Sunset 2022 

Meeting 2 - Review 

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

October 2020 

Introduction 

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

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

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

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

the USDA before their sunset dates. This document provides the substance’s current status on the 

National List, use description, references to past technical reports, past NOSB actions, and regulatory 

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

list. To see if any new technical report is available, please check for updates under the substance name 

in the Petitioned Substances Database. 

Request for Comments 

Written public comments will be accepted through October 1, 2020 via www.regulations.gov. 

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

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Sunset 2022 

Meeting 2 - Review 

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

October 2020 

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

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

group(s)).’’ 

§205.605(a) Nonsynthetics allowed: 

Kaolin 

Sodium bicarbonate 

Waxes (Wood resin) 

§205.605(b) Synthetics allowed: 

Ammonium bicarbonate 

Ammonium carbonate 

Calcium phosphates: monobasic, dibasic, tribasic 

Ozone 

Sodium hydroxide 

Reference: 7 CFR §205.606 Nonorganically produced agricultural products allowed as ingredients in or 

on processed products labeled as “organic.” 

Carnauba Wax 

Colors (18) 

Glycerin 

Inulin-oligofructose enriched 

Kelp 

Orange Shellac - unbleached 

Starches: Cornstarch (native) 

Starches: Sweet potato starch for bean thread production only. 

Turkish bay leaves 

Whey protein concentrate 

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Kaolin 

Reference: 205.605(a) 

Technical Report: 1995 TAP 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Filtering of organic juices, and for personal care products 

Manufacture: 

Kaolin is a soft white clay consisting principally of the mineral kaolinite. 

International: 

Allowed by Canadian Standards, CODEX, European Economic Community (EEC), Japan Agricultural 

Standards (JAS), and International Federation of Organic Agriculture Movements (IFOAM). 

Ancillary Substances: 

Unknown 

There were minimal comments about kaolin during the Spring 2020 Board meeting. Two certifiers 

commented that six entities list Kaolin in their organic system plan. The subcommittee felt this material 

was relatively benign with no significant environmental or health concerns. 

Subcommittee Vote: 

Motion to remove kaolin from §205.605 of the National List based on the following criteria in the 

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

Motion by: Kim Huseman 

Seconded by: Asa Bradman 

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

Sodium bicarbonate 

Reference: 205.605(a) 

Technical Report: 1995 TAP 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

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Subcommittee Review: 

Use: 

Sodium carbonates are used as raising (leavening) agents in food processing. Sodium bicarbonate 

(baking soda) is a common compound in baking powder; helps to regulate acidity for things like tomato 

soup, or in pastes and beverages. It can be used as an anti-caking agent or as a stabilizer helping to 

maintain the appearance and consistency of foods. Sodium bicarbonate is often used in pancakes, 

biscuits, muffins, crackers, and in cookies. It often is used in self-rising flour and confections. It may also 

be used as a neutralizer for use in butter, cream, and ice cream. 

Manufacture: 

Sodium bicarbonate (baking soda) – its main source is from natural deposits of trona ore. It can also 

come from natural brine found in Searles Lake, California. Trona ore (sodium sesquicarbonate) is heated 

and then mixed with water to dissolve the soda ash and separate out the impurities. Then it is allowed 

to evaporate to crystallization. Carbon dioxide is added to the kiln gas to a saturated pure sodium 

carbonate solution, the sodium bicarbonate then precipitates out. 

International Acceptance: 

Sodium bicarbonate is approved for use in the following organic standards: 

Canadian General Standards Board Permitted Substances List: allowed 

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

Organically Produced Foods (GL 32-1999): not specifically mentioned but sodium sesquicarbonate is 

allowed 

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

grouped under “sodium carbonates” and if so is allowed 

Japan Agricultural Standard (JAS) for Organic Production: Limited to be used for confectionary, sugar, 

processed bean foods, noodles and bread, beverages, vegetable products, processed fruits or for dairy 

products as neutralizing substance. 

International Federation of Organic Agriculture Movements (IFOAM): may be grouped with “sodium 

carbonates” and if so is allowed 

Environmental Issues: 

Since sodium bicarbonate is derived from sodium sesquicarbonate, a mined material, and the usual 

environmental issues of mining would be present. However, no major issues have been raised in past 

reviews. 

The original Technical Advisory Panel Report (TAP) combined the two sodium carbonates (sodium 

carbonate and sodium bicarbonate) for their preliminary review. The original TAP, previous 

Subcommittee reviews, public comments, historical information, and current review indicate no 

environmental concerns. Likewise, there were no human health concerns raised during the original TAP 

review or during the following sunset reviews. Previous public commenters have noted that sodium 

bicarbonate is a primary component of baking powder and is still widely used in a variety of baked 

goods, and that it is an essential leavening agent. 

The Subcommittee discussed the importance of sodium bicarbonate, its common usage, and general 

support for re-listing. Production from Trona deposits vs. the Solvay process was discussed, and the HS 

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strategized around how best to address developments in the manufacturing process. The question was 

raised as to whether requesting a work agenda item to annotate Sodium Bicarbonate to limit use to 

non-synthetic production forms and/or whether the decision tree could use some adjustment to capture 

updated manufacturing processes. 

Written and oral comments support the re-listing of sodium bicarbonate. Stakeholders confirmed wide 

usage across many categories of products. A commonly used item, stakeholders did not report major 

environmental concerns; one cited sodium bicarbonate as a great example of a National List eligible 

substance due to its non-toxic, home kitchen use as a leavening agent. 

Certifiers raised a classification question regarding the material produced from Trona deposits versus 

the use of the Solvay process for formulating Sodium Bicarbonate. Support was expressed for 

considering re-classifying and/or adding an annotation or some other guidance for clarifying the allowed 

process for Sodium Bicarbonate production. 

Subcommittee Vote: 

Motion to remove sodium bicarbonate from 205.605(a) of the National List based on the following 

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

Motion by: Mindee Jeffery 

Seconded by: Asa Bradman 

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

Waxes (Wood rosin) (sic. resin) 

Reference: 205.605(a) Nonsynthetics allowed: Waxes—nonsynthetic (Carnauba wax; and Wood resin). 

Technical Report: 1996 TAP; 2014 TR Carnauba Wax; 2014 TR - Wood Rosin 

Petition(s): N/A 

Past NOSB Actions: NOSB minutes and vote 09/1996; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation: 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Uses: 

According to the 2014 TR, wood rosin is used in organic processing and handling primarily as a 

component of fruit wax, most commonly applied to citrus fruit. 

At the most basic level, wood rosin, when formulated as part of a fruit wax, reduces the gas exchange 

between the surface of the fruit and the atmosphere, which in turn reduces the respiration rate and 

resulting weight loss. The reduced gas exchange is considered to happen in two different ways: the wax 

forms a physical barrier that the gas must permeate, and the coating also fills openings in the fruit peel 

(Hagenmaier and Baker 1993). Hagenmeier and Baker (1993) found that some factors such as thickness 

of coating, and the waxiness vs. resinous qualities of the coating, also affect the action of fruit waxes. 

For example, coating thickness is as important as type of coating for resistance to water vapor. Wood 

rosin, when formulated with carnauba wax at differing percentages, only offers limited resistance to 

water vapor unless carnauba wax consists of approximately 90% of the formula (Hagenmaeier and Baker 

1994) (2014 TR, Lines 120-128). 

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Manufacture: 

Wood chips are passed through a series of extractors where each batch of new chips is extracted with 

several portions of solvent in succession. Each portion of solvent is used on several different batches of 

chips. This is a counter-current process where fresh solvent is used on the final extraction of the wood 

chips, and then it is successively used on the chips that receive one, two or three more extractions. 

Thus, the oldest solvent is used on the freshest wood chips. After the wood chips have received the final 

solvent extraction wash, the solvent is drained, and the chips are pressure-steamed to recover any 

residual solvent. The solvent from the terpene oil-rosin solutions leaving the extractors is recovered by 

vacuum-distillation separation and reused for subsequent extraction processes. The resulting terpene 

oils are separated by fractional distillation into refined terpentine, dipentene, and pine oil. The 

remaining residue is the non-volatile extract and is considered to be crude wood rosin (not food grade). 

The crude wood rosin is further refined and purified by a liquid fractionation process. It is placed into 

refining towers where a proprietary polar solvent (Merck 2013) is used to extract the darker 

components. According to the EPA Toxic Release Inventory (2013), methanol is the likely solvent used in 

this process step. The solvent is evaporated off, recovered and reused. The resulting lighter wood rosin 

is called Vinsol and the remaining, darker grade (Grade K) wood rosin is that which is considered ‘food 

grade’ and permitted as an ingredient in citrus fruit waxes (Merck 2013). The manufacturing process 

may only differ by the solvents used, but this is the only known method for manufacturing wood rosin. 

No chemical changes occur during the extraction and refinement of wood rosin. (2014 TR, Lines 230-

248) 

International: 

Allowed under the Canadian Organic Standards 

Ancillary substances: 

Raw wood rosin is sold directly to further formulators of fruit wax and other products without any 

additional ingredients such as stabilizers or preservatives (Pinova 2013) (2014 TR, lines 141-142) 

Discussion: 

According to the 2014 TR, wood rosin is erroneously listed at 205.605(a) as “wood resin”. FDA 

regulations clearly permit and define only wood rosin and do not define or permit wood resin as a direct 

or indirect food additive. Wood resin is the raw material produced by coniferous trees prior to 

distillation of any terpene, tall oil, and other components. 

In terms of harm to the environment, wood rosin is derived from two pine species including Longleaf 

pine which is categorized as endangered by the IUCN Red List of Threatened Species (2013). While wood 

rosin is considered a by-product of the timber industry (derived from the remaining tree stumps) the 

conversion of farmland for timber use has contributed to the decline of Longleaf pine which due to its 

slow growth cannot economically compete with other pine species for replanting. 

