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 ascorbyl palmitate (CAS 137-66-6) to section 205.605(b) 

Barry Flamm

Petition Failed

Passed

 Motion to classify ascorbyl palmitate as petitioned (CAS 137-66-6) as synthetic. 

 

 

Ascorbyl palmitate as petitioned is synthetic. 

Nick Maravell

Jean Richardson

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 Ascorbyl palmitate (CAS 137-66-6) to the National List section 205.605(b) for use as a 

preservative in infant formula. 

 

Ascorbyl palmitate (AP) is not required by the FDA or other regulation to be added to infant formula. 

Permitted alternatives exist, including fat soluble ones, but none have been evaluated for use in 

infant processed foods. AP is a synthetic preservative and should not be added to the National List 

under restriction of 205.600(b)(4).

Nick Maravell

Jean Richardson

4 11 0 0 0
Handling:AscorbylPalmitate

National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Ascorbyl Palmitate

August 14, 2012

Summary of Proposed Action:

Ascorbyl palmitate (AP) is a synthetic ester of ascorbic acid and palmitic acid used in 

infant formula as a preservative. FDA lists it as GRAS. Ascorbyl Palmitate has 

antioxidant properties, but, as the TR states “ it remains inconclusive whether or not the 

body actually utilizes ascorbic acid that is metabolized from AP”.

Ascorbyl palmitate has some advantages as a food preservative because it is fat 

soluble and very slightly water soluble. AP synergistically improves the effectiveness of 

other preservatives, such as tocopherols, to protect fats and oils from rancidity and 

prevent rancid flavor. It is used in cosmetics, animal feeds and margarine to reduce 

rancidity (Petition page 2). Synthetic AP is currently used in infant formula to stabilize 

DHA and ARA edible oils. AP, DHA, and ARA are not required by FDA to be added to

infant formula. 

Use of AP for stabilizing edible oils raises the issue of a lack of an established policy on 

“other ingredients.” In December 2011 the NOSB approved use of DHA from Algal Oil 

and ARA from Fungal Oil, and specifically did not approve all the “other ingredients” 

(which included AP) for broad use in organic food. Approval was specific and explicitly 

not precedent setting, applying only to the petitioned formulations of DHA and ARA. 

Organic alternatives to Ascorbyl palmitate exist, especially rosemary extract and 

tocopherols. Synthetic tocopherols are also an alternative on the National List if organic 

rosemary extracts are not suitable. The Petition asserts that tocopherols are currently 

used in infant formulas, but have limited function without AP. Another alternative is to 

shorten shelf life date.

Agricultural organic alternatives to AP have not been evaluated for use in infant formula. 

The TR states, “Other organic agricultural fat-soluble antioxidants which may be 

potential alternative preservatives include, but are not limited to, alpha-tocopherol 

(vitamin E), beta-carotene, alpha-lipoic and dihydrolipoic acids, and ubiquinone. ... Like 

ascorbyl palmitate, ubiquinone and dihydrolipoic acid can function as synergistic 

antioxidants to regenerate tocopherols. No information was found to indicate whether 

or not these other fat-soluble antioxidants have been tested as alternatives to ascorbyl 

palmitate as preservatives in food or cosmetics, or are readily available for commercial 

use in processed foods.” 

According to the petitioner, certain organic alternative preservatives (carnosic acid from 

rosemary extract) could have effects harmful to pregnant mothers and unknown side 

effects in infants. No scientific data has been presented to show adverse effects or the 
Handling:AscorbylPalmitate

relative degree of efficacy of using rosemary extract in infant formula. However, the 

NOSB recommendation approving DHA Algal Oil and ARA Fungal Oil recognized that 

rosemary extract was included in both materials. It must be noted that the Petition (page 

7) states “for infant formula rosemary extracts are not a suitable option” and further 

states that “rosemary extracts have not been tested and accepted for use in infant 

formula” and it is “not prudent to use these substances in food for young infants” 

(Petition, page 8). 

