National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset 2020 Review 

Meeting 1 - Request for Public Comment

Handling Substances 

April 2018

Introduction

As part of the Sunset Process, the National Organic Program (NOP) announces substances on the 

National List of Allowed and Prohibited Substances (National List) that are coming up for sunset review 

by the National Organic Standard Board (NOSB). The following list announces substances that are on the 

National List for use in organic handling that must be reviewed by the NOSB and renewed by the USDA 

before their sunset dates in 2020. This list provides the substance’s current status on the National List, 

use description, references to past technical reports, past NOSB actions, and regulatory history, as 

applicable. If a new technical report has been requested for a substance, this is noted in this list. To see 

if any new technical report is available, please check for updates under the substance name in the 

Petitioned Substances Database. 

Request for Comments

While the NOSB will not complete its review and any recommendations on these substances until the 

Fall 2018 public meeting, the NOP is requesting that the public provide comments about these 

substances to the NOSB as part of the Spring 2018 public meeting. These comments should be provided 

through www.regulations.gov by April 4, 2018 as explained in the meeting notice published in the 

Federal Register. 

These comments are necessary to guide the NOSB’s review of each substance against the criteria in the 

Organic Foods Production Act (7 U.S.C. 6518(m)) and the USDA organic regulations (7 CFR 205.600). The 

current substances on the National List were originally recommended by the NOSB based on evidence 

available to the NOSB at the time of their last review which demonstrated that the substances were 

found to be: (1) not harmful to human health or the environment, (2) necessary because of the 

unavailability of wholly nonsynthetic alternatives, and (3) consistent and compatible with organic 

practices. 

Public comments should focus on providing new information about a substance since its last NOSB 

review. Such information could include research or data that may support a change in the NOSB’s 

determination for a substance. Public comment should also address the continuing need for a substance 

or whether the substance is no longer needed or in demand.

Guidance on Submitting Your Comments

Comments should clearly indicate your position on the allowance or prohibition of substances on the list 

and explain the reasons for your position. You should include relevant information and data to support 

your position (e.g., scientific, environmental, manufacturing, industry impact information, etc.). 

For Comments That Support Substances Under Review:

If you provide comments in support of an allowance of a substance on the National List, you should 

provide information demonstrating that the substance is: 

(1) not harmful to human health or the environment;

(2) necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

(3) consistent with organic crop production. 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

For Comments That Do Not Support Substances Under Review: 

If you provide comments that do not support a substance on the National List, you should provide 

reasons why the use of the substance should no longer be allowed in organic production or handling. 

Specifically, comments that support the removal of a substance from the National List should provide 

new information since its last NOSB review to demonstrate that the substance is: 

(1) harmful to human health or the environment; 

(2) unnecessary because of the availability of alternatives; and 

(3) inconsistent with crop production. 

For Comments Addressing the Availability of Alternatives: 

Comments may present information about the viability of alternatives for a substance under sunset 

review. Viable alternatives include, but are not limited to:

o Alternative management practices that would eliminate the need for the specific 

substance; 

o Other currently exempted substances that are on the National List, which could 

eliminate the need for this specific substance; and

o Other organic or nonorganic agricultural substances. 

Your comments should address whether any alternatives have a function and effect equivalent to or 

better than the allowed substance, and whether you want the substance to be allowed or removed from 

the National List. Assertions about alternative substances, except for those alternatives that already 

appear on the National List, should, if possible, include the name and address of the manufacturer of the 

alternative. Further, your comments should include a copy or the specific source of any supportive 

literature, which could include product or practice descriptions; performance and test data; reference 

standards; names and addresses of producers or handlers who have used the alternative under similar 

conditions and the date of use; and an itemized comparison of the function and effect of the proposed 

alternative(s) with substance under review. 

For Comments on Nonorganic Agricultural Substances at Section 205.606.

For nonorganic agricultural substances on section 205.606, the NOSB Handling Subcommittee requests 

current industry information regarding availability of and history of unavailability of an organic form of 

the substance in the appropriate form, quality, or quantity of the substance. The NOSB Handling 

Subcommittee would like to know if there is a change in supply of organic forms of the substance or 

demand for the substance (i.e. is an allowance for the nonorganic form still needed), as well as any new 

information about alternative substances that the NOSB did not previously consider. 

Written public comments will be accepted through April 4, 2018 via www.regulations.gov. Comments 

received after that date may not be reviewed by the NOSB before the meeting. 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sunset 2020 Review Summary 

Meeting 1 - Request for Public Comment

Handling Substances

April 2018

Note: With the exception of tragacanth and gellan gums, the materials included in this list are 

undergoing early sunset review as part of November 18, 2016 NOSB recommendation on efficient 

workload re-organization. 

Reference: 7 CFR 205.605 Nonagricultural (Nonorganic) substances allowed as ingredients in or on 

processed products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food 

group(s)).’’

Reference: 7 CFR §205.605(a) Nonsynthetics allowed:

Calcium carbonate

Flavors

Gellan Gum

Oxygen

Potassium chloride

Reference: 7 CFR §205.605(b) Synthetics allowed:

Alginates

Calcium hydroxide

Ethylene

Glycerides: mono and di

Magnesium stearate

Phosphoric acid

Potassium carbonate

Sulfur dioxide

Xanthan gum

Reference: 7 CFR §205.606

Fructooligosaccharides

Gums: Arabic, Carob bean, Guar, Locust bean

Lecithin - de-oiled

Tragacanth gum
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Calcium carbonate

Reference: 205.605(a)

Technical Report: 1995 TAP; 2018 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use:

Calcium carbonate is widely used as a dietary supplement, antacid, dough conditioner, acidity regulator 

in wines, food stabilizer, anticaking agent, gelling agent, glazing and release agent, thickener, bulking 

agent, and as a nutritional fortification additive. The FDA allows the use of calcium carbonate as a 

binding agent in meat and poultry pieces. Calcium carbonate is also a precursor to the substance 

calcium citrate, which is identified on the National List. Calcium carbonate has been used as a coloring 

agent. However, in historic organic food processing, both within the United States and internationally, 

calcium carbonate is not allowed for coloration purposes. 

Manufacture:

Calcium carbonate is a fine, white microcrystalline mined powder which is stable in air. It is a mined 

mineral of at least 98% purity that is ground and screened. 

International Equivalency:

Canada - Canadian General Standards Board Permitted Substances List; CAN/CGSB-32.311-2015 

• Allowed, prohibited for use as a coloring agent

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing 

of Organically Produced Foods (GL 32-1999)

• Appears on Table 3, Additives permitted for use under specified conditions in certain organic 

food categories or individual food items

• Appears on Table 4, Processing aids which may be used for the preparation of products of 

agricultural origin referred to in Section 3

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

• Appears in Annex VII, Section A - Food additives including carriers, shall not be used for 

colouring or calcium enrichment of products

• Appears in Annex VII, Section B – Processing aids and other products, which may be used for 

processing other ingredients of agricultural origin from organic production

Japan Agricultural Standard (JAS) for Organic Production

• Appears in Table 1, Food additives, Limited to be used for confectionary, sugar, processed bean 

foods, noodles and bread, or for dairy products as neutralizing substance
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

International Federation of Organic Agriculture Movements (IFOAM)

• Appears in Appendix 4 – Table 1: List of approved additives and processing/post-harvest 

handing aids

Environmental/Health Issues:

The mining and processing of calcium carbonate can have negative environmental impacts. These may 

be impacts on above and below ground water systems. Mining may have impacts on biological diversity 

as the mining may draw down the water table and impact surface water features that play host to a 

variety of species.

Inhalation of calcium carbonate dust may cause upper respiratory irritation, and exposure may cause 

eye irritation. Personal protective equipment will avoid these issues. There are limited studies on the 

impact of calcium carbonate on humans. In the reported studies, increased intake of calcium can result 

in hypercalcemia and the formation of kidney stones when total daily calcium intake reaches levels at or 

above 2000 mg.

Additional information requested by Subcommittee: None

Flavors

Reference: 205.605(a), nonsynthetic sources only and must not be produced using synthetic solvents and 

carrier systems or any artificial preservative.

Technical Report: 2005 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 04/2006 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset renewal 

notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use: Natural flavors are derived from natural sources and are compound substances derived from plants, 

herbs, spices, botanicals and other substances. They are typically used in very small amounts in products 

(approximately 0.05 to 0.40 percent of ingredients) that contain less than optimal amount of flavor 

necessary to give the finished products the desired flavor profile. Natural flavors are widely used in baked 

goods, dairy products, jams and jellies, snack foods, and juice products, as well as in many other foods. 

