NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP

For NOSB Meeting: May 2009 Substance: Lecithin- unbleached – for amending the listing to “Lecithin – deoiled” in 205.606

A. 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 Yes X No  N/A 

3. Compatibility & Consistency Yes X No  N/A 

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes X No  N/A  

B. Substance fails criteria? 

Criteria category: _________ 

Comments: 

C. Proposed Annotation: Deoiled 

Basis for annotation: To meet criteria above: ____ Criteria: _______________ 

 Other regulatory criteria: ____ Citation:_______________

D. Final Board Action & Vote (State Actual Motion): To AMEND the listing of Lecithin - unbleached in section 205.606 of the 

National List, to “ Lecithin – deoiled ” to 

section 205.606 of the National List. 

Motion: Julie Weisman Second: Joe Smillie 

Yes: 13 No: 1 Abstain: 0 Absent: 

1

 

Provide a summary narrative here or attach a more 

complete narrative, and attach the original 

committee recommendation that includes the evaluation criteria checklist:

This material, Lecithin – unbleached, was petitioned to be removed from the National List, section 205.606. After reviewing numerous 

public comments on this material, and receiving several thorough expert presentations and explanations during the May 2009 NOSB 

meeting, the board held a lively discussion regarding the appropriate action to take with respect to removing or amending the listing of 

unbleached lecithin on the National List. Bleached lecithin was also petitioned to be removed, from 205.605(b), with the Handling 

Committee recommending and the full board voting to remove bleached lecithin because organic forms of lecithin had become available. 

The board decision on bleached lecithin is detailed in a separate recommendation.

In its original committee recommendation, the Handling Committee recommended that lecithin – unbleached be removed from the 

National List 205.606. The expert explanations and presentations given at the full board meeting brought to light the fact that it was the 

“de-oiling” process, not necessarily the bleaching process, which truly differentiated types and potential uses of lecithins in a variety of 

products. In some cases, de-oiled lecithin was the only form appropriate for certain products and de-oiled lecithin is NOT currently 

available as organic in sufficient quantity or quality. Several handlers claimed the removal of de-oiled forms of lecithin from the National 

List would leave them without an option for some of their products. This manufacturing information was apparently either not available,

not well explained, or not understood by previous boards who considered the listing of lecithin, hence the dual listing of lecithin - the 

unbleached form in 205.606, and the bleached form in 205.605(b). 

In 6/00 comments on the proposed rule, a previous board asked that unbleached lecithin be listed as agricultural, needing to be organic 

when available. Their line of thinking is similar to what this board has recommended.

After much discussion, the board agreed to the following: 

• Remove Lecithin – unbleached from 206.606, and 

• Add “Lecithin – de-oiled ” to section 205.606 of the National List. 

This essentially amends the listing of “Lecithin – unbleached” in 205.606 to “Lecithin – deoiled” in 205.606 of the National List. Allowing

use of de-oiled forms only restricts the use of non-organic lecithin to only those forms not currently available as organic, and moving the 

material to 205.606 subjects it to certifier commercial availability scrutiny. Potential users of the de-oiled forms must prove to their certifier

that it is the only form of lecithin appropriate for their products, and that no organic alternatives are available. The petitioner (a lecithin 

supplier) was satisfied with this recommended action, and the lecithin using manufacturers present at the board meeting indicated this

amended listing would meet their needs as well. See May 2009 NOSB meeting transcripts for full discussion details. 

1—substance voted to be added as “allowed” on National List on National List to § 205.606 with Annotation (if any): Lecithin - Deoiled.

2—substance to be added to “prohibited” paragraph of National List to § 205.______ 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 § 205. ______ Describe why deferred; if any follow-up is needed. If follow-up needed, who

conducts follow-up ________________________________ ____________________________________ 

Agricultural X Nonagricultural Crops

Synthetic Not synthetic Livestock

Allowed1X Prohibited2

Handling X

No restriction Deferred4 Rejected3

E. Approved by NOSB Chair to transmit to NOP

Jeff Moyer . 

NOSB Chair Date

 May 6, 2009 .

