CELEX: 32012R0231
Language: en
Date: 2012-03-09 00:00:00
Title: Commission Regulation (EU) No 231/2012 of 9 March 2012 laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council  Text with EEA relevance

22.3.2012   
            
            
               EN
            
            
               Official Journal of the European Union
            
            
               L 83/1
            
         COMMISSION REGULATION (EU) No 231/2012
   of 9 March 2012
   laying down specifications for food additives listed in Annexes II and III to Regulation (EC) No 1333/2008 of the European Parliament and of the Council
   (Text with EEA relevance)
   THE EUROPEAN COMMISSION,
   Having regard to the Treaty on the Functioning of the European Union,
   Having regard to Regulation (EC) No 1333/2008 of the European Parliament and of the Council of 16 December 2008 on food additives (1), and in particular Articles 14 and 30(4) thereof, and Regulation (EC) No 1331/2008 of the European Parliament and of the Council of 16 December 2008 establishing a common authorisation procedure for food additives, food enzymes and food flavourings (2), and in particular Article 7(5) thereof,
   Whereas:
   
               (1)
            
            
               Specifications relating to origin, purity criteria and any other necessary information should be adopted for food additives listed in the Union lists in Annex II and III to Regulation (EC) No 1333/2008.
            
         
               (2)
            
            
               To that end, specifications previously developed for food additives in Commission Directive 2008/128/EC of 22 December 2008 laying down specific purity criteria concerning colours for use in foodstuffs (3), Commission Directive 2008/84/EC of 27 August 2008 laying down specific purity criteria on food additives other than colours and sweeteners (4) and Commission Directive 2008/60/EC of 17 June 2008 laying down specific purity criteria concerning sweeteners for use in foodstuffs (5) should be updated and taken over to this Regulation. As a consequence, those Directives should be repealed.
            
         
               (3)
            
            
               It is necessary to take into account the specifications and analytical techniques as set out in the Codex Alimentarius drafted by the Joint FAO/WHO Expert Committee on Food Additives (hereafter JECFA).
            
         
               (4)
            
            
               The European Food Safety Authority (hereinafter ‘the Authority’) expressed its opinion on the safety of basic methacrylate copolymer (6) as a glazing agent. That food additive has subsequently been authorised on the basis of specific uses and has been allocated the number E 1205. Therefore specifications should be adopted for that food additive.
            
         
               (5)
            
            
               Food colours ethyl ester of beta-apo-8'-carotenic acid (E 160 f), and brown FK (E 154), as well as the aluminium containing carrier bentonite (E 558) are not used any more according to information submitted by food manufacturers. Therefore, current specifications for those food additives should not be taken over to this Regulation.
            
         
               (6)
            
            
               On 10 February 2010 the Authority expressed an opinion on the safety of sucrose esters of fatty acids (E 473) prepared from vinyl esters of fatty acids (7). Current specifications should be adapted accordingly in particular by reducing maximum limits for impurities of safety concern.
            
         
               (7)
            
            
               Specific purity criteria currently applicable should be adapted by reducing maximum limits for individual heavy metals of interest where feasible and where the JECFA limits are lower than those currently in force. Pursuant to that approach maximum limits for the contaminant 4-methylimidazole in ammonia caramel (E 150 c), sulphated ash in beta-carotene (E 160 a (i)), and magnesium and alkali salts in calcium carbonate (E 170), should be lowered. That approach should be departed from only for additives trisodium citrate (E 331 (iii)) (lead content), carrageenan (E 407) and processed euchema seaweed (E407 a) (cadmium content), as manufacturers have declared that compliance with stricter Union provisions, reflecting JECFA limits, would not be technically feasible. The contribution to the total intake of those two contaminants (lead and cadmium) in those three individual food additives is not considered to be significant. On the contrary for phosphates (E 338-E 341 and E 450-E 452) new significantly lower values, compared to the ones indicated by JECFA, should be established due to new developments of the manufacturing processes, by taking into account the recent recommendations of the Authority on a reduction of the intake of arsenic, especially in the inorganic form (8). In addition, a new provision on arsenic for glutamic acid (E 620) should be introduced for safety reasons. The total balance of those adaptations benefits the consumers as maximum limits for heavy metals are becoming stricter in general and in most of the food additives. Detailed information on the production process and starting materials of a food additive should be included in the specifications to facilitate any future decision pursuant to Article 12 of Regulation (EC) No 1333/2008.
            
         
               (8)
            
            
               Specifications should not make reference to organoleptic tests related to the taste as it cannot be expected by the control authorities to take the risk to taste a chemical substance.
            
         
               (9)
            
            
               Specifications should not make reference to classes as there is no added value in this reference.
            
         
               (10)
            
            
               Specifications should not make reference to the general parameter ‘Heavy metals’ as this parameter does not relate with toxicity, but rather with a generic analytical method. Parameters related to individual heavy metals are toxicity related and are included in the specifications.
            
         
               (11)
            
            
               Some food additives are currently listed under various names (carboxy methyl cellulose (E 466), cross-linked sodium carboxymethylcellulose (E 468), enzymatically hydrolised carboxymethylcellulose (E 469) and beeswax, white and yellow (E 901)) in various provisions of Directive 95/2/EC of the European Parliament and of the Council (9). Therefore the specifications established by this Regulation should refer to those various names.
            
         
               (12)
            
            
               Current provisions on Polycyclic Aromatic Hydrocarbons (PAHs) are too generic and not relevant to safety and should be replaced by maximum limits for individual PAHs of concern for food additives vegetable carbon (E 153) and microcrystalline wax (E 905). Similar maximum limits should be established for formaldehyde in carageenan (E 407) and processed euchema seaweed (E 407 a), for particular microbiological criteria in agar (E 406) and for Salmonella spp. content in mannitol (E 421 (ii)) manufactured by fermentation.
            
         
               (13)
            
            
               The use of propan-2-ol (isopropanol, isopropyl alcohol) should be allowed for manufacturing the additives curcumin (E 100) and paprika extract (E 160 c), in line with JECFA specifications, as this particular use has been considered safe by the Authority (10). The use of ethanol in replacement of propan-2-ol in the manufacturing of gellan gum (E 418) should be permitted where the final product still complies with all other specifications and ethanol is considered to be of less safety concern.
            
         
               (14)
            
            
               The percentage of the colouring principle in cochineal, carminic acid, carmines (E 120) should be specified, as maximum limits are to apply to quantities of that principle.
            
         
               (15)
            
            
               The numbering system for subcategories of carotenes (E 160 a) should be updated in order to bring it in line with the Codex Alimentarius numbering system.
            
         
               (16)
            
            
               The solid form of lactic acid (E 270) should also be included in the specifications, as it can now be manufactured in the solid form and there is no safety concern.
            
         
               (17)
            
            
               The current temperature value in loss on drying for monosodium citrate (E 331 (i)), anhydrous form should be adjusted as under the currently listed conditions the substance decomposes. Drying conditions for trisodium citrate (E 331 (iii)) should also be adjusted to improve the reproducibility of the method.
            
         
               (18)
            
            
               The current specific absorption value for alpha-tocopherol (E 307) should be corrected and the sublimation point for sorbic acid (E 200) should be replaced by a ‘solubility test’ as the former is not relevant. The specification of bacterial sources for the manufacturing of nisin (E 234) and natamycin (E 235) should be updated according to the current taxonomic nomenclature.
            
         
               (19)
            
            
               As new innovative manufacturing techniques resulting in less contaminated food additives are now available, the presence of aluminium in food additives should be restricted. In order to enhance legal certainty and non-discrimination it is appropriate to provide the manufacturers of food additives with a transitional period to adapt gradually to those restrictions.
            
         
               (20)
            
            
               Maximum limits for aluminium should be established for food additives where relevant, and particularly for calcium phosphates (E 341 (i)-(iii)) intended to be used in food for infants and young children (11), according to the relevant opinion of Scientific Committee on Food expressed on 7 June 1996 (12). In this framework a maximum limit for aluminum in calcium citrate (E 333) should also be established.
            
         
               (21)
            
            
               The maximum limits for aluminium in calcium phosphates (E 341 (i)-(iii)), disodium diphosphate (E 450 (i)) and calcium dihydrogen diphosphate (E 450 (vii)) should be in accordance with the opinion of the Authority of 22 May 2008 (13). Current limits should be reduced, where this is technically feasible, and where the contribution to the total aluminium intake is significant. In this framework aluminium lakes of individual food colours should be authorised only if technically needed.
            
         
               (22)
            
            
               Provisions on maximum limits for aluminium in dicalcium phosphate (E 341 (ii)), tricalcium phosphate (E 341 (iii)) and calcium dihydrogen diphosphate (E 450 (vii)) should not cause any disruption of the market, due to a possible lack of supplies.
            
         
               (23)
            
            
               According to Commission Regulation (EU) No 258/2010 of 25 March 2010 imposing special conditions on the imports of guar gum originating in or consigned from India due to contamination risks by pentachlorophenol and dioxins (14), maximum limits should be set for the contaminant pentachlorophenol in guar gum (E 412).
            
         
               (24)
            
            
               According to recital 48 of Commission Regulation (EC) No 1881/2006 of 19 December 2006 setting maximum levels for certain contaminants in foodstuffs (15) Member States are requested to examine other foodstuffs than the ones included in that Regulation for the occurrence of contaminant 3-MCPD in order to consider the need to set maximum levels for that substance. French authorities have submitted data on high concentrations of 3-MCPD in the food additive glycerol (E 422) and the average use level of this food additive in various food categories. Maximum limits for 3-MCPD in this particular food additive should be set in order to avoid contamination of the final food at a higher than permissible level, taking into account the dilution factor.
            
         
               (25)
            
            
               Due to the development of analytical methods certain current specifications should be updated. The current limit value ‘not detectable’ is linked to the evolution of analytical methodologies and should be replaced by a specific number for additives acid esters of mono- and diglycerides (E 472 a-f), polyglycerol esters of fatty acids (E 475) and propane-1,2-diol esters of fatty acids (E 477).
            
         
               (26)
            
            
               Specifications relating to the manufacturing procedure should be updated for citric acid esters of mono- and diglycerides of fatty acids (E 472 c), as the use of alkaline bases is replaced today by the use of their milder acting salts.
            
         
               (27)
            
            
               The current criterion ‘free fatty acids’ for additives citric acid esters of mono- and diglycerides of fatty acids (E 472 c) and mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472 e) is not appropriate. It should be replaced by the criterion ‘acid value’ as the latter expresses better the titrimetric estimation of the free acidic groups. This is in accordance with the 71st report on food additives from JECFA (16) where such change was adopted for mono- and diacetyltartaric acid esters of mono- and diglycerides of fatty acids (E 472 e).
            
         
               (28)
            
            
               The current erroneous description of additive magnesium oxide (E 530) should be corrected according to information submitted by the manufacturers, in order to bring it in line with the Pharmacopoeia Europea (17). The current maximum value for the reducing matter in additive gluconic acid (E 574) should also be updated as this limit is not technically feasible. For the estimation of the water content of xylitol (E 967) the current method based on ‘loss on drying’, should be replaced by a more appropriate method.
            
         
               (29)
            
            
               Some current specifications for additive candelilla wax (E 902) should not be taken over to this Regulation since they are erratic. For calcium dihydrogen diphosphate (E 450 (vii)) the current entry concerning P2O5 content should be corrected.
            
         
               (30)
            
            
               In the current entry ‘assay’ for thaumatin (E 957) a calculation factor should be corrected. That factor is to be used in the Kjeldahl method for the estimation of the total content of the substance based on the measurement of nitrogen. The calculation factor should be updated according to the relevant published literature for thaumatin (E 957).
            
         
               (31)
            
            
               The Authority evaluated the safety of steviol glycosides, as a sweetener and expressed its opinion of 10 March 2010 (18). The use of steviol glycosides, which have been allocated number E 960, has subsequently been permitted on the basis of well defined conditions of use. Therefore specifications should be adopted for this food additive.
            
         
               (32)
            
            
               Due to a taxonomic change, current specifications for source materials (yeasts) used in the manufacturing of erythritol (E 968) should be updated.
            
         
               (33)
            
            
               For quillaia extract (E 999) the current specification relating to the pH range should be adjusted in order to bring it in line with JECFA.
            
         
               (34)
            
            
               The combination of citric acid and phosphoric acid (which are currently both individually authorised for use in the manufacturing of additive polydextrose (E 1200)), should be allowed, where the final product still complies with the purity specifications, as it improves yields and results to more controllable reaction kinetics. There is no safety concern involved in such amendment.
            
         
               (35)
            
            
               Unlike for small molecules, the molecular mass of a polymer is not one unique value. A given polymer may have a distribution of molecules with different masses. The distribution may depend on the way the polymer is produced. Polymer physical properties and behaviors are related to the mass and to the distribution of molecules with a certain mass in the mixture. A group of mathematical models describe the mixture in different ways in order to clarify the distribution of molecules in the mixture. Among the different models available, it is recommended in scientific literature to use the weight average molecular weight (Mw) to describe polymers. The specifications for polyvinylpyrrolidone (E 1201) should be adjusted accordingly.
            
         
               (36)
            
            
               The criterion ‘Distillation range’ referred to in current specifications for propane-1,2 diol (E 1520) leads to contradictory conclusions compared to results from the assay. That criterion should therefore be corrected and renamed into ‘Distillation test’.
            
         
               (37)
            
            
               The measures provided for in this Regulation are in accordance with the opinion of the Standing Committee on the Food Chain and Animal Health and neither the European Parliament nor the Council has opposed them,
            
         HAS ADOPTED THIS REGULATION:
   Article 1
   Specifications for food additives
   Specifications for food additives including colours and sweeteners listed in Annex II and III to Regulation (EC) No 1333/2008 are laid down in the Annex to this Regulation.
   Article 2
   Repeals
   Directives 2008/60/EC, 2008/84/EC and 2008/128/EC are repealed with effect from 1 December 2012.
   Article 3
   Transitional measures
   Foodstuffs containing food additives that have been lawfully placed on the market before 1 December 2012, but do not comply with this Regulation, may continue to be marketed until stocks are exhausted.
   Article 4
   Entry into force
   This Regulation shall enter into force on the 20th day following its publication in the Official Journal of the European Union.
   It shall apply from 1 December 2012.
   However, the specifications laid down in the Annex for additives steviol glycosides (E 960) and basic methacrylate copolymer (E 1205) shall apply from the date of entry into force of this Regulation.
   
      This Regulation shall be binding in its entirety and directly applicable in the Member States.
      Done at Brussels, 9 March 2012.
      
         
            For the Commission
         
         
            The President
         
         José Manuel BARROSO
      
   
   
      (1)  OJ L 354, 31.12.2008, p. 16.
   
      (2)  OJ L 354, 31.12.2008, p. 1.
   
      (3)  OJ L 6, 10.1.2009, p. 20.
   
      (4)  OJ L 253, 20.9.2008, p. 1.
   
      (5)  OJ L 158, 18.6.2008, p. 17.
   
      (6)  EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the use of Basic Methacrylate Copolymer as a food additive on request from the European Commission. EFSA Journal 2010; 8(2):1513.
   
      (7)  EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the safety of sucrose esters of fatty acids prepared from vinyl esters of fatty acids and on the extension of use of sucrose esters of fatty acids in flavourings on request from the European Commission. EFSA Journal 2010; 8(3):1512.
   
      (8)  EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Arsenic in Food. EFSA Journal 2009; 7(10):1351.
   
      (9)  OJ L 61, 18.3.1995, p. 1.
   
      (10)  EFSA Panel on Food Additives and Nutrient Sources added to Food (ANS); Scientific Opinion on the re-evaluation of curcumin (E 100) as a food additive. EFSA Journal 2010; 8(9):1679.
   
      (11)  As defined in Commission Directive 2006/125/EC of 5 December 2006 on processed cereal-based foods and baby foods for infants and young children (codified version), OJ L 339, 6.12.2006, p. 16.
   
      (12)  Opinion on Additives in nutrient preparations for use in infant formulae, follow-on formulae and weaning foods. Reports of the Scientific Committee on food (40th Series), p. 13-30, (1997).
   
      (13)  Scientific Opinion of the Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials on a request from European Commission on Safety of aluminium from dietary intake. EFSA Journal (2008) 754, 1-34.
   
      (14)  OJ L 80, 26.3.2010, p. 28.
   
      (15)  OJ L 364, 20.12.2006, p. 5.
   
      (16)  WHO Technical Report Series, No 956, 2010.
   
      (17)  EP 7.0 volume 2, p. 2415-2416.
   
      (18)  EFSA Panel on Food Additives and Nutrient Sources (ANS); Scientific Opinion on the safety of steviol glycosides for the proposed uses as a food additive. EFSA Journal (2010); 8(4):1537.
   
      ANNEX
      
         Note: Ethylene oxide may not be used for sterilising purposes in food additives
      
         Aluminium lakes for use in colours only where explicitly stated.
      
      
                  
                     Definition:
                  
               
               
                  Aluminium lakes are prepared by reacting colours complying with the purity criteria set out in the appropriate specification monograph with alumina under aqueous conditions. The alumina is usually freshly prepared undried material made by reacting aluminium sulphate or chloride with sodium or calcium carbonate or bicarbonate or ammonia. Following lake formation, the product is filtered, washed with water and dried. Unreacted alumina may also be present in the finished product.
               
            
                  HCl insoluble matter
               
               
                  Not more than 0,5 %
               
            
                  ΝaΟΗ insoluble matter
               
               
                  Νot more than 0,5 %, for Ε 127 erythrosine only
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % (under neutral conditions)
                  Specific purity criteria for the corresponding colours are applicable.
               
            
         E 100 CURCUMIN
      
      
                  
                     Synonyms
                  
               
               
                  CI Natural Yellow 3; Turmeric Yellow; Diferoyl Methane
               
            
                  
                     Definition
                  
               
               
                  Curcumin is obtained by solvent extraction of turmeric i.e. the ground rhizomes of strains of Curcuma longa L. In order to obtain a concentrated curcumin powder, the extract is purified by crystallization. The product consists essentially of curcumins; i.e. the colouring principle (1,7-bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-dien-3,5-dione) and its two desmethoxy derivatives in varying proportions. Minor amounts of oils and resins naturally occurring in turmeric may be present.
                  Curcumin is also used as the aluminium lake; the aluminium content is less than 30 %.
                  Only the following solvents may be used in the extraction: ethylacetate, acetone, carbon dioxide, dichloromethane, n-butanol, methanol, ethanol, hexane, propan-2-ol.
               
            
                  Colour Index No
               
               
                  75300
               
            
                  Einecs
               
               
                  207-280-5
               
            
                  Chemical name
               
               
                  
                              I
                           
                           
                              1,7-Bis(4-hydroxy-3-methoxyphenyl)hepta-1,6-diene-3,5-dione
                           
                        
                              II
                           
                           
                              1-(4-Hydroxyphenyl)-7-(4-hydroxy-3-methoxy-phenyl-)hepta-1,6-diene-3,5-dione
                           
                        
                              III
                           
                           
                              1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione
                           
                        
            
                  Chemical formula
               
               
                  
                              I
                           
                           
                              C21H20O6
                              
                           
                        
                              II
                           
                           
                              C20H18O5
                              
                           
                        
                              III
                           
                           
                              C19H16O4
                              
                           
                        
            
                  Molecular weight
               
               
                  
                              I.
                           
                           
                              368,39
                           
                        
               
                  
                              II.
                           
                           
                              338,39
                           
                        
               
                  
                              III.
                           
                           
                              308,39
                           
                        
            
                  Assay
               
               
                  Content not less than 90 % total colouring matters
                  
                     1 607 at ca. 426 nm in ethanol
               
            
                  
                     Description
                  
               
               
                  Orange-yellow crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in ethanol at ca. 426 nm
               
            
                  Melting range
               
               
                  179 °C-182 °C
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Ethylacetate
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Acetone
               
            
                  n-butanol
               
            
                  Methanol
               
            
                  Ethanol
               
            
                  Hexane
               
            
                  Propan-2-ol
               
            
                  Dichloromethane: not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 101 (i) RIBOFLAVIN
      
      
                  
                     Synonyms
                  
               
               
                  Lactoflavin;
               
            
                  
                     Definition
                  
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  201-507-1
               
            
                  Chemical name
               
               
                  7,8-Dimethyl-10-(D-ribo-2,3,4,5-tetrahydroxypentyl)benzo(g)pteridine-2,4(3H,10H)-dione; 7,8-dimethyl-10-(1′-D-ribityl)isoalloxazine
               
            
                  Chemical formula
               
               
                  C17H20N4O6
                  
               
            
                  Molecular weight
               
               
                  376,37
               
            
                  Assay
               
               
                  Content not less than 98 % on the anhydrous basis
                  
                      328 at ca. 444 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Yellow to orange-yellow crystalline powder, with slight odour
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  The ratio A375/A267 is between 0,31 and 0,33
               
               
                  in aqueous solution
               
            
                  The ratio A444/A267 is between 0,36 and 0,39
               
            
                  Maximum in water at ca. 375 nm
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between – 115° and – 140° in a 0,05 N sodium hydroxide solution
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1,5 % (105 °C, 4 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Primary aromatic amines
               
               
                  Not more than 100 mg/kg (calculated as aniline)
               
            
                  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 101 (ii) RIBOFLAVIN-5′-PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Riboflavin-5′-phosphate sodium
               
            
                  
                     Definition
                  
               
               
                  These specifications apply to riboflavin 5′-phosphate together with minor amounts of free riboflavin and riboflavin diphosphate.
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  204-988-6
               
            
                  Chemical name
               
               
                  Monosodium(2R,3R,4S)-5-(3′)10′-dihydro-7′,8′-dimethyl-2′,4′-dioxo-10′-benzo[γ]pteridinyl)-2,3,4-trihydroxypentyl phosphate; monosodium salt of 5′-monophosphate ester of riboflavin
               
            
                  Chemical formula
               
               
                  For the dihydrate form: C17H20N4NaO9P · 2H2O
               
            
                  For the anhydrous form: C17H20N4NaO9P
               
            
                  Molecular weight
               
               
                  514,36
               
            
                  Assay
               
               
                  Content not less than 95 % total colouring matters calculated as C17H20N4NaO9P.2H2O
                  
                      250 at ca. 375 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Yellow to orange crystalline hygroscopic powder, with slight odour
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  The ratio A375/A267 is between 0,30 and 0,34
               
               
                  in aqueous solution
               
            
                  The ratio A444/A267 is between 0,35 and 0,40
               
            
                  Maximum in water at ca. 375 nm
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 38° and + 42° in a 5 molar HCl solution
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 8 % (100 °C, 5 hours in vacuum over P2O5) for the dihydrate form
               
            
                  Sulphated ash
               
               
                  Not more than 25 %
               
            
                  Inorganic phosphate
               
               
                  Not more than 1,0 % (calculated as PO4 on the anhydrous basis)
               
            
                  Subsidiary colouring matters
               
               
                  Riboflavin (free): Not more than 6 %
                  Riboflavine diphosphate: Not more than 6 %
               
            
                  Primary aromatic amines
               
               
                  Not more than 70 mg/kg (calculated as aniline)
               
            
                  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 102 TARTRAZINE
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Yellow 4
               
            
                  
                     Definition
                  
               
               
                  Tartrazine is prepared from 4-amino-benzenesulphonic acid, which is diazotized using hydrochloric acid and sodium nitrite. The diazo compound is then coupled with 4,5-dihydro-5-oxo-1-(4sulphophenyl)-1H-pyrazole-3-carboxylic acid or with the methyl ester, the ethyl ester, or a salt of this carboxylic acid. The resulting dye is purified and isolated as the sodium salt. Tartrazine consists essentially of trisodium 5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
                  Tartrazine is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  19140
               
            
                  Einecs
               
               
                  217-699-5
               
            
                  Chemical name
               
               
                  Trisodium-5-hydroxy-1-(4-sulfonatophenyl)-4-(4-sulfonatophenylazo)-H-pyrazole-3-carboxylate
               
            
                  Chemical formula
               
               
                  C16H9N4Na3O9S2
                  
               
            
                  Molecular weight
               
               
                  534,37
               
            
                  Assay
               
               
                  Content not less than 85 % total colouring matters calculated as the sodium salt
                  
                      530 at ca. 426 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Light orange powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Yellow
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 426 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 1,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  4-hydrazinobenzene sulfonic acid
               
               
                  Total not more than 0,5 %
               
            
                  4-aminobenzene-1-sulfonic acid
               
            
                  5-oxo-1-(4-sulfophenyl)-2-pyrazoline-3-carboxylic acid
               
            
                  4,4′-diazoaminodi(benzene sulfonic acid)
               
            
                  Tetrahydroxysuccinic acid
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 104 QUINOLINE YELLOW
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Yellow 13
               
            
                  
                     Definition
                  
               
               
                  Quinoline Yellow is prepared by sulfonating 2-(2-quinolyl) indan-1,3-dione or a mixture containing about two thirds 2-(2-quinolyl)indane-1,3-dione and one third 2-(2-(6-methylquinolyl))indane-1,3-dione. Quinoline Yellow consists essentially of sodium salts of a mixture of disulfonates (principally), monosulfonates and trisulfonates of the above compound and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
                  Quinoline Yellow is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  47005
               
            
                  Einecs
               
               
                  305-897-5
               
            
                  Chemical name
               
               
                  The disodium salts of the disulfonates of 2-(2-quinolyl) indan-1,3-dione (principal component)
               
            
                  Chemical formula
               
               
                  C18H9N Na2O8S2 (principal component)
               
            
                  Molecular weight
               
               
                  477,38 (principal component)
               
            
                  Assay
               
               
                  Content not less than 70 % total colouring matters calculated as the sodium salt
                  Quinoline Yellow shall have the following composition:
                  Of the total colouring matters present:
                  
                              —
                           
                           
                              not less than 80 % shall be disodium 2-(2-quinolyl) indan-1,3-dione-disulfonates
                           
                        
                              —
                           
                           
                              not more than 15 % shall be sodium 2-(2-quinolyl) indan-1,3-dione-monosulfonates
                           
                        
                              —
                           
                           
                              not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate
                           
                        
                      865 (principal component) at ca. 411 nm in aqueous acetic acid solution
               
            
                  
                     Description
                  
               
               
                  Yellow powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Yellow
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in aqueous acetic acid solution of pH 5 at ca. 411 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 4,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  2-methylquinoline
               
               
                  Total not more than 0,5 %
               
            
                  2-methylquinoline-sulfonic acid
               
            
                  Phthalic acid
               
            
                  2,6-dimethyl quinoline
               
            
                  2,6-dimethyl quinoline sulfonic acid
               
            
                  2-(2-quinolyl)indan-1,3-dione
               
               
                  Not more than 4 mg/kg
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 110 SUNSET YELLOW FCF
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Yellow 3; Orange Yellow S
               
            
                  
                     Definition
                  
               
               
                  Sunset Yellow FCF consists essentially of disodium 2-hydroxy-1-(4-sulfonatophenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Sunset Yellow FCF is manufactured by diazotizing 4-aminobenzenesulphonic acid using hydrochloric acid and sodium nitrite or sulphuric acid and sodium nitrite. The diazo compound is coupled with 6-hydroxy-2-naphthalene-sulphonic acid. The dye is isolated as the sodium salt and dried.
                  Sunset Yellow FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  15985
               
            
                  Einecs
               
               
                  220-491-7
               
            
                  Chemical name
               
               
                  Disodium 2-hydroxy-1-(4-sulfonatophenylazo)naphthalene-6-sulfonate
               
            
                  Chemical formula
               
               
                  C16H10N2Na2O7S2
                  
               
            
                  Molecular weight
               
               
                  452,37
               
            
                  Assay
               
               
                  Content not less than 85 % total colouring matters calculated as the sodium salt
                  
                      555 at ca. 485 nm in aqueous solution at pH 7
               
            
                  
                     Description
                  
               
               
                  Orange-red powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Orange
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 485 nm at pH 7
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 5,0 %
               
            
                  1-(Phenylazo)-2-naphthalenol (Sudan I)
               
               
                  Not more than 0,5 mg/kg
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  4-aminobenzene-1-sulfonic acid
               
               
                  Total not more than 0,5 %
               
            
                  3-hydroxynaphthalene-2,7-disulfonic acid
               
            
                  6-hydroxynaphthalene-2-sulfonic acid
               
            
                  7-hydroxynaphthalene-1,3-disulfonic acid
               
            
                  4,4′-diazoaminodi(benzene sulfonic acid)
               
            
                  6,6′-oxydi(naphthalene-2-sulfonic acid)
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 120 COCHINEAL, CARMINIC ACID, CARMINES
      
      
                  
                     Synonyms
                  
               
               
                  CI Natural Red 4
               
            
                  
                     Definition
                  
               
               
                  Carmines and carminic acid are obtained from aqueous, aqueous alcoholic or alcoholic extracts from Cochineal, which consists of the dried bodies of the female insect Dactylopius coccus Costa.
                  The colouring principle is carminic acid.
                  Aluminium lakes of carminic acid (carmines) can be formed in which aluminium and carminic acid are thought to be present in the molar ratio 1:2.
                  In commercial products the colouring principle is present in association with ammonium, calcium, potassium or sodium cations, singly or in combination, and these cations may also be present in excess.
                  Commercial products may also contain proteinaceous material derived from the source insect, and may also contain free carminate or a small residue of unbound aluminium cations.
               
            
                  Colour Index No
               
               
                  75470
               
            
                  Einecs
               
               
                  Cochineal: 215-680-6; carminic acid: 215-023-3; carmines: 215-724-4
               
            
                  Chemical name
               
               
                  7-β-D-glucopyranosyl-3,5,6,8-tetrahydroxy-1-methyl-9,10-dioxoanthracene-2-carboxylic acid (carminic acid); carmine is the hydrated aluminium chelate of this acid
               
            
                  Chemical formula
               
               
                  C22H20O13 (carminic acid)
               
            
                  Molecular weight
               
               
                  492,39 (carminic acid)
               
            
                  Assay
               
               
                  Content not less than 2,0 % carminic acid in the extracts containing carminic acid; not less than 50 % carminic acid in the chelates.
               
            
                  
                     Description
                  
               
               
                  Red to dark red, friable, solid or powder. Cochineal extract is generally a dark red liquid but can also be dried as a powder.
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in aqueous ammonia solution at ca. 518 nm
                  Maximum in dilute hydrochloric solution at ca. 494 nm for carminic acid
                  
                      139 at peak around 494 nm in dilute hydrochloric acid for carminic acid
               
            
                  
                     Purity
                  
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 122 AZORUBINE, CARMOISINE
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Red 3
               
            
                  
                     Definition
                  
               
               
                  Azorubine consists essentially of disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
                  Azorubine is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  14720
               
            
                  Einecs
               
               
                  222-657-4
               
            
                  Chemical name
               
               
                  Disodium 4-hydroxy-3-(4-sulfonato-1-naphthylazo) naphthalene-1-sulfonate
               
            
                  Chemical formula
               
               
                  C20H12N2Na2O7S2
                  
               
            
                  Molecular weight
               
               
                  502,44
               
            
                  Assay
               
               
                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  
                      510 at ca. 516 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Red to maroon powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Red
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 516 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 1 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  4-aminonaphthalene-1-sulfonic acid
               
               
                  Total not more than 0,5 %
               
            
                  4-hydroxynaphthalene-1-sulfonic acid
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 123 AMARANTH
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Red 9
               
            
                  
                     Definition
                  
               
               
                  Amaranth consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Amaranth is manufactured by coupling 4-amino-1-naphthalenesulphonic acid with 3-hydroxy-2,7-naphthalenedisulphonic acid.
                  Amaranth is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  16185
               
            
                  Einecs
               
               
                  213-022-2
               
            
                  Chemical name
               
               
                  Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-3,6-disulfonate
               
            
                  Chemical formula
               
               
                  C20H11N2Na3O10S3
                  
               
            
                  Molecular weight
               
               
                  604,48
               
            
                  Assay
               
               
                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  
                      440 at ca. 520 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Reddish-brown powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Red
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 520 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 3,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  4-aminonaphthalene-1-sulfonic acid
               
               
                  Total not more than 0,5 %
               
            
                  3-hydroxynaphthalene-2,7-disulfonic acid
               
            
                  6-hydroxynaphthalene-2-sulfonic acid
               
            
                  7-hydroxynaphthalene-1,3-disulfonic acid
               
            
                  7-hydroxynaphthalene-1,3-6-trisulfonic acid
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 124 PONCEAU 4R, COCHINEAL RED A
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Red 7; New Coccine
               
            
                  
                     Definition
                  
               
               
                  Ponceau 4R consists essentially of trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Ponceau 4R is manufactured by coupling diazotized naphthionic acid to G acid (2-naphthol-6,8- disulphonic acid) and converting the coupling product to the trisodium salt.
                  Ponceau 4R is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  16255
               
            
                  Einecs
               
               
                  220-036-2
               
            
                  Chemical name
               
               
                  Trisodium 2-hydroxy-1-(4-sulfonato-1-naphthylazo) naphthalene-6,8-disulfonate
               
            
                  Chemical formula
               
               
                  C20H11N2Na3O10S3
                  
               
            
                  Molecular weight
               
               
                  604,48
               
            
                  Assay
               
               
                  Content not less than 80 % total colouring matters, calculated as the sodium salt.
                  
                      430 at ca. 505 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Reddish powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Red
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 505 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 1,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  4-aminonaphthalene-1-sulfonic acid
               
               
                  Total not more than 0,5 %
               
            
                  7-hydroxynaphthalene-1,3-disulfonic acid
               
            
                  3-hydroxynaphthalene-2,7-disulfonic acid
               
            
                  6-hydroxynaphthalene-2-sulfonic acid
               
            
                  7-hydroxynaphthalene-1,3-6-trisulfonic acid
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 127 ERYTHROSINE
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Red 14
               
            
                  
                     Definition
                  
               
               
                  Erythrosine consists essentially of disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl) benzoate monohydrate and subsidiary colouring matters together with water, sodium chloride and/or sodium sulphate as the principal uncoloured components. Erythrosine is manufactured by iodination of fluorescein, the condensation product of resorcinol and phthalic anhydride
                  Erythrosine is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  45430
               
            
                  Einecs
               
               
                  240-474-8
               
            
                  Chemical name
               
               
                  Disodium 2-(2,4,5,7-tetraiodo-3-oxido-6-oxoxanthen-9-yl)benzoate monohydrate
               
            
                  Chemical formula
               
               
                  C20H6I4Na2O5 H2O
               
            
                  Molecular weight
               
               
                  897,88
               
            
                  Assay
               
               
                  Content not less than 87 % total colouring matters, calculated as the anhydrous sodium salt
                  
                     1 100 at ca. 526 nm in aqueous solution at pH 7
               
            
                  
                     Description
                  
               
               
                  Red powder or granules.
               
            
                  Appearance of the aqueous solution
               
               
                  Red
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 526 nm at pH 7
               
            
                  
                     Purity
                  
               
            
                  Inorganic iodides
               
               
                  Not more than 0,1 % (calculated as sodium iodide)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters (except fluorescein)
               
               
                  Not more than 4,0 %
               
            
                  Fluorescein
               
               
                  Not more than 20 mg/kg
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  Tri-iodoresorcinol
               
               
                  Not more than 0,2 %
               
            
                  2-(2,4-dihydroxy-3,5-diiodobenzoyl) benzoic acid
               
               
                  Not more than 0,2 %
               
            
                  Ether extractable matter
               
               
                  From a solution of pH from 7 through 8, not more than 0,2 %
               
            
                  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
               
            
         
            Aluminium Lakes of this colour may be used.
         
      
      
         E 129 ALLURA RED AC
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Red 17
               
            
                  
                     Definition
                  
               
               
                  Allura Red AC consists essentially of disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonato-phenylazo) naphthalene-6-sulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components. Allura Red AC is manufactured by coupling diazotized 5-amino-4-methoxy-2-toluenesulphonic acid with 6-hydroxy-2-naphthalene sulphonic acid
                  Allura Red AC is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  16035
               
            
                  Einecs
               
               
                  247-368-0
               
            
                  Chemical name
               
               
                  Disodium 2-hydroxy-1-(2-methoxy-5-methyl-4-sulfonatophenylazo) naphthalene-6-sulfonate
               
            
                  Chemical formula
               
               
                  C18H14N2Na2O8S2
                  
               
            
                  Molecular weight
               
               
                  496,42
               
            
                  Assay
               
               
                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  
                      540 at ca. 504 nm in aqueous solution at pH 7
               
            
                  
                     Description
                  
               
               
                  Dark red powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Red
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 504 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 3,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  6-hydroxy-2-naphthalene sulfonic acid, sodium salt
               
               
                  Not more than 0,3 %
               
            
                  4-amino-5-methoxy-2-methylbenezene sulfonic acid
               
               
                  Not more than 0,2 %
               
            
                  6,6-oxybis (2-naphthalene sulfonic acid) disodium salt
               
               
                  Not more than 1,0 %
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  From a solution of pH 7, not more than 0,2 %
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 131 PATENT BLUE V
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Blue 5
               
            
                  
                     Definition
                  
               
               
                  Patent Blue V consists essentially of the calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene)2,5-cyclohexadien-1-ylidene] diethylammonium hydroxide inner salt and subsidiary colouring matters together with sodium chloride and/or sodium sulphate and/or calcium sulphate as the principal uncoloured components.
                  The potassium salt is also permitted.
               
            
                  Colour Index No
               
               
                  42051
               
            
                  Einecs
               
               
                  222-573-8
               
            
                  Chemical name
               
               
                  The calcium or sodium compound of [4-(α-(4-diethylaminophenyl)-5-hydroxy-2,4-disulfophenyl-methylidene) 2,5-cyclohexadien-1-ylidene] diethyl-ammonium hydroxide inner salt
               
            
                  Chemical formula
               
               
                  Calcium compound: C27H31N2O7S2Ca1/2
                  
                  Sodium compound: C27H31N2O7S2Na
               
            
                  Molecular weight
               
               
                  Calcium compound: 579,72
                  Sodium compound: 582,67
               
            
                  Assay
               
               
                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  
                     2 000 at ca. 638 nm in aqueous solution at pH 5
               
            
                  
                     Description
                  
               
               
                  Dark blue powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Blue
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at 638 nm at pH 5
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 2,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  3-hydroxy benzaldehyde
               
               
                  Total not more than 0,5 %
               
            
                  3-hydroxy benzoic acid
               
            
                  3-hydroxy-4-sulfobenzoic acid
               
            
                  N,N-diethylamino benzene sulfonic acid
               
            
                  Leuco base
               
               
                  Not more than 4,0 %
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  From a solution of pH 5 not more than 0,2 %
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 132 INDIGOTINE, INDIGO CARMINE
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Blue 1
               
            
                  
                     Definition
                  
               
               
                  Indigotine consists essentially of a mixture of disodium 3,3′dioxo-2,2′-bi-indolylidene-5,5′-disulfonate, and disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
                  Indigotine is described as the sodium salt. The calcium and the potassium salt are also permitted.
                  Indigo carmine is obtained by sulphonation of indigo. This is accomplished by heating indigo (or indigo paste) in the presence of sulphuric acid. The dye is isolated and subjected to purification procedures.
               
