National Organic Standards Board

Handling Subcommittee Proposal

Ancillary Substances Permitted in Microorganisms and Dairy Cultures

August 4, 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. While some of 

these substances are removed or consumed in their processing, many may remain in the final product in 

tiny amounts.

Many public commenters for the first posting were concerned about a process for amending the ancillary 

substances included in this review between sunset periods. The Handling Subcommittee believes that this 

captures all of the functional classes in use for microorganism and Dairy Cultures products. Additional 

ancillaries that fall within one of the functional classes below do not need to be reviewed further to be 

used. Any new functional class of ancillaries however will have to be petitioned.

1. Identity of Ancillary Substances Permitted for use in Microorganisms and Dairy Cultures

Functional class Substance name 

Anti-caking & anti-stick 

agents

magnesium 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. 

potassium phosphate, potassium sulfate, tricalcium phosphate.

Preservatives sodium benzoate, potassium sorbate, ascorbic acid, sodium formate

Stabilizers maltodextrin

Cryoprotectants used to 

freeze-dry (& freeze) 

microorganisms and 

Dairy Cultures

liquid nitrogen, maltodextrin, magnesium sulfate, dimethyl sulfoxide, sodium 

aspartate, mannitol, sorbitol , polysorbate

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?

"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.

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 to approve the functional classes of ancillary substances in the chart above for use with

Microorganisms and Dairy Cultures.

Motion by: Zea Sonnabend 

Seconded by: Tom Chapman

Yes: 7 No: 0 Abstain: 0 Absent: 0 Recuse: 0

Approved by Tom Chapman, Subcommittee Chair, to transmit to NOSB August 4, 2015