The solvent extraction of wood rosin from the wood chips has potential to negatively affect human 

health. Although the specific solvents used by Pinova, Inc. are proprietary, the EPA Toxic Release 

Inventory (2013) suggests that methyl isobutyl ketone (MIBK) is the likely solvent used for the initial 

extraction, and methanol for the further refinement. According to the EPA (2003), human studies of 

acute inhalation exposures to MIBK indicated “transient sensory irritation, neurological effects, and/or 

strong odor sensation during exposure”. Another study showed some nose and throat irritation at an 

exposure rate of 100-200 mg/m3. A study by the National Institute for Occupational Safety and Health 

on the other hand did not find any changes in neurological or irritation systems after a 2-hour exposure 

to MIBK at 100ppm (EPA 2003). For the second extraction step, methanol is considered to be 

environmentally preferable to other solvents of similar properties (Capello, Fischer and Hungerbuhler 

2007). However, workers repeatedly exposed to methanol have experienced headaches, sleep 

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disorders, gastrointestinal problems and optic nerve damage. Exposure to large amounts of methanol 

can result in death or severe abdominal, leg and back pain (EPA 1994). No information is available on the 

carcinogenic, reproductive, and developmental effects of methanol in humans, but birth defects have 

been observed in the offspring of rats and mice exposed to methanol by inhalation (EPA 2000) (TR 2014, 

Lines 393-414) 

Most commenters from the Spring 2020 meeting are in support of relisting wood rosin. Commenters 

also suggested the addition of an annotation to include ‘not extracted using volatile synthetic solvents; 

contains only ancillary substances approved for organic production’. The Subcommittee supports the 

option of having multiple waxes which allows for more market share as some countries do not allow the 

use of certain formulations of waxes. The Subcommittee also recommends a technical correction to the 

listing - wood rosin is the accurate listing and resin should be removed. 

Subcommittee Vote: 

Motion to remove waxes (wood rosin) (sic. resin) from §205.605 of the National List based on the 

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

Motion by: Kim Huseman 

Seconded by: Scott Rice 

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

Ammonium bicarbonate 

Reference: 205.605(b) - for use only as a leavening agent 

Technical Report: 1995 TAP 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Ammonium carbonates are used as leavening agents, and may be used in baking where yeast is not 

used. Ammonium bicarbonate has critical functionality as a raising (leavening) agent in certain cookies 

and crackers. Compared to baking soda it produces more gas and in the finished baked goods, 

ammonium bicarbonate completely decomposes into water and gaseous products that evaporate during 

the baking process. It does not leave behind the salty or soapy taste that sodium bicarbonate may leave 

when used at higher concentrations. Since ammonium bicarbonate completely breaks down in heat it 

has no effect on the pH of the baked product. Ammonium bicarbonate cannot be used for moist baked 

goods since if there is more than 5% moisture in the baked good, the ammonia gas will dissolve in the 

water and give an ammoniacal flavor to the baked good. Ammonium carbonate may also help provide 

certain characteristic textures (such as in crackers), as well as aids in controlling cookie spread. 

Since this is the only leavening agent (ammonium carbonates) that is completely eliminated through the 

baking process, there are no organic alternatives to replace ammonium bicarbonate. 

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Manufacture: 

Ammonium carbonates are made from ammonia and carbon dioxide. Ammonium bicarbonate is made 

when carbon dioxide is bubbled through an ammonia solution. Crystals of ammonium bicarbonate 

precipitate from this saturated solution. It is a component of what was formerly known as sal volatile 

and salt of hartshorn. The ammonium carbonates are considered Generally Regarded as Safe (GRAS) by 

the FDA. 

International Acceptance: 

Ammonium bicarbonate is approved for use in the following organic standards: 

Canadian General Standards Board Permitted Substances List: Allowed as a leavening agent 

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

Organically Produced Foods (GL 32-1999): Not specifically mentioned but “ammonium carbonates” are 

allowed for food of plant origin 

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

grouped under “ammonium carbonates” and if so is allowed for food of plant origin 

Japan Agricultural Standard (JAS) for Organic Production: Limited to be used for processed foods of plant 

origin 

International Federation of Organic Agriculture Movements (IFOAM): May be grouped with “ammonium 

carbonates” and if so is allowed only for cereal products, confectionary, cakes and biscuits 

Environmental Issues: 

The original TAP, previous subcommittee reviews, public comments, and historical information indicated 

no environmental concerns. Ammonium bicarbonate can be an irritant to the skin, eyes, and respiratory 

system. There may be short term health effects after exposure and long term exposure may cause lung 

damage. 

The original TAP combined the two ammonium carbonates (ammonium carbonate and ammonium 

bicarbonate) for their preliminary review. These two substances have been reviewed together during 

their subsequent two sunset reviews. The original TAP, previous subcommittee reviews, public 

comments, and historical information indicated no environmental concerns. Likewise, there were no 

human health concerns raised during the original TAP review or during the following sunset reviews. 

Previous public commenters have noted that this material is still critical for organic food processing, 

especially for baking crackers and similar baked goods. 

Stakeholders reflected mixed reviews on Ammonium Bicarbonate. Some certifiers reported little or no 

handlers known to be utilizing the substance. A trade association reported that it is essential as a 

leavening agent and alternatives have not been identified. Other certifiers support re-listing and 

reported common usage. An environmental group recommended delisting due to the emission of 

ammonia and carbon dioxide during manufacture or use. 

Subcommittee Vote: 

Motion to remove Ammonium Bicarbonate from 205.605(b) of the National List based on the following 

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

Motion by: Mindee Jeffery 

Seconded by: Scott Rice 

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

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Ammonium carbonate 

Reference: 205.605(b) –for use only as a leavening agent 

Technical Report: 1995 TAP 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Ammonium carbonates are used as leavening agents. Ammonium carbonate is used as a raising 

(leavening) agent for flat baked goods, such as cookies and crackers. It is often referred to as “Bakers 

Ammonia” in cooking recipes and by chefs. Ammonium carbonate is also used to make breadsticks, 

cookies, and crackers because it helps to make them both lighter and crispier. It is also used in many 

traditional Greek cooking recipes. Ammonium carbonates are heat activated, so baked goods will not 

rise until whatever is being baked actually goes into the oven, thus helping with food preparation and 

time requirements. This is the only leavening agent (ammonium carbonates) that is completely 

eliminated through the baking process. There are no organic alternatives to replace ammonium 

carbonates. 

Manufacture: 

Ammonium carbonates are made from ammonia and carbon dioxide. Ammonium carbonate is made 

when carbon dioxide is passed through an ammonia solution and by then allowing the vapors to distill, 

thus the resulting solid is ammonium carbonate. It is a component of what was formerly known as sal 

volatile and salt of hartshorn. Ammonium carbonates are considered Generally Regarded as Safe (GRAS) 

by the FDA. 

International Acceptance: 

Ammonium carbonate is approved for use in the following organic standards: 

Canadian General Standards Board Permitted Substances List: allowed as a leavening agent 

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

Marketing of Organically Produced Foods (GL 32-1999): allowed for food of plant origin 

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

allowed for food of plant origin 

Japan Agricultural Standard (JAS) for Organic Production: Limited to be used for processed foods 

of plant origin 

International Federation of Organic Agriculture Movements (IFOAM): allowed only for cereal 

products, confectionary, cakes and biscuits 

Environmental Issues: 

The original TAP, previous subcommittee reviews, public comments, and historical information indicated 

no environmental concerns. Ammonium carbonate can be an irritant to the skin, eyes and respiratory 

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system. There may be short term health effects after exposure and long term exposure may cause lung 

damage. 

The original TAP combined the two ammonium carbonates (ammonium carbonate and ammonium 

bicarbonate) for their preliminary review. These two substances have been reviewed together during 

their subsequent two sunset reviews. The original TAP, previous subcommittee review, public 

comments, and historical information indicated few environmental concerns. Likewise, there were no 

human health concerns raised during the original TAP review or during the following sunset reviews. 

Previous public commenters have noted that this material is still critical for organic food processing, 

especially for baking crackers and similar baked goods. 

The Handling Subcommittee discussed the material, noting that Ammonium Carbonate has low levels of 

concern in both environmental and human health areas. 

An Environmental group supported delisting due to emissions of ammonia and carbon dioxide during 

manufacture and use. Certifiers listed little to no record of usage. One farm group supported relisting. 

Subcommittee Vote: 

Motion to remove Ammonium Carbonate from 205.605(b) of the National List based on the following 

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

Motion by: Mindee Jeffery 

Seconded by: Steve Ela 

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

Calcium phosphates (monobasic, dibasic, and tribasic) 

Reference: 205.605(b) 

Technical Report: 1995 TAP; 2016 TR (Phosphates) 

Petition(s): N/A 

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

recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Calcium phosphates are used as raising (leavening) agents and used as a critical component in baking 

powder (aluminium free). All three of the calcium phosphates are used as leavening agents: dough 

conditioner, yeast food, or as an expanding agent. Monobasic and dibasic calcium phosphate are often 

used for reduced sodium baking. Monobasic is also a buffer, firming agent, sequestering agent, and is 

popular in pancake mixes. It is the commonly used acid along with sodium bicarbonate used to make 

baking powder. It is also used in baked goods, such as cookies, cakes, and potato chips, and as a firming 

agent for canned fruits and vegetables. Dibasic is used in enriched flour, noodle products, and in both 

dry and cooked forms of breakfast cereals. It is often used as a dough conditioner. It also can be used as 

a thickening agent for various cheese products. Tribasic is an anti-caking agent and buffering agent. It 

also provides a very critical function as a free flow aid in finely powdered salt used in baking. 

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Additionally, it is used as a food source for yeast in bread making, as an anti-caking agent in dry 

powders, such as in spices, and as a thickener, stabilizer, and sequestering agent for some dairy 

products. Calcium is derived from either mined limestone or from oyster shells. 

Manufacture: 

Calcium and phosphorus are sourced from limestone and phosphate rock, respectively. The food grade 

phosphates are formed by reacting purified phosphoric acid with sodium, potassium, or calcium 

hydroxides (TR 2016 43-44). 

International: 

Calcium phosphates are allowed for use in Canada, IFOAM and JAS. 

