Sunset 2020 Meeting 2 - Review

Handling Substances §205.605, §205.606

October 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 production 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. 

Request for Comments

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

received after that date may not be reviewed by the NOSB before the October meeting. 

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

early sunset review as part of November 18, 2016 NOSB recommendation on efficient workload reorganization. 

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

NOSB Oct 2018 proposals and discussion documents pg. 65 of 204
Calcium carbonate

Reference: 205.605(a) Nonsynthetics allowed: Calcium carbonate.

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

Subcommittee Review

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 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. 

Public comments widely supported the relisting of this material, noting its essentiality to organic 

production in the absence of viable alternatives. Commenters detailed uses including in soy cheese, yogurts 

and beverages as a source of calcium, as much as 15% of the RDA. Comments also pointed to its use as a 

stabilizer. 

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 

 

NOSB Oct 2018 proposals and discussion documents pg. 66 of 204
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, which may 

include 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.

This proposal to remove will be considered by the NOSB at its public meeting. The Handling Subcommittee 

has determined that calcium carbonate continues to be essential to organic production.

Subcommittee vote

Motion to remove calcium carbonate from §205.605(a) of the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A

Motion by: Lisa de Lima

Seconded by: Scott Rice

Yes: 0 No: 4 Abstain: 0 Absent: 3 Recuse: 0

Flavors

Reference: 205.605(a) Nonsynthetics allowed: Flavors, 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 

Subcommittee Review

Use

Natural flavors are compound substances derived from natural sources including 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 

NOSB Oct 2018 proposals and discussion documents pg. 67 of 204
product.1

 The significant function of natural flavors must be flavor rather than nutrition. The FDA defines 

Natural Flavors in 21 CFR 101.22 as:

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 liquids derived 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. They are 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. Oleoresins are solvent extracts of spices where the solvent has 

been completely removed. An oleoresin will contain the essential oil plus other important non-volatile 

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.

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

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

NOSB Oct 2018 proposals and discussion documents pg. 68 of 204
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 re-listing and 

stated:

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 that stated, in part:

In 1995, the National Organic Standards Board (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 product market will continue to grow and develop.

On November 6, 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 recommended revising the annotation for flavors 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 NOSB 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, the 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: 

NOSB Oct 2018 proposals and discussion documents pg. 69 of 204
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.

Public comment was received from several interest groups and industry that encouraged the adoption of 

the 2015 NOSB proposal to change the annotation for natural flavors. There was also support from 

interest groups for furthering the requirements for organic flavor usage. Some commenters specified that 

that the flavoring constituents in the flavor, as well as the carrier system, need to be organic. Other 

comments objected to the fact that flavors were a categorical listing. Several businesses and trade 

associations commented on use and essentiality. In one of the surveys by one of the associations, 

manufacturers rated flavors as a 9 or 10 on a scale of 1 to 10 of essentiality; 10 being the most essential. 

Certifiers also reported a wide usage of flavors amongst their clients. One retailer asked about further 

restriction of flavors when their use is to replace the natural source of the food’s advertised flavor, stating 

that natural flavors should not be allowed to be used as the only defining source of a food's advertised 

flavor. This is addressed and regulated by the FDA, particularly under 21 CFR 101.22 and 21 CFR 102.5 that 

define characterizing flavors based on the label, including words and pictures, advertisement or consumer 

expectations. If the characterizing flavors are not present without the use of a natural flavor ingredient, 

then the product would need to be labeled as naturally or artificially flavored on the front panel even 

when natural flavors were used depending on formulation. 

The NOSB received no new information to support removing flavors from the National List. To the 

contrary, the NOSB received significant public comment in support of the relisting of natural flavors. 

This proposal to remove will be considered by the NOSB at its public meeting. The Handling Subcommittee 

supports the relisting of flavors. 

 

Subcommittee vote

Motion to remove flavors from §205.605(a) from the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A

Motion by: Tom Chapman 

Seconded by: Scott Rice 

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

Gellan gum 

Reference: 205.605(a) Nonsynthetics allowed: Gellan gum (CAS # 71010-52-1)—high-acyl form only.

