Decision Sheets

December 2006

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: Fall 2011 Substance: DHA from Algal Oil 

Committee: Crops • Livestock • Handling X Petition is for: inclusion on the National List 7 

CFR, §205.605

A. Evaluation Criteria (Applicability noted for each category; Documentation attached) Criteria Satisfied? (see B below) 

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

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

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

4. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes • No • N/A X 

B. Substance Fails Criteria Category: _________ Comments: ___________________________________________________ 

________________________________________________________________________________________________________

C. Proposed Annotation (if any): _____________________________________________________________________________

________________________________________________________________________________________________________

 Basis for annotation: To meet criteria above: _______ Other regulatory criteria: _______ Citation:______________________

D. Recommended Committee Action & Vote (State Actual Motion): _

Motion is list the material as a non-synthetic, designating the material for §205.605(a)

Motion by: _Tracy MIedema______________ Seconded:_Katrina Heinze_______________ Yes: 7_____ No: _0____ 

Absent: _______ Abstain: _____ 

Motion is to list the petitioned material, “DHA Algal Oil” on the National List 7 CFR, §205.605(a) as “DHA from Algal 

Oil”

________________________________________________________________________________________________________

Motion by: _Tracy MIedema______________ Seconded:_Katrina Heinze_______________ Yes: 7_____ No: _0____ 

Absent: _______ Abstain: _____ 

 

 

1) Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any) ______________________

________________________________________________________________________________________________________

2) Substance to be added as “prohibited” on National List to § 205. with Annotation (if any) _________________________

________________________________________________________________________________________________________

Describe why a prohibited substance:__________________________________________________________________________

________________________________________________________________________________________________________ 

 

3) Substance was rejected by vote for amending National List to § 205. _____ Describe why material was rejected:___________ 

________________________________________________________________________________________________________

4) Substance was recommended to be deferred because ___________________________________________________________

_____________________________________________________________________________ If follow-up needed, who will 

follow up ________________________________________________________________________________________________

Crops Agricultural Allowed1 x

Livestock Non-Synthetic x Prohibited2 

Handling x Synthetic Rejected3

No restriction 

Commercially UnAvailable as Organic1

 

Deferred4
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December 2006

E. Approved by Committee Chair to transmit to NOSB:

Steve Demuri October 7, 2011

 Committee Chair Date
Decision Sheets

December 2006

NOSB EVALUATION CRITERIA FOR SUBSTANCES ADDED TO THE NATIONAL LIST

Category 1. Adverse impacts on humans or the environment? Substance - _ DHA from Algal Oil 

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal? 1

[§205.600 b.2]

x The TR evaluated the petitioned substance and concluded that 

there are no adverse effects under this criterion. See TR lines

409-407 and 430-455; see also Question 2 below (statutory 

form of criterion)

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

x The TR concluded that there are no adverse environmental 

impacts, noting that the sole solvent used is “recycled.” See 

generally TR lines 430-455 (describing inputs, manufacturing 

process and waste byproducts); (disposal method for biomass 

substrate for algal growth “eliminates” any possibility of 

adverse environmental impact); (noting that algae are grown 

and not wild-harvested so possibility of “excessive harvesting” 

is inapplicable); (no information that algal oil production has 

“adverse impact on biodiversity”); see also lines 407-409 

(noting FDA GRAS notice reported no heavy metals or 

pesticides detected in petitioned substance)

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x See Question 2 above, citing TR lines 407-409 and 430-455

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

x This is a substance used as an ingredient in an organic 

processed food. It is not used in production and contains no 

listed inerts.

5. Is there potential for detrimental 

chemical interaction with other 

materials used?2

[§6518 m.1]

x No detrimental interactions were noted in the TR. See TR 

lines 123-151 (discussing combinations with substances) 

6. Are there adverse biological and 

chemical interactions in agroecosystem? [§6518 m.5]

x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem.

7. Are there detrimental 

physiological effects on soil 

organisms, crops, or livestock? 

