Commission Directive 98/86/EC of 11 November 1998 amending Commission Directive 96/77/EC laying down specific purity criteria on food additives other than colours and sweeteners (Text with EEA relevance)
Date: 1998-11-11
Institutions: European Commission
Subjects: approximation of laws, food additive, foodstuffs legislation, human nutrition, product quality

9.12.98

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Official  Journal  of  the  European  Communities

L 334/1

I

(Acts  whose  publication  is  obligatory)

COMMISSION  DIRECTIVE  98/86/EC

of  11  November  1998

amending  Commission  Directive  96/77/EC  laying  down  specific  purity  criteria  on  food
additives  other  than  colours  and  sweeteners

(Text  with  EEA  relevance)

THE  COMMISSION  OF  THE  EUROPEAN  COMMUNITIES,

Having  regard  to  the  Treaty  establishing  the  European
Community,

Having  regard  to  Council  Directive  89/107/EEC  of
21  December  1988  on  the  approximation  of  the  laws  of
the  Member  States  concerning  food  additives  authorised
for use in foodstuffs intended for human consumption (1),
as  amended  by  European  Parliament  and  Council
Directive  94/34/EC (2)  and  in  particular  Article  3(3)(a)
thereof;

After  consulting  the  Scientific  Committee  for  Food;

Whereas, it is necessary to establish purity criteria for all
additives other than colours and sweeteners mentioned in
European  Parliament  and  Council  Directive  95/2/EC  of
20  February  1995  on  food  additives  other  than  colours
last  amended  by  Directive
and 
98/72/EC (4);

sweeteners (3),  as 

Whereas,  it  is  necessary  to  replace  the  purity  criteria  set
out  in  Council  Directive  78/663/EEC  of  25  July  1978
laying  down  specific  criteria  of  purity  for  emulsifiers,
stabilisers,  thickeners  and  gelling  agents  which  may  be
used  in  foodstuffs  intended  for  human  consumption (5),
as  last  amended  by  Commission  Directive  92/4/EEC (6);

(1) OJ  L  40,  11.2.1989,  p.  27.
(2) OJ  L  237,  10.9.1994,  p.  1.
(3) OJ  L  61,  18.3.1995,  p.  1.
(4) OJ  L  295,  4.11.1998,  p.  18.
(5) OJ  L  223,  14.8.1978,  p.  7.
(6) OJ  L  55,  29.2.1992,  p.  96.

Whereas  Commission  Directive  96/77/EC  of  2  December
laying  down  specific  purity  criteria  on  food
1996 
additives  other  than  colours  and  sweeteners (7)  set  out  a
first list of purity criteria for a number of food additives;
whereas  this  list  should  now  be  complemented  with  the
newly  established  purity  criteria  for  other  additives;

it 

is  necessary  to  take 

Whereas 
into  account  the
specifications  and  analytical  techniques  for  additives  as
set  out  in  the  Codex  Alimentarius  as  drafted  by  the
Joint  FAO/WHO  Expert  Committee  on  Food  Additives
(JECFA);

included 

Whereas  food  additives, 
if  prepared  by  production
methods  or  starting  materials  significantly  different  from
in  the  evaluation  of  the  Scientific
those 
Committee 
those
if  different 
mentioned  in  this  Directive,  should  be  submitted  for
evaluation  by  the  Scientific  Committee  for  Food  for  the
purposes of a full evaluation with emphasis on the purity
criteria;

for  Food,  or 

from 

Whereas,  the  measures  provided  for  in  this  Directive
are  in  accordance  with  the  opinion  of  the  Standing
Committee  for  Foodstuffs,

HAS  ADOPTED  THIS  DIRECTIVE:

Article  1

Directive  96/77/EC  shall  be  amended  as  follows:

(7) OJ  L  339,  30.12.1996,  p.  1.

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1. Article  2  is  replaced  by  the  following:

‘Article  2

Products put on the market or labelled before 1 July
2.
1999  which  do  not  comply  with  this  Directive  may  be
marketed  until  stocks  are  exhausted.

The purity criteria referred to in Article 1 replace the
in  Directives  65/66/EEC,
purity  criteria  set  out 
78/663/EEC  and  78/664/EEC.’

Article  3

2.

In  the  Annex,  the  text  of  the  Annex  to  this  Directive
shall  be  added.

This  Directive  shall  enter  into  force  on  the  20th  day
following that of its publication in the Official Journal of
the  European  Communities.

Article  2

Article  4

1. Member  States  shall  bring  into  force  the  laws,
regulations  and  administrative  provisions  necessary  to
comply with this Directive before 1 July 1999. They shall
immediately  inform  the  Commission  thereof.

When  Member  States  adopt  these  provisions,  these  shall
contain  a  reference  to  this  Directive  or  shall  be
accompanied  by  such  reference  at  the  time  of  their
official  publication.  The  procedure  for  such  reference
shall  be  adopted  by  Member  States.

This  Directive  is  addressed  to  the  Member  States.

Done  at  Brussels,  11  November  1998.

For  the  Commission

Martin BANGEMANN

Member  of  the  Commission

9.12.98

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ANNEX

‘Ethylene  oxide  may  not  be  used  for  sterilising  purposes  in  food  additives

E 400  ALGINIC  ACID

Definition

Linear glycuronoglycan consisting mainly of (cid:226)-(1-4) linked D-mannuronic and Æ-(1-4)
form.  Hydrophilic  colloidal
linked  L-guluronic  acid  units 
carbohydrate  extracted  by  the  use  of  dilute  alkali  from  natural  strains  of  various
species  of  brown  seaweeds  (Phaeophyceae)

in  pyranose  ring 

Einecs

Chemical  formula

232-680-1

(C6H8O6)n

Molecular  weight

10 000—600 000  (typical  average)

Assay

Description

Identification

A. Solubility

B. Calcium  chloride  precipitation  test

C. Ammonium  sulphate  precipitation

test

D. Colour  reaction

Purity

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)

Alginic acid occurs in filamentous, grainy, granular and powdered forms. It is a white
to  yellowish  brown  and  nearly  odourless

Insoluble  in  water  and  organic  solvents,  slowly  soluble  in  solutions  of  sodium
carbonate,  sodium  hydroxide  and  trisodium  phosphate

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

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

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  of  a  3 %  suspension

Between  2,0  and  3,5

Loss  on  drying

Sulphated  ash

Not  more  than  15 %  (105 °C,  4  hours)

Not  more  than  8 %  on  the  anhydrous  basis

Sodium  hydroxide  (1  M  solution)

Not  more  than  2 %  on  the  anhydrous  basis  insoluble  matter

Arsenic

Not  more  than  3  mg/kg

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Lead

Mercury

Cadmium

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total  plate  count

Not  more  than  5 000  colonies  per  gram

Yeast  and  moulds

Not  more  than  500  colonies  per  gram

E.  coli

Salmonella spp.

Negative  in  5  g

Negative  in  10  g

E  401  SODIUM  ALGINATE

Definition

Chemical name

Chemical  formula

Molecular  weight

Assay

Sodium  salt  of  alginic  acid

(C6H7NaO6)n

10 000-600 000  (typical  average)

Yields, on the anhydrous basis, not less than 18 % and not more than 21 % of carbon
dioxide corresponding to not less than 90,8 % and not more than 106,0 % of sodium
alginate  (calculated  on  equivalent  weight  basis  of  222)

Description

Nearly  odourless,  white  to  yellowish  fibrous  or  granular  powder

Identification

A. Positive  test  for  sodium  and  alginic

acid

Purity

Loss  on  drying

Not  more  than  15 %  (105 °C,  4  hours)

Water-insoluble  matter

Not  more  than  2 %  on  the  anhydrous  basis

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total  plate  count

Not  more  than  5 000  colonies  per  gram

Yeast  and  moulds

Not  more  than  500  colonies  per  gram

E.  coli

Salmonella spp.

Negative  in  5  g

Negative  in  10  g

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E  402  POTASSIUM  ALGINATE

Definition

Chemical name

Chemical  formula

Molecular  weight

Assay

Potassium  salt  of  alginic  acid

(C6H7KO6)n

10 000-600 000  (typical  average)

Yields,  on  the  anhydrous  basis,  not  less  than  16,5 %  and  not  more  than  19,5 %  of
carbon dioxide corresponding to not less than 89,2 % and not more than 105,5 %  of
potassium  alginate  (calculated  on  an  equivalent  weight  basis  of  238)

Description

Nearly  odourless,  white  to  yellowish  fibrous  or  granular  powder

Identification

A. Positive  test  for  potassium  and  for

alginic acid

Purity

Loss  on  drying

Not  more  than  15 %  (105 °C,  4  hours)

Water-insoluble  matter

Not  more  than  2 %  on  the  anhydrous  basis

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total  plate  count

Not  more  than  5 000  colonies  per  gram

Yeast  and  moulds

Not  more  than  500  colonies  per  gram

E.  coli

Salmonella spp.

Negative  in  5  g

Negative  in  10  g

E  403  AMMONIUM  ALGINATE

Definition

Chemical name

Chemical  formula

Molecular  weight

Assay

Ammonium  salt  of  alginic  acid

(C6H11NO6)n

10 000-600 000  (typical  average)

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

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Identification

A. Positive  test  for  ammonium  and

alginic acid

Purity

Loss  on  drying

Sulphated  ash

Not  more  than  15 %  (105 °C,  4  hours)

Not  more  than  7 %  on  the  dried  basis

Water-insoluble  matter

Not  more  than  2 %  on  the  anhydrous  basis

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy metals

Not  more  than  20  mg/kg

Total  plate  count

Not  more  than  5 000  colonies  per  gram

Yeast  and  moulds

Not  more  than  500  colonies  per  gram

E.  coli

Salmonella spp.

Negative  in  5  g

Negative  in  10  g

E  404  CALCIUM  ALGINATE

Synonyms

Definition

Chemical name

Chemical  formula

Molecular  weight

Assay

Calcium  salt  of  alginate

Calcium  salt  of  alginic  acid

(C6H7Ca1/2O6)n

10 000-600 000  (typical  average)

Yields,  on  the  anhydrous  basis,  not  less  than  18 %  and  not  more  than  21 %  carbon
dioxide corresponding to not less than 89,6 % and not more than 104,5 % of calcium
alginate  (calculated  on  an  equivalent  weight  basis  of  219)

Description

Nearly  odourless,  white  to  yellowish  fibrous  or  granular  powder

Identification

A. Positive  test  for  calcium  and

alginic acid

Purity

Loss  on  drying

Arsenic

Not  more  than  15,0 %  (105 °C,  4  hours)

Not  more  than  3  mg/kg

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Lead

Mercury

Cadmium

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total  plate  count

Yeast  and  moulds

E.  coli

Salmonella spp.

Not  more  than  5 000  colonies  per  gram

Not  more  than  500  colonies  per  gram

Negative  in  5  g

Negative  in  10  g

E 405  PROPANE-1,2-DIOL  ALGINATE

Synonyms

Definition

Chemical name

Hydroxypropyl alginate
1,2-propanediol  ester  of  alginic  acid
Propylene glycol alginate

Propane-1,2-diol ester of alginic acid; varies in composition according to its degree of
esterification  and  the  percentage  of  free  and  neutralised  carboxyl  groups  in  the
molecule

Chemical  formula

(C9H14O7)n
(esterified)

Molecular  weight

10 000—600 000  (typical  average)

Assay

Yields, on the anhydrous basis, not less than 16 % and not more than 20 % of CO2  of
carbon  dioxide

Description

Nearly  odourless,  white  to  yellowish  brown  fibrous  or  granular  powder

Identification

A. Positive test for 1,2-propanediol and

alginic  acid  after  hydrolysis

Purity

Loss  on  drying

Not  more  than  20 %  (105 °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

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

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Total  plate  count

Not  more  than  5 000  colonies  per  gram

Yeast  and  moulds

Not  more  than  500  colonies  per  gram

E.  coli

Negative  in  5  g

Salmonella spp.

