EN   EN 
 
 
 EUROPEAN  
COMMISSION   
Brussels, XXX   
SANTE/12606/2019 ANNEX 
(POOL/E2/2019/12606/12606 -EN 
ANNEX.docx)  
[…](2020) XXX  draft  
ANNEXES 1 to 2  
 
ANNEXES  
to the  
COMMISSION REGULATION (EU) …/…  
amending Annexes II and III to Regulation (EC) No 1333/2008 of the European 
Parliament and of the Council and the Annex to Commission Regulation (EU) 
No 231/2012 as regards Annatto, Bixin, Norbixin (E 160b)    
EN 1  EN ANNEX  I 
(1) Annex II to Regulation (EC) No 1333/2008 is amended as follows:  
(a) in point 2 of Part A, point 5 is replaced by the following : 
'The colours E 123, E 127, E 160b(i),  E 160b(i i), E 161g, E 173 and E 180 and mixtures thereof may not be sold directly to the 
consumer. ' 
(b) in Part B,  point 1: 'Colours ', the entry for E 160b  (Annatto, Bixin, Norbixin ) is replaced by the following  two entries : 
' 
E 160b(i)  Annatto b ixin 
E 160b(ii)  Annatto n orbixin  
 ' 
(c) Part E is amended as follows:  
1) Category 01.4 (Flavoured fermented milk products including heat -treated products)  is amended as follows : 
(i) the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following :  
' 
 E 160b(i)  Annatto b ixin 15 (94)  
 E 160b(ii)  Annatto n orbixin  4 (94)  
' 
(ii) the following  footnote  (94) is added after footnote (74) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded .'  
EN 2  EN 2) Category 01.7.2 (Ripened cheese)  is amended as follows:  
(i) the entr ies for E 160b ( Annatto, Bixin, Norbixin ) are replaced by the following :  
' 
 E 160b(i)  Annatto b ixin 15 (94) only ripened orange, yellow and 
broken -white cheese and red and green 
pesto cheese  
 E 160b(ii)  Annatto norbixin  15 (94) only ripened orange, yellow and 
broken -white cheese and red and green 
pesto cheese  
 E 160b(ii)  Annatto n orbixin  50  only red Leicester  cheese  
 E 160b(ii)  Annatto n orbixin  35  only Mimolette cheese  
' 
(ii) the following  footnote (94) is added after footnote (83) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded .' 
3) Category 01.7. 3 (Edible cheese rind ) is amended as follows : 
 (i) the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following :  
' 
 E 160b(i)  Annatto bixin  20 (94)  
 E 160b(ii)  Annatto norbixin  20  (94)  
'  
EN 3  EN (ii) the following  footnote (94) is added after footnote (67) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
4) Category 01.7.5 (Processed cheese)  is amended as follows : 
(i) the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following :  
' 
 E 160b(i)  Annatto bixin  15 (94)  
 E 160b(ii)  Annatto norbixin  8 (94)  
' 
(ii) the following  footnote (94) is added after footnote (66) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
5) in Category 01.7.6 (Cheese products (excluding products falling in category  16)), the entry for E 160b  (Annatto, Bixin, Norbixin ) 
is replaced by the following : 
' 
 E 160b(ii)  Annatto norbixin  8  only ripened orange, yellow and 
broken -white products  
' 
6) in category 02.1 (Fats and oils essentially free from water (excluding anhydrous milkfat) ), the entry for E 160b ( Annatto, Bixin, 
Norbixin ) is replaced by the following : 
' 
 E 160b(i)  Annatto bixin  10  only fats   
EN 4  EN ' 
7) in category 02.2.2 (Other fat and oil emulsions including spreads as defined by Council Regulation (EC) No 1234/2007 and liqui d 
emulsions) , the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following :  
' 
 E 160b(i)  Annatto bixin  10  excluding reduced fat butter  
' 
8) in category 0 3 (Edible ices ), the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following : 
' 
 E 160b(ii)  Annatto norbixin  20   
' 
9) Category 04.2.5.2 (Jam, jellies and marmalades and sweetened chestnut pur ée as defined by Directive 2001/113/EC)  is amended 
as follows : 
(i) the following new entries for E 160b(i)  (Annatto bixin ) and E 160b(ii)  (Annatto norbixin ) are inserted after the entry for E 
160a (Carotenes) :  
' 
 E 160b(i)  Annatto bixin  20 (94) except chestnut purée  
 E 160b(ii)  Annatto norbixin  20 (94) except chestnut purée  
' 
(ii) the following  footnote (94) is added after footnote (66) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded .'  
