This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised June 20 2013

National Organic Standards Board

Livestock Subcommittee

Petitioned Material Proposal

Tocopherols in aquatic animal production

August 22, 2013

*Reviewed and revised January 21, 2014

Summary of Proposed Action:

Synthetic Tocopherols are proposed to be added to the National List at 205.611 for use in 

aquatic animal production as an anti-oxidant added to feed. Section 205.611 of the National List 

will contain the list of synthetic substances allowed in organic aquatic animal production. 

Tocopherols were petitioned in 2012 by the Aquaculture Working Group for use in aquaculture 

livestock production. Tocopherols are a group of lipophilic phenolic antioxidants that occur 

naturally in a variety of plant species. Rich sources of naturally-occurring tocopherols include 

cereal grains, oilseeds, nuts, and vegetables (Burdock, 1997). The term “tocopherols” refers to 

structurally similar compounds that occur in nature in four forms: alpha-, beta-, gamma-, and 

delta-tocopherol (CIR, 2002). Tocopherols that are derived from plant products are often 

referred to as “mixed tocopherols” because the mixture contains all four forms of tocopherol 

(CIR, 2002). (TR lines 37-41). Tocopherols are mixed with fish oil, fishmeal, and other feed 

ingredients to prevent oxidation of the polyunsaturated fatty acids present in the lipids and 

thereby protect the nutritional value of the feed. Polyunsaturated fatty acids are very 

susceptible to autoxidation when exposed to oxygen in the atmosphere (Tacon, 1992). During 

the process of lipid autoxidation, toxic degradation products are formed in the feed that may 

cause pathological changes in the fish (Hardy and Roley, 2000). Furthermore, oxidation 

destroys essential fatty acids in the feed, and consuming oxidized lipids may have deleterious 

effects on tissue levels of vitamins C and E. Finally, oxidation of the lipids in fish meal 

generates heat that is sometime sufficient to cause spontaneous combustion of feeds (Hardy 

and Roley, 2000). Tocopherols are considered essential for the health of aquatic animals

Tocopherols are not specifically named in the National List as synthetic feed additives allowed 

for use in organic livestock production. However, mixed tocopherols are a source of vitamin E. 

Vitamins (used for enrichment or fortification when FDA approved) are included on the National 

List as synthetic ingredients allowed as feed additives in organic livestock production (7 CFR 

205.603[d][3]). Tocopherols derived from vegetable oil are allowed for use as ingredients in or 

on processed products labeled as “organic” or “made with organic (specified ingredients or food 

group[s])” when rosemary extracts are not a suitable alternative (7 CFR 205.605[b])(TR lines 

26-32).

Tocopherols are also affirmed as GRAS by the FDA when used as chemical preservatives (21 

CFR 582.3890) and nutrients and/or dietary supplements (21 CFR 582.5890) in animal feeds in 

accordance with good manufacturing or feeding practice. No sources were identified that 

discuss any negative effects of tocopherols on biological or chemical interactions in the aquatic 

agro-ecosystem, including nontarget aquatic organisms, physical water conditions, endangered 

species, or biodiversity. TR lines 464-466. “Tocopherols are currently permitted by Canadian, 

European, and Japanese Organic Standards, IFOAM and CODEX, although they may not 

specifically be permitted as antioxidants in livestock feed production.

In reviewing whether use of synthetic tocopherols is compatible with or essential to organic 

agriculture the subcommittee took into consideration the Organic Foods Production Act (OFP) 

which limits use of synthetics. Tocopherols are in the vitamin group listed at section 

6517(c)(1)(B)(i).
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised June 20 2013

It should be noted that at the time of drafting this proposal there are no federal standards 

promulgated for aquatic plant or animal production, and this proposal is based on the NOSB 

Recommendations of standards voted in 2007, 2008, and 2009. Therefore the livestock 

subcommittee recommends reassessment of this material when regulations for open and closed 

systems are in place.

Evaluation Criteria (see attached checklist for criteria in each category)

Criteria Satisfied? 

1. Impact on Humans and Environment X Yes ☐ No ☐ N/A 

2. Essential & Availability Criteria X Yes ☐ No ☐ N/A

3. Compatibility & Consistency X Yes ☐ No ☐ N/A

Substance Fails Criteria Category: [ ] Comments:

Subcommittee Action & Vote

Classification Motion: Motion to classify tocopherols, as petitioned, as synthetic.