            
                  Colour Index No
               
               
                  73015
               
            
                  Einecs
               
               
                  212-728-8
               
            
                  Chemical name
               
               
                  Disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,5′-disulfonate
               
            
                  Chemical formula
               
               
                  C16H8N2Na2O8S2
                  
               
            
                  Molecular weight
               
               
                  466,36
               
            
                  Assay
               
               
                  Content not less than 85 % total colouring matters, calculated as the sodium salt;
                  disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 18 %
                  
                      480 at ca. 610 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Dark-blue powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Blue
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 610 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Excluding disodium 3,3′-dioxo-2,2′-bi-indolylidene-5,7′-disulfonate: not more than 1,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  Isatin-5-sulfonic acid
               
               
                  Total not more than 0,5 %
               
            
                  5-sulfoanthranilic acid
               
            
                  Anthranilic acid
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 133 BRILLIANT BLUE FCF
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Blue 2
               
            
                  
                     Definition
                  
               
               
                  Brilliant Blue FCF consists essentially of disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate and its isomers and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
                  Brilliant Blue FCF is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  42090
               
            
                  Einecs
               
               
                  223-339-8
               
            
                  Chemical name
               
               
                  Disodium α-(4-(N-ethyl-3-sulfonatobenzylamino) phenyl)-α-(4-N-ethyl-3-sulfonatobenzylamino) cyclohexa-2,5-dienylidene) toluene-2-sulfonate
               
            
                  Chemical formula
               
               
                  C37H34N2Na2O9S3
                  
               
            
                  Molecular weight
               
               
                  792,84
               
            
                  Assay
               
               
                  Content not less than 85 % total colouring matters, calculated as the sodium salt
                  
                     1 630 at ca. 630 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Reddish-blue powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Blue
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 630 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 6,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  Sum of 2-, 3- and 4-formyl benzene sulfonic acids
               
               
                  Not more than 1,5 %
               
            
                  3-((ethyl)(4-sulfophenyl) amino) methyl benzene sulfonic acid
               
               
                  Not more than 0,3 %
               
            
                  Leuco base
               
               
                  Not more than 5,0 %
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % at pH 7
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 140 (i) CHLOROPHYLLS
      
      
                  
                     Synonyms
                  
               
               
                  CI Natural Green 3; Magnesium Chlorophyll; Magnesium Phaeophytin
               
            
                  
                     Definition
                  
               
               
                  Chlorophylls are obtained by solvent extraction of strains of edible plant material, grass, lucerne and nettle. During the subsequent removal of solvent, the naturally present coordinated magnesium may be wholly or partly removed from the chlorophylls to give the corresponding phaeophytins. The principal colouring matters are the phaeophytins and magnesium chlorophylls. The extracted product, from which the solvent has been removed, contains other pigments such as carotenoids as well as oils, fats and waxes derived from the source material. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
               
            
                  Colour Index No
               
               
                  75810
               
            
                  Einecs
               
               
                  Chlorophylls: 215-800-7, chlorophyll a: 207-536-6, Chlorophyll b: 208-272-4
               
            
                  Chemical name
               
               
                  The major colouring principles are:
                  Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta [at]-porphyrin-17-yl)propionate, (Phaeophytin a), or as the magnesium complex (Chlorophyll a)
                  Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate, (Pheophytin b), or as the magnesium complex (Chlorophyll b)
               
            
                  Chemical formula
               
               
                  Chlorophyll a (magnesium complex): C55H72MgN4O5
                  
                  Chlorophyll a: C55H74N4O5
                  
                  Chlorophyll b (magnesium complex): C55H70MgN4O6
                  
                  Chlorophyll b: C55H72N4O6
                  
               
            
                  Molecular weight
               
               
                  Chlorophyll a (magnesium complex): 893,51
                  Chlorophyll a: 871,22
                  Chlorophyll b (magnesium complex): 907,49
                  Chlorophyll b: 885,20
               
            
                  Assay
               
               
                  Content of total combined Chlorophylls and their magnesium complexes is not less than 10 %
                  
                      700 at ca. 409 nm in chloroform
               
            
                  
                     Description
                  
               
               
                  Waxy solid ranging in colour from olive green to dark green depending on the content of coordinated magnesium
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in chloroform at ca. 409 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Acetone
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Methyl Ethyl ketone
               
            
                  Methanol
               
            
                  Ethanol
               
            
                  Propan-2-ol
               
            
                  Hexane
               
            
                  Dichloromethane:
               
               
                  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
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 140 (ii) CHLOROPHYLLINS
      
      
                  
                     Synonyms
                  
               
               
                  CI Natural Green 5; Sodium Chlorophyllin; Potassium Chlorophyllin
               
            
                  
                     Definition
                  
               
               
                  The alkali salts of chlorophyllins are obtained by the saponification of a solvent extract of strains of edible plant material, grass, lucerne and nettle. The saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. The acid groups are neutralised to form the salts of potassium and/or sodium.
                  Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
               
            
                  Colour Index No
               
               
                  75815
               
            
                  Einecs
               
               
                  287-483-3
               
            
                  Chemical name
               
               
                  The major colouring principles in their acid forms are:
                  
                              —
                           
                           
                              3-(10-carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin a)
                              and
                           
                        
                              —
                           
                           
                              3-(10-carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl)propionate (chlorophyllin b)
                           
                        Depending on the degree of hydrolysis the cyclopentenyl ring may be cleaved with the resultant production of a third carboxyl function.
                  Magnesium complexes may also be present.
               
            
                  Chemical formula
               
               
                  Chlorophyllin a (acid form): C34H34N4O5
                  
                  Chlorophyllin b (acid form): C34H32N4O6
                  
               
            
                  Molecular weight
               
               
                  Chlorophyllin a: 578,68
                  Chlorophyllin b: 592,66
                  Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
               
            
                  Assay
               
               
                  Content of total chlorophyllins is not less than 95 % of the sample dried at ca. 100 °C for 1 hour.
                  
                      700 at ca. 405 nm in aqueous solution at pH 9
                  
                      140 at ca. 653 nm in aqueous solution at pH 9
               
            
                  
                     Description
                  
               
               
                  Dark green to blue/black powder
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in aqueous phosphate buffer at pH 9 at ca. 405 nm and at ca. 653 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Acetone
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Methyl ethyl ketone
               
            
                  Methanol
               
            
                  Ethanol
               
            
                  Propan-2-ol
               
            
                  Hexane
               
            
                  Dichloromethane:
               
               
                  not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 141 (i) COPPER COMPLEXES OF CHLOROPHYLLS
      
      
                  
                     Synonyms
                  
               
               
                  CI Natural Green 3; Copper Chlorophyll; Copper Phaeophytin
               
            
                  
                     Definition
                  
               
               
                  Copper chlorophylls are obtained by addition of a salt of copper to the substance obtained by solvent extraction of strains of edible plant material, grass, lucerne, and nettle. The product, from which the solvent has been removed, contains other pigments such as carotenoids as well as fats and waxes derived from the source material. The principal colouring matters are the copper phaeophytins. Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide, methanol, ethanol, propan-2-ol and hexane.
               
            
                  Colour Index No
               
               
                  75810
               
            
                  Einecs
               
               
                  Copper chlorophyll a: 239-830-5; copper chlorophyll b: 246-020-5
               
            
                  Chemical name
               
               
                  [Phytyl (132R,17S,18S)-3-(8-ethyl-132-methoxycarbonyl-2,7,12,18-tetramethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper Chlorophyll a)
                  [Phytyl (132R,17S,18S)-3-(8-ethyl-7-formyl-132-methoxycarbonyl-2,12,18-trimethyl-13′-oxo-3-vinyl-131-132-17,18-tetrahydrocyclopenta[at]-porphyrin-17-yl)propionate] copper (II) (Copper chlorophyll b)
               
            
                  Chemical formula
               
               
                  Copper chlorophyll a: C55H72Cu N4O5
                  
                  Copper chlorophyll b: C55H70Cu N4O6
                  
               
            
                  Molecular weight
               
               
                  Copper chlorophyll a: 932,75
                  Copper chlorophyll b: 946,73
               
            
                  Assay
               
               
                  Content of total copper chlorophylls is not less than 10 %.
                  
                      540 at ca. 422 nm in chloroform
                  
                      300 at ca. 652 nm in chloroform
               
            
                  
                     Description
                  
               
               
                  Waxy solid ranging in colour from blue green to dark green depending on the source material
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in chloroform at ca. 422 nm and at ca. 652 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Acetone
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Methyl ethyl ketone
               
            
                  Methanol
               
            
                  Ethanol
               
            
                  Propan-2-ol
               
            
                  Hexane
               
            
                  Dichloromethane:
               
               
                  not more than 10 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
               
            
                  Copper ions
               
               
                  Not more than 200 mg/kg
               
            
                  Total copper
               
               
                  Not more than 8,0 % of the total copper phaeophytins
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 141 (ii) COPPER COMPLEXES OF CHLOROPHYLLINS
      
      
                  
                     Synonyms
                  
               
               
                  Sodium Copper Chlorophyllin; Potassium Copper Chlorophyllin; CI Natural Green 5
               
            
                  
                     Definition
                  
               
               
                  The alkali salts of copper chlorophyllins are obtained by the addition of copper to the product obtained by the saponification of a solvent extraction of strains of edible plant material, grass, lucerne, and nettle; the saponification removes the methyl and phytol ester groups and may partially cleave the cyclopentenyl ring. After addition of copper to the purified chlorophyllins, the acid groups are neutralised to form the salts of potassium and/or sodium.
                  Only the following solvents may be used for the extraction: acetone, methyl ethyl ketone, dichloromethane, carbon dioxide methanol, ethanol, propan-2-ol and hexane.
               
            
                  Colour Index No
               
               
                  75815
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  The major colouring principles in their acid forms are 3-(10-Carboxylato-4-ethyl-1,3,5,8-tetramethyl-9-oxo-2-vinylphorbin-7-yl)propionate, copper complex (Copper chlorophyllin a) and 3-(10-Carboxylato-4-ethyl-3-formyl-1,5,8-trimethyl-9-oxo-2-vinylphorbin-7-yl) propionate, copper complex (Copper chlorophyllin b)
               
            
                  Chemical formula
               
               
                  Copper chlorophyllin a (acid form): C34H32Cu N4O5
                  
                  Copper chlorophyllin b (acid form): C34H30Cu N4O6
                  
               
            
                  Molecular weight
               
               
                  Copper chlorophyllin a: 640,20
                  Copper chlorophyllin b: 654,18
                  Each may be increased by 18 daltons if the cyclopentenyl ring is cleaved.
               
            
                  Assay
               
               
                  Content of total copper chlorophyllins is not less than 95 % of the sample dried at 100 °C for 1 h.
                  
                      565 at ca. 405 nm in aqueous phosphate buffer at pH 7,5
                  
                      145 at ca. 630 nm in aqueous phosphate buffer at pH 7,5
               
            
                  
                     Description
                  
               
               
                  Dark green to blue/black powder
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in aqueous phosphate buffer at pH 7,5 at ca. 405 nm and at 630 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Acetone
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Methyl ethyl ketone
               
            
                  Methanol
               
            
                  Ethanol
               
            
                  Propan-2-ol
               
            
                  Hexane
               
            
                  Dichloromethane:
               
               
                  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
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Copper ions
               
               
                  Not more than 200 mg/kg
               
            
                  Total copper
               
               
                  Not more than 8,0 % of the total copper chlorophyllins
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 142 GREEN S
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Green 4, Brilliant Green BS
               
            
                  
                     Definition
                  
               
               
                  Green S consists essentially of sodium N-[4-[[4-(dimethylamino)phenyl] 2-hydroxy-3,6-disulfo-1-naphthalenyl)methylene]-2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured compounds.
                  Green S is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  44090
               
            
                  Einecs
               
               
                  221-409-2
               
            
                  Chemical name
               
               
                  Sodium N-[4-[[4-(dimethylamino)phenyl](2-hydroxy-3,6-disulfo-1-naphthalenyl)-methylene]2,5-cyclohexadien-1-ylidene]-N-methylmethanaminium; Sodium 5-[4-dimethylamino-α-(4-dimethyliminocyclohexa-2,5-dienylidene) benzyl]-6-hydroxy-7-sulfonato-naphthalene-2-sulfonate (alternative chemical name).
               
            
                  Chemical formula
               
               
                  C27H25N2NaO7S2
                  
               
            
                  Molecular weight
               
               
                  576,63
               
            
                  Assay
               
               
                  Content not less than 80 % total colouring matters calculated as the sodium salt
                  
                     1 720 at ca. 632 nm in aqueous solution
               
            
                  
                     Description
                  
               
               
                  Dark blue or dark green powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Blue or green
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 632 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 1,0 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  4,4′-bis(dimethylamino)-benzhydryl alcohol
               
               
                  Not more than 0,1 %
               
            
                  4,4′-bis(dimethylamino)-benzophenone
               
               
                  Not more than 0,1 %
               
            
                  3-hydroxynaphthalene-2,7-disulfonic acid
               
               
                  Not more than 0,2 %
               
            
                  Leuco base
               
               
                  Not more than 5,0 %
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 150a PLAIN CARAMEL
      
      
                  
                     Synonyms
                  
               
               
                  Caustic caramel
               
            
                  
                     Definition
                  
               
               
                  Plain caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose). To promote caramelisation, acids, alkalis and salts may be employed, with the exception of ammonium compounds and sulphites.
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  232-435-9
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Dark brown to black liquids or solids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Colour bound by DEAE cellulose
               
               
                  Not more than 50 %
               
            
                  Colour bound by phosphoryl cellulose
               
               
                  Not more than 50 %
               
            
                  Colour intensity (1)
                  
               
               
                  0,01-0,12
               
            
                  Total nitrogen
               
               
                  Not more than 0,1 %
               
            
                  Total sulphur
               
               
                  Not more than 0,2 %
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 150b CAUSTIC SULPHITE CARAMEL
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Caustic sulphite caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of sulphite compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite and sodium bisulphite); no ammonium compounds are used.
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  232-435-9
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Dark brown to black liquids or solids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Colour bound by DEAE cellulose
               
               
                  More than 50 %
               
            
                  Colour intensity (2)
                  
               
               
                  0,05-0,13
               
            
                  Total nitrogen
               
               
                  Not more than 0,3 % (3)
                  
               
            
                  Sulphur dioxide
               
               
                  Not more than 0,2 % (3)
                  
               
            
                  Total sulphur
               
               
                  0,3-3,5 % (3)
                  
               
            
                  Sulphur bound by DEAE cellulose
               
               
                  More than 40 %
               
            
                  Absorbance ratio of colour bound by DEAE cellulose
               
               
                  19-34
               
            
                  Absorbance ratio (A 280/560)
               
               
                  Greater than 50
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 150c AMMONIA CARAMEL
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof, e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis, in the presence of ammonium compounds (ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate and ammonium phosphate); no sulphite compounds are used.
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  232-435-9
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Dark brown to black liquids or solids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Colour bound by DEAE cellulose
               
               
                  Not more than 50 %
               
            
                  Colour bound by phosphoryl cellulose
               
               
                  More than 50 %
               
            
                  Colour intensity (4)
                  
               
               
                  0,08-0,36
               
            
                  Ammoniacal nitrogen
               
               
                  Not more than 0,3 % (5)
                  
               
            
                  4-methylimidazole
               
               
                  Not more than 200 mg/kg (5)
                  
               
            
                  2-acetyl-4-tetrahydroxy-butylimidazole
               
               
                  Not more than 10 mg/kg (5)
                  
               
            
                  Total sulphur
               
               
                  Not more than 0,2 % (5)
                  
               
            
                  Total nitrogen
               
               
                  0,7-3,3 % (5)
                  
               
            
                  Absorbance ratio of colour bound by phosphoryl cellulose
               
               
                  13-35
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 150d SULPHITE AMMONIA CARAMEL
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Sulphite ammonia caramel is prepared by the controlled heat treatment of carbohydrates (commercially available food grade nutritive sweeteners which are the monomers glucose and fructose and/or polymers thereof (e.g. glucose syrups, sucrose, and/or invert syrups, and dextrose) with or without acids or alkalis in the presence of both sulphite and ammonium compounds (sulphurous acid, potassium sulphite, potassium bisulphite, sodium sulphite, sodium bisulphite, ammonium hydroxide, ammonium carbonate, ammonium hydrogen carbonate, ammonium phosphate, ammonium sulphate, ammonium sulphite and ammonium hydrogen sulphite).
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  232-435-9
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Dark brown to black liquids or solids
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Colour bound by DEAE cellulose
               
               
                  More than 50 %
               
            
                  Colour intensity (6)
                  
               
               
                  0,10-0,60
               
            
                  Ammoniacal nitrogen
               
               
                  Not more than 0,6 % (7)
                  
               
            
                  Sulphur dioxide
               
               
                  Not more than 0,2 % (7)
                  
               
            
                  4-methylimidazole
               
               
                  Not more than 250 mg/kg (7)
                  
               
            
                  Total nitrogen
               
               
                  0,3-1,7 % (7)
                  
               
            
                  Total sulphur
               
               
                  0,8-2,5 % (7)
                  
               
            
                  Nitrogen/sulphur ratio of alcohol precipitate
               
               
                  0,7-2,7
               
            
                  Absorbance ratio of alcohol precipitate (8)
                  
               
               
                  8-14
               
            
                  Absorbance ratio (A 280/560)
               
               
                  Not more than 50
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 151 BRILLIANT BLACK BN, BLACK PN
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Black 1
               
            
                  
                     Definition
                  
               
               
                  Brilliant Black BN consists essentially of tetrasodium-4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate and subsidiary colouring matters together with sodium chloride and/or sodium sulphate as the principal uncoloured components.
                  Brilliant Black BN is described as the sodium salt. The calcium and the potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  28440
               
            
                  Einecs
               
               
                  219-746-5
               
            
                  Chemical name
               
               
                  Tetrasodium 4-acetamido-5-hydroxy-6-[7-sulfonato-4-(4-sulfonatophenylazo)-1-naphthylazo] naphthalene-1,7-disulfonate
               
            
                  Chemical formula
               
               
                  C28H17N5Na4O14S4
                  
               
            
                  Molecular weight
               
               
                  867,69
               
            
                  Assay
               
               
                  Content not less than 80 % total colouring matters calculated as the sodium salt
                  
                      530 at ca. 570 nm in solution
               
            
                  
                     Description
                  
               
               
                  Black powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Black-bluish
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water at ca. 570 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 4 % (expressed on the dye content)
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  4-acetamido-5-hydroxynaphthalene-1,7-disulfonic acid
               
               
                  Total not more than 0,8 %
               
            
                  4-amino-5-hydroxynaphthalene-1,7-disulfonic acid
               
            
                  8-aminonaphthalene-2-sulfonic acid
               
            
                  4,4′-diazoaminodi-(benzenesulfonic acid)
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % under neutral conditions
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 153 VEGETABLE CARBON
      
      
                  
                     Synonyms
                  
               
               
                  Vegetable black
               
            
                  
                     Definition
                  
               
               
                  Vegetable activated carbon is produced by the carbonisation of vegetable material such as wood, cellulose residues, peat and coconut and other shells. The activated carbon thus produced is milled by a roller mill and the resulting highly activated powdered carbon is treated by a cyclone. The fine fractio40800n from the cyclone is purified by hydrochloric acid washing, neutralised and then dried. The resulting product is what is known traditionally as vegetable black. Products with a higher colouring power are produced from the fine fraction by a further cyclone treatment or by extra milling, followed by acid washing, neutralising and drying. It consists essentially of finely divided carbon. It may contain minor amounts of nitrogen, hydrogen and oxygen. Some moisture may be absorbed on the product after manufacture.
               
            
                  Colour Index No
               
               
                  77266
               
            
                  Einecs
               
               
                  231-153-3
               
            
                  Chemical name
               
               
                  Carbon
               
            
                  Chemical formula
               
               
                  C
               
            
                  Atomic weight
               
               
                  12,01
               
            
                  Assay
               
               
                  Content not less than 95 % of carbon calculated on an anhydrous and ash-free basis
               
            
                  Loss on drying
               
               
                  Not more than 12 % (120 °C 4 h)
               
            
                  
                     Description
                  
               
               
                  Black, odourless powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water and organic solvents
               
            
                  Burning
               
               
                  When heated to redness it burns slowly without a flame
               
            
                  
                     Purity
                  
               
            
                  Ash (Total)
               
               
                  Not more than 4,0 % (ignition temperature: 625 °C)
               
            
                  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
               
            
                  Polycyclic aromatic hydrocarbons
               
               
                  Benzo(a)pyrene less than 50 μg/kg in the extract obtained by extraction of 1 g of the product with 10 g pure cyclohexane in a continuous extraction.
               
            
                  Alkali soluble matter
               
               
                  The filtrate obtained by boiling 2 g of the sample with 20 ml N sodium hydroxide and filtering shall be colourless
               
            
         E 155 BROWN HT
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Brown 3
               
            
                  
                     Definition
                  
               
               
                  Brown HT consists essentially of disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo) di (naphthalene-1-sulfonate) and subsidiary colouring matters together with sodium chloride and/or sulphate as the principal uncoloured components.
                  Brown HT is described as the sodium salt. The calcium and potassium salt are also permitted.
               
            
                  Colour Index No
               
               
                  20285
               
            
                  Einecs
               
               
                  224-924-0
               
            
                  Chemical name
               
               
                  Disodium 4,4′-(2,4-dihydroxy-5-hydroxymethyl-1,3-phenylene bisazo)di (naphthalene-1-sulfonate)
               
            
                  Chemical formula
               
               
                  C27H18N4Na2O9S2
                  
               
            
                  Molecular weight
               
               
                  652,57
               
            
                  Assay
               
               
                  Content not less than 70 % total colouring matters calculated as the sodium salt.
                  
                      403 at ca. 460 nm in aqueous solution at pH 7
               
            
                  
                     Description
                  
               
               
                  Reddish-brown powder or granules
               
            
                  Appearance of the aqueous solution
               
               
                  Brown
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water of pH 7 at ca. 460 nm
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 10 % (TLC method)
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  4-aminonaphthalene- 1-sulfonic acid
               
               
                  Not more than 0,7 %
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (calculated as aniline)
               
            
                  Ether extractable matter
               
               
                  Not more than 0,2 % in a solution of pH 7
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 160 a (i) BETA-CAROTENE
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Orange 5
               
            
                  
                     Definition
                  
               
               
                  These specifications apply predominantly to all trans isomer of beta-carotene together with minor amounts of other carotenoids. Diluted and stabilised preparations may have different trans-cis isomer ratios.
               
            
                  Colour Index No
               
               
                  40800
               
            
                  Einecs
               
               
                  230-636-6
               
            
                  Chemical name
               
               
                  Beta-carotene; beta, beta-carotene
               
            
                  Chemical formula
               
               
                  C40H56
                  
               
            
                  Molecular weight
               
               
                  536,88
               
            
                  Assay
               
               
                  Not less than 96 % total colouring matters (expressed as beta-carotene)
                  
                     2 500 at approximately by 440 nm to 457 nm in cyclohexane
               
            
                  
                     Description
                  
               
               
                  Red to brownish-red crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in cyclohexane at 453 nm to 456 nm
               
            
                  
                     Purity
                  
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Subsidiary colouring matters
               
               
                  Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 160 a (ii) PLANT CAROTENES
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Orange 5
               
            
                  
                     Definition
                  
               
               
                  Plant carotenes are obtained by solvent extraction of strains of edible plants, carrots, vegetable oils, grass, alfalfa (lucerne) and nettle.
                  The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha, gamma-carotene and other pigments may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.
                  Only the following solvents may be used in the extraction: acetone, methyl ethyl ketone, methanol, ethanol, propan-2-ol, hexane (9), dichloromethane and carbon dioxide.
               
            
                  Colour Index No
               
               
                  75130
               
            
                  Einecs
               
               
                  230-636-6
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                  Beta-carotene: C40H56
                  
               
            
                  Molecular weight
               
               
                  Beta-carotene: 536,88
               
            
                  Assay
               
               
                  Content of carotenes (calculated as beta-carotene) is not less than 5 %. For products obtained by extraction of vegetables oils: not less than 0,2 % in edible fats
                  
                     2 500 at approximately 440 nm to 457 nm in cyclohexane
               
            
                  
                     Description
                  
               
               
                   
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in cyclohexane at 440 nm to 457 nm and 470 nm to 486 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Acetone
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Methyl ethyl ketone
               
            
                  Methanol
               
            
                  Propan-2-ol
               
            
                  Hexane
               
            
                  Ethanol
               
            
                  Dichloromethane
               
               
                  Not more than 10 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 160 a (iii) BETA-CAROTENE FROM Blakeslea trispora
         
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Orange 5
               
            
                  
                     Definition
                  
               
               
                  Obtained by a fermentation process using a mixed culture of the two sexual mating types (+) and (–) of strains of the fungus Blakeslea trispora. The beta-carotene is extracted from the biomass with ethyl acetate or isobutyl acetate followed by propan-2-ol and crystallised. The crystallised product consists mainly of trans beta-carotene. Because of the natural process approximately 3 % of the product consists of mixed carotenoids, which is specific for the product.
               
            
                  Colour Index No
               
               
                  40800
               
            
                  Einecs
               
               
                  230-636-6
               
            
                  Chemical name
               
               
                  Beta-carotene; beta, beta-carotene
               
            
                  Chemical formula
               
               
                  C40H56
                  
               
            
                  Molecular weight
               
               
                  536,88
               
            
                  Assay
               
               
                  Not less than 96 % total colouring matters (expressed as beta-carotene)
                  
                     2 500 at approximately 440 nm to 457 nm in cyclohexane
               
            
                  
                     Description
                  
               
               
                  Red, brownish-red or purple-violet crystals or crystalline powder (colour varies according to extraction solvent used and conditions of crystallisation)
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in cyclohexane at 453 nm to 456 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Ethyl acetate
               
               
                  Not more than 0,8 %, singly or in combination
               
            
                  Ethanol
               
            
                  Isobutyl acetate: Not more than 1,0 %
               
            
                  Propan-2-ol: Not more than 0,1 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 %
               
            
                  Subsidiary colouring matters
               
               
                  Carotenoids other than beta-carotene: not more than 3,0 % of total colouring matters
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Moulds
               
               
                  Not more than 100 colonies per gram
               
            
                  Yeasts
               
               
                  Not more than 100 colonies per gram
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 25 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
         E 160 a (iv) ALGAL CAROTENES
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Orange 5
               
            
                  
                     Definition
                  
               
               
                  Mixed carotenes may also be produced from strains of the algae Dunaliella salina, grown in large saline lakes located in Whyalla, South Australia. Beta-carotene is extracted using an essential oil. The preparation is a 20 to 30 % suspension in edible oil. The ratio of trans-cis isomers is in the range of 50/50 to 71/29.
                  The main colouring principle consists of carotenoids of which beta-carotene accounts for the major part. Alpha-carotene, lutein, zeaxanthin and beta-cryptoxanthin may be present. Besides the colour pigments, this substance may contain oils, fats and waxes naturally occurring in the source material.
               
            
                  Colour Index No
               
               
                  75130
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                  Beta-Carotene: C40H56
                  
               
            
                  Molecular weight
               
               
                  Beta-Carotene: 536,88
               
            
                  Assay
               
               
                  Content of carotenes (calculated as beta-carotene) is not less than 20 %
                  
                     2 500 at approximately by 440 nm to 457 nm in cyclohexane
               
            
                  
                     Description
                  
               
               
                   
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in cyclohexane at 440 nm to 457 nm and 474 nm to 486 nm
               
            
                  
                     Purity
                  
               
            
                  Natural tocopherols in edible oil
               
               
                  Not more than 0,3 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 160 b ANNATTO, BIXIN, NORBIXIN
      
      (i)   SOLVENT-EXTRACTED BIXIN AND NORBIXIN
      
                  
                     Synonyms
                  
               
               
                  CI Natural Orange 4
               
            
                  
                     Definition
                  
               
               
                  Bixin is prepared by the extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with one or more of the following solvents: acetone, methanol, hexane or dichloromethane, carbon dioxide followed by the removal of the solvent.
                  Norbixin is prepared by hydrolysis by aqueous alkali of the extracted bixin.
                  Bixin and norbixin may contain other materials extracted from the annatto seed.
                  The bixin powder contains several coloured components, the major single one being bixin, which may be present in both cis- and trans- forms. Thermal degradation products of bixin may also be present.
                  The norbixin powder contains the hydrolysis product of bixin, in the form of the sodium or potassium salts as the major colouring principle. Both cis- and trans-forms may be present.
               
            
                  Colour Index No
               
               
                  75120
               
            
                  Einecs
               
               
                  Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7
               
            
                  Chemical name
               
               
                  Bixin:
               
               
                  6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate
               
            
                  6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate
               
            
                  Norbixin:
               
               
                  9′cis-6,6′-Diapocarotene-6,6′-dioic acid
               
            
                  9′-trans-6,6′-Diapocarotene-6,6′-dioic acid
               
            
                  Chemical formula
               
               
                  Bixin:
               
               
                  C25H30O4
                  
               
            
                  Norbixin:
               
               
                  C24H28O4
                  
               
            
                  Molecular weight
               
               
                  Bixin:
               
               
                  394,51
               
            
                  Norbixin:
               
               
                  380,48
               
            
                  Assay
               
               
                  Content of bixin powders not less than 75 % total carotenoids calculated as bixin.
               
            
                  Content of norbixin powders not less than 25 % total carotenoids calculated as norbixin
               
            
                  Bixin:
               
               
                  
                     2 870 at ca. 502 nm in chloroform
            
                  Norbixin:
               
               
                  
                     2 870 at ca. 482 nm in KOH solution
            
                  
                     Description
                  
               
               
                  Reddish-brown powder, suspension or solution
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Bixin:
               
               
                  maximum in chloroform at ca. 502 nm
               
            
                  Norbixin:
               
               
                  maximum in dilute KOH solution at ca. 482 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Acetone
               
               
                  not more than 50 mg/kg, singly or in combination
               
            
                  Methanol
               
            
                  Hexane
               
            
                  Dichloromethane:
               
               
                  not more than 10 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
               
            (ii)   ALKALI EXTRACTED ANNATTO
      
                  
                     Synonyms
                  
               
               
                  CI Natural Orange 4
               
            
                  
                     Definition
                  
               
               
                  Water soluble annatto is prepared by extraction with aqueous alkali (sodium or potassium hydroxide) of the outer coating of the seeds of the annatto tree (Bixa orellana L.)
                  Water soluble annatto contains norbixin, the hydrolysis product of bixin, in the form of the sodium or potassium salts, as the major colouring principle. Both cis- and trans- forms may be present.
               
            
                  Colour Index No
               
               
                  75120
               
            
                  Einecs
               
               
                  Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7
               
            
                  Chemical name
               
               
                  Bixin:
               
               
                  6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate
               
            
                  6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate
               
            
                  Norbixin:
               
               
                  9′cis-6,6′-Diapocarotene-6,6′-dioic acid
               
            
                  6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate
               
            
                  Chemical formula
               
               
                  Bixin:
               
               
                  C25H30O4
                  
               
            
                  Norbixin:
               
               
                  C24H28O4
                  
               
            
                  Molecular weight
               
               
                  Bixin:
               
               
                  394,51
               
            
                  Norbixin:
               
               
                  380,48
               
            
                  Assay
               
               
                  Contains not less than 0,1 % of total carotenoids expressed as norbixin
               
            
                  Norbixin:
               
               
                  
                     2 870 at ca. 482 nm in KOH solution
            
                  
                     Description
                  
               
               
                  Reddish-brown powder, suspension or solution
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Bixin:
               
               
                  maximum in chloroform at ca. 502 nm
               
            
                  Norbixin:
               
               
                  maximum in dilute KOH solution at ca. 482 nm
               
            
                  
                     Purity
                  
               
            
                  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
               
            (iii)   OIL EXTRACTED ANNATTO
      
                  
                     Synonyms
                  
               
               
                  CI Natural Orange 4
               
            
                  
                     Definition
                  
               
               
                  Annatto extracts in oil, as solution or suspension, are prepared by extraction of the outer coating of the seeds of the annatto tree (Bixa orellana L.) with edible vegetable oil. Annatto extract in oil contains several coloured components, the major single one being bixin, which may be present in both cis- and trans-forms. Thermal degradation products of bixin may also be present.
               
            
                  Colour Index No
               
               
                  75120
               
            
                  Einecs
               
               
                  Annatto: 215-735-4, annatto seed extract: 289-561-2; bixin: 230-248-7
               
            
                  Chemical name
               
               
                  Bixin:
               
               
                  6′-Methylhydrogen-9′-cis-6,6′-diapocarotene-6,6′-dioate
               
            
                  6′-Methylhydrogen-9′-trans-6,6′-diapocarotene-6,6′-dioate
               
            
                  Norbixin:
               
               
                  9′cis-6,6′-Diapocarotene-6,6′-dioic acid
               
            
                  9′-trans-6,6′-Diapocarotene-6,6′-dioic acid
               
            
                  Chemical formula
               
               
                  Bixin:
               
               
                  C25H30O4
                  
               
            
                  Norbixin:
               
               
                  C24H28O4
                  
               
            
                  Molecular weight
               
               
                  Bixin:
               
               
                  394,51
               
            
                  Norbixin:
               
               
                  380,48
               
            
                  Assay
               
               
                  Contains not less than 0,1 % of total carotenoids expressed as bixin
               
            
                  Bixin:
               
               
                  
                     2 870 at ca. 502 nm in chloroform
            
                  
                     Description
                  
               
               
                  Reddish-brown powder, suspension or solution
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Bixin:
               
               
                  maximum in chloroform at ca. 502 nm
               
            
                  Norbixin:
               
               
                  maximum in dilute KOH solution at ca. 482 nm
               
            
                  
                     Purity
                  
               
            
                  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 160 c PAPRIKA EXTRACT, CAPSANTHIN, CAPSORUBIN
      
      
                  
                     Synonyms
                  
               
               
                  Paprika Oleoresin
               
            
                  
                     Definition
                  
               
               
                  Paprika extract is obtained by solvent extraction of the strains of paprika, which consists of the ground fruits pods, with or without seeds, of Capsicum annuum L., and contains the major colouring principles of this spice. The major colouring principles are capsanthin and capsorubin. A wide variety of other coloured compounds is known to be present.
                  Only the following solvents may be used in the extraction: methanol, ethanol, acetone, hexane, dichloromethane, ethyl acetate, propan-2-ol and carbon dioxide.
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  Capsanthin: 207-364-1, capsorubin: 207-425-2
               
            
                  Chemical name
               
               
                  Capsanthin: (3R, 3′S, 5′R)-3,3′-dihydroxy-β,κ-carotene-6-one
                  Capsorubin: (3S, 3′S, 5R, 5R′)-3,3′-dihydroxy-κ,κ-carotene-6,6′-dione
               
            
                  Chemical formula
               
               
                  Capsanthin:
               
               
                  C40H56O3
                  
               
            
                  Capsorubin:
               
               
                  C40H56O4
                  
               
            
                  Molecular weight
               
               
                  Capsanthin:
               
               
                  584,85
               
            
                  Capsorubin:
               
               
                  600,85
               
            
                  Assay
               
               
                  Paprika extract: content not less than 7,0 % carotenoids
                  Capsanthin/capsorubin: not less than 30 % of total carotenoids
                  
                     2 100 at ca. 462 nm in acetone
               
            
                  
                     Description
                  
               
               
                  Dark-red viscous liquid
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in acetone at ca. 462 nm
               
            
                  Colour reaction
               
               
                  A deep blue colour is produced by adding one drop of sulphuric acid to one drop of sample in 2-3 drops of chloroform
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Ethyl acetate
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Methanol
               
            
                  Ethanol
               
            
                  Acetone
               
            
                  Hexane
               
            
                  Propan-2-ol
               
            
                  Dichloromethane:
               
               
                  not more than 10 mg/kg
               
            
                  Capsaicin
               
               
                  Not more than 250 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
               
            
         E 160 d LYCOPENE
      
      (i)   SYNTHETIC LYCOPENE
      
                  
                     Synonyms
                  
               
               
                  Lycopene from chemical synthesis
               
            
                  
                     Definition
                  
               
               
                  Synthetic lycopene is a mixture of geometric isomeres of lycopenes and is produced by the Wittig condensation of synthetic intermediates commonly used in the production of other carotenoids used in food. Synthetic lycopene consists predominantly of all-trans-lycopene together with 5-cis-lycopene and minor quantities of other isomers. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder.
               
            
                  Colour Index No
               
               
                  75125
               
            
                  Einecs
               
               
                  207-949-1
               
            
                  Chemical name
               
               
                  ψ,ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene
               
            
                  Chemical formula
               
               
                  C40H56
                  
               
            
                  Molecular weight
               
               
                  536,85
               
            
                  Assay
               
               
                  Not less than 96 % total lycopenes (not less than 70 % all-trans-lycopene)
                  
                      at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450
               
            
                  
                     Description
                  
               
               
                  Red crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Spectrophotometry
               
               
                  A solution in hexane shows an absorption maximum at approximately 470 nm
               
            
                  Test for carotenoids
               
               
                  The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid
               
            
                  Solubility
               
               
                  Insoluble in water, freely soluble in chloroform
               
            
                  Properties of 1 % solution in chloroform
               
               
                  Is clear and has intensive red-orange colour
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (40 °C, 4 h at 20 mm Hg)
               
            
                  Apo-12’-lycopenal
               
               
                  Not more than 0,15 %
               
            
                  Triphenyl phosphine oxide
               
               
                  Not more than 0,01 %
               
            
                  Solvent residues
               
               
                  Methanol not more than 200 mg/kg,
                  Hexane, Propan-2-ol: Not more than 10 mg/kg each.
                  Dichloromethane: Not more than 10 mg/kg (in commercial preparations only)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         (ii)   LYCOPENE FROM RED TOMATOES
      
      
                  
                     Synonyms
                  
               
               
                  Natural Yellow 27
               
            
                  
                     Definition
                  
               
               
                  Lycopene is obtained by solvent extraction of red tomatoes (Lycopersicon esculentum L.) with subsequent removal of the solvent. Only the following solvent may be used: carbon dioxide, ethyl acetate, acetone, propan-2-ol, methanol, ethanol and hexane. The major colouring principle of tomatoes is lycopene; minor amounts of other carotenoid pigments may be present. Besides the colour pigments the product may contain oil, fats, waxes and flavour components naturally occurring in tomatoes.
               
            
                  Colour Index No
               
               
                  75125
               
            
                  Einecs
               
               
                  207-949-1
               
            
                  Chemical name
               
               
                  Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, (all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene
               
            
                  Chemical formula
               
               
                  C40H56
                  
               
            
                  Molecular weight
               
               
                  536,85
               
            
                  Assay
               
               
                  
                      at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450.
                  Content not less than 5 % total colouring matters
               
            
                  
                     Description
                  
               
               
                  Dark red viscous liquid
               
            
                  
                     Identification
                  
               
            
                  Spectrophotometry
               
               
                  Maximum in hexane at ca. 472 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Propan-2-ol
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Hexane
               
            
                  Acetone
               
            
                  Ethanol
               
            
                  Methanol
               
            
                  Ethylacetate
               
            
                  Sulphated ash
               
               
                  Not more than 1 %
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            (iii)   LYCOPENE FROM BLAKESLEA TRISPORA
      
      
                  
                     Synonyms
                  
               
               
                  Natural Yellow 27
               
            
                  
                     Definition
                  
               
               
                  Lycopene from Blakeslea trispora is extracted from the fungal biomass and purified by crystallisation and filtration. It consists predominantly of all-trans-lycopene. It also contains minor quantities of other carotenoids. Propan-2-ol and isobutyl acetate are the only solvents used in the manufacture. Commercial lycopene preparations intended for use in food are formulated as suspensions in edible oils or water-dispersible or water-soluble powder.
               
