Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: April 2015

Subject: Petition to remove Glycerin from §205.605(b) 

NOSB Chair: Jean Richardson

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: X 

Guidance Statement:

Other:

Statement of the Recommendation (Motion #1): 

Motion to list Glycerin at §205.606, produced from agricultural source materials and processed 

using biological or mechanical/physical methods as described under §205.270(a), passed. 

Statement of the Recommendation (Motion #2): 

Motion to remove Glycerin - produced by hydrolysis of fats and oils - from §205.605(b), passed

Rationale Supporting Recommendation (including consistency with OFPA and Organic 

Regulations): 

The NOSB recommends the listing of glycerin at §205.606 and removal of glycerin from 

§205.605(b) after review of the manufacturing methods and sources. Based upon the draft 

classification of materials document, glycerin that would qualify for listing at §205.606 would 

include glycerin produced by microbial fermentation of carbohydrate substances as well as 

glycerin produced from hydrolysis of fats and oils using mechanical/physical methods, as long 

as the original source material was agricultural. It is the NOSB’s intent with this 

recommendation to provide an incentive to increase the amount of organic glycerin used, while 

also recognizing the possibility of issues around commercial availability. Synthetic glycerin 

produced by hydrolysis of fats and oil (using sodium/potassium hydroxide as a reagent) may be 

used only when certified organic. 

Committee Vote: 

Motion to list Glycerin at §205.606, produced from agricultural source materials and processed 

using biological or mechanical/physical methods as described under §205.270(a).

Moved: Tracy Favre

Second: Zea Sonnabend

Yes: 14 No: 0 Abstain: 0 Absent: 1 Recusal: 0 

Motion passed
Motion to remove Glycerin - produced by hydrolysis of fats and oils - from §205.605(b)

Moved: Tracy Favre

Second: Zea Sonnabend

Yes: 14 No: 0 Abstain: 0 Absent: 1 Recusal: 0

Motion passed
National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal - Glycerin

October 21, 2014

Summary of Proposed Action:

Petitioner has requested removal of glycerin from §205.605(b) (synthetic materials for handling), stating 

that there is now sufficient quantity of organically produced glycerin and that synthetic glycerin is no 

longer required. The petitioner believes that the process of microbial fermentation – used to produce 

organic glycerin – is a superior method for the production of organic glycerin, because it uses only 

mechanical and biological processes as required in §205.270(a) without the use of allowed synthetics 

listed in §205.605(b). Further, they state, “An important reason that glycerin produced by hydrolysis of 

fats and oils should have been included at §205.606 is that items listed at §205.606 are subject to the 

restriction that they can be used “only when the product is not commercially available in organic form.” 

Certified organic glycerin is currently available, but there is no “commercial availability” requirement to 

incentivize processors to use it or certifiers to require it. Consequently, glycerin should be removed from 

the National List in order to encourage organic agricultural production.”

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STELPRDC5101924) 

There has been a significant amount of confusion regarding the classification of glycerin as 

synthetic/non-synthetic because of the various methods by which it can be manufactured. In April 2013, 

the National Organic Program (NOP) issued draft guidance on classification of materials that should 

provide some clarification on the status of glycerin produced by these various methods. However, as of 

this date, this guidance document has not been issued in its final form. Further, the Handling 

subcommittee recognizes the irony that glycerin produced from organic source materials using hydrolysis 

could be classified as both organic and synthetic.

Additionally, public written and oral comments presented for the Spring 2014 and the Fall 2014 NOSB 

meetings indicated that the removal of glycerin from §205.605(b) could have significant negative impact 

on natural flavorings used in organic products, due to the fact that glycerin is often used as a carrier. 

The comments generally expressed concern regarding the commercial availability of sufficient quantities 

of organically produced glycerin to meet the demand. With the current listing for flavors at §205.605(a), 

the annotation is as follows: “non-synthetic sources only and must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.” During the Handling subcommittee 

discussion, the question came up as to whether current practice is to allow glycerin – from hydrolysis of 

fats and oils – currently classified as synthetic, to be used as a carrier in natural flavorings. 

Because of the confusion around classification of glycerin (depending upon the manufacturing methods 

and source material), and the concerns regarding commercial availability of organically produced 

glycerin, the Handling subcommittee, after significant discussion, is proposing the listing of glycerin at 

§205.606 and removal of glycerin from §205.605(b). 