Motion by: Jean Richardson 

Seconded by: Mac Stone

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

Listing Motion: Motion to list tocopherols at §205.611 of the National List for use in aquatic 

livestock production as an antioxidant added to aquatic animal feed with the following 

annotation: Tocopherols derived from vegetable oils are allowed as ingredients in aquatic 

livestock production when rosemary extracts are not a suitable alternative.

Motion by: Jean Richardson 

Seconded by: Mac Stone

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

 Proposed Annotation (if any): Tocopherols derived from vegetable oils are allowed as 

ingredients in aquatic livestock production when rosemary extracts are not a suitable 

alternative.

Basis for annotation: x☐ To meet criteria above ☐ Other regulatory criteria ☐ Citation 

Notes: 

Minority Opinion: see end of document

Approved by Tracy Favre, Subcommittee Chair, to transmit to NOSB January 21, 2014
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised June 20 2013

NOSB Evaluation Criteria for Substances Added To the National List: Livestock

Category 1. Adverse impacts on humans or the environment? Tocopherols (aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is there a probability of environmental 

contamination during, use or misuse?

[§6518(m)(3)]

X If solvents used in the manufacturing are 

released into the environment through 

waste streams, environmental 

contamination could occur. However, no 

sources were identified that discussed 

environmental contamination resulting 

from the manufacturing of tocopherols. 

(TR lines 498-501)

2. Is there a probability of environmental 

contamination during, manufacture or 

disposal? [§6518(m)(3)]

X X The extraction of tocopherols from 

vegetable oil byproducts may include one 

or more of the following chemical 

processes: esterification, saponification, 

solvent extraction, and/or crystallization 

using a solvent (TR 281-314). Physical 

separation methods may also be used 

during the extraction of tocopherols, and 

these include various distillation steps. 

Solvents used include: hexane, ethanol, 

isopropanol, acetone, isopentane, 

isohexane, and trichloroethylene (TR 

lines 282-284). Can also be made from a 

byproduct of vegetable oil refining (oils of 

soybean, canola, sunflower, corn, and 

cottonseed, some of which may be 

genetically engineered) (TR lines 289-

292). 

3. Does the substance contain inerts 

classified by EPA as ‘inerts of 

toxicological concern’? 

[§6517 (c)(1)(B)(ii)]

X

4. Is there potential for detrimental chemical 

interaction with other materials used in 

organic farming systems? [§6518(m)(1)]

X TR lines 451-450.

5. Is there a toxic or other adverse action of 

the material or its breakdown products?

[§6518(m)(2)]

X Excessive intake of tocopherols above 

the vitamin E requirement of fish could 

result in hypervitaminosis E, a condition 

of high storage levels of the vitamin in the 

fish which could result in toxic symptoms 

such as poor growth, toxic liver reaction, 

and death (De Silva et al., 2012; Halver, 

2002) (TR lines 480-483). 
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised June 20 2013

6. Is there persistence or concentration of 

the material or breakdown products in 

the environment? [§6518(m)(2)]

X Tocopherols exert their antioxidant 

properties by reacting with free radicals, 

so they are unlikely to persist. Oxidized 

tocopherols can be recycled in the 

presence of other antioxidants, however, 

and some of the metabolites of 

tocopherols can be toxic.1

7. Would the use of the substance be 

harmful to human health or the 

environment? [§6517 (c)(1)(A)(i); §6517 

(c)(2)(A)(i); §6518(m)(4)]

X See TR lines 393-439.

The tocopherol level found in the flesh of 

a fish is related to the fish’s total dietary 

intake of tocopherols (Sargent et al., 

2002). The use of tocopherols as an 

antioxidant or vitamin supplement in 

aquatic animal feed will possibly increase 

tocopherol levels in those fish that 

consume the feed, with unknown effects 

on the human consumer (TR lines 522-

524). 

No sources were identified that discuss 

adverse effects upon human health from 

the use of tocopherols as an antioxidant 

in aquatic or terrestrial animal feed. It is 

unlikely that the use of tocopherols as an 

antioxidant in aquatic animal feed would 

be harmful to human health. (TR lines 

509-511)

8. Are there adverse biological and 

chemical interactions in the agroecosystem, including biodiversity? 

[§6518(m)(5)]

X No sources were identified that discuss 

any negative effects of tocopherols on 

biological or chemical interactions in the 

aquatic agro-ecosystem, including 

nontarget aquatic organisms, physical 

water conditions, endangered species, or 

biodiversity. (TR lines 464-466.)

9. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518(m)(5)]

X

Category 2. Is the Substance Essential for Organic Production? Tocopherols (aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance agricultural? [§6502(1)] X

2. Is the substance formulated or 

manufactured by a chemical process? 

[§6502(21)]

X TR lines 276-369.

The 1995 Technical Advisory Panel 

(TAP) Report for Tocopherols, which 

 1 Aalt Bast and Guido R.M.M. Haenen, 2002. The toxicity of antioxidants and their metabolites. Environmental 

Toxicology and Pharmacology 11 (2002) 251–258.
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised June 20 2013

reviewed the use of tocopherols as a food 

antioxidant, states that tocopherols are 

made via vacuum steam distillation of 

edible vegetable oil products (NOSB, 

1995). (TR lines 285-287)

3. Is the substance formulated or 

manufactured by a process that 

chemically changes a substance 

extracted from naturally occurring plant, 

animal, or mineral sources? 

[§6502(21)]

X (TR lines 276-369.) Synthetics are added 

in extraction process. 

All of the methods found in the literature 

involve chemical processes. At the end 

of the process used to extract and purify 

tocopherols, the compounds remain in 

the same form as in the naturally 

occurring source materials. (TR lines 

320-322)

The petitioner provided a material safety 

data sheet (MSDS) for a product called 

Naturox® IPO Liquid (Kemin Industries, 

Inc.) which lists organic sunflower oil, 

lecithin, and rosemary extract as 

components of the mixed tocopherols 

formulation (Kemin Industries, Inc., 

2008). The Joint Expert Committee on 

Food Additives (JECFA) specification for 

the food additive “mixed tocopherols 

concentrate” states that it may contain an 

edible vegetable oil added to adjust the 

required amount of total tocopherols 

(JECFA, 2006). Powdered forms of 

mixed tocopherols contain a carrier such 

as tapioca starch, gum acacia, and/or 

maltodextrin (Organic Technologies, 

2009; NOSB, 1995). No additional 

sources were found that discuss possible 

additives to commercially-produced 

tocopherols for use as antioxidants in 

food or feed, including aquaculture feed 

products. (TR lines 55-63)

4. Is the substance created by naturally 

occurring biological processes? 

[§6502(21)]

X X Naturally occurring tocopherols exist. But 

the petition is for synthetic tocopherols.

5. Is there a natural source of the 

substance? [§ 205.600(b)(1)]

X Tocopherols are a group of lipophilic 

phenolic antioxidants that occur naturally 

in a variety of plant species. Rich 

sources of naturally-occurring 

tocopherols include cereal grains, 

oilseeds, nuts, and vegetables (Burdock, 

1997). The term “tocopherols” refers to 

structurally similar compounds that occur 

in nature in four forms: alpha-, beta-, 

gamma-, and delta-tocopherol (CIR, 

2002). Tocopherols that are derived from 
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised June 20 2013

plant products are often referred to as 

“mixed tocopherols” because the mixture 

contains all four forms of tocopherol (CIR, 

2002). (TR lines 37-41)

6. Is there an organic substitute? 

[§205.600(b)(1)]

X Organic Rosemary oil may work in some 

applications.

7. Is there a wholly natural substitute 

product?

[§6517(c)(1)(A)(ii)]

X Rosemary extract, lecithin, vitamin C, 

natural sources of vitamin E (eg, wheat 

germ oil), and others (TR lines 531-583).

8. Are there any alternative substances? 

[§6518(m)(6)]

X See 7 above.

9. Are there other practices that would 

make the substance unnecessary? 

[§6518(m)(6)]

X No sources were identified that 

discussed alternative practices that would 

make the use of an antioxidant 

unnecessary in aquatic animal feed (TR 

595-597).

Category 3. Is the substance compatible with organic production practices? Tocopherols 

(aquatic animals)

Question Yes No N/A Comments/Documentation (TAP; 

petition; regulatory agency; other)

1. Is the substance consistent with organic 

farming and handling? 

[§6517(c)(1)(A)(iii); 6517(c)(2)(A)(ii)]

X Synthetic tocopherols are currently 

permitted for specific uses in organic 

livestock production and organic 

handling. Tocopherols are not 

specifically named in the National List as 

synthetic feed additives allowed for use in 

organic livestock production. However, 

mixed tocopherols are a source of vitamin 

E. Vitamins (used for enrichment or 

fortification when FDA approved) are 

included on the National List as synthetic 

ingredients allowed as feed additives in 

organic livestock production (7 CFR 

205.603[d][3]). Tocopherols derived from 

vegetable oil are allowed for use as 

ingredients in or on processed products 

labeled as “organic” or “made with 

organic (specified ingredients or food 

group[s])” when rosemary extracts are 

not a suitable alternative (7 CFR 

205.605[b])(TR lines 26-32). 