Natural flavors are often proprietary formulations developed specifically for their intended purpose and 

functionality of the finished product.1 Flavorings significant function must be flavor rather than nutrition. 

The FDA defines Natural Flavors in 21 CFR 101.22 as:

 1 http://www.ams.usda.gov/sites/default/files/media/Flavors%20nonsynthetic%201%20Petition.pdf
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

The term natural flavor or natural flavoring means the essential oil, oleoresin, essence or 

extractive, protein hydrolysate, distillate, or any product of roasting, heating or enzymolysis, which 

contains the flavoring constituents derived from a spice, fruit or fruit juice, vegetable or vegetable 

juice, edible yeast, herb, bark, bud, root, leaf or similar plant material, meat, seafood, poultry, 

eggs, dairy products, or fermentation products thereof, whose significant function in food is 

flavoring rather than nutritional. Natural flavors, include the natural essence or extractives 

obtained from plants listed in subpart A of part 582 of this chapter, and the substances listed in 

172.510 of this chapter.

Manufacture: Flavors can be derived via several different methods. Distillates are a clear, flavorful liquid 

produced from fruits, herbs, roots, etc., produced and condensed by distillation. Extracts are products that 

use solvents (typically alcohol or alcohol-water mixture) to pull out certain volatile and non-volatile 

fractions from raw materials such as spices and herbs, cocoa and vanilla, or flowers. Extracts found on the 

grocer’s shelf, such as orange, almond, lemon, etc. are essential oils dissolved in an alcohol-water mixture. 

Essential Oils are volatile oils that give a botanical its aroma and can be the aromatic essence of a spice, 

flower, root, leaf or peel. It’s made by steam distillation or cold pressing. Essential Oil Isolate is an isolate 

of an essential oil. Isolates are a chemical or fraction obtained from a natural substance. For example, 

citral can be isolated from lemon oil or lemongrass. Oleoresin are solvent extracts of spices where the 

solvent has been completely removed. An oleoresin will contain the essential oil plus other important nonvolatile components that characterize the flavor, color and other aspects of the starting raw material. For 

example, the oleoresin of pepper will contain its aroma as well as its taste sensations of heat and spice. A 

single flavor chemical is a single molecule that provides flavor. These can be naturally or artificially 

derived, but they are specified to have a greater than 95% purity. Mixtures of these substances can also 

be considered natural flavors. A Compounded flavor is a mixture of ingredients such as extracts, essential 

oils and natural isolates.2 Processed flavors, also known as reaction flavors, are ones which are generated 

as a result of some form of processing upon a mixture of ingredients. A process flavor is a unique mixture 

of starting materials, like carbohydrates, proteins and fat, which must then be heated for a length of time 

to yield the desired profile.3 

Flavoring components as listed here can typically make up 5-100% of the formulation of a flavor. The 

remaining 0-95% of flavor formulas contain carriers/solvents and/or non-flavor constituents used to 

stabilize or maintain the flavor. Non-synthetic flavors are also subject to the general requirement that they 

are not produced using sewage sludge, irradiation or GMOs.

Flavors can be further divided into “Natural” or containing only flavoring constituents from the named 

flavor; “WONF” or containing flavoring constituents from the named product as well as other natural 

flavors derived from other sources that enhance or support the named flavor; or “type” which contain 

non-flavoring constituents from the named product but still impart the characteristic named flavor. 

International: Natural/Non-synthetic flavors are listed as allowed on the EU, Canadian, Japanese, IFOAM 

and Codex Standards.

Ancillary Substances: Ancillary substances are present in flavors and are reviewed for compliance against 

the criteria in the annotation: “must not be produced using synthetic solvents and carrier systems or any 

artificial preservative.” Flavoring constituents are considered proprietary by flavoring companies and are 

not normally disclosed. 

Discussion: During the Fall 2010 NOSB meeting, the NOSB completed its sunset review of flavors for relisting and stated:

 2 http://www.ams.usda.gov/sites/default/files/media/Flavors%20nonsynthetic%201%20Petition.pdf

3 http://www.fona.com/sites/default/files/WhitePaper_DevelopmentResources.pdf
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

The Handling Committee recognizes that the category of flavors is broad, including everything 

from simple herbal extracts to complex compound flavors...The complexity of the category and 

proprietary nature of most flavor formulas and processes was such that the board did not feel that 

it was practical to individually list flavors on the National List, so chose to relist the category as a 

single listing...In order to avoid unnecessary disruption to industry, we are recommending relisting 

of flavors on §205.605(a), but we are also communicating our belief that the full category Sunset 

should not be relisted in five years when next reviewed for sunset. Instead, we are recommending 

that the NOSB, in consultation with the National Organic Program, establish a Flavors Task Force. 

The Flavors Task Force would be asked to develop a recommendation to appropriately divide 

flavors into rational subparts, or classes, composed of flavors which shared similar sources and 

processes. The recommendation would include whether the class was compatible with organic 

production, how the sub-part should be classified on the National List, and would petition for 

listing of the class, if necessary, on the National List. We expect that this work could be done prior 

to the next sunset review for flavors.

On January 21, 2011 the NOP issued a Policy Memorandum on Use of Natural Flavors 

This states in part:

In 1995 the NOSB reviewed the use of natural flavors and recognized that natural flavors are 

complex; they are derived from natural sources and are compound substances derived from 

plants, herbs, spices and botanicals....The NOP recognizes that some accredited certifying agents 

are certifying flavors that meet the NOP requirements for handling organic products, and that this 

organic market will continue to grow and develop...

On November 6th 2014, the NOP received a petition from the Organic Trade Association to change the 

flavor annotation to read:

Flavors – Non-synthetic flavors may be used in products labeled as “organic” when organic flavors 

are not commercially available. All flavors must be derived from organic or nonsynthetic sources 

only, and must not be produced using synthetic solvents and carrier systems or any artificial 

preservative

At the Fall 2015 NOSB meeting the NOSB approved a petition to revise the flavors listing annotation to 

read as follows:

Flavors – Non-synthetic flavors may be used when organic flavors are not commercially available. 

All flavors must be derived from organic or nonsynthetic sources only, and must not be produced 

using synthetic solvents and carrier systems or any artificial preservative. 

At the Fall 2015 meeting, substantial comment was received from industry, trade associations, and 

Accredited Certifying Agents (ACAs) supporting the continued listing of natural flavors as well as the 

adoption of the flavor petition. 

On January 17, 2018, NOP published a proposed rule (83 FR 2498) to adopt the Fall 2015 recommendation 

and change the annotation for flavors at § 205.605(a) to: 

Flavors, non-synthetic flavors may be used when organic flavors are not commercially available. All flavors 

must be derived from organic or nonsynthetic sources only, and must not be produced using synthetic 

solvents and carrier systems or any artificial preservative.

Additional information requested by Subcommittee: None
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Gellan gum 

Reference: 7 CFR 205.605(a) – high acyl form only - As a nonagricultural (nonorganic) substance allowed 

as ingredient in or on processed products.

Technical Report: 2006 TAP; 2018 TR

Petition(s): 2004 Gellan gum 

Past NOSB Actions: 2007 Formal Recommendation; 2014 sunset recommendation

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), 

Added to National List 12/13/2010 (75 FR 7751). Sunset renewal notice published 06/22/2015 (80 FR 

35177)

Sunset Date: 6/22/20

Background from Subcommittee:

Material Use:

Gellan gum is water soluble, heat stable, low pH stable, and is able to form thicker gels when positive 

ions (cations) are added to a solution (2006 TR 32-34, Petition pg 10). Gellan gum is considered a 

hydrocolloid and is very useful as a thickening and gelling agent in food products, including bakery 

fillings, confections, dairy products, dessert gels, frostings, icings, glazes, jams, and personal care items 

(2018 TR 182-187, 2006 TR 37-41, Petition pg 2). Typical use of gellan gum is at <0.5% of a finished 

product formula (Petition pg 2). The firmness of the gel can be enhanced by the additions of cationic 

materials such as potassium, calcium, etc. and this gives it numerous applications in different areas of 

food products. 

