Formal Recommendation 

From: National Organic Standards Board (NOSB) 

To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: 

Other: 

Statement of Recommendation: (Motion # 1) 

 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

 

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 3DJHUHYLVHGPD

October 17, 2012

Petition to add L-carnitine to §205.605 (b) for infant formula

Barry Flamm

Petition Failed

Passed

 Motion to classify L-Carnitine [CAS #541-15-1] as petitioned as synthetic. 

 

 

 

 

 

 

L-carnitine occurs naturally in food, but the form being petitioned is synthetic.

Zea Sonnabend

Tracy Favre

15 0 0 0 0
Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Statement of Recommendation: (Motion # 2)

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 

 

3DJHUHYLVHGPD

Failed

Motion to add L-Carnitine [CAS #541-15-1] as petitioned to the National List 205.605 (b)--for use in infant 

formula only. 

 

L-Carnitine [CAS #541-15-1] is not deemed essential by FDA regulations for the fortification of infant 

formula.

Zea Sonnabend

Colehour Bondera

6 9 0 0 0
Handling:LCarnitine

National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

L-Carnitine

June 19, 2012

Summary of Proposed Action:

L-Carnitine is a compound that is synthesized in the body from the amino acids lysine 

and methionine. These amino acids are abundant in foods such as beans, avocado and 

red meat. The synthetic form has been petitioned for use in infant formula because soybased formulas contain very low levels of carnitine, and infants are less able to 

synthesize carnitine for themselves. Cow's milk formulas also can be low in carnitine 

because the milk is diluted in the formula.

Unlike some other ingredients petitioned for infant formula, carnitine is not required 

under the FDA in 21 CFR 104.20, 107.100 or 107.10 as clarified in the NOP proposed 

rule on Nutrient Vitamins and Minerals. Also it appears that carnitine would be feasible 

to make or extract from non-synthetic sources, although that is not commercially done 

at this time. For these reasons the Handling Sub-committee is not recommending to add 

synthetic L-carnitine to the National List.

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria 

Satisfied? (see “B” below)

1. Impact on Humans and Environment X Yes ܆

No ܆ N/A 

2. Essential & Availability Criteria ܆ Yes X

No ܆ N/A

3. Compatibility & Consistency ܆ Yes X

No ܆ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ܆ Yes ܆

No X ܆ N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [2] Comments:

This substance is not deemed to be essential by FDA regulations for the fortification of 

infant formula.

Proposed Annotation (if any):

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

Citation 

Notes: 
Handling:LCarnitine

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: L-Carnitine [CAS #541-15-1] as petitioned is synthetic.

Motion by: Zea Sonnebend Seconded by: Harold Austin

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

Listing Motion: To add L-Carnitine [CAS #541-15-1] to the National List 205.605 

(b)--for use in infant formula only.

Motion by: John Foster Seconded by: Harold Austin

Yes: # 2 No: # 3 Absent: # 1 Abstain: # 0 Recuse: #0

܆ 1Allowed ܆ Agricultural ܆ Crops

Livestock ܆ Non-synthetic ܆ Prohibited2 ܆

Handling x Synthetic x Rejected3 x

No restriction ܆ Commercial unavailable as 

organic

܆ 4Deferred ܆

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: It appears that carnitine would be feasible to make or extract 

from non-synthetic sources, although that is not commercially done at this time.

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair June 19, 2012

NOSB Evaluation Criteria for Substances Added To the National List

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

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, 

X
Handling:LCarnitine

use, misuse, or disposal? [§6518 

m.3]

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X

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

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 may be self identified. See TR 

Evaluation question #4 (lines 350 

- 363)

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:LCarnitine

NOSB Evaluation Criteria for Substances Added To the National List

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

L-Carnitine

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 while there are non-synthetic ways 

to manufacture it, most in use for 

supplementation is synthesized 

from epichlorhydrine or 

trimethlamine. (TR lines 285-287)

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 X it can be produced by "biosynthetic 

or fermentative methods" (TR lines 

294-295) but it is not clear if these 

would be considered nonsynthetic. It appears from the TR 

discussion for Evaluation questions 

#1 and #2, that non-synthetic 

production would be possible but is 

not commercially done in the US at 

this time.

4. Is there a natural source of the 

substance? [§205.600 b.1]

X abundant in food and human 

breast milk.

5. Is there an organic substitute? 

[§205.600 b.1]

X organic food

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

8. Is the substance used in handling, 

not synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X

9. Is there any alternative X human breast milk
Handling:LCarnitine

substances? 

[§6518 m.6]

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:LCarnitine

NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: L-Carnitine 

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X since the substance could be 

obtained from organic foods, the 

synthetic fortification is not 

compatible with organic handling.

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

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, 

X
Handling:LCarnitine

insect traps, sticky barriers, 

row covers, and equipment 

cleaners?

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:LCarnitine

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 provided but not convincing.

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 

X
Handling:LCarnitine

climate and number of 

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.