Subcommittee Review: 

The NOSB Subcommittee Review of Calcium Phosphates for the 11/27/2017 review process raised 

concerns regarding the cumulative effect on human health associated with the use of phosphorous 

additives in foods. These concerns were raised by stakeholders during both the oral and written 

comment process. However, some of the oral and written comments also refuted these same health 

concerns. 

The Handling subcommittee was instructed to look into the concerns and come back to the full NOSB 

with further findings. This was done, and included a broader look at all phosphates with 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. Given the new information and research since the last Sunset Review, 

the Handling Subcommittee requested a new Technical Report (TR) which it received in 2016. 

The TR indicates that small amounts of sodium phosphates may not cause human health 

problems, but no long term impacts are fully understood. 

In reviewing all of the comments from the Spring 2020 meeting, no further concerns were expressed 

with the exception of the original concerns stated above. There were also several specific references to 

calcium phosphate as having a positive impact on bone health. 

The Board is always concerned about allowing exceptions that could stifle innovation. However, it is our 

determination that calcium phosphates have no real substitute, particularly in baked products. 

Subcommittee Vote: 

Motion to remove calcium phosphates from §205.605 of the National List based on the following criteria 

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

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

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Ozone 

Reference: 205.605(b) 

Technical Report: 1995 TAP 

Petition(s): N/A Past NOSB Actions: 10/1995 NOSB minutes and vote; 11/2005 sunset recommendation; 

10/2010 sunset recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Ozone is a powerful oxidant with many industrial and consumer applications related to oxidation. 

Ozone, which has approximately 150% of the oxidizing potential of chlorine, is used as an equipment 

and food disinfectant and in post-harvest treatment for produce to retard spoilage in cold storage or in 

wash water. It is an effective and environmentally benign substance used to reduce and control 

microorganisms for food safety purposes. 

Manufacture: 

Ozone, or trioxygen, is an inorganic molecule with the chemical formula O3. It is a pale blue gas with a 

distinctively pungent smell. It is an allotrope of oxygen that is much less stable than the diatomic 

allotrope O2, breaking down in the lower atmosphere to O2 (dioxygen). Ozone's odor is reminiscent of 

chlorine, and detectable by many people at concentrations as low as 0.1 ppm in air. 

Ozone is an unstable gas in the air and even more so in water. Because of this, it must be produced 

onsite. To do so, typically an oxygen supply is fed to a corona discharge system which uses ambient air 

to produce ozonated water that is used as a liquid disinfectant. 

International: 

Canadian General Standards Board Permitted Substances List 

Included as an ingredient classified as a food additive, and as a processing aid, as a food-grade cleaner, 

disinfectant and sanitizer. 

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

Organically Produced Foods (GL 32-1999) 

While section 5 outlines criteria for the inclusion of substances, the guidelines do not include a 

permitted substance list. 

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

The regulation does not specifically address the use of ozone. 

Japan Agricultural Standard (JAS) for Organic Production 

The standard limits ozone use to processed foods of plant origin, animal intestine disinfection, or as egg 

cleansing. 

International Federation of Organic Agriculture Movements (IFOAM) Norms for Organic Production and 

Processing 

The norms allow ozone as an equipment cleanser and disinfectant. 

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Ancillary Substances: 

N/A 

Environmental Issues and Human Health Impacts: 

According to the U.S. Environmental Protection Agency, ozone exposure in the air we breathe can be 

harmful to human health and the environment. However, the application of ozone directly into water as 

a disinfectant minimizes this exposure. Once introduced into water, ozone decomposes into elemental 

oxygen in a brief amount of time. Exposure to atmospheric ozone generated from on-site production 

can be minimized through equipment maintenance. 

During its first review at the April 2020 meeting, the Board received comments voicing broad support for 

the continued listing of ozone. Comments from certifiers noted 51 operations list this material in their 

organic system plans (OSPs). Numerous comments pointed to ozone’s importance as a disinfectant and 

sanitizer for food contact surfaces. Many noted the material’s essentiality in reducing microbial loads on 

finished produce and grains. 

One group acknowledged ozone’s strong oxidizing properties and usage that does not leave toxic 

residues. However, they noted the potential risk to workers from leaks in irrigation water treatment 

when the material is not transferred to the water and is released as a gas. The group encouraged the 

Crop and Handling Subcommittees to review ozone in the context of all sanitizers. 

The Handling Subcommittee considers that the positive attributes of ozone and its role in food safety 

programs outweigh the manageable risks to worker safety and supports relisting at this time. 

Subcommittee Vote: 

Motion to remove ozone from §205.605 of the National List based on the following criteria in the 

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

Motion by: Scott Rice 

Seconded by: Asa Bradman 

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

Sodium hydroxide 

Reference: 205.605(b) - prohibited for use in lye peeling of fruits and vegetables. 

Technical Report: 1995 TAP; 2020 TR IN PROGRESS 

Petition(s): N/A 

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

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Sodium hydroxide is a highly caustic substance, used as a processing aid in cocoa manufacture, as a 

caustic bath for pretzels that makes the pretzel surface smooth and helps it to develop brown color 

during baking and for removing bitterness from olives. It is also used as an alkali to peel fruits and 

vegetables, but this use is specifically prohibited in organic foods by an annotation. Sodium hydroxide is 

used to manufacture soaps, oral care products and detergents, and can be used as an ingredient in food 

preservatives to prevent the growth of mold and bacteria. Soda ash (NaCO3), Magnesium Oxide (MgO) 

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or Sodium Hydroxide can be used in the production of sugar to increase the pH and alkalinity of the 

sugar cane juice. It is highly soluble in water. 

Manufacture: 

Sodium hydroxide is derived from saltwater brine, and manufactured by the electrolysis of this salt brine 

solution. During the electrolysis process, the water (H20) is reduced to a hydrogen gas (H) and a 

hydroxide ion (OH). The hydroxide ion bonds with the sodium to form sodium hydroxide (NaOH). 

Chlorine is also produced during this process. 

International Acceptance: 

Sodium Hydroxide is listed on the Canadian General Standards Board Permitted Substances List as an 

approved food additive. It is approved for use in the CODEX Alimentarius Commission, Guidelines for the 

Production, Processing, Labeling and Marketing of Organically Produced Foods (GL 32-1999) for bakery 

wares within the food category. It is approved on the European Economic Community (EEC) Council 

Regulation, EC No. 834/2007 and 889/2008 for the production of sugar, for the production of rape seed 

and for the surface treatment on pretzels and pretzel breads. It is not listed in the Japan Agricultural 

Standard (JAS) for Organic Production. It is listed as approved by International Federation of Organic 

Agriculture Movements (IFOAM) for sugar processing and the surface treatment of traditional bakery 

products. IFOAM also has sodium hydroxide on its list of allowed cleansers and disinfectants, with the 

annotation that an intervening event or action must occur after this type of use, to eliminate risks of 

contamination. 

Ancillary Substances: 

It does not appear there are any ancillary substances associated with this material. 

Environmental Issues: 

Must be handled by personnel according to manufacturer guidelines because of caustic nature. 

Concentration of sodium hydroxide is routinely monitored in pretzel production to verify complete 

conversion to sodium bicarbonate during baking. The EPA allows sodium hydroxide for use in treating 

sewage systems to control tree roots, and as a fungicide and algicide on water well casings. Effluent 

containing sodium hydroxide is not to be discharged into lakes, streams and other public waters without 

a NPDES (National Pollutant Discharge Elimination System) permit. Well water casing treatment would 

result in minimal exposure of birds, mammals and other organisms. The EPA states that current product 

labeling helps to protect wildlife from undue exposure to sodium hydroxide. 

The recent Technical Report states there are no alternatives that provide the desired browning 

properties of pretzels. Baking soda can be used but is not sufficiently alkaline to result in distinctive crust 

and flavor. Certain varieties of olives rely on sodium hydroxide to remove bitterness, as salt or water 

curing does not result in acceptable product. Potassium carbonate, potassium bicarbonate, sodium 

carbonate, sodium bicarbonate, ammonium carbonate, ammonium bicarbonate, ammonium hydroxide, 

magnesium carbonate and magnesium oxide, as well as sodium hydroxide can be used to alkalize cocoa. 

Each type of alkalizing agent results in different flavors and functional attributes. The label claim 

“processed with alkali” is used when these alkalis are used in cocoa production. It appears sodium 

hydroxide is the only alkali in use when an alkali is needed in sugar processing. 

The Subcommittee discussed the wide usage of sodium hydroxide in organic systems. Several brands, 

certifiers, and a trade association listed wide usage of sodium hydroxide. A trade association further 

noted that alternatives are insufficient and, if removed, products would lose organic certification as 

reformulation is not an option. 

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Several commenters suggested an annotation to limit use solely for essential purposes. An 

environmental group noted that the current annotation only lists prohibitions and requested that the 

Board investigate essential uses of sodium hydroxide and move towards allowance of essential uses 

exclusively. 

Subcommittee Vote: 

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

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

Motion by: Kim Huseman 

Seconded by: Mindee Jeffery 

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

Waxes (Carnauba) 

Reference: 205.606 Waxes – nonsynthetic (Carnauba wax; and Wood resin). 

Technical Report: 1996 TAP; 2014 TR - Carnauba Wax 

Petition(s): N/A 

Past NOSB Actions: NOSB minutes and vote 09/1996; 11/2005 sunset recommendation; 10/2010 sunset 

recommendation; 10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Used as a component in fresh fruit coatings, as a candy coating, and as component of an edible coating 

for nuts. Other uses include a base for chewing gum and in soft drinks. It can also be used as a 

processing aid, as a releasing agent, and in defoamers. It’s Generally Regarded as Safe (GRAS) listing 

doesn’t provide any limitations on its use as an ingredient in food. 

When formulated as part of a fruit coating, carnauba wax functions to reduce gas exchange between the 

surface of the fruit and the atmosphere, thereby reducing the respiration rate and weight loss of the 

fruit. It also has antifungal properties beyond the creation of a gas barrier. 

Manufacture: 

The production of carnauba wax begins with leaves cut from the carnauba palm tree during Brazil’s dry 

season. They are dried in the sun and then beat or scraped until the wax falls off as a fine powder. The 

wax is collected and then either melted via steam or a solvent. The wax is then cooled and filtered via a 

filter press or through filter cloth, and then cooled and dried. The wax may also be clarified by 

centrifugation or with hydrogen peroxide. 

