Handling:Lutein

National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Lutein

July 17, 2012

Summary of Proposed Action:

Lutein (commonly referred to as xanthophyll) is a carotenoid, is related to betacarotene. It is a strong antioxidant, as well as a natural pigment. Lutein is present in 

many vegetables such as: spinach, kale, broccoli, and green peas. The petitioned 

Lutein is derived from dried food grade marigolds. This is the primary source of Lutein 

used as a coloring agent, food and livestock feed additive, and as a nutritional 

supplement. Lutein comprises the macular pigment of the eye and is found in the lens. It 

acts as a filter to blue light and serves an important role in eye health. All Lutein must be 

acquired through ones diet and cannot be synthesized by the body.

The primary source of Lutein for young infants is from human breast milk. The level of 

Lutein in human breast milk will vary depending on the dietary intake of Lutein rich 

vegetables by the infant’s mother. This will vary in different parts of the world due to 

cultural dietary eating habits. Cow milk or soy based infant formulas would need to be 

fortified with Lutein to equal the amounts normally found in human breast milk. 

This ingredient is not required by the FDA under 21 CFR 104.20(d)(3).

The petitioner has requested their product listed as Lutein- derived from marigold: 

(Tagetes erecta), and meeting the “Lutein” monograph established by the U.S. 

Pharmacopeia (“USP”) (when mixed with organic delivery ingredients including 

organic corn or safflower oil, and organic sugar and starch) as a listed substance 

pursuant to 7CFR 205.606, on the National List of Allowed and Prohibited Substances 

in the category of “Non-organically produced agricultural products allowed as 

ingredients in or on processed products labeled as ‘organic’”. They are requesting to 

list two specific uses of Lutein : (1) In organically labeled Infant Formula, (2) In 

organically labeled foods. The current petitioned source of Lutein is currently being used 

in organic handling. Because Lutein falls into the “accessory nutrients” category and 

was not one of the substances listed in 21CFR 104.20(d)(3) it is being petitioned for 

inclusion to the list of allowed substances. Because the actual method of producing 

Lutein is Confidential Business Information (CBI), the sub-committee could not verify 

that Lutein would be considered non-synthetic. Therefore the recommendation for 

classification of Lutein as petitioned is synthetic.

The Handling Sub-Committee was split on the listing of Lutein for use in infant formula. 

The basis of those voting in favor of listing it was that it currently is being used in some 

organic infant formulas and secondly because of the role it plays in the eye health of 

infants (and adults). Those on the sub-committee opposed to listing Lutein believe it is 

not a mandated additive by FDA for infant formula, did not have enough information in 
Handling:Lutein

the CBI version of the petition to determine it to be non-synthetic, it does not appear to 

be “essential” since it is in some brands and not in others, and there appear to be viable 

non-synthetic alternatives such as whey protein and microalgae sources. The rationale 

behind the sub-committee choosing not to include the petitioners request for the second 

proposed listing, for use in organically labeled foods, is based on the fact that there are 

currently several alternatives available as a food additive. There are also many natural 

and organic sources available for adults to obtain Lutein through their diet.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria 

Satisfied? (see “B” below)

1. Impact on Humans and Environment ☒ Yes ☐

No ☐ N/A 

2. Essential & Availability Criteria ☐ Yes ☒

No ☐ N/A

3. Compatibility & Consistency ☐ Yes ☒

No ☐ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ☒ Yes ☐

No ☐ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ 2] Comments: This substance has not been 

deemed to be essential by the FDA regulations for use in fortification of infant formulas.

Proposed Annotation (if any): 

Basis for annotation: ☐ To meet criteria above ☐ Other regulatory criteria ☐

Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: Lutein (CAS 127-40-2) as petitioned as a synthetic. 

Motion by: Harold Austin Seconded by:Jean Richardson 

Yes: # 7 No: # 0 Absent: # 0 Abstain: # 0 Recuse: # 0

Listing Motion: To add Lutein (CAS 127-40-2) to the National List 205.605(B) for 

use in infant formula only. Lutein using approved organic delivery ingredients.

Motion by: Harold Austin Seconded by: John Foster 

Yes: # 3 No: # 4 Absent: # 0 Abstain: # 0 Recuse: # 0
Handling:Lutein

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☒ Synthetic x Rejected3 x

No restriction ☐ Commercial unavailable as 

organic

☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205. with 

Annotation (if any): 

2

Substance to be added as “prohibited” on National List to § 205. with Annotation (if 

any): 

Describe why a prohibited substance: 

3

Substance was rejected by vote for amending National List to § 205. . Describe 

why material was rejected: This substance has not been deemed to be essential by 

the FDA regulations for use in fortification of infant formulas. 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

 John Foster, Subcommittee Chair July 17, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal?

