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

Sunset 2026

Meeting 1 - Request for Public Comment

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

April 2024

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 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, annotation, references to past technical reports, past NOSB actions, and 

regulatory history, as applicable. If a new technical report has been requested for a substance, it is noted in 

this list. Substances included in this document may also be viewed in the NOP’s Petitioned Substances 

Index. 

Request for Comments

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

2024 public meeting, the NOP requests that the public provide comments about these substances to the 

NOSB as part of the Spring 2024 public meeting. Written comments should be submitted via 

Regulations.gov at www.regulations.gov on or before April 3, 2024, as explained in the meeting notice 

published in the Federal Register.

Public 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 Substances in Organic Production at § 205.605(a), §

205.605(b), and/or § 205.606:

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 Substances in Organic Production at § 

205.605(a), § 205.605(b), and/or § 205.606:

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 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 201 of 267
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.

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. 

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. 

For Comments on Nonorganic Agricultural Substances at § 205.606: 

For nonorganic agricultural substances at § 205.606, the NOSB Handling Subcommittee requests current 

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

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

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

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

alternative substances that the NOSB did not previously consider.

Written public comments will be accepted through April 3, 2024 via www.regulations.gov. Comments 

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

§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)).’’:

Acids - Citric

Acids - Lactic

Calcium chloride

Enzymes

L-Malic acid

Magnesium sulfate

Microorganisms

Perlite

Potassium iodide

Pullulan

Yeast

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 202 of 267
§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)).’’:

Activated charcoal

Ascorbic acid

Calcium citrate

Collagen gel

Ferrous sulfate

Hydrogen peroxide

Nutrient vitamins and minerals

Peracetic acid/Peroxyacetic acid

Potassium citrate

Potassium phosphate

Sodium acid pyrophosphate

Sodium citrate

Tocopherols

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

processed products labeled as “organic.”:

Celery powder

Fish oil

Gelatin

Orange pulp, dried

Seaweed, Pacific kombu

Wakame seaweed (Undaria pinnatifida)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 203 of 267
Acids – Citric

Reference: § 205.605(a) Nonsynthetics allowed

(1) Acids (Citric – produced by microbial fermentation of carbohydrate substances; and Lactic).

Technical Report: 1995 TAP - Citric; 2015 TR - Citric; 1995 TAP - Lactic; 2015 TR - Lactic; 2023 Limited Scope 

TR pending

Petition(s): N/A

Past NOSB Actions: 04/1995 recommendation; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Citric acid is widely used in food processing. It is used as an ingredient, acidulant, pH control agent, 

flavoring, and as a sequestrant. It is used as a dispersant in flavor or color additives. It is also an ingredient 

in dietary supplements and a nutrient, sequestrant, buffer, antioxidant, firming agent, acidity regulator (in 

jams and jellies, soft drinks and wines), raising agent, and emulsifying salt for many other products. It is also 

used to improve baking properties of flours, and as a stabilizer, and to inhibit color and flavor deterioration 

in fruits. Roughly 75% of all citric acid commercially produced is used by the food industry including baby 

food, breakfast cereals, frozen desserts, frozen entrees and certified organic personal care products. The 

remainder is used in cleaning agents, or in the cosmetics and pharmaceutical industries.

Manufacture

First isolated from lemons, it was extracted from lemons and limes until 1919 when production shifted to 

fermentation (a biological process by which sugars are metabolized to acids, gases, and/or alcohol). Today, 

the mold Aspergillus niger is cultured with low pH values and high levels of sugars and mineral salts to 

economically produce high yields through fermentation. Various chemical synthesis of citric acid appeared 

but none have reached the economics derived from the fermentation process. The fermentation process 

has been refined over the years to produce high levels of citric acid instead of high levels of the by-product 

oxalic acid. Some public commenters expressed a concern that the fermentation process involves the use of 

synthetic chemical reactions that were not considered in the original 1995 classification.

NOSB requested a limited scope TR for citric acid in preparation for this sunset review. The limited scope 

TR focused on the microorganisms used in the fermentation process to manufacture citric acid and what 

potential there is for these microorganisms to have been produced through excluded methods as defined 

by the NOP regulations. Based on available information, most citric acid manufacturers use wild type 

fungal strains or strains that are products of classical induced mutagenesis. The use of microorganisms 

developed using excluded methods appears to remain at an experimental phase and is not commercially 

available. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed in feed. Preference should be given to bacterial or enzymatic additives derived from bacteria, 

fungi, plants, and food by-products (such as molasses and whey). The following acids may be used: lactic, 

propionic, and formic. (Table 5.2, Hay or silage preservation products listing, CAN/CGSB-32.311-2020 page 

24)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 204 of 267
Allowed as food additives. (Table 6.3, CAN/CGSB-32.311-2020, page 30)

Allowed as processing aids from fruit and vegetable products or produced by microbial fermentation of 

carbohydrate substances. (Table 6.5, Citric acid listing, CAN/CGSB-32.311-2020, page 38)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Citric acid is allowed in plant & animal products as a processing aid. Lactic acid is allowed in the brine of 

cheese products (Annex V, Part A, Section A2, 2021/1165)

Both lactic and citric acids are allowed in animal and plant products as additives. (Annex V, Part A, Section 

A1, 2021/1165)

Both lactic and citric acids are allowed for the regulation of pH in primary yeast production. (Annex V, Part 

C, 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Citric acid is allowed in the following foods of plant origin: Fruits and vegetables (including mushrooms and 

fungi, roots and tubers, pulses and legumes, and aloe vera, seaweeds, and nuts and seeds). 

Citric acid is allowed in the following foods of animal origin: fats and oils essentially free from water, egg 

and egg products, and as a coagulation agent for specific cheese products and for cooked eggs. (Table 3 - 

page 24) 

Lactic acid is allowed in the following foods of plant origin: Fermented vegetables (including mushrooms 

and fungi, roots and tubers, pulses and legumes and aloe vera) and seaweed products. Not allowed in 

fermented soybean products.

Allowed in the following foods of animal origin: Dairy products and analogues. Not allowed in edible 

casings. (Table 3 - page 24) 

International Federation of Organic Agriculture Movements (IFOAM)

The IFOAM NORMS for Organic Production and Processing allow citric acid as an additive and a processing 

and post-harvest handling aid in Appendix 4, Table 1.

Citric acid is allowed in equipment cleaners and disinfectants (Appendix 4, Table 2).

Japan Agricultural Standard (JAS) for Organic Production

Allowed as an additive. Limited to the use as a pH control agent or in processed vegetable products or 

processed fruit products. (Appended Table 1)

Ancillary Substances

Citric acid is commercially supplied as a pure compound and otherwise does not contain ancillary 

substances.

Human Health and Environmental Issues

Although it is a weak acid, exposure to pure citric acid may cause coughing, shortness of breath, and skin 

irritation. The fermentation process does produce by-products including oxalic acid. Citric acid will degrade 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 205 of 267
to produce non-toxic and non-persistent environmental products. The potential health hazard of citric acid 

is moderate based on systemic toxicity (EPA 2007). EPA listed citric acid as List 4A (minimal risk inert) in 

their 2004 list and currently list citric acid at 40 CFR 180.950(e) as a tolerance exempt inert ingredient.

Discussion 

Citric acid remains an essential ingredient for organic food processors, and NOSB does not have any new 

information to suggest that citric acid should be removed from the National List at 7 CFR 205.605(a). NOSB 

requested a limited scope TR to evaluate the potential for microorganisms used in the fermentation 

process of citric acid manufacturing to be products of excluded methods. The TR indicated that the use of 

genetically modified microorganisms remains only in experimental phase in the production of citric acid, 

and it listed numerous suppliers of citric acid that utilize either wild type fungal strains or strains that are 

the product of classical induced mutagenesis. This indicates that there is ample supply of citric acid that 

complies with the prohibition on excluded methods in organic food.

Questions to our Stakeholders

There are now numerous suppliers of certified organic citric acid. Should NOSB consider recommending 

the addition of an annotation to citric acid requiring processors to use an organic version of citric acid when 

commercially available?

Acids – Lactic

Reference: § 205.605(a) Nonsynthetics allowed

(1) Acids (Citric – produced by microbial fermentation of carbohydrate substances; and Lactic).

Technical Report: 1995 TAP - Citric; 2015 TR - Citric; 1995 TAP – Lactic; 2015 TR - Lactic; 2023 Limited 

Scope TR pending

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Lactic acid is widely used in almost every segment of the food industry, where it carries out a wide range of 

functions. The major use of lactic acid is in food and food-related applications, which in the U.S. accounts 

for approximately 85% of the demand. It is found naturally in milk, meat, and beer but is normally 

associated with sour milk. Lactic acid controls the growth of bacteria including listeria (NOSB Fall Meeting 

Transcript 2015 pp. 263). The other uses are non-food industrial applications. Lactic acid occurs naturally in 

many food products. It has been in use as an acidulant and pH regulator for many years. It regulates 

microflora in food and has been found to be very effective against certain types of microorganisms, giving it 

pronounced efficacy as a preservative (Vijayakumar, Aravindan and Viruthagiri 2008). Other uses include 

mixing with sodium, potassium, and distilled water to form intravenous fluids commonly used after blood 

loss. It is sometimes used in the pharmaceutical industry to adjust acidity. Lactic acid appears on the 

National List, 7 CFR Part 205.605(a), as a non-synthetic material without further annotation. 

Common uses include, but are not limited to: 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 206 of 267
1. In sugar confectionery, it is used in a continuous production line for high boiled sweets to make 

perfectly clear sweets with minimum sugar inversion and with no air trapped. 

2. In bakery products it is used for direct acidification of bread. 

3. It increases butter stability and volume. 

4. It produces a mild and pleasant taste in acid pickles, relishes and salad dressings. 

5. Lactic acid suppresses Coliform and NOSB Mesentericur groups of bacteria. 

6. Lactic acid can be used as a meat carcass “wash” or in meat products to reduce microbial 

contamination. 

7. It is used in jams, jellies, and frozen fruit desserts. 

8. In dairy products such as cottage cheese, the addition of lactic acid is preferred by some 

manufacturers to fermentation. 

9. Used in imitation dairy products such as non-dairy cheese and non-dairy yogurt powder. 

10. Lactic acid is widely used in preserving fruits, for example helping to maintain firmness of apple 

slices during processing. It also inhibits discoloration of fruits and some vegetables. 

11. Buffered lactic acid improves the taste and flavor of many beverages, such as soft drinks, mineral 

water and carbonated fruit juices. 

12. In breweries, lactic acid is used for pre-adjustments during the mashing process and during cooking. 

13. Acidification of lager beer with lactic acid improves the microbial stability as well as flavor. 

13. It is used in processing of meal in sauces for canned fish, to improve the taste and flavors and to 

mask amine flavor from fish meal. 

14. Lactic acid is used for flavor development and the control of microorganisms in soy cheese.

Manufacture

First isolated in 1780 from sour milk, lactic acid can be produced both naturally and synthetically. It can be 

produced in either a solid, water-soluble state, or a colorless liquid state. Lactic acid is produced on an 

industrial scale through carbohydrate fermentation performed by lactic acid bacteria converting simple 

carbohydrates such as glucose, sucrose, or galactose to lactic acid. A secondary manufacturing process 

involves chemical synthesis of adding hydrogen cyanide to acetaldehyde, an organic chemical compound 

found in coffee, bread, ripe fruit, coal, or crude oil. This process only exists today in Japan. There is also a 

group of microbes known broadly as Lactic Acid Bacteria which produce lactic acid as a result of 

carbohydrate fermentation.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed in feed. Preference should be given to bacterial or enzymatic additives derived from bacteria, 

fungi, plants, and food by-products (such as molasses and whey). The following acids may be used: lactic, 

propionic, and formic. (Table 5.2, Hay or silage preservation products listing, CAN/CGSB-32.311-2020 page 

24)

Allowed as food additives. (Table 6.3, CAN/CGSB-32.311-2020, page 30)

Allowed as processing aids from fruit and vegetable products or produced by microbial fermentation of 

carbohydrate substances. (Table 6.5, Citric acid listing, CAN/CGSB-32.311-2020, page 38)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Citric acid is allowed in plant & animal products as a processing aid. Lactic acid is allowed in the brine of 

cheese products (Annex V, Part A, Section A2, 2021/1165)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 207 of 267
Both lactic and citric acids are allowed in animal and plant products as additives. (Annex V, Part A, Section 

A1, 2021/1165)

Both lactic and citric acids are allowed for the regulation of pH in primary yeast production. (Annex V, Part 

C, 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Citric acid is allowed in the following foods of plant origin: Fruits and vegetables (including mushrooms and 

fungi, roots and tubers, pulses and legumes, and aloe vera, seaweeds, and nuts and seeds). 

Citric acid is allowed in the following foods of animal origin: fats and oils essentially free from water, egg 

and egg products, and as a coagulation agent for specific cheese products and for cooked eggs. (Table 3 - 

page 24) 

Lactic acid is allowed in the following foods of plant origin: Fermented vegetables (including mushrooms 

and fungi, roots and tubers, pulses and legumes and aloe vera) and seaweed products. Not allowed in 

fermented soybean products.

Allowed in the following foods of animal origin: Dairy products and analogues. Not allowed in edible 

casings. (Table 3 - page 24) 

International Federation of Organic Agriculture Movements (IFOAM)

The IFOAM NORMS for Organic Production and Processing allow citric acid as an additive and a processing 

and post-harvest handling aid in Appendix 4, Table 1.

Citric acid is allowed in equipment cleaners and disinfectants (Appendix 4, Table 2).

Japan Agricultural Standard (JAS) for Organic Production

Allowed as an additive. Limited to the use as a pH control agent or in processed vegetable products or 

processed fruit products. (Appended Table 1)

Ancillary Substances

None

Human Health and Environmental Issues

The fermentation process produces calcium sulfate waste (sometimes sold as fertilizer), but it is not known 

to create any negative environmental impacts.

Discussion 

Lactic acid is a “Direct Food Substance Affirmed as Generally Recognized as Safe,” or GRAS, as an 

antimicrobial agent, curing and pickling agent, flavor enhancer, flavoring agent and adjuvant, pH control 

agent, and as a solvent and vehicle, with no limitation other than current good manufacturing practice 

according to FDA regulations at 21 CFR 184.1061. 

Lactic acid is one of the most widely distributed acids and preservatives in nature. It is produced naturally 

by humans, animals, and microorganisms. Lactic acid is an acidulate that is a natural organic acid present in 

milk, meat and beer, but is normally associated with sour milk. It occurs naturally in two isomers (D) and (L). 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 208 of 267
(D) is harmful to humans so (L) is the preferred isomer for food and pharmaceuticals. It functions as a flavor 

agent, preservative and acidity adjuster in foods. 

There is no known organic alternative to lactic acid.

Questions to our Stakeholders

None

Calcium chloride

Reference: § 205.605(a) Nonsynthetics allowed

(7) Calcium chloride.

Technical Report: 1995 TAP, 2023 TR (pending)

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Used in a wide variety of food processing applications including the following as listed in the Table 3 in the 

2023 draft TR:

• Firming agent (fish, mushrooms, processed whole and cut vegetables)

• Flavor enhancer (beer, canned breadnut seeds, cucumber pickles, processed meat products)

• Nutrient supplement (dairy products, nutrition beverages, tofu)

• pH control agent (beer)

• Processing aid (bakery products, beer, cheese, tofu)

• Stabilizer and thickener (fruit jams and jellies)

• Synergist in combination with sodium alginate (dressings, fruit snacks, sauces, soups)

• Tenderizer/texturizer (beef, chicken, goose, lamb, rabbit)

Manufacture

According to the 2023 draft TR, calcium chloride can be produced from three different sources/processes:

• From natural brines

• Reaction of calcium hydroxide with ammonium chloride (Solvay ammonia-soda process)

• Reaction of hydrochloric acid with calcium carbonate

The TR also mentioned a fourth method claimed by TETRA Technologies, as a byproduct of the 

manufacturing of magnesium oxide. The TR authors couldn’t find details on this process or mention of it 

elsewhere. [2023 TR 487-494]

 

Calcium chloride derived from brines are nonsynthetic in many cases. However sometimes depending on 

the brine process, classification becomes more complicated. The starting material is a natural brine solution 

that is pumped out from underground salt beds and calcium chloride is what is left when other materials 

are extracted from the brine. When calcium chloride uses evaporation for the extraction, it is effectively 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 209 of 267
unchanged (more concentrated and some ions are removed). This process is nonsynthetic. However, 

sometimes other chemicals are added such as calcium hydroxide or slaked dolime. These substances are 

processing aids added to remove other substances and they may leave residues of calcium and chloride in 

the final calcium chloride product and would be indistinguishable from their natural counterparts. [2023 TR 

496-628]

Calcium chloride may also be commercially obtained as a byproduct in the ammonia-soda (Solvay) process 

(synthetic). Soda ash can also be produced in other ways, such as through the chlor-alkali process or by 

utilizing an ore called “trona”. According to the TR, trona is rare in the EU, so almost all of the soda ash 

produced in the EU utilizes the Solvay process. However, trona is plentiful in the US and since that process 

is cheaper, very little soda ash is produced from the Solvay process in the US. Therefore, when calcium 

chloride is sourced from the US, the likelihood that it is processed using the Solvay process is quite low. 

[2023 TR 630-676]

Lastly, calcium carbonate can be produced from the reaction of hydrochloric acid with calcium carbonate, 

which is a process that renders the calcium chloride synthetic. However, the TR states that it is unclear how 

relevant this process is for current industrial production. [2023 TR 678-697]

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as food additives in milk products; fat products; soybean products; and fruits and vegetables. 

(Table 6.3, CAN/CGSB-32.311-2020, page 30)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed as a coagulation agent in dairy products. (Annex V, Part A, Section A1, 2021/1165)

Allowed as a coagulation agent in products of plant origin & sausages based on meat. (Annex V, Part A, 

Section A2, 2021/1165)

Allowed as a processing aid for the production of primary yeast. (Annex V, Part C, 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Allowed in the following plant origin products: fruits and vegetables (including mushrooms, seaweeds, and 

nuts and seeds) and soybean products (excluding seasonings, condiments and fermented soybean 

products).

Allowed in the following animal origin products: Dairy products and analogues. Not allowed in processed 

meat, poultry, poultry and game products, edible casings. (Table 3 - page 28). Allowed as a 

firming/coagulation agent in cheese making. (Table 4 - pages 30-31)

International Federation of Organic Agriculture Movements (IFOAM)

Allowed as an as additive and processing/post-harvest handling aid. (Appendix 4 - Table 1 - page 80)

Japan Agricultural Standard (JAS) for Organic Production

Allowed as an additive. Limited to the use as a coagulant in processed products of plant 

origin/cheesemaking, or in edible oils or fats, processed vegetable products, processed fruit products, 

products containing beans, dairy products, or processed meat products. (Appended Table 1)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 210 of 267
Ancillary Substances

None

Human Health and Environmental Issues

Environment: The 2023 draft TR indicated that calcium chloride, at the concentrations used for food 

commodities, is unlikely to negatively affect the environment when disposed, as it dissociates into calcium 

and chloride ions that can easily be taken up and metabolized by plants (at low concentrations). However, it 

was noted that calcium chloride can be toxic to plants and animals at high concentrations. 