F. NOP Action: Include in FR to amend National List: 

 Return to NOSB Reason: _________________________________________________________________________________ 

_________________________ Date 
Revised Committee Recommendation to amend

“Lecithin – unbleached” to “Lecithin – de oiled” on 205.606.

Revised May 5, 2009 during the full board meeting May 2009:

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: _____Spring 2009________________ Substance: ____Lecithin, unbleached, 

Committee: Crops  Livestock  Handling X Petition is for: amending the listing of Lecithin, unbleached, to 

lecithin, deoiled on the National List § 205. 606

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

4. Impact on Humans and Environment Yes X No  N/A 

5. Essential & Availability Criteria Yes X No  N/A 

6. Compatibility & Consistency Yes X No  N/A 

7. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes X No  N/A  

B. Substance Fails Criteria Category: _________ Comments: 

________________________________________________________________________________________________________

C. Proposed Annotation (if any): ”deoiled” will be added to the current listing of Lecithin, on § 205._ 606 _of the National List___ 

 Basis for annotation: To meet criteria above: ___X____ Other regulatory criteria: _______Citation:______________________

D. Recommended Committee Action & Vote (State Actual Motion): To amend the listing of Lecithin, unbleached, to 

lecithin, deoiled on the National List § 205. 606.

Motion by: Julie Weisman Seconded: Joe Smillie Yes:_5 No: __0 _ Absent: _1___ Abstain: __0___ 

 

 

1) Substance voted to be added as “allowed” on National List to § 205.606 with Annotation (if any) De-oiled 

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 ___________________________________________________

5) Substance was recommended to be removed (a suggested addition to accommodate petitions to remove) Describe why material 

is to be removed:_At this time there are many forms of organic unbleached fluid lecithin available, as well as organic and 

conventional non-synthetiic gums These make the use of non-organic unbleached fluid lecithin, which is made with synthetic 

processing aids, no longer essential in organic handling. There is not enough information available at this time about the 

commercial availability of dry forms of organic unbleached lecithin. The annotation proposed in this recommendation will allow it’s 

further use until it’s next Sunset date.

Crops Agricultural X Allowed1 X

Livestock Non-Synthetic Prohibited2 /Removal

Handling X Synthetic Rejected3

No restriction Commercially UnAvailable as Organic1

 Deferred4

E. Approved by Committee Chair to transmit to NOSB:

 Steve DeMuri______________ _____May 5, 2009___________________

 Committee Chair Date
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance - _ Lecithin, unbleached, amend to 

Lecithin – deoiled in 205.606

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 Increased environmental concerns about the use of hexane and and 

peroxides have resulted in legislation that could restrict oil 

processing operations that use them. ( TR p. 6, lines 281-285)

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X See above

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X

“It is not likely to produce harmful degradation products in the short 

term.’ In the long term it may degrade, however, the TR (p.6, line 293 

) does not indicate that the long-term degradation products would be 

harmful.

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

The TR ( p.3 lines 131-134 ) states that the EPA exempts from the 

requirement of a tolerance, the residues resulting from the use of 

lecithin as an inert or active ingredient in pesticides as long use is in 

accordance with good agricultural or manufacturing practices.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X

See above

8. Is there a toxic or other adverse 

action of the material or its breakdown 

products? [§6518 m.2]

X

See # 3 and #6 above

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

X

See #3 and #6 above

10. Is there any harmful effect on 

human health? [§6517 c (1)(A)(i) ; 6517

c(2)(A)i; §6518 m.4]

X

The TR (p.6, lines 287-291) states that there is “no reasonable 

grounds to suspect that any form of lecithin poses a hazard to the 

public when used at levels that are now current.” 

11. Is there an adverse effect on 

human health as defined by applicable 

Federal regulations? [205.600 b.3]

X

FDA approves all forms of lecithin for use in food with no limitation 

other than GMP. (TR p. 3 lines 128-129).

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.
Category 2. Is the Substance Essential for Organic Production? Substance - _ Lecithin, unbleached, amend to 

Lecithin – deoiled in 205.606

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

According to the TR (pp. 4-5 )

Crude soy obtained by hexane extraction from soy flakes. It is then 

de-oiled using acetone. 

