CELEX: 32008L0084
Language: en
Date: 2008-08-27 00:00:00
Title: Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)(Codified version)

20.9.2008   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 253/1
            
         
      COMMISSION DIRECTIVE 2008/84/EC
   of 27 August 2008
   laying down specific purity criteria on food additives other than colours and sweeteners
   (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 authorised for use in foodstuffs intended for human consumption (1), and in particular Article 3(3)(a) thereof,
   Whereas:
   
               (1)
            
            
               Commission Directive 96/77/EC of 2 December 1996 laying down specific purity criteria on food additives other than colours and sweeteners (2) has been substantially amended several times (3). In the interests of clarity and rationality the said Directive should be codified.
            
         
               (2)
            
            
               It is necessary to establish purity criteria for all additives other than colours and sweeteners mentioned in European Parliament and Council Directive 95/2/EC of 20 February 1995 on food additives other than colours and sweeteners (4).
            
         
               (3)
            
            
               It is necessary to take into account the specifications and analytical techniques for additives as set out in the Codex Alimentarius as drafted by the Joint FAO/WHO Expert Committee on Food Additives (JECFA).
            
         
               (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 accordance 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 food additives other than colours and sweeteners, as mentioned in Directive 95/2/EC, are set out in Annex I to this Directive.
   Article 2
   Directive 96/77/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 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 20th day following its publication in the Official Journal of the European Union.
   Article 4
   This Directive is addressed to the Member States.
   
      Done at Brussels, 27 August 2008.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
         
      
   
   
      (1)  OJ L 40, 11.2.1989, p. 27.
   
      (2)  OJ L 339, 30.12.1996, p. 1.
   
      (3)  See Annex II, part A.
   
      (4)  OJ L 61, 18.3.1995, p. 1.
   
      ANNEX I
      Ethylene oxide may not be used for sterilising purposes in food additives.
      E 170 (i) CALCIUM CARBONATE
      Purity criteria for this additive are the same as set out for this additive in the Annex to Commission Directive 95/45/EC (1).
      E 200 SORBIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sorbic acid
               
            
                  Trans, trans-2,4-hexadienoic acid
               
            
                  Einecs
               
               
                  203-768-7
               
            
                  Chemical formula
               
               
                  C6H8O2
                  
               
            
                  Molecular weight
               
               
                  112,12
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless needles or white free flowing powder, having a slight characteristic odour and showing no change in colour after heating for 90 minutes at 105 oC
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  Between 133 oC and 135 oC, after vacuum drying for four hours in a sulphuric acid desiccator
               
            
                  
                              B.
                           
                           
                              Spectrometry
                           
                        
               
                  An isopropanol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm
               
            
                  
                              C.
                           
                           
                              Positive test for double bonds
                           
                        
               
                   
               
            
                  
                              D.
                           
                           
                              Sublimation point
                           
                        
               
                  80 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  Not more than 0,5 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 %
               
            
                  Aldehydes
               
               
                  Not more than 0,1 % (as formaldehyde)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 202 POTASSIUM SORBATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium sorbate
               
            
                  Potassium (E, E)-2,4-hexadienoate
               
            
                  Potassium salt of trans, trans 2,4-hexadienoic acid
               
            
                  Einecs
               
               
                  246-376-1
               
            
                  Chemical formula
               
               
                  C6H7O2K
               
            
                  Molecular weight
               
               
                  150,22
               
            
                  Assay
               
               
                  Content not less than 99 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White crystalline powder showing no change in colour after heating for 90 minutes at 105 oC
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive tests for potassium and for double bonds
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % (105 oC, 3h)
               
            
                  Acidity or alkalinity
               
               
                  Not more than about 1,0 % (as sorbic acid or K2CO3)
               
            
                  Aldehydes
               
               
                  Not more than 0,1 %, calculated as formaldehyde
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 203 CALCIUM SORBATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium sorbate
               
            
                  Calcium salts of trans, trans-2,4-hexadienoic acid
               
            
                  Einecs
               
               
                  231-321-6
               
            
                  Chemical formula
               
               
                  C12H14O4Ca
               
            
                  Molecular weight
               
               
                  262,32
               
            
                  Assay
               
               
                  Content not less than 98 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  Fine white crystalline powder not showing any change in colour after heating at 105 oC for 90 minutes
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range of sorbic acid isolated by acidification and not recrystallised 133 oC to 135 oC after vacuum drying in a sulphuric acid desiccator
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive tests for calcium and for double bonds
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 %, determined by vacuum drying for four hours in a sulphuric acid desiccator
               
            
                  Aldehydes
               
               
                  Not more than 0,1 % (as formaldehyde)
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 210 BENZOIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Benzoic acid
               
            
                  Benzenecarboxylic acid
               
            
                  Phenylcarboxylic acid
               
            
                  Einecs
               
               
                  200-618-2
               
            
                  Chemical formula
               
               
                  C7H6O2
                  
               
            
                  Molecular weight
               
               
                  122,12
               
            
                  Assay
               
               
                  Content not less than 99,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  121,5 oC to 123,5 oC
               
            
                  
                              B.
                           
                           
                              Positive sublimation test and test for benzoate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % after drying for three hours over sulphuric acid
               
            
                  pH
               
               
                  About 4 (solution in water)
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 %
               
            
                  Chlorinated organic compounds
               
               
                  Not more than 0,07 % expressed as chloride corresponding to 0,3 % expressed as monochlorobenzoic acid
               
            
                  Readily oxidisable substances
               
               
                  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
               
            
                  Readily carbonisable substances
               
               
                  A cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC (3), 0,3 ml of ferric chloride TSC (4), 0,1 ml of copper sulphate TSC (5) and 4,4 ml of water
               
            
                  Polycyclic acids
               
               
                  On fractional acidification of a neutralised solution of benzoic acid, the first precipitate must not have a different melting point from that of the benzoic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
            E 211 SODIUM BENZOATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium benzoate
               
            
                  Sodium salt of benzenecarboxylic acid
               
            
                  Sodium salt of phenylcarboxylic acid
               
            
                  Einecs
               
               
                  208-534-8
               
            
                  Chemical formula
               
               
                  C7H5O2Na
               
            
                  Molecular weight
               
               
                  144,11
               
            
                  Assay
               
               
                  Not less than 99 % of C7H5O2Na, after drying at 105 oC for four hours
               
            
                  
                     Description
                  
               
               
                  A white, almost odourless, crystalline powder or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water, sparingly soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Melting range for benzoic acid
                           
                        
               
                  Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after drying in a sulphuric acid desiccator
               
            
                  
                              C.
                           
                           
                              Positive tests for benzoate and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1,5 % after drying at 105 oC for four hours
               
            
                  Readily oxidisable substances
               
               
                  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
               
            
                  Polycyclic acids
               
               
                  On fractional acidification of a (neutralised) solution of sodium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
               
            
                  Chlorinated organic compounds
               
               
                  Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
               
            
                  Degree of acidity or alkalinity
               
               
                  Neutralisation of 1 g of sodium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 212 POTASSIUM BENZOATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium benzoate
               
            
                  Potassium salt of benzenecarboxylic acid
               
            
                  Potassium salt of phenylcarboxylic acid
               
            
                  Einecs
               
               
                  209-481-3
               
            
                  Chemical formula
               
               
                  C7H5KO2·3H2O
               
            
                  Molecular weight
               
               
                  214,27
               
            
                  Assay
               
               
                  Content not less than 99 % C7H5KO2 after drying at 105 oC to constant weight
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive tests for benzoate and for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 26,5 %, determined by drying at 105 oC
               
            
                  Chlorinated organic compounds
               
               
                  Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acid
               
            
                  Readily oxidisable substances
               
               
                  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
               
            
                  Readily carbonisable substances
               
               
                  A cold solution of 0,5 g of benzoic acid in 5 ml 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
               
            
                  Polycyclic acids
               
               
                  On fractional acidification of a (neutralised) solution of potassium benzoate, the first precipitate must not have a different melting range from that of benzoic acid
               
            
                  Degree of acidity or alkalinity
               
               
                  Neutralisation of 1 g of potassium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 213 CALCIUM BENZOATE
      
                  
                     Synonyms
                  
               
               
                  Monocalcium benzoate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium benzoate
               
            
                  Calcium dibenzoate
               
            
                  Einecs
               
               
                  218-235-4
               
            
                  Chemical formula
               
               
                  Anhydrous:
               
               
                  C14H10O4Ca
               
            
                  Monohydrate:
               
               
                  C14H10O4Ca· H2O
               
            
                  Trihydrate:
               
               
                  C14H10O4Ca· 3H2O
               
            
                  Molecular weight
               
               
                  Anhydrous:
               
               
                  282,31
               
            
                  Monohydrate:
               
               
                  300,32
               
            
                  Trihydrate:
               
               
                  336,36
               
            
                  Assay
               
               
                  Content not less than 99 % after drying at 105 oC
               
            
                  
                     Description
                  
               
               
                  White or colourless crystals, or white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 oC to 123,5 oC, after vacuum drying in a sulphuric acid desiccator
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive tests for benzoate and for calcium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 17,5 % determined by drying at 105 oC to constant weight
               
            
                  Water insoluble matter
               
               
                  Not more than 0,3 %
               
            
                  Chlorinated organic compounds
               
               
                  Not more than 0,06 % expressed as chloride, corresponding to 0,25 % expressed as monochlorobenzoic acids
               
            
                  Readily oxidisable substances
               
               
                  Add 1,5 ml of sulphuric acid to 100 ml of water, heat to boiling point and add 0,1 N KMnO4 in drops, until the pink colour persists for 30 seconds. Dissolve 1 g of the sample, weighed to the nearest mg, in the heated solution, and titrate with 0,1 N KMnO4 to a pink colour that persists for 15 seconds. Not more than 0,5 ml should be required
               
            
                  Readily carbonisable substances
               
               
                  Cold solution of 0,5 g of benzoic acid in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
               
            
                  Polycyclic acids
               
               
                  On fractional acidification of a (neutralised) solution of calcium benzoate, the first precipitate must not be a different melting range from that of benzoic acid
               
            
                  Degree of acidity or alkalinity
               
               
                  Neutralisation of 1 g of calcium benzoate, in the presence of phenolphthalein, must not require more than 0,25 ml of 0,1 N NaOH or 0,1 N HCl
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 214 ETHYL p-HYDROXYBENZOATE
      
                  
                     Synonyms
                  
               
               
                  Ethylparaben
               
            
                  Ethyl p-oxybenzoate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ethyl-p-hydroxybenzoate
               
            
                  Ethyl ester of p-hydroxybenzoic acid
               
            
                  Einecs
               
               
                  204-399-4
               
            
                  Chemical formula
               
               
                  C9H10O3
                  
               
            
                  Molecular weight
               
               
                  166,8
               
            
                  Assay
               
               
                  Content not less than 99,5 % after drying for two hours at 80 oC
               
            
                  
                     Description
                  
               
               
                  Almost odourless, small, colourless crystals or a white, crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  115 oC to 118 oC
               
            
                  
                              B.
                           
                           
                              Positive test for p-hydroxybenzoate
                           
                        
               
                  Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 oC to 217 oC, after vacuum drying in a sulphuric acid desiccator
               
            
                  
                              C.
                           
                           
                              Positive test for alcohol
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % after drying for two hours at 80 oC
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 %
               
            
                  
                     p-Hydroxybenzoic acid and salicylic acid
               
               
                  Not more than 0,35 % expressed as p-hydroxybenzoic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 215 SODIUM ETHYL p-HYDROXYBENZOATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium ethyl p-hydroxybenzoate
               
            
                  Sodium compound of the ethyl ester of p-hydroxybenzoic acid
               
            
                  Einecs
               
               
                  252-487-6
               
            
                  Chemical formula
               
               
                  C9H9O3Na
               
            
                  Molecular weight
               
               
                  188,8
               
            
                  Assay
               
               
                  Content of ethylester of p-hydroxybenzoic acid not less than 83 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, crystalline hygroscopic powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  115 oC to 118 oC, after vacuum drying in a sulphuric acid desiccator
               
            
                  
                              B.
                           
                           
                              Positive test for p-hydroxybenzoate
                           
                        
               
                  Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC
               
            
                  
                              C.
                           
                           
                              Positive test for sodium
                           
                        
               
                   
               
            
                  
                              D.
                           
                           
                              pH of a 0,1 % aqueous solution must be between 9,9 and 10,3
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 5 %, determined by vacuum drying in a sulphuric acid desiccator
               
            
                  Sulphated ash
               
               
                  37 to 39 %
               
            
                  
                     p-Hydroxybenzoic acid and salicylic acid
               
               
                  Not more than 0,35 % expressed as p-hydroxybenzoic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 218 METHYL p-HYDROXYBENZOATE
      
                  
                     Synonyms
                  
               
               
                  Methylparaben
               
            
                  Methyl-p-oxybenzoate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Methyl p-hydroxybenzoate
               
            
                  Methyl ester of p-hydroxybenzoic acid
               
            
                  Einecs
               
               
                  243-171-5
               
            
                  Chemical formula
               
               
                  C8H8O3
                  
               
            
                  Molecular weight
               
               
                  152,15
               
            
                  Assay
               
               
                  Content not less than 99 % after drying for two hours at 80 oC
               
            
                  
                     Description
                  
               
               
                  Almost odourless, small colourless crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  125 oC to 128 oC
               
            
                  
                              B.
                           
                           
                              Positive test for p-hydroxybenzoate
                           
                        
               
                  Melting range of p-hydroxybenzoic acid derived from the sample is 213 oC to 217 oC after drying for two hours at 80 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 %, after drying for two hours at 80 oC
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 %
               
            
                  
                     p-Hydroxybenzoic acid and salicylic acid
               
               
                  Not more than 0,35 % expressed as p-hydroxybenzoic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 219 SODIUM METHYL p-HYDROXYBENZOATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium methyl p-hydroxybenzoate
               
            
                  Sodium compound of the methylester of p-hydroxybenzoic acid
               
            
                  Chemical formula
               
               
                  C8H7O3Na
               
            
                  Molecular weight
               
               
                  174,15
               
            
                  Assay
               
               
                  Content not less than 99,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, hygroscopic powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              The white precipitate formed by acidifying with hydrochloric acid a 10 % (w/v) aqueous solution of the sodium derivative of methyl p-hydroxybenzoate (using litmus paper as indicator) shall, when washed with water and dried at 80 oC for two hours, have a melting range of 125 oC to 128 oC
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for sodium
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 0,1 % solution in carbon dioxide free water, not less than 9,7 and not more than 10,3
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  Not more than 5 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  40 % to 44,5 % on the anhydrous basis
               
            
                  
                     p-Hydroxybenzoic acid and salicylic acid
               
               
                  Not more than 0,35 % expressed as p-hydroxybenzoic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 220 SULPHUR DIOXIDE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sulphur dioxide
               
            
                  Sulphurous acid anhydride
               
            
                  Einecs
               
               
                  231-195-2
               
            
                  Chemical formula
               
               
                  SO2
                  
               
            
                  Molecular weight
               
               
                  64,07
               
            
                  Assay
               
               
                  Content not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, non-flammable gas with strong pungent suffocating odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for sulphurous substances
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  Not more than 0,05 %
               
            
                  Non-volatile residue
               
               
                  Not more than 0,01 %
               
            
                  Sulphur trioxide
               
               
                  Not more than 0,1 %
               
            
                  Selenium
               
               
                  Not more than 10 mg/kg
               
            
                  Other gases not normally present in the air
               
               
                  No trace
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 221 SODIUM SULPHITE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium sulphite (anhydrous or heptahydrate)
               
            
                  Einecs
               
               
                  231-821-4
               
            
                  Chemical formula
               
               
                  Anhydrous:
               
               
                  Na2SO3
                  
               
            
                  Heptahydrate:
               
               
                  Na2SO37H2O
               
            
                  Molecular weight
               
               
                  Anhydrous:
               
               
                  126,04
               
            
                  Heptahydrate:
               
               
                  252,16
               
            
                  Assay
               
               
                  Anhydrous:
               
               
                  Not less than 95 % of Na2SO3 and not less than 48 % of SO2
                  
               
            
                  Heptahydrate:
               
               
                  Not less than 48 % of Na2SO3 and not less than 24 % of SO2
                  
               
            
                  
                     Description
                  
               
               
                  White crystalline powder or colourless crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sulphite and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % solution (anhydrous) or a 20 % solution (heptahydrate) between 8,5 and 11,5
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Thiosulphate
               
               
                  Not more than 0,1 % based on the SO2 content
               
            
                  Iron
               
               
                  Not more than 50 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 222 SODIUM BISULPHITE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium bisulphite
               
            
                  Sodium hydrogen sulphite
               
            
                  Einecs
               
               
                  231-921-4
               
            
                  Chemical formula
               
               
                  NaHSO3 in aqueous solution
               
            
                  Molecular weight
               
               
                  104,06
               
            
                  Assay
               
               
                  Content not less than 32 % w/w NaHSO3
                  
               
            
                  
                     Description
                  
               
               
                  A clear, colourless to yellow solution
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sulphite and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % aqueous solution between 2,5 and 5,5
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Iron
               
               
                  Not more than 50 mg/kg of Na2SO3 based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 223 SODIUM METABISULPHITE
      
                  
                     Synonyms
                  
               
               
                  Pyrosulphite
               
            
                  Sodium pyrosulphite
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium disulphite
               
            
                  Disodium pentaoxodisulphate
               
            
                  Einecs
               
               
                  231-673-0
               
            
                  Chemical formula
               
               
                  Na2S2O5
                  
               
            
                  Molecular weight
               
               
                  190,11
               
            
                  Assay
               
               
                  Content not less than 95 % Na2S2O5 and not less than 64 % of SO2
                  
               
            
                  
                     Description
                  
               
               
                  White crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sulphite and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % aqueous solution between 4,0 and 5,5
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Thiosulphate
               
               
                  Not more than 0,1 % based on the SO2 content
               
            
                  Iron
               
               
                  Not more than 50 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 224 POTASSIUM METABISULPHITE
      
                  
                     Synonyms
                  
               
               
                  Potassium pyrosulphite
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium disulphite
               
            
                  Potassium pentaoxo disulphate
               
            
                  Einecs
               
               
                  240-795-3
               
            
                  Chemical formula
               
               
                  K2S2O5
                  
               
            
                  Molecular weight
               
               
                  222,33
               
            
                  Assay
               
               
                  Content not less than 90 % of K2S2O5 and not less than 51,8 % of SO2, the remainder being composed almost entirely of potassium sulphate
               
            
                  
                     Description
                  
               
               
                  Colourless crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sulphite and for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Thiosulphate
               
               
                  Not more than 0,1 % based on the SO2 content
               
            
                  Iron
               
               
                  Not more than 50 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 226 CALCIUM SULPHITE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium sulphite
               
            
                  Einecs
               
               
                  218-235-4
               
            
                  Chemical formula
               
               
                  CaSO3·2H2O
               
            
                  Molecular weight
               
               
                  156,17
               
            
                  Assay
               
               
                  Content not less than 95 % of CaSO3·2H2O and not less than 39 % of SO2
                  
               
            
                  
                     Description
                  
               
               
                  White crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sulphite and for calcium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Iron
               
               
                  Not more than 50 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 227 CALCIUM BISULPHITE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium bisulphite
               
            
                  Calcium hydrogen sulphite
               
            
                  Einecs
               
               
                  237-423-7
               
            
                  Chemical formula
               
               
                  Ca(HSO3)2
                  
               
            
                  Molecular weight
               
               
                  202,22
               
            
                  Assay
               
               
                  6 to 8 % (w/v) of sulphur dioxide and 2,5 to 3,5 % (w/v) of calcium dioxide corresponding to 10 to 14 % (w/v) of calcium bisulphite [Ca(HSO3)2]
               
            
                  
                     Description
                  
               
               
                  Clear greenish-yellow aqueous solution having a distinct odour of sulphur dioxide
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sulphite and for calcium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Iron
               
               
                  Not more than 50 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 228 POTASSIUM BISULPHITE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium bisulphite
               
            
                  Potassium hydrogen sulphite
               
            
                  Einecs
               
               
                  231-870-1
               
            
                  Chemical formula
               
               
                  KHSO3 in aqueous solution
               
            
                  Molecular weight
               
               
                  120,17
               
            
                  Assay
               
               
                  Content not less than 280 g KHSO3 per litre (or 150 g SO2 per litre)
               
            
                  
                     Description
                  
               
               
                  Clear colourless aqueous solution
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sulphite and for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Iron
               
               
                  Not more than 50 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 230 BIPHENYL
      
                  
                     Synonyms
                  
               
               
                  Diphenyl
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  1,1′-biphenyl
               
            
                  Phenylbenzene
               
            
                  Einecs
               
               
                  202-163-5
               
            
                  Chemical formula
               
               
                  C12H10
                  
               
            
                  Molecular weight
               
               
                  154,20
               
            
                  Assay
               
               
                  Content not less than 99,8 %
               
            
                  
                     Description
                  
               
               
                  White or pale yellow to amber crystalline solid having a characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  68,5 oC to 70,5 oC
               
            
                  
                              B.
                           
                           
                              Distillation range
                           
                        
               
                  It distils completely within a 2,5 oC range between 252,5 oC and 257,5 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Benzene
               
               
                  Not more than 10 mg/kg
               
            
                  Aromatic amines
               
               
                  Not more than 2 mg/kg (as aniline)
               
            
                  Phenol derivatives
               
               
                  Not more than 5 mg/kg (as phenol)
               
            
                  Readily carbonisable substances
               
               
                  Cold solution of 0,5 g of biphenyl in 5 ml of 94,5 to 95,5 % sulphuric acid must not show a stronger colouring than that of a reference liquid containing 0,2 ml of cobalt chloride TSC, 0,3 ml of ferric chloride TSC, 0,1 ml of copper sulphate TSC and 4,4 ml of water
               
            
                  Terphenyl and higher polyphenyl derivatives
               
               
                  Not more than 0,2 %
               
            
                  Polycyclic aromatic hydrocarbons
               
               
                  Absent
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 231 ORTHOPHENYLPHENOL
      
                  
                     Synonyms
                  
               
               
                  Orthoxenol
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  (1,1'-Biphenyl)-2-ol
               
            
                  2-Hydroxydiphenyl
               
            
                  
                     o-Hydroxydiphenyl
               
            
                  Einecs
               
               
                  201-993-5
               
            
                  Chemical formula
               
               
                  C12H10O
               
            
                  Molecular weight
               
               
                  170,20
               
            
                  Assay
               
               
                  Content not less than 99 %
               
            
                  
                     Description
                  
               
               
                  White or slightly yellowish crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  56 oC to 58 oC
               
            
                  
                              B.
                           
                           
                              Positive test for phenolate
                           
                        
               
                  An ethanolic solution (1 g in 10 ml) produces a green colour on addition of 10 % ferric chloride solution
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 %
               
            
                  Diphenyl ether
               
               
                  Not more than 0,3 %
               
            
                  
                     p-Phenylphenol
               
               
                  Not more than 0,1 %
               
            
                  1-Naphthol
               
               
                  Not more than 0,01 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 232 SODIUM ORTHOPHENYLPHENOL
      
                  
                     Synonyms
                  
               
               
                  Sodium orthophenylphenate
               
            
                  Sodium salt ofo-phenylphenol
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium orthophenylphenol
               
            
                  Einecs
               
               
                  205-055-6
               
            
                  Chemical formula
               
               
                  C12H9ONa· 4H2O
               
            
                  Molecular weight
               
               
                  264,26
               
            
                  Assay
               
               
                  Content not less than 97 % of C12H9ONa· 4H2O
               
            
                  
                     Description
                  
               
               
                  White or slightly yellowish crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for phenolate and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Melting range of orthophenylphenol isolated by acidification and not recrystallised derived from the sample 56 oC to 58 oC after drying in a sulphuric acid desiccator
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 2 % aqueous solution must be between 11,1 and 11,8
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Diphenylether
               
               
                  Not more than 0,3 %
               
            
                  
                     p-phenylphenol
               
               
                  Not more than 0,1 %
               
            
                  1-naphthol
               
               
                  Not more than 0,01 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 233 THIABENDAZOLE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  4-(2-benzimidazolyl)thiazole
               
            
                  2-(4-thiazolyl)-1H-benzimidazole
               
            
                  Einecs
               
               
                  205-725-8
               
            
                  Chemical formula
               
               
                  C10H7N3S
               
            
                  Molecular weight
               
               
                  201,26
               
            
                  Assay
               
               
                  Content not less than 98 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, or almost white, odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  296 oC to 303 oC
               
            
                  
                              B.
                           
                           
                              Spectrometry
                           
                        
               
                  Absorption maxima in 0,1 N HCl (0,0005 % w/v) at 302 nm, 258 nm and 243 nm
               
            
                  
                     at 302 nm ± 2 nm: approximately 1 230
            
                  
                     at 258 nm ± 2 nm: approximately 200
            
                  
                     at 243 nm ± 2 nm: approximately 620
            
                  Ratio of absorption 243 nm/302 nm = 0,47 to 0,53
               
            
                  Ratio of absorption 258 nm/302 nm = 0,14 to 0,18
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  Not more than 0,5 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 %
               
            
                  Selenium
               
               
                  Not more than 3 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 234 NISIN
      
                  
                     Definition
                  
               
               
                  Nisin consists of several closely related polypeptides produced by natural strains of Streptococcus lactis, Lancefield group N
               
            
                  Einecs
               
               
                  215-807-5
               
            
                  Chemical formula
               
               
                  C143H230N42O37S7
                  
               
            
                  Molecular weight
               
               
                  3 354 ,12
               
            
                  Assay
               
               
                  Nisin concentrate contains not less than 900 units per mg in a mixture of non-fat milk solids and a minimum sodium chloride content of 50 %
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 3 % when dried to constant weight at 102 oC to 103 oC
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 235 NATAMYCIN
      
                  
                     Synonyms
                  
               
               
                  Pimaricin
               
            
                  
                     Definition
                  
               
               
                  Natamycin is a fungicide of the polyene macrolide group, and is produced by natural strains of Streptomyces natalensis or of Streptococcus lactis
                  
               
            
                  Einecs
               
               
                  231-683-5
               
            
                  Chemical formula
               
               
                  C33H47O13N
               
            
                  Molecular weight
               
               
                  665,74
               
            
                  Assay
               
               
                  Content not less than 95 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White to creamy-white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Colour reactions
                           
                        
               
                  On adding a few crystals of natamycin on a spot plate, to a drop of:
                  
                              —
                           
                           
                              concentrated hydrochloric acid, a blue colour develops,
                           
                        
                              —
                           
                           
                              concentrated phosphoric acid, a green colour develops,
                           
                        which changes into pale red after a few minutes
               
            
                  
                              B.
                           
                           
                              Spectrometry
                           
                        
               
                  A 0,0005 % w/v solution in 1 % methanolic acetic acid solution has absorption maxima at about 290 nm, 303 nm and 318 nm, a shoulder at about 280 nm and exhibits minima at about 250 nm, 295,5 nm and 311 nm
               
            
                  
                              C.
                           
                           
                              pH
                           
                        
               
                  5,5 to 7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)
               
            
                  
                              D.
                           
                           
                              Specific rotation
                           
                        
               
                  [α]D
                     20 = + 250o to + 295o (a 1 % w/v solution in glacial acetic acid, at 20 oC and calculated with reference to the dried material)
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 8 % (over P2O5, in vacuum at 60 oC to constant weight)
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Microbiological criteria: total viable count
               
               
                  Not more than 100/g
               
            E 239 HEXAMETHYLENE TETRAMINE
      
                  
                     Synonyms
                  
               
               
                  Hexamine
               
            
                  Methenamine
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine
               
            
                  Einecs
               
               
                  202-905-8
               
            
                  Chemical formula
               
               
                  C6H12N4
                  
               
            
                  Molecular weight
               
               
                  140,19
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for formaldehyde and for ammonia
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Sublimation point approximately 260 oC
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % after drying at 105 oC in vacuum over P2O5 for two hours
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 %
               
            
                  Sulphates
               
               
                  Not more than 0,005 % expressed as SO4
                  
               
            
                  Chlorides
               
               
                  Not more than 0,005 % expressed as Cl
               
            
                  Ammonium salts
               
               
                  Not detectable
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 242 DIMETHYL DICARBONATE
      
                  
                     Synonyms
                  
               
               
                  DMDC
               
            
                  Dimethyl pyrocarbonate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dimethyl dicarbonate
               
            
                  Pyrocarbonic acid dimethyl ester
               
            
                  Einecs
               
               
                  224-859-8
               
            
                  Chemical formula
               
               
                  C4H6O5
                  
               
            
                  Molecular weight
               
               
                  134,09
               
            
                  Assay
               
               
                  Content not less than 99,8 %
               
            
                  
                     Description
                  
               
               
                  Colourless liquid, decomposes in aqueous solution. It is corrosive to skin and eyes and toxic by inhalation and ingestion
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Decomposition
                           
                        
               
                  After dilution positive tests for CO2 and methanol
               
            
                  
                              B.
                           
                           
                              Melting point
                           
                        
               
                  17 oC
               
            
                  Boiling point
               
               
                  172 oC with decomposition
               
            
                  
                              C.
                           
                           
                              Density 20 oC
                           
                        
               
                  Approximately 1,25 g/cm3
                  
               
            
                  
                              D.
                           
                           
                              Infrared spectrum
                           
                        
               
                  Maxima at 1 156 and 1 832 cm- 1
                  
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Dimethyl carbonate
               
               
                  Not more than 0,2 %
               
            
                  Chlorine, total
               
               
                  Not more than 3 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 249 POTASSIUM NITRITE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium nitrite
               
            
                  Einecs
               
               
                  231-832-4
               
            
                  Chemical formula
               
               
                  KNO2
                  
               
            
                  Molecular weight
               
               
                  85,11
               
            
                  Assay
               
               
                  Content not less than 95 % on the anhydrous basis (6)
                  
               
            
                  
                     Description
                  
               
               
                  White or slightly yellow, deliquescent granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for nitrite and for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution:
                           
                        
               
                  Not less than 6,0 and not more than 9,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 3 % after drying for four hours over silica gel
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 250 SODIUM NITRITE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium nitrite
               
            
                  Einecs
               
               
                  231-555-9
               
            
                  Chemical formula
               
               
                  NaNO2
                  
               
            
                  Molecular weight
               
               
                  69,00
               
            
                  Assay
               
               
                  Content not less than 97 % on the anhydrous basis (7)
                  
               
            
                  
                     Description
                  
               
               
                  White crystalline powder or yellowish lumps
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for nitrite and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % after drying over silica gel for four hours
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 251 SODIUM NITRATE
      1.   SOLID SODIUM NITRATE
      
                  
                     Synonyms
                  
               
               
                  Chile saltpetre
               
            
                  Cubic or soda nitre
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium nitrate
               
            
                  Einecs
               
               
                  231-554-3
               
            
                  Chemical formula
               
               
                  NaNO3
                  
               
            
                  Molecular weight
               
               
                  85,00
               
            
                  Assay
               
               
                  Content not less than 99 % after drying
               
            
                  
                     Description
                  
               
               
                  White crystalline, slightly hygroscopic powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for nitrate and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Not less than 5,5 and more than 8,3
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2 % after drying at 105 oC for four hours
               
            
                  Nitrites
               
               
                  Not more than 30 mg/kg expressed as NaNO2
                  
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 251 SODIUM NITRATE
      2.   LIQUID SODIUM NITRATE
      
                  
                     Definition
                  
               
               
                  Liquid sodium nitrate is an aqueous solution of sodium nitrate as the direct result of the chemical reaction between sodium hydroxide and nitric acid in stoechiometric amounts, without subsequent crystallisation. Standardised forms prepared from liquid sodium nitrate meeting these specifications may contain nitric acid in excessive amounts, if clearly stated or labelled.
               
            
                  Chemical name
               
               
                  Sodium nitrate
               
            
                  Einecs
               
               
                  231-554-3
               
            
                  Chemical formula
               
               
                  NaNO3
                  
               
            
                  Molecular weight
               
               
                  85,00
               
            
                  Assay
               
               
                  Content between 33,5 % and 40,0 % of NaNO3
                  
               
            
                  
                     Description
                  
               
               
                  Clear colourless liquid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for nitrate and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH
                           
                        
               
                  Not less than 1,5 and not more than 3,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Free nitric acid
               
               
                  Not more than 0,01 %
               
            
                  Nitrites
               
               
                  Not more than 10 mg/kg expressed as NaNO2
                  
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,3 mg/kg
               
            
                  This specification refers to a 35 % aqueous solution
               
               
                   
               
            E 252 POTASSIUM NITRATE
      
                  
                     Synonyms
                  
               
               
                  Chile saltpetre
                  Cubic or soda nitre
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium nitrate
               
            
                  Einecs
               
               
                  231-818-8
               
            
                  Chemical formula
               
               
                  KNO3
                  
               
            
                  Molecular weight
               
               
                  101,11
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline powder or transparent prisms having a cooling, saline, pungent taste
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for nitrate and for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Not less than 4,5 and not more than 8,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1 % after drying at 105 oC for four hours
               
            
                  Nitrites
               
               
                  Not more than 20 mg/kg expressed as KNO2
                  
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 260 ACETIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Acetic acid
               
            
                  Ethanoic acid
               
            
                  Einecs
               
               
                  200-580-7
               
            
                  Chemical formula
               
               
                  C2H4O2
                  
               
            
                  Molecular weight
               
               
                  60,05
               
            
                  Assay
               
               
                  Content not less than 99,8 %
               
            
                  
                     Description
                  
               
               
                  Clear, colourless liquid having a pungent, characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Boiling point
                           
                        
               
                  118 oC at 760 mm pressure (of mercury)
               
            
                  
                              B.
                           
                           
                              Specific gravity
                           
                        
               
                  About 1,049
               
            
                  
                              C.
                           
                           
                              A one in three solution gives positive tests for acetate
                           
                        
               
                   
               
            
                  
                              D.
                           
                           
                              Solidification point
                           
                        
               
                  Not lower than 14,5 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Non-volatile residue
               
               
                  Not more than 100 mg/kg
               
            
                  Formic acid, formates and other oxidisable substances
               
               
                  Not more than 1 000 mg/kg expressed as formic acid
               
            
                  Readily oxidisable substances
               
               
                  Dilute 2 ml of the sample in a glass-stoppered container with 10 ml of water and add 0,1 ml of 0,1 N potassium permanganate. The pink colour does not change to brown within 30 minutes
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 261 POTASSIUM ACETATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium acetate
               
            
                  Einecs
               
               
                  204-822-2
               
            
                  Chemical formula
               
               
                  C2H3O2K
               
            
                  Molecular weight
               
               
                  98,14
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless, deliquescent crystals or a white crystalline powder, odourless or with a faint acetic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              pH of a 5 % aqueous solution
                           
                        
               
                  Not less than 7,5 and not more than 9,0
               
            
                  
                              B.
                           
                           
                              Positive tests for acetate and for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 8 % after drying at 150 oC for two hours
               
            
                  Formic acid, formates and other oxidisable substances
               
               
                  Not more than 1 000 mg/kg expressed as formic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 262 (i) SODIUM ACETATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium acetate
               
            
                  Einecs
               
               
                  204-823-8
               
            
                  Chemical formula
               
               
                  C2H3NaO2·nH2O (n = 0 or 3)
               
            
                  Molecular weight
               
               
                  Anhydrous:
               
               
                  82,03
               
            
                  Trihydrate:
               
               
                  136,08
               
            
                  Assay
               
               
                  Content (for both of anhydrous and trihydrate form) not less than 98,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Anhydrous:
               
               
                  White, odourless, granular, hygroscopic powder
               
            
                  Trihydrate:
               
               
                  Colourless, transparent crystals or a granular crystalline powder, odourless or with a faint, acetic odour. Effloresces in warm, dry air
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              pH of a 1 % aqueous solution
                           
                        
               
                  Not less than 8,0 and not more than 9,5
               
            
                  
                              B.
                           
                           
                              Positive tests for acetate and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Anhydrous:
               
               
                  Not more than 2 % (120 oC, 4 hours)
               
            
                  Trihydrate:
               
               
                  Between 36 and 42 % (120 oC, 4 hours)
               
            
                  Formic acid, formates and other oxidisable substances
               
               
                  Not more than 1 000 mg/kg expressed as formic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 262 (ii) SODIUM DIACETATE
      
                  
                     Definition
                  
               
               
                  Sodium diacetate is a molecular compound of sodium acetate and acetic acid
               
            
                  Chemical name
               
               
                  Sodium hydrogen diacetate
               
            
                  Einecs
               
               
                  204-814-9
               
            
                  Chemical formula
               
               
                  C4H7NaO4·nH2O (n = 0 or 3)
               
            
                  Molecular weight
               
               
                  142,09 (anhydrous)
               
            
                  Assay
               
               
                  Content 39 to 41 % of free acetic acid and 58 to 60 % of sodium acetate
               
            
                  
                     Description
                  
               
               
                  White, hygroscopic crystalline solid with an acetic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              pH of a 10 % aqueous solution
                           
                        
               
                  Not less than 4,5 and not more than 5,0
               
            
                  
                              B.
                           
