Sunset 2024 

Meeting 2 - Review

Handling Substances § 205.605(a), § 205.605(b), § 205.606 

October 2022 

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 scheduled 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 crop production that must be reviewed by the NOSB and renewed by the USDA 

before their sunset dates. This document provides the substance’s current status on the National List, use 

description, references to past technical reports, past NOSB actions, and regulatory history, as applicable. If 

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

Request for Comments

Written public comments will be accepted through September 29, 2022 via www.regulations.gov. 

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

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

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

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

available to the NOSB at the time of their last review, which demonstrated that the substances were: (1) 

not harmful to human health or the environment, (2) necessary because of the unavailability of wholly 

nonsynthetic alternatives, and (3) consistent and compatible with organic practices. 

Public comments should clearly indicate the commentor’s position on the allowance or prohibition of 

substances on the National List and explain the reasons for the position. Public comments should focus on 

providing relevant new information about a substance since its last NOSB review. Such information could 

include research or data that may support a change in the NOSB’s determination for a substance (e.g., 

scientific, environmental, manufacturing, industry impact information, etc.). Public comment should also 

address the continuing need for a substance or whether the substance is no longer needed or in demand.

For Comments that Support the Continued Use of §205.605(a), §205.605(b), and/or §205.606 Substances 

in Organic Production:

If you provide comments supporting the allowance of a substance at §205.605(a), §205.605(b), and/or 

§205.606, you should provide information demonstrating that the substance is: 

1. not harmful to human health or the environment;

2. necessary to the production of the agricultural products because of the unavailability of wholly 

nonsynthetic substitute products; and 

3. consistent with organic handling. 

For Comments that Do Not Support the Continued Use of §205.605(a), §205.605(b), and/or §205.606 

Substances in Organic Production:

If you provide comments that do not support a substance on §205.605(a), §205.605(b), and/or §205.606, 

you should provide reasons why the use of the substance should no longer be allowed in organic 

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

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

1. harmful to human health or the environment; 

2. unnecessary because of the availability of alternatives; and 

3. inconsistent with organic handling. 

NOSB Proposals & Discussion Documents October 2022 129 of 152
For Comments Addressing the Availability of Alternatives: 

Comments may include information about the viability of alternatives for a substance under sunset review. 

Viable alternatives include, but are not limited to:

• Alternative management practices that would eliminate the need for the specific substance; 

• Other currently exempted substances that are on the National List, which could eliminate the need 

for this specific substance; and

• Other organic or nonorganic agricultural substances. 

For Comments on Nonorganic Agricultural Substances at Section §205.606: 

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

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

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

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

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

alternative substances that the NOSB did not previously consider.

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

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

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

the National List, should, if possible, include the name and address of the manufacturer of the alternative. 

Further, your comments should include a copy or the specific source of any supportive literature, which 

could include: product or practice descriptions, performance and test data, reference standards, names and 

addresses of organic operations who have used the alternative under similar conditions and the date of 

use, and an itemized comparison of the function and effect of the proposed alternative(s) with substance 

under review. 

 

§205.605(a) Sunsets: Nonagricultural (Nonorganic) substances allowed as ingredients in or on processed 

products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’:

• Attapulgite

• Bentonite

• Diatomaceous earth

• Magnesium chloride

• Nitrogen

• Sodium carbonate

§205.605(b) Sunsets: Nonagricultural (Nonorganic) substances allowed as ingredients in or on processed 

products labeled as ‘‘organic’’ or ‘‘made with organic (specified ingredients or food group(s)).’’:

• Acidified sodium chlorite

• Carbon dioxide

• Sodium phosphates

§205.606 Sunsets: Nonorganically produced agricultural products allowed as ingredients in or on

processed products labeled as “organic.”:

• Casings

• Pectin 

• Potassium acid tartrate

NOSB Proposals & Discussion Documents October 2022 130 of 152
Attapulgite

Reference: §205.605(a) Nonsynthetics allowed:

Attapulgite—as a processing aid in the handling of plant and animal oils.

Technical Report: 2010 TR. 

Petition: 2009. 

Past NOSB Actions: 4/2011 recommendation; 10/2015 sunset review; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577) 

Sunset Date: 10/30/2024

Subcommittee Review

Use

Attapulgite is used as a natural bleaching clay for the purification of vegetable and animal oils. The function 

of a bleaching clay is to remove undesirable by-products (impurities) for the vegetable oil and animal fat, 

thus improving the appearance, flavor, taste, and stability of the final product.

Manufacture

Attapulgus is the principal mineral of attapulgus clay, which is surface mined by open-pit method with 

stripping by scrapers, draglines, or bulldozers and extraction by shovels, backhoes, small draglines, or frontend loaders. The clay is then loaded onto trucks and transported to the processing plant. The clay is then 

dried, milled, and sieved to obtain a desired range of particle sizes [TR 143-146].

International Acceptance

Note: In the United States, the term attapulgite is used in place of palygorskite; however, the International 

Nomenclature Committee determined that palygorskite is the preferred name.

Canadian General Standards Board Permitted Substances List

Canadian Food Inspection Agency, Feed Program— Schedule IV of the Feeds Regulations, 1983, lists 

ingredients approved for use as livestock feed. Attapulgite clay (Schedule IV Number 8.111) is listed under 

Class 8. Miscellaneous Product of the Feeds Regulations. It stated, ―Attapulgite clay (IFN6 8-14-008) is 

hydrated aluminum-magnesium silica, a naturally occurring mineral mined in Attapulgus, Georgia... It shall 

be labeled with the following statement: This product is for use in non-medicated feeds only as an 

anticaking agent or pelleting aid in an amount not to exceed 0.25% of the finished feed or as an emulsifier 

in liquid feed supplements at a level not to exceed 2.5% of the supplement.

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

Regulation (EC) 1831/2003— ―Attapulgite (clay) CAS No. 12174-11-7‖, under silage additives functional 

group, listed in Community Register of Feed Additives. The date of first entry in the Register is July 11, 2005.

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

Organically Produced Foods (CXG 32-1999)

Attapulgite/palygorskite is not specifically listed.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Attapulgite/palygorskite is not specifically listed.

Japan Agricultural Standard (JAS) for Organic Production

Attapulgite/palygorskite is not specifically listed.

NOSB Proposals & Discussion Documents October 2022 131 of 152
Environmental Issues

Attapulgite is surface mined, and, in most countries, the mining company is required by law to reclaim the 

land. Common practice is to open a cut, mine the clay, and then spoil the overburden from the next cut into 

the mined-out area. The spoil is leveled or sloped to meet the standards prescribed by the government, and 

grasses and/or trees are planted. Sometimes the topsoil is put back on top of the spoil and is used for 

agriculture. The major environmental issue is air quality from the dust generated during manufacture, use, 

or disposal. Repeated or prolonged inhalation of dust may cause delayed lung injury.

