Lutein from Tagetes erecta

E number E161bINS 161b(i)CAS 127-40-2

Listed as a colour by Codex and the EU.

Listed as colours (EU, Codex)
Chemical structure of Lutein from Tagetes erecta, from PubChem compound 5281243
Structure from PubChem CID 5281243 (National Library of Medicine, public domain). A depiction of one compound: where a listing covers a family, or a substance has no single structure, this page shows none.

Lutein is a yellow carotenoid obtained from marigold petals, used to colour drinks, dairy products and confectionery. The same substance is sold as a dietary supplement, which is a separate regulatory question from its use as a colour.

Where it is and isn’t permitted

Status of Lutein from Tagetes erecta by jurisdiction. Every jurisdiction this site covers is listed, including those where the substance does not appear.
JurisdictionStatusScope and limitsCitation
Australia and New ZealandFood Standards Australia New ZealandPermitted, with conditions

47 food categories

no numerical limit (good manufacturing practice)

Show every food category
  • 0.2 Colourings — GMP
  • 0.3 Flavourings — GMP
  • 1.1.2 Liquid milk products and flavoured liquid milk — GMP
  • 1.2.2 Fermented milk products and rennetted milk products — GMP
  • 1.3 Condensed milk and evaporated milk — GMP
  • 1.4.2 Cream products (flavoured, whipped, thickened, sour cream etc) — GMP
  • 1.5 Dried milk, milk powder, cream powder — GMP
  • 1.6 Cheese and cheese products — GMP
  • 11.1.1 Rainbow sugar — GMP
  • 11.4 Tabletop sweeteners — GMP
  • 12.1.2 Reduced sodium salt mixture — GMP
  • 12.1.3 Salt substitute — GMP
  • 12.3 Vinegars and related products — GMP
  • 12.5 Yeast and yeast products — GMP
  • 12.6 Vegetable protein products — GMP
  • 13.3 Formulated meal replacements and formulated supplementary foods — GMP
  • 13.4 Formulated supplementary sports foods — GMP
  • 13.5 Food for special medical purposes — GMP
  • 14.1.1.2 Carbonated, mineralised and soda waters — GMP
  • 14.1.2.1 Fruit and vegetable juices — GMPFor juice separated by other than mechanical means only.
  • 14.1.2.2 Fruit and vegetable juice products — GMP
  • 14.1.3 Water based flavoured drinks — GMP
  • 14.1.4 Formulated Beverages — GMP
  • 14.2.3 Wine based drinks and reduced alcohol wines — GMP
  • 14.2.4.1 Fruit wine products and vegetable wine products — GMP
  • 14.2.5 Spirits and liqueurs — GMP
  • 14.3 Alcoholic beverages not included in item 14.2 — GMP
  • 2.1 Edible oils essentially free of water — GMPNot for olive oil.
  • 2.2.1.2 Butter products — GMP
  • 2.2.1.3 Margarine and similar products — GMP
  • 2.2.2 Oil emulsions (<80% oil) — GMP
  • 20 Foods not included in items 0 to 14 — GMP
  • 3 Ice cream and edible ices — GMP
  • 4.3 Processed fruits and vegetables — GMP
  • 5.1 Chocolate and cocoa products — GMPPermitted on the surface of chocolate only.
  • 5.2 Sugar confectionery — GMP
  • 5.4 Icings and frostings — GMP
  • 6.3 Processed cereal and meal products — GMP
  • 6.4 Flour products (including noodles and pasta) — GMP
  • 7 Breads and bakery products — GMP
  • 8.2 Processed meat, poultry and game products in whole cuts or pieces — GMP
  • 8.3 Processed comminuted meat, poultry and game products, other than products listed in item 8.3.2 — GMPNot for sausage or sausage meat containing raw, unprocessed meat.
  • 8.4 Edible casings — GMP
  • 8.5 Animal protein products — GMP
  • 9.2 Processed fish and fish products — GMP
  • 9.3 Semi preserved fish and fish products — GMP
  • 9.4 Fully preserved fish including canned fish products — GMP
Food Standards Code, Schedule 15, S15—5and 46 further provisionsretrieved 2026-10-17
CanadaHealth CanadaNo listing matchedHealth Canada’s lists name additives without E or INS numbers, so this site matches them by exact name. A substance listed there under a name this site does not recognise has no row here.
European UnionEuropean Commission / EFSAPermitted, with conditions