                           
                              Positive tests for acetate and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  Not more than 2 % (Karl Fischer method)
               
            
                  Formic acid, formates and other oxidisable substances
               
               
                  Not more than 1 000 mg/kg expressed as formic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 263 CALCIUM ACETATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium acetate
               
            
                  Einecs
               
               
                  200-540-9
               
            
                  Chemical formula
               
               
                  Anhydrous:
               
               
                  C4H6O4Ca
               
            
                  Monohydrate:
               
               
                  C4H6O4Ca· H2O
               
            
                  Molecular weight
               
               
                  Anhydrous:
               
               
                  158,17
               
            
                  Monohydrate:
               
               
                  176,18
               
            
                  Assay
               
               
                  Content not less than 98 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Anhydrous calcium acetate is a white, hygroscopic, bulky, crystalline solid with a slightly bitter taste. A slight odour of acetic acid may be present. The monohydrate may be needles, granules or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              pH of a 10 % aqueous solution
                           
                        
               
                  Not less than 6,0 and not more than 9,0
               
            
                  
                              B.
                           
                           
                              Positive tests for acetate and for calcium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 11 % after drying (155 oC to constant weight, for the monohydrate)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,3 %
               
            
                  Formic acid, formates and other oxidisable substances
               
               
                  Not more than 1 000 mg/kg expressed as formic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 270 LACTIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Lactic acid
               
            
                  2-Hydroxypropionic acid
               
            
                  1-Hydroxyethane-1-carboxylic acid
               
            
                  Einecs
               
               
                  200-018-0
               
            
                  Chemical formula
               
               
                  C3H6O3
                  
               
            
                  Molecular weight
               
               
                  90,08
               
            
                  Assay
               
               
                  Content not less than 76 % and not more than 84 %
               
            
                  
                     Description
                  
               
               
                  Colourless or yellowish, nearly odourless, syrupy liquid with an acid taste, consisting of a mixture of lactic acid (C3H6O3) and lactic acid lactate (C6H10O5). It is obtained by the lactic fermentation of sugars or is prepared synthetically
               
            
                  
                     Note:
                  
                  Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyzes to lactic acid
               
               
                   
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for lactate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Sulphate
               
               
                  Not more than 0,25 %
               
            
                  Iron
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  
                     Note:
                  
                  This specification refers to a 80 % aqueous solution; for weaker aqueous solutions, calculate values corresponding to their lactic acid content
               
               
                   
               
            E 280 PROPIONIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Propionic acid
               
            
                  Propanoic acid
               
            
                  Einecs
               
               
                  201-176-3
               
            
                  Chemical formula
               
               
                  C3H6O2
                  
               
            
                  Molecular weight
               
               
                  74,08
               
            
                  Assay
               
               
                  Content not less than 99,5 %
               
            
                  
                     Description
                  
               
               
                  Colourless or slightly yellowish, oily liquid with a slightly pungent odour
               
            
                  
                     Indentification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting point
                           
                        
               
                  - 22 oC
               
            
                  
                              B.
                           
                           
                              Distillation range
                           
                        
               
                  138,5 oC to 142,5 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Non-volatile residue
               
               
                  Not more than 0,01 % when dried at 140 oC to constant weight
               
            
                  Aldehydes
               
               
                  Not more than 0,1 % expressed as formaldehyde
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 281 SODIUM PROPIONATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium propionate
               
            
                  Sodium propanoate
               
            
                  Einecs
               
               
                  205-290-4
               
            
                  Chemical formula
               
               
                  C3H5O2Na
               
            
                  Molecular weight
               
               
                  96,06
               
            
                  Assay
               
               
                  Content not less than 99 % after drying for two hours at 105 oC
               
            
                  
                     Description
                  
               
               
                  White crystalline hygroscopic powder, or a fine white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for propionate and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % aqueous solution
                           
                        
               
                  Not less than 7,5 and not more than 10,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 4 % determined by drying for two hours at 105 oC
               
            
                  Water insolubles
               
               
                  Not more than 0,1 %
               
            
                  Iron
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 282 CALCIUM PROPIONATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium propionate
               
            
                  Einecs
               
               
                  223-795-8
               
            
                  Chemical formula
               
               
                  C6H10O4Ca
               
            
                  Molecular weight
               
               
                  186,22
               
            
                  Assay
               
               
                  Content not less than 99 %, after drying for two hours at 105 oC
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for propionate and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % aqueous solution
                           
                        
               
                  Between 6,0 and 9,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 4 %, determined by drying for two hours at 105 oC
               
            
                  Water insolubles
               
               
                  Not more than 0,3 %
               
            
                  Iron
               
               
                  Not more than 50 mg/kg
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 283 POTASSIUM PROPIONATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium propionate
               
            
                  Potassium propanoate
               
            
                  Einecs
               
               
                  206-323-5
               
            
                  Chemical formula
               
               
                  C3H5KO2
                  
               
            
                  Molecular weight
               
               
                  112,17
               
            
                  Assay
               
               
                  Content not less than 99 % after drying for two hours at 105 oC
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for propionate and for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 4 %, determined by drying for two hours at 105 oC
               
            
                  Water-insoluble substances
               
               
                  Not more than 0,3 %
               
            
                  Iron
               
               
                  Not more than 30 mg/kg
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 284 BORIC ACID
      
                  
                     Synonyms
                  
               
               
                  Boracic acid
               
            
                  Orthoboric acid
               
            
                  Borofax
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Einecs
               
               
                  233-139-2
               
            
                  Chemical formula
               
               
                  H3BO3
                  
               
            
                  Molecular weight
               
               
                  61,84
               
            
                  Assay
               
               
                  Content not less than 99,5 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, transparent crystals or white granules or powder; slightly unctuous to the touch; occurs in nature as the mineral sassolite
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting point
                           
                        
               
                  At approximately 171 oC
               
            
                  
                              B.
                           
                           
                              Burns with a nice green flame
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 3,3 % aqueous solution
                           
                        
               
                  Between 3,8 and 4,8
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Peroxides
               
               
                  No colour develops with added KI-solution
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 285 SODIUM TETRABORATE (BORAX)
      
                  
                     Synonyms
                  
               
               
                  Sodium borate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium tetraborate
               
            
                  Sodium biborate
               
            
                  Sodium pyroborate
               
            
                  Anhydrous tetraborate
               
            
                  Einecs
               
               
                  215-540-4
               
            
                  Chemical formula
               
               
                  Na2B4O7
                  
               
            
                  Na2B4O7·10H2O
               
            
                  Molecular weight
               
               
                  201,27
               
            
                  
                     Description
                  
               
               
                  Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  Between 171 oC and 175 oC with decomposition
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Peroxides
               
               
                  No colour develops with added KI-solution
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 290 CARBON DIOXIDE
      
                  
                     Synonyms
                  
               
               
                  Carbonic acid gas
               
            
                  Dry ice (solid form)
               
            
                  Carbonic anhydride
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Carbon dioxide
               
            
                  Einecs
               
               
                  204-696-9
               
            
                  Chemical formula
               
               
                  CO2
                  
               
            
                  Molecular weight
               
               
                  44,01
               
            
                  Assay
               
               
                  Content not less than 99 % v/v on the gaseous basis
               
            
                  
                     Description
                  
               
               
                  A colourless gas under normal environmental conditions with a slight pungent odour. Commercial carbon dioxide is shipped and handled as a liquid in pressurised cylinders or bulk storage systems, or in compressed solid blocks of ‘dry ice’. Solid (dry ice) forms usually contain added substances, such as propylene glycol or mineral oil, as binders
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Precipitation (Precipitate formation)
                           
                        
               
                  When a stream of the sample is passed through a solution of barium hydroxide, a white precipitate is produced which dissolves with effervescence in dilute acetic acid
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acidity
               
               
                  915 ml of gas bubbled through 50 ml of freshly boiled water must not render the latter more acid to methylorange than is 50 ml freshly boiled water to which has been added 1 ml of hydrochloric acid (0,01 N)
               
            
                  Reducing substances, hydrogen phosphide and sulphide
               
               
                  915 ml of gas bubbled through 25 ml of ammoniacal silver nitrate reagent to which has been added 3 ml of ammonia must not cause clouding or blackening of this solution
               
            
                  Carbon monoxide
               
               
                  Not more than 10 μl/l
               
            
                  Oil content
               
               
                  Not more than 0,1 mg/l
               
            E 296 MALIC ACID
      
                  
                     Synonyms
                  
               
               
                  DL-Malic acid, pomalous acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  DL-Malic acid, hydroxybutanedioic acid, hydroxysuccinic acid
               
            
                  Einecs
               
               
                  230-022-8
               
            
                  Chemical formula
               
               
                  C4H6O5
                  
               
            
                  Molecular weight
               
               
                  134,09
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  White or nearly white crystalline powder or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range between 127 oC and 132 oC
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for malate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Solutions of this substance are optically inactive in all concentrations
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Fumaric acid
               
               
                  Not more than 1,0 %
               
            
                  Maleic acid
               
               
                  Not more than 0,05 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 297 FUMARIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Trans-butenedioic acid, trans-1,2-ethylene-dicarboxylic acid
               
            
                  Einecs
               
               
                  203-743-0
               
            
                  Chemical formula
               
               
                  C4H4O4
                  
               
            
                  Molecular weight
               
               
                  116,07
               
            
                  Assay
               
               
                  Content not less than 99,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline powder or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  286 oC-302 oC (closed capillary, rapid heating)
               
            
                  
                              B.
                           
                           
                              Positive tests for double bonds and for 1,2-dicarboxylic acid
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 0,05 % solution at 25 oC
                           
                        
               
                  3,0-3,2
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (120 oC, 4h)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Maleic acid
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 300 ASCORBIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  L-ascorbic acid
               
            
                  Ascorbic acid
               
            
                  2,3-Didehydro-L-threo-hexono-1,4-lactone
               
            
                  3-Keto-L-gulofuranolactone
               
            
                  Einecs
               
               
                  200-066-2
               
            
                  Chemical formula
               
               
                  C6H8O6
                  
               
            
                  Molecular weight
               
               
                  176,13
               
            
                  Assay
               
               
                  Ascorbic acid, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H8O6
                  
               
            
                  
                     Description
                  
               
               
                  White to pale yellow, odourless crystalline solid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  Between 189 oC and 193 oC with decomposition
               
            
                  
                              B.
                           
                           
                              Positive tests for ascorbic acid
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,4 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between +20,5o and +21,5o (10 % w/v aqueous solution)
               
            
                  pH of a 2 % aqueous solution
               
               
                  Between 2,4 and 2,8
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 301 SODIUM ASCORBATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium ascorbate
               
            
                  Sodium L-ascorbate
               
            
                  2,3-Didehydro-L-threo-hexono-1,4-lactone sodium enolate
               
            
                  3-Keto-L-gulofurano-lactone sodium enolate
               
            
                  Einecs
               
               
                  205-126-1
               
            
                  Chemical formula
               
               
                  C6H7O6Na
               
            
                  Molecular weight
               
               
                  198,11
               
            
                  Assay
               
               
                  Sodium ascorbate, after drying in a vacuum desiccator over sulphuric acid for 24 hours, contains not less than 99 % of C6H7O6Na
               
            
                  
                     Description
                  
               
               
                  White or almost white, odourless crystalline solid which darkens on exposure to light
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for ascorbate and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 103o and + 106o (10 % w/v aqueous solution)
               
            
                  pH of 10 % aqueous solution
               
               
                  Between 6,5 and 8,0
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 302 CALCIUM ASCORBATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium ascorbate dihydrate
               
            
                  Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
               
            
                  Einecs
               
               
                  227-261-5
               
            
                  Chemical formula
               
               
                  C12H14O12Ca· 2H2O
               
            
                  Molecular weight
               
               
                  426,35
               
            
                  Assay
               
               
                  Content not less than 98 % on a volatile matter-free basis
               
            
                  
                     Description
                  
               
               
                  White to slightly pale greyish-yellow odourless crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for ascorbate and for calcium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 95o and + 97o (5 % w/v aqueous solution)
               
            
                  pH of 10 % aqueous solution
               
               
                  Between 6,0 and 7,5
               
            
                  Volatile matter
               
               
                  Not more than 0,3 % determined by drying at room temperature for 24 hours in a desiccator containing sulphuric acid or phosphorus pentoxide
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 304 (i) ASCORBYL PALMITATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ascorbyl palmitate
               
            
                  L-ascorbyl palmitate
               
            
                  2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate
               
            
                  6-palmitoyl-3-keto-L-gulofuranolactone
               
            
                  Einecs
               
               
                  205-305-4
               
            
                  Chemical formula
               
               
                  C22H38O7
                  
               
            
                  Molecular weight
               
               
                  414,55
               
            
                  Assay
               
               
                  Content not less than 98 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White or yellowish-white solid with a citrus-like odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  Between 107 oC and 117 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % after drying in a vacuum oven at 56 oC and 60 oC for one hour
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 21o and + 24o (5 % w/v in methanol solution)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 304 (ii) ASCORBYL STEARATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ascorbyl stearate
               
            
                  L-ascorbyl stearate
               
            
                  2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate
               
            
                  6-stearoyl-3-keto-L-gulofuranolactone
               
            
                  Einecs
               
               
                  246-944-9
               
            
                  Chemical formula
               
               
                  C24H42O7
                  
               
            
                  Molecular weight
               
               
                  442,6
               
            
                  Assay
               
               
                  Content not less than 98 %
               
            
                  
                     Description
                  
               
               
                  White or yellowish, white solid with a citrus-like odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting point
                           
                        
               
                  About 116 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % after drying in a vacuum oven at 56 oC to 60 oC for one hour
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 306 TOCOPHEROL-RICH EXTRACT
      
                  
                     Definition
                  
               
               
                  Product obtained by the vacuum steam distillation of edible vegetable oil products, comprising concentrated tocopherols and tocotrienols
               
            
                  Contains tocopherols such as d-α-, d-β-, d-γ- and d-ς-tocopherols
               
            
                  Molecular weight
               
               
                  430,71 (d-α-tocopherol)
               
            
                  Assay
               
               
                  Content not less than 34 % of total tocopherols
               
            
                  
                     Description
                  
               
               
                  Brownish red to red, clear, viscous oil having a mild, characteristic odour and taste. May show a slight separation of wax-like constituents in microcrystalline form
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              By suitable gas liquid chromatographic method
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility tests
                           
                        
               
                  Insoluble in water. Soluble in ethanol. Miscible in ether
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Specific rotation
               
               
                  [α]D
                     20 not less than + 20o
                  
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 307 ALPHA-TOCOPHEROL
      
                  
                     Synonyms
                  
               
               
                  DL-α-Tocopherol
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  DL-5,7,8-Trimethyltocol
               
            
                  DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
               
            
                  Einecs
               
               
                  233-466-0
               
            
                  Chemical formula
               
               
                  C29H50O2
                  
               
            
                  Molecular weight
               
               
                  430,71
               
            
                  Assay
               
               
                  Content not less than 96 %
               
            
                  
                     Description
                  
               
               
                  Slightly yellow to amber, nearly odourless, clear, viscous oil which oxidises and darkens on exposure to air or light
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility tests
                           
                        
               
                  Insoluble in water, freely soluble in ethanol, miscible in ether
               
            
                  
                              B.
                           
                           
                              Spectro-photometry
                           
                        
               
                  In absolute ethanol the maximum absorption is about 292 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Refractive index
               
               
                  n D
                     201,503-1,507
               
            Specific absorption 
                      in ethanol
               
                  
                     (292 nm) 72-76
                  (0,01 g in 200 ml of absolute ethanol)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Specific rotation
               
               
                  [α]D
                     25 0o±0,05o (1 in 10 solution in chloroform)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 308 GAMMA-TOCOPHEROL
      
                  
                     Synonyms
                  
               
               
                  dl-γ-Tocopherol
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
               
            
                  Einecs
               
               
                  231-523-4
               
            
                  Chemical formula
               
               
                  C28H48O2
                  
               
            
                  Molecular weight
               
               
                  416,69
               
            
                  Assay
               
               
                  Content not less than 97 %
               
            
                  
                     Description
                  
               
               
                  Clear, viscous, pale yellow oil which oxidises and darkens on exposure to air or light
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Spectrometry
                           
                        
               
                  Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            Specific absorption 
                      in ethanol
               
                  
                     (298 nm) between 91 and 97
            
                  
                     (257 nm) between 5,0 and 8,0
            
                  Refractive index
               
               
                  
                     1,503-1,507
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 309 DELTA-TOCOPHEROL
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
               
            
                  Einecs
               
               
                  204-299-0
               
            
                  Chemical formula
               
               
                  C27H46O2
                  
               
            
                  Molecular weight
               
               
                  402,7
               
            
                  Assay
               
               
                  Content not less than 97 %
               
            
                  
                     Description
                  
               
               
                  Clear, viscous, pale yellowish or orange oil which oxidises and darkens on exposure to air or light
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Spectrometry
                           
                        
               
                  Maximum absorptions in absolute ethanol at about 298 nm and 257 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            Specific absorption 
                      in ethanol
               
                  
                     (298 nm) between 89 and 95
            
                  
                     (257 nm) between 3,0 and 6,0
            
                  Refractive index
               
               
                  
                     1,500-1,504
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 310 PROPYL GALLATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Propyl gallate
               
            
                  Propyl ester of gallic acid
               
            
                  n-propyl ester of 3,4,5-trihydroxybenzoic acid
               
            
                  Einecs
               
               
                  204-498-2
               
            
                  Chemical formula
               
               
                  C10H12O5
                  
               
            
                  Molecular weight
               
               
                  212,20
               
            
                  Assay
               
               
                  Content not less than 98 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White to creamy-white, crystalline, odourless solid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility tests
                           
                        
               
                  Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 146 oC and 150 oC after drying at 110 oC for four hours
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % (110 oC, four hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Free acid
               
               
                  Not more than 0,5 % (as gallic acid)
               
            
                  Chlorinated organic compound
               
               
                  Not more than 100 mg/kg (as C1)
               
            Specific absorption 
                      in ethanol
               
                  
                     (275 nm) not less than 485 and not more than 520
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 311 OCTYL GALLATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Octyl gallate
               
            
                  Octyl ester of gallic acid
               
            
                  n-octyl ester of 3,4,5-trihydroxybenzoic acid
               
            
                  Einecs
               
               
                  213-853-0
               
            
                  Chemical formula
               
               
                  C15H22O5
                  
               
            
                  Molecular weight
               
               
                  282,34
               
            
                  Assay
               
               
                  Content not less than 98 % after drying at 90 oC for six hours
               
            
                  
                     Description
                  
               
               
                  White to creamy-white odourless solid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility tests
                           
                        
               
                  Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 99 oC and 102 oC after drying at 90 oC for six hours
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (90 oC, six hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 %
               
            
                  Free acid
               
               
                  Not more than 0,5 % (as gallic acid)
               
            
                  Chlorinated organic compound
               
               
                  Not more than 100 mg/kg (as C1)
               
            Specific absorption 
                      in ethanol
               
                  
                     (275 nm) not less than 375 and not more than 390
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 312 DODECYL GALLATE
      
                  
                     Synonyms
                  
               
               
                  Lauryl gallate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dodecyl gallate
               
            
                  n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid
               
            
                  Dodecyl ester of gallic acid
               
            
                  Einecs
               
               
                  214-620-6
               
            
                  Chemical formula
               
               
                  C19H30O5
                  
               
            
                  Molecular weight
               
               
                  338,45
               
            
                  Assay
               
               
                  Content not less than 98 % after drying at 90 oC for six hours
               
            
                  
                     Description
                  
               
               
                  White or creamy-white odourless solid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility tests
                           
                        
               
                  Insoluble in water, freely soluble in ethanol and ether
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 95 oC and 98 oC after drying at 90 oC for six hours
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (90 oC, six hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 %
               
            
                  Free acid
               
               
                  Not more than 0,5 % (as gallic acid)
               
            
                  Chlorinated organic compound
               
               
                  Not more than 100 mg/kg (as Cl)
               
            Specific absorption 
                      in ethanol
               
                  
                     (275 nm) not less than 300 and not more than 325
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 30 mg/kg
               
            E 315 ERYTHORBIC ACID
      
                  
                     Synonyms
                  
               
               
                  Isoascorbic acid
               
            
                  D-Araboascorbic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  D-Erythro-hex-2-enoic acid γ-lactone
               
            
                  Isoascorbic acid
               
            
                  D-Isoascorbic acid
               
            
                  Einecs
               
               
                  201-928-0
               
            
                  Chemical formula
               
               
                  C6H8O6
                  
               
            
                  Molecular weight
               
               
                  176,13
               
            
                  Assay
               
               
                  Content not less than 98 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White to slightly yellow crystalline solid which darkens gradually on exposure to light
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  About 164 oC to 172 oC with decomposition
               
            
                  
                              B.
                           
                           
                              Positive test for ascorbic acid/colour reaction
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,4 % after drying under reduced pressure on silica gel for 3 hours
               
            
                  Sulphated ash
               
               
                  Not more than 0,3 %
               
            
                  Specific rotation
               
               
                  [α]10 % (w/v) aqueous solution between -16,5o to -18,0o
                  
               
            
                  Oxalate
               
               
                  To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 316 SODIUM ERYTHORBATE
      
                  
                     Synonyms
                  
               
               
                  Sodium isoascorbate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium isoascorbate
               
            
                  Sodium D-isoascorbic acid
               
            
                  Sodium salt of 2,3-didehydro-D-erythro-hexono-1,4-lactone
               
            
                  3-keto-D-gulofurano-lactone sodium enolate monohydrate
               
            
                  Einecs
               
               
                  228-973-9
               
            
                  Chemical formula
               
               
                  C6H7O6Na· H2O
               
            
                  Molecular weight
               
               
                  216,13
               
            
                  Assay
               
               
                  Content not less than 98 % after drying in a vacuum desiccator over sulphuric acid for 24 hours expressed on the monohydrate basis
               
            
                  
                     Description
                  
               
               
                  White crystalline solid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility tests
                           
                        
               
                  Freely soluble in water, very slightly soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Positive test for ascorbic acid/colour reaction
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Positive test for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % after drying in a vacuum desiccator over sulphuric acid for 24 hours
               
            
                  Specific rotation
               
               
                  [α]10 % (w/v) aqueous solution between + 95o and + 98o
                  
               
            
                  pH of a 10 % aqueous solution
               
               
                  5,5 to 8,0
               
            
                  Oxalate
               
               
                  To a solution of 1 g in 10 ml of water add 2 drops of glacial acetic acid and 5 ml of 10 % calcium acetate solution. The solution should remain clear
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)
      
                  
                     Synonyms
                  
               
               
                  TBHQ
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical names
               
               
                  Tert-butyl-1,4-benzenediol
               
            
                  2-(1,1-Dimethylethyl)-1,4-benzenediol
               
            
                  Einecs
               
               
                  217-752-2
               
            
                  Chemical formula
               
               
                  C10H14O2
                  
               
            
                  Molecular weight
               
               
                  166,22
               
            
                  Assay
               
               
                  Content not less than 99 % of C10H14O2
                  
               
            
                  
                     Description
                  
               
               
                  White crystalline solid having a characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Practically insoluble in water; soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Melting point
                           
                        
               
                  Not less than 126,5 oC
               
            
                  
                              C.
                           
                           
                              Phenolics
                           
                        
               
                  Dissolve about 5 mg of the sample in 10 ml of methanol and add 10,5 ml of dimethylamine solution (1 in 4). A red to pink colour is produced
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Tertiary-Butyl-p-benzoquinone
               
               
                  Not more than 0,2 %
               
            
                  2,5-Di-tertiary-butyl hydroquinone
               
               
                  Not more than 0,2 %
               
            
                  Hydroxyquinone
               
               
                  Not more than 0,1 %
               
            
                  Toluene
               
               
                  Not more than 25 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 320 BUTYLATED HYDROXYANISOLE (BHA)
      
                  
                     Synonyms
                  
               
               
                  BHA
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical names
               
               
                  3-Tertiary-butyl-4-hydroxyanisole
               
            
                  A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole
               
            
                  Einecs
               
               
                  246-563-8
               
            
                  Chemical formula
               
               
                  C11H16O2
                  
               
            
                  Formula weight
               
               
                  180,25
               
            
                  Assay
               
               
                  Content not less than 98,5 % of C11H16O2 and not less than 85 % of 3-tertiary-butyl-4-hydroxyanisole isomer
               
            
                  
                     Description
                  
               
               
                  White or slightly yellow crystals or waxy solid with a slight aromatic smell
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, freely soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 48 °C and 63 °C
               
            
                  
                              C.
                           
                           
                              Colour reaction
                           
                        
               
                  Passes test for phenol groups
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 % after calcination at 800 ± 25 °C
               
            
                  Phenolic impurities
               
               
                  Not more than 0,5 %
               
            Specific absorption
                     
               
               
                  
                      (290 nm) not less than 190 and not more than 210
            Specific absorption
                     
               
               
                  
                      (228 nm) not less than 326 and not more than 345
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 321 BUTYLATED HYDROXYTOLUENE (BHT)
      
                  
                     Synonyms
                  
               
               
                  BHT
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  2,6-Ditertiary-butyl-p-cresol
               
            
                  4-Methyl-2,6-ditertiarybutylphenol
               
            
                  Einecs
               
               
                  204-881-4
               
            
                  Chemical formula
               
               
                  C15H24O
               
            
                  Molecular weight
               
               
                  220,36
               
            
                  Assay
               
               
                  Content not less than 99 %
               
            
                  
                     Description
                  
               
               
                  White, crystalline or flaked solid, odourless or having a characteristic faint aromatic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility tests
                           
                        
               
                  Insoluble in water and propane- 1,2-diol
               
            
                  Freely soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Melting point
                           
                        
               
                  At 70 oC
               
            
                  
                              C.
                           
                           
                              Absorbance maximum
                           
                        
               
                  The absorption in the range 230 to 320 nm of a 2 cm layer of a 1 in 100 000 solution in dehydrated ethanol exhibits a maximum only at 278 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,005 %
               
            
                  Phenolic impurities
               
               
                  Not more than 0,5 %
               
            Specific absorption 
                      in ethanol
               
                  
                      (278 nm) not less than 81 and not more than 88
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 322 LECITHINS
      
                  
                     Synonyms
                  
               
               
                  Phosphatides
               
            
                  Phospholipids
               
            
                  
                     Definition
                  
               
               
                  Lecithins are mixtures or fractions of phosphatides obtained by physical procedures from animal or vegetable foodstuffs; they also include hydrolysed products obtained through the use of harmless and appropriate enzymes. The final product must not show any signs of residual enzyme activity The lecithins may be slightly bleached in aqueous medium by means of hydrogen peroxide. This oxidation must not chemically modify the lecithin phosphatides
               
            
                  Einecs
               
               
                  232-307-2
               
            
                  Assay
               
               
                  
                              —
                           
                           
                              Lecithins: not less than 60,0 % of substances insoluble in acetone
                           
                        
            
                  
                              —
                           
                           
                              Hydrolysed lecithins: not less than 56,0 % of substances insoluble in acetone
                           
                        
            
                  
                     Description
                  
               
               
                  
                              —
                           
                           
                              Lecithins: brown liquid or viscous semi-liquid or powder
                           
                        
            
                  
                              —
                           
                           
                              Hydrolysed lecithins: light brown to brown viscous liquid or paste
                           
                        
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for choline, for phosphorus and fatty acids
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Test for hydrolysed lecithin
                           
                        
               
                  To a 800 ml beaker add 500 ml of water (30 oC-35 oC). Then slowly add 50 ml of the sample with constant stirring. Hydrolysed lecithin will form a homogeneous emulsion. Non-hydrolysed lecithin will form a distinct mass of about 50 g
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % determined by drying at 105 oC for one hour
               
            
                  Toluene-insoluble matter
               
               
                  Not more than 0,3 %
               
            
                  Acid value
               
               
                  
                              —
                           
                           
                              Lecithins: not more than 35 mg of potassium hydroxide per gram
                           
                        
            
                  
                              —
                           
                           
                              Hydrolysed lecithins: not more than 45 mg of potassium hydroxide per gram
                           
                        
            
                  Peroxide value
               
               
                  Equal to or less than 10
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 325 SODIUM LACTATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium lactate
               
            
                  Sodium 2-hydroxypropanoate
               
            
                  Einecs
               
               
                  200-772-0
               
            
                  Chemical formula
               
               
                  C3H5NaO3
                  
               
            
                  Molecular weight
               
               
                  112,06 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 57 % and not more than 66 %
               
            
                  
                     Description
                  
               
               
                  Colourless, transparent, liquid. Odourless, or with a slight, characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for lactate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acidity
               
               
                  Not more than 0,5 % after drying expressed as lactic acid
               
            
                  pH of a 20 % aqueous solution
               
               
                  6,5 to 7,5
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Reducing substances
               
               
                  No reduction of Fehling's solution
               
            
                  
                     Note:
                  
                  This specification refers to a 60 % aqueous solution
               
               
                   
               
            E 326 POTASSIUM LACTATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Cheminal name
               
               
                  Potassium lactate
               
            
                  Potassium 2-hydroxypropanoate
               
            
                  Einecs
               
               
                  213-631-3
               
            
                  Chemical formula
               
               
                  C3H5O3K
               
            
                  Molecular weight
               
               
                  128,17 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 57 % and not more than 66 %
               
            
                  
                     Description
                  
               
               
                  Slightly viscous, almost odourless clear liquid. Odourless, or with a slight, characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Ignition
                           
                        
               
                  Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added
               
            
                  
                              B.
                           
                           
                              Colour reaction
                           
                        
               
                  Overlay 2 ml of potassium lactate solution on 5 ml of a 1 in 100 solution of catechol in sulphuric acid. A deep red colour is produced at the zone of contact
               
            
                  
                              C.
                           
                           
                              Positive tests for potassium and for lactate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Acidity
               
               
                  Dissolve 1 g of potassium lactate solution in 20 ml of water, add 3 drops of phenolphthalein TS and titrate with 0,1 N sodium hydroxide. Not more than 0,2 ml should be required
               
            
                  Reducing substances
               
               
                  Potassium lactate solution shall not cause any reduction of Fehling's solution
               
            
                  
                     Note:
                  
                  This specification refers to a 60 % aqueous solution
               
               
                   
               
            E 327 CALCIUM LACTATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium dilactate
               
            
                  Calcium dilactate hydrate
               
            
                  2-Hydroxypropanoic acid calcium salt
               
            
                  Einecs
               
               
                  212-406-7
               
            
                  Chemical formula
               
               
                  (C3H5O2)2 Ca· nH2O (n = 0-5)
               
            
                  Molecular weight
               
               
                  218,22 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 98 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Almost odourless, white crystalline powder or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for lactate and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility tests
                           
                        
               
                  Soluble in water and practically insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Determined by drying at 120 oC for four hours:
               
            
                  
                              —
                           
                           
                              anhydrous: not more than 3,0 %
                           
                        
            
                  
                              —
                           
                           
                              with 1 molecule of water: not more than 8,0 %
                           
                        
            
                  
                              —
                           
                           
                              with 3 molecules of water: not more than 20,0 %
                           
                        
            
                  
                              —
                           
                           
                              with 4,5 molecules of water: not more than 27,0 %
                           
                        
            
                  Acidity
               
               
                  Not more than 0,5 % of the dry matter expressed as lactic acid
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  pH of a 5 % solution
               
               
                  Between 6,0 and 8,0
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Reducing substances
               
               
                  No reduction of Fehling's solution
               
            E 330 CITRIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Citric acid
               
            
                  2-Hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  β-Hydroxytricarballytic acid
               
            
                  Einecs
               
               
                  201-069-1
               
            
                  Chemical formula
               
               
                  
                              (a)
                           
                           
                              C6H8O7 (anhydrous)
                           
                        
            
                  
                              (b)
                           
                           
                              C6H8O7·H2O (monohydrate)
                           
                        
            
                  Molecular weight
               
               
                  
                              (a)
                           
                           
                              192,13 (anhydrous)
                           
                        
            
                  
                              (b)
                           
                           
                              210,15 (monohydrate)
                           
                        
            
                  Assay
               
               
                  Citric acid may be anhydrous or it may contain 1 molecule of water. Citric acid contains not less than 99,5 % of C6H8O7, calculated on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Citric acid is a white or colourless, odourless, crystalline solid, having a strongly acid taste. The monohydrate effloresces in dry air
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility tests
                           
                        
               
                  Very soluble in water; freely soluble in ethanol; soluble in ether
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  Anhydrous citric acid contains not more than 0,5 % water; citric acid monohydrate contains not more than 8,8 % water (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 % after calcination at 800 ± 25 oC
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg, expressed as oxalic acid, after drying
               
            
                  Readily carbonisable substances
               
               
                  Heat 1 g of powdered sample with 10 ml of 98 % minimum sulphuric acid in a water bath at 90 oC in the dark for one hour. Not more than a pale brown colour should be produced (Matching Fluid K)
               
            E 331 (i) MONOSODIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Monosodium citrate
                  Monobasic sodium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monosodium citrate
               
            
                  Monosodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  Chemical formula
               
               
                  
                              (a)
                           
                           
                              C6H7O7Na (anhydrous)
                           
                        
            
                  
                              (b)
                           
                           
                              C6H7O7Na· H2O (monohydrate)
                           
                        
            
                  Molecular weight
               
               
                  
                              (a)
                           
                           
                              214,11 (anhydrous)
                           
                        
            
                  
                              (b)
                           
                           
                              232,23 (monohydrate)
                           
                        
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Crystalline white powder or colourless crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for citrate and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Determined by drying at 180 oC for four hours:
                  
                              —
                           
                           
                              anhydrous: not more than 1,0 %
                           
                        
            
                  
                              —
                           
                           
                              monohydrate: not more than 8,8 %
                           
                        
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  pH of a 1 % aqueous solution
               
               
                  Between 3,5 and 3,8
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            E 331 (ii) DISODIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Disodium citrate
                  Dibasic sodium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium citrate
               
            
                  Disodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  Disodium salt of citric acid with 1,5 molecules of water
               
            
                  Einecs
               
               
                  205-623-3
               
            
                  Chemical formula
               
               
                  C6H6O7Na2·1,5H2O
               
            
                  Molecular weight
               
               
                  263,11
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Crystalline white powder or colourless crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for citrate and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 13,0 % by drying at 180 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  pH of a 1 % aqueous solution
               
               
                  Between 4,9 and 5,2
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            E 331 (iii) TRISODIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Trisodium citrate
                  Tribasic sodium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Trisodium citrate
               
            
                  Trisodium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  Trisodium salt of citric acid, in anhydrous, dihydrate or pentahydrate form
               
            
                  Einecs
               
               
                  200-675-3
               
            
                  Chemical formula
               
               
                  Anhydrous:
               
               
                  C6H5O7Na3
                  
               
            
                  Hydrated:
               
               
                  C6H5O7Na3·nH2O (n = 2 or 5)
               
            
                  Molecular weight
               
               
                  258,07 (anhydrous)
               
            
                  Assay
               
               
                  Not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Crystalline white powder or colourless crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for citrate and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Determined by drying at 180 oC for four hours:
               
            
                  
                              —
                           
                           
                              anhydrous:
                           
                        
               
                  not more than 1,0 %
               
            
                  
                              —
                           
                           
                              dihydrate:
                           
                        
               
                  not more than 13,5 %
               
            
                  
                              —
                           
                           
                              pentahydrate:
                           
                        
               
                  not more than 30,3 %
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  pH of a 5 % aqueous solution
               
               
                  Between 7,5 and 9,0
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            E 332 (i) MONOPOTASSIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Monopotassium citrate
                  Monobasic potassium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monopotassium citrate
               
            
                  Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  Anhydrous monopotassium salt of citric acid
               
            
                  Einecs
               
               
                  212-753-4
               
            
                  Chemical formula
               
               
                  C6H7O7K
               
            
                  Molecular weight
               
               
                  230,21
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, hygroscopic, granular powder or transparent crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for citrate and for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % determined by drying at 180 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  pH of a 1 % aqueous solution
               
               
                  Between 3,5 and 3,8
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            E 332 (ii) TRIPOTASSIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Tripotassium citrate
                  Tribasic potassium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Tripotassium citrate
               
            
                  Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  Monohydrated tripotassium salt of citric acid
               
            
                  Einecs
               
               
                  212-755-5
               
            
                  Chemical formula
               
               
                  C6H5O7K3·H2O
               
            
                  Molecular weight
               
               
                  324,42
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, hygroscopic, granular powder or transparent crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for citrate and for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 6,0 % determined by drying at 180 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  pH of a 5 % aqueous solution
               
               
                  Between 7,5 and 9,0
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            E 333 (i) MONOCALCIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Monocalcium citrate
                  Monobasic calcium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monocalcium citrate
               
            
                  Monocalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  Monohydrate monocalcium salt of citric acid
               
            
                  Chemical formula
               
               
                  (C6H7O7)2Ca· H2O
               
            
                  Molecular weight
               
               
                  440,32
               
            
                  Assay
               
               
                  Content not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Fine white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for citrate and for calcium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 7,0 % determined by drying at 180 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  pH of a 1 % aqueous solution
               
               
                  Between 3,2 and 3,5
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            
                  Carbonates
               
               
                  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
               
            E 333 (ii) DICALCIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Dicalcium citrate
                  Dibasic calcium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dicalcium citrate
               
            
                  Dicalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  Trihydrated dicalcium salt of citric acid
               
            
                  Chemical formula
               
               
                  (C6H7O7)2Ca2·3H2O
               
            
                  Molecular weight
               
               
                  530,42
               
            
                  Assay
               
               
                  Not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Fine white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for citrate and for calcium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 20,0 % determined by drying at 180 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            
                  Carbonates
               
               
                  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
               
            E 333 (iii) TRICALCIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Tricalcium citrate
                  Tribasic calcium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Tricalcium citrate
               
            
                  Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid
               
            
                  Tetrahydrated tricalcium salt of citric acid
               
            
                  Einecs
               
               
                  212-391-7
               
            
                  Chemical formula
               
               
                  (C6H6O7)2Ca3·4H2O
               
            
                  Molecular weight
               
               
                  570,51
               
            
                  Assay
               
               
                  Not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Fine white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for citrate and for calcium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 14,0 % determined by drying at 180 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            
                  Carbonates
               
               
                  Dissolving 1 g of calcium citrate in 10 ml 2 N hydrochloric acid must not liberate more than a few isolated bubbles
               
            E 334 L(+)-TARTARIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  L-tartaric acid
               
            
                  L-2,3-dihydroxybutanedioic acid
               
            
                  d-α, β-dihydroxysuccinic acid
               
            
                  Einecs
               
               
                  201-766-0
               
            
                  Chemical formula
               
               
                  C4H6O6
                  
               
            
                  Molecular weight
               
               
                  150,09
               
            
                  Assay
               
               
                  Content not less than 99,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless or translucent crystalline solid or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  Between 168 oC and 170 oC
               
            
                  
                              B.
                           