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: 6/22/2020

Subcommittee Review

Material Use

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

NOSB Oct 2018 proposals and discussion documents pg. 70 of 204
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. 

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 

NOSB Oct 2018 proposals and discussion documents pg. 71 of 204
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).

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).

East African Organic Product Standard

Gellan gum is neither listed as allowed or prohibited (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. 

The two available technical reports (TRs) did not list any notable human health or environmental 

concerns regarding the use of gellan gum. 

During the 2018 spring public comment period, a number of manufacturers wrote in support of the 

material, with multiple manufacturers stating that they are using gellan gum as a carrageenan 

replacement due to customer concerns. Examples of specific products that use gellan gum include 

plant-based creamers and beverages, dairy beverages, and yogurt. 

A couple different organizations requested that the Confidential Business Information (CBI) from the 

original petition be disclosed and requested the material be delisted until that happens. One retailer 

commented that organic consumers want to avoid products with stabilizers and emulsifiers, including 

gellan gum, and was opposed to its re-listing. 

Additional information requested by Subcommittee

None

NOSB Oct 2018 proposals and discussion documents pg. 72 of 204
Subcommittee vote

Motion to remove gellan gum from §205.605(a) from the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Lisa de Lima

Seconded by: Steve Ela

Yes: 0 No: 4 Abstain: 1 Absent: 2 Recuse: 0

Oxygen

Reference: 205.605(a) Nonsynthetics allowed: Oxygen—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

Subcommittee Review

Use

Oxygen is used in modified atmosphere packaging, the processing of olives, and by wineries, breweries, and 

manufacturers of carbonated beverages. 

Manufacture

Oxygen is separated from air cryogenically; super cold temperature liquefaction of air and fractional 

distillation. 

International

The use of oxygen is permitted in organic standards in Canada, CODEX, EU, IFOAM, and Japan. 

Ancillary Substances

None. 

Additional information requested by Subcommittee

None

Public comment prior to the spring 2018 NOSB meeting was mostly in favor of relisting. One organization 

commented that oxygen should be removed from the National List if necessity wasn’t documented. 

According to public comment it is used by wineries, breweries, and manufacturers of carbonated 

beverages. One certifier reported that it is listed on 14 Organic System Plans (OSPs). One winery 

commented they use it for micro-oxygenation, a process where oxygen is added to red wine at a controlled 

rate and flow to stabilize color, improve astringency, and aromatic components of the final wine. Microoxygenation also allows wines to be released to consumers at a younger age which in turn reduces the 

amount of sulfur dioxide that needs to be added during the wine making process. 

No negative impacts on health or the environment were brought to the subcommittee’s attention. 

NOSB Oct 2018 proposals and discussion documents pg. 73 of 204
Subcommittee vote

Motion to remove oxygen from§205.605(a) from the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Lisa de Lima

Seconded by: Scott Rice

Yes: 0 No: 5 Abstain: 0 Absent: 2 Recuse: 0

Potassium chloride

Reference: 205.605(a) Nonsynthetics allowed: Potassium chloride.

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 

Subcommittee Review

Specific Uses

According to the Food & Drug Administration FDA), potassium chloride is 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 impact 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.

Discussion

During Subcommittee review, one Board member stated that potassium chloride is primarily used in 

infant and baby products. 

The following questions were posed to stakeholders:

1. Is the substance essential for organic food production?

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

 emerged?

Public Comment

The public comment was unanimous in support of re-listing potassium chloride. Several commenters 

focused on potassium chloride as a key ingredient in low-sodium products. Another commenter stated 

that potassium chloride is essential in the fortification of infant and baby formula.

NOSB Oct 2018 proposals and discussion documents pg. 74 of 204
Subcommittee vote

Motion to remove potassium chloride from§205.605(a) from the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.605(a) if applicable: N/A

Motion by: A-dae Romero-Briones

Seconded by: Steve Ela

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

Alginates

Reference: 205.605(b) Synthetics allowed: Alginates.