EN 5  EN 10) Category 04.2.5.3 (Other similar fruit or vegetable spreads)  is amended as follows : 
(i) the following new entries for E 160b(i)  (Annatto bixin ) and E 160b(ii)  (Annatto norbixin ) are inserted after the entry for E 
142 (Green S) :  
' 
 E 160b(i)  Annatto  bixin  20 (94) except crème de pruneaux  
 E 160b(ii)  Annatto norbixin  20 (94) except crème de pruneaux  
' 
(ii) the following  footnote (94) is added after footnote (60) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
11) Category 04.2.6 (Processed potato products)  is amended as follows : 
(i) the following new entries for E 160b(i)  (Annatto bixi n) and E 160b(ii)  (Annatto norbixin ) are inserted after the entry for E 
160a (Carotenes) :  
' 
 E 160b(i)  Annatto bixin  10 (94) only dried potato granules and flakes  
 E 160b(ii)  Annatto norbixin  10 (94) only dried potato granules and flakes  
' 
(ii) the following  footnote (94) is added after footnote (46) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. '  
EN 6  EN 12) Category 05.2 (Other confectionery including breath freshening microsweets)  is amended as follows : 
(i) the following new entries for E 160b(i)  (Annatto bixin ) and E 160b(ii)  (Annatto norbixin ) are inserted after the entr ies for E 
124 (Ponceau 4R, Cochineal Red A ):  
' 
 E 160b(i)  Annatto bixin  30 (94)  
 E 160b(ii)  Annatto norbixin  25 (94)  
' 
(ii) the following  footnote (94) is added after footnote (72) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded .' 
13) Category 05.4 (Decorations, coatings and fillings, except fruit -based fillings covered by category 4.2.4)  is amended as follows : 
(i) the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following :  
' 
 E 160b(i)  Annatto bixin  80 
 (94) only decorations and coatings  
 E 160b(ii)  Annatto norbixin  20 (94) only decorations and coatings  
' 
(ii) the following  footnote (94) is added after footnote (73) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
14) in category 06.3 (Breakfast cereals ), the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following : 
'  
EN 7  EN  E 160b(ii)  Annatto norbixin  20  only extruded puffed and or fruit -
flavoured breakfast cereals  
' 
15) Category 06. 5 (Noodles ) is amended as follows : 
(i) the following new entries for E 160b(i) (Annatto bixin ) and E 160b(ii) (Annatto norbixin)  are inserted after the entry for 
group II (Colours at quantum satis ): 
' 
 E 160b(i)  Annatto bixin  20 (94)  
 E 160b(ii)  Annatto norbixin  20 (94)  
' 
(ii) the following  footnote (94) is added after footnote (81) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
16) Category 0 6.6 (Batters ) is amended as follows : 
(i) the entry for E 160b ( Annatto , Bixin, Norbixin ) is replaced by the following : 
' 
 E 160b(i)  Annatto bixin  50 (94) only batters for coating  
 E 160b(ii)  Annatto norbixin  50 (94) only batters for coating  
' 
(ii) the following  footnote (94) is added after footnote (81) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. '  
EN 8  EN 17) in category 07.2 (Fine bakery wares) , the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following : 
' 
 E 160b(ii)  Annatto norbixin  10   
' 
18) Category 08. 2 (Meat preparations as defined by Regulation (EC) No 853/2004 ) is amended as follows : 
(i) the following new entries for E 160b(i)  (Annatto bixin ) and E 160b(ii)  (Annatto norbixin ) are inserted after the entry for E 
150a -d (Caramels ):  
' 
 E 160b(i)  Annatto bixin  20 (94) only breakfast sausages  with a 
minimum cereal content of 6 % and 
burger meat with a minimum vegetable 
and/or cereal content of 4 % mixed 
within the meat; In these products, the  
meat is minced in such a way so  that the 
muscle and fat tissue are completely 
dispersed, so th at fibre makes an 
emulsion with the fat, giving those 