29 food categories

highest permitted level 500 mg/l

Show every food category
  • 1.4 flavoured fermented milk products including heat-treated products — 150 mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 150 mg/l. Period of application: from 1 August 2014. Note 74: Maximum limit for aluminium coming from all aluminium lakes 15 mg/kg. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 1.6.3 other creams — 150 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 150 mg/kg. only flavoured creams.
  • 1.7.1 unripened cheese excluding products falling in category 16 — 150 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 150 mg/kg. only flavoured unripened cheese.
  • 1.7.3 edible cheese rind — quantum satisAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. quantum satis. Period of application: from 1 August 2014. Note 67: Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines and E 180 litholrubine BK 10 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 1.7.5 processed cheese — 100 mg/kgAuthorised under E 161b, Lutein. ML = 100 mg/kg. only flavoured processed cheese. Note 33: Maximum individually or for the combination of E 100, E 102, E 120, E 122, E 160e and E 161b.
  • 1.7.6 cheese products (excluding products falling in category 16) — 100 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 100 mg/kg. only flavoured unripened products.
  • 12.4 Mustard — 300 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 300 mg/kg.
  • 12.5 Soups and broths — 50 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 50 mg/kg.
  • 12.9 Protein products excluding products covered in category 1 8 — 100 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 100 mg/kg. only meat and fish analouges based on vegetable proteins.
  • 13.2 Foods for special medical purposes as defined by Regulation (EU) No 609/2013 (excluding products from food category 13.1.5.) — 50 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 50 mg/kg.
  • 13.3 Total diet replacement for weight control food as defined by Regulation (EU) No 609/2013 — 50 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 50 mg/kg.
  • 14.2.3 Cider and perry — 200 mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 200 mg/l. excluding cidre bouché, cydr jakościowy, perry jakościowe, cydr lodowy, perry lodowe.
  • 14.2.4 Fruit wine and made wine — 200 mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 200 mg/l. excluding wino owocowe jakościowe.
  • 14.2.6 Spirit drinks as defined in Regulation (EU) 2019/787 — 200 mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 200 mg/l. except: spirit drinks as defined in categories 1-17, 22, 36, 37 and 41 of Annex I of Regulation (EU) 2019/787. Note 87: Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 14.2.7.3 Aromatised wine-product cocktails — 200 mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 200 mg/l. Note 87: Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 14.2.8 Other alcoholic beverages including mixtures of alcoholic beverages with non-alcoholic beverages and other alcoholic beverages based on distilled alcohol with alcoholic strength by volume less than 15 % — 200 mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 200 mg/l. only alcoholic beverages with alcoholic strength by volume less than 15 %. Note 87: Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 15.2 Processed nuts — 100 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 100 mg/kg. only savoury coated nuts.
  • 17.2 food supplements supplied in a liquid form excluding food supplements for Infants and young children — 100 mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 100 mg/l.
  • 18.2 Meal replacement for weight control as referred to in Commission Regulation (EU) No 432/2012 — 50 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 50 mg/kg.
  • 3 edible ices — 150 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 150 mg/kg. Note 25: The quantities of each of the colours E 122 and E 155 may not exceed 50 mg/kg or mg/l.
  • 4.2.4.1 fruit and vegetable preparations excluding compote — 200 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 200 mg/kg. only mostarda di frutta.
  • 4.2.5 jam jellies and marmalades and similar products — 100 mg/kgAuthorised under E 161b, Lutein. ML = 100 mg/kg. except chestnut puree. Note 31: Maximum individually or in combination with E 120, E 142, E 160d and E 161b.
  • 4.2.5.2 Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC — 100 mg/kgAuthorised under E 161b, Lutein. ML = 100 mg/kg. except chestnut purée.
  • 4.2.5.3 other similar fruit or vegetable spreads — 100 mg/kgAuthorised under E 161b, Lutein. ML = 100 mg/kg. except crème de pruneaux. Note 31: Maximum individually or in combination with E 120, E 142, E 160d and E 161b.
  • 6.6 Batters — 500 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 500 mg/kg. only batters for coating.
  • 8.3.3 Casings and coatings and decorations for meat — 500 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 500 mg/kg. only decorations and coatings except edible external coating of pasturmas Period of application: from 1 August 2014. Note 78: Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 10 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 9.2 Processed fish and fishery products including molluscs and crustaceans — 100 mg/kgAuthorised under E 161b, Lutein. ML = 100 mg/kg. only fish paste and crustacean paste. Note 35: Maximum individually or for the combination of E 100, E 102, E 120, E 122, E 142, E 151, E 160e, E 161b.
  • 9.2 Processed fish and fishery products including molluscs and crustaceans — 500 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 500 mg/kg. only surimi and similar products and salmon substitutes based on Theragra chalcogramma, Pollachius virens and Clupea harengus’. Note 84: Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 4 mg/kg. As a derogation to this rule, the maximum limit only for salmon substitutes shall be 5,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 9.3 fish roe — 300 mg/kgAuthorised under E 161b, Lutein. Permitted as a member of Group III, Colours with combined maximum limit. ML = 300 mg/kg. except Sturgeons' eggs (Caviar). Note 86: Maximum limit for aluminium coming from aluminium lakes of E 120 cochineal, carminic acid, carmines 3 mg/kg. As a derogation to this rule, the maximum limit only for pasteurised products shall be 50 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
Regulation (EC) No 1333/2008, Annex IIand 28 further provisionsretrieved 2026-10-18
Great BritainFood Standards Agency / Food Standards ScotlandPermitted, with conditions