Despite having some similar characteristics, not all gums are interchangeable. Due to the structure of 

the gums, some behave differently in different temperatures, pH ranges, physical agitation, etc. (2018 

TR 194-200). This variability requires formulations specific to the type of food product, intended shelflife and product use. Many times these gums are used in combination to impart the correct properties 

in the finished goods (2018 TR 416). The table provided on line 285 in the 2018 Technical report 

distinguishes the different characteristics of common gums.
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Manufacture:

Gellan gum is a high molecular weight polysaccharide gum produced through fermentation by the 

bacterium Sphingomonas elodea. This aerobic, gram-negative bacterium produces the material through 

fermentation and then separation of the gellan gum by isopropyl alcohol or ethanol (2006 TR 16-19, 66-

70, 2018 TR 648-660). The 2018 Technical report notes that no known genetically modified strain of this 

bacteria exists (2018 TR 662-670). Isopropyl alcohol cannot be at greater than 0.075% in the finished 

materials as dictated by FDA (2006 TR 54-55). The firmness of the gellan gum can be adjusted by the 

removal of acetyl groups through addition of cations (e.g. potassium, calcium, magnesium); these 

deacylated forms are not approved on 205.605(a) (2006 TR 109-112). As a result, the generation of 

gellan gum approved for 205.605(a) is through a naturally-occurring biological process (2006 TR 107-

117).

International Equivalency:

The material is FDA approved as a direct food additive in accordance with 21 CFR 172.665; it is also 

approved in many countries worldwide in food and non-food items. Gellan gum is listed by the World 

Health Organization Joint Expert Committee for Food Additives (Petition pg 5). 

Canadian Organic Regime’s Canadian General Standards Board Permitted Substances List (Nov 2015 ed.) 

allows the use of gellan gum as long as it is derived using solvents on their Table 6.3 Extraction solvents, 

carriers, and precipitation aids [in the source document]. By exception isopropyl alcohol may also be 

used to derive gums (2018 TR 491-496).

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999) 

Gellan gum is allowed and the CODEX General Standard for Food Additives (GSFA) 502 describes the 

compliant uses (2018 TR 498-504).
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

European Economic Community (EEC) Council Regulation, EC Nos. 834/2007 and 889/2008

Gellan gum is allowed for use as compliant with Annex II and III in processed organic foods and as a food 

additive in the preparation of foodstuffs of plant or animal origin (2018 TR 506-515).

Japan Agricultural Standard (JAS) for Organic Production

Gellan gum is neither listed as allowed, nor as prohibited (2018 TR 525-536).

International Federation of Organic Agriculture Movements (IFOAM)

Gellan gum is not listed as allowed, nor prohibited (2018 TR 538-541).

Other international standards

East African Organic Product Standard uses IFOAM and thus gellan gum is not prohibited, nor allowed 

(2018 TR 543-541).

Ancillary Substances:

According to the 2018 TR (434-438) no information was found indicating that any additional materials 

are generally added to commercially available forms of the gums. However, according to the 2016 TR on 

xanthan gum two exceptions were identified during a review of publically available specification sheets: 

glucose used to standardize a xanthan and guar gum blend, and polysorbate 60 in GRINSTED. 

Background Information:

The two available TRs did not list any notable human health or environmental concerns regarding the 

use of gellan gum.

Public comment in 2014 supported the ongoing essentiality of this material.

Additional information requested by Subcommittee: None

Oxygen

Reference: 205.605(a) - oil-free grades.

Technical Report: 1995 TAP

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee

Use: Oxygen is used in modified atmosphere packaging and the processing of olives. 

Manufacture: Oxygen is separated from air cryogenically; super cold temperature liquefaction of air and 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

fractional distillation. 

International: The use of oxygen is permitted in organic standards in Canada, CODEX, EU, IFOAM, and 

Japan. 

Ancillary Substances: None. 

This material was reviewed by the NOSB during 2015 and the Board voted to continue its listing on the 

National List.

Additional information requested by Subcommittee:

None 

Potassium chloride

Reference: (a) Nonsynthetics allowed: 

Technical Report: 1995 TAP; 2015 TR Nutrient Vitamins and Minerals

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Manufacturing Process:

Potassium Chloride is a metal halide salt composed of potassium and chloride. Potassium Chloride is 

extracted from minerals sylvite, carnalite and potash. It is also extracted from salt water and can be 

manufactured by crystallization from solution floatation or electrostatic separation from suitable 

minerals. It is a by-product of the production of nitric acid from potassium nitrate and hydrochloric 

acid. It is odorless and has a white or colorless vitreous crystal appearance. 

Specific Uses: 

According to the Food & Drug Administration, generally recognized as safe (GRAS) affirmed uses of 

potassium chloride in foods are as: a flavor enhancer, flavoring agent, nutrient supplement, pH control 

agent, and stabilizer or thickener. Like salt, potassium chloride provides a salty flavor and can also often 

play other functional roles (e.g. microbial management, protein modification, flavor enhancement) that 

impacts the taste, texture, and shelf life of food products.

Potassium chloride is generally used for two main purposes in food products. The first is to provide 

potassium enrichment to foods. The second is as a salt replacement to reduce the sodium content in 

foods. 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Additional information requested by Subcommittee:

1. Is the substance essential for organic food production? 

2. Since the material was last reviewed, have additional commercially available alternatives emerged?

Alginates

Reference: 205.605(b) Synthetics allowed

Technical Report: 1995 TAP; 2015 TR

Petition(s): 1995 Alginates

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use:

Alginates are useful as gelling, thickening and stabilizing agents in a wide variety of organic products, 

including drinks, ice cream, puddings, cookies, meat and pasta dishes. They are particularly useful in 

that they do not need heat to be activated. They can be used to gel cold products and do not melt if the 

product is heated. They can be used in coatings to help preserve moisture content, protect flavor and 

enhance shelf life. They can also be used to generate spheres with a thin membrane and liquid center 

that provide texture and flavor “pops” in certain foods. While not technically a preservative in 

themselves, they can be used as carriers for preservatives and may inhibit food deterioration due to 

moisture loss. 

Despite their widespread use in a variety of foods, alginates have several limitations. They have limited 

solubility at low pH values and high calcium content foods can interfere with their activity. 

Alginates have been accepted for use in organic foods since the National Organic Program Rule was 

published in 2000. They have been recommended for relisting in each of three sunset reviews. A 2015 

technical report detailed the production, use and alternatives to alginates. Information from that 

technical report was used for the following summation.

Manufacture:

Alginates are normally extracted from the cell walls of seaweed, specifically, brown algae. While they 

can also be generated by bacterial fermentation, the fermentation process is not currently economically 

viable. To isolate alginate from seaweed, several isolation steps involving extraction, acid additions, 

purifications, and base additions are required. The final result is either alginic acid or the salt form, 

alginates. Alkali extraction renders alginates as synthetic.
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

International (drawn from the 2015 TR):

Canada – certain alginates are permitted under the Canada Organic Regime due to their appearance in 

the section titled “Non-organic Ingredients Classified as Food Additives, of the Organic Production 

Systems Permitted Substances List.” In this section, alginates (alginic acid, sodium alginate and 

potassium alginate) are included in Table 6.3 (Canadian General Standards Board 2011).

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999) - certain alginates are permitted. Only potassium (402) and 

sodium (401) alginates are listed as allowed food additives in Table 3.1 as an ingredient of 

nonagricultural origin in the CODEX Alimentarius Commission, Guidelines for the Production, Processing, 

Labeling and Marketing of Organically Produced Foods (Codex Alimentarius Commission 2014).

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008 - alginates 

(E401-E405) are permitted because they are included in the list of allowed food additives for use as 

thickeners and stabilizers (E400-E499). Alginates are classified as nonagricultural in the EU Organic

Regulations (The Council of the European Union 2008). Sodium alginate (E 401) is listed as an approved 

food additive for use in certain unprocessed fruit and vegetables in an amendment to Annex II of the

Commission Regulation (EC) No 969/2014 (The Council of the European Union 2014).

Japan Agricultural Standard (JAS) for Organic Production - certain alginates are permitted. The JAS for 

Organic Processed Foods identifies sodium alginate as an allowed food additive limited to use only in 

processed foods of plant origin, INS number 401 (The Japanese Organic Standard 2005).

International Federation of Organic Agriculture Movements (IFOAM) - certain alginates are permitted. 

Sodium and potassium alginate are recognized by IFOAM as approved additives for use in an organic 

processed products without annotation (IFOAM 2014) (Appendix 4: Table 1).

Ancillary Substances:

No ancillary substances (e.g. stabilizers, 352 preservatives or anti-caking agents) were listed on 

publically available specification sheets (2015 TR).

Discussion:

Alginates are Generally Recognized As Safe (GRAS) when used with good manufacturing practices. 

Alginates are not absorbed by the human body, making them useful as a low- calorie ingredient. While 

human health effects are generally recognized is minimal, there is evidence that alginates in foods may 

reduce iron absorption.