products their typical appearance  
 E 160b(ii)  Annatto norbixin  20 (94) only breakfast sausages  with a 
minimum cereal content of 6 % and 
burger meat with a minimum vegetable 
and/or cereal content of 4 % mixed 
within the meat; In these products, the  
meat is minced in such  a way so  that the 
muscle and fat tissue are completely 
dispersed, so th at fibre makes an 
emulsion with the fat, giving those  
EN 9  EN products their typical appearance  
' 
(ii) the following  footnote (94) is added after footnote (66) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
19) Category 08. 3.1 (Non-heat–treated meat products ) is amended as  follows : 
(i) the following new entries for E 160b(i)  (Annatto bixin ) and E 160b(ii)  (Annatto norbixin ) are inserted after the entry for E 
160a (Carotenes) :  
' 
 E 160b(i)  Annatto bixin  20 (94) only chorizo sausage , salchichon , 
pasturmas  and sobrasada  
 E 160b(ii)  Annatto norbixin  20 (94) only chorizo sausage , salchichon , 
pasturmas  and sobrasada  
' 
(ii) the following  footnote (94) is added after footnote (66) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination,  the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. '  
EN 10  EN 20) Category 08.3.2 (Heat -treated meat products)  is amended as follows : 
(i) the following new entries for E 160b(i)  (Annatto bixin ) and E 16 0b(ii)  (Annatto norbixin ) are inserted after the entry for E 
160a (Carotenes) :  
' 
 E 160b(i)  Annatto bixin  20 (94) only sausages, pâtés , terrines  and 
luncheon meat  
 E 160b(ii)  Annatto norbixin  20 (94) only sausages, pâtés, terrines and 
luncheon meat  
' 
(ii) the following footnote (94) is added after footnote (66) :  
'(94): When E 160b(i) (Annatto bixin) and E 160b(ii) (Annatto norbixin) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded.'  
21) Category 08.3.3 (Casings and coatings and decorations for meat) is amended as follows : 
(i) the entry for E 160b (Annatto, Bixin, Norbixin) is repla ced by the following :   
' 
 E 160b(i)  Annatto bixin  50 (94)  
 E 160b(ii)  Annatto norbixin  50  (94)  
' 
(ii) the following  footnote (94) is added after footnote ( 89):  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. '  
EN 11  EN 22) Category 09.2 (Processed fish and fishery products including molluscs and crustaceans)  is amended as follows : 
(i) the entry for E 160b (Annatto, Bixin, Norbixin) concerning ‘only smoked fish’ is replaced by the following new entries for 
Annatto bixin and Annato norbixin, respectively for ‘only smoked fish’ and for ‘ only surimi and similar products and 
salmon substitutes ’: 
' 
 E 160b(i)  Annatto bixin  10 (94) only smoked fish  
 E 160b(i)  Annatto bixin  30 (94) only surimi and similar products and 
salmon substitutes  
 E 160b(ii)  Annatto norbixin  10 (94) only smoked fish  
 E 160b(ii)  Annatto norbixin  30 (94) only surimi and similar products and 
salmon substitutes  
 ' 
(ii) the following  footnote (94) is added after footnote (85) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
23) Category 12.5 (Soups and broths)  is amended as follows : 
(i) the following new entries for E 160b(i)  (Annatto bixin ) and E 160b(ii)  (Annatto norbixin ) are inserted after the entry for 
Group III  (Colours with combined maximum limit) :  
' 
 E 160b(i)  Annatto bixin  15 (94)  
 E 160b(ii)  Annatto norbixin  10 (94)   
EN 12  EN ' 
(ii) the following  footnote (94) is added after footnote (60) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
24) Category 12.6 (Sauces)  is amended as follows : 
(i) the following new entries for E 160b(i)  (Annatto bixin ) and E 160b(ii)  (Annatto norbixin ) are inserted after the entry for E 
110 (Sunset Yellow FCF/Orange Yellow S ):  
' 
 E 160b(i)  Annatto bixin  30 (94) including pickles, relishes, ch utney and 
piccalilli; excluding tomato -based 
sauces  