Discussion

During the Spring 2022 meeting commentors brought forward a couple concerns regarding the listing of 

attapulgite. As listed, only non-synthetic forms of attapulgite should be used at 205.605(a). Attapulgite 

that is acid-activated, which is treated with sulfuric or hydrochloric acid, should be listed at 205.605(b) if 

allowed. Without clarity, certifiers may be inconsistent with allowing certain forms of attapulgite. One 

certifying agency responded that they do verify that attapulgite is not acid-leaching, acid-activated, or acidtreated and prohibits the synthetic form. There were a few requests by commenters to annotate the 

listing. The Handling Subcommittee acknowledges that only non-synthetic forms should be used, as allowed 

by the listing. 

A couple commenters said that the material does not appear to be in widespread use and may not be 

necessary for the industry especially as both bentonite and kaolin are also approved as effective nonsynthetic bleaching agents. The Board did not receive public comments from stakeholders currently using 

attapulgite. One Subcommittee member cast a vote to remove the material based on this discussion. 

Based on this review and public comment, the Handling Subcommittee finds attapulgite compliant with 

OFPA criteria. 

Justification for Vote

The Subcommittee finds attapulgite compliant with the Organic Foods Production Act (OFPA) and/or 7 CFR 

205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove attapulgite from the National List 

Motion by: Kim Huseman

Seconded by: Mindee Jeffery

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

Bentonite

Reference: §205.605(a) Nonsynthetics allowed:

Bentonite.

Technical Report: 1995 TAP. 

Petition: N/A

Past NOSB Actions: 4/1995 minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset review; 11/2017 sunset recommendation. 

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577) 

Sunset Date: 10/30/2024

NOSB Proposals & Discussion Documents October 2022 132 of 152
Subcommittee Review

Use

Bentonite is used as a processing aid, not an ingredient. Its adsorptive qualities make it useful for removing 

impurities in edible oils like soy, palm, and canola. It can also be used to clarify beer, fruit juice, wine, 

sugar, and honey and is not present in the final product.

Manufacture

It is a naturally occurring porous rock of clay materials that derives from weathered volcanic ash. It is mined 

and thus subject to environmental mitigation and monitoring by other agencies. It is a fine white to 

yellowish white or graphic aluminum silicate clay with limited shrink-swell features. It darkens and takes on 

a distinct clayey smell in the presence of liquid. It is insoluble in water, alcohol, dilute acids, and alkali 

solutions.

International Acceptance

Canadian General Standards Board Permitted Substances List

The material is allowed in food handling.

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

The material is not listed.

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

Organically Produced Foods (CXG 32-1999) 

The material is allowed in food handling.

International Federation of Organic Agriculture Movements (IFOAM) Norms

The material is not listed.

Japan Agricultural Standard (JAS) for Organic Production

The material is not listed as a food handling aid.

Environmental Issues

While mining activities are regulated by other agencies, bentonite does derive from mining activities, which 

do produce negative impacts by definition.

It is generally regarded as safe (GRAS) and does not produce human toxicity, although if consumed in large 

quantities, particularly during pregnancy, can produce iron deficiency.

Historically, there has been strong public support for the continued use of bentonite. 

Discussion

The Handling Subcommittee discussed the longstanding support for keeping bentonite on the National List 

for this use. At the same time, the Subcommittee did note the similarity of bentonite as a food processing 

aid to other listed substances (for example, diatomaceous earth) and indicated a desire to understand more 

fully how, why, and to what extent the material is being used in organic applications.

The Subcommittee continues to seek public comment to specifically address the ongoing need for 

bentonite, given other similar (although perhaps not identical) substances. 

NOSB Proposals & Discussion Documents October 2022 133 of 152
During the Spring 2022 meeting commenters expressed specific but limited issues regarding the listing of 

bentonite, that were similar to those conveyed about attapulgite. Commenters maintain that, as listed, 

only non-synthetic forms of bentonite should be used at §205.605(a) and that acid-activated bentonite, 

which is treated with sulfuric or hydrochloric acid, should be listed at §205.605(b) if allowed. Without 

clarity, certifiers may be inconsistent with allowing certain forms of bentonite, which could be remedied 

with clarity provided by an annotation, as some commenters requested. The Handling Subcommittee 

acknowledges that only non-synthetic forms should be used, as allowed by the listing. 

Justification for Vote

Based on the Subcommittee review and public comment, the Handling Subcommittee finds bentonite 

compliant with OFPA criteria, and does not recommend removal from the National List.

Subcommittee Vote

Motion to remove bentonite from the National List 

Motion by: Wood Turner

Seconded by: Mindee Jeffery

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

Diatomaceous earth

Reference: §205.605(a) Nonsynthetics allowed:

Diatomaceous earth—food filtering aid only.

Technical Report: 1995 TAP. 

Petition: N/A

Past NOSB Actions: 4/1995 minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset review; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577) 

Sunset Date: 10/30/2024

Subcommittee Review

Use

Used as a filtering aid in food production of syrups, juices, beer, beverages, and other products.

Manufacture

Diatomaceous earth is made from the fossilized remains of diatoms, whose skeletons are made of a natural 

substance called silica. Diatoms accumulate in the sediment of rivers, streams, lakes, and oceans, and 

diatomaceous earth is mined in quarries or open-pits.

International Acceptance

Diatomaceous earth is permitted for use in organic processing by:

International Federation of Organic Agriculture Movements (IFOAM) Norms, 

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

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

Organically Produced Foods (CXG 32-1999)

NOSB Proposals & Discussion Documents October 2022 134 of 152
Unsure if it is allowed by Canadian General Standards Board Permitted Substances List or 

Japan Agricultural Standard (JAS) for Organic Production

Environmental Issues

Dust produced during processing can be a human health concern for workers and would be subject to 

OSHA requirements (1995 TAP pg. 5). Waste material can, in some states, be considered a hazardous waste 

requiring special disposal requirements (1995 TAP pg. 5). The 1995 Technical Advisory Panel was made up 

of three people. One TAP reviewer expressed concern for possible concentrations of mercury, lead, 

cadmium, arsenic, thallium, and antimony and the need to verify “food grade” quality of diatomaceous 

earth.

