# L_2008158EN.01001701.xml

| 18.6.2008 | EN | Official Journal of the European Union | L 158/17 |
| --- | --- | --- | --- |

18.6.2008

EN

Official Journal of the European Union

L 158/17

---

COMMISSION DIRECTIVE 2008/60/EC

of 17 June 2008

laying down specific purity criteria concerning sweeteners for use in foodstuffs

(Text with EEA relevance)

(Codified version)

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

Whereas:

| (1) | Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs (2) has been substantially amended several times (3). In the interest of clarity and rationality the said Directive should be codified. |
| --- | --- |

(1)

Commission Directive 95/31/EC of 5 July 1995 laying down specific criteria of purity concerning sweeteners for use in foodstuffs (2) has been substantially amended several times (3). In the interest of clarity and rationality the said Directive should be codified.

| (2) | It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (4). |
| --- | --- |

(2)

It is necessary to establish purity criteria for all sweeteners mentioned in European Parliament and Council Directive 94/35/EC of 30 June 1994 on sweeteners for use in foodstuffs (4).

| (3) | It is necessary to take into account the specifications and analytical techniques for sweeteners as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA). |
| --- | --- |

(3)

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

| (4) | Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria. |
| --- | --- |

(4)

Food additives prepared by production methods or starting materials significantly different from those evaluated by the Scientific Committee for Food or different from those mentioned in this Directive should be submitted for safety evaluation by the European Food Safety Authority with emphasis on the purity criteria.

| (5) | The measures provided for in this Directive are in line with the opinion of the Standing Committee on the Food Chain and Animal Health. |
| --- | --- |

(5)

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

| (6) | This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B, |
| --- | --- |

(6)

This Directive should be without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B,

HAS ADOPTED THIS DIRECTIVE:

Article 1

The purity criteria referred to in Article 3(3)(a) of Directive 89/107/EEC for sweeteners mentioned in Directive 94/35/EC are set out in Annex I to this Directive.

Article 2

Directive 95/31/EC, as amended by the Directives listed in Annex II, Part A, is repealed, without prejudice to the obligations of the Member States relating to the time-limits for transposition into national law of the Directives set out in Annex II, Part B.

References to the repealed Directive shall be construed as references to this Directive and shall be read in accordance with the correlation table in Annex III.

Article 3

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

Article 4

This Directive is addressed to the Member States.

Done at Brussels, 17 June 2008.

For the Commission

The President

José Manuel BARROSO

---

(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).

1

(2)  
  OJ L 178, 28.7.1995, p. 1. Directive as last amended by Directive 2006/128/EC (OJ L 346, 9.12.2006, p. 6).

2

(3)  See Annex II, Part A.

3

(4)  
  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).

4

---

ANNEX I

| E 420 (i) —   SORBITOL |
| --- |
| Synonyms | D-glucitol, D-sorbitol |
| Definition |
| Chemical name | D-glucitol |
| Einecs | 200-061-5 |
| Chemical formula | C6H14O6 |
| Relative molecular mass | 182,17 |
| Assay | Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis.
  Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer |
| Description | White hygroscopic powder, crystalline powder, flakes or granules having a sweet taste |
| Identification |
| A. | Solubility |

SORBITOL

Synonyms

D-glucitol, D-sorbitol

Definition

Chemical name

D-glucitol

Einecs

200-061-5

Chemical formula

C6H14O6

Relative molecular mass

182,17

Assay

Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis.

Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer

Description

White hygroscopic powder, crystalline powder, flakes or granules having a sweet taste

Identification

A.

Solubility

Very soluble in water, slightly soluble in ethanol

| B. | Melting range |
| --- | --- |

B.

Melting range

88 to 102 °C

| C. | Sorbitol monobenzylidene derivative |
| --- | --- |

C.

Sorbitol monobenzylidene derivative

To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C

Purity

Water content

Not more than 1 % (Karl Fischer method)

Sulphated ash

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

Reducing sugars

Not more than 0,3 % expressed as glucose on dry weight basis

Total sugars

Not more than 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

Heavy metals

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

SORBITOL SYRUP

Synonyms

D-glucitol syrup

Definition

Chemical name

Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides.