 E 160b(ii)  Annatto norbixin  30 (94) including pickles, relishes, chutney and 
piccalilli; excluding tomato -based 
sauces  
' 
(ii) the following  footnote (94) is added after footnote (65) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
25) in category 14.1.4 (Flavoured drinks) , the following new entr y for E 160b(i)  (Annatto bixin ) is inserted after the entry for E 124  
(Ponceau 4R, Cochineal Red A ):  
' 
 E 160b(i)  Annatto bixin  20    
EN 13  EN ' 
26) in category 14.2.6 (Spirit drinks as defined in Regulation (EC) No 110/2008 ), the entry for E 160b (Annatto, Bixin, Norbixin) is 
replaced by the following :  
' 
 E 160b(i)  Annatto bixin  10  only liqueurs  
' 
27) in category 14.2. 8 (Other alcoholic drinks including mixtures of alcoholic drinks with non -alcoholic drinks and spirits with less 
than 15  % of alcohol ), the entry for E 160b (Annatto, Bixin, Norbixin) is replaced by the following :  
' 
 E 160b(ii)  Annatto norbixin  10  only alcoholic drinks with less than 
15 % of alcohol  
' 
28) Category 15.1 (Potato -, cereal -, flour - or starch -based snacks)  is amended as follows : 
(i) the two entries for E 160b ( Annatto, Bixin, Norbixin ) are replaced by the following :  
' 
 E 160b(i)  Annatto bixin  20 (94)  
 E 160b(ii)  Annatto norbixin  20 (94)  
' 
(ii) the following  footnote (94) is added after footnote (71) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
29) Category 15.2 (Processed nuts)  is amend ed as follows :  
EN 14  EN (i) the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following :  
' 
 E 160b(i)  Annatto bixin  10 (94)  
 E 160b(ii)  Annatto norbixin  10 (94)  
' 
(ii) the following  footnote (94) is added after footnote (60) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
30) Category 16 (Desserts excluding products cove red in category 1, 3 and 4)  is amended as follows : 
(i) the entry for E 160b ( Annatto, Bixin, Norbixin ) is replaced by the following :  
' 
 E 160b(i)  Annatto bixin  15  (94)  
 E 160b(ii)  Annatto norbixin  7.5 (94)  
' 
(ii) the following  footnote (94) is added after footnote (74) :  
'(94): When E 160b(i) (Annatto bixin ) and  E 160b(ii) (Annatto norbixin ) are added in combination, the highe r individual 
maximum level applies to the sum, but the individual maximum levels should not be exceeded. ' 
(2) In Part 2 of Annex III to Regulation (EC) No 1333/2008, the entry for E 900 (Dimethyl polysiloxane) is replaced by the following : 
'  
EN 15  EN E 900  Dimethyl polysiloxane  
 200 mg/kg in the 
preparation, 0,2 mg/l in final 
food Colour preparations of E 
160a carotenes, E 160b(i) 
annatto bixin , E 160b(ii) 
annatto norbixin , E 160c 
paprika extract, capsanthin, 
capsorubin, E 160d 
lycopene and E 160e beta-
apo-8′-carotenal  
'  
EN 16  EN ANNEX II  
In the Annex to Regulation (EU) No 231/2012, the respective entries for E 160b Annatto, Bixin, Norbixin : (i) Solvent -extracted bixin and norbixin, (ii) 
alkali extracted annatto and (iii) oil extracted annatto  are replaced by the following:   
' 
E 160 b (i) ANNATTO BIXIN  
(I) SOLVENT -EXTRACTED BIXIN  
Synonyms  Annatto B, Orlean, Terre orellana, L. Orange, Natural 
Orange 4  
Definition  Solvent -extracted bixin is obtained by the extraction of the 
outer coating of the seeds of the annatto tree ( Bixa orellana  
L.) with one or more of the following food grade solvents: 
acetone, methanol, hexane, ethanol, isopropyl alcohol, ethyl 
acetate, alkaline alcohol or supercritic al carbon dioxide. 
The resulting preparation may be acidified, followed by the 
removal of the solvent, drying and milling.  
Solvent -extracted bixin contains several coloured 
components; the major colouring principle is cis -bixin, a 
minor colouring principle  is trans -bixin; thermal 
degradation products of bixin may also be present as a 
result of processing.  