            
                  Colour Index No
               
               
                  75125
               
            
                  Einecs
               
               
                  207-949-1
               
            
                  Chemical name
               
               
                  Ψ,Ψ-carotene, all-trans-lycopene, (all-E)-lycopene, ((all-E)-2,6,10,14,19,23,27,31-octamethyl-2,6,8,10,12,14,16,18,20,22,24,26,30-dotriacontatridecaene
               
            
                  Chemical formula
               
               
                  C40H56
                  
               
            
                  Molecular weight
               
               
                  536,85
               
            
                  Assay
               
               
                  Not less than 95 % total lycopenes and not less than 90 % all-trans-lycopene of all colouring matters
                  
                      at 465-475 nm in hexane (for 100 % pure all-trans-lycopene) is 3 450
               
            
                  
                     Description
                  
               
               
                  Red crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Spectrophotometry
               
               
                  A solution in hexane shows an absorption maximum at approximately 470 nm
               
            
                  Test of carotenoids
               
               
                  The colour of the solution of the sample in acetone disappears after successive additions of a 5 % solution of sodium nitrite and 1N sulphuric acid
               
            
                  Solubility
               
               
                  Insoluble in water, freely soluble in chloroform
               
            
                  Properties of 1 % solution in chloroform
               
               
                  Is clear and has intensive red-orange colour
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (40 °C, 4 h at 20 mm Hg)
               
            
                  Other carotenoids
               
               
                  Not more than 5 %
               
            
                  Solvent residues
               
               
                  Propan-2-ol: not more than 0,1 %
                  Isobutyl acetate: not more than 1,0 %
                  Dichloromethane: not more than 10 mg/kg (in commercial preparations only)
               
            
                  Sulphated ash
               
               
                  Not more than 0,3 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 160 e BETA-APO-8′-CAROTENAL (C30)
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Orange 6
               
            
                  
                     Definition
                  
               
               
                  These specifications apply predominantly to the all-trans isomer of β-apo-8′-carotenal together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from β-apo-8′-carotenal meeting these specifications and include solutions or suspensions of ß-apo-8′carotenal in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
               
            
                  Colour Index No
               
               
                  40820
               
            
                  Einecs
               
               
                  214-171-6
               
            
                  Chemical name
               
               
                  β-Apo-8′-carotenal; trans-β-Apo-8′carotene-aldehyde
               
            
                  Chemical formula
               
               
                  C30H40O
               
            
                  Molecular weight
               
               
                  416,65
               
            
                  Assay
               
               
                  Not less than 96 % of total colouring matters
                  
                     2 640 at 460-462 nm in cyclohexane
               
            
                  
                     Description
                  
               
               
                  Dark violet crystals with metallic lustre or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in cyclohexane at 460-462 nm
               
            
                  
                     Purity
                  
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Subsidiary colouring matters
               
               
                  Carotenoids other than β-apo-8′-carotenal:
                  not more than 3,0 % of total colouring matters
               
            
                  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 161 b LUTEIN
      
      
                  
                     Synonyms
                  
               
               
                  Mixed Carotenoids; Xanthophylls
               
            
                  
                     Definition
                  
               
               
                  Lutein is obtained by solvent extraction of the strains of edible fruits and plants, grass, lucerne (alfalfa) and Tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material.
                  Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone and carbon dioxide
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  204-840-0
               
            
                  Chemical name
               
               
                  3,3′-dihydroxy-d-carotene
               
            
                  Chemical formula
               
               
                  C40H56O2
                  
               
            
                  Molecular weight
               
               
                  568,88
               
            
                  Assay
               
               
                  Content of total colouring matter not less than 4 % calculated as lutein
                  
                     2 550 at ca. 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)
               
            
                  
                     Description
                  
               
               
                  Dark, yellowish brown liquid
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in chloroform/ethanol (1:9) at ca. 445 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Acetone
               
               
                  Not more than 50 mg/kg, singly or in combination
               
            
                  Methyl ethyl ketone
               
            
                  Methanol
               
            
                  Ethanol
               
            
                  Propan-2-ol
               
            
                  Hexane
               
            
                  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
               
            
         E 161g CANTHAXANTHIN
      
      
                  
                     Synonyms
                  
               
               
                  CI Food Orange 8
               
            
                  
                     Definition
                  
               
               
                  These specifications apply to predominantly all-trans isomers of canthaxanthin together with minor amounts of other carotenoids. Diluted and stabilised forms are prepared from canthaxanthin meeting these specifications and include solutions or suspensions of canthaxanthin in edible fats or oils, emulsions and water dispersible powders. These preparations may have different cis/trans isomer ratios.
               
            
                  Colour Index No
               
               
                  40850
               
            
                  Einecs
               
               
                  208-187-2
               
            
                  Chemical name
               
               
                  β-Carotene-4,4′-dione; canthaxanthin; 4,4′-dioxo-β-carotene
               
            
                  Chemical formula
               
               
                  C40H52O2
                  
               
            
                  Molecular weight
               
               
                  564,86
               
            
                  Assay
               
               
                  Not less than 96 % of total colouring matters (expressed as canthaxanthin)
               
            
                  
                     2 200
               
                  at ca. 485 nm in chloroform
               
            
                  at 468-472 nm in cyclohexane
               
            
                  at 464-467 nm in petroleum ether
               
            
                  
                     Description
                  
               
               
                  Deep violet crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in chloroform at ca. 485 nm
                  Maximum in cyclohexane at 468-472 nm
                  Maximum in petroleum ether at 464-467 nm
               
            
                  
                     Purity
                  
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Subsidiary colouring matters
               
               
                  Carotenoids other than canthaxanthin: not more than 5,0 % of total colouring matters
               
            
                  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 162 BEETROOT RED, BETANIN
      
      
                  
                     Synonyms
                  
               
               
                  Beet Red
               
            
                  
                     Definition
                  
               
               
                  Beet red is obtained from the roots of strains of red beets (Beta vulgaris L. var. rubra) by pressing crushed beet as press juice or by aqueous extraction of shredded beet roots and subsequent enrichment in the active principle. The colour is composed of different pigments all belonging to the class betalaine. The main colouring principle consists of betacyanins (red) of which betanin accounts for 75-95 %. Minor amounts of betaxanthin (yellow) and degradation products of betalaines (light brown) may be present.
                  Besides the colour pigments the juice or extract consists of sugars, salts, and/or proteins naturally occurring in red beets. The solution may be concentrated and some products may be refined in order to remove most of the sugars, salts and proteins.
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  231-628-5
               
            
                  Chemical name
               
               
                  (S-(R′,R′)-4-(2-(2-Carboxy-5(β-D-glucopyranosyloxy)-2,3-dihydro-6-hydroxy-1H-indol-1-yl)ethenyl)-2,3-dihydro-2,6-pyridine-dicarboxylic acid; 1-(2-(2,6-dicarboxy-1,2,3,4-tetrahydro-4-pyridylidene)ethylidene)-5-β-D-glucopyranosyloxy)-6-hydroxyindolium-2-carboxylate
               
            
                  Chemical formula
               
               
                  Betanin: C24H26N2O13
                  
               
            
                  Molecular weight
               
               
                  550,48
               
            
                  Assay
               
               
                  Content of red colour (expressed as betanine) is not less than 0,4 %
                  
                     1 120 at ca. 535 nm in aqueous solution at pH 5
               
            
                  
                     Description
                  
               
               
                  Red or dark red liquid, paste, powder or solid
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in water of pH 5 at ca. 535 nm
               
            
                  
                     Purity
                  
               
            
                  Nitrate
               
               
                  Not more than 2 g nitrate anion/g of red colour (as calculated from assay).
               
            
                  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 163 ANTHOCYANINS
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Anthocyanins are obtained by maceration or extraction with sulphited water, acidified water, carbon dioxide, methanol or ethanol from the strains of vegetables and edible fruits, with subsequent concentration and/or purification if necessary. The resulting product can be transformed into powder by an industrial drying process. Anthocyanins contain common components of the source material, namely anthocyanine, organic acids, tannins, sugars, minerals etc., but not necessarily in the same proportions as found in the source material. Ethanol may naturally be present as a result of the maceration process. The colouring principle is anthocyanin. Products are marketed according to their colour strength as determined by the assay. Colour content is not expressed using quantitative units.
               
            
                  Colour Index No
               
               
                   
               
            
                  Einecs
               
               
                  208-438-6 (cyanidin); 205-125-6 (peonidin); 208-437-0 (delphinidin); 211-403-8 (malvidin); 205-127-7 (pelargonidin); 215-849-4 (petunidin)
               
            
                  Chemical name
               
               
                  3,3′,4′,5,7-Pentahydroxy-flavylium chloride (cyanidin)
                  3,4′,5,7-Tetrahydroxy-3′-methoxyflavylium chloride (peonidin)
                  3,4′,5,7-Tetrahydroxy-3′,5′-dimethoxyflavylium chloride (malvidin)
                  3,5,7-Trihydroxy-2-(3,4,5,trihydroxyphenyl)-1-benzopyrylium chloride (delphinidin)
                  3,3′4′,5,7-Pentahydroxy-5′-methoxyflavylium chloride (petunidin)
                  3,5,7-Trihydroxy-2-(4-hydroxyphenyl)-1-benzopyrilium chloride (pelargonidin)
               
            
                  Chemical formula
               
               
                  Cyanidin: C15H11O6Cl
                  Peonidin: C16H13O6Cl
                  Malvidin: C17H15O7Cl
                  Delphinidin: C15H11O7Cl
                  Petunidin: C16H13O7Cl
                  Pelargonidin: C15H11O5Cl
               
            
                  Molecular weight
               
               
                  Cyanidin: 322,6
                  Peonidin: 336,7
                  Malvidin: 366,7
                  Delphinidin: 340,6
                  Petunidin: 352,7
                  Pelargonidin: 306,7
               
            
                  Assay
               
               
                  
                      300 for the pure pigment at 515-535 nm at pH 3,0
            
                  
                     Description
                  
               
               
                  Purplish-red liquid, powder or paste, having a slight characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in methanol with 0,01 % conc. HCl
                  Cyanidin: 535 nm
                  Peonidin: 532 nm
                  Malvidin: 542 nm
                  Delphinidin: 546 nm
                  Petunidin: 543 nm
                  Pelargonidin: 530 nm
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Methanol
               
               
                  Not more than 50 mg/kg
               
            
                  Ethanol
               
               
                  Not more than 200 mg/kg
               
            
                  Sulfur dioxide
               
               
                  Not more than 1 000 mg/kg per percent pigment
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 170 CALCIUM CARBONATE
      
      
                  
                     Synonyms
                  
               
               
                  CI Pigment White 18; Chalk
               
            
                  
                     Definition
                  
               
               
                  Calcium carbonate is the product obtained from ground limestone or by the precipitation of calcium ions with carbonate ions.
               
            
                  Colour Index No
               
               
                  77220
               
            
                  Einecs
               
               
                  Calcium carbonate: 207-439-9
                  Limestone: 215-279-6
               
            
                  Chemical name
               
               
                  Calcium carbonate
               
            
                  Chemical formula
               
               
                  CaCO3
                  
               
            
                  Molecular weight
               
               
                  100,1
               
            
                  Assay
               
               
                  Content not less than 98 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline or amorphous, odourless and tasteless powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Practically insoluble in water and in alcohol. Dissolves with effervescence in diluted acetic acid, in diluted hydrochloric acid and in diluted nitric acid, and the resulting solutions, after boiling, give positive tests for calcium.
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (200 °C, 4 hours)
               
            
                  Acid-insoluble substances
               
               
                  Not more than 0,2 %
               
            
                  Magnesium and alkali salts
               
               
                  Not more than 1 %
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg
               
            
                  Antimony (as Sb)
               
               
                  Not more than 100 mg/kg, singly or in combination
               
            
                  Copper (as Cu)
               
            
                  Chromium (as Cr)
               
            
                  Zinc (as Zn)
               
            
                  Barium (as Ba)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 171 TITANIUM DIOXIDE
      
      
                  
                     Synonyms
                  
               
               
                  CI Pigment White 6
               
            
                  
                     Definition
                  
               
               
                  Titanium dioxide consists essentially of pure anatase and/or rutile titanium dioxide which may be coated with small amounts of alumina and/or silica to improve the technological properties of the product.
                  The anatase grades of pigmentary titanium dioxide can only be made by the sulphate process which creates a large amount of sulphuric acid as a by-product. The rutile grades of titanium dioxide are typically made by the chloride process.
                  Certain rutile grades of titanium dioxide are produced using mica (also known as potassium aluminum silicate) as a template to form the basic platelet structure. The surface of the mica is coated with titanium dioxide using a specialised patented process.
                  Rutile titanium dioxide, platelet form is manufactured by subjecting titanium dioxide (rutile) coated mica nacreous pigment to an extractive dissolution in acid followed by an extractive dissolution in alkali. All of the mica is removed during this process and the resulting product is a platelet form of rutile titanium dioxide.
               
            
                  Colour Index No
               
               
                  77891
               
            
                  Einecs
               
               
                  236-675-5
               
            
                  Chemical name
               
               
                  Titanium dioxide
               
            
                  Chemical formula
               
               
                  TiO2
                  
               
            
                  Molecular weight
               
               
                  79,88
               
            
                  Assay
               
               
                  Content not less than 99 % on an alumina and silica-free basis
               
            
                  
                     Description
                  
               
               
                  White to slightly coloured powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water and organic solvents. Dissolves slowly in hydrofluoric acid and in hot concentrated sulphuric acid.
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 °C, 3 hours)
               
            
                  Loss on ignition
               
               
                  Not more than 1,0 % on a volatile matter free basis (800 °C)
               
            
                  Aluminium oxide and/or silicon dioxide
               
               
                  Total not more than 2,0 %
               
            
                  Matter soluble in 0,5 N HCl
               
               
                  Not more than 0,5 % on an alumina and silica-free basis and, in addition, for products containing alumina and/or silica, not more than 1,5 % on the basis of the product as sold.
               
            
                  Water soluble matter
               
               
                  Not more than 0,5 %
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg after an extraction with 0,5 N HCl.
               
            
                  Antimony
               
               
                  Not more than 2 mg/kg after an extraction with 0,5 N HCl.
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg after an extraction with 0,5 N HCl.
               
            
                  Lead
               
               
                  Not more than 10 mg/kg after an extraction with 0,5 N HCl.
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg after an extraction with 0,5 N HCl.
               
            
         E 172 IRON OXIDES AND IRON HYDROXIDES
      
      
                  
                     Synonyms
                  
               
               
                  Iron Oxide Yellow: CI Pigment Yellow 42 and 43
               
            
                  Iron Oxide Red: CI Pigment Red 101 and 102
               
            
                  Iron Oxide Black: CI Pigment Black 11
               
            
                  
                     Definition
                  
               
               
                  Iron oxides and iron hydroxides are produced synthetically and consist essentially of anhydrous and/or hydrated iron oxides. The range of hues includes yellows, reds, browns and blacks. Food quality iron oxides are primarily distinguished from technical grades by the comparatively low levels of contamination by other metals. This is achieved by the selection and control of the source of the iron and/or by the extent of chemical purification during the manufacturing process.
               
            
                  Colour Index No
               
               
                  Iron Oxide Yellow:
               
               
                  77492
               
            
                  Iron Oxide Red:
               
               
                  77491
               
            
                  Iron Oxide Black:
               
               
                  77499
               
            
                  Einecs
               
               
                  Iron Oxide Yellow:
               
               
                  257-098-5
               
            
                  Iron Oxide Red:
               
               
                  215-168-2
               
            
                  Iron Oxide Black:
               
               
                  235-442-5
               
            
                  Chemical name
               
               
                  Iron Oxide Yellow: hydrated ferric oxide, hydrated iron (III) oxide
               
            
                  Iron Oxide Red: anhydrous ferric oxide, anhydrous iron (III) oxide
               
            
                  Iron Oxide Black: ferroso ferric oxide, iron (II, III) oxide
               
            
                  Chemical formula
               
               
                  Iron Oxide Yellow:
               
               
                  FeO(OH) · H2O
               
            
                  Iron Oxide Red:
               
               
                  Fe2O3
                  
               
            
                  Iron Oxide Black:
               
               
                  FeO.Fe2O3
                  
               
            
                  Molecular weight
               
               
                  88,85:
               
               
                  FeO(OH)
               
            
                  159,70:
               
               
                  Fe2O3
                  
               
            
                  231,55:
               
               
                  FeO.Fe2O3
                  
               
            
                  Assay
               
               
                  Yellow not less than 60 %, red and black not less than 68 % total iron, expressed as iron
               
            
                  
                     Description
                  
               
               
                  Powder; yellow, red, brown or black in hue
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water and in organic solvents
                  Soluble in concentrated mineral acids
               
            
                  
                     Purity
                  
               
            
                  Water soluble matter
               
               
                  Not more than 1,0 %
               
               
                  By total dissolution
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Chromium
               
               
                  Not more than 100 mg/kg
               
            
                  Copper
               
               
                  Not more than 50 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Nickel
               
               
                  Not more than 200 mg/kg
               
            
                  Zinc
               
               
                  Not more than 100 mg/kg
               
            
         E 173 ALUMINIUM
      
      
                  
                     Synonyms
                  
               
               
                  CI Pigment Metal
               
            
                  
                     Definition
                  
               
               
                  Aluminium powder is composed of finely divided particles of aluminium. The grinding may or may not be carried out in the presence of edible vegetable oils and/or food additive quality fatty acids. It is free from admixture with substances other than edible vegetable oils and/or food additive quality fatty acids.
               
            
                  Colour Index No
               
               
                  77000
               
            
                  Einecs
               
               
                  231-072-3
               
            
                  Chemical name
               
               
                  Aluminium
               
            
                  Chemical formula
               
               
                  Al
               
            
                  Atomic weight
               
               
                  26,98
               
            
                  Assay
               
               
                  Not less than 99 % calculated as Al on an oil-free basis
               
            
                  
                     Description
                  
               
               
                  A silvery-grey powder or tiny sheets
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water and in organic solvents. Soluble in dilute hydrochloric acid.
               
            
                  Test for aluminium
               
               
                  A sample dissolved in dilute hydrochloric acid passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 °C, to constant weight)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 10 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 174 SILVER
      
      
                  
                     Synonyms
                  
               
               
                  Argentum
               
            
                  
                     Definition
                  
               
            
                  Colour Index No
               
               
                  77820
               
            
                  Einecs
               
               
                  231-131-3
               
            
                  Chemical name
               
               
                  Silver
               
            
                  Chemical formula
               
               
                  Ag
               
            
                  Atomic weight
               
               
                  107,87
               
            
                  Assay
               
               
                  Content not less than 99,5 % Ag
               
            
                  
                     Description
                  
               
               
                  Silver-coloured powder or tiny sheets
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
               
                   
               
            
         E 175 GOLD
      
      
                  
                     Synonyms
                  
               
               
                  Pigment Metal 3; Aurum
               
            
                  
                     Definition
                  
               
            
                  Colour Index No
               
               
                  77480
               
            
                  Einecs
               
               
                  231-165-9
               
            
                  Chemical name
               
               
                  Gold
               
            
                  Chemical formula
               
               
                  Au
               
            
                  Atomic weight
               
               
                  197,0
               
            
                  Assay
               
               
                  Content not less than 90 % Au
               
            
                  
                     Description
                  
               
               
                  Gold-coloured powder or tiny sheets
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Silver
               
               
                  Not more than 7 %
               
               
                  After complete dissolution
               
            
                  Copper
               
               
                  Not more than 4 %
               
            
         E 180 LITHOLRUBINE BK
      
      
                  
                     Synonyms
                  
               
               
                  CI Pigment Red 57; Rubinpigment; Carmine 6B
               
            
                  
                     Definition
                  
               
               
                  Lithol Rubine BK consists essentially of calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalenecarboxylate and subsidiary colouring matters together with water, calcium chloride and/or calcium sulphate as the principal uncoloured components.
               
            
                  Colour Index No
               
               
                  15850:1
               
            
                  Einecs
               
               
                  226-109-5
               
            
                  Chemical name
               
               
                  Calcium 3-hydroxy-4-(4-methyl-2-sulfonatophenylazo)-2-naphthalene-carboxylate
               
            
                  Chemical formula
               
               
                  C18H12CaN2O6S
               
            
                  Molecular weight
               
               
                  424,45
               
            
                  Assay
               
               
                  Content not less than 90 % total colouring matters
                  
                      200 at ca. 442 nm in dimethylformamide
               
            
                  
                     Description
                  
               
               
                  Red powder
               
            
                  
                     Identification
                  
               
            
                  Spectrometry
               
               
                  Maximum in dimethylformamide at ca. 442 nm
               
            
                  
                     Purity
                  
               
            
                  Subsidiary colouring matters
               
               
                  Not more than 0,5 %
               
            
                  Organic compounds other than colouring matters:
               
               
                   
               
            
                  2-Amino-5-methylbenzenesulfonic acid, calcium salt
               
               
                  Not more than 0,2 %
               
            
                  3-hydroxy-2-naphthalenecarboxylic acid, calcium salt
               
               
                  Not more than 0,4 %
               
            
                  Unsulfonated primary aromatic amines
               
               
                  Not more than 0,01 % (expressed as aniline)
               
            
                  Ether extractable matter
               
               
                  From a solution of pH 7, not more than 0,2 %
               
            
                  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
               
            
         
            Aluminium lakes of this colour may be used.
         
      
      
         E 200 SORBIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  203-768-7
               
            
                  Chemical name
               
               
                  Sorbic acid; trans, trans-2,4-Hexadienoic acid
               
            
                  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 °C
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  Between 133 °C and 135 °C, after vacuum drying for four hours in a sulphuric acid desiccator
               
            
                  Spectrometry
               
               
                  A propan-2-ol solution (1 in 4 000 000) shows absorbance maximum at 254 ± 2 nm
               
            
                  Test for double bonds
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Slightly soluble in water, soluble in ethanol.
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 202 POTASSIUM SORBATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  246-376-1
               
            
                  Chemical name
               
               
                  Potassium sorbate; Potassium (E,E)-2,4-hexadienoate; Potassium salt of trans, trans 2,4-hexadienoic acid
               
            
                  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 °C
               
            
                  
                     Identification
                  
               
            
                  Melting range for sorbic acid
               
               
                  Melting range of sorbic acid isolated by acidification and not recrystallised 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for double bonds
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % (105 °C, 3 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 203 CALCIUM SORBATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-321-6
               
            
                  Chemical name
               
               
                  Calcium sorbate; Calcium salts of trans, trans-2,4-hexadienoic acid
               
            
                  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 °C for 90 minutes
               
            
                  
                     Identification
                  
               
            
                  Melting range for sorbic acid
               
               
                  Melting range of sorbic acid isolated by acidification and not recrystallised 133 °C to 135 °C after vacuum drying in a sulphuric acid desiccator
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for double bonds
               
               
                  Passes test
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 210 BENZOIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-618-2
               
            
                  Chemical name
               
               
                  Benzoic acid; Benzenecarboxylic acid; Phenylcarboxylic acid
               
            
                  Chemical formula
               
               
                  C7H6O2
                  
               
            
                  Molecular weight
               
               
                  122,12
               
            
                  Assay
               
               
                  Content not less than 99,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  121,5 °C -123,5 °C
               
            
                  Sublimation test
               
               
                  Passes test
               
            
                  Test for benzoate
               
               
                  Passes test
               
            
                  pH
               
               
                  About 4 (solution in water)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (3 hours, over sulphuric acid)
               
            
                  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 (10), 0,3 ml of ferric chloride TSC (11), 0,1 ml of copper sulphate TSC (12) 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 211 SODIUM BENZOATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  208-534-8
               
            
                  Chemical name
               
               
                  Sodium benzoate; Sodium salt of benzenecarboxylic acid; Sodium salt of phenylcarboxylic acid
               
            
                  Chemical formula
               
               
                  C7H5O2Na
               
            
                  Molecular weight
               
               
                  144,11
               
            
                  Assay
               
               
                  Not less than 99 % of C7H5O2Na, after drying at 105 °C for four hours
               
            
                  
                     Description
                  
               
               
                  A white, almost odourless, crystalline powder or granules
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble in water, sparingly soluble in ethanol
               
            
                  Melting range for benzoic acid
               
               
                  Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after drying in a sulphuric acid desiccator
               
            
                  Test for benzoate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1,5 % (105 °C, 4 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
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 212 POTASSIUM BENZOATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  209-481-3
               
            
                  Chemical name
               
               
                  Potassium benzoate; Potassium salt of benzenecarboxylic acid; Potassium salt of phenylcarboxylic acid
               
            
                  Chemical formula
               
               
                  C7H5KO2·3H2O
               
            
                  Molecular weight
               
               
                  214,27
               
            
                  Assay
               
               
                  Content not less than 99 % C7H5KO2 after drying at 105 °C to constant weight
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Melting range for benzoic acid
               
               
                  Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
               
            
                  Test for benzoate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 26,5 % (105 °C, 4 hours)
               
            
                  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
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 213 CALCIUM BENZOATE
      
      
                  
                     Synonyms
                  
               
               
                  Monocalcium benzoate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  218-235-4
               
            
                  Chemical name
               
               
                  Calcium benzoate; Calcium dibenzoate
               
            
                  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 °C
               
            
                  
                     Description
                  
               
               
                  White or colourless crystals, or white powder
               
            
                  
                     Identification
                  
               
            
                  Melting range for benzoic acid
               
               
                  Melting range of benzoic acid isolated by acidification and not recrystallised 121,5 °C to 123,5 °C, after vacuum drying in a sulphuric acid desiccator
               
            
                  Test for benzoate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 17,5 % (105 °C, 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 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
               
               
                  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
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 214 ETHYL p-HYDROXYBENZOATE
      
      
                  
                     Synonyms
                  
               
               
                  Ethylparaben; Ethyl p-oxybenzoate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-399-4
               
            
                  Chemical name
               
               
                  Ethyl-p-hydroxybenzoate; Ethyl ester of p-hydroxybenzoic acid
               
            
                  Chemical formula
               
               
                  C9H10O3
                  
               
            
                  Molecular weight
               
               
                  166,8
               
            
                  Assay
               
               
                  Content not less than 99,5 % after drying for two hours at 80 °C
               
            
                  
                     Description
                  
               
               
                  Almost odourless, small, colourless crystals or a white, crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  115-118 °C
               
            
                  Test for p-hydroxybenzoate
               
               
                  Melting range of p-hydroxybenzoic acid isolated by acidification and not recrystallised: 213 °C to 217 °C, after vacuum drying in a sulphuric acid desiccator
               
            
                  Test for alcohol
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (80 °C, 2 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 215 SODIUM ETHYL p-HYDROXYBENZOATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  252-487-6
               
            
                  Chemical name
               
               
                  Sodium ethyl p-hydroxybenzoate; Sodium compound of the ethyl ester of p-hydroxybenzoic acid
               
            
                  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
                  
               
            
                  Melting range
               
               
                  115 °C to 118 °C, after vacuum drying in a sulphuric acid desiccator
               
            
                  Test for p-hydroxybenzoate
               
               
                  Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  9,9-10,3 (0,1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 5 %, (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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 218 METHYL p-HYDROXYBENZOATE
      
      
                  
                     Synonyms
                  
               
               
                  Methylparaben; Methyl-p-oxybenzoate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  243-171-5
               
            
                  Chemical name
               
               
                  Methyl p-hydroxybenzoate; Methyl ester of p-hydroxybenzoic acid
               
            
                  Chemical formula
               
               
                  C8H8O3
                  
               
            
                  Molecular weight
               
               
                  152,15
               
            
                  Assay
               
               
                  Content not less than 99 % after drying for two hours at 80 °C
               
            
                  
                     Description
                  
               
               
                  Almost odourless, small colourless crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  125 °C - 128 °C
               
            
                  Test for p-hydroxybenzoate
               
               
                  Melting range of p-hydroxybenzoic acid derived from the sample is 213 °C to 217 °C after drying for two hours at 80 °C
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (80 °C, 2 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 219 SODIUM METHYL p-HYDROXYBENZOATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Melting range
               
               
                  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 °C for two hours, have a melting range of 125 °C to 128 °C
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  9,7-10,3 (0,1 % solution in carbon dioxide free water)
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 220 SULPHUR DIOXIDE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-195-2
               
            
                  Chemical name
               
               
                  Sulphur dioxide; Sulphurous acid anhydride
               
            
                  Chemical formula
               
               
                  SO2
                  
               
            
                  Molecular weight
               
               
                  64,07
               
            
                  Assay
               
               
                  Content not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, non-flammable gas with strong pungent suffocating odour
               
            
                  
                     Identification
                  
               
            
                  Test for sulphurous substances
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 0,05 % (Karl Fischer method)
               
            
                  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
               
            
         E 221 SODIUM SULPHITE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-821-4
               
            
                  Chemical name
               
               
                  Sodium sulphite (anhydrous or heptahydrate)
               
            
                  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
                  
               
            
                  Test for sulphite
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  8,5-11,5 (anhydrous: 10 % solution; heptahydrate: 20 % solution)
               
            
                  
                     Purity
                  
               
            
                  Thiosulphate
               
               
                  Not more than 0,1 % based on the SO2 content
               
            
                  Iron
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 5 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 222 SODIUM BISULPHITE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-921-4
               
            
                  Chemical name
               
               
                  Sodium bisulphite; Sodium hydrogen sulphite
               
            
                  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
                  
               
            
                  Test for sulphite
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  2,5-5,5 (10 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Iron
               
               
                  Not more than 10 mg/kg of Na2SO3 based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 5 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 223 SODIUM METABISULPHITE
      
      
                  
                     Synonyms
                  
               
               
                  Pyrosulphite; Sodium pyrosulphite
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-673-0
               
            
                  Chemical name
               
               
                  Sodium disulphite; Disodium pentaoxodisulphate
               
            
                  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
                  
               
            
                  Test for sulphite
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  4,0-5,5 (10 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Thiosulphate
               
               
                  Not more than 0,1 % based on the SO2 content
               
            
                  Iron
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 5 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 224 POTASSIUM METABISULPHITE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium pyrosulphite
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  240-795-3
               
            
                  Chemical name
               
               
                  Potassium disulphite; Potassium pentaoxo disulphate
               
            
                  Chemical formula
               
               
                  K2S2O5
                  
               
            
                  Molecular weight
               
               
                  222,33
               
            
                  Assay
               
               
                  Content not less than 90 % 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
                  
               
            
                  Test for sulphite
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Thiosulphate
               
               
                  Not more than 0,1 % based on the SO2 content
               
            
                  Iron
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 5 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 226 CALCIUM SULPHITE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  218-235-4
               
            
                  Chemical name
               
               
                  Calcium sulphite
               
            
                  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
                  
               
            
                  Test for sulphite
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Iron
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 5 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 227 CALCIUM BISULPHITE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  237-423-7
               
            
                  Chemical name
               
               
                  Calcium bisulphite; Calcium hydrogen sulphite
               
            
                  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
                  
               
            
                  Test for sulphite
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Iron
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 5 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 228 POTASSIUM BISULPHITE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-870-1
               
            
                  Chemical name
               
               
                  Potassium bisulphite; Potassium hydrogen sulphite
               
            
                  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
                  
               
            
                  Test for sulphite
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Iron
               
               
                  Not more than 10 mg/kg based on the SO2 content
               
            
                  Selenium
               
               
                  Not more than 5 mg/kg based on the SO2 content
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 234 NISIN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Nisin consists of several closely related polypeptides produced by strains of Lactococcus lactis subsp. lactis
                  
               
            
                  Einecs
               
               
                  215-807-5
               
            
                  Chemical name
               
               
                   
               
            
                  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
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 3 % (102 °C to 103 °C, to constant weight)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 235 NATAMYCIN
      
      
                  
                     Synonyms
                  
               
               
                  Pimaricin
               
            
                  
                     Definition
                  
               
               
                  Natamycin is a fungicide of the polyene macrolide group, and is produced by strains of Streptomyces natalensis and other relevant species
               
            
                  Einecs
               
               
                  231-683-5
               
            
                  Chemical name
               
               
                  A stereoisomer of 22-(3-Amino-3,6-dideoxy-β-D- mannopyranosyloxy)-1,3,26-trihydroxy-12-methyl-10-oxo-6,11,28-trioxatricyclo[22.3.1.05,7]octacosa-8,14,16,18,20-pentaene-25-carboxylic acid.
               
            
                  Chemical formula
               
               
                  C33H47O13N
               
            
                  Molecular weight
               
               
                  665,74
               
            
                  Assay
               
               
                  Content not less than 95 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White to creamy-white crystalline powder
               
            
                  
                     Identification
                  
               
            
                  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
                           
                        
            
                  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
               
            
                  pH
               
               
                  5,5-7,5 (1 % w/v solution in previously neutralised mixture of 20 parts dimethylformamide and 80 parts of water)
               
            
                  Specific rotation
               
               
                  [α]D
                     20 + 250° to + 295° (a 1 % w/v solution in glacial acetic acid, at 20 °C and calculated with reference to the dried material)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 8 % (over P2O5, in vacuum at 60 °C to constant weight)
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 100 colonies per gram
               
            
         E 239 HEXAMETHYLENE TETRAMINE
      
      
                  
                     Synonyms
                  
               
               
                  Hexamine; Methenamine
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  202-905-8
               
            
                  Chemical name
               
               
                  1,3,5,7-Tetraazatricyclo [3.3.1.13,7]-decane, hexamethylenetetramine
               
            
                  Chemical formula
               
               
                  C6H12N4
                  
               
            
                  Molecular weight
               
               
                  140,19
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless or white crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for formaldehyde
               
               
                  Passes test
               
            
                  Test for ammonia
               
               
                  Passes test
               
            
                  Sublimation point:
               
               
                  Approximately 260 °C
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (at 105 °C in vacuum over P2O5 for 2 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 242 DIMETHYL DICARBONATE
      
      
                  
                     Synonyms
                  
               
               
                  DMDC; Dimethyl pyrocarbonate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  224-859-8
               
            
                  Chemical name
               
               
                  Dimethyl dicarbonate; Pyrocarbonic acid dimethyl ester
               
            
                  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
                  
               
            
                  Decomposition
               
               
                  After dilution positive tests for CO2 and methanol
               
            
                  Melting point
               
               
                  17 °C
               
            
                  Boiling point
               
               
                  172 °C with decomposition
               
            
                  Density 20 °C
               
               
                  Approximately 1,25 g/cm3
                  
               
            
                  Infrared absorption 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 249 POTASSIUM NITRITE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-832-4
               
            
                  Chemical name
               
               
                  Potassium nitrite
               
            
                  Chemical formula
               
               
                  KNO2
                  
               
            
                  Molecular weight
               
               
                  85,11
               
            
                  Assay
               
               
                  Content not less than 95 % on the anhydrous basis (14)
                  
               
            
                  
                     Description
                  
               
               
                  White or slightly yellow, deliquescent granules
               
            
                  
                     Identification
                  
               
            
                  Test for nitrite
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  6,0-9,0 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 3 % (4 hours, over silica gel)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 250 SODIUM NITRITE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-555-9
               
            
                  Chemical name
               
               
                  Sodium nitrite
               
            
                  Chemical formula
               
               
                  NaNO2
                  
               
            
                  Molecular weight
               
               
                  69,00
               
            
                  Assay
               
               
                  Content not less than 97 % on the anhydrous basis (15)
                  
               
            
                  
                     Description
                  
               
               
                  White crystalline powder or yellowish lumps
               
            
                  
                     Identification
                  
               
            
                  Test for nitrite
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % (4 hours, over silica gel)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 251 SODIUM NITRATE
      
      (i)   SOLID SODIUM NITRATE
      
                  
                     Synonyms
                  
               
               
                  Chile saltpetre; Cubic or soda nitre
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-554-3
               
            
                  Chemical name
               
               
                  Sodium nitrate
               
            
                  Chemical formula
               
               
                  NaNO3
                  
               
            
                  Molecular weight
               
               
                  85,00
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline, slightly hygroscopic powder
               
            
                  
                     Identification
                  
               
            
                  Test for nitrate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  5,5-8,3 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2 % (105 °C, 4 hours)
               
            
                  Nitrites
               
               
                  Not more than 30 mg/kg expressed as NaNO2
                  
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  (ii)
               
               LIQUID SODIUM NITRATE
            
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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.
               
            
                  Einecs
               
               
                  231-554-3
               
            
                  Chemical name
               
               
                  Sodium nitrate
               
            
                  Chemical formula
               
               
                  NaNO3
                  
               
            
                  Molecular weight
               
               
                  85,00
               
            
                  Assay
               
               
                  Content between 33,5 % and 40,0 % of NaNO3
                  
               
            
                  
                     Description
                  
               
               
                  Clear colourless liquid
               
            
                  
                     Identification
                  
               
            
                  Test for nitrate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  1,5-3,5
               
            
                  
                     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
                  
               
            
                  Einecs
               
               
                  231-818-8
               
            
                  Chemical name
               
               
                  Potassium nitrate
               
            
                  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
                  
               
            
                  Test for nitrate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  4,5-8,5 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1 % (105 °C, 4 hours)
               
            
                  Nitrites
               
               
                  Not more than 20 mg/kg expressed as KNO2
                  
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 260 ACETIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-580-7
               
            
                  Chemical name
               
               
                  Acetic acid; Ethanoic acid
               
            
                  Chemical formula
               
               
                  C2H4O2
                  
               
            
                  Molecular weight
               
               
                  60,05
               
            
                  Assay
               
               
                  Content not less than 99,8 %
               
            
                  
                     Description
                  
               
               
                  Clear, colourless liquid having a pungent, characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Boiling point
               
               
                  118 °C at 760 mm pressure (of mercury)
               
            
                  Specific gravity
               
               
                  About 1,049
               
            
                  Test for acetate
               
               
                  A one in three solution gives positive tests for acetate
               
            
                  Solidification point
               
               
                  Not lower than 14,5 °C
               
            
                  
                     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 0,5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 261 POTASSIUM ACETATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-822-2
               
            
                  Chemical name
               
               
                  Potassium acetate
               
            
                  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
                  
               
            
                  pH
               
               
                  7,5-9,0 (5 % aqueous solution)
               
            
                  Test for acetate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 8 % (150 °C, 2 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 262 (i) SODIUM ACETATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-823-8
               
            
                  Chemical name
               
               
                  Sodium acetate
               
            
                  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
                  
               
            
                  pH
               
               
                  8,0-9,5 (1 % aqueous solution)
               
            
                  Test for acetate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Anhydrous:
               
               
                  Not more than 2 % (120 °C, 4 hours)
               
            
                  Trihydrate:
               
               
                  Between 36 and 42 % (120 °C, 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 262 (ii) SODIUM DIACETATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Sodium diacetate is a molecular compound of sodium acetate and acetic acid
               
            
                  Einecs
               
               
                  204-814-9
               
            
                  Chemical name
               
               
                  Sodium hydrogen diacetate
               
            
                  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
                  
               
            
                  pH
               
               
                  4,5-5,0 (10 % aqueous solution)
               
            
                  Test for acetate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 263 CALCIUM ACETATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-540-9
               
            
                  Chemical name
               
               
                  Calcium acetate
               
            
                  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
                  
               
            
                  pH
               
               
                  6,0-9,0 (10 % aqueous solution)
               
            
                  Test for acetate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 11 % (155 °C 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 270 LACTIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Consists 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.
                  Lactic acid is hygroscopic and when concentrated by boiling, it condenses to form lactic acid lactate, which on dilution and heating hydrolyses to lactic acid.
               
