Lutein esters from Tagetes erecta

INS 161b(iii)

Listed as a colour by Codex and the EU.

Listed as colours (EU, Codex)

Lutein esters from marigold are a yellow food colour. The same flower is fed to hens to deepen yolk colour, but here the extracted pigment is added to food directly.

Where it is and isn’t permitted

Status of Lutein esters 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 ZealandNo listed food uses foundThis site has not matched this substance to any food use on this jurisdiction’s list of authorised food additives. A food additive may be used only in foods that list names. Flavourings, enzymes, processing aids and added nutrients are regulated separately and do not appear on it.Related listing with permitted uses here: Lutein from Tagetes erecta (E161b). This site cannot tell whether that listing covers this exact form.
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 SafetyNo listing matchedThis site imports Part III of South Korea’s Standards and Specifications for Food Additives, matched by CAS number, then INS number, then exact name. Mixed preparations and sanitisers are not imported, and an entry whose identifiers disagreed with a page’s is held for review, so an empty row does not show that South Korea does not permit the substance.Related listing with permitted uses here: Lutein from Tagetes erecta (E161b). This site cannot tell whether that listing covers this exact form.
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

no numerical limit (good manufacturing practice)

CXS 192-1995 Table Three, INS 161b(iii)retrieved 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.

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
Codex Alimentarius—1 GMP

What it is made from

Extracted from the flowers of Tagetes erecta, the Aztec marigold, where lutein occurs bound to fatty acids as esters.

  • Vegan
  • Vegetarian

Compare other additives on the dietary indexes.

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.

INS 161b(iii) Lutein esters from Tagetes erecta

Lutein esters from Tagetes erecta is obtained by solvent extraction of dried petals of Tagetes erecta L., further purification and subsequent removal of solvents under vacuum. Lutein diesters account for the major part and a smaller proportion of zeaxanthin diesters is also present. The esters contain saturated long chain fatty acids, such as myristic, palmitic and stearic acid in various proportions with palmitic acid being a major component. Waxes naturally occurring in the source material may also be present. Only the following solvents may be used in the production: methanol, ethanol, 2-propanol, hexane, acetone, methyl ethyl ketone and carbon dioxide. Usually food grade antioxidants are added to stabilize the product. Products of commerce are normally further formulated e.g. in order to standardize colour content or to obtain water soluble/dispersible products

Synonyms: Xanthophyll esters Xanthophylls

Assay, identification and purity criteria

Description and assay

Specification history
Prepared at the 82nd JECFA (2016) and published in FAO JECFA Monograph 19 (2016), superseding tentative specifications for Lutein esters from Tagetes erecta prepared at the 79th JECFA (2014), published in FAO JECFA Monographs 16 (2014). An ADI ”not specified” was established at the 82nd JECFA (2016).
Chemical formula
Lutein esters: R = CH3(CH2)10CO, CH3(CH2)12CO, CH3(CH2)14CO or CH3(CH2)16CO
Formula weight Assay
496.43 Not less than 75% total carotenoid esters (as lutein esters)
DESCRIPTION
Dark orange brown solid
FUNCTIONAL USES
Colour, nutrient
METHOD OF ASSAY
Determine the total content of carotenoid esters as follows: Apparatus: UV/VIS spectrophotometer 1-cm cuvettes Sample analysis: Accurately weigh about 1.0 g of the sample into a 100 ml volumetric flask. Add about 80 ml hexane and 5 ml 2-propanol. Place the volumetric flask into an ultrasonic bath for 5 min to achieve complete dissolution. Let cool to room temperature. Adjust to the 100 ml volume mark with hexane. Mix well. Make serial dilutions with hexane such that the absorbance at 428 nm falls between 0.2 and 0.8.. Measure absorbance of the sample at 428 nm (inflection point of the curve, isosbestic point of all lutein isomers) using hexane as blank. Calculation: Total carotenoid ester content (% w/w) = Abs x d x 100 A 1% 1cm isosbestic xW Where: Abs is the measured absorbance d is the dilution factor A 1% 1cm isosbestic (specific absorbance of lutein ester at the wavelength of the isosbestic point) = 898 W is the weight of sample (g)