[§6518 m.5]

x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem.

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products? 

[§6518 m.2]

x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem.

9. Is there undesirable persistence 

or concentration of the material or 

breakdown products in 

environment?[§6518 m.2]

x This is a substance used as an ingredient in an organic 

processed food. It is no longer in the agro-ecosystem.

10. Is there any harmful effect on 

human health? 

[§6517 c (1)(A)(i) ; 6517 c(2)(A)i; 

x The substance is widely added to food products, including 

infant formulas, for its healthful benefits. See TR at lines 496-

524 The TR contains a chart at lines 775-776 that lists more 

 

1

The criteria set forth in 7 CFR §205.600(b) are applicable solely to “synthetic substances used as a processing aid 

or adjuvant.” The petitioned substance is not a processing aid or adjuvant. See TR at lines 49-50 The TR 

determined the petitioned substance be a “nonsynthetic.” See TR at line 298 (“the substance should be considered 

non-synthetic.”) Accordingly, the criteria listed in §205.600(b) are inapplicable to the petitioned subst ance. See e.g. 

7 CFR §205.600(c)(“Nonsynthetics...will be evaluated using the criteria [in the OFPA].”) However, the TR 

included review of most of these questions so the results are cited out of an abundance of caution.

2 The criterion appearing at 7 U.S.C. §6518(m)(1), applies only to “interactions with other materials used in organic 

farming systems.” Because this substance is petitioned as a handling material, this criterion appears inapplicable.
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December 2006

§6518 m.4] than 10 countries, including the U.S., E.U., Canada, Japan, 

France, Belgium, U.K. etc. that have set reference intake 

levels of DHA for optimal health. The chart includes intake 

levels from leading organizations, such as the World Health 

Organization, World Association of Perinatal Medicine, Early 

Nutrition Academy and the Child Health Foundation.

With regard to harmful effects, the TR reported that the 

scientific literature revealed no harmful effects for adults 

except those associated with “Consumption of high levels of 

DHA (in the form of fish oil)...” See TR at lines 463-494 

With regard to infant formula, no studies were cited that found 

adverse events reported to FDA have been treated as de 

minimis and below the threshold of regulatory significance by 

FDA. See TR at lines 463-494; See also #11 below

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

x The petitioned substance is recognized as GRAS, and thus is 

considered safe under federal law, and is defined as a food 

additive that is properly used in foods, beverages and infant 

formula. It has no adverse impact on human health when used 

under normal conditions. The TR notes that specific GRAS 

notices were submitted by Petitioner that described DHA use 

levels for certain products, including infant formula and that 

“The notices were reviewed by FDA and at the time of 

submission, FDA had no questions about the proposed 

supplementation levels of DHA or the rationale behind adding 

DHA to the specific food products.” See TR at lines 804-06 

The TR cites reports of adverse events for adults based on 

excessive consumption via fish oil sources. See TR at lines

457-524. The safety of the substance is also evident in that 

adverse events reported to FDA regarding infant formula that 

contains DHA have been treated as de minimis and below the 

threshold of regulatory significance by the FDA See also #12 

below.

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

x See e.g. TR Line 670 (“DHA Algal Oil is a substance which is 

considered GRAS (FDA, 2001)”); TR lines 75-85 (citing FDA 

GRAS Notices No. GRN 000041 and No. GRN 000137) The 

GRAS notices establish that FDA has no objection to the use 

of DHA Algal Oil under the conditions of use. (FDA, 2001). 

In addition to GRAS status, when DHA Algal Oil appears as 

an ingredient in infant formulas, the manufacturers submit 

premarket notification to FDA under section 412 of the 

Federal Food, Drug, and Cosmetic Act (FFDCA). Section 412 

of FFDCA describes the more stringent statutory requirements 

that apply to infant formula as compared to the regulation of 

other foods (FDA, 2006).

