Food Safety Substance

LuteinE161B

Lutein (E161B) is a food additive with PUBLISHED in the EU, FDA has no questions; some uses may require a color additive listing in the US, and data from 8 regulatory sources.

CAS 127-40-2 E161B Indexable evidence set

FDA

FDA has no questions; some uses may require a color additive listing

ADI / TDI

EFSA ADI = 1 mg/kg bw/day

Codex

3 row(s)

SOURCE D1 identity resolution e number aliases | Food Additives | dsstox identifiers | 8 matched regulatory source group(s)

Substance Identity

Resolved identifiers used to render this food-safety record.

Substance name

Lutein

CAS

127-40-2

E-number

E161B

DTXSID

DTXSID8046749

PubChem CID

5281243

Evidence tier

Indexable evidence set (13)

SOURCE EU Commission FDA | Health Canada | Codex Alimentarius

Multi-Jurisdiction Comparison

Side-by-side status rows for the same resolved substance across public food regulators.

Jurisdiction	Authority	Status	Evidence
European Union	EU Commission	PUBLISHED	EU additive listing; Annex II entry
United States	FDA	FDA has no questions; some uses may require a color additive listing	GRAS notice
Codex	Codex Alimentarius	Listed	Colour

SOURCE EU Commission EU Food Additives | EU Food Additives Database

EU Food Additive Status

EU Commission food-additive listing rows from eu_food_additives.

Jurisdiction	E-number	Status	Type	Name	Note
European Union	E161B	PUBLISHED	substanceFAD	Lutein	-

SOURCE EU Commission EU Annex II Authorised | EU Food Additives Database

EU Annex II Authorised Uses

Authorised additive rows and use conditions from EU Annex II tables.

Jurisdiction	E-number	Name	INS	Policy item	Note
European Union	E161B	Lutein	-	POL-FAD-IMPORT-3015	-

Conditions and restrictions

Jurisdiction	Food category	Restriction	Comment	Source
European Union	4.2.5 jam jellies and marmalades and similar products	ML 100 mg/kg	except chestnut puree	EU Annex II Union List
European Union	4.2.5.2 Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC	ML 100 mg/kg	except chestnut purée	EU Annex II Union List
European Union	4.2.5.3 other similar fruit or vegetable spreads	ML 100 mg/kg	except crème de pruneaux	EU Annex II Union List
European Union	9.2 Processed fish and fishery products including molluscs and crustaceans	ML 100 mg/kg	only fish paste and crustacean paste	EU Annex II Union List
European Union	9.2 Processed fish and fishery products including molluscs and crustaceans	ML 250 mg/kg	only precooked crustacean	EU Annex II Union List
European Union	1.7.5 processed cheese	ML 100 mg/kg	only flavoured processed cheese	EU Food Additives Database
European Union	4.2.5 jam jellies and marmalades and similar products	ML 100 mg/kg	except chestnut puree	EU Food Additives Database
European Union	4.2.5.3 other similar fruit or vegetable spreads	ML 100 mg/kg	except crème de pruneaux	EU Food Additives Database
European Union	9.2 Processed fish and fishery products including molluscs and crustaceans	ML 100 mg/kg	only fish paste and crustacean paste	EU Food Additives Database
European Union	9.2 Processed fish and fishery products including molluscs and crustaceans	ML 250 mg/kg	only precooked crustacean	EU Food Additives Database
European Union	4.2.5.2 Jam, jellies and marmalades and sweetened chestnut puree as defined by Directive 2001/113/EC	ML 100 mg/kg	except chestnut purée	EU Food Additives Database

SOURCE Codex Alimentarius Codex GSFA

Codex GSFA Status

Codex Alimentarius GSFA permissions and maximum-use rows.

Jurisdiction	INS / E-number	Function	Food category	Max level	Notes
Codex	161b(i)	Colour	01.1.4 Flavoured fluid milk drinks	100 mg/kg	Except for use in products conforming to the Standard for Fermented Milks (CXS 243- 2003) at 150 mg/kg.; Excluding chocolate milk.
Codex	161b(i)	Colour	01.7 Dairy-based desserts (e.g. pudding, fruit or flavoured yoghurt)	150 mg/kg	For use in products conforming to the Standard for Fermented Milks (CXS243-2003) only.
Codex	161b(iii)	Colour	Table 3 Foods in General (GMP)	GMP	Table 3 additive - GMP in foods in general

SOURCE FDA FDA GRAS

FDA GRAS Status

US FDA GRAS notice evidence from enriched and notice tables.