                           
                              Positive test for tartrate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (over P2O5, three hours)
               
            
                  Sulphated ash
               
               
                  Not more than 1 000 mg/kg after calcination at 800 ± 25 oC
               
            
                  Specific optical rotation of a 20 % w/v aqueous solution
               
               
                  [α] 20
                     D between +11,5o and +13,5o
                  
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            E 335 (i) MONOSODIUM TARTRATE
      
                  
                     Synonyms
                  
               
               
                  Monosodium salt of L-(+)-tartaric acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monosodium salt of L-2,3-dihydroxybutanedioic acid
               
            
                  Monohydrated monosodium salt of L-(+)-tartaric acid
               
            
                  Chemical formula
               
               
                  C4H5O6Na· H2O
               
            
                  Molecular weight
               
               
                  194,05
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Transparent colourless crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for tartrate and for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 10,0 % determined by drying at 105 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 335 (ii) DISODIUM TARTRATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium L-tartrate
               
            
                  Disodium (+)-tartrate
               
            
                  Disodium (+)-2,3-dihydroxybutanedioic acid
               
            
                  Dihydrated disodium salt of L-(+)-tartaric acid
               
            
                  Einecs
               
               
                  212-773-3
               
            
                  Chemical formula
               
               
                  C4H4O6Na2·2H2O
               
            
                  Molecular weight
               
               
                  230,8
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Transparent, colourless crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for tartrate and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility tests
                           
                        
               
                  1 gram is insoluble in 3 ml of water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 17,0 % determined by drying at 150 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  pH of a 1 % aqueous solution
               
               
                  Between 7,0 and 7,5
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 336 (i) MONOPOTASSIUM TARTRATE
      
                  
                     Synonyms
                  
               
               
                  Monobasic potassium tartrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Anhydrous monopotassium salt of L-(+)-tartaric acid
               
            
                  Monopotassium salt of L-2,3-dihydroxybutanedioic acid
               
            
                  Chemical formula
               
               
                  C4H5O6K
               
            
                  Molecular weight
               
               
                  188,16
               
            
                  Assay
               
               
                  Content not less than 98 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline or granulated powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for tartrate and for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Melting point
                           
                        
               
                  230 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  pH of a 1 % aqueous solution
               
               
                  3,4
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % determined by drying at 105 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 336 (ii) DIPOTASSIUM TARTRATE
      
                  
                     Synonyms
                  
               
               
                  Dibasic potassium tartrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dipotassium salt of L-2,3-dihydroxybutanedioic acid
               
            
                  Dipotassium salt with half a molecule of water of L-(+)-tartaric acid
               
            
                  Einecs
               
               
                  213-067-8
               
            
                  Chemical formula
               
               
                  C4H4O6K2·1/2H2O
               
            
                  Molecular weight
               
               
                  235,2
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline or granulated powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for tartrate and for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  pH of a 1 % aqueous solution
               
               
                  Between 7,0 and 9,0
               
            
                  Loss on drying
               
               
                  Not more than 4,0 % determined by drying at 150 oC for four hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 337 POTASSIUM SODIUM TARTRATE
      
                  
                     Synonyms
                  
               
               
                  Potassium sodium L-(+)-tartrate
               
            
                  Rochelle salt
               
            
                  Seignette salt
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium sodium salt of L-2,3-dihydroxybutanedioic acid
               
            
                  Potassium sodium L-(+)-tartrate
               
            
                  Einecs
               
               
                  206-156-8
               
            
                  Chemical formula
               
               
                  C4H4O6KNa· 4H2O
               
            
                  Molecular weight
               
               
                  282,23
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for tartrate, for potassium and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility tests
                           
                        
               
                  1 gram is soluble in 1 ml of water, insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              Melting range
                           
                        
               
                  Between 70 and 80 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 26,0 % and not less than 21,0 % determined by drying at 150 oC for three hours
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  pH of 1 % aqueous solution
               
               
                  Between 6,5 and 8,5
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 338 PHOSPHORIC ACID
      
                  
                     Synonyms
                  
               
               
                  Orthophosphoric acid
               
            
                  Monophosphoric acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Phosphoric acid
               
            
                  Einecs
               
               
                  231-633-2
               
            
                  Chemical formula
               
               
                  H3PO4
                  
               
            
                  Molecular weight
               
               
                  98,00
               
            
                  Assay
               
               
                  Phosphoric acid is commercially available as an aqueous solution at variable concentrations. Content not less than 67,0 % and not more than 85,7 %.
               
            
                  
                     Description
                  
               
               
                  Clear, colourless, viscous liquid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for acid and for phosphate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Volatile acids
               
               
                  Not more than 10 mg/kg (as acetic acid)
               
            
                  Chlorides
               
               
                  Not more than 200 mg/kg (expressed as chlorine)
               
            
                  Nitrates
               
               
                  Not more than 5 mg/kg (as NaNO3)
               
            
                  Sulphates
               
               
                  Not more than 1 500 mg/kg (as CaSO4)
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Note:
                  This specification refers to a 75 % aqueous solution
               
               
                   
               
            E 339 (i) MONOSODIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Monosodium monophosphate
               
            
                  Acid monosodium monophosphate
               
            
                  Monosodium orthophosphate
               
            
                  Monobasic sodium phosphate
               
            
                  Sodium dihydrogen monophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium dihydrogen monophosphate
               
            
                  Einecs
               
               
                  231-449-2
               
            
                  Chemical formula
               
               
                  Anhydrous: NaH2PO4
                  
               
            
                  Monohydrate: NaH2PO4 · H2O
               
            
                  Dihydrate: NaH2PO4 · 2H2O
               
            
                  Molecular weight
               
               
                  Anhydrous: 119,98
               
            
                  Monohydrate: 138,00
               
            
                  Dihydrate: 156,01
               
            
                  Assay
               
               
                  After drying at 60 oC for one hour and then at 105 oC for four hours, contains not less than 97 % of NaH2PO4
                  
               
            
                  P2O5 content
               
               
                  Between 58,0 % and 60,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A white odourless, slightly deliquescent powder, crystals or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol or ether
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 4,1 and 5,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, and the dihydrate not more than 25 % when dried first at 60 oC for one hour, then at 105 oC for four hours
               
            
                  Water-insoluble substances
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 339 (ii) DISODIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Disodium monophosphate
               
            
                  Secondary sodium phosphate
               
            
                  Disodium orthophosphate
               
            
                  Acid disodium phosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium hydrogen monophosphate
               
            
                  Disodium hydrogen orthophosphate
               
            
                  Einecs
               
               
                  231-448-7
               
            
                  Chemical formula
               
               
                  Anhydrous: Na2HPO4
                  
               
            
                  Hydrat: Na2HPO4 · nH2O (n = 2,7 or 12)
               
            
                  Molecular weight
               
               
                  141,98 (anhydrous)
               
            
                  Assay
               
               
                  After drying at 40 oC for three hours and subsequently at 105 oC for five hours, contains not less than 98 % of Na2HPO4
                  
               
            
                  P2O5 content
               
               
                  Between 49 % and 51 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Anhydrous disodium hydrogen phosphate is a white, hygroscopic, odourless powder. Hydrated forms available include the dihydrate: a white crystalline, odourless solid; the heptahydrate: white, odourless, efflorescent crystals or granular powder; and the dodecahydrate: white, efflorescent, odourless powder or crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 8,4 and 9,6
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  When dried at 40 oC for three hours and then at 105 oC for five hours, the losses in weight are as follows: anhydrous not more than 5,0 %, dihydrate not more than 22,0 %, heptahydrate not more than 50,0 %, dodecahydrate not more than 61,0 %
               
            
                  Water-insoluble substances
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 339 (iii) TRISODIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Sodium phosphate
               
            
                  Tribasic sodium phosphate
               
            
                  Trisodium orthophosphate
               
            
                  
                     Definition
                  
               
               
                  Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains 1/4 molecule of NaOH
               
            
                  Chemical name
               
               
                  Trisodium monophosphate
               
            
                  Trisodium phosphate
               
            
                  Trisodium orthophosphate
               
            
                  Einecs
               
               
                  231-509-8
               
            
                  Chemical formula
               
               
                  Anhydrous: Na3PO4
                  
               
            
                  Hydrated: Na3PO4 · nH2O (n = 1/2, 1, 6, 8, or 12)
               
            
                  Molecular weight
               
               
                  163,94 (anhydrous)
               
            
                  Assay
               
               
                  Sodium phosphate anhydrous and the hydrated forms, with the exception of the dodecahydrate, contain not less than 97,0 % of Na3PO4 calculated on the dried basis. Sodium phosphate dodecahydrate contains not less than 92,0 % of Na3PO4 calculated on the ignited basis
               
            
                  P2O5 content
               
               
                  Between 40,5 % and 43,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White odourless crystals, granules or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 11,5 and 12,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  When dried at 120 oC for two hours and then ignited at about 800 oC for 30 minutes, the losses in weight are as follows: anhydrous not more than 2,0 %, monohydrate not more than 11,0 %, dodecahydrate: between 45,0 % and 58,0 %
               
            
                  Water insoluble substances
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 340 (i) MONOPOTASSIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Monobasic potassium phosphate
               
            
                  Monopotassium monophosphate
               
            
                  Potassium orthophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium dihydrogen phosphate
               
            
                  Monopotassium dihydrogen orthophosphate
               
            
                  Monopotassium dihydrogen monophosphate
               
            
                  Einecs
               
               
                  231-913-4
               
            
                  Chemical formula
               
               
                  KH2PO4
                  
               
            
                  Molecular weight
               
               
                  136,09
               
            
                  Assay
               
               
                  Content not less than 98,0 % after drying at 105 oC for four hours
               
            
                  P2O5 content
               
               
                  Between 51,0 % and 53,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless crystals or white granular or crystalline powder, hygroscopic
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for potassium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 4,2 and 4,8
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % determined by drying at 105 oC for four hours
               
            
                  Water-insoluble substances
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 340 (ii) DIPOTASSIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Dipotassium monophosphate
               
            
                  Secondary potassium phosphate
               
            
                  Dipotassium acid phosphate
               
            
                  Dipotassium orthophosphate
               
            
                  Dibasic potassium phosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dipotassium hydrogen monophosphate
               
            
                  Dipotassium hydrogen phosphate
               
            
                  Dipotassium hydrogen orthophosphate
               
            
                  Einecs
               
               
                  231-834-5
               
            
                  Chemical formula
               
               
                  K2HPO4
                  
               
            
                  Molecular weight
               
               
                  174,18
               
            
                  Assay
               
               
                  Content not less than 98 % after drying at 105 oC for four hours
               
            
                  P2O5 content
               
               
                  Between 40,3 % and 41,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless or white granular powder, crystals or masses; deliquescent substance
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for potassium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 8,7 and 9,4
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % determined by drying at 105 oC for four hours
               
            
                  Water-insoluble substances
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 340 (iii) TRIPOTASSIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Potassium phosphate
               
            
                  Tribasic potassium phosphate
               
            
                  Tripotassium orthophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Tripotassium monophosphate
               
            
                  Tripotassium phosphate
               
            
                  Tripotassium orthophosphate
               
            
                  Einecs
               
               
                  231-907-1
               
            
                  Chemical formula
               
               
                  Anhydrous: K3PO4
                  
               
            
                  Hydrated: K3PO4 · nH2O (n = 1 or 3)
               
            
                  Molecular weight
               
               
                  212,27 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 97 % calculated on the ignited basis
               
            
                  P2O5 content
               
               
                  Between 30,5 % and 33,0 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for potassium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 11,5 and 12,3
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 %. Determined by drying at 105 oC for one hour and then ignite at about 800 oC ± 25 oC for 30 minutes
               
            
                  Water insoluble substances
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 341 (i) MONOCALCIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Monobasic calcium phosphate
               
            
                  Monocalcium orthophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium dihydrogen phosphate
               
            
                  Einecs
               
               
                  231-837-1
               
            
                  Chemical formula
               
               
                  Anhydrous: Ca(H2PO4)2
                  
               
            
                  Monohydrate: Ca(H2PO4)2 · H2O
               
            
                  Molecular weight
               
               
                  234,05 (anhydrous)
               
            
                  252,08 (monohydrate)
               
            
                  Assay
               
               
                  Content not less than 95 % on the dried basis
               
            
                  P2O5 content
               
               
                  Between 55,5 % and 61,1 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Granular powder or white, deliquescent crystals or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              CaO content
                           
                        
               
                  Between 23,0 % and 27,5 % (anhydrous)
               
            
                  Between 19,0 % and 24,8 % (monohydrate)
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 14 % determined by drying at 105 oC for four hours (anhydrous)
               
            
                  Not more than 17,5 % determined by drying at 60 oC for one hour, then at 105 oC for four hours (monohydrate)
               
            
                  Loss on ignition
               
               
                  Not more than 17,5 % after ignition at 800 oC ± 25 oC for 30 minutes (anhydrous)
               
            
                  Not more than 25,0 % determined by drying at 105 oC for one hour, then ignite at 800 oC ± 25 oC for 30 minutes (monohydrate)
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 341 (ii) DICALCIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Dibasic calcium phosphate
               
            
                  Dicalcium orthophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium monohydrogen phosphate
               
            
                  Calcium hydrogen orthophosphate
               
            
                  Secondary calcium phosphate
               
            
                  Einecs
               
               
                  231-826-1
               
            
                  Chemical formula
               
               
                  Anhydrous: CaHPO4
                  
               
            
                  Dihydrate: CaHPO4 · 2H2O
               
            
                  Molecular weight
               
               
                  136,06 (anhydrous)
               
            
                  172,09 (dihydrate)
               
            
                  Assay
               
               
                  Dicalcium phosphate, after drying at 200 oC for three hours, contains not less than 98 % and not more than the equivalent of 102 % of CaHPO4
                  
               
            
                  P2O5 content
               
               
                  Between 50,0 % and 52,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or granules, granular powder or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility tests
                           
                        
               
                  Sparingly soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 8,5 % (anhydrous), or 26,5 % (dihydrate) after ignition at 800 oC ± 25 oC for 30 minutes
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 341 (iii) TRICALCIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Calcium phosphate, tribasic
               
            
                  Calcium orthophosphate
               
            
                  Pentacalcium hydroxy monophosphate
               
            
                  Calcium hydroxyapatite
               
            
                  
                     Definition
                  
               
               
                  Tricalcium phosphate consists of a variable mixture of calcium phosphates obtained from neutralisation of phosphoric acid with calcium hydroxide and having the approximate composition of 10CaO · 3P2O5 · H2O
               
            
                  Chemical name
               
               
                  Pentacalcium hydroxy monophosphate
               
            
                  Tricalcium monophosphate
               
            
                  Einecs
               
               
                  235-330-6 (Pentacalcium hydroxy monophosphate)
               
            
                  231-840-8 (Calcium orthophosphate)
               
            
                  Chemical formula
               
               
                  Ca5(PO4)3· OH or Ca3(PO4)2
                  
               
            
                  Molecular weight
               
               
                  502 or 310
               
            
                  Assay
               
               
                  Content not less than 90 % calculated on the ignited basis
               
            
                  P2O5 content
               
               
                  Between 38,5 % and 48,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A white, odourless powder which is stable in air
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Practically insoluble in water; insoluble in ethanol soluble in dilute hydrochloric and nitric acid
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 8 % after ignition at 800 oC ± 25 oC, to constant weight
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 343(i) MONOMAGNESIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Magnesiumdihydrogenphosphate
               
            
                  Magnesiumphosphate, monobasic
               
            
                  Monomagnesium orthophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monomagnesiumdihydrogenmonophosphate
               
            
                  Einecs
               
               
                  236-004-6
               
            
                  Chemical formula
               
               
                  Mg(H2PO4)2 · nH2O (where n = 0 to 4)
               
            
                  Molecular weight
               
               
                  218,30 (anhydrous)
               
            
                  Assay
               
               
                  Not less than 51,0 % after ignition
               
            
                  
                     Description
                  
               
               
                  White, odourless, crystalline powder, slightly soluble in water
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for magnesium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              MgO content
                           
                        
               
                  Not less than 21,5 % after ignition
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 343(ii) DIMAGNESIUM PHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Magnesiumhydrogenphosphate
               
            
                  Magnesiumphosphate, dibasic
               
            
                  Dimagnesium orthophosphate
               
            
                  Secondary magnesiumphosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dimagnesiummonohydrogenmonophosphate
               
            
                  Einecs
               
               
                  231-823-5
               
            
                  Chemical formula
               
               
                  MgHPO4 · nH2O (where n = 0-3)
               
            
                  Molecular weight
               
               
                  120,30 (anhydrous)
               
            
                  Assay
               
               
                  Not less than 96 % after ignition
               
            
                  
                     Description
                  
               
               
                  White, odourless, crystalline powder, slightly soluble in water
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for magnesium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              MgO content:
                           
                        
               
                  Not less than 33,0 % calculated on an anhydrous basis
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 350 (i) SODIUM MALATE
      
                  
                     Synonyms
                  
               
               
                  Sodium salt of malic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium DL-malate, disodium salt of hydroxybutanedioic acid
               
            
                  Chemical formula
               
               
                  Hemihydrate: C4H4Na2O5 · 1/2 H2O
               
            
                  Trihydrate: C4H4Na2O5 · 3H2O
               
            
                  Molecular weight
               
               
                  Hemihydrate: 187,05
               
            
                  Trihydrate: 232,10
               
            
                  Assay
               
               
                  Content not less than 98,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline powder or lumps
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for 1,2-dicarboxylic acid and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Azo dye formation
                           
                        
               
                  Positive
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 7,0 % (130 oC, 4h) for the hemihydrate, or 20,5 %-23,5 % (130 oC, 4h) for the trihydrate
               
            
                  Alkalinity
               
               
                  Not more than 0,2 % as Na2CO3
                  
               
            
                  Fumaric acid
               
               
                  Not more than 1,0 %
               
            
                  Maleic acid
               
               
                  Not more than 0,05 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 350 (ii) SODIUM HYDROGEN MALATE
      
                  
                     Synonyms
                  
               
               
                  Monosodium salt of DL-malic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monosodium DL-malate, monosodium 2-DL-hydroxy succinate
               
            
                  Chemical formula
               
               
                  C4H5NaO5
                  
               
            
                  Molecular weight
               
               
                  156,07
               
            
                  Assay
               
               
                  Content not less than 99,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for 1,2-dicarboxylic acid and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Azo dye formation
                           
                        
               
                  Positive
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (110 oC, 3h)
               
            
                  Maleic acid
               
               
                  Not more than 0,05 %
               
            
                  Fumaric acid
               
               
                  Not more than 1,0 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 351 POTASSIUM MALATE
      
                  
                     Synonyms
                  
               
               
                  Potassium salt of malic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dipotassium DL-malate, dipotassium salt of hydroxybutanedioic acid
               
            
                  Chemical formula
               
               
                  C4H4K2O5
                  
               
            
                  Molecular weight
               
               
                  210,27
               
            
                  Assay
               
               
                  Content not less than 59,5 %
               
            
                  
                     Description
                  
               
               
                  Colourless or almost colourless aqueous solution
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for 1,2-dicarboxylic acid and for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Azo dye formation
                           
                        
               
                  Positive
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Alkalinity
               
               
                  Not more than 0,2 % as K2CO3
                  
               
            
                  Fumaric acid
               
               
                  Not more than 1,0 %
               
            
                  Maleic acid
               
               
                  Not more than 0,05 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 352 (i) CALCIUM MALATE
      
                  
                     Synonyms
                  
               
               
                  Calcium salt of malic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium DL-malate, calcium-α-hydroxysuccinate, calcium salt of hydroxybutanedioic acid
               
            
                  Chemical formula
               
               
                  C4H5CaO5
                  
               
            
                  Molecular weight
               
               
                  172,14
               
            
                  Assay
               
               
                  Content not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for malate, 1,2-dicarboxylic acid and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Azo dye formation
                           
                        
               
                  Positive
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Slightly soluble in water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2 % (100 oC, 3h)
               
            
                  Alkalinity
               
               
                  Not more than 0,2 % as CaCO3
                  
               
            
                  Maleic acid
               
               
                  Not more than 0,05 %
               
            
                  Fumaric acid
               
               
                  Not more than 1,0 %
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 352 (ii) CALCIUM HYDROGEN MALATE
      
                  
                     Synonyms
                  
               
               
                  Monocalcium salt of DL-malic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monocalcium DL-malate, monocalcium 2-DL-hydroxysuccinate
               
            
                  Chemical formula
               
               
                  (C4H5O5)2Ca
               
            
                  Assay
               
               
                  Content not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for 1,2-dicarboxylic acid and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Azo dye formation
                           
                        
               
                  Positive
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (110 oC, 3h)
               
            
                  Maleic acid
               
               
                  Not more than 0,05 %
               
            
                  Fumaric acid
               
               
                  Not more than 1,0 %
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 353 METATARTARIC ACID
      
                  
                     Synonyms
                  
               
               
                  Ditartaric acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Metatartaric acid
               
            
                  Chemical formula
               
               
                  C4H6O6
                  
               
            
                  Assay
               
               
                  Not less than 99,5 %
               
            
                  
                     Description
                  
               
               
                  Crystalline or powder form with a white or yellowish colour. Very deliquescent with a faint odour of caramel
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  A.
               
               
                  Very soluble in water and ethanol
               
            
                  B.
               
               
                  Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulfuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 oC, an intense violet coloration appears
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 354 CALCIUM TARTRATE
      
                  
                     Synonyms
                  
               
               
                  L-Calcium tartrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium L(+)-2,3-dihydroxybutanedioate di-hydrate
               
            
                  Chemical formula
               
               
                  C4H4CaO6 · 2H2O
               
            
                  Molecular weight
               
               
                  224,18
               
            
                  Assay
               
               
                  Not less than 98,0 %
               
            
                  
                     Description
                  
               
               
                  Fine crystalline powder with a white or off-white colour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 oC). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Specific rotation [α]20
                                 D
                              
                           
                        
               
                  +7,0o to +7,4o (0,1 % in a 1N de HCl solution)
               
            
                  
                              C.
                           
                           
                              pH of a 5 % slurry
                           
                        
               
                  Between 6,0 and 9,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphates (as H2SO4)
               
               
                  Not more than 1 g/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 355 ADIPIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Hexanedioic acid, 1,4-butanedicarboxylic acid
               
            
                  Einecs
               
               
                  204-673-3
               
            
                  Chemical formula
               
               
                  C6H10O4
                  
               
            
                  Molecular weight
               
               
                  146,14
               
            
                  Assay
               
               
                  Content not less than 99,6 %
               
            
                  
                     Description
                  
               
               
                  White odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  151,5 oC-154,0 oC
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Slightly soluble in water. Freely soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,2 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 20 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 356 SODIUM ADIPATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium adipate
               
            
                  Einecs
               
               
                  231-293-5
               
            
                  Chemical formula
               
               
                  C6H8Na2O4
                  
               
            
                  Molecular weight
               
               
                  190,11
               
            
                  Assay
               
               
                  Content not less than 99,0 % (on anhydrous basis)
               
            
                  
                     Description
                  
               
               
                  White odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  151 oC-152 oC (for adipic acid)
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Approximately 50 g/100 ml water (20 oC)
               
            
                  
                              C.
                           
                           
                              Positive test for sodium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 357 POTASSIUM ADIPATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium adipate
               
            
                  Einecs
               
               
                  242-838-1
               
            
                  Chemical formula
               
               
                  C6H8K2O4
                  
               
            
                  Molecular weight
               
               
                  222,32
               
            
                  Assay
               
               
                  Content not less than 99,0 % (on anhydrous basis)
               
            
                  
                     Description
                  
               
               
                  White odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  151 oC-152 oC (for adipic acid)
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Approximately 60 g/100 ml water (20 oC)
               
            
                  
                              C.
                           
                           
                              Positive test for potassium
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 363 SUCCINIC ACID
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Butanedioic acid
               
            
                  Einecs
               
               
                  203-740-4
               
            
                  Chemical formula
               
               
                  C4H6O4
                  
               
            
                  Molecular weight
               
               
                  118,09
               
            
                  Assay
               
               
                  Content no less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless or white, odourless crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  Between 185,0 oC and 190,0 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Residue on ignition
               
               
                  Not more than 0,025 % (800 oC, 15 min)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 380 TRIAMMONIUM CITRATE
      
                  
                     Synonyms
                  
               
               
                  Tribasic ammonium citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid
               
            
                  Einecs
               
               
                  222-394-5
               
            
                  Chemical formula
               
               
                  C6H17N3O7
                  
               
            
                  Molecular weight
               
               
                  243,22
               
            
                  Assay
               
               
                  Content not less than 97,0 %
               
            
                  
                     Description
                  
               
               
                  White to off-white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for ammonium and for citrate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Oxalate
               
               
                  Not more than 0,04 % (as oxalic acid)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
      
                  
                     Synonyms
                  
               
               
                  Calcium disodium EDTA
               
            
                  Calcium disodium edetate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  N, N′-1,2-Ethanediylbis [N-(carboxymethyl)-glycinate] [(4-)-O,O′,ON,ON]calciate(2)-disodium
               
            
                  Calcium disodium ethylenediaminetetra acetate Calcium disodium (ethylenedinitrilo)tetra acetate
               
            
                  Einecs
               
               
                  200-529-9
               
            
                  Chemical formula
               
               
                  C10H12O8CaN2Na2·2H2O
               
            
                  Molecular weight
               
               
                  410,31
               
            
                  Assay
               
               
                  Content not less than 97 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, odourless crystalline granules or white to nearly white powder, slightly hygroscopic
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Chelating activity to metal ions positive
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution between 6,5 and 7,5
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  5 to 13 % (Karl Fischer method)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 400 ALGINIC ACID
      
                  
                     Definition
                  
               
               
                  Linear glycuronoglycan consisting mainly of β-(1-4) linked D-mannuronic and α-(1-4) linked L-guluronic acid units in pyranose ring form. Hydrophilic colloidal carbohydrate extracted by the use of dilute alkali from natural strains of various species of brown seaweeds (Phaeophyceae)
               
            
                  Einecs
               
               
                  232-680-1
               
            
                  Chemical formula
               
               
                  (C6H8O6)n
                  
               
            
                  Molecular weight
               
               
                  10 000-600 000 (typical average)
               
            
                  Assay
               
               
                  Alginic acid yields, on the anhydrous basis, not less than 20 % and not more than 23 % of carbon dioxide (CO2), equivalent to not less than 91 % and not more than 104,5 % of alginic acid (C6H8O6)n (calculted on equivalent weight basis of 200)
               
            
                  
                     Description
                  
               
               
                  Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white to yellowish brown and nearly odourless
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate
               
            
                  
                              B.
                           
                           
                              Calcium chloride precipitation test
                           
                        
               
                  To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one fifth of its volume of a 2,5 % solution of calcium chloride. A voluminous, gelatinous precipitate is formed. This test distinguishes alginic acid from acacia gum, sodium carboxymethyl cellulose, carboxymethyl starch, carrageenan, gelatin, gum ghatti, karaya gum, locust bean gum, methyl cellulose and tragacanth gum
               
            
                  
                              C.
                           
                           
                              Ammonium sulphate precipitation test
                           
                        
               
                  To a 0,5 % solution of the sample in 1 M sodium hydroxide solution, add one half of its volume of a saturated solution of ammonium sulphate. No precipitate is formed. This test distinguishes alginic acid from agar, sodium carboxymethyl cellulose, carrageenan, de-esterified pectin, gelatin, locust bean gum, methyl cellulose and starch
               
            
                  
                              D.
                           
                           
                              Colour reaction
                           
                        
               
                  Dissolve as completely as possible 0,01 g of the sample by shaking with 0,15 ml of 0,1 N sodium hydroxide and add 1 ml of acid ferric sulphate solution. Within 5 minutes, a cherry-red colour develops that finally becomes deep purple
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  pH of a 3 % suspension
               
               
                  Between 2,0 and 3,5
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 oC, 4 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 8 % on the anhydrous basis
               
            
                  Sodium hydroxide (1 M solution)
               
               
                  Not more than 2 % on the anhydrous basis insoluble matter
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 401 SODIUM ALGINATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium salt of alginic acid
               
            
                  Chemical formula
               
               
                  (C6H7NaO6)n
                  
               
            
                  Molecular weight
               
               
                  10 000-600 000 (typical average)
               
            
                  Assay
               
               
                  Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium alginate (calculated on equivalent weight basis of 222)
               
            
                  
                     Description
                  
               
               
                  Nearly odourless, white to yellowish fibrous or granular powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for sodium and alginic acid
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 oC, 4 hours)
               
            
                  Water-insoluble matter
               
               
                  Not more than 2 % on the anhydrous basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 402 POTASSIUM ALGINATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium salt of alginic acid
               
            
                  Chemical formula
               
               
                  (C6H7KO6)n
                  
               
            
                  Molecular weight
               
               
                  10 000-600 000 (typical average)
               
            
                  Assay
               
               
                  Yields, on the anhydrous basis, not less than 16,5 % and not more than 19,5 % of carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 % of potassium alginate (calculated on an equivalent weight basis of 238)
               
            
                  
                     Description
                  
               
               
                  Nearly odourless, white to yellowish fibrous or granular powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for potassium and for alginic acid
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 oC, 4 hours)
               
            
                  Water-insoluble matter
               
               
                  Not more than 2 % on the anhydrous basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 403 AMMONIUM ALGINATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ammonium salt of alginic acid
               
            
                  Chemical formula
               
               
                  (C6H11NO6)n
                  
               
            
                  Molecular weight
               
               
                  10 000 — 600 000 (typical average)
               
            
                  Assay
               
               
                  Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon dioxide corresponding to not less than 88,7 % and not more than 103,6 % ammonium alginate (calculated on an equivalent weight basis of 217)
               
            
                  
                     Description
                  
               
               
                  White to yellowish fibrous or granular powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ammonium and alginic acid
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 oC, 4 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 7 % on the dried basis
               
            
                  Water-insoluble matter
               
               
                  Not more than 2 % on the anhydrous basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals
               
               
                  Not more than 20 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 404 CALCIUM ALGINATE
      
                  
                     Synonyms
                  
               
               
                  Calcium salt of alginate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium salt of alginic acid
               
            
                  Chemical formula
               
               
                  (C6H7Ca1/2O6)n
                  
               
            
                  Molecular weight
               
               
                  10 000-600 000 (typical average)
               
            
                  Assay
               
               
                  Yields, on the anhydrous basis, not less than 18 % and not more than 21 % carbon dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium alginate (calculated on an equivalent weight basis of 219)
               
            
                  
                     Description
                  
               
               
                  Nearly odourless, white to yellowish fibrous or granular powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for calcium and alginic acid
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % (105 oC, 4 hours)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 405 PROPANE-1,2-DIOL ALGINATE
      
                  
                     Synonyms
                  
               
               
                  Hydroxypropyl alginate
               
            
                  1,2-propanediol ester of alginic acid
               
            
                  Propylene glycol alginate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of esterification and the percentage of free and neutralised carboxyl groups in the molecule
               
            
                  Chemical formula
               
               
                  (C9H14O7)n (esterified)
               
            
                  Molecular weight
               
               
                  10 000-600 000 (typical average)
               
            
                  Assay
               
               
                  Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2 of carbon dioxide
               
            
                  
                     Description
                  
               
               
                  Nearly odourless, white to yellowish brown fibrous or granular powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for 1,2-propanediol and alginic acid after hydrolysis
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 20 % (105 oC, 4 hours)
               
            
                  Total propane-1,2-diol content
               
               
                  Not less than 15 % and not more than 45 %
               
            
                  Free propane-1,2-diol content
               
               
                  Not more than 15 %
               
            
                  Water-insoluble matter
               
               
                  Not more than 2 % on the anhydrous basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 406 AGAR
      
                  
                     Synonyms
                  
               
               
                  Gelose
               
            
                  Japan agar
               
            
                  Bengal, Ceylon, Chinese or Japanese isinglass
               
            
                  Layor Carang
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Agar is a hydrophilic colloidal polysaccharide consisting mainly of D-galactose units. On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium. It is extracted from certain natural strains of marine algae of the families Gelidiaceae and Sphaerococcaceae and related red algae of the class Rhodophyceae
                  
               
            
                  Einecs
               
               
                  232-658-1
               
            
                  Assay
               
               
                  The threshold gel concentration should not be higher than 0,25 %
               
            
                  
                     Description
                  
               
               
                  Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in bundles consisting of thin, membranous, agglutinated strips, or in cut, flaked or granulated forms. It may be light yellowish-orange, yellowish-grey to pale yellow, or colourless. It is tough when damp, brittle when dry. Powdered agar is white to yellowish-white or pale yellow. When examined in water under a microscope, the agar appears granular and somewhat filamentous. A few fragments of the spicules of sponges and a few frustules of diatoms may be present. In chloral hydrate solution, the powdered agar appears more transparent than in water, more or less granular, striated, angular and occasionally contains frustules of diatoms. Gel strength may be standardised by the addition of dextrose and maltodextrines or sucrose
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in cold water; soluble in boiling water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 22 % (105 oC, 5 hours)
               
            
                  Ash
               
               
                  Not more than 6,5 % on the anhydrous basis determined at 550 oC
               
            
                  Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)
               
               
                  Not more than 0,5 % determined at 550 oC on the anhydrous basis
               
            
                  Insoluble matter (in hot water)
               
               
                  Not more than 1,0 %
               
            
                  Starch
               
               
                  Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
               
            
                  Gelatin and other proteins
               
               
                  Dissolve about 1 g of agar in 100 ml of boiling water and allow to cool of about 50 oC. To 5 ml of the solution add 5 ml of trinitrophenol solution (1 g of anhydrous trinitrophenol/100 ml of hot water). No turbidity appears within 10 minutes
               
            
                  Water absorption
               
               
                  Place 5 g to agar in a 100 ml graduated cylinder, fill to the mark with water, mix and allow to stand at about 25 oC for 24 hours. Pour the contents of the cylinder through moistened glass wool, allowing the water to drain into a second 100 ml graduated cylinder. Not more than 75 ml of water is obtained
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 407 CARRAGEENAN
      
                  
                     Synonyms
                  
               
               
                  Products of commerce are sold under different names such as:
               
            
                  Irish moss gelose
               
            
                  Eucheuman (from Eucheuma spp.)
               
            
                  Iridophycan (from Iridaea spp.)
               
            
                  Hypnean (from Hypnea spp.)
               
            
                  Furcellaran or Danish agar (from Furcellaria fastigiata)
               
            
                  Carrageenan (from Chondrus and Gigartina spp.)
               
