Formal Recommendation 

From: National Organic Standards Board (NOSB)

To: the National Organic Program (NOP)

Date: April 27, 2016

Subject: Ancillary Substances Procedure Proposal

NOSB Chair: Tracy Favre

The NOSB hereby recommends to the NOP the following: 

Rulemaking Action: 

Guidance Statement: X

Other: Program Manual and PPM 

Statement of the Recommendation: 

The NOSB recommends a review process for ancillary substances, supported by the definition, criteria 

for compliance, and procedure as outlined. 

Rationale Supporting Recommendation 

The ancillary substances policy passed by the NOSB in 2014 did not completely address procedures 

needed by the Board in order to review ancillary substances, nor did the policy provide adequate 

guidance to ACAs. Therefore, this recommendation creates a clear set of steps that the NOSB will use to 

review ancillary substances, and provide optional template items that ACAs may use in determining 

compliance. The Board’s intention is to establish sound and sensible processes for review of substances, 

while maintaining transparency.

The NOSB will seek guidance from the NOP about adding these procedures to the NOSB policy and 

procedures manual as well as the NOP Program Handbook. 

NOSB Vote: 

Listing Motion: Motion to adopt the proposal on ancillary substance review procedures. 

Motion by: Zea Sonnabend 

Seconded by: Jean Richardson

Yes: 15 No: 0 Abstain: 0 Absent: 0 Recuse: 0

 

Motion Passed
National Organic Standards Board

Handling Subcommittee

Ancillary Substances Procedure - Proposal

February 16, 2016

Background

Ancillary substances have been discussed by the NOSB for several years now, with an overall policy 

being passed in 2014 and ancillaries being looked at in Technical Reports (TR) and NOSB reviews since 

then. 

However, attempts to pass a separate ancillary substance proposal to accompany the review of specific 

National List entries have all been withdrawn by the board due to issues brought up by the public during 

the comment period. So far these have included ancillaries in microorganisms (brought forward 3 

times), pectin, and yeast. Additional listings from the National List were recently renewed in the Sunset 

2017 process that also have ancillary substances, including enzymes and nutrient vitamins and minerals. 

While ancillaries were covered in the TRs for these, it was decided not to bring forward proposals until 

the previous ones were approved and a standard format could be established.

Discussion

The main issues raised in public comment have been examined by the Handling Subcommittee (HS) and 

are as follows:

• Accredited Certifying Agents (ACA) would have to do a lot more paperwork to verify ancillary 

substances by functional class. Right now most specification sheets may list names of ancillaries 

but not specify the functional class each one is in.

• While the charts presented of the known ancillary substances are helpful, there is no clear 

procedure for ACAs to evaluate those that are not on the chart.

• Allowing other ancillaries that are not on the chart could result in some very problematic 

substances being allowed, specifically preservatives.

• A separate proposal and vote is not necessarily needed for those ancillaries that are allowed, 

but is needed for any that the NOSB wishes to prohibit.

• All ancillary substances should be reviewed separately and added to the National List. (This was

rejected by the NOSB in the 2014 recommendation but it still keeps coming back in public 

comment).

In light of some of these issues, the HS has decided to propose an additional set of criteria and 

procedures for ACAs and suppliers of ingredients so that it is clear what tools everyone can use for 

compliance with the 2014 recommendation. If these are adopted and followed, there will not be a need 

for a separate ancillary substance proposal for each listing on the National List. 

The proposal includes:

1. A definition of Ancillary Substance

2. Criteria used to review ancillary substances that can be used by both the NOSB in initial review 

and ACAs in subsequent verifications.

3. Procedures for the NOSB to follow for those materials that may have ancillary substances to be 

reviewed.

4. (optional) Example of a standardized template for ACAs to determine compliance.
Proposal

1. Definition

Ancillary Substance: Additives intentionally added to a non-organic substance on the National List 

that are not removed and have a technical or functional effect on the non-organic substance, not on 

the final organic product that the non-organic substance is used in. Ancillary substances may be 

present in the final organic product but only in insignificant amounts. Ancillary substances fall under 

the FDA definition and labeling regulations for “incidental additives,” which do not need to be 

declared on the label of the final food (including organic product) (CFR Title 21 101.22(h)(3) and 

101.100 (a)(3 i to iii4). To illustrate: Enzymes are listed on 205.605(a). The enzymes might contain 

the following additives, which are considered by the organic industry as “ancillary ingredients”: 

calcium silicate (anticaking agent), calcium phosphate (carrier and/or filler), stearic acid 

(preservative), sorbitol (stabilizer), sodium citrate (pH control, buffer). 

