Decision Sheets

December 2006

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: ____Fall 2011__________ Substance: Color, Beta-carotene extract, derived from carrots

Committee: Crops  Livestock  Handling X Petitioned for annotation change from Beta-carotene extract color, 

derived from carrots (CAS# 1393-63-1) to beta-carotene extract color, derived from carrots or algae (CAS#7235-40-7) on the 

National List § 205.606

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. Not or Inconsistently Available as Organic Yes X No  N/A  

B. Substance Fails Criteria Category: _________ Comments: ___________________________________________________ 

________________________________________________________________________________________________________

C. Proposed Annotation (if any): annotation change from Beta-carotene extract color, derived from carrots (CAS# 1393-63-1) to 

beta-carotene extract color, derived from carrots or algae (CAS#7235-40-7)

 Basis for annotation: To meet criteria above: ________ Other regulatory criteria: The petition is to change the annotation for 

the current §205.606 listing of beta-carotene extract color to add beta-carotene derived from algae (see evaluation category #4 for 

details) and to change the CAS# to the correct one for beta-carotene. The current CAS# is for annatto extract Citation:__

D. Recommended Committee Action & Vote (State Motion): __Recommend changing the annotation for colors derived from 

agricultural products (3) Beta-carotene extract color, derived from carrots (CAS# 1393-63-1) to colors derived from agricultural 

products (3) beta-carotene extract color, derived from carrots or algae (CAS#7235-40-7) 

________________________________________________________________________________________________________

Motion by: Heinze Seconded:_Demuri___ Yes: _4__ No: _0___ Absent: _3______ Abstain: _____ 

 

 

1) Substance voted to be added as “allowed” on National List to § 205.606 with Annotation (if any) beta-carotene extract color, 

derived from carrots or algae (CAS#7235-40-7______________

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 X Allowed1 X

Livestock Non-Synthetic Prohibited2 

Handling X Synthetic Rejected3

No restriction Commercially UnAvailable as Organic1

 

Deferred4
Decision Sheets

December 2006

E. Approved by Committee Chair to transmit to NOSB:

___Steve Demuri_________ ___September 20, 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 - Color, Beta-carotene extract, 

derived from carrots

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Are there adverse effects on 

environment from manufacture, 

use, or disposal? 

[§205.600 b.2]

X Technical Review lines 531-545: “Production of betacarotene from (algae) will surpass synthetic as well as other 

natural sources due to microalgae sustainability of production 

and their renewable nature.”

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X Technical Review lines 531-545: “Production of betacarotene from (algae) will surpass synthetic as well as other 

natural sources due to microalgae sustainability of production 

and their renewable nature.”

3. Is the substance harmful to the 

environment?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X Naturally present in variety of agricultural products

4. Does the substance contain List 

1, 2, or 3 inerts? 

[§6517 c (1)(B)(ii); 205.601(m)2]

X

5. Is there potential for detrimental 

chemical interaction with other 

materials used?

[§6518 m.1]

X

6. Are there adverse biological and 

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

X This is an agricultural product 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 an agricultural product 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 an agricultural product 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 an agricultural product 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; 

§6518 m.4]

X See #11 below

11. Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X Technical Review lines 136-140: Recognized as GRAS by 

FDA. Certification of the color not needed to protect human 

health

12. Is the substance GRAS when 

used according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

X Technical Review lines 136-140, 385-416: Recognized as 

GRAS by FDA. 

13. Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X Technical Review lines 485-492

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 - Color, Beta-carotene extract, derived 

from carrots

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 Petition: Beta-carotene is produced from natural strains of the 

algae D. salina and is extracted from the algae using carbon 

dioxide, ethanol, or vegetable oil. 

Technical Report lines 243-248: Other extraction solvents 

that can be used to extract beta-carotene from algae are carbon 

dioxide, acetone, methanol, propan-2-ol, hexane, ethanol, and 

vegetable oil. Note that a previous NOSB recommendation 

(http://www.ams.usda.gov/AMSv1.0/getfile?dDocName=STE

LPRDC5088018&acct=nosb) recommended an annotation be 

added to the broad listing of colors, derived from agricultural 

products on §205.606. The added annotation change was 

“Must not be produced using synthetic solvents and carrier 

systems or any artificial preservative.”

Full description of manufacturing, derived from algae, is listed 

in Technical Review lines 325-346. The TR also describes 

synthetic sources of beta-carotene. These are not the subject 

of this petition.

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 Beta-carotene is extracted from the algae

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X Beta-carotene produced by strains of algae (petition and TR)

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Petitioned material is from a natural source

5. Is there an organic substitute? 

[§205.600 b.1]

X Beta-carotene derived from carrots was originally 

recommended for listing by the NOSB (see transcripts from 

Spring 2007 meeting) because of evidence that specific 

varieties of carrots/growing conditions were required to 

produce the color and none were available in organic form. 

This petition goes on (see question #1 above) to say that the 

color derived from carrots is not available in organic form 

because of the solvents that would be used for extraction. 

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

X

 

Petitioner states that color is used to make products meet 

consumer expectations. 

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

X Petitioned material is from a natural source

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

X Material is being petitioned for listing on §205.606. See 

category 4.

9. Is there any alternative 

substances? [§6518 m.6]

 X Beta-carotene extract derived from carrots is currently listed 

on §205.606. The petition is to add an annotation to also list 

beta-carotene extracted from algae. The petitioner states that 

beta-carotene extracted from carrots is not commercially 

available because use of synthetic solvents is required. The 

Technical Review supports that statement (lines 257-262, 353-

355).
Decision Sheets

December 2006

Technical Review states that annatto color may be used as an 

alternate in some applications. 

10. Is there another practice that 

would make the substance 

unnecessary? [§6518 m.6]

X

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 - Color, Beta-carotene 

extract, derived from carrots

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? [§205.600 

b.2]

X Use of colors in organic handling is fairly common. There are 

other colors on §205.606

2. Is the substance consistent with 

organic farming and handling? 

[§6517 c (1)(A)(iii); 6517 c 

(2)(A)(ii)]

X Not used in farming. Use of colors in organic handling is 

fairly common

3. Is the substance compatible 

with a system of sustainable 

agriculture? [§6518 m.7]

X This is an agricultural product used as an ingredient in an 

organic processed food. It is not used in agriculture.

4. Is the nutritional quality of the 

food maintained with the 

substance? [§205.600 b.3]

X Nutritional quality of food not affected by use of color.

5. Is the primary use as a 

preservative? [§205.600 b.4]

X Use is as a color in handling products

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 This material is not used to replace color lost during 

processing, but to enhance color of finished product to meet 

consumer expectations.

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 Petitioned material is not for use in production

b. toxins derived from bacteria; X

c. pheromones, soaps, 

horticultural oils, fish emulsions, 

treated seed, vitamins and 

minerals?

X

d. livestock parasiticides and 

medicines?

X

e. production aids including 

netting, tree wraps and seals, 

insect traps, sticky barriers, row 

covers, and equipment cleaners?

x

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 agricultural substance inconsistently or not commercially available as organic? 

Substance - Color, Beta-carotene extract, derived from carrots

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 petitioner states that beta-carotene extracted from 

carrots is not commercially available because use of 

synthetic solvents is required. The Technical Review 

supports that statement (lines 257-262, 353-355).

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 

temporarily restrict supplies; or

X

e. Are there other issues which may 

present a challenge to a consistent 

supply?

X See response to question #1.