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

x The TR concluded the available literature demonstrates no 

heavy metal or other harmful residues have been detected in 

the petitioned product. See TR lines 403-424

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable.
Decision Sheets

December 2006

Category 2. Is the Substance Essential for Organic Production? Substance - DHA from Algal Oil

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance formulated or 

manufactured by a chemical 

process? [6502 (21)]

x The TR concluded the algal oil is the product of a “naturally 

occurring biological process,” line 278, but the DHA 

extraction process is a “chemical process.” See TR at 279

2. 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 See TR line 298 (“the substance should be considered nonsynthetic.”); see also TR lines 288-292 (Applying National 

Organic Standards Board (NOSB) Joint Materials and 

Handling Committee draft policy: “extraction with a synthetic 

not on the National List would not result in a material being 

classified as synthetic unless either the extraction resulted in 

chemical change or the synthetic remained in the final material 

at a significant level.”)

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

x The TR concluded that the petitioned substance is the product 

a biological process. See TR lines 278-279

4. Is there a natural source of the 

substance? [§205.600 b.1]

x DHA is found in fish flesh, eggs and marine algae. See TR 

lines 327-341 (noting fish, shellfish and egg sources). 

However, DHA must be extracted from the natural materials 

using extraction technologies. See TR lines 330-338 (noting 

extraction methodologies). For example, while fish oil 

appears on 7 CFR §205.606, it is not known if the processing 

necessary to obtain or isolate the DHA from fish oil renders 

the final food additive a synthetic or non-agricultural, nonsynthetic under 7 CFR §205.605. See e.g. TR at line 685 

(“DHA and EPA are components of fish oil but are not 

specifically regulated” by the GRAS specifications for fish 

oil)(italics in TR)

5. Is there an organic substitute? 

[§205.600 b.1]

x There are no known certified organic sources of algal oil, nor 

certified organic sources of algal oil DHA. There are no 

certified organic sources of fish oil or DHA obtained from fish 

oil.

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

 x

DHA Algal Oil is the most widely used source of DHA in 

infant formula. Unlike fish oil sources of DHA, DHA from 

algal oil is vegetarian, carries no risk of containing harmful 

environmental contaminants like mercury and does not deplete 

wild fish or algae stocks. See TR at lines 399-419 

In addition, DHA is currently widely used in organic foods. 

Consumers, seeing products labeled as both Organic and 

containing DHA have chosen to purchase these products. 

DHA is essential for consumers to continue to have access to 

these organic products.

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

x The petitioned substance is plant based non-synthetic, nonagricultural substance. There is no plant-based agricultural 

substitute for the petitioned substance..

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

x The TR concluded the substance is a non-synthetic, nonagricultural substance. See TR line 298 (“the substance should 

be considered non-synthetic.”).

9. Are there “alternatives to using 

the substance in terms of practices 

or other available materials”? 

 x According to the TR, there are no other plant-based sources of 

DHA. See TR lines 327-341 (noting fish, shellfish and egg 

sources). Fish sources of DHA require the animals be 
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December 2006

[§6518(m)(6)] “cooked, then strained and pressed to extract the oil and other 

liquids.” TR at line 331 The TR noted that several factors 

can cause fish oil additives to “increase fishy off-flavors in 

milk,” see TR at lines 905-907, and that the various types of 

fish oil each behave differently in formulation and several 

types of antioxidants to “prevent oxidation and development 

of off-flavors” have been studied. TR at lines 910-917 Lastly, 

unlike animal-based DHA sources that require the animal be 

slaughtered, the TR notes the absence of any findings in the 

scientific literature that the algal source lessens biodiversity. 

See TR at line 455

The breadth of uses for the petitioned substance also suggests 

that another material is unlikely to always be an acceptable 

substitute—“DHA Algal Oil is as an ingredient as a source of 

DHA in foods, beverages, infant formulas, and as a dietary 

supplement. Some of the foods and products the petitioner 

lists as intended or current foods to supplement with DHA 

Algal Oil include: cookies and crackers, breads and rolls, meat 

products, condiments, beverages (including flavored milk and 

milk products, soy milk, other dairy products, and juices), 

pasta, dietary supplements, and infant formula.” See TR at 

lines 49-54.