Negative  in  10  g

E  406  AGAR

Synonyms

Definition

Chemical name

Einecs

Assay

Description

Identification

Gelose
Japan agar
Bengal,  Ceylon,  Chinese  or  Japanese  isinglass
Layor  Carang

Agar  is  a  hydrophilic  colloidal  polysaccharide  consisting  mainly  of  D-galactose  units.
On about every tenth D-galactopyranose unit one of the hydroxyl groups is esterified
with sulphuric acid which is neutralised by calcium, magnesium, potassium or sodium.
It  is  extracted  from  certain  natural  strains  of  marine  algae  of  the  families  Gelidiaceae
und  Sphaerococcaceae and  related  red  algae  of  the  class  Rhodophyceae

232-658-1

The  threshold  gel  concentration  should  not  be  higher  than  0,25 %

Agar is odourless or has a slight characteristic odour. Unground agar usually occurs in
bundles  consisting  of  thin,  membranous,  agglutinated  strips,  or  in  cut,  flaked  or
granulated  forms.  It  may  be  light  yellowish-orange,  yellowish-grey  to  pale  yellow,  or
colourless.  It  is  tough  when  damp,  brittle  when  dry.  Powdered  agar  is  white  to
yellowish-white or pale yellow. When examined in water under a microscope, the agar
appears  granular  and  somewhat  filamentous.  A  few  fragments  of  the  spicules  of
sponges  and  a  few  frustules  of  diatoms  may  be  present.  In  chloral  hydrate  solution,
the  powdered  agar  appears  more  transparent  than  in  water,  more  or  less  granular,
striated,  angular  and  occasionally  contains  frustules  of  diatoms.  Gel  strength  may  be
standardised  by  the  addition  of  dextrose  and  maltodextrines  or  sucrose

A. 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  (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

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Gelatin  and  other  proteins

Water  absorption

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

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

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  407  CARRAGEENAN

Synonyms

Definition

Products  of  commerce  are  sold  under  different  names  such  as:
— Irish  moss  gelose
— Eucheuman  (from  Eucheuma  spp.)
— Iridophycan  (from  Irdidaea  spp.)
— Hypnean  (from  Hypnea  spp.)
— Furcellaran  or  Danish  agar  (from  Furcellaria fastigiata)
— Carrageenan  (from  Chondrus  and  Gigartina  spp.)

Carrageenan  is  obtained  by  aqueous  extraction  of  natural  strains  of  seaweeds  of
Gigartinaceae,  Solieriaceae,  Hypneaceae  and  Furcellariaceae,  families  of  the  class
Rhodophyceae  (red  seaweeds).  No  organic  precipitant  shall  be  used  other  than
methanol,  ethanol  and  propane-2-ol.  Carrageenan  consists  chiefly  of  the  potassium,
sodium,  magnesium  and  calcium  salts  of  polysaccharide  sulphate  esters  which,  on
hydrolysis,  yield  galactose  and  3,6-anhydrogalactose.  Carrageenan  shall  not  be
hydrolysed  or  otherwise  chemically  degraded

Einecs

232-524-2

Description

Yellowish  to  colourless,  coarse  to  fine  powder  which  is  practically  odourless

Identification

A. Positive 

tests 

for  galactose, 

for

anhydrogalactose  and  for  sulphate

Purity

Methanol,  ethanol  propane-2-ol  content

Not  more  than  0,1 %  singly  or  in  combination

Viscosity  of  a  1,5 %  solution  at  75 °C

Not  less  than  5  mPa.s

Loss  on  drying

Not  more  than  12 %  (105 °C,  4  hours)

Sulphate

Not  less  than  15 %  and  not  more  than  40 %  on  the  anhydrous  basis  (as  SO4)

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Ash

Not  less  than  15 %  and  not  more  than  40 %  determined  on  the  anhydrous  basis  at
550 °C

Acid-insoluble  ash

Not  more  than  1 %  on  the  anhydrous  basis  (insoluble  in  10 %  hydrochloric  acid)

Acid-insoluble  matter

Not  more  than  2 %  on  the  anhydrous  basis  (insoluble  in  1 %  v/v  sulphuric  acid)

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total  plate  count

Not  more  than  5 000  colonies  per  gram

Yeast  and  moulds

Not  more  than  300  colonies  per  gram

E.  coli

Salmonella spp.

Negative  in  5  g

Negative  in  10  g

E  407a  PROCESSED  EUCHEUMA  SEAWEED

Synonyms

Definition

PES  (acronym  for  processed  eucheuma  seaweed)

Processed eucheuma seaweed is obtained by aqueous alkaline (KOH) treatment of the
natural  strains  of  seaweeds  Eucheuma  cottonii  und  Eucheuma  spinosum,  of  the  class
Rhodophyceae  (red  seaweeds)  to  remove  impurities  and  by  fresh  water  washing  and
drying  to  obtain  the  product.  Further  purification  may  be  achieved  by  washing  with
methanol,  ethanol  or  propane-2-ol  and  drying.  The  product  consists  chiefly  of  the
potassium salts of polysaccharide sulphate esters which, on hydrolysis, yield galactose
and 3,6-anhydrogalactose. Sodium, calcium and magnesium salts of the polysaccharide
sulphate esters are present in lesser amounts. Up to 15 % algal cellulose is also present
in  the  product.  The  carrageenan  in  processed  eucheuma  seaweed  shall  not  be
hydrolysed  or  otherwise  chemically  degraded

Description

Tan  to  yellowish,  coarse  to  fine  powder  which  is  practically  odourless

Identification

A. Positive  tests  for  galactose,  for

anhydrogalactose  and  for  sulphate

B. Solubility

Forms  cloudy  viscous  suspensions  in  water.  Insoluble  in  ethanol

Purity

Methanol,  ethanol,  propane-2-ol
content

Not  more  than  0,1 %  singly  or  in  combination

Viscosity  of  a  1,5 %  solution  at  75 °C

Not  less  than  5  mPa.s

Loss  on  drying

Not  more  than  12 %  (105 °C,  4  hours)

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Sulphate

Ash

Not  less  than  15 %  and  not  more  than  40 %  on  the  dried  basis  (as  SO4)

Not  less  than  1 %  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)

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total  plate  count

Not  more  than  5 000  colonies  per  gram

Yeast  and  mould

Not  more  than  300  colonies  per  gram

E.  coli

Negative  in  5  g

Salmonella spp.

Negative  in  10  g

E  410  LOCUST  BEAN  GUM

Synonyms

Definition

Carob  bean  gum
Algaroba gum

Locust bean gum is the ground endosperm of the seeds of the natural strains of carob
tree,  Cerationia  siliqua  (L.)  Taub.  (family  Leguminosae).  Consists  mainly  of  a  high
molecular  weight  hydrocolloidal  polysaccharide,  composed  of  galactopyranose  and
mannopyranose  units  combined  through  glycosidic  linkages,  which  may  be  described
chemically as galactomannan

Molecular  weight

50 000—3 000 000

Einecs

Assay

232-541-5

Galactomannan  content  not  less  than  75 %

Description

White  to  yellowish-white,  nearly  odourless  powder

Identification

A. Positive  tests  for  galactose  mannose

B. Microscopic  examination

Place  some  ground  sample  in  an  aqueous  solution  containing  0,5 %  iodine  and  1 %
potassium  iodide  on  a  glass  slide  and  examine  under  microscope.  Locust  bean  gum
contains  long  stretched  tubiform  cells,  separated  or  slightly  interspaced.  Their  brown
contents are much less regularly formed in guar gum. Guar gum shows close groups of
round  to  pear  shaped  cells.  Their  contents  are  yellow  to  brown

C. Solubility

Soluble  in  hot  water,  insoluble  in  ethanol

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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

Arsenic

Lead

Mercury

Cadmium

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

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Ethanol  and  propane-2-ol

Not  more  than  1 %,  single  or  in  combination

E  412  GUAR  GUM

Synonyms

Definition

Gum  cyamopsis
Guar  flour

Guar  gum  is  the  ground  endosperm  of  the  seeds  of  natural  strains  of  the  guar  plant,
Cyamopsis tetragonolobus (L.) Taub. (family Leguminosae). Consists mainly of a high
molecular  weight  hydrocolloidal  polysaccharide  composed  of  galactopyranose  and
mannopyranose  units  combined  through  glycosidic  linkages,  which  may  be  described
chemically as galactomannan

Einecs

232-536-0

Molecular  weight

50 000—8 000 000

Assay

Description

Identification

Galactomannan  content  not  less  than  75 %

A  white  to  yellowish-white,  nearly  odourless  powder

A. Positive  tests  for  galactose  and  for

mannose

B. Solubility

Purity

Soluble  in  cold  water

Loss  on  drying

Not  more  than  15 %  (105 °C,  5  hours)

Ash

Not  more  than  1,5 %  determined  at  800 °C

Acid-insoluble  matter

Not  more  than  7 %

Protein  (N  ×  6,25)

Not  more  than  10 %

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L 334/13

Starch

Arsenic

Lead

Mercury

Cadmium

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)

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E 413  TRAGACANTH

Synonyms

Definition

Tragacanth  gum
Tragant

Tragacanth  is  a  dried  exudation  obtained  from  the  stems  and  branches  of  natural
strains  of  Astragalus  gummifer  Labillardiere  and  other  Asiatic  species  of  Astragalus
(family  Leguminosae).  It  consists  mainly  of  high  molecular  weight  polysaccharides
(galactoarabans  and  acidic  polysaccharides)  which,  on  hydrolysis,  yield  galacturonic
acid,  galactose,  arabinose,  xylose  and  fucose.  Small  amounts  of  rhamnose  and  of
glucose  (derived  from  traces  of  starch  and/or  cellulose)  may  also  be  present

Molecular  weight

Approximately  800 000

Einecs

Description

Identification

A. Solubility

Purity

232-252-5

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

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

Negative  test  for  Karaya  gum

Boil  1  g  with  20  ml  of  water  until  a  mucilage  is  formed.  Add  5  ml  of  hydrochloric
acid  and  again  boil  the  mixture  for  five  minutes.  No  permanent  pink  or  red  colour
develops

Loss  on  drying

Total  ash

Not  more  than  16 %  (105 °C  ,  5  hours)

Not  more  than  4 %

Acid  insoluble  ash

Not  more  than  0,5 %

Acid  insoluble  matter

Not  more  than  2 %

Arsenic

Lead

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

L 334/14

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9.12.98

Mercury

Cadmium

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Salmonella spp.

E.  coli

Negative  in  10  g

Negative  in  5  g

E  414  ACACIA  GUM

Synonyms

Definition

Gum arabic

Acacia  gum  is  a  dried  exudation  obtained  from  the  stems  and  branches  of  natural
strains  of  Acacia  senegal  (L)  Willdenow  or  closely  related  species  of  Acacia  (family
Leguminosae).  It  consists  mainly  of  high  molecular  weight  polysaccharides  and  their
calcium,  magnesium  and  potassium  salts,  which  on  hydrolysis  yield  arabinose,
galactose,  rhamnose  and  glucuronic  acid

Molecular  weight

Approximately  350 000

Einecs

Description

Identification

A. Solubility

Purity

Loss  on  drying

232-519-5

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.

1 g dissolves in 2 ml of cold water forming a solution which flows readily and is acid
to  litmus,  insoluble  in  ethanol

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

Arsenic

Lead

Mercury

Cadmium

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

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

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L 334/15

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Hydrolysis  products

Mannose,  xylose  and  galacturonic  acid  are  absent  (determined  by  chromatography)

Salmonella spp.

