NOSB RECOMMENDED DECISION FORM

Form NOPLIST2. Full Board Transmittal to NOP

For NOSB Meeting: May 2009_____ Substance: _Lecithin, bleached_for removal from the National List _§ 205.605b 

_ 

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  No X N/A 

3. Compatibility & Consistency Yes X No  N/A 

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

B. Substance fails criteria? 

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 synthetic 

extractants and bleaches.

C. Proposed Annotation: ____________________________________ 

___________________________________________________________ 

Basis for annotation: 

To meet criteria above: ____ Criteria: _______________ 

Other regulatory criteria: ____ Citation:_______________

D. Final Board Action & Vote (State Actual Motion): It is moved that Lecithin, bleached be removed from § 205.605b of the 

National List

Motion: __Steve DeMuri____ Second:_ Hue Karreman________ Yes: __13__ No: ___1_ Abstain: __0__ Absent: 

 

 1 .

 No longer exempt from prohibition X

Provide a summary narrative here or 

attach a more complete narrative, 

and attach the original committee 

recommendation that includes the evaluation criteria checklist:

The petitioner requested the removal of both the unbleached and bleached forms of lecithin. During the May 2009 

NOSB meeting, several experts and lecithin industry members provided informational presentations describing the types 

of lecithin available, and the methods of manufacture for each. It was explained that it is the “de-oiling” process, not the 

bleaching process, which truly differentiated the types and functionality of lecithin, and dictated in which products they 

could be used. At this time, there are now many forms of organic lecithin available, as well as organic and conventional 

non-synthetic gums, which make the use of this synthetic form of lecithin no longer essential in organic handling. The 

board voted to remove the “bleached” form of lecithin from 205.605(b), but in a separate vote, agreed to list “lecithin –

de-oiled” in 205.606, making that form available to organic manufacturers who truly needed it, but subjecting its use to 

commercial availability scrutiny by certifiers. Both the petitioner and lecithin using handlers present at the NOSB 

meeting were satisfied with this recommendation. 

1—substance voted to be added as “allowed” on National List on National List to § 205.______ with Annotation (if any): ____ __ 

__________________________________________________________________________________________________ _ 

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 ________________________________ ____________________________________

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

organic lecithin available, as well as organic and conventional non-synthetic gums, which make the use of this synthetic 

form of lecithin no longer essential in organic handling.

Agricultural Nonagricultural Crops

Synthetic X Not synthetic Livestock

Allowed1Prohibited2

Handling X

No restriction Deferred4 Rejected / Remove X 3

E. Approved by NOSB Chair to transmit to NOP

Jeff Moyer 

Chair Date

August 17, 2009 .

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

 Return to NOSB Reason: ____________________________________________________________________ 

 _________________________ 

 Date 
NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: _____Spring 2009 Substance: ________________ for removal from the National List _§ 205.605b 

Committee: Crops  Livestock X Handling  Petition is for: For removal of lecithin - bleached from the National 

List § 205.605 b

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  No X N/A 

6. Compatibility & Consistency Yes X No  N/A 

7. 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): _____________________________________________________________________________

________________________________________________________________________________________________________

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:______________________

D. Recommended Committee Action & Vote (State Actual Motion): _____It is moved that the Lecithin, bleached be removed 

from § 205.60b of the National List__________________________________________ 

________________________________________________________________________________________________________

Motion by: _Julie Weisman _ Seconded:__Steve DeMuri

 

__ 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_____

Crops

At this time there are many 

forms of organic lecithin available, as well as organic and conventional non-synthetiic gums which make the use of this 

synthetic form of lecithin no longer essential in organic handling.

Agricultural Allowed1

 

Livestock Non-Synthetic Prohibited2 

Handling X Synthetic X Rejected / Remove X 3

No restriction Commercially UnAvailable as Organic1

 Deferred4

E. Approved by Committee Chair to transmit to NOSB:

_Steve DeMuri 

 Committee Chair Date

March 17, 2009
NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance - __Lecithin, bleached for removal from 

§ 205.605 b_______________________

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, bleached for removal from § 

205.605 b_________________________

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. Lecithin is bleached via hydrogen peroxide 

and benzyl peroxide.

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 and bleaching agents, although theoretically this 

could be done using non-organic agricultural ingredients.

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 

materials, such as gums which serve similar functions. 

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, bleached 

for removal from § 205.605 b________________

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 in handling, not crop 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 bleached 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, bleached for removal from § 205.605 b_____________________________________

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 on detail new methods for making organic 

lecithin that is light in color using only allowed methods. 

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

There are now numerous varieties of light-colored, certified organic 

lecithin. The Technical Review in response to “Evaluation Question 

#5, identifies 4 manufacturers worldwide, of such lecithin.

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

Petitioner states that products made with organic lecithin and the 

listed material 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 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 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