The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present. Glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer

Einecs

270-337-8

Assay

Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis

Description

Clear colourless and sweet-tasting aqueous solution

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Miscible with water, with glycerol, and with propane-1,2-diol

| B. | Melting range |
| --- | --- |

B.

Melting range

To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C

Purity

Water content

Not more than 31 % (Karl Fischer method)

Sulphated ash

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

Reducing sugars

Not more than 0,3 % 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

Heavy metals

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

MANNITOL

MANNITOL

Synonyms

D-mannitol

Definition

Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose

Chemical name

D-mannitol

Einecs

200-711-8

Chemical formula

C6H14O6

Molecular weight

182,2

Assay

Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis

Description

White, odourless, crystalline powder

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Soluble in water, very slightly soluble in ethanol, practically insoluble in ether

| B. | Melting range |
| --- | --- |

B.

Melting range

Between 164 and 169 °C

| C. | Thin layer chromatography |
| --- | --- |

C.

Thin layer chromatography

Passes test

| D. | Specific rotation |
| --- | --- |

D.

Specific rotation

[α] 20
  D: + 23 ° to + 25 ° (borate solution)

| E. | pH |
| --- | --- |

E.

pH

Between 5 and 8

Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH

Purity

Loss on drying

Not more than 0,3 % (105 °C, four hours)

Reducing sugars

Not more than 0,3 % (as glucose)

Total sugars

Not more than 1 % (as glucose)

Sulphated ash

Not more than 0,1 %

Chlorides

Not more than 70 mg/kg

Sulphate

Not more than 100 mg/kg

Nickel

Not more than 2 mg/kg

Lead

Not more than 1 mg/kg

MANNITOL MANUFACTURED BY FERMENTATION

Synonyms

D-mannitol

Definition

Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii

Chemical name

D-mannitol

Einecs

200-711-8

Chemical formula

C6H14O6

Molecular weight

182,2

Assay

Not less than 99 % on the dried basis

Description

White, odourless crystalline powder

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Soluble in water, very slightly soluble in ethanol, practically insoluble in ether

| B. | Melting range |
| --- | --- |

B.

Melting range

Between 164 and 169 °C

| C. | Thin layer chromatography |
| --- | --- |

C.

Thin layer chromatography

Passes test

| D. | Specific rotation |
| --- | --- |

D.

Specific rotation

[α] 20
  D: + 23 ° to + 25 ° (borate solution)

| E. | pH |
| --- | --- |

E.

pH

Between 5 and 8

Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH

Purity

Arabitol

Not more than 0,3 %

Loss on drying

Not more than 0,3 % (105 °C, four hours)

Reducing sugars

Not more than 0,3 % (as glucose)

Total sugars

Not more than 1 % (as glucose)

Sulphated ash

Not more than 0,1 %

Chlorides

Not more than 70 mg/kg

Sulphate

Not more than 100 mg/kg

Lead

Not more than 1 mg/kg

Aerobic mesophilic bacteria

Not more than 103/g

Coliforms

Absent in 10 g

Salmonella

Absent in 10 g

E. Coli

Absent in 10 g

Staphylococcus aureus

Absent in 10 g

Pseudomonas aeruginosa

Absent in 10 g

Moulds

Not more than 100/g

Yeasts

Not more than 100/g

ACESULFAME K

Synonyms

Acesulfame potassium, potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one,2,2-dioxide

Definition

Chemical name

6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt

Einecs

259-715-3

Chemical formula

C4H4KNO4S

Molecular weight

201,24

Assay

Content not less than 99 % of C4H4KNO4S on the anhydrous basis

Description

Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Very soluble in water, very slightly soluble in ethanol

| B. | Ultraviolet absorption |
| --- | --- |

B.

Ultraviolet absorption

Maximum 227 ± 2 nm for a solution of 10 mg in 1 000  ml of water

| C. | Positive test for potassium |
| --- | --- |

C.

Positive test for potassium

Passes test (test the residue obtained by igniting 2 g of the sample)

| D. | Precipitation test |
| --- | --- |

D.