Negative  in  10  g

E.  coli

Negative  in  5  g

E  415  XANTHAN  GUM

Definition

Xanthan  gum  is  a  high  molecular  weight  polysaccharide  gum  produced  by  a
pure-culture  fermentation  of  a  carbohydrate  with  natural  strains  of  Xanthomonas
campestris,  purified  by  recovery  with  ethanol  or  propane-2-ol,  dried  and  milled.  It
contains  D-glucose  and  D-mannose  as  the  dominant  hexose  units,  along  with
D-glucuronic  acid  and  pyruvic  acid,  and  is  prepared  as  the  sodium,  potassium  or
calcium  salt.  Its  solutions  are  neutral

Molecular  weight

Approximately  1 000 000

Einecs

Assay

234-394-2

Yields,  on  dried  basis,  not  less  than  4,2 %  and  not  more  than  5 %  of  CO2
corresponding  to  between  91 %  and  108 %  of  xanthan  gum

Description

Cream-coloured  powder

Identification

A. Solubility

Purity

Soluble  in  water.  Insoluble  in  ethanol

Loss  on  drying

Not  more  than  15 %  (105 °C,  21⁄2  hours)

Total  ash

Pyruvic acid

Nitrogen

Propane-2-ol

Arsenic

Lead

Mercury

Cadmium

Not  more  than  16 %  on  the  anhydrous  basis  determined  at  650 °C  after  drying  at
105 °C  for  four  hours

Not  less  than  1,5 %

Not  more  than  1,5 %

Not  more  than  500  mg/kg

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total  plate  count

Not  more  than  10 000  colonies  per  gram

Yeast  and  mould

Not  more  than  300  colonies  per  gram

L 334/16

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E.  coli

Salmonella spp.

Negative  in  5  g

Negative  in  10  g

Xanthomonas  campestris

Viable  cells  absent

E  416  KARAYA-GUM

Synonyms

Definition

Einecs

Description

Identification

A. Solubility

Katilo
Kadaya
Gum  sterculia
Sterculia
Karaya, gum karaya
Kullo
Kuterra

Karaya  gum  is  a  dried  exudation  from  the  stems  and  branches  of  natural  strains  of:
Sterculia urens Roxburgh and other species of Sterculia (family Sterculiaceae) or from
Cochlospermum  gossypium  A.P.  De  Candolle  or  other  species  of  Cochlospermum
(family  Bixaceae). 
It  consists  mainly  of  high  molecular  weight  acetylated
polysaccharides, which on hydrolysis yield galactose, rhamnose, and galacturonic acid,
together  with  minor  amounts  of  glucuronic  acid

232-539-4

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

Insoluble  in  ethanol

B. Swelling  in  ethanol  solution

Karaya  gum  swells  in  60 %  ethanol  distinguishing  it  from  other  gums

Purity

Loss  on  drying

Total  ash

Not  more  than  20 %  (105 °C,  5  hours)

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

Arsenic

Lead

Mercury

Cadmium

Not  detectable

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Salmonella spp.

E.  coli

Negative  in  10  g

Negative  in  5  g

9.12.98

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L 334/17

E  417  TARA  GUM

Definition

Einecs

Description

Identification

A. Solubility

Tara  gum  is  obtained  by  grinding  the  endosperm  of  the  seeds  of  natural  strains  of
Caesalpinia  spinosa  (family  Leguminosae).  It  consists  chiefly  of  polysaccharides  of
high molecular weight composed mainly of galactomannans. The principal component
consists of a linear chain of (1-4)-(cid:226)-D-mannopyranose units with Æ-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)

254-409-6

A  white  to  white-yellow  odourless  powder

Soluble  in  water
Insoluble  in  ethanol

B. Gel  formation

To  an  aqueous  solution  of  the  sample  add  small  amounts  of  sodium  borate.  A  gel  is
formed

Purity

Loss  on  drying

Not  more  than  15 %

Ash

Not  more  than  1,5 %

Acid  insoluble  matter

Not  more  than  2 %

Protein

Starch

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3,5 %  (factor  N  x  5,7)

Not  detectable

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  418  GELLAN  GUM

Definition

Gellan gum is a high molecular weight polysaccharide gum produced by a pure culture
fermentation of a carbohydrate by natural strains of Pseudomonas elodea, purified by
recovery  with  isopropyl  alcohol,  dried,  and  milled.  The  high  molecular  weight
polysaccharide  is  principally  composed  of  a  tetrasaccharide  repeating  unit  of  one
rhamnose,  one  glucuronic  acid,  and  two  glucoses,  and  substituted  with  acyl  (glyceryl
and  acetyl)  groups  as  the  O-glycosidically  linked  esters.  The  glucuronic  acid  is
neutralised  to  a  mixed  potassium,  sodium,  calcium,  and  magnesium  salt

Einecs

275-117-5

Molecular  weight

Approximately  500 000

L 334/18

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Assay

Description

Identification

A. Solubility

Purity

Loss  on  drying

Nitrogen

Propane-2-ol

Arsenic

Lead

Mercury

Cadmium

Yields,  on  the  dried  basis,  not  less  than  3,3 %  and  not  more  than  6,8 %  of  CO2

An  off-white  powder

Soluble  in  water,  forming  a  viscous  solution.
Insoluble  in  ethanol

Not  more  than  15 %  after  drying  (105 °C,  2½  hours)

Not  more  than  3 %

Not  more  than  750  mg/kg

Not  more  than  3  mg/kg

Not  more  than  2  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total  plate  count

Yeast  and  mould

E.  coli

Salmonella spp.

E  422  GLYCEROL

Synonyms

Definition

Chemical  names

Einecs

Chemical  formula

Molecular  weight

Assay

Description

Identification

Not  more  than  10 000  colonies  per  gram

Not  more  than  400  colonies  per  gram

Negative  in  5  g

Negative  in  10  g

Glycerin
Glycerine

1,2,3-propanetriol
Glycerol
Trihydroxypropane

200-289-5

C3H8O3

92,10

Content  not  less  than  98 %  of  glycerol  on  the  anhydrous  basis

Clear,  colourless  hygroscopic  syrupy  liquid  with  not  more  than  a  slight  characteristic
odour,  which  is  neither  harsh  nor  disagreeable

A. Acrolein  formation  on  heating

Heat  a  few  drops  of  the  sample  in  a  test  tube  with  about  0,5  g  of  potassium
bisulphate.  The  characteristic  pungent  vapours  of  acrolein  are  evolved

B. Specific  gravity  (25/25 °C)

Not  less  than  1,257

C. Refractive  index  [n]D20

Between  1,471  and  1,474

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L 334/19

Purity

Water

Not  more  than  5 %  (Karl  Fischer  method)

Sulphated  ash

Not  more  than  0,01 %  determined  at  800 – 25 °C

Butanetriols

Acrolein, 
compounds

Not  more  than  0,2 %

glucose 

and 

ammonium

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)

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  2  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  5  mg/kg

E 431  POLYOXYETHYLENE  (40)  STEARATE

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polyoxyl  (40)  stearate,  polyoxyethylene  (40)  monostearate

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

Content  not  less  than  97,5 %  on  the  anhydrous  basis

Cream-coloured  flakes  or  waxy  solid  at  25 °C  with  a  faint  odour

Soluble  in  water,  ethanol,  methanol  and  ethyl  acetate
Insoluble  in  mineral  oil

B. Congealing range

39-44 °C

C.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyoxyethylated  polyol

Purity

Water

Not  more  than  3 %  (Karl  Fischer  method)

Acid value

Not  more  than  1

Saponification value

Not  less  than  25  and  not  more  than  35

Hydroxyl value

1,4-Dioxane

Not  less  than  27  and  not  more  than  40

Not  more  than  5  mg/kg

Free  ethylene  oxide

Not  more  than  1  mg/kg

L 334/20

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Ethylene  glycols  (mono-  and  di-)

Not  more  than  0,25 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  432  POLYOXYETHYLENE  SORBITAN  MONOLAURATE  (POLYSORBATE  20)

Synonyms

Definition

Assay

Polysorbate  20
Polyoxyethylene  (20)  sorbitan  monolaurate

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

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

A. Solubility

Soluble  in  water,  ethanol,  methanol,  ethyl  acetate  and  dioxane.
Insoluble  in  mineral  oil  and  petroleum  ether

B.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyoxyethylated  polyol

Purity

Water

Not  more  than  3 %  (Karl  Fischer  method)

Acid value

Not  more  than  2

Saponification value

Not  less  than  40  and  not  more  than  50

Hydroxyl value

1,4-Dioxane

Not  less  than  96  and  not  more  than  108

Not  more  than  5  mg/kg

Free  ethylene  oxide

Not  more  than  1  mg/kg

Ethylene  glycols  (mono-  and  di-)

Not  more  than  0,25 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

9.12.98

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Official  Journal  of  the  European  Communities

L 334/21

E  433  POLYOXYETHYLENE  SORBITAN  MONOOLEATE  (POLYSORBATE  80)

Synonyms

Definition

Assay

Polysorbate  80
Polyoxyethylene  (20)  sorbitan  monooleate

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

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

A. Solubility

Soluble  in  water,  ethanol,  methanol,  ethyl  acetate  and  toluene.
Insoluble  in  mineral  oil  and  petroleum  ether

B.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyoxyethylated  polyol

Purity

Water

Not  more  than  3 %  (Karl  Fischer  method)

Acid value

Not  more  than  2

Saponification value

Not  less  than  45  and  not  more  than  55

Hydroxyl value

1,4-Dioxane

Not  less  than  65  and  not  more  than  80

Not  more  than  5  mg/kg

Free  ethylene  oxide

Not  more  than  1  mg/kg

Ethylene  glycols  (mono-  and  di-)

Not  more  than  0,25 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  434  POLYOXYETHYLENE  SORBITAN  MONOPALMITATE  (POLYSORBATE  40)

Synonyms

Definition

Assay

Description

Polysorbate  40
Polyoxyethylene  (20)  sorbitan  monopalmitate

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

Content not less than 66 % of oxyethylene groups, equivalent to not less than 97 % of
polyoxyethylene  (20)  sorbitan  monopalmitate  on  the  anhydrous  basis

A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic
odour

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Identification

A. Solubility

Soluble  in  water,  ethanol,  methanol,  ethyl  acetate  and  acetone.
Insoluble  in  mineral  oil

B.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyoxyethylated  polyol

Purity

Water

Not  more  than  3 %  (Karl  Fischer  method)

Acid value

Not  more  than  2

Saponification value

Not  less  than  41  and  not  more  than  52

Hydroxyl value

1,4-Dioxane

Not  less  than  90  and  not  more  than  107

Not  more  than  5  mg/kg

Free  ethylene  oxide

Not  more  than  1  mg/kg

Ethylene  glycols  (mono-  and  di-)

Not  more  than  0,25 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  435  POLYOXYETHYLENE  SORBITAN  MONOSTEARATE  (POLYSORBATE  60)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polysorbate  60
Polyoxyethylene  (20)  sorbitan  monostearate

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

Content not less than 65 % of oxyethylene groups, equivalent to not less than 97 % of
polyoxyethylene  (20)  sorbitan  monostearate  on  the  anhydrous  basis

A lemon to orange-coloured oily liquid or semi-gel at 25 °C with a faint characteristic
odour

Soluble  in  water,  ethyl  acetate  and  toluene.  Insoluble  in  mineral  oil  and  vegetable
oils

B.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyoxyethylated  polyol

Purity

Water

Not  more  than  3 %  (Karl  Fischer  method)

Acid value

Not  more  than  2

Saponification value

Not  less  than  45  and  not  more  than  55

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L 334/23

Hydroxyl value

1,4-Dioxane

Not  less  than  81  and  not  more  than  96

Not  more  than  5  mg/kg

Free  ethylene  oxide

Not  more  than  1  mg/kg

Ethylene  glycols  (mono-  and  di-)

Not  more  than  0,25 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  436  POLYOXYETHYLENE  SORBITAN  TRISTEARATE  (POLYSORBATE  65)

Synonyms

Definition

Assay

Description

Identification

A. Solubility

Polysorbate  65
Polyoxyethylene  (20)  sorbitan  tristearate

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

Content not less than 46 % of oxyethylene groups, equivalent to not less than 96 % of
polyoxyethylene  (20)  sorbitan  tristearate  on  the  anhydrous  basis

A  tan-coloured,  waxy  solid  at  25 °C  with  a  faint  characteristic  odour

Dispersible  in  water.  Soluble  in  mineral  oil,  vegetable  oils,  petroleum  ether,  acetone,
ether,  dioxane,  ethanol  and  methanol