Discussion

The NOSB reviewed diatomaceous earth (DE) in November 2005, April 2010, and October 2015, and 

recommended relisting each time. Diatomaceous earth does not exist within the final organic product and 

is classified as a processing aid and not an ingredient. At the Spring 2022 NOSB meeting, numerous 

stakeholders expressed strong support for the relisting of DE as a filtering aid in the production of organic 

food. The use of filter aids is necessary to help remove insoluble materials from finished products to ensure 

consistent quality. One commentor mentioned that stakeholders have experimented manufacturing with 

and without the use of filter aids and cannot guarantee quality without their use. Stakeholders have also 

experimented with alternatives to DE, such as using organic rice hulls or cellulose as filter aids, but none 

have been successful in application. For example, when using organic rice hulls instead of DE, the resulting 

product contained insoluble materials, in addition to changing the color from colorless to amber which was 

not acceptable to meet quality standards or customer expectations. A couple commentors suggested the 

need to review the impact of mining activities, although no new information was provided regarding mining 

concerns. Diatomaceous earth was found to satisfy the OFPA evaluation criteria in previous reviews.

Justification for Vote

The Subcommittee finds diatomaceous earth compliant with the Organic Foods Production Act (OFPA) 

and/or 7 CFR 205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove diatomaceous earth from the National List 

Motion by: Kim Huseman

Seconded by: Mindee Jeffery

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

Magnesium chloride

Reference: §205.605(a) Nonsynthetics allowed:

Magnesium chloride.

Technical Report: 1995 TAP; 2016 TR. 

Petition: N/A

Past NOSB Actions: 10/1995 minutes and vote; 10/1999 minutes and vote; 11/2005 sunset 

recommendation; 10/2010 sunset recommendation; 10/2015 sunset review; 11/2017 sunset 

recommendation.

NOSB Proposals & Discussion Documents October 2022 135 of 152
Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577); Classification change from synthetic to nonsynthetic effective 

11/22/2019 (85 FR 56673).

Sunset Date: 11/22/2024

Subcommittee Review

Use

Magnesium chloride is used in organic food processing as a processing aid, used in tofu production as a 

coagulant/firming agent, and used in certified organic dietary supplements. It can also be used to dress 

cotton fibers, or as a color retention agent and as a source of essential mineral magnesium in infant 

formula. 

The EPA regulates magnesium chloride as a pesticide on List D, pesticides of less concern (EPA 1998). 

Magnesium chloride has also been used to treat bovine hypomagnesemia (low blood magnesium levels). 

Manufacture

Natural commercial sources of magnesium chloride can be classified as: (a) sea water; (b) terminal lake 

brines; (c) subsurface brine deposits; and (d) mineral ore deposits. Magnesium chloride produced from 

each of these natural sources is the product of a brine comprising soluble ions of various mineral elements, 

primarily sodium, potassium, magnesium, calcium, chloride, and sulfate (TR 2016, 186-189). 

(a) Sea Water 

Sea water is processed in solar ponds to produce concentrated brines from which specific minerals 

crystallize and are recovered. These specific minerals, called “evaporites,” crystallize in a sequence 

based on the concentrations of anions and cations in the brine and their innate solubility in water (TR 

192-194). 

(b) Terminal lake brines

A terminal lake is a lake where water is flowing in, but no water flows out, so that the dissolved salts 

concentrate and form brine as the water evaporates. The Great Salt Lake in Utah is a familiar example. 

Great Salt Lake brine is the primary source of magnesium chloride in North America. The Great Salt 

Lake contains sodium-magnesium-chloride-sulfate brine with low alkalinity (Domagalski, Orem, and 

Eugester 1989). Like solarization of seawater, the first evaporite of Great Salt Lake brine to form is 

halite (sodium chloride), followed by schoenite (magnesium-potassium sulfate), kainite (potassium 

chloride-magnesium sulfate double salt), and carnallite (potassium-magnesium chloride), resulting in a 

magnesium chloride brine (Neitzel 1971 ). Evaporating the water in this magnesium chloride brine 

creates crude solid magnesium chloride (TR 2016, 221-234). 

(c) Subsurface brine deposits

Brine deposits in Midland, Michigan, have been a source of magnesium chloride since the 1890s. The 

Dow company originally obtained its bromine, chlorine, sodium, calcium, and magnesium from the brine 

of ancient seas under Midland (TR 2016, 264-266). 

(d) Mined mineral deposits 

The two major mined mineral sources of magnesium chloride are bischofite and carnallite, both of which 

were formed during prehistoric solar evaporation of sea water (Butts 2004). Solution mining of these ore 

bodies creates a brine that is processed on the surface. Water is pumped into the ore body to dissolve 

these soluble minerals, forming a brine which is pumped to the surface. Most of the patented processes 

for purification and concentration of these brines rely on water and evaporation, without any additional 

NOSB Proposals & Discussion Documents October 2022 136 of 152
chemicals However, because magnesium chloride is soluble in alcohol while potassium chloride is not, 

several patented processes for separating pure magnesium chloride from carnallite employ a low 

molecular weight alcohol, such as methanol, to recover pure magnesium chloride (TR 2016, 291-297). 

Synthesis of magnesium chloride by the reaction of a magnesium compound such as the oxide, hydroxide, 

or carbonate with hydrochloric acid is a chemical process, which involves chemical reaction of an acid and 

an alkali to form a salt. (TR 2016, 340-342). 

GRAS: Magnesium chloride hexahydrate is affirmed by the FDA as Generally Recognized As Safe (GRAS) as a 

food ingredient (21 CFR 184.1426). It is allowed by the FDA as a flavoring agent, adjuvant, nutrient 

supplement, and may be used in infant formula (TR 2016, 94-96). 

Ancillary substances: Magnesium chloride hexahydrate is commercially available as colorless, odorless 

flakes, crystals, granules, or lumps. Both JECFA and FCC require that the material assays at 99% to 105% 

MgCl2·6H2O. Commercial sources contain no additional or ancillary ingredients (e.g., inert ingredients, 

stabilizers, preservatives, carriers, anti-caking agents or other materials) (TR 2016, 110- 113). 

International Acceptance

Canadian General Standards Board Permitted Substances List

Magnesium chloride is a permitted processing substance listed in CAN/CGSB-32.311-2015, Table 6.3, 

“ingredients classified as food additives,” with the annotation, “derived from seawater.”

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

The European Community regulation permits the use of the magnesium chloride (or “nigari”) in processing 

organic foods of plant origin as a coagulation agent (EC No. 889/2008 Annex VIII, Section B – Processing 

Aids).

