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 establishing the European Community,

Having regard to Council Directive 89/107/EEC of 21 December 1988 on the approximation of the laws of the Member States concerning food additives authorised for use in foodstuffs intended for human consumption1, and in particular Article 3(3)(a) thereof,

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

Whereas:

(1)

Directive 94/35/EC of the European Parliament and of the Council of 30 June 1994 on sweeteners for use in foodstuffs2, lists those substances which may be used as sweeteners in foodstuffs.

(2)

Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs3, sets out the purity criteria for the sweeteners listed in Directive 94/35/EC.

(3)

It is necessary to adopt specific criteria for E 968 erythritol, a new food additive authorised by Directive 2006/52/EC of the European Parliament and 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.

(4)

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 corrected. In addition 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). 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.

(5)

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.

(6)

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

(7)

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

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.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 8 December 2006.

For the Commission

Markos Kyprianou

Member of the Commission

ANNEX

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

  1. 1.

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

    E 968 ERYTHRITOL

    Synonyms

    Meso-erythritol, tetrahydroxybutane, erythrite

    Definition

    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

    Chemical name

    1,2,3,4-Butanetetrol

    Einecs

    205-737-3

    Chemical formula

    C4H10O4

    Molecular weight

    122,12

    Assay

    Not less than 99 % after drying

    Description

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

    Identification

    A.

    Solubility

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

    B.

    Melting range

    119-123 °C

    Purity

    Loss on drying

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

    Sulphated ash

    Not more than 0,1 %

    Reducing substances

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

    Ribitol and glycerol

    Not more than 0,1 %

    Lead

    Not more than 0,5 mg/kg

  2. 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

    201-321-0

    Chemical formula

    C7H5NO3S

    Relative molecular mass

    183,18

    Assay

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

    Description

    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

    Identification

    Solubility

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

    Purity

    Loss on drying

    Not more than 1 % (105 °C, two hours)

    Melting range

    226-230 °C

    Sulphated ash

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

    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-sulfonamide

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

    Readily carbonisable substances

    Absent

    Arsenic

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

    Selenium

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

    Lead

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

    (II) SODIUM SACCHARIN

    Synonyms

    Saccharin, sodium salt of saccharin

    Definition

    Chemical name

    Sodium o-benzosulphimide, sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole, oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide sodium salt dihydrate

    Einecs

    204-886-1

    Chemical formula

    C7H4NNaO3S·2H2O

    Relative molecular mass

    241,19

    Assay

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

    Description

    White crystals or a white crystalline efflorescent 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

    Identification

    Solubility

    Freely soluble in water, sparingly soluble in ethanol

    Purity

    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

    Benzoic acid p-sulphonamide

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

    Readily carbonisable substances

    Absent

    Arsenic

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

    Selenium

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

    Lead

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

    (III) CALCIUM SACCHARIN

    Synonyms

    Saccharin, calcium salt of saccharin

    Definition

    Chemical name

    Calcium o-benzosulphimide, calcium salt of 2,3-dihydro-3-oxobenzisosulfonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)

    Einecs

    229-349-9

    Chemical formula

    C14H8CaN2O6S2·31/2H2O

    Relative molecular mass

    467,48

    Assay

    Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis

    Description

    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

    Identification

    Solubility

    Freely soluble in water, soluble in ethanol

    Purity

    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

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

    Selenium

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

    Lead

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

    (IV) POTASSIUM SACCHARIN

    Synonyms

    Saccharin, potassium salt of saccharin

    Definition

    Chemical name

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

    Einecs

    Chemical formula

    C7H4KNO3S·H2O

    Relative molecular mass

    239,77

    Assay

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

    Description

    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

    Identification

    Solubility

    Freely soluble in water, sparingly soluble in ethanol

    Purity

    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

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

    Selenium

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

    Lead

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

  3. 3.

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

    E 955 SUCRALOSE

    Synonyms

    4,1′,6′-Trichlorogalactosucrose

    Definition

    Chemical name

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

    Einecs

    259-952-2

    Chemical formula

    C12H19Cl3O8

    Molecular weight

    397,64

    Assay

    Content not less than 98 % and not more than 102 % of C12H19Cl3O8 calculated on an anhydrous basis.

