National Organic Standards Board

Handling Committee

Petitioned Material Proposal

Choline

March 20, 2012

Summary of Proposed Action:

Choline is a synthetically made nutrient that also occurs naturally in food. It is considered by most 

regulatory bodies to be essential in non-milk-based infant formula and is required by the FDA for this 

purpose. It is permitted but not required to be added to milk-based infant formulas. All the organic 

infant formula brands that could be found through an internet search contain added choline, both 

milk-based and non-milk-based. 

Choline has been petitioned for addition to adult food items as well as infant formula. There is no 

compelling reason to think that this is essential to handling organic food, although it is not harmful 

either. Therefore there are 2 proposed actions on choline. First, to add it to the National List for use in 

infant formula labeled organic or made with organic ( ). Second, to add it to the National List for use 

only in agricultural products other than infant formula labeled "made with organic (specified 

ingredients or food group(s))" and prohibited in agricultural products labeled "organic".

Allowing it in adult foods that are in the Made with organic category would allow such foods to 

highlight the fact they are fortified, while at the same time limiting the number of non-essential 

synthetics in organic processing.

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: Essential Comments: 

The substance is deemed essential in infant formula by regulating authorities but the NOSB 

committee does not feel it is essential to supplement it for adults.

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: Move that Choline as petitioned is synthetic.

Motion by: Zea Sonnabend Seconded by: Harold Austin 

Yes: # 5 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0 

HC 1 Choline
Listing Motion: 1. Move to add Choline to the National List 205.605(b) for use in infant formula 

labeled organic or made with organic (specified ingredients or food group(s))

Motion by: Zea Sonnabend Seconded by: Harold Austin 

Yes: # 5 No: # 0 Absent: # 1 Abstain: # Recuse: # 

Listing Motion: 2. Move to add Choline to the National List 205.605(b) for use only in agricultural 

products other than infant formula labeled "made with organic (specified ingredients or food 

group(s))" and prohibited in agricultural products labeled "organic".

Motion by: Zea Sonnabend Seconded by: Tracy Favre 

Yes: # 5 No: # 0 Absent: # 1 Abstain: # 0 Recuse: # 0 

Crops ☐ Agricultural ☐ Allowed1 ☐

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling ☐ Synthetic ☐ Rejected3 ☐

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: 

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, Committee Chair March 20, 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

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X

3. Is the substance harmful to the 

environment and biodiversity?

X

HC 2 Choline
[§6517c(1)(A)(i);6517(c)(2)(A)i] 

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.Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 

c(2)(A)i; §6518 m.4]

X

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

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.

HC 3 Choline
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

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

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 food sources are abundant, such as 

eggs, liver, wheat germ, lecithin, 

human milk.

5. Is there an organic substitute? 

[§205.600 b.1]

X X food sources can be organic but are 

not strictly substitutes in infant 

formula.

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

X all the products in the petition can be 

made without this substance, 

although it is required by the FDA in 

non-milk-based infant formula.

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

X For uses in adult food, the food is a 

substitute. In infant formula there is no 

natural substitute.

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? 

[§6518 m.6]

X

10.Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

X breastfeeding. However in some 

circumstances breastfeeding is not 

feasible.

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.

HC 4 Choline
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 nutritional quality is improved.

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 is required by law for non-milkbased infant formula only.

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 Although this is considered a vitamin 

on product labels, it is not considered 

a vitamin by other entities.

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

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.

HC 5 Choline
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 non-organic 

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 Other than for infant formula, there 

seems no compelling justification as 

to why choline should not be obtained 

from organic food sources.

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 same as above.

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 regions);

X

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 

X

HC 6 Choline
production or destroy crops or 

supplies; 

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.

HC 7 Choline