# L_2012083EN.01000101.xml

| 22.3.2012 | EN | Official Journal of the European Union | L 83/1 |
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22.3.2012

EN

Official Journal of the European Union

L 83/1

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 As a consequence, those Directives should be repealed.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

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

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(1)  
  OJ L 354, 31.12.2008, p. 16.

1

(2)  
  OJ L 354, 31.12.2008, p. 1.

2

(3)  
  OJ L 6, 10.1.2009, p. 20.

3

(4)  
  OJ L 253, 20.9.2008, p. 1.

4

(5)  
  OJ L 158, 18.6.2008, p. 17.

5

(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.

6

EFSA Journal

(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.

7

EFSA Journal

(8)  EFSA Panel on Contaminants in the Food Chain (CONTAM); Scientific Opinion on Arsenic in Food. EFSA Journal 2009; 7(10):1351.

8

EFSA Journal

(9)  
  OJ L 61, 18.3.1995, p. 1.

9

(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.

10

EFSA Journal

(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.

11

(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).

12

(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.

13

EFSA Journal

(14)  
  OJ L 80, 26.3.2010, p. 28.

14

(15)  
  OJ L 364, 20.12.2006, p. 5.

15

(16)  WHO Technical Report Series, No 956, 2010.

16

(17)  EP 7.0 volume 2, p. 2415-2416.

17

(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.

18

EFSA Journal

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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. |
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| 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. |

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 |

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 |
| --- | --- |

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 |
| --- | --- |

III

1,7-Bis(4-hydroxyphenyl)hepta-1,6-diene-3,5-dione

Chemical formula

| I | C21H20O6 |
| --- | --- |

I

C21H20O6

| II | C20H18O5 |
| --- | --- |

II

C20H18O5

| III | C19H16O4 |
| --- | --- |

III

C19H16O4

Molecular weight

| I. | 368,39 |
| --- | --- |

I.

368,39

| II. | 338,39 |
| --- | --- |

II.

338,39

| III. | 308,39 |
| --- | --- |

III.

308,39

Assay

Content not less than 90 % total colouring matters

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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 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 |
| --- | --- |

—

not more than 7,0 % shall be trisodium 2-(2-quinolyl) indan-1,3-dione-trisulfonate

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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.

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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 %

Formula
  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 |

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

Formula
  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 |

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 %

Formula
  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 |

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) |
| --- | --- |

—

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.

Formula
  700 at ca. 405 nm in aqueous solution at pH 9

Formula
  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 |

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 %.

Formula
  540 at ca. 422 nm in chloroform

Formula
  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 |

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.

Formula
  565 at ca. 405 nm in aqueous phosphate buffer at pH 7,5

Formula
  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 |

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

Formula
  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 |

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 |

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 |

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 |

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 |

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

Formula
  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 |

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 |

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.

Formula
  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 |

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)

Formula
  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 |

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

Formula
  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 |

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)

Formula
  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 |

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 %

Formula
  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 |

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:

Formula

Norbixin:

Formula

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 |

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:

Formula

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 |

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:

Formula

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 |

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

Formula
  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 |

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)

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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

Formula
  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 |

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)

Formula

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 |

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 %

Formula
  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 |

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

Formula

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 |

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. |

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 |

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 |

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 | |

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 % |

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 |

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

Formula
  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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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, |

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 |
| --- | --- |

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 |

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 |

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 |

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 |

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 |

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 |
| --- | --- |

(ii)

| 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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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

Formula
  (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 |

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

Formula
  (298 nm) between 91 and 97

Formula
  (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 |

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

Formula

Formula
  (298 nm) between 89 and 95

Formula
  (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 |

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

Formula

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 |

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

Formula

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 |

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

Formula

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 |

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 |

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 |

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 |

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

Formula
  (290 nm) not less than 190 and not more than 210

Formula
  (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 |

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

Formula

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 |

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 |

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 |

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 |

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) |

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) |
| --- | --- |

(b)

C6H8O7·H2O (monohydrate)

Molecular weight

| (a) | 192,13 (anhydrous) |
| --- | --- |

(a)