Based upon the draft classification of materials document, glycerin that would qualify for listing at 

§205.606 would include glycerin produced by microbial fermentation of carbohydrate substances as well 

as glycerin produced from hydrolysis of fats and oils using mechanical/physical methods, as long as the 

original source material was agricultural. It is the Handling subcommittee’s intent with this 

recommendation to provide an incentive to increase the amount of organic glycerin used, while also 

recognizing the possibility of issues around commercial availability. 
Background

Glycerin is a viscous fluid that has a sweet taste. It is used in a wide variety of products including food, 

cosmetics, medical and industrial applications. As listed at §205.605(b), glycerin is formulated from 

hydrolysis of fats and oils. Per the Technical Review (line 122), there are a variety of methods for 

manufacture of glycerin from hydrolysis of fats and oils: 

Table 2 Processes for producing glycerin by hydrolysis of fats and oils

Lemmens Fryer’s Process Oil or fat is subjected in an autoclave to the conjoint action of 

heat and pressure (about 100 PSI) in the presence of an 

emulsifying and accelerating agent, e.g. zinc oxide or 

hydroxide (sodium hydroxide can be substituted) for about 

eight hours. The strong solution of glycerin formed is 

withdrawn and replaced by a quantity of hot, clean and 

preferably distilled water equal to about one third to one 

fourth of the weight of the original charge of oil or fat and 

treatment continued for an additional four hours. The dilute 

glycerin obtained from the latter part of the process is drawn 

off and used for the initial treatment of the further charge of 

oil or fat.

Budde and Robertson’s 

Process

The oils or fats are heated and mechanically agitated with 

water and sulphuric acid gas, under pressure in a closed 

vessel or autoclave. The advantages claimed for the process 

are that the contents of the vessel are free from foreign 

matter introduced by reagents and need no purification; that 

the liberated glycerin is in the form of a pure and 

concentrated solution; that no permanent emulsion is formed 

and that the fatty acids are not discolored.

Ittner’s Process Coconut oil is kept in an autoclave in the presence of water at 

70 atmospheres pressure and 225-245oC temperature and 

split into fatty acids and glycerin, both being soluble under 

these conditions in water. The glycerin solution separates in 

the bottom of the autoclave. The aqueous solution contains at 

the end of the splitting process more than 30 percent 

glycerin.

Continuous High Pressure 

Hydrolysis

In this process a constant flow of fat is maintained flowing 

upward through an autoclave column tower against a 

downward counter-flow of water at a pressure of 600 PSI 

maintained at temperature of 480-495o

F. Under these 

conditions, the fat is almost completely miscible in water and 

the hydrolysis take place in a very short time. The liberated 

fatty acids, washed free of glycerin by the downward 

percolating water, leave the top of the column and pass 

through a flash tank while the liberated glycerin dissolves in 

the downward flow of water and is discharged from the 

bottom of the tower into the sweet-water storage tank.

Additionally, per the petitioner, “Saponification of natural fats and oils, a process of hydrolyzing the 

agricultural products fat or oil with water (steam) under pressure (high-pressure splitting) or with a 

solution of sodium carbonate, sodium hydroxide, or potassium hydroxide (traditional process) to produce 

synthetic glycerin and fatty acids. The steam process is described in the 1995 Technical Advisory Panel 

Report on glycerin. The alkali process is the traditional process used to saponify fats and oils.” 
Hydrolysis of fats and oils does change the chemical properties of the source material, therefore, it is 

considered a synthetic. 

The forms identified below as agriculture would be allowed at §205.606. Synthetic forms would 

not be allowed unless produced organically. 

Per the petition: Four general methods of commercial glycerin production are or have been used:

1. Chemical synthesis by hydrogenolysis of carbohydrates (21 CFR 178.3500; 21CFR 172.866)) or 

by synthesis from propylene (mentioned in the 1995 Technical Advisory Panel report on glycerin). 

Neither chemical synthetic process has ever been deemed worthy of serious consideration for 

use in organic. Per the draft classification of materials guidance document, this form would be 

considered synthetic.

2. Biodiesel production comprises reaction of natural fats and oils – triglycerides – with methyl 

alcohol or ethyl alcohol to produce the methyl or ethyl esters of fatty acids. These synthetic fatty 

acid esters are the diesel fuel. Glycerin is a synthetic waste byproduct of this chemical process. 

The commercialization of the biodiesel process in the past few years has created an enormous 

supply of biodiesel glycerin that has largely displaced chemical synthesis from propylene. In fact, 

the low cost of biodiesel glycerin has resulted in commercialization of processes to use it as a raw 

material to produce epichlorohydrin, acrolein, propylene glycol, and other organic chemicals. 