As reported by the Journal of the European Food Safety Authority (June 2008), a study 

in rats found no effect of rosemary extract on fetus development or on the ability of the 

fetus to reach full term. However, this same scientific opinion states, “The toxicological 

data on the rosemary extracts are insufficient to establish a numerical ADI [Acceptable 

Daily Intake], because the toxicity data set does not provide reproductive toxicity studies 

or a long term study. On the other hand, the existing data, including the absence of 

effects in the 90-day studies on reproductive organs and lack of genotoxicity, do not 

give reason for concern.”

Ascorbyl palmitate, as petitioned for use in “organic” infant formula, is not used to fortify 

food or add nutritional value.

AP is not listed for use as a preservative in organic infant formula in European, 

Canadian or Japanese standards. In European standards it appears that AP as vitamin 

C is permitted in organic infant formula to the extent it is required by infant formula 

directives on vitamins (although, as noted above, data is inconclusive on actual 

potential absorption of ascorbic acid from AP).

According to the TR, AP does not have significant adverse impacts on the environment 

or on human health, although it is noted in the Petition (page 5) that high levels of 

ascorbic acid increase oxalic acid production and excretion with potential for oxalate 

bladder stones.

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 &3 ] Comments:

Proposed Annotation (if any):
Handling:AscorbylPalmitate

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

Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: Ascorbyl palmitate (CAS 137-66-6) is synthetic.

Motion by: Nick Maravell Seconded by: Jean Richardson 

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

Listing Motion: To add Ascorbyl palmitate (CAS 137-66-6) to the National List sec 

205.605(b) for use as a preservative in infant formula.

Motion by: Nick Maravell Seconded by: Jean Richardson

Yes: 0 No: 6 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 § 205.605(b). Describe 

why material was rejected: Ascorbyl palmitate (AP) is not required by FDA or other 

regulation to be added to infant formula. Permitted alternatives exist, including fat 

soluble ones, but none have been evaluated for use in infant processed foods. 

Objections to organic rosemary abstract are not supported by scientific data. DHA and 

ARA, already added to list, contain rosemary extracts. AP is a synthetic preservative 

and should not be added to the National List under restriction of 205.600(b)(4). 

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 8/14/12
Handling:AscorbylPalmitate

NOSB Evaluation Criteria for Substances Added To the National List

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

Ascorbyl palmitate

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

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

x

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.Is there any harmful effect on 

human health? [§6517 c (1)(A)(i); 

6517 c(2)(A)i; §6518 m.4]

x At high doses ascorbic acid 

increases oxalic acid production 

and excretion with potential for 

oxalate bladder stones (Petition, 

page 5)

11.Is there an adverse effect on 

human health as defined by 

x
Handling:AscorbylPalmitate

applicable Federal regulations? 

[205.600 b.3]

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:AscorbylPalmitate

NOSB Evaluation Criteria for Substances Added To the National List

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

Ascorbyl palmitate

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 Petition; TR lines 227-234

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 Not the petitioned material.

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

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 Shorter shelf life of product

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

x Natural alternatives, such as 

rosemary oil and extracts, for 

addition to infant formula have 

not been evaluated.

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 Tocopherols, derived from 

vegetable oils, and “only when 

rosemary extracts are not a 

suitable alternative” TR lines

124-125

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:AscorbylPalmitate

NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: Ascorbyl palmitate 

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 TR (lines 317-318) states AP 

“is used as a preservative, which 

includes the prevention of offflavors or bad odors during shelf 

life of product”.

5. Is the primary use as a 

preservative? [§205.600 b.4]

x Petition and TR state; “The 

primary function of ascorbyl 

palmitate is as a preservative” 

(TR line 301)

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 Primary use is to prevent 

“development of off-flavors or bad 

odors that would otherwise occur 

over time” (TR line 303)

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
Handling:AscorbylPalmitate

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.
Handling:AscorbylPalmitate

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 Ascorbyl palmitate

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

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 x
Handling:AscorbylPalmitate

amount produced;

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.