This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and then may be 

voted upon by the full Board. They are not final Board recommendations or NOP policy. 

Revised Jun 2013 

National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Glycerin CAS # 56-81-5

August 20, 2013

Reviewed January 21, 2014 - No revisions

Summary of Proposed Action:

The 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 that is 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. This is why 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)

Because glycerin produced by hydrolysis of fats and oils is currently listed at 205.605(b), the 

NOSB seeks public comment regarding the potential impact to producers and industry should 

glycerin as is presently listed be removed from 205.605(b) of the National List. At present, the 

NOSB has not received a petition to add Glycerin produced by other methods to the National 

List. 

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 advantage 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 
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and then may be 

voted upon by the full Board. They are not final Board recommendations or NOP policy. 

Revised Jun 2013 

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 counterflow 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, and therefore it is considered a synthetic. 

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.

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. 

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 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 used at 

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

organic fats and oils.
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and then may be 

voted upon by the full Board. They are not final Board recommendations or NOP policy. 

Revised Jun 2013 

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 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. 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: [ ] Comments:

Subcommittee Action & Vote, including classification proposal (state actual motion):

Classification Motion: N/A

Listing Motion: Motion to remove Glycerin produced by hydrolysis of fats and oils, CAS #

56-81-5 from 205.605(b) of the National List.

Motion by: Tracy Favre 

Seconded by: Harold Austin

Yes: 7 No: 0 Absent: 1 Abstain: 0 Recuse: 0

 Proposed Annotation (if any): N/A

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

Notes: 

Approved by John Foster, Subcommittee Chair, to transmit to NOSB August 20, 2013
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and then may be 

voted upon by the full Board. They are not final Board recommendations or NOP policy. 

Revised Jun 2013 

NOSB Evaluation Criteria for Substances Added To the National List

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 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. TR indicates it is readily 

biodegradable (line 568).

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.
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and then may be 

voted upon by the full Board. They are not final Board recommendations or NOP policy. 

Revised Jun 2013 

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 originally been listed at 205.606 

since it is manufactured using steam. If so, 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 

chemically changes a substance 

extracted from naturally occurring 

plant, animal, or mineral sources? 

[§6502(21)]

X Hydrolysis is the opposite of condensation. A 

large molecule is split 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.
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and then may be 

voted upon by the full Board. They are not final Board recommendations or NOP policy. 

Revised Jun 2013 

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 

manufacturing using a fermentation process. See 

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)]

X X Alcohols could be used a carriers for flavorings.

And there are myriad other materials that could 

have a similar functional use in other formulations 

(such as softening and mouth feel in ice creams, 

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
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and then may be 

voted upon by the full Board. They are not final Board recommendations or NOP policy. 

Revised Jun 2013 

NOSB Evaluation Criteria for Substances Added To the National List

Handling

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 TR 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 preferred for 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)]

X Petition is to remove this substance from 

National List

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 is used to improve textures.

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 

X See above. Petitioner claims there is 

sufficient organic glycerin available and the 

synthetic non-organic version is no longer 
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and then may be 

voted upon by the full Board. They are not final Board recommendations or NOP policy. 

Revised Jun 2013 

/substance cannot be obtained 

organically in the appropriate form to 

fulfill an essential function in a system of 

organic handling? 

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 or 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 

produced;

X There are currently 21 USDA certified 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