Decision Sheets

December 2006

NOSB COMMITTEE RECOMMENDATION

Form NOPLIST1. Committee Transmittal to NOSB

For NOSB Meeting: November 2011 Substance: Annatto extract color (pigment CAS # 1393–63–

1)—water and oil soluble_

Committee: Crops  Livestock  Handling X Petition is for removal of Annatto extract color (pigment CAS # 1393–

63–1)—water and oil soluble 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. Commercial Supply is Fragile or Potentially Unavailable as Organic (only for 606) Yes  No X N/A  

B. Substance Fails Criteria Category: _4___ Comments: At this time, the Handling Committee believes that sufficient evidence 

exists that both forms, liquid and powdered, of organic annatto extract color are available. We understand that there may be 

applications where the forms available do not perform. We ask that handlers or certifiers who are aware of these applications 

provide written public comment for the fall 2011 NOSB meeting so they can be considered. 

C. Proposed Annotation (if any): _Current annotation is “Oil and Water Extracted.” Proposed annotation is “Liquid and powdered 

forms.” See committee comments at end of document for details________

 Basis for annotation: To meet criteria above: __X_ Other regulatory criteria: _______ Citation:__The Handling Committee is 

recommending an annotation change to include both forms of annatto extract color so that the NOSB has the flexibility to list one or 

the other should public comment be received that the forms of organic extract color that are available do not perform in all 

applications__

D. Recommended Committee Action & Vote (State Actual Motion): Recommend changing the annotation of Annatto Extract 

Color from “Water and Oil Soluble” to “Liquid and Powdered Forms.”

Motion by: Heinze Seconded: Dickson Yes: 6 No: 0 Absent: 1 Abstain: 0

Recommend removing Annatto color, with all annotations, from the National List §205.606

 

Motion by: Heinze Seconded: Dickson Yes: 6 No: 0 Absent: 1 Abstain: 0

 

1) Substance voted to be REMOVED as “allowed” on National List to § 205. 606 with Annotation (if any) Liquid and Powdered 

Forms________

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 / 

REMOVED 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 29, 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 – Annatto extract color (pigment CAS # 

1393–63–1)—water and oil soluble

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

2. Is there environmental 

contamination during manufacture, 

use, misuse, or disposal? [§6518 

m.3]

X

3. Is the substance harmful to the 

environment?

[§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

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

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.
Decision Sheets

December 2006

Category 2. Is the Substance Essential for Organic Production? Substance – Annatto extract color (pigment CAS 

# 1393–63–1)—water and oil soluble

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 Material is manufactured by extraction from the annatto seed 

with either oil or water combined with physical agitation. 

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 This is the natural source

5. Is there an organic substitute? 

[§205.600 b.1]

X Organic forms of this material are available in the marketplace

6. Is the substance essential for 

handling of organically produced 

agricultural products? [§205.600 

b.6]

X Not used for production 

7. Is there a wholly natural 

substitute product? 

[§6517 c (1)(A)(ii)]

X This is the natural source

8. Is the substance used in 

handling, not synthetic, but not 

organically produced? 

[§6517 c (1)(B)(iii)]

X This petition is for evaluation of commercial availability. See 

category 4.

9. Is there any alternative 

substances? [§6518 m.6]

X

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 – Annatto extract color 

(pigment CAS # 1393–63–1)—water and oil soluble

Question Yes No N/A1 Documentation

(TAP; petition; regulatory agency; other)

1. Is the substance compatible 

with organic handling? [§205.600 

b.2]

X

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 Primary use is as a color. However use is not to recreate or 

improve color lost in processing but to provide consumers 

with a color with which they are familiar. For example, 

cheddar cheese is orange due to use of annatto. 

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.
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 - Annatto extract color (pigment CAS # 1393–63–1)—water and oil soluble

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 Annatto extract color (pigment CAS # 1393–63–1)—water 

and oil soluble was added to the National List (Federal 

Register Vol. 72, #123, June 27, 2007). The NOSB 

recommended relisting at the October 2010 NOSB meeting: 

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

ELPRDC5088016&acct=nosb

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 When annatto was originally listed public comment was 

received saying that organic annatto seeds were not 

available. Today organic seeds are available. However, 

annatto is used in both a liquid and powdered form. During 

the Sunset 2012 review of this material public comment was 

received, and supported by an informal market review by 

the NOSB Handling Committee, that the liquid form was 

available. Mixed public comment was received about the 

availability of the powdered form. At the time, removing 

one form but not the other could not be done during the 

sunset review process. 

This petition is for the removal of all forms from §205.606. 

The petitioner states that they have provided an organic 

liquid form for some time and have just recently, spring 

2010, introduced a powdered form. The Handling 

Committee has conducted a second informal market survey 

and found that some, but not most, products (e.g., some 

brands of organic mac & cheese) that would be expected to 

be using the powdered form have switched to using organic 

annatto. 

At this time, the HC believes that sufficient evidence exists 

that both forms, liquid and powdered, of organic annatto 

extract color are available. We understand that there may be 

applications where the forms available do not perform. We 

ask that handlers or certifiers who are aware of these 

applications provide written public comment for the fall 

2011 NOSB meeting so they can be considered. 

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 Quality of the organic annatto extract color has not been a 

question. The committee has no information indicating that 

organic forms of the material are not commercially 

available.

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 The petitioner states that there is sufficient supply of organic 

annatto seeds and both liquid and powdered organic annatto 

extract color to meet demand. The committee has no 

information to contradict this statement.
Decision Sheets

December 2006

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 The petition is from the supplier of organic annatto extract 

color. 

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