National Organic Standards Board

Handling Subcommittee Proposal

Ancillary Substances Permitted in Cellulose

January 3, 2017

This proposal addresses the additional ancillary substances for use with cellulose, which is currently 

listed on the National List at §205.605(b) Cellulose- for use in regenerative casings, as an anti-caking 

agent (non-chlorine bleached) and filtering aid.

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, some may remain in the final product 

in tiny amounts.

While the ancillary substances for use in cellulose in the current chart were approved during the recent 

sunset review and vote by the NOSB at the St. Louis meeting, there were several additional ancillaries

(listed in chart below) that were identified during the second public comment period that were not on 

that list. These additional ancillary substances were identified after the final proposal had been posted1

 

and thus there is a need to bring those forward now.

The Handling Subcommittee believes that this should capture all of the functional classes in use for 

cellulose, along with those ancillary substances currently in use with cellulose under said functional 

classes. Any additional ancillaries that fall within one of the functional classes listed below do not need 

to be reviewed further in order to be used. Any new functional class of ancillaries however, would need 

to be petitioned in order to be allowed for use with cellulose.

1. Identity of Additional Ancillary Substances Permitted for use in cellulose.

 

Functional class Substance name CAS or INS number- if known Synonyms

Shirring Aid Food Grade Mineral Oil

Shirring Aid Food Grade “White” 

Mineral Oil

CAS # 8042-47-5

Humectant Glycerin CAS # 56-81-5 Glycerine

Coating Polyvinylidene, vinyl 

chloride

CAS # 9002-85-1

Coating Kymene

Coating, pH control 

agent

Sodium Hydroxide CAS # 1310-73-2

Peeling aid Carboxymethyl 

cellulose, with 

CAS # 9000-11-7

 

1 Substantive changes are not allowed once the final document has been posted

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Polysorbate 80 as an 

emulsifier to aid the 

CMC

CAS # 9005-65-6

Synthetic binder Resin

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

Mineral oils, untreated or mildly treated, appear on the IARC list - However, “food grade” mineral oils 

and white mineral oils are not included under this listing. The food grade types of mineral oils go 

through a refinement process that classifies them as a “highly refined” mineral oil with the potential 

carcinogens having been removed via these processes. Thus, mineral oils that are untreated or mildly 

treated, should not be allowed as an ancillary substance for use with cellulose or any other substance 

used in organic handling. Only highly refined mineral oils (food grade or white) should be allowed. 

(Information provided in the Report on Carcinogens for Mineral Oil: Untreated or Mildly Treated; 

Fourteenth Edition. National Toxicology Program, Department of Health and Human Services).

3. Describe need for material, review of material, discussion, and subcommittee vote. 

Ancillary substances for cellulose consist of coating agents (used primarily in casings), anti-caking/antisticking agents, binders, carriers, and as releasing agents. Because of the 3 different types of listed uses 

for cellulose on the National List, the presence of these ancillaries may vary slightly depending on how 

each type of cellulose is intended to be used. Ancillary substances, including those on this additional list, 

were discussed at the fall 2016 NOSB Meeting in St. Louis. It was at that time the decision was made 

that an additional proposal would need to come forward so that those additionally identified ancillaries 

could be added to the ancillary chart for cellulose. 

Evaluation Criteria:

 

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

human health or the environment?

 

The Handling Subcommittee ascertains that the small amounts of ancillary substances used in 

cellulose have not shown to be of concern to human health or the environment. Additionally, 

the Subcommittee is confident that cellulose manufacturers are following all regulations about 

waste disposal and are properly adhering to those regulations to ensure worker safety due to 

any possible unnecessary exposure.

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? 

 

During the most recent Sunset Review of cellulose, organic handlers provided the NOSB with

comments about essentiality. According to the latest technical evaluation report (TR), while 

there are sources of cellulose that may not contain ancillary substances, these materials are 

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needed for consistency and performance in cellulose used for several applications. While some 

handlers have found alternatives to cellulose, those that still use cellulose provided the NOSB

with a broad variety of reasons why it is still essential to their handling process.

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

handling practices? 

 

Yes, the Subcommittee found no reason why the use of these ancillaries in cellulose should not 

be allowed for the currently allowed uses of cellulose as listed, with annotations, on the 

National List.

Subcommittee Action & Vote: 

Motion to accept this document in support of, or to restrict the use of, the following ancillary 

substances or categories of substances in cellulose, as shown in the above chart and/or text of this 

document

Motion by: Harold V. Austin IV 

Seconded by: Ashley Swaffer 

Yes: 7 No: 0 Abstain: 0 Absent: 2 Recuse: 0

Approved by Lisa de Lima, Handling Subcommittee Chair, to transmit to NOP January 3, 2017

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