acid, add three drops of an approximately molar
solution of ferric chloride in water. No precipitate or violet colour
appears

o-Toluenesulphonamide

Not more than 10 mg/kg expressed on dry weight basis

p-Toluenesulphonamide

Not more than 10 mg/kg expressed on dry weight basis

Benzoic acid p-sulphonamide

Not more than 25 mg/kg expressed on dry weight basis

Readily carbonisable substances

Absent

Arsenic

Selenium

Lead

Not more than 3 mg/kg expressed on dry weight basis

Not more than 30 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis’

3. The text concerning E 955 sucralose is replaced by the following:

‘E 955 SUCRALOSE

Synonyms

Definition

Chemical name

Einecs

Chemical formula

4,1′,6′-Trichlorogalactosucrose

1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-
α-D-galactopyranoside

259-952-2

C12H19Cl3O8

Molecular weight

397,64

Assay

Description

Identification

Content not
C12H19Cl3O8 calculated on an anhydrous basis.

less than 98 % and not more than 102 % of

White to off-white, practically odourless crystalline powder.

A. Solubility

Freely soluble in water, methanol and ethanol

Slightly soluble in ethyl acetate

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B.

Infrared absorption

C. Thin layer chromatography

D. Specific rotation

Purity

Water

The infrared spectrum of a potassium bromide dispersion of the
sample exhibits relative maxima at similar wave numbers as those
shown in the reference spectrum obtained using a sucralose
reference standard

The main spot in the test solution has the same Rf value as that
of the main spot of standard solution A referred to in the test for
other chlorinated disaccharides. This standard solution is obtained
by dissolving 1,0 g of sucralose reference standard in 10 ml of
methanol

20 = + 84,0° to + 87,5° calculated on the anhydrous basis

[α]D
(10 % w/v solution)

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

Sulphated ash

Not more than 0,7 %

Other chlorinated disaccharides

Not more than 0,5 %

Chlorinated monosaccharides

Not more than 0,1 %

Triphenylphosphine oxide

Not more than 150 mg/kg

Methanol

Lead

Not more than 0,1 %

Not more than 1 mg/kg’

4. The text concerning E 962 salt of aspartame-acesulfame is replaced by the following:

‘E 962 SALT OF ASPARTAME-ACESULFAME

Synonyms

Definition

Chemical name

Chemical formula

Molecular weight

Assay

Description

Identification

A. Solubility

B. Transmittance

Aspartame-acesulfame, aspartame-acesulfame salt

The salt is prepared by heating an approximately 2:1 ratio (w/w)
of aspartame and acesulfame K in solution at acidic pH and
allowing crystallisation to occur. The potassium and moisture
are eliminated. The product is more stable than aspartame alone

6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phe-
nylalanyl-2-methyl-L-α-aspartic acid

C18H23O9N3S

457,46

63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37 %
acesulfame (acid form on a dry basis)

A white, odourless, crystalline powder

Sparingly soluble in water, slightly soluble in ethanol

The transmittance of a 1 % solution in water determined in a
1 cm cell at 430 nm with a suitable spectrophotometer using
water as a reference,
is not less than 0,95, equivalent to an
absorbance of not more than approximately 0,022

C. Specific rotation

[α]D

20 = + 14,5° to + 16,5°

Determine at concentration of 6,2 g in 100 ml formic acid (15N)
the solution. Divide the
within 30 min of preparation of
calculated specific
the
rotation by 0,646 to correct
aspartame content of the salt of aspartame-acesulfame

for

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Purity

Loss on drying

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

5-Benzyl-3,6-dioxo-2-piperazineacetic acid

Not more than 0,5 %

Lead

Not more than 1 mg/kg’

5. The text concerning E 965 (i) maltitol is replaced by the following:

‘E 965 (i) MALTITOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Relative molecular mass

D-Maltitol, hydrogenated maltose

(α)-D-Glucopyranosyl-1,4-D-glucitol

209-567-0

C12H24O11

344,31

Assay

Content not less than 98 % of D-maltitol

Description

Identification

A. Solubility

B. Melting range

C. Specific rotation

Purity

Water

Sulphated ash

Reducing sugars

Chlorides

Sulphates

Nickel

Arsenic

Lead

C12H24O11 on the anhydrous basis

Sweet tasting, white crystalline powder

Very soluble in water, slightly soluble in ethanol

148 to 151 °C

[α]D

20 = + 105,5° to + 108,5° (5 % w/v solution)

Not more than 1 % (Karl Fischer method)

Not more than 0,1 % expressed on dry weight basis

Not more than 0,1 % expressed as glucose on dry weight basis

Not more than 50 mg/kg expressed on dry weight basis

Not more than 100 mg/kg expressed on dry weight basis

Not more than 2 mg/kg expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis’

6. The text concerning E 965 (ii) maltitol syrup is replaced by the following:

‘E 965 (ii) MALTITOL SYRUP

Synonyms

Definition

Assay

Hydrogenated high-maltose glucose syrup, hydrogenated glucose
syrup

A mixture consisting of mainly maltitol with sorbitol and hydro-
genated oligo- and polysaccharides.
It is manufactured by the
catalytic hydrogenation of high maltose-content glucose syrup
or by the hydrogenation of its individual components followed
by blending. The article of commerce is supplied both as a syrup
and as a solid product

Content not less than 99 % of total hydrogenated saccharides on
the anhydrous basis and not less than 50 % of maltitol on the
anhydrous basis

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Description

Identification

A. Solubility

Colourless and odourless, clear viscous liquids or white crystalline
masses

Very soluble in water, slightly soluble in ethanol

B. Thin layer chromatography

Passes test

Purity

Water

Reducing sugars

Sulphated ash

Chlorides

Sulphate

Nickel

Lead

Not more than 31 % (Karl Fischer)

Not more than 0,3 % (as glucose)

Not more than 0,1 %

Not more than 50 mg/kg

Not more than 100 mg/kg

Not more than 2 mg/kg

Not more than 1 mg/kg’

7. The text concerning E 966 lactitol is replaced by the following:

‘E 966 LACTITOL

Synonyms

Definition

Chemical name

Einecs

Chemical formula

Relative molecular mass

Assay

Description

Identification

A. Solubility

B. Specific rotation

Purity

Water

Other polyols

Reducing sugars

Chlorides

Sulphates

Sulphated ash

Nickel

Arsenic

Lead

Lactit, lactositol, lactobiosit

4-O-β-D-Galactopyranosyl-D-glucitol

209-566-5

C12H24O11

344,32

Not less than 95 % on the dry weight basis

Sweet-tasting crystalline powders or colourless solutions. Crys-
and
talline
dihydrate forms

anhydrous, monohydrate

products

occur

in

Very soluble in water

20 = + 13° to + 16° calculated on the anhydrous basis (10 %

[α]D
w/v aqueous solution)

Crystalline products; not more than 10,5 % (Karl Fischer method)

Not more than 2,5 % on the anhydrous basis

Not more than 0,2 % expressed as glucose on dry weight basis

Not more than 100 mg/kg expressed on dry weight basis

Not more than 200 mg/kg expressed on dry weight basis

Not more than 0,1 % expressed on dry weight basis

Not more than 2 mg/kg expressed on dry weight basis

Not more than 3 mg/kg expressed on dry weight basis

Not more than 1 mg/kg expressed on dry weight basis’