The production of alginates generally involves the harvesting of wild seaweed. Increased harvesting of 

seaweeds leads to questions about the sustainability. Seaweed populations are potentially impacted by 

overharvesting, the effects of increased ocean water temperatures, and pollution. Attempts at farming 

seaweed have not been economically successful, thus the sustainability of current wild harvesting is 

crucial to future alginate production.

While there are a number of alternative thickeners and gelling agents available to organic handlers, the 

property of alginates to make gels without the use of heat distinguishes them from many other 

products. 

Additional information requested by NOSB
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Are there any organic alternatives to alginates that have become available for use since the 2015 

technical report was written?

Calcium hydroxide

Reference: 205.605(b)

Technical Report: 1995 TAP

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Manufacturing Process:

Calcium hydroxide (also known as “slaked lime” or “hydrated lime”) is lime that is calcined in a kiln to 

obtain carbon dioxide and quick lime. The quicklime is mixed with water to produce calcium hydroxide. 

Specific Uses of the Substance:

It is used as a component of aluminum free baking powder, to clarify sugar for molasses, and as a 

conditioner for corn tortillas. 

Additional information requested by Subcommittee:

1. Is the substance essential for organic food production? 

2. Since the material was last reviewed, have additional commercially available alternatives emerged?

Ethylene

Reference: 205.605(b) allowed for postharvest ripening of tropical fruit and degreening of citrus.

Technical Report: 1995 TAP; 1999 TAP - Processing

Petition(s): 1995 N/A, 2008 Ethylene (for use with pears)

Past NOSB Actions: 10/1995 NOSB minutes and vote; 10/1999 NOSB minutes and vote (add tropical 

fruit and citrus); 11/2005 sunset recommendation; 11/2008 recommendation for pears; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Use:

Ethylene gas (CAS # 74-85-1) is currently listed at 205.605(b) as a material allowed for postharvest 

ripening of tropical fruit and degreening of citrus.

Manufacture:

Ethylene (CH2=CH2) is a colorless gas at room temperature. It is produced naturally in small

amounts by some plants and functions as a ripening agent. The commercially used form, 

which is synthetic, is chemically identical to the natural occurring form. The synthetic form is

produced from hydrocarbon feedstocks, such as natural gas liquids or crude oil, and may 

also be derived from liquid ethanol.

Use of ethylene naturally produced by fruits has not been commercialized. Amounts 

produced for agriculture are small compared to emissions from car exhaust, petrochemical 

plants, or fires. It is used in the post-harvest ripening of tropical fruit and the de-greening of 

citrus. 

International (acceptance/nonacceptance) by other international certification agencies:

Canada: allowed for post-harvest ripening of tropical fruit and degreening of citrus.

Japan: Limited to use after-ripening banana and kiwifruits.

IFOAM: De-greening of citrus and ripening

EU: Degreening bananas, kiwis and kakis; Degreening of citrus fruit only as part of a 

strategy for the prevention of fruit fly damage in citrus.

CODEX: For degreening of citrus for fruit fly prevention. As sprouting inhibitor for potatoes 

and onions.

Environment/Health Issues:

Ethylene is potentially flammable, and also an asphyxiate if high concentrations displace 

oxygen, but significant impacts on human health and the environment are likely minimal 

based on previous reviews.

Discussion:

In previous discussions, the Handling Subcommittee considered removing ethylene gas for 

use in the de- greening of citrus. However, historically there has been no opposition to 

relisting ethylene. The 2015 NOSB approved continued use of ethylene as a post-harvest 

ripening tool. The Handling subcommittee found ethylene to be compatible with current 

organic processing standards. 

Additional information requested by Subcommittee:

The NOSB requests input on the continuing need for ethylene as a fruit ripening tool.
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Glycerides (mono and di)

Reference: 205.605(b) for use only in drum drying of food. 

Technical Report: 1995 TAP; 2015 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use: 

Mono- and diglycerides have many applications as food processing aids. They are principally used as 

emulsifiers. This function also translates into stabilization, preventing food separation, stabilizing air

pockets and extending shelf life (Frank 2014). However, the only use for which mono- and diglycerides 

are permitted in organic food processing is in the drum drying of food. In this application, mono- and 

diglycerides can have various functions, but most significantly they act as an emulsifier and release 

agent. When mixed with food, mono- and diglycerides help prevent sticking during processing, and in 

drum drying they help to strip the food from the cylinder walls once dried. In drum drying, a puree or 

slurry of food is added to one or two heated cylinders at varying feed rates depending on the particular 

food’s viscosity. As the cylinders or drums rotate, the slurry dries. The process creates powder or very 

fine flakes that can serve as the basis for snacks, soups, baked chips, some bakery items and cereals 

(Fusaro 2012). The use of mono- and diglycerides in dehydrated potatoes also aids in rehydration 

(O'Brien 2004). 

Manufacture: 

Mono- and diglycerides occur naturally in food as minor constituents of fats, in combination with the

major constituent of food fats: triglycerides. They are also metabolic intermediates of triglycerides.

When manufactured, they are prepared by the glycerolysis of fats or oils, or from fatty acids derived

from edible sources (FDA 2014). These edible sources are commonly animal fats or vegetable oils such

as soybean, canola, sunflower, cottonseed, coconut or palm oil (Frank 2014), and their main fatty acids

used to manufacture mono- and diglycerides include lauric, linoleic, myristic, oleic, palmitic, and stearic

acid (FDA 2014). The glycerol component of mono- and diglycerides is also derived from these edible

fats and oils. (TR 2015 56-62). 

International: 

Glycerides are permitted in organic standards in Canada, with the annotations: From organic sources if 

commercially available. For use in drum drying of products. 

They do not appear in organic standards: CODEX, EU, IFOAM or Japan. 

Ancillary Substances: 

None. 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Alternatives: 

According to the 2015 TR, alternative ways to dry foods include spray drying, freeze drying, fluidized bed 

dryers, air lift dryers, scraped wall heat exchangers, etc. Drum drying is said to be preferred for potato 

flakes. Freeze drying is said to be an acceptable alternative to drum drying.

Organic soy lecithin and gum arabic could be alternative substances to glycerides. Both are currently on 

the National List. 

This material was reviewed by the NOSB during 2015 and the Board voted to continue its listing on the 

National List.

Additional information requested by Subcommittee:

1. The TR lists possible alternatives to drum drying, such as spray drying, freeze drying, fluidized 

bed dryers, air lift dryers, scraped wall heat exchangers, etc. Why is drum drying preferred for 

the production of potato flakes? Have alternatives been tried? And if so, what were the results? 

2. Have soy lecithin or gum arabic been tried as an alternative to glycerides (mono and di) in drum 

drying? What were the results? 

Magnesium stearate

Reference: 205.605(b) - for use only in agricultural products labeled “made with organic (specified 

ingredients or food group(s)),” prohibited in agricultural products labeled “organic”.

Technical Report: 1995 TAP; 2018 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset renewa 

notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use:

Magnesium stearate (CAS # 557-04-0) is used as an anti-caking agent in salt. It is a flow agent, food 

processing machine lubricant, and may be an incidental additive. The most common use of magnesium 

stearate is as a binding agent in dietary supplements. Magnesium stearate is permitted for use only in 

agricultural products labeled “made with organic (specified ingredients or food group(s))” but is prohibited 

in agricultural products labeled “organic.”

Manufacture:

Typically manufactured as a synthetic from hydrogenation of animal fats or vegetable oils. Magnesium 

stearate is produced by adding aqueous solution of magnesium chloride to sodium stearate. Stearic acid is 

made by saponification of edible fat (lye plus tallow) that is treated with an acid to form stearic acid.

Alternatives:
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Organic flours and starches can replace magnesium stearate as an additive in some products. Non-synthetic 

flow agents are available as alternatives, depending on the product and process.

International:

As reviewed in the 2018 Technical Report:

“The Canadian General Standards Board (CGSB) includes nonsynthetic sources (and synthetic sources 

provided that nonsynthetic sources are not commercially available) of magnesium stearate as a permitted 

substance for organic production systems under CAN/CGSB-32.311-2015 for use as an anticaking or 

releasing agent in products whose contents are ≥70% and <95% organic ingredients. 

The Codex Alimentarius Commission’s “Guidelines for the Production, Processing, Labelling and Marketing 

of Organically Produced Foods” lists magnesium stearate (INS No. 470(iii)) as a food additive that may be 

used in foods as an anticaking agent, emulsifier, or thickener under the conditions of good manufacturing 

practices (GL 32-1999). 

Magnesium stearate was not found to be listed under any other international standard for organic handling 

and processing”.