As with all mined substances on the National List, the biggest impact to the environment is caused by the 

manufacturing of calcium chloride. Calcium chloride utilizes similar extraction and recovery techniques 

used by the oil and gas industry. [2023 TR 944-1105]

Human Health: GRAS. When used in concentrations utilized in food products the 2023 draft TR stated that 

calcium chloride is unlikely to have a negative effect on human health as it readily dissociates into calcium 

and chloride ions which are both essential body constituents in all animal species.

The 2023 draft TR also stated that although rare, in certain circumstances, calcium chloride may cause soft 

tissue necrosis. [2023 TR 1110-1133]

Discussion 

The Handling Subcommittee received the draft TR on January 22, 2024. It was reviewed and the 

Subcommittee had additional questions regarding the manufacturing process when calcium chloride is 

produced from soda ash derived from trona ore, as well as commercial availability of calcium chloride 

manufactured by the various processes.

The Subcommittee discussed the wide use of calcium chloride. The TR authors found no evidence of a 

single substance offering the versatility of calcium chloride that is also non-synthetic. [2023 TR 1166-1290]

The 2023 draft TR mentions the following alternatives by function:

• Anti-microbial agents: carbon dioxide and ozone

• Firming agent: ozone and other sources of calcium such as calcium sulfate, calcium citrate and 

monocalcium phosphate

• Coagulants: calcium phosphate, calcium sulfate and magnesium sulfate 

• Curing/pickling: other salts such as sodium chloride, calcium hydroxide, magnesium chloride and 

potassium chloride

• Nutrient supplement: calcium carbonate, calcium citrate, calcium hydroxide, and calcium 

phosphate

• pH control in brewing: calcium sulfate

• Tenderizer/texturizer: sodium chloride, lactic acid

The Subcommittee discussed the various ways to manufacture calcium chloride, some of which are 

nonsynthetic and some synthetic, as noted in the 2023 draft TR. Calcium chloride is currently listed at 

§205.605(a), so only the nonsynthetic forms are allowed. The TR noted that some methods used to extract 

calcium chloride from the natural brine use chemicals as processing aids. According to the TR when 

evaluating the classification of this manufacturing process using the decision tree, it falls into a gray area. 

The Subcommittee determined that use of these chemicals as processing aids would result in a 

nonsynthetic classification as the calcium chloride did not undergo a chemical change (it is still calcium 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 211 of 267
chloride) and the additional calcium or chloride ions that may still be present were not added with the 

intent of providing a technical effect. [2023 TR 476-782]

During the previous review most stakeholders were in favor of relisting due to essentiality and lack of 

negative impact on the environment and human health.

Questions to our Stakeholders

1. Is the calcium chloride that is commercially used/available produced using non-synthetic 

processes?

2. CERTIFIERS: What kinds of supporting documentation is obtained to verify the manufacturing 

process of calcium chloride is non-synthetic?

Enzymes

Reference: § 205.605(a) Nonsynthetics allowed

(11) Enzymes—must be derived from edible, nontoxic plants, nonpathogenic fungi, or 

nonpathogenic bacteria.

Technical Report: 1995 TAP (bacterial); 1996 TAP (plant); 1996 TAP (microbial); 2003 TAP (enzymes: plant, 

fungal); 2011 TR; 2015 TR; 2023 Limited Scope TR pending

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 10/1999 recommendation (plant, fungal): 11/2005 

sunset recommendation; 04/2011 sunset recommendation; 10/2015 sunset recommendation; 10/2019 

sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Enzymes are naturally occurring proteins that act as highly efficient catalysts in biochemical reactions. 

Enzymes are produced by all living organisms; however, the 2023 Limited Scope TR only focuses on 

enzymes produced by microorganisms (including fungi). In some cases, enzymes are produced by 

microorganisms that are developed using excluded methods, which was the focus of the 2023 Limited 

Scope TR. 

In the organic food industry, enzymes are used to carry out biological processes that are useful in the 

processing of food products or ingredients. Commonly used in the production of sweeteners, chocolate 

syrups, bakery products, alcoholic beverages, precooked cereals, infant foods, fish meal, cheese and dairy 

products, egg products, fruit juice, soft drinks, vegetable oil and puree, candy, spice and flavor extracts, and 

liquid coffee, and are used for dough conditioning, chill proofing of beer, flavor development, and meat 

tenderizing. Enzymes can also be used to help reduce production costs, reduce the length of time required 

for aging foods such as cheese, clarify or stabilize food products, and control the content of alcohol and 

sugar in certain foods. (Technical Report 2011 lines 140-148).

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 212 of 267
Manufacture

According to the 2023 draft TR, “Food-grade enzymes are typically produced in pure culture fermentation 

using “Current Good Manufacturing Practices” for food. Almost all fermentation processes used to produce 

enzymes are aerobic. Most industrial producers of food-grade enzymes use aerobic submerged 

fermentation or liquid fermentation (LF). Fungi produce approximately 50% of the enzymes used globally, 

bacteria produce 35%, and the remaining 15% are produced from non-fermentation organisms like plants 

and animals.”

Some examples of different sources of food-grade enzymes include:

Microbial rennet is a coagulating agent produced by a specific type of mold, fungus, or yeast organism, 

grown and fermented in a lab. (TR 2011 466-467) 

Bromelain is extracted from the pineapple’s fruit, stem, peel and juice. First the fruit is crushed. Bromelain 

is then further isolated, separated, and purified using chromatography, ultrafiltration, precipitation, freeze 

drying, and other procedures. (TR 2011 494-496) 

Pectinase is produced by the controlled fermentation of nonpathogenic and nontoxicogenic strains of 

Aspergillus niger that are isolated from growth medium (FOA, 2000). (TR 2011 504-505) 

Fermentation produced chymosin (FPC) rennet is derived from genetically modified organisms and is not 

allowed in organic processing. The 2023 TR takes an intensive look at the excluded methods used to 

produce enzymes (such as using genetically modified organisms) and found that there is currently no 

capacity for regulators to determine the origin of an enzyme sample once it has been produced (Draft TR 

2023 976-983).

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as food additives. The following sources of enzymes are allowed: a) any preparations of enzymes 

normally used in food processing derived from edible, non-toxic plants, non-pathogenic fungi or nonpathogenic bacteria; b) derived from animals—shall be organic if commercially available: rennet; catalase 

from bovine liver; animal lipase; pancreatin; pepsin; and trypsin. Animal-derived enzymes shall be free of 

Specified Risk Material (SRM); and c) egg white lysozyme. (Table 6.3, CAN/CGSB-32.311-2020, page 31)

Allowed as processing aids. The following sources of enzymes are allowed: a) any preparations of enzymes 

normally used in food processing derived from edible, non-toxic plants, non-pathogenic fungi or nonpathogenic bacteria; b) animal-derived—shall be organic if commercially available: rennet; catalase from 

bovine liver; animal lipase; pancreatin; pepsin; and trypsin. Animal-derived enzymes shall be free of 

Specified Risk Material (SRM); c) egg white lysozyme. (Table 6.5, CAN/CGSB-32.311-2020, page 39)

European Economic Community (EEC) Council Regula�on, EC No. 2018/848 and 2021/1165

Allowed (Annex II, Part IV, 2.2.2 (a), 2018/848)

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

Organically Produced Foods (GL 32-1999)

Allowed. Enzymes derived from genetic engineering organisms is prohibited. (Table 3 - 3.4 - page 29 & 31)

International Federation of Organic Agriculture Movements (IFOAM)

Allowed if derived from naturally occurring organisms. Genetically engineered microorganisms and their 

products are prohibited. Nonorganic forms are allowed in organic products only if there are no organic 

sources. (7.2.5 - page 58 & 72)

Japan Agricultural Standard (JAS) for Organic Production

Allowed as an additive. (Appended Table 1)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 213 of 267
Ancillary Substances

Ancillary substances are explained in the 2015 Technical Report: 

“Enzyme products used in food processing may be single ingredient, stand-alone preparations of the 

enzyme, or formulated with other ingredients (OMRI, 2015). In many cases the enzyme product which 

results from a fermentation process is not effective in food applications without further formulation 

(Whitehurst & Van Oort , 2009). Enzyme preparations therefore commonly contain other substances, not 

only as incidental secondary metabolites and residual growth media from the enzyme production, but also 

intentionally added ingredients which function as diluents, preservatives, stabilizers, antioxidants, etc. 

(FDA, 2010). These additives must be generally recognized as safe (GRAS), or be FDA approved food 

additives for this use (FDA, 2014).” 

To prevent the loss of enzyme activity, ancillary substances, such as stabilizers, are added. This is especially 

true for liquid enzyme preparations due to the destabilizing effect of water. Stabilizers are also used to 

combat the degradation of enzyme structures due to autolysis or proteolysis. 

To control microbial contamination of enzyme preparations, preservatives are added. The development of 

alternatives to preservatives (plant extracts, peptides, compounds from herbs and spices) is increasing but 

there are microbial resistance challenges and the need for continued research. Currently it is unknown if 

natural preservatives are being used in any enzyme formulations. 

The following additional ancillary substances were identified through public comment during the last sunset 

review: 

Anti-caking & anti-stick agents: calcium stearate, magnesium silicate/talc, magnesium sulfate, sodium 

aluminosilicate. 

Carriers and fillers: calcium phosphate, calcium acetate, calcium carbonate, calcium chloride, calcium 

sulfate, dextrin, dried glucose syrup, ethyl alcohol, glucose, glycol, lactic acid, maltose, mannitol, mineral 

oil, palm oil, propylene, purity gum (starch), saccharose, sorbitol, soy flour, soy oil, sunflower oil, trehalose, 

vegetable oil. 

Preservatives: alpha (hops) extract, benzoic acids and their salts, calcium propionate, citric acid, potassium 

chloride, potassium phosphate, sodium acetate, sodium chloride, sodium propionate, sodium sulfate, 

sorbic acid and its salts, stearic acid, tannic acid, trisodium citrate, zinc sulfate. 

Stabilizers: betaine (trimethylglycine), glucose, glycerol, sodium chloride, sodium phytate, sorbitol, sucrose. 

pH control, buffers: acetic acid, citric acid anhydrous, sodium citrate, sodium phosphate, trisodium citrate. 

Public comment submitted during the Spring 2019 NOSB meeting suggest adding several other ancillary 

substances to this list: 

Anti-Caking & Anti-Stick Agents: manganese sulphate, magnesium sulphate, microcrystalline cellulose 

powder 

Carriers and Fillers: corn gluten, corn steep powder, dextrose, lactose, propylene glycol, soya flour, soya oil, 

soyatone, sucrose. 

Preservatives: propyl p-Hydroxybenzoate, sodium metabisulfite, sodium nitrate. 

Stabilizers: calcium lactate, ethylene diamine tetra acetic acid, glycerin, sodium alginate. 

pH control, Buffers: adipic acid, di potassium phosphate (K2HPO4), diammonium phosphate, disodium 

phosphate (Na2HPO4), hydrochloric acid, mono potassium phosphate (KH2PO4), tri ammonium citrate. 

Human Health and Environmental Issues

The 2011 TR did not find the manufacture or use of enzymes to be harmful to the environment or 

biodiversity. Enzymes are used in small amounts, are biodegradable, and the release of enzymes into the 

environment is not an environmental concern. 

The 2011 TR did not find significant effects upon human health. Enzymes can remain active after they are 

digested and, as proteins, cause allergic reactions in sensitive individuals. FDA reports it is not aware of any 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 214 of 267
allergic reactions associate with the ingestion of food containing enzymes commonly used in food 

processing (TR 2011 752- 758). 

The 2023 Limited Scope TR does not add any information about human health or environmental issues, 

beyond those which would be of concern should excluded methods be used.

Discussion 

During the 2015 sunset review, a variety of organizations and manufacturers commented in support of 

keeping enzymes on the National List. There were no commenters opposed. One organization suggested 

that enzymes be classified as synthetic unless annotated to define those that have not undergone synthetic 

chemical change. Public comments received during the Spring and Fall 2019 NOSB meetings widely favored 

relisting of enzymes and numerous examples of their use in organic handling were listed. One group did 

object to the review of enzymes as a class noting that this broad review was insufficient to address 

classification and adherence to all OFPA criteria. They noted that enzymes should be classified as synthetic 

unless annotated to define those that have not undergone synthetic chemical change. 

The new 2023 Limited Scope TR brings up a variety of new questions relevant to the use of excluded 

methods in the production of this material.

Questions to our Stakeholders

1. For manufacturers: describe how you ensure no excluded methods are used when including 

enzymes into your organic formulation.

2. For certifiers: describe how you ensure organic processors' compliance with the prohibition on 

excluded methods in organic products when enzymes are used in the formulation.

3. Are there ancillary substances that should be prohibited for use, due to concerns about excluded 

methods?

 L-Malic acid

Reference: § 205.605(a) Nonsynthetics allowed

(16) L-Malic acid (CAS # 97-67-6).

Technical Report: 2003 TR; 2019 TR

Petition(s): 2002

Past NOSB Actions: 05/2003 sunset recommendation; 11/2009 sunset recommendation; 10/2019 sunset 

recommendation

Recent Regulatory Background: Added to National List 09/11/06 (71 FR 53299) 

Renewed 08/03/2011 (76 FR 46595); Renewed 09/12/16 (81 FR 8821); Renewed 8/3/2021 (86 FR 41699) 

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Malic acid exists in D-, L-, and racemic DL-forms, which is a mixture of equal parts of D- and L-. L-malic acid 

is the form listed at §205.605(a), while the D- and DL-forms are not approved for use in organic production. 

L-malic acid is used as a flavor enhancer, flavoring agent, adjuvant, and pH control agent in a variety of 

foods. The 2002 malic acid petition also notes it is used in dry mix beverages, carbonated beverages, bakery 

products, fruit juices, candies, gelatins, desserts, frozen specialties, and tea as a flavor enhancer and food 

acidulant, and that malic acid provides greater tartness and better taste retention than other major food 

acids. Malic acid has a smooth, persistent sourness and can be blended with other organic acids, sugars, 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 215 of 267
sweeteners, and flavors. It also intensifies and extends the impact of flavors, allowing producers to reduce 

the amount of added flavoring. U.S. Food and Drug Administration (FDA) lists L-malic acid as a Generally 

Recognized as Safe (GRAS) food additive as a pH control agent, flavor enhancer, flavoring agent, and 

adjuvant in all food types except for baby food. The listing also includes maximum good manufacturing 

practice (GMP) levels for various applications (21 CFR 184.1069; U.S. FDA 2018).

Manufacture

L-malic acid occurs naturally in many fruits and vegetables, including apples and cherries, and can be 

obtained by enzymatic conversion of fumaric acid and by fermentation of glucose and other carbohydrates. 

It is not economical to extract L-malic acid from natural foodstuffs such as apple juice. In the first round of 

the Spring 2019 sunset review, a number of commenters questioned whether commercially available Lmalic acid comes from nonsynthetic sources, as this listing restricts. Commenters noted that while 

supporting documentation may state L-malic acid is produced naturally via enzymatic fermentation, this 

statement refers to only the second half of the process. Industrial quantities of L-malic acid are made using 

biological processes, with the major industrial process to produce L-malic acid being a two-step procedure:

1. Production of fumaric acid either synthetically from petroleum or by fermentation of 

carbohydrates; and

2. Enzymatic conversion of fumaric acid to L-malic acid by immobilized microbes producing the 

enzyme fumarase.

More detailed information on the two-step process can be found in Appendix A of the 2019 Technical 

Report.

There are two options for obtaining the fumaric acid in the first step in this process: 1) The fumaric acid 

precursor is obtained through the fermentation of carbohydrates (i.e., Rhizopus spp.) or, 2) The fumaric 

acid precursor is obtained as a synthetic product from maleic acid of petroleum origin. Commercial 

quantities of nonsynthetic L-malic acid may also be produced using a one-step fermentation process 

through biological methods such as microbial fermentation using Aureobasidium pullulans and Penicillium 

vitacola, though it is not believed that this process is occurring on a scale that would accommodate the 

needs of the current market. The major commercial source of L-malic acid is enzymatic conversion of 

synthetic fumaric acid to L-malic acid by immobilized microbes (Chibata et al. 1983; Chi et al. 2016a; Dai et 

al. 2018). If the malic acid produced by this method is synthetic, most, if not all, of the L-malic acid on the 

market will also be synthetic (Goldberg et al. 2006; Chibata et al. 1983; Engel et al. 2008; Chi et al. 2016a; 

Dai et al. 2018).[All citations from 2019 TR]

L-malic acid can also be made from ethanol and biodiesel production waste but, again, this is not the 

production method that commonly supplies the market. Thin stillage is a byproduct of corn fermentation in 

the production of ethanol from which Aspergillus niger ATCC 9142 can produce L-malic acid (West 2017). 

Another L-malic acid production process is the fermentation of crude glycerol obtained from production of 

biodiesel. Non-engineered Ustilago trichophora can be used for high yield production. A. niger MTCC 281 

can also produce L-malic acid from crude glycerol (Iyyappan et al. 2018ab).

L-malic acid can also be produced by microbes in a one-step fermentation process fueled by glucose or 

other carbohydrates. Reaction conditions are adjusted to cause overproduction of L-malic acid, which is an 

essential product of microbe metabolism. While this production process is possible, it is not clear how 

much is produced and whether it will be able to produce sufficient quantities to supply handlers currently 

relying on the L-malic acid produced by the synthetic process.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 216 of 267
The production of DL-malic acid is a synthetic process according to NOP Guidance 5033-1; the malic acid 

undergoes a chemical change that is not the result of a naturally occurring biological process (USDA 2016b). 

Note this is similar to the method of production for synthetic fumaric acid used as precursor for industrial Lmalic production.

Research quantities of D-malic acid and L-malic acid can be obtained by chemically separating the racemic 

DL-malic acid into its components in a process called chiral resolution. Chiral resolution is an expensive 

process that is not used to make large commercial quantities. D- or L-malic acid produced by chiral 

resolution is synthetic according to NOP Guidance 5033-1 because the isomers are isolated by chemical 

processes (USDA 2016b; West 2017).

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as ingredients classified as food additives: listed as malic acid (Table 6.3, CAN/CGSB-32.311-2020, 

page 33).

European Economic Community (EEC) Council Regulation, EC No. 2018/848 & 2021/1165

Malic acid is allowed in products of plant origin (Annex V, Part A, Section A1, 2021/1165).

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

Organically Produced Foods (GL 32-1999)

In Table 3 of “Annex 2: “Permitted substances for production of organic foods,” malic acid (INS no. 296) is a 

permitted food additive listed without conditions (Codex 2013). L-malic acid is not explicitly mentioned; DLmalic acid is allowed.

International Federation of Organic Agriculture Movements (IFOAM)

L-malic acid (INS no. 296) is listed on page 79 in Appendix 4, “Table 1: List of approved additives and 

processing/post-harvest handling aids.” L-malic acid is listed both as a food additive and post-harvest 

handling aid without restrictions (IFOAM 2014).

Japan Agricultural Standard (JAS) for Organic Production

On page 6, “Appended Table 1-1, Additives,” DL-malic acid (INS no. 296) is an approved food additive 

limited to use in processed foods of plant origin (JAS 2022). L-malic acid is not explicitly mentioned. 