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

See below

5. Is there an organic substitute? 

[§205.600 b.1] X

TR identifies 4 manufacturers of organic lecithin. One in France, one 

in India and 2 in the U.S.

6. Is the substance essential for

handling of organically produced 

agricultural products? [§205.600 b.6]

X 

A wide variety of organic products currently available could not be 

made with out an emulsifier. ( See TR p.2 ) Lecithin is the primary 

emulsifier used in these products.

7. Is there a wholly natural substitute 

product? 

[§6517 c (1)(A)(ii)]

X

According to both the petitioner and the TR , the organic forms are 

the only forms of lecithin that are being produced without using 

synthetic solvents. Theoretically the extraction could be done, 

producing a non-organic (i.e. natural) soy lecithin, but none are 

being produced at this time.

8. Is the substance used in handling, 

not synthetic, but not organically 

produced? 

[§6517 c (1)(B)(iii)]

X

 There are four manufacturer known to the Technical Reviewer that 

are currently producing a variety of formulations of organic lecithin. ( 

TR p.6, line 275 )

9. Is there any alternative 

substances? [§6518 m.6]

 X A number of forms of organic lecithin which achieve a light color

without bleaching, are now available in commercial quantities. In 

addition, there are now other organic and conventional non-synthetic, 

non-soy materials, such as gums and rice products which serve 

similar functions. There is no information given by the petitioner or in 

the TR suggesting that dry forms of organic unbleached lecithin are 

commercially available at this time.

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X

TR describes production process for organic substitute ( p. 6 )

Oil obtained by expeller press instead of hexane extraction. Varieties 

of soy yielding lighter-colored oil, combined with filtration are used to 

achieve the same effect as bleaching.

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

Substance - Lecithin, unbleached, amend to Lecithin – deoiled in 205.606

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

Substance is used handling, not production.

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

X

There is no published evidence to suggest that unbleached fluid 

lecithin has any impact on the nutritional quality of the food in which it 

is used. ( TR p. 7, line 319)

5. Is the primary use as a 

preservative? [§205.600 b.4]

X The primary use of lecithin is as an emulsifier. (TR p.7, lines 325-

326. )

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

Although lecithin does have an effect on texture and dispersion of 

ingredients in a food, it is not used “recreate or improve” qualities 

that were lost in processing.

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.
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 - _ Lecithin, unbleached, amend to Lecithin – deoiled in 205.606

Question Yes No N/A Comments on Information Provided (sufficient, plausible, 

reasonable, thorough, complete, unknown)

1. Is the comparative description provided

as to why the non-organic form of the 

material /substance is/is no longer

necessary for use in organic handling? 

X

 The petition describes in detail new methods for making organic 

fluid lecithin in a range of shades using only allowed methods. 

2. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance can/cannot be obtained 

organically in the appropriate form to fulfill 

an essential function in a system of 

organic handling? 

X

There are now numerous varieties of certified organic lecithin. The 

Technical Review in response to “Evaluation Question #5, 

identifies 4 manufacturers worldwide, of such lecithin. There is no 

information included on the petition or the TR indicating that dry 

forms of unbleached organic lecithin are commercially available at 

this time. 

3. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance can/cannot be obtained 

organically in the appropriate quality to 

fulfill an essential function in a system of 

organic handling? 

X

Petitioner states that products made with organic fluid lecithin and 

non-organic fluid lecithin are indistinguishable. Panel testing has 

been conducted which confirms this, according to the petition.

4. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance can/cannot be obtained 

organically in the appropriate quantity to 

fulfill an essential function in a system of 

organic handling?

X

Petitioner states that there is currently unsold inventory and 

additional capacity available to make organic fluid lecithin sufficient 

to meet current requirements. 

5. Does the industry information provided 

on material / substance nonavailability/availability as organic, include 

( but not limited to) the following:

a. Regions of production (including factors 

such as climate and number of regions); N/A

b. Number of suppliers and amount 

produced; X

See number 2 above

c. Current and historical supplies related to 

weather events such as hurricanes, floods, 

and droughts that may/no longer 

temporarily halt production or destroy 

crops or supplies; 

N/A

d. Trade-related issues such as evidence 

of hoarding, war, trade barriers, or civil 

unrest that may/no longer temporarily 

restrict supplies; or

N/A

e. Are there other issues which may/no 

longer present a challenge to a consistent 

supply?