10. Is there an “alternative[s] to 

using the substance in terms of 

practices” that would make the 

substance unnecessary? [§6518

(m)(6)]

x The petitioned substance is a food additive and there are no 

“practices” that substitute for its presence.

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable.
Decision Sheets

December 2006

Category 3. Is the substance compatible with organic production practices? Substance - DHA from Algal 

Oil

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? [§205.600 

b.2]

x As noted earlier, the criteria set forth in 7 CFR §205.600(b) 

are applicable solely to “synthetic substances used as a 

processing aid or adjuvant.” The petitioned substance is not a 

processing aid or adjuvant. See TR at lines 49-50 The TR 

determined the petitioned substance be a “nonsynthetic.”

For a lengthy description of the manufacturing process of this 

substance, please See TR lines 225-272

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

x

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

x

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3]

x See TR line 49. (“The petitioned use of DHA Algal Oil is as 

an ingredient as a source of DHA in foods, beverages, infant 

formulas, and as a dietary supplement.”)

5. Is the primary use as a 

preservative? [§205.600 b.4]

x See TR line 49. (“The petitioned use of DHA Algal Oil is as 

an ingredient as a source of DHA in foods, beverages, infant 

formulas, and as a dietary supplement.”)

6. Is the primary use to recreate or 

improve flavors, colors, textures, 

or nutritive values lost in 

processing (except when required 

by law, e.g., vitamin D in milk)? 

[205.600 b.4]

x See TR line 49. (“The petitioned use of DHA Algal Oil is as 

an ingredient as a source of DHA in foods, beverages, infant 

formulas, and as a dietary supplement.”)

7. Is the substance used in 

production, and does it contain an 

active synthetic ingredient in the 

following categories:

a. copper and sulfur compounds;

x The substance is not used in production.

b. toxins derived from bacteria; x The substance is not used in production.

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals?

x The substance is not used in production.

d. livestock parasiticides and 

medicines?

x The substance is not used in production.

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners?

x The substance is not used in production.

1

If the substance under review is for crops or livestock production, all of the questions from 205.600 (b) are N/A—

not applicable.
Decision Sheets

December 2006

Category 4. Is the commercial supply of an agricultural substance as organic, fragile or potentially 

unavailable? [§6610, 6518, 6519, 205.2, 205.105 (d), 205.600 (c) 205.2, 205.105 (d), 205.600 (c)] 

Substance DHA from Algal Oil

Question Yes No N/A Comments on Information Provided (sufficient, 

plausible, reasonable, thorough, complete, unknown)

1. Is the comparative description 

provided as to why the non-organic 

form of the material /substance is 

necessary for use in organic handling? 

 x The substance is not petitioned for inclusion on 7 CFR 

§205.606

2. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

form to fulfill an essential function in 

a system of organic handling? 

x

3. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quality to fulfill an essential function 

in a system of organic handling? 

x

4. Does the current and historical 

industry information, research, or 

evidence provided explain how or why 

the material /substance cannot be 

obtained organically in the appropriate 

quantity to fulfill an essential 

function in a system of organic 

handling?

x

5. Does the industry information 

provided on material / substance nonavailability as organic, include ( but 

not limited to) the following:

a. Regions of production (including 

factors such as climate and number of 

regions);

x

b. Number of suppliers and amount 

produced;

x

c. Current and historical supplies 

related to weather events such as 

hurricanes, floods, and droughts that 

may temporarily halt production or 

destroy crops or supplies; 

x

d. Trade-related issues such as 

evidence of hoarding, war, trade 

barriers, or civil unrest that may 

x
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December 2006

temporarily restrict supplies; or

e. Are there other issues which may 

present a challenge to a consistent 

supply?

x