37 food categories

highest permitted level 500 mg/kg or mg/l

Show every food category
  • 1.4 Flavoured fermented milk products including heat-treated products — 150 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 150. Period of application: from 1 August 2014. Note (74): Maximum limit for aluminium coming from all aluminium lakes 15 mg/kg. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 1.6.3 Other creams — 150 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 150. only flavoured creams.
  • 1.7.1 Unripened cheese excluding products falling in category 16 — 150 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 150. only flavoured unripened cheese.
  • 1.7.3 Edible cheese rind — quantum satisAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. quantum satis. Period of application: from 1 August 2014. Note (67): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine and E 180 litholrubine BK 10 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of this Regulation, that limit shall apply from 1 February 2013.
  • 1.7.5 Processed cheese — 100 mg/kg or mg/lAuthorised under E 161b, Lutein. ML = 100. only flavoured processed cheese. Note (33): Maximum individually or for the combination of E 100, E 102, E 120, E 122, E 160e and E 161b.
  • 1.7.6 Cheese products (excluding products falling in category 16) — 100 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 100. only flavoured unripened products.
  • 12.2.2 Seasonings and condiments — 500 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 500. only seasonings, for example curry powder, tandoori Period of application: from 1 August 2014. Note (70): Maximum limit for aluminium coming from all aluminium lakes 120 mg/kg. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 12.4 Mustard — 300 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 300.
  • 12.5 Soups and broths — 50 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 50.
  • 12.6 Sauces — 500 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 500. including pickles, relishes, chutney and picalilli; excluding tomato-based sauces Period of application: from 1 August 2014. Note (65): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 10 mg/kg. No other aluminium lakes may be used. For the puroposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 12.9 Protein products, excluding products covered in category 1.8 — 100 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 100. only meat and fish analogues based on vegetable proteins.
  • 13.2 Dietary foods for special medical purposes defined in Directive 1999/21/EC (excluding products from food category 13.1.5) — 50 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 50. Note (88): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 3 mg/kg only in liquid heat-treated products. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 13.3 Dietary foods for weight control diets intended to replace total daily food intake or an individual meal (the whole or part of the total daily diet) — 50 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 50.
  • 14.1.4 Flavoured drinks — 100 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 100. excluding chocolate milk and malt products Period of application: from 1 August 2014. Note (25): The quantities of each of the colours E 122 and E 155 may not exceed 50 mg/kg or mg/l. Note (74): Maximum limit for aluminium coming from all aluminium lakes 15 mg/kg. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 14.2.3 Cider and perry — 200 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 200. excluding cidre bouché.
  • 14.2.4 Fruit wine and made wine — 200 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 200. Excluding wino owocowe markowe.
  • 14.2.6 Spirit drinks as defined in Regulation (EC) No 110/2008 — 200 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 200. except: spirit drinks as defined in Article 5(1) and sales denominations listed in Annex II, paragraphs 1-14 of Regulation (EC) No 110/2008 and spirits (preceded by the name of the fruit) obtained by maceration and distillation, Geist (with the name of the fruit or the raw material used), London Gin, Sambuca, Maraschino, Marrasquino or Maraskino and Mistrà. Note (87): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 14.2.7.3 Aromatised wine-product cocktails — 200 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 200. Note (87): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 14.2.8 Other alcoholic drinks including mixtures of alcoholic drinks with non-alcoholic drinks and spirits with less than 15 % of alcohol — 200 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 200. only alcoholic drinks with less than 15 % of alcohol and nalewka na winie owocowym, aromatyzowana nalewka na winie owocowym, nalewka na winie z soku winogronowego, aromatyzowana nalewka na winie z soku winogronowego, napój winny owocowy lub miodowy, aromatyzowany napój winny owocowy lub miodowy, wino owocowe niskoalkoholowe and aromatyzowane wino owocowe niskoalkoholowe. Note (87): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 1,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 15.1 Potato-, cereal-, flour- or starch-based snacks — several limitsAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. (1) ML 100: excluding extruded or expanded savoury snack products Period of application: from 1 August 2014; (2) ML 200: only extruded or expanded savoury snack products Period of application: from 1 August 2014. Note (71): Maximum limit for aluminium coming from all aluminium lakes 30 mg/kg. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 15.2 Processed nuts — 100 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 100. only savoury-coated nuts.
  • 16 Desserts excluding products covered in categories 1, 3 and 4 — 150 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 150. Period of application: from 1 August 2014. Note (74): Maximum limit for aluminium coming from all aluminium lakes 15 mg/kg. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 17.1 Food supplements supplied in a solid form, excluding food supplements for infants and young children — 300 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 300. Period of application: from 1 August 2014. Note (69): Maximum limit for aluminium coming from all aluminium lakes 150 mg/kg. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 17.2 Food supplements supplied in a liquid form, excluding food supplements for infants and young children — 100 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 100.
  • 3 Edible ices — 150 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 150. Note (25): The quantities of each of the colours E 122 and E 155 may not exceed 50 mg/kg or mg/l.
  • 4.2.4.1 Fruit and vegetable preparations excluding compote — 200 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 200. only mostarda di frutta.
  • 4.2.5.2 Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC — 100 mg/kg or mg/lAuthorised under E 161b, Lutein. ML = 100. except chestnut purée. Note (31): Maximum individually or in combination with E 120, E 142, E 160d and E 161b.
  • 4.2.5.3 Other similar fruit or vegetable spreads — 100 mg/kg or mg/lAuthorised under E 161b, Lutein. ML = 100. except crème de pruneaux. Note (31): Maximum individually or in combination with E 120, E 142, E 160d and E 161b.
  • 5.2 Other confectionery including breath refreshening microsweets — several limitsAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. (1) ML 300: except candied fruit and vegetables Period of application: from 1 August 2014; (2) ML 200: only candied fruit and vegetables Period of application: from 1 August 2014. Note (25): The quantities of each of the colours E 122 and E 155 may not exceed 50 mg/kg or mg/l. Note (72): Maximum limit for aluminium coming from all aluminium lakes 70 mg/kg. As a derogation to this rule, the maximum limit only for microsweets shall be 40 mg/kg. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 5.3 Chewing gum — 300 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 300. Period of application: from 1 August 2014. Note (25): The quantities of each of the colours E 122 and E 155 may not exceed 50 mg/kg or mg/l. Note (73): Maximum limit for aluminium coming from all aluminium lakes 300 mg/kg For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 5.4 Decorations, coatings and fillings, except fruit based fillings covered by category 4.2.4 — several limitsAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. (1) ML 500: only decorations, coatings and sauces, except fillings Period of application: from 1 August 2014; (2) ML 300: only fillings Period of application: from 1 August 2014. Note (73): Maximum limit for aluminium coming from all aluminium lakes 300 mg/kg. For the puroposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013. Note (25): The quantities of each of the colours E 122 and E 155 may not exceed 50 mg/kg or mg/l.
  • 6.6 Batters — 500 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 500. only batters for coating.
  • 7.2 Fine bakery wares — 200 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 200. Period of application: from 1 August 2014. Note (25): The quantities of each of the colours E 122 and E 155 may not exceed 50 mg/kg or mg/l. Note (76): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22 (1) (g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 8.3.3 Casings and coatings and decorations for meat — several limitsAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. (1) ML 500: only decorations and coatings except edible external coating of pasturma s Period of application: from 1 August 2014; (2) quantum satis: only edible casings Period of application: From 1 August 2014. Note (78): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 10 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of this Regulation, that limit shall apply from 1 February 2013.
  • 9.2 Processed fish and fishery products including mollusks and crustaceans — 500 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 500. only surimi and similar products and salmon substitutes based on Theragra chalcogramma , Pollachius virens and Clupea harengus. Note (84): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 4 mg/kg. As a derogation to this rule, the maximum limit only for salmon substitutes shall be 5,5 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
  • 9.2 Processed fish and fishery products including mollusks and crustaceans — several limitsAuthorised under E 161b, Lutein. (1) ML 100: only fish paste and crustacean paste; (2) ML 250: only precooked crustacean. Note (35): Maximum individually or for the combination of E 100, E 102, E 120, E 122, E 142, E 151, E 160e, E 161b. Note (36): Maximum individually or for the combination of E 100, E 102, E 120, E 122, E 129, E 142, E 151, E 160e, E 161b.
  • 9.3 Fish roe — 300 mg/kg or mg/lAuthorised under E 161b, Lutein. Permitted as a member of Group III: Food colours with combined maximum limit. ML = 300. except Sturgeons' eggs (Caviar). Note (86): Maximum limit for aluminium coming from aluminium lakes of E 120 carminic acid, carmine 3 mg/kg. As a derogation to this rule, the maximum limit only for pasteurised products shall be 50 mg/kg. No other aluminium lakes may be used. For the purposes of Article 22(1)(g) of Regulation (EC) No 1333/2008 that limit shall apply from 1 February 2013.
Assimilated Regulation (EC) No 1333/2008, Annex II (as at 28 June 2024)and 36 further provisionsretrieved 2026-10-18
JapanConsumer Affairs AgencyNo listing matchedThis site imports only Japan’s list of designated additives (Appended Table 1 to the Regulations for Enforcement of the Food Sanitation Act), matched by English name. Existing additives, natural flavouring agents and ordinary foods used as additives are permitted outside that list and are not imported, so an empty row does not show that Japan does not permit the substance.
South KoreaMinistry of Food and Drug SafetyPermitted, with conditions
Designated food additive: Standards and Specifications for Food Additives, Part III, 1. …

Designated food additive: Standards and Specifications for Food Additives, Part III, 1. 일반식품첨가물 (general food additives), 알팔파추출색소 (“Alfalfa Extract”, the English the Code prints beside it). Main use (주용도) of 알팔파추출색소: 착색료. Standard for use (사용기준) of 알팔파추출색소: (1) [must not be used in the foods listed] “알팔파추출색소는 아래의 식품에 사용하여서는 아니 된다. 1. 천연식품〔식육류, 어패류, 과일류, 채소류, 해조류, 콩류 등 및 그 단순가공품(탈피, 절단 등)〕 2. 다류 3. 커피 4. 고춧가루, 실고추 5. 김치류 6. 고추장, 조미고추장 7. 식초” The Korean is the standard as published. There is no official English translation of the current Code (the English version on MFDS’s website is the 2020 edition and has no legal effect); the English in square brackets is this site’s description of what each sentence does, not a translation of the foods or the levels. Compositional specifications (Part IV) are not imported, nor are the general standards in Part II, which apply to every additive.