            
                  Einecs
               
               
                  200-018-0
               
            
                  Chemical name
               
               
                  Lactic acid; 2-Hydroxypropionic acid; 1-Hydroxyethane-1-carboxylic acid
               
            
                  Chemical formula
               
               
                  C3H6O3
                  
               
            
                  Molecular weight
               
               
                  90,08
               
            
                  Assay
               
               
                  Content not less than 76 %
               
            
                  
                     Description
                  
               
               
                  Colourless or yellowish, nearly odourless, syrupy liquid to solid
               
            
                  
                     Identification
                  
               
            
                  Test for lactate
               
               
                  Passes test
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  201-176-3
               
            
                  Chemical name
               
               
                  Propionic acid; Propanoic acid
               
            
                  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
               
            
                  
                     Identification
                  
               
            
                  Melting point
               
               
                  – 22 °C
               
            
                  Distillation range
               
               
                  138,5 °C to 142,5 °C
               
            
                  
                     Purity
                  
               
            
                  Non-volatile residue
               
               
                  Not more than 0,01 % when dried at 140 °C to constant weight
               
            
                  Aldehydes
               
               
                  Not more than 0,1 % expressed as formaldehyde
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 281 SODIUM PROPIONATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  205-290-4
               
            
                  Chemical name
               
               
                  Sodium propionate; Sodium propanoate
               
            
                  Chemical formula
               
               
                  C3H5O2Na
               
            
                  Molecular weight
               
               
                  96,06
               
            
                  Assay
               
               
                  Content not less than 99 % after drying for two hours at 105 °C
               
            
                  
                     Description
                  
               
               
                  White crystalline hygroscopic powder, or a fine white powder
               
            
                  
                     Identification
                  
               
            
                  Test for propionate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  7,5-10,5 (10 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 4 % (105 °C, 2 hours)
               
            
                  Water insoluble matter
               
               
                  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
               
            
         E 282 CALCIUM PROPIONATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  223-795-8
               
            
                  Chemical name
               
               
                  Calcium propionate
               
            
                  Chemical formula
               
               
                  C6H10O4Ca
               
            
                  Molecular weight
               
               
                  186,22
               
            
                  Assay
               
               
                  Content not less than 99 %, after drying for two hours at 105 °C
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for propionate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  pH
               
               
                  6,0-9,0 (10 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 4 % (105 °C, 2 hours)
               
            
                  Water insoluble matter
               
               
                  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
               
            
         E 283 POTASSIUM PROPIONATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  206-323-5
               
            
                  Chemical name
               
               
                  Potassium propionate; Potassium propanoate
               
            
                  Chemical formula
               
               
                  C3H5KO2
                  
               
            
                  Molecular weight
               
               
                  112,17
               
            
                  Assay
               
               
                  Content not less than 99 % after drying for two hours at 105 °C
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for propionate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 4 % (105 °C, 2 hours)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,1 %
               
            
                  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
               
            
         E 284 BORIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  Boracic acid; Orthoboric acid; Borofax
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  233-139-2
               
            
                  Chemical name
               
               
                   
               
            
                  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
                  
               
            
                  Melting point
               
               
                  At approximately 171 °C
               
            
                  Burning test
               
               
                  Burns with a nice green flame
               
            
                  pH
               
               
                  3,8-4,8 (3,3 % aqueous solution)
               
            
                  
                     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
               
            
         E 285 SODIUM TETRABORATE (BORAX)
      
      
                  
                     Synonyms
                  
               
               
                  Sodium borate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  215-540-4
               
            
                  Chemical name
               
               
                  Sodium tetraborate; Sodium biborate; Sodium pyroborate; Anhydrous tetraborate
               
            
                  Chemical formula
               
               
                  Na2B4O7
                  
                  Na2B4O7·10H2O
               
            
                  Molecular weight
               
               
                  201,27
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Powder or glass-like plates becoming opaque on exposure to air; slowly soluble in water
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  Between 171 °C and 175 °C 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
               
            
         E 290 CARBON DIOXIDE
      
      
                  
                     Synonyms
                  
               
               
                  Carbonic acid gas; Dry ice (solid form); Carbonic anhydride
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-696-9
               
            
                  Chemical name
               
               
                  Carbon dioxide
               
            
                  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
                  
               
            
                  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 5 mg/kg
               
            
         E 296 MALIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  Pomalous acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  230-022-8, 210-514-9, 202-601-5
               
            
                  Chemical name
               
               
                  hydroxybutanedioic acid; hydroxysuccinic acid
               
            
                  Chemical formula
               
               
                  C4H6O5
                  
               
            
                  Molecular weight
               
               
                  134,09
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  White or nearly white crystalline powder or granules
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  127-132 °C
               
            
                  Test for malate
               
               
                  Passes test
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 297 FUMARIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  203-743-0
               
            
                  Chemical name
               
               
                  
                     trans-Butenedioic acid; trans-1,2-Ethylene-dicarboxylic acid
               
            
                  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
                  
               
            
                  Melting range
               
               
                  286-302 °C (closed capillary, rapid heating)
               
            
                  Test for double bonds
               
               
                  Passes test
               
            
                  Test for 1,2-dicarboxylic acid
               
               
                  Passes test
               
            
                  pH
               
               
                  3,0-3,2 (0,05 % solution at 25 °C)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (120 °C, 4 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 300 ASCORBIC ACID, L-ASCORBIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  L-xylo-Ascorbic acid; L(+)- Ascorbic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-066-2
               
            
                  Chemical name
               
               
                  L-ascorbic acid; Ascorbic acid; 2,3-Didehydro-L-threo-hexono-1,4-lactone; 3-Keto-L-gulofuranolactone
               
            
                  Chemical formula
               
               
                  C6H8O6
                  
               
            
                  Molecular weight
               
               
                  176,13
               
            
                  Assay
               
               
                  contains not less than 99 % of C6H8O6 after drying in a vacuum desiccator over sulphuric acid for 24 hours,
               
            
                  
                     Description
                  
               
               
                  White to pale yellow, odourless crystalline powder
               
            
                  Melting range
               
               
                  Between 189 °C and 193 °C with decomposition
               
            
                  
                     Identification
                  
               
            
                  Test for ascorbic acid
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 2,4 and 2,8 (2 % aqueous solution)
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 20,5° and + 21,5° (10 % w/v aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,4 % (in vacuum over sulphuric acid, 24 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 301 SODIUM ASCORBATE
      
      
                  
                     Synonyms
                  
               
               
                  Sodium L-ascorbate; L-Ascorbic acid monosodium salt
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  205-126-1
               
            
                  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
               
            
                  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 powder which darkens on exposure to light
               
            
                  
                     Identification
                  
               
            
                  Test for ascorbate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 6,5 and 8,0 (10 % aqueous solution)
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 103° and + 106° (10 % w/v aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % (in vacuum over sulphuric acid, 24 hours)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 302 CALCIUM ASCORBATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium ascorbate dihydrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  227-261-5
               
            
                  Chemical name
               
               
                  Calcium ascorbate dihydrate; Calcium salt of 2,3-didehydro-L-threo-hexono-1,4-lactone dihydrate
               
            
                  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
                  
               
            
                  Test for ascorbate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 6,0 and 7,5 (10 % aqueous solution)
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 95° and + 97° (5 % w/v aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 304 (i) ASCORBYL PALMITATE
      
      
                  
                     Synonyms
                  
               
               
                  L-ascorbyl palmitate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  205-305-4
               
            
                  Chemical name
               
               
                  Ascorbyl palmitate; L-ascorbyl palmitate; 2,3-didehydro-L-threo-hexono-1,4-lactone-6-palmitate; 6-palmitoyl-3-keto-L-gulofuranolactone
               
            
                  Chemical formula
               
               
                  C22H38O7
                  
               
            
                  Molecular weight
               
               
                  414,55
               
            
                  Assay
               
               
                  Content not less than 98 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White or yellowish-white powder with a citrus-like odour
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  Between 107 °C and 117 °C
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 21° and + 24° (5 % w/v in methanol solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 304 (ii) ASCORBYL STEARATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  246-944-9
               
            
                  Chemical name
               
               
                  Ascorbyl stearate; L-ascorbyl stearate; 2,3-didehydro-L-threo-hexono-1,4-lactone-6-stearate; 6-stearoyl-3-keto-L-gulofuranolactone
               
            
                  Chemical formula
               
               
                  C24H42O7
                  
               
            
                  Molecular weight
               
               
                  442,6
               
            
                  Assay
               
               
                  Content not less than 98 %
               
            
                  
                     Description
                  
               
               
                  White or yellowish, white powder with a citrus-like odour
               
            
                  
                     Identification
                  
               
            
                  Melting point
               
               
                  About 116 °C
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (vacuum oven, 56-60 °C, 1 hour)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 306 TOCOPHEROL-RICH EXTRACT
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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-δ-tocopherols
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  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
                  
               
            
                  By suitable gas liquid chromatographic method
               
               
                   
               
            
                  Specific rotation
               
               
                  [α]D
                     20 not less than + 20°
               
            
                  Solubility
               
               
                  Insoluble in water. Soluble in ethanol. Miscible in ether
               
            
                  
                     Purity
                  
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 307 ALPHA-TOCOPHEROL
      
      
                  
                     Synonyms
                  
               
               
                  dl-α-Tocopherol; (all rac)-α-Tocopherol
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  233-466-0
               
            
                  Chemical name
               
               
                  DL-5,7,8-Trimethyltocol; DL-2,5,7,8-tetramethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Insoluble in water, freely soluble in ethanol, miscible in ether
               
            
                  Spectrophotometry
               
               
                  In absolute ethanol the maximum absorption is about 292 nm
               
            
                  Specific rotation
               
               
                  [α]D
                     25 0° ± 0,05° (1 in 10 solution in chloroform)
               
            
                  
                     Purity
                  
               
            
                  Refractive index
               
               
                  [n]D
                     20 1,503-1,507
               
            
                  Specific absorption in ethanol
               
               
                  
                      (292 nm) 71-76
                  (0,01 g in 200 ml of absolute ethanol)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 308 GAMMA-TOCOPHEROL
      
      
                  
                     Synonyms
                  
               
               
                  dl-γ-Tocopherol
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-523-4
               
            
                  Chemical name
               
               
                  2,7,8-trimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
               
            
                  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
                  
               
            
                  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
               
               
                  [n]D
                     20 1,503-1,507
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 309 DELTA-TOCOPHEROL
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-299-0
               
            
                  Chemical name
               
               
                  2,8-dimethyl-2-(4′,8′,12′-trimethyltridecyl)-6-chromanol
               
            
                  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
                  
               
            
                  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
               
               
                  [n]D
                     20 1,500-1,504
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 310 PROPYL GALLATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-498-2
               
            
                  Chemical name
               
               
                  Propyl gallate; Propyl ester of gallic acid; n-propyl ester of 3,4,5-trihydroxybenzoic acid
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Slightly soluble in water, freely soluble in ethanol, ether and propane-1,2-diol
               
            
                  Melting range
               
               
                  Between 146 °C and 150 °C after drying at 110 °C for four hours
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5% (110 °C, 4 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 311 OCTYL GALLATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  213-853-0
               
            
                  Chemical name
               
               
                  Octyl gallate; Octyl ester of gallic acid; n-octyl ester of 3,4,5-trihydroxybenzoic acid
               
            
                  Chemical formula
               
               
                  C15H22O5
                  
               
            
                  Molecular weight
               
               
                  282,34
               
            
                  Assay
               
               
                  Content not less than 98 % after drying at 90 °C for six hours
               
            
                  
                     Description
                  
               
               
                  White to creamy-white odourless solid
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, freely soluble in ethanol, ether and propane-1,2-diol
               
            
                  Melting range
               
               
                  Between 99 °C and 102 °C after drying at 90 °C for six hours
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (90 °C, 6 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 312 DODECYL GALLATE
      
      
                  
                     Synonyms
                  
               
               
                  Lauryl gallate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  214-620-6
               
            
                  Chemical name
               
               
                  Dodecyl gallate; n-dodecyl (or lauryl) ester of 3,4,5-trihydroxybenzoic acid; Dodecyl ester of gallic acid
               
            
                  Chemical formula
               
               
                  C19H30O5
                  
               
            
                  Molecular weight
               
               
                  338,45
               
            
                  Assay
               
               
                  Content not less than 98 % after drying at 90 °C for six hours
               
            
                  
                     Description
                  
               
               
                  White or creamy-white odourless solid
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, freely soluble in ethanol and ether
               
            
                  Melting range
               
               
                  Between 95 °C and 98 °C after drying at 90 °C for six hours
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (90 °C, 6 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 315 ERYTHORBIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  Isoascorbic acid; D-Araboascorbic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  201-928-0
               
            
                  Chemical name
               
               
                  D-Erythro-hex-2-enoic acid γ-lactone; Isoascorbic acid; D-Isoascorbic acid
               
            
                  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
                  
               
            
                  Melting range
               
               
                  About 164 °C to 172 °C with decomposition
               
            
                  Test for ascorbic acid/colour reaction
               
               
                  Passes test
               
            
                  Specific rotation
               
               
                  [α]D
                     25 10 % (w/v) aqueous solution between – 16,5° to – 18,0°
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,4 % after drying under (reduced pressure on silica gel, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,3 %
               
            
                  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
                  
               
            
                  Einecs
               
               
                  228-973-9
               
            
                  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
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Freely soluble in water, very slightly soluble in ethanol
               
            
                  Test for ascorbic acid/colour reaction
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  5,5 to 8,0 (10 % aqueous solution)
               
            
                  Specific rotation
               
               
                  [α]D
                     25 10 % (w/v) aqueous solution between + 95° and + 98°
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % after drying (in vacuum over sulphuric acid, 24 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 319 TERTIARY-BUTYLHYDROQUINONE (TBHQ)
      
      
                  
                     Synonyms
                  
               
               
                  TBHQ
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  217-752-2
               
            
                  Chemical name
               
               
                  Tert-butyl-1,4-benzenediol; 2-(1,1-Dimethylethyl)-1,4-benzenediol
               
            
                  Chemical formula
               
               
                  C10H14O2
                  
               
            
                  Molecular weight
               
               
                  166,22
               
            
                  Assay
               
               
                  Content not less than 99 % of C10H14O2
                  
               
            
                  
                     Description
                  
               
               
                  White crystalline solid having a characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Practically insoluble in water; soluble in ethanol
               
            
                  Melting point
               
               
                  Not less than 126,5 °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
                  
               
            
                  Einecs
               
               
                  246-563-8
               
            
                  Chemical name
               
               
                  3-Tertiary-butyl-4-hydroxyanisole; A mixture of 2-tertiary-butyl-4-hydroxyanisole and 3-tertiary-butyl-4-hydroxyanisole
               
            
                  Chemical formula
               
               
                  C11H16O2
                  
               
            
                  Molecular 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 flakes or waxy solid with a slight aromatic smell
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, freely soluble in ethanol
               
            
                  Melting range
               
               
                  Between 48 °C and 63 °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
                  
                      (228 nm) not less than 326 and not more than 345
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 321 BUTYLATED HYDROXYTOLUENE (BHT)
      
      
                  
                     Synonyms
                  
               
               
                  BHT
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-881-4
               
            
                  Chemical name
               
               
                  2,6-Ditertiary-butyl-p-cresol; 4-Methyl-2,6-ditertiarybutylphenol
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Insoluble in water and propane- 1,2-diol
                  Freely soluble in ethanol
               
            
                  Melting point
               
               
                  At 70 °C
               
            
                  Spectrometry
               
               
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for choline
               
               
                  Passes test
               
            
                  Test for phosphorus
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for hydrolysed lecithin
               
               
                  To a 800 ml beaker add 500 ml of water (30-35 °C). 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 % (105 °C, 1 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 325 SODIUM LACTATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-772-0
               
            
                  Chemical name
               
               
                  Sodium lactate; Sodium 2-hydroxypropanoate
               
            
                  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
                  
               
            
                  Test for lactate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  6,5 to 7,5 (20 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Acidity
               
               
                  Not more than 0,5 % after drying expressed as lactic acid
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Reducing substances
               
               
                  No reduction of Fehling's solution
               
            
         Note: This specification refers to a 60 % aqueous solution
      
         E 326 POTASSIUM LACTATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  213-631-3
               
            
                  Cheminal name
               
               
                  Potassium lactate; Potassium 2-hydroxypropanoate
               
            
                  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
                  
               
            
                  Ignition
               
               
                  Ignite potassium lactate solution to an ash. The ash is alkaline, and an effervescence occurs when acid is added
               
            
                  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
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for lactate
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 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
               
               
                  No reduction of Fehling's solution
               
            
         Note: This specification refers to a 60 % aqueous solution
      
         E 327 CALCIUM LACTATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  212-406-7
               
            
                  Chemical name
               
               
                  Calcium dilactate; Calcium dilactate hydrate; 2-Hydroxypropanoic acid calcium salt
               
            
                  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
                  
               
            
                  Test for lactate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in water and practically insoluble in ethanol
               
            
                  pH
               
               
                  Between 6,0 and 8,0 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  anhydrous: not more than 3,0 % (120 °C, 4 hours)
                  with 1 molecule of water: not more than 8,0 % (120 °C, 4 hours)
                  with 3 molecules of water: not more than 20,0 % (120 °C, 4 hours)
                  with 4,5 molecules of water: not more than 27,0 % (120 °C, 4 hours)
               
            
                  Acidity
               
               
                  Not more than 0,5 % of the dry matter expressed as lactic acid
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Reducing substances
               
               
                  No reduction of Fehling's solution
               
            
         E 330 CITRIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Citric acid is produced from lemon or pineapple juice, by fermentation of carbohydrate solutions or other suitable media using Candida spp. or non-toxicogenic strains of Aspergillus niger
                  
               
            
                  Einecs
               
               
                  201-069-1
               
            
                  Chemical name
               
               
                  Citric acid; 2-Hydroxy-1,2,3-propanetricarboxylic acid; β-Hydroxytricarballylic acid
               
            
                  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
                  
               
            
                  Solubility
               
               
                  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 °C
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 0,5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 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 °C 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
                  
               
               
                  Monobasic sodium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  242-734-6
               
            
                  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
                  
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 3,5 and 3,8 (1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  anhydrous: not more than 1,0 % (140 °C, 0,5 hour)
                  monohydrate: not more than 8,8 % (180 °C, 4 hours)
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 331 (ii) DISODIUM CITRATE
      
      
                  
                     Synonyms
                  
               
               
                  Dibasic sodium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  205-623-3
               
            
                  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
               
            
                  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
                  
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 4,9 and 5,2 (1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 13,0 % (180 °C, 4 hours)
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 331 (iii) TRISODIUM CITRATE
      
      
                  
                     Synonyms
                  
               
               
                  Tribasic sodium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-675-3
               
            
                  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
               
            
                  Chemical formula
               
               
                  Anhydrous: C6H5O7Na3
                  
                  Hydrated: C6H5O7Na3·nH2O (n = 2 or 5)
               
            
                  Molecular weight
               
               
                  258,07 (anhydrous)
                  294,10 (hydrated n = 2)
                  348,16 (hydrated n = 5)
               
            
                  Assay
               
               
                  Not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Crystalline white powder or colourless crystals
               
            
                  
                     Identification
                  
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,5 and 9,0 (5 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss of drying
               
               
                  Anhydrous: not more than 1,0 % (180 °C, 18 hours)
                  Dihydrate: 10,0 to 13,0 % (180 °C, 18 hours)
                  Pentahydrate: not more than 30,3 % (180 °C, 4 hours)
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 332 (i) MONOPOTASSIUM CITRATE
      
      
                  
                     Synonyms
                  
               
               
                  Monobasic potassium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  212-753-4
               
            
                  Chemical name
               
               
                  Monopotassium citrate; Monopotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Anhydrous monopotassium salt of citric acid
               
            
                  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
                  
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 3,5 and 3,8 (1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % (180 °C, 4 hours)
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg expressed as oxalic acid, after drying
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 332 (ii) TRIPOTASSIUM CITRATE
      
      
                  
                     Synonyms
                  
               
               
                  Tribasic potassium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  212-755-5
               
            
                  Chemical name
               
               
                  Tripotassium citrate; Tripotassium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Monohydrated tripotassium salt of citric acid
               
            
                  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
                  
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,5 and 9,0 (5 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 6,0 % (180 °C, 4 hours)
               
            
                  Oxalates
               
               
                  Not more than 100 mg/kg (expressed as oxalic acid, after drying)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 333 (i) MONOCALCIUM CITRATE
      
      
                  
                     Synonyms
                  
               
               
                  Monobasic calcium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 3,2 and 3,5 (1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 7,0 % (180 °C, 4 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
               
            
                  Aluminium
               
               
                  Not more than 30 mg/kg (only if added to food for infants and young children)
                  Not more than 200 mg/kg (for all uses except food for infants and young children)
               
            
                  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
                  
               
               
                  Dibasic calcium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 20,0 % (180 °C, 4 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
               
            
                  Aluminium
               
               
                  Not more than 30 mg/kg (only if added to food for infants and young children)
                  Not more than 200 mg/kg (for all uses except food for infants and young children)
               
            
                  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
                  
               
               
                  Tribasic calcium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  212-391-7
               
            
                  Chemical name
               
               
                  Tricalcium citrate; Tricalcium salt of 2-hydroxy-1,2,3-propanetricarboxylic acid; Tetrahydrated tricalcium salt of citric acid
               
            
                  Chemical formula
               
               
                  (C6H6O7)2Ca3·4H2O
               
            
                  Molecular weight
               
               
                  570,51
               
            
                  Assay
               
               
                  Not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Fine white powder
               
            
                  
                     Identification
                  
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 14,0 % (180 °C, 4 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
               
            
                  Aluminium
               
               
                  Not more than 30 mg/kg (only if added to food for infants and young children)
                  Not more than 200 mg/kg (for all uses except food for infants and young children)
               
            
                  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, TARTARIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  201-766-0
               
            
                  Chemical name
               
               
                  L-tartaric acid; L-2,3-dihydroxybutanedioic acid; d-α,β-dihydroxysuccinic acid
               
            
                  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
                  
               
            
                  Melting range
               
               
                  Between 168 °C and 170 °C
               
            
                  Test for tartrate
               
               
                  Passes test
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 11,5° and + 13,5° (20 % w/v aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (over P2O5, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 1 000 mg/kg (after calcination at 800 ± 25 °C)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 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
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for tartrate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 10,0 % (105 °C, 4 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 335 (ii) DISODIUM TARTRATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  212-773-3
               
            
                  Chemical name
               
               
                  Disodium L-tartrate; Disodium (+)-tartrate; Disodium salt of (+)-2,3-dihydroxybutanedioic acid; Dihydrated disodium salt of L-(+)-tartaric acid
               
            
                  Chemical formula
               
               
                  C4H4O6Na2·2H2O
               
            
                  Molecular weight
               
               
                  230,8
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Transparent, colourless crystals
               
            
                  
                     Identification
                  
               
            
                  Test for tartrate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Solubility
               
               
                  1 gram is insoluble in 3 ml of water. Insoluble in ethanol
               
            
                  pH
               
               
                  Between 7,0 and 7,5 (1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 17,0 % (150 °C, 4 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 336 (i) MONOPOTASSIUM TARTRATE
      
      
                  
                     Synonyms
                  
               
               
                  Monobasic potassium tartrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for tartrate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Melting point
               
               
                  230 °C
               
            
                  pH
               
               
                  3,4 (1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % (105 °C, 4 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 336 (ii) DIPOTASSIUM TARTRATE
      
      
                  
                     Synonyms
                  
               
               
                  Dibasic potassium tartrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  213-067-8
               
            
                  Chemical name
               
               
                  Dipotassium salt of L-2,3-dihydroxybutanedioic acid; Dipotassium salt with half a molecule of water of L-(+)-tartaric acid
               
            
                  Chemical formula
               
               
                  C4H4O6K2·½H2O
               
            
                  Molecular weight
               
               
                  235,2
               
            
                  Assay
               
               
                  Content not less than 99 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline or granulated powder
               
            
                  
                     Identification
                  
               
            
                  Test for tartrate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 9,0 (1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 4,0 % (150 °C, 4 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 337 POTASSIUM SODIUM TARTRATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium sodium L-(+)-tartrate; Rochelle salt; Seignette salt
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  206-156-8
               
            
                  Chemical name
               
               
                  Potassium sodium salt of L-2,3-dihydroxybutanedioic acid; Potassium sodium L-(+)-tartrate
               
            
                  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
                  
               
            
                  Test for tartrate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Solubility
               
               
                  1 gram is soluble in 1 ml of water, insoluble in ethanol
               
            
                  Melting range
               
               
                  70-80 °C
               
            
                  pH
               
               
                  Between 6,5 and 8,5 (1 % aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 26,0 % and not less than 21,0 % (150 °C, 3 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 338 PHOSPHORIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  Orthophosphoric acid; Monophosphoric acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-633-2
               
            
                  Chemical name
               
               
                  Phosphoric acid
               
            
                  Chemical formula
               
               
                  H3PO4
                  
               
            
                  Molecular weight
               
               
                  98,00
               
            
                  Assay
               
               
                  Content not less than 67,0 % and not more than 85,7 %. Phosphoric acid is commercially available as an aqueous solution at variable concentrations.
               
            
                  
                     Description
                  
               
               
                  Clear, colourless, viscous liquid
               
            
                  
                     Identification
                  
               
            
                  Test for acid
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  
                     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 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 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
                  
               
            
                  Einecs
               
               
                  231-449-2
               
            
                  Chemical name
               
               
                  Sodium dihydrogen monophosphate
               
            
                  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 °C for one hour and then at 105 °C 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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol or ether
               
            
                  pH
               
               
                  Between 4,1 and 5,0 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  The anhydrous salt loses not more than 2,0 %, the monohydrate not more than 15,0 %, the dihydrate not more than 25 % (60 °C, 1 hour then 105 °C, 4 hours)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 339 (ii) DISODIUM PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Disodium monophosphate; Secondary sodium phosphate; Disodium orthophosphate;
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-448-7
               
            
                  Chemical name
               
               
                  Disodium hydrogen monophosphate; Disodium hydrogen orthophosphate
               
            
                  Chemical formula
               
               
                  Anhydrous:Na2HPO4
                  
                  Hydrate: Na2HPO4 · nH2O (n = 2, 7 or 12)
               
            
                  Molecular weight
               
               
                  141,98 (anhydrous)
               
            
                  Assay
               
               
                  After drying at 40 °C for three hours and subsequently at 105 °C 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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  pH
               
               
                  Between 8,4 and 9,6 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  The anhydrous salt loses not more than 5,0 %, the dihydrate not more than 22,0 %, the heptahydrate not more than 50,0 %, the dodecahydrate not more than 61,0 % (40 °C, 3 hours then 105 °C, 5 hours)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 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 ¼ molecule of NaOH
               
            
                  Einecs
               
               
                  231-509-8
               
            
                  Chemical name
               
               
                  Trisodium monophosphate; Trisodium phosphate; Trisodium orthophosphate
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  pH
               
               
                  Between 11,5 and 12,5 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  When dried at 120 °C for two hours and then ignited at about 800 °C 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 matter
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 340 (i) MONOPOTASSIUM PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Monobasic potassium phosphate; Monopotassium monophosphate; Mono potassium orthophosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-913-4
               
            
                  Chemical name
               
               
                  Potassium dihydrogen phosphate; Monopotassium dihydrogen orthophosphate; Monopotassium dihydrogen monophosphate
               
            
                  Chemical formula
               
               
                  KH2PO4
                  
               
            
                  Molecular weight
               
               
                  136,09
               
            
                  Assay
               
               
                  Content not less than 98,0 % after drying at 105 °C 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
               
            
                  
                     Identification
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  pH
               
               
                  Between 4,2 and 4,8 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (105 °C, 4 hours)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 % on the anhydrous basis
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 340 (ii) DIPOTASSIUM PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Dipotassium monophosphate; Secondary potassium phosphate; Dipotassium orthophosphate; Dibasic potassium phosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-834-5
               
            
                  Chemical name
               
               
                  Dipotassium hydrogen monophosphate; Dipotassium hydrogen phosphate; Dipotassium hydrogen orthophosphate
               
            
                  Chemical formula
               
               
                  K2HPO4
                  
               
            
                  Molecular weight
               
               
                  174,18
               
            
                  Assay
               
               
                  Content not less than 98 % after drying at 105 °C 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, hygroscopic
               
            
                  
                     Identification
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  pH
               
               
                  Between 8,7 and 9,4 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (105 °C, 4 hours)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 % (on the anhydrous basis)
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 340 (iii) TRIPOTASSIUM PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Tribasic potassium phosphate; Tripotassium orthophosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-907-1
               
            
                  Chemical name
               
               
                  Tripotassium monophosphate; Tripotassium phosphate; Tripotassium orthophosphate
               
            
                  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 34,0 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Colourless or white, odourless hygroscopic crystals or granules. Hydrated forms available include the monohydrate and trihydrate
               
            
                  
                     Identification
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  pH
               
               
                  Between 11,5 and 12,3 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Anhydrous: not more than 3,0 %; hydrated: not more than 23,0 % (determined by drying at 105 °C for one hour and then ignite at about 800 °C ± 25 °C for 30 minutes)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 % (on the anhydrous basis)
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 341 (i) MONOCALCIUM PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Monobasic calcium phosphate; Monocalcium orthophosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-837-1
               
            
                  Chemical name
               
               
                  Calcium dihydrogen phosphate
               
            
                  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
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  CaO content
               
               
                  Between 23,0 % and 27,5 % (anhydrous)
                  Between 19,0 % and 24,8 % (monohydrate)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Anhydrous: not more than 14 % (105 °C, 4 hours)
                  Monohydrate: not more than 17,5 % (105 °C, 4 hours)
               
            
                  Loss on ignition
               
               
                  Anhydrous: not more than 17,5 % (after ignition at 800 °C ± 25 °C for 30 minutes)
                  Monohydrate: not more than 25,0 % (determined by drying at 105 °C for one hour, then ignite at 800 °C ± 25 °C for 30 minutes)
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Aluminium
               
               
                  Not more than 70 mg/kg (only if added to food for infants and young children)
                  Not more than 200 mg/kg (for all uses except food for infants and young children)
               
            
         E 341 (ii) DICALCIUM PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Dibasic calcium phosphate; Dicalcium orthophosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-826-1
               
            
                  Chemical name
               
               
                  Calcium monohydrogen phosphate; Calcium hydrogen orthophosphate; Secondary calcium phosphate
               
            
                  Chemical formula
               
               
                  Anhydrous: CaHPO4
                  
                  Dihydrate: CaHPO4 · 2H2O
               
            
                  Molecular weight
               
               
                  136,06 (anhydrous)
                  172,09 (dihydrate)
               
            
                  Assay
               
               
                  Dicalcium phosphate, after drying at 200 °C 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
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  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 °C ± 25 °C for 30 minutes
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Aluminium
               
               
                  Not more than 100 mg/kg for the anhydrous form and not more than 80 mg/kg for the dihydrated form (only if added to food for infants and young children)
                  Not more than 600 mg/kg for the anhydrous form and not more than 500 mg/kg for the dihydrated form (for all uses except food for infants and young children). This applies until 31 March 2015.
                  Not more than 200 mg/kg for the anhydrous form and the dihydrated form (for all uses except food for infants and young children). This applies from 1 April 2015.
               
            
         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
               
            
                  Einecs
               
               
                  235-330-6 (Pentacalcium hydroxy monophosphate)
                  231-840-8 (Calcium orthophosphate)
               
            
                  Chemical name
               
               
                  Pentacalcium hydroxy monophosphate; Tricalcium monophosphate
               
            
                  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
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  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 °C ± 25 °C for 0,5 hour
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Aluminium
               
               
                  Not more than 150 mg/kg (only if added to food for infants and young children)
                  Not more than 500 mg/kg (for all uses except food for infants and young children). This applies until 31 March 2015
                  Not more than 200 mg/kg (for all uses except food for infants and young children). This applies from 1 April 2015.
               
            
         E 343 (i) MONOMAGNESIUM PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Magnesiumdihydrogenphosphate; Magnesiumphosphate, monobasic; Monomagnesium orthophosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  236-004-6
               
            
                  Chemical name
               
               
                  Monomagnesiumdihydrogenmonophosphate
               
            
                  Chemical formula
               
               
                  Mg(H2PO4)2 nH2O (where n = 0 to 4)
               
            
                  Molecular weight
               
               
                  218,30 (anhydrous)
               
            
                  Assay
               
               
                  Not less than 51,0 % after ignition calculated as P2O5 at the ignited basis (800 °C ± 25 °C for 30 minutes)
               
            
                  
                     Description
                  
               
               
                  White, odourless, crystalline powder, slightly soluble in water
               
            
                  
                     Identification
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  MgO content
               
               
                  Not less than 21,5 % after ignition or at an anhydrous basis (105 °C, 4 hours)
               
            
                  
                     Purity
                  
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 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
                  
               
            
                  Einecs
               
               
                  231-823-5
               
            
                  Chemical name
               
               
                  Dimagnesiummonohydrogenmonophosphate
               
            
                  Chemical formula
               
               
                  MgHPO4 · nH2O (where n = 0-3)
               
            
                  Molecular weight
               
               
                  120,30 (anhydrous)
               
            
                  Assay
               
               
                  Not less than 96 % after ignition (800 °C ± 25 °C for 30 minutes)
               
            
                  
                     Description
                  
               
               
                  White, odourless, crystalline powder, slightly soluble in water
               
            
                  
                     Identification
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  MgO content
               
               
                  Not less than 33,0 % calculated on the anhydrous basis (105 °C, 4 hours)
               
            
                  
                     Purity
                  
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 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
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium DL-malate; disodium salt of hydroxybutanedioic acid
               
            
                  Chemical formula
               
               
                  Hemihydrate: C4H4Na2O5 ½ 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
                  
               
            
                  Test for 1,2-dicarboxylic acid
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Azo dye formation
               
               
                  Positive
               
            
                  Solubility
               
               
                  Freely soluble in water
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Hemihydrate: Not more than 7,0 % (130 °C, 4 hours)
                  Trihydrate: 20,5-23,5 % (130 °C, 4 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 350 (ii) SODIUM HYDROGEN MALATE
      
      
                  
                     Synonyms
                  
               
               
                  Monosodium salt of DL-malic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for 1,2-dicarboxylic acid
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Azo dye formation
               
               
                  Positive
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (110 °C, 3 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 351 POTASSIUM MALATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium salt of malic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for 1,2-dicarboxylic acid
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 352 (i) CALCIUM MALATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium salt of malic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for malate
               
               
                  Passes test
               
            
                  Test 1,2-dicarboxylic acid
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Azo dye formation
               
               
                  Positive
               
            
                  Solubility
               
               
                  Slightly soluble in water
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2 % (100 °C, 3 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 352 (ii) CALCIUM HYDROGEN MALATE
      
      
                  
                     Synonyms
                  
               
               
                  Monocalcium salt of DL-malic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Monocalcium DL-malate; monocalcium 2-DL-hydroxysuccinate
               
            
                  Chemical formula
               
               
                  (C4H5O5)2Ca
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Content not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Identification
                  
               
            
                  Test for 1,2-dicarboxylic acid
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Azo dye formation
               
               
                  Positive
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (110 °C, 3 hours)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 353 METATARTARIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  Ditartaric acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Metatartaric acid
               
            
                  Chemical formula
               
               
                  C4H6O6
                  
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Very soluble in water and ethanol
               
            
                  Identification test
               
               
                  Place a sample of 1 to 10 mg of this substance in a test tube with 2 ml of concentrated sulphuric acid and 2 drops of sulpho-resorcinol reagent. When heated to 150 °C, an intense violet coloration appears
               
            
                  
                     Purity
                  
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 354 CALCIUM TARTRATE
      
      
                  
                     Synonyms
                  
               
               
                  L-Calcium tartrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Slightly soluble in water. Solubility approximately 0,01 g/100 ml water (20 °C). Sparingly soluble in ethanol. Slightly soluble in diethyl ether. Soluble in acids
               
            
                  Specific rotation
               
               
                  [α]D
                     20 + 7,0° to + 7,4° (0,1 % in a 1N HCl solution)
               
            
                  pH
               
               
                  Between 6,0 and 9,0 (5 % slurry)
               
            
                  
                     Purity
                  
               
            
                  Sulphates
               
               
                  Not more than 1 g/kg (as H2SO4)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 355 ADIPIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-673-3
               
            
                  Chemical name
               
               
                  Hexanedioic acid; 1,4-butanedicarboxylic acid
               
            
                  Chemical formula
               
               
                  C6H10O4
                  
               
            
                  Molecular weight
               
               
                  146,14
               
            
                  Assay
               
               
                  Content not less than 99,6 %
               
            
                  
                     Description
                  
               
               
                  White odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  151,5-154,0 °C
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 356 SODIUM ADIPATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-293-5
               
            
                  Chemical name
               
               
                  Sodium adipate
               
            
                  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
                  
               
            
                  Melting range
               
               
                  151-152 °C (for adipic acid)
               
            
                  Solubility
               
               
                  Approximately 50 g/100 ml water (20 °C)
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 3 % (Karl Fischer)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 357 POTASSIUM ADIPATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  242-838-1
               
            
                  Chemical name
               
               
                  Potassium adipate
               
            
                  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
                  
               
            
                  Melting range
               
               
                  151-152 °C (for adipic acid)
               
            
                  Solubility
               
               
                  Approximately 60 g/100 ml water (20 °C)
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Water
               
               
                  Not more than 3 % (Karl Fischer)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 363 SUCCINIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  203-740-4
               
            
                  Chemical name
               
               
                  Butanedioic acid
               
            
                  Chemical formula
               
               
                  C4H6O4
                  
               
            
                  Molecular weight
               
               
                  118,09
               
            
                  Assay
               
               
                  Content no less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless or white, odourless crystals
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  185,0-190,0 °C
               
            
                  
                     Purity
                  
               
            
                  Residue on ignition
               
               
                  Not more than 0,025 % (800 °C, 15 min)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 380 TRIAMMONIUM CITRATE
      
      
                  
                     Synonyms
                  
               
               
                  Tribasic ammonium citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  222-394-5
               
            
                  Chemical name
               
               
                  Triammonium salt of 2-hydroxypropan-1,2,3-tricarboxylic acid
               
            
                  Chemical formula
               
               
                  C6H17N3O7
                  
               
            
                  Molecular weight
               
               
                  243,22
               
            
                  Assay
               
               
                  Content not less than 97,0 %
               
            
                  
                     Description
                  
               
               
                  White to off-white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for ammonium
               
               
                  Passes test
               
            
                  Test for citrate
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 385 CALCIUM DISODIUM ETHYLENEDIAMINETETRAACETATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium disodium EDTA; Calcium disodium edetate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-529-9
               
            
                  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
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Chelating activity to metal ions
               
               
                  Positive
               
            
                  pH
               
               
                  Between 6,5 and 7,5 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  5 to 13 % (Karl Fischer method)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 392 EXTRACTS OF ROSEMARY
      
      
                  
                     Synonyms
                  
               
               
                  Extract of rosemary leaf (antioxidant)
               
            
                  
                     Definition
                  
               
               
                  Extracts of rosemary contain several components, which have been proven to exert antioxidative functions. These components belong mainly to the classes of phenolic acids, flavonoids, diterpenoids. Besides the antioxidant compounds, the extracts can also contain triterpenes and organic solvent extractable material specifically defined in the following specification.
               
