Formal Recommendation by the 

National Organic Standards Board (NOSB) 

to the National Organic Program (NOP)

Date: December 2, 2011

Subject: Petition to Remove Annatto extract color (pigment CAS # 1393–63– 

 1): water and oil soluble -- from the National List §205.606

Chair: Tracy Miedema

 

 

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action

Statement of the Recommendation (Including Recount of Vote): 

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

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

Rationale Supporting Recommendation (including consistency with 

OFPA and NOP): 

A petition to remove Annatto Extract Color: water and oil soluble was reviewed by 

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

committee’s recommendation is attached. 

The Handling committee had originally recommended that the annotation for 

Annatto extract color be changed from “water and oil soluble” to “liquid and 

powdered forms.” Rationale for this annotation change is included in the 

committee’s recommendation. Since no public comment was received indicating 

that either form of annatto extract color was not commercially available in sufficient 

quantity, quality or form, the NOSB decided that a vote on the annotation change 

was not necessary. However, it was noted that the original annotation did not 

properly represent the forms available in the market. 

At the time of the Handling committee’s recommendation they had received public 

comment confirmed through an informal market survey that the liquid form of 

annatto extract color was commercially available and widely used. They also had 

public comment that the dry form was available but the informal market survey 

showed that it was not as widely used. The committee recommended that both 

forms be removed from the National List section §205.606 but asked for public 

comment with examples of where the dry form that is available could not be used. 

No such public comment was received.
Two public comments were received in response to the committee’s 

recommendation and posting for the November 2011 meeting. One supported the 

annotation change and supported the recommendation to remove both forms only 

if no public comment to the contrary was received. The other public comment 

asked that an appropriate transition time for handlers to reformulate and change 

packaging be considered. 

Given that there was no public comment supporting the continued listing of 

annatto extract color, the NOSB voted unanimously for its removal. 

NOSB Vote:

Moved: Steve DeMuri Second: Jay Feldman

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

s

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 

agro-ecosystem? [§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 

X
other contaminants in excess of 

FDA tolerances? [§205.600 b.5]

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 – 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.
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.
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 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 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

=STELPRDC5088016&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 X The petitioner states that there is sufficient supply of 
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?

organic annatto seeds and both liquid and powdered 

organic annatto extract color to meet demand. The 

committee has no information to contradict this 

statement.

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 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