Standards and Specifications for Food Additives (식품첨가물의 기준 및 규격), MFDS Notification, Part III (Standards for use, by item)retrieved 2026-10-18
United StatesFood and Drug AdministrationNot listedDoes not appear on this jurisdiction’s permitted list. That is not the same as being prohibited.
Codex AlimentariusCodex Alimentarius Commission / JECFAPermitted, with conditions

3 food categories

highest permitted level 150 mg/kg

Show every food category and its notes
  • 01.1.4 Flavoured Fluid Milk Drinks — 100 mg/kg
    • Note 52 Excluding chocolate milk.
    • Note 400 Except for use in products conforming to the Standard for Fermented Milks (CXS 243-2003) at 150 mg/kg.
  • 01.7 Dairy-based desserts (e.g. pudding, fruit or flavoured yoghurt) — 150 mg/kg
    • Note 634 For use in products conforming to the Standard for Fermented Milks (CXS243-2003) only.
  • 04.2.2.7 Fermented vegetable (including mushrooms and fungi, roots and tubers, pulses and legumes, and aloe vera) and seaweed products, excluding fermented soybean products of food categories 06.8.6, 06.8.7, 12.9.1, — GMP
    • Note XS38 Excluding products conforming to the General Standard for Edible Fungi and Fungus Products (CODEX STAN 38-1981).
    • Note XS151 Excluding products conforming to the Standard for Gari (CXS 151-1985).
    • Note XS223 Excluding products conforming to the Standard for Kimchi (CXS 223-2001).
    • Note XS294 Excluding products conforming to the Standard for Gochujang (CXS 294-2009).
CXS 192-1995 Table Three, INS 161b(i)and 3 further provisionsretrieved 2026-09-07

How much is permitted

A listing usually limits the quantity as well as the food. Only one of the forms that takes is a figure: quantum satis and good manufacturing practice permit the amount the technological effect requires and no more, which is a limit rather than the absence of one. Figures below are the range across every food category this page is listed in, and categories differ between regulators — see how much is permitted.

Australia and New Zealand—47 GMP
European Union50 mg/kg – 500 mg/kg28 numeric limit, 1 quantum satis
Great Britain50 mg/kg – 500 mg/kg31 numeric limit, 5 several limits, 1 quantum satis
South Korea—1 no quantity stated
Codex Alimentarius100 mg/kg – 150 mg/kg2 numeric limit, 2 GMP

What it is made from

Extracted with solvents from the dried petals of the Aztec marigold, Tagetes erecta, then saponified to free the lutein from the fatty acid esters it occurs as in the flower.

  • Vegan
  • Vegetarian

Compare other additives on the dietary indexes.

CAS registry number
127-40-2
InChIKey
KBPHJBAIARWVSC-RGZFRNHPSA-N
PubChem
CID 5281243

The two specifications, compared

The European Union sets identity and purity by regulation; JECFA publishes its own through FAO, advisory until a country adopts it. Both documents are below in full. These are the parameters each puts a number on.

ParameterEuropean UnionJECFA
Assayno less than 4 %stated in prose
Leadno more than 3 mg/kgno more than 5 mg/kg
Arsenicno more than 3 mg/kg—
Mercuryno more than 1 mg/kg—
Cadmiumno more than 1 mg/kg—

One parameter differs between the two documents. A difference is not a disagreement about safety: the two are revised on their own cycles, and an assay or a drying loss can be measured against a different preparation of the substance, which is why only the contaminant ceilings are marked. Within the EU the EU's figure is the one that binds.

How the EU defines it

The legal specification an additive must meet to be sold as this E number in the EU — what it is, how it may be made, and the purity it must reach. From Commission Regulation (EU) No 231/2012.

E 161b Lutein

Lutein is obtained by solvent extraction of the strains of edible fruits and plants, grass, lucerne (alfalfa) and Tagetes erecta. The main colouring principle consists of carotenoids of which lutein and its fatty acid esters account for the major part. Variable amounts of carotenes will also be present. Lutein may contain fats, oils and waxes naturally occurring in the plant material. Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, methyl ethyl ketone and carbon dioxide

Synonyms: Mixed Carotenoids; Xanthophylls

Assay, identification and purity criteria

Description and assay

Einecs
204-840-0
Chemical name
3,3′-dihydroxy-d-carotene
Chemical formula
C₄₀H₅₆O₂
Molecular weight
568,88
Assay
Content of total colouring matter not less than 4 % calculated as lutein [image] 2 550 at ca. 445 nm in chloroform/ethanol (10 + 90) or in hexane/ethanol/acetone (80 + 10 + 10)
Description
Dark, yellowish brown liquid

Identification

Spectrometry
Maximum in chloroform/ethanol (1:9) at ca. 445 nm

Purity criteria

Solvent residues
Acetone [image] | Not more than 50 mg/kg, singly or in combination Methyl ethyl ketone Methanol Ethanol Propan-2-ol Hexane
Arsenic
Not more than 3 mg/kg
Lead
Not more than 3 mg/kg
Mercury
Not more than 1 mg/kg
Cadmium
Not more than 1 mg/kg

Commission Regulation (EU) No 231/2012, Annex, E 161b

How JECFA defines it

The international specification for identity and purity, prepared by the Joint FAO/WHO Expert Committee on Food Additives and published by FAO. It is a different document from any above, written by a different body and revised on its own cycle; it is advisory, and a country adopts it or does not.