International: 

Allowed by Canadian Standards, CODEX, European Economic Community (EEC), Japan Agricultural 

Standards (JAS), and International Federation of Organic Agriculture Movements (IFOAM). 

Ancillary substances: 

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According to the 2014 TR, raw carnauba is sold to formulators without any additional ingredients such as 

stabilizers or preservatives. While formulations containing carnauba as the only wax are available, it is 

more common to combine it with other waxes and coasting materials, such as beeswax, candelilla wax, 

wood rosin, or shellac. 

Discussion: 

Carnauba wax was originally listed at §205.605(a) of the National List. In October 2015 the NOSB passed 

a recommendation to reclassify the substance as agricultural and move it to §205.606. 

The 2014 TR did not find the manufacture or use of carnauba wax to be harmful to the environment or 

human health. 

Unlike other fruit coating materials like orange shellac and wood rosin, carnauba wax is available 

organically. There are 19 listings in the USDA’s Organic Integrity Database. 

The Spring 2020 comment period presented arguments both for and against delisting carnauba wax at § 

205.606. Some commenters referenced the sufficient availability of organically produced carnauba wax 

and therefore supported the delisting. Others suggested the organic form does not provide a 

satisfactory result when used as a processing aid. It was also mentioned through several comments that 

waxes in general are not always used, but they are important on those occasions when and where 

necessary; having alternative forms of waxes available allows for more export opportunities due to 

regulation differences at the respective destination. 

The Subcommittee vote was split based on concerns about the use of volatiles in the production of 

carnauba wax, the possible availability of organic forms, and the issue of an unlabeled 

ingredient/additive used on produce. The Handling Subcommittee is seeking more information from 

stakeholders regarding the use of solvents in carnauba wax production. 

Subcommittee Vote: 

Motion to remove waxes (carnauba) from §205.606 of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Availability of organically produced 

alternatives. 

Motion by: Kim Huseman 

Seconded by: Scott Rice 

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

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Colors - Beet juice extract color, Beta Carotene, Black Currant juice color, Black/Purple 

Carrot Juice color, Blueberry Juice color, Carrot Juice color, Cherry Juice color, 

Chokeberry/Aronia Juice color, Elderberry Juice color, Grape Juice color, Grape Skin Extract 

color, Paprika color, Pumpkin Juice color, Purple Potato juice color, Red Cabbage Extract 

color, Red radish Extract color, Saffron Extract color, Turmeric Extract color 

Reference: 205.606(d) Colors derived from agricultural products - Must not be produced using synthetic 

solvents and carrier systems or any artificial preservative 

(1) Beet juice extract color (pigment CAS #7659-95-2) 

(2) Beta carotene extract color 

(3) Black currant juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

(4) Black/Purple carrot juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-

7, and 134-04-3) 

(5) Blueberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

(6) Carrot juice color (pigment CAS #1393-63-1) 

(7) Cherry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3) 

(8) Chokeberry—Aronia juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-

7, and 134-04-3) 

(9) Elderberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

(10) Grape juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3) 

(11) Grape skin extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3) 

(12) Paprika color (CAS #68917-78-2)—dried, and oil extracted 

(13) Pumpkin juice color (pigment CAS #127-40-2) 

(14) Purple potato juice (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134- 04-3) 

(15) Red cabbage extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3) 

(16) Red radish extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3 

(17) Saffron extract color (pigment CAS #1393-63-1). 

(18) Turmeric extract color (CAS #458-37-7) 

Technical Report: 2015 TR - Colors (all); 2011 (Beta carotene); 2012 Supplemental TR 

Petition(s): 2007 Petition 

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

sunset recommendation 

Recent Regulatory Background: Added to NL effective 06/21/07 (72 FR 35137); Sunset renewal notice 

published 06/06/12 (77 FR 33290); Sunset renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date (All except beta carotene): 3/15/2022 

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Sunset Date: Beta carotene extract color: 5/29/2023 

Subcommittee Review: 

Use: 

Colors are added to food products to enhance the attractiveness of the food, to assure uniformity of color, 

to add back color lost during processing, to intensify existing colors. (TR 12-25). 

Manufacture: 

Colors can be produced via a number of production methodologies that vary by individual crop and 

pigment. While most sources have common agricultural crop names, those used for color extraction are 

often specific varieties that are grown in specific geographical regions using specific production techniques 

to produce the specific pigments for coloring purposes. Since these items are listed as agricultural – 

processing is restricted to physical or biological means. The most common types of extraction will be 

water extraction, milling, pressing, drying, distillation, enzyme treatment, ethanol extraction, or oil 

extraction. The annotation prohibits the use of synthetic solvents, carrier systems and artificial 

preservatives. 

International: 

Colors are allowed on the Canadian, Codex and EU lists but are not listed on the Japanese (JAS) or IFOAM 

lists. 

Subcommittee Review: 

It should be noted that §205.600(b)(4), which states “The substance's primary use is not as a preservative 

or to recreate or improve flavors, colors, textures, or nutritive value lost during processing, except where 

the replacement of nutrients is required by law,” is only applicable to synthetic substances used as a 

processing aid or adjuvant per §205.600(b). Citing this section is not a reason to delist colors as they are 

only listed as agricultural, nor are they considered a processing aid or adjuvant. 

During the Fall 2015 NOSB sunset review the NOSB ultimately supported relisting all colors. However, the 

initial Subcommittee review, as well as a statement from the lead reviewer recommended removing all 

colors but beet, black currant, black/purple carrot, cherry, pumpkin, red cabbage and turmeric juices. The 

lack of complete information about availability and whether some were available in powdered form was a 

factor in the Board’s decision to relist. The Board noted the emerging presence of certified organic colors 

and recommended future NOSBs do not renew colors in whole on §205.606. Because of differences in 

supply of the various colors it is important to review each color individually rather than lumping them as a 

group. It is also worth noting that since these colors are on §205.606 they are currently subject to 

commercial availability of organic forms. 

Should those stakeholders interested in maintaining a particular color on §205.606 not respond, the NOSB 

should take that as an indication that the color no longer needs to be listed on §205.606 and vote to 

remove it. 

Public comment received during the Spring 2020 NOSB meeting addressed similar issues as the 2015 

sunset review. Arguments were made for and against the renewal of all or some of the colors, but overall 

there was a dearth of comments given the number of companies that use colors. One commenter stated 

that the onus was on users of colors covered by this listing to make the case for relisting. If there were 

few or no comments in support of relisting, the NOSB should vote to remove the color. Several companies 

noted that they were able to source certain organic colors but there was insufficient supply of other 

colors. Other companies presented comments that there is sufficient supply of nearly all colors with a few 

exceptions. One comment came from a company that said they are a large manufacturer of organic colors 

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and can supply market demands, but that price may be a deterrent for some companies. If this is the case, 

then there is commercial availability and price should not be a reason for relisting. Based on these, often 

conflicting, comments, the Handling subcommittee has compiled a list of colors where there seems to be 

sufficient organic supply and should be delisted. The Handling Subcommittee has questions about supply 

of the remaining colors. In many cases the Subcommittee was split as to whether a color should be 

relisted or delisted, and would appreciate additional public comment for the Fall 2020 meeting. A listing 

of each color follows with comments specific to that color. 

(1) Beet juice extract color (pigment CAS #7659-95-2) 

Beet juice extract received conflicting public comments with one large supplier saying they had 

adequate organic supply and another supplier asking for it to be relisted. There was also a 

comment from an end user noting they had moved to nearly all organic colors, but this color 

should be relisted because of difficulties in using the organic color. The 2015 NOSB HS 

recommended this color be relisted. One commenter noted there were 47 listings for this color in 

the Organic Integrity Database. The HS recommends that this color should be relisted. 

Motion to remove beet juice extract from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

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

(2) Beta carotene extract color 

Public comment, from both manufacturers and end users, from Spring 2020 for beta carotene 

extract recommended relisting of this color. Without adequate evidence that this color has 

adequate organic supply, the HS recommends relisting of this color. 

Motion to remove beta carotene extract from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

(3) Black currant juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

Public comment from Spring 2020 was mixed with several commenters recommending relisting 

and one manufacturer recommending that this color be delisted. One end user of this color 

commented that they had adequate supply of this color in organic forms. The 2015 NOSB HS 

review recommended relisting of this color. Given that one large manufacturer says they have 

adequate supply and that cost may be the limiting factor and that the only end user commenting 

on this color noted adequate supply, but that others comments recommended relisting, the HS 

had an even split vote as to relisting or delisting. 

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Motion to remove black currant juice color from §205.606 of the National List based on the 

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

Commercial availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(4) Black/Purple carrot juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-

7, and 134-04-3) 

Public comment from Spring 2020 was mixed. One end user and one manufacturer commented 

that this color should be relisted while another end user and manufacturer noted there was 

sufficient organic supply. The end user asking for relisting noted that they were using organic 

colors for other products but needed this color relisted for another product. Another commenter 

noted there were 47 listings for this color in the Organic Integrity Database. The 2015 NOSB HS 

recommended relisting this color. Given the mixed comments, the HS recommends relisting this 

color. 

Motion to remove black/purple carrot juice color from §205.606 of the National List based on the 

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

Commercial availability 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

(5) Blueberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting this material 

while another asked for delisting. One end user that uses mostly organic colors in other products 

asked for this color to be relisted. However, given increase in organic blueberry supply, the HS 

recommends this color be delisted. 

Motion to remove blueberry juice color from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

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

(6) Carrot juice color (pigment CAS #1393-63-1) 

Comments from the Spring 2020 meeting were mixed. One manufacturer asked for relisting while 

another asked for delisting. Similarly, one end user asked for relisting while another noted 

adequate organic supply. Given that there are commenters, both manufacturers and end users, 

that commented on adequate supply, HS recommends this color be delisted. 

