Regulatory Information Sheet

Approved Drug Colourants Listed by the European Union

Colour
(a)

Allura Red AC
Aluminum***
(a)
Amaranth***
Annatto***
(a)
Anthocyanins
Beetroot Red
Beta APO-8-Carotenal
(a)
Brilliant Black BN
(a)
Brilliant Blue FCF
(a)
Brown HT
Calcium Carbonate
Canthaxanthin*
Caramel,-Plain
Caramel,-Caustic Sulphite
Caramel,-Ammonia
Caramel, Sulphite Ammonia
(a)
Carmine
(a)

Carmoisine
Carotenes
Chlorophylls/Chlorophyllins
Copper Complexes of
(a)
Chlorophylls/Chlorophyllins
Curcumin

(a)

Erythrosine***
Gold***
(a)
Green S
(a)
Indigotine

(a)

Iron Oxides & Hydroxides

Litholrubine BK***
Lutein
Lycopene***
Paprika Extract
(a)
Patent Blue V
(a)
Ponceau 4R

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(a)

E Number

Colour Index
Number

E129
E173
E123
E160b
E163
E162
E160e
E151
E133
E155
E170
E161g
E150a
E150b
E150c
E150d
E120

16035
77000
16185
75120
--40820
28440
42090
20285
77220
40850
----75470

E122
E160a
E140

14720
40800 / 75130
75810 / 75815

E141

75815

E100
E127
E175
E142
E132

75300
45430
77480
44090
73015
77491 / 77492 /
77499
--75125
-42051
16255

E172
E180
E161b
E160d
E160c
E131
E124

Alternate Names
FD&C Red #40
-Delisted FD&C Red #2
Bixin, norbixin
-Betanin
-Black BN
FD&C Blue #1
-------Carminic Acid, Cochineal
Azorubine
---Turmeric
FD&C Red #3
-Acid Brilliant Green BS
FD&C Blue #2, Indigo Carmine
Iron Oxide Red, Yellow, Black
---Capsanthin, Capsorubin
Acid Blue 3
Cochineal Red A

Document GLO-10107, Version2, September 2014

Colour
(a)

Quinoline Yellow**
(a)
Riboflavins
Silver***
(a)
Sunset Yellow FCF
(a)
Tartrazine
Titanium Dioxide
Vegetable Carbon

E
Number

Colour Index
Number

E104
E101
E174
E110
E102
E171
E153

47005
--15985
19140
77891
77268:1

Alternate Names
China Yellow
--FD&C Yellow #6, Orange Yellow S
FD&C Yellow #5
-Carbo Medicinalis Vegetalis

The above list is derived from Part B, List of All Additives, from Annex II to Regulation (EC) No 1333/2008
on food additives.
Aluminium lakes can be prepared from the above colours marked (a).

NOTE:
* Colorcon does not recommend the use of this colour in new drug applications.
** This is not D&C Yellow #10. Although the C.I. numbers are the same, the dyes differ in composition.
Quinoline Yellow is primarily the disulfonated quinoline dye, whereas D&C Yellow #10 is the
monosulfonated colour. Quinoline Yellow is not accepted for use in the U.S; conversely, D&C Yellow #10
cannot be used in the EU.
*** Colorcon does not recommend the use of this colour in new drug applications. Although these are
permitted food additives according to current EU legislation, their use is restricted to specific food
categories.

The information contained herein, to the best of our knowledge is true and accurate. Any recommendations or suggestions are made without warranty or
guarantee, since the conditions of use are beyond our control. Any information contained herein is intended as a recommendation for use of our products so
as not to infringe on any patent.

2013 Colorcon, Inc. The information contained in this document is proprietary to Colorcon, Inc. and may not be used or disseminated inappropriately.

Global Headquarters
Colorcon
275 Ruth Road, Harleysville, PA 19438
Tel: +1 215.256.7700 Fax: +1 215.256.7799
Website: www.colorcon.com
BPSI Holdings LLC, 2014.
All trademarks, except where noted, are property of BPSI Holdings LLC.

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Document GLO-10107, Version 2, September 2014