Mixed Carotenoids

Mixed carotenoids are obtained by solvent extraction of alfalfa, removal of chlorophylls through saponification and subsequent purification of the carotenoids by solvent extraction. The main colouring principle consists of carotenoids of which lutein accounts for the major part. Variable amounts of neoxanthin, violaxanthin and ß-carotene are present. Mixed carotenoids may contain fats, oils and waxes naturally occurring in the plant material. Vegetable oils may be added for standardizing purposes. Only the following solvents may be used for the extraction: methanol, ethanol, propan-2-ol, hexane, acetone, dichloromethane and methyl ethyl ketone. (Note: Articles of commerce may contain approved food additives in order to formulate water soluble products.)

Assay, identification and purity criteria

Description and assay

Specification history
Prepared at the 49th JECFA (1997), published in FNP 52 Add 5 (1997) superseding specifications prepared at the 37th JECFA (1990), published in FNP 52 (1992). Metals and arsenic specifications revised at the 59th JECFA (2002). No ADI was allocated at the 31st JECFA (1987)
Chemical name
Lutein: 3,3'-dihydroxy-d-carotene; ß,epsilon-carotene-3,3'-diol
C.A.S. number
Lutein: 127-40-2
Chemical formula
Lutein: C 40 H 56 O 2
Formula weight
Lutein: 568.88
Assay
Total colouring matter (as lutein) not less than declared
DESCRIPTION
Dark, yellowish brown liquids with a weak hay-like odour
FUNCTIONAL USES
Colour
METHOD OF ASSAY
Proceed as directed in Volume 4, General Methods , Methods for Food Colours, Colouring Matters, Total Content by Spectrophotometry, Procedure 2, using the following conditions: W = amount (g) to obtain adequate absorbance V 1 = V 2 = V 3 = 100 ml v 1 = v 2 = 10 ml A 1% = 2500 1cm lambda max = app. 445 nm

Identification

Solubility (Vol. 4)
Insoluble in water; soluble in hexane.
Spectrophotometry (Vol. 4)
A chloroform solution of the sample shows maximum absorption at about 445 nm
Carr-Price test
A solution of the sample in chloroform turns blue on addition of an excess of Carr-Price TS.

Purity criteria

Synthetic colours
Samples should be free of synthetic pigments, canthaxanthin, and apocarotenoic acid ethyl ester. See description under TESTS
Residual solvent (Vol. 4)
Acetone, methanol, ethanol, propan-2-ol, and hexane, not more than 50 mg/kg, singly or in combination. Dichloromethane and methyl ethyl ketone, not more than 10 mg/kg, individually.
Lead (Vol. 4)
Not more than 5 mg/kg Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4, “Instrumental Methods.”
Test: Synthetic colours
Unknown samples are compared to authentic alfalfa carotenoids. Ground dried alfalfa is extracted with dichloromethane. The extract is saponified and the carotenoids separated by reverse phase liquid chromatography. This test is qualitative and is intended to differentiate alfalfa mixed carotenoids from artificial colours. Apparatus High pressure liquid chromatograph (HPLC) equipped with a variable wavelength detector, a Zorbax ODS 150 mm x 4.6 mm id reverse phase column or equivalent, and a suitable 10-μl injection value. Reagents Acetonitrile, dichloromethane, ethyl acetate, acetone (all HPLC grade), n-decanol, butylated hydroxytoluene (BHT), potassium hydroxide, methanol, sodium sulfate (all analytical reagent or better grade). Add 1 g/l of BHT to all solvents. Add 0.1% (v/v) n-decanol to all mobile phases. Chromatography and detection Mobile phase: ethyl acetate: acetonitrile (12:88) 1.6 ml/min; injection volume 10 μl; detector wavelength 450 nm, full scale range 0.16 AUFS. Procedure Grind dried alfalfa to pass 1-mm mesh screen and thoroughly mix. Accurately weigh 1-2 g sample in a glass stoppered boiling tube. Add 30 ml dichlormethane: acetone (2:1) and shake. Let stand overnight. Add 20 ml dichloromethane, 2 ml 40% (w/v) methanolic potassium hydroxide, shake, and let stand 60 min. Add 30 ml of 10% (w/v) aqueous sodium sulfate, shake, and let stand 60 min. Remove an aliquot of the lower layer and centrifuge 10 min at 2000 rpm. Remove a 3-ml aliquot of the lower yellow layer, mix with 3 ml acetonitrile, and use this solution for analysis. Unknown mixed carotenoid samples are prepared by dissolving a 0.1-0.2 g sample in 50 ml of dichloromethane:acetonitrile (1:1). Inject 10 μl of alfalfa mixed carotenoid standard followed by 10 μl of unknown mixed carotenoid sample and compare chromatograms. The approximate retention times for neoxanthin, violaxanthin, lutein, zeaxanthin, alpha-carotene, and ß-carotene are 3.5, 3.9, 6.0, 7.0, 18, and 19 min, respectively. Synthetic pigments, canthaxanthin, and apocarotenoic acid ethyl ester elute just before lutein.

FAO JECFA Monograph 1 (2006)

INS 161b(i) Lutein from Tagetes erecta

Lutein from Tagetes erecta is a purified extract of xanthophylls obtained from oleoresin in marigold. The oleoresin is prepared from hexane extracts of Tagetes erecta L. flowers, saponified with potassium hydroxide in either methanol or propylene glycol. The resulting reaction mixture is diluted with water and dried. The crystalline product contains lutein along with minor components that include other carotenoids and waxes.

Synonyms: INS No. 161b(i), Vegetable lutein; vegetable luteol; Bo-Xan, luteine Bo-Xan (lutein); Vegetable llutein