There are safety concerns with biodiesel glycerin, discussed in Section B-11. Per the draft 

classification of materials guidance document, this form would be considered non-agricultural 

synthetic.

3. Saponification of natural fats and oils, a process of hydrolyzing the agricultural products fat or oil 

with water (steam) under pressure (high-pressure splitting) or with a solution of sodium 

carbonate, sodium hydroxide, or potassium hydroxide (traditional process) to produce synthetic 

glycerin and fatty acids. The steam process is described in the 1995 Technical Advisory Panel

(TAP) Report on glycerin. The alkali process is the traditional process used to saponify fats and 

oils. The three sources of alkali used in this process are included in the National List. Glycerin 

produced by saponification was recommended by the NOSB in 1995 for inclusion on the National 

List with the annotation “produced by hydrolysis of fats and oils.” It is currently included on the 

National List as a synthetic nonagricultural substance at §205.605(b) [and also for livestock use 

at §205.603(a)(12)]. Certified organic glycerin is being produced by saponification of organic fats 

and oils. Per the draft classification of materials guidance document, glycerin produced using 

saponification of natural fats and oils using steam would be considered agricultural. However, the 

material would be considered synthetic if an alkali catalyst was used. 

4. Microbial fermentation of carbohydrate substances (analogous to citric acid currently included in 

the National List at §205.605(a)) to produce non-synthetic glycerin. This production method is 

briefly mentioned generically in the 1995 TAP Report and referred to in the Merck Index 

monograph on glycerol (glycerin), which cites a U.S. Patent No. 3,012,945 issued to Noda in 

1961 for yeast fermentation to produce glycerin. Currently, microbial fermentation of organic 

cornstarch by the yeast Candida krusei1 is used commercially to produce certified organic 

glycerin as well as non-synthetic non-organic glycerin. Per the draft classification of materials 

guidance document, this form would be considered agricultural.

According to the Technical Report, glycerin can be produced organically by the process of microbial 

fermentation using only mechanical and biological processes as required in §205.270(a) without the use 

of allowed synthetics listed in §205.605(b). In addition, certified organic glycerin can be produced by 

hydrolysis of organic fats and oils using either steam splitting or traditional saponification with a catalytic 

amount of an alkali (sodium carbonate, sodium hydroxide, or potassium hydroxide) on the National List. 

Glycerin, produced organically by fermentation is an agricultural product as defined in 7 CFR 205.2, 

since it is a processed product produced from an agricultural commodity, e.g. cornstarch (TR lines 130 – 

131). There are currently 21 USDA certified organic operations supplying glycerin for organic food 

or cosmetic products. Specific supplier information (TR Table Line: 674)
Evaluation Criteria (see attached checklist for criteria in each category)

 Criteria Satisfied? 

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 X No ☐ N/A 

as Organic (only for §205.606)

Substance Fails Criteria Category 2, 3, 4

Subcommittee Action & Vote

Classification Motion: Motion to classify glycerin as agricultural when derived from agricultural 

source material and processed using biological or mechanical/physical methods described under 

§205.270(a).

Motion by: Tracy Favre 

Seconded by: Zea Sonnabend 

Yes: 6 No: 0 Absent: 2 Abstain: 0 Recuse: 0

Listing Motion: Motion to list glycerin at §205.606, produced from agricultural source materials and 

processed using biological or mechanical/physical methods as described under §205.270(a).

Motion by: Tracy Favre 

Seconded by: Zea Sonnabend

Yes: 6 No: 0 Absent: 2 Abstain: 0 Recuse: 0

 

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

Notes: 

Listing Motion: Motion to remove glycerin - produced by hydrolysis of fats and oils – from 

§205.605(b)

Motion by: Tracy Favre 

Seconded by: Zea Sonnabend

Yes: 6 No: 0 Absent: 2 Abstain: 0 Recuse: 0

Approved by Harold Austin, Subcommittee Chair, to transmit to NOSB December 2, 2014
NOSB Evaluation Criteria for Substances Added to the National List - Handling

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

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Are there adverse effects on the 

environment, or is there a probability of 

environmental contamination during use

or misuse of the substance? 

[§205.600(b)(2), [§6518(m)(3)] 

X Wide variety of uses for food and 

industrial applications. Long-term history 

of safe use, TAP indicates no incidence 

of industrial poisoning. Glycerin should 

not come into contact with a strong 

oxidizing agent. 