B.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyoxyethylated  polyol

C. Congealing range

29-33 °C

Purity

Water

Acid value

Not  more  than  3 %  (Karl  Fischer  method)

Not  more  than  2

Saponification value

Not  less  than  88  and  not  more  than  98

Hydroxyl value

1,4-Dioxane

Not  less  than  40  and  not  more  than  60

Not  more  than  5  mg/kg

Free  ethylene  oxide

Not  more  than  1  mg/kg

Ethylene  glycols  (mono-  and  di-)

Not  more  than  0,25 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

L 334/24

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9.12.98

E  440 (i)  PECTIN

Definition

Einecs

Assay

Pectin  consists  mainly  of  the  partial  methyl  esters  of  polygalacturonic  acid  and  their
ammonium,  sodium,  potassium  and  calcium  salts.  It  is  obtained  by  extraction  in  an
aqueous medium of natural strains of appropriate edible plant material, usually citrus
fruits  or  apples.  No  organic  precipitant  shall  be  used  other  than  methanol,  ethanol
and  propane-2-ol

232-553-0

Content  not  less  than  65 %  of  galacturonic  acid  on  the  ash-free  and  anhydrous  basis
after  washing  with  acid  and  alcohol

Description

White,  light  yellow,  light  grey  or  light  brown  powder

Identification

A. Solubility

Soluble  in  water  forming  a  colloidal,  opalescent  solution.  Insoluble  in  ethanol

Purity

Loss  on  drying

Not  more  than  12 %  (105 °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

Free  methanol,  ethanol  and
propane-2-ol

Not  more  than  1 %,  singly  or  in  combination,  on  the  anhydrous  basis

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E 440 (ii)  AMIDATED  PECTIN

Definition

Assay

Amidated  pectin  consists  mainly  of  the  partial  methyl  esters  and  amides  of
polygalacturonic acid and their ammonium, sodium, potassium and calcium salts. It is
obtained by extraction in an aqueous medium of appropriate natural strains of edible
plant  material,  usually  citrus  fruits  or  apples  and  treatment  with  ammonia  under
alkaline conditions. No organic precipitant shall be used other than methanol, ethanol
and  propane-2-ol

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

9.12.98

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L 334/25

Identification

A. Solubility

Purity

Soluble  in  water  forming  a  colloidal,  opalescent  solution.  Insoluble  in  ethanol

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

Free  methanol,  ethanol  and
propane-2-ol

Not  more  than  1 %  single  or  in  combination,  on  a  volatile  matter-free  basis

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  442  AMMONIUM  PHOSPHATIDES

Synonyms

Definition

Assay

Ammonium  salts  of  phosphatidic  acid,  mixed  ammonium  salts  of  phoshorylated
glycerides

A mixture of the ammonium compounds of phosphatidic acids derived from edible fat
and  oil  (usually  partially  hardened  rapeseed  oil).  One  or  two  or  three  glyceride
moieties  may  be  attached  to  phosphorus.  Moreover,  two  phosphorus  esters  may  be
linked  together  as  phosphatidyl  phosphatides

The phosphorus content is not less than 3 % and not more than 3,4 % by weight; the
ammonium  content  is  not  less  than  1,2 %  and  not  more  than  1,5 %  (calculated  as
N)

Description

Unctuous  semi-solid

Identification

A. Solubility

B. Positive  tests  for  glycerol,  for  fatty

acid  and  for  phosphate

Purity

Soluble  in  fats.  Insoluble  in  water.  Partially  soluble  in  ethanol  and  in  acetone

Petroleum  ether  insoluble  matter

Not  more  than  2,5 %

Arsenic

Not  more  than  3  mg/kg

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Lead

Mercury

Cadmium

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  444  SUCROSE  ACETATE  ISOBUTYRATE

Synonyms

Definition

SAIB

Sucrose  acetate  isobutyrate  is  a  mixture  of  the  reaction  products  formed  by  the
esterification  of  food  grade  sucrose  with  acetic  acid  anhydride  and  isobutyric
anhydride, followed by distillation. The mixture contains all possible combinations of
esters  in  which  the  molar  ratio  of  acetate  to  butyrate  is  about  2:6

Einecs

204-771-6

Chemical name

Sucrose  diacetate  hexaisobutyrate

Chemical formulae

C40H62O19

Molecular  weight

832-856  (approximate),  C40H62O19 : 846,9

Assay

Description

Identification

Content  not  less  than  98,8 %  and  not  more  than  101,9 %  of  C40H62O19

A  pale  straw-coloured  liquid,  clear  and  free  of  sediment  and  having  a  bland  odour

A. Solubility

Insoluble  in  water.  Soluble  in  most  organic  solvents

B. Refractive  index

C. Specific gravity

[n]40

D:  1,4492 - 1,4504

[d]25

D:  1,141 - 1,151

Purity

Triacetin

Acid value

Not  more  than  0,1 %

Not  more  than  0,2

Saponification value

Not  less  than  524  and  not  more  than  540

Arsenic

Mercury

Cadmium

Lead

Not  more  than  3  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Not  more  than  3  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  5  mg/kg

9.12.98

EN

Official  Journal  of  the  European  Communities

L 334/27

E  445  GLYCEROL  ESTERS  OF  WOOD  ROSIN

Synonyms

Definition

Ester  gum

A  complex  mixture  of  tri-  and  diglycerol  esters  of  resin  acids  from  wood  rosin.  The
rosin  is  obtained  by  the  solvent  extraction  of  aged  pine  stumps  followed  by  a
liquid-liquid  solvent  refining  process.  Excluded  from  these  specifications  are
substances  derived  from  gum  rosin,  and  exudate  of  living  pine  trees,  and  substances
derived  from  tall  oil  rosin,  a  by-product  of  kraft  (paper)  pulp  processing.  The  final
product is composed of approximately 90 % resin acids and 10 % neutrals (non-acidic
compounds).  The  resin  acid  fraction  is  a  complex  mixture  of  isomeric  diterpenoid
monocarboxylic  acids  having  the  empirical  molecular  formula  of  C20H30O2,  chiefly
abietic  acid.  The  substance  is  purified  by  steam  stripping  or  by  countercurrent  steam
distillation

Description

Hard,  yellow  to  pale  amber-coloured  solid

Identification

A. Solubility

Insoluble  in  water,  soluble  in  acetone

B.

Infrared  absorption  spectrum

Characteristic  of  the  compound

Purity

Specific  gravity  of  solution

25  not  less  than  0,935  when  determined  in  a  50 %  solution  in  d-limonene  (97 %,

[d]20
boilding  point  175,5-176 °C,  d20

4: 0,84)

Ring  and  ball  softening  range

Between  82 °C  and  90 °C

Acid value

Hydroxyl value

Arsenic

Lead

Mercury

Cadmium

Not  less  than  3  and  not  more  than  9

Not  less  than  15  and  not  more  than  45

Not  more  than  3  mg/kg

Not  more  than  2  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Test for absence of tall oil rosin (sulphur
test)

When  sulphur-containing  organic  compounds  are  heated  in  the  presence  of  sodium
formate,  the  sulphur  is  converted  to  hydrogen  sulphide  which  can  readily  be  detected
by  the  use  of  lead  acetate  paper.  A  positive  test  indicates  the  use  of  tall  oil  rosin
instead  of  wood  rosin

E  450 (i)  DISODIUM  DIPHOSPHATE

Synonyms

Definition

Disodium  dihydrogen  diphosphate
Disodium  dihydrogen  pyrophosphate
Sodium  acid  pyrophosphate

Chemical name

Disodium  dihydrogen  diphosphate

Einecs

231-835-0

Chemical  formula

Na2H2P2O7

L 334/28

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9.12.98

Molecular  weight

221,94

Assay

Content not less than 95 % of disodium diphosphate and not less than 63 % and not
more  than  64,5 %  expressed  as  P2O5

Description

White  powder  or  grains

Identification

A. Positive  tests  for  sodium  and  for

phosphate

B. Solubility

Purity

Soluble  in  water

pH  of  a  1 %  solution

Between  3,7  and  5,0

Loss  on  drying

Not  more  than  0,5 %  (105 °C,  4  hours)

Water-insoluble  matter

Not  more  than  1 %

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg  (expressed  as  fluorine)

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  450 (ii)  TRISODIUM  DIPHOSPHATE

Synonyms

Definition

Einecs

238-735-6

Chemical  formula

Molecular  weight

Assay

Acid  trisodium  pyrophosphate
Trisodium  monohydrogen  diphosphate

Monohydrate:
Anhydrous:

Na3HP2O7·H2O
Na3HP2O7

Monohydrate:
Anhydrous:

261,95
243,93

Content  not  less  than  95 %  on  the  anhydrous  basis  and  not  less  than  57 %  and  not
more  than  59 %  expressed  as  P2O5

Description

White  powder  or  grains,  occurs  anhydrous  or  as  a  monohydrate

Identification

A. Positive  tests  for  sodium  and  for

phosphate

B. Soluble  in  water

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L 334/29

Purity

pH  of  a  1 %  solution

Between  6,7  and  7,3

Loss  on  ignition

4,5 %  on  the  anhydrous  compound
11,5 %  on  the  monohydrous  basis

Loss  on  drying

Not  more  than  0,5 %  (105 °C,  4  hours)

Water-insoluble  matter

Not  more  than  0,2 %

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg  expressed  as  fluorine

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  450 (iii)  TETRASODIUM  DIPHOSPHATE

Synonyms

Definition

Tetrasodium  pyrophosphate
Sodium  pyrophosphate

Chemical name

Tetrasodium  diphosphate

Einecs

231-767-1

Chemical  formula

Molecular  weight

Assay

Description

Identification

Anhydrous:
Decahydrate:

Na4P2O7
Na4P2O7·10 H2O

Anhydrous:
Decahydrate:

265,94
446,09

Content not less than 95 % of Na4P2O7, in the ignited basis and not less than 52,5 %
and  not  more  than  54 %  expressed  as  P2O5

Colourless  or  white  crystals,  or  a  white  crystalline  or  granular  powder.  The
decahydrate  effloresces  slightly  in  dry  air

A. Positive  tests  for  sodium  and  for

phosphate

B. Solubility

Purity

Soluble  in  water.  Insoluble  in  ethanol

pH  of  a  1 %  solution

Between  9,8  and  10,8

Loss  on  ignition

Not  more  than  0,5 %  for  the  anhydrous  salt,  not  less  than  38 %  and  not  more  than
42 %  for  the  decahydrate,  in  both  cases  determined  after  drying  at  105 °C  for  four
hours,  followed  by  ignition  at  550 °C  for  30  minutes

L 334/30

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Water-insoluble  matter

Not  more  than  0,2 %

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg  expressed  as  fluorine

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E 450 (v)  TETRAPOTASSIUM  DIPHOSPHATE

Synonyms

Definition

Potassium  pyrophosphate
Tetrapotassium  pyrophosphate

Chemical name

Tetrapotassium  diphosphate

Einecs

Chemical  formula

Molecular  weight

Assay

230-785-7

K4P2O7

330,34  (anhydrous)

Content not less than 95 % on the ignited basis and not less than 42 % and not more
than  43,7 %  expressed  as  P2O5

Description

Colourless  crystals  or  white,  very  hygroscopic  powder

Identification

A. Positive  tests  for  potassium  and  for

phosphate

B. Solubility

Purity

Soluble  in  water,  insoluble  in  ethanol

pH  of  a  1 %  solution

Between  10,0  and  10,8

Loss  on  ignition

Not  more  than  2 %  after  drying  at  105 °C  for  4  hours  then  ignition  at  550 °C  for  30
minutes

Water-insoluble  matter

Not  more  than  0,2 %

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg  expressed  as  fluorine

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

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L 334/31

E  450 (vi)  DICALCIUM  DIPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical  formula

Molecular  weight

Assay

Description

Identification

Calcium  pyrophosphate

Dicalcium  diphosphate
Dicalcium pyrophosphate

232-221-5

Ca2P2O7

254,12

Content not less than 96 % and not less than 55 % and not more than 56 % expressed
as  P2O5

