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
Date: 2012-03-09
Institutions: European Commission
Subjects: food additive, food chemistry, food safety, foodstuff, human nutrition




L_2012083EN.01000101.xml










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 As a consequence, those Directives should be repealed.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 (13)






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 (14)






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). 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.

(*1)  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.

(13)  May only be sold in a mixture with salt or a salt substitute.

(14)  May only be sold in a mixture with salt or a salt substitute.