Formal Recommendation 

From: National Organic Standards Board (NOSB) 

To: the National Organic Program (NOP)

Date: 

Subject: 

Chair: 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: 

Other: 

Statement of Recommendation: (Motion # 1) 

 

Rationale Supporting Recommendation (including consistency with OFPA and NOP):

 

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 3DJHUHYLVHGPD

October 17, 2012

Petition to add beta carotene to §205.605(b) for use in infant formula

Barry Flamm

Petition Failed

Passed

 Motion to classify Beta Carotene as petitioned as synthetic.

 

 

 

Beta Carotene, as petitioned, is synthetic.

Tracy Favre

Colehour Bondera

15 0 0 0 0
Rationale Supporting Recommendation (including consistency with OFPA and NOP):

Statement of Recommendation: (Motion # 2)

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 

 

3DJHUHYLVHGPD

Failed

Motion to add Beta-Carotene as petitioned to 205.605(b) for use in infant formula.

 

 

 

 

 

 

Beta Carotene is not required for inclusion in infant formula, therefore the committee had 

concerns regarding the addition of a synthetic material that is not absolutely necessary. Further, 

the ingredient was petitioned for use as an anti-oxident, with the primary function of stabilizing 

the lipids in the formula, and therefore acting as a preservative. This provided further 

disincentive to list the synthetic.

Tracy Favre

Harold Austin

1 14 0 0 0
Handling:BetaCarotene

National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Synthetic Beta-Carotene

August 7, 2012

Summary of Proposed Action:

1. Petitioned for inclusion on 205.605(b) synthetic, non-agricultural addition to “organic” 

and “made with organic” ingredients

2. The synthetic version is what is being petitioned but there are natural versions of the 

ingredient on the market. Commercial availability may be a limiting factor.

3. The petition mentions for use in infant formula as a nutritional supplement and to 

prevent lipid components in the formula from going rancid (preservative) and as a 

colorant.

4. Beta-Carotene is necessary for proper development of retinas, and acts as an antioxidant, and in some cases as preservative.

5. Is considered GRAS as a food additive for nutrition. As a food colorant, it is exempt 

from certification (colors are not considered GRAS).

6. B-C can be manufactured from a variety of processes including wholly chemical, 

from natural sources including fungi and algae, but these methods typically use toxic 

solvents. 

7. BASF is a key manufacturer of the ingredient

8. Commercially available manufacturing process utilizes toxic solvents and/or solvents 

that pose environmental risk to aquatic species if released. 

9. One method of manufacture uses relatively benign solvent made from soy and corn 

feedstuffs. 

10.Only one method from natural dehydrated carrots was discussed. 

11.B-C is not required for inclusion in infant formula, therefore the committee had 

concerns regarding the addition of a synthetic material that is not absolutely 

necessary.

Evaluation Criteria

(Applicability noted for each category; Documentation attached) Criteria 

Satisfied? (see “B” below)

1. Impact on Humans and Environment X Yes ܆

No ܆ N/A 

2. Essential & Availability Criteria X Yes X

No ܆ N/A

3. Compatibility & Consistency X Yes ܆

No ܆ N/A

4. Commercial Supply is Fragile or Potentially Unavailable ܆ Yes X

No ܆ N/A

as Organic (only for § 205.606)
Handling:BetaCarotene

Substance Fails Criteria Category: [ ] Comments:

Proposed Annotation (if any):

Basis for annotation: ܆ To meet criteria above ܆ Other regulatory criteria ܆

Citation 

Notes: 

Recommended Committee Action & Vote, including classification recommendation 

(state actual motion):

Classification Motion: Classify Beta-Carotene as petitioned as synthetic

Motion by: Tracy Favre Seconded by: Harold Austin

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

Listing Motion: Add Beta-Carotene as petitioned to 205.605(b) for use in infant 

formula.

Motion by: Tracy Favre Seconded by: Joe Dickson

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

܆ 1Allowed ܆ Agricultural ܆ Crops

Livestock ܆ Non-synthetic ܆ Prohibited2 ܆

Handling X Synthetic ܆ Rejected3 X

No restriction ܆ Commercial unavailable as 

organic

܆ 4Deferred ܆

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: The committee was reluctant to approve the addition of 

a synthetic material that was not absolutely necessary. 

4

Substance was recommended to be deferred because 

If follow-up needed, who will follow up: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair August 7, 2012
Handling:BetaCarotene

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment?