A  fine,  white,  odourless  powder

A. Positive  tests  for  calcium  and  for

phosphate

B. Solubility

Purity

Insoluble  in  water.  Soluble  in  dilute  hydrochloric  and  nitric  acids

pH  of  a  10 %  suspension  in  water

Between  5,5  and  7,0

Loss  on  ignition

Not  more  than  1,5 %  at  800 – 25 °C  for  30  minutes

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  50  mg/kg  expressed  as  fluorine

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E 450 (vii)  CALCIUM  DIHYDROGEN  DIPHOSPHATE

Synonyms

Definition

Acid  calcium  pyrophosphate
Monocalcium  dihydrogen  pyrophosphate

Chemical name

Calcium  dihydrogen  diphosphate

Einecs

Chemical  formula

Molecular  weight

Assay

Description

238-933-2

CaH2P2O7

215,97

Content  not  less  than  90 %  on  the  anhydrous  basis  and  not  less  than  61 %  and  not
more  than  64 %  expressed  as  P2O5

White  crystals  or  powder

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Identification

A. Positive  tests  for  calcium  and  for

phosphate

Purity

Acid-insoluble  matter

Not  more  than  0,4 %

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  30  mg/kg  expressed  as  fluorine

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  451 (i)  PENTASODIUM  TRIPHOSPHATE

Synonyms

Definition

Pentasodium  tripolyphosphate
Sodium  tripolyphosphate

Chemical name

Pentasodium  triphosphate

Einecs

231-838-7

Chemical formulae

Na5O10P3·xH2O  (x  =  0  or  6)

Molecular  weight

367,86

Assay

Content  not  less  than  85 %
Content  in  P2O5  not  less  than  56 %  and  not  more  than  58 %  (anhydrous)  or  not  less
than  43 %  and  not  more  than  45 %  (hexahydrate)

Description

White,  slightly  hygroscopic  granules  or  powder

Identification

A. Solubility

Freely  soluble  in  water.
Insoluble  in  ethanol

B. Positive  tests  for  sodium  and  for

phosphate

C. pH  of  a  1 %  solution

Between  9,1  and  10,2

Purity

Loss  on  drying

Anhydrous:  Not  more  than  0,7 %  (105 °C,  1  hour)
Hexahydrate:  Not  more  than  23,5 %  (60 °C,  1  hour,  followed  by  drying  at  105 °C,
4  hours)

Water  insoluble  matter

Not  more  than  0,1 %

9.12.98

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L 334/33

Higher  polyphosphates

Not  more  than  1 %

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  451 (ii)  PENTAPOTASSIUM  TRIPHOSPHATE

Synonyms

Definition

Chemical name

Einecs

Chemical formulae

Molecular  weight

Assay

Pentapotassium  tripolyphosphate
Potassium  triphosphate
Potassium  tripolyphosphate

Pentapotassium  triphosphate
Pentapotassium  tripolyphosphate

237-574-9

K5O10P3

448,42

Content  not  less  than  85 %  on  the  dried  basis
Content  in  P2O5  not  less  than  46,5 %  and  not  more  than  48 %

Description

White,  hygroscopic  powder  or  granules

Identification

A. Solubility

B. Positive  tests  for  potassium  and  for

phosphate

Very  soluble  in  water

C. pH  of  a  1 %  solution

Between  9,2  and  10,5

Purity

Loss  on  ignition

Not  more  than  0,4 %  (105 °C,  4  hours,  followed  by  ignition  at  550 °C,  30  minutes)

Water  insoluble  matter

Not  more  than  2 %

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

L 334/34

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Official  Journal  of  the  European  Communities

9.12.98

E  452 (i)  SODIUM  POLYPHOSPHATE

1. SOLUBLE  POLYPHOSPHATE

Synonyms

Definition

Sodium  hexametaphosphate
Sodium  tetrapolyphosphate
Graham’s  salt
Sodium  polyphosphates,  glassy
Sodium  polymetaphosphate
Sodium  metaphosphate

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 
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  between  3,0  and  9,0

composed  of 

linear 

Chemical name

Sodium  polyphosphate

Einecs

272-808-3

Chemical formulae

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

Description

Identification

A. Solubility

Content  in  P2O5  not  less  than  60 %  and  not  more  than  71 %  on  the  ignited  basis

Colourless  or  white,  transparent  platelets,  granules,  or  powders

Very  soluble  in  water

B. Positive  tests  for  sodium  and  for

phosphate

C. pH  of  a  1 %  solution

Between  3,0  and  9,0

Purity

Loss  on  ignition

Not  more  than  1 %

Water  insoluble  matter

Not  more  than  0,1 %

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

9.12.98

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Official  Journal  of  the  European  Communities

L 334/35

2.

INSOLUBLE  POLYPHOSPHATE

Synonyms

Definition

Insoluble  sodium  metaphosphate
Maddrell’s salt
Insoluble  sodium  polyphosphate,  IMP

Insoluble  sodium  metaphosphate  is  a  high  molecular  weight  sodium  polyphosphate
composed  of  two  long  metaphosphate  chains  (NaPO3)x  that  spiral  in  opposite
directions about a common axis. The Na2O/P2O5  ratio is about 1,0. The pH of 1 in 3
suspension  in  water  is  about  6,5

Chemical name

Sodium  polyphosphate

Einecs

272-808-3

Chemical formulae

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

Description

Identification

A. Solubility

Not  less  than  68,7 %  and  not  more  than  70 %  of  P2O5

White  crystalline  powder

Insoluble  in  water,  soluble  in  mineral  acids  and  in  solutions  of  potassium  and
ammonium  (but  not  sodium)  chlorides

B. Positive  tests  for  sodium  and  for

phosphate

C. pH  of  a  1  in  3  suspension  in  water

About  6,5

Purity

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  452 (ii)  POTASSIUM  POLYPHOSPHATE

Synonyms

Definition

Potassium  metaphosphate
Potassium  polymetaphosphate
Kurrol  salt

Chemical name

Potassium  polyphosphate

L 334/36

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Official  Journal  of  the  European  Communities

9.12.98

Einecs

232-212-6

Chemical formulae

(KPO3)n
Heterogenous mixtures of potassium salts of linear condensed polyphosphoric acids of
general  formula  H(n + 2)PnO(3n + 1)  where  9n9  is  not  less  than  2

Molecular  weight

(134)n

Assay

Content  in  P2O5  not  less  than  53,5 %  and  not  more  than  61,5 %  on  the  ignited
basis

Description

Fine  white  powder  or  crystals  or  colourless  glassy  platelets

Identification

A. Solubility

1  g  dissolves  in  100  ml  of  a  1  in  25  solution  of  sodium  acetate

B. Positive  tests  for  potassium  and  for

phosphate

C. pH  of  a  1 %  solution

Not  more  than  7,8

Purity

Loss  on  ignition

Not  more  than  2 %  (105 °C,  4  hours  followed  by  ignition  at  550 °C,  30  minutes)

Water  insoluble  matter

Not  more  than  0,2 %

Cyclic  phosphate

Not  more  than  8 %  on  P2O5  content

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  10  mg/kg

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  452 (iv)  CALCIUM  POLYPHOSPHATES

Synonyms

Definition

Calcium  metaphosphate
Calcium  polymetaphosphate

Chemical name

Calcium  polyphosphate

Einecs

236-769-6

Chemical formulae

(CaP2O6)n
A  heterogeneous  mixture  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

Description

Content  in  P2O5  not  less  than  50 %  and  not  more  than  71 %  on  the  ignited  basis

Odourless,  colourless  crystals  or  white  powder

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L 334/37

Identification

A. Solubility

Usually  sparingly  soluble  in  water.  Soluble  in  acid  medium

B. Positive  tests  for  calcium  and  for

phosphate

C. CaO  content

27-29,5 %

Purity

Loss  on  ignition

Cyclic  phosphate

Fluoride

Arsenic

Lead

Mercury

Cadmium

Not  more  than  2 %  (105 °C,  4  hours  followed  by  ignition  at  550 °C,  30  minutes)

Not  more  than  8 %  on  P2O5  content

Not  more  than  30  mg/kg

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  460 (i)  MICROCRISTALLINE  CELLULOSE

Synonyms

Definition

Chemical name

Einecs

Chemical  formula

Cellulose gel

Microcrystalline  cellulose  is  purified,  partally  depolymerised  cellulose  prepared  by
treating  alpha-cellulose,  obtained  as  a  pulp  from  natural  strains  of  fibrous  plant
material,  with  mineral  acids.  The  degree  of  polymerisation  is  typically  less  than  400

Cellulose

232-674-9

(C6H10O5)n

Molecular  weight

About  36 000

Assay

Description

Identification

A. Solubility

B. Colour  reaction

C. To  be  identified  by  IR  spectroscopy

Not  less  than  97 %  calculated  as  cellulose  on  the  anhydrous  basis

A  fine  white  or  almost  white  odourless  powder

Insoluble  in  water,  ethanol,  ether  and  dilute  mineral  acids.  Slightly  soluble  in  sodium
hydroxide  solution

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

L 334/38

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9.12.98

D. Suspension  test

Purity

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

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 %  determined  at  800 – 25 °C

pH  of  a  10 %  suspension  in  water

The  pH  of  the  supernatant  liquid  is  between  5,0  and  7,5

Starch

Not  detectable
To  20  ml  of  the  dispersion  obtained  in  identification,  test  D,  add  a  few  drops  of
iodine  solution  and  mix.  No  purplish  to  blue  or  blue  colour  should  be  produced

Particle  size

Not  less  than  5  em  (not  more  than  10 %  of  particles  of  less  than  5  em)

Carboxyl  groups

Not  more  than  1 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  460 (ii)  POWDERED  CELLULOSE

Definition

Chemical name

Einecs

Chemical  formula

Molecular  weight

Assay

Description

Identification

A. Solubility

Purified,  mechanically  disintegrated  celluslose  prepared  by  processing  alpha-cellulose
obtained  as  a  pulp  from  natural  strains  of  fibrous  plant  materials

Cellulose
Linear  polymer  of  1:4  linked  glucose  residues

232-674-9

(C6H10O5)n

(162)n  (n  is  predominantly  1 000  and  greater)

Content  not  less  than  92 %

A  white,  odourless  powder

Insoluble  in  water,  ethanol,  ether  and  dilute  mineral  acids.  Slightly  soluble  in  sodium
hydroxide  solution

9.12.98

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Official  Journal  of  the  European  Communities

L 334/39

B. Suspension  test

Purity

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

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 %  determined  at  800 – 25 °C

pH  of  a  10 %  suspension  in  water

The  pH  of  the  supernatant  liquid  is  between  5,0  and  7,5

Starch

Arsenic

Lead

Mercury

Cadmium

Not  detectable
To 20 ml of the dispersion obtained in identification, test B, add a few drops of iodine
solution  and  mix.  No  purplish  to  blue  or  blue  colour  should  be  produced

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Particle  size

Not  less  than  5  em  (not  more  than  10 %  of  particles  of  less  than  5  em)

E  461  METHYL  CELLULOSE

Synonyms

Definition

Chemical name

Chemical  formula

Cellulose  methyl  ether

Methyl  cellulose  is  cellulose  obtained  directly  from  natural  strains  of  fibrous  plant
material  and  partially  etherified  with  methyl  groups

Methyl  ether  of  cellulose

The  polymers  contain  substituted  anhydroglucose  units  with  the  following  general
formula:
C6H7O2(OR1)(OR2)(OR3)  where  R1,  R2,  R3  each  may  be  one  of  the  following:
— H
— CH3  or
— CH2CH3

Molecular  weight

From  about  20 000  to  380 000

Assay

Description

Identification

A. Solubility

Content not less than 25 % and not more than 33 % of methoxyl groups (-OCH3) and
not  more  than  5 %  of  hydroxyethoxyl  groups  (-OCH2CH2OH)

Slightly  hygroscopic  white  or  slightly  yellowish  or  greyish  odourless  and  tasteless,
granular  or  fibrous  powder