Identification

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

Purity criteria

Ash (Vol. 4)
Not more than 1%
Zeaxanthin (Vol. 4)
Not more than 10% of total carotenoids. See description under TESTS.
Residual solvents (Vol. 4)
Determine using method (I) Hexane Methanol Not more than 50 mg/kg, Ethanol singly or in combination 2-Propanol Acetone Methyl ethyl ketone
Waxes
Not more than 25%. See description under TESTS)
Lead (Vol. 4)
Not more than 2 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 method described in Volume 4 (under “General Methods, Metallic Impurities”)..”
Test: Zeaxanthin
Principle The saponified sample is analysed by reversed phase liquid chromatography (HPLC). Reagents Extraction solvent: Hexane:acetone:toluene:absolute ethanol (10:7:7:6) 40% Methanolic potassium hydroxide: Dissolve 40 g of KOH in about 50 ml methanol. Dilute to 100 ml with methanol. 10% Sodium sulfate solution: Dissolve 10 g of sodium sulfate in 100 ml water. Hexane, HPLC-grade Ethyl acetate, HPLC-grade Chromatography Column: 250 mm x 4.6 mm i.d. beta-cyclodextrin (Cyclobond I or equivalent) Mobile phase: Hexane/Ethyl acetate (75/25) Filter through a 0.45μm membrane Flow rate: 1.0 ml/min Detector wavelength: UV/Vis or PDA at 445nm Injection volume: 10 μl Procedure Weigh about 10 mg of sample and transfer into a 100 ml round bottom flask. Dissolve in 30 ml of extraction solvent. Add 2 ml methanolic potassium hydroxide solution. Attach a reflux condenser to the flask to prevent loss of solvent. Place flask in a 56° water bath for 20 min. Cool sample and transfer to a 100 ml volumetric flask using a small volume of extraction solvent. Let stand in the dark for 1 h. Add 30 ml of hexane, swirl for 1 min. Dilute with sodium sulfate solution up to the 100 ml mark. Shake 1 min. Let stand in the dark until organic layer (top layer) is clear (about 1 h). Transfer 1 ml of organic layer to a scintillation vial. Evaporate to almost dry under vacuum at 45°. Dissolve residue with 1 ml mobile phase. Inject 10 μl of this solution into the chromatograph. Results A typical chromatograph should look as follows. Integrate the area under peaks at ca: 18min (di-cis lutein) 19.5 min(trans lutein) 22 min(trans zeaxanthin) 32 min (9-cis lutein) 37.6 min (13-cis lutein) 40.3min (15-cis lutein) 59.8 min (13-cis zeaxanthin) Calculate the percentage of zeaxanthin from the sum of the areas of the trans-zeaxanthin peak (RT ~ 20 – 22 min) and cis-zeaxanthin peak (RT ~ 55 - 65 min) vs the sum of the areas of all the lutein and zeaxanthin peaks.
Test: Waxes
Determine by gas chromatography using the following conditions: Apparatus Gas chromatograph (GC) equipped with an autosampler, a splitless injection system, flame ionization detector (FID), programmable column and detector 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 methylene 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 Inject 1.0 μl of each of the standards solutions. 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) x 2 ml x 20 ml x100 Waxes % w/w = ----------------------------------------- 1000 (ml/l) x W (mg) x 0.04 ml = (100 x 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 (2016)

Every name it appears under

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

E number

  • E161b

As it appears in regulation

  • Lutein

Hazard reference values

Values set by assessing bodies. A body that has not set a value is not listed here.
TypeValuePopulationAssessed byOpinion
group ADInot specified—JECFA2018

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 INS 161b(iii)?
INS 161b(iii) is Lutein esters from Tagetes erecta. Lutein esters from marigold are a yellow food colour. The same flower is fed to hens to deepen yolk colour, but here the extracted pigment is added to food directly.
What is Lutein esters 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 esters from Tagetes erecta permitted?
Of the seven regulators this site reads, the EU, Great Britain 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 esters from Tagetes erecta vegan?
Yes. Lutein esters 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

  • eu retrieved 2026-10-18
  • gb retrieved 2026-10-18
  • gsfa retrieved 2026-09-07
  • jecfaspecs retrieved 2026-09-23

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