X
Original Committee Recommendation and Evaluation Checklist from March 17, 2009 for

Removal of Lecithin – unbleached from §205.606

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: _____Spring 2009________________ Substance: ____Lecithin, unbleached_fluid________________

Committee: Crops  Livestock  Handling X Petition is for:__ for removal from listing of Lecithin, unbleached, 

fluid_______________________________________________________ on the National List § 205._ 606 _____________

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

8. Impact on Humans and Environment Yes X No  N/A 

9. Essential & Availability Criteria Yes  No X N/A 

10. Compatibility & Consistency Yes X No  N/A 

11. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No X N/A  

B. Substance Fails Criteria Category: _2 , 4________ Comments: ____Numerous varieties of organic lecithin are now 

commercially available which perform the same function as the listed material, but are made without the use of the synthetic 

extractants and bleaches.

________________________________________________________________________________________________________

C. Proposed Annotation (if any): ___”dry forms only” will be added to the current listing of Lecithin, unbleached on __§ 205._ 

606 _of the National List___ ______________________________________________________________

 Basis for annotation: To meet criteria above: ___X____ Other regulatory criteria: _______Citation:______________________

D. Recommended Committee Action & Vote (State Actual Motion): _______________________________________________ 

________________________________________________________________________________________________________

Motion by: Julie Weisman Seconded: Joe Smillie Yes:_5 No: __0 _ Absent: _1___ Abstain: __0___ 

 

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 ___________________________________________________

5) Substance was recommended to be removed. Describe why material is to be removed:_At this time there are many forms of 

organic unbleached fluid lecithin available, as well as organic and conventional non-synthetiic gums These make the use of nonorganic unbleached fluid lecithin, which is made with synthetic processing aids, no longer essential in organic handling. There is not 

enough information available at this time about the commercial availability of dry forms of organic unbleached lecithin. The 

annotation proposed in this recommendation will allow it’s further use until it’s next Sunset date.

Crops Agricultural Allowed1 

Livestock Non-Synthetic Prohibited2 /Removal X

Handling X Synthetic X Rejected3

No restriction Commercially UnAvailable as Organic1

 Deferred4

E. Approved by Committee Chair to transmit to NOSB:

 Steve DeMuri______________ _____March 17, 2009___________________

 Committee Chair Date
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance - __Lecithin, unbleached, fluid for 

removal from § 205.606_______________________

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 Increased environmental concerns about the use of hexane and and 

peroxides have resulted in legislation that could restrict oil 

processing operations that use them. ( TR p. 6, lines 281-285)

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X See above

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X

“It is not likely to produce harmful degradation products in the short 

term.’ In the long term it may degrade, however, the TR (p.6,line 293 

) does not indicate that the long-term degradation products would be 

harmful.

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

The TR ( p.3 lines 131-134 ) states that the EPA exempts from the 

requirement of a tolerance, the residues resulting from the use of 

lecithin as an inert or active ingredient in pesticides as long use is in 

accordance with good agricultural or manufacturing practices.

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X

See above

8. Is there a toxic or other adverse 

action of the material or its breakdown 

products? [§6518 m.2]

X

See # 3 and #6 above

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in

environment?[§6518 m.2]

X

See #3 and #6 above

10. Is there any harmful effect on 

human health? [§6517 c (1)(A)(i) ; 6517 

c(2)(A)i; §6518 m.4]

X

The TR ( p.6, lines 287-291 ) states that there is “ no reasonable 

grounds to suspect that any form of lecithin poses a hazard to the 

public when used at levels that are now current.” 

11. Is there an adverse effect on 

human health as defined by applicable 

Federal regulations? [205.600 b.3]

X

FDA approves all forms of lecithin for use in food with no limitation 

other than GMP. ( TR p. 3 lines 128-129).

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.
Category 2. Is the Substance Essential for Organic Production? Substance - _ Lecithin, unbleached, fluid for 

removal from § 205.606_________________________

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

According to the TR (pp. 4-5 )

Crude soy obtained by hexane extraction from soy flakes. It is then 

de-oiled using acetone. 