Motion to remove carrot juice color from §205.606 of the National List based on the following 

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

availability 

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Motion by: Steve Ela 

Seconded by: Scott Rice 

Yes: 5 No: 1 Abstain: 0 Absent: 1 Recuse: 0 

(7) Cherry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color while another commenter noted 23 listings in the Organic Integrity Database. 

The 2015 NOSB HS recommended relisting this color. The HS had an even split vote on whether 

this color be relisted. 

Motion to remove cherry juice color from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Kim Huseman 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(8) Chokeberry—Aronia juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-

30-7, and 134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. With no other information, the HS recommends this color be relisted. 

Motion to remove chokecherry – aronia juice color from §205.606 of the National List based on 

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

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 1 No: 5 Abstain: 0 Absent: 1 Recuse: 0 

(9) Elderberry juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. With no other information, the HS recommends this color be relisted. 

Motion to remove elderberry juice color from §205.606 of the National List based on the following 

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

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

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(10) Grape juice color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 134-

04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for delisting. One end 

user that uses organic colors in other products asked for relisting of this color. With no other 

information, the HS had an even split vote as to whether this color should be relisted. 

Motion to remove grape juice color from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Asa Bradman 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(11) Grape skin extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for delisting. One end 

user that uses organic colors in other products asked for relisting of this color. With no other 

information, the HS had an even split vote as to whether this color should be relisted. 

Motion to remove grape skin extract color from §205.606 of the National List based on the 

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

Commercial availability 

Motion by: Steve Ela 

Seconded by: Scott Rice 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(12) Paprika color (CAS #68917-78-2) - dried, and oil extracted 

Public comment from Spring 2020 were mixed but were more in favor of delisting. One end user 

and one manufacturer asked for relisting. However, two other manufacturers and one end user 

commented they had adequate supply. Without comments listing the exact reasons this color 

needs to be relisted and that there are several manufacturers noting they are able to provide 

adequate supply, the HS recommends delisting this color. 

Motion to remove paprika color from §205.606 of the National List based on the following criteria 

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

Motion by: Steve Ela 

Seconded by: Kim Huseman 

Yes: 5 No: 1 Abstain: 0 Absent: 1 Recuse: 0 

(13) Pumpkin juice color (pigment CAS #127-40-2) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. Another commenter noted 25 listings in the Organic Integrity Database. The 

2015 NOSB HS recommended relisting. With no other information, the HS had an even split vote 

NOSB Proposals and Discussion Documents October 2020 86 of 173
 

 

 

 

 

as to whether this color should be relisted. 

Motion to remove pumpkin juice color from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(14) Purple potato juice (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, and 

134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. With no other information, the HS recommends this color be relisted. 

Motion to remove purple potato juice extract from §205.606 of the National List based on the 

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

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

(15) Red cabbage extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3) 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. Another commenter noted 24 listings in the Organic Integrity Database. 

With no other information, the HS had an even split vote as to whether this color should be 

relisted. 

Motion to remove red cabbage extract color from §205.606 of the National List based on the 

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

Commercial availability 

Motion by: Steve Ela 

Seconded by: Mindee Jeffery 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

(16) Red radish extract color (pigment CAS #'s: 528-58-5, 528-53-0, 643-84-5, 134-01-0, 1429-30-7, 

and 134-04-3 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. One end user that uses organic colors in other products asked for 

relisting of this color. The 2015 NOSB HS recommends relisting. With no other information, the 

HS recommends this color be relisted. 

Motion to remove red radish extract color from §205.606 of the National List based on the 

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

Motion by: Steve Ela 

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Seconded by: Kim Huseman 

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

(17) Saffron extract color (pigment CAS #1393-63-1). 

Public comments from Spring 2020 were mixed. One manufacturer asked for delisting noting they 

had adequate supply to meet market demands. Another manufacturer that also makes organic 

colors has asked for relisting on other colors due to difficulties in supply but did not ask for 

relisting of this color. One end user that uses organic colors in other products asked for relisting of 

this color. Given conflicting information, the HS recommends this color be relisted. 

Motion to remove saffron extract color from §205.606 of the National List based on the following 

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

Motion by: Steve Ela 

Seconded by: Asa Bradman 

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

(18) Turmeric extract 

Public comments from Spring 2020 were mixed. One manufacturer asked for relisting while 

another asked for delisting. Two end users that use organic colors in other products asked for 

relisting of this color, while a third user says they have sufficient supply of organic product. 

Another commenter noted 40 listings in the Organic Integrity Database. The 2015 NOSB HS 

recommended relisting at that time. With no other information and an apparent adequate supply 

based on comments from a manufacturer and end user, the HS recommends this color be delisted. 

Motion to remove turmeric extract from §205.606 of the National List based on the following 

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

availability 

Motion by: Steve Ela 

Seconded by: Kim Huseman 

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

Glycerin 

Reference: 205.606(h) Glycerin (CAS # 56-81-5)—produced from agricultural source materials and 

processed using biological or mechanical/physical methods as described under §205.270(a). 

Technical Report: 1995 TAP; 2013 TR 

Petition(s): 1995 N/A, Glycerin (2012 Petition to remove) 

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

recommendation; 10/2015 sunset recommendation 

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

notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

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Subcommittee Review: 

Use: 

Glycerin is used in food as a binder, humectant, solvent, and carrier. It is widely used in natural flavors. It 

is used in alcohol-free applications as an alternative to ethanol (as a carrier or solvent). It is also used in 

cosmetic and personal care products as an emollient, carrier, lubricant and filler. It has a neutral to sweet 

taste. (TR 24-25) 

Manufacture: 

Glycerin can be manufactured from a variety of sources using a variety of means. Glycerin exists in nature 

as part of triglycerides as a backbone glycerin molecule with three fatty acid chains. The product must 

undergo processing to break the fatty acids from the glycerin. The processing of glycerin will determine if 

it is agricultural or non-agricultural and the organic certification status of the raw materials, processing 

plant, and compliance with the National List would determine if the product could be organic or not. It 

should be noted that it is possible to produce an organic glycerin that would be classified as nonagricultural. Common practices are high-pressure hydrolysis (considered agricultural), saponification 

(considered synthetic but possible to be certified organic if origin materials are organic and the caustic 

material is on the national list), methyl esterification (product of biodiesel, considered synthetic), and 

fermentation of carbohydrates (considered agricultural, but uncommon). Common feedstocks to produce 

glycerin are palm oil, soy oil, tallow, canola oil, and rapeseed oil. Fermented glycerin is produced from 

carbohydrates with the common source being corn. When produced from a fat, the glycerin yield is 

generally 1:10 glycerin to fatty acid. 

International: 

Glycerin is allowed in the EU (from vegetable sources), Canada (From hydrolysis of fats and oils), and 

CODEX. It is not on the Japanese (JAS) or IFOAM lists. 

In 2012 the NOSB received a petition to remove glycerin from §205.605(b), reclassify it as agricultural, and 

move its listing to § 205.606. The petitioner stated as follows: “....An important reason that glycerin 

produced by hydrolysis of fats and oils should have been included at § 205.606 is that items listed at § 

205.606 are subject to the restriction that they can be used “only when the product is not commercially 

available in organic form.” Certified organic glycerin is currently available, but there is no “commercial 

availability” requirement to incentivize processors to use it or certifiers to require it. Consequently, 

glycerin should be removed from the National List in order to encourage organic agricultural production.” 

This matter was discussed at length by the NOSB and received considerable public comment over a period 

of two years, including presentation at the NOSB meetings in Spring and Fall 2014 and Spring of 2015. 

The NOSB proposal dated October 21, 2014, included the following: 

“....Because of the confusion around classification of glycerin (depending upon the manufacturing methods 

and source material), and the concerns regarding commercial availability of organically produced glycerin, 

the Handling Subcommittee, after significant discussion, is proposing the listing of glycerin at §205.606 

and removal of glycerin from §205.605(b). ...” 

In April 2015 the NOSB voted to remove glycerin produced by hydrolysis of fats and oils from § 

205.605(b). In December 2018 the NOP finalized rulemaking on the NOSB recommendation, moving 

glycerin from § 205.605(b) to § 205.606 and changing the annotation to read “produced from agricultural 

source materials and processed using biological or mechanical/physical methods as described under 

§ 205.270(a)” 

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-

During the Spring 2020 NOSB meeting, held virtually from April 29 to May 1, 2020, and during subsequent 

Handling Subcommittee (HS) discussions, the issue of “commercial availability” was discussed and there 

was general agreement that, given the wide use of glycerin as a binder, humectant, solvent, and carrier, 

there is currently no suitable commercially available alternative. During this same time period, the HS 

addressed the question about the make-up of the remaining 1% left over from the “99% pure” claim 

attributed to glycerin? In reviewing the 2013 TR and through review of several stakeholder written 

comments, it is generally held that glycerin is at least 99% pure with the balance of the remaining material 

being water and fatty acids that, perhaps, support processing. 

Subcommittee Vote: 

Motion to remove glycerin from § 205.606 of the National List based on the following criteria in the 

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

Motion by: Jerry D’Amore 

Seconded by: Kim Huseman 

Yes: 2 No: 3 Abstain: 1 Absent: 1 Recuse: 0 

Inulin oligofructose enriched 

Reference: 205.606(j) Inulin-oligofructose enriched (CAS # 9005-80-5) 

Technical Report: 2015 TR 

Petition(s): 2007 Petition 

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

recommendation 

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

notice published 07/06/17 (82 FR 31241) 

Sunset Date: 6/27/2022 

Subcommittee Review: 

Use: 

Inulin-oligofructose enriched (IOE) is on the National List as a nonorganically produced agricultural product 

allowed in or on processed products labeled as “organic.” IOE is a non-digestible carbohydrate that is used 

to increase calcium bioavailability and absorption, as a soluble dietary fiber, as a noncaloric sweetener, 

and for functional effects on the texture/consistency of food. It is used in many foods including yogurt, 

baked goods, candies, jams, baby formulas, and other dairy products. 