Ancillary Substances

The 2019 TR does not describe any ancillary substances in L-malic acid.

Human Health and Environmental Issues

The manufacture of L-malic acid by fermentation is fairly benign to the environment. Waste products such 

as spent cells and fermentation media can be composted. Processing chemicals include low toxicity acids 

and bases; while some of these can be recycled, they may end up in industrial landfills (West 2017; Dai et 

al. 2018). L-malic acid is found extensively throughout the environment in rotting fruit in agricultural or 

garden applications. Because it is soluble in water, L-malic acid eventually leaches out into the soil, where it 

is degraded by microbes. Manufactured malic acid is not deliberately released into the environment, and 

the amounts released incidentally into the environment through manufacturing processes and spills are 

likely to be small compared to the amounts already found in nature. The impacts of the manufactured 

material on beneficial insects, diversity, and other important aspects of environmental quality are negligible 

compared to natural exposures from rotting vegetation (Baker and Grant 2016). 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 217 of 267
Animal tests show that malic acid has low acute toxicity. Because it is easily metabolized in the body and 

occurs naturally in many fruits, there are no known reports of animal or human toxicity (Cornell 

Cooperative Extension 2016). Malic acid is an eye and skin irritant. The consumption of acidic soft drinks 

containing malic acid can lead to erosion of tooth enamel and can cause tooth decay.

Discussion 

The ongoing discussion around L-malic acid is not whether it is essential to organic handling or if it has 

detrimental effects on the environment or human health. In fact, there is broad agreement that it is 

essential, particularly to juice manufacturers, and there is no evidence to suggest that it does not meet 

National List criteria. However, as the organic material review process has become more refined and the 

production methods of L-malic acid has changed, we now see that much of the L-malic acid used in organic 

processing is “synthetic” while L-malic acid is currently listed at 7 CFR 205.605(a) as a “nonsynthetic” 

substance. 

Previous Handling Subcommittees have suggested relisting L-malic acid on §205.605(b) as a “synthetic” 

substance to accurately reflect the predominant production method, and to ensure that the classifications 

inherent to the National List of nonagricultural (nonorganic) substances allowed as ingredients in or on 

processed products labeled as “organic” or “made with organic (specified ingredients or food group(s))” are 

consistent with NOP material classification guidance.

This Subcommittee agrees with the previous thinking of the Board and would like to suggest adding L-malic 

acid to §205.605(b) to reflect that most L-malic acid used in organic food processing is synthetic in origin. 

However, the Subcommittee also questions whether L-malic acid should be removed from §205.605(a), as 

there may be nonsynthetic forms of L-malic acid in use, and should commercial quantities of nonsynthetic 

L-malic acid become available, organic processors may show a preference for a nonsynthetic option.

Questions to our Stakeholders

1. Do any organic products contain nonsynthetic forms of L-malic acid?

2. Do stakeholders think L-malic acid should be reclassified as a synthetic substance and added to 

§205.605(b)?

3. If L-malic acid is added to §205.605(b), should its nonsynthetic listing be removed from 

§205.605(a)?

Magnesium sulfate

Reference: § 205.605(a) Nonsynthetics allowed

(18) Magnesium sulfate, nonsynthetic sources only.

Technical Report: 1995 TAP; 2011 TR; 2023 TR pending

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2011 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 218 of 267
Use 

Magnesium sulfate is Generally Recognized as Safe (GRAS) and has a wide variety of uses in food processing 

and personal care products. It is used as a firming agent, and sometimes combined with other coagulators, 

in the production of tofu. Magnesium sulfate is also used as a nutrient in salt-replacer products, dietary 

supplements, carbonated beverages, sports drinks, and fortified water beverages, and as a fermentation 

and malting aid in beer, ale, and other malt beverages. In addition, magnesium sulfate has a variety of 

human medicine applications. Epson salts are a common form of magnesium sulfate.

Manufacture

Both nonsynthetic and synthetic forms of magnesium sulfate exist. The nonsynthetic forms are from 

naturally occurring salt deposits or rocks, with isolation from open-pit mines or salt ponds. Various levels of 

hydration create different crystalline structures that impact commercial viability, and manufacturers 

control humidity and temperature to isolate useful forms of magnesium sulfate. Magnesium sulfate can 

also be manufactured synthetically through the chemical reaction of magnesium containing materials and 

sulfuric acid.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as food additive. (Table 6.3, CAN/CGSB-32.311-2020, page 33)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 & 2021/1165

Not addressed 

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

Organically Produced Foods (GL 32-1999)

Not addressed

International Federation of Organic Agriculture Movements (IFOAM)

Not addressed

Japan Agricultural Standard (JAS) for Organic Production

Not addressed

Ancillary Substances

None identified.

Human Health and Environmental Issues

Magnesium sulfate is primarily extracted from salt lakes in the northern part of the Tibet Autonomous 

Region and Qaidam Basin of the Qinghai Province using large-scale open-pit mining, which results in heavy 

damage to surface vegetation, as well as water and air pollution from equipment. There is limited 

information available about mining magnesium sulfate specifically, relative to other magnesium materials. 

Use of magnesium sulfate in food processing does not appear to cause significant health or environmental 

issues, particularly relative to industrial uses. 

Discussion 

There are alternatives to magnesium sulfate for at least some applications, including tofu and beer 

production, but they may change properties of the finished product. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 219 of 267
During the last sunset review, there were no comments on this listing, and the vote to relist was 

unanimous. 

Questions to our Stakeholders

1. What organic products currently include magnesium sulfate?

2. Are there adequate alternatives to magnesium sulfate?

3.

Microorganisms

Reference: § 205.605(a) Nonsynthetics allowed

(19) Microorganisms—any food grade bacteria, fungi, and other microorganism.

Technical Report: 2003 TAP; 2014 TR; 2023 Limited Scope TR pending

Petition(s): 2002 petition

Past NOSB Actions: 05/2003 minutes and vote; 11/2009 sunset recommendation; 04/2015 sunset 

recommendation; 10/2019 sunset recommendation

Recent Regulatory Background: Added to National List with annotation 09/11/06 (71 FR 53299)

Renewed 08/03/2011 (76 FR 46595); Renewed 09/12/16 (81 FR 8821); Renewed 8/3/2021 (86 FR 41699)

Sunset Date 9/12/2026 

Subcommittee Review

Use 

Microorganisms are organisms that are so small they can only be viewed with a microscope, broadly 

encompassing bacteria, fungi, viruses and other single-celled organisms. The microorganisms used in 

organic handling include bacteria, yeasts and viruses, but yeasts are reviewed separately as their 

applications are broad. Microorganisms are used as probiotics, for fermentation, and bacteriophages are 

used for food safety. Microorganisms are used by organic processors to make many well-known products 

including yogurts, miso, soy sauce and sake. The use of these microorganisms can increase the digestibility 

of products, create different flavors and textures, and provide potential health benefits to the consumer. 

Additionally, bacteriophages can work to decrease harmful food organisms and increase the safety of 

processed foods. 

Manufacture

There are a variety of ways microorganisms can be produced. As noted in the 2014 technical report (TR), 

generally a medium is inoculated with a sample of the fermented food to produce a starter culture. 

Different microbiological species produce different flavor compounds and in turn produce different 

products. Depending on the organism desired, different mediums ranging from milk products to rice may 

be used to create the starter culture. After a culture is generated, the starter culture may be inoculated 

directly into a product that will be altered by the microorganisms or the culture may be preserved by 

drying, encapsulating, freezing or other method and used at a later time in the handling process. 

The 2023 Limited Scope TR stated that there is no direct evidence that microorganisms other than yeast were 

produced by excluded methods, but there were cases in which no methods were disclosed. It went on to say that 

for microorganisms created through solid state fermentation, many are genetically modified using recombinant 

DNA technology. Any microorganism that is genetically modified is not permitted in organic food.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 220 of 267
International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed in feed. If organic sources of yeast are not commercially available, non-organic yeast sources shall 

be used. (Table 5.2, Microorganisms and yeasts listing, CAN/CGSB-32.311-2020, page 24)

Allowed as ingredients not classified as food additives. Microbial preparations may contain substrates 

derived from agricultural or biological substances such as milk, lactose, soy, agar, etc. May also contain 

allowed carriers (see Table 6.3 & 6.4 Carriers). Starter and dairy cultures and other preparations of 

microorganisms normally used in product processing are allowed. (Table 6.4, CAN/CGSB-32.311-2020, page 

36)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed (Annex I, 3. Micro-organisms, 2021/1165)

Rules for the production of processed feed and food. 

For the purpose of Article 19(2)(b) of Regulation (EC) No 834/2007, only the following substances can be 

used in the processing of organic food, with the exception of wine: 

(a) substances listed in Annex VIII to this Regulation;

(b) preparations of micro-organisms and enzymes normally used in food processing. 

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

Organically Produced Foods (GL 32-1999)

Allowed. Micro-organisms that are genetically engineered/modified are prohibited. (Table 3 - 3.4 - pages 29 

& 31)

International Federation of Organic Agriculture Movements (IFOAM)

Allowed if derived from naturally occurring organisms. Genetically engineered microorganisms and their 

products prohibited. Nonorganic forms are allowed in organic products only if there are no organic sources. 

(7.2.5 - pages 58 & 72)

Japan Agricultural Standard (JAS) for Organic Production

JAS does not specifically mention microorganisms as an ingredient or additive to organic food. 

Ancillary Substances

Ancillary substances may be present in microorganism cultures. Ancillary substances for microorganisms 

primarily include the growth media used to produce the microorganism, and fillers or carriers to bring the 

microorganisms to purchasers in a stable and predictable form. According to the 2023 Limited Scope TR, 

“growth media can be as simple as a single feedstock and water, or may be comprised of as many as 40 

different components.” These components may include corn steep liquor, molasses and horse manure 

extract. Additional preservatives or anti-caking agents are used with some species. 

The 2023 Limited Scope TR includes the following table of allowed ancillary substances in organic microbial 

preparations.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 221 of 267
Functional class Substance name 

Anti-caking & anti-stick agents magnesium stearate, calcium silicate, silicon dioxide

Carriers and fillers, agricultural or 

nonsynthetic

lactose, maltodextrins, sucrose, dextrose, potato starch, 

non-GMO soy oil, rice protein, grain (rice, wheat, corn, 

barley) flour, milk, autolyzed yeast, inulin, cornstarch, 

sucrose

Carriers and fillers, synthetic

micro-crystalline cellulose, propylene glycol, stearic acid, 

dicalcium phosphate. potassium phosphate, potassium 

sulfate, tricalcium phosphate

Preservatives sodium benzoate, potassium sorbate, ascorbic acid, sodium 

formate

Stabilizers maltodextrin

Cryoprotectants used to freeze-dry (& 

freeze) microorganisms and Dairy Cultures

liquid nitrogen, maltodextrin, magnesium sulfate, dimethyl 

sulfoxide, sodium aspartate, mannitol, sorbitol, polysorbate

Substrate that may remain in final product milk, lactose, grain (rice, barley, wheat) flour, brewed black 

tea and sugar, soy

Potential concerns have been raised about ancillary substances used in cultures and their compatibility with 

organic handling standards. It is unclear, for example, whether the corn used to make the starches and 

liquors mentioned above is required to be organic. Functional foods may contain a combination of probiotic 

culture with a prebiotic substrate that favors its growth (2014 TR). The use of ancillary substances has not 

prevented the relisting and general support for microorganisms. In general, they have not been implicated 

in negative health effects, but are something that should be continually monitored. Additionally, as with all 

organic materials, any culture that is genetically modified is disallowed. 

Human Health and Environmental Issues

Microorganisms have been a staple in food production for centuries and they are generally viewed as a 

necessary input for organic production of many products. They pose minimal health risks, and in many 

cases can enhance health. As noted in the 2014 TR, the health effects can be expressed directly through the 

interactions of the ingestion of the live microorganisms (probiotic effect) or indirectly as the result of 

ingesting the metabolites synthesized by the microbes during fermentation (biogenic effect). Food-grade 

bacteria may also be used for improved vitamin production, raw food materials are often fortified with food 

grade bacteria that produce an excess of B vitamins in situ, and bacteriophages (viruses) are utilized as 

antimicrobials to control bacteria during the production of foods on the farm, on perishable foods postharvest, and during food processing (2014 TR). 

The 2023 Limited Scope TR did not bring up additional concerns for human health or the environment, 

beyond those that would occur through the use of excluded methods. 

Discussion 

In general, microorganisms are essential to the production of many organic foods, and they are widely used 

in the industry. A question could be posed regarding whether yeast should be grouped with other 

microorganisms, as they certainly fall within the classification of microorganisms. The definition is critical 

for microorganisms in use currently, and can be used to determine whether additional organisms, such as 

unicellular algae, should be considered microorganisms. 

This discussion could be taken a step further to determine whether the products of microorganisms, 

substances such as citric acid, malic acid, and others, could also be grouped under the umbrella of 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 222 of 267
microorganisms. As the primary concern for most of these microbial products is whether the 

microorganisms used to produce them were genetically modified, the broader guidelines may apply. These 

comments do not suggest that microorganisms should be delisted, but rather that additional attention 

needs to be paid to this particular listing and the definitions associated with it. 

The new 2023 Limited Scope TR brings up a variety of new questions relevant to the use of excluded 

methods in the production of this material.

Questions to our Stakeholders

1. For manufacturers: describe how you ensure no excluded methods are used when including 

microorganisms in your organic formulation.

2. For certifiers: describe how you ensure organic processors' compliance with the prohibition on 

excluded methods in organic products when microorganisms are used in the formulation.

3. Are there any ancillary substances that should be prohibited due to the potential for excluded 

methods?

Perlite

Reference: § 205.605(a) Nonsynthetics allowed

(22) Perlite—for use only as a filter aid in food processing.

Technical Report: 1996 TAP; 2023 TR pending

Petition(s): N/A

Past NOSB Actions: 09/1996 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Perlite is used as a filter aid in food processing, such as in the filtration of juices, beer, wine, and vegetable 

oils. 

Manufacture

Perlite is an amorphous volcanic glass that occurs naturally and is sourced primarily from mines in the U.S., 

Greece, Turkey and China. The high-water content of the mineral causes it to expand many times its 

original volume when exposed to temperatures of 850-900°C.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as a filtering aid. (Table 6.5, CAN/CGSB-32.311-2020, page 39)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 & 2021/1165

Perlite is allowed as a processing aid in products of plant origin and gelatine. (Annex V, Part A, Section A2, 

2021/1165)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 223 of 267
CODEX Alimentarius Commission, Guidelines for the Production, Processing, Labelling and Marketing of 

Organically Produced Foods (GL 32-1999)

Allowed as a processing aid for the preparation of products of agricultural origin. (Table 4, page 30)

International Federation of Organic Agriculture Movements (IFOAM)

Allowed as a processing/post-harvest handling aid. (Appendix 4, Table 1, page 81)

Japan Agricultural Standard (JAS) for Organic Production

Perlite is an approved food additive limited to use in processed products of plant origin. (Appended Table 1-

1: Additives, page 8)

Ancillary Substances

None Identified

Human Health and Environmental Issues

There is some concern with the potential human health hazard of inhalation of fine silica dust when using 

this material. Personal protective equipment such as a dust mask can minimize this risk.

Discussion 

Subcommittee discussion was brief and overall supportive to relist. 

Questions to our Stakeholders

Have there been any advancements in food processing that would eliminate the need of perlite on the 

National List?

Potassium iodide

Reference: § 205.605(a) Nonsynthetics allowed

(24) Potassium iodide.

Technical Report: 1995 TAP; 2011 TR; 2023 TR pending

Petition(s): N/A

Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2011 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Potassium iodide is used as a form of iodine in trace mineral supplements. Iodine is an essential component 

of the thyroid hormones that regulate basal metabolism. Iodine deficiency causes thyroid enlargement 

(goiter), mental retardation that can be severe (cretinism in 10% of the population), and hypothyroidism. 

The developing brain is the most sensitive organ; iodine deficiency reduces IQ by 13.5 points [2011 TR 356-

359]. Iodization of salt eliminated new cases of cretinism in Switzerland. According to FDA, potassium 

iodide may be used as a food additive in the following functions: 

• A nutrient in table salt as a source of iodine.

• A dietary supplement for human consumption and in animal feeds. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 224 of 267
• A sanitizing agent for food processing equipment. [2011 TR 35-38]

Manufacture

Potassium iodide can be refined non-synthetically from sea water and in salt deposits. It can be produced 

synthetically by reacting hydriodic acid with potassium bicarbonate or by electrolysis of hydriodic acid and 

potassium bicarbonate or, industrially, by treating potassium hydroxide with iodine. [21 CFR 184.1634] 

[2011 TR 200-201].

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as ingredients not classified as food additives. Use when legally required or allowed. (Table 6.4, 

CAN/CGSB-32.311-2020, page 36)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 & 2021/1165 

Allowed for use as feed or in feed production (Annex III, Part B, 3(b), 2021/1165). Not explicitly mentioned 

for use in/on processed products.

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned.

International Federation of Organic Agriculture Movements (IFOAM)

Not explicitly mentioned.

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned.

Ancillary Substances

No identified

Human Health and Environmental Issues

Potassium iodide may be added to food as a nutrient/nutritional supplement for human consumption or to 

animal feeds. Iodine (in the form of iodide) is a necessary human nutrient that is required for proper 

functioning of the human endocrine system, specifically synthesis of thyroid hormones—thyroxine (T4) and 

triiodothyronine (T3) [2011 TR 352-354]. It is well-documented that pre-existing nutritional deficiency of 

iodine in the diet can perturb levels of thyroid hormones which cause a spectrum of disorders that include 

in increasing order of severity, goiter and hypothyroidism, mental retardation, and cretinism. There are no 

indications of special sensitivity of infants or children resulting from exposure to iodine. Therefore, the 

Food Quality Protection Act (FQPA) Safety Factor has been removed (i.e., reduced to 1x) for iodine [2011 TR 

396-397].

Based on a review of the available toxicology data, the U.S. Environmental Protection Agency (EPA) has 

concluded that iodine and iodophor complexes are of very low toxicity by the oral, dermal, and inhalation 

routes of exposure. Acute and chronic risks to non-target birds, aquatic invertebrates, and fish are highly 

unlikely [2011 TR 345-346].

Discussion 

Potassium iodide is an important material that helps prevent a range of health issues caused by iodine 

deficiencies. In previous sunset reviews the NOSB asked questions to stakeholders regarding the use of this 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 225 of 267
substance as a sanitizer, but no feedback was received. Stakeholders favored keeping this listing in addition 

to the current Nutrient Vitamin and Mineral listing. The NOSB has unanimously supported relisting 

potassium iodide at each sunset date.

Questions to our Stakeholders

None

Pullulan

Reference: § 205.605(a) Nonsynthetics allowed

(25) Pullulan—for use only in tablets and capsules for dietary supplements labeled “made with 

organic (specified ingredients or food group(s)).

