National Organic Standards Board

Handling Subcommittee Proposal

Ancillary Substances Permitted in Microorganisms

February 2, 2015

Ancillary substances are intentionally added to a formulated generic handling substance on the 

National List. These substances do not have a technical or functional effect in the finished product, and 

are not considered part of the manufacturing process that has already been reviewed by the NOSB. 

1. Identity of Ancillary Substances Permitted for use in Microorganisms

 

Functional class Substance name 

Anti-caking & antistick agentsmagnesium stearate, calcium silicate, silicon dioxide

Carriers and fillers, 

agricultural or 

nonsynthetic

lactose, maltodextrins, sucrose, dextrose, potato starch, non-GMO 

soy oil, rice protein, grain (rice, wheat, corn, barley) flour, milk, 

autolyzed yeast, inulin, cornstarch, sucrose.

Carriers and fillers, 

synthetic

micro-crystalline cellulose, propylene glycol, stearic acid, dicalcium 

phosphate.

Preservatives sodium benzoate, potassium sorbate, ascorbic acid

Stabilizers maltodextrin

Cyroprotectants 

used to freeze-dry 

microorganisms

liquid nitrogen, maltodextrin, magnesium sulfate, dimethyl sulfoxide, 

sodium aspartate, mannitol, sorbitol 

Substrate that may 

remain in final 

product

milk, lactose, grain (rice, barley, wheat) flour, brewed black tea and 

sugar, soy

2. Identify any ancillary substances, or categories of substances prohibited for use in Microorganisms: 

 None Known

3. Describe need for the ancillary substances, review of materials, discussion, and subcommittee vote. 

Ancillary substances for microorganisms primarily include the growth media used to produce the 

microorganism and then fillers or carriers to bring the microorganisms to purchasers in a stable and 

predictable form. Additional preservatives or anti-caking agents are used with some species. 

Capsules forms may have additional cryoprotectants and excipients. (See criteria below for 

discussion points). 

Evaluation Criteria (provide narrative responding to each question, repeat as necessary for additional 

ancillary substances or groups)

 

1. Impact on Humans and Environment: Is there any evidence the substance(s) may be harmful 

to human health or the environment? 

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"There is no literature to suggest that the manufacture or use of microbial preparations with 

ancillary substances is harmful to the environment or biodiversity." (2014 TR page 26). There is 

no literature to suggest that microbial preparations with ancillary substances have negative 

effects on human health. (2014 TR page 28)

2. Essential & Availability: Is the substance necessary to the handling of the product because of

unavailability of wholly natural substitute products, or essential for the handling of an organic 

product? 

All the substances in the chart above are necessary because they are what keep the 

microorganism alive, pure and able to perform its function. Formulations of the desired 

microorganism products are not available without some of these ancillary substances. The 

availability of organic carriers and substrates is sometimes possible and the NOSB encourages 

the use of organic ancillary substances whenever possible. Therefore a second motion is 

proposed below to recommend that organic sources of ancillary substances must be used when 

available.

3. Compatibility & Consistency: Is the substance’s use consistent and compatible with organic 

handling practices?

"There is no literature to suggest preservatives used in microbial preparations as ancillary 

substances exert any technical or functional preservative effect in the final fermented product. 

Typically, Good Manufacturing Practices (GMP) dictate that preservatives are added at a 

maximum level of 0.1% by weight of the finished product to exert the desired effect (FDA 

2013b)." (2014 TR page 23)

Subcommittee Action & Vote

Motion: Move to approve the ancillary substances in the chart above for use with Microorganisms. 

Motion by: Zea Sonnabend 

Seconded by: Tom Chapman 

Yes: 6 No: 0 Absent: 2 Abstain: 0 Recuse: 0 

Second Motion: 

Motion to amend the National List at 205.605(a) to state: 

Microorganisms - any food-grade bacteria, fungi, and other microorganism. Organic sources for 

ancillary substances must be used when available.

Motion by: Zea Sonnabend

Seconded by: Tracy Favre 

Yes: 6 No: 0 Absent: 2 Abstain: 0 Recuse: 0 

Approved by Harold Austin, Subcommittee Chair, to transmit to NOSB February 2, 2015

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