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

See below

5. Is there an organic substitute? 

[§205.600 b.1] X

TR identifies 4 manufacturers of organic lecithin. One in France, one 

in India and 2 in the U.S.

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 b.6]

X 

A wide variety of organic products currently available could not be 

made with out an emulsifier. ( See TR p.2 ) Lecithin is the primary 

emulsifier used in these products.

7. Is there a wholly natural substitute 

product? 

[§6517 c (1)(A)(ii)]

X

According to both the petitioner and the TR , the organic forms are 

the only forms of lecithin that are being produced without using 

synthetic solvents. Theoretically the extraction could be done, 

producing a non-organic (i.e. natural) soy lecithin, but none are 

being produced at this time.

8. Is the substance used in handling, 

not synthetic, but not organically 

produced? 

[§6517 c (1)(B)(iii)]

X

 There are four manufacturer known to the Technical Reviewer that 

are currently producing a variety of formulations of organic lecithin. ( 

TR p.6, line 275 )

9. Is there any alternative 

substances? [§6518 m.6]

 X A number of forms of organic lecithin which achieve a light color 

without bleaching, are now available in commercial quantities. In 

addition, there are now other organic and conventional non-synthetic, 

non-soy materials, such as gums and rice products which serve 

similar functions. There is no information given by the petitioner or in 

the TR suggesting that dry forms of organic unbleached lecithin are 

commercially available at this time.

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X

TR describes production process for organic substitute ( p. 6 )

Oil obtained by expeller press instead of hexane extraction. Varieties 

of soy yielding lighter-colored oil, combined with filtration are used to 

achieve the same effect as bleaching.

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.
Category 3. Is the substance compatible with organic production practices? Substance - Lecithin, unbleached, fluid 

for removal from § 205.606________________

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

Substance is used handling, not production.

4. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600 b.3]

X

There is no published evidence to suggest that unbleached fluid 

lecithin has any impact on the nutritional quality of the food in which it 

is used. ( TR p. 7, line 319)

5. Is the primary use as a 

preservative? [§205.600 b.4]

X The primary use of lecithin is as an emulsifier. (TR p.7, lines 325-

326. )

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

Although lecithin does have an effect on texture and dispersion of 

ingredients in a food, it is not used “recreate or improve” qualities

that were lost in processing.

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.
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 - __ Lecithin, unbleached fluid for removal from § 205.606_____________________________________

Question Yes No N/A Comments on Information Provided (sufficient, plausible, 

reasonable, thorough, complete, unknown)

1. Is the comparative description provided

as to why the non-organic form of the 

material /substance is (or is no longer) 

necessary for use in organic handling? 

X

 The petition describes in detail new methods for making organic 

fluid lecithin in a range of shades using only allowed methods. 

2. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance can be obtained organically in 

the appropriate form to fulfill an essential 

function in a system of organic handling? 

X

There are now numerous varieties of certified organic lecithin. The 

Technical Review in response to “Evaluation Question #5, 

identifies 4 manufacturers worldwide, of such lecithin. There is no 

information included on the petition or the TR indicating that dry 

forms of unbleached organic lecithin are commercially available at 

this time. 

3. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance can be obtained organically in 

the appropriate quality to fulfill an 

essential function in a system of organic 

handling? 

X

Petitioner states that products made with organic fluid lecithin and 

non-organic fluid lecithin are indistinguishable. Panel testing has 

been conducted which confirms this, according to the petition.

4. Does the current and historical industry 

information, research, or evidence 

provided explain how or why the material 

/substance can be obtained organically in 

the appropriate quantity to fulfill an 

essential function in a system of organic 

handling?

X

Petitioner states that there is currently unsold inventory and 

additional capacity available to make organic fluid lecithin sufficient 

to meet current requirements. 

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);

N/A

b. Number of suppliers and amount 

produced; X

See number 2 above

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; 

N/A

d. Trade-related issues such as evidence 

of hoarding, war, trade barriers, or civil 

unrest that may temporarily restrict 

supplies; or

N/A

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X