Environmental/Health Issues:

Magnesium stearate is listed as Generally Recognized as Safe (GRAS) by the U.S. Food and Drug 

Administration (21 CFR 184.1440). Magnesium stearate must meet the specifications outlined in the Food 

Chemicals Codex (21 CFR 184. 1440(b)) and can be used in food with no limitation other than current good 

manufacturing practice. There was no information provided indicating any significant human health 

impacts and historically there have not been comments recommending removal of this material from the 

National List. 

Discussion:

In the past, the Subcommittee has requested public comment on availability of alternatives and any

information on possible negative human health impacts. Public comment has been limited.

Magnesium stearate is allowed only in agricultural products labeled “made with organic’” and is prohibited 

in agricultural products labeled “organic”.

Additional information requested by Subcommittee: 

None

Phosphoric acid

Reference: 205.605(b) - cleaning of food-contact surfaces and equipment only

Technical Report: 2003 TAP

Petition(s):N/A

Past NOSB Actions: 10/1999 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Background from Subcommittee:

Manufacturing Process:

Phosphoric acid can be made in two ways: the wet process or the thermal process. In the wet process, 

mined phosphate ore is treated with sulfuric acid and then the resulting phosphoric acid is separated 

from the calcium sulfate crystals produced. 

The process conserves most of the impurities found in the ore but the product can then be purified 

further for technical and food grade phosphoric acid. The thermally produced acid is made from the 

elemental phosphorus and is considerably more expensive and purer than the wet processed acid. The 

pure phosphorus is burned in excess air and the resulting phosphorus pentoxide is then hydrated and 

cooled, and the acid mist is collected.

Specific Uses of the Substance:

Phosphoric acid is used in cleaning operations to remove encrusted surface matter and mineral scale 

found on metal equipment such as boilers and steam producing equipment. Orthophosphoric acid is 

routinely used as a cleaning compound in its dilute form to remove oxidation from non-stainless steel 

surfaces, staining of stainless steel, lime and scale from heat exchangers and in Clean In Place cleaning 

operations, especially in dairy processing to remove buildup of calcium and phosphate salts from 

processing equipment. 

Additional Information requested by Subcommittee: 

1. Is the substance essential for organic food production? 

2. Since the material was last reviewed, have additional commercially available alternatives emerged? 

The Handling Subcommittee encourages current users of phosphoric acid to provide detailed comments 

describing the situations in which it is the most effective cleaner for a given application.

Potassium carbonate

Reference: 205.605(b)

Technical Report: 1995 TAP

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use:

Commonly used in the Dutch alkali process for processing cocoa and chocolate to reduce acidity. Used 

as a pH control; leavening agent; as a boiler water additive; as a tenderize tripe; and in soap production. 

Used in soft drinks and confections. Used as a buffering agent in making wine and mead to reduce 

acidity. 

The 1995 Technical Advisory Report (TAP) notes that it be used only when sodium carbonate is not 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

appropriate. However it can be used to replace sodium carbonate when a lower sodium content is 

desired.

During the last sunset review, public comment indicated that it is not widely used.

Manufacture:

Potassium carbonate is a strongly alkaline white salt, a major component of the mined salt potash, 

which is made by passing carbon dioxide through a solution of potassium hydroxide. It is a caustic 

material with chlorine gas as a bi-product. During manufacture the gas is collected to avoid 

environmental pollution and human health impacts.

International Equivalency: 

Canada - Canadian General Standards Board Permitted Substances List; CAN/CGSB-32.311-2015 

• Appears on Table 6.3—Ingredients classified as food additives

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing 

of Organically Produced Foods (GL 32-1999)

• Appears on Table 3, Additives permitted for use under specified conditions in certain organic 

food categories or individual food items

• 05.0 Confectionery

• 06.0 Cereals and cereal products, derived from cereal grains, from roots and tubers, pulses and 

legumes, excluding bakery wares of food category

• 07.007.2 Fine Bakery wares (sweet, salty, savoury) and mixes; not permitted in food of animal 

origin

• Appears on Table 4, Processing aids which may be used for the preparation of products of 

agricultural origin referred to in Section 3

• Drying of grape raisins

European Economic Community (EEC) Council Regulation, EC No. 834/2007 and 889/2008

• Appears in Annex VII, Section A - Food additives including carriers

• Appears in Annex VII, Section B – Processing aids and other products, which may be used for 

processing other ingredients of agricultural origin from organic production, drying of grapes

Japan Agricultural Standard (JAS) for Organic Production

• Appears in Table 1, Food additives, Limited to be used for drying processed fruit products, or 

used for grain processed foods, sugar, processed beans products, noodles, bread or 

confectionary.

International Federation of Organic Agriculture Movements (IFOAM)

• Appears in Appendix 4 – Table 1: List of approved additives and processing/post-harvest 

handling aids

Additional information requested by Subcommittee: 

1. Is potassium carbonate in use in organic products?

2. What type of products is it used in?
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Sulfur dioxide

Reference: 205.605(b) for use only in wine labeled “made with organic grapes,” Provided, That, total 

sulfite concentration does not exceed 100 ppm. 

Technical Report: 1995 TAP; 2011 TR

Petition(s): 1995 N/A; 2010 Sulfur Dioxide

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 12/2011 annotation change; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use: 

Sulfur dioxide is primarily used to prevent spoilage and oxidation in wine. It may also be used to 

preserve meats, fruits and other products, however, there are limitations to its use. These limitations 

include foods used as a source for Vitamin B1, raw fruits and vegetables, foods consumed in large 

quantities or meats. The current organic annotation limits the use of sulfur dioxide to wine labeled 

“made with organic grapes” and further limits the sulfite concentration to not exceed 100 ppm. This 

annotation prevents the use of sulfur dioxide in products where the more serious health effects might 

be present. 

Sulfur dioxide has undergone three sunset reviews and has been relisted each time. A technical report 

was done in 2011 and forms the bases of the comments summarized below:

In wines, sulfur dioxide is commonly referred to as ‘sulfite’ or ‘sulfites’. The sulfur dioxide inhibits 

microbial growth and prevents oxidation. Sulfur dioxide is often added to grapes to be fermented in 

very specific doses. Cultivated yeasts added to enhance fermentation of wines have been selected to be 

more tolerant of sulfur dioxide than wild yeasts. Enough sulfur dioxide is added to deter growth of the 

wild yeasts or bacteria present in the grape juice, while not exceeding a level that will deter the growth 

of the desired, added, yeasts to the juice. This process helps to prevent the formation of off flavors and 

helps to preserve the “freshness” flavor in white wines. While sulfur dioxide occurs naturally in wines, 

the level is too low to have pragmatic effect. Wines without added sulfur dioxide generally have to be 

kept in perfect storage conditions and have a shortened shelf life of around six months. This is often 

very difficult to achieve and the addition of sulfur dioxide has become accepted for meeting consumer 

expectations of wine quality.

Manufacture:

Sulfur dioxide can be produced commercially from several sources including elemental sulfur, ores of 

sulfide containing minerals, gypsum and anhydrite, and waste materials or flue gasses that contain 

sulfur. Most commonly, sulfur dioxide is generated by simply burning sulfur in devices that control air 

flow and that can capture the sulfur dioxide as it is generated. 

International (drawn from the 2011 TR):

Canada – Canadian standards permit the use of sulfurous acid as preservative only in alcoholic 

beverages labeled as organic, but do allow those beverages to be made from grapes or other fruits, 

unlike the United States which limits its use to wine made from grapes. Furthermore, the Canadian 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

standards allow the alcohol to be labeled as “organic” and set a range of allowable sulfite 

concentrations that depend on the residual sugar content of the beverage.

The European Economic Community (EEC) allows sulfur dioxide at a maximum of 50 mg/L after 

fermentation in fruit wines, cider, perry or mead that do not have added sugar. They allow sulfur 

dioxide at a maximum of 100 mg/L after fermentation for cider and perry that have sugar added. All 

these beverages may be labeled as organic. 

The CODEX Alimentarius Commission permits the use of sulfur dioxide for making cider, perry, mead, 

and wines made from grapes or other fruits.

Ancillary substances:

The 2011 TR makes no mention of ancillary substances associated with sulfur dioxide.

Discussion:

Sulfur dioxide is considered to be Generally Recognized As Safe (GRAS) by the Food and Drug 

Administration when used in accordance with good manufacturing practices, except it is not to be used 

in meats, food recognized as a source of vitamin B1, on fruits or vegetables intended to be served raw 

to consumers or sold raw to consumers, or to be presented as fresh (21 CFR 182.3862). It is recognized 

to be used in organic products internationally, although various restrictions are placed on its use, either 

in limitations of concentration or on the products it may be used in.