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

Organically Produced Foods (CXG 32-1999) 

The Codex organic guidelines permit the use of magnesium chloride (INS 511) in food category 06.8, 

soybean products (excluding soybean products of food category 12.9 and fermented soybean products of 

food category 12.10); food category 12.9.1, soybean protein products; and food category 12.10, fermented 

soybean products

International Federation of Organic Agriculture Movements (IFOAM) Norms

The IFOAM Norms, Appendix 4, Table 1, permit the use of magnesium chloride (INS 511) as an additive and 

also as a processing and post-harvest handling aid for soybean products only.

Japan Agricultural Standard (JAS) for Organic Production

Article 4, Table 1, Food Additives permits the use of food additive INS 511, magnesium chloride, and also 

“crude seawater magnesium chloride,” for processed foods of plant origin as a coagulating agent or for 

processed bean products.

Environmental Issues

The historical process of solar evaporation of sea water to obtain salt and additional minerals such as 

magnesium chloride creates saline ponds and infertile soil. Solar salt ponds have been reused for several 

millennia in the Eastern Mediterranean so that the environmental damage is localized. With respect to 

terminal lakes such as the Great Salt Lake, the major environmental threat here is not related to mineral 

extraction operations; it is the reduction of water flow into this terminal lake caused by agricultural and 

other diversions (Wurtsbaugh et al. 2016). Winds blowing over dry lake beds cause dust storms and urban 

NOSB Proposals & Discussion Documents October 2022 137 of 152
pollution. An environmental risk with solution mining is surface subsidence, as the underlying mineral is 

dissolved and removed, effectively creating a cavern. (TR 414-423).

Discussion

Magnesium chloride is currently allowed under the USDA organic regulations at 7 CFR 205.605(a) as a 

nonagricultural nonsynthetic substance for use as an ingredient in or on processed products labeled 

“organic” or “made with organic (specified ingredients or food group(s)).” Magnesium chloride was 

previously listed at §205.605(b) with the annotation “derived from sea water.” However, during the Spring 

2018, the Board put forth a proposal to reclassify magnesium chloride as non-synthetic and to remove the 

annotation “derived from sea water” since there are multiple sources from which non-synthetic magnesium 

chloride can be derived. This proposal passed unanimously, went through the rulemaking process, and 

became effective on November 22, 2019.

During the Spring 2022 meeting, most if not all commenters were in favor of relisting. However, several 

commenters suggested annotating to limit the use to tofu production and dietary supplements. Similar 

comments were made during previous sunset reviews. We didn’t receive direct answers to the questions 

posed for the Spring 2022 meeting, however, based on the comments suggesting an annotation to limit the 

use, it might be inferred that those comments indicate that perhaps the use of color enhancement is not 

consistent with organic principles. The Handling Subcommittee will evaluate this annotation change 

suggestion as a potential work agenda item.

We also didn’t receive comments on our question regarding other substances on the National List (e.g., 

glucono delta-lactone and calcium sulfate) and whether they perform the same or similar function in tofu 

production. The Subcommittee is still interested in this information.

Justification for Vote

Based on this review and public comment submitted during the Spring 2022 meeting, the Handling 

Subcommittee finds magnesium chloride compliant with the Organic Foods Production Act (OFPA) and/or 7 

CFR 205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove magnesium chloride from the National List 

Motion by: Kyla Smith

Seconded by: Allison Johnson

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

NOSB Proposals & Discussion Documents October 2022 138 of 152
Nitrogen

Reference: §205.605(a) Nonsynthetics allowed:

Nitrogen—oil-free grades.

Technical Report: 1995 TAP. 

Petition: N/A

Past NOSB Actions: 4/1995 minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset review; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577)

Sunset Date: 10/30/2024

Subcommittee Review

Use

Nitrogen is used to displace oxygen and thereby reduce oxidation of product during processing, storage, 

and packaging. It can be used in the flash freezing of foods. It also functions as a propellant when used 

under pressure and doesn’t have ozone-depleting properties. 

Manufacture

Nitrogen is a colorless, odorless gas. Cryogenic distillation, where air is compressed, cooled, and then 

filtered, is the most economic and highest purity method for separating nitrogen from air. 

International Acceptance

The use of nitrogen is permitted in organic processing in Canada, CODEX, EU, IFOAM, and Japan.

Canadian General Standards Board Permitted Substances List

The material is allowed in food handling.

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

The material is allowed in food handling.

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

Organically Produced Foods (CXG 32-1999) 

The material is allowed in food handling.

International Federation of Organic Agriculture Movements (IFOAM) Norms

The material is allowed in food handling.

Japan Agricultural Standard (JAS) for Organic Production

The material is allowed in food handling.

Environmental Issues

None. Nitrogen is a naturally occurring inert atmospheric gas.

Discussion

During the spring 2022 meeting, all commenters expressed support in relisting. 

Based on this review and public comment submitted during the spring 2022 meeting, the Handling 

Subcommittee finds nitrogen compliant with OFPA criteria.

NOSB Proposals & Discussion Documents October 2022 139 of 152
Justification for Vote

The Subcommittee finds nitrogen compliant with the Organic Foods Production Act (OFPA) and/or 7 CFR 

205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove nitrogen from the National List 

Motion by: Kyla Smith

Seconded by: Allison Johnson

Yes: 0 No: 5 Abstain: 0 Recuse: 0 Absent: 3 

Sodium carbonate

Reference: §205.605(a) Nonsynthetics allowed:

Sodium carbonate.

Technical Report: 1995 TAP. 

Petition: N/A

Past NOSB Actions: 4/1995 minutes and vote; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset review; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577) 

Sunset Date: 10/30/2024

Subcommittee Review

Use

Sodium carbonate is used as a raising (leavening) agent. Sodium carbonate (also referred to as washing 

soda or soda ash) can also be used as an anti-caking agent, as an acidity regulator, or as a stabilizer, as well 

as a neutralizer for butter, cream, fluid milk, and ice cream. Sodium carbonate is the material used to give

pretzels and lye rolls their brown crust without burning. Sodium carbonate is also used in the processing of

olives prior to canning, in the making of ramen noodles, and in cocoa products.

Manufacture

Sodium carbonate is produced in North America from natural deposits of trona ore (sodium 

sesquicarbonate) that is heated and then mixed with water to dissolve the soda ash and separate out the 

impurities. This solution is then concentrated by evaporation to crystallization. This method is considered to 

be the most sustainable form of producing sodium carbonate. Additionally, in California, sodium carbonate

can be produced from a similar method using natural brine (Searles Lake).