Swelling  in  water,  producing  a  clear  to  opalescent,  viscous,  colloidal  solution.
Insoluble  in  ehtanol,  ether  and  chloroform.
Soluble  in  glacial  acetic  acid

L 334/40

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Purity

Loss  on  drying

Sulphated  ash

Not  more  than  10 %  (105 °C,  3  hours)

Not  more  than  1,5 %  determined  at  800 – 25 °C

pH  of  a  1 %  colloidal  solution

Not  less  than  5,0  and  not  more  than  8,0

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  463  HYDROXYPROPYL  CELLULOSE

Synonyms

Definition

Chemical name

Chemical  formula

Cellulose  hydroxypropyl  ether

Hydroxypropylcellulose  is  cellulose  obtained  directly  from  natural  strains  of  fibrous
plant  material  and  partially  etherified  with  hydroxypropyl  groups

Hydroxypropyl  ether  of  cellulose

The  polymers  contain  substituted  anhydroglucose  units  with  the  following  general
formula:
C6H7O2(OR1)(OR2)(OR3),  where  R1,  R2,  R3  each  may  be  one  of  the  following:
— H
— CH2CHOHCH3
— CH2CHO(CH2CHOHCH3)CH3
— CH2CHO[CH2CHO(CH2CHOHCH3)CH3]CH3

Molecular  weight

From  about  30 000  to  1 000 000

Assay

Description

Identification

A. Solubility

Content  not  less  than  80,5 %  of  hydroxypropoxyl  groups  (-OCH2CHOHCH3)
equivalent to not more than 4,6 hydroxypropyl groups per anhydroglucose unit on the
anhydrous  basis

Slightly  hygroscopic  white  or  slightly  yellowish  or  greyish  odourless  and  tasteless,
granular  or  fibrous  powder

Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble
in  ethanol.  Insoluble  in  ether

B. Gas chromatography

Determine  the  substituents  by  gas  chromotography

Purity

Loss  on  drying

Sulphated  ash

Not  more  than  10 %  (105 °C,  3  hours)

Not  more  than  0,5 %  determined  at  800 – 25 °C

pH  of  a  1 %  colloidal  solution

Not  less  than  5,0  and  not  more  than  8,0

Propylene  chlorohydrins

Not  more  than  0,1  mg/kg

9.12.98

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L 334/41

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E 464  HYDROXYPROPYL  METHYL  CELLULOSE

Definition

Chemical name

Chemical  formula

Hydroxypropyl  methyl  cellulose  is  cellulose  obtained  directly  from  natural  strains  of
fibrous  plant  material  and  partially  etherified  with  methyl  groups  and  containing  a
small  degree  of  hydroxypropyl  substitution

2-Hydroxypropyl  ether  of  methylcellulose

The  polymers  contain  substituted  anhydroglucose  units  with  the  following  general
formula:
C6H7O2(OR1)(OR2)(OR3),  where
R1,  R2  R3  each  may  be  one  of  the  following:
— H
— CH3
— CH2CHOHCH3
— CH2CHO  (CH2CHOHCH3)  CH3
— CH2CHO[CH2CHO  (CH2CHOHCH3)  CH3]CH3

Molecular  weight

From  about  13 000  to  200 000

Assay

Description

Identification

A. Solubility

Content  not  less  than  19 %  and  not  more  than  30 %  methoxyl  groups  (-OCH3)  and
than  12 %  hydroxypropoxyl  groups
not 
(-OCH2CHOHCH3),  on  the  anhydrous  basis

than  3 %  and  not  more 

less 

Slightly  hygroscopic  white  or  slightly  yellowish  or  greyish  odourless  and  tasteless,
granular  or  fibrous  powder

Swelling  in  water,  producing  a  clear  to  opalescent,  viscous,  colloidal  solution.
Insoluble  in  ethanol

B. Gas chromatography

Determine  the  substituents  by  gas  chromatography

Purity

Loss  on  drying

Sulphated  ash

Not  more  than  10 %  (105 °C,  3  hours)

Not  more  than  1,5 %  for  products  with  viscosities  of  50  mPa.s  or  above
Not  more  than  3 %  for  products  with  viscosities  below  50  mPa.s

pH  of  a  1 %  colloidal  solution

Not  less  than  5,0  and  not  more  than  8,0

Propylene  chlorohydrins

Not  more  than  0,1  mg/kg

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

L 334/42

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9.12.98

E  465  ETHYL  METHYL  CELLULOSE

Synonyms

Definition

Methylethylcellulose

Ethyl  methyl  cellulose  is  cellulose  obtained  directly  from  natural  strains  of  fibrous
plant  material  and  partially  etherified  with  methyl  and  ethyl  groups

Chemical name

Ethyl  methyl  ether  of  cellulose

Chemical  formula

The  polymers  contain  substituted  anhydroglucose  units  with  the  following  general
formula:
C6H7O2(OR1)(OR2)(OR3),  where
R1,  R2  R3  each  may  be  one  of  the  following:
— H
— CH3
— CH2CH3

Molecular  weight

From  about  30 000  to  40 000

Assay

Description

Identification

A. Solubility

Purity

Loss  on  drying

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

Slightly  hygroscopic  white  or  slightly  yellowish  or  greyish  odourless  and  tasteless,
granular  or  fibrous  powder

Swelling in water, producing a clear to opalescent, viscous, colloidal solution. Soluble
in  ethanol.  Insoluble  in  ether

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 %

pH  of  a  1 %  colloidal  solution

Not  less  than  5,0  and  not  more  than  8,0

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

E  466  SODIUM  CARBOXY  METHYL  CELLULOSE

Synonyms

Carboxy  methyl  cellulose
CMC
NaCMC
Sodium  CMC
Cellulose gum

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L 334/43

Definition

Carboxy  methyl  cellulose  is  the  partial  sodium  salt  of  a  carboxymethyl  ether  of
cellulose,  the  cellulose  being  obtained  directly  from  natural  strains  of  fibrous  plant
material

Chemical name

Sodium  salt  of  the  carboxymethyl  ether  of  cellulose

Chemical  formula

The  polymers  contain  substituted  anhydroglucose  units  with  the  following  general
formula:
C6H7O2(OR1)(OR2)(OR3),  where  R1,  R2  R3  each  may  be  one  of  the  following:
— H
— CH2COONa
— CH2COOH

Molecular  weight

Higher  than  approximately  17 000  (degree  of  polymerisation  approximately  100)

Assay

Description

Identification

A. Solubility

B. Foam  test

C. Precipitate  formation

D. Colour  reaction

Purity

Degree  of  substitution

Content  on  the  anhydrous  basis  not  less  than  99,5 %

Slightly  hygroscopic  white  or  slightly  yellowish  or  greyish  odourless  and  tasteless,
granular  or  fibrous  powder

Yields  a  viscous  colloidal  solution  with  water.  Insoluble  in  ethanol

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)

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)

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

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)

pH  of  a  1 %  colloidal  solution

Not  less  than  5,0  and  not  more  than  8,5

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  20  mg/kg

Total glycolate

Not  more  than  0,4 %,  calculated  as  sodium  glycolate  on  the  anhydrous  basis

Sodium

Not  more  than  12,4 %  on  the  anhydrous  basis

L 334/44

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Official  Journal  of  the  European  Communities

9.12.98

E  470a  SODIUM,  POTASSIUM  AND  CALCIUM  SALTS  OF  FATTY  ACIDS

Definition

Assay

Description

Identification

A. Solubility

B. Positive  tests  for  cations  and  for

fatty  acids

Purity

Sodium

Potassium

Calcium

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

Content  on  the  anhydrous  basis  not  less  than  95 %

White  or  creamy  white  light  powders,  flakes  or  semi-solids

Sodium  and  potassium  salts:  soluble  in  water  and  ethanol  calcium  salts:  insoluble  in
water,  ethanol  and  ether

Not  less  than  9 %  and  not  more  than  14 %  expressed  as  Na2O

Not  less  than  13 %  and  not  more  than  21,5 %  expressed  as  K2O

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

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Free alkali

Not  more  than  0,1 %  expressed  as  NaOH

Matter  insoluble  in  alcohol

Not  more  than  0,2 %  (sodium  and  potassium  salts  only)

E  470b  MAGNESIUM  SALTS  OF  FATTY  ACIDS

Definition

Assay

Description

Identification

A. Solubility

B. Positive tests for magnesium and for

fatty  acids

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

Content  on  the  anhydrous  basis  not  less  than  95 %

White  or  creamy-white  light  powders,  flakes  or  semi-solids

Insoluble  in  water,  partially  soluble  in  ethanol  and  ether

9.12.98

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L 334/45

Purity

Magnesium

Free alkali

Not  less  than  6,5 %  and  not  more  than  11 %  expressed  as  MgO

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

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  471  MONO-  AND  DIGLYCERIDES  OF  FATTY  ACIDS

Synonyms

Definition

Assay

Description

Identification

Glyceryl monostearate
Glyceryl monopalmitate
Glyceryl  monooleate,  etc.
Monostearin,  monopalmitin,  monoolein,  etc.
GMS  (for  glyceryl  monostearate)

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

Content  of  mono-  and  diesters:  not  less  than  70 %

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

A.

Infrared  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyol

B. Positive  tests  for  glycerol  and

for  fatty  acids

C. Solubility

Insoluble  in  water,  soluble  in  ethanol  and  toluene

Purity

Water  content

Acid value

Free glycerol

Polyglycerols

Arsenic

Lead

Not  more  than  2 %  (Karl  Fischer  method)

Not  more  than  6

Not  more  than  7 %

Not more than 4 % diglycerol and not more than 1 % higher polyglycerols both based
on  total  glycerol  content

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

L 334/46

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Official  Journal  of  the  European  Communities

9.12.98

Mercury

Cadmium

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Total glycerol

Sulphated  ash

Not  less  than  16 %  and  not  more  than  33 %

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

Definition

Acetic  acid  esters  of  mono-  and  diglycerides
Acetoglycerides
Acetylated  mono-  and  diglycerides
Acetic  and  fatty  acid  esters  of  glycerol

Esters of glycerol with acetic and fatty acids occurring in food fats and oils. They may
contain  small  amounts  of  free  glycerol,  free  fatty  acids,  free  acetic  acid  and  free
glycerides

Description

Clear,  mobile  liquids  to  solids,  from  white  to  pale  yellow  in  colour

Identification

A. Positive  tests  for  glycerol,  for  fatty

acids  and  for  acetic  acid

B. Solubility

Insoluble  in  water.  Soluble  in  ethanol

Purity

Acids  other  than  acetic  and  fatty  acids

Not  detectable

Free glycerol

Not  more  than  2 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Total  acetic  acid

Not  less  than  9 %  and  not  more  than  32 %

Free  fatty  acids  (and  acetic  acid)

Not  more  than  3 %  estimated  as  oleic  acid

Total glycerol

Sulphated  ash

Not  less  than  14 %  and  not  more  than  31 %

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)

9.12.98

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L 334/47

E 472 b  LACTIC  ACID  ESTERS  OF  MONO-  AND  DIGLYCERIDES  OF  FATTY  ACIDS

Synonyms

Definition

Description

Identification

Lactic  acid  esters  of  mono-  and  diglycerides
Lactoglycerides
Mono-  and  diglycerides  of  fatty  acids  esterified  with  lactic  acid

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

Clear, mobile liquids to waxy solids of variable consistency, from white to pale yellow
in  colour

A. Positive  tests  for  glycerol,  for  fatty

acids  and  for  lactic  acid

B. Solubility

Insoluble  in  cold  water  but  dispersible  in  hot  water

Purity

Acids  other  than  lactic  and  fatty  acids

Not  detectable

Free glycerol

Not  more  than  2 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Total  lactic  acid

Not  less  than  13 %  and  not  more  than  45 %

Free  fatty  acids  (and  lactic  acid)

Not  more  than  3 %  estimated  as  oleic  acid

Total glycerol

Sulphated  ash

Not  less  than  13 %  and  not  more  than  30 %

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 c  CITRIC  ACID  ESTERS  OF  MONO-  AND  DIGLYCERIDES  OF  FATTY  ACIDS

