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 crystalline lycopene to section 205.605(b) for use in infant formula 

Barry Flamm

Petition Failed

Passed

 Motion to classify Crystalline Lycopene as petitioned (CAS #502-65-8) as synthetic. 

 

 

 

Crystalline Lycopene was petitioned as a synthetic.

Nick Maravell

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

Petition Failed

Motion to list crystalline lycopene (CAS #502-65-8) to section 205.605(b) for use in infant formula . 

 

 

Lycopene is not essential to or consistent with organic production. Lycopene is not required by the FDA 

or other regulation for infant formula. Neither the petition nor the TR presented definitive scientific 

information to conclude that lycopene is essential for addition to infant formula.

Nick Maravell

Harold Austin

0 15 0 0 0
Handling:Lycopene

National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Lycopene

July 24 2012

Summary of Proposed Action:

Synthetic lycopene is currently used in organic infant formula. Under previous NOP 

policy regarding nutrient vitamins and minerals, an interpretation was made that 

synthetic ingredients such as lycopene were allowed without being added to the 

National List. Current NOP policy requires a specific addition to the National List. 

Lycopene is neither a vitamin nor a mineral. Lycopene is a carotenoid used as a dietary 

antioxidant and a color. Its petitioned use is not as a preservative or a color.

In 1995, the NOSB made the following recommendation in “The Use of Nutrient 

Supplementation in Organic Foods”.

Upon implementation of the National Organic Program, the use of synthetic 

vitamins, minerals, and/or accessory nutrients in products labeled as organic 

must be limited to that which is required by regulation or recommended for 

enrichment and fortification by independent professional associations. 

The NOP did not include “accessory nutrients” in the final rule published in December 

2000. Lycopene is not required by FDA or other regulation for infant formula. Neither 

the petition nor the Technical Review (TR) states that any independent professional 

association recommends it as an accessory nutrient at any specific level for enrichment 

or fortification. Neither the petition nor the TR presented definitive scientific information 

to conclude that lycopene is essential for addition to infant formula. The manufacturer 

notification to FDA of GRAS status (generally recognized as safe) for synthetic forms of 

lycopene for nutrient use does not include use in infant formula. 

The human body does not produce Lycopene. However, depending on the amount of 

Lycopene consumed in the diet of lactating mothers, Lycopene appears in varying 

amounts in colostrum and breast milk. Lycopene is added to infant formula to make it 

more closely resemble breast milk. Levels of lycopene from natural sources in infant 

formulas are low. Natural and organic sources of lycopene are derived mainly from 

tomatoes. These sources also contain proteins from the originating plant that could be 

allergens. According to the petition, it is advisable to delay the introduction of potential 

allergens in infants less than 6 months old or even older for infants with allergy prone 

parents. There is no evidence that an allergy to tomatoes would produce allergic 

reactions to nonsynthetic lycopene, and the information in the TR hypothesized that 

allergic reactions to tomatoes are related to acidity and not specifically to lycopene.

The TR presented very little information on what alternatives are available in infant 

formula. Lycopene in breast milk is nonsynthetic. Natural and organic lycopene can be 

consumed in many foods, especially tomatoes, by lactating mothers. The TR states, 
Handling:Lycopene

“The commercial use of nonsynthetic lycopene in infant formula, rather than synthetic 

lycopene, has not been reported, and no evidence indicating that nonsynthetic lycopene 

would act as a viable substitute for synthetic lycopene in infant formula has been 

identified.” Nonorganic agricultural lycopene for use as a coloring was rejected for 

addition to the National List by the NOSB in 2007 for lack of justification for not 

producing lycopene from organic sources. There is no allowance for synthetic lycopene 

in organic infant formula or other organic foods in European, Canadian or Japanese 

organic standards. 