Sulfur dioxide may cause health effects in sensitive individuals. These effects range from allergic 

reactions in individuals born without the enzyme sulfite oxidase, asthma attacks, which vary depending 

on individual sensitivity, hives and swelling, to anaphylaxis.

There are no expected adverse environmental effects from the use of sulfur dioxide as currently listed in 

the organic rules. 

The current annotation allows the use of sulfur dioxide only in wine made from grapes. The increasing 

interest in ciders, wines not made from grapes, and other fermented beverages has led to inquiries 

about possible use in these products, however, a petition to the NOSB would be required to change this 

annotation. 

While alternatives to sulfur dioxide for winemaking have been investigated, the technical report notes 

that there are not organic alternatives that are satisfactory to prevent spoilage and oxidation in wine.

Additional information requested by Subcommittee: 

Have any organic alternatives to sulfur dioxide for use in winemaking been identified since the issuance 

of the 2011 technical report?
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Xanthan gum

Reference: 205.605(b)

Technical Report: 1995 TAP; 2016 TR; 2018 TR

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 10/2010 

sunset recommendation; 10/2015 sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Material Use:

Xanthan gum is used in numerous foods products as a hydrocolloid (i.e. substances that disperse water, 

giving a thickening or gelling effect) including but not limited to: baked goods, beverages, dairy 

products, dressings, nutritional supplements, frozen foods, etc. (TR 758-759, 135-137). The gum is used 

in small percentages of the finished products, usually at <0.5% by weight (TR 145-146). Xanthan gum is 

used along with other gums to achieve the desired viscosities and product structures for firmness, water 

binding, flavor delivery, etc. (TR 229-236); it is particularly effective in frozen and chilled products where 

it can impart thickness, freeze-thaw protection, and stability during processing and shelf-life (TR 251-

256). Common synergistic gums used along with xanthan gum are locust bean gums, guar gums, 

carrageenan gums (TR 229-236). 

Despite having some similar characteristics, not all gums are interchangeable. Due to the structure of 

the gums, some behave differently in different temperatures, pH ranges, physical agitation, etc. (2018 

TR 194-200). This variability requires formulations specific to the type of food product, intended shelflife and product use. Many times these gums are used in combination to impart the correct properties 

in the finished goods (2018 TR 416). The table provided on line 285 in the 2018 Technical report 

distinguishes the different characteristics of common gums.
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Manufacture:

Xanthan gum is a high-molecular weight polysaccharide produced though natural fermentation by 

Xanthomonas campestris and precipitation through addition of an alcohol; it subsequently is dewatered, 

possibly washed in a salt solution, dried and milled (TR 36-38, 90-97). The gum is water soluble, stable 

at numerous pH, salt and temperature ranges (including frozen temperatures) (TR 120-124). The side 

chains carry negative charges and will associate with positive cations to increase the firmness of the 

solution (TR 50-55). Overall, the structure of xanthan gum is such that it is a cellulose chain with 

trisaccharide side chains. In solution, the side chains wrap around the cellulose backbone and aid in the

ability for xanthan gum to be stable in low pH and high salinity solutions (TR 48-50). In addition to its 

wide applicability under differing food mediums, it also has pseudo-plastic characteristics which under 

shear force make the solution less viscous and thus easier to move during processing. When the shear 

force is removed, the solution will again exhibit its characteristic thickness. Xanthan gum is not a gelling 

agent, and as a result it is often used in combination with other materials including locust bean gum, 

guar gum, starches, carrageenan and konjac glucomannan to increase viscosity (2018 Gums TR 424-

432).

International Equivalency:

FDA has approved the use of xanthan gum as a food additive since 1969 without restrictions on quantity 

in finished applications (TR 162-163, 637-638); it must be isolated by isopropyl alcohol precipitation and 

made into a sodium, potassium, or calcium salt (TR 164-166). It is approved by FDA at 21 CFR 172.695 

but is not GRAS; though three FDA notices for GRAS allow isolation of xanthan gum by ethanol and 

pyruvate, and in combination with konjac glucomannan and sodium alginate (TR 651-659). 

Canadian Organic Regime’s Canadian General Standards Board Permitted Substances List (Nov 2015 ed.) 

allows the use of xanthan gum as long as it is derived using solvents on their Table 6.3 Extraction 

solvents, carriers, and precipitation aids [in the source document]. By exception isopropyl alcohol may 

also be used to derive gums (2018 Gums TR 491-496).

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999) 

Xanthan gum is allowed and the CODEX General Standard for Food Additives (GSFA) 502 describes the 

compliant uses (2018 Gums TR 498-504).

European Economic Community (EEC) Council Regulation, EC Nos. 834/2007 and 889/2008

Xanthan gum is allowed for use as compliant with General Standard for Food Additives Annex II and III in 

processed organic foods and as a food additive in the preparation of foodstuffs of plant or animal origin 

(2018 Gums TR 506-515).

Japan Agricultural Standard (JAS) for Organic Production

Xanthan gum is allowed in processed foods of animal origin limited to dairy or confectionary (2018 

Gums TR 525-536).

International Federation of Organic Agriculture Movements (IFOAM)

Xanthan gum is allowed with no limitations on use (2018 Gums TR 538-541).

Ancillary Substances:

According to the 2016 TR (258-263), ancillary substances are not commonly added to commercially 

available forms of xanthan gum for use in foods. Through a search of publically available specification 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

sheets a few exceptions were identified: glucose in a xanthan and guar gum blend and polysorbate 60 in 

GRINSTED. 

Background Information:

Xanthan gum has been used for decades globally in the food system, and subsequently has undergone 

numerous clinical trials and studies to look for impacts on human health in adults, children, infants, and 

animals (TR 637-742). Some studies have shown that xanthan gum is beneficial to human health; soluble 

fiber that may help improve colon health and reduce cholesterol (2018 TR 933, 963-976). In 2011 there 

was a recall of a xanthan gum product that was being fed to premature babies due to the lack of 

destruction of potentially harmful bacteria that may lead to necrotizing enterocolitis; no conclusions 

were made regarding the safety of xanthan gum thickeners for premature baby formulas (TR 678-711).

There was no mention of specific environmental issues regarding the production of xanthan gum.

Additional information requested by Subcommittee: 

None

Fructooligosaccharides 

Reference: 205.606(h) Fructooligosaccharides (CAS # 308066-66-2)

Technical Report: 2006 TAP; 2015 TR

Petition(s): 2006 Petition

Past NOSB Actions: 04/2007 NOSB recommendation; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use: Fructooligosaccharides (FOS) is on the National List as a non-organically produced agricultural 

product allowed as an ingredient in or on processed products labeled as “organic.” FOS is a nondigestible carbohydrate that is used as a soluble prebiotic fiber, sweetening agent, flavor enhancer, 

bulking agent and humectant. It is used in many foods including yogurts, infant foods, medical food, 

baked goods, candies, soups, beverages and other dairy products. FOS are mostly indigestible by 

human digestive enzymes. 

Manufacture: There are a two common commercial methods to produce FOS

• Inulin derived. Inulin, a dietary fiber found in chicory (Belgian endive), Jerusalem artichoke 

(sunchokes), Agave and other plants. Chicory inulin is extracted from the source material via 

water extraction – the resulting inulin undergoes a partial enzymatic hydrolysis using the 

enzyme inulinase, which is extracted from an enzyme complex (carbohydrase) found in the 

fungus Aspergillus niger. The hydrolysis breaks long chain inulin into the shorter chain FOS.

• Sucrose derived. Sugar cane or sugar beet extracted sugar is fermented with Aspergillus 

japonicas. The A. japonicus cells must be immobilized for production of high-purity FOS, which 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

can be accomplished by creating beads of the A. japonicus culture suspended in calcium 

alginate, an immobilizer. A. japonicus cells hydrolyzes (breaks) the sucrose molecules into 

glucose and fructose and then transfers fructose molecules to an existing glucose-fructose chain 

to create one of the FOS complex sugars. Fermentation of sucrose by A. japonicus is generally 

inefficient, higher purity FOS solutions can be achieved by several methods: filtration, enzyme 

extraction, or mixed culture fermentation with the yeast P. heimii to increase the purity of the 

FOS solution. Each of these methods introduces additional chemical or physical agents to the

production process.

Both processes also use heat and pH control to speed up the enzymatic reactions. Specifically, the 

adjustment of pH is accomplished using hydrochloric acid (a strong acid) or sodium hydroxide (a strong 

base); potassium phosphate is also used for pH control.