2. Is the substance compatible with a 

system of sustainable agriculture? 

[§6518(m)(7)]

X See 1 above

3. If used in livestock feed or pet food, Is 

the nutritional quality of the food 

maintained with the substance? 

[§205.600(b)(3)]

X Tocopherols are mixed with fish oil, fish 

meal, and other feed ingredients to 

prevent oxidation of the polyunsaturated 

fatty acids present in the lipids and 
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised June 20 2013

thereby protect the nutritional value of the 

feed. Polyunsaturated fatty acids are 

very susceptible to autoxidation when 

exposed to oxygen in the atmosphere 

(Tacon, 1992). During the process of 

lipid autoxidation, toxic degradation 

products are formed in the feed that may 

cause pathological changes in the fish 

(Hardy and Roley, 2000). (TR lines 99-

105) Furthermore, oxidation destroys 

essential fatty acids in the feed, and 

consuming oxidized lipids may have 

deleterious effects on tissue levels of 

vitamins C and E. 

4. If used in livestock feed or pet food, Is 

the primary use as a preservative? 

[§205.600(b)(4)]

X Oxidation of the lipids in fish meal 

generates heat that is sometime sufficient 

to cause spontaneous combustion of 

feeds (Hardy and Roley, 2000). (TR lines 

107-109) Tocopherols are used to 

stabilize fishmeal and are required under 

law if fishmeal is to be transported.

5. If used in livestock feed or pet food, Is 

the primary use to recreate or improve 

flavors, colors, textures, or nutritive value 

lost in processing (except when required 

by law)? [§205.600(b)(4)]

X See comments at Item 3 above.

6. Is the substance used in production, and 

does it contain an active synthetic 

ingredient in the following categories: 

[§6517(c)(1)(B)(i);

copper and sulfur compounds

X

toxins derived from bacteria X

pheromones, soaps, horticultural oils, 

fish emulsions, treated seed, vitamins 

and minerals

X Tocopherols are in the vitamin group

livestock parasiticides and medicines X

production aids including netting, tree 

wraps and seals, insect traps, sticky 

barriers, row covers, and equipment 

cleansers

X
This is a proposal by a Subcommittee of the National Organic Standards Board (NOSB). Proposals are posted for public comment and 

then may be voted upon by the full Board. They are not final Board recommendations or NOP policy.

Revised June 20 2013

Minority Opinion - Tocopherols in aquatic animal production

February 21, 2014

Since this petition is being considered in the absence of regulations defining acceptable 

practices in organic aquaculture, essentiality in particular cannot be judged at this time, so the 

NOSB needs to reconsider the approval in five (5) years. The minority believes that there should 

be a five-year expiration date as an annotation. Current consideration of the material has raised 

issues relating to health or environmental impacts, especially relating to those relating to 

extractants, as well as alterative natural materials. The review in five (5) years provides an 

opportunity for the Board to monitor the use of the material, update its scientific and essentiality 

review, incentivize alternatives and continuous improvement, and vote on continued or modified 

use of the material under the same standard of review that is used to approve the material 

during its petition review, pending the receipt of a petition requesting the use be extended.

The minority also has concerns about the unnecessary presence of volatile synthetic solvents in 

tocopherols. The Livestock Subcommittee received a letter from Oh Oh Organics supporting the 

consistent availability of natural tocopherols extracted without synthetic solvents. The letter 

states, 

I have sold Non-GMO, non-solvent extracted tocopherol since 2005. Both BASF, an 

international ingredient manufacturer out of Germany and BTSA, a company specializing 

in non-GMO Tocopherols supply this material. It is consistently available and is broadly 

used in the food, cosmetic and household cleaning business. Additionally I have seen 

ISO certified documents for a supplier in China...so, I believe it available around the 

world.

The minority believes that the use of synthetic tocopherols is incompatible with organic 

agriculture because:

• It is inconsistent with use of vitamins in terrestrial animals, where they are restricted to 

use for, “enrichment or fortification when FDA approved.” 

• It is a synthetic preservative.