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-Methionine to the National List at §205.605

Barry Flamm

✔ Petition Passed

Passed

Motion to classify L-Methionine as petitioned on 205.605(b) as synthetic, non-agricultural. 

 

 

 

 

 

L-Methionine, as petitioned, is a wholly synthetic manufactured ingredient.

Tracy Favre

John Foster

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

Passed

Motion to list L Methionine as petitioned for inclusion on 205.605(b). For use only in infant formula made 

with soy-based protein. 

 

 

Methionine is an essential amino acid that cannot be synthesized by the body; thus, it is used primarily as 

a dietary supplement in humans and a feed additive in livestock. Physiologically, methionine is required 

for nitrogen balance, cell metabolism, protein formation, and growth (Brosnan and Brosnan, 2006). A 

number of soy-based baby formulas are supplemented with L-methionine because soy formula (unlike 

milk-based formula or breast milk) does not provide adequate levels of methionine to ensure adequate 

growth, nitrogen balance, and plasma albumin concentrations (Agostoni et al., 2006). Therefore 

L-Methionine is required in soy based infant formulas in order to meet FDA requirements for protein 

quality at 21 CFR 107.100 (f). The Handling subcommittee recommends approval, acknowledging the fact 

that if L-Methionine is not added to soy formula there would be no organic soy based formula. The group 

discussed the fact that protein is the essential building block and there does not seem to be an alternate 

source of non-milk protein available in commerce for use for infant formula. 

Tracy Favre

Jean Richardson

13 2 0 0 0
Handling:LMethionine

National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

L-Methionine

July 3, 2012

Summary of Proposed Action:

The Team Leader for Infant Formula Regulation at FDA provided information about the 

need for L-Methionine in soy based formulas in order to meet requirements for protein 

quality at 21 CFR 107.100 (f) . Subcommittee members have reservations about 

approving synthetic L Methionine, because toxic solvents are used in extraction 

process. However the subcommittee recommends approval, acknowledging the fact 

that if L-Methionine is not added to soy formula there would be no organic soy based 

formula. The group discussed the fact that protein is the essential building block and 

there does not seem to be an alternate source of non-milk protein available in 

commerce for use for infant formula. 

Additional comments: The Handling Subcommittee would welcome public comment 

about alternatives. 

Evaluation Criteria 

(Applicability noted for each category; Documentation attached) Criteria 

Satisfied? (see “B” below)

1. Impact on Humans and Environment ܆ Yes X

No ܆ N/A 

2. Essential & Availability Criteria X Yes ܆

No ܆ N/A

3. Compatibility & Consistency ܆ Yes ܆

No X N/A

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

No ܆ N/A

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ ] Comments:

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):
Handling:LMethionine

Classification Motion: Motion to list L-Methionine on 205.605(b) as synthetic, nonagricultural.

Motion by: TF Seconded by: HA

Yes: # 6 No: # 0 Absent: # 1 Abstain: #0 Recuse: #0

Listing Motion: Motion to list L Methionine for inclusion on 205.605(b). For use only 

in infant formula and medical nutritional enteral products labeled organic or made 

with organic (specified ingredients or food group(s)) soy-based protein.

Motion by: TF Seconded by: HA

Yes: # 6 No: # 0 Absent: # 1 Abstain: # 0 Recuse: #0

Crops ܆ Agricultural ܆ Allowed1 X

Livestock ܆ Non-synthetic ܆ Prohibited2 ܆

Handling X Synthetic X Rejected3 ܆

2No 

restriction

܆ Commercial unavailable as 

organic

X Deferred4 ܆

1

Substance voted to be added as “allowed” on National List to § 205.605(b) with 

Annotation (if any): For use in or on processed infant formula labeled as “organic” 

or “made with organic ingredients”. Annotated: For use only in formula made with 

isolated soy-based protein.

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 July 3, 2012
Handling:LMethionine

NOSB Evaluation Criteria for Substances Added To the National List

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

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 X Yes, manufacture of synthetic LMethionine typically is obtained 

from a precursor DL-Methionine, 

which uses Cyanide, considered 

an extremely toxic and volatile 

chemical. Inadvertent release of 

Cyanide has happened and has 

caused environmental damage.

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X X

Yes, see above comment.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X

Continued use of synthetically 

manufactured L-Methionine has 

the potential to delay the 

development of naturally 

obtained sources, including 

aquatic sources

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 Over supplementation of LMethionine has shown to have 

detrimental effect on the uptake 

of other critical amino acids

6. Are there adverse biological and 

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

X L-Methionine breaks down fairly 

quickly in the environment and is 

therefore not considered a risk to 

soil or water health.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X See above comments

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 X
Handling:LMethionine

concentration of the material or 

breakdown products in 

environment? [§6518 m.2]

10.Is there any harmful effect on 

human health? [§6517 c (1)(A)(i);

6517 c(2)(A)i; §6518 m.4]

X X Over supplementation of LMethionine is hepatoxic, causing 

fatty deposits in the liver. Normal 

supplementation has not shown 

detrimental effects, and is, in fact, 

an essential amino acid.

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.
Handling:LMethionine

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production?

Substance: L-Methionine

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 X Both synthetic and non-synthetic 

methods exist, but only the 

synthetic method is commercially 

available.

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 X The manufacture of L-Methionine 

can be accomplished from natural 

materials, however, only the 

completely synthetic methods are 

commercially viable.

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X L-Methionine is an essential amino 

acid that is obtained in the human 

diet from meat, dairy and some 

grains. The human body is not 

able to synthesize it.

4. Is there a natural source of the 

substance? [§205.600 b.1]

X See above

5. Is there an organic substitute? 

[§205.600 b.1]

X Yes, but not commercially viable at 

this time.

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 It may be obtained from natural, 

whole food sources.

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 X Cow’s milk, meat and some grains 

are sources, but for soy-based 

formulas, L-methionine is not 

available in sufficient amounts to 

meet the dietary requirements of 

infants.

10.Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X Breastfeeding would eliminate the 

need for soy-based formulas
Handling:LMethionine

NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: L-Methionine

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X Previous TAP and TR indicate 

that the synthetic manufacture of 

L-methionine is not considered 

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 X Petitioned use is for soy-based 

infant formula only, but is not 

consistent with organic farming.

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 In fact, this is the only justification 

for inclusion of L-methionine in 

soy-based formulas

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 in order to bring 

nutrient contents of soy-based 

formula up to milk-based formulas 

and mother’s milk.

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

copper and sulfur compounds;

X This is a sulfur-based amino acid.

a. toxins derived from bacteria; X

b. pheromones, soaps, 

horticultural oils, fish 

emulsions, treated seed, 

vitamins and minerals?

X

c. livestock parasiticides and 

medicines?

X

d. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, 

row covers, and equipment 

cleaners?

X
Handling:LMethionine

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 L-Methionine

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 Quality of the substance has not 

been discussed, rather the 

commercial availability of the 

organic version

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
Handling:LMethionine

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 X Not provided but not relevant to 

manufacture.

d. Trade-related issues such as 

evidence of hoarding, war, 

trade barriers, or civil unrest 

that may temporarily restrict 

supplies; or

X X Same as above

e. Are there other issues which 

may present a challenge to a 

consistent supply?

X Only as related to organic and 

non-synthetic versions of LMethionine

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.