Jurisdiction	GRN	Substance	FDA response	Intended use	Basis	Notifier
United States	110	Lutein esters	FDA has no questions; some uses may require a color additive listing	Ingredient in baked goods and baking mixes, soy milk, beverages and beverage powders, frozen dairy desserts and mixes, processed fruit and vegetable products, egg products and egg...	Scientific procedures	Cognis Corporation
United States	140	Crystalline lutein	FDA has no questions; some uses may require a color additive listing	Intended for use as an ingredient at levels ranging from 0.3 to 3 milligrams (mg) per eating occasion (serving) in baked goods and baking mixes, beverages and beverage bases...	Scientific procedures	Kemin Foods, L.C.
United States	221	Suspended lutein	FDA has no questions; some uses may require a color additive listing	Ingredient in term infant formula at a maximum level of 250 micrograms/liter	Scientific procedures	Kemin Health, L.C.
United States	291	Crystalline lutein	FDA has no questions; some uses may require a color additive listing	Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, fats and oils, frozen dairy desserts and mixes...	Scientific procedures	Industrial Organica S.A. de C. V.
United States	385	Lutein	FDA has no questions; some uses may require a color additive listing	Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg products, fats and oils, frozen dairy desserts...	Scientific procedures	OmniActive Health Technologies Ltd.
United States	390	Suspended lutein	FDA has no questions; some uses may require a color additive listing	Ingredient in formulas intended for premature infants at levels up to 210 micrograms of lutein per liter of formula	Scientific procedures	Abbott Nutrition
United States	416	Lutein diacetate	At the notifier's request, FDA ceased to evaluate this notice	As an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy products analogs, fats and oils, frozen dairy desserts and...	Scientific procedures	Industrial Organica S.A. de C. V.
United States	432	Lutein diacetate	FDA has no questions; some uses may require a color additive listing	As an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, fats and oils, frozen dairy desserts and...	Scientific procedures	Industrial Organica S.A. de CV
United States	542	Lutein	FDA has no questions; some uses may require a color additive listing	Intended for use in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg substitute products, fats and oils...	Scientific Procedures	INNOBIO Limited
United States	543	Lutein esters	FDA has no questions; some uses may require a color additive listing	Intended for use in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg substitute products, fats and oils...	Scientific Procedures	INNOBIO Limited
United States	110	Lutein esters	FDA has no questions; some uses may require a color additive listing	Ingredient in baked goods and baking mixes, soy milk, beverages and beverage powders, frozen dairy desserts and mixes, processed fruit and vegetable products, egg products and egg...	Scientific procedures	Cognis Corporation
United States	140	Crystalline lutein	FDA has no questions; some uses may require a color additive listing	Intended for use as an ingredient at levels ranging from 0.3 to 3 milligrams (mg) per eating occasion (serving) in baked goods and baking mixes, beverages and beverage bases...	Scientific procedures	Kemin Foods, L.C.
United States	221	Suspended lutein	FDA has no questions; some uses may require a color additive listing	Ingredient in term infant formula at a maximum level of 250 micrograms/liter	Scientific procedures	Kemin Health, L.C.
United States	291	Crystalline lutein	FDA has no questions; some uses may require a color additive listing	Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, fats and oils, frozen dairy desserts and mixes...	Scientific procedures	Industrial Organica S.A. de C. V.
United States	385	Lutein	FDA has no questions; some uses may require a color additive listing	Ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg products, fats and oils, frozen dairy desserts...	Scientific procedures	OmniActive Health Technologies Ltd.
United States	390	Suspended lutein	FDA has no questions; some uses may require a color additive listing	Ingredient in formulas intended for premature infants at levels up to 210 micrograms of lutein per liter of formula	Scientific procedures	Abbott Nutrition
United States	416	Lutein diacetate	At the notifier's request, FDA ceased to evaluate this notice	As an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy products analogs, fats and oils, frozen dairy desserts and...	Scientific procedures	Industrial Organica S.A. de C. V.
United States	432	Lutein diacetate	FDA has no questions; some uses may require a color additive listing	As an ingredient in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, fats and oils, frozen dairy desserts and...	Scientific procedures	Industrial Organica S.A. de CV
United States	542	Lutein	FDA has no questions; some uses may require a color additive listing	Intended for use in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg substitute products, fats and oils...	Scientific Procedures	INNOBIO Limited
United States	543	Lutein esters	FDA has no questions; some uses may require a color additive listing	Intended for use in baked goods and baking mixes, beverages and beverage bases, breakfast cereals, chewing gum, dairy product analogs, egg substitute products, fats and oils...	Scientific Procedures	INNOBIO Limited

SOURCE JECFA JECFA ADI

JECFA ADI Values

JECFA ADI records and evaluation years.

Jurisdiction	Chemical name	JECFA no.	CAS	ADI	ADI upper	Function	Evaluation year
JECFA	XANTHOPHYLLS	-	127-40-2	NO ADI ALLOCATED	-	COLOUR	1977
JECFA	LUTEIN from TAGETES ERECTA	-	-	0-2 mg/kg bw	2	COLOUR, NUTRIENT_SUPPLEMENT	2018
JECFA	LUTEIN ESTERS from TAGETES ERECTA	-	-	NOT SPECIFIED (TEMPORARY)	-	COLOUR, NUTRIENT_SUPPLEMENT	2018

SOURCE ingredients ghs classifications

Cross-Reference to Cosmetics / Chemicals / Pharma

Same-CAS public rows from adjacent Roots verticals where available.

SOURCE Cross-vertical comparison ingredients | ghs classifications

Cross-Vertical Regulatory Divergence

This substance has different regulatory treatment across food, cosmetics, and industrial use.

CosmeticsXanthophyllsEU status: permitted Industrial / GHSDangerEuropean Chemicals Agency (ECHA)

SOURCE FAQPage JSON-LD public food renderer rows

Frequently Asked Questions

Food-use, safety, ADI, and cross-vertical answers mirrored into FAQPage JSON-LD.

What is Lutein used for in food?

Lutein appears in food-use rows as: Antioxidant/Color; Colour.

Is Lutein / E161B safe?

This page does not assign a standalone safety verdict; it renders public regulatory evidence. ADI/reference value: EFSA ADI = 1 mg/kg bw/day. EU status evidence: PUBLISHED. US/FDA evidence: FDA has no questions; some uses may require a color additive listing.

What is the ADI for Lutein?

Lutein has this ADI/reference value in the food-safety tables: EFSA ADI = 1 mg/kg bw/day. Source: EFSA ANS 2012.

Is Lutein also used in cosmetics?

Lutein has a same-CAS cosmetics cross-reference: Xanthophylls, EU status permitted.