International Acceptance

Sodium carbonate is permitted for use in organic processing in the following International Standards: 

International Federation of Organic Agriculture Movements (IFOAM) Norms, 

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

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

Organically Produced Foods (CXG 32-1999)

NOSB Proposals & Discussion Documents October 2022 140 of 152
Canadian General Standards Board Permitted Substances List or 

Japan Agricultural Standard (JAS) for Organic Production

Ancillary Substances

None

Discussion

Public comments during prior sunset reviews have stated that sodium carbonate is essential for use as a

leavening agent, neutralizer in baked goods, frozen desserts, and soy base extraction. It is also used as a pH 

adjuster in organic laundry detergents. One certifier commented that it is also used to clean fruit and

remove mold. Past public comments have been supportive of sodium carbonate remaining on the National

List. Prior comments have raised concerns about possible hazards during mining and manufacturing and 

requested a technical report to evaluate the synthetic/non synthetic status of this material, essentiality, 

and research potential alternatives.

During the spring 2022 NOSB meeting, most commenters were in favor of relisting of Sodium carbonate as 

this is an important tool for producers. Stakeholders supporting relisting of this material included three 

trade groups, a farmer group, and a manufacturer. One trade group, a material review organization, and 

several certifiers submitted data on the number of users who list this material on their organic system 

plans. This material is essential for organic handling and processing and there are no alternatives available 

that can replace sodium carbonate. Removal of any materials allowed for cleaning can be problematic.

According to the TAP review, sodium carbonate may be produced from mined deposits or by chemical 

reaction (Solvay process). In written submissions for the Spring 2022 NOSB meeting, a certifier commented:

Based on the original 1995 TAP Reviews, the reviewers considered sodium carbonate produced via the 

Trona process to be non-synthetic and that produced via the Solvay process to be synthetic. However, 

based on NOP Guidance 5033-1, it appears that both processes result in a synthetic classification for the 

sodium carbonate. QAI currently permits sodium carbonate produced via the Trona process based on 1995 

TAP Review, but encourages the NOSB to examine the prevalent manufacturing processes to ensure 

appropriate classification and/or annotation. It appears sodium carbonate would be more appropriately 

listed at 205.605(b) with an annotation to only permit forms produced via the Trona process.

The Handling Subcommittee will evaluate this as a future work agenda item.

Questions to our Stakeholders

1. Is this material still essential for organic handling and processing?

2. Are there alternative materials that can replace sodium carbonate?

3. What are the relative environmental impacts of trona mining or brine extraction during 

production of sodium carbonate?

4. Is sodium carbonate produced from trona or brine extraction non-synthetic? 

Justification for Vote

The Subcommittee finds that sodium carbonate continues to be compliant with the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) and is not proposing removal.

NOSB Proposals & Discussion Documents October 2022 141 of 152
Subcommittee Vote:

Motion to remove sodium carbonate from the National List 

Motion by: Dilip Nandwani

Seconded by: Kyla Smith

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

Acidified sodium chlorite

Reference: §205.605(b) Synthetics allowed:

Acidified sodium chlorite—Secondary direct antimicrobial food treatment and indirect food contact 

surface sanitizing. Acidified with citric acid only.

Technical Report: 2008 TAP; 2013 TR (livestock). 

Petition: 2006.

Past NOSB Actions: 2009 recommendation; 10/2015 sunset review; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577) 

Sunset Date: 10/30/2024

Subcommittee Review

Use 

Acidified sodium chlorite (ASC) solution is used as a processing aid in wash and/or rinse water, in 

accordance with the FDA limitation, for direct food contact and indirect food contact: 

• Direct Food Contact (Secondary Direct Food Additive) ─ Poultry carcass, organs, and parts; red meat 

carcass, organs and parts, seafood (finfish and crustaceans), and fruits and vegetables (raw and further 

processed); processed, comminuted, or formed meat products; and 

• Indirect Food Contact ─ Hard surface food contact sanitation.

Manufacture 

ASC solutions are made on-site and on-demand by mixing a solution of sodium chlorite with natural citric 

acid. Sodium chlorite (25%) and citric acid (50%) solutions are stored separately in bulk on site. Both 

solutions are pumped by proportional pumps and a water dilution module to make the final use dilution 

product, which typically contains 0.1% sodium chlorite and 0.6% citric acid and 99.3% water. Sodium 

chlorite is made by the reduction of chlorine dioxide, which is, in turn, from the reduction of sodium 

chlorate in the presence of sulfuric and hydrogen peroxide or sulfuric acid and sodium chloride. The 

resulting solution may be dried to a solid and the sodium chlorite content may be adjusted to about 80% by 

the addition of sodium chloride, sodium sulfate, or sodium carbonate. Sodium chlorite is marketed as a 

solid or an aqueous solution (such as 25% by weight). 

The acid used to acidify sodium chlorite is natural citric acid, which was specified in the [year?] petition. 

However, there was no information in the petition regarding how the natural citric acid was manufactured.

International Acceptance

Canadian General Standards Board Permitted Substances List

Acidified sodium chlorite is not specifically listed.

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

There is no specific listing for acidified sodium chlorite in handling.

NOSB Proposals & Discussion Documents October 2022 142 of 152
CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (CXG 32-1999) 

There is no specific listing for acidified sodium chlorite in handling.

International Federation of Organic Agriculture Movements (IFOAM) Norms

There is no specific listing for acidified sodium chlorite in handling.

Japan Agricultural Standard (JAS) for Organic Production 

Limited to the use for disinfecting meat and poultry at slaughter, or washing eggs. 

Environmental Issues

While the manufacture and use of acidified sodium chlorite solutions have resulted in releases to the 

environment, the risk of environmental contamination from released acidified sodium chlorite is minimal. 

Certain manufacturing facilities have reported releases of chlorine dioxide, a portion of which was 

generated through reaction of chlorite with a strong acid, to air, water, and soil (ATSDR, 2004). Strong acids 

(e.g., hydrochloric acid) and bases (sodium hydroxide) are used in the commercial production of sodium 

chlorite, and their release due to improper handling/disposal could lead to serious environmental 

impairments. Likewise, the release of strong oxidizing agents in large quantities may lead to ecotoxicity in 

both terrestrial and aquatic environments. This is true of both the chemical feedstocks (e.g., hydrogen 

peroxide) used in the manufacture of acidified sodium chlorite precursors and the chemicals in acidified 

sodium chlorite solutions (i.e., chlorous acid, chlorine dioxide, chlorite). Regarding the former, several lower 

reactivity sulfur-containing and carbonaceous substances have been evaluated for the conversion of 

chlorine dioxide to sodium chlorite.

The acid used to acidify sodium chlorite is natural citric acid. The petitioner did not provide information 

about how natural citric acid is manufactured. 