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 

Subcommittee Review

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 of, use of, 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.

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 

NOSB Oct 2018 proposals and discussion documents pg. 75 of 204
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 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 as 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 the Handling Subcommittee

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

technical report was written?

Of the comments received during the Spring 2018 public comment period, most manufacturers and 

NOSB Oct 2018 proposals and discussion documents pg. 76 of 204
users of alginates noted that the unique properties of alginates were critical to the formulations of their 

products. Many commenters supported the relisting of alginates on the National List. 

Other commenters noted that alginates are synthetic derivatives of brown seaweeds. Thus, issues of 

sustainable harvesting of seaweeds, disturbances of marine ecology through their harvesting, and 

bioaccumulation of contaminants such as heavy metals and radioactivity should be accounted for in the 

review of this material. Several of these commenters asked that the use of alginates require the 

seaweeds to be organically produced, either through cultivation or by following the wild harvesting 

rules. 

Finally, several commenters noted that they believed the NOSB should review each ingredient derived 

from brown seaweeds separately. The National List should list each of these substances separately, 

together with the species name the substance is derived from, and not lump these ingredients under 

the more general category of “alginates”. 

Subcommittee vote

Motion to remove alginates from §205.605(a) from the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Steve Ela

Seconded by: Lisa de Lima

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

Calcium hydroxide

Reference: 205.605(b) Synthetics allowed: Calcium hydroxide.

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

 

Subcommittee Review

Specific Uses and approved legal uses of the Substance

Calcium hydroxide is used as a component of aluminum free baking powder, to clarify sugar for

molasses, and as a conditioner for corn tortillas. It is known as “slaked lime” or “hydrated lime.” 

Calcium hydroxide 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. Calcium hydroxide is used as a pH buffer 

and as the alkaline substance in aluminum-free baking powder. It is also used to fortify foods with 

calcium, clarify sugar cane or beet juice, for making hominy and masa, and as a firming agent. It is also 

used in the production of organic corn starch and to remove impurities from solutions. 

Discussion

The subcommittee requested the following information from stakeholders:

1. Is calcium hydroxide essential for organic food production?

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

NOSB Oct 2018 proposals and discussion documents pg. 77 of 204
Public Comment

The majority of commenters supported relisting. However, one commenter suggested that the NOSB 

clarify which uses of calcium hydroxide are permitted, specifically if calcium hydroxide can be used as a 

firming agent. Additional commenters stated that they use calcium hydroxide in infant formula. 

Subcommittee vote

Motion to remove calcium hydroxide from §205.605(b) from the National List based on the following 

criteria in the Organic Food Productions Act (OFPA) and/or 7 CFR 205.506(b) if applicable: N/A

Motion by: A-dae Romero Briones

Seconded by: Lisa de Lima

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

Ethylene

Reference: 205.605(b) Synthetics allowed: Ethylene—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 

Subcommittee Review

Ethylene is currently listed at §205.605(b) as a material allowed for postharvest ripening of tropical fruit 

and degreening of citrus. 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 naturally 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

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

Japan: Limited to use for 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: Degreening of citrus for fruit fly prevention. As sprouting inhibitor for potatoes and onions.

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

NOSB Oct 2018 proposals and discussion documents pg. 78 of 204
on previous reviews, significant impacts on human health and the environment are likely minimal.

Public comment about ethylene gas (EG) was very limited and reflects two opposing views. Some consumer 

groups considered EG to be an unnecessary synthetic growth regulator (ripening agent) and contrary to 

organic principals, while wholesale and grocer organizations considered it essential for tropical fruits and 

allowing organic fruit production that is important to the organic produce sector. 

This proposal to remove will be considered by the NOSB at its public meeting. The Handling Subcommittee 

supports relisting of ethylene.