Synthetic crystalline lycopene, the petitioned material, involves the use of synthetic 

solvents dichloromethane and toluene in the extraction process. The TR states, 

“Synthetic lycopene may also contain residues of volatile solvents. However, no 

information has been identified to indicate that any reported residues of heavy metals or 

other contaminant in excess of FDA tolerances have been identified.” Information is 

presented on residual extracting solvents in the final product in a different form (not 

petitioned) of synthetic lycopene produced from B. trispora by the manufacturer 

Vitatene. 

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 ܆ Yes x܆ No 

܆ N/A

3. Compatibility & Consistency ܆ Yes x܆ No 

܆ N/A 

4. Commercial Supply is Fragile or Potentially Unavailable ܆ Yes ܆ No 

x

as Organic (only for § 205.606)

Substance Fails Criteria Category: [2 & 3 ] 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: Moved that Crystalline Lycopene be classified as a synthetic 

material. 

Motion by: Zea Sonnabend Seconded by: Tracy Favre 

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

Listing Motion: Moved that Crystalline Lycopene (CAS #502-65-8) for use in infant formula 

be added to the National List sec. 205.605(b). 
Handling:Lycopene

Motion by: Jean Richardson Seconded by: Harold Austin 

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

܆ 1Allowed ܆ Agricultural ܆ Crops

Livestock ܆ Non-synthetic ܆ Prohibited2 ܆

܆] 3Rejected ܆] Synthetic ܆] Handling

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: Not essential to or consistent with organic production. 

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 July 24, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment?

Substance: Lycopene

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 No specific information found with 

regard to use of volatile synthetic 

solvents to demonstrate no adverse 

effects.

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

x No specific information found with 

regard to use of volatile synthetic 

solvents to demonstrate no adverse 

effects.

3. Is the substance harmful to the 

environment and biodiversity?

[§6517c(1)(A)(i);6517(c)(2)(A)i] 

x

4. Does the substance contain List 1, 2 

or 3 inerts? [§6517 c (1)(B)(ii); 

205.601(m)2]

x
Handling:Lycopene

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

7. Are there detrimental physiological 

effects on soil organisms, crops, or 

livestock? [§6518 m.5]

x

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.Is there any harmful effect on human 

health? [§6517 c (1)(A)(i); 6517 

c(2)(A)i; §6518 m.4]

x

11.Is there an adverse effect on human 

health as defined by applicable 

Federal regulations? [205.600 b.3]

x

12.Is the substance GRAS when used 

according to FDA’s good 

manufacturing practices? [§205.600 

b.5]

x Self certified as GRAS but not for 

infant formula.

13.Does the substance contain residues 

of heavy metals or other contaminants 

in excess of FDA tolerances? 

[§205.600 b.5]

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:Lycopene

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production?

Substance: Lycopene

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 and TR.

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

3. Is the substance created by naturally 

occurring biological processes? [6502

(21)]

x

4. Is there a natural source of the 

substance? [§205.600 b.1]

x Foods high in lycopene, such as 

tomatoes.

5. Is there an organic substitute? [§205.600 

b.1]

x

6. Is the substance essential for handling of 

organically produced agricultural 

products? [§205.600 b.6]

x

7. Is there a wholly natural substitute 

product?

[§6517 c (1)(A)(ii)]

x Agricultural sources, such as 

tomatoes.

8. Is the substance used in handling, not 

synthetic, but not organically produced?

[§6517 c (1)(B)(iii)]

x

9. Is there any alternative substances? 

[§6518 m.6]

x Natural agricultural lycopenes.

10. Is there another practice that would 

make the substance unnecessary? 

[§6518 m.6]

x Breast feeding.

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:Lycopene

NOSB Evaluation Criteria for Substances Added To the National List

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

Substance: Lycopene 

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

x Not a processing aid or adjuvant as 

referred to in 205.600(b)(2)

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

5. Is the primary use as a preservative? 

[§205.600 b.4]

x

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

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, 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.
Handling:Lycopene

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: Lycopene

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

regulatory agency; other)

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

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 

x
Handling:Lycopene

production or destroy crops or 

supplies; 

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