            
                  
                     Definition
                  
               
               
                  Carrageenan is obtained by aqueous extraction of natural strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds). No organic precipitant shall be used other than methanol, ethanol and propane-2-ol. Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Carrageenan shall not be hydrolysed or otherwise chemically degraded
               
            
                  Einecs
               
               
                  232-524-2
               
            
                  
                     Description
                  
               
               
                  Yellowish to colourless, coarse to fine powder which is practically odourless
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for galactose, for anhydrogalactose and for sulphate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Methanol, ethanol propane-2-ol content
               
               
                  Not more than 0,1 % singly or in combination
               
            
                  Viscosity of a 1,5 % solution at 75 oC
               
               
                  Not less than 5 mPa.s
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 oC, four hours)
               
            
                  Sulphate
               
               
                  Not less than 15 % and not more than 40 % on the dried basis (as SO4)
               
            
                  Ash
               
               
                  Not less than 15 % and not more than 40 % determined on the dried basis at 550 oC
               
            
                  Acid-insoluble ash
               
               
                  Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
               
            
                  Acid-insoluble matter
               
               
                  Not more than 2 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
               
            
                  Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)
               
               
                  Not more than 5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 300 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 407a PROCESSED EUCHEUMA SEAWEED
      
                  
                     Synonyms
                  
               
               
                  PES (acronym for processed eucheuma seaweed)
               
            
                  
                     Definition
                  
               
               
                  Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the natural strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) to remove impurities and by fresh water washing and drying to obtain the product. Further purification may be achieved by washing with methanol, ethanol or propane-2-ol and drying. The product consists chiefly of the potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present in the product. The carrageenan in processed eucheuma seaweed shall not be hydrolysed or otherwise chemically degraded
               
            
                  
                     Description
                  
               
               
                  Tan to yellowish, coarse to fine powder which is practically odourless
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for galactose, for anhydrogalactose and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Forms cloudy viscous suspensions in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Methanol, ethanol, propane-2-ol content
               
               
                  Not more than 0,1 % singly or in combination
               
            
                  Viscosity of a 1,5 % solution at 75 oC
               
               
                  Not less than 5 mPa.s
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 oC, four hours)
               
            
                  Sulphate
               
               
                  Not less than 15 % and not more than 40 % on the dried basis (as SO4)
               
            
                  Ash
               
               
                  Not less than 15 % and not more than 40 % determined on the dried basis at 550 oC
               
            
                  Acid-insoluble ash
               
               
                  Not more than 1 % on the dried basis (insoluble in 10 % hydrochloric acid)
               
            
                  Acid-insoluble matter
               
               
                  Not less than 8 % and not more than 15 % on the dried basis (insoluble in 1 % v/v sulphuric acid)
               
            
                  Low molecular weight carrageenan (Molecular weight fraction below 50 kDa)
               
               
                  Not more than 5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 300 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 410 LOCUST BEAN GUM
      
                  
                     Synonyms
                  
               
               
                  Carob bean gum
               
            
                  Algaroba gum
               
            
                  
                     Definition
                  
               
               
                  Locust bean gum is the ground endosperm of the seeds of the natural strains of carob tree, Cerationia siliqua (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide, composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
               
            
                  Molecular weight
               
               
                  50 000-3 000 000
               
            
                  Einecs
               
               
                  232-541-5
               
            
                  Assay
               
               
                  Galactomannan content not less than 75 %
               
            
                  
                     Description
                  
               
               
                  White to yellowish-white, nearly odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for galactose mannose
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Microscopic examination
                           
                        
               
                  Place some ground sample in an aqueous solution containing 0,5 % iodine and 1 % potassium iodide on a glass slide and examine under microscope. Locust bean gum contains long stretched tubiform cells, separated or slightly interspaced. Their brown contents are much less regularly formed in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in hot water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 oC, 5 hours)
               
            
                  Ash
               
               
                  Not more than 1,2 % determined at 800 oC
               
            
                  Protein (N × 6,25)
               
               
                  Not more than 7 %
               
            
                  Acid-insoluble matter
               
               
                  Not more than 4 %
               
            
                  Starch
               
               
                  Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. No blue colour is produced
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Ethanol and propane-2-ol
               
               
                  Not more than 1 %, single or in combination
               
            E 412 GUAR GUM
      
                  
                     Synonyms
                  
               
               
                  Gum cyamopsis
               
            
                  Guar flour
               
            
                  
                     Definition
                  
               
               
                  Guar gum is the ground endosperm of the seeds of natural strains of the guar plant, Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high molecular weight hydrocolloidal polysaccharide composed of galactopyranose and mannopyranose units combined through glycosidic linkages, which may be described chemically as galactomannan
               
            
                  Einecs
               
               
                  232-536-0
               
            
                  Molecular weight
               
               
                  50 000-8 000 000
               
            
                  Assay
               
               
                  Galactomannan content not less than 75 %
               
            
                  
                     Description
                  
               
               
                  A white to yellowish-white, nearly odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for galactose and for mannose
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in cold water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 oC, 5 hours)
               
            
                  Ash
               
               
                  Not more than 1,5 % determined at 800 oC
               
            
                  Acid-insoluble matter
               
               
                  Not more than 7 %
               
            
                  Protein (N × 6,25)
               
               
                  Not more than 10 %
               
            
                  Starch
               
               
                  Not detectable by the following method: to a 1 in 10 solution of the sample add a few drops of iodine solution. (No blue colour is produced)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 413 TRAGACANTH
      
                  
                     Synonyms
                  
               
               
                  Tragacanth gum
               
            
                  Tragant
               
            
                  
                     Definition
                  
               
               
                  Tragacanth is a dried exudation obtained from the stems and branches of natural strains of Astragalus gummifer Labillardiere and other Asiatic species of Astragalus (family Leguminosae). It consists mainly of high molecular weight polysaccharides (galactoarabans and acidic polysaccharides) which, on hydrolysis, yield galacturonic acid, galactose, arabinose, xylose and fucose. Small amounts of rhamnose and of glucose (derived from traces of starch and/or cellulose) may also be present
               
            
                  Molecular weight
               
               
                  Approximately 800 000
               
            
                  Einecs
               
               
                  232-252-5
               
            
                  
                     Description
                  
               
               
                  Unground Tragacanth gum occurs as flattened, lamellated, straight or curved fragments or as spirally twisted pieces 0,5-2,5 mm thick and up to 3 cm in length. It is white to pale yellow in colour but some pieces may have a red tinge. The pieces are horny in texture, with a short fracture. It is odourless and solutions have an insipid mucilaginous taste. Powdered tragacanth is white to pale yellow or pinkish brown (pale tan) in colour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  1 g of the sample in 50 ml of water swells to form a smooth, stiff, opalescent mucilage; insoluble in ethanol and does not swell in 60 % (w/v) aqueous ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Negative test for Karaya gum
               
               
                  Boil 1 g with 20 ml of water until a mucilage is formed. Add 5 ml of hydrochloric acid and again boil the mixture for five minutes. No permanent pink or red colour develops
               
            
                  Loss on drying
               
               
                  Not more than 16 % (105 oC, 5 hours)
               
            
                  Total ash
               
               
                  Not more than 4 %
               
            
                  Acid insoluble ash
               
               
                  Not more than 0,5 %
               
            
                  Acid insoluble matter
               
               
                  Not more than 2 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            E 414 ACACIA GUM
      
                  
                     Synonyms
                  
               
               
                  Gum arabic
               
            
                  
                     Definition
                  
               
               
                  Acacia gum is a dried exudation obtained from the stems and branches of natural strains of Acacia senegal (L) Willdenow or closely related species of Acacia (family Leguminosae). It consists mainly of high molecular weight polysaccharides and their calcium, magnesium and potassium salts, which on hydrolysis yield arabinose, galactose, rhamnose and glucuronic acid
               
            
                  Molecular weight
               
               
                  Approximately 350 000
               
            
                  Einecs
               
               
                  232-519-5
               
            
                  
                     Description
                  
               
               
                  Unground acacia gum occurs as white or yellowish-white spheroidal tears of varying sizes or as angular fragments and is sometimes mixed with darker fragments. It is also available in the form of white to yellowish-white flakes, granules, powder or spray-dried material.
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid to litmus, insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 17 % (105 oC, 5 hours) for granular and not more than 10 % (105 oC, 4 hours) for spray-dried material
               
            
                  Total ash
               
               
                  Not more than 4 %
               
            
                  Acid insoluble ash
               
               
                  Not more than 0,5 %
               
            
                  Acid insoluble matter
               
               
                  Not more than 1 %
               
            
                  Starch or dextrin
               
               
                  Boil a 1 in 50 solution of the gum and cool. To 5 ml add 1 drop of iodine solution. No bluish or reddish colours are produced
               
            
                  Tannin
               
               
                  To 10 ml of a 1 in 50 solution add about 0,1 ml of ferric chloride solution (9 g FeCl3.6H2O made up to 100 ml with water). No blackish colouration or blackish precipitate is formed
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Hydrolysis products
               
               
                  Mannose, xylose and galacturonic acid are absent (determined by chromatography)
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            E 415 XANTHAN GUM
      
                  
                     Definition
                  
               
               
                  Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with natural strains of Xanthomonas campestris, purified by recovery with ethanol or propane-2-ol, dried and milled. It contains D-glucose and D-mannose as the dominant hexose units, along with D-glucuronic acid and pyruvic acid, and is prepared as the sodium, potassium or calcium salt. Its solutions are neutral
               
            
                  Molecular weight
               
               
                  Approximately 1 000 000
               
            
                  Einecs
               
               
                  234-394-2
               
            
                  Assay
               
               
                  Yields, on dried basis, not less than 4,2 % and not more than 5 % of CO2 corresponding to between 91 % and 108 % of xanthan gum
               
            
                  
                     Description
                  
               
               
                  Cream-coloured powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 oC, 21/2 hours)
               
            
                  Total ash
               
               
                  Not more than 16 % on the anhydrous basis determined at 650 oC after drying at 105 oC for four hours
               
            
                  Pyruvic acid
               
               
                  Not less than 1,5 %
               
            
                  Nitrogen
               
               
                  Not more than 1,5 %
               
            
                  Ethanol and propan-2-ol
               
               
                  Not more than 500 mg/kg singly or in combination
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and mould
               
               
                  Not more than 300 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
                  
                     Xanthomonas campestris
                  
               
               
                  Viable cells absent in 1 g
               
            E 416 KARAYA-GUM
      
                  
                     Synonyms
                  
               
               
                  Katilo
               
            
                  Kadaya
               
            
                  Gum sterculia
                  
               
            
                  
                     Sterculia
                  
               
            
                  Karaya, gum karaya
               
            
                  Kullo
               
            
                  Kuterra
               
            
                  
                     Definition
                  
               
               
                  Karaya gum is a dried exudation from the stems and branches of natural strains of: Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from Cochlospermum gossypium A.P. De Candolle or other species of Cochlospermum (family Bixaceae). It consists mainly of high molecular weight acetylated polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid, together with minor amounts of glucuronic acid
               
            
                  Einecs
               
               
                  232-539-4
               
            
                  
                     Description
                  
               
               
                  Karaya gum occurs in tears of variable size and in broken irregular pieces having a characteristic semi-crystalline appearance. It is pale yellow to pinkish brown in colour, translucent and horny. Powdered karaya gum is a pale grey to pinkish brown. The gum has a distinctive odour of acetic acid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Swelling in ethanol solution
                           
                        
               
                  Karaya gum swells in 60 % ethanol distinguishing it from other gums
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 20 % (105 oC, 5 hours)
               
            
                  Total ash
               
               
                  Not more than 8 %
               
            
                  Acid insoluble ash
               
               
                  Not more than 1 %
               
            
                  Acid insoluble matter
               
               
                  Not more than 3 %
               
            
                  Volatile acid
               
               
                  Not less than 10 % (as acetic acid)
               
            
                  Starch
               
               
                  Not detectable
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            E 417 TARA GUM
      
                  
                     Definition
                  
               
               
                  Tara gum is obtained by grinding the endosperm of the seeds of natural strains of Caesalpinia spinosa (family Leguminosae). It consists chiefly of polysaccharides of high molecular weight composed mainly of galactomannans. The principal component consists of a linear chain of (1-4)-β-D-mannopyranose units with α-D-galactopyranose units attached by (1-6) linkages. The ratio of mannose to galactose in tara gum is 3:1. (In locust bean gum this ratio is 4:1 and in guar gum 2:1)
               
            
                  Einecs
               
               
                  254-409-6
               
            
                  
                     Description
                  
               
               
                  A white to white-yellow odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water
               
            
                  Insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Gel formation
                           
                        
               
                  To an aqueous solution of the sample add small amounts of sodium borate. A gel is formed
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 %
               
            
                  Ash
               
               
                  Not more than 1,5 %
               
            
                  Acid insoluble matter
               
               
                  Not more than 2 %
               
            
                  Protein
               
               
                  Not more than 3,5 % (factor N × 5,7)
               
            
                  Starch
               
               
                  Not detectable
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 418 GELLAN GUM
      
                  
                     Definition
                  
               
               
                  Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by natural strains of Pseudomonas elodea, purified by recovery with isopropyl alcohol, dried, and milled. The high molecular weight polysaccharide is principally composed of a tetrasaccharide repeating unit of one rhamnose, one glucuronic acid, and two glucoses, and substituted with acyl (glyceryl and acetyl) groups as the O-glycosidically linked esters. The glucuronic acid is neutralised to a mixed potassium, sodium, calcium, and magnesium salt
               
            
                  Einecs
               
               
                  275-117-5
               
            
                  Molecular weight
               
               
                  Approximately 500 000
               
            
                  Assay
               
               
                  Yields, on the dried basis, not less than 3,3 % and not more than 6,8 % of CO2
                  
               
            
                  
                     Description
                  
               
               
                  An off-white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, forming a viscous solution.
               
            
                  Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % after drying (105 oC, 21/2 hours)
               
            
                  Nitrogen
               
               
                  Not more than 3 %
               
            
                  Propane-2-ol
               
               
                  Not more than 750 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Total plate count
               
               
                  Not more than 10 000 colonies per gram
               
            
                  Yeast and mould
               
               
                  Not more than 400 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            E 420(i) SORBITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Commission Directive 2008/60/EC (8).
      E 420(ii) SORBITOL SYRUP
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 421 MANNITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 422 GLYCEROL
      
                  
                     Synonyms
                  
               
               
                  Glycerin
               
            
                  Glycerine
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical names
               
               
                  1,2,3-propanetriol
               
            
                  Glycerol
               
            
                  Trihydroxypropane
               
            
                  Einecs
               
               
                  200-289-5
               
            
                  Chemical formula
               
               
                  C3H8O3
                  
               
            
                  Molecular weight
               
               
                  92,10
               
            
                  Assay
               
               
                  Content not less than 98 % of glycerol on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Clear, colourless hygroscopic syrupy liquid with not more than a slight characteristic odour, which is neither harsh nor disagreeable
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Acrolein formation on heating
                           
                        
               
                  Heat a few drops of the sample in a test tube with about 0,5 g of potassium bisulphate. The characteristic pungent vapours of acrolein are evolved
               
            
                  
                              B.
                           
                           
                              Specific gravity (25/25 oC)
                           
                        
               
                  Not less than 1,257
               
            
                  
                              C.
                           
                           
                              Refractive index [n]D20
                              
                           
                        
               
                  Between 1,471 and 1,474
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 5 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,01 % determined at 800 ± 25 oC
               
            
                  Butanetriols
               
               
                  Not more than 0,2 %
               
            
                  Acrolein, glucose and ammonium compounds
               
               
                  Heat a mixture of 5 ml of glycerol and 5 ml of potassium hydroxide solution (1 in 10) at 60 oC for five minutes. It neither becomes yellow nor emits an odour of ammonia
               
            
                  Fatty acids and esters
               
               
                  Not more than 0,1 % calculated as butyric acid
               
            
                  Chlorinated compounds
               
               
                  Not more than 30 mg/kg (as chlorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            E 425(i) KONJAC GUM
      
                  
                     Definition
                  
               
               
                  Konjac gum is a water-soluble hydrocolloid obtained from the Konjac flour by aqueous extraction. Konjac flour is the unpurified raw product from the root of the perennial plant Amorphophallus konjac. The main component of Konjac gum is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds. Shorter side chains are attached through β(1-3)-glycosidic bonds, and acetyl groups occur at random at a ratio of about 1 group per 9 to 19 sugar units
               
            
                  Molecular weight
               
               
                  The main component, glucomannan, has an average molecular weight of 200 000 to 2 000 000
               
            
                  Assay
               
               
                  Not less than 75 % carbohydrate
               
            
                  
                     Description
                  
               
               
                  A white to cream to light tan powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0
               
            
                  
                              B.
                           
                           
                              Gel formation
                           
                        
               
                  Add 5 ml of a 4 % sodium borate solution to a 1 % solution of the sample in a test tube, and shake vigorously. A gel forms
               
            
                  
                              C.
                           
                           
                              Formation of heat-stable gel
                           
                        
               
                  Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
               
            
                  
                              D.
                           
                           
                              Viscosity (1 % solution)
                           
                        
               
                  Not less than 3 kgm-1s-1 at 25 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 oC, 5 h)
               
            
                  Starch
               
               
                  Not more than 3 %
               
            
                  Protein
               
               
                  Not more than 3 % (N × 5,7)
               
            
                  Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
               
            
                  Ether-soluble material
               
               
                  Not more than 0,1 %
               
            
                  Total ash
               
               
                  Not more than 5,0 % (800 oC, 3 to 4h)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 12,5 g
               
            
                  
                     E. coli
                  
               
               
                  Absent in 5 g
               
            E 425(ii) KONJAC GLUCOMANNAN
      
                  
                     Definition
                  
               
               
                  Konjac glucomannan is a water-soluble hydrocolloid obtained from Konjac flour by washing with water-containing ethanol. Konjac flour is the unpurified raw product from the tuber of the perennial plant Amorphophallus konjac. The main component is the water-soluble high-molecular-weight polysaccharide glucomannan, which consists of D-mannose and D-glucose units at a molar ratio of 1,6:1,0, connected by β(1-4)-glycosidic bonds with a branch at about each 50th or 60th unit. About each 19th sugar residue is acetylated
               
            
                  Molecular weight
               
               
                  500 000 to 2 000 000
               
            
                  Assay
               
               
                  Total dietary fibre: not less than 95 % on a dry weight basis
               
            
                  
                     Description
                  
               
               
                  White to slightly brownish fine particle size, free flowing and odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Dispersible in hot or cold water forming a highly viscous solution with a pH between 5,0 and 7,0. Solubility is increased by heat and mechanical agitation
               
            
                  
                              B.
                           
                           
                              Formation of heat-stable gel
                           
                        
               
                  Prepare a 2 % solution of the sample by heating it in a boiling water bath for 30 min, with continuous agitation and then cooling the solution to room temperature. For each g of the sample used to prepare 30 g of the 2 % solution, add 1 ml of 10 % potassium carbonate solution to the fully hydrated sample at ambient temperature. Heat the mixture in a water bath to 85 oC, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
               
            
                  
                              C.
                           
                           
                              Viscosity (1 % solution)
                           
                        
               
                  Not less than 20 kgm-1s-1 at 25 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 8 % (105 oC, 3h)
               
            
                  Starch
               
               
                  Not more than 1 %
               
            
                  Protein
               
               
                  Not more than 1,5 % (N × 5,7)
               
            
                  Determine nitrogen by Kjeldahl method. The percentage of nitrogen in the sample multiplied by 5,7 gives the percent of protein in the sample
               
            
                  Ether-soluble material
               
               
                  Not more than 0,5 %
               
            
                  Sulphite (as SO2)
               
               
                  Not more than 4 mg/kg
               
            
                  Chloride
               
               
                  Not more than 0,02 %
               
            
                  50 % Alcohol-soluble
               
               
                  Not more than 2,0 % material
               
            
                  Total ash
               
               
                  Not more than 2,0 % (800 oC, 3 to 4h)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 12,5 g
               
            
                  
                     E. coli
                  
               
               
                  Absent in 5 g
               
            E 426 SOYBEAN HEMICELLULOSE
      
                  
                     Definition
                  
               
               
                  Soybean hemicellulose is a refined water-soluble polysaccharide obtained from natural strain soybean fibre by hot water extraction
               
            
                  Chemical names
               
               
                  Water soluble soybean polysaccharides
               
            
                  Water soluble soybean fibre
               
            
                  Assay
               
               
                  Not less than 74 % carbohydrate
               
            
                  
                     Description
                  
               
               
                  Free flowing spray-dried white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility pH of 1 % solution
                           
                        
               
                  Soluble in hot and cold water without gel formation
               
            
                  5,5±1,5
               
            
                  
                              B.
                           
                           
                              Viscosity of 10 % solution
                           
                        
               
                  Not more than 200 mPa.s
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 7 % (105 oC, 4h)
               
            
                  Protein
               
               
                  Not more than 14 %
               
            
                  Total ash
               
               
                  Not more than 9,5 % (600 oC, 4h)
               
            
                  Arsenic
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Standard plate count
               
               
                  Not more than 3 000 colonies per gram
               
            
                  Yeast and mould
               
               
                  Not more than 100 colonies per gram
               
            
                  
                     E. coli
                  
               
               
                  Negative in 10 g
               
            E 431 POLYOXYETHYLENE (40) STEARATE
      
                  
                     Synonyms
                  
               
               
                  Polyoxyl (40) stearate
               
            
                  polyoxyethylene (40) monostearate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the mono- and diesters of edible commercial stearic acid and mixed polyoxyethylene diols (having an average polymer length of about 40 oxyethylene units) together with free polyol
               
            
                  Assay
               
               
                  Content not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Cream-coloured flakes or waxy solid at 25 oC with a faint odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil
               
            
                  
                              B.
                           
                           
                              Congealing range
                           
                        
               
                  39 oC-44 oC
               
            
                  
                              C.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer method)
               
            
                  Acid value
               
               
                  Not more than 1
               
            
                  Saponification value
               
               
                  Not less than 25 and not more than 35
               
            
                  Hydroxyl value
               
               
                  Not less than 27 and not more than 40
               
            
                  1,4-Dioxane
               
               
                  Not more than 5 mg/kg
               
            
                  Ethylene oxide
               
               
                  Not more than 0,2 mg/kg
               
            
                  Ethylene glycols (mono- and di-)
               
               
                  Not more than 0,25 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            E 432 POLYOXYETHYLENE SORBITAN MONOLAURATE (POLYSORBATE 20)
      
                  
                     Synonyms
                  
               
               
                  Polysorbate 20
               
            
                  Polyoxyethylene (20) sorbitan monolaurate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial lauric acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
               
            
                  Assay
               
               
                  Content not less than 70 % of oxyethylene groups, equivalent to not less than 97,3 % of polyoxyethylene (20) sorbitan monolaurate on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A lemon to amber-coloured oily liquid at 25 oC with a faint characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether
               
            
                  
                              B.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer method)
               
            
                  Acid value
               
               
                  Not more than 2
               
            
                  Saponification value
               
               
                  Not less than 40 and not more than 50
               
            
                  Hydroxyl value
               
               
                  Not less than 96 and not more than 108
               
            
                  1,4-dioxane
               
               
                  Not more than 5 mg/kg
               
            
                  Ethylene oxide
               
               
                  Not more than 0,2 mg/kg
               
            
                  Ethylene glycols (mono- and di-)
               
               
                  Not more than 0,25 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            E 433 POLYOXYETHYLENE SORBITAN MONOOLEATE (POLYSORBATE 80)
      
                  
                     Synonyms
                  
               
               
                  Polysorbate 80
               
            
                  Polyoxyethylene (20) sorbitan monooleate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial oleic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
               
            
                  Assay
               
               
                  Content not less than 65 % of oxyethylene groups, equivalent to not less than 96,5 % of polyoxyethylene (20) sorbitan monooleate on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A lemon to amber-coloured oily liquid at 25 oC with a faint characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
               
            
                  
                              B.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer method)
               
            
                  Acid value
               
               
                  Not more than 2
               
            
                  Saponification value
               
               
                  Not less than 45 and not more than 55
               
            
                  Hydroxyl value
               
               
                  Not less than 65 and not more than 80
               
            
                  1,4-dioxane
               
               
                  Not more than 5 mg/kg
               
            
                  Ethylene oxide
               
               
                  Not more than 0,2 mg/kg
               
            
                  Ethylene glycols (mono- and di-)
               
               
                  Not more than 0,25 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            E 434 POLYOXYETHYLENE SORBITAN MONOPALMITATE (POLYSORBATE 40)
      
                  
                     Synonyms
                  
               
               
                  Polysorbate 40
               
            
                  Polyoxyethylene (20) sorbitan monopalmitate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial palmitic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
               
            
                  Assay
               
               
                  Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monopalmitate on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
               
            
                  
                              B.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer method)
               
            
                  Acid value
               
               
                  Not more than 2
               
            
                  Saponification value
               
               
                  Not less than 41 and not more than 52
               
            
                  Hydroxyl value
               
               
                  Not less than 90 and not more than 107
               
            
                  1,4-dioxane
               
               
                  Not more than 5 mg/kg
               
            
                  Ethylene oxide
               
               
                  Not more than 0,2 mg/kg
               
            
                  Ethylene glycols (mono- and di-)
               
               
                  Not more than 0,25 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            E 435 POLYOXYETHYLENE SORBITAN MONOSTEARATE (POLYSORBATE 60)
      
                  
                     Synonyms
                  
               
               
                  Polysorbate 60
               
            
                  Polyoxyethylene (20) sorbitan monostearate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
               
            
                  Assay
               
               
                  Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of polyoxyethylene (20) sorbitan monostearate on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A lemon to orange-coloured oily liquid or semi-gel at 25 oC with a faint characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
               
            
                  
                              B.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer method)
               
            
                  Acid value
               
               
                  Not more than 2
               
            
                  Saponification value
               
               
                  Not less than 45 and not more than 55
               
            
                  Hydroxyl value
               
               
                  Not less than 81 and not more than 96
               
            
                  1,4-dioxane
               
               
                  Not more than 5 mg/kg
               
            
                  Ethylene oxide
               
               
                  Not more than 0,2 mg/kg
               
            
                  Ethylene glycols (mono- and di-)
               
               
                  Not more than 0,25 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            E 436 POLYOXYETHYLENE SORBITAN TRISTEARATE (POLYSORBATE 65)
      
                  
                     Synonyms
                  
               
               
                  Polysorbate 65
               
            
                  Polyoxyethylene (20) sorbitan tristearate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its mono- and dianhydrides with edible commercial stearic acid and condensed with approximately 20 moles of ethylene oxide per mole of sorbitol and its anhydrides
               
            
                  Assay
               
               
                  Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of polyoxyethylene (20) sorbitan tristearate on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A tan-coloured, waxy solid at 25 oC with a faint characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol
               
            
                  
                              B.
                           
                           
                              Congealing range
                           
                        
               
                  29-33 oC
               
            
                  
                              C.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer method)
               
            
                  Acid value
               
               
                  Not more than 2
               
            
                  Saponification value
               
               
                  Not less than 88 and not more than 98
               
            
                  Hydroxyl value
               
               
                  Not less than 40 and not more than 60
               
            
                  1,4-dioxane
               
               
                  Not more than 5 mg/kg
               
            
                  Ethylene oxide
               
               
                  Not more than 0,2 mg/kg
               
            
                  Ethylene glycols (mono- and di-)
               
               
                  Not more than 0,25 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            E 440 (i) PECTIN
      
                  
                     Definition
                  
               
               
                  Pectin consists mainly of the partial methyl esters of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of natural strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
               
            
                  Einecs
               
               
                  232-553-0
               
            
                  Assay
               
               
                  Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
               
            
                  
                     Description
                  
               
               
                  White, light yellow, light grey or light brown powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 oC, 2 hours)
               
            
                  Acid insoluble ash
               
               
                  Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg on the anhydrous basis
               
            
                  Nitrogen content
               
               
                  Not more than 1,0 % after washing with acid and ethanol
               
            
                  Free methanol, ethanol and propane-2-ol
               
               
                  Not more than 1 %, singly or in combination, on the anhydrous basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 440 (ii) AMIDATED PECTIN
      
                  
                     Definition
                  
               
               
                  Amidated pectin consists mainly of the partial methyl esters and amides of polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is obtained by extraction in an aqueous medium of appropriate natural strains of edible plant material, usually citrus fruits or apples and treatment with ammonia under alkaline conditions. No organic precipitant shall be used other than methanol, ethanol and propane-2-ol
               
            
                  Assay
               
               
                  Content not less than 65 % of galacturonic acid on the ash-free and anhydrous basis after washing with acid and alcohol
               
            
                  
                     Description
                  
               
               
                  White, light yellow, light greyish or light brownish powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 oC, 2 hours)
               
            
                  Acid-insoluble ash
               
               
                  Not more than 1 % (insoluble in approximately 3N hydrochloric acid)
               
            
                  Degree of amidation
               
               
                  Not more than 25 % of total carboxyl groups
               
            
                  Sulphur dioxide residue
               
               
                  Not more than 50 mg/kg on the anhydrous basis
               
            
                  Nitrogen content
               
               
                  Not more than 2,5 % after washing with acid and ethanol
               
            
                  Free methanol, ethanol and propane-2-ol
               
               
                  Not more than 1 % single or in combination, on a volatile matter-free basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 442 AMMONIUM PHOSPHATIDES
      
                  
                     Synonyms
                  
               
               
                  Ammonium salts of phosphatidic acid, mixed ammonium salts of phoshorylated glycerides
               
            
                  
                     Definition
                  
               
               
                  A mixture of the ammonium compounds of phosphatidic acids derived from edible fat and oil (usually partially hardened rapeseed oil). One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
               
            
                  Assay
               
               
                  The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the ammonium content is not less than 1,2 % and not more than 1,5 % (calculated as N)
               
            
                  
                     Description
                  
               
               
                  Unctuous semi-solid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
               
            
                  
                              B.
                           
                           
                              Positive tests for glycerol, for fatty acid and for phosphate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Petroleum ether insoluble matter
               
               
                  Not more than 2,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 444 SUCROSE ACETATE ISOBUTYRATE
      
                  
                     Synonyms
                  
               
               
                  SAIB
               
            
                  
                     Definition
                  
               
               
                  Sucrose acetate isobutyrate is a mixture of the reaction products formed by the esterification of food grade sucrose with acetic acid anhydride and isobutyric anhydride, followed by distillation. The mixture contains all possible combinations of esters in which the molar ratio of acetate to butyrate is about 2:6
               
            
                  Einecs
               
               
                  204-771-6
               
            
                  Chemical name
               
               
                  Sucrose diacetate hexaisobutyrate
               
            
                  Chemical formulae
               
               
                  C40H62O19
                  
               
            
                  Molecular weight
               
               
                  832-856 (approximate), C40H62O19: 846,9
               
            
                  Assay
               
               
                  Content not less than 98,8 % and not more than 101,9 % of C40H62O19
                  
               
            
                  
                     Description
                  
               
               
                  A pale straw-coloured liquid, clear and free of sediment and having a bland odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water. Soluble in most organic solvents
               
            
                  
                              B.
                           
                           
                              Refractive index
                           
                        
               
                  [n]40
                     D: 1,4492-1,4504
               
            
                  
                              C.
                           
                           
                              Specific gravity
                           
                        
               
                  [d]25
                     D: 1,141-1,151
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Triacetin
               
               
                  Not more than 0,1 %
               
            
                  Acid value
               
               
                  Not more than 0,2
               
            
                  Saponification value
               
               
                  Not less than 524 and not more than 540
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 3 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 5 mg/kg
               
            E 445 GLYCEROL ESTERS OF WOOD ROSIN
      
                  
                     Synonyms
                  
               
               
                  Ester gum
               
            
                  
                     Definition
                  
               
               
                  A complex mixture of tri- and diglycerol esters of resin acids from wood rosin. The rosin is obtained by the solvent extraction of aged pine stumps followed by a liquid-liquid solvent refining process. Excluded from these specifications are substances derived from gum rosin, and exudate of living pine trees, and substances derived from tall oil rosin, a by-product of kraft (paper) pulp processing. The final product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic compounds). The resin acid fraction is a complex mixture of isomeric diterpenoid monocarboxylic acids having the empirical molecular formula of C20H30O2, chiefly abietic acid. The substance is purified by steam stripping or by countercurrent steam distillation
               
            
                  
                     Description
                  
               
               
                  Hard, yellow to pale amber-coloured solid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, soluble in acetone
               
            
                  
                              B.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of the compound
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Specific gravity of solution
               
               
                  [d]20
                     25 not less than 0,935 when determined in a 50 % solution in d-limonene (97 %, boilding point 175,5-176 oC, d20
                     4: 0,84)
               
            
                  Ring and ball softening range
               
               
                  Between 82 oC and 90 oC
               
            
                  Acid value
               
               
                  Not less than 3 and not more than 9
               
            
                  Hydroxyl value
               
               
                  Not less than 15 and not more than 45
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Test for absence of tall oil rosin (sulphur test)
               
               
                  When sulphur-containing organic compounds are heated in the presence of sodium formate, the sulphur is converted to hydrogen sulphide which can readily be detected by the use of lead acetate paper. A positive test indicates the use of tall oil rosin instead of wood rosin
               
            E 450 (i) DISODIUM DIPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Disodium dihydrogen diphosphate
               
            
                  Disodium dihydrogen pyrophosphate
               
            
                  Sodium acid pyrophosphate
               
            
                  Disodium pyrophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium dihydrogen diphosphate
               
            
                  Einecs
               
               
                  231-835-0
               
            
                  Chemical formula
               
               
                  Na2H2P2O7
                  
               
            
                  Molecular weight
               
               
                  221,94
               
            
                  Assay
               
               
                  Content not less than 95 % of disodium diphosphate
               
            
                  P2O5 Content
               
               
                  Not less than 63,0 % and not more than 64,5 %
               
            
                  
                     Description
                  
               
               
                  White powder or grains
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 3,7 and 5,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 oC, four hours)
               
            
                  Water-insoluble matter
               
               
                  Not more than 1 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 450 (ii) TRISODIUM DIPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Acid trisodium pyrophosphate
               
            
                  Trisodium monohydrogen diphosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Einecs
               
               
                  238-735-6
               
            
                  Chemical formula
               
               
                  Monohydrate: Na3HP2O7 · H2O
               
            
                  Anhydrous: Na3HP2O7
                  
               
            
                  Molecular weight
               
               
                  Monohydrate: 261,95
               
            
                  Anhydrous: 243,93
               
            
                  Assay
               
               
                  Content not less than 95 % on the anhydrous basis
               
            
                  P2O5 content
               
               
                  Not less than 57 % and not more than 59 %
               
            
                  
                     Description
                  
               
               
                  White powder or grains, occurs anhydrous or as a monohydrate
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 6,7 and 7,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 4,5 % on the anhydrous compound
               
            
                  Not more than 11,5 % on the monohydrous basis
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 oC, four hours)
               
            
                  Water-insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 450 (iii) TETRASODIUM DIPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Tetrasodium pyrophosphate
               
            
                  Sodium pyrophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Tetrasodium diphosphate
               
            
                  Einecs
               
               
                  231-767-1
               
            
                  Chemical formula
               
               
                  Anhydrous: Na4P2O7
                  
               
            
                  Decahydrate: Na4P2O7 · 10H2O
               
            
                  Molecular weight
               
               
                  Anhydrous: 265,94
               
            
                  Decahydrate: 446,09
               
            
                  Assay
               
               
                  Content not less than 95 % of Na4P2O7 on the ignited basis
               
            
                  P2O5 content
               
               
                  Not less than 52,5 % and not more than 54,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless or white crystals, or a white crystalline or granular powder. The decahydrate effloresces slightly in dry air
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water. Insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 9,8 and 10,8
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 0,5 % for the anhydrous salt, not less than 38 % and not more than 42 % for the decahydrate, in both cases determined after drying at 105 oC for four hours, followed by ignition at 550 oC for 30 minutes
               
            
                  Water-insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 450 (v) TETRAPOTASSIUM DIPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Potassium pyrophosphate
               
            
                  Tetrapotassium pyrophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Tetrapotassium diphosphate
               
            
                  Einecs
               
               
                  230-785-7
               
            
                  Chemical formula
               
               
                  K4P2O7
                  
               
            
                  Molecular weight
               
               
                  330,34 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 95 % on the ignited basis
               
            
                  P2O5 content
               
               
                  Not less than 42,0 % and not more than 43,7 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless crystals or white, very hygroscopic powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for potassium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 10,0 and 10,8
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 2 % after drying at 105 oC for four hours and then ignition at 550 oC for 30 minutes
               
            
                  Water-insoluble substances
               
               
                  Not more than 0,2 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 450 (vi) DICALCIUM DIPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Calcium pyrophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dicalcium diphosphate
               
            
                  Dicalcium pyrophosphate
               
            
                  Einecs
               
               
                  232-221-5
               
            
                  Chemical formula
               
               
                  Ca2P2O7
                  
               
            
                  Molecular weight
               
               
                  254,12
               
            
                  Assay
               
               
                  Content not less than 96 %
               
            
                  P2O5 content
               
               
                  Not less than 55 % and not more than 56 %
               
            
                  
                     Description
                  
               
               
                  A fine, white, odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water. Soluble in dilute hydrochloric and nitric acids
               
            
                  
                              C.
                           
                           
                              pH of a 10 % suspension in water
                           
                        
               
                  Between 5,5 and 7,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 1,5 % at 800 oC ± 25 oC for 30 minutes
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Acid calcium pyrophosphate
               
            
                  Monocalcium dihydrogen pyrophosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium dihydrogen diphosphate
               
            
                  Einecs
               
               
                  238-933-2
               
            
                  Chemical formula
               
               
                  CaH2P2O7
                  
               
            
                  Molecular weight
               
               
                  215,97
               
            
                  Assay
               
               
                  Content not less than 90 % on the anhydrous basis
               
            
                  P2O5 content
               
               
                  Not less than 61 % and not more than 64 %
               
            
                  
                     Description
                  
               
               
                  White crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium and for phosphate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acid-insoluble matter
               
               
                  Not more than 0,4 %
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 451 (i) PENTASODIUM TRIPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Pentasodium tripolyphosphate
               
            
                  Sodium tripolyphosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Pentasodium triphosphate
               
            
                  Einecs
               
               
                  231-838-7
               
            
                  Chemical formula
               
               
                  Na5O10P3 · nH2O (n = 0 or 6)
               
            
                  Molecular weight
               
               
                  367,86
               
            
                  Assay
               
               
                  Content not less than 85,0 % (anhydrous) or 65,0 % (hexahydrate)
               
            
                  P2O5 content
               
               
                  Not less than 56 % and not more than 59 % (anhydrous) or not less than 43 % and not more than 45 % (hexahydrate)
               
            
                  
                     Description
                  
               
               
                  White, slightly hygroscopic granules or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 9,1 and 10,2
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Anhydrous: Not more than 0,7 % (105 oC, one hour)
               
            
                  Hexahydrate: Not more than 23,5 % (60 oC, one hour, followed by drying at 105 oC, four hours)
               
            
                  Water-insoluble substances
               
               
                  Not more than 0,1 %
               
            
                  Higher polyphosphates
               
               
                  Not more than 1 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Pentapotassium tripolyphosphate
               
            
                  Potassium triphosphate
               
            
                  Potassium tripolyphosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Pentapotassium triphosphate
               
            
                  Pentapotassium tripolyphosphate
               
            
                  Einecs
               
               
                  237-574-9
               
            
                  Chemical formula
               
               
                  K5O10P3
                  
               
            
                  Molecular weight
               
               
                  448,42
               
            
                  Assay
               
               
                  Content not less than 85 % on the anhydrous basis
               
            
                  P2O5 content
               
               
                  Not less than 46,5 % and not more than 48 %
               
            
                  
                     Description
                  
               
               
                  White, very hygroscopic powder or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water
               
            
                  
                              B.
                           