            
                  Einecs
               
               
                  283-291-9
               
            
                  Chemical name
               
               
                  Rosemary extract (Rosmarinus officinalis)
               
            
                  
                     Description
                  
               
               
                  Rosemary leaf extract antioxidant is prepared by extraction of the leaves of Rosmarinus officinalis using a food approved solvent system. Extracts may then be deodorised and decolourised. Extracts may be standardised.
               
            
                  
                     Identification
                  
               
            
                  Reference antioxidative compounds: phenolic diterpenes
               
               
                  Carnosic acid (C20H28O4) and Carnosol (C20H26O4)
                  (which comprise not less than 90 % of the total phenolic diterpenes)
               
            
                  Reference key volatiles
               
               
                  Borneol, Bornyl Acetate, Camphor, 1,8-Cineol, Verbenone
               
            
                  Density
               
               
                  > 0,25 g/ml
               
            
                  Solubility
               
               
                  Insoluble in water
               
            
                  
                     Purity
                  
               
            
                  Loss of drying
               
               
                  < 5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         1 —   Extracts of rosemary produced from dried rosemary leaves by acetone extraction.
      
      
                  
                     Description
                  
               
               
                  Extracts of rosemary are produced from dried rosemary leaves by acetone extraction, filtration, purification and solvent evaporation, followed by drying and sieving to obtain a fine powder or a liquid.
               
            
                  
                     Identification
                  
               
            
                  Content of reference antioxidative compounds
               
               
                  ≥ 10 % w/w, expressed as the total of carnosic acid and carnosol
               
            
                  Antioxidant/Volatiles — Ratio
               
               
                  (Total % w/w of carnosic acid and carnosol) ≥ 15
                  (% w/w of reference key volatiles)*
                  (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)
               
            
                  
                     Purity
                  
               
            
                  Residual solvents
               
               
                  Acetone: Not more than 500 mg/kg
               
            
         2 —   Extracts of rosemary prepared by extraction of dried rosemary leaves by means of supercritical carbon dioxide.
      
      
                  
                     Description
                  
               
               
                  Extracts of rosemary produced from dried rosemary leaves extracted by means of supercritical carbon dioxide with a small amount of ethanol as entrainer.
               
            
                  
                     Identification
                  
               
            
                  Content of reference antioxidative compounds
               
               
                  ≥ 13 % w/w, expressed as the total of carnosic acid and carnosol
               
            
                  Antioxidant/Volatiles – Ratio
               
               
                  (Total % w/w of carnosic acid and carnosol) ≥ 15
                  (% w/w of reference key volatiles)*
                  (* as a percentage of total volatiles in the extract, measured by Gas Chromatography — Mass Spectrometry Detection, ‘GC-MSD’)
               
            
                  
                     Purity
                  
               
            
                  Residual solvents
               
               
                  Ethanol: not more than 2 %
               
            
         3 —   Extracts of rosemary prepared from a deodorised ethanolic extract of rosemary.
      
      
                  
                     Description
                  
               
               
                  Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary. The extracts may be further purified, for example by treatment with active carbon and/or molecular distillation. The extracts may be suspended in suitable and approved carriers or spray dried.
               
            
                  
                     Identification
                  
               
            
                  Content of reference antioxidative compounds
               
               
                  ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol
               
            
                  Antioxidant/Volatiles – Ratio
               
               
                  (Total % w/w of carnosic acid and carnosol) ≥ 15
                  (% w/w of reference key volatiles)*
                  (* as a percentage of total volatiles in the extract, measured by Gas Chromatography – Mass Spectrometry Detection, ‘GC-MSD’)
               
            
                  
                     Purity
                  
               
            
                  Residual solvents
               
               
                  Ethanol: not more than 500 mg/kg
               
            
         4 —   Extracts of rosemary decolourised and deodorised, obtained by a two-step extraction using hexane and ethanol.
      
      
                  
                     Description
                  
               
               
                  Extracts of rosemary which are prepared from a deodorised ethanolic extract of rosemary, undergone a hexane extraction. The extract may be further purified, for example by treatment with active carbon and/or molecular distillation. They may be suspended in suitable and approved carriers or spray dried.
               
            
                  
                     Identification
                  
               
            
                  Content of reference antioxidative compounds
               
               
                  ≥ 5 % w/w, expressed as the total of carnosic acid and carnosol
               
            
                  Antioxidant/Volatiles – Ratio
               
               
                  (Total % w/w of carnosic acid and carnosol) ≥ 15
                  (% w/w of reference key volatiles)*
                  (* as a percentage of total volatiles in the extract, measured by Gas Chromatography – Mass Spectrometry Detection, ‘GC-MSD’)
               
            
                  
                     Purity
                  
               
            
                  Residual solvents
               
               
                  Hexane: not more than 25 mg/kg
                  Ethanol: not more than 500 mg/kg
               
            
         E 400 ALGINIC ACID
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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 strains of various species of brown seaweeds (Phaeophyceae)
               
            
                  Einecs
               
               
                  232-680-1
               
            
                  Chemical name
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Insoluble in water and organic solvents, slowly soluble in solutions of sodium carbonate, sodium hydroxide and trisodium phosphate
               
            
                  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.
               
            
                  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.
               
            
                  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.
               
            
                  pH
               
               
                  Between 2,0 and 3,5 (3 % suspension)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 °C, 4 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 8 % on the anhydrous basis
               
            
                  Sodium hydroxide (1 M solution) insoluble matter
               
               
                  Not more than 2 % on the anhydrous basis
               
            
                  Formaldehyde
               
               
                  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
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
         E 401 SODIUM ALGINATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for alginic acid
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 °C, 4 hours)
               
            
                  Water insoluble matter
               
               
                  Not more than 2 % on the anhydrous basis
               
            
                  Formaldehyde
               
               
                  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
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
         E 402 POTASSIUM ALGINATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for alginic acid
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 °C, 4 hours)
               
            
                  Water insoluble matter
               
               
                  Not more than 2 % on the anhydrous basis
               
            
                  Formaldehyde
               
               
                  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
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
         E 403 AMMONIUM ALGINATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for ammonium
               
               
                  Passes test
               
            
                  Test for alginic acid
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 °C, 4 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 7 % on the dried basis
               
            
                  Water insoluble matter
               
               
                  Not more than 2 % on the anhydrous basis
               
            
                  Formaldehyde
               
               
                  Not more than 50 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
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
         E 404 CALCIUM ALGINATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium salt of alginate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for alginic acid
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15,0 % (105 °C, 4 hours)
               
            
                  Formaldehyde
               
               
                  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
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
         E 405 PROPANE-1,2-DIOL ALGINATE
      
      
                  
                     Synonyms
                  
               
               
                  Hydroxypropyl alginate; 1,2-Propanediol ester of alginic acid; Propylene glycol alginate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  1,2-Propanediol 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 carbon dioxide (CO2)
                  
               
            
                  
                     Description
                  
               
               
                  Nearly odourless, white to yellowish brown fibrous or granular powder
               
            
                  
                     Identification
                  
               
            
                  Test for 1,2-propanediol
               
               
                  Passes test (after hydrolysis)
               
            
                  Test for alginic acid
               
               
                  Passes test (after hydrolysis)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 20 % (105 °C, 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
               
            
                  Formaldehyde
               
               
                  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
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 500 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
         E 406 AGAR
      
      
                  
                     Synonyms
                  
               
               
                  Gelose; Kanten, Bengal, Ceylon, Chinese or Japanese isinglass; Layor Carang
               
            
                  
                     Definition
                  
               
               
                  Agar is a hydrophilic colloidal polysaccharide consisting mainly of galactose units with a regular alternation of L and D isomeric forms. These hexoses are alternately linked with alpha-1,3 and beta-1,4 bonds in the copolymer. 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 strains of marine algae of the families Gelidiaceae and Gracilariaceae and relevant red algae of the class Rhodophyceae
                  
               
            
                  Einecs
               
               
                  232-658-1
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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, agar powder appears more transparent. 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
                  
               
            
                  Solubility
               
               
                  Insoluble in cold water; soluble in boiling water
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 22 % (105 °C, 5 hours)
               
            
                  Ash
               
               
                  Not more than 6,5 % on the anhydrous basis determined at 550 °C
               
            
                  Acid-insoluble ash (insoluble in approximately 3N Hydrochloric acid)
               
               
                  Not more than 0,5 % determined at 550 °C on the anhydrous basis
               
            
                  Insoluble matter (after stirring for 10 minutes 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 °C. 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 °C 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
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 300 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 5 g
               
            
         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 extraction with water or dilute aqueous alkali of strains of seaweeds of Gigartinaceae, Solieriaceae, Hypneaceae and Furcellariaceae, families of the class Rhodophyceae (red seaweeds).
                  Carrageenan consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysacharide. These hexoses are alternately linked α-1,3 and β-1,4 in the copolymer.
                  The prevalent polysaccharides in carrageenan are designated as kappa, iota, lambda depending on the number of sulphate by repeating unit (i.e. 1,2,3 sulphate). Between kappa and iota there is a continuum of intermediate compositions differing in number of sulphates per repeat units between 1 and 2.
                  During the process, no organic precipitant shall be used other than methanol, ethanol and propan-2-ol.
                  The wording carrageenan is reserved for the non hydrolysed or otherwise chemically degraded polymer.
                  Formaldehyde may be present as an adventitious impurity up to a maximum of 5 mg/kg.
               
            
                  Einecs
               
               
                  232-524-2
               
            
                  Chemical name
               
               
                  Sulphate esters of polygalactose
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Yellowish to colourless, coarse to fine powder which is practically odourless
               
            
                  
                     Identification
                  
               
            
                  Test for galactose
               
               
                  Passes test
               
            
                  Test for anhydrogalactose
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in hot water; insoluble in alcohol for a 1,5 % dilution
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in combination
               
            
                  Viscosity
               
               
                  Not less than 5 mPa.s (1,5 % solution at 75 °C)
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 °C, 4 hours)
               
            
                  Sulphates
               
               
                  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 °C
               
            
                  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 2 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 300 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
         E 407a PROCESSED EUCHEUMA SEAWEED
      
      
                  
                     Synonyms
                  
               
               
                  PES (acronym for processed eucheuma seaweed). The PES obtained from Euchema cottonii is generally called kappa PES and the PES from Euchema spinosum iota PES.
               
            
                  
                     Definition
                  
               
               
                  Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment at high temperature of the strains of seaweeds Eucheuma cottonii and Eucheuma spinosum, of the class Rhodophyceae (red seaweeds) followed by fresh water washing to remove impurities and drying to obtain the product. Further purification may be achieved by washing with an alcohol. The alcohols authorised are restricted to methanol, ethanol or propan-2-ol. The product consists chiefly of the potassium, sodium, magnesium and calcium sulphate esters of galactose and 3,6-anhydrogalactose polysaccharide. Up to 15 % algal cellulose is also present in the product. The wording processed eucheuma seaweed is reserved to the non hydrolysed or otherwise chemically degraded polymer. Formaldehyde may be present up to a maximum of 5 mg/kg.
               
            
                  
                     Description
                  
               
               
                  Tan to yellowish, coarse to fine powder which is practically odourless
               
            
                  
                     Identification
                  
               
            
                  Test for galactose
               
               
                  Passes test
               
            
                  Test for anhydrogalactose
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Forms cloudy viscous suspensions in water. Insoluble in ethanol for a 1,5 % solution.
               
            
                  
                     Purity
                  
               
            
                  Solvent residues
               
               
                  Not more than 0,1 % of methanol, ethanol, propan-2-ol, singly or in combination
               
            
                  Viscosity
               
               
                  Not less than 5 mPa.s (1,5 % solution at 75 °C)
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 °C, 4 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 °C
               
            
                  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 2 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 300 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent 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 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
               
            
                  Einecs
               
               
                  232-541-5
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                  50 000-3 000 000
               
            
                  Assay
               
               
                  Galactomannan content not less than 75 %
               
            
                  
                     Description
                  
               
               
                  White to yellowish-white, nearly odourless powder
               
            
                  
                     Identification
                  
               
            
                  Test for galactose
               
               
                  Passes test
               
            
                  Test for mannose
               
               
                  Passes test
               
            
                  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 than in guar gum. Guar gum shows close groups of round to pear shaped cells. Their contents are yellow to brown
               
            
                  Solubility
               
               
                  Soluble in hot water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 °C, 5 hours)
               
            
                  Ash
               
               
                  Not more than 1,2 % determined at 800 °C
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Ethanol and propan-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 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. The gum may be partially hydrolysed by either heat treatment, mild acid or alcaline oxidative treatment for viscosity adjustment.
               
            
                  Einecs
               
               
                  232-536-0
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                  50 000-8 000 000
               
            
                  Assay
               
               
                  Galactomannan content not less than 75 %
               
            
                  
                     Description
                  
               
               
                  A white to yellowish-white, nearly odourless powder
               
            
                  
                     Identification
                  
               
            
                  Test for galactose
               
               
                  Passes test
               
            
                  Test for mannose
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in cold water
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 °C, 5 hours)
               
            
                  Ash
               
               
                  Not more than 5,5 % determined at 800 °C
               
            
                  Acid-insoluble matter
               
               
                  Not more than 7 %
               
            
                  Protein
               
               
                  Not more than 10 % (factor N x 6,25)
               
            
                  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)
               
            
                  Organic peroxides
               
               
                  Not more than 0,7 meq active oxygen/kg sample
               
            
                  Furfural
               
               
                  Not more than 1 mg/kg
               
            
                  Pentachlorophenol
               
               
                  Not more than 0,01 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
               
            
         E 413 TRAGACANTH
      
      
                  
                     Synonyms
                  
               
               
                  Tragacanth gum; Tragant
               
            
                  
                     Definition
                  
               
               
                  Tragacanth is a dried exudation obtained from the stems and branches of 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
               
            
                  Einecs
               
               
                  232-252-5
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                  Approximately 800 000
               
            
                  Assay
               
               
                   
               
            
                  
                     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
                  
               
            
                  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
                  
               
            
                  Test for Karaya gum
               
               
                  Negative. 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 °C, 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
         E 414 ACACIA GUM
      
      
                  
                     Synonyms
                  
               
               
                  Gum arabic
               
            
                  
                     Definition
                  
               
               
                  Acacia gum is a dried exudation obtained from the stems and branches of 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
               
            
                  Einecs
               
               
                  232-519-5
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                  Approximately 350 000
               
            
                  Assay
               
               
                   
               
            
                  
                     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
                  
               
            
                  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 °C, 5 hours) for granular and not more than 10 % (105 °C, 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Hydrolysis products
               
               
                  Mannose, xylose and galacturonic acid are absent (determined by chromatography)
               
            
                  
                     Microbiological criteria
                  
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
         E 415 XANTHAN GUM
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Xanthan gum is a high molecular weight polysaccharide gum produced by a pure-culture fermentation of a carbohydrate with strains of Xanthomonas campestris, purified by recovery with ethanol or propan-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
               
            
                  Einecs
               
               
                  234-394-2
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                  Approximately 1 000 000
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 °C, 2,5 hours)
               
            
                  Total ash
               
               
                  Not more than 16 % on the anhydrous basis determined at 650 °C after drying at 105 °C 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
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 300 colonies per gram
               
            
                  
                     Escherichia 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 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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     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
                  
               
            
                  Solubility
               
               
                  Insoluble in ethanol
               
            
                  Swelling in ethanol solution
               
               
                  Karaya gum swells in 60 % ethanol distinguishing it from other gums
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 20 % (105 °C, 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 10 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
         E 417 TARA GUM
      
      
                  
                     Definition
                  
               
               
                  Tara gum is obtained by grinding the endosperm of the seeds of 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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  A white to white-yellow odourless powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, insoluble in ethanol
               
            
                  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 x 5,7)
               
            
                  Starch
               
               
                  Not detectable
               
            
                  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 418 GELLAN GUM
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture fermentation of a carbohydrate by strains of Pseudomonas elodea, purified by recovery with propan-2-ol or ethanol, 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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Soluble in water, forming a viscous solution.
                  Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % after drying (105 °C, 2,5 hours)
               
            
                  Nitrogen
               
               
                  Not more than 3 %
               
            
                  Propan-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
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 10 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 400 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Negative in 5 g
               
            
                  
                     Salmonella spp.
               
               
                  Negative in 10 g
               
            
         E 420 (i) SORBITOL
      
      
                  
                     Synonyms
                  
               
               
                  D-glucitol; D-sorbitol
               
            
                  
                     Definition
                  
               
               
                  Sorbitol is obtained by hydrogenation of D-glucose. It is mainly composed of D-sorbitol. According to the level of D-glucose, the part of the products which is not D-sorbitol is composed of related substances such as mannitol, iditol, maltitol.
               
            
                  Einecs
               
               
                  200-061-5
               
            
                  Chemical name
               
               
                  D-glucitol
               
            
                  Chemical formula
               
               
                  C6H14O6
                  
               
            
                  Molecular weight
               
               
                  182,2
               
            
                  Assay
               
               
                  Content not less than 97 % of total glycitols and not less than 91 % of D-sorbitol on dry weight basis (glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer).
               
            
                  
                     Description
                  
               
               
                  White hygroscopic powder, crystalline powder, flakes or granules.
               
            
                  Appearance of the aqueous solution:
               
               
                  The solution is clear.
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Very soluble in water, slightly soluble in ethanol
               
            
                  Melting range
               
               
                  88 to 102 °C
               
            
                  Sorbitol monobenzylidene derivative
               
               
                  To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot, cool the filtrate, filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 1,5 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 % (expressed on dry weight basis)
               
            
                  Reducing sugars
               
               
                  Not more than 0,3 % (expressed as glucose on dry weight basis)
               
            
                  Total sugars
               
               
                  Not more than 1 % (expressed as glucose on dry weight basis)
               
            
                  Chlorides
               
               
                  Not more than 50 mg/kg (expressed on dry weight basis)
               
            
                  Sulphates
               
               
                  Not more than 100 mg/kg (expressed on dry weight basis)
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg (expressed on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
         E 420 (ii) SORBITOL SYRUP
      
      
                  
                     Synonyms
                  
               
               
                  D-glucitol syrup
               
            
                  
                     Definition
                  
               
               
                  Sorbitol syrup formed by hydrogenation of glucose syrup is composed of D-sorbitol, D-mannitol and hydrogenated saccharides.
                  The part of the product which is not D-sorbitol is composed mainly of hydrogenated oligosaccharides formed by the hydrogenation of glucose syrup used as raw material (in which case the syrup is non-crystallising) or mannitol. Minor quantities of glycitols where n ≤ 4 may be present (glycitols are compounds with the structural formula CH2OH-(CHOH)n-CH2OH, where ‘n’ is an integer)
               
            
                  Einecs
               
               
                  270-337-8
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Content not less than 69 % total solids and not less than 50 % of D-sorbitol on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Clear and colourless aqueous solution
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Miscible with water, with glycerol, and with propane-1,2-diol
               
            
                  Sorbitol monobenzylidene derivative
               
               
                  To 5 g of the sample add 7 ml of methanol, 1 ml of benzaldehyde and 1 ml of hydrochloric acid. Mix and shake in a mechanical shaker until crystals appear. Filter with the aid of suction, dissolve the crystals in 20 ml of boiling water containing 1 g of sodium bicarbonate, filter while hot. Cool the filtrate filter with suction, wash with 5 ml of methanol-water mixture (1 in 2) and dry in air. The crystals so obtained melt between 173 and 179 °C
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 31 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 % (on dry weight basis)
               
            
                  Reducing sugars
               
               
                  Not more than 0,3 % (expressed as glucose on dry weight basis)
               
            
                  Chlorides
               
               
                  Not more than 50 mg/kg (on dry weight basis)
               
            
                  Sulphates
               
               
                  Not more than 100 mg/kg (on dry weight basis)
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg (on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (on dry weight basis)
               
            
         E 421 MANNITOL
      
      (i)   MANNITOL
      
                  
                     Synonyms
                  
               
               
                  D-mannitol
               
            
                  
                     Definition
                  
               
               
                  The product contains min. 96 % mannitol. The part of the product which is not mannitol is mainly composed of sorbitol (2 % max), maltitol (2 % max) and isomalt (1,1 GPM (1-O-alpha-D-Glucopyranosyl-D-mannitol dehydrate): 2 % max and 1,6 GPS (6-O-alpha-D-Glucopyranosyl-D-Sorbitol): 2 % max). Unspecified impurities shall not represent more than 0,1 % of each.
                  Manufactured by catalytic hydrogenation of carbohydrate solutions containing glucose and/or fructose
               
            
                  Einecs
               
               
                  200-711-8
               
            
                  Chemical name
               
               
                  D-mannitol
               
            
                  Chemical formula
               
               
                  C6H14O6
                  
               
            
                  Molecular weight
               
               
                  182,2
               
            
                  Assay
               
               
                  Content not less than 96,0 % D-mannitol and not more than 102 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White, odourless, crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
               
            
                  Melting range
               
               
                  Between 164 and 169 °C
               
            
                  Infrared absorption spectrometry
               
               
                  Comparison with a reference standard e.g. EP or USP
               
            
                  Specific rotation
               
               
                  [α]D
                     20 + 23° to + 25° (borate solution)
               
            
                  pH
               
               
                  Between 5 and 8. Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 0,5 % (Karl Fischer method)
               
            
                  Reducing sugars
               
               
                  Not more than 0,3 % (as glucose)
               
            
                  Total sugars
               
               
                  Not more than 1 % (expressed as glucose)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Chlorides
               
               
                  Not more than 70 mg/kg
               
            
                  Sulphate
               
               
                  Not more than 100 mg/kg
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            (ii)   MANNITOL MANUFACTURED BY FERMENTATION
      
                  
                     Synonyms
                  
               
               
                  D-mannitol
               
            
                  
                     Definition
                  
               
               
                  Manufactured by discontinuous fermentation under aerobic conditions using a conventional strain of the yeast Zygosaccharomyces rouxii. The part of the product which is not mannitol is mainly composed of sorbitol, maltitol and isomalt.
               
            
                  Einecs
               
               
                  200-711-8
               
            
                  Chemical name
               
               
                  D-mannitol
               
            
                  Chemical formula
               
               
                  C6H14O6
                  
               
            
                  Molecular weight
               
               
                  182,2
               
            
                  Assay
               
               
                  Not less than 99 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White, odourless crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, very slightly soluble in ethanol, practically insoluble in ether
               
            
                  Melting range
               
               
                  Between 164 and 169 °C
               
            
                  Infrared absorption spectrometry
               
               
                  Comparison with a reference standard e.g. EP or USP
               
            
                  Specific rotation
               
               
                  [α]D
                     20 + 23° to + 25° (borate solution)
               
            
                  pH
               
               
                  Between 5 and 8
                  Add 0,5 ml of a saturated solution of potassium chloride to 10 ml of a 10 % w/v solution of the sample, then measure the pH
               
            
                  
                     Purity
                  
               
            
                  Arabitol
               
               
                  Not more than 0,3 %
               
            
                  Water content
               
               
                  Not more than 0,5 % (Karl Fischer method)
               
            
                  Reducing sugars
               
               
                  Not more than 0,3 % (expressed as glucose)
               
            
                  Total sugars
               
               
                  Not more than 1 % (as glucose)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Chlorides
               
               
                  Not more than 70 mg/kg
               
            
                  Sulphate
               
               
                  Not more than 100 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Aerobic mesophilic bacteria
               
               
                  Not more than 1 000 colonies per gram
               
            
                  Coliforms
               
               
                  Absent in 10 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 25 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 10 g
               
            
                  
                     Staphylococcus aureus
                  
               
               
                  Absent in 10 g
               
            
                  
                     Pseudomonas aeruginosa
                  
               
               
                  Absent in 10 g
               
            
                  Moulds
               
               
                  Not more than 100 colonies per gram
               
            
                  Yeasts
               
               
                  Not more than 100 colonies per gram
               
            
         E 422 GLYCEROL
      
      
                  
                     Synonyms
                  
               
               
                  Glycerin; Glycerine
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-289-5
               
            
                  Chemical name
               
               
                  1,2,3-propanetriol; Glycerol; Trihydroxypropane
               
            
                  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
                  
               
            
                  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
               
            
                  Specific gravity (25 °C/25 °C)
               
               
                  Not less than 1,257
               
            
                  Refractive index
               
               
                  [n]D
                     20 between 1,471 and 1,474
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 5 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,01 % determined at 800 ± 25 °C
               
            
                  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 °C 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)
               
            
                  3-Monochloropropane-1,2-diol (3-MCPD)
               
               
                  Not more than 0,1 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
               
            
         E 425 (i) KONJAC GUM
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Dispersible in hot or cold water forming a highly viscous solution with a pH between 4,0 and 7,0
               
            
                  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
               
            
                  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 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 °C, 5 hours)
               
            
                  Starch
               
               
                  Not more than 3 %
               
            
                  Protein
               
               
                  Not more than 3 % (factor N × 5,7)
               
            
                  Viscosity (1 % solution)
               
               
                  Not less than 3 kgm– 1s– 1 at 25 °C
               
            
                  Ether-soluble material
               
               
                  Not more than 0,1 %
               
            
                  Total ash
               
               
                  Not more than 5,0 % (800 °C, 3 to 4 hours)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 12,5 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
         E 425 (ii) KONJAC GLUCOMANNAN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  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
                  
               
            
                  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
               
            
                  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 °C, and maintain for 2 h without agitation. Under these conditions a thermally stable gel is formed
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 8 % (105 °C, 3 hours)
               
            
                  Starch
               
               
                  Not more than 1 %
               
            
                  Viscosity (1 % solution)
               
               
                  Not less than 20 kgm– 1s– 1 at 25 °C
               
            
                  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 material
               
               
                  Not more than 2,0 %
               
            
                  Total ash
               
               
                  Not more than 2,0 % (800 °C, 3 to 4 hours)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 12,5 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 5 g
               
            
         E 426 SOYBEAN HEMICELLULOSE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Soybean Hemicellulose is a refined water-soluble polysaccharide obtained from strain soybean fibre by hot water extraction. No organic precipitant shall be used other than ethanol
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Water soluble soybean polysaccharides; Water soluble soybean fibre
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Not less than 74 % carbohydrate
               
            
                  
                     Description
                  
               
               
                  Free flowing white or yellowish white powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in hot and cold water without gel formation
               
            
                  pH
               
               
                  5,5 ± 1,5 (1% solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 7 % (105 °C, 4 hours)
               
            
                  Protein
               
               
                  Not more than 14 %
               
            
                  Viscosity
               
               
                  Not more than 200 mPa.s (10 % solution)
               
            
                  Total ash
               
               
                  Not more than 9,5 % (600 °C, 4 hours)
               
            
                  Arsenic
               
               
                  Not more than 2 mg/kg
               
            
                  Ethanol
               
               
                  Not more than 2%
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 3 000 colonies per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 100 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 10 g
               
            
         E 427 CASSIA GUM
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Cassia gum is the ground purified endosperm of the seeds of Cassia tora and Cassia obtusifoli (Leguminosae) containing less than 0,05 % of Cassia occidentalis. It consists mainly of high molecular weight polysaccharides composed primarily of a linear chain of 1,4-β-D-mannopyranose units linked with 1,6-α-D-galactopyranose units. The ratio of mannose to galactose is about 5:1.
                  In the manufacture the seeds are dehusked and degermed by thermal mechanical treatment followed by milling and screening of the endosperm. The ground endosperm is further purified by extraction with propan-2-ol.
               
            
                  Assay
               
               
                  Not less than 75 % of Galactomannan
               
            
                  
                     Description
                  
               
               
                  Pale yellow to off-white, odourless powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in ethanol. Disperses well in cold water forming a colloidal solution.
               
            
                  Gel formation with borate
               
               
                  To an aqueous dispersion of the sample add sufficient sodium borate test solution (TS) to raise the pH to above 9; a gel is formed.
               
            
                  Gel formation with xanthan gum
               
               
                  Weigh 1,5 g of the sample and 1,5 g of xanthan gum and blend them. Add this blend (with rapid stirring) into 300 ml water at 80 °C in a 400 ml beaker. Stir until the mixture is dissolved and continue stirring for an extra 30 min after dissolution (maintain the temperature above 60 °C during the stirring process). Discontinue stirring and allow the mixture to cool at room temperature for at least 2 h.
                  A firm, viscoelastic gel forms after the temperature drops below 40 °C, but no such gel forms in a 1 % control solution of cassia gum or xanthan gum alone prepared in a similar manner.
               
            
                  Viscosity
               
               
                  Less than 500 mPa.s (25 °C, 2h, 1 % solution) corresponding to an average molecular weight of 200 000-300 000 Da
               
            
                  
                     Purity
                  
               
            
                  Acid insoluble matter
               
               
                  Not more than 2,0 %
               
            
                  pH
               
               
                  5,5-8 (1 % aqueous solution)
               
            
                  Crude fat
               
               
                  Not more than 1 %
               
            
                  Protein
               
               
                  Not more than 7 %
               
            
                  Total ash
               
               
                  Not more than 1,2 %
               
            
                  Loss on drying
               
               
                  Not more than 12 % (5h, 105 °C)
               
            
                  Total anthraquinones
               
               
                  Not more than 0,5 mg/kg(detection limit)
               
            
                  Solvent residues
               
               
                  Not more than 750 mg/kg Propan-2-ol
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total plate count
               
               
                  Not more than 5 000 colony forming units per gram
               
            
                  Yeast and moulds
               
               
                  Not more than 100 colony forming units per gram
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 25 g
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 1 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Content not less than 97,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Cream-coloured flakes or waxy solid at 25 °C with a faint odour
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, ethanol, methanol and ethyl acetate. Insoluble in mineral oil
               
            
                  Congealing range
               
               
                  39-44 °C
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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 °C with a faint characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, ethanol, methanol, ethyl acetate and dioxane. Insoluble in mineral oil and petroleum ether
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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 °C with a faint characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, ethanol, methanol, ethyl acetate and toluene. Insoluble in mineral oil and petroleum ether
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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 °C with a faint characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, ethanol, methanol, ethyl acetate and acetone. Insoluble in mineral oil
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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 °C with a faint characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, ethyl acetate and toluene. Insoluble in mineral oil and vegetable oils
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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 °C with a faint characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Dispersible in water. Soluble in mineral oil, vegetal oils, petroleum ether, acetone, ether, dioxane, ethanol and methanol
               
            
                  Congealing range
               
               
                  29-33 °C
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyoxyethylated polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 440 (i) PECTIN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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 strains of appropriate edible plant material, usually citrus fruits or apples. No organic precipitant shall be used other than methanol, ethanol and propan-2-ol
               
            
                  Einecs
               
               
                  232-553-0
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 °C, 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
               
            
                  Total insolubles
               
               
                  Not more than 3 %
               
            
                  Solvent residues
               
               
                  Not more than 1 % of free methanol, ethanol and propan-2-ol, singly or in combination, on the 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
               
            
         E 440 (ii) AMIDATED PECTIN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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 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 propan-2-ol
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Soluble in water forming a colloidal, opalescent solution. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 °C, 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
               
            
                  Total insolubles:
               
               
                  Not more than 3 %
               
            
                  Solvent residues
               
               
                  Not more than 1 % of methanol, ethanol and propan-2-ol, singly 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
               
            
         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. One or two or three glyceride moieties may be attached to phosphorus. Moreover, two phosphorus esters may be linked together as phosphatidyl phosphatides
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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 to oily solid
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in fats. Insoluble in water. Partially soluble in ethanol and in acetone
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test fatty acids
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Petroleum ether insoluble matter
               
               
                  Not more than 2,5 %
               
            
                  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 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 formula
               
               
                  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
                  
               
            
                  Solubility
               
               
                  Insoluble in water. Soluble in most organic solvents
               
            
                  Refractive index
               
               
                  [n]D
                     40: 1,4492-1,4504
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Hard, yellow to pale amber-coloured solid
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, soluble in acetone
               
            
                  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 %, boiling point 175,5-176 °C, d20
                     4: 0,84)
               
            
                  Ring and ball softening range
               
               
                  Between 82 °C and 90 °C
               
            
                  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
               
            
                  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
                  
               
            
                  Einecs
               
               
                  231-835-0
               
            
                  Chemical name
               
               
                  Disodium dihydrogen diphosphate
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in water
               
            
                  pH
               
               
                  Between 3,7 and 5,0 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 °C, 4 hours)
               
            
                  Water insoluble matter
               
               
                  Not more than 1 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Aluminium
               
               
                  Not more than 200 mg/kg
               
            
         E 450 (ii) TRISODIUM DIPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Trisodium pyrophosphate; Trisodium monohydrogen diphosphate; Trisodium monohydrogen pyrophosphate; Trisodium diphosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  238-735-6
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                  Monohydrate: Na3HP2O7 · H2O
                  Anhydrous: Na3HP2O7
                  
               
            
                  Molecular weight
               
               
                  Monohydrate: 261,95
                  Anhydrous: 243,93
               
            
                  Assay
               
               
                  Content not less than 95 % on the dried basis
                  P2O5 content not less than 57 % and not more than 59 %
               
            
                  
                     Description
                  
               
               
                  White powder or grains, occurs anhydrous or as a monohydrate
               
            
                  
                     Identification
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in water
               
            
                  pH
               
               
                  Between 6,7 and 7,5 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 4,5 % on the anhydrous compound (450-550 °C).
                  Not more than 11,5 % on the monohydrate basis
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 °C, 4 hours) for anhydrous
                  Not more than 1,0 % (105 °C, 4 hours) for monohdyrate
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 450 (iii) TETRASODIUM DIPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Tetrasodium pyrophosphate; Tetrasodium disphosphate; Tetrasodium phosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-767-1
               
            
                  Chemical name
               
               
                  Tetrasodium diphosphate
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in water. Insoluble in ethanol
               
            
                  pH
               
               
                  Between 9,8 and 10,8 (1 % solution)
               
            
                  
                     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 (105 °C, 4 hours then 550 °C, 30 minutes)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 450 (v) TETRAPOTASSIUM DIPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Tetrapotassium pyrophosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  230-785-7
               
            
                  Chemical name
               
               
                  Tetrapotassium diphosphate
               
            
                  Chemical formula
               
               
                  K4P2O7
                  
               
            
                  Molecular weight
               
               
                  330,34 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 95 % (800 °C for 0,5 hours)
                  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
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in water, insoluble in ethanol
               
            
                  pH
               
               
                  Between 10,0 and 10,8 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 2 % (105 °C, 4 hours then 550 °C, 30 minutes)
               
            
                  Water insoluble matter
               
               
                  Not more than 0,2 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 450 (vi) DICALCIUM DIPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium pyrophosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  232-221-5
               
            
                  Chemical name
               
               
                  Dicalcium diphosphate
                  Dicalcium pyrophosphate
               
            
                  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
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Insoluble in water. Soluble in dilute hydrochloric and nitric acids
               
            
                  pH
               
               
                  Between 5,5 and 7,0 (10 % suspension in water)
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 1,5 % (800 °C ± 25 °C, 30 minutes
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 450 (vii) CALCIUM DIHYDROGEN DIPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Acid calcium pyrophosphate; Monocalcium dihydrogen pyrophosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  238-933-2
               
            
                  Chemical name
               
               
                  Calcium dihydrogen diphosphate
               
            
                  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 66 %
               
            
                  
                     Description
                  
               
               
                  White crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Acid-insoluble matter
               
               
                  Not more than 0,4 %
               
            
                  Fluoride
               
               
                  Not more than 30 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Aluminium
               
               
                  Not more than 800 mg/kg. This applies until 31 March 2015.
                  Not more than 200 mg/kg. This applies from 1 April 2015.
               
