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 Lutein to 205.605(b) on the National List

Barry Flamm

Petition Failed

Motion to Classify Lutein as petitioned (CAS 127-40-2) as synthetic 

 

Passed

The petitioner claims that the method of Lutein extraction would make it a non-synthetic material. 

However, based on the petitioner's public testimony that saponification (esterification or 

de-esterification) is a process involving the use of multiple solvents and is part of the formulation process, 

which was confirmed in the technical report, the NOSB recommends the listing of Lutein (CAS 127-40-2) 

as a synthetic. (Technical Evaluation Report April 26, 2012).

Harold Austin

Jean Richardson

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

Statement of Recommendation: (Motion # )

Committee Vote:

 

Moved: 

SecondĞĚ: 

Yes:EŽ͗ďƐƚĂŝŶ͗ďƐĞŶƚ͗ZĞĐƵƐĞ͗

 

 

 

 

3DJHUHYLVHGPD

Failed

 Motion to list Lutein (CAS 127-40-2) on 205.605(b) for use in infant formula only, using approved 

 organic delivery ingredients on the National List section 205.605(b): Non-agricultural (non-organic) 

substances allowed as ingredients in or on processed products labeled as "organic" or "made with organic 

 (specified ingredients or food group(s)).' 

 

While Lutein is not listed by the FDA under 21 CFR 104.20(d)(3), nor is it required by FDA in infant formula 

at 21 CFR §107.100 or §107.10, it is currently in use by organic handlers. Public comment was split, with 

approximately half in favor of listing Lutein, and half not in favor. Supporters cited benefits for eye and 

neural health in infants, however, the NOSB did not find it to be essential or required by FDA for any use. 

Harold Austin

Jean Richardson

6 9 0 0 0
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National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Lutein

July 17, 2012

Summary of Proposed Action:

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Evaluation Criteria 

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Satisfied? (see “B” below)

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Proposed Annotation (if any):

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Approved by Committee Chair to Transmit to NOSB

John Foster, Subcommittee Chair   -XO\ 

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