Technical Report: 2018 TR

Petition: 2004; 2018

Past NOSB Actions: 04/2019 recommendation to add

Recent Regulatory Background: Added to National List effective 07/26/2021 (86 FR 33479) 

Sunset Date: 7/26/2026

Subcommittee Review

Use 

According to the FDA Center for Drug Evaluation and Research (CDER), pullulan is a “product used for tablet 

coating, as an excipient to aid tableting processes, in the production of edible films, and as an alternative 

to gelatin in capsule production” (FDA 2014). The unique film-forming property of pullulan 74 enables the 

production of clear capsules and coatings for dietary supplements (Farris et al. 2014). [2018 TR 72-75]

In addition to the petitioned use of pullulan as an ingredient in tablets and capsules for dietary supplements, 

edible pullulan films are used to extend the shelf life of various foods. These films prevent moisture loss and 

reduce surface exposure to oxygen and spoilage bacteria in intact berries (Krasniewska et al. 2017; TrevinoGarza et al. 2015; Diab et al. 2001), Brussels sprouts (Krasniewska et al. 2016), baby carrots (Gniewosz et al. 

2013), nuts (Gounga et al. 2008), fresh eggs (Ozaki, Nomura and Miyake 1996), intact apples (ChlebowskaŚmigiel, Gniewosz and Świńczak 2007), and cut fruits such as apple slices (Wu and Chen 2013). [2018 TR 88-

94]

Manufacture

All pullulan is created by microbial fermentation. The microorganism is usually the black, yeast-like fungus A. 

pullulans, although other species from this genus of black fungus—such as A. fermentans (Ozaki, Nomura and 

Miyake 1996) and A. melanogenum (Jiang et al. 2018)—have also been shown to produce pullulan. Nitrogen 

is provided in the growth medium in the form of inorganic nitrogen sources such as ammonium salts and 

nitrates and biological sources such as glutamate, peptone, yeast extract, and corn steep liquor. Essential 

nutrient minerals are provided as phosphates, magnesium salts, and the sulfates of iron, manganese, and 

zinc. [2018 TR 219-225]

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Not explicitly mentioned. 

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 226 of 267
Not explicitly mentioned. 

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned. 

International Federation of Organic Agriculture Movements (IFOAM)

Not explicitly mentioned. 

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned. 

Ancillary Substances

None

Human Health and Environmental Issues

According to 2018 TR no adverse effect on human health and environmental issues mentioned.

Discussion 

Public comments urge NOSB to recommend applying the commercial availability clause to the entirety of the 

substances on §205.605 including Pullulan. 

Questions to our Stakeholders

Does pullulan have the potential to be produced organically, and if so, would a commercial availability 

requirement help drive commercialization of organic pullulan?

Yeast

Reference: § 205.605(a) Nonsynthetics allowed

(30) Yeast—When used as food or a fermentation agent in products labeled as “organic,” yeast 

must be organic if its end use is for human consumption; nonorganic yeast may be used when 

organic yeast is not commercially available. Growth on petrochemical substrate and sulfite waste 

liquor is prohibited. For smoked yeast, nonsynthetic smoke flavoring process must be documented.

Technical Report: 1995 TAP (smoked yeast); 1995 TAP (baker’s yeast); 1995 TAP (autolysate); 1995 TAP

(brewers); 2014 TR; 2023 Limited Scope TR pending

Petition(s): 2006 Petition; 2010 Petition Supplement; 2010 Petition memo

Past NOSB Actions: 10/1995 sunset recommendation; 11/2005 sunset recommendation; 3/2007 NOSB 

committee recommendation; 10/2010 NOSB recommendation; 10/2015 sunset recommendation; 10/2019 

sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 227 of 267
Use 

Yeast is widely used and has been for centuries. Yeast is a microorganism that is commonly used for 

fermentation, baking, food flavors, adding nutritional value and providing health benefits. Yeasts are in 

kingdom Fungi and are single celled eukaryotic organisms. They utilize organic materials for energy by 

releasing enzymes that digest organic matter or by absorbing simple molecules directly through their cell 

walls. Yeasts differ from other fungi, such as molds and mushrooms, in that they exist as individual cells 

rather than forming hyphae that interconnect with other cells. 

In general, yeast species (brewer’s yeast) used in anaerobic conditions are for fermentation whereby they 

convert sugars to ethanol. This process includes ciders, beers, wines, and distilled spirits. Other uses for 

yeast are generally in aerobic conditions where they may be used as leavening agents (baker’s yeast), for 

the addition of vitamins or minerals (nutritional yeast, chromium yeast, selenium yeast, torula yeast), as 

probiotics that may prevent or treat pathological conditions (probiotic yeast), and for flavoring (smoked 

yeast, torula yeast) (2014 TR). As the 2014 TR notes, they may be used synergistically or in conjunction with 

bacteria or other materials to create specific foods such as when kombucha is fermented with yeast and 

acetic acid bacteria to create fermented, sweetened tea. 

Many organic products rely on the use of yeast for their distinctive features and characteristics. While there 

has been broad support for the relisting of yeast on the National List in past reviews, significant discussion 

has been centered on ancillary substances and whether organic forms of yeast are available. Yeast 

underwent a significant review that led to a 2010 recommendation to change the listing. The 2014 

Technical Review added information about the current status of various yeasts and looked at the ancillary 

substances. There are many types of yeast and yeast is used to produce many substances, so this is a 

constantly changing playing field. As part of the prior sunset review many commenters noted that organic 

yeast forms are readily available, but that for certain uses there are some forms that are not yet organically 

produced in sufficient quantity or quality. These included torula yeast, nutritional yeast for livestock feed, 

gluten-free yeast, fresh yeast, and some types of wine yeast. This led to the extensive annotation for the 

listing of yeast on the National List. 

Manufacture 

Many yeasts are ubiquitous in the environment and in some cases, handlers use these wild yeasts to make 

breads or for fermentation. However, since most handlers prefer more control over the specific type and 

strain of yeast that is utilized, most yeasts are grown under controlled conditions and then sold to end 

users. Typically, yeast is grown in a lab environment to prevent contamination from undesirable or 

pathogenic organisms. The lab grown yeast is then used to inoculate growth media for industrial production 

(2014 TR). In many cases there are several iterations of inoculation and addition of growth media in order 

to achieve the desired quantities. The yeast may then be used directly for food production or be 

concentrated and packaged for future use. Traditionally, smoked yeast is made by passing smoke through 

dried yeast, but it may also be manufactured using chemical processes. This necessitated the annotation 

that when smoked yeast is used, documentation that the yeast is smoked by natural processes must be 

submitted by the user. 

The 2023 Limited Scope TR made it clear that yeast may be genetically modified, primarily within brewing and 

fermentation applications. Yeast manufacturers are increasingly using tools like CRISPR to edit genes and add 

desirable traits from wild strains [2023 TR 499-504]. These genetically modified yeast would be prohibited under 

current NOP regulations.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 228 of 267
International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as ingredients classified as food additives. If organic sources of yeast are not commercially 

available, these alternative sources of yeast may be used: a) autolysate; b) bakers’ (may contain lecithin, as 

listed in Table 6.3); c) brewers’; d) nutritional; and e) torula. Growth on petrochemical substrate and 

sulphite waste liquor is prohibited. Yeast may be smoked or smoke-flavoured. When smoked, the smoke 

shall come from concentrated, condensed smoke from wood without additional ingredients (unless listed in 

Tables 6.3, 6.4 or 6.5). (Table 5.2, CAN/CGSB-32.311-2020, page 35)

Allowed as ingredients not classified as food additives: If organic sources of yeast are not commercially 

available, these alternative sources of yeast may be used: a) autolysate; b) bakers’ (may contain lecithin, as 

listed in Table 6.3); c) brewers’; d) nutritional; and e) torula. Growth on petrochemical substrate and 

sulphite waste liquor is prohibited. Yeast may be smoked or smoke flavoured. When smoked, the smoke 

shall come from concentrated, condensed smoke from wood without additional ingredients (unless listed in 

Tables 6.3, 6.4 or 6.5). (page 37)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 & 2021/1165

Allowed (Annex II, Part VII, 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned; may be considered a micro-organism, which is allowed. Micro-organisms that are 

genetically engineered/modified are prohibited. (Table 3 - 3.4 - page 29 and 31)

 

International Federation of Organic Agriculture Movements (IFOAM)

Allowed if derived from naturally occurring organisms. Genetically engineered microorganisms and their 

products are prohibited. Cultures that are prepared or multiplied in house shall comply with the 

requirements for the organic production of microorganisms. Nonorganic forms are allowed in organic 

products only if there are no organic sources. (7.2.5 - page 58 and 72)

Japan Agricultural Standard (JAS) for Organic Production

JAS does not specifically mention yeast as an additive or ingredient to organic food.

Ancillary Substances

During the 2015 sunset review, the following Functional Classes were reviewed for ancillary substances in 

yeasts: Antioxidants, preservatives, emulsifiers, defoaming agents, and substrate that may remain in the 

final product. It was suggested that starch be added to this list during that review. One substance, BHT, was 

questioned as problematic for exposure. 

According to the 2014 TR, there are a few yeast species that are formulated with no ancillary substances; 

however, many commercially available yeasts are formulated with other ingredients. These substances, 

such as ascorbic acid, may be listed on the National List. However, other ancillary ingredients not appearing 

on the National List are routinely combined with yeast on a commercial scale. These may be water, 

emulsifiers, and cutting oils. The compounds used for emulsifiers are enumerated in the TR (2014 TR) and 

that extensive list should be referred to for specific details of ancillary substances in yeast products. 

The 2023 Limited Scope TR indicates that for yeast to be certified as organic, the inputs such as molasses or 

corn steep liquor must also be organic and no synthetic substance that is not on the National List may be 

included [2023 TR 1255-1261].

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 229 of 267
Human Health and Environmental Issues

It should be noted that while yeast itself is often considered of minimal risk to both the environment and in 

human use, there can be negative environmental impacts from the manufacturing processes used to create 

yeast formulations. Appropriate mitigation strategies for these impacts, such as the emissions of 

acetaldehyde and ethanol, exist and when appropriately used minimize environmental impact (2014 TR). 

The 2023 Limited Scope TR did not provide additional information on the potential impacts to human 

health or environmental issues, aside from those that could potentially occur through the use of excluded 

methods.

Discussion 

Public comment from the Spring and Fall 2019 meetings was overwhelmingly in favor of relisting of yeasts 

as annotated. Commenters noted that since yeast is commonly not available in organic form necessary for 

certain flavors, yeasts are not always available in the quantities needed, and that organic yeast quality can 

vary, the annotation and listing should remain as is. It isn’t currently clear how to determine whether a 

non-organic form of yeast may be used in an organic product.

The new 2023 Limited Scope TR brings up a number of new questions relevant to the use of excluded 

methods in the production of this material.

Questions to our Stakeholders

1. For manufacturers: describe how you ensure no excluded methods are used when including yeast 

into your organic formulation.

2. For certifiers: describe how you ensure organic processors' compliance with the prohibition on 

excluded methods in organic products when yeast is used in the formulation.

3. Are there ancillary substances that should be prohibited for use, due to concerns about excluded 

methods?

Activated charcoal

Reference: § 205.605(b) Synthetics allowed

(2) Activated charcoal (CAS #s 7440-44-0; 64365-11-3)—only from vegetative sources; for use only 

as a filtering aid.

Technical Report: 2002 TAP; 2023 TR pending

Petition(s): 2002 petition

Past NOSB Actions: 09/2002 sunset recommendation; 11/2009 sunset recommendation; 04/2015 sunset 

recommendation; 10/2019 sunset recommendation

Regulatory Background: Added to National List with annotation 9/11/06 (71 FR 53299); Renewed 

8/03/2011 (76 FR 46595); Renewed 09/12/16 (81 FR 8821); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026 

Subcommittee Review

Use 

Activated charcoal is used in processing for mechanical filtration involving the physical separation of 

suspended solids from a liquid passing through carbon arrayed as a porous media in a column or bed. This 

type of filtration is used as a taste and odor-removing agent and purification agent in water and food. 

Activated carbon has a very large surface area and pore volume that gives it its unique adsorption capacity.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 230 of 267
Manufacture

Activated charcoal of vegetative origin can be made from a large variety of sources such as hardwoods, 

grain hulls, corn cobs, and nut shells. The material undergoes pyrolysis at a very high heat. These 

agricultural byproducts may be chemically activated using a variety of acids and bases. Acids may be acetic 

acid, and potassium hydroxide and sodium hydroxide are possible bases. The charcoal may also be 

activated through exposure to oxygenated gas or steam.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Canada General Standards Board Permitted Substances List allows the use of activated charcoal as an 

ingredient classified as a food additive. Shall be of plant origin. Prohibited for use in the production of 

maple syrup.

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Lists activated carbon for the preparation of foodstuffs of plant and animal origin.

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

Organically Produced Foods (GL 32-1999)

Codex Alimentarius lists activated carbon as a processing aid which may be used for the preparation of 

products of agricultural origin.

International Federation of Organic Agriculture Movements (IFOAM)

IFOAM Norms Appendix 4 – Table 1 lists activated carbon as allowed for use as a processing and 

postharvest handling aid. Synthetic forms are allowed if organic or natural sources are not commercially 

available. May be used as a processing or a post-harvest handling aid.

Japan Agricultural Standard (JAS) for Organic Production

Appended Table 1-1, Additives (Organic processed foods other than organic alcohol); Appended Table 1-2, 

Additives (Organic alcohol beverages). Limits the use of active carbon for processed foods of plant origin; 

also beverages. 

Ancillary Substances

None identified.

Human Health and Environmental Issues

Activated charcoal has minimal impact on human health and the environment. It may cause respiratory 

problems for those who handle it, especially as the particle size decreases. Its use in processing doesn’t 

generally have an effect or chemical interaction in the agroecosystem. The greatest impact of activated 

charcoal from vegetative sources is the removal of organic matter from the system.

Discussion 

An updated TR was received during the Subcommittee review. The Subcommittee discussion was brief and 

in favor of relisting.

Questions to our Stakeholders

Are there any industry changes that would challenge the current listing for activated charcoal?

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 231 of 267
Ascorbic acid

Reference: § 205.605(b) Synthetics allowed

(6) Ascorbic acid.

Technical Report: 1995 TAP; 2019 TR

Petition(s): N/A

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

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Ascorbic acid is used as a dietary supplement and nutrient, flavor ingredient, used in meat and meat 

containing products, curing and pickling, in flour to improve baking quality, as an antioxidant in fats and 

oils, and a wide variety of other food processing uses. It is also used in frozen and precut fruits as an 

antioxidant. Industrially produced L-ascorbic acid is widely used in the feed, food, and pharmaceutical 

sector as a nutritional supplement and preservative, making use of its antioxidative properties. Ascorbic 

acid is often added to processed foods for nutritional purposes and is one of the most common sources of 

Vitamin C, which provides many important biological functions. Several animals, including humans, a 

variety of primates and guinea pigs have lost the ability to produce ascorbic acid and must obtain this 

essential vitamin through their diets. As it is water soluble, and cannot be stored in the body, it must be 

consumed daily. However, its addition as a nutritional fortifier also provides preservative properties. The 

preservative nature of the compound is derived from its reducing nature, through which it reacts with 

oxidized species (including radicals and molecular oxygen) to prevent enzymatic browning and food 

spoilage. Ascorbic acid is GRAS as a chemical preservative (21 CFR 182.3013), a dietary supplement (21 CFR 

182.5013), and nutrient (21 CFR 182.8013) when used in accordance with Good Manufacturing Practices. 

The FDA has identified ascorbic acid as a required nutrient in infant formula (21 CFR 107.100).

Manufacture

For more than 50 years, the predominant industrial production of ascorbic acid involved synthesis using the 

Reichstein and Grussner process, a six-step process developed in the 1930’s. The process begins with Dglucose and involves hydrogenation, oxidizing, and treatment with acetone and then hydrogen chloride to 

yield L-ascorbic acid. Despite the effectiveness of the purely synthetic production of ascorbic acid with the 

Reichstein process, most modern industrial production processes use fermentation of glucose with 

additional biooxidation steps adding a bio-catalyst which eliminates the need for the chemical steps. 

Despite the use of various microorganisms for the bulk of the synthesis, the use of acid in the final step of 

the process to convert the 2-keto-L-gluconic acid to ascorbic acid results in the substance’s classification as 

“synthetic,” according to the guidelines in NOP 5033-1.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as ingredients classified as food additives. (Table 6.3, CAN/CGSB-32.311-2020, page 30)

Allowed as processing aid, specifically anti-browning agents prior to the extraction or concentration of fruit 

or vegetable juice. (Table 6.5, CAN/CGSB-32.311-2020, page 38)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 232 of 267
European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed in products of plant origin & meat products. (Annex V, Part A, Section A1, 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Allowed in food of plant origin, provided natural sources are not available. Allowed in the following foods of 

animal origin, provided natural sources are not available: processed meat, poultry, game products, poultry 

and edible casings. (Table 3 - page 24) 

International Federation of Organic Agriculture Movements (IFOAM)

Allowed as an as additive. (Appendix 4 - Table 1 - page 79)

Japan Agricultural Standard (JAS) for Organic Production

Allowed as an additive. Limited to the use in processed products of plant origin. (Appended Table 1)

Ancillary Substances

No discussion of ancillary substances in the 2019 TR.

Human Health and Environmental Issues

The 2019 Technical Report found no published studies on the persistence or impacts to biodiversity of 

ascorbic acid. Given the natural prevalence of the substance in plants and animals, the incorporation of 

ascorbic acid in the handling/processing of organic food products is unlikely to provide any significant 

increase to environmental levels of the substance.

Discussion 

Ascorbic acid is a vital nutrient necessary for humans and other primates. Humans cannot synthesize 

Vitamin C and must rely on dietary intake. Modern production techniques rely on fermentation of glucose, 

but addition of synthetic acids in the process render the final ascorbic acid product a “synthetic” substance 

according to NOP 5033-1. Previous sunset reviews of the substance asked whether excluded methods are 

used in the production of ascorbic acid, and the 2019 TR indicates that the microorganisms used in its 

manufacture are not the product of excluded methods.

Some stakeholders have identified its use as a preservative as incompatible with the requirements in 

organic handling, however, other stakeholders report it remains essential for numerous functions in food 

including protein processing in cheese, color stabilization in fruit juice, and as an antioxidant and vitamin C 

source. The subcommittee notes that evaluation criteria at 7 CFR 205.600(b) restricting a material’s use as 

a preservative or its use to recreate or improve flavors, colors, textures, or nutritive value lost during 

processing is limited to processing aids and adjuvants.

The 2019 Technical Report notes alternative acids such as citric and lactic acid, nonsynthetic substances 

permitted at 7 CFR 205.605(a). These weak acids inhibit food discoloration, however the inability of these 

acids to provide the reducing power of ascorbic acid prevents preservative action against reactive oxidized 

species and limits their efficacy against viral contamination. The Technical Report cites the use of controlled 

atmosphere with little to no oxygen to retard microbial-based spoilage. However, the use of controlled 

atmospheres in packaging and processing has also been known to affect the color and other organoleptic 

properties of the foods. Other alternatives include the use of fruit juices to fortify foods. However, this 

strategy is limited; the relative instability of ascorbic acid and the presence of additional substances present 

in fruit juices that may result in undesired changes to the organoleptic properties of the processed foods.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 233 of 267
Questions to our Stakeholders

Do stakeholders have any experience with natural or organic alternatives to ascorbic acid for some or all of 

its uses in organic handling?