The FOS produced can then be further purified through filtration or further fermentation. 

Ancillary Substances: According to the 2014 TR: “There are no ancillary substances intentionally 

included in the FOS formulations as described in the petition, and no ancillary substances are 

intentionally added to the FOS products in the selected high-purity FOS fermentation.”

International: FOS is not specifically listed in the Codex, EU, Japanese organic standards or Canadian 

standards. However non-organic agricultural products are not listed in these standards. 

Discussion: During the 2015 sunset review the NOSB received limited feedback from users of this 

substance. However, comments were received in support of continued listing for usage in the baking 

industry and no sources of organic FOS were identified. 

Additional information requested by NOSB 

1. Have organic sources of FOS become available? What additional actions have organic industry 

users of FOS taken to source or develop organic FOS? 

2. What functional essentiality does FOS have in current specific organic certified applications and 

would alternatives (i.e. other fibers, organic inulin, etc.) be functionally similar in the same 

application? If not, why?

3. Is the summary of both inulin derived and sucrose derived FOS correct? Do both of these 

processes meet the agricultural classification in line with NOP Guidance 5033 on 

Agricultural/Non-Agricultural classification?

Gums: (Arabic, Guar, Locust bean , and Carob bean)

Reference: 205.606(k) Gums - water extracted only (Arabic; Guar; Locust bean; and Carob bean)

Technical Report: 1995 TAP; 2018 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation

Recent Regulatory Background: Sunset renewal notice published 06/06/12 (77 FR 33290); Sunset 

renewal notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Material Use:

Gum arabic, locust bean gum, carob bean gum, and guar gum are high molecular-weightpolysaccharides extracted via water processing and then drying and milling (2018 TR 78-103). These 

gums are extracted from the endosperm of plants of the Leguminosae. The specific plants are guar, 

carob and locust bean. Gum Arabic is obtained from the exudate from the bark of the acacia tree and is 

one of the oldest known natural gums (TAP pg 8, 2018 TR 443). These gums are used in various food 

applications due to their ability to modify viscosity of products (hydrocolloid function) through the 

binding of water and generation of gelling effects (2018 TR 182-187). These properties are the primary 

function of gums and lend them to be common and popular thickeners and stabilizers in food products. 

Guar gum, gum Arabic and locust bean/carob bean gum are also thickening agents, which makes them 

useful since not all hydrocolloids function as thickening agents (2018 TR 189-192). 

Despite having some similar characteristics, not all gums are interchangeable. Due to the structure of 

the gums, some behave differently in different temperatures, pH ranges, physical agitation, etc. (2018 

TR 194-200). This variability requires formulations specific to the type of food product, intended shelflife and product use. Many times these gums are used in combination to impart the correct properties 

in the finished goods (2018 TR 416). The table provided on line 285 in the 2018 technical report 

distinguishes the different characteristics of common gums.

Manufacture:

Gum arabic is obtained from the exudate from dried sap collected from the stems and branches of the 

Acacia tree, both wild grown and cultivated. The gum is cleaned by mechanical sieves and graded, then 

milled to a powder. (2018 TR 566-573)

Locust/carob bean gum is derived from the seeds of the carob tree, which are processed through a 

series of crushing, sifting, and grinding steps (2018 TR 594-595)

Guar gum is formed form the seeds of the guar bean plant. The endosperm is dehusked, milled and 

screened, and the gum is then clarified (2018 TR 584-586). 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

International Equivalency:

Gum arabic, locust/carob bean gum and guar gum are all listed by the FDA as Generally Recognized as 

Safe (GRAS) (2018 TR 750-752).

Canadian Organic Regime’s Canadian General Standards Board Permitted Substances List (Nov 2015 ed.) 

allows the use of Gum Arabic, locust/carob bean gum, and guar gum as long as they are derived using 

solvents on their Table 6.3 Extraction solvents, carriers, and precipitation aids [in the source document]. 

By exception isopropyl alcohol may also be used to derive gums (2018 TR 491-496).

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999) 

Gum Arabic (414), locust/carob bean gum (410), and guar gum (412) are allowed and the CODEX 

General Standard for Food Additives (GSFA) describes the compliant uses (2018 TR 498-504).

European Economic Community (EEC) Council Regulation, EC Nos. 834/2007 and 889/2008

Gum Arabic, locust/carob bean gum, and guar gum are allowed for use in processed organic foods as a 

food additive in the preparation of foodstuffs of plant 508 or animal origin with no specific limitations 

(2018 TR 506-515).

Japan Agricultural Standard (JAS) for Organic Production

Arabian gum (INS 414) is limited to dairy products, edible fat, and oil and confectionary products (2018 

TR 527).

Carob bean gum/locust bean gum (INS 410) is limited to dairy and processed meats. (2018 TR 529)

Guar gum (INS 412) can be used in processed foods of animal origin limited to dairy, canned meat or egg 

products. (2018 TR 531)

International Federation of Organic Agriculture Movements (IFOAM)

IFOAM allows locust bean gum (INS 410), guar gum (INS 412), tragacanth gum (INS 413), Arabic gum 

(INS 414) and xanthan gum (INS 415). There are no restrictions on how any of these items can be used 

(IFOAM, 2014). (2018 TR 539-541)

East African Organic Product Standard

Locust bean gum, guar gums are allowed with no restrictions. Arabic gum is allowed for milk products, 

fat products, confectionary, sweets and eggs (2018 TR 544-550).

Ancillary Substances:

According to the 2018 TR (434-438) no information was found indicating that any additional materials 

are generally added to commercially available forms of the gums. However, according to the 2016 TR on 

xanthan gum two exceptions were identified during a review of publically available specification sheets: 

glucose used to standardize a xanthan and guar gum blend, and polysorbate 60 in GRINSTED. 

Background Information:

No environmental or health concerns were noted in the manufacture or use of these gums in the 

general population. The EFSA (European Food Safety Authority) re-evaluated five gums in 2017 including 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

arabic, guar, and locust. The panel concluded there wasn’t adequate data available to assess the effects 

of locust bean and guar gum on infants and young children, and recommend that additional data be 

generated. 

In 2015 these gums were unanimously voted by the NOSB to remain on 205.606(k).

Additional information requested by Subcommittee: 

Are organic versions of gum arabic, locust/carob bean gum, and guar gums commercially available?

Lecithin -de-oiled 

Reference: 205.606(o) Lecithin - de-oiled

Technical Report: 1995 TAP; 2009 TR 

Petition(s): Lecithin, bleached (remove 2008)

Past NOSB Actions: 04/1995 NOSB minutes and vote; 05/2009 recommendation (remove from 605b);

05/2009 Recommendation (amend 606); 10/2015 sunset recommendation

Recent Regulatory Background: Annotation change effective 03/15/2012 (77 FR 8089); Sunset renewal 

notice published 03/21/17 (82 FR 14420)

Sunset Date: 3/15/2022

Background from Subcommittee:

Use:

Lecithin is the substance isolated as a gum following hydration of solvent-extracted soy, safflower or 

corn oils. Lecithin has a wide range of food application, which includes emulsification, release 

properties, wetting, dispersing, and texturization. The major applications for lecithin include margarine, 

chocolates, instantizing powders, release sprays, and baked goods. It is used as a natural surfactant 

between oil and water systems as seen in margarine products. Lecithin also helps modify chocolates for 

better enrobing and reduces crystallization of cocoa fat. In release applications, lecithin modifies the 

cooking surface to allow products to be more easily removed. As an instantizing agent, lecithin reduces 

the hydration properties of powders that would otherwise clump during dispersion in water and milk 

products. In baking, the lecithin provides a multifunction application by emulsifying the fat and water 

and as an anti-staling agent by inhibiting starch retrogradation. Lecithin improves water absorption in 

baked goods and dough, increasing volume and shelf life, and improving uniformity of the products. It is 

also used as a packaging aid and directly on processing equipment as a lubricant. In addition, lecithin is

used in pharmaceuticals (as dietary supplements, emulsifying agent for intravenous injections, and 

dispersant for vitamins); in cosmetics (as emulsifier and emollient in hair and make-up preparations, 

creams, and oils); and in animal feeds (as a nutritional ingredient, emulsifier, and wetting aid in calf milk 

replacers, pet foods, and many other types of feeds required high fat and oil contents). Bleached 

lecithin is used in applications where a lighter color is deemed important. Unbleached fluid lecithin has 

a dark brown color which does not permit high use levels in white or very light colored products; 

however, in some formulations, brown fluid lecithin can be used effectively at low concentrations 

(Scocca, 1976). Dry lecithin is used in commercial applications of food systems where liquid lecithin is 

more difficult to handle and the powdered or granular lecithin is more easily incorporated. 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Manufacture:

Lecithin is the substance isolated as a gum following hydration of solvent-extracted soy, safflower or 

corn oils. Most commercial lecithin is made from crude soy oil extracted from soy flakes. The crude soy 

oil is then treated with water or steam to precipitate the lecithin as a gum. The wet gums is centrifuged, 

bleached (with hydrogen peroxide and/or benzoyl peroxide), and dried to become bleached lecithin.