Discussion

In the 2017 sunset review, public comment regarding acidified sodium chlorite was mixed. Those in favor 

stated that this is an essential tool in the fight against food borne pathogens. Those opposed to relisting 

stated that the NOSB should do a comprehensive review of sanitizers. The NOSB believes a review of 

sanitizers is beyond the scope of the sunset review process. 

In the 2022 sunset review, there were few comments on this material. A couple of commenters reminded 

the NOSB about the need for an overall review of sanitizers as a class, but no specific objections were raised 

regarding this product. Use of acidified sodium chlorite is not widespread, and delisting was not 

recommended by any commenters.

Justification for Vote

The Subcommittee finds acidified sodium chlorite (ASC) compliant with the Organic Foods Production Act 

(OFPA) and/or 7 CFR 205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove acidified sodium chlorite (ASC) from the National List.

Motion by: Carolyn Dimitri

Seconded by: Kyla Smith

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

NOSB Proposals & Discussion Documents October 2022 143 of 152
Carbon dioxide

Reference: §205.605(b) Synthetics allowed:

Carbon dioxide.

Technical Report: 1995 TAP; 2006 TAP. 

Petition: 2005.

Past NOSB Actions: 10/1995 minutes and vote; 2007 recommendation; 11/2005 sunset recommendation; 

10/2010 sunset recommendation; 10/2015 sunset review; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577)

Sunset Date: 10/30/2024

Subcommittee Review

Use

Carbon dioxide is used in modified atmosphere packaging, modified atmospheric storage, the freezing of 

foods, beverage carbonation, as an extracting agent, and for pest control in grain and produce storage. 

Manufacture

Carbon dioxide is available in limited supplies from underground wells and as a byproduct of various 

manufacturing processes. All of the processes require purification of carbon dioxide before being used in 

food processing and handling. 

International Acceptance

Canadian General Standards Board Permitted Substances List

Carbonation of wine or mead is prohibited. Carbon dioxide is allowed for controlled atmosphere storage 

and for pest control during storage. 

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

Carbon dioxide is listed as an allowable processing aid for ingredients of agricultural origin from organic 

production. 

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

Organically Produced Foods (CXG 32-1999) 

Carbon dioxide is allowed for use as a pest control method in storage facilities and as a processing aid.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Carbon dioxide is approved as a processing and post-harvest handling aid (for flavoring agents, e.g.). It is 

also approved as an additive.

Japan Agricultural Standard (JAS) for Organic Production 

Carbon dioxide is approved for use a fumigant in storage facilities.

Environmental Issues

According to the 2006 TAP report, the production of carbon dioxide is a byproduct of environmentally 

damaging processes via air pollution, solid waste streams, and drilling underground wells.

Carbon dioxide is a greenhouse gas and its use in organic food production means there may be a delayed 

release to the atmosphere in some cases.

NOSB Proposals & Discussion Documents October 2022 144 of 152
Discussion

Carbon dioxide is on the FDA list of generally recognized as safe (GRAS) products. The EPA allows carbon 

dioxide for use as a fumigant, insecticide, and rodenticide.

In the previous [year?] sunset review, there was no substantive discussion about this material. No public 

comment supported delisting carbon dioxide. There was support for its continued use by food 

manufacturers and associations. 

Response to the questions posed to stakeholders

Questions posed: Is the substance essential for organic food production? Since the material was last 

reviewed, have additional commercially available alternatives emerged? 

Response summary: In the comments for the April 2022 meeting, only a few comments were made on this 

material. The commenters indicated that carbon dioxide is essential for organic handling and there were no 

available organic alternatives. Loss of this product would be problematic for those using it.

Justification for Vote

The Subcommittee finds carbon dioxide compliant with the Organic Foods Production Act (OFPA) and/or 7 

CFR 205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove carbon dioxide from the National List

Motion by: Carolyn Dimitri

Seconded by: Kim Huseman

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

Sodium phosphates

Reference: §205.605(b) Synthetics allowed:

Sodium phosphates—for use only in dairy foods.

Technical Report: 2001 TAP; 2016 TR (phosphates). 

Petition: 2001.

Past NOSB Actions: 10/1995 minutes and vote; 10/2001 minutes and vote; 11/2005 sunset 

recommendation; 10/2010 sunset recommendation; 10/2015 sunset review; 11/2017 sunset 

recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577)

Sunset Date: 10/30/2024

Subcommittee Review

Use

Sodium phosphates are salts used as pH control agents and buffers, acidulants, sequestrants, texturizers, 

and nutrients in organic dairy products. They act as stabilizers in milk and as emulsifiers in cheese. Disodium 

phosphate can be used as a processing agent in heavy whipping cream, where it binds to milk minerals to 

prevent the milk from coating the equipment during processing. Sodium phosphates are used in some 

organic milk products, such as half-and-half and heavy whipping cream, to stabilize the milk protein and to 

ensure the products do not separate or lose protein prior to consumer use.

NOSB Proposals & Discussion Documents October 2022 145 of 152
Sodium phosphates are generally recognized as safe (GRAS) across multiple regulatory entities.

Manufacture

Finely ground, mined phosphate rock is mixed with sulfuric acid to form phosphoric acid. It is then reacted 

with sodium hydroxide to form sodium phosphate. There is a purification step in each reaction to remove

substances like arsenic and fluorine.

International Acceptance

Canadian General Standards Board Permitted Substances List

Permitted for dairy use only. 

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

Not listed.

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

Organically Produced Foods (CXG 32-1999)

Not listed.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Not listed.

Japan Agricultural Standard (JAS) for Organic Production

Not listed.

Environmental Issues

Phosphates, including sodium phosphates, can pollute water bodies and lead to eutrophication and there 

have been global efforts to remove phosphates from detergents. That said, there is no widespread concern 

about adverse impacts of these substances in food uses (specifically dairy) on the environment. 

Also, since sodium phosphates derive from the mining of phosphate rock, there are environmental impacts 

associated with the manufacture. 

Discussion

Public comment regarding sodium phosphates has historically been mixed. During the previous sunset 

review, stakeholders in support of the material’s use in organics stated that sodium phosphate is essential 

in organic cheese products, including liquid and powdered forms, specifically as an emulsifier and stabilizer 

for shelf-stable cheese products. Opposing stakeholders have expressed concern about potential human 

health impacts (the 2016 technical report was inconclusive) and material essentiality. Prior subcommittee 

review concluded that since there are four phosphates on the National List at § 205.605(b), no single 

phosphate food additive or ingredient can be implicated for inordinate and isolated risk. Some studies have 

indicated that high levels of phosphate consumption can accelerate aging and vascular damage, although 

sodium phosphate itself also has use among athletes for performance enhancement.