 

Subcommittee vote

Motion to remove ethylene from §205.605(b) from the National List based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.605(b): N/A

Motion by: Asa Bradman

Seconded by: Tom Chapman

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

Glycerides (mono and di)

Reference: 205.605(b) Synthetics allowed: Glycerides (mono and di)—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 

Subcommittee Review

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 (TR 2015 82-83). 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 (TR 2015 91-92). The use of mono- and diglycerides in dehydrated potatoes also aids in 

rehydration (TR 2015 105-106). 

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.

NOSB Oct 2018 proposals and discussion documents pg. 79 of 204
When manufactured, they are prepared by the glycerolysis of fats or oils, or from fatty acids derived

from edible sources (TR 2015 56-59). These edible sources are commonly animal fats or vegetable oils 

such as soybean, canola, sunflower, cottonseed, coconut or palm oil (TR 2015 59-60), 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 the following organic standards: CODEX, EU, IFOAM or Japan. 

Ancillary Substances

None. 

According to the 2015 technical report (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 has been suggested as an acceptable alternative to drum 

drying.

Evaluation question #13 in the 2015 TR suggested a few potential agricultural alternatives. One is a 

commercial product, made of organic rice bran extract, which is marketed as an emulsifier and drum 

release agent. Trials by the manufacturer concluded that rice bran extract had the highest capacity for 

oil-in-water binding. However, the hydrophilic –lipophilic balance of rice bran extract is narrower than 

that of mono- and diglycerides, which may make it less versatile as an emulsifier depending on the 

composition of the mix to which it is added. 

Organic soy lecithin and gum arabic (both currently on the National List) were also raised as possible 

alternative substances to glycerides, although the use of gum arabic in drum dried food is not widely 

reported. The TR also considered the use of lecithin as an alternative but stated that as compared to 

mono and diglycerides it provides much less emulsion stability, much less starch interaction, and more 

fat modification. 

The TR concluded that in general, each emulsifier (and its form) is selected based on specification of the 

food and the processing application (TR 2015 522-547). 

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. Have any of these alternatives 

been tried? And if so, what were the results? 

2. Has rice bran extract, soy lecithin, or gum arabic been tried as an alternative to glycerides 

(mono and di) in drum drying? What were the results? 

Subcommittee vote

Motion to remove mono- and diglycerides from §205.605(b) from the National List based on the 

following criteria in the Organic Food Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Lisa de Lima

Seconded by: Steve Ela

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

NOSB Oct 2018 proposals and discussion documents pg. 80 of 204
Magnesium stearate

Reference: 205.605(b) Synthetics allowed: Magnesium stearate—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 

Subcommittee Review

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))” and is prohibited in agricultural products labeled “organic.”

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

magnesium stearate is produced by adding an 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.

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 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. 

In the past, the NOSB Subcommittee has requested public comment on availability of

alternatives and any information on possible negative human health impacts. Public comment

has been very limited. One certifier commented that two of their members use magnesium 

stearate to manufacture pharmaceutical and dietary products. The Council for Food Additives 

supported relisting. Others raised concerns about the use of pesticides/genetic engineering in 

the non-organic production of oils used for its manufacture and the availability of organic or 

NOSB Oct 2018 proposals and discussion documents pg. 81 of 204
sustainable alternatives. Magnesium stearate is allowed only in agricultural products labeled

“made with organic.” Some of those same commenters said they were not opposed to the 

relisting since the material is only used in “made-with products” and, hence, does not threaten 

organic integrity. 

This proposal to remove magnesium stearate will be considered by the NOSB at its public meeting. The 

Handling Subcommittee supports relisting magnesium stearate.

Subcommittee vote 

Motion to remove magnesium stearate from §205.605(b) from the National List based on the

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.605(b) if

applicable: N/A

Motion by: Asa Bradman

Seconded by: Tom Chapman

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

Reference: 205.605(b) Synthetics allowed: Phosphoric acid—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 

Subcommittee Review

Specific Uses of the Substance

Phosphoric acid is used in cleaning procedures 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 on 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.

Discussion

The Handling Subcommittee reviewed phosphoric acid as part of a larger discussion about “sanitizers” and 

whether phosphoric acid has safer alternatives. The discussions were inconclusive. 