Precipitation test

Add a few drops of a 10 % solution of sodium cobalt nitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced

Purity

Loss on drying

Not more than 1 % (105 °C, two hours)

Organic impurities

Passes test for 20 mg/kg of UV active components

Fluoride

Not more than 3 mg/kg

Lead

Not more than 1 mg/kg

ASPARTAME

Synonyms

Aspartyl phenylalanine methyl ester

Definition

Chemical name

N-L-α-(Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester

Einecs

245-261-3

Chemical formula

C14H18N2O5

Relative molecular mass

294,31

Assay

Not less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis

Description

White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose

Identification

Solubility

Slightly soluble in water and in ethanol

Purity

Loss on drying

Not more than 4,5 % (105 °C, four hours)

Sulphated ash

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

pH

Between 4,5 and 6,0 (1 in 125 solution)

Transmittance

The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022

Specific rotation

[α]D
  20: + 14,5 to + 16,5 °

Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution

Arsenic

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

Lead

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

Heavy metals

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

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

Not more than 1,5 % expressed on dry weight basis

CYCLAMIC ACID AND ITS Na AND Ca SALTS

CYCLAMIC ACID

Synonyms

Cyclohexylsulphamic acid, cyclamate

Definition

Chemical name

Cyclohexanesulphamic acid, cyclohexylaminosulphonic acid

Einecs

202-898-1

Chemical formula

C6H13NO3S

Relative molecular mass

179,24

Assay

Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis

Description

A practically colourless, white crystalline powder with a sweet-sour taste. Approximately 40 times as sweet as sucrose

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Soluble in water and in ethanol

| B. | Precipitation test |
| --- | --- |

B.

Precipitation test

Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.

Purity

Loss on drying

Not more than 1 % (105 °C, one hour)

Selenium

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

Lead

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

Heavy metals

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

Arsenic

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

Cyclohexylamine

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

Dicyclohexylamine

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

Aniline

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

SODIUM CYCLAMATE

Synonyms

Cyclamate, sodium salt of cyclamic acid

Definition

Chemical name

Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate

Einecs

205-348-9

Chemical formula

C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O

Relative molecular mass

201,22 calculated on the anhydrous form

237,22 calculated on the hydrated form

Assay

Not less than 98 % and not more than 102 % on the dried basis

Dihydrate form: not less than 84 % on the dried basis

Description

White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose

Identification

Solubility

Soluble in water, practically insoluble in ethanol

Purity

Loss on drying

Not more than 1 % (105 °C, one hour)

Not more than 15,2 % (105 °C, two hours) for the dihydrate form

Selenium

Not more than 30 mg/kg expressed as selenium 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

Heavy metals

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

Cyclohexylamine

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

Dicyclohexylamine

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

Aniline

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

CALCIUM CYCLAMATE

Synonyms

Cyclamate, calcium salt of cyclamic acid

Definition

Chemical name

Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate

Einecs

205-349-4

Chemical formula

C12H24CaN2O6S2·2H2O

Relative molecular mass

432,57

Assay

Not less than 98 % and not more than 101 % on the dried basis

Description

White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose

Identification

Solubility

Soluble in water, sparingly soluble in ethanol

Purity

Loss on drying

Not more than 1 % (105 °C, one hour)

Not more than 8,5 % (140 °C, four hours) for the dihydrate form

Selenium

Not more than 30 mg/kg expressed as selenium 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

Heavy metals

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

Cyclohexylamine

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

Dicyclohexylamine

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

Aniline

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

ISOMALT

Synonyms

Hydrogenated isomaltulose, hydrogenated palatinose.

Definition

Chemical name

Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides:

| | 6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and |
| --- | --- |

6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and

| | 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM) |
| --- | --- |

1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)

Chemical formula

6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O11

1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O

Relative molecular mass

6-O-α-D-Glucopyranosyl-D-sorbitol: 344,32

1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,32

Assay

Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.

Description

Odourless, white, slightly hygroscopic, crystalline mass.

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Soluble in water, very slightly soluble in ethanol.

| B. | Thin layer chromatography |
| --- | --- |

B.

Thin layer chromatography

Examine by thin layer chromatography using a plate coated with an approximately 0,2 mm layer of chromatographic silica gel. The principal spots in the chromatogram are those of 1,1-GPM and 1,6-GPS.