    Description

    White to off-white, practically odourless crystalline powder.

    Identification

    A.

    Solubility

    Freely soluble in water, methanol and ethanol

    Slightly soluble in ethyl acetate

    B.

    Infrared absorption

    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

    C.

    Thin layer chromatography

    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

    D.

    Specific rotation

    [α]D20 = + 84,0° to + 87,5° calculated on the anhydrous basis (10 % w/v solution)

    Purity

    Water

    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

    Not more than 0,1 %

    Lead

    Not more than 1 mg/kg

  4. 4.

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

    E 962 SALT OF ASPARTAME-ACESULFAME

    Synonyms

    Aspartame-acesulfame, aspartame-acesulfame salt

    Definition

    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

    Chemical name

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

    Chemical formula

    C18H23O9N3S

    Molecular weight

    457,46

    Assay

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

    Description

    A white, odourless, crystalline powder

    Identification

    A.

    Solubility

    Sparingly soluble in water, slightly soluble in ethanol

    B.

    Transmittance

    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]D20 = + 14,5° to + 16,5°

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

    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. 5.

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

    E 965 (i) MALTITOL

    Synonyms

    D-Maltitol, hydrogenated maltose

    Definition

    Chemical name

    (α)-D-Glucopyranosyl-1,4-D-glucitol

    Einecs

    209-567-0

    Chemical formula

    C12H24O11

    Relative molecular mass

    344,31

    Assay

    Content not less than 98 % of D-maltitol

    C12H24O11 on the anhydrous basis

    Description

    Sweet tasting, white crystalline powder

    Identification

    A.

    Solubility

    Very soluble in water, slightly soluble in ethanol

    B.

    Melting range

    148 to 151 °C

    C.

    Specific rotation

    [α]D20 = + 105,5° to + 108,5° (5 % w/v solution)

    Purity

    Water

    Not more than 1 % (Karl Fischer method)

    Sulphated ash

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

    Reducing sugars

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

    Chlorides

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

    Sulphates

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

    Nickel

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

    Arsenic

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

    Lead

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

  6. 6.

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

    E 965 (ii) MALTITOL SYRUP

    Synonyms

    Hydrogenated high-maltose glucose syrup, hydrogenated glucose syrup

    Definition

    A mixture consisting of mainly maltitol with sorbitol and hydrogenated 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

    Assay

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

    Description

    Colourless and odourless, clear viscous liquids or white crystalline masses

    Identification

    A.

    Solubility

    Very soluble in water, slightly soluble in ethanol

    B.

    Thin layer chromatography

    Passes test

    Purity

    Water

    Not more than 31 % (Karl Fischer)

    Reducing sugars

    Not more than 0,3 % (as glucose)

    Sulphated ash

    Not more than 0,1 %

    Chlorides

    Not more than 50 mg/kg

    Sulphate

    Not more than 100 mg/kg

    Nickel

    Not more than 2 mg/kg

    Lead

    Not more than 1 mg/kg

  7. 7.

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

    E 966 LACTITOL

    Synonyms

    Lactit, lactositol, lactobiosit

    Definition

    Chemical name

    4-O-β-D-Galactopyranosyl-D-glucitol

    Einecs

    209-566-5

    Chemical formula

    C12H24O11

    Relative molecular mass

    344,32

    Assay

    Not less than 95 % on the dry weight basis

    Description

    Sweet-tasting crystalline powders or colourless solutions. Crystalline products occur in anhydrous, monohydrate and dihydrate forms

    Identification

    A.

    Solubility

    Very soluble in water

    B.

    Specific rotation

    [α]D20 = + 13° to + 16° calculated on the anhydrous basis (10 % w/v aqueous solution)

    Purity

    Water

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

    Other polyols

    Not more than 2,5 % on the anhydrous basis

    Reducing sugars

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

    Chlorides

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

    Sulphates

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

    Sulphated ash

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

    Nickel

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

    Arsenic

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

    Lead

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