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Regulatory contextEuropean Union legislation on colors for use in foodstuffs is given in:

•Regulation (EC) N° 1333/2008 and current amendments on food additives, which harmonizes the use of food additives in foods, including food supplements, in the European Union,

•Regulation (EC) N° 1129/2011 establishes a union list of food additives, including colorants, the level at which they can be used and the foodstuffs to which they can be added (including food supplements).

•Regulation (EC) N° 231/2012 lays down specifications for food additives, including specific purity requirements concerning colors for use in foodstuffs.

Applicability for Capsugel Empty Capsules intended for Food supplements 1. Colorants meet the purity criteria as per Regulation 231/2012.

2. Below table indicates the applicable limits for solid food supplements as per Regulation 1129/2011 - category 17.1.

Colorant name E number Specified combined maximum level

Colorant labeling requirement in food

supplements

Tartrazine E 102 300 mg/kg Name or E number of the color(s), “may have an adverse effect on activity and attention in children” (Article 24 Regulation (EC) N° 1333/2008)

Azorubine E 122 300 mg/kg

Allura red AC E 129 300 mg/kg

Patent blue V E 131 300 mg/kg

Name or E number of the color(s)

Indigotine E 132 300 mg/kg

Brilliant blue FCF E 133 300 mg/kg

Brilliant black BN E 151 300 mg/kg

Chlorophyllin Copper complex E 141 Quantum satis*

Caramel E 150c Quantum satis*

Titanium dioxide E 171 Quantum satis*

Iron oxides E 172 Quantum satis*

* Quantum satis: No maximum level specified, however colorings matters shall be used according to good manufacturing practices

2012

1100

1-H

GC

Color Guide for Food SupplementsEurope

Capsugel’s Global Footprint Ensures Certainty of Supply Our customers span the world, and so does Capsugel. Each year we produce close to 200 billion capsules for more than 4,000 customers in over 100 countries. Our vast production capacity helps us effectively respond to changing marketplace demands no matter where our customers are located – providing you with the peace of mind that your dosage-form requirements will be met rapidly and with world-class quality.

Capsugel operates 24x7 in manufacturing locations, state-of-the-art Product Development Centers and multiple business offices around the world.

To work together or learn more, contact us at capsugel.com

Our global presence, industry-leading capsule products, and innovative drug delivery technologies translate into shorter go-to-market time for Capsugel customers.

MorristownNew Jersey

BostonMassachusetts

Rio de JanerioBrazil

BornemBelgium

PueblaMexico

GreenwoodSouth Carolina

StrasbourgFrance

PloërmelFrance

ColmarFrance

DelhiIndia

SuzhouChina

SagamiharaJapan

Hong KongChina

BangkokThailand

JakartaIndonesia West Ryde

Australia

Capsugel codes

Opaque colors

Capsugel codes

Transparent colors

Labelling additional labeling Labelling additional

labeling

44.000 43.000

11.044

01.312

18.084

18.172

18.230

17.147 16.305

17.361 15.301

17.441 13.306

18.347

17.042

38.025 39.007

38.063 39.314

42.322

41.019 39.309

46.350 06.018

46.351

36.093 20.309

21.035 20.006

36.304

36.330

22.027

09.025

37.024

37.063

24.052 23.304

24.093

24.312

24.351

32.364

33.334

29.324

29.334

51.337

53.356

04.000

04.007

05.367 03.000

53.345

Capsugel has made every effort to ensure the accuracy of this color guide for the food supplements market in Europe.

Nevertheless, we recommend that careful consideration is given to your final color choice so that only defined / permitted colors are used according to the product market and countries of destination.

A cross check by your regulatory department, as well as with the appropriate authorities in the countries of application of the product, is advised in order to ensure that products are formulated and labeled in conformity with current regulations.

To help you in your selection, the colors are presented in two groups: opaque colors, recommended to mask content, and transparent colors.