Synonyms

Definition

Citric  acid  esters  of  mono-  and  diglycerides
Citroglycerides
Mono-  and  diglycerides  of  fatty  acids  esterified  with  citric  acid

Esters of glycerol with citric acid and fatty acids occurring in food oils and fats. They
may  contain  small  amounts  of  free  glycerol,  free  fatty  acids,  free  citric  acid  and  free
glycerides. They may be partially or wholly neutralised with sodium hydroxide or with
potassium  hydroxide

Description

Yellowish  or  light  brown  liquids  to  waxy  solids  or  semi-solids

L 334/48

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Official  Journal  of  the  European  Communities

9.12.98

Identification

A. Positive  tests  for  glycerol,  for  fatty

acids  and  for  citric  acid

B. Solubility

Insoluble  in  cold  water
Dispersible  in  hot  water
Soluble  in  oils  and  fats
Insoluble  in  cold  ethanol

Purity

Acids  other  than  citric  and  fatty  acids

Not  detectable

Free glycerol

Total glycerol

Total  citric  acid

Sulphated  ash

Arsenic

Lead

Mercury

Cadmium

Not  more  than  2 %

Not  less  than  8 %  and  not  more  than  33 %

Not  less  than  13 %  and  not  more  than  50 %

Not  more  than  0,5 %  determined  at  800 – 25 °C

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

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  472 d  TARTARIC  ACID  ESTERS  OF  MONO-  AND  DIGLYCERIDES  OF  FATTY  ACIDS

Synonyms

Definition

Description

Identification

Tartaric  acid  esters  of  mono-  and  diglycerides
Mono-  and  diglycerides  of  fatty  acids  esterified  with  tartaric  acid

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

Sticky  viscous  yellowish  liquids  to  hard  yellow  waxes

A. Positive  tests  for  glycerol,  for  fatty

acids  and  for  tartaric  acid

Purity

Acids  other  than  tartaric  and  fatty
acids

Not  detectable

Free glycerol

Total glycerol

Arsenic

Not  more  than  2 %

Not  less  than  12 %  and  not  more  than  29 %

Not  more  than  3  mg/kg

9.12.98

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L 334/49

Lead

Mercury

Cadmium

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Total  tartaric  acid

Not  less  than  15 %  and  not  more  than  50 %

Free  fatty  acids

Sulphated  ash

Not  more  than  3 %  estimated  as  oleic  acid

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 e MONO-  AND  DIACETYLTARTARIC  ACID  ESTERS  OF  MONO-  AND  DIGLYCERIDES  OF  FATTY  ACIDS

Synonyms

Definition

Description

Identification

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

Mixted esters of glycerol with mono- and diacetyltartaric acids (obtained from tartaric
acid) and fatty acids occurring in food fats and oils. They may contain small amounts
of  free  glycerol,  free  fatty  acids,  free  tartaric  and  acetic  acids  and  their  combinations,
and  free  glycerides.  Contains  also  tartaric  and  acetic  esters  of  fatty  acids

Sticky  viscous  liquids  through  a  fat-like  consistency  to  yellow  waxes  which  hydrolyse
in  moist  air  to  liberate  acetic  acid

A. Positive  tests  for  glycerol,  for  fatty
acids, for tartaric acid and for acetic
acid

Purity

Acids  other  than  acetic,  tartaric  and
fatty  acids

Not  detectable

Free glycerol

Total glycerol

Sulphated  ash

Arsenic

Lead

Mercury

Cadmium

Not  more  than  2 %

Not  less  than  11 %  and  not  more  than  28 %

Not  more  than  0,5 %  determined  at  800 – 25 °C

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Total  tartaric  acid

Not  less  than  10 %  and  not  more  than  40 %

Total  acetic  acid

Free  fatty  acids

Not  less  than  8 %  and  not  more  than  32 %

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)

L 334/50

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9.12.98

E  472 f  MIXED  ACETIC  AND  TARTARIC  ACID  ESTERS  OF  MONO-  AND  DIGLYCERIDES  OF  FATTY  ACIDS

Synonyms

Definition

Mono-  and  diglycerides  of  fatty  acids  esterified  with  acetic  acid  and  tartaric  acid

Esters  of  glycerol  with  acetic  and  tartaric  acids  and  fatty  acids  occurring  in  food  fats
and  oils.  They  may  contain  small  amounts  of  free  glycerol,  free  fatty  acids,  free
tartaric  and  ecetic  acids,  and  free  glycerides.  May  contain  mono-  and  diacetyltartaric
esters  of  mono-  and  diglycerides  of  fatty  acids

Description

Sticky  liquids  to  solids,  from  white  to  pale-yellow  in  colour

Identification

A. Positive  tests  for  glycerol,  for  fatty
acids, for tartaric acid and for acetic
acid

Purity

Acids  other  than  acetic,  tartaric  and
fatty  acids

Not  detectable

Free glycerol

Total glycerol

Sulphated  ash

Arsenic

Lead

Mercury

Cadmium

Not  more  than  2 %

Not  less  than  12 %  and  not  more  than  27 %

Not  more  than  0,5 %  determined  at  800 – 25 °C

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Total  acetic  acid

Not  less  than  10 %  and  not  more  than  20 %

Total  tartaric  acid

Not  less  than  20 %  and  not  more  than  40 %

Free  fatty  acids

Not  more  than  3 %  estimated  as  oleic  acid

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

Definition

Sucroesters
Sugar esters

Essentially  the  mono-,  di-  and  triesters  of  sucrose  with  fatty  acids  occurring  in  food
fats  and  oils.  They  may  be  prepared  from  sucrose  and  the  methyl  and  ethyl  esters
of  food  fatty  acids  or  by  extraction  from  sucroglycerides.  No  organic  solvent  other
than 
propane-2-ol,
2-methyl-1-propanol,  propylene  glycol  and  methyl  ethyl  ketone  may  be  used  for  their
preparation

dimethylsulphoxide, 

dimethylformamide, 

acetate, 

ethyl 

9.12.98

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L 334/51

Assay

Description

Identification

A. Positive  tests  for  sugar  for  fatty

Content  not  less  than  80 %

Stiff  gels,  soft  solids  or  white  to  slightly  greyish-white  powders

acids

B. Solubility

Purity

Sulphated  ash

Free  sugar

Free  fatty  acids

Arsenic

Lead

Mercury

Cadmium

Sparingly  soluble  in  water
Soluble  in  ethanol

Not  more  than  2 %  determined  at  800 – 25 °C

Not  more  than  5 %

Not  more  than  3 %  estimated  as  oleic  acid

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Methanol

Not  more  than  10  mg/kg

Dimethylsulphoxide

Not  more  than  2  mg/kg

Dimethylformamide

Not  more  than  1  mg/kg

2-methyl-1-propanol

Not  more  than  10  mg/kg

Ethyl  acetate
Propane-2-ol
Propylene glycol

Not  more  than  350  mg/kg,  singly  or  in  combination

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

Definition

Assay

Description

Sugar glycerides

Sucroglycerides are produced by reacting sucrose with an edible fat or oil to produce a
mixture of essentially mono-, di- and triesters of sucrose and fatty acids together with
residual mono-, di- and triglycerides from fat or oil. No organic solvents shall be used
in  their  preparation  other  than  cyclohexane,  dimethylformamide,  ethyl  acetate,
2-methyl-1-propanol  and  propane-2-ol

Content  not  less  than  40 %  and  not  more  than  60 %  of  sucrose  fatty  acid  esters

Soft  solid  masses,  stiff  gels  or  white  to  off-white  powders

(cid:252)
(cid:253)
(cid:254)
L 334/52

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9.12.98

Identification

A. Positive  tests  for  sugar
and  for  fatty  acids

B. Solubility

Purity

Sulphated  ash

Free  sugar

Free  fatty  acids

Arsenic

Lead

Mercury

Cadmium

Insoluble  in  cold  water
Soluble  in  ethanol

Not  more  than  2 %  determined  at  800 – 25 °C

Not  more  than  5 %

Not  more  than  3 %  estimated  as  oleic  acid

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Methanol

Not  more  than  10  mg/kg

Dimethylformamide

Not  more  than  1  mg/kg

2-methyl-1-propanol
Cyclohexane

Ethyl  acetate
Propane-2-ol

Not  more  than  10  mg/kg,  single  or  in  combination

Not  more  than  350  mg/kg,  single  or  in  combination

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

Definition

Assay

Description

Identification

A. Positive 

for  glycerol, 
polyglycerols  and  for  fatty  acids

tests 

Polyglycerol  fatty  acid  esters
Polyglycerin  esters  of  fatty  acid  esters

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

Content  of  total  fatty  acid  ester  not  less  than  90 %

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

for

B. Solubility

The  esters  range  from  very  hydrophilic  to  very  lipophilic,  but  as  a  class  tend  to  be
dispersible  in  water  and  soluble  in  organic  solvents  and  oils

(cid:252)
(cid:253)
(cid:254)
(cid:252)
(cid:253)
(cid:254)
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Purity

Sulphated  ash

Not  more  than  0,5 %  determined  at  800 – 25 °C

Acids  other  than  fatty  acids

Not  detectable

Free  fatty  acids

Not  more  than  6 %  estimated  as  oleic  acid

Total  glycerol  and  polyglycerol

Not  less  than  18 %  and  not  more  than  60 %

Free  glycerol  and  polyglycerol

Not  more  than  7 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

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  476  POLYGLYCEROL  POLYRICINOLEATE

Synonyms

Definition

Glycerol  esters  of  condensed  castor  oil  fatty  acids
Polyglycerol  esters  of  polycondensed  fatty  acids  from  castor  oil
Polyglycerol  esters  of  interesterified  ricinoleic  acid
PGPR

Polyglycerol  polyricinoleate  is  prepared  by  the  esterification  of  polyglycerol  with
condensed  castor  oil  fatty  acids

Description

Clear,  highly  viscous  liquid

Identification

A. Solubility

Insoluble  in  water  and  in  ethanol.
Soluble  in  ether,  hydrocarbons  and  halogenated  hydrocarbons

B. Positive  tests  for  glycerol,

polyglycerol  and  for  ricinoleic  acid

C. Refractive  index  [n]65

Between  1,4630  and  1,4665

Purity

Polyglycerols

The  polyglycerol  moiety  shall  be  composed  of  not  less  than  75 %  of  di-,  tri-  and
tetraglycerols  and  shall  contain  not  more  than  10 %  of  polyglycerols  equal  to  or
higher  than  heptaglycerol

Hydroxyl value

Not  less  than  80  and  not  more  than  100

Acid value

Arsenic

Lead

Mercury

Cadmium

Not  more  than  6

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

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E  477  PROPANE-1,2-DIOL  ESTERS  OF  FATTY  ACIDS

Synonyms

Definition

Assay

Description

Identification

Propylene  glycol  esters  of  fatty  acids

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.