The following information was requested from stakeholders:

1) Is the substance essential for organic food production?

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

Public Comment

The majority of stakeholders supported the relisting of phosphoric acid; however, there were numerous 

comments that suggested the Board find ways to explore safer alternatives to phosphoric acid. One 

 Phosphoric acid

NOSB Oct 2018 proposals and discussion documents pg. 82 of 204
commenter in particular focused attention on the environmental damage to water resources because of 

the continuous build of phosphoric acid when washed down drains. Many commenters focused on 

phosphoric acid as part of a food safety plan for organic operations since many other sanitizers cannot be 

used in contact with food like phosphoric acid. Other commenters mentioned that some phosphoric acid 

alternatives have already been removed from the list so phosphoric acid is even more important to food 

safety planning. The majority of commenters agreed that a safer alternative needs to be explored, but is 

not readily available at this time.

Subcommittee vote

Motion to remove phosphoric acid from §205.605(b) from the National List based on the following criteria 

in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.605(b): N/A

Motion by: A-dae Romero-Briones 

Seconded by: Scott Rice 

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

Potassium carbonate

Reference: 205.605(b) Synthetics allowed: Potassium carbonate.

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 

Subcommittee Review

Use

Potassium carbonate has many uses. It is commonly used in the Dutch alkali process for processing 

cocoa and chocolate to reduce acidity. It is also used as a pH control, leavening agent, a boiler water 

additive, a tenderizer for tripe, in soap production, soft drinks, and confections. Also, it is used as a 

buffering agent in making wine and mead to reduce acidity. 

The original technical advisory panel (TAP) notes that it be used only when sodium carbonate is not 

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

desired.

Public comments demonstrated a continued need for this material. One manufacturer noted its use as a 

sodium reduction agent and that removal from the list would result in a rise in sodium levels in their 

product by 18%. Other commenters noted use in a protein bar and as a nutritional supplement.

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, a bi-product at manufacture, collected to avoid environmental pollution and 

human health impacts.

NOSB Oct 2018 proposals and discussion documents pg. 83 of 204
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

This proposal to remove will be considered by the NOSB at its public meeting. Potassium carbonate 

continues to be essential to organic production, and the Handling Subcommittee supports relisting. 

Subcommittee vote

Motion to remove potassium carbonate from §205.605(b) of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): N/A. 

Motion by: Lisa de Lima

Seconded by: Scott Rice

Yes: 0 No: 4 Abstain: 0 Absent: 3 Recuse: 0

NOSB Oct 2018 proposals and discussion documents pg. 84 of 204
Sulfur dioxide

Reference: 205.605(b) Synthetics allowed: Sulfur dioxide—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 

Subcommittee Review 

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 National List 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. 

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

(TR) 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 must 

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 

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 

NOSB Oct 2018 proposals and discussion documents pg. 85 of 204
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 on the National List. 

The current annotation allows the use of sulfur dioxide only in wine made from organic 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 the current annotation. While alternatives to sulfur dioxide for winemaking have been 

investigated, the TR notes that there are not organic alternatives that are satisfactory to prevent 

spoilage and oxidation in wine.

Public comments received during the Spring, 2018, public comment period noted the essentiality of 

sulfur dioxide for winemaking. Wine producers used sulfur dioxide to prevent oxidation and spoilage of 

wines. No alternatives have been identified, and commenters noted that they would not be able to 

produce quality white wines and that red wines would have a limited shelf life without the use of this 

material. 

A number of commenters noted that in the United States, wines that use sulfur dioxide can only be 

labelled “made with organic grapes,” whereas in many parts of the world wines may be labelled as 

“organic” when this material is used. Thus, the United States is more restrictive than most countries. 

Several commenters noted that if the material were removed, there would be a considerable loss of 

market share and quality for wines made with organic grapes.

Subcommittee vote

Motion to remove sulfur dioxide based on the following criteria in the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Steve Ela

Seconded by: Eric Schwartz 

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

NOSB Oct 2018 proposals and discussion documents pg. 86 of 204
Xanthan gum

Reference: 205.605(b) Synthetics allowed: Xanthan gum.