                           
                              Positive tests for potassium and for phosphate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 9,2 and 10,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 0,4 % (after drying at 105 oC, four hours, followed by ignition at 550 oC, 30 minutes)
               
            
                  Water-insoluble matter
               
               
                  Not more than 2 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 452 (i) SODIUM POLYPHOSPHATE
      1.   SOLUBLE POLYPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Sodium hexametaphosphate
               
            
                  Sodium tetrapolyphosphate
               
            
                  Graham's salt
               
            
                  Sodium polyphosphates, glassy
               
            
                  Sodium polymetaphosphate
               
            
                  Sodium metaphosphate
               
            
                  
                     Definition
                  
               
               
                  Soluble sodium polyphosphates are obtained by fusion and subsequent chilling of sodium orthophosphates. These compounds are a class consisting of several amorphous, water-soluble polyphosphates composed of linear chains of metaphosphate units, (NaPO3)x where x ≥ 2, terminated by Na2PO4 groups. These substances are usually identified by their Na2O/P2O5 ratio or their P2O5 content. The Na2O/P2O5 ratios vary from about 1,3 for sodium tetrapolyphosphate, where x = approximately 4; to about 1,1 for Graham's salt, commonly called sodium hexametaphosphate, where x = 13 to 18; and to about 1,0 for the higher molecular weight sodium polyphosphates, where x = 20 to 100 or more. The pH of their solutions varies from 3,0 to 9,0
               
            
                  Chemical name
               
               
                  Sodium polyphosphate
               
            
                  Einecs
               
               
                  272-808-3
               
            
                  Chemical formula
               
               
                  Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2
               
            
                  Molecular weight
               
               
                  (102)n
                  
               
            
                  Assay P2O5 content
               
               
                  Not less than 60 % and not more than 71 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Colourless or white, transparent platelets, granules, or powders
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water
               
            
                  
                              B.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 3,0 and 9,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 1 %
               
            
                  Water-insoluble matter
               
               
                  Not more than 0,1 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            2.   INSOLUBLE POLYPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Insoluble sodium metaphosphate
               
            
                  Maddrell's salt
               
            
                  Insoluble sodium polyphosphate, IMP
               
            
                  
                     Definition
                  
               
               
                  Insoluble sodium metaphosphate is a high molecular weight sodium polyphosphate composed of two long metaphosphate chains (NaPO3)x that spiral in opposite directions about a common axis. The Na2O/P2O5 ratio is about 1,0. The pH of 1 in 3 suspension in water is about 6,5
               
            
                  Chemical name
               
               
                  Sodium polyphosphate
               
            
                  Einecs
               
               
                  272-808-3
               
            
                  Chemical formula
               
               
                  Heterogenous mixtures of sodium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2
               
            
                  Molecular weight
               
               
                  (102)n
                  
               
            
                  P2O5 content
               
               
                  Not less than 68,7 % and not more than 70,0 %
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides
               
            
                  
                              B.
                           
                           
                              Positive tests for sodium and for phosphate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of 1 in 3 suspension in water
                           
                        
               
                  About 6,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 452 (ii) POTASSIUM POLYPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Potassium metaphosphate
               
            
                  Potassium polymetaphosphate
               
            
                  Kurrol salt
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium polyphosphate
               
            
                  Einecs
               
               
                  232-212-6
               
            
                  Chemical formula
               
               
                  (KPO3)n
               
            
                  Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of general formula H(n + 2)PnO(3n + 1) where ‘n’ is not less than 2
               
            
                  Molecular weight
               
               
                  (118)n
                  
               
            
                  P2O5 content
               
               
                  Not less than 53,5 % and not more than 61,5 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Fine white powder or crystals or colourless glassy platelets
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate
               
            
                  
                              B.
                           
                           
                              Positive tests for potassium and for phosphate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 1 % suspension
                           
                        
               
                  Not more than 7,8
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 2 % (105 oC, four hours followed by ignition at 550 oC, 30 minutes)
               
            
                  Cyclic phosphate
               
               
                  Not more than 8 % on P2O5 content
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 452(iii) SODIUM CALCIUM POLYPHOSPHATE
      
                  
                     Synonym
                  
               
               
                  Sodium calcium polyphosphate, glassy
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium calcium polyphosphate
               
            
                  Einecs
               
               
                  233-782-9
               
            
                  Chemical formula
               
               
                  (NaPO3)n CaO where n is typically 5
               
            
                  Assay
               
               
                  Not less than 61 % and not more than 69 % as P2O5
                  
               
            
                  
                     Description
                  
               
               
                  White glassy crystals, spheres
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              pH of a 1 % m/m slurry
                           
                        
               
                  Approximately 5 to 7
               
            
                  
                              B.
                           
                           
                              CaO content
                           
                        
               
                  7 %-15 % m/m
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 452 (iv) CALCIUM POLYPHOSPHATE
      
                  
                     Synonyms
                  
               
               
                  Calcium metaphosphate
               
            
                  Calcium polymetaphosphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium polyphosphate
               
            
                  Einecs
               
               
                  236-769-6
               
            
                  Chemical formula
               
               
                  (CaP2O6)n
               
            
                  Heterogenous mixtures of calcium salts of condensed polyphosphoric acids of general formula H(n + 2)PnO(n + 1) where ‘n’ is not less than 2
               
            
                  Molecular weight
               
               
                  (198)n
                  
               
            
                  P2O5 content
               
               
                  Not less than 71 % and not more than 73 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless crystals or white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Usually sparingly soluble in water. Soluble in acid medium
               
            
                  
                              B.
                           
                           
                              Positive tests for calcium and for phosphate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              CaO content
                           
                        
               
                  27 to 29,5 %
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 2 % (105 oC, four hours followed by ignition at 550 oC, 30 minutes)
               
            
                  Cyclic phosphate
               
               
                  Not more than 8 % on P2O5 content
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 459 BETA-CYCLODEXTRIN
      
                  
                     Definition
                  
               
               
                  Beta-cyclodextrin is a non-reducing cyclic saccharide consisting of seven α-1,4-linked D-glucopyranosyl units. The product is manufactured by the action of the enzyme cycloglycosyltransferase (CGTase) obtained from Bacillus circulans, Paenibacillus macerans or recombinant Bacillus licheniformis strain SJ1608 on partially hydrolysed starch
               
            
                  Chemical name
               
               
                  Cycloheptaamylose
               
            
                  Einecs
               
               
                  231-493-2
               
            
                  Chemical formula
               
               
                  (C6H10O5)7
                  
               
            
                  Molecular weight
               
               
                  1 135
               
            
                  Assay
               
               
                  Content not less than 98,0 % of (C6H10O5)7 on an anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Virtually odourless white or almost white crystalline solid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Specific rotation
                           
                        
               
                  [α]25
                     D: + 160o to + 164o (1 % solution)
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 14 % (Karl Fischer method)
               
            
                  Other cyclodextrins
               
               
                  Not more than 2 % on an anhydrous basis
               
            
                  Residual solvents (toluene and trichloroethylene)
               
               
                  Not more than 1 mg/kg for each solvent
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            E 460 (i) MICROCRISTALLINE CELLULOSE
      
                  
                     Synonyms
                  
               
               
                  Cellulose gel
               
            
                  
                     Definition
                  
               
               
                  Microcrystalline cellulose is purified, partally depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from natural strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400
               
            
                  Chemical name
               
               
                  Cellulose
               
            
                  Einecs
               
               
                  232-674-9
               
            
                  Chemical formula
               
               
                  (C6H10O5)n
                  
               
            
                  Molecular weight
               
               
                  About 36 000
               
            
                  Assay
               
               
                  Not less than 97 % calculated as cellulose on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A fine white or almost white odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
               
            
                  
                              B.
                           
                           
                              Colour reaction
                           
                        
               
                  To 1 mg of the sample, add 1 ml of phosphoric acid and heat on a water bath for 30 minutes. Add 4 ml of a 1 in 4 solution of pyrocatechol in phosphoric acid and heat for 30 minutes. A red colour is produced
               
            
                  
                              C.
                           
                           
                              To be identified by IR spectroscopy
                           
                        
               
                   
               
            
                  
                              D.
                           
                           
                              Suspension test
                           
                        
               
                  Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-following suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settles and a supernatant liquid appears
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 7 % (105 oC, 3 hours)
               
            
                  Water-soluble matter
               
               
                  Not more than 0,24 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  pH of a 10 % suspension in water
               
               
                  The pH of the supernatant liquid is between 5,0 and 7,5
               
            
                  Starch
               
               
                  Not detectable
               
            
                  To 20 ml of the dispersion obtained in identification, test D, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
               
            
                  Particle size
               
               
                  Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
               
            
                  Carboxyl groups
               
               
                  Not more than 1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 460 (ii) POWDERED CELLULOSE
      
                  
                     Definition
                  
               
               
                  Purified, mechanically disintegrated celluslose prepared by processing alpha-cellulose obtained as a pulp from natural strains of fibrous plant materials
               
            
                  Chemical name
               
               
                  Cellulose
               
            
                  Linear polymer of 1:4 linked glucose residues
               
            
                  Einecs
               
               
                  232-674-9
               
            
                  Chemical formula
               
               
                  (C6H10O5)n
                  
               
            
                  Molecular weight
               
               
                  (162)n (n is predominantly 1 000 and greater)
               
            
                  Assay
               
               
                  Content not less than 92 %
               
            
                  
                     Description
                  
               
               
                  A white, odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
               
            
                  
                              B.
                           
                           
                              Suspension test
                           
                        
               
                  Mix 30 g of the sample with 270 ml of water in a high-speed (12 000 rpm) power blender for 5 minutes. The resultant mixture will be either a free-flowing suspension or a heavy, lumpy suspension which flows poorly, if at all, settles only slightly and contains many trapped air bubbles. If a free-flowing suspension is obtained, transfer 100 ml into a 100-ml graduated cylinder and allow to stand for 1 hour. The solids settle and a supernatant liquid appears
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 7 % (105 oC, 3 hours)
               
            
                  Water-soluble matter
               
               
                  Not more than 1,0 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,3 % determined at 800 ± 25 oC
               
            
                  pH of a 10 % suspension in water
               
               
                  The pH of the supernatant liquid is between 5,0 and 7,5
               
            
                  Starch
               
               
                  Not detectable
               
            
                  To 20 ml of the dispersion obtained in identification, test B, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Particle size
               
               
                  Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
               
            E 461 METHYL CELLULOSE
      
                  
                     Synonyms
                  
               
               
                  Cellulose methyl ether
               
            
                  
                     Definition
                  
               
               
                  Methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups
               
            
                  Chemical name
               
               
                  Methyl ether of cellulose
               
            
                  Chemical formula
               
               
                  The polymers contain substituted anhydroglucose units with the following general formula:
               
            
                  C6H7O2(OR1)(OR2)(OR3) where R1, R2, R3 each may be one of the following:
                  
                              —
                           
                           
                              H
                           
                        
                              —
                           
                           
                              CH3
                              
                           
                        
                              —
                           
                           
                              or CH2CH3
                              
                           
                        
            
                  Molecular weight
               
               
                  From about 20 000 to 380 000
               
            
                  Assay
               
               
                  Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and not more than 5 % of hydroxyethoxyl groups (-OCH2CH2OH)
               
            
                  
                     Description
                  
               
               
                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution.
               
            
                  Insoluble in ethanol, ether and chloroform.
               
            
                  Soluble in glacial acetic acid
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 oC, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 1,5 % determined at 800 ± 25 oC
               
            
                  pH of a 1 % colloidal solution
               
               
                  Not less than 5,0 and not more than 8,0
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 462 ETHYL CELLULOSE
      
                  
                     Synonyms
                  
               
               
                  Cellulose ethyl ether
               
            
                  
                     Definition
                  
               
               
                  Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups
               
            
                  Chemical name
               
               
                  Ethyl ether of cellulose
               
            
                  Chemical formula
               
               
                  The polymers contain substituted anhydroglucose units with the following general formula:
               
            
                  C6H7O2(OR1)(OR2) where R1 and R2 may be any of the following:
                  
                              —
                           
                           
                              H
                           
                        
                              —
                           
                           
                              CH2CH3
                              
                           
                        
            
                  Assay
               
               
                  Content not less than 44 % and not more than 50 % of ethoxyl groups (-OC2H5) on the dried basis (equivalent to not more than 2,6 ethoxyl groups per anhydroglucose unit)
               
            
                  
                     Description
                  
               
               
                  Slightly hygroscopic white to off-white, odourless and tasteless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Practically insoluble in water, in glycerol and in propane-1,2-diol but soluble in varying proportions in certain organic solvents depending upon the ethoxyl content. Ethyl cellulose containing less than 46 to 48 % of ethoxyl groups is freely soluble in tetrahydrofuran, in methyl acetate, in chloroform and in aromatic hydrocarbon ethanol mixtures. Ethyl cellulose containing 46 to 48 % or more of ethoxyl groups is freely soluble in ethanol, in methanol, in toluene, in chloroform and in ethyl acetate
               
            
                  
                              B.
                           
                           
                              Film forming test
                           
                        
               
                  Dissolve 5 g of the sample in 95 g of an 80:20 (w/w) mixture of toluene ethanol. A clear, stable, slightly yellow solution is formed. Pour a few ml of the solution onto a glass plate and allow the solvent to evaporate. A thick, tough, continuous, clear film remains. The film is flammable
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 3 % (105 oC, 2 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,4 %
               
            
                  pH of a 1 % colloidal solution
               
               
                  Neutral to litmus
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            E 463 HYDROXYPROPYL CELLULOSE
      
                  
                     Synonyms
                  
               
               
                  Cellulose hydroxypropyl ether
               
            
                  
                     Definition
                  
               
               
                  Hydroxypropylcellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with hydroxypropyl groups
               
            
                  Chemical name
               
               
                  Hydroxypropyl ether of cellulose
               
            
                  Chemical formula
               
               
                  The polymers contain substituted anhydroglucose units with the following general formula:
               
            
                  C6H7O2(OR1)(OR2)(OR3), where R1, R2, R3 each may be one of the following:
                  
                              —
                           
                           
                              H
                           
                        
                              —
                           
                           
                              CH2CHOHCH3
                              
                           
                        
                              —
                           
                           
                              CH2CHO(CH2CHOHCH3)CH3
                              
                           
                        
                              —
                           
                           
                              CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3
                              
                           
                        
            
                  Molecular weight
               
               
                  From about 30 000 to 1 000 000
               
            
                  Assay
               
               
                  Content not less than 80,5 % of hydroxypropoxyl groups (-OCH2CHOHCH3) equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
               
            
                  
                              B.
                           
                           
                              Gas chromatography
                           
                        
               
                  Determine the substituents by gas chromotography
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 oC, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  pH of a 1 % colloidal solution
               
               
                  Not less than 5,0 and not more than 8,0
               
            
                  Propylene chlorohydrins
               
               
                  Not more than 0,1 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 464 HYDROXYPROPYL METHYL CELLULOSE
      
                  
                     Definition
                  
               
               
                  Hydroxypropyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution
               
            
                  Chemical name
               
               
                  2-Hydroxypropyl ether of methylcellulose
               
            
                  Chemical formula
               
               
                  The polymers contain substituted anhydroglucose units with the following general formula:
               
            
                  C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:
                  
                              —
                           
                           
                              H
                           
                        
                              —
                           
                           
                              CH3
                              
                           
                        
                              —
                           
                           
                              CH2CHOHCH3
                              
                           
                        
                              —
                           
                           
                              CH2CHO (CH2CHOHCH3) CH3
                              
                           
                        
                              —
                           
                           
                              CH2CHO[CH2CHO (CH2CHOHCH3) CH3]CH3
                              
                           
                        
            
                  Molecular weight
               
               
                  From about 13 000 to 200 000
               
            
                  Assay
               
               
                  Content not less than 19 % and not more than 30 % methoxyl groups (-OCH3) and not less than 3 % and not more than 12 % hydroxypropoxyl groups (-OCH2CHOHCH3), on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Gas chromatography
                           
                        
               
                  Determine the substituents by gas chromatography
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 oC, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 1,5 % for products with viscosities of 50 mPa.s or above
               
            
                  Not more than 3 % for products with viscosities below 50 mPa.s
               
            
                  pH of a 1 % colloidal solution
               
               
                  Not less than 5,0 and not more than 8,0
               
            
                  Propylene chlorohydrins
               
               
                  Not more than 0,1 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 465 ETHYL METHYL CELLULOSE
      
                  
                     Synonyms
                  
               
               
                  Methylethylcellulose
               
            
                  
                     Definition
                  
               
               
                  Ethyl methyl cellulose is cellulose obtained directly from natural strains of fibrous plant material and partially etherified with methyl and ethyl groups
               
            
                  Chemical name
               
               
                  Ethyl methyl ether of cellulose
               
            
                  Chemical formula
               
               
                  The polymers contain substituted anhydroglucose units with the following general formula:
               
            
                  C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:
                  
                              —
                           
                           
                              H
                           
                        
                              —
                           
                           
                              CH3
                              
                           
                        
                              —
                           
                           
                              CH2CH3
                              
                           
                        
            
                  Molecular weight
               
               
                  From about 30 000 to 40 000
               
            
                  Assay
               
               
                  Content on the anhydrous basis not less than 3,5 % and not more than 6,5 % of methoxyl groups (-OCH3) and not less than 14,5 % and not more than 19 % of ethoxyl groups (-OCH2CH3), and not less than 13,2 % and not more than 19,6 % of total alkoxyl groups, calculated as methoxyl
               
            
                  
                     Description
                  
               
               
                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 oC to constant weight)
               
            
                  Sulphated ash
               
               
                  Not more than 0,6 %
               
            
                  pH of a 1 % colloidal solution
               
               
                  Not less than 5,0 and not more than 8,0
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            E 466 SODIUM CARBOXY METHYL CELLULOSE
      
                  
                     Synonyms
                  
               
               
                  Carboxy methyl cellulose
               
            
                  CMC
               
            
                  NaCMC
               
            
                  Sodium CMC
               
            
                  Cellulose gum
               
            
                  
                     Definition
                  
               
               
                  Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from natural strains of fibrous plant material
               
            
                  Chemical name
               
               
                  Sodium salt of the carboxymethyl ether of cellulose
               
            
                  Chemical formula
               
               
                  The polymers contain substituted anhydroglucose units with the following general formula:
               
            
                  C6H7O2(OR1)(OR2)(OR3), where R1, R2 R3 each may be one of the following:
                  
                              —
                           
                           
                              H
                           
                        
                              —
                           
                           
                              CH2COONa
                           
                        
                              —
                           
                           
                              CH2COOH
                           
                        
            
                  Molecular weight
               
               
                  Higher than approximately 17 000 (degree of polymerisation approximately 100)
               
            
                  Assay
               
               
                  Content on the anhydrous basis not less than 99,5 %
               
            
                  
                     Description
                  
               
               
                  Slightly hygroscopic white or slightly yellowish or greyish odourless and tasteless, granular or fibrous powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Yields a viscous colloidal solution with water. Insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Foam test
                           
                        
               
                  A 0,1 % solution of the sample is shaken vigorously. No layer of foam appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers)
               
            
                  
                              C.
                           
                           
                              Precipitate formation
                           
                        
               
                  To 5 ml of a 0,5 % solution of the sample, add 5 ml of 5 % solution of copper sulphate or of aluminium sulphate. A precipitate appears. (This test permits the distinction of sodium carboxymethyl cellulose from other cellulose ethers and from gelatine, locust bean gum and tragacanth)
               
            
                  
                              D.
                           
                           
                              Colour reaction
                           
                        
               
                  Add 0,5 g powdered carboxy methyl cellulose sodium to 50 ml of water, while stirring to produce an uniform dispersion. Continue the stirring until a clear solution is produced, and use the solution for the following test:
                  To 1 mg of the sample, diluted with an equal volume of water, in a small test tube, add 5 drops of 1-naphthol solution. Incline the test tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Degree of substitution
               
               
                  Not less than 0,2 and not more than 1,5 carboxymethyl groups (-CH2COOH) per anhydroglucose unit
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 oC to constant weight)
               
            
                  pH of a 1 % colloidal solution
               
               
                  Not less than 5,0 and not more than 8,5
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 20 mg/kg
               
            
                  Total glycolate
               
               
                  Not more than 0,4 %, calculated as sodium glycolate on the anhydrous basis
               
            
                  Sodium
               
               
                  Not more than 12,4 % on the anhydrous basis
               
            E 468 CROSS-LINKED SODIUM CARBOXYMETHYLCELLULOSE
      
                  
                     Synonyms
                  
               
               
                  Cross-linked carboxymethyl cellulose
               
            
                  Cross-linked CMC
               
            
                  Cross-linked sodium CMC
               
            
                  Cross-linked cellulose gum
               
            
                  
                     Definition
                  
               
               
                  Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose
               
            
                  Chemical name
               
               
                  Sodium salt of the cross-linked carboxymethyl ether cellulose
               
            
                  Chemical formula
               
               
                  The polymers containing substituted anhydroglucose units with the general formula:
               
            
                  C6H7O2(OR1)(OR2)(OR3)
               
            
                  where R1, R2 and R3 may be any of the following:
                  
                              —
                           
                           
                              H
                           
                        
                              —
                           
                           
                              CH2COONa
                           
                        
                              —
                           
                           
                              CH2COOH
                           
                        
            
                  
                     Description
                  
               
               
                  Slightly hygroscopic, white to off white, odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  A.
               
               
                  Shake 1 g with 100 ml of a solution containing 4 mg/kg methylene blue and allow to settle. The substance to be examined absorbs the methylene blue and settles as a blue, fibrous mass
               
            
                  B.
               
               
                  Shake 1 g with 50 ml of water. Transfer 1 ml of the mixture to a test tube, add 1 ml water and 0,05 ml of freshly prepared 40 g/l solution of alpha-naphthol in methanol. Incline the test tube and add carefully 2 ml of sulphuric acid down the side so that it forms a lower layer. A reddish-violet colour develops at the interface
               
            
                  C.
               
               
                  It gives the reaction of sodium
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 6 % (105 oC, 3h)
               
            
                  Water solubles
               
               
                  Not more than 10 %
               
            
                  Degree of substitution
               
               
                  Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit
               
            
                  pH of 1 %
               
               
                  Not less than 5,0 and not more than 7,0
               
            
                  Sodium content
               
               
                  Not more than 12,4 % on anhydrous basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE
      
                  
                     Synonyms
                  
               
               
                  Sodium carboxymethyl cellulose, enzymatically hydrolysed
               
            
                  
                     Definition
                  
               
               
                  Enzymatically hydrolysed carboxymethylcellulose is obtained from carboxymethylcellulose by enzymatic digestion with a cellulase produced by Trichoderma longibrachiatum (formerly T. reesei)
               
            
                  Chemical name
               
               
                  Carboxymethyl cellulose, sodium, partially enzymatically hydrolysed
               
            
                  Chemical formula
               
               
                  Sodium salts of polymers containing substituted anhydroglucose units with the general formula:
               
            
                  [C6H7O2(OH)x(OCH2COONa)y]n
                  
               
            
                  where n is the degree of polymerisation
               
            
                  x = 1,50 to 2,80
               
            
                  y = 0,2 to 1,50
               
            
                  x + y = 3,0
               
            
                  (y = degree of substitution)
               
            
                  Formula weight
               
               
                  178,14 where y = 0,20
               
            
                  282,18 where y = 1,50
               
            
                  Macromolecules: Not less than 800 (n about 4)
               
            
                  Assay
               
               
                  Not less than 99,5 %, including mono- and disaccharides, on the dried basis
               
            
                  
                     Description
                  
               
               
                  White or slightly yellowish or greyish, odourless, slightly hygroscopic granular or fibrous powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Foam test
                           
                        
               
                  Vigorously shake a 0,1 % solution of the sample. No layer of foam appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from alginates and natural gums
               
            
                  
                              C.
                           
                           
                              Precipitate formation
                           
                        
               
                  To 5 ml of a 0,5 % solution of the sample add 5 ml of a 5 % solution of copper or aluminium sulphate. A precipitate appears. This test distinguishes sodium carboxymethyl cellulose, whether hydrolysed or not, from other cellulose ethers and from gelatine, carob bean gum and tragacanth gum
               
            
                  
                              D.
                           
                           
                              Colour reaction
                           
                        
               
                  Add 0,5 g of the powdered sample to 50 ml of water, while stirring to produce a uniform dispersion. Continue the stirring until a clear solution is produced. Dilute 1 ml of the solution with 1 ml of water in a small test tube. Add 5 drops of 1-naphthol TS. Incline the tube, and carefully introduce down the side of the tube 2 ml of sulphuric acid so that it forms a lower layer. A red-purple colour develops at the interface
               
            
                  
                              E.
                           
                           
                              Viscosity (60 % solids)
                           
                        
               
                  Not less than 2,500 kgm-1s-1 at 25 oC corresponding to an average molecule weight of 5 000 D
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 oC to constant weight)
               
            
                  Degree of substitution
               
               
                  Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit on the dried basis
               
            
                  pH of a 1 % colloidal solution
               
               
                  Not less than 6,0 and not more than 8,5
               
            
                  Sodium chloride and sodium glycolate
               
               
                  Not more than 0,5 % singly or in combination
               
            
                  Residual enzyme activity
               
               
                  Passes test. No change in viscosity of test solution occurs, which indicates hydrolysis of the sodium carboxymethyl cellulose
               
            
                  Lead
               
               
                  Not more than 3 mg/kg
               
            E 470a SODIUM, POTASSIUM AND CALCIUM SALTS OF FATTY ACIDS
      
                  
                     Definition
                  
               
               
                  Sodium, potassium and calcium salts of fatty acids occurring in food oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
               
            
                  Assay
               
               
                  Content on the anhydrous basis not less than 95 %
               
            
                  
                     Description
                  
               
               
                  White or creamy white light powders, flakes or semi-solids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Sodium and potassium salts: soluble in water and ethanol calcium salts:
               
            
                  insoluble in water, ethanol and ether
               
            
                  
                              B.
                           
                           
                              Positive tests for cations and for fatty acids
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sodium
               
               
                  Not less than 9 % and not more than 14 % expressed as Na2O
               
            
                  Potassium
               
               
                  Not less than 13 % and not more than 21,5 % expressed as K2O
               
            
                  Calcium
               
               
                  Not less than 8,5 % and not more than 13 % expressed as CaO
               
            
                  Unsaponifiable matter
               
               
                  Not more than 2 %
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Free alkali
               
               
                  Not more than 0,1 % expressed as NaOH
               
            
                  Matter insoluble in alcohol
               
               
                  Not more than 0,2 % (sodium and potassium salts only)
               
            E 470b MAGNESIUM SALTS OF FATTY ACIDS
      
                  
                     Definition
                  
               
               
                  Magnesium salts of fatty acids occurring in foods oils and fats, these salts being obtained either from edible fats and oils or from distilled food fatty acids
               
            
                  Assay
               
               
                  Content on the anhydrous basis not less than 95 %
               
            
                  
                     Description
                  
               
               
                  White or creamy-white light powders, flakes or semi-solids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, partially soluble in ethanol and ether
               
            
                  
                              B.
                           
                           
                              Positive tests for magnesium and for fatty acids
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Magnesium
               
               
                  Not less than 6,5 % and not more than 11 % expressed as MgO
               
            
                  Free alkali
               
               
                  Not more than 0,1 % expressed as MgO
               
            
                  Unsaponifiable matter
               
               
                  Not more than 2 %
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 471 MONO- AND DIGLYCERIDES OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Glyceryl monostearate
               
            
                  Glyceryl monopalmitate
               
            
                  Glyceryl monooleate, etc.
               
            
                  Monostearin, monopalmitin, monoolein, etc.
               
            
                  GMS (for glyceryl monostearate)
               
            
                  
                     Definition
                  
               
               
                  Mono- and diglycerides of fatty acids consist of mixtures of glycerol mono-, di- and triesters of fatty acids occurring in food oils and fats. They may contain small amounts of free fatty acids and glycerol
               
            
                  Assay
               
               
                  Content of mono- and diesters: not less than 70 %
               
            
                  
                     Description
                  
               
               
                  The product varies from a pale yellow to pale brown oily liquid to a white or slightly off-white hard waxy solid. The solids may be in the form of flakes, powders or small beads
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Infrared spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyol
               
            
                  
                              B.
                           
                           
                              Positive tests for glycerol and for fatty acids
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, soluble in ethanol and toluene
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  Not more than 2 % (Karl Fischer method)
               
            
                  Acid value
               
               
                  Not more than 6
               
            
                  Free glycerol
               
               
                  Not more than 7 %
               
            
                  Polyglycerols
               
               
                  Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based on total glycerol content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Total glycerol
               
               
                  Not less than 16 % and not more than 33 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 472 a ACETIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Acetic acid esters of mono- and diglycerides
               
            
                  Acetoglycerides
               
            
                  Acetylated mono- and diglycerides
               
            
                  Acetic and fatty acid esters of glycerol
               
            
                  
                     Definition
                  
               
               
                  Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free acetic acid and free glycerides
               
            
                  
                     Description
                  
               
               
                  Clear, mobile liquids to solids, from white to pale yellow in colour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for glycerol, for fatty acids and for acetic acid
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water. Soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acids other than acetic and fatty acids
               
               
                  Not detectable
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Total acetic acid
               
               
                  Not less than 9 % and not more than 32 %
               
            
                  Free fatty acids (and acetic acid)
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  Total glycerol
               
               
                  Not less than 14 % and not more than 31 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 472 b LACTIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Lactic acid esters of mono- and diglycerides
               
            
                  Lactoglycerides
               
            
                  Mono- and diglycerides of fatty acids esterified with lactic acid
               
            
                  
                     Definition
                  
               
               
                  Esters of glycerol with lactic acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free lactic acid and free glycerides
               
            
                  
                     Description
                  
               
               
                  Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow in colour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for glycerol, for fatty acids and for lactic acid
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in cold water but dispersible in hot water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acids other than lactic and fatty acids
               
               
                  Not detectable
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Total lactic acid
               
               
                  Not less than 13 % and not more than 45 %
               
            
                  Free fatty acids (and lactic acid)
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  Total glycerol
               
               
                  Not less than 13 % and not more than 30 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 472 c CITRIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Citrem
               
            
                  Citric acid esters of mono- and diglycerides
               
            
                  Citroglycerides
               
            
                  Mono- and diglycerides of fatty acids esterified with citric acid
               
            
                  
                     Definition
                  
               
               
                  Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They may contain small amounts of free glycerol, free fatty acids, free citric acid and free glycerides. They may be partially or wholly neutralised with sodium hydroxide or with potassium hydroxide
               
            
                  
                     Description
                  
               
               
                  Yellowish or light brown liquids to waxy solids or semi-solids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for glycerol, for fatty acids and for citric acid
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in cold water
               
            
                  Dispersible in hot water
               
            
                  Soluble in oils and fats
               
            
                  Insoluble in cold ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acids other than citric and fatty acids
               
               
                  Not detectable
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  Total glycerol
               
               
                  Not less than 8 % and not more than 33 %
               
            
                  Total citric acid
               
               
                  Not less than 13 % and not more than 50 %
               
            
                  Sulphated ash (determined at 800 ± 25 oC)
               
               
                  Non-neutralised products: not more than 0,5 %
               
            
                  Partially or wholly neutralised products: not more than 10 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however, these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 472 d TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Tartaric acid esters of mono- and diglycerides
               
            
                  Mono- and diglycerides of fatty acids esterified with tartaric acid
               
            
                  
                     Definition
                  
               
               
                  Esters of glycerol with tartaric acid and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric acid and free glycerides
               
            
                  
                     Description
                  
               
               
                  Sticky viscous yellowish liquids to hard yellow waxes
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for glycerol, for fatty acids and for tartaric acid
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acids other than tartaric and fatty acids
               
               
                  Not detectable
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  Total glycerol
               
               
                  Not less than 12 % and not more than 29 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Total tartaric acid
               
               
                  Not less than 15 % and not more than 50 %
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 472 e MONO- AND DIACETYLTARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Diacetyltartaric acid esters of mono- and diglycerides
               
            
                  Mono-and diglycerides of fatty acids esterified with mono- and diacetyltartaric acid
               
            
                  Diacetyltartaric and fatty acid esters of glycerol
               
            
                  
                     Definition
                  
               
               
                  Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric acid) and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and acetic acids and their combinations, and free glycerides. Contains also tartaric and acetic esters of fatty acids
               
            
                  
                     Description
                  
               
               
                  Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acids other than acetic, tartaric and fatty acids
               
               
                  Not detectable
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  Total glycerol
               
               
                  Not less than 11 % and not more than 28 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Total tartaric acid
               
               
                  Not less than 10 % and not more than 40 %
               
            
                  Total acetic acid
               
               
                  Not less than 8 % and not more than 32 %
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 472 f MIXED ACETIC AND TARTARIC ACID ESTERS OF MONO- AND DIGLYCERIDES OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Mono- and diglycerides of fatty acids esterified with acetic acid and tartaric acid
               
            
                  
                     Definition
                  
               
               
                  Esters of glycerol with acetic and tartaric acids and fatty acids occurring in food fats and oils. They may contain small amounts of free glycerol, free fatty acids, free tartaric and ecetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
               
            
                  
                     Description
                  
               
               
                  Sticky liquids to solids, from white to pale-yellow in colour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for glycerol, for fatty acids, for tartaric acid and for acetic acid
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acids other than acetic, tartaric and fatty acids
               
               
                  Not detectable
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  Total glycerol
               
               
                  Not less than 12 % and not more than 27 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Total acetic acid
               
               
                  Not less than 10 % and not more than 20 %
               
            
                  Total tartaric acid
               
               
                  Not less than 20 % and not more than 40 %
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 473 SUCROSE ESTERS OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Sucroesters
               
            
                  Sugar esters
               
            
                  
                     Definition
                  
               
               
                  Essentially the mono-, di- and triesters of sucrose with fatty acids occurring in food fats and oils. They may be prepared from sucrose and the methyl and ethyl esters of food fatty acids or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propane-2-ol, 2-methyl-1-propanol, propylene glycol and methyl ethyl ketone may be used for their preparation
               
            
                  Assay
               
               
                  Content not less than 80 %
               
            
                  
                     Description
                  
               
               
                  Stiff gels, soft solids or white to slightly greyish-white powders
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sugar for fatty acids
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Sparingly soluble in water
               
            
                  Soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 2 % determined at 800 ± 25 oC
               
            
                  Free sugar
               
               
                  Not more than 5 %
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Methanol
               
               
                  Not more than 10 mg/kg
               
            
                  Dimethylsulphoxide
               
               
                  Not more than 2 mg/kg
               
            
                  Dimethylformamide
               
               
                  Not more than 1 mg/kg
               
            
                  2-methyl-1-propanol
               
               
                  Not more than 10 mg/kg
               
            
                  Ethylacetate
               
               
                   
               
               
                  Not more than 350 mg/kg, singly or in combination
               
            
                  Propane-2-ol
               
            
                  Prolyleneglycol
               
            
                  Methyl ethyl ketone
               
               
                  Not more than 10 mg/kg
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 474 SUCROGLYCERIDES
      
                  
                     Synonyms
                  
               
               
                  Sugar glycerides
               
            
                  
                     Definition
                  
               
               
                  Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used in their preparation other than cyclohexane, dimethylformamide, ethyl acetate, 2-methyl-1-propanol and propane-2-ol
               
            
                  Assay
               
               
                  Content not less than 40 % and not more than 60 % of sucrose fatty acid esters
               
            
                  
                     Description
                  
               
               
                  Soft solid masses, stiff gels or white to off-white powders
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sugar and for fatty acids
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in cold water
               
            
                  Soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 2 % determined at 800 ± 25 oC
               
            
                  Free sugar
               
               
                  Not more than 5 %
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Methanol
               
               
                  Not more than 10 mg/kg
               
            
                  Dimethylformamide
               
               
                  Not more than 1 mg/kg
               
            
                  2-methyl-1-propanol
               
               
                   
               
               
                  Not more than 10 mg/kg, single or in combination
               
            
                  Cyclohexane
               
            
                  Ethylacetate
               
               
                   
               
               
                  Not more than 350 mg/kg, single or in combination
               
            
                  Propane-2-ol
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 475 POLYGLYCEROL ESTERS OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Polyglycerol fatty acid esters
               
            
                  Polyglycerin esters of fatty acid esters
               
            
                  
                     Definition
                  
               
               
                  Polyglycerol esters of fatty acids are produced by the esterification of polyglycerol with food fats and oils or with fatty acids occurring in foods fats and oils. The polyglycerol moiety is predominantly di-, tri- and tetraglycerol and contains not more than 10 % of polyglycerols equal to or higher than heptaglycerol
               
            
                  Assay
               
               
                  Content of total fatty acid ester not less than 90 %
               
            
                  
                     Description
                  
               
               
                  Light yellow to amber, oily to very viscous liquids; light tan to medium brown, plastic or soft solids; and light tan to brown, hard, waxy solids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for glycerol, for polyglycerols and for fatty acids
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  The esters range from very hydrophilic to very lipophilic, but as a class tend to be dispersible in water and soluble in organic solvents and oils
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  Acids other than fatty acids
               
               
                  Not detectable
               
            
                  Free fatty acids
               
               
                  Not more than 6 % estimated as oleic acid
               
            
                  Total glycerol and polyglycerol
               
               
                  Not less than 18 % and not more than 60 %
               
            
                  Free glycerol and polyglycerol
               
               
                  Not more than 7 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 476 POLYGLYCEROL POLYRICINOLEATE
      
                  
                     Synonyms
                  
               
               
                  Glycerol esters of condensed castor oil fatty acids
               
            
                  Polyglycerol esters of polycondensed fatty acids from castor oil
               
            
                  Polyglycerol esters of interesterified ricinoleic acid
               
            
                  PGPR
               
            
                  
                     Definition
                  
               
               
                  Polyglycerol polyricinoleate is prepared by the esterification of polyglycerol with condensed castor oil fatty acids
               
            
                  
                     Description
                  
               
               
                  Clear, highly viscous liquid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water and in ethanol.
               