Manufacture: 

IOE contains inulin and oligofructose, two carbohydrates found in many plant foods that function as 

dietary fiber. Oligofructose can be produced from sucrose or inulin, however, the most common 

commercial method to produce oligofructose for use in IOE production is from inulin. Inulin is a dietary 

fiber found in chicory (Belgian endive), Jerusalem artichoke (sunchokes), agave, and other plants. Chicory 

inulin is the most commercially available inulin, however in organic production, inulin is generally derived 

from Agave (Mexico) and Jerusalem artichokes (China). Chicory inulin is produced by shredding chicory 

roots, which are treated with hot water, juiced, and filtered to remove the raw inulin. The raw inulin is 

purified by treatment with calcium hydroxide, carbonated, and filtered and spray-dried. The resulting 

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inulin polymers range in chain length from 2–60 units. The shortest polymers range from 2–10 fructose 

units and are called oligofructose. The longer polymers range from 10–60 units. If insufficient amounts of 

oligofructose are present, polymers range from 10–60 units are treated with inulinase enzyme from 

Aspergillus niger to create more oligofructose and is mixed back in with the original inulin. 

Ancillary substances: 

The 2015 TR indicated no ancillary substances but noted that IOE could contain up to 20% glucose, 

fructose, and sucrose left over from the chicory source material or enzymatic conversion. Further the TR 

noted processing aids are removed in favor of a pure IOE product. The amounts of these remaining 

substances may vary, but the general approach in producing IOE is to purify the IOE solution and thereby 

limit the amount of processing aids that remain. The TR for fructooligosaccharides (FOS) noted the 

following residuals: glucose, sucrose, calcium gluconate, glucose oxidase enzyme, catalase enzyme, or 

ethyl alcohol. There are no ancillary substances to list for IOE. 

International: 

IOE is not specifically listed in the CODEX, EU, or Japanese organic standards, however, non-organic 

agricultural products are not listed in these standards. IOE is not specifically listed on the Canadian 

standards. 

In the Fall of 2015 the NOSB voted to sunset IOE based on the availability of alternatives like inulin derived 

from organic agave and the continued listing of conventional FOS. However, in the public comment period 

for the proposed rule a processor and trade association asserted that IOE from chicory was still needed. 

The USDA decided to renew the listing for IOE even though these same comments were received in the 

Fall 2015 meeting during oral comment, and were considered by the NOSB. 

During the Spring 2020 public meeting the NOSB received about 25 public comments, mostly written, with 

about 75% in favor of relisting. Of the remaining 25% about 60% expressed strong opposition citing 

commercial availability, with 40% expressing some concern, again, centering around commercial 

availability. Many of the entities in favor of relisting provided compelling documentation regarding the 

widespread use of IOE as well as examples of its unique functionality. Most of those opposed to relisting 

referenced adequate supply with little or no supporting documentation. 

Regarding the acceptability of using organic inulin + conventional FOS (already listed at §205 606), there 

were numerous public comments asserting that this alternative has a distinct lack of functionality, mostly 

concerning fiber and sweetness. 

Subcommittee Vote: 

Motion to remove inulin-oligofructose enriched from §205.606 of the National List based on the following 

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

Motion by: Jerry D’Amore 

Seconded by: Scott Rice 

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

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Kelp 

Reference: 205.606(k) Kelp—for use only as a thickener and dietary supplement. 

Technical Report: 1995 TAP; 2016 TR (Marine Plants & Algae) 

Petition(s): N/A 

Past NOSB Actions: 04/1995 NOSB recommendation; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420); Sunset renewal notice published 03/21/2017 (82 

FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Kelp is a term used for seaweeds belonging to the brown algae (Phaeophyceae) class in the order 

Laminariales. There are about 30 genera and many species. Kelp is dark green or brown in color and has 

a salty, characteristic taste. Through the 19th century, the word "kelp" was closely associated with 

seaweeds that could be burned to obtain soda ash (primarily sodium carbonate). The seaweeds used 

included species from both the orders Laminariales and Fucales. The word "kelp" was also used directly 

to refer to these processed ashes. Used for centuries in traditional Japanese food, kelp provides a 

unique flavor profile and can be used as a thickening agent or as a base for broth. Kelp can also be used 

as a source of iodine within maximum daily iodine intake limits. 

Manufacture: 

Kelp is harvested, dried and then ground or chopped for use in food. Giant kelp can be harvested fairly 

easily because of its surface canopy and growth habit of staying in deeper water. 

International: 

Kelp is allowed in Canadian General Standards Board Organic Production Systems under aquatic plants 

and aquatic plant products, Table 4.2. It is also listed in the European Union Annex IX 1.1.3 Algae, 

including seaweed, permitted in non-organic foodstuffs preparation. It is also listed in the Japanese 

Agricultural Standard for Organic Plants-Dried Algae, including the powdered form. 

Environmental Issues and Human Health Impacts: 

Kelp is a renewable resource. It is also a keystone species, and there are concerns over responsible 

harvest of kelp beds. Climate change is also impacting the distribution of kelp populations. For 

example, Northern California populations of kelp have been reduced by 90% due to sea urchin 

populations that exploded after disease killed local sea stars, which are natural predators of the urchins. 

The bacteria affecting sea stars may be increasing due to warmer water temperatures resulting from 

global warming. The impact of the loss of kelp on the California coastal marine ecosystem is potentially 

catastrophic, and the Handling Committee would like more information on the impact of harvesting on 

kelp populations. There are also concerns over contamination of kelp from ocean radiation. 

Subcommittee Discussion 

While the term “kelp” generally refers to seaweeds belonging to the brown algae in the order 

Laminariales, by tradition some forms of kelp have more specific names, for instance, wakame or 

kombu. Most kombu is from the species Saccharina japonica (Laminaria japonica). However, some 

edible kelps in the family Laminariaceae are not always called kombu, such as arame, kurome (Ecklonia 

kurome) or Macrocystis pyrifera. The name "wakame" was derived from the Japanese name wakame. 

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Starting in the 1960s, the word "wakame" started to be used widely in the United States, and the 

product (imported in dried form from Japan) became widely available at natural food stores and AsianAmerican grocery stores. There has been some confusion around the separate listings on the National 

List for wakame and kombu, both forms of edible seaweeds. 

The NOSB asked several questions of the organic community. The questions were: 

1. Are there organic supplies of kelp available? If so, are there enough organic supplies available to 

meet commercial demand? 

2. How is organic kelp’s use in livestock production different from uses for human consumption? 

3. Are there organic supplies of kelp available for human consumption? 

4. Is the availability of organic kelp enough to supply both livestock and human consumption 

demand in handling? 

5. What are the handling (human consumption) needs of kelp as a thickener and dietary 

supplement? 

Several commenters requested the delisting of kelp because of the ambiguity of the listing and 

suggested a relisting of kelp under §205.607(b) - the wild crop certification. Other commenters 

suggested relisting with an annotation. The Subcommittee also discussed, in relation to the listing of 

kelp, the NOSB’s discussion document regarding marine materials. Because the marine materials 

document will ultimately affect all marine materials, including kelp, there remains some uncertainty 

about how to proceed with kelp and other seaweeds that will have to be better defined, preferably at 

once, since many of the terms such as kelp can include other separate listings. 

Subcommittee Vote: 

Motion to remove kelp from §205.606 of the National List based on the following criteria in the Organic 

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

Motion by: A-dae Briones 

Seconded by: Steve Ela 

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

Orange shellac 

Reference: 205.606(o) Orange shellac-unbleached (CAS # 9000-59-3). 

Technical Report: 2002 TAP; 2014 TR 

Petition(s): N/A 

Past NOSB Actions: 10/1999 NOSB minutes and vote; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Orange shellac is used to coat fruits and vegetables to reduce water loss and retain firmness. It is an 

ingredient in lozenges, capsules and tablets, and is a part of confectionary glazes on candy, chocolate 

and coffee beans. A dye from shellac is used as a food color. It is a natural bio-adhesive polymer that is 

soluble in alkaline solutions such as ammonia and in solvents such as ethanol. Shellac is water insoluble. 

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There are also numerous non-food uses: on wood, in cosmetics, in clothing, on seeds, and in adhesives, 

varnish, and polishes. 

Manufacture: 

Orange shellac or “shellac” as it is commonly known is the purified product of the natural resin lac, 

which is the hardened secretion of the small, parasitic insect Kerria lacca, popularly known as the lac 

insect. These insects suck the sap of certain host trees, and when digested by the insects the sap 

undergoes a chemical transformation and is eventually secreted through the pores of the insect. When 

this secretion comes into contact with the air, if forms a hard shell-like coating over the larger swarm of 

insects. The main areas of the world where it is produced are India, Thailand, and Myanmar. 

International Acceptance: 

Orange shellac is not listed on the Canadian General Standards Board Permitted Substances List, on the 

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

Organically Produced Foods (GL 32-1999), on the European Economic Community (EEC) Council 

Regulation, EC No. 834/2007 and 889/2008, on the Japan Agricultural Standard (JAS) for Organic 

Production, nor by International Federation of Organic Agriculture Movements (IFOAM). Therefore, 

these international organic standard bodies do not allow this substance in or on organic foods. 

Ancillary Substances: 

From the 2014 Technical Report (TR), there are a number of substances that are used to process the 

orange shellac for use in fruit coatings. Some are allowed in organic production and some are not, they 

include: isopropyl alcohol, morpholine, oleic acid, candelilla wax, fatty acid soaps and fast drying 

solvents, wood rosins, paraffin wax, petroleum wax, carnauba wax, sugar cane wax, polyethylene 

emulsions, castor oil, triethanolamine, ammonia, sodium o-phenyl phenate, stearic acid, alkyl 

naphthalene sulfonates, sodium hydroxide, bentonite, borax, potassium hydroxide, glycerol, palmitic 

acid, luric acid, and stearic acid. Fungicides, growth regulators, and preservatives could be added as well 

as plasticizers such as castor oil, vegetable oils (corn, soy, etc.), acetylated monoglycerides, fatty acids, 

etc. that are not soluble in water can be used in formulating shellac products. Plasticizers are additives 

that increase the plasticity or fluidity of material. Coloring agents such as dyes, titanium dioxide, iron 

oxide, natural colors and other materials such as talc, calcium carbonate and alumina may be used. Only 

items allowed on the National List can be included in orange shellac used in or on organic products. 