Assay, identification and purity criteria

Description and assay

Specification history
2 out of 7 Prepared at the 86 th JECFA (2018) and published in FAO JECFA Monograph 22 (2018), superseding specifications prepared at the 63rd JECFA (2004) and published in FNP52 Add 12 (2004). A group ADI of “not specified” was established for Tagetes extract, Lutein from Tagetes erecta, Lutein esters from Tagetes erecta, Zeaxanthin (synthetic), and meso-zeaxanthin at the 86 th JECFA (2018) superseding the group ADI of 0 - 2 mg/kg bw for lutein from T. erecta L. and synthetic zeaxanthin established at the 63rd JECFA (2004).
Chemical names
3R,3’R,6’R- β,ε -carotene-3,3'-diol; all- trans -lutein; 4’,5’- didehydro-5’,6’-dihydro-beta,beta-carotene-3,3’-diol
C.A.S. number
127-40-2
Chemical formula
C40H56O2
Formula weight
568.88
Assay
Not less than 80% total carotenoids, not less than 70% lutein
DESCRIPTION
A free-flowing, orange-red powder
FUNCTIONAL USES
Colour, nutrient supplement 3 out of 7
METHOD OF ASSAY
Determine the total carotenoid content and the content of lutein and zeaxanthin by UV spectrophotometry and HPLC using the following conditions: Reagents: - Hexane (HPLC grade) - Ethyl acetate (HPLC grade) - Acetone - Dehydrated ethyl alcohol (absolute alcohol) - Toluene - Solvent Mixture: (10:6:7:7 hexane:dehydrated ethyl alcohol:acetone:toluene, v/v/v/v) System Suitability Solution for HPLC: 150 μg/ml of lutein standard in solvent mixture (use USP Lutein RS available from U. S. Pharmacopeia, or equivalent standard) Apparatus UV/Vis spectrophotometer; 1-cm cuvettes HPLC system with suitable diode array detector, autosampler, column oven, signal processor and degasser. Analytical column: 3 μm silica, 4.6 mm x 250 mm Instrument Conditions - Temperature: ambient - Mobile Phase: 70:30 (v:v) hexane/ethyl acetate (isocratic elution) - Flow Rate: 1.5 ml/min - Injection: 10 μl 7 out of 7 - Detection: UV/Vis 446 nm - Run Time: approximately 40 min Concentrated Sample Preparation For the UV/Vis spectrophotometry weigh sample (30 mg) into a glass weighing funnel. Using the solvent mixture, wash crystals into a 100 ml volumetric flask, dilute to the mark with the solvent mixture and stir for 10 min. Sample Preparation Pipette 1 ml of concentrated sample preparation into a 100 ml volumetric flask. Dilute up to the mark with dehydrated ethyl alcohol, mix by inversion for 20 seconds. Read samples in a spectrophotometer at 446 nm using dehydrated ethyl alcohol as the blank. For HPLC, evaporate 1 ml of the concentrated sample preparation to dryness using a stream of nitrogen, dissolve solids in 1 ml 70:30 hexane:ethyl acetate, and add 0.5 ml to HPLC vials. Analyze this sample and the system suitability solution for HPLC using the HPLC conditions above. Results Compare the results of the chromatogram from the system suitability solution for HPLC to identify the lutein and zeaxanthin peaks at a resolution of not less than 3. Calculation Using the results obtained from the UV/Vis spectrophotometry calculate the % Total carotenoids Absorbance at 446 nm × 10000 × 100 % Total carotenoids = sample weight in g × 2550 Note: The factors 10000 and 2550 are the dilution factor and extinction value for a 1% solution, respectively. Using the chromatogram of the sample, calculate the concentration of lutein and zeaxanthin. 𝑃𝑃 𝐿𝐿𝑇𝑇 𝑃𝑃 𝐴𝐴 𝑐𝑐𝐿𝐿𝑇𝑇 𝐿𝐿𝐿𝐿 𝑇𝑇 𝐿𝐿𝐿𝐿𝐿𝐿 𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿𝐿 (%) = % 𝑇𝑇𝑇𝑇 𝐿𝐿 𝑇𝑇𝑇𝑇 𝑐𝑐 𝑇𝑇 𝑐𝑐 𝑇𝑇𝐿𝐿𝐿𝐿𝐿𝐿𝑇𝑇𝐿𝐿 𝑐𝑐𝑐𝑐 × 𝑃𝑃 𝐿𝐿𝑇𝑇 𝑃𝑃 𝐴𝐴 𝑐𝑐𝐿𝐿𝑇𝑇 𝑇𝑇𝑇𝑇𝑇𝑇 𝐴𝐴𝐿𝐿 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝐴𝐴𝐴𝐴 𝑃𝑃𝑃𝑃 𝑍𝑍𝑍𝑍 𝐴𝐴 𝑍𝑍 𝐴𝐴 𝑍𝑍𝑍𝑍𝑍𝑍𝑍𝑍𝑍𝑍 𝑍𝑍 𝐿𝐿𝑇𝑇 𝑍𝑍 𝑇𝑇𝐿𝐿𝐿𝐿 ℎ 𝐿𝐿𝐿𝐿 (%) = % 𝑇𝑇𝑇𝑇 𝐿𝐿 𝑇𝑇𝑇𝑇 𝑐𝑐 𝑇𝑇 𝑐𝑐 𝑇𝑇𝐿𝐿𝐿𝐿𝐿𝐿𝑇𝑇𝐿𝐿 𝑐𝑐𝑐𝑐 × 𝑃𝑃𝑃𝑃𝑃𝑃𝑃𝑃 𝐴𝐴𝐴𝐴 𝑃𝑃𝑃𝑃 𝑍𝑍 𝑇𝑇 𝑍𝑍𝐴𝐴 𝑇𝑇

Identification

Solubility (Vol. 4)
Insoluble in water, soluble in hexane
Spectrophotometry (Vol. 4)
A 2 mg/l solution in acetone shows maximum absorbance at approximately 446 nm.
Test for carotenoids (Vol. 4)
The colour of 2 ml of a 2 – 4 mg/l solution of the sample in acetone immediately disappears after successive addition of about 0.5 ml of 5% sodium nitrite and about 0.5 ml of 0.5 M sulfuric acid.