In each group:

• left column colors need to be labeled with name or E number of the color(s),

• right column colors needs to be labeled with name or E number of the color(s), “may have an adverse effect on activity and attention in children” (Article 24 Regulation (EC) N° 1333/2008).

Other colors may be available or developed upon request.

Some capsules may be sensitive to heat and light, and will require appropriate product packaging.

Choose a color for your Hard Gelatin capsules!Select a color and get its composition.

E 102 Tartrazine E 132 Indigotine E 150c Caramel E 172 Yellow iron oxide

E 122 Azorubine E 133 Brilliant blue FCF E 171 Titanium dioxide

E 129 Allura red AC E 151 Brilliant Black BN E 172 Black iron oxide

E 131 Patent blue V E 141 Copper-chlorophyllin E 172 Red iron oxide

Capsugel code: Reference used by Capsugel to identify the colors. Pantone code: selected from the Pantone Formula Guide Solid Coated. Pantone codes are as close as possible to the original colors and therefore remain indicative only. Real samples may be provided on request for some selected colors.

Capsugel code

Pantone code

Capsugel description E

10

2

E 12

2

E 12

9

E 13

1

E 13

2

E 13

3

E 15

1

E 14

1

E 15

0c

E 17

1

E 17

2

E 17

2

E 17

2

01.312 447C BLACK OP.C312                        

03.000 306c LIGHT BLUE TR                        

04.000 639c LIGHT BLUE OP                      

04.007 2995c LT BLUE OP.C007                      

05.367 311c POWDER BLUE OP.367                      

06.018 7509c STD BROWN TR.C018                        

09.025 483c CHOC.BROWN OP.C025                    

11.044 421c LT GREY OP.C044                      

13.306 7489c STD GREEN TR.C306                      

15.301 344c LIGHT GREEN TR.C301                      

16.305 7716c BLUISH GREEN TR.C305                      

17.042 465c LT GREEN OP.C042                    

17.147 339c LT GREEN OP.C147                    

17.361 556c LIGHT GREEN OP.C361                    

17.441 7488c LIGHT GREEN OP.C441                    

18.084 349c DARK GREEN OP.C084                      

18.172 555c DARK GREEN OP.C172                    

18.230 342c DARK GREEN OP.C230                    

18.347 7495c DARK GREEN OP.C347                    

20.006 7413c LT ORANGE TR.C006                      

20.309 144c LT ORANGE TR.C309                      

21.035 157c MEDIUM ORANGE OP.C035                    

22.027 484c SWEDISH ORANGE OP.C027                      

23.304 190c PINK TR.C304                        

24.052 204c PINK OP.C052                      

24.093 702c PINK OP.C093                  

24.312 1785c PINK OP.C312                      

24.351 214c PINK OP.C351                      

29.324 5275c STD PURPLE OP.C324

29.334 5135c STD PURPLE OP.C334

32.364 1797c SCARLET OP.C364                

33.334 690c MAROON OP.C334

36.093 7411c CARAMEL OP.C093                      

36.304 7515c CARAMEL OP.C304                  

36.330 1675c CARAMEL OP.C330                    

37.024 7520c FLESH OP.C024                      

37.063 486c FLESH OP.C063                      

38.025 7401c IVORY OP.C025                      

38.063 7506c IVORY OP.C063                      

39.007 155c STD YELLOW TR.C007                        

39.309 142c STD YELLOW TR.C309                        

39.314 461c STD YELLOW TR.C314                        

41.019 142c RICH YELLOW OP.C019                      

42.322 102c STD YELLOW OP.C322                      

43.000 - NATURAL TR                          

44.000 - WHITE OP                        

46.350 1485c LIGHT ORANGE OP.C350                    

46.351 7410c LIGHT ORANGE OP.C351                    

51.337 5285c AMETHYST OP.C337                    

53.345 7463c DARK BLUE OP.C345                    

53.356 7683c DARK BLUE OP.C356