Comments from stakeholders in written and verbal form at the Spring 2022 NOSB meeting were limited and 

did not advance a strong position in favor of removal from the National List. While the Handling 

Subcommittee is reiterating its stakeholder questions for the coming meeting, it does not expect to 

recommend removal of sodium phosphates at this time.

NOSB Proposals & Discussion Documents October 2022 146 of 152
Questions to our Stakeholders

1. How essential are sodium phosphates to your operations or the operations of your stakeholders? Are 

there other natural substances or synthetic substances on the National List that could perform the 

same essential functions as sodium phosphates?

2. Do you have any new and compelling evidence that demonstrates health impacts from sodium 

phosphates are significant?

Justification for Vote

The Subcommittee finds sodium phosphates compliant with the Organic Foods Production Act (OFPA) 

and/or 7 CFR 205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove sodium phosphates from the National List 

Motion by: Wood Turner

Seconded by: Kim Huseman

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

Casings

Reference: §205.606(b) Casings, from processed intestines.

Technical Report: N/A

Petition: 2006

Past NOSB Actions: 4/2007 recommendation; 10/2010 sunset recommendation; 10/2015 sunset review.

Recent Regulatory Background: Added to National List on 06/21/2007 (72 FR 35137); Sunset renewal 

notice 03/21/2017 (82 FR 14420); Sunset renewal notice effective 10/30/2019 (84 FR 53577)

Sunset Date: 10/30/2024

Subcommittee Review

Use

The intestines of beef, lamb, and pork are used to make natural casings for sausage. The alternative 

material for casings is synthetic cellulose or synthetic collagen.

Casings have not received a Generally Recognized as Safe (GRAS) status, according to the 2019 Technical 

Report (TR).

Manufacture

Intestines are washed in pure water with no chemicals, and salted using sodium chloride (NaCl) and water. 

No other ingredients or processing aids are used. Animal intestines may be from organic or nonorganic 

animals as slaughterhouses do not separate certified organic and non-organic offal.

International Standards

Canadian General Standards Board Permitted Substances List

Collagen casings are allowed for poultry sausages

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

Allowed

NOSB Proposals & Discussion Documents October 2022 147 of 152
Environmental Issues

There are no published reports of heavy metals and other contaminants present in formulations of collagen 

gel and casings. According to the TR, there are no published studies on environmental impacts of casings, 

but “the manufacture of collagen may result in reductions to livestock and fish wastes”.

Discussion

Since 2007, all sunset reviews of this material have considered limitations on the availability of casings 

produced from organically raised livestock and agreed that the current listing is appropriate. Echoing earlier 

comments, commenters at the Spring 2017 meeting raised concerns about the limited availability of 

organically produced casing material. Comments were in favor of retaining use of non-organically produced 

casings as an option for production of organic sausage meat. Concerns were raised about the need to 

incentivize production of organic casings but that was viewed as a long-term effort.

In Spring 2022, there was strong public support for the continued use of casings, with a few areas 

suggested for discussion. One group noted that non-organic casings rely on chemically intensive livestock 

production, which in turn relies on chemically intensive corn and soy production. This comment specifically 

asked NOSB (via TR process) to identify the barriers to organic casing production. Another group requested 

a work agenda item and a discussion document on the topic of organic casing; reasoning that if organic 

meat is being slaughtered, then organic casings exist and should be required. One certifier reflected that 

most organic sausage makers use cellulose as an alternative, but this does not meet consumer 

expectations.

Barriers to organic production of casing were well documented in one producer’s comments. The extensive 

description included an overview of the scale of animal processing and the necessary infrastructure 

developments that would need to occur for intestines from organic hogs to be segregated at that stage of 

processing. Additionally, the producer’s comments described the need for industrial infrastructure 

development that would have to occur in the final stages of processing to produce an organic casing.

Justification for Vote

The Subcommittee finds casings compliant with the Organic Foods Production Act (OFPA) and/or 7 CFR 

205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove casings from the National List 

Motion by: Mindee Jeffery

Seconded by: Kyla Smith

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

Pectin

Reference: 205.606(o) Pectin (non-amidated forms only).

Technical Report: 1995 TAP; 2009 TR; 2010 TR (supplemental); 2015 Limited Scope TR. 

Petition: 2005 (low methoxy).

Past NOSB Actions: 4/1995 minutes and vote; 11/2005 sunset recommendation; 10/2010 

recommendation; 10/2015 sunset review; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420). Sunset renewal 

notice effective 10/30/2019 (84 FR 53577)

Sunset date: 10/30/2024

NOSB Proposals & Discussion Documents October 2022 148 of 152
Subcommittee Review

Use

Pectin is extracted from citrus and pome fruits but so far there is limited organic supply of extracted pectin. 

It is used as a gelling agent in jams, preserves, fillings and other products. It is a desirable ingredient in 

organic food because it allows food to gel with less sugar than would be used without it. Excess sugar has 

the potential for more negative human health effects than pectin.

Manufacture

The most common production of non-amidated pectin is by treatment of pectin-containing byproducts 

(pome fruit cores, citrus peels) with acidified water. Insoluble materials are filtered and removed, and the 

pectin is precipitated out with alcohol.

International Standards

Canadian General Standards Board Permitted Substances List

Compliant with the Canadian organic standards (both high and low methoxy allowed)

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

Pectin allowed in all products but meat-based products

Japan Agricultural Standard (JAS) for Organic Production

Pectin allowed in all products but meat-based products

International Federation of Organic Agriculture Movements (IFOAM).

Unmodified forms only

Environmental Issues

According to the most recent Technical Report (TR), the FDA “suggest that the petitioned substance is not 

harmful to human health or the environment. Since the manufacture of pectin is a by-product of the fruit 

juice industry, its production therefore serves to reduce the waste streams generated from the making of 

fruit juices.”

Ancillary Substances

Ancillary substances used in pectin as stabilizers/standardizing agents include sugar (and dextrose), and 

buffering agents trisodium citrate (or other salt buffers described in the 2015 TR).

Discussion

During the Spring 2022 sunset review, public comments submitted by organic manufacturers, trade 

associations, material suppliers and certifiers detailed pectin’s extensive use and necessity in organic 

production. One commenter emphasized that pectin is routinely used as a stabilizer, a thickener and a 

gelling agent, and that organic alternatives are not available or do not function at the same quality. 

Comments from a trade association representing the pectin industry spoke to constraints in 

commercializing organic pectin due to commingled raw materials and the limited availability and 

functionality of organic pectin. Another commenter noted that pectin is essential to low sugar jams and 

there are no alternatives for that specific function at this time. A comment from an interest group stated 

pectin should be limited to high methoxyl pectin (HMP), extracted from citrus peel and apple pomace.