Purity criteria

Moisture (Vol. 4)
Not more than 1.0%
Ash (Vol. 4)
Not more than 1.0%
Zeaxanthin
Not more than 9.0% See description under METHOD OF ASSAY
Lead (Vol. 4)
Not more than 3 mg/kg. Determine using a method appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the methods described in Vol. 4 (under “General Methods, Metallic Impurities”).
Hexane (Vol. 4)
Not more than 50 mg/kg
Methanol (Vol. 4)
Not more than 10 mg/kg
Propylene glycol
Not more than 1000 mg/kg See description under TESTS
Waxes
Not more than 14.0% See description under TESTS 4 out of 7
Test: Propylene glycol
Determine by gas chromatography (Vol. 4) under the following conditions. Internal standard solution Prepare a 500 μg/ml solution of ethylene glycol in tetrahydrofuran. Standard solutions Prepare a range of standard solutions containing 1, 5, 10, 25 and 50 μg/ml of propylene glycol and 5 μg/ml of ethylene glycol in tetrahydrofuran. Chromatography conditions - Column: Polydimethylsiloxane (30 m x 0.32 mm i.d. with 0.25 μm film) - Carrier gas: Helium - Flow rate: 1.5 ml/min (Constant flow) - Detector: FID - Temperatures: injection port: 230° - Column Temperature: Hold for 3 min at 40°, then 40-250° at 20°/min, hold for 5 min at 250° - Detector Temperature: 270° The retention times of ethylene glycol and propylene glycol derivatives under the above conditions are approx. 7.6 min and 7.8 min, respectively. Procedure Weigh accurately 1 g of the sample into a 10-ml volumetric flask, and add 100 μl of the internal standard solution. Dissolve and make up to volume with tetrahydrofuran. Take 0.5 ml of the sample solution in a centrifugation tube, and add 0.25 ml of 1,1,1,3,3,3-hexamethyldisilazane (HMDS) and 0.1 ml of trimethylchlorosilane (TMCS). After sealing the tube, shake it vigorously, let stand for 30 min at room temperature, then centrifuge. Inject 1 .0 μl of this centrifugal supernatant into the chromatograph. Standard curve Prepare following the same procedure using 0.5 ml of the 5 out of 7 standard solutions in place of the sample solution. Calculate the concentration of propylene glycol in mg/kg (CPG) from: CPG (mg/kg) = C × 10 / W where C is polyethylene glycol concentration determined (μg/ml); and W is weight of sample (g)
Test: Waxes
Determine by gas chromatography (Vol. 4) using the following conditions: - GC column DB- 5 (30 m x 0.25 mm ID with a 0.25 μm film thickness) or equivalent. - GC injector temperature: 280° - FID temperature: 350° - GC temperature program: 50° (2 min) 13°/min to 340° and hold for 8 min - Carrier gas (Helium) flow rate: 1.0 ml/min - Injection mode: splitless - Injection volume: 1.0 μl Standards: - Hydrocarbons mixed standard: C25 to C46 - Internal standard: Hexatriancontane (C36) Standard solutions: Prepare standard solutions by addition of hydrocarbon standards to methylene chloride to get hydrocarbon concentrations of 2.0, 5.0, 10, 25, 50, mg/l respectively. Add required quantity of hexatriancontane internal standard to get a final concentration 50 mg/l in all standard solutions. Sample Preparation Accurately weigh 100 mg of sample into a centrifuge tube and dissolve in exactly 20 ml of methylene chloride. Sonication or vortex mixing may be required to completely dissolve the product. Centrifuge sample at 2500 rpm for 5 min, if the sample appears turbid. Add 1.6 ml of methyl ene chloride and 20 μl of (5000 mg/l) hexatriancontane solution (to a final concentration of 50 mg/l) into 2 ml volumetric flask. Transfer 40 μl of sample solution and dilute with methylene chloride to the 2 ml. Transfer the solution into a 2 ml autosampler vial. Analysis 6 out of 7 Inject 1.0 μl of each of the standards solution s. Record the peak areas. Construct standard curves using the peak ratios of each hydrocarbon to the internal standard against the concentration of the hydrocarbon. Inject 1.0 μl of the sample solution and determine individual wax in the sample (mg/l) from the respective standard curve. Add the concentration of individual waxes to get the total wax concentration in the sample solution (mg/l) Calculation: C (mg/l) × 2 ml × 20 ml × 100 Waxes % w/w = 1000 (ml/l) × W (mg) × 0.04 ml = (100 × C)/W Where: C is the total concentration of waxes, mg/l in the sample W is the weight of sample, mg

FAO JECFA Monograph 22 (2018)

INS 161b(ii) Tagetes Extract

The major colouring principles are lutein and its dipalmitate (helenien), obtained by hexane extraction of dried petals of Tagetes erecta L. with subsequent removal of the solvent. Other hydroxy derivatives of carotenes may be present together with other oxyderivatives such as epoxides; may contain fats, oils and waxes naturally occurring in the plant material. Products of commerce are normally further formulated e.g. in order to standardise the colour content or to obtain water soluble/dispersible products.

Synonyms: Xanthophylls, INS No. 161b(ii) Xanthophylls

Assay, identification and purity criteria

Description and assay

Specification history
Prepared at the 57th JECFA (2001) and published in FNP 52 Add 9 (2001), superseding tentative specifications prepared at the 55th JECFA (2000) and published in FNP 52 Add 8 (2000). No ADI was allocated at the 31st JECFA (1987).
Chemical names
Lutein: β , ε -Carotene-3,3'-diol, Helenien: Lutein dipalmitate; β , ε -Carotene-3,3'-diol dipalmitate
C.A.S. number
127-40-2 (Lutein)
Chemical formula
Lutein: C 40 H 56 0 2 Helenien: C 72 H 116 0 4
Structural formula
Lutein: R = H Helenien: R = CH 3 (CH 2 ) 14 CO
Formula weight
Lutein: 568.88 Helenien: 1045.71
Assay
Content of total colouring matter (calculated as lutein) not less than declared
DESCRIPTION
Dark yellow-brown liquid
FUNCTIONAL USES
Colour
METHOD OF ASSAY
Accurately weigh 0.5 - 1.5 g of the sample into a 50 ml volumetric flask. Add about 30 ml of a 1:1 mixture of cyclohexane and ethanol (96%) and swirl gently until the sample is dissolved. Fill to the mark with cyclohexane/ethanol mixture and mix well. Pipette 0.200 ml of the solution into a 25 ml volumetric flask. Make up to mark with cyclohexane/ethanol and mix well. Measure the absorbance at maximum of about 444 nm using cyclohexane/ethanol mixture as blank. The absorbance should be between 0.2 and 0.8, otherwise an appropriate dilution must be prepared. Calculation: Where A = absorbance V 1 = Volume of fist volumetric flask (ml) V 2 = Volume of second volumetric flask (ml) 2900 = specific absorbance for lutein in cyclohexane/ethanol at 444 nm v = volume of pipette (0.200 ml) W = weight of sample (g)

Identification

Solubility (Vol. 4)
Insoluble in water; soluble in hexane
Spectrophotometry
An acetone solution of the sample shows maximum absorption at about 444 nm
Positive test for carotenoids
The colour of a solution of the sample in acetone disappears after successive addition of a 5% solution of sodium nitrite and 0.5 M of sulfuric acid.

Purity criteria

Residual solvent (Vol. 4)
Hexane: not more than 50 mg/kg
Lead (Vol. 4)
Not more than 2 mg/kg Determine using an atomic absorption technique appropriate to the specified level. The selection of sample size and method of sample preparation may be based on the principles of the method described in Volume 4, "Instrumental methods".

FAO JECFA Monograph 3 (2006)

Every name it appears under

81 recorded names. A label may use any of them.