Calcium citrate

Reference: § 205.605(b) Synthetics allowed

(7) Calcium citrate.

Technical Report: 1995 TAP; 2015 TR; 2023 Limited Scope TR pending

Petition(s): N/A

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

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Calcium citrate is used as an ingredient in dietary supplements, where it provides calcium. It is also used as 

a nutrient; sequestrant; buffer; antioxidant; firming agent; acidity regulator in jams and jellies, soft drinks 

and wines; raising agent; an emulsifying salt; to improve the baking properties of flours; a stabilizer; to 

remove scale from boilers, evaporators and other processing equipment; to wash equipment to remove off 

flavors; in cosmetic and personal care items; and as a water softener. 

Calcium citrate may be added to foods to supplement calcium per FDA nutrition guidelines, although there 

are other calcium sources for supplementation purposes including calcium carbonate, calcium oxide, 

calcium sulfate, etc., all of which are permitted per a separate listing on §205.605(b) as Nutrient 

Vitamins and Minerals.

Manufacture

Citric acid is a naturally-produced, non-volatile organic acid with a long history of use in food processing. 

The 2015 TR considered production of citric acid by microbial fermentation with Aspergillus niger or 

Candida yeasts from carbohydrate sources, but includes additional information regarding production from 

plant sources. 

Note that the process that creates citric acid is fermentation of carbohydrates. In terms of concern about 

excluded methods, the 2015 TR indicates that the organisms underlying the fermentation process are 

considered ‘classical mutants,’ and further notes that the prohibition on excluded methods in food by the 

European countries suggests the underlying citric acid is unlikely to include carbohydrates that have 

manipulated genes. 

The citrate salts – calcium citrate, potassium citrate and sodium citrate – are all derived from citric acid. The 

citrate salts are produced by chemical reaction with citric acid and the hydroxide or carbonate of the 

respective salt (calcium, sodium or potassium). 

Calcium citrate is the calcium salt of citric acid. It is prepared by neutralizing citric acid with calcium 

hydroxide or calcium carbonate and subsequent crystallization. It is most commonly found in the 

tetrahydrate form. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 234 of 267
International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as food additives. (Table 6.3, CAN/CGSB-32.311-2020, page 30)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed as a food additive and processing aid in products of plant origin. (Annex V, Part A, A1, 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Calcium citrate is allowed in food of plant origin and dairy products/analogues. Not allowed in fats, oils, and 

fat emulsions. (page 25)

https://www.ifoam.bio/our-work/how/standards-certification/organic-guarantee-system/ifoamnormsInternational Federation of Organic Agriculture Movements (IFOAM)

Allowed as an additive. (Appendix 4 - Table 1 - page 79)

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned.

Ancillary Substances

None

Human Health and Environmental Issues

There are no expected significant human health impacts or remarkable environmental issues, according to 

the 2015 TR.

Discussion 

The bulk of the discussion about this product addresses the production process for citric acid. The 

Subcommittee supports relisting.

Questions to our Stakeholders

Is there any information we should consider regarding the sunset of this substance?

Collagen gel

Reference: § 205.605(b) Synthetics allowed

(13) Collagen gel—as casing, may be used only when organic collagen gel is not commercially 

 available. 

Technical Report: 2019 TR

Petition(s): 2018 (for addition at 205.606)

Past NOSB Actions: 04/2019 Recommendation to add

Recent Regulatory Background: Added to NL 07/26/2021 (86 FR 33479) 

Sunset Date: 7/26/2026

Subcommittee Review

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 235 of 267
Use 

Collagen gel acts as an edible film used in meat products (e.g. sausage) as an alternative to casings, which is 

listed at §205.606(b). Collagen casings protect the meat product from oxidation and discoloration by acting 

as a semipermeable membrane for gases, moisture, and other solvents. The casing also provides a more 

desirable bite and texture to meat products as well as aids in

additional flavorings to the product [2019 TR 282-284]. Collagen gel is a more affordable, efficient, and 

sanitary means of manufacturing meat products and increases opportunities to produce a larger variety of 

organic meat products [2019 TR 27-28]. It allows production of single-species products that can meet the 

needs and preferences of different consumer populations.

Manufacture

Collagen is a natural animal protein found in skin, bones, muscle, and connective tissues that is isolated 

from mostly bovine and porcine sources at USDA-inspected facilities following all pertinent regulations. 

The animal-based collagen source is partially hydrolyzed through enzymatic, thermal, or acid treatment 

from meat processing byproducts to cleave the protein. Once cleaved, the collagen extract is decalcified 

and ground to uniformity within the collagen fibers. The collagen fibers are then swollen with an acid 

treatment before the extrusion process.

According to the TR, collagen gel is comprised of 3.0–4.5% collagen, <3% cellulose, and 95.5-97% water. 

Collagen is a naturally occurring protein that is abundant in the connective tissue, bones, blood vessels, 

skin, and muscles of animals. The unique structural properties of collagen’s triple helix provide the 

desirable qualities of high-tensile strength and flexibility important to edible film casings [2019 TR 43-47].

Cellulose is currently approved for use as a synthetic substance in regenerative casings [extruded collagen 

casing that is dried prior to use], as an anti-caking agent (non-chlorine bleached) and filtering aid, and for 

processed products labeled “organic or made with organic,” at 7 CFR 205.605.

Marine collagen is rarely used. Dark coloration and odor have been difficult to overcome. Isolating collagen 

from marine sources are based on processing fish by-products. Sources are not well defined and may vary 

from bones and skins to include viscera and heads [2019 TR 99-102]. At the time of the technical review, 

marine sources of collagen remained largely in research state. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Collagen is listed in the Canadian General Standards Board Permitted Substances List (CAN/CGSB-32.311-

2015) in Table 6.4 as allowed for “ingredients not classified as food additives” in the form of “collagen 

casings.” Collagen casings are required to “be derived from animal sources,” and “if derived from cattle, 

shall be guaranteed free of specified risk materials.” Moreover, collagen casings are permitted to include 

“other ingredients (such as, but not limited to cellulose, calcium coatings, glycerin, etc.) added to collagen 

casings during their manufacture, which remain in the collagen casing.”

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 236 of 267
International Federation of Organic Agriculture Movements (IFOAM)

Not explicitly mentioned

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned

Ancillary Substances

Cellulose powder, derived from plant sources, is an inert substance in collagen gel. Cellulose’s functionality 

is, however, critical once collagen gel has been coextruded into an enrobed extruded sausage. Cellulose 

adds permeability to the sausage’s skin, allowing for the release of the meat emulsion’s oil and fats during 

the sausage’s cooking process. In finished collagen gel, cellulose is present in the range of 2 – 5%, 

depending on targeted product characteristics.

Human Health and Environmental Issues

Collagen gel has no known toxicities and breaks down into its constituent amino acids upon digestion. It has 

no environmental persistence and use of collagen gel is unlikely to have any additional adverse impact on 

the environment.

Discussion 

Collagen gel, added to the National List in 2021, has provided more options for edible films and thus 

created a bigger market for organically produced meat; it is consistent with current regulations. 

Collagen gel is GRAS (Generally Recognized as Safe) for use in meat products.

Questions to our Stakeholders

1. Is there a method of production for nonsynthetic collagen gel?

2. Are organic livestock by-products commercially available for organic collagen gel production?

3. Have advancements been made with testing the viability of marine sourced collagen gel?

Ferrous sulfate

Reference: § 205.605(b) Synthetics allowed

(15) Ferrous sulfate—for iron enrichment or fortification of foods when required by regulation or 

recommended (independent organization).

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; 10/2019 sunset recommendation

Recent Regulatory Background: Renewed 06/06/12 (77 FR 33290); Renewed 03/15/2017 (82 FR 14420); 

Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Ferrous sulfate is commonly added to flours and cereal products to make an optional enriched claim and 

often found in baked products and infant snacks (oat cereal, teething biscuits, etc.). 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 237 of 267
Manufacture

Ferrous sulfate is made by reacting sulfuric acid with iron. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Ferrous sulphate is allowed for use if legally required and may be used, on a voluntary basis, if legally 

allowed. (Table 6.4, Vitamins and mineral nutrients listing, CAN/CGSB-32.311-2020, page 37)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 & 2021/1165

Not explicitly mentioned.

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

Organically Produced Foods (CXG 32-1999)

Not explicitly mentioned.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Not explicitly mentioned.

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned.

Ancillary Substances

The 2015 TR for nutrient vitamins and minerals notes that ferrous sulfate is sometimes encapsulated to 

prevent the iron from catalyzing oxidation reactions that lead to rancidity, color and taste changes, or other 

undesirable effects. It is usually encapsulated in hydrogenated vegetable fat, with lecithin as an optional 

ingredient. 

Human Health and Environmental Issues

Iron is an essential component of hemoglobin, enzymes involved in energy metabolism, and other enzymes. 

Hemoglobin transports oxygen to body tissues. 

Iron deficiency leads to anemia, poor work performance and endurance, persistent cognitive and 

developmental impairment, increased maternal perinatal mortality and a greater rate of premature labor 

and delivery, and depressed immune function. 

However, excess dietary iron can also cause health problems. Accidental overdose of ferrous sulfate drops 

is the most common cause of poisoning deaths in children in the U.S. Chronic excess consumption can 

cause constipation, nausea, vomiting, iron accumulation in the liver, higher cancer risk, and 

hemochromatosis. 

Ferrous sulfate may also be hazardous in cases of skin contact (irritant), eye contact (irritant), ingestion, or 

inhalation. Possibly hazardous short term biodegradation products are not likely. However, long term 

biodegradation products may arise. The products of biodegradation are less toxic than the product itself.

The 2015 TR does not include information on environmental concerns for ferrous sulfate. 

Discussion 

There has been past discussion about whether ferrous sulfate is encompassed within the nutrient vitamins 

and minerals listing or needs to be listed separately. The NOSB recommended identical annotations for 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 238 of 267
ferrous sulfate and nutrient vitamins and minerals in 1995, but they were ultimately listed with different 

annotations. The nutrient vitamins and minerals annotation is broader and would encompass ferrous 

sulfate and potentially allow other uses. However, because of the risks of excess iron consumption, it is 

unlikely that it would be added to products outside the uses currently allowed under the ferrous sulfate 

annotation.

The Subcommittee recommends retaining the current listing. 

Questions to our Stakeholders

Should the individual listing for ferrous sulfate be removed from the National List, with continued use of 

ferrous sulfate allowed under the nutrient vitamins and minerals listing, to eliminate redundancy?

Hydrogen peroxide

Reference: § 205.605(b) Synthetics allowed

(17) Hydrogen peroxide.

Technical Report: 2015 TR (Crops) 

Petition(s): N/A

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

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Hydrogen peroxide (CAS# 7722-84-1) is a very simple molecule with a formula of H2O2. It is a weak acid

but also a strong oxidizer, which makes it an effective microbial pesticide for organic handling purposes.

It is used as a disinfectant, sanitizer, and for post-harvest treatment of produce. USDA organic

regulations currently allow the use of hydrogen peroxide in organic crop production under 7 CFR

§205.601(a) as an algicide, disinfectant and sanitizer, and under 7 CFR 205.601(i) for plant disease

control as a fungicide. Hydrogen peroxide is also permitted for use in organic livestock production as a

disinfectant, sanitizer and medical treatment under 7 CFR 205.603(a). Lastly, synthetic hydrogen peroxide 

may be used as an ingredient in or on processed products labeled as “organic” or “made with

organic (specified ingredients or food group(s))” under 7 CFR 205.605(b).

Manufacture

According to the 2015 TR, commercially available hydrogen peroxide is industrially produced using the

anthraquinone autoxidation (AO) process. The AO method involves initial catalytic reduction of an alkyl

anthraquinone with hydrogen to form the corresponding hydroquinone. Subsequent autoxidation of the

hydroquinone intermediate in air regenerates the anthraquinone with concomitant liberation of

hydrogen peroxide. The simplified overall reaction involves direct combination of gaseous hydrogen (H2)

and oxygen (O2): H2+ O2 → H2O2

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Permitted for many uses including as food-grade cleaners, disinfectants and sanitizers that are

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 239 of 267
allowed without mandatory removal of residues; cleaners, disinfectants and sanitizers allowed on

food contact surfaces including equipment, provided that substances are removed from food contact

surfaces prior to organic production; and as a food-grade processing aid for bleaching proteins and 

starches. 

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed as a processing aid for gelatine. (Annex V, Part A, Section A2, 2021/1165)

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

Organically Produced Foods (CXG 32-1999)

Not explicitly mentioned.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Allowed as an equipment cleanser and disinfectant. (Appendix 4 - Table 2- page 82).

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned.

Environmental Issues

Concentrated solutions may be corrosive to eyes, exposed skin, and mucous membranes. Warnings for

high concentrations include: 

Corrosive. Causes irreversible eye damage. May be fatal if swallowed or absorbed through the skin. Causes 

skin burns or temporary discoloration on exposed skin. Do not breathe vapor. Do not get in eyes, on skin or 

on clothing. Wear protective eyewear such as goggles or face shield. Wash thoroughly with soap and water 

after handling. Remove and wash contaminated clothing before reuse.

Extensive toxicological testing of hydrogen peroxide has been completed, and it is unlikely to cause

chronic systemic toxicity or reproductive, development, or carcinogenic effects. However, chronic

exposure to vapors may damage lungs. Hydrogen peroxide is reported to have low to moderate toxicity

to aquatic invertebrates and no danger to fish. Because hydrogen peroxide is unstable and breaks down

into water and oxygen gas, long-term impacts on the environment are unlikely. According to the 2015 TR, 

some toxic chemicals used to manufacture hydrogen peroxide, including alkyl anthraquinones, aromatic 

solvents and metal catalysts (e.g., nickel and palladium), are removed from the product and can be 

returned to the reactors to make more product. Overall, this material is relatively safe but should be used 

according to FDA, USDA, and EPA labels and regulations.

Ancillary Substances

Other ingredients may include peroxyacetic acid (listed separately on the National List). The 2015 TR 

reports other potential materials present including caprylic acid and mono-and di-potassium salts of 

phosphorous acid, which is an oxidant stabilizer. Phosphorous acid is listed on the EPA Safer Choice list with 

a yellow triangle designation; the yellow triangle means that the chemical has met Safer Choice Criteria for 

its functional ingredient class, but has some hazard profile issues. Specifically, a chemical with this code is 

not associated with a low level of hazard concern for all human health and environmental endpoints (See 

Safer Choice Criteria). While it is a best-in-class chemical and among the safest available for a particular 

function, the function fulfilled by the chemical should be considered an area for safer chemistry innovation.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 240 of 267
Discussion 

Hydrogen peroxide continues to receive strong support from the organic community and has been

consistently relisted on the National List. Oral and written comments submitted for the Spring 2019

NOSB meeting represent hundreds, if not thousands, of crop and livestock farmers and processors who

uniformly support relisting this essential and relatively safe material. When used appropriately, hydrogen 

peroxide should not have adverse impacts on human health and the environment.

Most recently, it was supported by the prior Handling Subcommittee without dissent and was relisted by 

the full NOSB without dissent. Discussion during this sunset cycle at the subcommittee level has focused on 

the need to understand disposal factors for this substance, the essentiality of this material in the overall 

rotation of allowed sanitizers, and whether it has specific value in one sector or another. Questions 

emerged about the fact that the annotation on this substance differs from that on peracetic acid (another 

sanitizer) and why that might be.

Questions to our Stakeholders

1. Is hydrogen peroxide an alternative to other more problematic sanitizers?

2. Do certifiers allow it to be used in direct contact with products?

Nutrient vitamins and minerals

Reference: § 205.605(b) Synthetics allowed

(20) Nutrient vitamins and minerals, in accordance with 21 CFR 104.20, Nutritional Quality 

Guidelines For Foods.

Technical Report: 1995 TAP - Minerals; 1995 TAP - Vitamins; 2015 TR

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 03/2011 Handling 

Subcommittee Proposal; 04/2011 sunset recommendation; 10/2015 sunset recommendation; 10/2019 

sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

This listing allows nutrient vitamins and minerals to be added to organic food in accordance with 21 CFR 

104.20, which is the U.S. Food and Drug Administration’s (FDA) fortification policy. That policy lays out 

principles intended to serve as a model for the rational addition of nutrients to food and promote a 

balanced and nutritious food supply, while avoiding over- or under- fortification of consumer diets. It 

outlines situations in which it may be appropriate to add nutrients to food, including certain situations 

where needed to correct a dietary insufficiency recognized by the scientific community to exist and known 

to result in nutritional deficiency; to restore nutrients lost in storage, handling, or processing; to avoid 

nutritional inferiority of a food that replaces a traditional food; as well as where required by regulation. It 

states that FDA does not encourage indiscriminate addition of nutrients to foods, nor does it consider it 

appropriate to fortify fresh produce; meat, poultry, or fish products; sugars; or snack foods such as candies 

or carbonated beverages. Manufacturers are urged to use these principles to design fortified foods. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 241 of 267
The 2015 TR breaks this umbrella listing into five categories: fat-soluble vitamins (Vitamins A, D, E, K, 

carotenoids), water-soluble vitamins (Vitamins C, B1, B2, B6, B12, niacin, folate, pantothenic acid, biotin, 

choline, inositol), trace mineral elements (chromium, copper, iodine, iron, manganese, molybdenum, 

selenium, zinc), major minerals in bone (calcium, phosphorus, magnesium, fluorine), and major electrolyte 

minerals (potassium, sodium, chloride).

Manufacture

Because this listing encompasses a wide range of substances with nutritional value, the processes used to 

create them also vary widely. Vitamins can be extracted from food, synthesized, produced via 

fermentation, or some combination of these methods. Of note, fermentation methods may involve 

genetically engineered microorganisms. Minerals are pulled from the environment, including brines, salt 

deposits, and mineral ores. 

International Acceptance

In addition to the categorical listings described below, all international standards also individually list some 

substances that may be considered vitamins and minerals (i.e. ascorbic acid or calcium carbonate). 

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Vitamins and mineral nutrients are allowed as ingredients not classified as food additives in three 

situations:

1. Shall be used if legally required (e.g., fluid milk, white flour, infant formula, meal replacement, etc.).

2. The following non-dairy substitute products may be fortified on a voluntary basis, if legally 

permitted: plant-based beverages, products that resemble cheese, and butter substitutes.

3. Ferrous sulphate shall be used if legally required and may be used, on a voluntary basis, if legally 

permitted. 

European Economic Community (EEC) Council Regulation, EC No. 2018/848 & 2021/1165

Vitamins are allowed in the processing of food if their use is legally required. (Annex II, Part IV, 2.2.2 (f), 

2018/848)

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

Organically Produced Foods (GL 32-1999)

Vitamins and minerals are allowed if their use is legally required in the food products in which they are 

incorporated. (3.5, page 29)

International Federation of Organic Agriculture Movements (IFOAM)

Minerals (including trace elements), vitamins, essential fatty, amino acids, and other isolated nutrients 

allowed when their use is legally required or strongly recommended in the food products in which they are 

incorporated. (Processing and Handling, page 19)

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned.