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 

Subcommittee Review

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). Xanthan gum is 

commercially available to consumers for use in gluten-free baking and other recipes. 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.

NOSB Oct 2018 proposals and discussion documents pg. 87 of 204
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; although 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).

East African Organic Product Standard

NOSB Oct 2018 proposals and discussion documents pg. 88 of 204
Xanthan gums is allowed in fats, fruits and vegetable products, and cakes and biscuits. 

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 

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

GRINSTED. 

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. The recall was 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 in the TR of specific environmental issues regarding the production of xanthan 

gum. 

During the Spring 2018 public comment period, a number of organizations, certifiers, and 

manufacturers expressed support for the material, with one larger certifier stating that of all the gums 

xanthan is the most commonly found in organic system plans. One manufacturer stated that other 

organic gums didn’t have the same functionality in their organic baked goods. One retailer commented 

that organic consumers want to avoid products with stabilizers and emulsifiers, including xanthan gum, 

and was opposed to its re-listing. 

Additional information requested by Subcommittee: None

Subcommittee vote

Motion to remove xanthan gum based on the following criteria in the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Lisa de Lima

Seconded by: Scott Rice

Yes: 0 No: 4 Abstain: 1 Absent: 2 Recuse: 0

Fructooligosaccharides 

Reference: 205.606(e) 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

NOSB Oct 2018 proposals and discussion documents pg. 89 of 204
Subcommittee Review

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 non-digestible 

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 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 can be 

accomplished by creating beads of the A. japonicus culture suspended in calcium alginate, an 

immobilizer. A. japonicus cells hydrolyze (break) the sucrose molecules into glucose and fructose 

and then transfer 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 technical report (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, the comments that were received supported the continued listing for usage in the 

baking industry and no sources of organic FOS were identified. During the current sunset review the NOSB 

posed questions about the development and general availability of organic FOS. No comments were 

received on this question. The NOSB also inquired about the difference between inulin- and sucrosederived FOS, but no new information was presented about its manufacture that wasn’t known to the NOSB 

in 2015 when it concurred with previous NOSB determinations that this substance was agricultural. Lastly 

NOSB Oct 2018 proposals and discussion documents pg. 90 of 204
the NOSB asked about the functional necessity of FOS, and while detailed information was not provided, 

several manufacturers (some via trade associations) spoke about its essential usage as a prebiotic, 

particularly in baby and infant foods and in kombucha beverages. 

This product is currently used in organic processed products, and no new material information was received 

to justify removing this substance from the national list. 

This proposal to remove will be considered by the NOSB at its public meeting. The Handling Subcommittee 

supports relisting of FOS. 

Subcommittee vote

Motion to remove fructooligosaccharides (FOS) from §205.606 based on the following criteria in the 

Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Tom Chapman 

Seconded by: Lisa de Lima 

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

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

Reference: 205.606(g) 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

Subcommittee Review

Material Use

Gum arabic, locust bean gum, carob bean gum, and guar gum are high molecular-weight-polysaccharides 

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 shelf-life 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.

NOSB Oct 2018 proposals and discussion documents pg. 91 of 204
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). 

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

NOSB Oct 2018 proposals and discussion documents pg. 92 of 204
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. 

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) Panel on Food Additives and Nutrient Sources 

evaluated five gums in 2017 including arabic, guar, and locust. The panel found no need for a numerical 

acceptable daily intake (ADI) and no safety concerns for the general population. The panel also concluded 

there wasn’t adequate data available to assess the effects of locust bean and guar gum on infants and 

young children and recommended that additional data be generated. 

Public comment prior to the Spring 2018 NOSB meeting included manufacturers and associations in support 

of these gums on the National List. One manufacturer noted that they source organic guar and locust bean 

gum but are in favor of retaining them on the list as they don’t know if the organic supply is adequate. 