192,13 (anhydrous)

| (b) | 210,15 (monohydrate) |
| --- | --- |

(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) |

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) |
| --- | --- |

(b)

C6H7O7Na·H2O (monohydrate)

Molecular weight

| (a) | 214,11 (anhydrous) |
| --- | --- |

(a)

214,11 (anhydrous)

| (b) | 232,23 (monohydrate) |
| --- | --- |

(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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 | C4H4O6K2·1⁄2H2O |
| 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 |

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

C4H4O6K2·1⁄2H2O

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 |

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 |

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 |

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 |

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 1⁄4 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 |

Synonyms

Sodium phosphate; Tribasic sodium phosphate; Trisodium orthophosphate

Definition

Trisodium phosphate is obtained from aqueous solutions and crystallises in the anhydrous form and with 1/2, 1, 6, 8 or 12 H2O. The dodecahydrate always crystallises from aqueous solutions with an excess of sodium hydroxide. It contains 1⁄4 molecule of NaOH

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 |

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 |

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 |

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) |

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. |

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. |

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 |

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 |

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 1⁄2 H2O
  Trihydrate: C4H4Na2O5 3H2O |
| Molecular weight | Hemihydrate: 187,05
  Trihydrate: 232,10 |
| Assay | Content not less than 98,0 % on the anhydrous basis |
| Description | White crystalline powder or lumps |
| Identification |
| 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 |

Synonyms

Sodium salt of malic acid

Definition

Einecs

Chemical name

Disodium DL-malate; disodium salt of hydroxybutanedioic acid

Chemical formula

Hemihydrate: C4H4Na2O5 1⁄2 H2O

Trihydrate: C4H4Na2O5 3H2O

Molecular weight

Hemihydrate: 187,05

Trihydrate: 232,10

Assay

Content not less than 98,0 % on the anhydrous basis

Description

White crystalline powder or lumps

Identification

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 % |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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) |

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) |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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. |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |
| --- | --- |

—

CH3 or

| — | CH2CH3 |
| --- | --- |

—

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 |

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 |
| --- | --- |

—

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 |

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 |
| --- | --- |

—

CH2CHOHCH3

| — | CH2CHO(CH2CHOHCH3)CH3 |
| --- | --- |

—

CH2CHO(CH2CHOHCH3)CH3

| — | CH2CHO[CH2CHO(CH2CHOHCH3)CH3]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 |

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 |
| --- | --- |

—

CH3

| — | CH2CHOHCH3 |
| --- | --- |

—

CH2CHOHCH3

| — | CH2CHO (CH2CHOHCH3) CH3 |
| --- | --- |

—

CH2CHO (CH2CHOHCH3) CH3

| — | CH2CHO[CH2CHO (CH2CHOHCH3) CH3]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 |

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 |
| --- | --- |

—

CH3

| — | CH2CH3 |
| --- | --- |

—

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 |

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 |
| --- | --- |

—

CH2COONa

| — | CH2COOH |
| --- | --- |

—

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 |

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 |
| --- | --- |

—

CH2COONa

| — | CH2COOH |
| --- | --- |

—

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 |

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) |

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 |

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 |

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 |

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) |

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 |

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) |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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) |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 % |

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 % |
| --- | --- |

—

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 |

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 |

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 |

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 % |

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 % |
| --- | --- |

—

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 |

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 % |

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 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 % |
| --- | --- |

—

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 % |

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 % |
| --- | --- |

C40: 35-70 %

| | C50: 9-25 % |
| --- | --- |

C50: 9-25 %

| | C60: 1-7 % |
| --- | --- |

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 |

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 |

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 |

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 |

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) |

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) |

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 % |

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 |

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 % |

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 % |

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 % |

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) |

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 |

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 |

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) |

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) |

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) |

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) |

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) |

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) |

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) |

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 | C14H8CaN2O6S2·31⁄2H2O |
| 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) |

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

C14H8CaN2O6S2·31⁄2H2O

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) |

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 |

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 |

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) |

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 |

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 |

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 |

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) |

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 |

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) |

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) |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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 |

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) |

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 |

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 |

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 |

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 |

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 |

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 |

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

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(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.

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