Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program (NOP)

Date: May 25, 2012

Subject: Petition to add Inositol §205.605(b) of National List

Chair: Barry Flamm

 

 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action ___x_____

Guidance Statement __________

Other __________

Statement of the Recommendation (Including Recount of Vote):

Classification Motion: Move that inositol (CAS 87-89-8 (myo-inositol) and 6917-

35-7 (non-specific isomer) are synthetic. (

Vote: 15 yes 0 no Abstain: 0 Absent: 0 Recusal: 0

Listing Motion: 1. Move to add inositol (CAS 87-89-8 (myo-inositol) and 6917-35-

7 (non-specific isomer) to the National List §205.605(b) for use in infant formula

and medical nutritional enteral products labeled organic or made with organic 

(specified ingredients or food group(s))

 Vote: 10 yes 5 no Abstain: 0 Absent: 0 Recusal: 0

Rationale Supporting Recommendation (including consistency with 

OFPA and NOP): 

Consistent with OFPA and NOP policies, this petitioned substance was 

determined to be synthetic and only approved for infant formula as mandated by 

the FDA. See also attached recommendation.

Committee Vote-Classsification:

Moved: John Foster Second: Joe Dickson

Yes: 15 No: 0 Abstain: 0 Absent: 0 Recusal: 0

Committee Vote-Listing:

Moved: John Foster Second: Joe Dickson

Yes: 10 No: 5 Abstain: 0 Absent: 0 Recusal: 0
National Organic Standards Board

Handling Committee

Petitioned Material Proposal

Inositol

May 25, 2012

Summary of Proposed Action:

Inositol is an important biologic compound that serves numerous biologic functions/roles including but not 

limited to the following: a structural component of cell membranes, messenger molecules in 

reactions/processes, assist in overall muscle function and cell growth. Inositol may be formed endogenously 

using glucose as a substrate or it may be obtained by the human body through dietary sources. In addition to 

the aforementioned roles, inositol has been found to influence fat accumulation within the liver/intestines, 

control triacyglycerol and esterified cholesterol levels, and impact insulin resistance. Due to its association 

with these biologic processes/conditons, inositol is often marketed as a dietary supplement for those with these 

afflictions. The category of dietary supplements in the United States are not required to be regulated by the 

FDA in order to assure the validity and safety of using a substance to treat conditions, and as long as no health 

claims are made on the supplement they may be sold to American consumers without restrictions.

Inositol is found naturally in many foods which include fruits, beans, grains, seeds, and nuts. Another notable 

source of inositol is human breast milk which has been found to contain high concentrations of inositol (1500-

4000 mM/L) as stated in the March 2012 Tap review. The FDA list inositol as Generally Recognized as Safe 

(GRAS) for human consumption by the under 21 CFR 184.1370 and also mandates that all infant formulas 

sold in the United States must contain a minimum 4mg/ 100 kilocalories of inositol in order to assure infants fed 

solely on formula sources acquire adequate nutrition to grow as successfully as breast-fed infants. 

Commercial production of inositol is often obtained from hydrolysis and acidification that begins from the 

corn/rice steeping process by using the phytic acid extracted from the corn/rice, and then using this phytic acid 

in one of several different chemical processes that ultimately results in isolating inositol. Additional methods 

also include utilization of microbial byproducts and processes (yeast); however these reactions are also 

dependent on synthetic reactions, or reactions that would not normally occur in nature to produce the final 

product of isolated inositol. Therefore, while inositol is a natural compound, the methods by which we can 

obtain commercial quantities of inositol are synthetic. 

The Handling Committee, based on public comment received at the Spring 2012 meeting amended the 

previously recommended proposal to include CAS numbers and to allow for the use of the substance in 

medical applications as specified in the annotation.

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 X Yes ☐ No ☐ N/A

3. Compatibility & Consistency X Yes ☐ 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: [ ] Comments:

Proposed Annotation (if any):

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

Notes: 

Recommended Committee Action & Vote, including classification recommendation (state actual motion):
Revised March 2012

Classification Motion: Move that inositol as petitioned (CAS Numbers: 87-89-8 (myo-inositol) 6917-35-7 

(non-specific isomer) is synthetic.

Motion by: John Foster Seconded by: Joe Dickson 

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

Listing Motion: 1. Move to add inositol (CAS Numbers: 87-89-8 (myo-inositol) 6917-35-7 (non-specific 

isomer) to the National List 205.605(b) for use in infant formula and medical nutritional enteral 

products labelled organic or made with organic (specified ingredients or food group(s))

Motion by: John Foster Seconded by: Joe Dickson

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

Listing Motion: 2. Move to add inositol (CAS Numbers: 87-89-8 (myo-inositol) 6917-35-7 (non-specific 

isomer) to the National List 205.605(b) for use only in agricultural products other than infant formula and 

medical nutritional enteral products labeled "made with organic (specified ingredients or food group(s))" and 

prohibited in agricultural products labeled "organic".

Motion by: John Foster Seconded by: Joe Dickson

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

Crops ☐ Agricultural ☐ Allowed1 X

Livestock ☐ Non-synthetic ☐ Prohibited2 ☐

Handling x Synthetic X Rejected3 ☐

No restriction ☐ Commercial unavailable as organic ☐ Deferred4 ☐

1

Substance voted to be added as “allowed” on National List to § 205.605 with Annotation (if any): 

As noted above.

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 May 25, 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 TR 3/9/12
Revised March 2012

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

x TR 3/9/12

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x TR 3/9/12 

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 agro-ecosystem? 

[§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.
Revised March 2012

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 May be obtained through yeast hydrolysis

3. Is the substance created by naturally 

occurring biological processes? [6502 (21)]

x Yes, but can also be made synthetically

4. Is there a natural source of the substance? 

[§205.600 b.1]

x

5. Is there an organic substitute? [§205.600 b.1] x

6. Is the substance essential for handling of 

organically produced agricultural products? 

[§205.600 b.6]

x Yes, but only for infant formula as req in 

21 CFR 107.100

7. Is there a wholly natural substitute product?

[§6517 c (1)(A)(ii)]

x

8. Is the substance used in handling, not 

synthetic, but not organically produced?

[§6517 c (1)(B)(iii)]

x Mass production is via synthetic 

pathways. Could be produced using 

organic yeast to provide organic inositol

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

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.
Revised March 2012

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 Nutritive, but not replacing nutrients

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

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.
Revised March 2012

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

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 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 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 

x
Revised March 2012

supply? 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.