            
         E 451 (i) PENTASODIUM TRIPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Pentasodium tripolyphosphate; Sodium tripolyphosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-838-7
               
            
                  Chemical name
               
               
                  Pentasodium triphosphate
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 9,1 and 10,2 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Anhydrous: Not more than 0,7 % (105 °C, 1 hour)
                  Hexahydrate: Not more than 23,5 % (60 °C, 1 hour, then 105 °C, 4 hours)
               
            
                  Water insoluble matter
               
               
                  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 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 451 (ii) PENTAPOTASSIUM TRIPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Pentapotassium tripolyphosphate; Potassium triphosphate; Potassium tripolyphosphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  237-574-9
               
            
                  Chemical name
               
               
                  Pentapotassium triphosphate; Pentapotassium tripolyphosphate
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Very soluble in water
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 9,2 and 10,5 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 0,4 % (105 °C, 4 hours, then 550 °C, 30 minutes)
               
            
                  Water insoluble matter
               
               
                  Not more than 2 %
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 452 (i) SODIUM POLYPHOSPHATE
      
      
         I.   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
               
            
                  Einecs
               
               
                  272-808-3
               
            
                  Chemical name
               
               
                  Sodium polyphosphate
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Very soluble in water
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 3,0 and 9,0 (1 % solution)
               
            
                  
                     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 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         II.   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
               
            
                  Einecs
               
               
                  272-808-3
               
            
                  Chemical name
               
               
                  Sodium polyphosphate
               
            
                  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 68,7 % and not more than 70,0 %
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, soluble in mineral acids and in solutions of potassium and ammonium (but not sodium) chlorides
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  pH
               
               
                  About 6,5 (1 in 3 suspension in water)
               
            
                  
                     Purity
                  
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg (expressed as fluorine)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 452 (ii) POTASSIUM POLYPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium metaphosphate; Potassium polymetaphosphate; Kurrol salt
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  232-212-6
               
            
                  Chemical name
               
               
                  Potassium polyphosphate
               
            
                  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
                  
               
            
                  Assay
               
               
                  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
                  
               
            
                  Solubility
               
               
                  1 g dissolves in 100 ml of a 1 in 25 solution of sodium acetate
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Not more than 7,8 (1 % suspension)
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 2 % (105 °C, 4 hours then 550 °C, 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 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 452(iii) SODIUM CALCIUM POLYPHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Sodium calcium polyphosphate, glassy
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  233-782-9
               
            
                  Chemical name
               
               
                  Sodium calcium polyphosphate
               
            
                  Chemical formula
               
               
                  (NaPO3)n CaO where n is typically 5
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  P2O5 content not less than 61 % and not more than 69 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  White glassy crystals, spheres
               
            
                  
                     Identification
                  
               
            
                  pH
               
               
                  Approximately 5 to 7 (1 % m/m slurry)
               
            
                  CaO content
               
               
                  7 % - 15 % m/m
               
            
                  
                     Purity
                  
               
            
                  Fluoride
               
               
                  Not more than 10 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 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
                  
               
            
                  Einecs
               
               
                  236-769-6
               
            
                  Chemical name
               
               
                  Calcium polyphosphate
               
            
                  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
                  
               
            
                  Assay
               
               
                  P2O5 content not less than 71 % and not more than 73 % on the ignited basis
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless crystals or white powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Usually sparingly soluble in water. Soluble in acid medium
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  CaO content
               
               
                  27 to 29,5 %
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 2 % (105 °C, 4 hours then 550 °C, 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 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 459 BETA-CYCLODEXTRIN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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
               
            
                  Einecs
               
               
                  231-493-2
               
            
                  Chemical name
               
               
                  Cycloheptaamylose
               
            
                  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
               
            
                  Appearance of the aqueous solution
               
               
                  Clear and colourless
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Sparingly soluble in water; freely soluble in hot water; slightly soluble in ethanol
               
            
                  Specific rotation
               
               
                  [α]D
                     25 + 160° to + 164° (1 % solution)
               
            
                  pH value:
               
               
                  5,0-8,0 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 14 % (Karl Fischer method)
               
            
                  Other cyclodextrins
               
               
                  Not more than 2 % on an anhydrous basis
               
            
                  Solvent residues
               
               
                  Not more than 1 mg/kg of each of toluene and trichloroethylene
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 460 (i) MICROCRYSTALLINE CELLULOSE
      
      
                  
                     Synonyms
                  
               
               
                  Cellulose gel
               
            
                  
                     Definition
                  
               
               
                  Microcrystalline cellulose is purified, partially depolymerised cellulose prepared by treating alpha-cellulose, obtained as a pulp from strains of fibrous plant material, with mineral acids. The degree of polymerisation is typically less than 400
               
            
                  Einecs
               
               
                  232-674-9
               
            
                  Chemical name
               
               
                  Cellulose
               
            
                  Chemical formula
               
               
                  (C6H10O5)n
                  
               
            
                  Molecular weight
               
               
                  About 36 000
               
            
                  Assay
               
               
                  Not less than 97 % calculated as cellulose on the anhydrous basis
               
            
                  Particle size
               
               
                  Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
               
            
                  
                     Description
                  
               
               
                  A fine white or almost white odourless powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
               
            
                  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
               
            
                  Infrared absorption spectroscopy
               
               
                  To be identified
               
            
                  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
               
            
                  pH
               
               
                  The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 7 % (105 °C, 3 hours)
               
            
                  Water soluble matter
               
               
                  Not more than 0,24 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % (800 ± 25 °C)
               
            
                  Starch
               
               
                  Not detectable
                  To 20 ml of the dispersion obtained in Identification, suspension test, add a few drops of iodine solution and mix. No purplish to blue or blue colour should be produced
               
            
                  Carboxyl groups
               
               
                  Not more than 1 %
               
            
                  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 460 (ii) POWDERED CELLULOSE
      
      
                  
                     Definition
                  
               
               
                  Purified, mechanically disintegrated cellulose prepared by processing alpha-cellulose obtained as a pulp from strains of fibrous plant materials
               
            
                  Einecs
               
               
                  232-674-9
               
            
                  Chemical name
               
               
                  Cellulose; Linear polymer of 1:4 linked glucose residues
               
            
                  Chemical formula
               
               
                  (C6H10O5)n
                  
               
            
                  Molecular weight
               
               
                  (162)n (n is predominantly 1 000 and greater)
               
            
                  Assay
               
               
                  Content not less than 92 %
               
            
                  Particle size
               
               
                  Not less than 5 μm (not more than 10 % of particles of less than 5 μm)
               
            
                  
                     Description
                  
               
               
                  A white, odourless powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, ethanol, ether and dilute mineral acids. Slightly soluble in sodium hydroxide solution
               
            
                  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 settles and a supernatant liquid appears
               
            
                  pH
               
               
                  The pH of the supernatant liquid is between 5,0 and 7,5 (10 % suspension in water)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 7 % (105 °C, 3 hours)
               
            
                  Water soluble matter
               
               
                  Not more than 1,0 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,3 % (800 ± 25 °C)
               
            
                  Starch
               
               
                  Not detectable
                  To 20 ml of the dispersion obtained in Identification, suspension test, 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 461 METHYL CELLULOSE
      
      
                  
                     Synonyms
                  
               
               
                  Cellulose methyl ether
               
            
                  
                     Definition
                  
               
               
                  Methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl groups
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution.
                  Insoluble in ethanol, ether and chloroform.
                  Soluble in glacial acetic acid
               
            
                  pH
               
               
                  Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 °C, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 1,5 % (800 ± 25 °C)
               
            
                  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 462 ETHYL CELLULOSE
      
      
                  
                     Synonyms
                  
               
               
                  Cellulose ethyl ether
               
            
                  
                     Definition
                  
               
               
                  Ethyl cellulose is cellulose obtained directly from fibrous plant material and partially etherified with ethyl groups
               
            
                  Einecs
               
               
                   
               
            
                  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
                              
                           
                        
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  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
               
            
                  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
               
            
                  pH
               
               
                  Neutral to litmus (1 % colloidal solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 3 % (105 °C, 2 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,4 %
               
            
                  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 strains of fibrous plant material and partially etherified with hydroxypropyl groups
               
            
                  Einecs
               
               
                   
               
            
                  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 more 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
                  
               
            
                  Solubility
               
               
                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
               
            
                  Gas chromatography
               
               
                  Determine the substituents by gas chromotography
               
            
                  pH
               
               
                  Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 °C, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 °C
               
            
                  Propylene chlorohydrins
               
               
                  Not more than 0,1 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
               
            
         E 464 HYDROXYPROPYL METHYL CELLULOSE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Hydroxypropyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl groups and containing a small degree of hydroxypropyl substitution
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Insoluble in ethanol
               
            
                  Gas chromatography
               
               
                  Determine the substituents by gas chromatography
               
            
                  pH
               
               
                  Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 °C, 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
               
            
                  Propylene chlorohydrins
               
               
                  Not more than 0,1 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
               
            
         E 465 ETHYL METHYL CELLULOSE
      
      
                  
                     Synonyms
                  
               
               
                  Methylethylcellulose
               
            
                  
                     Definition
                  
               
               
                  Ethyl methyl cellulose is cellulose obtained directly from strains of fibrous plant material and partially etherified with methyl and ethyl groups
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble in ethanol. Insoluble in ether
               
            
                  pH
               
               
                  Not less than 5,0 and not more than 8,0 (1 % colloidal solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % for the fibrous form, and not more than 10 % for the powdered form (105 °C to constant weight)
               
            
                  Sulphated ash
               
               
                  Not more than 0,6 %
               
            
                  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 466 SODIUM CARBOXY METHYL CELLULOSE, CARBOXY METHYL CELLULOSE, CELLULOSE GUM
      
      
                  
                     Synonyms
                  
               
               
                  CMC; NaCMC; Sodium CMC;
               
            
                  
                     Definition
                  
               
               
                  Carboxy methyl cellulose is the partial sodium salt of a carboxymethyl ether of cellulose, the cellulose being obtained directly from strains of fibrous plant material
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Yields a viscous colloidal solution with water. Insoluble in ethanol
               
            
                  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)
               
            
                  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)
               
            
                  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
               
            
                  pH
               
               
                  Not less than 5,0 and not more than 8,5 (1 % colloidal solution)
               
            
                  
                     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 °C to constant weight)
               
            
                  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
               
            
                  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, CROSS-LINKED CELLULOSE GUM
      
      
                  
                     Synonyms
                  
               
               
                  Cross-linked carboxymethyl cellulose; Cross-linked CMC; Cross-linked sodium CMC;
               
            
                  
                     Definition
                  
               
               
                  Cross-linked sodium carboxymethyl cellulose is the sodium salt of thermally cross-linked partly O-carboxymethylated cellulose
               
            
                  Einecs
               
               
                   
               
            
                  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
                           
                        
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Slightly hygroscopic, white to off white, odourless powder
               
            
                  
                     Identification
                  
               
            
                  Precipitate formation
               
               
                  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
               
            
                  Colour reaction
               
               
                  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
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Not less than 5,0 and not more than 7,0 (1 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 6 % (105 °C, 3 hours)
               
            
                  Water soluble matter
               
               
                  Not more than 10 %
               
            
                  Degree of substitution
               
               
                  Not less than 0,2 and not more than 1,5 carboxymethyl groups per anhydroglucose unit
               
            
                  Sodium content
               
               
                  Not more than 12,4 % on anhydrous basis
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 469 ENZYMATICALLY HYDROLYSED CARBOXYMETHYLCELLULOSE, ENZYMATICALLY HYDROLISED CELLULOSE GUM
      
      
                  
                     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)
               
            
                  Einecs
               
               
                   
               
            
                  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)
               
            
                  Molecular 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
                  
               
            
                  Solubility
               
               
                  Soluble in water, insoluble in ethanol
               
            
                  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
               
            
                  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
               
            
                  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
               
            
                  Viscosity (60 % solids)
               
               
                  Not less than 2 500 kgm– 1s– 1 at 25 °C corresponding to an average molecule weight of 5 000 Da
               
            
                  pH
               
               
                  Not less than 6,0 and not more than 8,5 (1 % colloidal solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 12 % (105 °C 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
               
            
                  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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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.
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Content on the anhydrous basis not less than 95 % (105 °C till a constant weight)
               
            
                  
                     Description
                  
               
               
                  White or creamy white light powders, flakes or semi-solids
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Sodium and potassium salts: soluble in water and ethanol. Calcium salts: insoluble in water, ethanol and ether
               
            
                  Test for cations
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Content on the anhydrous basis not less than 95 % (105 °C till a constant weight)
               
            
                  
                     Description
                  
               
               
                  White or creamy-white light powders, flakes or semi-solids
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, partially soluble in ethanol and ether
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyol
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Insoluble in water, soluble in ethanol and toluene at 50 °C
               
            
                  
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
                  Total glycerol
               
               
                  Not less than 16 % and not more than 33 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % determined at 800 ± 25 °C
               
            
         
            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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Clear, mobile liquids to solids, from white to pale yellow in colour
               
            
                  
                     Identification
                  
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for acetic acid
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Insoluble in water. Soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Acids other than acetic and fatty acids
               
               
                  Less than 1 %
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  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
               
            
                  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 °C
               
            
         
            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
                  
               
            
                  Test for glycerol,
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for lactic acid
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Insoluble in cold water but dispersible in hot water
               
            
                  
                     Purity
                  
               
            
                  Acids other than lactic and fatty acids
               
               
                  Less than 1 %
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  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
               
            
                  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 % (800 ± 25 °C)
               
            
         
            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, potassium or calcium salts suitable for the purpose and authorised as food additives according to this Regulation.
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Yellowish or light brown liquids to waxy solids or semi-solids
               
            
                  
                     Identification
                  
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for citric acid
               
               
                  Passes test
               
            
                  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
               
               
                  Less than 1 %
               
            
                  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
               
               
                  Non-neutralised products: not more than 0,5 % (800 ± 25 °C)
                  Partially or wholly neutralised products: not more than 10 % (800 ± 25 °C)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Acid value
               
               
                  Not more than 130
               
            
         
            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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Sticky viscous yellowish liquids to hard yellow waxes
               
            
                  
                     Identification
                  
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for tartaric acid
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Acids other than tartaric and fatty acids
               
               
                  Less than 1,0 %
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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 % (800 ± 25 °C)
               
            
         
            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
                  
               
               
                  Mixed 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Sticky viscous liquids through a fat-like consistency to yellow waxes which hydrolyse in moist air to liberate acetic acid
               
            
                  
                     Identification
                  
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for tartaric acid
               
               
                  Passes test
               
            
                  Test for acetic acid
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Acids other than acetic, tartaric and fatty acids
               
               
                  Less than 1 %
               
            
                  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 °C
               
            
                  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
               
            
                  Total tartaric acid
               
               
                  Not less than 10 % and not more than 40 %
               
            
                  Total acetic acid
               
               
                  Not less than 8 % and not more than 32 %
               
            
                  Acid value
               
               
                  Not less than 40 and not more than 130
               
            
         
            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 acetic acids, and free glycerides. May contain mono- and diacetyltartaric esters of mono- and diglycerides of fatty acids
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Sticky liquids to solids, from white to pale-yellow in colour
               
            
                  
                     Identification
                  
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for tartaric acid
               
               
                  Passes test
               
            
                  Test for acetic acid
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Acids other than acetic, tartaric and fatty acids
               
               
                  Less than 1,0 %
               
            
                  Free glycerol
               
               
                  Not more than 2 %
               
            
                  Total glycerol
               
               
                  Not less than 12 % and not more than 27 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % (800 ± 25 °C)
               
            
                  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
               
            
                  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
               
            
         
            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, ethyl and vinyl esters of food fatty acids (including lauric acid) or by extraction from sucroglycerides. No organic solvent other than dimethylsulphoxide, dimethylformamide, ethyl acetate, propan-2-ol, 2-methyl-1-propanol, propylene glycol, methyl ethyl ketone and supercritical carbondioxide may be used for their preparation. p-methoxy phenol can be used as a stabiliser during the manufacturing procedure.
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Content not less than 80 %
               
            
                  
                     Description
                  
               
               
                  Stiff gels, soft solids or white to slightly greyish-white powders
               
            
                  
                     Identification
                  
               
            
                  Test for sugar
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Sparingly soluble in water, soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Sulphated ash
               
               
                  Not more than 2 % (800 ± 25 °C)
               
            
                  Free sugar
               
               
                  Not more than 5 %
               
            
                  Free fatty acids
               
               
                  Not more than 3 % estimated as oleic acid
               
            
                  
                     p-methoxy-phenol
               
               
                  Not more than 100 μg/kg
               
            
                  Acetaldehyde
               
               
                  Not more than 50 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
               
            
                  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
               
            
                  Ethyl acetate
               
               
                  Not more than 350 mg/kg, singly or in combination
               
            
                  Propan-2-ol
               
            
                  Propylene glycol
               
            
                  Methyl ethyl ketone
               
               
                  Not more than 10 mg/kg
               
            
         
            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 (including lauric acid) 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 propan-2-ol
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for sugar
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Insoluble in cold water, soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Sulphated ash
               
               
                  Not more than 2 % (800 ± 25 °C)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
               
            
                  Ethyl acetate
               
               
                  Not more than 350 mg/kg, single or in combination
               
            
                  Propan-2-ol
               
            
         
            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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for glycerol,
               
               
                  Passes test
               
            
                  Test for polyglycerols
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  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 % (800 ± 25 °C)
               
            
                  Acids other than fatty acids
               
               
                  Less than 1 %
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         
            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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Clear, highly viscous liquid
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water and in ethanol; soluble in ether, hydrocarbons and halogenated hydrocarbons
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test for polyglycerol
               
               
                  Passes test
               
            
                  Test for ricinoleic acid
               
               
                  Passes test
               
            
                  Refractive index
               
               
                  [n]D
                     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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for propylene glycol
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % (800 ± 25 °C)
               
            
                  Acids other than fatty acids
               
               
                  Less than 1 %
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         
            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 deodorisation under vacuum at 130 °C of 10 % of thermally oxidised soya bean oil and 90 % mono- and diglycerides of food fatty acids. Soya bean oil is exclusively made from strains of soya beans
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Pale yellow to light brown a waxy or solid consistency
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water. Soluble in hot oil or fat
               
            
                  
                     Purity
                  
               
            
                  Melting range
               
               
                  55-65 °C
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
               
            
                  Einecs
               
               
                  246-929-7
               
            
                  Chemical name
               
               
                  Sodium di-2-stearoyl lactate
                  Sodium di(2-stearoyloxy)propionate
               
            
                  Chemical formula
               
               
                  C21H39O4Na; C19H35O4Na (major components)
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or slightly yellowish powder or brittle solid with a characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for lactic acid
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
               
            
                  Einecs
               
               
                  227-335-7
               
            
                  Chemical name
               
               
                  Calcium di-2-stearoyl lactate
                  Calcium di(2-stearoyloxy)propionate
               
            
                  Chemical formula
               
               
                  C42H78O8Ca; C38H70O8Ca, C40H74O8Ca (major components)
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or slightly yellowish powder or brittle solid with a characteristic odour
               
            
                  
                     Identification
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for fatty acids
               
               
                  Passes test
               
            
                  Test for lactid acid
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Distearyl tartrate
                  Dipalmityl tartrate
                  Stearylpalmityl tartrate
               
            
                  Chemical formula
               
               
                  C40H78O6 (Distearyl tartrate)
                  C36H70O6 (Dipalmityl tartrate)
                  C38H74O6 (Stearylpalmityl tartrate)
               
            
                  Molecular weight
               
               
                  655 (Distearyl tartrate)
                  599 (Dipalmityl tartrate)
                  627 (Stearylpalmityl tartrate)
               
            
                  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 °C)
               
            
                  
                     Identification
                  
               
            
                  Test for tartrate
               
               
                  Passes test
               
            
                  Melting range
               
               
                  Between 67 °C and 77 °C. After saponification the saturated long chain fatty alcohols have a melting range of 49 °C to 55 °C
               
            
                  
                     Purity
                  
               
            
                  Hydroxyl value
               
               
                  Not less than 200 and not more than 220
               
            
                  Acid value
               
               
                  Not more than 5,6
               
            
                  Total tartaric acid
               
               
                  Not less than 18 % and not more than 35 %
               
            
                  Sulphated ash
               
               
                  Not more than 0,5 % (800 ± 25 °C)
               
            
                  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
               
            
                  Unsaponifiable matter
               
               
                  Not less than 77 % and not more than 83 %
               
            
                  Iodine value
               
               
                  Not more than 4 (Wijs method)
               
            
         E 491 SORBITAN MONOSTEARATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
               
            
                  Einecs
               
               
                  215-664-9
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  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 °C in mineral oil and ethyl acetate
               
            
                  Congealing range
               
               
                  50-52 °C
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 492 SORBITAN TRISTEARATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial stearic acid
               
            
                  Einecs
               
               
                  247-891-4
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  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
               
            
                  Congealing range
               
               
                  47-50 °C
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 493 SORBITAN MONOLAURATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  A mixture of the partial esters of sorbitol and its anhydrides with edible, commercial lauric acid
               
            
                  Einecs
               
               
                  215-663-3
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Dispersible in hot and cold water
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of a polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 494 SORBITAN MONOOLEATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline, toluene, dioxane, petroleum ether and carbon tetra-chloride. Insoluble in cold water, dispersible in warm water
               
            
                  Iodine value
               
               
                  The residue of oleic acid, obtained from the saponification of the sorbitan monooleate in assay, has a iodine value between 80 and 100
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  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
               
            
                  Congealing range
               
               
                  45-47 °C
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic of a partial fatty acid ester of polyol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 1 mg/kg
               
            
         E 500 (i) SODIUM CARBONATE
      
      
                  
                     Synonyms
                  
               
               
                  Soda ash
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  207-838-8
               
            
                  Chemical name
               
               
                  Sodium carbonate
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2 % (anhydrous), 15 % (monohydrate) or 55 %-65 % (decahydrate) (70 °C raising gradually to 300 °C, to constant weight)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 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
                  
               
            
                  Einecs
               
               
                  205-633-8
               
            
                  Chemical name
               
               
                  Sodium hydrogen carbonate
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 8,0 and 8,6 (1 % solution)
               
            
                  Solubility
               
               
                  Soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % (over silica gel, 4 hours)
               
            
                  Ammonium salts
               
               
                  No odour of ammonia detectable after heating
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 500 (iii) SODIUM SESQUICARBONATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  208-580-9
               
            
                  Chemical name
               
               
                  Sodium monohydrogen dicarbonate
               
            
                  Chemical formula
               
               
                  Na2CO3 · 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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 501 (i) POTASSIUM CARBONATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  209-529-3
               
            
                  Chemical name
               
               
                  Potassium carbonate
               
            
                  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
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Very soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 5 % (anhydrous) or 18 % (hydrate) (180 °C, 4 hours)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 501 (ii) POTASSIUM HYDROGEN CARBONATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium bicarbonate; Acid potassium carbonate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  206-059-0
               
            
                  Chemical name
               
               
                  Potassium hydrogen carbonate
               
            
                  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
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,25 % (over silica gel, 4 hours)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 503 (i) AMMONIUM CARBONATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Ammonium carbonate consists of ammonium carbamate, ammonium carbonate and ammonium hydrogen carbonate in varying proportions
               
            
                  Einecs
               
               
                  233-786-0
               
            
                  Chemical name
               
               
                  Ammonium carbonate
               
            
                  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
                  
               
            
                  Test for ammonium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  pH
               
               
                  About 8,6 (5 % solution)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 503 (ii) AMMONIUM HYDROGEN CARBONATE
      
      
                  
                     Synonyms
                  
               
               
                  Ammonium bicarbonate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  213-911-5
               
            
                  Chemical name
               
               
                  Ammonium hydrogen carbonate
               
            
                  Chemical formula
               
               
                  CH5NO3
                  
               
            
                  Molecular weight
               
               
                  79,06
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  White crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for ammonium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  pH
               
               
                  About 8,0 (5 % solution)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 504 (i) MAGNESIUM CARBONATE
      
      
                  
                     Synonyms
                  
               
               
                  Hydromagnesite
               
            
                  
                     Definition
                  
               
               
                  Magnesium carbonate is a basic hydrated or a monohydrated magnesium carbonate or a mixture of the two.
               
            
                  Einecs
               
               
                  208-915-9
               
            
                  Chemical name
               
               
                  Magnesium carbonate
               
            
                  Chemical formula
               
               
                  MgCO3 · nH2O
               
            
                  Assay
               
               
                  Not less than 24 % and not more than 26,4 % of Mg
               
            
                  
                     Description
                  
               
               
                  Odourless, light, white friable masses or as a bulky white powder
               
            
                  
                     Identification
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Practically insoluble both in water or ethanol
               
            
                  
                     Purity
                  
               
            
                  Acid insoluble matter
               
               
                  Not more than 0,05 %
               
            
                  Water soluble matter
               
               
                  Not more than 1,0 %
               
            
                  Calcium
               
               
                  Not more than 0,4 %
               
            
                  Arsenic
               
               
                  Not more than 4 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 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
                  
               
            
                  Einecs
               
               
                  235-192-7
               
            
                  Chemical name
               
               
                  Magnesium carbonate hydroxide hydrated
               
            
                  Chemical formula
               
               
                  4MgCO3Mg(OH)2 · 5H2O
               
            
                  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
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for carbonate
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 507 HYDROCHLORIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  Hydrogen chloride; Muriatic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-595-7
               
            
                  Chemical name
               
               
                  Hydrochloric acid
               
            
                  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
                  
               
            
                  Test for acid
               
               
                  Passes test
               
            
                  Test for chloride
               
               
                  Passes test
               
            
                  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
                  
               
            
                  Einecs
               
               
                  231-211-8
               
            
                  Chemical name
               
               
                  Potassium chloride
               
            
                  Chemical formula
               
               
                  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
                  
               
            
                  Solubility
               
               
                  Freely soluble in water. Insoluble in ethanol
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for chloride
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1 % (105 °C, 2 hours)
               
            
                  Test for sodium
               
               
                  Negative
               
            
                  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 509 CALCIUM CHLORIDE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  233-140-8
               
            
                  Chemical name
               
               
                  Calcium chloride
               
            
                  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
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for chloride
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in water and in ethanol
               
            
                  
                     Purity
                  
               
            
                  Magnesium and alkali salts
               
               
                  Not more than 5 % on the dried basis (calculated as sulphates)
               
            
                  Fluoride
               
               
                  Not more than 40 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 511 MAGNESIUM CHLORIDE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  232-094-6
               
            
                  Chemical name
               
               
                  Magnesium chloride
               
            
                  Chemical formula
               
               
                  MgCl2 · 6H2O
               
            
                  Molecular weight
               
               
                  203,30
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, very deliquescent flakes or crystals
               
            
                  
                     Identification
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for chloride
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 512 STANNOUS CHLORIDE
      
      
                  
                     Synonyms
                  
               
               
                  Tin chloride; Tin dichloride
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-868-0
               
            
                  Chemical name
               
               
                  Stannous chloride dihydrate
               
            
                  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
                  
               
            
                  Test for tin (II)
               
               
                  Passes test
               
            
                  Test for chloride
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
         E 513 SULPHURIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  Oil of vitriol; Dihydrogen sulphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-639-5
               
            
                  Chemical name
               
               
                  Sulphuric acid
               
            
                  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
                  
               
            
                  Test for acid
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 514 (i) SODIUM SULPHATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Neutral or slightly alkaline to litmus paper (5 % solution)
               
            
                  
                     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 2 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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Solutions are strongly acidic
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,8 %
               
            
                  Water insoluble matter
               
               
                  Not more than 0,05 %
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 515 (i) POTASSIUM SULPHATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 5,5 and 8,5 (5 % solution)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 515 (ii) POTASSIUM HYDROGEN SULPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium bisulphate; Potassium acid sulphate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium hydrogen sulphate
               
            
                  Chemical formula
               
               
                  KHSO4
                  
               
            
                  Molecular weight
               
               
                  136,17
               
            
                  Assay
               
               
                  Content not less than 99 %
               
            
                  
                     Description
                  
               
               
                  White deliquescent crystals, pieces or granules
               
            
                  
                     Identification
                  
               
            
                  Melting point
               
               
                  197 °C
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 516 CALCIUM SULPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Gypsum; Selenite; Anhydrite
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-900-3
               
            
                  Chemical name
               
               
                  Calcium sulphate
               
            
                  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
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Slightly soluble in water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Anhydrous: not more than 1,5 % (250 °C, constant weight)
                  Dihydrate: not more than 23 % (250 °C, constant weight)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 517 AMMONIUM SULPHATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-984-1
               
            
                  Chemical name
               
               
                  Ammonium sulphate
               
            
                  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
                  
               
            
                  Test for ammonium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  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 3 mg/kg
               
            
         E 520 ALUMINIUM SULPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Alum
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Aluminium sulphate
               
            
                  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
                  
               
            
                  Test for aluminium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  pH
               
               
                  2,9 or above (5 % solution)
               
            
                  Solubility
               
               
                  Freely soluble in water, insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 5 % (500 °C, 3 hours)
               
            
                  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 5 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 521 ALUMINIUM SODIUM SULPHATE
      
      
                  
                     Synonyms
                  
               
               
                  Soda alum; Sodium alum
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  233-277-3
               
            
                  Chemical name
               
               
                  Aluminium sodium sulphate
               
            
                  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
                  
               
            
                  Test for aluminium
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  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 °C, 16 hours)
                  Dodecahydrate: not more than 47,2 % (50-55 °C, 1 hour then 200 °C, 16 hours)
               
            
                  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
                  
               
            
                  Einecs
               
               
                  233-141-3
               
            
                  Chemical name
               
               
                  Aluminium potassium sulphate dodecahydrate
               
            
                  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
                  
               
            
                  Test for aluminium
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 3,0 and 4,0 (10 % solution)
               
            
                  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
                  
               
            
                  Einecs
               
               
                  232-055-3
               
            
                  Chemical name
               
               
                  Aluminium ammonium sulphate
               
            
                  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
                  
               
            
                  Test for aluminium
               
               
                  Passes test
               
            
                  Test for ammonium
               
               
                  Passes test
               
            
                  Test for sulphate
               
               
                  Passes test
               
            
                  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 3 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 524 SODIUM HYDROXIDE
      
      
                  
                     Synonyms
                  
               
               
                  Caustic soda; Lye
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  215-185-5
               
            
                  Chemical name
               
               
                  Sodium hydroxide
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Strongly alkaline (1 % solution)
               
            
                  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
                  
               
            
                  Einecs
               
               
                  215-181-3
               
            
                  Chemical name
               
               
                  Potassium hydroxide
               
            
                  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
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  Strongly alkaline (1 % solution)
               
            
                  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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 526 CALCIUM HYDROXIDE
      
      
                  
                     Synonyms
                  
               
               
                  Slaked lime; Hydrated lime
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  215-137-3
               
            
                  Chemical name
               
               
                  Calcium hydroxide
               
            
                  Chemical formula
               
               
                  Ca(OH)2
                  
               
            
                  Molecular weight
               
               
                  74,09
               
            
                  Assay
               
               
                  Content not less than 92,0 %
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Identification
                  
               
            
                  Test for alkali
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  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 2,7 %
               
            
                  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 2 mg/kg
               
            
         E 527 AMMONIUM HYDROXIDE
      
      
                  
                     Synonyms
                  
               
               
                  Aqua ammonia; Strong ammonia solution
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for ammonia
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Non-volatile matter
               
               
                  Not more than 0,02 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 528 MAGNESIUM HYDROXIDE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Magnesium hydroxide
               
            
                  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
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for alkali
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Practically insoluble in water and in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,0 % (105 °C, 2 hours)
               
            
                  Loss on ignition
               
               
                  Not more than 33 % (800 °C to constant weight)
               
            
                  Calcium oxide
               
               
                  Not more than 1,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 529 CALCIUM OXIDE
      
      
                  
                     Synonyms
                  
               
               
                  Burnt lime
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  215-138-9
               
            
                  Chemical name
               
               
                  Calcium oxide
               
            
                  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
                  
               
            
                  Test for alkali
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Reaction with water
               
               
                  Heat is generated on moistening the sample with water
               
            
                  Solubility
               
               
                  Slightly soluble in water. Insoluble in ethanol. Soluble in glycerol
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 10,0 % (ca. 800 °C 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 3,6 %
               
            
                  Fluoride
               
               
                  Not more than 50 mg/kg
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 530 MAGNESIUM OXIDE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  215-171-9
               
            
                  Chemical name
               
               
                  Magnesium oxide
               
            
                  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 at least 33 ml, while 5 g of heavy magnesium oxide occupy a volume of not more than 20 ml
               
            
                  
                     Identification
                  
               
            
                  Test for alkali
               
               
                  Passes test
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Practically insoluble in water. Insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not more than 5,0 % (ca. 800 °C to constant weight)
               
            
                  Calcium oxide
               
               
                  Not more than 1,5 %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 535 SODIUM FERROCYANIDE
      
      
                  
                     Synonyms
                  
               
               
                  Yellow prussiate of soda; Sodium hexacyanoferrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  237-081-9
               
            
                  Chemical name
               
               
                  Sodium ferrocyanide
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for ferrocyanide
               
               
                  Passes test
               
            
                  
                     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
                  
               
            
                  Einecs
               
               
                  237-722-2
               
            
                  Chemical name
               
               
                  Potassium ferrocyanide
               
            
                  Chemical formula
               
               
                  K4Fe(CN)6 · 3 H2O
               
            
                  Molecular weight
               
               
                  422,4
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Lemon yellow crystals
               
            
                  
                     Identification
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for ferrocyanide
               
               
                  Passes test
               
            
                  
                     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
                  
               
            
                  Einecs
               
               
                  215-476-7
               
            
                  Chemical name
               
               
                  Calcium ferrocyanide
               
            
                  Chemical formula
               
               
                  Ca2Fe(CN)6 · 12H2O
               
            
                  Molecular weight
               
               
                  508,3
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Yellow crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for ferrocyanide
               
               
                  Passes test
               
            
                  
                     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
                  
               
            
                  Einecs
               
               
                  232-090-4
               
            
                  Chemical name
               
               
                  Sodium trialuminium tetradecahydrogen octaphosphate tetrahydrate (A); Trisodium dialuminium pentadecahydrogen octaphosphate (B)
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for aluminium
               
               
                  Passes test
               
            
                  Test for phosphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Acid to litmus
               
            
                  Solubility
               
               
                  Insoluble in water. Soluble in hydrochloric acid
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  19,5-21,0 % (A) (750-800 °C, 2 hours)
                  15-16 % (B) (750-800 °C, 2 hours)
               
            
                  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
               
            
                  Einecs
               
               
                  231-545-4
               
            
                  Chemical name
               
               
                  Silicon dioxide
               
            
                  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
                  
               
            
                  Test for silica
               
               
                  Positive
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 2,5 % (fumed silica, 105 °C, 2 hours)
                  Not more than 8,0 % (precipitated silica and silica gel, 105 °C, 2 hours)
                  Not more than 70 % (hydrous silica, 105 °C, 2 hours)
               
            
                  Loss on ignition
               
               
                  Not more than 2,5 % after drying (1 000 °C, fumed silica)
                  Not more than 8,5 % after drying (1 000 °C, 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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Calcium silicate is a hydrous or anhydrous silicate with varying proportions of CaO and SiO2. The product should be free of asbestos.
               
            
                  Einecs
               
               
                  215-710-8
               
            
                  Chemical name
               
               
                  Calcium silicate
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for silicate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Gel formation
               
               
                  Forms a gel with mineral acids
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 °C, 2 hours)
               
            
                  Loss on ignition
               
               
                  Not less than 5 % and not more than 14 % (1 000 °C, 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 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 553a (i) MAGNESIUM SILICATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Magnesium silicate is a synthetic compound of which the molar ratio of magnesium oxide to silicon dioxide is approximately 2:5
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for silicate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 10,8 (10 % slurry)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (105 °C, 2 hours)
               
            
                  Loss on ignition
               
               
                  Not more than 15 % after drying (1 000 °C, 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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  239-076-7
               
            
                  Chemical name
               
               
                  Magnesium trisilicate
               
            
                  Chemical formula
               
               
                  Mg2Si3O8 · nH2O (approximate composition)
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for silicate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 6,3 and 9,5 (5 % slurry)
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Not less than 17 % and not more than 34 % (1 000 °C)
               
            
                  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. The product should be free of asbestos.
               
            
                  Einecs
               
               
                  238-877-9
               
            
                  Chemical name
               
               
                  Magnesium hydrogen metasilicate
               
            
                  Chemical formula
               
               
                  Mg3(Si4O10)(OH)2
                  
               
            
                  Molecular weight
               
               
                  379,22
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Light, homogeneous, white or almost white powder, greasy to the touch
               
            
                  
                     Identification
                  
               
            
                  Infrared absorption spectrum
               
               
                  Characteristic peaks at 3 677, 1 018 and 669 cm-1
                  
               
            
                  X-ray diffraction
               
               
                  Peaks at 9,34/4,66/3,12 Å
               
            
                  Solubility
               
               
                  Insoluble in water and ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 °C, 1 hour)
               
            
                  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 2 mg/kg
               
            
         E 554 SODIUM ALUMINIUM SILICATE
      
      
                  
                     Synonyms
                  
               
               
                  Sodium silicoaluminate; Sodium aluminosilicate; Aluminium sodium silicate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Sodium aluminium silicate
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for aluminium
               
               
                  Passes test
               
            
                  Test for silicate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 6,5 and 11,5 (5 % slurry)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 8,0 % (105 °C, 2 hours)
               
            
                  Loss on ignition
               
               
                  Not less than 5,0 % and not more than 11,0 % on the anhydrous basis (1 000 °C to 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 formula
               
               
                  KAl2[AlSi3O10](OH)2
                  
               
            
                  Molecular weight
               
               
                  398
               
            
                  Assay
               
               
                  Content not less than 98 %
               
            
                  
                     Description
                  
               
               
                  Light grey to white crystalline platelets or powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, diluted acids and alkali and organic solvents
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 °C, 2 hours)
               
            
                  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 5 mg/kg
               
            
         E 556 CALCIUM ALUMINIUM SILICATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium aluminosilicate; Calcium silicoaluminate; Aluminium calcium silicate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium aluminium silicate
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for aluminium
               
               
                  Passes test
               
            
                  Test for silicate
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 10,0 % (105 °C, 2 hours)
               
            
                  Loss on ignition
               
               
                  Not less than 14,0 % and not more than 18,0 on the anhydrous basis (1 000 °C, constant weight)
               
            
                  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 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. The product should be free of asbestos
               
            
                  Einecs
               
               
                  215-286-4 (kaolinite)
               
            
                  Chemical name
               
               
                   
               
            
                  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
                  
               
            
                  Test for alumina
               
               
                  Passes test
               
            
                  Test for silicate
               
               
                  Passes test
               
            
                  X-ray diffraction
               
               
                  Characteristic peaks at 7,18/3,58/2,38/1,78 Å
               
            
                  Infrared absorption spectrum
               
               
                  Peaks at 3 700 and 3 620 cm-1
                  
               
            
                  
                     Purity
                  
               
            
                  Loss on ignition
               
               
                  Between 10 and 14 % (1 000 °C, 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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Linear fatty acids, caprylic acid (C8), capric acid (C10), lauric acid (C12), myristic acid (C14), palmitic acid (C16), stearic acid (C18), oleic acid (C18:1)
               
            
                  Einecs
               
               
                   
               
            
                  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)
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Not less than 98 % by chromatography
               
            
                  
                     Description
                  
               
               
                  A colourless liquid or white solid obtained from oils and fats
               
            
                  
                     Identification
                  
               
            
                  Identification test
               
               
                  Individual fatty acids can be identified by acid value, iodine value, gas chromatography
               
            
                  
                     Purity
                  
               
            
                  Residue on ignition
               
               
                  Not more than 0,1 %
               
            
                  Unsaponifiable matter
               
               
                  Not more than 1,5 %
               
            
                  Water content
               
               
                  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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Gluconic acid
               
            
                  Chemical formula
               
               
                  C6H12O7 (gluconic acid)
               
            
                  Molecular weight
               
               
                  196,2
               
            
                  Assay
               
               
                  Content not less than 49,0 % (as gluconic acid)
               
            
                  
                     Description
                  
               
               
                  Colourless to light yellow, clear syrupy liquid
               
            
                  
                     Identification
                  
               
            
                  Formation of phenylhydrazine derivative
               
               
                  Positive. Compound formed melts between 196 °C and 202 °C with decomposition
               
            
                  
                     Purity
                  
               
            
                  Residue on ignition
               
               
                  Not more than 1,0 % 550 °C +/– 20 °C till disappearance of organic residues (black spots).
               
            
                  Reducing matter
               
               
                  Not more than 2,0 % (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 1 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
               
            
                  Einecs
               
               
                  202-016-5
               
            
                  Chemical name
               
               
                  D-Glucono-1,5-lactone
               
            
                  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
                  
               
            
                  Formation of phenylhydrazine derivative of gluconic acid
               
               
                  Positive. Compound formed melts between 196 °C and 202 °C with decomposition
               
            
                  Solubility
               
               
                  Freely soluble in water. Sparingly soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 0,2 % (Karl Fischer method)
               
            
                  Reducing substances
               
               
                  Not more than 0,5 % (as D-glucose)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 576 SODIUM GLUCONATE
      
      
                  
                     Synonyms
                  
               
               
                  Sodium salt of D-gluconic acid
               
            
                  
                     Definition
                  
               
               
                  Manufactured by fermentation or chemical catalytic oxidation
               
            
                  Einecs
               
               
                  208-407-7
               
            
                  Chemical name
               
               
                  Sodium D-gluconate
               
            
                  Chemical formula
               
               
                  C6H11NaO7 (anhydrous)
               
            
                  Molecular weight
               
               
                  218,14
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  White to tan, granular to fine, crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for gluconate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Very soluble in water. Sparingly soluble in ethanol
               
            
                  pH
               
               
                  Between 6,5 and 7,5 (10 % solution)
               
            
                  
                     Purity
                  
               
            
                  Reducing matter
               
               
                  Not more than 1,0 % (as D-glucose)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 577 POTASSIUM GLUCONATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium salt of D-gluconic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  206-074-2
               
            
                  Chemical name
               
               
                  Potassium D-gluconate
               
            
                  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
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for gluconate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,3 (10 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Anhydrous: not more than 3,0 % (105 °C, 4 hours, vacuum)
                  Monohydrate: not less than 6 % and not more than 7,5 % (105 °C, 4 hours, 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
                  
               
            
                  Einecs
               
               
                  206-075-8
               
            
                  Chemical name
               
               
                  Calcium di-D-gluconate
               
            
                  Chemical formula
               
               
                  C12H22CaO14 (anhydrous)
                  C12H22CaO14 · H2O (monohydrate)
               
            
                  Molecular weight
               
               
                  430,38 (anhydrous form)
                  448,39 (monohydrate)
               
            
                  Assay
               
               
                  anhydrous: Content not less than 98 % and not more than 102 % on the dried basis
                  monohydrate: not less than 98 % and not more than 102 % on the ‘as is’ basis.
               