Colour Index No  75120  
Einecs  230-248-7 
Chemical name  cis-Bixin: Methyl (9 -cis)-hydrogen -6,6'-diapo -Ψ,Ψ- 
EN 17  EN carotenedioate  
Chemical formula  cis-Bixin: C25H30O4 
Molecular weight  394,5  
Assay  Not less than 85 % colouring matter (expressed as bixin)  
E1%
1cm  3090 at ca. 487 nm in tetrahydrofuran and acetone  
Description    Dark red -brown to red -purple powder  
Identification   
Solubility  Insoluble in water, slightly soluble in ethanol  
Spectrometry  The sample in acetone shows absorbance maxima at about 
425, 457 and 487 nm  
Purity   
Norbixin  Not more than 5 % of total colouring matters  
Residual Solvents  Acetone: Not more than 30 mg/kg  
Methanol: Not more than 50 mg/kg  
Hexane: Not more than 25 mg/kg  
Ethanol : 
Isopropyl alcohol :  
Ethyl acetate : not more than 50 mg/kg, 
singly or in combination  
Arsenic  Not more than 2 mg/kg   
EN 18  EN Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 0,5 mg/kg  
 
(II) AQUEOUS -PROCESSED BIXIN  
Synonyms  Annatto E, Orlean, Terre orellana, L. Orange  
Definition  Aqueous -processed bixin is prepared by the extraction of 
the outer coating of the seeds of the annatto tree ( Bixa 
orellana  L.) by abrading the seeds in the presence of cold, 
mildly -alkaline water. The resultant preparation is acidified 
to precipitate bixin which is then filtered, dried and milled.  
Aqueous -processed bixin contains several coloured 
components; the major colour ing principle is cis -bixin, a 
minor colouring principle is trans -bixin; thermal 
degradation products of bixin may also be present as a 
result of processing.  
Colour Index No  75120  
Einecs  230-248-7 
Chemical name  cis-Bixin: Methyl (9-cis)-hydrogen -6,6'-diapo -Ψ,Ψ-
carotenedioate  
Chemical formula  cis-Bixin: C25H30O4 
Molecular weight  394,5   
EN 19  EN Assay  Not less than 25 % colouring matter (expressed as bixin)  
E1%
1cm  3090 at ca. 487 nm in tetrahydrofuran and acetone  
Description    Dark red-brown to red -purple powder  
Identification   
Solubility  Insoluble in water, slightly soluble in ethanol  
Spectrometry  The sample in acetone shows absorbance maxima at about 
425, 457 and 487 nm  
Purity   
Norbixin  Not more than 7 % of total colouring matters  
Arsenic  Not more than 2 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 0,5 mg/kg  
 
E 160 b (ii) ANNATTO NORBIXIN  
(I) SOLVENT -EXTRACTED NORBIXIN  
Synonyms  Annatto C, Orlean, Terre orellana, L. Orange, Natural 
Orange 4  
Definition  Solvent -extracted norbixin is obtained from the outer 
coating of the seeds of the annatto tree ( Bixa orellana  L.)  
EN 20  EN by washing with one or more of the following food grade 
solvents: acetone, methanol, hexane, ethanol, isopropyl 
alcohol, ethyl acetate, alkaline alcohol or supercritical 
carbon dioxide followed by solvent removal, crystallization 
and drying. Aqueous alkali is added to the resultant 
powder, which is then heated to hydrolyse the colouring 
matter and cooled. The aqueou s solution is filtered, and 
acidified to precipitate the norbixin. The precipitate is 
filtered, washed, dried and milled, to give a granular 
powder.  
Solvent -extracted norbixin contains several coloured 
components; the major colouring principle is cis-norbi xin, a 
minor colouring principle is trans -norbixin; thermal 
degradation products of norbixin may also be present as a 
result of processing.  
Colour Index No  75120  
Einecs  208-810-8 
Chemical name  cis-Norbixin: 6,6' -Diapo -Ψ,Ψ-carotenedioic acid  
cis-Norbixin  dipotassium salt: Dipotassium 6,6' -diapo -Ψ,Ψ-
carotenedioate  
cis-Norbixin disodium salt: Disodium 6,6' -diapo -Ψ,Ψ-
carotenedioate  
Chemical formula  cis-Norbixin: C 24H28O4 
cis-Norbixin dipotassium salt: C 24H26K2O4   
EN 21  EN cis-Norbixin disodium salt: C 24H26Na2O4 
Molecular weight  380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt)  
Assay  Not less than 85 % colouring matter (expressed as norbixin)  
E1%
1cm  2870 at ca. 482 nm in 0,5% potassium hydroxide 
solution  
Description    Dark red -brown to red -purple powder  
Identification   
Solubility  Soluble in alkaline water, slightly soluble in ethanol  
Spectrometry  The sample in 0,5% potassium hydroxide solution shows 
absorbance maxima at about 453 nm and 482 nm  
Purity   
Residual Solvents  Acetone: Not more than 30 mg/kg  
Methanol: Not more than 50 mg/kg  
Hexane: Not more than 25 mg/kg  
Ethanol : 
Isopropyl alcohol:  
Ethyl acetate : not more than 50 mg/kg, 
singly or in combination  
Arsenic  Not more than 2 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg   
EN 22  EN Cadmium  Not more than 0,5 mg/kg  
 
(II) ALKALI -PROCESSED NORBIXIN, ACID -PRECIPITATED  
Synonyms  Annatto F, Orlean, Terre orellana, L. Orange, Natural 
Orange 4  
Definition  Alkali -processed norbixin (acid -precipitated) is prepared by 
the extraction of the outer coating of the seeds of the 
annatto tree ( Bixa orellana L.) with aqueous alkali. The 
bixin is hydrolysed to norbixin in hot alkaline solution and 
is acidified to precipitate the norbixin. The precipitate is 
filtered, dried and milled to give a granul ar powder.  