2. Are there adverse effects on the 

environment or is there a probability of 

environmental contamination during 

manufacture or disposal of the 

substance? [§6518(m)(3)]

X For current listing: Manufactured from 

hydrolysis of fats and/or oils using steam 

splitting. Theoretically possible to have 

spill of oils, but this is unlikely. 

Fermentation methods: Unlikely

3. Are there any adverse impacts on 

biodiversity? (§205.200)

X However, the petitioner claims that the 

residue from biodiesel production is used 

in the manufacture of glycerin, and one 

could argue that growing corn for 

biodiesel does have an impact on 

biodiversity.

4. Does the substance contain inerts

classified by EPA as ‘inerts of 

toxicological concern’? [§6517 

(c)(1)(B)(ii)]

X

5. Is there undesirable persistence or 

concentration of the material or 

breakdown products in the environment?

[§6518(m)(2)]

X Per Environmental Working Group 

(EWG), there seems to be no persistence 

in the environment. TAP and other 

documentation have no comment.

6. Are there any harmful effects on human 

health from the main substance or the 

ancillary substances that may be added 

to it? [§6517(c))(1)(A)(i); 6517 

(c)(2)(A)(i); §6518(m)(4), 205.600(b)(3)]

X Glycerin is considered GRAS and has a 

long history of safe use in a wide variety 

of food, cosmetic and medical 

applications. It is metabolized as a 

carbohydrate in the body.

7. Is the substance, and any ancillary 

substances, GRAS when used according 

to FDA’s good manufacturing practices? 

[§205.600(b)(5)]

X See above comment.

8. Does the substance contain residues of 

heavy metals or other contaminants in 

excess of FDA tolerances? [§205.600 

(b)(5)]

X Manufactured from hydrolysis of fats and 

oils using steam splitting and then 

concentrated using distillation. 

Fermentation methods include isolation of 

cornstarch from organic corn.
NOSB Evaluation Criteria for Substances Added to the National List - Handling

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

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X X As currently listed it is not considered 

agricultural. However, the petitioner 

makes the argument that it should have 

been listed at §205.606; if it is 

manufactured using steam, then it should 

be considered agricultural. The 

fermentation method could be considered 

agricultural since it is manufactured using 

isolated cornstarch from organic corn. 

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X Per the petition: “Saponification of natural 

fats and oils, a process of hydrolyzing the 

agricultural products fat or oil with water 

(steam) under pressure (high-pressure 

splitting) or with a solution of sodium 

carbonate, sodium hydroxide, or 

potassium hydroxide (traditional process) 

to produce synthetic glycerin and fatty 

acids. The steam

process is described in the 1995 

Technical Advisory Panel Report on 

glycerin. The alkali process is the 

traditional process used to saponify fats 

and oils. The three sources of alkali used 

in this process are included in the 

National List.” 

Hydrolysis of fats and oils does change 

the chemical properties of the source 

material. 

Fermentation methods: The process for 

producing organic glycerin by microbial 

fermentation from carbohydrate 

substrates begins with organic corn from 

which cornstarch is isolated. The 

cornstarch is

treated with enzymes to hydrolyze the 

starch and liberate glucose. The glucose 

is then fermented with an appropriate 

microorganism to produce glycerin. The 

glycerin is purified by passing through 

ion-exchange columns to remove 

inorganic elements required for growth of 

the microorganism and through activated 

charcoal to remove color and impurities.

3. Is the substance formulated or 

manufactured by a process that 

X Hydrolysis is the opposite of

condensation. A large molecule is split 
chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

into smaller sections by breaking a bond, 

adding -H to one section and -OH to the 

other.

The products are simpler substances. 

Since it involves the addition of water, 

this explains why it is called hydrolysis, 

meaning splitting by water. 

A-B + H2O --> A-H + B-OH 

(http://www.biotopics.co.uk/as/

condensation_and_hydrolysis.html)

For fermentation method, see above.

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X The process of hydrolysis is a naturally 

occurring process, but this material is 

manufacturing using high heat and 

pressure. Incidentally, all (food) digestion 

reactions are examples of hydrolysis, and 

the involvement of water is often not 

appreciated. Generally these reactions 

are controlled by enzymes such as 

carbohydrases, proteases, lipases, 

nucleases, more specific examples of 

which are fairly well known. 

(http://www.biotopics.co.uk/as/

condensation_and_hydrolysis.html)

For fermentation, see above.