            
                  Soluble in ether, hydrocarbons and halogenated hydrocarbons
               
            
                  
                              B.
                           
                           
                              Positive tests for glycerol, polyglycerol and for ricinoleic acid
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Refractive index [n]65
                              
                           
                        
               
                  Between 1,4630 and 1,4665
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Polyglycerols
               
               
                  The polyglycerol moiety shall be composed of not less than 75 % of di-, tri- and tetraglycerols and shall contain not more than 10 % of polyglycerols equal to or higher than heptaglycerol
               
            
                  Hydroxyl value
               
               
                  Not less than 80 and not more than 100
               
            
                  Acid value
               
               
                  Not more than 6
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 477 PROPANE-1,2-DIOL ESTERS OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  Propylene glycol esters of fatty acids
               
            
                  
                     Definition
                  
               
               
                  Consists of mixtures of propane-1,2-diol mono- and diesters of fatty acids occurring in food fats and oils. The alcohol moiety is exclusively propane-1,2-diol together with dimer and traces of trimer. Organic acids other than food fatty acids are absent
               
            
                  Assay
               
               
                  Content of total fatty acid ester not less than 85 %
               
            
                  
                     Description
                  
               
               
                  Clear liquids or waxy white flakes, beads or solids having a bland odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for propylene glycol and for fatty acids
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  Acids other than fatty acids
               
               
                  Not detectable
               
            
                  Free fatty acids
               
               
                  Not more than 6 % estimated as oleic acid
               
            
                  Total propane-1,2-diol
               
               
                  Not less than 11 % and not more than 31 %
               
            
                  Free propane-1,2-diol
               
               
                  Not more than 5 %
               
            
                  Dimer and trimer of propylene glycol
               
               
                  Not more than 0,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  
                              
                                 Note:
                              
                           
                           
                              Purity criteria apply to the additive free of sodium, potassium and calcium salts of fatty acids, however these substances may be present up to a maximum level of 6 % (expressed as sodium oleate).
                           
                        
            E 479 b THERMALLY OXIDISED SOYA BEAN OIL INTERACTED WITH MONO- AND DIGLYCERIDES OF FATTY ACIDS
      
                  
                     Synonyms
                  
               
               
                  TOSOM
               
            
                  
                     Definition
                  
               
               
                  Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty acids from thermally oxidised soya bean oil. It is produced by interaction and desodorisation under vacuum at 130 oC of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from natural strains of soya beans
               
            
                  
                     Description
                  
               
               
                  Pale yellow to light brown a waxy or solid consistency
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water. Soluble in hot oil or fat
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Melting range
               
               
                  55-65 oC
               
            
                  Free fatty acids
               
               
                  Not more than 1,5 % estimated as oleic acid
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  Total fatty acids
               
               
                  83-90 %
               
            
                  Total glycerol
               
               
                  16-22 %
               
            
                  Fatty acid methyl esters, not forming adduct with urea
               
               
                  Not more than 9 % of total fatty acid methyl esters
               
            
                  Fatty acids, insoluble in petroleum ether
               
               
                  Not more than 2 % of total fatty acids
               
            
                  Peroxide value
               
               
                  Not more than 3
               
            
                  Epoxides
               
               
                  Not more than 0,03 % oxirane oxygen
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 481 SODIUM STEAROYL-2-LACTYLATE
      
                  
                     Synonyms
                  
               
               
                  Sodium stearoyl lactylate
               
            
                  Sodium stearoyl lactate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the sodium salts of stearoyl lactylic acids and its polymers and minor amounts of sodium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
               
            
                  Chemical names
               
               
                  Sodium di-2-stearoyl lactate
               
            
                  Sodium di(2-stearoyloxy)propionate
               
            
                  Einecs
               
               
                  246-929-7
               
            
                  Chemical formula (major components)
               
               
                  C21H39O4Na
               
            
                  C19H35O4Na
               
            
                  
                     Description
                  
               
               
                  White or slightly yellowish powder or brittle solid with a characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium, for fatty acids and for lactic acid
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water. Soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sodium
               
               
                  Not less than 2,5 % and not more than 5 %
               
            
                  Ester value
               
               
                  Not less than 90 and not more than 190
               
            
                  Acid value
               
               
                  Not less than 60 and not more than 130
               
            
                  Total lactic acid
               
               
                  Not less than 15 % and not more than 40 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 482 CALCIUM STEAROYL-2-LACTYLATE
      
                  
                     Synonyms
                  
               
               
                  Calcium stearoyl lactate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the calcium salts of stearoyl lactylic acids and its polymers and minor amounts of calcium salts of other related acids, manufactured by the reaction of stearic acid and lactic acid. Other food fatty acids may also be present, free or esterified, due to their presence in the stearic acid used
               
            
                  Chemical name
               
               
                  Calcium di-2-stearoyl lactate
               
            
                  Calcium di(2-stearoyloxy)propionate
               
            
                  Einecs
               
               
                  227-335-7
               
            
                  Chemical formula
               
               
                  C42H78O8Ca
               
            
                  C38H70O8Ca
               
            
                  
                     Description
                  
               
               
                  White or slightly yellowish powder or brittle solid with a characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium, for fatty acids and for lactid acid
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Slightly soluble in hot water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Calcium
               
               
                  Not less than 1 % and not more than 5,2 %
               
            
                  Ester value
               
               
                  Not less than 125 and not more than 190
               
            
                  Total lactic acid
               
               
                  Not less than 15 % and not more than 40 %
               
            
                  Acid value
               
               
                  Not less than 50 and not more than 130
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 483 STEARYL TARTRATE
      
                  
                     Synonyms
                  
               
               
                  Stearyl palmityl tartrate
               
            
                  
                     Definition
                  
               
               
                  Product of the esterification of tartaric acid with commercial stearyl alcohol, which consists essentially of stearyl and palmityl alcohols. It consists mainly of diester, with minor amounts of monoester and of unchanged starting materials
               
            
                  Chemical name
               
               
                  Distearyl tartrate
               
            
                  Dipalmityl tartrate
               
            
                  Chemical formula
               
               
                  C38H74O6 to C40H78O6
                  
               
            
                  Molecular weight
               
               
                  627 to 655
               
            
                  Assay
               
               
                  Content of total ester not less than 90 % corresponding to an ester value of not less than 163 and not more than 180
               
            
                  
                     Description
                  
               
               
                  Cream-coloured unctuous solid (at 25 oC)
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for tartare
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 67 oC and 77 oC. After saponification the saturated long chain fatty alcohols have a melting range of 49 oC to 55 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Hydroxyl value
               
               
                  Not less than 200 and not more than 220
               
            
                  Acid value
               
               
                  Not more than 5,6
               
            
                  Total tartaric acid content
               
               
                  Not less than 18 % and not more than 35 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 oC
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Unsaponifiable matter
               
               
                  Not less than 77 % and not more than 83 %
               
            
                  Iodine value
               
               
                  Not more than 4 (Wijs method)
               
            E 491 SORBITAN MONOSTEARATE
      
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
               
            
                  Einecs
               
               
                  215-664-9
               
            
                  Assay
               
               
                  Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
               
            
                  
                     Description
                  
               
               
                  Light, cream- to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble at temperatures above its melting point in toluene, dioxane, carbon tetrachloride, ether, methanol, ethanol and aniline; insoluble in petroleum ether and acetone; insoluble in cold water but dispersible in warm water; soluble with haze at temperatures above 50 oC in mineral oil and ethyl acetate
               
            
                  
                              B.
                           
                           
                              Congealing range
                           
                        
               
                  50-52 oC
               
            
                  
                              C.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 2 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 %
               
            
                  Acid value
               
               
                  Not more than 10
               
            
                  Saponification value
               
               
                  Not less than 147 and not more than 157
               
            
                  Hydroxyl value
               
               
                  Not less than 235 and not more than 260
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 492 SORBITAN TRISTEARATE
      
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
               
            
                  Einecs
               
               
                  247-891-4
               
            
                  Assay
               
               
                  Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
               
            
                  
                     Description
                  
               
               
                  Light, cream- to tan-coloured beads or flakes or hard, waxy solid with a slight odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in petroleum ether, mineral oil, vegetable oils, acetone and dioxane; insoluble in water, methanol and ethanol
               
            
                  
                              B.
                           
                           
                              Congealing range
                           
                        
               
                  47-50 oC
               
            
                  
                              C.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 2 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 %
               
            
                  Acid value
               
               
                  Not more than 15
               
            
                  Saponification value
               
               
                  Not less than 176 and not more than 188
               
            
                  Hydroxyl value
               
               
                  Not less than 66 and not more than 80
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 493 SORBITAN MONOLAURATE
      
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid
               
            
                  Einecs
               
               
                  215-663-3
               
            
                  Assay
               
               
                  Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
               
            
                  
                     Description
                  
               
               
                  Amber-coloured oily viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Dispersible in hot and cold water
               
            
                  
                              B.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of a polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 2 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 %
               
            
                  Acid value
               
               
                  Not more than 7
               
            
                  Saponification value
               
               
                  Not less than 155 and not more than 170
               
            
                  Hydroxyl value
               
               
                  Not less than 330 and not more than 358
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 494 SORBITAN MONOOLEATE
      
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial oleic acid. Major constituent is 1,4-sorbitan monooleate. Other constituents include isosorbide monooleate, sorbitan dioleate and sorbitan trioleate
               
            
                  Einecs
               
               
                  215-665-4
               
            
                  Assay
               
               
                  Content not less than 95 % of a mixture of sorbitol, sorbitan and isosorbide esters
               
            
                  
                     Description
                  
               
               
                  Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water, dispersible in warm water
               
            
                  
                              B.
                           
                           
                              Iodine value
                           
                        
               
                  The residue of oleic acid, obtained from the saponification of the sorbitan monoleate in assay, has a iodine value between 80 and 100
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 2 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 %
               
            
                  Acid value
               
               
                  Not more than 8
               
            
                  Saponification value
               
               
                  Not less than 145 and not more than 160
               
            
                  Hydroxyl value
               
               
                  Not less than 193 and not more than 210
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 495 SORBITAN MONOPALMITATE
      
                  
                     Synonyms
                  
               
               
                  Sorbitan palmitate
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial palmitic acid
               
            
                  Einecs
               
               
                  247-568-8
               
            
                  Assay
               
               
                  Content not less than 95 % of a mixture of sorbitol, sorbitan, and isosorbide esters
               
            
                  
                     Description
                  
               
               
                  Light cream to tan-coloured beads or flakes or a hard, waxy solid with a slight characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble at temperatures above its melting point in ethanol, methanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble in cold water but dispersible in warm water
               
            
                  
                              B.
                           
                           
                              Congealing range
                           
                        
               
                  45-47 oC
               
            
                  
                              C.
                           
                           
                              Infrared absorption spectrum
                           
                        
               
                  Characteristic of a partial fatty acid ester of polyol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 2 % (Karl Fischer method)
               
            
                  Sulphate ash
               
               
                  Not more than 0,5 %
               
            
                  Acid value
               
               
                  Not more than 7,5
               
            
                  Saponification value
               
               
                  Not less than 140 and not more than 150
               
            
                  Hydroxyl value
               
               
                  Not less than 270 and not more than 305
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 500(i) SODIUM CARBONATE
      
                  
                     Synonyms
                  
               
               
                  Soda ash
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium carbonate
               
            
                  Einecs
               
               
                  207-838-8
               
            
                  Chemical formula
               
               
                  Na2CO3 · nH2O (n = 0, 1 or 10)
               
            
                  Molecular weight
               
               
                  106,00 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 99 % of Na2CO3 on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless crystals or white, granular or crystalline powder
               
            
                  The anhydrous form is hygroscopic, the decahydrate efflorescent
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for carbonate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 oC raising gradually to 300 oC, to constant weight)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 500(ii) SODIUM HYDROGEN CARBONATE
      
                  
                     Synonyms
                  
               
               
                  Sodium bicarbonate, sodium acid carbonate, bicarbonate of soda, baking soda
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium hydrogen carbonate
               
            
                  Einecs
               
               
                  205-633-8
               
            
                  Chemical formula
               
               
                  NaHCO3
                  
               
            
                  Molecular weight
               
               
                  84,01
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless or white crystalline masses or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for carbonate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 1 % solution
                           
                        
               
                  Between 8,0 and 8,6
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % (over silica gel, 4h)
               
            
                  Ammonium salts
               
               
                  No odour of ammonia detectable after heating
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 500(iii) SODIUM SESQUICARBONATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium monohydrogen dicarbonate
               
            
                  Einecs
               
               
                  208-580-9
               
            
                  Chemical formula
               
               
                  Na2(CO)3 · NaHCO3 · 2H2O
               
            
                  Molecular weight
               
               
                  226,03
               
            
                  Assay
               
               
                  Content between 35,0 % and 38,6 % of NaHCO3 and between 46,4 % and 50,0 % of Na2CO3
                  
               
            
                  
                     Description
                  
               
               
                  White flakes, crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for carbonate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sodium chloride
               
               
                  Not more than 0,5 %
               
            
                  Iron
               
               
                  Not more than 20 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 501(i) POTASSIUM CARBONATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium carbonate
               
            
                  Einecs
               
               
                  209-529-3
               
            
                  Chemical formula
               
               
                  K2CO3 · nH2O (n = 0 or 1,5)
               
            
                  Molecular weight
               
               
                  138,21 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 99,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, very deliquescent powder.
               
            
                  The hydrate occurs as small, white, translucent crystals or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for potassium and for carbonate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 5 % (anhydrous) or 18 % (hydrate) (180 oC, 4h)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 501(ii) POTASSIUM HYDROGEN CARBONATE
      
                  
                     Synonyms
                  
               
               
                  Potassium bicarbonate, acid potassium carbonate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium hydrogen carbonate
               
            
                  Einecs
               
               
                  206-059-0
               
            
                  Chemical formula
               
               
                  KHCO3
                  
               
            
                  Molecular weight
               
               
                  100,11
               
            
                  Assay
               
               
                  Content not less than 99,0 % and not more than 101,0 % KHCO3 on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless crystals or white powder or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for potassium and for carbonate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % (over silica gel, 4h)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 503(i) AMMONIUM CARBONATE
      
                  
                     Definition
                  
               
               
                  Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions
               
            
                  Chemical name
               
               
                  Ammonium carbonate
               
            
                  Einecs
               
               
                  233-786-0
               
            
                  Chemical formula
               
               
                  CH6N2O2, CH8N2O3 and CH5NO3
                  
               
            
                  Molecular weight
               
               
                  Ammonium carbamate 78,06; ammonium carbonate 98,73; ammonium hydrogen carbonate 79,06
               
            
                  Assay
               
               
                  Content not less than 30,0 % and not more than 34,0 % of NH3
                  
               
            
                  
                     Description
                  
               
               
                  White powder or hard, white or translucent masses or crystals. Becomes opaque on exposure to air and is finally converted into white porous lumps or powder (of ammonium bicarbonate) due to loss of ammonia and carbon dioxide
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for ammonium and for carbonate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  about 8,6
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Non-volatile matter
               
               
                  Not more than 500 mg/kg
               
            
                  Chlorides
               
               
                  Not more than 30 mg/kg
               
            
                  Sulphate
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 503(ii) AMMONIUM HYDROGEN CARBONATE
      
                  
                     Synonyms
                  
               
               
                  Ammonium bicarbonate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ammonium hydrogen carbonate
               
            
                  Einecs
               
               
                  213-911-5
               
            
                  Chemical formula
               
               
                  CH5NO3
                  
               
            
                  Molecular weight
               
               
                  79,06
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  White crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for ammonium and for carbonate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  about 8,0
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Non-volatile matter
               
               
                  Not more than 500 mg/kg
               
            
                  Chlorides
               
               
                  Not more than 30 mg/kg
               
            
                  Sulphate
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 504(ii) MAGNESIUM HYDROXIDE CARBONATE
      
                  
                     Synonyms
                  
               
               
                  Magnesium hydrogen carbonate, magnesium subcarbonate (light or heavy), hydrated basic magnesium carbonate, magnesium carbonate hydroxide
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Magnesium carbonate hydroxide hydrated
               
            
                  Einecs
               
               
                  235-192-7
               
            
                  Chemical formula
               
               
                  4MgCO3Mg(OH)25H2O
               
            
                  Molecular weight
               
               
                  485
               
            
                  Assay
               
               
                  Mg content not less than 40,0 % and not more than 45,0 % calculated as MgO
               
            
                  
                     Description
                  
               
               
                  Light, white friable mass or bulky white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for magnesium and for carbonate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Practically insoluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acid insoluble matter
               
               
                  Not more than 0,05 %
               
            
                  Water soluble matter
               
               
                  Not more than 1,0 %
               
            
                  Calcium
               
               
                  Not more than 1,0 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 507 HYDROCHLORIC ACID
      
                  
                     Synonyms
                  
               
               
                  Hydrogen chloride, muriatic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Hydrochloric acid
               
            
                  Einecs
               
               
                  231-595-7
               
            
                  Chemical formula
               
               
                  HCl
               
            
                  Molecular weight
               
               
                  36,46
               
            
                  Assay
               
               
                  Hydrochloric acid is commercially available in varying concentrations. Concentrated hydrochloric acid contains not less than 35,0 % HCl
               
            
                  
                     Description
                  
               
               
                  Clear, colourless or slightly yellowish, corrosive liquid having a pungent odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for acid and for chloride
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water and in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Total organic compounds
               
               
                  Total organic compounds (non-fluorine containing): not more than 5 mg/kg
               
            
                  Benzene: not more than 0,05 mg/kg
               
            
                  Fluorinated compounds (total): not more than 25 mg/kg
               
            
                  Non-volatile matter
               
               
                  Not more than 0,5 %
               
            
                  Reducing substances
               
               
                  Not more than 70 mg/kg (as SO2)
               
            
                  Oxidising substances
               
               
                  Not more than 30 mg/kg (as Cl2)
               
            
                  Sulphate
               
               
                  Not more than 0,5 %
               
            
                  Iron
               
               
                  Not more than 5 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 508 POTASSIUM CHLORIDE
      
                  
                     Synonyms
                  
               
               
                  Sylvine
               
            
                  Sylvite
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium chloride
               
            
                  Einecs
               
               
                  231-211-8
               
            
                  Chemical formulae
               
               
                  KCl
               
            
                  Molecular weight
               
               
                  74,56
               
            
                  Assay
               
               
                  Content not less than 99 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  Colourless, elongated, prismatic or cubital crystals or white granular powder. Odourless
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Positive tests for potassium and for chloride
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1 % (105 oC, 2 hours)
               
            
                  Sodium
               
               
                  Negative test
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            E 509 CALCIUM CHLORIDE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium chloride
               
            
                  Einecs
               
               
                  233-140-8
               
            
                  Chemical formula
               
               
                  CaCl2 · nH2O (n = 0,2 or 6)
               
            
                  Molecular weight
               
               
                  110,99 (anhydrous), 147,02 (dihydrate), 219,08 (hexahydrate)
               
            
                  Assay
               
               
                  Content not less than 93,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, odourless, hygroscopic powder or deliquescent crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium and for chloride
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Anhydrous calcium chloride: freely soluble in water and ethanol
               
            
                  Dihydrate: freely soluble in water, soluble in ethanol
               
            
                  Hexahydrate: very soluble in water and ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Magnesium and alkali salts
               
               
                  Not more than 5 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 40 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 511 MAGNESIUM CHLORIDE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Magnesium chloride
               
            
                  Einecs
               
               
                  232-094-6
               
            
                  Chemical formula
               
               
                  MgCl2 · 6H2O
               
            
                  Molecular weight
               
               
                  203,30
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, very deliquescent flakes or crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for magnesium and for chloride
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water, freely soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Ammonium
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 512 STANNOUS CHLORIDE
      
                  
                     Synonyms
                  
               
               
                  Tin chloride, tin dichloride
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Stannous chloride dihydrate
               
            
                  Einecs
               
               
                  231-868-0
               
            
                  Chemical formula
               
               
                  SnCl2 · 2H2O
               
            
                  Molecular weight
               
               
                  225,63
               
            
                  Assay
               
               
                  Content not less than 98,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless or white crystals
               
            
                  May have a slight odour of hydrochloric acid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for tin (II) and for chloride
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Water: soluble in less than its own weight of water, but it forms an insoluble basic salt with excess water
               
            
                  Ethanol: soluble
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphate
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 513 SULPHURIC ACID
      
                  
                     Synonyms
                  
               
               
                  Oil of vitriol, dihydrogen sulphate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sulphuric acid
               
            
                  Einecs
               
               
                  231-639-5
               
            
                  Chemical formula
               
               
                  H2SO4
                  
               
            
                  Molecular weight
               
               
                  98,07
               
            
                  Assay
               
               
                  Sulphuric acid is commercially available in varying concentrations. The concentrated form contains not less than 96,0 %
               
            
                  
                     Description
                  
               
               
                  Clear, colourless or slightly brown, very corrosive oily liquid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for acid and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Miscible with water, with generation of much heat, also with ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Ash
               
               
                  Not more than 0,02 %
               
            
                  Reducing matter
               
               
                  Not more than 40 mg/kg (as SO2)
               
            
                  Nitrate
               
               
                  Not more than 10 mg/kg (on H2SO4 basis)
               
            
                  Chloride
               
               
                  Not more than 50 mg/kg
               
            
                  Iron
               
               
                  Not more than 20 mg/kg
               
            
                  Selenium
               
               
                  Not more than 20 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 514(i) SODIUM SULPHATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium sulphate
               
            
                  Chemical formula
               
               
                  Na2SO4 · nH2O (n = 0 or 10)
               
            
                  Molecular weight
               
               
                  142,04 (anhydrous)
               
            
                  322,04 (decahydrate)
               
            
                  Assay
               
               
                  Content not less than 99,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless crystals or a fine, white, crystalline powder
               
            
                  The decahydrate is efflorescent
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Acidity of a 5 % solution: neutral or slightly alkaline to litmus paper
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % (anhydrous) or not more than 57 % (decahydrate) at 130 °C
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 514(ii) SODIUM HYDROGEN SULPHATE
      
                  
                     Synonyms
                  
               
               
                  Acid sodium sulphate, sodium bisulphate, nitre cake
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium hydrogen sulphate
               
            
                  Chemical formula
               
               
                  NaHSO4
                  
               
            
                  Molecular weight
               
               
                  120,06
               
            
                  Assay
               
               
                  Content not less than 95,2 %
               
            
                  
                     Description
                  
               
               
                  White, odourless crystals or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solutions are strongly acidic
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,8 %
               
            
                  Water insoluble
               
               
                  Not more than 0,05 %
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 515(i) POTASSIUM SULPHATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium sulphate
               
            
                  Chemical formula
               
               
                  K2SO4
                  
               
            
                  Molecular weight
               
               
                  174,25
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless or white crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for potassium and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 5,5 and 8,5
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 515(ii) POTASSIUM HYDROGEN SULPHATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  
                     Synonyms
                  
               
               
                  Potassium bisulphate, potassium acid sulphate
               
            
                  Chemical name
               
               
                  Potassium hydrogen sulphate
               
            
                  Chemical formula
               
               
                  KHSO4
                  
               
            
                  Molecular weight
               
               
                  136,17
               
            
                  Assay
               
               
                  Content not less than 99 %
               
            
                  Melting point
               
               
                  197 oC
               
            
                  
                     Description
                  
               
               
                  White deliquescent crystals, pieces or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 516 CALCIUM SULPHATE
      
                  
                     Synonyms
                  
               
               
                  Gypsum, selenite, anhydrite
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium sulphate
               
            
                  Einecs
               
               
                  231-900-3
               
            
                  Chemical formula
               
               
                  CaSO4 · nH2O (n = 0 or 2)
               
            
                  Molecular weight
               
               
                  136,14 (anhydrous), 172,18 (dihydrate)
               
            
                  Assay
               
               
                  Content not less than 99,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Fine, white to slightly yellowish-white odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Slightly soluble in water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Anhydrous: not more than 1,5 % (250 oC, constant weight)
               
            
                  Dihydrate: not more than 23 % (ibid.)
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 517 AMMONIUM SULPHATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ammonium sulphate
               
            
                  Einecs
               
               
                  231-984-1
               
            
                  Chemical formula
               
               
                  (NH4)2SO4
                  
               
            
                  Molecular weight
               
               
                  132,14
               
            
                  Assay
               
               
                  Content not less than 99,0 % and not more than 100,5 %
               
            
                  
                     Description
                  
               
               
                  White powder, shining plates or crystalline fragments
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for ammonium and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 0,25 %
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 520 ALUMINIUM SULPHATE
      
                  
                     Synonyms
                  
               
               
                  Alum
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Aluminium sulphate
               
            
                  Einecs
               
               
                  233-135-0
               
            
                  Chemical formula
               
               
                  Al2(SO4)3
                  
               
            
                  Molecular weight
               
               
                  342,13
               
            
                  Assay
               
               
                  Content not less than 99,5 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  White powder, shining plates or crystalline fragments
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for aluminium and for sulphate
                           
                        
                              B.
                           
                           
                              pH of a 5 % solution 2,9 or above
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 5 % (500 oC, 3h)
               
            
                  Alkalies and alkaline earths
               
               
                  Not more than 0,4 %
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 521 ALUMINIUM SODIUM SULPHATE
      
                  
                     Synonyms
                  
               
               
                  Soda alum, sodium alum
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Aluminium sodium sulphate
               
            
                  Einecs
               
               
                  233-277-3
               
            
                  Chemical formula
               
               
                  AlNa(SO4)2 · nH2O (n = 0 or 12)
               
            
                  Molecular weight
               
               
                  242,09 (anhydrous)
               
            
                  Assay
               
               
                  Content on the anhydrous basis not less than 96,5 % (anhydrous) and 99,5 % (dodecahydrate)
               
            
                  
                     Description
                  
               
               
                  Transparent crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for aluminium, for sodium and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Dodecahydrate is freely soluble in water. The anhydrous form is slowly soluble in water. Both forms are insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Anhydrous form: not more than 10,0 % (220 oC, 16h)
               
            
                  Dodecahydrate: not more than 47,2 % (50 oC-55 oC, 1h then 200 oC, 16h)
               
            
                  Ammonium salts
               
               
                  No odour of ammonia detectable after heating
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 522 ALUMINIUM POTASSIUM SULPHATE
      
                  
                     Synonyms
                  
               
               
                  Potassium alum, potash alum
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Aluminium potassium sulphate dodecahydrate
               
            
                  Einecs
               
               
                  233-141-3
               
            
                  Chemical formula
               
               
                  AlK(SO4)2 · 12 H2O
               
            
                  Molecular weight
               
               
                  474,38
               
            
                  Assay
               
               
                  Content not less than 99,5 %
               
            
                  
                     Description
                  
               
               
                  Large, transparent crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for aluminium, for potassium and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % solution between 3,0 and 4,0
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Ammonium salts
               
               
                  No odour of ammonia detectable after heating
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 523 ALUMINIUM AMMONIUM SULPHATE
      
                  
                     Synonyms
                  
               
               
                  Ammonium alum
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Aluminium ammonium sulphate
               
            
                  Einecs
               
               
                  232-055-3
               
            
                  Chemical formula
               
               
                  AlNH4(SO4)2 · 12 H2O
               
            
                  Molecular weight
               
               
                  453,32
               
            
                  Assay
               
               
                  Content not less than 99,5 %
               
            
                  
                     Description
                  
               
               
                  Large, colourless crystals or white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for aluminium, for ammonium and for sulphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water, soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Alkali metals and alkaline earths
               
               
                  Not more than 0,5 %
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 524 SODIUM HYDROXIDE
      
                  
                     Synonyms
                  
               
               
                  Caustic soda, lye
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium hydroxide
               
            
                  Einecs
               
               
                  215-185-5
               
            
                  Chemical formula
               
               
                  NaOH
               
            
                  Molecular weight
               
               
                  40,0
               
            
                  Assay
               
               
                  Content of solid forms not less than 98,0 % of total alkali (as NaOH). Content of solutions accordingly, based on the stated or labelled percentage of NaOH
               
            
                  
                     Description
                  
               
               
                  White or nearly white pellets, flakes, sticks, fused masses or other forms. Solutions are clear or slightly turbid, colourless or slightly coloured, strongly caustic and hygroscopic and when exposed to the air they absorb carbon dioxide, forming sodium carbonate
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              A 1 % solution is strongly alkaline
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water. Freely soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water insoluble and organic matter
               
               
                  A 5 % solution is completely clear and colourless to slightly coloured
               
            
                  Carbonate
               
               
                  Not more than 0,5 % (as Na2CO3)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 0,5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 525 POTASSIUM HYDROXIDE
      
                  
                     Synonyms
                  
               
               
                  Caustic potash
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium hydroxide
               
            
                  Einecs
               
               
                  215-181-3
               
            
                  Chemical formula
               
               
                  KOH
               
            
                  Molecular weight
               
               
                  56,11
               
            
                  Assay
               
               
                  Content not less than 85,0 % of alkali calculated as KOH
               
            
                  
                     Description
                  
               
               
                  White or nearly white pellets, flakes, sticks, fused masses or other forms
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              A 1 % solution is strongly alkaline
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water. Freely soluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water insoluble matter
               
               
                  A 5 % solution is completely clear and colourless
               
            
                  Carbonate
               
               
                  Not more than 3,5 % (as K2CO3)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 526 CALCIUM HYDROXIDE
      
                  
                     Synonyms
                  
               
               
                  Slaked lime, hydrated lime
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium hydroxide
               
            
                  Einecs
               
               
                  215-137-3
               
            
                  Chemical formula
               
               
                  Ca(OH)2
                  
               
            
                  Molecular weight
               
               
                  74,09
               
            
                  Assay
               
               
                  Content not less than 92,0 %
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for alkali and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acid insoluble ash
               
               
                  Not more than 1,0 %
               
            
                  Magnesium and alkali salts
               
               
                  Not more than 1,0 %
               
            
                  Barium
               
               
                  Not more than 300 mg/kg
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            E 527 AMMONIUM HYDROXIDE
      
                  
                     Synonyms
                  
               
               
                  Aqua ammonia, strong ammonia solution
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ammonium hydroxide
               
            
                  Chemical formula
               
               
                  NH4OH
               
            
                  Molecular weight
               
               
                  35,05
               
            
                  Assay
               
               
                  Content not less than 27 % of NH3
                  
               
            
                  
                     Description
                  
               
               
                  Clear, colourless solution, having an exceedingly pungent, characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for ammonia
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Non-volatile matter
               
               
                  Not more than 0,02 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 528 MAGNESIUM HYDROXIDE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Magnesium hydroxide
               
            
                  Einecs
               
               
                  215-170-3
               
            
                  Chemical formula
               
               
                  Mg(OH)2
                  
               
            
                  Molecular weight
               
               
                  58,32
               
            
                  Assay
               
               
                  Content not less than 95,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, white bulky powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for magnesium and for alkali
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Practically insoluble in water and in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (105 oC, 2h)
               
            
                  Loss on ignition
               
               
                  Not more than 33 % (800 oC to constant weight)
               
            
                  Calcium oxide
               
               
                  Not more than 1,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            E 529 CALCIUM OXIDE
      
                  
                     Synonyms
                  
               
               
                  Burnt lime
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium oxide
               
            
                  Einecs
               
               
                  215-138-9
               
            
                  Chemical formula
               
               
                  CaO
               
            
                  Molecular weight
               
               
                  56,08
               
            
                  Assay
               
               
                  Content not less than 95,0 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Odourless, hard, white or greyish white masses of granules, or white to greyish powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for alkali and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Heat is generated on moistening the sample with water
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 10,0 % (ca 800 oC to constant weight)
               
            
                  Acid insoluble matter
               
               
                  Not more than 1,0 %
               
            
                  Barium
               
               
                  Not more than 300 mg/kg
               
            
                  Magnesium and alkali salts
               
               
                  Not more than 1,5 %
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            E 530 MAGNESIUM OXIDE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Magnesium oxide
               
            
                  Einecs
               
               
                  215-171-9
               
            
                  Chemical formula
               
               
                  MgO
               
            
                  Molecular weight
               
               
                  40,31
               
            
                  Assay
               
               
                  Content not less than 98,0 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  A very bulky, white powder known as light magnesium oxide or a relative dense, white powder known as heavy magnesium oxide. 5 g of light magnesium oxide occupy a volume of 40 to 50 ml, while 5 g of heavy magnesium oxide occupy a volume of 10 to 20 ml
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for alkali and for magnesium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Practically insoluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not more than 5,0 % (ca 800 oC to constant weight)
               
            
                  Calcium oxide
               
               
                  Not more than 1,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            E 535 SODIUM FERROCYANIDE
      
                  
                     Synonyms
                  
               
               
                  Yellow prussiate of soda, sodium hexacyanoferrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium ferrocyanide
               
            
                  Einecs
               
               
                  237-081-9
               
            
                  Chemical formula
               
               
                  Na4Fe(CN)6 · 10 H2O
               
            
                  Molecular weight
               
               
                  484,1
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Yellow crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for sodium and for ferrocyanide
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Free moisture
               
               
                  Not more than 1,0 %
               
            
                  Water insoluble matter
               
               
                  Not more than 0,03 %
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Sulphate
               
               
                  Not more than 0,1 %
               
            
                  Free cyanide
               
               
                  Not detectable
               
            
                  Ferricyanide
               
               
                  Not detectable
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 536 POTASSIUM FERROCYANIDE
      
                  
                     Synonyms
                  
               
               
                  Yellow prussiate of potash, potassium hexacyanoferrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium ferrocyanide
               
            
                  Einecs
               
               
                  237-722-2
               
            
                  Chemical formula
               
               
                  K4Fe(CN)6· 3 H2O
               
            
                  Molecular weight
               
               
                  422,4
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Lemon yellow crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for potassium and for ferrocyanide
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Free moisture
               
               
                  Not more than 1,0 %
               
            
                  Water insoluble matter
               
               
                  Not more than 0,03 %
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Sulphate
               
               
                  Not more than 0,1 %
               
            
                  Free cyanide
               
               
                  Not detectable
               
            
                  Ferricyanide
               
               
                  Not detectable
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 538 CALCIUM FERROCYANIDE
      
                  
                     Synonyms
                  
               
               
                  Yellow prussiate of lime, calcium hexacyanoferrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium ferrocyanide
               
            
                  Einecs
               
               
                  215-476-7
               
            
                  Chemical formula
               
               
                  Ca2Fe(CN)6 · 12H2O
               
            
                  Molecular weight
               
               
                  508,3
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Yellow crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for calcium and for ferrocyanide
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Free moisture
               
               
                  Not more than 1,0 %
               
            
                  Water insoluble matter
               
               
                  Not more than 0,03 %
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Sulphate
               
               
                  Not more than 0,1 %
               
            
                  Free cyanide
               
               
                  Not detectable
               
            
                  Ferricyanide
               
               
                  Not detectable
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 541 SODIUM ALUMINIUM PHOSPHATE, ACIDIC
      
                  
                     Synonyms
                  
               
               
                  SALP
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A) or
               
            
                  Trisodium dialuminium pentadecahydrogen octaphosphate (B)
               
            
                  Einecs
               
               
                  232-090-4
               
            
                  Chemical formula
               
               
                  NaAl3H14(PO4)8 · 4H2O (A)
               
            
                  Na3Al2H15(PO4)8 (B)
               
            
                  Molecular weight
               
               
                  949,88 (A)
               
            
                  897,82 (B)
               
            
                  Assay
               
               
                  Content not less than 95,0 % (both forms)
               
            
                  
                     Description
                  
               
               
                  White odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for sodium, for aluminium and for phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH
                           
                        
               
                  Acid to litmus
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water. Soluble in hydrochloric acid
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  19,5 %-21,0 % (A) } (750 oC-800 oC, 2h)
               
            
                  15 %-16 % (B) } (750 oC-800 oC, 2h)
               
            
                  Fluoride
               
               
                  Not more than 25 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 4 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 551 SILICON DIOXIDE
      
                  
                     Synonyms
                  
               
               
                  Silica, silicium dioxide
               
            
                  
                     Definition
                  
               
               
                  Silicon dioxide is an amorphous substance, which is produced synthetically by either a vapour-phase hydrolysis process, yielding fumed silica, or by a wet process, yielding precipitated silica, silica gel, or hydrous silica. Fumed silica is produced in essentially an anhydrous state, whereas the wet-process products are obtained as hydrates or contain surface absorbed water
               
            
                  Chemical name
               
               
                  Silicon dioxide
               
            
                  Einecs
               
               
                  231-545-4
               
            
                  Chemical formula
               
               
                  (SiO2)n
                  
               
            
                  Molecular weight
               
               
                  60,08 (SiO2)
               
            
                  Assay
               
               
                  Content after ignition not less than 99,0 % (fumed silica) or 94,0 % (hydrated forms)
               
            
                  
                     Description
                  
               
               
                  White, fluffy powder or granules
               
            
                  Hygroscopic
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for silica
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 2,5 % (fumed silica, 105 oC, 2h)
               
            
                  Not more than 8,0 % (precipitated silica and silica gel, 105 oC, 2h)
               
            
                  Not more than 70 % (hydrous silica, 105 oC, 2h)
               
            
                  Loss on ignition
               
               
                  Not more than 2,5 % after drying (1 000 oC, fumed silica)
               
            
                  Not more than 8,5 % after drying (1 000 oC, hydrated forms)
               
            
                  Soluble ionisable salts
               
               
                  Not more than 5,0 % (as Na2SO4)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 552 CALCIUM SILICATE
      
                  
                     Definition
                  
               
               
                  Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2
                  
               
            
                  Chemical name
               
               
                  Calcium silicate
               
            
                  Einecs
               
               
                  215-710-8
               
            
                  Assay
               
               
                  Content on the anhydrous basis:
                  
                              —
                           
                           
                              as SiO2 not less than 50 % and not more than 95 %
                           
                        
                              —
                           
                           
                              as CaO not less than 3 % and not more than 35 %
                           
                        
            
                  
                     Description
                  
               
               
                  White to off-white free-flowing powder that remains so after absorbing relatively large amounts of water or other liquids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for silicate and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Forms a gel with mineral acids
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 oC, 2h)
               
            
                  Loss on ignition
               
               
                  Not less than 5 % and not more than 14 % (1 000 oC, constant weight)
               
            
                  Sodium
               
               
                  Not more than 3 %
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 553a(i) MAGNESIUM SILICATE
      
                  
                     Definition
                  
               
               
                  Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
               
            
                  Assay
               
               
                  Content not less than 15 % of MgO and not less than 67 % of SiO2 on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Very fine, white, odourless powder, free from grittiness
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for magnesium and for silicate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % slurry
                           
                        
               
                  Between 7,0 and 10,8
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 oC, 2h)
               
            
                  Loss on ignition
               
               
                  Not more than 15 % after drying (1 000 oC, 20 min)
               
            
                  Water soluble salts
               
               
                  Not more than 3 %
               
            
                  Free alkali
               
               
                  Not more than 1 % (as NaOH)
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 553a(ii) MAGNESIUM TRISILICATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Magnesium trisilicate
               
            
                  Chemical formula
               
               
                  Mg2Si3O8 · xH2O (approximate composition)
               
            
                  Einecs
               
               
                  239-076-7
               
            
                  Assay
               
               
                  Content not less than 29,0 % of MgO and not less than 65,0 % of SiO2 both on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Fine, white powder, free from grittiness
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for magnesium and for silicate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % slurry
                           
                        
               
                  Between 6,3 and 9,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Not less than 17 % and not more than 34 % (1 000 oC)
               
            
                  Water soluble salts
               
               
                  Not more than 2 %
               
            
                  Free alkali
               
               
                  Not more than 1 % (as NaOH)
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 553b TALC
      
                  
                     Synonyms
                  
               
               
                  Talcum
               
            
                  
                     Definition
                  
               
               
                  Naturally occurring form of hydrous magnesium silicate containing varying proportions of such associated minerals as alpha-quartz, calcite, chlorite, dolomite, magnesite, and phlogopite
               
            
                  Chemical name
               
               
                  Magnesium hydrogen metasilicate
               
            
                  Einecs
               
               
                  238-877-9
               
            
                  Chemical formula
               
               
                  Mg3(Si4O10)(OH)2
                  
               
            
                  Molecular weight
               
               
                  379,22
               
            
                  
                     Description
                  
               
               
                  Light, homogeneous, white or almost white powder, greasy to the touch
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              IR absorption
                           
                        
               
                  Characteristic peaks at 3 677, 1 018 and 669 cm-1
                  
               
            
                  
                              B.
                           