2. Criteria for Compliance

At least one must apply:

1. The ancillary ingredient was considered part of the manufacturing process that has already 

been reviewed by the NOSB. 

2. The ancillary ingredient is certified organic, on the National List 205.605 or 205.606, or is 

agricultural (e.g., sugars as standardizing agents in pectin).

3. The ancillary ingredient is approved by FDA as GRAS for the particular use. 

4. The ancillary ingredient is approved by FDA as a direct food additive or incidental additive 

for the particular use.

5. The ancillary ingredient is approved by FDA as a food contact substance for the particular 

use, as evidenced by a Food Contact Notification (FCN).

Additionally, the ancillary ingredient cannot be a known or probable carcinogen according to the 

International Agency for Research on Cancer (IARC) or the National Toxicity Program (NTP). A compiled 

list is published by the American Cancer Society 

at http://www.cancer.org/cancer/cancercauses/othercarcinogens/generalinformationaboutcarcinogens

/known-and-probable-human-carcinogens

Examples of ancillaries that are listed on the IARC and/or NTP list, and would therefore be prohibited, 

include formaldehyde and butylated hydroxyanisole (BHA)

3. Procedure for NOSB review of ancillaries

The first three of these procedures are already in place, but the last ones are different from the past 

approach.

• At the time of requesting a TR for a new or sunset substance, the NOSB will ask that information 

about identity and functional classes of ancillary substances be reviewed along with the other 

evaluation questions.

• For new substances, a chart of the ancillary substances by functional class will be incorporated 

in the checklist document or whatever review template is used.
• For sunset substances, a chart of the ancillary substances by functional class will be included in 

the first posting along with a request for new information about existing ancillaries and/or 

additional ancillary substances to be brought forward in public comment.

• The vote to approve a new substance will be considered to also approve the ancillaries that are 

associated with that substance unless the NOSB specifically states that one is not approved. 

Similarly, the vote to finalize the sunset review after the second posting will be considered to 

also approve ancillaries unless one is pulled out as not approved.

• Any ancillary substances that the NOSB wishes to prohibit (that are not already on the IARC and 

NTP lists) will have to come before the board in a separate proposal that can be voted on at the 

same meeting or a subsequent meeting of the board.

4. Example of Information for an Ancillary Substances Compliance Template.

For ancillary substances that are already on the list of those reviewed by the NOSB, another form may 

not be needed. But for new ancillary substances, and if ACAs wish to develop a compliance template, 

the following information should be included on the template:

1. Definition of ancillary ingredients (see 1 above)

2. A request for the name of the non-organic ingredient that the ancillary ingredient is in (e.g., 

pectin)

3. A request for the name of the ancillary ingredients in the product and CAS #’s (e.g., dextrose, 

CAS#: 50-99-7)

4. The Criteria for Compliance (see 2 above)

5. A request for the justification that ancillary ingredients meet the criteria (e.g., the FDA 

regulatory reference and confirmation that the ancillary is not a known or probable carcinogen 

according to the International Agency for Research on Cancer (IARC) or the National Toxicity 

Program (NTP)).

6. A request for a specification sheet with full ingredient disclosure for the non-organic ingredient 

(e.g., a specification sheet with full ingredient disclosure listing pectin and also the dextrose, 

which is used as a standardizing agent).

7. A request for the name, signature and date of the party signing the compliance declaration. 

8. Language that speaks to the legal ramifications of falsifying information to ACAs.

Note: All requested information is required to be completed by the responsible party in order for the 

compliance declaration to be accepted by the ACA. 

Motion to adopt the proposal as stated above for the definition, criteria for compliance, and procedure 

for the review of ancillary substances.

Motion by: Zea Sonnabend

Seconded by: Jean Richardson

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