E number

  • E161
  • E161B

INS number

  • 161b(i)

CAS registry number

  • 127-40-2

As it appears in regulation

  • Lutein

Other names

  • ( inverted exclamation markA)-Lutein
  • ()-Lutein
  • (3R,3'R,6'R)-beta,epsilon-carotene-3,3'-diol
  • (3R,3'R,6'R)-Lutein
  • (all-E)-Lutein
  • .beta.,.epsilon.-Carotene-3,3'-diol
  • .beta.,.epsilon.-Carotene-3,3'-diol, (3R,3'R,6'R)-
  • ?-Carotene-3,3'-diol
  • A1LXP
  • all-trans-(+)-Xanthophyll
  • all-trans-Lutein
  • all-trans-Xanthophyll
  • beta,epsilon-Carotene-3, 3'-Diol, (3R,3'R,6'S)-
  • beta,epsilon-Carotene-3,3'-diol
  • beta,epsilon-Carotene-3,3'-diol, (3R,3'R,6'R)-
  • beta,epsilon-Carotene-3,3'-diol, (3S,3'R,6'S)-
  • Bo-Xan
  • Citranaxanthin
  • E 161(i) (feed)
  • E 161b
  • e-carotene-3,3'-diol
  • FloraGLO
  • FloraGLO Lutein
  • gamma Lutein
  • INS NO.161B(I)
  • INS-161B(I)
  • Leutein
  • Leutin
  • Lutamax
  • Lutein
  • Lutein (Standard)
  • Lutein (Xanthophyll)
  • Lutein - 10%
  • Lutein - 20%
  • Lutein - 5%
  • Lutein - 50%
  • Lutein - 95%
  • Lutein A
  • Lutein ester
  • LUTEIN FROM TAGETES ERECTA
  • Lutein Powder
  • Lutein, 88%
  • Lutein, all-trans-
  • Lutein, analytical standard
  • Lutein, gamma
  • Lutein; Xantofyl
  • Mixed Carotenoids
  • Noon for Kids
  • Oro Glo 7
  • trans-Lutein
  • Vegetable lutein
  • Vegetable luteol
  • Xanthophyll (~80%)
  • XANTHOPHYLL [MI]
  • Xanthophyll, all-trans-(+)-
  • Xanthophyll, from marigold
  • Xanthophyll, tech grade
  • Xanthophylls
  • Xantofyl

Systematic names

  • (1R)-4-[(1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-[(1R,4R)-4-hydroxy-2,6,6-trimethylcyclohex-2-en-1-yl]-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaenyl]-3,5,5-trimethylcyclohex-3-en-1-ol
  • (1R,4R)-4-((1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-((R)-4-hydroxy-2,6,6-trimethylcyclohex-1-en-1-yl)-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl)-3,5,5-trimethylcyclohex-2-en-1-ol
  • (1R,4R)-4-((1E,3E,5E,7E,9E,11E,13E,15E,17E)-18-((R)-4-hydroxy-2,6,6-trimethylcyclohex-1-en-1-yl)-3,7,12,16-tetramethyloctadeca-1,3,5,7,9,11,13,15,17-nonaen-1-yl)-3,5,5-trimethylcyclohex-2-enol
  • (3E,5E,7E,9E,11E,13E,15E,17E,19E)-5,9,14,18-tetramethyl-20-(2,6, 6-trimethylcyclohexen-1-yl)icosa-3,5,7,9,11,13,15,17,19-nonaen-2-one
  • 4-(18-(4-hydroxy-2,6,6-trimethyl-1-cyclohex-2-enyl)-3,7,12,16-tetramethyl-octadeca-1,3,5,7,9,11,13,15,17-nonaenyl)-3,5,5-trimethyl-cyclohex-3-en-1-ol

The EU re-evaluation programme

Every additive authorised in the EU before 20 January 2009 was put back through EFSA by Commission Regulation (EU) No 257/2010, and this one is named in it. What the Regulation required is below; whether the opinion has since been published is not something this site records.

  • To be evaluated by 31 December 2010. Named in Annex II, Part I, point 2 as “Lutein”, among the additives given priority within its class.

Hazard reference values

Values set by assessing bodies. A body that has not set a value is not listed here.
TypeValuePopulationAssessed byOpinion
ADI1 mg/kg bw/dayconsumersEFSAnot identified in the dataset

Evidence and how bodies read it

What assessing bodies concluded

Each conclusion is paraphrased in the body's own framing, from the published opinion linked beneath it. Where bodies differ, both stand; this site does not adjudicate between them or add a view of its own.

  1. EFSA 2011

    Reviewing additional studies on lutein esters from Tagetes erecta, the ANS Panel concluded that the ADI of 1 mg/kg bw/day also covers lutein preparations present as esters at levels of at least 60%, and that the esters raise no concern for genotoxicity. It considered the data too limited to extend the ADI to lower-purity preparations or other sources.

    Source document

  2. EFSA 2010

    The ANS Panel established an ADI of 1 mg/kg bw/day for lutein (E 161b), applying an uncertainty factor of 200 because multigeneration and long-term studies were lacking, and specified that it refers to lutein from Tagetes erecta with at least 80% carotenoids. It concluded that refined intake estimates at current use levels were above the ADI at the upper end of the range.

    Source document

Common questions

Assembled from what is above, in the words the questions are usually asked in. Each answer is the same statement the relevant section makes, with the same citations behind it.

What is E 161b?
E 161b is Lutein from Tagetes erecta. Lutein is a yellow carotenoid obtained from marigold petals, used to colour drinks, dairy products and confectionery. The same substance is sold as a dietary supplement, which is a separate regulatory question from its use as a colour.
What is Lutein from Tagetes erecta used for in food?
It is listed as a colour — the role Codex and the EU assign it. This page shows every function each regulator records, with the citation for each.
Where is Lutein from Tagetes erecta permitted?
Of the seven regulators this site reads, Australia and New Zealand, the EU, Great Britain, South Korea and the Codex standard permit it. Each permission is for named foods at named levels, not a blanket one; the table on this page gives them with citations.
Is Lutein from Tagetes erecta vegan?
Yes. Lutein from Tagetes erecta is not derived from animals, and is suitable for vegetarians. This page says what it is made from and how.

Sources for this page

  • anz retrieved 2026-10-17
  • eu retrieved 2026-10-18
  • gb retrieved 2026-10-18
  • kr retrieved 2026-10-18
  • gsfa retrieved 2026-09-07
  • euspecs retrieved 2026-10-18
  • jecfaspecs retrieved 2026-09-23

Full licence terms and publisher details on Sources. How this page is built and updated: Method.

Machine-readable: a JSON record of this additive is given on request —how to ask for access.

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