Purity

Water content

Not more than 7 % (Karl Fischer Method)

Sulphated ash

Not more than 0,05 % expressed on dry weight basis

D-Mannitol

Not more than 3 %

D-Sorbitol

Not more than 6 %

Reducing sugars

Not more than 0,3 % expressed as glucose 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

Heavy metals (as Pb)

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

SACCHARIN AND ITS Na, K AND Ca SALTS

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 to 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-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

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

CALCIUM SACCHARIN

Synonyms

Saccharin, calcium salt of saccharin

Definition

Chemical name

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

Einecs

229-349-9

Chemical formula

Formula

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

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

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 % C12H19Cl3O8 calculated on an anhydrous basis.

Description

White to off-white, practically odourless, crystalline powder.

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Freely soluble in water, methanol and ethanol

Slightly soluble in ethyl acetate

| B. | Infrared absorption |
| --- | --- |

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 |
| --- | --- |

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 1,0g of sucralose reference standard in 10 ml of methanol.

| D. | Specific rotation |
| --- | --- |

D.

Specific rotation

[α] 20
  D + 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

THAUMATIN

Synonyms

Definition

Chemical name

Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of the natural strain of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material

Einecs

258-822-2

Chemical formula

Polypeptide of 207 amino acids

Relative molecular mass

Thaumatin I 22209

Thaumatin II 22293

Assay

Not less than 16 % nitrogen on the dried basis equivalent to not less than 94 % proteins (N × 5,8)

Description

Odourless, cream-coloured powder with an intensely sweet taste. Approximately 2 000 to 3 000 times as sweet as sucrose

Identification

Solubility

Very soluble in water, insoluble in acetone

Purity

Loss on drying

Not more than 9 % (105 °C to constant weight)

Carbohydrates

Not more than 3 % expressed on dry weight basis

Sulphated ash

Not more than 2 % expressed on dry weight basis

Aluminium

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

Arsenic

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

Lead

3 mg/kg expressed on dry weight basis

Microbiological criteria

Total aerobic microbial count: Max 1 000 /g E. Coli: absent in 1 g

NEOHESPERIDINE DIHYDROCHALCONE

Synonyms

Neohesperidin dihydrochalcone, NHDC, hesperetin dihydrochalcone-4′-β-neohesperidoside, neohesperidin DC

Definition

Chemical name

2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone; obtained by catalytic hydrogenation of neohesperidin

Einecs

243-978-6

Chemical formula

C28H36O15

Relative molecular mass

612,6

Assay

Content not less than 96 % on the dried basis

Description

Off-white, odourless, crystalline powder having a characteristic, intensive sweet taste. Approximately between 1 000 and 1 800 times as sweet as sucrose

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene

| B. | Ultraviolet absorption maximum |
| --- | --- |

B.

Ultraviolet absorption maximum

282 to 283 nm for a solution of 2 mg in 100 ml methanol

| C. | Neu's test |
| --- | --- |

C.

Neu's test

Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced

Purity

Loss on drying

Not more than 11 % (105 °C, three hours)

Sulphated ash

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

Arsenic

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

Lead

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

Heavy metals

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

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 37,0 % acesulfame (acid form on a dry basis)

Description

A white, odourless, crystalline powder.

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Sparingly soluble water; slightly soluble in ethanol

| B. | Transmittance |
| --- | --- |

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 |
| --- | --- |

C.

Specific rotation

[α] 20
  D + 14,5 ° to + 16,5 °

Determine at a 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-piper-azineacetic acid

Not more than 0,5 %

Lead

Not more than 1 mg/kg

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 % D-maltitol C12H24O11 on the anhydrous basis

Description

Sweet tasting, white crystalline powder

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Very soluble in water, slightly soluble in ethanol

| B. | Melting range |
| --- | --- |

B.

Melting range

148 to 151 °C

| C. | Specific rotation |
| --- | --- |

C.

Specific rotation

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

Purity

Water content

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

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 |
| --- | --- |

A.

Solubility

Very soluble in water, slightly soluble in ethanol

| B. | Thin layer chromatography |
| --- | --- |

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

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 |
| --- | --- |

A.