Substance: Synthetic Beta-Carotene

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 X

Potential exists for environmental 

damage due to solvents used in 

the extraction process, which are

toxic to aquatic life

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X X

The solvents used in the 

manufacturing process are not 

easily biodegraded and must be 

properly recycled, leading to 

potential for improper disposal or 

spillage. Under proper recycling 

there is no environmental 

contamination.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

X X

Could be harmful should solvents 

used in manufacturing be

improperly disposed of

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]

Information not available

6. Are there adverse biological and 

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

X X See comments above regarding 

potential for environmental 

contamination

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

X X See comments above regarding 

potential for environmental 

contamination

8. Is there a toxic or other adverse 

action of the material or its 

breakdown products?

[§6518 m.2]

X

9. Is there undesirable persistence or 

concentration of the material or 

breakdown products in 

environment? [§6518 m.2]

X

10.Are there any harmful effects on

human health? [§6517 c (1)(A)(i); 

X X Some studies have linked betaCarotene with increases in lung 
Handling:BetaCarotene

6517 c(2)(A)i; §6518 m.4] cancer of smokers, but generally 

the effects of the ingredient are 

considered beneficial

11.Is there an adverse effect on 

human health as defined by 

applicable Federal regulations? 

[205.600 b.3]

X X See comments above

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? 

[§205.600 b.5]

X When considered as a nutritional 

additive, when as a colorant 

GRAS is not applicable

13.Does the substance contain 

residues of heavy metals or other 

contaminants in excess of FDA 

tolerances? [§205.600 b.5]

X X The FDA has established residue 

limits for heavy metals but there 

is no evidence that contamination 

exists in the ingredient

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.
Handling:BetaCarotene

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production?

Substance: Synthetic Beta-Carotene

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 Per both the petition and TR, the 

ingredient is considered 

synthetically manufactured

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 X The most common formulation of 

the petitioned ingredient is wholly 

synthetic and is manufactured 

using a Confidential method,

however there are other methods 

using solvent extraction from 

naturally occurring sources

3. Is the substance created by 

naturally occurring biological 

processes? [6502 (21)]

X The petitioned material is Synthetic 

Beta-Carotene

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Beta-Carotene is widely available 

in red, orange and yellow fruits and 

vegetables, leafy greens, some 

types of fungus and algae

5. Is there an organic substitute? 

[§205.600 b.1]

X X Beta-Carotene can be extracted 

from plants using environmentally 

benign solvents from fermented 

corn and soybean feedstocks, but 

it is not clear whether this process 

would be considered organic

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

X X As a nutritional additive, BetaCarotene has unique anti-oxidant 

and preservative properties, but 

the use as a color additive could 

be replaced with alternatives such 

as organic annatto.

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

X Naturally derived Beta-Carotene is 

an alternate source, although 

commercial viability is an issue

8. Is the substance used in handling, 

not synthetic, but not organically 

produced?

[§6517 c (1)(B)(iii)]

X Beta-Carotene may be produced 

by extraction from some fungi and 

algae using solvents

9. Is there any alternative 

substances? 

[§6518 m.6]

X X Organic annatto could be used as 

a replacement for color additive, 

but would not address the anti-
Handling:BetaCarotene

oxidant and preservative properties 

of Beta-Carotene

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.
Handling:BetaCarotene

NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: Synthetic Beta-Carotene

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X Synthetic Beta-Carotene is wholly 

synthetic manufactured from 

chemical compounds

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 Beta-Carotene is used as a 

nutritional substance as a 

precursor to Vitamin A

5. Is the primary use as a 

preservative? [§205.600 b.4]

X X Beta-Carotene is used as both a 

preservative of lipids (in infant 

formula, for instance) but also as 

nutritional 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 A use of Beta-Carotene is as a 

coloring agent but the ingredient 

has other uses as described 

above

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

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, 

X
Handling:BetaCarotene

row covers, and equipment 

cleaners?

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.
Handling:BetaCarotene

NOSB Evaluation Criteria for Substances Added To the National List

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: Name Synthetic Beta-Carotene

Question Yes No N/A1 Documentation (TAP; petition; 

regulatory agency; other)

1. Is the comparative description 

provided as to why the nonorganic form of the material 

/substance is necessary for use in 

organic handling? 

X Neither the TR nor petition makes 

it clear as to why synthetic BetaCarotene is necessary over 

natural 

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 There is some discussion that 

there is only one naturally derived 

substitute that is commercially 

available.

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
Handling:BetaCarotene

b. Number of suppliers and 

amount produced;

X X Two suppliers are mentioned but 

no quantities are listed

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 X

d. Trade-related issues such as 

evidence of hoarding, war, 

trade barriers, or civil unrest 

that may temporarily restrict 

supplies; or

X X

e. Are there other issues which 

may present a challenge to a 

consistent supply?

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.