Environmental Issues: 

The TR states there are no major adverse environmental effects on the production and processing of 

orange shellac. However, wash-water originating from processing units contain water soluble dye, 

fragments from insect bodies, proteinaceous matter, vegetable glue, and some sugars. These effluents 

collect in a pit outside factories and putrefy, generating an offensive smell. This may be a potential 

environmental hazard for which further studies are required. During washing of sticklac to seedlac, the 

effluents of lac factories are allowed to flow and collect in reservoirs. This accumulated water is treated 

with acid, precipitating all solid matter called lac-mud. Lac-mud is also a source of lac dye and lac wax 

(Baboo and Goswammi 437 2010). 

Discussion: 

At the previous sunset review, public commenters expressed the desire to add an annotation that would 

require labeling of fruits and vegetables that may have had orange shellac applied. This option would be 

a future work agenda item, since annotations are not changed at sunset. The TR states: “There have 

been no reports showing adverse effects on human health due to orange shellac. Some individuals may 

show allergic symptoms and some vegetarians may consider it an animal product not suitable for their 

consumption.” Corn zein and starch are alternative materials for shellac that provide a high gloss to 

some food products. For example, zein is a protein of the prolamine group occurring in maize and used 

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in food coating. Carnauba wax has been used commercially to coat apples but has less gloss than shellac. 

There are primarily four different non-synthetic substances that may be used in place of orange shellac 

as a component of citrus fruit waxes: wood rosin, carnauba wax, beeswax, and candelilla wax. Each has 

their own positives and negatives for handling purposes, including shine, permeability, cost, etc. 

Limited public comments were presented during the Spring 2020 meeting; however, all the comments 

supported relisting orange shellac. Public commenters again suggested adding an annotation that 

would require labeling of fruits and vegetables that may have had orange shellac applied. As noted 

above, this would be a future work agenda item since annotations are not addressed during the sunset 

review. A petition is currently under review by the Board for corn zein, an alternative material to orange 

shellac that also provides a high gloss finish to some foods. The Subcommittee was split over relisting 

orange shellac. There is lack of information about whether its use in organic products is widespread or 

necessary as well as the absence of comments on this ingredient. 

Subcommittee Vote: 

Motion to remove orange shellac from §205.606 of the National List based on the following criteria in 

the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Alternatives, 7 U.S.C. 6518(m)(6) 

Motion by: Kim Huseman 

Seconded by: Jerry D’Amore 

Yes: 3 No: 3 Abstain: 0 Absent: 1 Recuse: 0 

Starches: cornstarch 

Reference: 205.606(s) Starches. 

(1) Cornstarch (native). 

Technical Report: 1995 TAP - Cornstarch 

Petition(s): N/A - Cornstarch; 2007 Petition - Sweet Potato Starch 

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

10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420); 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

“Starches are used in many foods as thickeners, formulation aids, to make corn syrup, and as 

bulking agents and moisture adsorption agents. Cornstarch is made from special strains of corn 

that are high in amylose and amylopectin” (prior review). 

Manufacture: 

Cornstarch is obtained from the endosperm of the kernel. The corn is steeped for 30 to 48 

hours, which ferments it slightly. The germ is separated from the endosperm and those two 

components are ground separately (still soaked). The starch is then removed by washing. The 

starch is separated from the corn steep liquor, the cereal germ, the fibers and the corn gluten 

mostly in hydrocyclones and centrifuges, and then dried. This process is called wet milling. 

Finally, the starch may be modified for specific uses. 

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Ancillary substances: 

None noted. 

International acceptance: 

Canada: Yes, with restrictions on materials used for manufacture. 

Codex: Not listed. 

EU: From corn, not chemically modified. 

Japan: Not listed. 

IFOAM: Not listed 

Environmental/Health Issues: 

Cornstarch poses no acute health hazards from ingestion or dermal absorption. Dusts 

produced during production may pose inhalation risks, and potentially a fire hazard if levels in 

air reach critical combustion concentrations. Cornstarch that is not organic may be produced 

from conventional corn that was grown with synthetic fertilizers and pesticides that pose risks 

to human health and the environment. 

Discussion: 

There are organic starches on the market, but they are not necessarily suitable for all uses. “Cornstarches 

are described by the relative content of two glucose polymers: amylopectin and amylose. Special strains 

of corn are grown to achieve the right ratio of the polymers and these special varieties are all identity 

preserved to maintain their amylose ratio and so are never genetically engineered”. During the 2017 

review, public commenters indicated that some types of organic cornstarch are not available. A recent 

search of the Organic Integrity Database identified 55 suppliers of “cornstarch” or “corn starch”, 

including many in the United States. Cornstarch is listed under §205.606, so non-organic material 

should be used only when organic cornstarch is not available. The Handling Subcommittee requested 

public comment on the need to list cornstarch under §205.606. 

During the Spring 2020 NOSB meeting, many certifiers, trade organizations, and food manufacturers 

supported relisting of cornstarch on §205.606. Although various forms of organic cornstarch are 

available and abundant, many commenters noted that some organic forms were not functional to 

manufacture their products or there was not enough specialized organic material available to meet their 

needs. Overall, certifiers and producers reported non-GMO derived cornstarch, albeit not organic, was 

readily available. Several organic cornstarch manufactures reported production of thousands of metric 

tons of organic cornstarch and also possible alternatives derived from pea starch or other products. One 

commenter recommended an annotation limiting cornstarch on §205.606 to specialized forms that are 

not available organically and thus encouraging broader use of available organic cornstarch when it 

meets production requirements. Note that an annotation is beyond the scope of the sunset review and 

would have to be considered as a separate work agenda item. The Subcommittee wanted to encourage 

policies that increase use of organically sourced cornstarch and there was debate about whether this 

could be accomplished by an annotation as described above or by removing cornstarch, as listed, from 

§205.606, and encouraging direct listing of any specialized forms that are not available organically. The 

Subcommittee ultimately voted to recommend removal of cornstarch from §205.606 because of an 

abundant supply of organic cornstarch. 

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Subcommittee Vote: 

Motion to remove starches: cornstarch from §205.606 of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Commercial availability 

Motion by: Asa Bradman 

Seconded by: Scott Rice 

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

Starches: sweet potato 

Reference: 205.606(s) Starches. 

(2) Sweet potato starch - for bean thread production only. 

Technical Report: 1995 TAP - Cornstarch 

Petition(s): N/A – Cornstarch; 2007 Petition - Sweet Potato Starch 

Past NOSB Actions: 10/1995 NOSB minutes and vote; 10/2010 sunset review Sweet potato starch; 

10/2015 sunset recommendation 

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

renewal notice published 03/21/2017 (82 FR 14420) 

Sunset Date: 3/15/2022 

Subcommittee Review: 

Use: 

Sweet potato starch is specifically used as a formulation aid for bean thread production. 

Manufacture: 

The sweet potatoes are crushed, and the starch is washed out and dried to a powder. 

Ancillary substances: 

None noted. 

International acceptance: 

Canada: Not listed. 

Codex: Not listed. 

EU: Not listed. 

Japan: Not listed. 

IFOAM: Not listed 

Environmental/Health Issues: 

Sweet potato starch poses no acute health hazards from ingestion or dermal absorption. Dusts produced 

during production may pose inhalation risks. Sweet potato starch that is not organic may be produced 

from conventional sweet potatoes that were grown with synthetic fertilizers and pesticides that pose 

risks to human health and the environment. 

Discussion: 

A recent search of the Organic Integrity Database identified two suppliers of “sweet potato starch”, 

including one in the United States and one in China. Sweet potato starch is listed under §205.606, so 

non-organic forms can be used only when organic cornstarch is not available. The Handling 

Subcommittee requested public comment on the need to list cornstarch under §205.606 and whether 

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current supplies are adequate to meet demand for organic bean thread products. 

Public comment on sweet potato starch was very limited, with only a few reported users of this project. 

One organic starch manufacturer suggested pea starch provided a workable alternative to sweet potato 

starch, although this claim was not addressed by food producers currently using sweet potato starch. 

Another commenter noted that taking sweet potato starch off §205.606 would likely increase 

availability of organically sourced material. The Subcommittee wanted to encourage policies that 

increase use of organically sourced sweet potato starch and ultimately voted to recommend removal of 

sweet potato starch from §205.606 to encourage use of organically sourced material. 

Subcommittee Vote: 

Motion to remove starches: sweet potato starch from §205.606 of the National List based on the 

following criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Commercial 

availability 

Motion by: Asa Bradman 

Seconded by: Jerry D’Amore 

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

Turkish bay leaves 

Reference: 205.606(u) Turkish bay leaves. 

Technical Report: N/A 

Petition(s): 2006 Petition 

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

recommendation 

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

renewal notice published 07/06/17 (82 FR 31241) 

Sunset Date: 6/27/2022 

Subcommittee Review: 

Use: 

Turkish bay leaves are an herb that has been used traditionally to flavor food. 

Manufacture: 

Turkish bay leaves (Laurus nobilis) are widely cultivated in the Mediterranean and Asia. Leaves are 

harvested, sorted and then sold fresh or dried. 

International: 

There is no list of individual non-organic agricultural commodities allowed under the Japanese 

Agricultural Standards (JAS), International Federation of Organic Agricultural Movements (IFOAM) or 

Codex standards. However, these standards allow for up to 5% non-organic content. The EU Organic 

Standards do not list Turkish bay leaves. 

Ancillary Substances: 

None noted 

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Discussion: 

During the review of 2017 sunset materials conducted in 2015, the NOSB requested information from 

the public to assess commercial demand, commercial availability, alternatives, necessity and use in 

organic production. At that time, the original petitioner noted a source of Turkish bay leaves but 

believed the supply was too fragile to have the listing removed. Searches of publicly available organic 

sourcing pages by the NOSB in June of 2015 resulted in 85 NOP organic certificate holders of bay leaves 

with 12 specifying Laurus nobilis. Additionally three spice companies were contacted, and all had 

sources of Turkish bay leaves from Turkey, India or both. 

