CELEX: 32008L0060
Language: en
Date: 2008-06-17 00:00:00
Title: Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (Codified version) (Text with EEA relevance)

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.
            
         
               (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).
            
         
               (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.
            
         
               (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).
   
      (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).
   
      (3)  See Annex II, Part A.
   
      (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).
   
      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
                           
                        
               
                  Very soluble in water, slightly soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  88 to 102 °C
               
            
                  
                              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
               
            E 420 (ii) —   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
                           
                        
               
                  Miscible with water, with glycerol, and with propane-1,2-diol
               
            
                  
                              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
               
            E 421 —   MANNITOL
               
            (I)   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
                           
                        
               
                  Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 164 and 169 °C
               
            
                  
                              C.
                           
                           
                              Thin layer chromatography
                           
                        
               
                  Passes test
               
            
                  
                              D.
                           
                           
                              Specific rotation
                           
                        
               
                  [α] 20
                     D: + 23 ° to + 25 ° (borate solution)
               
            
                  
                              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
               
            (II)   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
                           
                        
               
                  Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 164 and 169 °C
               
            
                  
                              C.
                           
                           
                              Thin layer chromatography
                           
                        
               
                  Passes test
               
            
                  
                              D.
                           
                           
                              Specific rotation
                           
                        
               
                  [α] 20
                     D: + 23 ° to + 25 ° (borate solution)
               
            
                  
                              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
               
            E 950 —   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
                           
                        
               
                  Very soluble in water, very slightly soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Ultraviolet absorption
                           
                        
               
                  Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water
               
            
                  
                              C.
                           
                           
                              Positive test for potassium
                           
                        
               
                  Passes test (test the residue obtained by igniting 2 g of the sample)
               
            
                  
                              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
               
            E 951 —   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
               
            E 952 —   CYCLAMIC ACID AND ITS Na AND Ca SALTS
               
            (I)   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
                           
                        
               
                  Soluble in water and in ethanol
               
            
                  
                              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
               
            (II)   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
               
            (III)   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
               
            E 953 —   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
                           
                        
                               
                           
                           
                              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
                           
                        
               
                  Soluble in water, very slightly soluble in ethanol.
               
            
                  
                              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.
               
            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 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
               
            (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-oxobenzisosulphonazole, 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)
               
            
                  Einecs
               
               
                  229-349-9
               
            
                  Chemical formula
               
               C14H8CaN2O6S2·3
                     H2O
            
                  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
               
            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 % 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 1,0g of sucralose reference standard in 10 ml of methanol.
               
            
                  
                              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
               
            E 957 —   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
               
            E 959 —   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
                           
                        
               
                  Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene
               
            
                  
                              B.
                           
                           
                              Ultraviolet absorption maximum
                           
                        
               
                  282 to 283 nm for a solution of 2 mg in 100 ml methanol
               
            
                  
                              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
               
            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 37,0 % acesulfame (acid form on a dry basis)
               
            
                  
                     Description
                  
               
               
                  A white, odourless, crystalline powder.
               
            
                  Identification
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Sparingly soluble 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] 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
               
            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 % 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]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
               
            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
               
            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]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
               
            E 967 —   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
                           
                        
               
                  Very soluble in water, sparingly soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  92 to 96 °C
               
            
                  
                              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
               
            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
               
            
   
      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)
               
            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
               
            
         (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