            
                  
                     Description
                  
               
               
                  Odourless, white crystalline granules or powder, stable in air
               
            
                  
                     Identification
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for gluconate
               
               
                  Passes test
               
            
                  Solubility
               
               
                  Soluble in water, insoluble in ethanol
               
            
                  pH
               
               
                  Between 6,0 and 8,0 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 3,0 % (105 °C, 16 hours) (anhydrous)
                  Not more than 2,0 % (105 °C, 16 hours) (monohydrate)
               
            
                  Reducing substances
               
               
                  Not more than 1,0 % (as D-glucose)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 579 FERROUS GLUCONATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  206-076-3
               
            
                  Chemical name
               
               
                  Ferrous di-D-gluconate dihydrate; Iron(II) di-gluconate dihydrate
               
            
                  Chemical formula
               
               
                  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
                  
               
            
                  Solubility
               
               
                  Soluble with slight heating in water. Practically insoluble in ethanol
               
            
                  Test for ferrous ion
               
               
                  Passes test
               
            
                  Formation of phenylhy-drazine derivative of gluconic acid
               
               
                  Positive
               
            
                  pH
               
               
                  Between 4 and 5,5 (10 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 10 % (105 °C, 16 hours)
               
            
                  Oxalic acid
               
               
                  Not detectable
               
            
                  Iron (Fe III)
               
               
                  Not more than 2 %
               
            
                  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
               
            
                  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
                  
               
            
                  Einecs
               
               
                  227-608-0
               
            
                  Chemical name
               
               
                  Ferrous 2-hydroxy propanoate
               
            
                  Chemical formula
               
               
                  C6H10FeO6· nH2O (n = 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
                  
               
            
                  Solubility
               
               
                  Soluble in water. Practically insoluble in ethanol
               
            
                  Test for ferrous ion
               
               
                  Passes test
               
            
                  Test for lactate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 4 and 6 (2 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 18 % (100 °C, 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 1 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
                  
               
            
                  Einecs
               
               
                  205-257-4
               
            
                  Chemical name
               
               
                  4-Hexylresorcinol
               
            
                  Chemical formula
               
               
                  C12H18O2
                  
               
            
                  Molecular weight
               
               
                  197,24
               
            
                  Assay
               
               
                  Not less than 98 % on the dried basis (4 hours at room temperature)
               
            
                  
                     Description
                  
               
               
                  White powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble in ether and acetone; very slightly soluble in water
               
            
                  Nitric acid test
               
               
                  To 1 ml of a saturated solution of the sample, add 1 ml of nitric acid. A light red colour appears
               
            
                  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
               
            
                  
                     Purity
                  
               
            
                  Melting range
               
               
                  62 to 67 °C
               
            
                  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
                  
               
            
                  Einecs
               
               
                  200-293-7
               
            
                  Chemical name
               
               
                  L-Glutamic acid; L-2-amino-pentanedioic acid
               
            
                  Chemical formula
               
               
                  C5H9NO4
                  
               
            
                  Molecular weight
               
               
                  147,13
               
            
                  Assay
               
               
                  Content not less than 99,0 % and not more than 101,0 % on the anhydrous basis
               
            
                  Solubility
               
               
                  Sparingly soluble in water; practically insoluble in ethanol or ether
               
            
                  
                     Description
                  
               
               
                  White crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for glutamic acid (by thin layer chromatography)
               
               
                  Passes test
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 31,5° and + 32,2°
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  pH
               
               
                  Between 3,0 and 3,5 (saturated solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,2 % (80 °C, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 %
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Arsenic
               
               
                  Not more than 2,5 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 621 MONOSODIUM GLUTAMATE
      
      
                  
                     Synonyms
                  
               
               
                  Sodium glutamate; MSG
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  205-538-1
               
            
                  Chemical name
               
               
                  Monosodium L-glutamate monohydrate
               
            
                  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
               
            
                  Solubility
               
               
                  Freely soluble in water; practically insoluble in ethanol or ether
               
            
                  
                     Description
                  
               
               
                  White, practically odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  Test for glutamic acid (by thin-layer chromatography)
               
               
                  Passes test
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 24,8° and + 25,3°
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  pH
               
               
                  Between 6,7 and 7,2 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (98 °C, 5 hours)
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 622 MONOPOTASSIUM GLUTAMATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium glutamate; MPG
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  243-094-0
               
            
                  Chemical name
               
               
                  Monopotassium L-glutamate monohydrate
               
            
                  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
               
            
                  Solubility
               
               
                  Freely soluble in water; practically insoluble in ethanol or ether
               
            
                  
                     Description
                  
               
               
                  White, practically odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  Test for glutamic acid (by thin-layer chromatography)
               
               
                  Passes test
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 22,5° and + 24,0°
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  pH
               
               
                  Between 6,7 and 7,3 (2 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,2 % (80 °C, 5 hours)
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 623 CALCIUM DIGLUTAMATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium glutamate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  242-905-5
               
            
                  Chemical name
               
               
                  Monocalcium di-L-glutamate
               
            
                  Chemical formula
               
               
                  C10H16CaN2O8 · nH2O (n = 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
               
            
                  Solubility
               
               
                  Freely soluble in water; practically insoluble in ethanol or ether
               
            
                  
                     Description
                  
               
               
                  White, practically odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  Test for glutamic acid (by thin-layer chromatography)
               
               
                  Passes test
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 27,4° and + 29,2° (for calcium diglutamate with n = 4) (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 19,0 % (for calcium diglutamate with n = 4) (Karl Fischer)
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 624 MONOAMMONIUM GLUTAMATE
      
      
                  
                     Synonyms
                  
               
               
                  Ammonium glutamate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-447-1
               
            
                  Chemical name
               
               
                  Monoammonium L-glutamate monohydrate
               
            
                  Chemical formula
               
               
                  C5H12N2O4 · H2O
               
            
                  Molecular weight
               
               
                  182,18
               
            
                  Assay
               
               
                  Content not less than 99,0 % and not more 101,0 % on the anhydrous basis
               
            
                  Solubility
               
               
                  Freely soluble in water; practically insoluble in ethanol or ether
               
            
                  
                     Description
                  
               
               
                  White, practically odourless crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for ammonium
               
               
                  Passes test
               
            
                  Test for glutamic acid (by thin-layer chromatography)
               
               
                  Passes test
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 25,4° and + 26,4°
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  pH
               
               
                  Between 6,0 and 7,0 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (50 °C, 4 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 625 MAGNESIUM DIGLUTAMATE
      
      
                  
                     Synonyms
                  
               
               
                  Magnesium glutamate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  242-413-0
               
            
                  Chemical name
               
               
                  Monomagnesium di-L-glutamate tetrahydrate
               
            
                  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
               
            
                  Solubility
               
               
                  Very soluble in water; practically insoluble in ethanol or ether
               
            
                  
                     Description
                  
               
               
                  Odourless, white or off-white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for magnesium
               
               
                  Passes test
               
            
                  Test for glutamic acid (by thin-layer chromatography)
               
               
                  Passes test
               
            
                  Specific rotation
               
               
                  [α]D
                     20 between + 23,8° and + 24,4°
                  (10 % solution (anhydrous basis) in 2N HCl, 200 mm tube)
               
            
                  pH
               
               
                  Between 6,4 and 7,5 (10 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 24 % (Karl Fischer)
               
            
                  Chloride
               
               
                  Not more than 0,2 %
               
            
                  Pyrrolidone carboxylic acid
               
               
                  Not more than 0,2 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 626 GUANYLIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  5'-Guanylic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  201-598-8
               
            
                  Chemical name
               
               
                  Guanosine-5'-monophosphoric acid
               
            
                  Chemical formula
               
               
                  C10H14N5O8P
               
            
                  Molecular weight
               
               
                  363,22
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  Solubility
               
               
                  Slightly soluble in water, practically insoluble in ethanol
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 1,5 and 2,5 (0,25 % solution)
               
            
                  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 °C, 4 hours)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 627 DISODIUM GUANYLATE
      
      
                  
                     Synonyms
                  
               
               
                  Sodium guanylate; Sodium 5'-guanylate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  221-849-5
               
            
                  Chemical name
               
               
                  Disodium guanosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H12N5Na2O8P · nH2O (n = ca. 7)
               
            
                  Molecular weight
               
               
                  407,19 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  Solubility
               
               
                  Soluble in water, sparingly soluble in ethanol, practically insoluble in ether
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,5 (5 % solution)
               
            
                  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 °C, 4 hours)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 628 DIPOTASSIUM GUANYLATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium guanylate; Potassium 5'-guanylate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  226-914-1
               
            
                  Chemical name
               
               
                  Dipotassium guanosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H12K2N5O8P
               
            
                  Molecular weight
               
               
                  439,40
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  Solubility
               
               
                  Freely soluble in water, practically insoluble in ethanol
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or white crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,5 (5 % solution)
               
            
                  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 °C, 4 hours)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 629 CALCIUM GUANYLATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium 5'-guanylate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
               
            
                  Solubility
               
               
                  Sparingly soluble in water
               
            
                  
                     Description
                  
               
               
                  Odourless, white or off-white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,0 (0,05 % solution)
               
            
                  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 °C, 4 hours)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 630 INOSINIC ACID
      
      
                  
                     Synonyms
                  
               
               
                  5'-Inosinic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  205-045-1
               
            
                  Chemical name
               
               
                  Inosine-5'-monophosphoric acid
               
            
                  Chemical formula
               
               
                  C10H13N4O8P
               
            
                  Molecular weight
               
               
                  348,21
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  Solubility
               
               
                  Freely soluble in water, slightly soluble in ethanol
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 1,0 and 2,0 (5 % solution)
               
            
                  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 °C, 4 hours)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 631 DISODIUM INOSINATE
      
      
                  
                     Synonyms
                  
               
               
                  Sodium inosinate; Sodium 5'-inosinate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  225-146-4
               
            
                  Chemical name
               
               
                  Disodium inosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H11N4Na2O8P · H2O
               
            
                  Molecular weight
               
               
                  392,17 (anhydrous)
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  Solubility
               
               
                  Soluble in water, sparingly soluble in ethanol, practically insoluble in ether
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,5
               
            
                  Spectrometry
               
               
                  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 28,5 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 632 DIPOTASSIUM INOSINATE
      
      
                  
                     Synonyms
                  
               
               
                  Potassium inosinate; Potassium 5'-inosinate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  243-652-3
               
            
                  Chemical name
               
               
                  Dipotassium inosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H11K2N4O8P
               
            
                  Molecular weight
               
               
                  424,39
               
            
                  Assay
               
               
                  Content not less than 97,0 % on the anhydrous basis
               
            
                  Solubility
               
               
                  Freely soluble in water; practically insoluble in ethanol
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  Test for potassium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,5 (5 % solution)
               
            
                  Spectrometry
               
               
                  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 10,0 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 633 CALCIUM INOSINATE
      
      
                  
                     Synonyms
                  
               
               
                  Calcium 5'-inosinate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
               
            
                  Solubility
               
               
                  Sparingly soluble in water
               
            
                  
                     Description
                  
               
               
                  Odourless, colourless or white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,0 (0,05 % solution)
               
            
                  Spectrometry
               
               
                  Maximum absorption of a 20 mg/l solution in 0,01N HCl at 250 nm
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 23,0 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 634 CALCIUM 5'-RIBONUCLEOTIDE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Calcium 5′-ribonucleotide is essentially a mixture of calcium inosine-5′-monophosphate and calcium guanosine-5′-monophosphate
               
            
                  Chemical formula
               
               
                  C10H11N4CaO8P · nH2O
                  C10H12N5CaO8P · nH2O
               
            
                  Molecular weight
               
               
                   
               
            
                  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
               
            
                  Solubility
               
               
                  Sparingly soluble in water
               
            
                  
                     Description
                  
               
               
                  Odourless, white or nearly white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  Test for calcium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,0 (0,05 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 23,0 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 635 DISODIUM 5'-RIBONUCLEOTIDE
      
      
                  
                     Synonyms
                  
               
               
                  Sodium 5'-ribonucleotide
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Disodium 5'-ribonucleotide is essentially a mixture of disodium inosine-5'-monophosphate and disodium guanosine-5'-monophosphate
               
            
                  Chemical formula
               
               
                  C10H11N4O8P · nH2O
                  C10H12N5Na2O8P · nH2O
               
            
                  Molecular weight
               
               
                   
               
            
                  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
               
            
                  Solubility
               
               
                  Soluble in water, sparingly soluble in ethanol practically insoluble in ether
               
            
                  
                     Description
                  
               
               
                  Odourless, white or nearly white crystals or powder
               
            
                  
                     Identification
                  
               
            
                  Test for ribose
               
               
                  Passes test
               
            
                  Test for organic phosphate
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 7,0 and 8,5 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 26,0 % (Karl Fischer)
               
            
                  Other nucleotides
               
               
                  Not detectable by thin-layer chromatography
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 640 GLYCINE AND ITS SODIUM SALT
      
      (i)   GLYCINE
      
                  
                     Synonyms
                  
               
               
                  Aminoacetic acid; Glycocoll
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-272-2
               
            
                  Chemical name
               
               
                  Aminoacetic acid
               
            
                  Chemical formula
               
               
                  C2H5NO2
                  
               
            
                  Molecular weight
               
               
                  75,07
               
            
                  Assay
               
               
                  Content not less than 98,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for amino acid
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,2 % (105 °C, 3 hours)
               
            
                  Residue on ignition
               
               
                  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
               
            (ii)   SODIUM GLYCINATE
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  227-842-3
               
            
                  Chemical name
               
               
                  Sodium glycinate
               
            
                  Chemical formula
               
               
                  C2H5NO2 Na
               
            
                  Molecular weight
               
               
                  98
               
            
                  Assay
               
               
                  Content not less than 98,5 % on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Test for amino acid
               
               
                  Passes test
               
            
                  Test for sodium
               
               
                  Passes test
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,2 % (105 °C, 3 hours)
               
            
                  Residue on ignition
               
               
                  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
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Test for acetate
               
               
                  Passes test
               
            
                  Test for zinc
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 6,0 and 8,0 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water 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 stabilised with trimethylsiloxy end-blocking units of the formula (CH3)3 SiO
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Siloxanes and silicones, di-methyl
               
            
                  Chemical formula
               
               
                  (CH3)3-Si-[O-Si(CH3)2]n-O-Si(CH3)3
                  
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Content of total silicon not less than 37,3 % and not more than 38,5 %
               
            
                  
                     Description
                  
               
               
                  Clear, colourless, viscous liquid
               
            
                  
                     Identification
                  
               
            
                  Specific gravity (25° C/25 °C)
               
               
                  Between 0,964 and 0,977
               
            
                  Refractive index
               
               
                  [n]D
                     25 between 1,400 and 1,405
               
            
                  Infrared absorption spectrum
               
               
                  The infrared absorption spectrum of a liquid film of the sample between two sodium chloride plates exhibits relative maxima at the same wavelengths as those of a similar preparation of Dimethylpolysiloxane Reference Standard
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (150 °C, 4h)
               
            
                  Viscosity
               
               
                  Not less than 1,00 · 10– 4 m2s– 1 at 25 °C
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 901 BEESWAX, WHITE AND YELLOW
      
      
                  
                     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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     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
                  
               
            
                  Melting range
               
               
                  Between 62 °C and 65 °C
               
            
                  Specific gravity
               
               
                  About 0,96
               
            
                  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
               
               
                  Transfer 3,0 g of the sample to a 100 ml round-bottomed flask, add 30 ml of a 4% w/v solution of potassium hydroxide in aldehyde-free ethanol and boil gently under a reflux condenser for 2 h. Remove the condenser and immediately insert a thermometer. Place the flask in water at 80 °C and allow to cool, swirling the solution continuously. No precipitate is formed before the temperature reaches 65 °C, although the solution may be opalescent.
               
            
                  Fats, Japan wax, rosin and soaps
               
               
                  Boil 1 g of the sample for 30 min with 35 ml of a 1 in 7 solution of sodium hydroxide, maintaining the volume by the occasional addition of water, and cool the mixture. The wax separates and the liquid remains clear. Filter the cold mixture and acidify the filtrate with hydrochloric acid. No precipitate is formed.
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 902 CANDELILLA WAX
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Candelilla wax is a purified wax obtained from the leaves of the candelilla plant, Euphorbia antisyphilitica
                  
               
            
                  Einecs
               
               
                  232-347-0
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Hard, yellowish brown, opaque to translucent wax
               
            
                  
                     Identification
                  
               
            
                  Specific gravity
               
               
                  About 0,98
               
            
                  Melting range
               
               
                  Between 68,5 °C and 72,5 °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
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 903 CARNAUBA WAX
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Light brown to pale yellow powder or flakes or hard and brittle solid with a resinous fracture
               
            
                  
                     Identification
                  
               
            
                  Specific gravity
               
               
                  About 0,997
               
            
                  Melting range
               
               
                  Between 82 °C and 86 °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 2 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
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Bleached shellac — off-white, amorphous, granular resin
                  Wax-free bleached shellac — light yellow, amorphous, granular resin
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water; freely (though very slowly) soluble in alcohol; slightly soluble in acetone
               
            
                  Acid value
               
               
                  Between 60 and 89
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 6,0 % (40 °C, over silica gel, 15 hours)
               
            
                  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; Hydrocarbon wax; Fischer-Tropsch wax; Synthetic wax; Synthetic paraffin
               
            
                  
                     Definition
                  
               
               
                  Refined mixtures of solid, saturated hydrocarbons, obtained from petroleum or synthetic feedstocks
               
            
                  
                     Description
                  
               
               
                  White to amber, odourless wax
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Insoluble in water, very slightly soluble in ethanol
               
            
                  Refractive index
               
               
                  [n]D
                     100 1,434-1,448
                  Alternative [n]D
                     1201,426-1,440
               
            
                  
                     Purity
                  
               
            
                  Molecular weight
               
               
                  Average not less than 500
               
            
                  Viscosity
               
               
                  Not less than 1,1 × 10– 5 m2s– 1at 100 °C
                  Alternative: Not less than 0,8 × 10– 5 m2s– 1at 120 °C, if solid at 100 °C
               
            
                  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 wt %
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 3 mg/kg
               
            
                  Polycyclic aromatic compounds
               
               
                  Benzo(a)pyrene no more than 50 μg/kg
               
            
         E 907 HYDROGENATED POLY-1-DECENE
      
      
                  
                     Synonyms
                  
               
               
                  Hydrogenated polydec-1-ene; Hydrogenated poly-alpha-olefin
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Insoluble in water; slightly soluble in ethanol; soluble in toluene
               
            
                  Burning
               
               
                  Burns with a bright flame and a paraffin-like characteristic smell
               
            
                  Viscosity
               
               
                  Between 5,7 × 10– 6 and 6,1 × 10– 6 m2s– 1 at 100 °C
               
            
                  
                     Purity
                  
               
            
                  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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Montan acids and/or esters with ethylene glycol and/or 1,3-butanediol and/or glycerol
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Montan acid esters
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Almost white to yellowish flakes, powder, granules or pellets
               
            
                  
                     Identification
                  
               
            
                  Density
               
               
                  Between 0,98 and 1,05 (20 °C)
               
            
                  Drop point
               
               
                  Greater than 77 °C
               
            
                  
                     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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Polar reaction products from mild oxidation of polyethylene
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Oxidised polyethylene
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Almost white flakes, powder, granules or pellets
               
            
                  
                     Identification
                  
               
            
                  Density
               
               
                  Between 0,92 and 1,05 (20 °C)
               
            
                  Drop point
               
               
                  Greater than 95 °C
               
            
                  
                     Purity
                  
               
            
                  Acid value
               
               
                  Not more than 70
               
            
                  Viscosity
               
               
                  Not less than 8,1 · 10– 5 m2s– 1 at 120 °C
               
            
                  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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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 name
               
               
                   
               
            
                  Chemical formula
               
               
                  C3H7NO2S · HCl · nH2O (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
                  
               
            
                  Solubility
               
               
                  Freely soluble in water and in ethanol
               
            
                  Melting range
               
               
                  Anhydrous form melts at about 175 °C
               
            
                  Specific rotation
               
               
                  [α]D
                     20: between + 5,0° and + 8,0° or
                  [α]D
                     25: between + 4,9° and 7,9°
               
            
                  
                     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 name
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Very soluble in water
                  Soluble in ethanol
               
            
                  Precipitation with nitric acid
               
               
                  To pass the test a white, crystalline precipitate is formed
               
            
                  Colour reaction
               
               
                  To pass the test a reddish-violet colour is produced
               
            
                  Melting range
               
               
                  132 °C to 135 °C
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1,0 % (105 °C, 1 hour)
               
            
                  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 2 mg/kg
               
            
         E 938 ARGON
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-147-0
               
            
                  Chemical name
               
               
                  Argon
               
            
                  Chemical formula
               
               
                  Ar
               
            
                  Atomic weight
               
               
                  40
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, non-flammable gas
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 0,05 %
               
            
                  Methane and other hydrocarbons
               
               
                  Not more than 100 μl/l (calculated as methane)
               
            
         E 939 HELIUM
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-168-5
               
            
                  Chemical name
               
               
                  Helium
               
            
                  Chemical formula
               
               
                  He
               
            
                  Atomic weight
               
               
                  4
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, non-flammable gas
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 0,05 %
               
            
                  Methane and other hydrocarbons
               
               
                  Not more than 100 μl/l (calculated as methane)
               
            
         E 941 NITROGEN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-783-9
               
            
                  Chemical name
               
               
                  Nitrogen
               
            
                  Chemical formula
               
               
                  N2
                  
               
            
                  Molecular weight
               
               
                  28
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, non-flammable gas
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 0,05 %
               
            
                  Carbon monoxide
               
               
                  Not more than 10 μl/l
               
            
                  Methane and other hydrocarbons
               
               
                  Not more than 100 μl/l (calculated as methane)
               
            
                  Nitrogen dioxide and nitrogen oxide
               
               
                  Not more than 10 μl/l
               
            
                  Oxygen
               
               
                  Not more than 1 %
               
            
         E 942 NITROUS OXIDE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  233-032-0
               
            
                  Chemical name
               
               
                  Nitrous oxide
               
            
                  Chemical formula
               
               
                  N2O
               
            
                  Molecular weight
               
               
                  44
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, non-flammable gas, sweetish odour
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Vapour pressure
               
               
                  108,935 kPa at 20 °C
               
            
                  
                     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
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Vapour pressure
               
               
                  205,465 kPa at 20 °C
               
            
                  
                     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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  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
                  
               
            
                  Vapour pressure
               
               
                  732,910 kPa at 20 °C
               
            
                  
                     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
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  231-956-9
               
            
                  Chemical name
               
               
                  Oxygen
               
            
                  Chemical formula
               
               
                  O2
                  
               
            
                  Molecular weight
               
               
                  32
               
            
                  Assay
               
               
                  Not less than 99 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, non-flammable gas
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 0,05 %
               
            
                  Methane and other hydrocarbons
               
               
                  Not more than 100 μl/l (calculated as methane)
               
            
         E 949 HYDROGEN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  215-605-7
               
            
                  Chemical name
               
               
                  Hydrogen
               
            
                  Chemical formula
               
               
                  H2
                  
               
            
                  Molecular weight
               
               
                  2
               
            
                  Assay
               
               
                  Content not less than 99,9 %
               
            
                  
                     Description
                  
               
               
                  Colourless, odourless, highly flammable gas
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 0,005 % v/v
               
            
                  Oxygen
               
               
                  Not more than 0,001 % v/v
               
            
                  Nitrogen
               
               
                  Not more than 0,07 % v/v
               
            
         E 950 ACESULFAME K
      
      
                  
                     Synonyms
                  
               
               
                  Acesulfame potassium; Potassium salt of 3,4-dihydro-6-methyl-1,2,3-oxathiazin-4-one-2,2-dioxide
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  259-715-3
               
            
                  Chemical name
               
               
                  6-methyl-1,2,3-oxathiazin-4(3H)-one-2,2-dioxide potassium salt
               
            
                  Chemical formula
               
               
                  C4H4KNO4S
               
            
                  Molecular weight
               
               
                  201,24
               
            
                  Assay
               
               
                  Content not less than 99 % of C4H4KNO4S on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Odourless, white, crystalline powder. Approximately 200 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Very soluble in water, very slightly soluble in ethanol
               
            
                  Ultraviolet absorption
               
               
                  Maximum 227 ± 2 nm for a solution of 10 mg in 1 000 ml of water
               
            
                  Test for potassium
               
               
                  Passes test (test the residue obtained by igniting 2 g of the sample)
               
            
                  Precipitation test
               
               
                  Add a few drops of a 10 % solution of sodium cobaltnitrite to a solution of 0,2 g of the sample in 2 ml of acetic acid and 2 ml of water. A yellow precipitate is produced
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1 % (105 °C, 2 hours)
               
            
                  Organic impurities
               
               
                  Passes test for 20 mg/kg of UV active components
               
            
                  Fluoride
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 951 ASPARTAME
      
      
                  
                     Synonyms
                  
               
               
                  Aspartyl phenylalanine methyl ester
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  245-261-3
               
            
                  Chemical name
               
               
                  N-L-α-Aspartyl-L-phenylalanine-1-methyl ester, 3-amino-N-(α-carbomethoxy-phenethyl)-succinamic acid-N-methyl ester
               
            
                  Chemical formula
               
               
                  C14H18N2O5
                  
               
            
                  Molecular weight
               
               
                  294,31
               
            
                  Assay
               
               
                  Not less than 98 % and not more than 102 % of C14H18N2O5 on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, odourless, crystalline powder having a sweet taste. Approximately 200 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Slightly soluble in water and in ethanol
               
            
                  pH
               
               
                  Between 4,5 and 6,0 (1 in 125 solution)
               
            
                  Specific rotation
               
               
                  [α]D
                     20: + 14,5° to + 16,5°
                  Determine in a 4 in 100/15 N formic acid solution within 30 minutes after preparation of the sample solution
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 4,5 % (105 °C, 4 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 % (expressed on dry weight basis)
               
            
                  Transmittance
               
               
                  The transmittance of a 1 % solution in 2N hydrochloric acid, determined in a 1-cm cell at 430 nm with a suitable spectrophotometer, using 2N hydrochloric acid as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
                  5-Benzyl-3,6-dioxo-2-piperazineacetic acid
               
               
                  Not more than 1,5 % (expressed on dry weight basis)
               
            
         E 952 CYCLAMIC ACID AND ITS Na AND Ca SALTS
      
      (i)   CYCLAMIC ACID
      
                  
                     Synonyms
                  
               
               
                  Cyclohexylsulphamic acid; Cyclamate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  202-898-1
               
            
                  Chemical name
               
               
                  Cyclohexanesulphamic acid; cyclohexylaminosulphonic acid
               
            
                  Chemical formula
               
               
                  C6H13NO3S
               
            
                  Molecular weight
               
               
                  179,24
               
            
                  Assay
               
               
                  Cyclohexylsulphamic acid contains not less than 98 % and not more than the equivalent of 102 % of C6H13NO3S, calculated on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  A practically colourless, white crystalline powder. Approximately 40 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water and in ethanol
               
            
                  Precipitation test
               
               
                  Acidify a 2 % solution with hydrochloric acid, add 1 ml of an approximately molar solution of barium chloride in water and filter if any haze or precipitate forms. To the clear solution add 1 ml of a 10 % solution of sodium nitrite. A white precipitate forms.
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1 % (105 °C, 1 hour)
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg (expressed as selenium on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Cyclohexylamine
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  Dicyclohexylamine
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
                  Aniline
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            (ii)   SODIUM CYCLAMATE
      
                  
                     Synonyms
                  
               
               
                  Cyclamate; Sodium salt of cyclamic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  205-348-9
               
            
                  Chemical name
               
               
                  Sodium cyclohexanesulphamate, sodium cyclohexylsulphamate
               
            
                  Chemical formula
               
               
                  C6H12NNaO3S and the dihydrate form C6H12NNaO3S·2H2O
               
            
                  Molecular weight
               
               
                  201,22 calculated on the anhydrous form
                  237,22 calculated on the hydrated form
               
            
                  Assay
               
               
                  Not less than 98 % and not more than 102 % on the dried basis
                  Dihydrate form: not less than 84 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White, odourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, practically insoluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1 % (105 °C, 1 hour)
                  Not more than 15,2 % (105 °C, 2 hours) for the dihydrate form
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg (expressed as selenium on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
                  Cyclohexylamine
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  Dicyclohexylamine
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
                  Aniline
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            (iii)   CALCIUM CYCLAMATE
      
                  
                     Synonyms
                  
               
               
                  Cyclamate; Calcium salt of cyclamic acid
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  205-349-4
               
            
                  Chemical name
               
               
                  Calcium cyclohexanesulphamate, calcium cyclohexylsulphamate
               
            
                  Chemical formula
               
               
                  C12H24CaN2O6S2· 2H2O
               
            
                  Molecular weight
               
               
                  432,57
               
            
                  Assay
               
               
                  Not less than 98 % and not more than 101 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  White, colourless crystals or crystalline powder. Approximately 30 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, sparingly soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1 % (105 °C, 1 hour)
                  Not more than 8,5 % (140 °C, 4 hours) for the dihydrate form
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg (expressed as selenium on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
                  Cyclohexylamine
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  Dicyclohexylamine
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
                  Aniline
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
         E 953 ISOMALT
      
      
                  
                     Synonyms
                  
               
               
                  Hydrogenated isomaltulose.
               
            
                  
                     Definition
                  
               
               
                  Manufactured by enzymatic conversion of sucrose with nonviable cells of Protaminobacter rubrum followed by catalytic hydrogenation
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Isomalt is a mixture of hydrogenated mono- and disaccharides whose principal components are the disaccharides:
                  6-O-α-D-Glucopyranosyl-D-sorbitol (1,6-GPS) and
                  1-O-α-D-Glucopyranosyl-D-mannitol dihydrate (1,1-GPM)
               
            
                  Chemical formula
               
               
                  6-O-α-D-Glucopyranosyl-D-sorbitol: C12H24O11
                  
                  1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: C12H24O11.2H2O
               
            
                  Molecular weight
               
               
                  6-O-α-D-Glucopyranosyl-D-sorbitol: 344,3
                  1-O-α-D-Glucopyranosyl-D-mannitol dihydrate: 380,3
               
            
                  Assay
               
               
                  Content not less than 98 % of hydrogenated mono- and disaccharides and not less than 86 % of the mixture of 6-O-α-D-Glucopyranosyl-D-sorbitol and 1-O-α-D-Glucopyranosyl-D-mannitol dihydrate determined on the anhydrous basis.
               
            
                  
                     Description
                  
               
               
                  Odourless, white, slightly hygroscopic, crystalline mass.
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, very slightly soluble in ethanol.
               
            
                  HPLC test
               
               
                  Comparison with an appropriate reference standard of Isomalt shows that the 2 principal peaks in the chromatogram of the test solution are similar in retention time to the 2 principal peaks in the chromatogram obtained with the reference solution.
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 7 % (Karl Fischer Method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,05 % (expressed on dry weight basis)
               
            
                  D-Mannitol
               
               
                  Not more than 3 %
               
            
                  D-Sorbitol
               
               
                  Not more than 6 %
               
            
                  Reducing sugars
               
               
                  Not more than 0,3 % (expressed as glucose on dry weight basis)
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg (expressed on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
         E 954 SACCHARIN AND ITS Na. K AND Ca SALTS
      
      (i)   SACCHARIN
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  201-321-0
               
            
                  Chemical name
               
               
                  3-Oxo-2,3dihydrobenzo(d)isothiazol-1,1-dioxide
               
            
                  Chemical formula
               
               
                  C7H5NO3S
               
            
                  Molecular weight
               
               
                  183,18
               
            
                  Assay
               
               
                  Not less than 99 % and not more than 101 % of C7H5NO3S on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or a white crystalline powder, odourless or with a faint, aromatic odour. Approximately between 300 and 500 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Slightly soluble in water, soluble in basic solutions, sparingly soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 1 % (105 °C, 2 hours)
               
            
                  Melting range
               
               
                  226 to 230 °C
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 % (expressed on dry weight basis)
               
            
                  Benzoic and salicylic acid
               
               
                  To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
               
            
                  
                     o-Toluenesulphonamide
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  
                     p-Toluenesulphonamide
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  Benzoic acid p-sulphonamide
               
               
                  Not more than 25 mg/kg (expressed on dry weight basis)
               
            
                  Readily carbonisable substances
               
               
                  Absent
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            (ii)   SODIUM SACCHARIN
      
                  
                     Synonyms
                  
               
               
                  Saccharin; Sodium salt of saccharin
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  204-886-1
               
            
                  Chemical name
               
               
                  Sodium o-benzosulphimide; sodium salt of 2,3-dihydro-3-oxobenzisosulphonazole; oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1, 1-dioxide sodium salt dihydrate
               
            
                  Chemical formula
               
               
                  C7H4NNaO3S·2H2O
               
            
                  Molecular weight
               
               
                  241,19
               
            
                  Assay
               
               
                  Not less than 99 % and not more than 101 % of C7H4NNaO3S on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or a white crystalline efflorescent powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble in water, sparingly soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 15 % (120 °C, 4 hours)
               
            
                  Benzoic and salicylic acid
               
               
                  To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
               
            
                  
                     o-Toluenesulphonamide
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  
                     p-Toluenesulphonamide
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  Benzoic acid p-sulphonamide
               
               
                  Not more than 25 mg/kg (expressed on dry weight basis)
               
            
                  Readily carbonisable substances
               
               
                  Absent
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            (iii)   CALCIUM SACCHARIN
      
                  
                     Synonyms
                  
               
               
                  Saccharin; Calcium salt of saccharin
               
            
                  
                     Definition
                  
               
            
                  Chemical name
               
               
                  Calcium o-benzosulphimide; calcium salt of 2,3-dihydro-3-oxobenzisosulphonazole; 1,2-benzisothiazolin-3-one-1,1-dioxide calcium salt hydrate (2:7)
               
            
                  Einecs
               
               
                  229-349-9
               
            
                  Chemical formula
               
               
                  C14H8CaN2O6S2·3½H2O
               
            
                  Molecular weight
               
               
                  467,48
               
            
                  Assay
               
               
                  Not less than 95 % of C14H8CaN2O6S2 on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or a white crystalline powder, odourless or with a faint odour. Approximately between 300 and 500 times as sweet as sucrose in dilute solutions
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble in water, soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 13,5 % (120 °C, 4 hours)
               
            
                  Benzoic and salicylic acid
               
               
                  To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
               
            
                  
                     o-Toluenesulphonamide
               
               
                  Not more than 10 mg/kg expressed (on dry weight basis)
               
            
                  
                     p-Toluenesulphonamide
               
               
                  Not more than 10 mg/kg expressed (on dry weight basis)
               
            
                  Benzoic acid p-sulphonamide
               
               
                  Not more than 25 mg/kg expressed (on dry weight basis)
               
            
                  Readily carbonisable substances
               
               
                  Absent
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            (iv)   POTASSIUM SACCHARIN
      
                  
                     Synonyms
                  
               
               
                  Saccharin; Potassium salt of saccharin
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Potassium o-benzosulphimide; potassium salt of 2,3-dihydro-3-oxobenzisosulphonazole; potassium salt of 1,2-benzisothiazolin-3-one-1,1-dioxide monohydrate
               
            
                  Chemical formula
               
               
                  C7H4KNO3S·H2O
               
            
                  Molecular weight
               
               
                  239,77
               
            
                  Assay
               
               
                  Not less than 99 % and not more than 101 % of C7H4KNO3S on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystals or a white crystalline powder, odourless or with a faint odour, having an intensely sweet taste, even in very dilute solutions. Approximately between 300 and 500 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble in water, sparingly soluble in ethanol
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 8 % (120 °C, 4 hours)
               
            
                  Benzoic and salicylic acid
               
               
                  To 10 ml of a 1 in 20 solution, previously acidified with five drops of acetic acid, add three drops of an approximately molar solution of ferric chloride in water. No precipitate or violet colour appears
               
            
                  
                     o-Toluenesulphonamide
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  
                     p-Toluenesulphonamide
               
               
                  Not more than 10 mg/kg (expressed on dry weight basis)
               
            
                  Benzoic acid p-sulphonamide
               
               
                  Not more than 25 mg/kg (expressed on dry weight basis)
               
            
                  Readily carbonisable substances
               
               
                  Absent
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Selenium
               
               
                  Not more than 30 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
         E 955 SUCRALOSE
      
      
                  
                     Synonyms
                  
               
               
                  4,1’,6’-Trichlorogalactosucrose
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  259-952-2
               
            
                  Chemical name
               
               
                  1,6-Dichloro-1,6-dideoxy-β-D-fructofuranosyl-4-chloro-4-deoxy-α-D-galactopyranoside
               
            
                  Chemical formula
               
               
                  C12H19Cl3O8
                  
               
            
                  Molecular weight
               
               
                  397,64
               
            
                  Assay
               
               
                  Content not less than 98 % and not more than 102 % C12H19Cl3O8 calculated on an anhydrous basis.
               
            
                  
                     Description
                  
               
               
                  White to off-white, practically odourless, crystalline powder.
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble in water, methanol and ethanol
                  Slightly soluble in ethyl acetate
               
            
                  Infrared absorption spectrum
               
               
                  The infrared spectrum of a potassium bromide dispersion of the sample exhibits relative maxima at similar wave numbers as those shown in the reference spectrum obtained using a sucralose reference standard.
               
            
                  Thin layer chromatography
               
               
                  The main spot in the test solution has the same Rf value as that of the main spot of standard solution A referred to in the test for other chlorinated disaccharides. This standard solution is obtained by dissolving 1,0g of sucralose reference standard in 10 ml of methanol.
               