Overall, there is strong public support for the continued use of pectin. Previous Board discussion noted the 

desire for the development of greater supplies of organic pectin and noted the lack of commercial 

NOSB Proposals & Discussion Documents October 2022 149 of 152
availability.

Justification for Vote

The Subcommittee finds pectin compliant with the Organic Foods Production Act (OFPA) and/or 7 CFR 

205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove pectin from the National List 

Motion by: Mindee Jeffery

Seconded by: Kyla Smith

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

Potassium acid tartrate

Reference: §205.606(p) Potassium acid tartrate.

Technical Report: 1995 TAP; 2017 TR. 

Petition: N/A

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

recommendation; 10/2015 sunset review; 11/2017 sunset recommendation.

Recent Regulatory Background: Sunset renewal notice effective 3/15/2017 (82 FR 14420); Classification 

changed from non-agricultural to agricultural 5/30/2019 (84 FR 18133). 

Sunset Date: 5/30/2024

Subcommittee Review

Use

Potassium acid tartrate is a by-product of wine making. It is commonly known as Cream of Tartar. It is used 

in baked goods, a component of baking powder, for stabilizing egg whites or other food uses, pH control, 

and as an antimicrobial agent (TR 2017). A detailed discussion of the historical documents relevant to 

potassium acid tartrate is provided in the 2017 TR.

Potassium acid tartrate was previously allowed under the National Organic Program (NOP) regulations at 7 

CFR 205.605(b) as a “nonagricultural, synthetic substance for use as an ingredient in or on processed 

products labeled “organic” or “made with organic (specified ingredients or food group(s)).” However, 

during the 2017 sunset review, a number of commenters noted that it should be listed at § 205.606 as a 

non-organically produced agricultural substance. The NOSB agreed with this assessment and passed a 

recommendation for the change of listing. That recommendation underwent subsequent rulemaking and 

potassium acid tartrate is now listed under § 205.606.

Manufacture

During the winemaking process, sediments form that must be removed to produce a clear wine. “Lees” is 

the name of the sediment consisting of dead yeast cells, grape pulp, seed, and other grape matter that 

accumulates during fermentation. “Argol” and “tartar” are synonyms used to describe the crust that builds 

up in wine vats and casks. Argol is defined as crude potassium hydrogen tartrate, deposited as a crust on 

the sides of wine vats. Tartar is defined as a substance consisting essentially of cream of tartar that is 

derived from the juice of grapes and deposited in wine casks together with yeast and other suspended 

matter as a pale or dark reddish crust or sediment. Tartar consists of about 80% potassium acid tartrate. 

Potassium acid tartrate is only slightly soluble in cold water but highly soluble in hot water (6.1g/100 mL at 

100°C). Extracting wine lees with hot water dissolves the potassium acid tartrate. When the filtered 

NOSB Proposals & Discussion Documents October 2022 150 of 152
extraction solution is cooled, potassium acid tartrate precipitates as very pure crystals (>99.5% pure). No 

other reagents or solvents are involved in the extraction (TR 2017, 58-69).

Potassium acid tartrate is Generally Recognized as Safe (GRAS) (TR 2017, 350).

Ancillary Substances

There are no ancillary substances associated with potassium acid tartrate.

International Use

According to the 2017 TR, international guidance and regulations include use of potassium acid tartrate 

(INS 336i) in organic processing and are generally consistent with the limited uses described by FDA at 21 

CFR 184.1077(c). The European-focused regulations and guidance – CODEX, IFOAM and the EU – also 

include dipotassium tartrate (INS 336ii) as an allowed potassium tartrate.

Canadian General Standards Board Permitted Substances List

Potassium acid tartrate (KC4H5O6) is a permitted processing substance listed in Table 6.3, ingredients 

classified as food additives, with the following annotation: “If the non-synthetic form is not commercially 

available, the synthetic form is permitted.”

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

Consistent with the Codex guidelines, the European Community regulation permits the use of the 

potassium tartrates (i.e., both potassium acid tartrate E 336i and dipotassium tartrate E 336ii) in processing 

organic foods of plant origin (EC No. 889/2008 Annex VIII, Section A Food Additives).

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

Marketing of Organically Produced Foods (CXG 32-1999)

The Codex organic guidelines permit the use of potassium acid tartrate (INS 336i) and dipotassium tartrate 

(INS 336ii) in plant foods, specifically confectionary, flours and starches, and cakes, but not in animal foods.

International Federation of Organic Agriculture Movements (IFOAM) Norms

The IFOAM Norms, Appendix 4, Table 1, permit the use of INS 336 (i.e., both potassium acid tartrate E 336i 

and dipotassium tartrate E 336ii) as an additive and as a processing and post-harvest handling aid, without 

limitation.

Japan Agricultural Standard (JAS) for Organic Production

Article 4, Table 1, Food Additives permits the food additive INS 336i, potassium acid tartrate, for limited use 

for grain processed foods or confectionary only.

Environmental Issues

Since potassium acid tartrate is a byproduct of the winemaking process, the environmental issues are 

limited to those associated with the production of conventional grapes. There are increasing quantities of 

organically produced grapes and wines available. 

Discussion

Public commenters confirmed that potassium acid tartrate is currently used as a pH adjuster in winemaking 

and in baked goods. Commenters largely supported relisting of this substance during the public sunset 

review process in 2022. One commenter supported removal because nonorganic potassium acid tartrate is 

a product of chemical-intensive agriculture. 

No commenters identified any organic potassium acid tartrate in production or use or commented on its 

commercial availability. The labeling requirements for wine produced with organic grapes are likely to 

remain a barrier to commercial availability of organic potassium acid tartrate; production of “organic” wine 

NOSB Proposals & Discussion Documents October 2022 151 of 152
(as opposed to wine “made with organic grapes”) remains relatively limited, and only potassium acid 

tartrate produced from “organic” wine production could be sold as organic potassium acid tartrate. 

Questions to our Stakeholders

1. Is there currently any organic potassium acid tartrate on the market? If so, is it in sufficient 

quantities for commercial uses? 

Justification for Vote

The Subcommittee finds that potassium acid tartrate continues to be compliant with the Organic Foods 

Production Act (OFPA) and/or 7 CFR 205.600(b) and is not proposing removal.

Subcommittee Vote

Motion to remove potassium acid tartrate from the National List 

Motion by: Allison Johnson

Seconded by: Kyla Smith

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

NOSB Proposals & Discussion Documents October 2022 152 of 152