Notes Key - The Feingold Diet

1 Listed as permittedNot listed as permittedData unknown or unreliable Allowed in existing formulations; should be avoided in newformulationsDye only allowed; aluminium lake not permittedKnown to be used though notofficially listedPermitted, but use generallydiscouragedQuantity restriction applies Colorants accepted in , Japanand Notes F 1 FDA certification is required. F ratification of food color Directivefor pharma products expected (listed as E129). F ratification of food color Directive for pharma products expected(listed as E133). F 4 The scientific committee on medi-cinal products and medical devices(EC DG XXIV) expressed, inOctober 1998, the opinion thatthere is no toxicological reason todelist this color.

2 It is thought thatthis color will remain permanentlylisted for pharmaceutical usesometime after 2002 in the F 5 Not used. F 6 Coating only, not core-coloring. F 7 Not more than 5mg/day. F 8 Not more than 5mg/day elemental iron. F 9 Specific ADI values apply, and are listedon page 9. F 10 Not more than by weight of color(lake or dye). F 11 Not more than by weight of color(lake or dye). F 12 Should be listed as turmeric extract. F 13 Must comply with medicinal carbonJP specifications if used for manufacture inJapan. F 14 Chlorophyllin copper complex only. F 15 Not more than six synthetic colorsmay be blended. (Slovakia) F 16 Avoid in new formulations. F 17 Use generally discouraged.

3 F 18 ADI values are reportedly mandatorybut not known to be enforced. (Iran) F 19 Permitted for external use only. F 20 Based on French regulations;no local list known. (Vietnam) F 21 Not more than by weight. F 22 Not more than 5mg/kg of weight per day(meaning is unclear). F 23 Future status is under debate. F 24 All lakes must have a pure color contentgreater than 10%. (Japan) F 25 Requires label declaration. F 26 Requires label declaration: Allergic reac-tion may occur. F 27 Only -carotene. F 28 Should not be made by Notes on countries Costa Rica:Maximum of 3 colorants permitted to obtainthe desired color. Croatia:Not yet known to have issued new regulations -Utilises regulation from ex-Yugoslavia.

4 Ecuador:No specific local regulations known - Union Iran: ADI values are reportedly mandatory but not knownto be enforced. (F18) Japan:All lakes must have a pure color content greaterthan 10%. (F24) Latvia: Has not yet issued own regulations. Permits allcolors accepted in the or Lithuania:Not yet known to have issued new regulation from Slovakia:Not more than six synthetic colors may beblended. (F15) Slovenia:Not yet known to have issued new regulations -Utilises regulation from ex-Yugoslavia. Arab Emirates Ukraine: Not yet known to have issued new regulations - Utilises regulation from Vietnam:Based on French regulations; not local list known.(F20) Yugoslavia (Serbia and Montenegro):Not yet known to have issued new regulations - Utilises regulation from : Newly independent states of the former Yugoslavia arenot yet known to have issued individual color daily intake .

5 An estimate ofthe amount of a substance in food ordrinking-water, expressed on a body-weight basis, that can be ingested dailyover a lifetime without appreciable risk(standard human = 60 kg). The ADI islisted in units of mg per kg of Health OrganizationADI/WHOADI recommended by WHOD&CDesignation applied in USA to dyespermitted for use in drugs and cosmeticsFDAFood and Drug Administration ( )FD&CDesignation applied in USA to dyespermitted for use in foods, drugsand Index numbers of Arab EmiratesJPJapanese EEC 78/25 and 95/45 JapanSpecification and standards for foodadditives VIIthedition, 1999; JapanesePharmacopoeia rev. 14, 2001; JapanesePharmaceutical Excipients CFR parts 73-74 AbbreviationsMain regulatorytexts8 LIST OF COLORANTS 11TH EDITIONC olorWhiteBeigeRedYellowGreenBlueBlackPri ncipal NameTitanium DioxideCaramelAcid Fuchsine BAllura Red ACAmaranthAnthocyaninsAzorubineBeetroot RedCanthaxanthinCochineal ExtractEosine YSErythrosineIron Oxide RedPhloxine BPonceau 4 RRed 2 GBeta-CaroteneBeta-Apo-8'-CarotenalCurcu minD&C Yellow 10 Iron Oxide YellowQuinoline Yellow WSRiboflavinSunset Yellow FCFT artrazineChlorophyllsChlorophylls & Chlorophyllin Cu ComplexFast Green FCFG reen SBrilliant Blue FCFI ndigo CarminePatent Blue VBrilliant Black BNIron Oxide BlackVegetable CarbonUS NameD&C Red 33FD&C Red