            
                  Specific rotation
               
               
                  [α]D
                     20 + 84,0° to + 87,5° calculated on the anhydrous basis (10 % w/v solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 2,0 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,7 %
               
            
                  Other chlorinated disaccharides
               
               
                  Not more than 0,5 %
               
            
                  Chlorinated monosaccharides
               
               
                  Not more than 0,1 %
               
            
                  Triphenylphosphine oxide
               
               
                  Not more than 150 mg/kg
               
            
                  Methanol
               
               
                  Not more than 0,1 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 957 THAUMATIN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  258-822-2
               
            
                  Chemical name
               
               
                  Thaumatin is obtained by aqueous extraction (pH 2,5 to 4) of the arils of the fruit of strains of Thaumatococcus daniellii (Benth) and consists essentially of the proteins thaumatin I and thaumatin II together with minor amounts of plant constituents derived from the source material
               
            
                  Chemical formula
               
               
                  Polypeptide of 207 amino acids
               
            
                  Molecular weight
               
               
                  Thaumatin I 22209
                  Thaumatin II 22293
               
            
                  Assay
               
               
                  Not less than 15,1 % nitrogen on the dried basis equivalent to not less than 93 % proteins (N × 6,2)
               
            
                  
                     Description
                  
               
               
                  Odourless, cream-coloured powder. Approximately 2 000 to 3 000 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Very soluble in water, insoluble in acetone
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 9 % (105 °C to constant weight)
               
            
                  Carbohydrates
               
               
                  Not more than 3 % (expressed on dry weight basis)
               
            
                  Sulphated ash
               
               
                  Not more than 2 % (expressed on dry weight basis)
               
            
                  Aluminium
               
               
                  Not more than 100 mg/kg (expressed on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total aerobic microbial count
               
               
                  Not more than 1 000 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent in 1 g
               
            
         E 959 NEOHESPERIDINE DIHYDROCHALCONE
      
      
                  
                     Synonyms
                  
               
               
                  Neohesperidin dihydrochalcone; NHDC; Hesperetin dihydrochalcone-4′-β-neohesperidoside; Neohesperidin DC
               
            
                  
                     Definition
                  
               
               
                  It is obtained by catalytic hydrogenation of neohesperidin
               
            
                  Einecs
               
               
                  243-978-6
               
            
                  Chemical name
               
               
                  2-O-α-L-rhamnopyranosyl-4′-β-D-glucopyranosyl hesperetin dihydrochalcone.
               
            
                  Chemical formula
               
               
                  C28H36O15
                  
               
            
                  Molecular weight
               
               
                  612,6
               
            
                  Assay
               
               
                  Content not less than 96 % on the dried basis
               
            
                  
                     Description
                  
               
               
                  Off-white, odourless, crystalline powder. Approximately between 1 000 and 1 800 times as sweet as sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble in hot water, very slightly soluble in cold water, practically insoluble in ether and benzene
               
            
                  Ultraviolet absorption maximum
               
               
                  282 to 283 nm for a solution of 2 mg in 100 ml methanol
               
            
                  Neu's test
               
               
                  Dissolve about 10 mg of neohesperidine DC in 1 ml methanol, add 1 ml of a 1 % 2-aminoethyl diphenyl borate methanolic solution. A bright yellow colour is produced
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 11 % (105 °C, 3 hours)
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 % (expressed on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg expressed on dry weight basis
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (expressed on dry weight basis)
               
            
         E 960 STEVIOL GLYCOSIDES
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  The manufacturing process comprises two main phases: the first involving water extraction of the leaves of the Stevia rebaudiana Bertoni plant and preliminary purification of the extract by employing ion exchange chromatography to yield a steviol glycoside primary extract, and the second involving recrystallisation of the steviol glycosides from methanol or aqueous ethanol resulting in a final product consisting mainly (at least 75 %) of stevioside and/or rebaudioside A.
                  The additive may contain residues of ion-exchange resins used in the manufacturing process. Several other related steviol glycosides that may be generated as a result of the production process, but do not occur naturally in the Stevia rebaudiana plant have been identified in small amounts (0,10 to 0,37 % w/w).
               
            
                  Chemical name
               
               
                  Stevioside: 13-[(2-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
                  Rebaudioside A: 13-[(2-O-β-D-glucopyranosyl-3-O-β-D-glucopyranosyl-β-D-glucopyranosyl)oxy]kaur-16-en-18-oic acid, β-D-glucopyranosyl ester
               
            
                  Chemical formula
               
               
                  
                     Trivial name
                  
               
               
                  
                     Formula
                  
               
               
                  
                     Conversion factor
                  
               
            
                  Steviol
               
               
                  C20H30O3
                  
               
               
                  1,00
               
            
                  Stevioside
               
               
                  C38H60O18
                  
               
               
                  0,40
               
            
                  Rebaudioside A
               
               
                  C44H70O23
                  
               
               
                  0,33
               
            
                  Rebaudioside C
               
               
                  C44H70O22
                  
               
               
                  0,34
               
            
                  Dulcoside A
               
               
                  C38H60O17
                  
               
               
                  0,40
               
            
                  Rubusoside
               
               
                  C32H50O13
                  
               
               
                  0,50
               
            
                  Steviolbioside
               
               
                  C32H50O13
                  
               
               
                  0,50
               
            
                  Rebaudioside B
               
               
                  C38H60O18
                  
               
               
                  0,40
               
            
                  Rebaudioside D
               
               
                  C50H80O28
                  
               
               
                  0,29
               
            
                  Rebaudioside E
               
               
                  C44H70O23
                  
               
               
                  0,33
               
            
                  Rebaudioside F
               
               
                  C43H68O22
                  
               
               
                  0,34
               
            
                  Molecular weight and CAS No
               
               
                  
                     Trivial name
                  
               
               
                  
                     CAS Number
                  
               
               
                  
                     Molecular weight
                  
               
            
                  Stevioside
               
               
                  57817-89-7
               
               
                  804,87
               
            
                  Rebaudioside A
               
               
                  58543-16-1
               
               
                  967,01
               
            
                  Assay
               
               
                  Not less than 95 % stevioside, rebaudiosides A, B, C, D, E and F, steviolbioside, rubusoside and dulcoside on the dried basis.
               
            
                  
                     Description
                  
               
               
                  White to light yellow powder, approximately between 200 and 300 times sweeter than sucrose
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble to slightly soluble in water
               
            
                  Stevioside and rebaudioside A
               
               
                  The main peak in the chromatogram obtained following the procedure in Method of Assay corresponds to either stevioside or rebaudioside A
               
            
                  pH
               
               
                  Between 4,5 and 7,0 (1 in 100 solution)
               
            
                  
                     Purity
                  
               
            
                  Total ash
               
               
                  Not more than 1 %
               
            
                  Loss on drying
               
               
                  Not more than 6 % (105 °C, 2h)
               
            
                  Residual solvents
               
               
                  Not more than 200 mg/kg methanol
                  Not more than 5 000 mg/kg ethanol
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 961 NEOTAME
      
      
                  
                     Synonyms
                  
               
               
                  N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester;
                  N(3,3-dimethylbutyl)-L-aspartyl-L-phenylalanine methyl ester.
               
            
                  
                     Definition
                  
               
               
                  Neotame is manufactured by reaction under hydrogen pressure of aspartame with 3,3,-dimethylbutyraldehyde in methanol in presence of a palladium/carbon catalyst. It is isolated and purified by filtration, where diatomaceous earth may be used. After solvent removal via distillation, neotame is washed with water, isolated by centrifugation and finally vacuum dried.
               
            
                  CAS Nr.
               
               
                  165450-17-9
               
            
                  Chemical name
               
               
                  N-[N-(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine 1-methyl ester
               
            
                  Chemical formula
               
               
                  C20H30N2O5
                  
               
            
                  Molecular weight
               
               
                  378,47
               
            
                  
                     Description
                  
               
               
                  white to off-white powder
               
            
                  Assay
               
               
                  Not less than 97,0 % on the dried basis
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  4,75 % (w/w) at 60 °C in water, soluble in ethanol and ethyl acetate
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 5 % (Karl Fischer, sample size 25 ± 5mg)
               
            
                  pH
               
               
                  5,0-7,0 (0,5 % aqueous solution)
               
            
                  Melting range
               
               
                  81 °C to 84 °C
               
            
                  N-[(3,3-dimethylbutyl)-L-α-aspartyl]-L-phenylalanine
               
               
                  Not more than 1,5 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 962 SALT OF ASPARTAME-ACESULFAME
      
      
                  
                     Synonyms
                  
               
               
                  Aspartame-acesulfame; Aspartame-acesulfame salt
               
            
                  
                     Definition
                  
               
               
                  The salt is prepared by heating an approximately 2:1 ratio (w/w) of aspartame and acesulfame K in solution at acidic pH and allowing crystallisation to occur. The potassium and moisture are eliminated. The product is more stable than aspartame alone.
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  6-Methyl-1,2,3-oxathiazine-4(3H)-one-2,2-dioxide salt of L-phenylalanyl-2-methyl-L-α-aspartic acid
               
            
                  Chemical formula
               
               
                  C18H23O9N3S
               
            
                  Molecular weight
               
               
                  457,46
               
            
                  Assay
               
               
                  63,0 % to 66,0 % aspartame (dry basis) and 34,0 % to 37,0 % acesulfame (acid form on a dry basis)
               
            
                  
                     Description
                  
               
               
                  A white, odourless, crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Sparingly soluble water; slightly soluble in ethanol
               
            
                  Transmittance
               
               
                  The transmittance of a 1 % solution in water determined in a 1 cm cell at 430 nm with a suitable spectrophotometer using water as a reference, is not less than 0,95, equivalent to an absorbance of not more than approximately 0,022.
               
            
                  Specific rotation
               
               
                  [α]D
                     20 + 14,5° to + 16,5°
                  Determine at a concentration of 6,2 g in 100 ml formic acid (15N) within 30 min of preparation of the solution. Divide the calculated specific rotation by 0,646 to correct for the aspartame content of the salt of aspartame-acesulfame
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,5 % (105 °C, 4 hours)
               
            
                  5-Benzyl-3,6-dioxo-2-piperazineacetic acid
               
               
                  Not more than 0,5 %
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 965 (i) MALTITOL
      
      
                  
                     Synonyms
                  
               
               
                  D-Maltitol; Hydrogenated maltose
               
            
                  
                     Definition
                  
               
               
                  Maltitol is obtained by hydrogenation of D-maltose. It is mainly composed of D-maltitol. It may contain small amounts of sorbitol and related polyhydric alcohols.
               
            
                  Einecs
               
               
                  209-567-0
               
            
                  Chemical name
               
               
                  (α)-D-Glucopyranosyl-1,4-D-glucitol
               
            
                  Chemical formula
               
               
                  C12H24O11
                  
               
            
                  Molecular weight
               
               
                  344,3
               
            
                  Assay
               
               
                  Content not less than 98 % D-maltitol C12H24O11 on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White crystalline powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Very soluble in water, slightly soluble in ethanol
               
            
                  Melting range
               
               
                  148 to 151 °C
               
            
                  Specific rotation
               
               
                  [α]D
                     20 + 105,5° to + 108,5° (5 % w/v solution)
               
            
                  
                     Purity
                  
               
            
                  Appearance of the aqueous solution
               
               
                  The solution is clear and colourless
               
            
                  Water content
               
               
                  Not more than 1 % (Karl Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 % (expressed on an anhydrous basis)
               
            
                  Reducing sugars
               
               
                  Not more than 0,1 % (expressed as glucose on an anhydrous basis)
               
            
                  Chlorides
               
               
                  Not more than 50 mg/kg (expressed on anhydrous basis)
               
            
                  Sulphates
               
               
                  Not more than 100 mg/kg (expressed on anhydrous basis)
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg (expressed on anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on anhydrous basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on anhydrous basis)
               
            
         E 965 (ii) MALTITOL SYRUP
      
      
                  
                     Synonyms
                  
               
               
                  Hydrogenated high-maltose-glucose syrup; Hydrogenated glucose syrup; Maltitol liquid
               
            
                  
                     Definition
                  
               
               
                  A mixture consisting of mainly maltitol with sorbitol and hydrogenated oligo- and polysaccharides. It is manufactured by the catalytic hydrogenation of high maltose-content glucose syrup or by the hydrogenation of its individual components followed by blending. The article of commerce is supplied both as a syrup and as a solid product.
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Content not less than 99 % of total hydrogenated saccharides on the anhydrous basis and not less than 50 % of maltitol on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  Colourless and odourless, clear viscous liquids or white crystalline masses
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Very soluble in water, slightly soluble in ethanol
               
            
                  HPLC test
               
               
                  Comparison with an appropriate reference standard of Maltitol shows that the principle peak in the chromatogram of the test solution is similar in retention time to the principal peak in the chromatogram obtained with the reference solution (ISO 10504:1998).
               
            
                  
                     Purity
                  
               
            
                  Appearance of the aqueous solution
               
               
                  The solution is clear and colourless
               
            
                  Water content
               
               
                  Not more than 31 % (Karl Fischer method)
               
            
                  Reducing sugars
               
               
                  Not more than 0,3 % (expressed as glucose on an anhydrous basis)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Chlorides
               
               
                  Not more than 50 mg/kg
               
            
                  Sulphate
               
               
                  Not more than 100 mg/kg
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         E 966 LACTITOL
      
      
                  
                     Synonyms
                  
               
               
                  Lactit; Lactositol; Lactobiosit
               
            
                  
                     Definition
                  
               
               
                  Lactitol is manufactured via catalytic hydrogenation of lactose
               
            
                  Einecs
               
               
                  209-566-5
               
            
                  Chemical name
               
               
                  4-O-β-D-Galactopyranosyl-D-glucitol
               
            
                  Chemical formula
               
               
                  C12H24O11
                  
               
            
                  Molecular weight
               
               
                  344,3
               
            
                  Assay
               
               
                  Not less than 95 % on the dry weight basis
               
            
                  
                     Description
                  
               
               
                  Crystalline powder or colourless solution. Crystalline products occur in anhydrous, monohydrate and dihydrate forms. Nickel is used as a catalyst.
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Very soluble in water
               
            
                  Specific rotation
               
               
                  [α]D
                     20 = + 13° to + 16° calculated on the anhydrous basis (10 % w/v aqueous solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Crystalline products; not more than 10,5 % (Karl Fischer method)
               
            
                  Other polyols
               
               
                  Not more than 2,5 % (on the anhydrous basis)
               
            
                  Reducing sugars
               
               
                  Not more than 0,2 % (expressed as glucose on dry weight basis)
               
            
                  Chlorides
               
               
                  Not more than 100 mg/kg (expressed on dry weight basis)
               
            
                  Sulphates
               
               
                  Not more than 200 mg/kg (expressed on dry weight basis)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 % (expressed on dry weight basis)
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg (expressed on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
         E 967 XYLITOL
      
      
                  
                     Synonyms
                  
               
               
                  Xylitol
               
            
                  
                     Definition
                  
               
               
                  Xylitol is mainly composed of D-xylitol. The part which is not D-xylitol is composed of related substances such as L-arabinitol, galactitol, mannitol, sorbitol
               
            
                  Einecs
               
               
                  201-788-0
               
            
                  Chemical name
               
               
                  D-xylitol
               
            
                  Chemical formula
               
               
                  C5H12O5
                  
               
            
                  Molecular weight
               
               
                  152,2
               
            
                  Assay
               
               
                  Not less than 98,5 % as xylitol on the anhydrous basis
               
            
                  
                     Description
                  
               
               
                  White, crystalline powder, practically odourless.
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Very soluble in water, sparingly soluble in ethanol
               
            
                  Melting range
               
               
                  92 to 96 °C
               
            
                  pH
               
               
                  5 to 7 (10 % w/v aqueous solution)
               
            
                  Infrared absorption spectroscopy
               
               
                  Comparison with a reference standard e.g. EP or USP.
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 1% (Karl-Fischer method)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 % (expressed on dry weight basis)
               
            
                  Reducing sugars
               
               
                  Not more than 0,2 % (expressed as glucose on dry weight basis)
               
            
                  Other polyhydric alcohols
               
               
                  Not more than 1 % (expressed on dry weight basis)
               
            
                  Nickel
               
               
                  Not more than 2 mg/kg (expressed on dry weight basis)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg (expressed on dry weight basis)
               
            
                  Lead
               
               
                  Not more than 1 mg/kg (expressed on dry weight basis)
               
            
                  Chlorides
               
               
                  Not more than 100 mg/kg (expressed on dry weight basis)
               
            
                  Sulphates
               
               
                  Not more than 200 mg/kg (expressed on dry weight basis)
               
            
         E 968 ERYTHRITOL
      
      
                  
                     Synonyms
                  
               
               
                  Meso-erythritol; Tetrahydroxybutane; Erythrite
               
            
                  
                     Definition
                  
               
               
                  Obtained by fermentation of carbohydrate source by safe and suitable food grade osmophilic yeasts such as Moniliella pollinis or Moniliella megachilensis, followed by purification and drying
               
            
                  Einecs
               
               
                  205-737-3
               
            
                  Chemical name
               
               
                  1,2,3,4-Butanetetrol
               
            
                  Chemical formula
               
               
                  C4H10O4
                  
               
            
                  Molecular weight
               
               
                  122,12
               
            
                  Assay
               
               
                  Not less than 99 % after drying
               
            
                  
                     Description
                  
               
               
                  White, odourless, non-hygroscopic, heat-stable crystals with a sweetness of approximately 60-80 % that of sucrose.
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Freely soluble in water, slightly soluble in ethanol, insoluble in diethyl ether.
               
            
                  Melting range
               
               
                  119-123 °C
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 0,2 % (70 °C, 6 hours, in a vacuum desiccator)
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Reducing substances
               
               
                  Not more than 0,3 % expressed as D-glucose
               
            
                  Ribitol and glycerol
               
               
                  Not more than 0,1 %
               
            
                  Lead
               
               
                  Not more than 0,5 mg/kg
               
            
         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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  Quillaia extract in the powder form is light brown with a pink tinge. It is also available as an aqueous solution
               
            
                  
                     Identification
                  
               
            
                  pH
               
               
                  Between 3,7 and 5,5 (4 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  Not more than 6,0 % (Karl Fischer method) (powder form only)
               
            
                  Arsenic
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 1 mg/kg
               
            
         E 1103 INVERTASE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Invertase is produced from Saccharomyces cerevisiae
                  
               
            
                  Einecs
               
               
                  232-615-7
               
            
                  Enzyme Commission No
               
               
                  EC 3.2.1.26
               
            
                  Systematic name
               
               
                  β-D-Fructofuranoside fructohydrolase
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                   
               
            
                  
                     Identification
                  
               
               
                   
               
            
                  
                     Purity
                  
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 5 mg/kg
               
            
                  Cadmium
               
               
                  Not more than 0,5 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total bacterial count
               
               
                  Not more than 50 000 colonies per gram
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 25 g
               
            
                  Coliforms
               
               
                  Not more than 30 colonies per gram
               
            
                  
                     Escherichia coli
                  
               
               
                  Absent 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
               
            
                  Einecs
               
               
                  232-620-4
               
            
                  Enzyme Commission No
               
               
                  EC 3.2.1.17
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  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
                  
               
            
                  Isoelectric point
               
               
                  10,7
               
            
                  pH
               
               
                  Between 3,0 and 3,6 (2 % aqueous solution)
               
            
                  Spectrophotometry
               
               
                  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
               
            
                  
                     Microbiological criteria
                  
               
            
                  Total bacterial count
               
               
                  Not more than 5 × 104 colonies per gram
               
            
                  
                     Salmonella spp.
               
               
                  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 and/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 decolourised 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Test for sugar
               
               
                  Passes test
               
            
                  Test for reducing sugar
               
               
                  Passes test
               
            
                  pH
               
               
                  Between 2,5 and 7,0 for polydextrose (10 % solution)
                  Between 5,0 and 6,0 for polydextrose-N (10 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Polyvinylpyrrolidone, poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
               
            
                  Chemical formula
               
               
                  (C6H9NO)n
                  
               
            
                  Average 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
                  
               
            
                  Solubility
               
               
                  Soluble in water and in ethanol. Insoluble in ether
               
            
                  pH
               
               
                  Between 3,0 and 7,0 (5 % solution)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  Polyvinylpyrrolidone; poly-[1-(2-oxo-1-pyrrolidinyl)-ethylene]
               
            
                  Chemical formula
               
               
                  (C6H9NO)n
                  
               
            
                  Molecular weight
               
               
                   
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Insoluble in water, ethanol and ether
               
            
                  pH
               
               
                  Between 5,0 and 8,0 (1 % suspension in water)
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 mg/kg
               
            
         E 1203 POLYVINYL ALCOHOL
      
      
                  
                     Synonyms
                  
               
               
                  Vinyl alcohol polymer, PVOH
               
            
                  
                     Definition
                  
               
               
                  Polyvinyl alcohol is a synthetic resin prepared by the polymerisation of vinyl acetate, followed by partial hydrolysis of the ester in the presence of an alkaline catalyst. The physical characteristics of the product depend on the degree of polymerisation and the degree of hydrolysis.
               
            
                  Chemical name
               
               
                  Ethenol homopolymer
               
            
                  Chemical formula
               
               
                  (C2H3OR)n where R = H or COCH3
                  
               
            
                  
                     Description
                  
               
               
                  Odourless, tasteless, translucent, white or cream-coloured granular powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water; sparingly soluble in ethanol
               
            
                  Precipitation reaction
               
               
                  Dissolve 0,25 g of the sample in 5 ml of water with warming and let the solution cool to room temperature. The addition of 10 ml of ethanol to this solution leads to a white, turbid or flocculent precipitate.
               
            
                  Colour reaction
               
               
                  Dissolve 0,01 g of the sample in 100 ml of water with warming and let the solution cool to room temperature. A blue colour is produced when adding (to 5 ml solution) one drop of iodine test solution (TS) and a few drops of boric acid solution
                  Dissolve 0,5 g of the sample in 10 ml of water with warming and let the solution cool to room temperature. A dark red to blue colour is produced after adding one drop of iodine TS to 5 ml of solution.
               
            
                  Viscosity
               
               
                  4,8 to 5,8 mPa.s (4 % solution at 20 °C) corresponding to an average molecular weight of 26 000-30 000 Da
               
            
                  
                     Purity
                  
               
            
                  Water insoluble matter
               
               
                  Not more than 0,1 %
               
            
                  Ester value
               
               
                  Between 125 and 153 mg KOH/g
               
            
                  Degree of hydrolysis
               
               
                  86,5 to 89,0%
               
            
                  Acid value
               
               
                  Not more than 3,0
               
            
                  Solvent residues
               
               
                  Not more than 1,0 % Methanol, 1,0 % Methyl acetate
               
            
                  pH
               
               
                  5,0 to 6,5 (4 % solution)
               
            
                  Loss on drying
               
               
                  Not more than 5,0 % (105 °C, 3 hours)
               
            
                  Residue in ignition
               
               
                  Not more than 1,0 %
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 1204 PULLULAN
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     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 name
               
               
                   
               
            
                  Chemical formula
               
               
                  (C6H10O5)n
                  
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                  Not less than 90 % of glucan on the dried basis
               
            
                  
                     Description
                  
               
               
                  White to off-white odourless powder
               
            
                  
                     Identification
                  
               
            
                  Solubility
               
               
                  Soluble in water, practically insoluble in ethanol
               
            
                  pH
               
               
                  5,0 to 7,0 (10 % solution)
               
            
                  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
               
            
                  Depolymerisation 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 °C for 20 minutes, the viscosity of the pullulanase-treated solution is visibly lower than that of the untreated solution
               
            
                  Viscosity
               
               
                  100 to 180 mm2/s (10 % w/w aqueous solution at 30 °C)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 6 % (90 °C, pressure not more than 50 mm Hg, 6 hours)
               
            
                  Mono-, di- and oligosaccharides
               
               
                  Not more than 10 % expressed as glucose
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
                  
                     Microbiological criteria
                  
               
            
                  Yeast and moulds
               
               
                  Not more than 100 colonies per gram
               
            
                  Coliforms
               
               
                  Absent in 25 g
               
            
                  
                     Salmonella spp.
               
               
                  Absent in 25 g
               
            
         E 1205 BASIC METHACRYLATE COPOLYMER
      
      
                  
                     Synonyms
                  
               
               
                  Basic butylated methacrylate copolymer; amino methacrylate copolymer; aminoalkyl methacrylate copolymer E; butyl methacrylate, dimethylaminoethyl methacrylate, methyl methacrylate polymer; butyl methacrylate, methyl methacrylate, dimethylaminoethyl methacrylate polymer
               
            
                  
                     Definition
                  
               
               
                  Basic methacrylate copolymer is manufactured by thermic controlled polymerisation of the monomers methyl methacrylate, butyl methacrylate and dimethylaminoethyl methacrylate, dissolved in propan-2-ol) by using a free radical donor initiator system. An alkyl mercaptane is used as chain modifying agent. The solid polymer is milled (first milling step) and extruded and granulated under vacuum to remove residual volatile components. The granules resulting are commercialised as such or undergo a second milling step (micronisation).
               
            
                  Chemical name
               
               
                  Poly(butyl methacrylate-co-(2-dimethylaminoethyl)methacrylate-co-methyl methacrylate) 1:2:1
               
            
                  Chemical formula
               
               
                  Poly[(CH2:C(CH3)CO2(CH2)2N(CH3)2)-co-(CH2:C(CH3)CO2CH3)-co-(CH2:C(CH3)CO2(CH2)3CH3)]
               
            
                  Weight average molecular weight estimated by gel permeation chromatography
               
               
                  Approximately 47 000 g/mol
               
            
                  Particle size of powder (when used forms a film)
               
               
                  < 50 μm more than 50 %
                  < 0,1 μm 5,1-5,5 %
               
            
                  Assay
                  
                     (according to Ph. Eur. 2.2.20 ‘potentiometric titration’)
                  
               
               
                  20,8-25,5 % dimethylaminoethyl (DMAE) groups on dry substance
               
            
                  
                     Description
                  
               
               
                  Granules are colourless to yellow tinged, the powder is white
               
            
                  
                     Identification
                  
               
            
                  Infrared absorption spectroscopy
               
               
                  To be identified
               
            
                  Viscosity of a 12,5 % solution in 60:40 (w/w/) propan-2-ol to acetone
               
               
                  3-6 mPa.s
               
            
                  Refractive index
               
               
                  [n]D
                     20 1,380-1,385
               
            
                  Solubility
               
               
                  1 g dissolves in 7 g Methanol, Ethanol, propan-2-ol, dichloromethane, aqueous Hydrochloric acid 1N.
                  Not soluble in petroleum ether.
               
            
                  
                     Purity
                  
               
            
                  Loss of drying
               
               
                  Not more than 2,0 % (105 °C, 3H)
               
            
                  Alkali value
               
               
                  162-198 mg KOH/g of dried substance
               
            
                  Sulphated ash
               
               
                  Not more than 0,1 %
               
            
                  Residual monomers
               
               
                  Butylmethacrylate < 1 000 mg/kg
                  Methyl methacrylate < 1 000 mg/kg
                  Dimethylaminoethyl methacrylate < 1 000 mg/kg
               
            
                  Solvent residues
               
               
                  propan-2-ol < 0,5 %
                  Butanol < 0,5 %
                  Methanol < 0,1 %
               
            
                  Arsenic
               
               
                  Not more than 2 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
                  Mercury
               
               
                  Not more than 2 mg/kg
               
            
                  Copper
               
               
                  Not more than 10 mg/kg
               
            
         E 1404 OXIDISED STARCH
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Oxidised starch is starch treated with sodium hypochlorite
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 % (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1410 MONOSTARCH PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Monostarch phosphate is starch esterified with ortho-phosphoric acid, or sodium or potassium ortho-phosphate or sodium tripolyphosphate
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 (on an anhydrous basis)
                  Not more than 0,4 % (as P) for other starches (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1412 DISTARCH PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 (on an anhydrous basis)
                  Not more than 0,4 % (as P) for other starches (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1413 PHOSPHATED DISTARCH PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Phosphated distarch phosphate is starch having undergone a combination of treatments as described for monostarch phosphate and for distarch phosphate
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 (on an anhydrous basis)
                  Not more than 0,4 % (as P) for other starches (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1414 ACETYLATED DISTARCH PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Acetylated distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and esterified by acetic anhydride or vinyl acetate
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 % (on an anhydrous basis)
               
            
                  Residual phosphate
               
               
                  Not more than 0,14 % (as P) for wheat or potato starch (on an anhydrous basis)
                  Not more than 0,04 % (as P) for other starches (on an anhydrous basis)
               
            
                  Vinyl acetate
               
               
                  Not more than 0,1 mg/kg (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 % (on an anhydrous basis)
               
            
                  Vinyl acetate
               
               
                  Not more than 0,1 mg/kg (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1422 ACETYLATED DISTARCH ADIPATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Acetylated distarch adipate is starch cross-linked with adipic anhydride and esterified with acetic anhydride
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 % (on an anhydrous basis)
               
            
                  Adipate groups
               
               
                  Not more than 0,135 % (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1440 HYDROXYPROPYL STARCH
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Hydroxypropyl starch is starch etherified with propylene oxide
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 % (on an anhydrous basis)
               
            
                  Propylene chlorohydrin
               
               
                  Not more than 1 mg/kg (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1442 HYDROXYPROPYL DISTARCH PHOSPHATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Hydroxypropyl distarch phosphate is starch cross-linked with sodium trimetaphosphate or phosphorus oxychloride and etherified with propylene oxide
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 % (on an anhydrous basis)
               
            
                  Residual phosphate
               
               
                  Not more than 0,14 % (as P) for wheat or potato starch (on an anhydrous basis)
                  Not more than 0,04 % (as P) for other starches (on an anhydrous basis)
               
            
                  Propylene chlorohydrin
               
               
                  Not more than 1 mg/kg (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 % (on an anhydrous basis)
               
            
                  Octenylsuccinic acid residue
               
               
                  Not more than 0,3 % (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1451 ACETYLATED OXIDISED STARCH
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Acetylated oxidised starch is starch treated with sodium hypochlorite followed by esterification with acetic anhydride
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  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 % (on an anhydrous basis)
               
            
                  Acetyl groups
               
               
                  Not more than 2,5 % (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
         E 1452 STARCH ALUMINIUM OCTENYL SUCCINATE
      
      
                  
                     Synonyms
                  
               
               
                   
               
            
                  
                     Definition
                  
               
               
                  Starch aluminium octenyl succinate is starch esterified with octenylsuccinic anhydride and treated with aluminium sulphate
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                   
               
            
                  Chemical formula
               
               
                   
               
            
                  Molecular weight
               
               
                   
               
            
                  Assay
               
               
                   
               
            
                  
                     Description
                  
               
               
                  White or nearly white powder or granules or (if pregelatinised) flakes, amorphous powder or coarse particles
               
            
                  
                     Identification
                  
               
            
                  Microscopic observation
               
               
                  Passes test (if not pregelatinised)
               
            
                  Iodine staining
               
               
                  Passes test (dark blue to light red colour)
               
            
                  
                     Purity
                  
               
            
                  Loss on drying
               
               
                  Not more than 21,0 %
               
            
                  Octenylsuccinyl groups
               
               
                  Not more than 3 % (on an anhydrous basis)
               
            
                  Octenylsuccinic acid residue
               
               
                  Not more than 0,3 % (on an anhydrous basis)
               
            
                  Sulphur dioxide
               
               
                  Not more than 50 mg/kg for modified cereal starches (on an anhydrous basis)
                  Not more than 10 mg/kg for the other modified starches, unless otherwise specified (on an anhydrous basis)
               
            
                  Arsenic
               
               
                  Not more than 1 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg (on an anhydrous basis)
               
            
                  Mercury
               
               
                  Not more than 0,1 mg/kg
               
            
                  Aluminium
               
               
                  Not more than 0,3 % (on an anhydrous basis)
               
            
         E 1505 TRIETHYL CITRATE
      
      
                  
                     Synonyms
                  
               
               
                  Ethyl citrate
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  201-070-7
               
            
                  Chemical name
               
               
                  Triethyl-2-hydroxypropan-1,2,3-tricarboxylate
               
            
                  Chemical formula
               
               
                  C12H20O7
                  
               
            
                  Molecular weight
               
               
                  276,29
               
            
                  Assay
               
               
                  Content not less than 99,0 %
               
            
                  
                     Description
                  
               
               
                  Odourless, practically colourless, oily liquid
               
            
                  
                     Identification
                  
               
            
                  Specific gravity (25° C/25 °C)
               
               
                  1,135-1,139
               
            
                  Refractive index
               
               
                  [n]D
                     20: 1,439-1,441
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 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
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  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
                  
               
            
                  Solubility
               
               
                  Soluble in water. Miscible with ethanol
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Test for acetate
               
               
                  Passes test
               
            
                  Specific gravity (20° C/20 °C)
               
               
                  1,175-1,195
               
            
                  Boiling range
               
               
                  Between 259 and 261 °C
               
            
                  
                     Purity
                  
               
            
                  Total ash
               
               
                  Not more than 0,02 %
               
            
                  Acidity
               
               
                  Not more than 0,4 % (as acetic acid)
               
            
                  Arsenic
               
               
                  Not more than 3 mg/kg
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 1518 GLYCERYL TRIACETATE
      
      
                  
                     Synonyms
                  
               
               
                  Triacetin
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  203-051-9
               
            
                  Chemical name
               
               
                  Glyceryl triacetate
               
            
                  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
                  
               
            
                  Test for acetate
               
               
                  Passes test
               
            
                  Test for glycerol
               
               
                  Passes test
               
            
                  Refractive index
               
               
                  [n]D
                     25 between 1,429 and 1,431
               
            
                  Specific gravity (25 °C/25 °C)
               
               
                  Between 1,154 and 1,158
               
            
                  Boiling range
               
               
                  Between 258 and 270 °C
               
            
                  
                     Purity
                  
               
            
                  Water content
               
               
                  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 2 mg/kg
               
            
         E 1519 BENZYL ALCOHOL
      
      
                  
                     Synonyms
                  
               
               
                  Phenylcarbinol; Phenylmethyl alcohol; Benzenemethanol; Alpha-hydroxytoluene
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                   
               
            
                  Chemical name
               
               
                  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
                  
               
            
                  Solubility
               
               
                  Soluble in water, ethanol and ether
               
            
                  Refractive index
               
               
                  [n]D
                     20 1,538-1,541
               
            
                  Specific gravity (25° C/25 °C)
               
               
                  1,042-1,047
               
            
                  Test for peroxides
               
               
                  Passes test
               
            
                  Distillation range
               
               
                  Not less than 95 % v/v distils between 202 and 208 °C
               
            
                  
                     Purity
                  
               
            
                  Acid value
               
               
                  Not more than 0,5
               
            
                  Aldehydes
               
               
                  Not more than 0,2 % v/v (as benzaldehyde)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 1520 PROPANE-1,2-DIOL
      
      
                  
                     Synonyms
                  
               
               
                  Propylene glycol
               
            
                  
                     Definition
                  
               
            
                  Einecs
               
               
                  200-338-0
               
            
                  Chemical name
               
               
                  1,2-dihydroxypropane
               
            
                  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
                  
               
            
                  Solubility
               
               
                  Soluble in water, ethanol and acetone
               
            
                  Specific gravity (20° C/20 °C)
               
               
                  1,035-1,040
               
            
                  Refractive index
               
               
                  [n]D
                     20: 1,431-1,433
               
            
                  
                     Purity
                  
               
            
                  Distillation test
               
               
                  99,5% of the product distils between 185-189 °C. The remaining 0,5% consists mainly of dimers and traces of trimers from propylene glycol.
               
            
                  Sulphated ash
               
               
                  Not more than 0,07 %
               
            
                  Water content
               
               
                  Not more than 1,0 % (Karl Fischer method)
               
            
                  Lead
               
               
                  Not more than 2 mg/kg
               
            
         E 1521 POLYETHYLENE GLYCOL
      
      
                  
                     Synonyms
                  
               
               
                  PEG; Macrogol; Polyethylene oxide
               
            
                  
                     Definition
                  
               
               
                  Addition polymers of ethylene oxide and water usually designated by a number roughly corresponding to the molecular weight.
               
            
                  Chemical name
               
               
                  alpha-Hydro-omega-hydroxypoly (oxy-1,2-ethanediol)
               
            
                  Chemical formula
               
               
                  (C2H4O)n H2O (n = number of ethylene oxide units corresponding to a molecular weight of 6 000, about 140)
               
            
                  Average molecular weight
               
               
                  380 to 9 000 Da
               
            
                  Assay
               
               
                  PEG 400: Not less than 95 % and not more than 105 %
                  PEG 3000: Not less than 90 % and not more than 110 %
                  PEG 3350: Not less than 90 % and not more than 110 %
                  PEG 4000: Not less than 90 % and not more than 110 %
                  PEG 6000:Not less than 90 % and not more than 110 %
                  PEG 8000: Not less than 87,5 % and not more than 112,5 %
               
            
                  
                     Description
                  
               
               
                  PEG 400 is a clear, viscous, colourless or almost colourless hygroscopic liquid
                  PEG 3000, PEG 3350, PEG 4000, PEG 6000 and PEG 8000 are white or almost white solids with a waxy or paraffin-like appearance
               
            
                  
                     Identification
                  
               
            
                  Melting range
               
               
                  PEG 400: 4-8 °C
                  PEG 3000: 50-56 °C
                  PEG 3350: 53-57 °C
                  PEG 4000: 53-59 °C
                  PEG 6000:55-61 °C
                  PEG 8000: 55-62 °C
               
            
                  Viscosity
               
               
                  PEG 400: 105 to 130 mPa.s at 20 °C
                  PEG 3000: 75 to 100 mPa.s at 20 °C
                  PEG 3350: 83 to 120 mPa.s at 20 °C
                  PEG 4000: 110 to 170 mPa.s at 20 °C
                  PEG 6000: 200 to 270 mPa.s at 20 °C
                  PEG 8000: 260 to 510 mPa.s at 20 °C
                  For polyethylene glycols having a average molecular weight greater than 400, the viscosity is determined on a 50 per cent m/m solution of the candidate substance in water
               
            
                  Solubility
               
               
                  PEG 400 is miscible with water, very soluble in acetone, in alcohol and in methylene chloride, practically insoluble in fatty oils and in mineral oils
                  PEG 3000 and PEG 3350: very soluble in water and in methylene chloride, very slightly soluble in alcohol, practically insoluble in fatty oils and in mineral oils
                  PEG 4000, PEG 6000 and PEG 8000: very soluble in water and in methylene chloride, practically insoluble in alcohol and in fatty oils and in mineral oils.
               
            
                  
                     Purity
                  
               
            
                  Hydroxyl value
               
               
                  PEG 400: 264-300
                  PEG 3000: 34-42
                  PEG 3350: 30-38
                  PEG 4000: 25-32
                  PEG 6000: 16-22
                  PEG 8000: 12-16
               
            
                  Sulphated ash
               
               
                  Not more than 0,2 %
               
            
                  1,4-Dioxane
               
               
                  Not more than 10 mg/kg
               
            
                  Ethylene oxide
               
               
                  Not more than 0,2 mg/kg
               
            
                  Ethylene glycol and diethylene glycol
               
               
                  Total not more than 0,25 % °w/w individually or in combination
               
            
                  Lead
               
               
                  Not more than 1 mg/kg
               
            
         (1)  Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.
      
         (2)  Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.
      
         (3)  Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.
      
         (4)  Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.
      
         (5)  Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.
      
         (6)  Colour intensity is defined as the absorbance of a 0,1 % (w/v) solution of caramel colour solids in water in a 1 cm cell at 610 nm.
      
         (7)  Expressed on equivalent colour basis i.e. is expressed in terms of a product having a colour intensity of 0,1 absorbance units.
      
         (8)  Absorbance ratio of alcohol precipitate is defined as the absorbance of the precipitate at 280 nm divided by the absorbance at 560 nm (1 cm cell).
      
         (9)  Benzene not more than 0,05 % v/v.
      
         (10)  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.
      
         (11)  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.
      
         (12)  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.
      
         (13)  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.
      
         (14)  May only be sold in a mixture with salt or a salt substitute.
      
         (15)  May only be sold in a mixture with salt or a salt substitute.