Alkali -processed norbixin contains several coloured 
components; the major colouring principle is cis-norbixin, a 
minor colouring principle is trans -norbixin; thermal 
degradation products of norbixin may also be present as a 
result of processing.  
Colour Index No  75120  
Einecs  208-810-8 
Chemical name  cis-Norbixin: 6,6' -Diapo -Ψ,Ψ-carotenedioic acid  
cis-Norbixin dipotassium salt: Dipotassium 6,6' -diapo -Ψ,Ψ-
carotenedioate  
cis-Norbixin disodium salt: Disodium 6,6' -diapo -Ψ,Ψ-
carotenedioate   
EN 23  EN Chemical formula  cis-Norbixin: C 24H28O4 
cis-Norbixin dipotassium salt: C 24H26K2O4  
cis-Norbixin disodium salt: C 24H26Na2O4 
Molecular weight  380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt)  
Assay  Not less than 35 % colouring matter (expressed as norbixin)  
E1%
1cm  2870 at ca. 482 nm in 0,5% potassium hydroxide 
solution  
Description    Dark red -brown to red -purple powder  
Identification   
Solubility  Soluble in alkaline water, slightly soluble in ethanol  
Spectrometry  The sample in 0,5% potassium hydroxide solution shows 
absorbance maxima at about 453 nm and 482 nm  
Purity   
Arsenic  Not more than 2 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 0,5 mg/kg  
 
(III) ALKALI -PROCESSED NORBIXIN, NOT ACID -PRECIPITATED  
Synonyms  Annatto G, Orlean, Terre orellana, L. Orange, Natural  
EN 24  EN Orange 4  
Definition  Alkali -processed norbixin (not acid -precipitated) is 
prepared by the extraction of the outer coating of the seeds 
of the annatto tree ( Bixa orellana L.) with aqueous alkali. 
The bixin is hydrolysed to norbixin in hot alkaline solution. 
The precipitate is filtered, dried and milled to give a 
granular powder. Extracts contain mainly the potassium or 
sodium salt of norbixin as the major colouring matter.  
Alka li-processed norbixin (not acid -precipitated) contains 
several coloured components; the major colouring principle 
is cis-norbixin, a minor colouring principle is trans -
norbixin; thermal degradation products of norbixin may 
also be present as a result of pr ocessing.  
Colour Index No  75120  
Einecs  208-810-8 
Chemical name  cis-Norbixin: 6,6' -Diapo -Ψ,Ψ-carotenedioic acid  
cis-Norbixin dipotassium salt: Dipotassium 6,6' -diapo -Ψ,Ψ-
carotenedioate  
cis-Norbixin disodium salt: Disodium 6,6' -diapo -Ψ,Ψ-
carotenedioate  
Chemical formula  cis-Norbixin: C 24H28O4 
cis-Norbixin dipotassium salt: C 24H26K2O4  
cis-Norbixin disodium salt: C 24H26Na2O4  
EN 25  EN Molecular weight  380,5 (acid), 456,7 (dipotassium salt), 424,5 (disodium salt)  
Assay  Not less than 15 % colouring matter (expressed  as norbixin)  
E1%
1cm  2870 at ca. 482 nm in 0,5% potassium hydroxide 
solution  
Description    Dark red -brown to red -purple powder  
Identification   
Solubility  Soluble in alkaline water, slightly soluble in ethanol  
Spectrometry  The sample in 0,5% potassium  hydroxide solution shows 
absorbance maxima at about 453 nm and 482 nm  
Purity   
Arsenic  Not more than 2 mg/kg  
Lead  Not more than 1 mg/kg  
Mercury  Not more than 1 mg/kg  
Cadmium  Not more than 0,5 mg/kg  
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