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Petitioner claims to have a fully organic 

version of manufacturing using a 

fermentation process. See glycerin 

petition

(http://www.ams.usda.gov/AMSv1.0/

getfile?dDocName=STELPRDC5101924) 

Per the TR: Glycerin can be produced 

organically by the process of microbial 

fermentation using only mechanical and 

biological processes as required in 

§205.270(a) without the use of allowed 

synthetics listed in §205.605(b). In 

addition, certified organic glycerin can be 

produced by hydrolysis of organic fats 

and oils using either steam splitting or 

traditional saponification with a catalytic 

amount of an alkali (sodium carbonate, 

sodium hydroxide, or potassium 

hydroxide) on the National List. 

7. Is the substance essential for handling of 

organically produced agricultural 

products? [§205.600(b)(6)] 

X Glycerin is used in a wide variety of 

products including food, cosmetics, 

industrial and medical. It is a strong 

humectant. In organic food products it is 

used to improve texture, increase volume 
and is a major carrier for flavorings and 

colorings.

8. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

Alcohols could be used as carriers for 

flavorings. There are myriad of other 

materials that could have a similar 

functional use in other formulations (such 

as softening and mouth feel in ice cream, 

keeping baked items soft, etc.) but 

glycerin is unique in that it can serve in all 

these functions.

9. Are there any alternative substances? 

[§6518(m)(6)] 

X Glycerin manufactured from petroleum 

products, glycerin from saponification of 

fats and oils and fermentation methods.

10. Is there another practice (in farming or 

handling) that would make the substance 

unnecessary? [§6518(m)(6)]

X X Given the wide use of glycerin, it is likely 

that there are substitutes for particular 

uses, but it is unlikely that any one 

material would work in all the applications 

where glycerin is used. 

11. Have the ancillary substances associated 

with the primary substance been 

reviewed? Describe, along with any 

proposed limitations. 

X

Category 3. Is the substance compatible with organic handling practices? Substance: Glycerin

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X TAP says consistent when used with 

specific food products

2. Is the manner of the substance’s use, 

manufacture, and disposal compatible 

with organic handling? [§205.600(b)(2)] 

X Current version on the National List is 

considered a synthetic; therefore, it would 

not be compatible with organic handling. 

According to the petitioner, there is now 

sufficient capacity for organically 

produced glycerin to supply the organic 

market.

3. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

4. Are the ancillary substances reviewed 

compatible with organic handling [?

X

5. Is the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X

6. Is the primary use as a preservative? 

[§205.600(b)(4)]

X One of the uses of glycerin is as a 

preservative but it has many more uses

7. Is the primary use to recreate or improve 

flavors, colors, textures, or nutritive 

values lost in processing (except when 

required by law)? [§205.600(b)(4)]

X Glycerin is used as a flavor and/or color 

carrier, and it is used to improve textures.

NOSB Evaluation Criteria for Substances Added to the National List - Handling
Category 4. Is the commercial supply of an organic agricultural substance fragile or potentially 

unavailable? [§6610, §6518, §6519, §205.2, § 205.105(d), §205.600(c)] Substance: Glycerin

Question Yes No N/A Comments/Documentation. (TAP; 

petition; regulatory agency; other)

1. Is the comparative description as to why 

the non-organic form of the material 

/substance is necessary for use in 

organic handling provided? 

X Petition is for removal of synthetic 

glycerin. Petitioner claims there is 

sufficient quantity of organic glycerin 

available. Per the TR: Glycerin can be 

produced organically by the process of 

microbial fermentation using only 

mechanical and biological processes as 

required in §205.270(a) without the use of 

allowed synthetics listed in §205.605(b). 

In addition, certified organic glycerin can 

be produced by hydrolysis of organic fats 

and oils using either steam splitting or 

traditional saponification with a catalytic 

amount of an alkali (sodium carbonate, 

sodium hydroxide, or potassium 

hydroxide) on the National List. 

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 See above. Petitioner claims there is 

sufficient organic glycerin available and 

the synthetic version is no longer 

necessary.

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 See petition at: 

http://www.ams.usda.gov/AMSv1.0/

getfile?dDocName=STELPRDC5101924

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 When synthetic glycerin was 

recommended for inclusion on the 

National List, there was an insufficient 

supply of organic glycerin. According to 

the petitioner, that is no longer the case.

Per the TR: There are currently 21 USDA 

certified organic operations supplying 

glycerin for organic food or cosmetic 

products. 

5. Does the industry information about 

unavailability include (but is 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 X There are currently 21 USDA certified 
produced; organic operations supplying glycerin for 

organic food or cosmetic products. 

Specific supplier information (TR Table 

Line: 674)

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. Other issues which may present a 

challenge to a consistent supply?

X