Ancillary Substances

The 2015 TR states that ancillary substances are used to limit oxidation and promote even distribution of 

fat-soluble vitamins. Substances used to limit oxidation may include tocopherols, fat-soluble ascorbic acid 

(ascorbyl palmitate), carotenoids (e.g., beta carotene), and GRAS synthetic chemical antioxidants (BHT, 

BHA, PG, and TBHQ). Fat-soluble vitamin materials usually can be obtained free of BHT, BHA, PG, and TBHQ. 

Emulsifiers like lecithin are used to disperse fat-soluble vitamins in baby formula, and microencapsulation in 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 242 of 267
starch, gums, gelatin, casein, and a wide range of other GRAS substances help with dispersion in other 

foods. Encapsulation is also used to protect and disperse water-soluble vitamins and minerals in substances 

including fats, waxes, and cellulose. Many, but not all, of these substances are included on the National List.

Human Health and Environmental Issues

The 2015 TR does not identify significant human or environmental issues connected with this categorical 

listing. 

Discussion 

The NOSB’s original 1995 recommendation for the nutrient vitamins and minerals listing included this 

annotation: “Accepted for use in organic foods for enrichment or fortification when required by regulation 

or recommended by an independent professional organization,” but the final rule published in 2000 (65 FR 

13512) included the current annotation, which references FDA’s fortification policy.

The Board and NOP have considered various proposals to change this listing to align more closely with the 

NOSB’s original recommendation, to specifically address concerns about fortification of infant formula, and 

to consider nutrients that may fall in gray areas. According to the Board’s 2019 sunset recommendation, in 

2011 the Handling Subcommittee proposed to change the annotation at sunset but received approximately 

2000 comments against it. The Subcommittee withdrew the proposal prior to the April 2011 NOSB meeting, 

and the NOSB supported relisting with the existing annotation for the 2012 sunset review. 

Several subsequent actions were considered, but nothing further appears to have progressed after the 

current listing was retained in the 2021 sunset, in alignment with the Board’s 2019 recommendation. 

Specifically, no action has been taken to:

• Act on the 2016 Handling Subcommittee discussion document, which outlined several options for 

annotation changes.

• Finalize or withdraw the January 12, 2012 Proposed Rule (77 FR 1979), which would have changed 

the listing to: “Vitamins and minerals. For food- vitamins and minerals identified as essential in 21 

CFR 101.9. For infant formula-vitamins and minerals as required by 21 CFR 107.100 or §107.10.” 

NOP published an Interim Rule on September 27, 2012 (77 FR 59287), effective October 21, 2012, 

which renewed the current listing until completion of the Proposed Rule.

It appears that there has not been sufficient public demand or regulatory challenge to carry through 

with changes to this listing. The current reference to 21 CFR 104.20 in the annotation essentially 

commits the use of nutrient vitamins and minerals to an organic food manufacturer’s discretion, within 

the principles the FDA has set out. 

The subcommittee recommends retaining the current listing. 

Questions to our Stakeholders

1. Are you aware of nutrient vitamins and minerals being used in organic products in ways that do not 

conform to 21 CFR 104.20?

2. Are there any remaining issues with fortification of infant formula that have not been resolved?

3. Do certifiers find the current annotation enforceable? Are there any particular substances in this 

category that are being allowed or prohibited inconsistently? 

4. Are certifiers reviewing ancillary substances for nutrient vitamins and minerals in accordance with 

the Spring 2016 NOSB recommendation? Are they imposing limits on ancillary substances that may 

be present?

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 243 of 267
5. Are there any specific substances included in this categorical listing that pose health or 

environmental concerns requiring closer review?

Peracetic acid/Peroxyacetic acid

Reference: § 205.605(b) Synthetics allowed

(22) Peracetic acid/Peroxyacetic acid (CAS # 79-21-0)—for use in wash and/or rinse water according 

to FDA limitations. For use as a sanitizer on food contact surfaces.

Technical Report: 2000 TAP; 2016 TR

Petition(s): 2008 Petition (Crops)

Past NOSB Actions: 11/2000 recommendation (Periacetic [sic] acid p. 467); 04/2004 resolution (periacetic 

[sic] acid p. 2740); 11/2009 sunset recommendation; 04/2015 sunset recommendation; 10/2019 sunset 

recommendation. 

Recent Regulatory Background: Added to National List with annotation 9/11/2006 (71 FR 53299); Renewed 

8/03/2011 (76 FR 46595); Renewed 09/12/2016 (81 FR 8821); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026 

Subcommittee Review

Use 

Peracetic acid (CAS # 79-21-0) is currently allowed for use in organic handling in wash water and rinse

water, including during post-harvest handling, to disinfect organically produced agricultural products

according to FDA limitations, and to sanitize food contact surfaces, including dairy-processing equipment 

and food-processing equipment and utensils. It is an important sanitizer used in organic handling. It is 

widely used as a sanitizer on food contact surfaces and as a disinfectant for fruits and vegetables.

Peracetic acid/Peroxyacetic acid was added to the National List at §205.605(b) on September 12, 2006, 

with the annotation, “for use in wash and/or rinse water according to FDA limitations. For use as a 

sanitizer on food contact surfaces.” It is also on the National List at §205.601 and §205.603 for use in 

crops and livestock, respectively. Peracetic acid disinfects by oxidizing the outer cell membrane of 

vegetative bacterial cells, endospores, yeast, and mold spores, making it an effective sanitizer against all 

microorganisms, including bacterial spores. The end products of peracetic acid oxidation are acetic acid 

and water.

Manufacture

According to the 2016 technical report (TR), solutions of peracetic acid used as sanitizers are created by

combining aqueous mixtures of two substances: acetic acid (the acid in vinegar) and hydrogen peroxide.

At cool temperatures, acetic acid and hydrogen peroxide react over a few days to form an equilibrium

solution containing peracetic acid, acetic acid, and hydrogen peroxide. The equilibrium solution is the

substance sold commercially as the sanitizer “peracetic acid.” Solutions of peracetic acid, hydrogen

peroxide, acetic acid and water are produced by reacting glacial acetic acid with hydrogen peroxide,

often in the presence of a catalyst such as a mineral acid (e.g., sulfuric acid). Commercial grades are

available in concentrations ranging from about 0.3 to 40% by weight. A peracetic acid solution can also

be generated in situ by dissolving an activator and a persalt in water or on site by adding sodium

hydroxide to triacetin and hydrogen peroxide.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 244 of 267
International Acceptance

Canadian General Standards Board Permitted Substances List

Not explicitly mentioned for processed products. On food and plants, peracetic acid may be used in wash or 

rinse water and on food contact surfaces. (Table 7.3, page 42)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 & 2021/1165

Allowed for cleaning and disinfection. (Annex IV, Part D, 2021/ 1165) 

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

Organically Produced Foods (CXG 32-1999)

Not explicitly mentioned for processed products.

International Federation of Organic Agriculture Movements (IFOAM) Norms

Allowed as an equipment cleanser and disinfectant. (Appendix 4, Table 2, page 82)

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned.

Environmental Issues

Peracetic acid likely has no significant environmental impacts. Like other oxidative sanitizers (i.e.,

chlorine compounds), concentrated solutions of peracetic acid are strong irritants to the skin, eyes,

mucous membranes, and respiratory system. As reviewed in the TR, when using fully diluted sanitizing

solutions, no special eye, hand, skin, or respiratory protective equipment is normally required. No risk

through dietary exposure is anticipated. All uses of this material should be consistent with FDA, USDA,

and EPA labels and regulations and utilize personal protective equipment as needed.

Ancillary Substances

HEDP (1-hydroxyethylidene-1,1- diphosphonic acid) and dipicolinic acid (2,6- 

pyridinedicarboxylic (DPA) are added to peracetic acid solutions to chelate metals, especially iron,

copper and manganese, because decomposition of peracetic acid and, thus, loss of sanitizing power is

accelerated by these impurities. However, in past reviews, stakeholders did not declare the inclusion of

ancillary substances (see below).

Discussion 

Peracetic acid has been relisted each time it was reviewed during the sunset review process. There has

been strong support for continued availability of this material. Oral and written comments submitted for

the Spring and Fall 2019 NOSB meetings represent hundreds, if not thousands, of crop and livestock 

farmers and

processors who uniformly support relisting this essential and relatively safe material. In particular, many

processors identified the need for a “no-rinse” material as essential for treating equipment and other

food contact surfaces. Overall, this material is considered effective and offers a less toxic profile then

several other sanitizing materials, including many chlorine compounds. The TR does not offer new

evidence of unacceptable adverse impacts on human health or the environment. 

During the last sunset review, use of a synthetic stabilizer such as 1-hydroxyethylidene-1,1- diphosphonic 

acid (HEDP) or 2,6- pyridinedicarboxylic (dipicolinic) acid to slow the rate of oxidation or decomposition 

were judged to be “inerts” for EPA registration as an antimicrobial and not subject to review as an ancillary 

substance. However, comments submitted for the Spring 2019 meeting that at least “dipicolinic acid is a 

former List 3 ‘inert’ and not allowed in products used in organic production” and identifies additional 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 245 of 267
“inert” materials that warrant review. Only products with allowable “inert” ingredients should be used.

Most recently, it was supported by the prior Handling Subcommittee without dissent and was relisted by 

the full NOSB without dissent.

Discussion during this sunset cycle at the subcommittee level has focused on the need to understand 

disposal factors for this substance, the essentiality of this material in the overall rotation of allowed 

sanitizers, whether it has specific value in one sector or another, and how stakeholders might become more 

open to using sanitizers like peracetic acid that are less corrosive without losing efficacy. Questions 

emerged about the fact that the annotation on this substance differs from that on hydrogen peroxide 

(another sanitizer) and why that might be.

Questions to Stakeholders

None

Potassium citrate

Reference: § 205.605(b) Synthetics allowed

(25) Potassium citrate.

Technical Report: 1995 TAP; 2015 TR; 2023 Limited Scope TR pending

Petition(s): N/A

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

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Potassium and sodium citrate are used as ingredients where they function as acidulants, pH controls, 

flavoring agents, sequestrants, and buffering or emulsifying agents. Potassium citrate is used to replace 

sodium citrate whenever a low sodium content is desired. The three citrates are also used as dispersants in 

flavor or color additives, and to wash processing equipment to remove off flavors. 

Potassium citrate is commonly used in biscuits, baby food, soup mixes, soft drinks, and fermented meat.

Manufacture

Citric acid is a naturally-produced, non-volatile organic acid with a long history of use in food processing. 

The 2015 TR considered production of citric acid by microbial fermentation with Aspergillus niger or 

Candida yeasts from carbohydrate sources, but includes additional information regarding production from 

plant sources. 

Note that the process that creates citric acid is fermentation of carbohydrates. In terms of concern about 

excluded methods, the 2015 TR indicates that the organisms underlying the fermentation process are 

considered ‘classical mutants,’ and further notes that the prohibition on excluded methods in food by the 

European countries suggests the underlying citric acid is unlikely to include carbohydrates that have 

manipulated genes. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 246 of 267
The citrate salts – calcium citrate, potassium citrate and sodium citrate – are all derived from citric acid. The 

citrate salts are produced by chemical reaction with citric acid and the hydroxide or carbonate of the 

respective salt (calcium, sodium or potassium). 

Potassium citrate is the potassium salt of citric acid. It is prepared by neutralizing citric acid with potassium 

hydroxide or potassium carbonate and subsequent crystallization. It is most commonly found in the 

monohydrate form. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as food additives. (Table 6.3, CAN/CGSB-32.311-2020, page 33)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned.

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned

https://www.ifoam.bio/our-work/how/standards-certification/organic-guarantee-system/ifoamnormsInternational Federation of Organic Agriculture Movements (IFOAM)

Allowed as an additive. (Appendix 4 – Table 1 – page 79)

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned

Ancillary Substances

None

Human Health and Environmental Issues

There are no expected significant human health impacts or remarkable environmental issues, according to 

the 2015 TR. 

Discussion 

The bulk of the discussion about this product addresses the production process for citric acid. The 

Subcommittee supports relisting.

Questions to our Stakeholders

Is there any information we should consider regarding the sunset of this substance?

Potassium phosphate

Reference: § 205.605(b) Synthetics allowed

(28) Potassium phosphate—for use only in agricultural products labeled “made with organic 

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

Technical Report: 1995 TAP; 2016 TR

Petition(s): N/A

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 247 of 267
Past NOSB Actions: 04/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Potassium phosphate can be used as a pH control in milk and dairy products, to make acidified milk 

products and in milk protein stabilization. Potassium phosphate interacts with milk proteins, such as casein, 

to function as emulsifiers that prevent the separation of fat and water in cheese that stabilize milk and 

cheese by chelating (“sequestering”) calcium. [2016 TR, pgs. 4, 6] 

Potassium phosphate can also be used as a nutritional additive for a source of potassium and as a nutrient 

in yeast. It can also be used in prepared meat applications and liquid eggs. The 1995 Technical Advisory 

Panel report (TAP) included a recommendation to list this material as an approved synthetic in products 

labeled “organic,” but was only approved for use in “made with” products.

Manufacture

The 1995 TAP noted potassium phosphates are isolated from brines or salt deposits. However, the 2016 TR 

explained the manufacturing process to be as follows: All of the orthophosphate derivatives of potassium 

can be generated by neutralization of phosphoric acid with potassium hydroxide (Budavari 1996). 

Phosphoric acid is produced by treating phosphate rock (tricalcium phosphate) with sulfuric acid, forming 

phosphoric acid and calcium sulfate (Budavari 1996). Potassium hydroxide is obtained commercially from 

the electrolysis of potassium chloride solution in the presence of a porous diaphragm. [2016 TR, Table 5]

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as ingredients classified as food additives. For use in products whose contents are ≥ 70% and < 95% 

organic ingredients. (Table 6.3, CAN/CGSB-32.311-2020, page 33)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned

International Federation of Organic Agriculture Movements (IFOAM)

Not explicitly mentioned

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned

Ancillary Substances 

Not identified

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 248 of 267
Human Health and Environmental Issues

During the last sunset review commenters noted a concern with the use of phosphates in production of 

processed foods and that phosphorus may not appear on the nutritional panel making it difficult to be 

informed about total phosphorous intake– although they would appear on the ingredient list. There were 

concerns raised about the cumulative health impacts of phosphorous additives in food and in 2015 the 

NOSB requested a technical review and work agenda item to study this issue further. According to the 2016 

TR, most dairy foods naturally contain substantial amounts of both sodium and phosphorus from the milk, 

the small incremental amount of sodium and phosphorus contributed by a sodium phosphate stabilizer 

may exempt sodium phosphate from the requirement to be declared as an ingredient on the label; FDA 

requires more labeling in hypoallergenic foods and infant foods [2016 TR138-140]). The TR indicates that 

small amounts of sodium phosphates may not cause human health problems, but long-term cumulative 

impacts are not fully understood.

Discussion 

Concerns were based on peer reviewed research indicating that the cumulative effects of phosphates as a 

group contributing to renal damage and failure, osteoporosis, and heart failure. Sodium phosphate was 

reviewed in 2017 and the NOSB came to the following conclusion: No single phosphate food additive or 

ingredient can be implicated as an isolated risk factor. Concerns arise from the increase in cumulative use 

of phosphates and possible health effects on the general population. 

Questions to our Stakeholders

1. Are there any new studies supporting the link between potassium phosphate and health issues?

2. Are there any new alternatives?

Sodium acid pyrophosphate

Reference: § 205.605(b) Synthetics allowed

(30) Sodium acid pyrophosphate (CAS # 7758-16-9)—for use only as a leavening agent.

Technical Report: 2001 TAP (Sodium Phosphates); 2010 TR; 2016 TR

Petition(s): 2002; 2007 (Petition for expanded use) 

Past NOSB Actions: 05/2003 recommendation; 11/2009 sunset recommendation; 04/2011 

recommendation; 10/2019 sunset recommendation

Regulatory Background: Added to National List 09/12/06 (71 FR 53299); Renewed 8/03/2011 (76 FR 

46595); Renewed 09/12/16 (81 FR 8821); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026 

Subcommittee Review

Use 

The 2010 Technical Report (TR) indicates that sodium acid pyrophosphate is used in conventional foods as a 

chemical leavening agent in baked goods; a sequestrant (chelating agent) to maintain the appearance of 

cooked and uncooked fruits and vegetables, particularly processed potatoes; an emulsifying agent and 

stabilizer in cheeses and related products; an inhibitor of struvite formation in canned tuna; and a curing 

accelerator in processed meat and poultry products [2010 TR 36-40]. . The NOP regulations at 7 CFR 

205.605(b) limit the use of sodium acid pyrophosphate in organic foods to use only as a leavening agent. 

Sodium acid pyrophosphate is used as a component of chemical leavening agents (“baking powder”). 

In some meat- and poultry-containing processed foods, sodium acid pyrophosphate is used to accelerate 

color fixing or to preserve color during storage of cured pork and beef cuts, cured poultry, and cured 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 249 of 267
comminuted poultry and meat food products. However, in organic foods, sodium acid pyrophosphate is 

permitted solely for leavening, so this color-fixing use is not permitted.

Manufacture

Sodium carbonate is reacted with phosphoric acid to form monosodium phosphate, followed by heating 

the monosodium carbonate to 220oC to form sodium acid pyrophosphate. It is expressed by the formula 

Na2H2P2O7 and is composed of 20.72% Na, 0.91% H, 27.91% P, and 50.46% O. Sodium is isolated from 

brines or salt deposits. Phosphorous is isolated from phosphate rock. Food grade phosphates are formed by 

reacting purified phosphoric acid with sodium, potassium, or calcium hydroxides.

International Acceptance 

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed in ingredients classified as food additives. For use as a leavening agent. (Table 6.3, CAN/CGSB32.311-2020, page 34)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned

International Federation of Organic Agriculture Movements (IFOAM)

Not explicitly mentioned

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned

Ancillary Substances

None identified 

Human Health and Environmental Issues

The 2016 technical report (TR) on phosphates includes extensive discussion on the impact of phosphorous 

on the human diet, with particular focus on health effects of phosphorous provided by phosphate additives 

versus natural phosphorous in foods. Added phosphorous, as is found in sodium acid pyrophosphate, is 

immediately and completely bioavailable upon consumption whereas “food” phosphorous is much less 

available. High blood phosphate levels are associated with kidney and vascular disease. A sufficiently high 

intake of calcium appears to counteract some of the ill effects of excess dietary phosphorus but leads to an 

increased requirement for magnesium. Due to the restrictions on phosphate use in organic foods, it would 

be expected that basing a diet on organic foods would reduce phosphorus intake.

Discussion 

Yeast is a natural leavener but results in a different physical texture and requires more time than 

chemically-leavened foods. Chemical leavening is used instead of yeast for products where fermentation 

flavors would be undesirable or where the batter lacks the elastic structure to hold gas bubbles for more 

than a few minutes such as found with muffins, pancakes and cookies. 

Many manufacturers made comments during the 2019 sunset review about essentiality of this material 

because it is the only chemical leavening agent available. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 250 of 267
The Subcommittee is interested to know if there has been any more definitive research linking this material 

to human health issues.

