Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program (NOP)

Date: December 2, 2011

Subject: Petition for Annotation Change for Beta-carotene extract color, 

derived from carrots (CAS# 1393-63-1) on National List § 

205.606

Chair: Tracy Miedema

 

 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action X

Statement of the Recommendation (Including Recount of Vote): 

The NOSB recommended by a vote of 14 yes, zero no and zero absent to change 

the annotation for 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)

Rationale Supporting Recommendation (including consistency with 

OFPA and NOP): 

A petition to change the annotation for Beta-Carotene Extract Color was reviewed 

by the NOSB at the November 2011 meeting. A summary of the Handling 

committee’s recommendation is attached. 

Beta-carotene extract color derived from carrots was originally recommended for 

listing on the National List section §205.606 in 2007 by the NOSB because of 

evidence that specific varieties of carrots/growing conditions were required to 

produce the color and none were available in organic form. Subsequently the 

NOSB has recommended that 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.” The petition stated, and was supported by the 

Technical Review, that beta-carotene from carrots can only be extracted with 

synthetic solvents making it not commercially available for use in organic products. 

The beta-carotene derived from algae can be produced to meet the annotation.

Three public comments were received supporting the committee’s 

recommendation. None were received that did not support the recommendation. 
The NOSB voted unanimously to change the annotation for beta-carotene extract 

color.

NOSB Vote:

Moved: Steve DeMuri Second: Katrina Heinze

Yes: 14 No: 0 Abstain: 0 Absent: 0 Recusal: 0
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

E. Approved by Committee Chair to transmit to NOSB:

___Steve Demuri_________ ___September 20, 2011____________

 Committee Chair Date
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 

agro-ecosystem? [§6518 m.5]

X This is an agricultural product used as an ingredient in 

an organic processed food. It is no longer in the agroecosystem.

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 agroecosystem.

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 agroecosystem.

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 agroecosystem.

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.
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=

STELPRDC5088018&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 X Beta-carotene extract derived from carrots is currently 
substances? [§6518 m.6] 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).

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.
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.
Category 4. Is the agricultural substance inconsistently or not commercially available as organic? 

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

Question Ye

s

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 

non-availability 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.