[§205.600 b.2]

X Does require large amounts of 

land mass to produce. Solvents 

used during process of extraction 

could pose a potential threat to 

the environment. TR lines 502-

512

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X Solvent storage tanks could be a 

potential hazard. TR lines 516-

519

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X
Handling:Lutein

4. Does the substance contain List 1, 

2 or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

X

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

X

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

X

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment? [§6518 m.2]

X

10.Are there any harmful effects on 

human health? [§6517 c (1)(A)(i); 

6517 c(2)(A)i; §6518 m.4]

X There is some speculation that it 

may play a role in Autism and 

ADHDD. No scientific support of 

these claims were found. TR 

lines 539-543

11.Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? 

[§205.600 b.5]

X While the substance is not listed 

as GRAS, the petitioner has 

received several non-objection 

responses from the FDA for the 

use of Lutein, as petitioned. TR 

lines 416-433

13.Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X

1

If the substance under review is for crops or livestock production, all of the questions 

from 205.600 (b) are N/A—not applicable.
Handling:Lutein

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

X Solvents (hexane, isopropyl 

alcohol,etc) are used during the 

two step extraction process. TR 

lines 326-329

2. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral, 

sources? 

[6502 (21)]

X The petitioner claims that it uses a 

process similar to that used in the 

manufacture of Pectin or Lecithinunbleached. TR lines 373-378 

mention this claim. The TR lines 

384-389

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Human breast milk. Green 

vegetables such as spinach, kale, 

broccoli, and green peas.

5. Is there an organic substitute? 

[§205.600 b.1]

X Powdered Lutein processed from 

green vegetables can be made, 

but the amount needed to equal 

the marigold source is not feasible 

in handling and food processing. 

Beta-carotene would be an 

alternate source as a coloring 

agent. Green vegetables and 

human breast milk.

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

X

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

X Human breast milk. The TR (lines 

120-122) also mentions skim milk 

powder and whey protein.

8. Is the substance used in handling, 

not synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X

9. Is there any alternative 

substances? 

X The TR (lines 120-122) indicates 

that skim milk powder and whey 
Handling:Lutein

[§6518 m.6] protein are possible sources of 

Lutein. The TR (lines 360-371) 

discusses obtaining lutein from 

microalgae, which may be a truly 

non-synthetic source and appears 

to be feasible, although not in 

commercial production at this time.

10.Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X Breast feeding

1

If the substance under review is for crops or livestock production, all of the questions 

from 205.600 (b) are N/A—not applicable.
Handling:Lutein

NOSB Evaluation Criteria for Substances Added To the National List

Category 3. Is the substance compatible with organic production practices? 

Substance: 

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518 m.7]

X

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

X

5. Is the primary use as a 

preservative? [§205.600 b.4]

X

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4]

X It can be used as a color additive, 

but the primary petition purpose is 

as a nutritional additive.

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

a. copper and sulfur compounds;

X

b. toxins derived from bacteria; X

c. pheromones, soaps, 

horticultural oils, fish 

emulsions, treated seed, 

vitamins and minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, 

row covers, and equipment 

cleaners?

X
Handling:Lutein

NOSB Evaluation Criteria for Substances Added To the National List

Category 4. Is the commercial supply of an agricultural substance as organic, 

fragile or potentially unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 

(c) 205.2, 205.105 (d), 205.600 (c)] Substance: Name

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic form of the material 

/substance is necessary for use in 

organic handling? 

X

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance 

cannot be obtained organically in 

the appropriate form to fulfill an 

essential function in a system of 

organic handling? 

X

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance 

cannot be obtained organically in 

the appropriate quality to fulfill an 

essential function in a system of 

organic handling? 

X

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or 

why the material /substance 

cannot be obtained organically in 

the appropriate quantity to fulfill 

an essential function in a system 

of organic handling?

X

5. Does the industry information 

provided on material / substance 

non-availability as organic, include 

( but not limited to) the following:

a. Regions of production 

(including factors such as 

climate and number of 

X
Handling:Lutein

regions);

b. Number of suppliers and 

amount produced;

X

c. Current and historical supplies 

related to weather events such 

as hurricanes, floods, and 

droughts that may temporarily 

halt production or destroy 

crops or supplies; 

X

d. Trade-related issues such as 

evidence of hoarding, war, 

trade barriers, or civil unrest 

that may temporarily restrict 

supplies; or

X

e. Are there other issues which 

may present a challenge to a 

consistent supply?

X

1

If the substance under review is for crops or livestock production, all of the questions 

from 205.600 (b) are N/A—not applicable.