6 40FD&C Red 2D&C Red 22FD&C Red 3(As Dye Only)D&C Red 28D&C Yellow 10FD&C Yellow 6FD&C Yellow 5FD&C Green 3FD&C Blue 1FD&C Blue Pigment White Natural Brown Food Red Food Red Food Red Food Red Food Orange Natural Red Red Food Red Pigment Red 101 & Food Red Food Red Food Orange Food Orange Natural Yellow Food Yellow Pigment Yellow 42 & Food Yellow Food Yellow Food Yellow Natural Green Natural Green Food Green Food Green Food Blue Food Blue Food Blue Food Black Pigment Black Food Black 3 The Capsugel List of Colorants for oraldrugs is a practical and reliable tool tohelp in developing colored oral 11thedition has been extensivelyupdated.

7 It now comprises 36 colorantsand covers 80 table here lists many of the knownnames of the various colorants available,and the corresponding regulatoryinformation is contained in the tables onthe following pages. New to this edition are the statusdescriptions of colorants, with a keythat provides at-a-glance who are launching into morethan one major market will find on page10 a summary list of colorants acceptedin Europe, the or Japan. Colorantsaccepted in these three regions (thetriad) are indicated by the hope that this 11thedition will exceedyour expectations. Your feedback willtell us if we have succeeded. We lookforward to hearing from colorants covering80 countriesADIA cceptable daily intake .

8 An estimate of the amountof a substance in food or drinking-water, expressedon a body-weight basis, that can be ingested dailyover a lifetime without appreciable risk (standardhuman = 60 kg). The ADI is listed in units of mgper kg of body weightWHOW orld Health Organization9 LIST OF COLORANTS 11TH EDITIONC olorantsOther NamesAcid Red 33 Acid Red 27 Acid Red 14 Carmine Acid Red 87 Acid Red 92 Acid Red 18 Acid Red 1 Natural Yellow 26 Natural Yellow 26 Acid Yellow 3 Acid Yellow 3 Acid Yellow 23 Acid Green 50 Acid Blue 3 Burnt SugarRed 10 BGrape skin extractCarmoisineBetaninEosine ACochineal Red ATurmericLactoflavinOrange Yellow SLissamine GreenIndigotineBlack BNCarbon BlackADI/WHOno ADI0-200 mg0-7 mgno ADI0-4 mgnot mg0-5 mg0-4 mgno ADI0-5 mg0-10 mg0-10 mgno ADI0-25 mgno mg0-5 mgno ADI0-1 mgno ADIS pecific ADI per mg/Iran0-5

9 Mg/Iran0-15 mg/Peru0-5 mg/PeruBeet RedCarminic AcidEomine YBrilliant Scarlet 4 RIndian SaffronMin. 75% mono-sulfonates, disulfonatesMin. 80% disul-fonates, max. 15%monosulfonatesVitamine B2 Food green 5 Brilliant Black PNMedicinal Vege-table Charcoal(0-150 on a solid basis)Colorant SynonymsADI/WHOADI recommended by WHOD&CDesignation applied in USA to dyespermitted for use in drugs and cosmeticsFDAFood and Drug Administration ( )FD&CDesignation applied in USA to dyespermitted for use in foods, drugs and cosmeticsESubstance allowed for food in European Index numbers of 1971 ( )CASC hemical abstract number of colorantCFRCode of Federal Register 21 Indigo Carmine can only be used if:1.

10 Marketed pack is sealed HDPE bottles, or glass bottles2. Marketed pack is Alu/Alu sealed blister3. Concentration of Indigo Carmine should not exceed %E NumberE171E150E129E123E163E122E162E161gE 120E127E172E124E128E160aE160eE100iE172E1 04E101iE110E102E140E141E142E133E132E131E 151E172E153 CAS Number13463-67-73567-66-625956-17-6915-6 7-33567-69-9514-78-31390-65-417372-87-11 6423-68-01309-37-118472-87-22611-82-7723 5-40-71107-26-28004-92-051274-00-18004-7 2-02783-94-01934-21-02353-45-93844-45-98 60-22-03536-49-02519-30-41317-61-9 CFR Number73. 157573. 108574. 133374. 134073. 110074. 132274. 130373. 120074. 132873. 109574. 171073. 120074. 170674. 170573. 112574. 120374. 110174. 110273. Number7789117200160351618514720408507547 045380454307749145410162551805075130/408 0040820753004700577492470051598519140758 1075815420534409042090730154205128440774 9977266 Colorantsthat are accepted in the.