Content  of  total  fatty  acid  ester  not  less  than  85 %

Clear  liquids  or  waxy  white  flakes,  beads  or  solids  having  a  bland  odour

A. Positive  tests  for  propylene  glycol

and  for  fatty  acids

Purity

Sulphated  ash

Not  more  than  0,5 %  determined  at  800 – 25 °C

Acids  other  than  fatty  acids

Not  detectable

Free  fatty  acids

Not  more  than  6 %  estimated  as  oleic  acid

Total  propane-1,2-diol

Not  less  than  11 %  and  not  more  than  31 %

Free  propane-1,2-diol

Not  more  than  5 %

Dimer  and  trimer  of  propylene  glycol

Not  more  than  0,5 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

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  479 b  THERMALLY  OXIDISED  SOYA  BEAN  OIL  INTERACTED  WITH  MONO-  AND  DIGLYCERIDES  OF  FATTY  ACIDS

Synonyms

Definition

TOSOM

Thermally oxidised soya bean oil interacted with mono- and diglycerides of fatty acids
is a complex mixture of esters of glycerol and fatty acids found in edible fat and fatty
acids  from  thermally  oxidised  soya  bean  oil.  It  is  produced  by  interaction  and
desodorisation  under  vacuum  at  130 °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  natural  strains  of  soya  beans

Description

Pale  yellow  to  light  brown  a  waxy  or  solid  consistency

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L 334/55

Identification

A. Solubility

Purity

Melting  range

Free  fatty  acids

Free glycerol

Total  fatty  acids

Total glycerol

Insoluble  in  water.  Soluble  in  hot  oil  or  fat

55—65 °C

Not  more  than  1,5 %  estimated  as  oleic  acid

Not  more  than  2 %

83—90 %

16—22 %

Fatty  acid  methyl  esters,  not  forming
adduct  with  urea

Not  more  than  9 %  of  total  fatty  acid  methyl  esters

Fatty  acids, 
ether

Peroxide  value

Epoxides

Arsenic

Lead

Mercury

Cadmium

insoluble 

in  petroleum

Not  more  than  2 %  of  total  fatty  acids

Not  more  than  3

Not  more  than  0,03 %  oxirane  oxygen

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E 481  SODIUM  STEAROYL-2-LACTYLATE

Synonyms

Definition

Chemical  names

Einecs

Chemical  formula
(major  components)

Sodium  stearoyl  lactylate
Sodium  stearoyl  lactate

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

Sodium  di-2-stearoyl  lactate
Sodium  di(2-stearoyloxy)propionate

246-929-7

C21H39O4Na
C19H35O4Na

Description

White  or  slightly  yellowish  powder  or  brittle  solid  with  a  characteristic  odour

Identification

A. Positive  tests  for  sodium,  for  fatty

acids  and  for  lactic  acid

B. Solubility

Insoluble  in  water.  Soluble  in  ethanol

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Purity

Sodium

Ester  value

Acid value

Not  less  than  2,5 %  and  not  more  than  5 %

Not  less  than  90  and  not  more  than  190

Not  less  than  60  and  not  more  than  130

Total  lactic  acid

Not  less  than  15 %  and  not  more  than  40 %

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  482  CALCIUM  STEAROYL-2-LACTYLATE

Synonyms

Definition

Chemical name

Einecs

Chemical  formula

Description

Identification

Calcium  stearoyl  lactate

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

Calcium  di-2-stearoyl  lactate
Calcium  di(2-stearoyloxy)propionate

227-335-7

C42H78O8Ca
C38H70O8Ca

White  or  slightly  yellowish  powder  or  brittle  solid  with  a  characteristic  odour

A. Positive  tests  for  calcium,  for  fatty

acids  and  for  lactid  acid

B. Solubility

Slightly  soluble  in  hot  water

Purity

Calcium

Ester  value

Not  less  than  1 %  and  not  more  than  5,2 %

Not  less  than  125  and  not  more  than  190

Total  lactic  acid

Not  less  than  15 %  and  not  more  than  40 %

Acid value

Arsenic

Lead

Mercury

Cadmium

Not  less  than  50  and  not  more  than  130

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

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L 334/57

E  483  STEARYL  TARTRATE

Synonyms

Definition

Chemical name

Chemical  formula

Molecular  weight

Assay

Stearyl palmityl tartrate

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

Distearyl tartrate
Dipalmityl  tartrate

C38H74O6  to  C40H78O6

627  to  655

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

A. Positive  tests  for  tartare

B. Melting  range

Purity

Hydroxyl value

Acid value

Between  67 °C  and  77 °C.  After  saponification  the  saturated  long  chain  fatty  alcohols
have  a  melting  range  of  49 °C  to  55 °C

Not  less  than  200  and  not  more  than  220

Not  more  than  5,6

Total  tartaric  acid  content

Not  less  than  18 %  and  not  more  than  35 %

Sulphated  ash

Not  more  than  0,5 %  determined  at  800 – 25 °C

Arsenic

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

Unsaponifiable  matter

Not  less  than  77 %  and  not  more  than  83 %

Iodine  value

Not  more  than  4  (Wijs)

E  491  SORBITAN  MONOSTEARATE

Definition

Einecs

Assay

Description

A  mixture  of  the  partial  esters  of  sorbitol  and  its  anhydrides  with  edible,  commercial
stearic  acid

215-664-9

Content  not  less  than  95 %  of  a  mixture  of  sorbitol,  sorbitan,  and  isosorbide  esters

Light,  cream-  to  tan-coloured  beads  or  flakes  or  a  hard,  waxy  solid  with  a  slight
characteristic  odour

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Identification

A. Solubility

Soluble  at  temperatures  above  its  melting  point  in  toluene,  dioxane,  carbon
tetrachloride,  ether,  methanol,  ethanol  and  aniline;  insoluble  in  petroleum  ether  and
acetone;  insoluble  in  cold  water  but  dispersible  in  warm  water;  soluble  with  haze  at
temperatures  above  50 °C  in  mineral  oil  and  ethyl  acetate

B. Congealing range

50—52 °C

C.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyol

Purity

Water

Sulphated  ash

Acid value

Not  more  than  2 %  (Karl  Fischer  method)

Not  more  than  0,5 %

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

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  492  SORBITAN  TRISTEARATE

Definition

Einecs

Assay

Description

Identification

A. Solubility

A  mixture  of  the  partial  esters  of  sorbitol  and  its  anhydrides  with  edible,  commercial
stearic  acid

247-891-4

Content  not  less  than  95 %  of  a  mixture  of  sorbitol,  sorbitan,  and  isosorbide  esters

Light,  cream-  to  tan-coloured  beads  or  flakes  or  hard,  waxy  solid  with  a  slight
odour

Slightly soluble in toluene, ether, carbon tetrachloride and ethyl acetate; dispersible in
petroleum  ether,  mineral  oil,  vegetable  oils,  acetone  and  dioxane;  insoluble  in  water,
methanol  and  ethanol

B. Congealing range

47—50 °C

C.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyol

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Purity

Water

Sulphated  ash

Acid value

Not  more  than  2 %  (Karl  Fischer  method)

Not  more  than  0,5 %

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

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  493  SORBITAN  MONOLAURATE

Definition

Einecs

Assay

Description

Identification

A. Solubility

A  mixture  of  the  partial  esters  of  sorbitol  and  its  anhydrides  with  edible,  commercial
lauric acid

215-663-3

Content  not  less  than  95 %  of  a  mixture  of  sorbitol,  sorbitan,  and  isosorbide  esters

Amber-coloured  oily  viscous  liquid,  light  cream  to  tan-coloured  beads  or  flakes  or  a
hard,  waxy  solid  with  a  slight  odour

Dispersible  in  hot  and  cold  water

B.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  a  polyol

Purity

Water

Sulphated  ash

Acid value

Not  more  than  2 %  (Karl  Fischer  method)

Not  more  than  0,5 %

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

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

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9.12.98

E 494  SORBITAN  MONOOLEATE

Definition

Einecs

Assay

Description

Identification

A. Solubility

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

215-665-4

Content  not  less  than  95 %  of  a  mixture  of  sorbitol,  sorbitan  and  isosorbide  esters

Amber-coloured viscous liquid, light cream to tan-coloured beads or flakes or a hard,
waxy  solid  with  a  slight  characteristic  odour

Soluble at temperatures above its melting point in ethanol, ether, ethyl acetate, aniline,
toluene,  dioxane,  petroleum  ether  and  carbon  tetrachloride.  Insoluble  in  cold  water,
dispersible  in  warm  water

B.

Iodine  value

The  residue  of  oleic  acid,  obtained  from  the  saponification  of  the  sorbitan  monoleate
in  assay,  has  a  iodine  value  between  80  and  100

Purity

Water

Sulphated  ash

Acid value

Not  more  than  2 %  (Karl  Fischer  method)

Not  more  than  0,5 %

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

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  495  SORBITAN  MONOPALMITATE

Synonyms

Definition

Einecs

Assay

Description

Sorbitan  palmitate

A  mixture  of  the  partial  esters  of  sorbitol  and  its  anhydrides  with  edible,  commercial
palmitic acid

247-568-8

Content  not  less  than  95 %  of  a  mixture  of  sorbitol,  sorbitan,  and  isosorbide  esters

Light  cream  to  tan-coloured  beads  or  flakes  or  a  hard,  waxy  solid  with  a  slight
characteristic  odour

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L 334/61

Identification

A. Solubility

Soluble  at  temperatures  above  its  melting  point  in  ethanol,  methanol,  ether,  ethyl
acetate, aniline, toluene, dioxane, petroleum ether and carbon tetrachloride. Insoluble
in  cold  water  but  dispersible  in  warm  water

B. Congealing range

45—47 °C

C.

Infrared  absorption  spectrum

Characteristic  of  a  partial  fatty  acid  ester  of  polyol

Purity

Water

Sulphate  ash

Acid value

Not  more  than  2 %  (Karl  Fischer  method)

Not  more  than  0,5 %

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

Lead

Mercury

Cadmium

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  508  POTASSIUM  CHLORIDE

Synonyms

Definition

Sylvine
Sylvite

Chemical name

Potassium  chloride

Einecs

Chemical formulae

Molecular  weight

Assay

Description

Identification

A. Solubility

B. Positive  tests  for  potassium  and  for

chloride

231-211-8

KCl

74,56

Content  not  less  than  99 %  on  the  dried  basis

Colourless,  elongated,  prismatic  or  cubital  crystals  or  white  granular  powder.
Odourless

Freely  soluble  in  water.  Insoluble  in  ethanol

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Purity

Loss  on  drying

Not  more  than  1 %  (105 °C,  2  hours)

Sodium

Arsenic

Lead

Mercury

Cadmium

Negative  test

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Heavy  metals  (as  Pb)

Not  more  than  10  mg/kg

E  579  FERROUS  GLUCONATE

Definition

Chemical name

Ferrous  di-D-gluconate  dihydrate
Iron(II)  di-gluconate  dihydrate

Einecs

206-076-3

Chemical formulae

C12H22FeO14·2H2O

Molecular  weight

482,17

Assay

Description

Identification

A. Solubility

Content  not  less  than  95 %  on  the  dried  basis

Pale  greenish-yellow  to  yellowish-grey  powder  or  granules,  which  may  have  a  faint
odour  of  burnt  sugar

Soluble  with  slight  heating  in  water.  Practically  insoluble  in  ethanol

B. Positive  test  for  ferrous  ion

C. Formation  of  phenylhydrazine

derivative  of  gluconic  acid  positive

D. pH  of  a  10 %  solution

Between  4  and  5,5

Purity

Loss  on  drying

Not  more  than  10 %  (105 °C,  16  hours)

Oxalic acid

Iron  (Fe III)

Arsenic

Lead

Mercury

Cadmium

Not  detectable

Not  more  than  2 %

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg

Reducing  substances

Not  more  than  0,5 %  expressed  as  glucose

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L 334/63

E  585  FERROUS  LACTATE

Synonyms

Definition

Iron(II)  lactate
Iron(II)  2-hydroxy  propanoate
Propanoic  acid,  2-hydroxy-iron(2 +)  salt  (2:1)

Chemical name

Ferrous  2-hydroxy  propanoate

Einecs

227-608-0

Chemical formulae

Molecular  weight

Assay

Description

Identification

A. Solubility

C6H10FeO6·xH2O  (x = 2  or  3)

270,02  (dihydrate)
288,03  (trihydrate)

Content  not  less  than  96 %  on  the  dried  basis

Greenish-white  crystals  or  light  green  powder  having  a  characteristic  smell

Soluble  in  water.  Practically  insoluble  in  ethanol

B. Positive  test  for  ferrous  ion  and  for

lactate

C. pH  of  a  2 %  solution

Between  4  and  6

Purity

Loss  on  drying

Iron  (Fe III)

Arsenic

Lead

Mercury

Cadmium

Not  more  than  18 %  (100 °C,  under  vacuum,  approximately  700  mm  Hg)

Not  more  than  0,6 %

Not  more  than  3  mg/kg

Not  more  than  5  mg/kg

Not  more  than  1  mg/kg

Not  more  than  1  mg/kg’