Solubility

Very soluble in water

| B. | Specific rotation |
| --- | --- |

B.

Specific rotation

[α]D
  20 = + 13 ° to + 16 ° calculated on the anhydrous basis (10 % w/v aqueous solution)

Purity

Water content

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

XYLITOL

Synonyms

Xylitol

Definition

Chemical name

D-xylitol

Einecs

201-788-0

Chemical formula

C5H12O5

Relative molecular mass

152,15

Assay

Not less than 98,5 % as xylitol on the anhydrous basis

Description

White, crystalline powder, practically odourless with a very sweet taste

Identification

| A. | Solubility |
| --- | --- |

A.

Solubility

Very soluble in water, sparingly soluble in ethanol

| B. | Melting range |
| --- | --- |

B.

Melting range

92 to 96 °C

| C. | pH |
| --- | --- |

C.

pH

5 to 7 (10 % w/v aqueous solution)

Purity

Loss on drying

Not more than 0,5 %. Dry 0,5 g of sample in a vacuum over phosphorus at 60 °C for four hours

Sulphated ash

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

Reducing sugars

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

Other polyhydric alcohols

Not more than 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

Heavy metals

Not more than 10 mg/kg expressed as Pb 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

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 |
| --- | --- |

A.

Solubility

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

| B. | Melting range |
| --- | --- |

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

---

ANNEX II

PART A

Repealed Directive with list of its successive amendments

(referred to in Article 2)

| Commission Directive 95/31/EC | (OJ L 178, 28.7.1995, p. 1) |
| --- | --- |
| Commission Directive 98/66/EC | (OJ L 257, 19.9.1998, p. 35) |
| Commission Directive 2000/51/EC | (OJ L 198, 4.8.2000, p. 41) |
| Commission Directive 2001/52/EC | (OJ L 190, 12.7.2001, p. 18) |
| Commission Directive 2004/46/EC | (OJ L 114, 21.4.2004, p. 15) |
| Commission Directive 2006/128/EC | (OJ L 346, 9.12.2006, p. 6) |

Commission Directive 95/31/EC

(OJ L 178, 28.7.1995, p. 1)

Commission Directive 98/66/EC

(OJ L 257, 19.9.1998, p. 35)

Commission Directive 2000/51/EC

(OJ L 198, 4.8.2000, p. 41)

Commission Directive 2001/52/EC

(OJ L 190, 12.7.2001, p. 18)

Commission Directive 2004/46/EC

(OJ L 114, 21.4.2004, p. 15)

Commission Directive 2006/128/EC

(OJ L 346, 9.12.2006, p. 6)

PART B

List of time-limits for transposition into national law

(referred to in Article 2)

| Directive | Time-limit for transposition |
| --- | --- |
| 95/31/EC | 1 July 1996 (1) |
| 98/66/EC | 1 July 1999 |
| 2000/51/EC | 30 June 2001 |
| 2001/52/EC | 30 June 2002 |
| 2004/46/EC | 1 April 2005 |
| 2006/128/EC | 15 February 2008 |

Directive

Time-limit for transposition

95/31/EC

1 July 1996 (1)

98/66/EC

1 July 1999

2000/51/EC

30 June 2001

2001/52/EC

30 June 2002

2004/46/EC

1 April 2005

2006/128/EC

15 February 2008

---

(1)  According to Article 2(2) of Directive 95/31/EC, products put on the market or labelled before 1 July 1996 which do not comply with this Directive may be marketed until stocks are exhausted.

---

ANNEX III

Correlation table

| Directive 95/31/EC | This Directive |
| --- | --- |
| Article 1(1) | Article 1 |
| Article 1(2) | — |
| Article 2 | — |
| — | Article 2 |
| Article 3 | Article 3 |
| Article 4 | Article 4 |
| Annex | Annex I |
| — | Annex II |
| — | Annex III |

Directive 95/31/EC

This Directive

Article 1(1)

Article 1

Article 1(2)

—

Article 2

—

—

Article 2

Article 3

Article 3

Article 4

Article 4

Annex

Annex I

—

Annex II

—

Annex III

---