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 16, 2012

Petition to add Taurine to 205.605(b) on the National List

Barry Flamm

Petition Failed

Passed

 Motion to classify Taurine as petitioned (CAS # 107-35-7) as synthetic 

 

 

 

 

 

Taurine is a b-amino-sulfone created by chemical processes (Technical Report, 2011, lines 23 and 262)

Jean Richardson

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

Failed

 Motion to list Taurine as petitioned (CAS # 107-35-7) at 205.605 (b) 

 

 

 

 

 

 

The petitioned use does not fit into any of the allowable uses of synthetics in 7 USC Section 6517, and its 

use fails the criteria for essentiality and compatability with organic and sustainable agriculture. The NOSB 

recommends against approving the petition

Jean Richardson

Tracy Favre

1 14 0 0 0
Handling:Taurine

National Organic Standards Board

Handling Subcommittee

Petitioned Material Proposal

Taurine

July 3, 2012

Summary of Proposed Action:

Taurine is a compound that is synthesized in the body from methionine and cysteine metabolism. While 

not technically an amino acid it is more accurately classified as a B-amino sulfone. It is found in animal 

protein such as seafood, beef and chicken and nearly absent from vegetarian foods. The synthetic form 

has been petitioned for use in infant formula because insufficient taurine could result in subpar fat 

digestion and absorption in infants.

Taurine is not required under the FDA in 21 CFR 104.20(d)(3), 107.100 or 107.10. Taurine can be made 

or extracted from non-synthetic sources, although apparently available only in small amounts at this time. 

Although essential for cats and thus added to cat pet food, taurine is considered a non-essential human 

dietary supplement.

The Handling Sub-committee is not recommending addition of Taurine to the National List.

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 ; No ܆

N/A

3. Compatibility & Consistency ܆ Yes ; No ܆

N/A 

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

N/A 

as Organic (only for § 205.606)

Substance Fails Criteria Category: [ 2] Comments:

This substance is not deemed essential by FDA regulations for fortification of infant formula

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: Taurine (CAS# 107-35-7) as petitioned is synthetic.

Motion by: Jean Richardson Seconded by: Joe Dickson

Yes: 4 No: 0 Absent: 3 Abstain: 0 Recuse: 0

Listing Motion: To add Taurine (CAS 107-35-7) to the National List 205.605 b for use in 

infant formula only.
Handling:Taurine

Motion by: Seconded by: 

Yes: 0 No: 4 Absent: 3 Abstain: 0 Recuse: 0

܆ 1Allowed ܆ Agricultural ܆ Crops

Livestock ܆ Non-synthetic ܆ Prohibited2 ܆

Handling ; Synthetic ; Rejected3 ;

No restriction ܆ Commercial unavailable as

organic

܆ 4Deferred ܆

1

Substance voted to be added as “allowed” on National List to § 205. with Annotation (if any): 2Substance 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: 

Approved by Committee Chair to Transmit to NOSB

John Foster, Committee Chair July 3, 2012

NOSB Evaluation Criteria for Substances Added To the National List

Category 1. Adverse impacts on humans or the environment? Substance: Taurine 

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 Inasmuch as the TR addressed this 

issue there does not appear to be 

adverse environmental effects

2. Is there environmental contamination 

during manufacture, use, misuse, or 

disposal? [§6518 m.3]

X

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

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?

X
Handling:Taurine

[§6518 m.2]

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 None cited in TR

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 X TR Line 290 “taurine is not listed as 

GRAS..”

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:Taurine

NOSB Evaluation Criteria for Substances Added To the National List

Category 2. Is the Substance Essential for Organic Production? Substance: Taurine

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 There are non-synthetic ways to 

manufacture taurine (TR lines 264-

268) much of the taurine used is 

created by commercial chemical 

processes (TR lines 262-263) 

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 X Taurine is extracted from natural 

sources (TR 264-268) but only in 

small quantities

4. Is there a natural source of the 

substance? [§205.600 b.1]

X Abundant in animal protein in food 

sources, and in human breast milk.

5. Is there an organic substitute? [§205.600 

b.1]

X Organic food

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 Human breast milk

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 Human breast milk

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:Taurine

NOSB Evaluation Criteria for Substances Added To the National List

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

Taurine

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

regulatory agency; other)

1. Is the substance compatible with 

organic handling? [§205.600 b.2]

X Because the substance could be 

obtained from organic foods the 

synthetic dietary supplement 

fortification is not compatible with 

organic handling

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 Taurine is a non-essential dietary 

supplement (TR), lack of which “could 

result in subpar fat digestion and 

absorption by infants” (Petition, page 

4, paragraph 4)

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:Taurine

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: Taurine

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 Provided, but not detailed.

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 

production or destroy crops or 

supplies; 

X
Handling:Taurine

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

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.