One commenter noted concern regarding impacts of pesticide use and residue when a conventional 

agricultural ingredient is used. Products certified to the “made with organic...” may use non-organic 

agricultural ingredients that are not listed on §205.606 and have not undergone a review for compliance 

with OFPA criteria. However, these ingredients are still required to comply with §205.105, which 

prohibits ingredients that are irradiated, produced with sewage sludge or with excluded methods. 

Additionally, the commenter provided no data specifically on pesticide usage and residues on Turkish 

bay leaves and just cited EPA tolerance levels for pesticides on herbs subgroup 19A. 

Based on the availability of organic sources, the NOSB recommended at its October 2015 meeting to 

remove Turkish bay leaves from 205.606. In an August 7, 2017 final rule, USDA noted it received public 

comments opposing the remove of Turkish bay leaves from the National List. These extensive comments 

stated that Turkish bay leaves are not available in the quantity or quality needed to meet organic 

handling needs. Comments explained that while organic whole bay leaf may be commercially available, 

ground organic bay leaves provide a different flavor profile, are not presently commercially available, 

and removal of Turkish bay leaves from the National List would negatively impact finished products 

containing ground bay leaves. Comments requested that USDA maintain the allowance for nonorganic 

Turkish bay leaves while suppliers pursue sources of ground organic Turkish bay leaves in sufficient 

quality and quantity to meet industry needs. 

In response to these comments, USDA determined that nonorganic forms of Turkish bay leaves are 

essential to organic production and handling and should remain on the National List. At the time of this 

decision, USDA noted that organic handlers are permitted to use the nonorganic substance only if the 

organic substance is not commercially available. Handlers need to demonstrate, and certifiers need to 

verify, that the organic substance is not available in the form, quality or quantity needed. 

In a December 2019 review of the Organic Integrity Database, the Handling Subcommittee found 62 

records of certified handlers and crop producers listing “bay leaf,” 86 records listing “bay leaves,” and 

four records listing “Turkish bay leaves.” 

During its Spring 2020 review, the Handling Subcommittee heard overwhelming support to remove 

Turkish bay leaves from the National List. As noted above and attested to in public comments received, 

there appears to be a sufficient quantity of organic Turkish bay leaves in the market to support this 

removal. Of the certifiers that submitted comments on §205.606 sunset materials, only one noted the 

inclusion of nonorganic Turkish bay leaves in 4 organic system plans. One trade association noted one 

organic operation they surveyed used Turkish bay leaves in a wide range of canned soups but stated 

there is full availability of organic forms. The operation further noted there would be no impact from 

removal of this material because organic forms can be used and are available. 

Based on these comments and the apparent wide availability of organic sources, the Handling 

Subcommittee recommends the removal of Turkish bay leaves from §205.606 of the National List. 

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Subcommittee Vote: 

Motion to remove Turkish bay leaves from §205.606 of the National List based on the following criteria 

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

Motion by: Scott Rice 

Seconded by: Steve Ela 

Yes: 5 No: 1 Abstain: 0 Absent: 1 Recuse: 0 

Whey protein concentrate 

Reference: 205.606(w) Whey protein concentrate. 

Technical Report: 2015 TR 

Petition(s): 2007 Petition 

Past NOSB Actions: 05/2007 NOSB recommendation; 10/2010 NOSB sunset recommendation; 10/2015 

sunset recommendation 

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

renewal notice published 07/06/17 (82 FR 31241) 

Sunset Date: 6/27/2022 

Subcommittee Review: 

Use: 

Whey protein concentrate is used in dairy products, protein bars, and infant formulas. Whey protein 

concentrate is used as a source of protein, as a fat replacer, and as a texturizer. 

Manufacture: 

Whey protein concentrate is a soluble fraction of bovine milk composed of protein, minerals, and 

lactose and is a byproduct of cheese manufacturing. The primary method of production mixes milk with 

rennet to coagulate the casein to make cheese curds, the resulting liquid is whey. Another method of 

production is via microbiological fermentation or direct addition of lactic acid that acts to reduce the pH 

and coagulate the casein. The whey undergoes an ultra-filtration process to remove a large portion of 

the lactose and minerals. Low temperature processing ensures retention of both nutritional and 

functional properties. Whey protein concentrate is evaporated then spray-dried and sold as a dry 

ingredient. The whey protein concentrate may also be bleached with hydrogen peroxide or benzoyl 

peroxide. Whey protein concentrate can be concentrated to different protein levels (i.e., 35%) but max 

out around 80%. Concentrations higher than 90% are considered whey protein isolate. 

International: 

Whey protein concentrate is not specifically listed in the CODEX, Canadian, or Japanese organic 

standards. “Whey powder ‘herasuola’” is listed on the EU Organic Standards. 

Ancillary Substances: 

Soy lecithin may be added as an "instantizing" ancillary substance. 

Environmental Issues and Human Health Impacts: 

In most jurisdictions, environmental regulations now prevent disposal of untreated whey on agricultural 

land or discharging in municipal sewage system or surface water. Whey composition (high solids, 

lactose and salt content) makes disposal practices a problem. Rodenberg, 1998 reported that the five 

day biochemical oxygen demand (BOD5) is a measure of the organic pollutant concentration in the 

wastewater, and is proportional to the amount of milk or whey lost to the sewer (TR lines 629-631). 

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Normal dairy production plant wastewater is in the range of 2000 to 3000 mg/l which is 10 times the 

strength of domestic sewage. The BOD5 can go much higher if a milk spill occurs and the pH can 

fluctuate widely if spent cleaning in place chemicals are discharged as well. Dairies manage their 

wastewater discharge to avoid upsetting their biological treatment process or a publicly owned 

treatment system. With recent advances in technology, as well as increasing awareness of the 

environmental and financial costs of whey disposal, the dairy industry has found it profitable to process 

whey into high value added protein products for use as ingredients in food systems. Whey proteins are 

generally recognized as safe (GRAS) and are considered a label-friendly ingredient. A large portion of the 

energy used at a typical cheese making operation is devoted to processing whey powder or concentrate. 

Falling-film type evaporation systems are used to concentrate whey liquid. To fully dry the whey to a 

powder form, condensed whey from an evaporator is fed to a spray dryer. Both of these processes are 

highly energy intensive due to the thermal energy required. 

Subcommittee Review: 

During the Board’s previous review in 2015, the NOSB requested information from the public related to 

(1) ancillary substances, (2) commercial demand, (3) commercial availability, (4) other alternatives, and 

(5) use in the industry. In the past, one public comment was received from a certifier on the use of soy 

lecithin as an ancillary substance. No information was provided on commercial demand, alternatives or 

its use in the industry. One trade association commented on its essentiality and lack of supply but 

provided no detailed information on why the supply identified by the NOSB was insufficient. One 

certifier noted they have clients producing and selling organic whey protein concentrate. Given the 

availability of organic whey protein concentrate and the absence of information on continued 

commercial unavailability from industry, the Handling Subcommittee recommended this item be 

removed from the National List in 2015 (2015/Fall - Rec to Remove). To date, NOP has not removed 

WPC from the National List. A petition to remove whey protein concentrate from the National List 

(https://www.ams.usda.gov/sites/default/files/media/Addendum1_PetitionforRemovalofWheyProteinC 

oncentrate_2019.pdf) is currently under review by the Handling Subcommittee, and review of the 

Organic Integrity Database indicates several suppliers of whey protein concentrate. 

Public comments received during the Spring 2020 NOSB were overwhelmingly in support of removing 

whey protein concentrate from the National List. The Handling Subcommittee specifically requested 

information as to whether there were any forms of whey protein concentrate that were not available 

organically. In response to this explicit request, no public comments were received indicating that there 

were organic forms that were not available. Furthermore, several commenters replied that they had 

adequate supply of all forms and actually had so much supply that they were having to sell some organic 

product on the conventional market. These comments included: 

CROPP Cooperative: Organic Whey Protein is fully available in form and volume. The processing 

infrastructure has grown dramatically since whey protein concentrate was placed on the 

National List. Processors are established throughout the United States for both finished 

products and condensed whey. Roughly sixty percent of our whey is processed into whey 

powders, with future plans to utilize our entire whey stream. Our whey supply could produce 

1.4 million pounds of WPC annually. Today there is an ample supply of organic whey protein 

concentrate on the market and the supply will continue to grow. In fact, our WPC supply is 

greater that market demand, where large volumes of our supply are sold on the conventional 

market. 

Western Organic Dairy Producers: We have more than adequate product available to meet the 

current demand for Organic Whey Protein Concentrate. Given this availability, there is no need 

to utilize a conventional product for products labeled as organic. The removal of the 

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conventional Whey Protein Concentrate further supports organic dairy producers and organic 

dairy product utilization. 

Milk Specialties Global: As outlined in the petition, the decision to allow nonorganic whey in 

organic products may have been necessary in 2007, but no longer meets the threshold of 

necessity today. We urge the NOSB to remove Whey Protein Concentrate from the National List 

as part of the mandated sunset process. 

Furthermore, at least one organic certifier notes that all of their handlers are currently using organic 

forms of whey protein concentrate and a number of suppliers were identified on the Organic Integrity 

Database. Another commenter also noted that organic whey-based products are also offered from 

international partners, making the supply chain quite robust. 

As noted above, the NOSB has also received a petition to remove whey protein concentrate from the 

National List. The reasoning given in the petition is similar to the reasons listed above. There is 

adequate organic supply. Despite questions that have been directed towards identifying any forms that 

are not available organically, there has been no public comment received indicating that the organic 

supply is inadequate. In fact, there has been comment that at this point the supply exceeds the 

demand. For this reason the Handling Subcommittee recommends removing whey protein concentrate 

from the National List. 

Subcommittee Vote: 

Motion to remove whey protein concentrate from §205.606 of the National List based on the following 

criteria in the Organic Foods Production Act (OFPA) and/or 7 CFR 205.600(b): Alternatives (availability of 

organic whey protein concentrate), 7 U.S.C. 6518(m)(6) 

Motion by: Steve Ela 

Seconded by: Jerry D’Amore 

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

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