                           
                              X-ray diffraction
                           
                        
               
                  Peaks at 9,34/4,66/3,12 Å
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water and ethanol
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 oC, 1h)
               
            
                  Acid-soluble matter
               
               
                  Not more than 6 %
               
            
                  Water-soluble matter
               
               
                  Not more than 0,2 %
               
            
                  Acid-soluble iron
               
               
                  Not detectable
               
            
                  Arsenic
               
               
                  Not more than 10 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 554 SODIUM ALUMINIUM SILICATE
      
                  
                     Synonyms
                  
               
               
                  Sodium silicoaluminate, sodium aluminosilicate, aluminium sodium silicate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium aluminium silicate
               
            
                  Assay
               
               
                  Content on the anhydrous basis:
                  
                              —
                           
                           
                              as SiO2 not less than 66,0 % and not more than 88,0 %
                           
                        
                              —
                           
                           
                              as Al2O3 not less than 5,0 % and not more than 15,0 %
                           
                        
            
                  
                     Description
                  
               
               
                  Fine white amorphous powder or beads
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sodium, for aluminium and for silicate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % slurry
                           
                        
               
                  Between 6,5 and 11,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 8,0 % (105 oC, 2h)
               
            
                  Loss on ignition
               
               
                  Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000 oC, constant weight)
               
            
                  Sodium
               
               
                  Not less than 5 % and not more than 8,5 % (as Na2O) on the anhydrous basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 555 POTASSIUM ALUMINIUM SILICATE
      
                  
                     Synonyms
                  
               
               
                  Mica
               
            
                  
                     Definition
                  
               
               
                  Natural mica consists of mainly potassium aluminium silicate (muscovite)
               
            
                  Einecs
               
               
                  310-127-6
               
            
                  Chemical name
               
               
                  Potassium aluminium silicate
               
            
                  Chemical formulae
               
               
                  KAl2[AlSi3O10](OH)2
                  
               
            
                  Molecular weight
               
               
                  398
               
            
                  Assay
               
               
                  Content not less than 98 %
               
            
                  
                     Description
                  
               
               
                  Light grey to white crystalline platelets or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, diluted acids and alkali and organic solvents
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 oC, 2h)
               
            
                  Antimony
               
               
                  Not more than 20 mg/kg
               
            
                  Zinc
               
               
                  Not more than 25 mg/kg
               
            
                  Barium
               
               
                  Not more than 25 mg/kg
               
            
                  Chromium
               
               
                  Not more than 100 mg/kg
               
            
                  Copper
               
               
                  Not more than 25 mg/kg
               
            
                  Nickel
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            E 556 CALCIUM ALUMINIUM SILICATE
      
                  
                     Synonyms
                  
               
               
                  Calcium aluminosilicate, calcium silicoaluminate, aluminium calcium silicate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium aluminium silicate
               
            
                  Assay
               
               
                  Content on the anhydrous basis:
                  
                              —
                           
                           
                              as SiO2 not less than 44,0 % and not more than 50,0 %
                           
                        
                              —
                           
                           
                              as Al2O3 not less than 3,0 % and not more than 5,0 %
                           
                        
                              —
                           
                           
                              as CaO not less than 32,0 % and not more than 38,0 %
                           
                        
            
                  
                     Description
                  
               
               
                  Fine white, free-flowing powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for calcium, for aluminium and for silicate
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 10,0 % (105 oC, 2h)
               
            
                  Loss on ignition
               
               
                  Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000 oC, constant weight)
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 558 BENTONITE
      
                  
                     Definition
                  
               
               
                  Bentonite is a natural clay containing a high proportion of montmorillonite, a native hydrated aluminium silicate in which some aluminium and silicon atoms were naturally replaced by other atoms such as magnesium and iron. Calcium and sodium ions are trapped between the mineral layers. There are four common types of bentonite: natural sodium bentonite, natural calcium bentonite, sodium-activated bentonite and acid-activated bentonite
               
            
                  Einecs
               
               
                  215-108-5
               
            
                  Chemical formula
               
               
                  (Al, Mg)8(Si4O10) 4(OH)8 · 12H2O
               
            
                  Molecular weight
               
               
                  819
               
            
                  Assay
               
               
                  Montmorillonite content not less than 80 %
               
            
                  
                     Description
                  
               
               
                  Very fine, yellowish or greyish white powder or granules. The structure of bentonite allows it to absorb water in its structure and on its external surface (swelling properties)
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Methylene blue test
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              X-Ray diffraction
                           
                        
               
                  Characteristic peaks at 12,5/15 A
               
            
                  
                              C.
                           
                           
                              IR absorption
                           
                        
               
                  Peaks at 428/470/530/1 110-1 020/3 750 — 3 400 cm-1
                  
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % (105 oC, 2h)
               
            
                  Arsenic
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 20 mg/kg
               
            E 559 ALUMINIUM SILICATE (KAOLIN)
      
                  
                     Synonyms
                  
               
               
                  Kaolin, light or heavy
               
            
                  
                     Definition
                  
               
               
                  Aluminium silicate hydrous (kaolin) is a purified white plastic clay composed of kaolinite, potassium aluminium silicate, feldspar and quartz. Processing should not include calcination. The raw kaolinitic clay used in the production of aluminium silicate shall have a level of dioxin which does not make it injurious to health or unfit for human consumption
               
            
                  Einecs
               
               
                  215-286-4 (kaolinite)
               
            
                  Chemical formula
               
               
                  Al2Si2O5(OH)4 (kaolinite)
               
            
                  Molecular weight
               
               
                  264
               
            
                  Assay
               
               
                  Content not less than 90 % (sum of silica and alumina, after ignition)
               
            
                  Silica (SiO2)
               
               
                  Between 45 % and 55 %
               
            
                  Alumina (Al2O3)
               
               
                  Between 30 % and 39 %
               
            
                  
                     Description
                  
               
               
                  Fine, white or greyish white, unctuous powder. Kaolin is made up of loose aggregations of randomly oriented stacks of kaolinite flakes or of individual hexagonal flakes
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for alumina and for silicate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              X-ray diffraction:
                           
                        
               
                  Characteristic peaks at 7,18/3,58/2,38/1,78 Å
               
            
                  
                              C.
                           
                           
                              IR absorption:
                           
                        
               
                  Peaks at 3 700 and 3 620 cm-1
                  
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on ignition
               
               
                  Between 10 and 14 % (1 000 oC, constant weight)
               
            
                  Water soluble matter
               
               
                  Not more than 0,3 %
               
            
                  Acid soluble matter
               
               
                  Not more than 2 %
               
            
                  Iron
               
               
                  Not more than 5 %
               
            
                  Potassium oxide (K2O)
               
               
                  Not more than 5 %
               
            
                  Carbon
               
               
                  Not more than 0,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 570 FATTY ACIDS
      
                  
                     Definition
                  
               
               
                  Linear fatty acids, caprylic acid (C8), capric acid (C10), laurinc acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)
               
            
                  Chemical name
               
               
                  octanoic acid (C8), decanoic acid (C10), dodecanoic acid (C12), tetradecanoic acid (C14), hexadecanoic acid (C16), octadecanoic acid (C18), 9-octadecenoic acid (C18:1)
               
            
                  Assay
               
               
                  Not less than 98 % by chromatography
               
            
                  
                     Description
                  
               
               
                  A colourless liquid or white solid obtained from oils and fats
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Individual fatty acids can be identified by acid value, iodine value, gas chromatog-raphy and molecular weight
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Residue on ignition
               
               
                  Not more than 0,1 %
               
            
                  Unsaponifiable matter
               
               
                  Not more than 1,5 %
               
            
                  Water
               
               
                  Not more than 0,2 % (Karl Fischer method)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 574 GLUCONIC ACID
      
                  
                     Synonyms
                  
               
               
                  D-gluconic acid, dextronic acid
               
            
                  
                     Definition
                  
               
               
                  Gluconic acid is an aqueous solution of gluconic acid and glucono-delta-lactone
               
            
                  Chemical name
               
               
                  Gluconic acid
               
            
                  Chemical formula
               
               
                  C6H12O7 (gluconic acid)
               
            
                  Molecular weight
               
               
                  196,2
               
            
                  Assay
               
               
                  Content not less than 50,0 % (as gluconic acid)
               
            
                  
                     Description
                  
               
               
                  Colourless to light yellow, clear syrupy liquid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Formation of phenylhydrazine derivative positive
                           
                        
               
                  Compound formed melts between 196 oC and 202 oC with decomposition
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Residue on ignition
               
               
                  Not more than 1,0 %
               
            
                  Reducing matter
               
               
                  Not more than 0,75 % (as D-glucose)
               
            
                  Chloride
               
               
                  Not more than 350 mg/kg
               
            
                  Sulphate
               
               
                  Not more than 240 mg/kg
               
            
                  Sulphite
               
               
                  Not more than 20 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 575 GLUCONO-DELTA-LACTONE
      
                  
                     Synonyms
                  
               
               
                  Gluconolactone, GDL, D-gluconic acid delta-lactone, delta-gluconolactone
               
            
                  
                     Definition
                  
               
               
                  Glucono-delta-lactone is the cyclic 1,5-intramolecular ester of D-gluconic acid. In aqueous media it is hydrolysed to an equilibrium mixture of D-gluconic acid (55 %-66 %) and the delta- and gamma-lactones
               
            
                  Chemical name
               
               
                  D-Glucono-1,5-lactone
               
            
                  Einecs
               
               
                  202-016-5
               
            
                  Chemical formula
               
               
                  C6H10O6
                  
               
            
                  Molecular weight
               
               
                  178,14
               
            
                  Assay
               
               
                  Content not less than 99,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Fine, white, nearly odourless, crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Formation of phenylhydrazine derivative of gluconic acid positive
                           
                        
               
                  Compound formed melts between 196 oC and 202 oC with decomposition
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water. Sparingly soluble in ethanol
               
            
                  
                              C.
                           
                           
                              Melting point
                           
                        
               
                  152 oC ± 2 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 1,0 % (Karl Fischer method)
               
            
                  Reducing substances
               
               
                  Not more than 0,75 % (as D-glucose)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 576 SODIUM GLUCONATE
      
                  
                     Synonyms
                  
               
               
                  Sodium salt of D-gluconic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium D-gluconate
               
            
                  Einecs
               
               
                  208-407-7
               
            
                  Chemical formula
               
               
                  C6H11NaO7 (anhydrous)
               
            
                  Molecular weight
               
               
                  218,14
               
            
                  Assay
               
               
                  Content not less than 98,0 %
               
            
                  
                     Description
                  
               
               
                  White to tan, granular to fine, crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for sodium and for gluconate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water. Sparingly soluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 10 % solution
                           
                        
               
                  Between 6,5 and 7,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Reducing matter
               
               
                  Not more than 1,0 % (as D-glucose)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 577 POTASSIUM GLUCONATE
      
                  
                     Synonyms
                  
               
               
                  Potassium salt of D-gluconic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium D-gluconate
               
            
                  Einecs
               
               
                  206-074-2
               
            
                  Chemical formula
               
               
                  C6H11KO7 (anhydrous)
               
            
                  C6H11KO7 · H2O (monohydrate)
               
            
                  Molecular weight
               
               
                  234,25 (anhydrous)
               
            
                  252,26 (monohydrate)
               
            
                  Assay
               
               
                  Content not less than 97,0 % and not more than 103,0 % on dried basis
               
            
                  
                     Description
                  
               
               
                  Odourless, free flowing white to yellowish white, crystalline powder or granules
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for potassium and for gluconate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % solution
                           
                        
               
                  Between 7,0 and 8,3
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Anhydrous: not more than 3,0 % (105 oC, 4h, vacuum)
                  Monohydrate: not less than 6 % and not more than 7,5 % (105 oC, 4h, vacuum)
               
            
                  Reducing substances
               
               
                  Not more than 1,0 % (as D-glucose)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 578 CALCIUM GLUCONATE
      
                  
                     Synonyms
                  
               
               
                  Calcium salt of D-gluconic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium di-D-gluconate
               
            
                  Einecs
               
               
                  206-075-8
               
            
                  Chemical formula
               
               
                  C12H22CaO14 (anhydrous)
               
            
                  C12H22CaO14 · H2O (monohydrate)
               
            
                  Molecular weight
               
               
                  430,38 (anhydrous form)
               
            
                  448,39 (monohydrate)
               
            
                  Assay
               
               
                  Content not less than 98,0 % and not more than 102 % on the anhydrous and monohydrate basis
               
            
                  
                     Description
                  
               
               
                  Odourless, white crystalline granules or powder, stable in air
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for calcium and for gluconate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, insoluble in ethanol
               
            
                  
                              C.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 6,0 and 8,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 3,0 % (105 oC, 16h) (anhydrous)
               
            
                  Not more than 2,0 % (105 oC, 16h) (monohydrate)
               
            
                  Reducing substances
               
               
                  Not more than 1,0 % (as D-glucose)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 579 FERROUS GLUCONATE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ferrous di-D-gluconate dihydrate
               
            
                  Iron(II) di-gluconate dihydrate
               
            
                  Einecs
               
               
                  206-076-3
               
            
                  Chemical formulae
               
               
                  C12H22FeO14·2H2O
               
            
                  Molecular weight
               
               
                  482,17
               
            
                  Assay
               
               
                  Content not less than 95 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  Pale greenish-yellow to yellowish-grey powder or granules, which may have a faint odour of burnt sugar
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble with slight heating in water. Practically insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Positive test for ferrous ion
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Formation of phenylhy-drazine derivative of gluconic acid positive
                           
                        
               
                   
               
            
                  
                              D.
                           
                           
                              pH of a 10 % solution
                           
                        
               
                  Between 4 and 5,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 oC, 16 hours)
               
            
                  Oxalic acid
               
               
                  Not detectable
               
            
                  Iron (Fe III)
               
               
                  Not more than 2 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Reducing substances
               
               
                  Not more than 0,5 % expressed as glucose
               
            E 585 FERROUS LACTATE
      
                  
                     Synonyms
                  
               
               
                  Iron(II) lactate
               
            
                  Iron(II) 2-hydroxy propanoate
               
            
                  Propanoic acid, 2-hydroxy-iron(2 +) salt (2:1)
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Ferrous 2-hydroxy propanoate
               
            
                  Einecs
               
               
                  227-608-0
               
            
                  Chemical formulae
               
               
                  C6H10FeO6·xH2O (x = 2 or 3)
               
            
                  Molecular weight
               
               
                  270,02 (dihydrate)
               
            
                  288,03 (trihydrate)
               
            
                  Assay
               
               
                  Content not less than 96 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  Greenish-white crystals or light green powder having a characteristic smell
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water. Practically insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              Positive test for ferrous ion and for lactate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              pH of a 2 % solution
                           
                        
               
                  Between 4 and 6
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 18 % (100 oC, under vacuum, approximately 700 mm Hg)
               
            
                  Iron (Fe III)
               
               
                  Not more than 0,6 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            E 586 4-HEXYLRESORCINOL
      
                  
                     Synonyms
                  
               
               
                  4-Hexyl-1,3-benzenediol
               
            
                  Hexylresorcinol
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  4-Hexylresorcinol
               
            
                  Einecs
               
               
                  205-257-4
               
            
                  Chemical formula
               
               
                  C12H18O2
                  
               
            
                  Molecular weight
               
               
                  197,24
               
            
                  Assay
               
               
                  Not less than 98 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in ether and acetone; very slightly soluble in water
               
            
                  
                              B.
                           
                           
                              Nitric acid test
                           
                        
               
                  To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears
               
            
                  
                              C.
                           
                           
                              Bromine test
                           
                        
               
                  To 1 ml of saturated solution of the sample, add 1 ml of bromine TS. A yellow, flocculent precipitate dissolves producing a yellow solution
               
            
                  
                              D.
                           
                           
                              Melting range
                           
                        
               
                  62 to 67 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acidity
               
               
                  Not more than 0,05 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Resorcinol and other phenols
               
               
                  Shake about 1 g of the sample with 50 ml of water for a few minutes, filter, and to the filtrate add 3 drops of ferric chloride TS. No red or blue colour is produced
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 3 mg/kg
               
            E 620 GLUTAMIC ACID
      
                  
                     Synonyms
                  
               
               
                  L-Glutamic acid, L-α-aminoglutaric acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  L-Glutamic acid, L-2-amino-pentanedioic acid
               
            
                  Einecs
               
               
                  200-293-7
               
            
                  Chemical formula
               
               
                  C5H9NO4
                  
               
            
                  Molecular weight
               
               
                  147,13
               
            
                  Assay
               
               
                  Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for glutamic acid by thin layer chromatography
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Specific rotation [α]D20
                              
                           
                        
               
                  Between +31,5o and +32,2o
                  
               
            
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  
                              C.
                           
                           
                              pH of a saturated solution
                           
                        
               
                  Between 3,0 and 3,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,2 % (80 oC, 3h)
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 %
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 621 MONOSODIUM GLUTAMATE
      
                  
                     Synonyms
                  
               
               
                  Sodium glutamate, MSG
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monosodium L-glutamate monohydrate
               
            
                  Einecs
               
               
                  205-538-1
               
            
                  Chemical formula
               
               
                  C5H8NaNO4 · H2O
               
            
                  Molecular weight
               
               
                  187,13
               
            
                  Assay
               
               
                  Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, practically odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for glutamic acid by thin-layer chromatography
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Specific rotation [α]D
                                 20
                              
                           
                        
               
                  Between +24,8o and +25,3o
                  
               
            
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  
                              D.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 6,7 and 7,2
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (98 oC, 5h)
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 622 MONOPOTASSIUM GLUTAMATE
      
                  
                     Synonyms
                  
               
               
                  Potassium glutamate, MPG
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monopotassium L-glutamate monohydrate
               
            
                  Einecs
               
               
                  243-094-0
               
            
                  Chemical formula
               
               
                  C5H8KNO4 · H2O
               
            
                  Molecular weight
               
               
                  203,24
               
            
                  Assay
               
               
                  Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, practically odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for glutamic acid by thin-layer chromatog-raphy
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Specific rotation [α]D
                                 20
                              
                           
                        
               
                  Between +22,5o and +24,0o
                  
               
            
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  
                              D.
                           
                           
                              pH of a 2 % solution
                           
                        
               
                  Between 6,7 and 7,3
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,2 % (80 oC, 5h)
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 623 CALCIUM DIGLUTAMATE
      
                  
                     Synonyms
                  
               
               
                  Calcium glutamate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monocalcium di-L-glutamate
               
            
                  Einecs
               
               
                  242-905-5
               
            
                  Chemical formula
               
               
                  C10H16CaN2O8 · x H2O (x = 0, 1, 2 or 4)
               
            
                  Molecular weight
               
               
                  332,32 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 98,0 % and not more than 102,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, practically odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for glutamic acid by thin-layer chromatog-raphy
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Specific rotation [α]D
                                 20
                              
                           
                        
               
                  Between +27,4 and +29,2 (for calcium diglutamate with x = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 19,0 % (for calcium diglutamate with x = 4) (Karl Fischer)
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 624 MONOAMMONIUM GLUTAMATE
      
                  
                     Synonyms
                  
               
               
                  Ammonium glutamate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monoammonium L-glutamate monohydrate
               
            
                  Einecs
               
               
                  231-447-1
               
            
                  Chemical formula
               
               
                  C5H12N2O4 · H2O
               
            
                  Molecular weight
               
               
                  182,18
               
            
                  Assay
               
               
                  Content not less than 99,0 % and not more 101,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, practically odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ammonium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for glutamic acid by thin-layer chromatog-raphy
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Specific rotation [α]D
                                 20
                              
                           
                        
               
                  Between +25,4o and +26,4o
                  
               
            
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  
                              D.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 6,0 and 7,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (50 oC, 4h)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 625 MAGNESIUM DIGLUTAMATE
      
                  
                     Synonyms
                  
               
               
                  Magnesium glutamate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Monomagnesium di-L-glutamate tetrahydrate
               
            
                  Einecs
               
               
                  242-413-0
               
            
                  Chemical formula
               
               
                  C10H16MgN2O8 · 4H2O
               
            
                  Molecular weight
               
               
                  388,62
               
            
                  Assay
               
               
                  Content not less than 95,0 % and not more than 105,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, white or off-white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for magnesium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for glutamic acid by thin-layer chromatog-raphy
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Specific rotation [α]D
                                 20
                              
                           
                        
               
                  Between +23,8o and +24,4o
                  
               
            
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  
                              D.
                           
                           
                              pH of a 10 % solution
                           
                        
               
                  Between 6,4 and 7,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 24 % (Karl Fischer)
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 626 GUANYLIC ACID
      
                  
                     Synonyms
                  
               
               
                  Guanylic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Guanosine-5'-monophosphoric acid
               
            
                  Einecs
               
               
                  201-598-8
               
            
                  Chemical formula
               
               
                  C10H14N5O8P
               
            
                  Molecular weight
               
               
                  363,22
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose and for organic phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 0,25 % solution
                           
                        
               
                  Between 1,5 and 2,5
               
            
                  
                              C.
                           
                           
                              Spectrometry:
                           
                        
               
                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1,5 % (120 oC, 4h)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 627 DISODIUM GUANYLATE
      
                  
                     Synonyms
                  
               
               
                  Sodium guanylate, sodium 5'-guanylate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium guanosine-5'-monophosphate
               
            
                  Einecs
               
               
                  221-849-5
               
            
                  Chemical formula
               
               
                  C10H12N5Na2O8P· x H2O (x = ca. 7)
               
            
                  Molecular weight
               
               
                  407,19 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, for organic phosphate, and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 7,0 and 8,5
               
            
                  
                              C.
                           
                           
                              Spectrometry:
                           
                        
               
                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 25 % (120 oC, 4h)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 628 DIPOTASSIUM GUANYLATE
      
                  
                     Synonyms
                  
               
               
                  Potassium guanylate, potassium 5'-guanylate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dipotassium guanosine-5'-monophosphate
               
            
                  Einecs
               
               
                  226-914-1
               
            
                  Chemical formula
               
               
                  C10H12K2N5O8P
               
            
                  Molecular weight
               
               
                  439,40
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, for organic phosphate, and for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 7,0 and 8,5
               
            
                  
                              C.
                           
                           
                              Spectrometry:
                           
                        
               
                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 5 % (120 oC, 4h)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 629 CALCIUM GUANYLATE
      
                  
                     Synonyms
                  
               
               
                  Calcium 5'-guanylate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium guanosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H12CaN5O8P· nH2O
               
            
                  Molecular weight
               
               
                  401,20 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, white or off-white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, for organic phosphate, and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 0,05 % solution
                           
                        
               
                  Between 7,0 and 8,0
               
            
                  
                              C.
                           
                           
                              Spectrometry:
                           
                        
               
                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 256 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 23,0 % (120 oC, 4h)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 630 INOSINIC ACID
      
                  
                     Synonyms
                  
               
               
                  5'-Inosinic acid
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Inosine-5'-monophosphoric acid
               
            
                  Einecs
               
               
                  205-045-1
               
            
                  Chemical formula
               
               
                  C10H13N4O8P
               
            
                  Molecular weight
               
               
                  348,21
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, and for organic phosphate
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 1,0 and 2,0
               
            
                  
                              C.
                           
                           
                              Spectrometry:
                           
                        
               
                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 3,0 % (120 oC, 4h)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 631 DISODIUM INOSINATE
      
                  
                     Synonyms
                  
               
               
                  Sodium inosinate, sodium 5'-inosinate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium inosine-5'-monophosphate
               
            
                  Einecs
               
               
                  225-146-4
               
            
                  Chemical formula
               
               
                  C10H11N4Na2O8P· H2O
               
            
                  Molecular weight
               
               
                  392,17 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, and for organic phosphate and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 7,0 and 8,5
               
            
                  
                              C.
                           
                           
                              Spectrometry:
                           
                        
               
                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 28,5 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 632 DIPOTASSIUM INOSINATE
      
                  
                     Synonyms
                  
               
               
                  Potassium inosinate, potassium 5'-inosinate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Dipotassium inosine-5'-monophosphate
               
            
                  Einecs
               
               
                  243-652-3
               
            
                  Chemical formula
               
               
                  C10H11K2N4O8P
               
            
                  Molecular weight
               
               
                  424,39
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, and for organic phosphate and for potassium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 7,0 and 8,5
               
            
                  
                              C.
                           
                           
                              Spectrometry:
                           
                        
               
                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 10,0 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 633 CALCIUM INOSINATE
      
                  
                     Synonyms
                  
               
               
                  Calcium 5'-inosinate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium inosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H11CaN4O8P· nH2O
               
            
                  Molecular weight
               
               
                  386,19 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, and for organic phosphate and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 0,05 % solution
                           
                        
               
                  Between 7,0 and 8,0
               
            
                  
                              C.
                           
                           
                              Spectrometry:
                           
                        
               
                  maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 23,0 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 634 CALCIUM 5'-RIBONUCLEOTIDE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium 5'-ribonucleotide is essentially a mixture of calcium inosine-5'-monophosphate and calcium guanosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H11N4CaO8P· nH2O y
               
            
                  C10H12N5CaO8P· nH2O
               
            
                  Assay
               
               
                  Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, white or nearly white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, and for organic phosphate and for calcium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 0,05 % solution
                           
                        
               
                  Between 7,0 and 8,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 23,0 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 635 DISODIUM 5'-RIBONUCLEOTIDE
      
                  
                     Synonyms
                  
               
               
                  Sodium 5'-ribonucleotide
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H11N4Na2O8P · nH2O and
               
            
                  C10H12N5Na2O8P· nH2O
               
            
                  Assay
               
               
                  Content of both major components not less than 97,0 %, and of each component not less than 47,0 % and not more than 53 %, in every case on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, white or nearly white crystals or powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for ribose, and for organic phosphate and for sodium
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 7,0 and 8,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 26,0 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 640 GLYCINE AND ITS SODIUM SALT
      
                  
                     Synonyms
                     (gly)
                  
               
               
                  Aminoacetic acid, glycocoll
               
            
                  
                     (Na salt)
                  
               
               
                  Sodium glycinate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name (gly)
               
               
                  Aminoacetic acid
               
            
                  (Na salt)
               
               
                  Sodium glycinate
               
            
                  Chemical formula (gly)
               
               
                  C2H5NO2
                  
               
            
                  (Na salt)
               
               
                  C2H5NO2 Na
               
            
                  Einecs (gly)
               
               
                  200-272-2
               
            
                  (Na salt)
               
               
                  227-842-3
               
            
                  Molecular weight (gly)
               
               
                  75,07
               
            
                  (Na salt)
               
               
                  98
               
            
                  Assay
               
               
                  Content not less than 98,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or crystalline powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive test for amino acid (gly and Na salt)
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Positive test for sodium (Na salt)
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying (gly)
               
               
                  Not more than 0,2 % (105 oC, 3h)
               
            
                  (Na salt)
               
               
                  Not more than 0,2 % (105 oC, 3h)
               
            
                  Residue on ignition (gly)
               
               
                  Not more than 0,1 %
               
            
                  (Na salt)
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 650 ZINC ACETATE
      
                  
                     Synonyms
                  
               
               
                  Acetic acid, zinc salt, dihydrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Zinc acetate dihydrate
               
            
                  Chemical formula
               
               
                  C4H6O4 Zn· 2H2O
               
            
                  Molecular weight
               
               
                  219,51
               
            
                  Assay
               
               
                  Content not less than 98 % and not more than 102 % of C4H6O4 Zn · 2H2O
               
            
                  
                     Description
                  
               
               
                  Colourless crystals or fine, off-white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for acetate and for zinc
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 6,0 and 8,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Insoluble matter
               
               
                  Not more than 0,005 %
               
            
                  Chlorides
               
               
                  Not more than 50 mg/kg
               
            
                  Sulphates
               
               
                  Not more than 100 mg/kg
               
            
                  Alkalines and alkaline earths
               
               
                  Not more than 0,2 %
               
            
                  Organic volatile impurities
               
               
                  Passes test
               
            
                  Iron
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 20 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 5 mg/kg
               
            E 900 DIMETHYL POLYSILOXANE
      
                  
                     Synonyms
                  
               
               
                  Polydimethyl siloxane, silicone fluid, silicone oil, dimethyl silicone
               
            
                  
                     Definition
                  
               
               
                  Dimethylpolysiloxane is a mixture of fully methylated linear siloxane polymers containing repeating units of the formula (CH3)2 SiO and stablised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO
               
            
                  Chemical name
               
               
                  Siloxanes and silicones, di-methyl
               
            
                  Chemical formula
               
               
                  (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3
                  
               
            
                  Assay
               
               
                  Content of total silicon not less than 37,3 % and not more than 38,5 %
               
            
                  
                     Description
                  
               
               
                  Clear, colourless, viscous liquid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Specific gravity (25o/25 oC)
                           
                        
               
                  Between 0,964 and 0,977
               
            
                  
                              B.
                           
                           
                              Refractive index [n]D
                                 25
                              
                           
                        
               
                  Between 1,400 and 1,405
               
            
                  
                              C.
                           
                           
                              Infrared spectrum characteristic of the compound
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (150 oC, 4h)
               
            
                  Viscosity
               
               
                  Not less than 1,00 · 10-4 m2s-1 at 25 oC
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 901 BEESWAX
      
                  
                     Synonyms
                  
               
               
                  White wax, yellow wax
               
            
                  
                     Definition
                  
               
               
                  Yellow bees wax is the wax obtained by melting the walls of the honeycomb made by the honey bee, Apis mellifera L., with hot water and removing foreign matter
               
            
                  White beeswax is obtained by bleaching yellow beeswax
               
            
                  Einecs
               
               
                  232-383-7 (beeswax)
               
            
                  
                     Description
                  
               
               
                  Yellowish white (white form) or yellowish to greyish brown (yellow form) pieces or plates with a fine-grained and non-crystalline fracture, having an agreeable, honey-like odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Melting range
                           
                        
               
                  Between 62 oC and 65 oC
               
            
                  
                              B.
                           
                           
                              Specific gravity
                           
                        
               
                  About 0,96
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water
               
            
                  Sparingly soluble in alcohol
               
            
                  Very soluble in chloroform and ether
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acid value
               
               
                  Not less than 17 and not more than 24
               
            
                  Saponification value
               
               
                  87-104
               
            
                  Peroxide value
               
               
                  Not more than 5
               
            
                  Glycerol and other polyols
               
               
                  Not more than 0,5 % (as glycerol)
               
            
                  Ceresin, paraffins and certain other waxes
               
               
                  Absent
               
            
                  Fats, Japan wax, rosin and soaps
               
               
                  Absent
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 902 CANDELILLA WAX
      
                  
                     Definition
                  
               
               
                  Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica
                  
               
            
                  Einecs
               
               
                  232-347-0
               
            
                  
                     Description
                  
               
               
                  Hard, yellowish brown, opaque to translucent wax
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Specific gravity
                           
                        
               
                  About 0,983
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 68,5 oC and 72,5 oC
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water
               
            
                  Soluble in chloroform and toluene
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acid value
               
               
                  Not less than 12 and not more than 22
               
            
                  Saponification value
               
               
                  Not less than 43 and not more than 65
               
            
                  Glycerol and other polyols
               
               
                  Not more than 0,5 % (as glycerol)
               
            
                  Ceresin, paraffins and certain other waxes
               
               
                  Absent
               
            
                  Fats, Japan wax, rosin and soaps
               
               
                  Absent
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 903 CARNAUBA WAX
      
                  
                     Definition
                  
               
               
                  Carnauba wax is a purified wax obtained from the leaf buds and leaves of the Brazilian Mart wax palm, Copernicia cerifera
                  
               
            
                  Einecs
               
               
                  232-399-4
               
            
                  
                     Description
                  
               
               
                  Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Specific gravity
                           
                        
               
                  About 0,997
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 82 oC and 86 oC
               
            
                  
                              C.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water
               
            
                  Partly soluble in boiling ethanol
               
            
                  Soluble in chloroform and diethyl ether
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Sulphated ash
               
               
                  Not more than 0,25 %
               
            
                  Acid value
               
               
                  Not less than 2 and not more than 7
               
            
                  Ester value
               
               
                  Not less than 71 and not more than 88
               
            
                  Unsaponifiable matter
               
               
                  Not less than 50 % and not more than 55 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 904 SHELLAC
      
                  
                     Synonyms
                  
               
               
                  Bleached shellac, white shellac
               
            
                  
                     Definition
                  
               
               
                  Shellac is the purified and bleached lac, the resinous secretion of the insect Laccifer (Tachardia) lacca Kerr (Fam. Coccidae)
               
            
                  Einecs
               
               
                  232-549-9
               
            
                  
                     Description
                  
               
               
                  Bleached shellac — off-white, amorphous, granular resin
               
            
                  Wax-free bleached shellac — light yellow, amorphous, granular resin
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone
               
            
                  
                              B.
                           
                           
                              Acid value
                           
                        
               
                  Between 60 and 89
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 6,0 % (40 oC, over silica gel, 15h)
               
            
                  Rosin
               
               
                  Absent
               
            
                  Wax
               
               
                  Bleached shellac: not more than 5,5 %
               
            
                  Wax-free bleached shellac: not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 905 MICROCRYSTALLINE WAX
      
                  
                     Synonyms
                  
               
               
                  Petroleum wax
               
            
                  
                     Definition
                  
               
               
                  Microcrystalline wax is a refined mixture of solid, saturated hydrocarbons, mainly branched paraffin, obtained from petroleum
               
            
                  
                     Description
                  
               
               
                  White to amber, odourless wax
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, very slightly soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Refractive Index
                           
                        
               
                  n D
                     1001,434-1,448
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Molecular weight
               
               
                  Average not less than 500
               
            
                  Viscosity at 100 oC
               
               
                  Not less than 1,1 · 10-5 m2s-1
                  
               
            
                  Residue on ignition
               
               
                  Not more than 0,1 %
               
            
                  Carbon number at 5 % distillation point
               
               
                  Not more than 5 % of molecules with carbon number less than 25
               
            
                  Colour
               
               
                  Passes test
               
            
                  Sulphur
               
               
                  Not more than 0,4 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 3 mg/kg
               
            
                  Polycyclic aromatic compounds
               
               
                  The polycyclic aromatic hydrocarbons, obtained by extraction with dimethyl sulfoxide, shall meet the following ultraviolet absorbency limits:
               
            
                   
               
               
                  nm
               
               
                  Maximum absorbance per cm path length
               
            
                   
               
               
                  280-289
               
               
                  0,15
               
            
                   
               
               
                  290-299
               
               
                  0,12
               
            
                   
               
               
                  300-359
               
               
                  0,08
               
            
                   
               
               
                  360-400
               
               
                  0,02
               
            E 907 HYDROGENATED POLY-1-DECENE
      
                  
                     Synonyms
                  
               
               
                  Hydrogenated polydec-1-ene
               
            
                  Hydrogenated poly-alpha-olefin
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical formula
               
               
                  C10nH20n+2 where n = 3-6
               
            
                  Molecular weight
               
               
                  560 (average)
               
            
                  Assay
               
               
                  Not less than 98,5 % of hydrogenated poly-1-decene, having the following oligomer distribution:
               
            
                  C30: 13-37 %
               
            
                  C40: 35-70 %
               
            
                  C50: 9-25 %
               
            
                  C60: 1-7 %
               
            
                  
                     Description
                  
               
               
                   
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water; slightly soluble in ethanol; soluble in toluene
               
            
                  
                              B.
                           
