FORMAL RECOMMENDATION BY THE

NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

TO THE NATIONAL ORGANIC PROGRAM (NOP) 

Date: _________4/21/2007______

Subject: Lycopene, color for addition to National List under Colors, §205.606 

Chair: Andrea Caroe 

 

Recommendation

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: _____ ___ 

Guidance Statement: ________ 

Other: ________ 

Statement of the Recommendation (including Recount of Vote):

The Board recommends not adding Lycopene, color to the National List under §205.606-

nonorganically produced agricultural products 

NOSB Vote: Motion: Julie Weisman Second: Steve DeMuri

Board vote: Yes -5 No-8 Abstain- 0 Absent -2 Recuse- 0 

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

The National List of Allowed and Prohibited Substances §205.606 

Response by the NOP:
National Organic Standards Board 

Final Recommendation for 

Date: April 21, 2007 

I. List: (where in FR rule example 205.606) 

National Organic Program Subpart G: The National List of Allowed and Prohibited 

Substances. §205.606 Nonorganically produced agricultural products allowed as 

ingredients in or on processed products labeled as “organic” or “made with organic 

(specified ingredients or food groups(s)).” 

II. Committee Summary: 

On October 19, 2006, as part of the Sunset Review process the NOSB voted not to re-list 

“Colors, non-synthetic sources only” as a broad category on § 205.605a of the National List. This 

category appeared on the National List as part of the original Rule which became effective on 

October 21, 2002. It had come to the attention of the Board during the Sunset review that this 

listing occurred without “Colors” being petitioned and without any recommendation from the 

NOSB. Therefore it was determined that “Colors” was not eligible for re-listing at the conclusion 

of the Sunset period. (Please see the “NOSB Final Sunset Recommendation for Colors, NonSynthetic of October 19, 2006” for additional details) 

Organic processors using Colors were strongly urged by the Board to petition agricultural 

ingredients used for color onto 205.606 as quickly as possible to avert a complete loss of access 

to color ingredients after October 22, 2007 when the category “colors” sunsets from §205.605a. 

As a result, numerous petitions were received for agricultural color materials. Lycopene, color, 

was one such material. 

Simultaneous with the Sunset process was the development of criteria for determining 

commercial availability, an essential tool in evaluating whether or not petitioned materials 

could be listed on § 205.606. These criteria were finalized in the NOSB “Recommendation 

for the Establishment of Commercial Availability Criteria National List § 205.606” of 

October 19, 2006. That recommendation allows for pro-active listing on 205.606 of materials 

which may currently be available in an organic form, but the supply of which has a history of 

fragility due to factors such as limited growing regions, weather or trade-related issues. 

Furthermore, the recommendation reiterates the role of the Accredited Certifying Agent 

(ACA) in making the ultimate decision as to whether a 606-listed material may be used, on 

case by case basis. 

Petitions received for color materials contained widely varying amounts information with which to 

assess the current availability or fragility of current supply of organic forms of the petitioned color 

material. 

Members of the board knowledgeable and experienced in organic tomato production and 

processing believe that organic tomatoes are readily available. Tomatoes are the primary source 

of lycopene for color. The petitioner for Lycopene, color, did not make the case that an insufficient 

quantity of raw organic material (tomatoes) was available for organic color manufacture, nor that 

only specific non-common processing varieties are suitable for color production. Also, there was 

no information provided by the petitioner indicating there was an issue with color manufacturers 

being unwilling or unable to produce organic lycopene from organic tomatoes. There was also no 

additional public comment presented which supported the case for listing this color. 
The Handling Committee noted that agricultural substances are only required to be evaluated 

using the criteria specified in the Act (7 U.S.C. 6517 and 6518). 

6517(c)(1)(a) 

i) would not be harmful to human health or the environment; 

(ii) is necessary to the production or handling of the agricultural product because of 

unavailability of wholly natural substitute products; and 

(iii) is consistent with organic farming and handling; 

Agricultural substances do not need to be evaluated against section 205.600 (b). (i.e. 

essentialness). This additional criteria is only required for any synthetic substance used as a 

processing aid or adjuvant. 

The Handling Committee also considered what constitutes “essential” for organic handling of 

a finished retail product and how that may be different from that of a material used in crop or 

livestock production. It was agreed that color materials might be essential for creating a 

product that meets consumer expectations of a product’s visual appearance. The petitioner 

cited Lycopene, color, as an essential ingredient in the organic consumer products they make 

for this reason, but did not provide commercial availability evidence supporting the request for 

listing the color in 205.606. 

 The Handling Committee carefully considered the difference between the availability of a raw 

agricultural product as organic, and the availability of certified organic handlers to process 

that raw material into one useable for color purposes. The petitioner for Lycopene, color, did 

not provide evidence that either situation was the case for this petitioned color. 

 

III. Board Recommendation 

Lycopene, Color for inclusion on §205.606 of the National List

Moved: Julie Weisman Second: Steve DeMuri 

Board vote: Yes-5 No- 8 Absent- 2 Abstain-0 Recuse-0