Questions to our Stakeholders

1. Are there any new health studies regarding phosphorous consumption? 

2. Are there any new alternatives to this material?

Sodium citrate

Reference: § 205.605(b) Synthetics allowed

(31) Sodium citrate.

Technical Report: 1995 TAP; 2015 TR; 2023 Limited Scope TR pending

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; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Potassium and sodium citrate are used as ingredients where they function as acidulants, pH controls, 

flavoring agents, sequestrants, and buffering or emulsifying agents. Potassium citrate is used to replace 

sodium citrate whenever a low sodium content is desired. These materials are also used as dispersants in 

flavor or color additives, and to wash processing equipment to remove off flavors. 

Sodium citrate is used as an emulsifier in dairy products to keep fats from separating, and in cheese making 

where it allows the cheeses to melt without becoming greasy. 

Sodium citrate is chiefly used as a food additive, usually for flavoring or as a preservative. Sodium citrate 

gives club soda both its sour and salty flavors. It is common in lemon-lime soft drinks, and it is partly what 

causes them to have their sour taste. Additionally, it is used in jams, jellies, meat products, baby foods, and 

milk powder. 

Manufacture

Citric acid is a naturally-produced, non-volatile organic acid with a long history of use in food processing. 

The 2015 TR considered production of citric acid by microbial fermentation with Aspergillus niger or 

Candida yeasts from carbohydrate sources, but includes additional information regarding production from 

plant sources. 

Note that the process that creates citric acid is fermentation of carbohydrates. In terms of concern about 

excluded methods, the 2015 TR indicates that the organisms underlying the fermentation process are 

considered ‘classical mutants,’ and further notes that the prohibition on excluded methods in food by the 

European countries suggests the underlying citric acid is unlikely to include carbohydrates that have 

manipulated genes. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 251 of 267
The citrate salts – calcium citrate, potassium citrate and sodium citrate – are all derived from citric acid. The 

citrate salts are produced by chemical reaction with citric acid and the hydroxide or carbonate of the 

respective salt (calcium, sodium or potassium). 

Sodium citrate is the sodium salt of citric acid. It is prepared by neutralizing citric acid with sodium 

hydroxide or sodium carbonate and subsequent crystallization. It is most commonly found in the anhydrous 

or dihydrate forms. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as food additives. (Table 6.3, CAN/CGSB-32.311-2020, page 34)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed as a food additive and processing aid in products of plant and animal origin. (Annex V, Part A, A1, 

2021/1165)

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

Organically Produced Foods (GL 32-1999)

Sodium Dihydrogen Citrate is not allowed in food of plant origin. Allowed in milks/cream, dairy-based 

drinks, unripened cheese, and yogurt as a stabilizer only. Allowed in processed cheese as an emulsifier only. 

Allowed in whey and whey products; excluding whey cheeses; processed meat; poultry, and game 

products; and egg white products. (page 25)

International Federation of Organic Agriculture Movements (IFOAM)

Allowed as an additive. (Appendix 4 - Table 1 - page 79)

Japan Agricultural Standard (JAS) for Organic Production

Sodium citrate is allowed, but limited to use for dairy products, or for albumen and sausage as 

low temperature pasteurization. 

Ancillary Substances

None

Human Health and Environmental Issues

There are no expected significant human health impacts or remarkable environmental issues, according to 

the 2015 TR.

Discussion 

The bulk of the discussion about this product addresses the production process for citric acid. The 

Subcommittee supports relisting.

Questions to our Stakeholders

Is there any information we should consider regarding the sunset of this substance?

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 252 of 267
Tocopherols

Reference: § 205.605(b) Synthetics allowed

(36) Tocopherols—derived from vegetable oil when rosemary extracts are not a suitable 

alternative. 

Technical Report: 1995 TAP; 2015 Limited Scope TR; 2023 Limited Scope TR pending

Petition(s): N/A

Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 04/2011 sunset 

recommendation; 10/2015 sunset recommendation; 09/2016 Handling Subcommittee proposal to add

listing; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Synthetic tocopherols are currently permitted for use in organic agriculture handling/processing as an 

antioxidant ingredient in foods (2015 TR). Tocopherols are added to foods to help prevent oxidation of the 

fatty acids present in the lipid components of the food. Tocopherols derived from vegetable oil are allowed 

for use as ingredients in or on processed products labeled as “organic” or “made with organic (specified 

ingredients or food group[s])” when rosemary extracts are not a suitable alternative (7 CFR 205.605[b]).

Manufacture

Tocopherols are a group of lipophilic phenolic antioxidants that occur naturally in a variety of plant species. 

Sources of naturally-occurring tocopherols include cereal grains, oilseeds, nuts, and vegetables. As 

described in the 2015 TR, tocopherols are separated from the other compounds in the oil distillate by 

multiple extraction and refining steps. These steps can include solvent extraction, chemical treatment, 

crystallization, complexation, and vacuum or molecular distillation. The total tocopherol content of the 

resulting product is usually 30 - 80%. Liquid forms of mixed tocopherols are commercially available diluted 

in vegetable oils and are also available as mixtures with rosemary extracts, ascorbyl palmitate/ascorbic 

acid, lecithin and/or citric acid. Powdered forms of tocopherols are produced by spray-drying the liquid 

tocopherol oils onto a carrier or mixture of carriers. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as ingredients classified as food additives. Tocopherols may be derived from vegetable oil when 

rosemary extract is not a suitable alternative. (Table 6.3, CAN/CGSB-32.311-2020, page 34)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed as an antioxidant in products of plant & animal origin. (Annex V, Part A, Section A1, 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Natural tocopherols allowed. (Table 3 - page 24)

International Federation of Organic Agriculture Movements (IFOAM)

Allowed as a processing/post-harvest handling aid if from a natural source. (Appendix 4 - Table 1 - page 79)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 253 of 267
Japan Agricultural Standard (JAS) for Organic Production

Allowed as an additive when used in products of livestock origin. Limited to the use in processed meat. 

(Appended Table 1)

Ancillary Substances

The following ancillaries were listed in the 2015 TR: sunflower oil, soybean oil, gum acacia, sterols, 

squalene, monodiglycerides, calcium carbonate, silica, rice maltodextrin, organic sunflower oil, tapioca 

starch. The 2015 TR also listed “unknown” in the ancillary column for several tocopherol products. [2015 

TR, Table 1]

Human Health and Environmental Issues

Environment: Tocopherols are abundant in plant tissues and therefore are naturally abundant in the 

environment. Potential contamination could result from the manufacturing process of tocopherols if 

organic solvents and other chemicals are used. If these are released into the environment through waste 

streams, then environmental contamination could occur. The 2015 TR found no sources that discussed the 

possible persistence of tocopherols in the environment nor that concentrations of tocopherols or its 

breakdown products were present in the environment. [2015 TR 476-486]

Human Health: GRAS. It is unlikely that the use of tocopherols as an antioxidant in foods is harmful to 

human health. Tocopherols are a natural part of the human diet, with a large portion coming from naturally 

present in vegetable oils [2015 TR 507-509]

Discussion 

During previous reviews, the Board has consistently relisted tocopherols due to their wide use in many 

processed foods even though stakeholders have been divided about relisting. 

Those in favor stated that tocopherols are critically essential to maintaining food safety, preventing 

rancidity, and providing nutrients to their products, and that rosemary oil imparted off flavors or fragrances 

to their products that were not acceptable to consumers. 

Those opposed stated that the material’s primary use is as a preservative and therefore inconsistent with 

organic production, along with the assertion that non-synthetic tocopherols are commercially available and 

should be used instead of synthetic. 

At the Fall 2019 meeting, the 2017 decision by the Handling Subcommittee to not move forward with an 

annotation change was reiterated, noting that if there were sufficient commercial availability of 

tocopherols in another form that members of the public were encouraged to submit a petition.

The Handling Subcommittee requested a limited scope TR to address the following: update to evaluation 

questions 1, 2, 3 and 13 to clarify the different manufacturing process of non-synthetic and synthetic 

tocopherols, as well as the commercial availability of the different forms (non-synthetic vs. synthetic). The 

Handling Subcommittee did not receive the TR in time to include into this document. The information in the 

TR will be discussed during the spring 2024 board meeting and be included in the fall proposal document.

Questions to our Stakeholders

1. Are organic tocopherols commercially available?

2. Is there an adequate and suitable supply of non-synthetic tocopherols to meet commercial needs?

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 254 of 267
Celery powder

Reference: § 205.606 Nonorganic agriculturals allowed

(c) Celery powder

Technical Report: N/A

Petition(s): 2007 Petition

Past NOSB Actions: 03/2007 NOSB recommendation; 04/2010 sunset recommendation; 10/2015 sunset 

recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Celery powder serves a dual purpose in the formulation of meat products. In addition to flavor, its

primary function is as a natural source of nitrate which cures meat without relying on synthetic nitrates

and nitrites and has been used in this application for millennia. There are other vegetables and

minerals which contain natural nitrates including beets, spinach, and sea salt. Although each has its

benefits and challenges, none is an ideal substitute for natural celery powder in quality, form, and

function.

In the organic sector, celery powder is used in a variety of processed meat products (hot dogs, bacon, ham, 

corned beef, pastrami, pepperoni, salami, etc.) to provide “cured” meat attributes without using prohibited 

nitrites. Celery powder is naturally high in nitrates that are converted to nitrites during fermentation by a 

lactic acid culture. Celery powder and the presence of nitrate and nitrites protects against spoilage (as an 

antioxidant) and also reduces risk from food borne pathogens, including clostridium botulinum, which 

produces botulin toxin. Celery powder is used in place of synthetic chemical nitrate and nitrite which are 

not currently permitted in U.S. organic agriculture. Although functionally similar to the use of synthetic 

nitrate and nitrite, meat products processed with celery powder must be labeled “uncured.”

Manufacture 

Celery is cleaned, macerated, physically separated (liquid/solid), and the liquid is concentrated by

evaporation, then heated and vacuum dried. According to the original 2007 petition, 0.2-0.5% celery 

powder and 0.01-0.5% of lactic acid starter culture are used to convert the nitrates to nitrite and thus 

create the curing agent. According to the Kerry Inc. patent

(https://patentimages.storage.googleapis.com/1b/75/a5/082eb2538620f2/US20080305213A1.pdf), “the 

curing agent can further comprise additional components, including but not limited to, yeast extract, 

protein hydrolyzates, amino acids, vitamins, minerals, and carbohydrates. Prior to the conversion of nitrate 

to nitrite, the pH and salt content of the plant material can be adjusted with the addition of a suitable acid, 

base, salt, or combination thereof. The plant material can be subjected to additional processing steps prior 

to conversion of nitrate to nitrite. Such processing steps can include, but are not limited to, heat treatment, 

filter sterilization, or a process which reduces the initial microbial load.” Celery powder is typically 

standardized to a specific nitrite content. See discussion below for more information about source material.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 255 of 267
Allowed as food additives: Extracts, juice, or cultured powder of celery or chard are allowed. Shall be 

organic if commercially available. (Table 6.3, Meat curing agents listing, CAN/CGSB-32.311-2020, page 33)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned, although sodium nitrate (an alternative to celery powder) is allowed.

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

Organically Produced Foods (CXG 32-1999)

Not explicitly mentioned

International Federation of Organic Agriculture Movements (IFOAM) Norms

Not explicitly mentioned

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned

Environmental Issues

Nonorganic celery is used to produce celery powder, with concomitant use of allowed conventional 

pesticides and fertilizers. These materials may pose risks to workers, consumers and the environment. 

Additionally, health concerns have been raised about the use of synthetic nitrates and nitrites in processed 

meats (allowed in the European Union). For example, the International Association for Research in Cancer 

(IARC) listed processed meats as carcinogenic to humans due to the formation of nitrosamines, albeit with 

low potency, and the review committee was not unanimous. In terms of human health risks from 

nitrates/nitrites in food, there is no difference between celery or other plant- based nitrate sources versus 

synthetic nitrates and nitrites used on non-organic meats. In summary, nitrates and nitrites from celery 

powder would pose similar risks. Nitrates in food may provide some health benefits. For example, 

formation of nitrous oxide may result in lowered blood pressure and better cardiovascular function.

Ancillary Substances

Possibly materials listed in the patent and 2007 petition: “including but not limited to, yeast extract, protein 

hydrolyzates, amino acids, vitamins, minerals, and carbohydrates.”

Discussion 

In the organic sector, celery powder is used in a variety of processed meat products (hot dogs, bacon, 

ham, corned beef, pastrami, pepperoni, salami, etc.) to provide “cured” meat attributes without using 

prohibited nitrites. Celery powder is naturally high in nitrates that are converted to nitrites during 

fermentation by a lactic acid culture. 

Concerns were raised about the direct dependence on a conventionally grown agricultural product in 

organic trade and concomitant impacts on human health and the environment. Particular concerns have 

been raised about the possibility of enhanced use of nitrate fertilizers to “supercharge” the product used 

for celery powder manufacture.

In lieu of a technical report, a celery powder expert panel was convened for the April 2019 NOSB 

meeting. Experts spoke to key questions addressing nitrate safety, organic celery powder production, 

processing and manufacture of celery powder, progress toward organically sources celery or other 

substrates that could be used process organic meats, and the scale of the organic processed meat 

industry. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 256 of 267
Overall, trade and industry members of the organic community supported relisting of celery powder at 

§205.606, with the caveat that more research is needed to produce a viable organic alternative. Given 

the importance of the organic processed meat industry, public and NOSB comments encouraged the 

USDA to fund additional research to develop organic alternatives to conventionally produced celery 

powder. It continues to be included in the Handling Subcommittee’s annual research priorities (most 

recently on the approved proposal from the Fall 2023 NOSB meeting).

Celery powder was recommended for relisting by the NOSB in 2015 on a split vote (9-5). It was 

recommended by the Handing Subcommittee for relisting in 2019 with no dissent and relisted by the full 

Board with one member in dissent.

Discussion during the current sunset cycle has focused on questions of ancillary substance review, 

fermentation, and an interest in understanding environmental impacts from conventional celery 

production.

Questions to our Stakeholders

1. Is there stakeholder concern about ongoing non-specified ancillary substances used in this 

material? 

2. Is organic supply commercially available for this material? What are the barriers to organic 

production?

3. Is the organic version of the same caliber as the nonorganic?

Fish oil

Reference: § 205.606 Nonorganic agriculturals allowed

 (f) Fish oil (Fatty acid CAS #'s: 10417–94–4, and 25167–62–8)—stabilized with organic 

ingredients or only with ingredients on the National List, §§ 205.605 and 205.606

Technical Report: 2015 TR

Petition(s): 2007

Past NOSB Actions: 03/2007 recommendation; 04/2010 sunset recommendation; 10/2015 sunset 

recommendation; 10/2019 sunset recommendation

Recent Regulatory Background: Added to NL 6/21/2007 (72 FR 35137); Renewed 06/06/12 (77 FR 33290); 

Renewed 03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Fish oil is currently included on the National List as a nonorganically produced ingredient allowed in or on 

processed products labeled as “organic” when the substance is not commercially available in organic form 

(7 CFR 205.606). FDA GRAS notices (GRNs) exist for several variations of the term fish oil. 

• fish oil concentrate (GRN 105) 

• fish oil (GRN 138) 

• fish oil (predominantly sardine and anchovy); tuna oil (GRN 193) 

Fish oil is used in organic processing and handling as an ingredient to increase the content of omega-3 fatty 

acids—primarily, eicosapentaenoic acid (EPA) and docosahexaenoic acid (DHA)—in foods to benefit human 

health by contributing to healthy brain development and reducing risks of cardiovascular disease, diabetes, 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 257 of 267
inflammation, atherosclerosis. Fish oil is used in a variety of food products, including breads, pies, cereals, 

yogurt, cheese products, frozen dairy products, meat products, cookies, crackers, snack foods, condiments, 

sauces, and soup mixes. [2015 TR 19-25]

Fish oil is also used in aquaculture as a feed supplement for farmed fish (Naylor et al., 2001). The farmed 

fish are fed fish oil because their diets are typically deficient in plants and animals that lead to the inherent 

production of fish oil (Naylor et al., 2001). [2015 TR 148-150]

In addition to aquaculture—estimated to use about 81% of the fish oil produced worldwide—fish oil is used 

in feed for livestock such as pigs, cattle, poultry, and sheep. Industrial applications of fish oil include paint 

production, leather making, and biodiesel manufacture. Historically, fish oil was used as lamp oil, among 

other uses (Rizliya and Mendis, 2014). [2015 TR 155-158]

Manufacture

Fish oil is produced from fish byproducts or from fish that are caught specifically for the purpose of making 

fish oil (Kim and Venkatesan, 2014). Between 20 and 80 kilograms of fish oil can be extracted per ton of fish 

waste (Karadeniz and Kim, 2014). The steps for fish oil extraction areOnce the raw fish or fish parts are obtained, they are cooked in steam at 100 °C in a process called wet 

reduction (U.S. EPA, 1995; Kim and Venkatesan, 2014). The cooked material is then strained and sent to a 

press, where liquid, including the oil, is pressed from the cooked fish (U.S. EPA, 1995). The oil is decanted 

from the pressing liquid, and separation is accomplished using a centrifuge (U.S. EPA, 1995; Kim and 

Venkatesan, 2014). The oil may be further washed with hot water in a process called polishing (U.S.EPA, 

1995). The oil is stored in tanks until it is used for its commercial purpose as a food ingredient or 

supplement, and any remaining fish solids or fish solubles from the process are dried and used as fish meal 

(Kim and Venkatesan, 2014). At this point in the process, the only additions to the fish oil are water, heat, 

and pressure. The waste streams from this process include emissions of volatile organic compounds (VOCs) 

hydrogen sulfide and trimethylamine and wastewater. VOC emissions result during both the pre- of fish 

solids and fish solubles into fish meal (U.S. EPA, 1995). [2015 TR 283-296]

Fish oil may be further processed by hardening, which is performed to further purify the oil (U.S. EPA, 

1995). [2015 TR 304-305]

Further extraction and purification of the oil can be performed by selective hydrolysis, followed by 

filtration, neutralization with sodium hydroxide, removal of oxidized oil by clay, and deodorization using 

steam distillation (EPAX Norway, undated; U.S. FDA, 2002). [2015 TR 311-313]

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Not explicitly mentioned.

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Fish oil is allowed in feed for carnivorous aquaculture animals (EC No 2018/848, General requirements, 

3.1.3.3, page 76). 

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

Organically Produced Foods (GL 32-1999)

Not explicitly mentioned. 

International Federation of Organic Agriculture Movements (IFOAM)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 258 of 267
Not explicitly mentioned. 

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned. 

Ancillary Substances

None

Human Health and Environmental Issues

There are no expected significant human health impacts or remarkable environmental issues, according to 

the 2015 TR.

A laboratory analysis of 31 fish oil supplements found that every product contained measurable amounts of 

mercury, PCBs might also be present in fish oil. Dioxins and furans are hazardous environmental 

compounds that may also be found in fish and fish oil. 