                           
                              Burning
                           
                        
               
                  Burns with a bright flame and a paraffin-like characteristic smell
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Viscosity
               
               
                  Between 5,7 × 10-6 and 6,1 × 10-6 m2s-1 at 100 oC
               
            
                  Compounds with carbon number less than 30
               
               
                  Not more than 1,5 %
               
            
                  Readily carbonisable substances
               
               
                  After 10 minutes shaking in a boiling water bath, a tube of sulphuric acid with a 5 g sample of hydrogenated poly-1-decene is not darker than a very slight straw colour
               
            
                  Nickel
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            E 912 MONTAN ACID ESTERS
      
                  
                     Definition
                  
               
               
                  Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol
               
            
                  Chemical name
               
               
                  Montan acid esters
               
            
                  
                     Description
                  
               
               
                  Almost white to yellowish flakes, powder, granules or pellets
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Density (20 oC)
                           
                        
               
                  Between 0,98 and 1,05
               
            
                  
                              B.
                           
                           
                              Drop point
                           
                        
               
                  Greater than 77 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acid value
               
               
                  Not more than 40
               
            
                  Glycerol
               
               
                  Not more than 1 % (by gas chromatography)
               
            
                  Other polyols
               
               
                  Not more than 1 % (by gas chromatography)
               
            
                  Other wax types
               
               
                  Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)
               
            
                  Arsenic
               
               
                  Not more than 2 mg/kg
               
            
                  Chromium
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 914 OXIDISED POLYETHYLENE WAX
      
                  
                     Definition
                  
               
               
                  Polar reaction products from mild oxidation of polyethylene
               
            
                  Chemical name
               
               
                  Oxidised polyethylene
               
            
                  
                     Description
                  
               
               
                  Almost white flakes, powder, granules or pellets
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Density (20 oC)
                           
                        
               
                  Between 0,92 and 1,05
               
            
                  
                              B.
                           
                           
                              Drop point
                           
                        
               
                  Greater than 95 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Acid value
               
               
                  Not more than 70
               
            
                  Viscosity at 120 oC
               
               
                  Not less than 8,1 · 10-5 m2s-1
                  
               
            
                  Other wax types
               
               
                  Not detectable (by differential scanning calorimetry and/or infrared spectroscopy)
               
            
                  Oxygen
               
               
                  Not more than 9,5 %
               
            
                  Chromium
               
               
                  Not more than 5 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            E 920 L-CYSTEINE
      
                  
                     Definition
                  
               
               
                  L-cysteine hydrochloride or hydrochloride monohydrate. Human hair may not be used as a source for this substance
               
            
                  Einecs
               
               
                  200-157-7 (anhydrous)
               
            
                  Chemical formula
               
               
                  C3H7NO2S· HCl· n H20 (where n = 0 or 1)
               
            
                  Molecular weight
               
               
                  157,62 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 98,0 % and not more than 101,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White powder or colourless crystals
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Freely soluble in water and in ethanol
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Anhydrous form melts at about 175 oC
               
            
                  
                              C.
                           
                           
                              Specific rotation
                           
                        
               
                  [α]20
                     D: between +5,0o and +8,0o or
               
            
                  [α]25
                     D: between +4,9o and 7,9o
                  
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Between 8,0 % and 12,0 %
               
            
                  Not more than 2,0 % (anhydrous form)
               
            
                  Residue on ignition
               
               
                  Not more than 0,1 %
               
            
                  Ammonium-ion
               
               
                  Not more than 200 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 1,5 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 927b CARBAMIDE
      
                  
                     Synonyms
                  
               
               
                  Urea
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Einecs
               
               
                  200-315-5
               
            
                  Chemical formula
               
               
                  CH4N2O
               
            
                  Molecular weight
               
               
                  60,06
               
            
                  Assay
               
               
                  Content not less than 99,0 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless to white, prismatic, crystalline powder or small, white pellets
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water
               
            
                  Soluble in ethanol
               
            
                  
                              B.
                           
                           
                              Precipitation with nitric acid
                           
                        
               
                  To pass the test a white, crystalline precipitate is formed
               
            
                  
                              C.
                           
                           
                              Colour reaction
                           
                        
               
                  To pass the test a reddish-violet colour is produced
               
            
                  
                              D.
                           
                           
                              Melting range
                           
                        
               
                  132 oC to 135 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % (105 oC, 1h)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Ethanol-insoluble matter
               
               
                  Not more than 0,04 %
               
            
                  Alkalinity
               
               
                  Passes test
               
            
                  Ammonium-ion
               
               
                  Not more than 500 mg/kg
               
            
                  Biuret
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 938 ARGON
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Argon
               
            
                  Einecs
               
               
                  231-147-0
               
            
                  Chemical formula
               
               
                  Ar
               
            
                  Molecular weight
               
               
                  40
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, non-flammable gas
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,05 %
               
            
                  Methane and other hydrocarbons calculated as methane
               
               
                  Not more than 100 μl/l
               
            E 939 HELIUM
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Helium
               
            
                  Einecs
               
               
                  231-168-5
               
            
                  Chemical formula
               
               
                  He
               
            
                  Molecular weight
               
               
                  4
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, non-flammable gas
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,05 %
               
            
                  Methane and other hydrocarbons calculated as methane
               
               
                  Not more than 100 μl/l
               
            E 941 NITROGEN
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Nitrogen
               
            
                  Einecs
               
               
                  231-783-9
               
            
                  Chemical formula
               
               
                  N2
                  
               
            
                  Molecular weight
               
               
                  28
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, non-flammable gas
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,05 %
               
            
                  Carbon monoxide
               
               
                  Not more than 10 μl/l
               
            
                  Methane and other hydrocarbons calculated as methane
               
               
                  Not more than 100 μl/l
               
            
                  Nitrogen dioxide and nitrogen oxide
               
               
                  Not more than 10 μl/l
               
            
                  Oxygen
               
               
                  Not more than 1 %
               
            E 942 NITROUS OXIDE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Nitrous oxide
               
            
                  Einecs
               
               
                  233-032-0
               
            
                  Chemical formula
               
               
                  N2O
               
            
                  Molecular weight
               
               
                  44
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, non-flammable gas, sweetish odour
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,05 %
               
            
                  Carbon monoxide
               
               
                  Not more than 30 μl/l
               
            
                  Nitrogen dioxide and nitrogen oxide
               
               
                  Not more than 10 μl/l
               
            E 943a BUTANE
      
                  
                     Synonyms
                  
               
               
                  n-Butane
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Butane
               
            
                  Chemical formula
               
               
                  CH3CH2CH2CH3
                  
               
            
                  Molecular weight
               
               
                  58,12
               
            
                  Assay
               
               
                  Content not less than 96 %
               
            
                  
                     Description
                  
               
               
                  Colourless gas or liquid with mild, characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Vapour pressure
                           
                        
               
                  108,935 kPa at 20 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Methane
               
               
                  Not more than 0,15 % v/v
               
            
                  Ethane
               
               
                  Not more than 0,5 % v/v
               
            
                  Propane
               
               
                  Not more than 1,5 % v/v
               
            
                  Isobutane
               
               
                  Not more than 3,0 % v/v
               
            
                  1,3-butadiene
               
               
                  Not more than 0,1 % v/v
               
            
                  Moisture
               
               
                  Not more than 0,005 %
               
            E 943b ISOBUTANE
      
                  
                     Synonyms
                  
               
               
                  2-methyl propane
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  2-methyl propane
               
            
                  Chemical formula
               
               
                  (CH3)2CH CH3
                  
               
            
                  Molecular weight
               
               
                  58,12
               
            
                  Assay
               
               
                  Content not less than 94 %
               
            
                  
                     Description
                  
               
               
                  Colourless gas or liquid with mild, characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Vapour pressure
                           
                        
               
                  205,465 kPa at 20 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Methane
               
               
                  Not more than 0,15 % v/v
               
            
                  Ethane
               
               
                  Not more than 0,5 % v/v
               
            
                  Propane
               
               
                  Not more than 2,0 % v/v
               
            
                  n-Butane
               
               
                  Not more than 4,0 % v/v
               
            
                  1,3-butadiene
               
               
                  Not more than 0,1 % v/v
               
            
                  Moisture
               
               
                  Not more than 0,005 %
               
            E 944 PROPANE
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Propane
               
            
                  Chemical formula
               
               
                  CH3CH2CH3
                  
               
            
                  Molecular weight
               
               
                  44,09
               
            
                  Assay
               
               
                  Content not less than 95 %
               
            
                  
                     Description
                  
               
               
                  Colourless gas or liquid with mild, characteristic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Vapour pressure
                           
                        
               
                  732,910 kPa at 20 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Methane
               
               
                  Not more than 0,15 % v/v
               
            
                  Ethane
               
               
                  Not more than 1,5 % v/v
               
            
                  Isobutane
               
               
                  Not more than 2,0 % v/v
               
            
                  n-Butane
               
               
                  Not more than 1,0 % v/v
               
            
                  1,3-butadiene
               
               
                  Not more than 0,1 % v/v
               
            
                  Moisture
               
               
                  Not more than 0,005 %
               
            E 948 OXYGEN
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Oxygen
               
            
                  Einecs
               
               
                  231-956-9
               
            
                  Chemical formula
               
               
                  O2
                  
               
            
                  Molecular weight
               
               
                  32
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, non-flammable gas
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,05 %
               
            
                  Methane and other hydrocarbons calculated as methane
               
               
                  Not more than 100 μl/l
               
            E 949 HYDROGEN
      
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Hydrogen
               
            
                  Einecs
               
               
                  215-605-7
               
            
                  Chemical formula
               
               
                  H2
                  
               
            
                  Molecular weight
               
               
                  2
               
            
                  Assay
               
               
                  Content not less than 99,9 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, highly flammable gas
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,005 % v/v
               
            
                  Oxygen
               
               
                  Not more than 0,001 % v/v
               
            
                  Nitrogen
               
               
                  Not more than 0,75 % v/v
               
            E 950 ACESULFAME K
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 951 ASPARTAME
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 953 ISOMALT
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 957 THAUMATIN
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 959 NEOHESPERIDINE DIHYDROCHALCONE
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 965(i) MALTITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 965(ii) MALTITOL SYRUP
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 966 LACTITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 967 XYLITOL
      Purity criteria for this additive are the same as set out for this additive in Annex I to Directive 2008/60/EC.
      E 999 QUILLAIA EXTRACT
      
                  
                     Synonyms
                  
               
               
                  Soapbark extract, Quillay bark extract, Panama bark extract, Quillai extract, Murillo bark extract, China bark extract
               
            
                  
                     Definition
                  
               
               
                  Quillaia extract is obtained by aqueous extraction of Quillaia saponaria Molina, or other Quillaia species, trees of the family Rosaceae. It contains a number of triterpenoid saponins consisting of glycosides of quillaic acid. Some sugars including glucose, galactose, arabinose, xylose, and rhamnose are also present, along with tannin, calcium oxalate and other minor components
               
            
                  
                     Description
                  
               
               
                  Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              pH of a 2,5 % solution
                           
                        
               
                  Between 4,5 and 5,5
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 6,0 % (Karl Fischer method) (powder form only)
               
            
                  Arsenic
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            E 1103 INVERTASE
      
                  
                     Definition
                  
               
               
                  Invertase is produced from Saccharomyces cerevisiae
                  
               
            
                  Systematic name
               
               
                  β-D-Fructofuranoside fructohydrolase
               
            
                  Enzyme Commission No
               
               
                  EC 3.2.1.26
               
            
                  Einecs
               
               
                  232-615-7
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 0,5 mg/kg
               
            
                  Total bacterial count
               
               
                  Not more than 50 000/g
               
            
                  
                     Salmonella spp.
               
               
                  Absent by test in 25 g
               
            
                  Coliforms
               
               
                  Not more than 30/g
               
            
                  
                     E. coli
                  
               
               
                  Absent by test in 25 g
               
            E 1105 LYSOZYME
      
                  
                     Synonyms
                  
               
               
                  Lysozyme hydrochloride
               
            
                  Muramidase
               
            
                  
                     Definition
                  
               
               
                  Lysozyme is a linear polypeptide obtained from hens' egg whites consisting of 129 amino acids. It possesses enzymatic activity in its ability to hydrolyse the β(1-4) linkages between N-acetylmuramic acid and N-acetylglucosamine in the outer membranes of bacterial species, in particular gram-positive organisms. Is usually obtained as the hydrochloride
               
            
                  Chemical name
               
               
                  Enzyme Commission (EC) No: 3.2.1.17
               
            
                  Einecs
               
               
                  232-620-4
               
            
                  Molecular weight
               
               
                  About 14 000
               
            
                  Assay
               
               
                  Content not less than 950 mg/g on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, odourless powder having a slightly sweet taste
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Isoelectric point 10,7
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 2 % aqueous solution between 3,0 and 3,6
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Absorption maximum of an aqueous solution (25 mg/100 ml) at 281 nm, a minimum at 252 nm
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water content
               
               
                  Not more than 6,0 % (Karl Fischer method) (powder form only)
               
            
                  Residue on ignition
               
               
                  Not more than 1,5 %
               
            
                  Nitrogen
               
               
                  Not less than 16,8 % and not more than 17,8 %
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Heavy metals (as Pb)
               
               
                  Not more than 10 mg/kg
               
            
                  Microbiological criteria
               
               
                   
               
            
                  Total bacterial count
               
               
                  Not more than 5 × 104 col/g
               
            
                  
                     Salmonellae
                  
               
               
                  Absent in 25 g
               
            
                  
                     Staphylococcus aureus
                  
               
               
                  Absent in 1 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 1 g
               
            E 1200 POLYDEXTROSE
      
                  
                     Synonyms
                  
               
               
                  Modified polydextroses
               
            
                  
                     Definition
                  
               
               
                  Randomly bonded glucose polymers with some sorbitol end-groups, and with citric acid or phosphoric acid residues attached to the polymers by mono or diester bonds. They are obtained by melting and condensation of the ingredients and consist of approximately 90 parts D-glucose, 10 parts sorbitol and 1 part citric acid or 0,1 part phosphoric acid. The 1,6-glucosidic linkage predominates in the polymers but other linkages are present. The products contain small quantities of free glucose, sorbitol, levoglucosan (1,6-anhydro-D-glucose) and citric acid and may be neutralised with any food grade base and/or decolorised and deionised for further purification. The products may also be partially hydrogenated with Raney nickel catalyst to reduce residual glucose. Polydextrose-N is neutralised polydextrose
               
            
                  Assay
               
               
                  Content not less than 90 % of polymer on the ash free and anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White to light tan-coloured solid. Polydextroses dissolve in water to give a clear, colourless to straw coloured solution
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for sugar and for reducing sugar
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              pH of a 10 % solution
                           
                        
               
                  Between 2,5 and 7,0 for polydextrose
               
            
                  Between 5,0 and 6,0 for polydextrose-N
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 4,0 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,3 % (polydextrose)
               
            
                  Not more than 2,0 % (polydextrose N)
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg for hydrogenated polydextroses
               
            
                  1,6-Anhydro-D-glucose
               
               
                  Not more than 4,0 % on the ash-free and the dried basis
               
            
                  Glucose and sorbitol
               
               
                  Not more than 6,0 % combined on the ash-free and the dried basis; glucose and sorbitol are determined separately
               
            
                  Molecular weight limit
               
               
                  Negative test for polymers of molecular weight greater than 22 000
               
            
                  5-Hydroxy-methylfurfural
               
               
                  Not more than 0,1 % (polydextrose)
               
            
                  Not more than 0,05 % (polydextrose-N)
               
            
                  Lead
               
               
                  Not more than 0,5 mg/kg
               
            E 1201 POLYVINYLPYRROLIDONE
      
                  
                     Synonyms
                  
               
               
                  Povidone
               
            
                  PVP
               
            
                  Soluble polyvinylpyrrolidone
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
               
            
                  Chemical formula
               
               
                  (C6H9NO)n
                  
               
            
                  Molecular weight
               
               
                  Not less than 25 000
               
            
                  Assay
               
               
                  Content not less than 11,5 % and not more than 12,8 % of nitrogen (N) on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water and in ethanol. Insoluble in ether
               
            
                  
                              B.
                           
                           
                              pH of a 5 % solution
                           
                        
               
                  Between 3,0 and 7,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 5 % (Karl Fischer)
               
            
                  Total ash
               
               
                  Not more than 0,1 %
               
            
                  Aldehyde
               
               
                  Not more than 500 mg/kg (as acetaldehyde)
               
            
                  Free-N-vinylpyrrolidone
               
               
                  Not more than 10 mg/kg
               
            
                  Hydrazine
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 1202 POLYVINYLPOLYPYRROLIDONE
      
                  
                     Synonyms
                  
               
               
                  Crospovidone
               
            
                  Cross linked polyvidone
               
            
                  Insoluble polyvinylpyrrolidone
               
            
                  
                     Definition
                  
               
               
                  Polyvinylpolypyrrolidone is a poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene], cross linked in a random fashion. It is produced by the polymerisation of N-vinyl-2-pyrrolidone in the presence of either caustic catalyst or N, N'-divinyl-imidazolidone. Due to its insolubility in all common solvents the molecular weight range is not amenable to analytical determination
               
            
                  Chemical name
               
               
                  Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
               
            
                  Chemical formula
               
               
                  (C6H9NO)n
                  
               
            
                  Assay
               
               
                  Content not less than 11 % and not more than 12,8 % nitrogen (N) on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A white hygroscopic powder with a faint, non-objectionable odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Insoluble in water, ethanol and ether
               
            
                  
                              B.
                           
                           
                              pH of a 1 % suspension in water
                           
                        
               
                  Between 5,0 and 8,0
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 6 % (Karl Fischer)
               
            
                  Sulphated ash
               
               
                  Not more than 0,4 %
               
            
                  Water-soluble matter
               
               
                  Not more than 1 %
               
            
                  Free-N-vinylpyrrolidone
               
               
                  Not more than 10 mg/kg
               
            
                  Free-N, N'-divinyl-imidazolidone
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 1204 PULLULAN
      
                  
                     Definition
                  
               
               
                  Linear, neutral glucan consisting mainly of maltotriose units connected by -1,6 glycosidic bonds. It is produced by fermentation from a food-grade hydrolysed starch using a non-toxin-producing strain of Aureobasidium pullulans. After completion of the fermentation, the fungal cells are removed by microfiltration, the filtrate is heat-sterilised and pigments and other impurities are removed by adsorption and ion exchange chromatography
               
            
                  Einecs
               
               
                  232-945-1
               
            
                  Chemical formula
               
               
                  (C6H10O5)x
                  
               
            
                  Assay
               
               
                  Not less than 90 % of glucan on the dried basis
               
            
                  
                     Description
                  
               
               
                  White to off-white odourless powder
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, practically insoluble in ethanol
               
            
                  
                              B.
                           
                           
                              pH of 10 % solution
                           
                        
               
                  5,0 to 7,0
               
            
                  
                              C.
                           
                           
                              Precipitation with polyethylene glycol 600
                           
                        
               
                  Add 2 ml of polyethylene glycol 600 to 10 ml of a 2 % aqueous solution of pullulan. A white precipitate is formed
               
            
                  
                              D.
                           
                           
                              Depoly-merisation with pullulanase
                           
                        
               
                  Prepare two test tubes each with 10 ml of a 10 % pullulan solution. Add 0,1 ml pullulanase solution having activity 10 units/g to one test tube, and 0,1 ml water to the other. After incubation at about 25 oC for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 6 % (90 oC, pressure not more than 50 mm Hg, 6 h)
               
            
                  Mono-, di- and oligosaccharides
               
               
                  Not more than 10 % expressed as glucose
               
            
                  Viscosity
               
               
                  100 to 180 mm2/s (10 % w/w aqueous solution at 30 oC)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Yeast and moulds
               
               
                  Not more than 100 colonies per gram
               
            
                  Coliforms
               
               
                  Absent in 25 g
               
            
                  Salmonella
               
               
                  Absent in 25 g
               
            E 1404 OXIDISED STARCH
      
                  
                     Definition
                  
               
               
                  Oxidised starch is starch treated with sodium hypochlorite
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Carboxyl groups
               
               
                  Not more than 1,1 %
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1410 MONOSTARCH PHOSPHATE
      
                  
                     Definition
                  
               
               
                  Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Residual phosphate
               
               
                  Not more than 0,5 % (as P) for wheat or potato starch
               
            
                  Not more than 0,4 % (as P) for other starches
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1412 DISTARCH PHOSPHATE
      
                  
                     Definition
                  
               
               
                  Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Residual phosphate
               
               
                  Not more than 0,5 % (as P) for wheat or potato starch
               
            
                  Not more than 0,4 % (as P) for other starches
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1413 PHOSPHATED DISTARCH PHOSPHATE
      
                  
                     Definition
                  
               
               
                  Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Residual phosphate
               
               
                  Not more than 0,5 % (as P) for wheat or potato starch
               
            
                  Not more than 0,4 % (as P) for other starches
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1414 ACETYLATED DISTARCH PHOSPHATE
      
                  
                     Definition
                  
               
               
                  Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Acetyl groups
               
               
                  Not more than 2,5 %
               
            
                  Residual phosphate
               
               
                  Not more than 0,14 % (as P) for wheat or potato starch
               
            
                  Not more than 0,04 % (as P) for other starches
               
            
                  Vinyl acetate
               
               
                  Not more than 0,1 mg/kg
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1420 ACETYLATED STARCH
      
                  
                     Synonyms
                  
               
               
                  Starch acetate
               
            
                  
                     Definition
                  
               
               
                  Acetylated starch is starch esterified with acetic anhydride or vinyl acetate
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Acetyl groups
               
               
                  Not more than 2,5 %
               
            
                  Vinyl acetate
               
               
                  Not more than 0,1 mg/kg
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1422 ACETYLATED DISTARCH ADIPATE
      
                  
                     Definition
                  
               
               
                  Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Acetyl groups
               
               
                  Not more than 2,5 %
               
            
                  Adipate groups
               
               
                  Not more than 0,135 %
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1440 HYDROXYPROPYL STARCH
      
                  
                     Definition
                  
               
               
                  Hydroxypropyl starch is starch etherified with propylene oxide
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Hydroxypropyl groups
               
               
                  Not more than 7,0 %
               
            
                  Propylene chlorohydrin
               
               
                  Not more than 1 mg/kg
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE
      
                  
                     Definition
                  
               
               
                  Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Hydroxypropyl groups
               
               
                  Not more than 7,0 %
               
            
                  Residual phosphate
               
               
                  Not more than 0,14 % (as P) for wheat or potato starch
               
            
                  Not more than 0,04 (as P) for other starches
               
            
                  Propylene chlorohydrin
               
               
                  Not more than 1 mg/kg
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1450 STARCH SODIUM OCTENYL SUCCINATE
      
                  
                     Synonyms
                  
               
               
                  SSOS
               
            
                  
                     Definition
                  
               
               
                  Starch sodium octenyl succinate is starch esterified with octenylsuccinic anhydride
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Octenylsuccinyl groups
               
               
                  Not more than 3 %
               
            
                  Octenylsuccinic acid residue
               
               
                  Not more than 0,3 %
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1451 ACETYLATED OXIDISED STARCH
      
                  
                     Definition
                  
               
               
                  Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % for cereal starch
               
            
                  Not more than 21,0 % for potato starch
               
            
                  Not more than 18,0 % for other starches
               
            
                  Carboxyl groups
               
               
                  Not more than 1,3 %
               
            
                  Acetyl groups
               
               
                  Not more than 2,5 %
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE
      
                  
                     Synonyms
                  
               
               
                  SAOS
               
            
                  
                     Definition
                  
               
               
                  Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              If not pregelatinised: by microscopic observation
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Iodine staining positive (dark blue to light red colour)
                           
                        
               
                   
               
            
                  
                     Purity (all values expressed on an anhydrous basis except for loss on drying)
               
               
                   
               
            
                  Loss on drying
               
               
                  Not more than 21,0 %
               
            
                  Octenylsuccinyl groups
               
               
                  Not more than 3 %
               
            
                  Octenylsuccinic acid residue
               
               
                  Not more than 0,3 %
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches
               
            
                  Not more than 10 mg/kg for the other modified starches, unless otherwise specified
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
                  Aluminium
               
               
                  Not more than 0,3 %
               
            E 1505 TRIETHYL CITRATE
      
                  
                     Synonyms
                  
               
               
                  Ethyl citrate
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
               
            
                  Einecs
               
               
                  201-070-7
               
            
                  Chemical formula
               
               
                  C12H20O7
                  
               
            
                  Molecular weight
               
               
                  276,29
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Odourless, practically colourless, oily liquid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Specific gravity
                           
                        
               
                  d25
                     25: 1,135-1,139
               
            
                  
                              B.
                           
                           
                              Refractive index
                           
                        
               
                  [n]D
                     20: 1,439-1,441
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,25 % (Karl Fischer method)
               
            
                  Acidity
               
               
                  Not more than 0,02 % (as citric acid)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 1517 GLYCERYL DIACETATE
      
                  
                     Synonyms
                  
               
               
                  Diacetin
               
            
                  
                     Definition
                  
               
               
                  Glyceryl diacetate consist predominantly of a mixture of the 1,2- and 1,3-diacetates of glycerol, with minor amounts of the mono- and tri-esters
               
            
                  Chemical names
               
               
                  Glyceryl diacetate
               
            
                  1, 2, 3-propanetriol diacetate
               
            
                  Chemical formula
               
               
                  C7H12O5
                  
               
            
                  Molecular weight
               
               
                  176,17
               
            
                  Assay
               
               
                  Not less than 94,0 %
               
            
                  
                     Description
                  
               
               
                  Clear, colourless, hygroscopic, somewhat oily liquid with a slight, fatty odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water. Miscible with ethanol
               
            
                  
                              B.
                           
                           
                              Positive tests for glycerol and acetate
                           
                        
               
                   
               
            
                  
                              C.
                           
                           
                              Specific gravity
                           
                        
               
                  d20
                     20: 1,175-1,195
               
            
                  
                              D.
                           
                           
                              Boiling range
                           
                        
               
                  Between 259 and 261 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Total ash
               
               
                  Not more than 0,02 %
               
            
                  Acidity
               
               
                  Not more than 0,4 % (as ascetic acid)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 1518 GLYCERYL TRIACETATE
      
                  
                     Synonyms
                  
               
               
                  Triacetin
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical name
               
               
                  Glyceryl triacetate
               
            
                  Einecs
               
               
                  203-051-9
               
            
                  Chemical formula
               
               
                  C9H14O6
                  
               
            
                  Molecular weight
               
               
                  218,21
               
            
                  Assay
               
               
                  Content not less than 98,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless, somewhat oily liquid having a slightly fatty odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Positive tests for acetate and for glycerol
                           
                        
               
                   
               
            
                  
                              B.
                           
                           
                              Refractive index
                           
                        
               
                  Between 1,429 and 1,431 at 25 oC
               
            
                  
                              C.
                           
                           
                              Specific gravity (25 oC/25 oC)
                           
                        
               
                  Between 1,154 and 1,158
               
            
                  
                              D.
                           
                           
                              Boiling range
                           
                        
               
                  Between 258 and 270 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Water
               
               
                  Not more than 0,2 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,02 % (as citric acid)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 1519 BENZYL ALCOHOL
      
                  
                     Synonyms
                  
               
               
                  Phenylcarbinol
               
            
                  Phenylmethyl alcohol
               
            
                  Benzenemethanol
               
            
                  Alpha-hydroxytoluene
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical names
               
               
                  Benzyl alcohol
               
            
                  Phenylmethanol
               
            
                  Chemical formula
               
               
                  C7H8O
               
            
                  Molecular weight
               
               
                  108,14
               
            
                  Assay
               
               
                  Not less than 98,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless, clear liquid with a faint, aromatic odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, ethanol and ether
               
            
                  
                              B.
                           
                           
                              Refractive index
                           
                        
               
                  [n]D
                     20: 1,538-1,541
               
            
                  
                              C.
                           
                           
                              Specific gravity
                           
                        
               
                  d25
                     25: 1,042-1,047
               
            
                  
                              D.
                           
                           
                              Positive test for peroxides
                           
                        
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Distillation range
               
               
                  Not less than 95 % v/v distils between 202 and 208 oC
               
            
                  Acid value
               
               
                  Not more than 0,5
               
            
                  Aldehydes
               
               
                  Not more than 0,2 % v/v (as bezaldehyde)
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            E 1520 PROPANE-1,2-DIOL
      
                  
                     Synonyms
                  
               
               
                  Propylene glycol
               
            
                  
                     Definition
                  
               
               
                   
               
            
                  Chemical names
               
               
                  1,2-dihydroxypropane
               
            
                  Einecs
               
               
                  200-338-0
               
            
                  Chemical formula
               
               
                  C3H8O2
                  
               
            
                  Molecular weight
               
               
                  76,10
               
            
                  Assay
               
               
                  Content not less than 99,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Clear, colourless, hygroscopic, viscous liquid
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Soluble in water, ethanol and acetone
               
            
                  
                              B.
                           
                           
                              Specific gravity
                           
                        
               
                  d20
                     20: 1,035-1,040
               
            
                  
                              C.
                           
                           
                              Refractive index
                           
                        
               
                  [n]20
                     D: 1,431-1,433
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Distillation range
               
               
                  99 % v/v distils between 185 oC-189 oC
               
            
                  Sulphated ash
               
               
                  Not more than 0,07 %
               
            
                  Water
               
               
                  Not more than 1,0 % (Karl Fischer method)
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            POLYETHYLENE GLYCOL 6000
      
                  
                     Synonyms
                  
               
               
                  PEG 6000
               
            
                  Macrogol 6000
               
            
                  
                     Definition
                  
               
               
                  Polyethylene glycol 6000 is a mixture of polymers with the general formula H-(OCH2-CH)-OH corresponding to an average relative molecular mass of approximately 6 000
               
            
                  Chemical formula
               
               
                  (C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000, about 140)
               
            
                  Molecular weight
               
               
                  5 600-7 000
               
            
                  Assay
               
               
                  Not less than 90,0 % and not more than 110,0 %
               
            
                  
                     Description
                  
               
               
                  A white or almost white solid with a waxy or paraffin-like appearance
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                              A.
                           
                           
                              Solubility
                           
                        
               
                  Very soluble in water and in methylene chloride. Practically insoluble in alcohol, in ether and in fatty and mineral oils
               
            
                  
                              B.
                           
                           
                              Melting range
                           
                        
               
                  Between 55 oC and 61 oC
               
            
                  
                     Purity
                  
               
               
                   
               
            
                  Viscosity
               
               
                  Between 0,220 and 0,275 kgm-1s-1 at 20 oC
               
            
                  Hydroxyl value
               
               
                  Between 16 and 22
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 %
               
            
                  Ethylene oxide
               
               
                  Not more than 0,2 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
         (1)  OJ L 226, 22.9.1995, p. 1.
      
         (2)  Starch TS: triturate 0,5 g starch (potato starch, maize starch or soluable starch) with 5 ml of water; to the resulting paste add a sufficient quantity of water to give a total volume of 100 ml, stirring all the time. Boil for a few minutes, allow to cool, filter. The starch must be freshly prepared.
      
         (3)  Cobalt chloride TSC: dissolve approximately 65 g of cobalt chloride CoCl2·6H2O in a sufficient quantity of a mixture of 25 ml hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place exactly 5 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 5 ml of 3 % hydrogen peroxide, then 15 ml of a 20 % solution of sodium hydroxide. Boil for 10 minutes, allow to cool, add 2 g of potassium iodide and 20 ml of 25 % sulphuric acid. After the precipitate is completely dissolved, titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (). 1 ml of sodium thiosulphate (0,1 N) corresponds to 23,80 mg of CoCl2·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 59,5 mg of CoCl2·6H2O per ml.
      
         (4)  Ferric chloride TSC: dissolve approximately 55 g of ferric chloride in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 15 ml of water and 3 g of potassium iodide; leave the mixture to stand for 15 minutes. Dilute with 100 ml of water then titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (). 1 ml of sodium thiosulphate (0,1 N) corresponds to 27,03 mg of FeCl3·6H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water to give a solution containing 45,0 mg of FeCl3·6H2O per ml.
      
         (5)  Copper sulphate TSC: dissolve approximate by 65 g of copper sulphate CuSO4·5H2O in a sufficient quantity of a mixture of 25 ml of hydrochloric acid and 975 ml of water to give a total volume of 1 litre. Place 10 ml of this solution in a round-bottomed flask containing 250 ml of iodine solution, add 40 ml of water, 4 ml of acetic acid and 3 g of potassium iodide. Titrate the liberated iodine with sodium thiosulphate (0,1 N) in the presence of starch TS (). 1 ml of sodium thiosulphate (0,1 N) corresponds to 24,97 mg of CuSO4·5H2O. Adjust final volume of solution by the addition of a sufficient quantity of the hydrochloric acid/water mixture to give a solution containing 62,4 mg of CuSO4·5H2O per ml.
      
         (6)  When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.
      
         (7)  When labelled ‘for food use’, nitrite may only be sold in a mixture with salt or a salt substitute.
      
         (8)  OJ L 158, 18.6.2008, p. 17.
   
   
      ANNEX II
      PART A
      Repealed Directive with list of its successive amendments
      
         (referred to in Article 2)
      
      
                  Commission Directive 96/77/EC
                  
                               
                           
                           
                              Commission Directive 98/86/EC
                           
                        
                               
                           
                           
                              Commission Directive 2000/63/EC
                           
                        
                               
                           
                           
                              Commission Directive 2001/30/EC
                           
                        
                               
                           
                           
                              Commission Directive 2002/82/EC
                           
                        
                               
                           
                           
                              Commission Directive 2003/95/EC
                           
                        
                               
                           
                           
                              Commission Directive 2004/45/EC
                           
                        
                               
                           
                           
                              Commission Directive 2006/129/EC
                           
                        
               
                  (OJ L 339, 30.12.1996, p. 1)
                  
                               
                           
                           
                              (OJ L 334, 9.12.1998, p. 1)
                           
                        
                               
                           
                           
                              (OJ L 277, 30.10.2000, p. 1)
                           
                        
                               
                           
                           
                              (OJ L 146, 31.5.2001, p. 1)
                           
                        
                               
                           
                           
                              (OJ L 292, 28.10.2002, p. 1)
                           
                        
                               
                           
                           
                              (OJ L 283, 31.10.2003, p. 71)
                           
                        
                               
                           
                           
                              (OJ L 113, 20.4.2004, p. 19)
                           
                        
                               
                           
                           
                              (OJ L 346, 9.12.2006, p. 15)
                           
                        
            PART B
      List of time-limits for transposition into national law
      
         (referred to in Article 2)
      
      
                  Directive
               
               
                  Time-limit for transposition
               
            
                  96/77/EC
               
               
                  1 July 1997 (1)
                  
               
            
                  98/86/EC
               
               
                  1 July 1999 (2)
                  
               
            
                  2000/63/EC
               
               
                  31 March 2001 (3)
                  
               
            
                  2001/30/EC
               
               
                  1 June 2002 (4)
                  
               
            
                  2002/82/EC
               
               
                  31 August 2003
               
            
                  2003/95/EC
               
               
                  1 November 2004 (5)
                  
               
            
                  2004/45/EC
               
               
                  1 April 2005 (6)
                  
               
            
                  2006/129/EC
               
               
                  15 February 2008
               
            
         (1)  According to Article 3(2) of Directive 96/77/EC, products put on the market or labelled before 1 July 1997 which do not comply with this Directive may be marketed until stocks are exhausted.
      
         (2)  According to Article 2(2) of Directive 98/86/EC, products put on the market or labelled before 1 July 1999 which do not comply with this Directive may be marketed until stocks are exhausted.
      
         (3)  According to Article 2(3) of Directive 2000/63/EC, products put on the market or labelled before 31 March 2001 which do not comply with this Directive may be marketed until stocks are exhausted.
      
         (4)  According to Article 2(3) of Directive 2001/30/EC, products put on the market or labelled before 1 June 2002 which do not comply with this Directive may be marketed until stocks are exhausted.
      
         (5)  According to Article 3 of Directive 2003/95/EC, products put on the market or labelled before 1 November 2004 which do not comply with this Directive may be marketed until stocks are exhausted.
      
         (6)  According to Article 3 of Directive 2004/45/EC, products put on the market or labelled before 1 April 2005 which do not comply with this Directive may be marketed until stocks are exhausted.
   
   
      ANNEX III
      Correlation table
      
                  Directive 96/77/EC
               
               
                  This Directive
               
            
                  Article 1
               
               
                  Article 1
               
            
                  Article 2
               
               
                  —
               
            
                  Article 3
               
               
                  —
               
            
                  —
               
               
                  Article 2
               
            
                  Article 4
               
               
                  Article 3
               
            
                  Article 5
               
               
                  Article 4
               
            
                  Annex
               
               
                  Annex I
               
            
                  —
               
               
                  Annex II
               
            
                  —
               
               
                  Annex III