International: 

The Joint FAO/WHO Expert Committee on Food Additives— Lecithin (INS1: 322) functional uses as 

antioxidant and emulsifier agent. Acceptable daily intake is not limited. 

Canadian Organic Standards— Lecithin bleached form is allowed when unbleached form is not suitable 

from organic sources only. Lecithin is listed in the table of “Food Additives” of the “Non-organic 

Ingredients” section under permitted substances lists for processing and sanitation

The EU Organic Regulation No 2092/91— The use of lecithin as (1) a fungicide, listed in the section 

“Substances of crop or animal origin”, for plant protections; and (2) a food additive, listed in the 

subsection “Food additives, including carriers” of the section “INGREDIENTS OF NON-AGRICULTURAL 

ORIGIN”, for preparation of foodstuffs composed essentially of one or more ingredients of plant and/or 

animal origin. 

The Codex Guidelines for Organically Produced Foods— Lecithin used for pest and disease control need 

recognized by the certification body or authority, e.g., volume, frequency of application, specific 

purpose, etc. In addition, lecithin (obtained without bleaches and organic solvents) as a food additive is 

permitted for use in foods of plant origin and certain foods of animal origin (such as dairy products and 

analogues, fats and oils, fat emulsions, emulsified sauces, and infant formulae and follow-on formula) 

(2009 TR lines 159 -163).

Environmental Health Issues:

Lecithin is found in brain, nerve, liver, kidney, heart, blood, and other tissues. Because of its strong 

affinity for water, it facilitates the passage of fats in and out of the cells; and it probably plays a role in 

fat absorption from the intestine and transport of fats from the liver (Potter, 1973). No acute exposure 

studies were found for soybean-derived lecithin in humans. According to MSDS, the dust is predicated 

to be irritating to the eyes, skin, and respiratory tract from mechanical action. Inhalation of lecithin 

aerosols may cause pulmonary edema; it may cause occupational asthma from pulmonary sensitization. 

Acute ingestion may affect the liver (fatty liver degeneration). Safety glasses, lab coat, dust respirator, 

and gloves are needed for personal protection. 

Soy has also been recognized as one of the eight most common food allergens. During manufacture of 

lecithin derived from soy, most, but not all, of the soy protein is removed. Soy allergens, to the extent 

they are present in lecithin, would be found in the protein fraction of the ingredient. Accurately 

measuring lecithin’s protein content presents challenges to current analytical methodology due to the 

ingredient’s oily matrix and low levels of protein.

Discussion:

During the sunset review in October 2006, the NOSB recommended renewing lecithin-bleached under 7 

CFR 205.605(b) Synthetics allowed. In the committee summary, the Board further recognized that there 

are “plentiful non-synthetic and organic alternatives to synthetic bleached lecithin in liquid form” but 

that there is currently no such alternative for “bleached lecithin in dry, de-oiled form”. Because the 

sunset review provided no opportunities to add annotations, the board saw no alternative but to 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

recommend renewal of bleached lecithin. In its closing summary, the Board invited a petition to restrict 

the use of bleached lecithin to dry forms only. Since then, the supply of organic lecithin has evolved to 

the point that there is now certified organic lecithin available to replace the need for non-organic 

bleached lecithin. But, there still remains a question of whether there is an organic lecithin that is in dry, 

de-oiled form.

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 that differentiates 

the types and functionality of lecithin, and dictates 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 nonsynthetic 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.

In 2009, the NOSB reviewed the arguments for and against renewal of lecithin. Those in favor of 

renewing pointed out that there is was insufficient supply in an organic form, specifically from raw 

materials other than soy. Additionally other sources were not yet in production and were located in a 

country under political turmoil. Those in favor of removal argued the product was available in an 

organic form internationally. The majority of the NOSB concluded that it meets the OFPA criteria, is not 

available in an organic form, and should be renewed.

Additional information requested by Subcommittee: 

Are there commercially available organic forms of lecithin in de-oiled form?

Tragacanth gum

Reference: 7 CFR 205.606(x) - As nonorganically produced agricultural product allowed as ingredient in or 

on processed products.

Technical Report: 2018 TR

Original Petition: 2007 Tragacanth Gum

Past NOSB Actions: 2008 Final Recommendation; 2014 sunset recommendation

Regulatory Background: Proposed rule (including justification) published 06/03/09 (74 FR 26591), Added to 

National List 12/13/2010 (75 FR 7751). Sunset renewal notice published 06/22/2015 (80 FR 35177)

Sunset Date: 06/22/20

Material Use:

Tragacanth gum is a polysaccharide that forms gels and can be used as a thickener and emulsifier. This 

material is effective at low pH and at many temperatures; its stability at low pH is noted as one of its 

distinguishing characteristics and is commonly used in high acid products like salad dressings (2018 TR 218-

225, 337). The percentage in final formulations is usually low, below 1% of a total formula (2018 TR 338).

Despite having some similar characteristics, not all gums are interchangeable. Due to the structure of the 

gums, some behave differently in different temperatures, pH ranges, physical agitation, etc. (2018 TR 194-

200). This variability requires formulations specific to the type of food product, intended shelf-life and 
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

product use. Many times these gums are used in combination to impart the correct properties in the 

finished goods (2018 TR 416). The table provided on line 285 in the 2018 Technical report distinguishes the 

different characteristics of common gums.

Manufacture:

Tragacanth gum is prepared from the sap of various species of legumes in the Astragalus species during July 

to September (2018 TR 576-581). Once collected it is dried and ground into powder and may, or may not, 

undergo a mitigation step to reduce the microbial load of the powder (2018 TR 578-581). 

International Equivalency:

Tragacanth gum is listed as Generally Recognized as Safe (GRAS) by the FDA at 21 CFR 184.1351 (2018 TR 

750-752).

Canadian Organic Regime’s Canadian General Standards Board Permitted Substances List (Nov 2015 ed.) 

allows the use of tragacanth gum as long as it’s derived using solvents on their Table 6.3 Extraction 

solvents, carriers, and precipitation aids [in the source document]. By exception isopropyl alcohol may also 

be used to derive gums (2018 TR 491-496).

CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999) 

Tragacanth gum (412) is allowed and the CODEX General Standard for Food Additives (GSFA) describes the 

compliant uses (2018 TR 498-504).

European Economic Community (EEC) Council Regulation, EC Nos. 834/2007 and 889/2008

Tragacanth gum is allowed as a food additive in compliance with the General Standard for Food Additives 

Annex II and III of the Regulation (EC) No. 1333/2008 on food additives (2018 TR 506-515).
National Organic Program | Agricultural Marketing Service | U.S. Department of Agriculture

Japan Agricultural Standard (JAS) for Organic Production

Tragacanth gum is listed with no limitations (2018 TR 535).

International Federation of Organic Agriculture Movements (IFOAM)

IFOAM allows tragacanth gum (INS 413) with no restrictions on how any of this item can be used (IFOAM, 

2014) (2018 TR 539-541).

East African Organic Product Standard

Tragacanth gum is allowed with no restrictions (2018 TR 547).

Ancillary Substances:

According to the 2018 TR (434-438) no information was found indicating that any additional materials are 

generally added to commercially available forms of the gums. However, according to the 2016 TR on 

xanthan gum two exceptions were identified during a review of publically available specification sheets: 

glucose used to standardize a xanthan and guar gum blend, and polysorbate 60 in GRINSTED. 

Background Information:

No environmental or health concerns were noted in the manufacture or use of this gum. 

The NOSB Subcommittee noted in 2008 that due to limited growing regions (Turkey and Iran) and relevant 

trade embargoes, the supply of conventional tragacanth gum was fragile and limited. In October 2014 

organic tragacanth gum was not known to be in production. The 2014 Subcommittee was unable to find 

evidence that tragacanth is available in organic form, and received testimony from a certifier and a 

producer who currently uses non-organic tragacanth.

Additional information requested by Subcommittee: 

Is organic tragacanth now commercially available?