Discussion 

At the Fall 2023 NOSB meeting in Providence, RI, NOP indicated that they would not be moving forward 

with NOSB's recommendation to amend the annotation on fish oil restricting sources to fishing by-products 

only and to fishing industries that meet third-party sustainability standards. Moving forward with the 

organic aquaculture standard and developing an organic production standard for wild caught fish, as 

required by OFPA, would facilitate the production of certified organic fish oil and could alleviate concerns 

about overfishing and toxic contaminants present in fish oil. 

Questions to our Stakeholders 

Are there any environmental concerns to be considered?

Gelatin

Reference: § 205.606 Nonorganic agriculturals allowed

(h) Gelatin (CAS # 9000-70-8).

Technical Report: 2002 TAP; 2019 TR gelatin, collagen gel, and casings

Petition(s): 2001; 2002 (addition as ingredient (capsules); 2007 Petition (addition to 205.606)

Past NOSB Actions: 05/2002 NOSB recommendation; 05/2007 recommendation to add; 04/2010 sunset 

recommendation; 10/2015 sunset recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 09/12/2026

Subcommittee Review

Use 

Gelatin is used in a wide range of products as a clarification or fining agent in teas, juice, and wine, as a 

stabilizer, texturizer, thickener, and in capsules. It may either be an ingredient or a processing aid in candies 

(gummy bears), desserts (puddings, jello, marshmallows), dairy products (yogurt, sour cream, ice cream), 

cereals and cosmetics. Fish gelatin is widely preferred for uses in kosher foods. Collagen, also on the 

National List, is the native form of gelatin and chemically the two are indistinguishable.

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 259 of 267
Manufacture

Gelatin can be made from many different sources of collagen. Cattle bones, hides, pigskin, and fish are the 

principle commercial sources. Gelatin may be prepared in a way that is more like cooking and could be 

considered nonsynthetic. However, gelatin may also be processed in ways that would render it synthetic. 

All manufacturing operations extract and hydrolyze collagen found in fish skins, bovine bone, and porcine 

skin with subsequent purification, concentration, and drying operations. These can be either simple or 

complicated operations.

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Allowed as ingredients classified as food additives: shall be organic if commercially available. Gelatine may 

be sourced from plants or animals. If derived from cattle, gelatine shall be guaranteed free of Specified Risk 

Material (SRM). (Table 6.3, CAN/CGSB-32.311-2020, page 32)

Allowed as processing aids: shall be from organic sources if commercially available. Allowed sources are 

plants and animals. Animal gelatine may be used in preparations of canned meat or as a gelling agent for 

gummed candy. If derived from cattle, gelatine shall be guaranteed free of Specified Risk Material (SRM). 

(Table 6.5, CAN/CGSB-32.311-2020, page 39)

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Allowed in products of plant origin. (Annex V, Part A, Section A2, 2021/1165)

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

Organically Produced Foods (GL 32-1999)

Allowed as a processing aid for the preparation of products of agricultural origin. (Table 4 - page 30)

International Federation of Organic Agriculture Movements (IFOAM)

Allowed as a processing/post-harvest handling aid. (Appendix 4 - Table 1 - page 80)

Japan Agricultural Standard (JAS) for Organic Production

Additive allowed. Limited to the use in processed products of plant origin. (Appended Table 1)

Ancillary Substances 

It does not appear that there are any ancillary ingredients used regularly for gelatin, such as anti-caking 

agents, preservatives, colorings etc.

Human Health and Environmental Issues

There have been no published studies on the impact of gelatin on human health. Gelatin has been widely 

incorporated into a range of industries, including food and medicine, and is widely regarded as 

biocompatible and biodegradable. It is not anticipated to have a negative impact on human health or have 

a negative impact on the environment or biodiversity.

Discussion 

The 2019 TR did not contain new information indicating that organic gelatin would be commercially 

available in the near future. In 2021 the Handling Subcommittee hoped that at the next sunset review, the 

barriers to production of organic gelatin will no longer be present. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 260 of 267
Gelatin has been granted GRAS status by the FDA for “substances migrating from cotton and cotton fabrics 

used in dry food packaging,” at 21 CFR 182.70. Moreover, gelatin is generally recognized as safe (GRAS) 

when used “to clarify juice or wine,” at 27 CFR 24.246.

Questions to our Stakeholders

1. Is there sufficient commercially available organic gelatin?

2. What gaps persist that necessitate gelatin to be on the national list?

Orange pulp, dried

Reference: § 205.606 Nonorganic agriculturals allowed

(m) Orange pulp, dried.

Technical Report: N/A

Petition(s): 2008 Petition

Past NOSB Actions: 11/2008 NOSB recommendation for addition to the National List; 10/2015 sunset 

recommendation; 10/2019 sunset recommendation

Recent Regulatory Background: Added to NL effective 03/15/2012 (77 FR 8089); Renewed 03/15/2017 (82 

FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Dried orange pulp is used as a moisture retention agent and fat substitute in baked goods, pastas, salad 

dressing, confectionary, processed cheese spreads, beverages, meat products and frozen foods. Dried 

orange pulp is used in rates up to 5 percent depending on use but is self-limiting after that point due to loss 

of desirable eating qualities.

Manufacture

Dried orange pulp is a byproduct of the orange juice industry and is manufactured from the washed orange 

peel, core and rag (membrane) remaining after juicing. The pulp is then mechanically dewatered, stabilized 

with heat, dried, and mill-ground to a powder. The only processing aid used is water. No chemicals are used 

to process the product. The petitioner notes, due to food safety and economics, dried orange pulp 

manufacture must be co-located with orange juice processing facilities. 

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Not listed

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not listed

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

Organically Produced Foods (GL 32-1999)

Not listed individually as non-organic agricultural commodities allowed. However, CODEX allows for up to 

5% non-organic content.

International Federation of Organic Agriculture Movements (IFOAM)

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 261 of 267
Not listed individually as non-organic agricultural commodities allowed. However, IFOAM allows for up to 

5% non-organic content.

Japan Agricultural Standard (JAS) for Organic Production

Not listed individually as non-organic agricultural commodities allowed. However, JAS allows for up to 5% 

non-organic content.

Ancillary Substances 

No ancillary substances are indicated.

Human Health and Environmental Issues

The only noted concern pertaining to orange pulp is the use of conventional pesticides in conventional 

orange production that may negatively impact the environment and potentially leave residue in the final 

product of orange pulp, dried. 

Discussion 

During the Spring 2019 review, the Handling Subcommittee voted to remove this item from the National 

List because orange pulp, dried, does not seem to be necessary for or consistent with organic handling 

(failing OFPA criteria at 7 U.S.C. 6517(c)(ii)–(iii)), and alternatives exist (failing OFPA criteria at § 

6518(m)(6)). There were no comments that supported its use, nor any known organic products that include 

it as an ingredient. However, orange peel and orange pulp were listed as ingredients in organic products. It 

was noted that this listing also has a patent which may limit its use in organic products. Additionally, during 

the in-person Fall 2019 NOSB meeting, the petitioner for this substance provided verbal comment, and 

stated that they wished to continue the listing. . They indicated that they have customers who wish to 

continue the use of this nonorganic product in their organically labeled foods. The petitioner also clarified 

the supply of organic oranges is located about an hour too far away from their processing facility to use 

their patented process and make their dried orange pulp.

While numerous NOSB members felt that the use of dried orange pulp is very small, and in the future, the 

distance issues and other barriers may be overcome, a decisive vote to remove it from §205.606 was not 

reached, therefore the motion to remove orange pulp from §205.606 failed. (7/5)

A search in September 2023 of the Organic Integrity Database for orange pulp, dried, or dried orange pulp, 

resulting in zero results. However, when searching for orange pulp, 6 entities were found and when 

searching for orange powder, 29 entities were found.

Questions to our Stakeholders

1. Is there a sufficient and suitable supply of organic orange pulp, dried? If not, how can we overcome 

the barriers that limit organic production of orange pulp, dried

2. Are there organic products that would not be able to be produced if orange pulp, dried was 

removed from the National List? 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 262 of 267
Seaweed, Pacific kombu

Reference: § 205.606 Nonorganic agriculturals allowed

(q) Seaweed, Pacific kombu.

Technical Report: 2016 TR (Marine Plants & Algae)

Petition(s): 2007 Petition

Past NOSB Actions: 05/2008 NOSB recommendation; 10/2015 sunset recommendation; 10/2019 sunset 

recommendation

Recent Regulatory Background: Added to NL effective 03/15/12 (77 FR 8089); Renewed 03/15/2017 (82 FR 

14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 09/12/2026

Subcommittee Review

At §205.606 (d)(3), (n), (v) and (z), four substances from marine plants and algae are specifically identified as 

nonorganically produced agricultural products allowed as ingredients in or on processed products labeled as 

‘‘organic’’ when the specific product is not commercially available in “organic” form: (d)(3) beta-carotene 

extract color, derived from algae (CAS #1393– 59 63–1), not produced using synthetic solvents and carrier 

systems or any artificial preservative; (n) Kelp used only as a thickener and dietary supplement; (v) Pacific 

kombu; and (z) Wakame seaweed (Undaria pinnatifida) [2016 TR 55-61]

Use 

Seaweed is used as food, in cosmetics and fertilizers, processed to extract thickening agents, and as an 

additive to animal feed (FAO, 2014). Increasing demand over the last fifty years outstripped the ability to 

supply the market from natural (wild) stocks. Cultivation industries now produce more than 90 percent of 

the markets’ demand. Some commercial organizations have been promoting seaweed for restaurant and 

domestic use, with some success. An informal market exists among coastal dwellers in some developing 

countries where there has been a tradition of using fresh seaweeds as vegetables and in salads (FAO, 2012). 

[2016 TR 193-195]

Kombu, produced from hundreds of hectares of brown seaweed, Laminaria japonica that is grown on 

suspended ropes in the ocean. 

Seaweeds as a source of hydrocolloids dates back to 1658, when the gelling properties of agar that is 

extracted with hot water from a red seaweed were first discovered in Japan. Extracts of Irish moss, another 

red seaweed, contain carrageenan and were popular as thickening agents in the nineteenth century. [2016 

TR 217-219]

Seaweed meal, used an additive to animal feed, has been produced in Norway, where its production was 

pioneered in the 1960s. It is made from brown seaweeds that are collected, dried and milled.

Cosmetic products, such as creams and lotions, sometimes show on their labels that the contents include 

“marine extract”, “extract of alga”, “seaweed extract” or similar. Usually this means that one of the 

hydrocolloids extracted from seaweed has been added. 2016 TR 252-254]

Manufacture

Kelps are seaweed and recognized as Kombu in Japan and various kinds of food made from Kombu, one of 

the most important of the marine vegetable preparations. The seaweeds used in the manufacture of Kombu 

are coarse, broad-fronded members of the kelp family (Laminariaceae), and until Laminaria japonica was 

introduced. Other kelps utilized in Kombu manufacture are Arthrothamnus bifidus and kurilensis, Alaria 

fistulosa (Smith, 1904). [2016 TR 858-866] The gathering of kelp begins in July and ends in October and is 

engaged in by many fishermen. The fishermen go to the kelp grounds in open boats, each boat with one to 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 263 of 267
three men and a complement of hooks with which the kelp is torn or twisted from its strong attachment on 

the rocky bottom. The hooks are of various patterns; some are attached to long wooden handles, and some 

are weighted and dragged on the bottom by means of ropes while the boats are under way (Smith, 1904).

[2016 TR 868-872]

Uses of the Argentinian seaweeds have expanded to new markets for human consumption, nutraceuticals, 

and cosmetics including the fucoidan industries. Local farmers directly sell the seaweeds to the processing 

companies or companies with concessions which directly employ their own workers for harvesting during the 

year and contracted divers in the summer. The National Center of Patagonia (CENPAT) guarantees that the 

harvesting methods are performed in a sustainable way. Regulations for the management of brown seaweeds 

and marine concessions are particularly well developed, and the supply in brown seaweed to the alginate 

industry is well managed and organized (Rebours et al., 2014). [2016 TR 889-892]

An Icelandic company whose products include rockweed (Acophyllum nodosum) and kelp 

(Laminaria digitata). Mechanical harvesting uses specialized equipment and takes place between 

April and October. As with other areas where Ascophyllum nodosum and Laminaria digitata are harvested 

commercially, ecological concerns about changes in species diversity resulting from harvesting have been 

noted (Ingolfsson, 2010). [2016 TR 893-897]

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Seaweed and seaweed products are allowed in crop production (Table 4.2, page 19). Seaweed meal is 

allowed as feed, feed additives, and feed supplements (Table 5.2, page 25).

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned.

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

Organically Produced Foods (GL 32-1999)

Seaweeds and seaweed products are allowed for use in soil fertilizing and conditioning (Table 1, page 19). 

Seaweed, seaweed meal, seaweed extracts, sea salts, and salty water are allowed for plant pest and disease 

control (Table 2, page 22).

International Federation of Organic Agriculture Movements (IFOAM)

Seaweed and seaweed products allowed as fertilizers and soil conditioners if obtained by physical 

processes, extraction with water or potassium hydroxide solutions when the minimum amount of solvent 

necessary for extraction is used, and fermentation (Appendix 2, page 75). 

Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned. 

Ancillary Substances 

None

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 264 of 267
Human Health and Environmental Issues

No known impact on human health impact and environmental issues, per 2016 TR.

Discussion 

Public comment from the previous sunset review indicated that the two seaweed materials be reviewed 

within the broader context of marine materials. At that time, commenters suggested that as part of the 

review, the NOSB should consider the addition of an annotation related to harvest restrictions and riskbased testing for toxic materials, using a decision tree to identify harvesting areas where testing would 

need to be performed. At the fall 2023 meeting, the NOP stated that it will not take action on the NOSB’s 

fall 2020 recommendations on other marine materials, in light of the “technical complexity of marine 

environments.” 

Questions to our Stakeholders

Is organic Pacific kombu commercially available? If not, what barriers remain?

Wakame seaweed

Reference: § 205.606 Nonorganic agriculturals allowed

(t) Wakame seaweed (Undaria pinnatifida).

Technical Report: 2016 TR (Marine Plants & Algae)

Petition(s): 2007 Petition

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

recommendation; 10/2019 sunset recommendation

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

03/15/2017 (82 FR 14420); Renewed 8/3/2021 (86 FR 41699)

Sunset Date: 9/12/2026

Subcommittee Review

Use 

Seaweed is used as food, in cosmetics and fertilizers, processed to extract thickening agents, and as an 

additive to animal feed (FAO, 2014). As the world has internationalized, seaweed consumption as food 

including Wakame, has expanded from China, Japan and Korea to the entire world. Farming seaweed on 

lines in the ocean has expanded globally for production of alginates, carrageenans, other chemicals and the 

edible seaweed varieties, as management of harvest of wild seaweed forests continues throughout the

world (Hunter, 1975). [2016 TR 379-383] Increasing demand over the last fifty years outstripped the ability 

to supply the market from natural (wild) stocks. Cultivation industries now produce more than 90 percent 

of the markets’ demand. Some commercial organizations have been promoting seaweed for restaurant and 

domestic use, with some success. [2016 TR 192-193]

Seaweed meal, used an additive to animal feed, has been produced in Norway, where its production was 

pioneered in the 1960s. It is made from brown seaweeds that are collected, dried and milled. Cosmetic 

products, such as creams and lotions, sometimes show on their labels that the contents include “marine 

extract”, “extract of alga”, “seaweed extract” or similar. Usually this means that one of the hydrocolloids 

extracted from seaweed has been added. 

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 265 of 267
Whole algae incorporated into food and food additives has been used to develop healthier and more 

nutritious foods particularly because there is a technical advantage in the use of algae as natural 

ingredients in food reformulation for healthy foods and beverages. Wakame (Undaria pinnatifida) a widely 

consumed brown algae contains high levels of dietary fiber and minerals. [2016 TR 505-508]

Manufacture

The edible seaweed wakame is produced by drying Undaria pinnatifida and is generally regarded 

as safe (FDA GRN No. 565 — 21 CFR 184.1120). The Republic of Korea grows three different species, and 

about 50 percent of this is for Wakame, produced from a different brown seaweed, Undaria pinnatifida, 

grown in a similar fashion to Laminaria in China. 

Undaria pinnatifida (wakame) and Saccharina latissima (sugar kombu) are two of the most valuable 

seaweeds in northern Spain due to their high demand and economic value. On a commercial basis along the 

Atlantic coast of Europe, particularly in northern Spain, water movement is a key factor controlling the 

production and quality of kelp. U. pinnatifida is best cultured at more exposed sites rather than at sheltered 

sites, whereas both sheltered and exposed sites are suitable for S. latissima cultivation; hanging rope 

culture is best in sheltered areas, while horizontal rope culture is better suited for exposed locations. The 

fixed-pole anchor system for raft culture has been used successfully in exposed open-ocean sites as an 

alternative to the traditional system with concrete blocks; outplanting dates for the U. pinnatifida and S. 

latissima on the Atlantic coast of southern Europe are from October to November and from November to 

December, respectively. Harvesting is conducted from March to April and from April to May for these two 

outplanting seasons, respectively. Seawater temperature and seawater nitrogen concentration are the 

main determinants of the start and end of culture in the sea for both species. S. latissima is more 

economically and environmentally advantageous 1057 than U. pinnatifida (Peteiro et al., 2016). [2016 TR 

1046-1057]

In Argentina, the National Center of Patagonia (CENPAT) guarantees that the harvesting methods are 

performed in a sustainable way. Regulations for the management of brown seaweeds and marine 

concessions are particularly well developed, and the supply in brown seaweed to the alginate industry is 

well managed and organized (Rebours et al., 2014). [2016 TR 889-892]

International Acceptance

Canadian General Standards Board Allowed Substances List (CAN/CGSB 32.311-2020)

Seaweed and seaweed products are allowed in crop production (Table 4.2, page 19). Seaweed meal is 

allowed as feed, feed additives, and feed supplements (Table 5.2, page 25). 

European Economic Community (EEC) Council Regulation, EC No. 2018/848 and 2021/1165

Not explicitly mentioned.

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

Organically Produced Foods (GL 32-1999)

Seaweeds and seaweed products are allowed for use in soil fertilizing and conditioning (Table 1, page 19). 

Seaweed, seaweed meal, seaweed extracts, sea salts, and salty water are allowed for plant pest and disease 

control (Table 2, page 22).

International Federation of Organic Agriculture Movements (IFOAM)

Seaweed and seaweed products allowed as fertilizers and soil conditioners if obtained by physical 

processes, extraction with water or potassium hydroxide solutions when the minimum amount of solvent 

necessary for extraction is used, and fermentation (Appendix 2, page 75).

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 266 of 267
Japan Agricultural Standard (JAS) for Organic Production

Not explicitly mentioned. 

Ancillary Substances 

None

Human Health and Environmental Issues

No known impact on human health impact and environmental issues, per 2016 TR.

Discussion 

Public comment indicated that the two seaweed materials be reviewed within the broader context of Marine 

Materials. At that time, commenters suggested that as part of the review, the NOSB should consider the 

addition of an annotation related to harvest restrictions and risk-based testing for toxic materials, using a 

decision tree to identify harvesting areas where testing would need to be performed.

Questions to our Stakeholders

Is organic wakame commercially available? If not, what barriers remain?

National Organic Standards Board (NOSB) Proposals and Discussion Documents April 2024 267 of 267