During the public comment webinar one manufacturer said they were able to source organic gum arabic 

this year but that in previous years supply has been inconsistent, and that the supply chain is variable due 

to the geography of where the gum is coming from. One organization thought that the Board should 

investigate whether there is gum arabic that could be certified as wild-crafted organic and also look at the 

availability of organic carob/locust bean gum. A couple of organizations requested that the gums be listed 

individually so that organic supply could be taken into account for those that are produced organically. 

 

Additional information requested by Subcommittee 

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

Subcommittee vote

Motion to remove gum arabic, locust bean gum, carob bean gum, and guar gum based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Lisa de Lima

Seconded by: Scott Rice 

Yes: 0 No: 4 Abstain: 1 Absent: 2 Recuse: 0

NOSB Oct 2018 proposals and discussion documents pg. 93 of 204
Lecithin—de-oiled 

Reference: 205.606(k) 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 

Subcommittee Review

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 applications, including 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 antistaling 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. 

Approved Legal Uses of the Substance

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 gums. These wet gums are 

centrifuged, bleached (with hydrogen peroxide and/or benzoyl peroxide), and dried to become a 

bleached lecithin.

International (acceptance/non-acceptance) by other International certification agencies

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 

NOSB Oct 2018 proposals and discussion documents pg. 94 of 204
“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).

Discussion

The NOSB reviewed the points in favor of renewing the substance as well as those in favor of removal 

from the list. Those in favor of renewing pointed out that there is insufficient supply in an organic form, 

specifically from raw materials other than soy. Those in favor of removal argued the product was 

available in an organic form internationally and was closer to becoming available in other organic forms. 

The following question was posed to stakeholders: Are there organic forms of lecithin in de-oiled form?

Public Comment:

The majority of public comment supported relisting with the exception of one commenter, who 

suggested de-listing based on hazards associated with the production of lecithin and current availability 

of organic lecithin. Another commenter said while they support re-listing, de-listing the lecithin would 

give more incentive to processors to create organic forms. Again, public commenters emphasized that 

organic lecithin is not available except from soy products. 

This proposal to remove lecithin-de-oiled will be considered by the NOSB at its public meeting. The 

Handling Subcommittee supports relisting lecithin de-oiled. 

Subcommittee vote

Motion to remove lecithin, de-oiled from the National List based on the following criteria in the Organic

Foods Production Act (OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: A-dae Romero Briones

Seconded by: Eric Schwartz

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

Tragacanth gum

Reference: 205.606(q) Tragacanth gum (CAS #-9000-65-1).

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: 06/22/2020

NOSB Oct 2018 proposals and discussion documents pg. 95 of 204
Subcommittee Review

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 

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 

NOSB Oct 2018 proposals and discussion documents pg. 96 of 204
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).

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. 

Subcommittee Review

No environmental or health concerns were noted in the manufacture or use of tragacanth gum. The 2018 

technical report (TR) for gums summarized the results from the 2017 European Food Safety Authority Panel 

on Food Additives and Nutrient Sources Added to Food, and for tragacanth gum the panel found no need 

for a numerical acceptable daily intake (ADI) and no safety concerns for the general population. 

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. During the last sunset 

review in 2014, the Handling Subcommittee was unable to find evidence that tragacanth was available in 

organic form and received testimony from a certifier and a producer who used non-organic 

tragacanth. Public comment prior to the Spring 2018 NOSB meeting was very limited, with one 

organization opposed to the listing because they believed potential health effects hadn’t been taken into 

account, as well the possible impacts of non-organic production. 

Additional information requested by Subcommittee 

Is organic tragacanth now commercially available?

NOSB Oct 2018 proposals and discussion documents pg. 97 of 204
Subcommittee vote

Motion to remove tragacanth gum based on the following criteria in the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.600(b) if applicable: N/A

Motion by: Lisa de Lima

Seconded by: Steve Ela 

Yes: 0 No: 4 Abstain: 1 Absent: 2 Recuse: 0 

NOSB Oct 2018 proposals and discussion documents pg. 98 of 204