National Organic Standards Board

Certification, Accreditation & Compliance Committee

Discussion Document Proposal

Use of Sanitizers on Eligibility for 100% Organic Claims

March 29, 2012

Introduction & Background

 

Four labeling categories have been established for products intended for human consumption 

under the National Organic Program (7 CFR Part 205.301). From lowest to highest organic 

composition they are: 

Products comprised of less than 70% organic ingredients 

Products comprised of at least 70% organic ingredients ( “made with”) 

Products comprised of 95% or more organic ingredients 

Products comprised of 100% organic ingredients. 

All four categories may be produced using processing aids which are either removed prior to 

packaging or remain behind in “insignificant amounts,” and which do not have to be identified 

on the ingredient statement. (FDA regulations in 21 CFR Subpart F) However, under the NOP 

the use of such processing aids is restricted in the three highest categories: 

At least 70% - processing aids must be on National List 

95% or more - processing aids must be on National List 

100% - processing aids must be organic 

From the beginning of NOP implementation, the use of food contact sanitizers did not impede 

a producers or handlers ability to make a 100% organic label claim on products coming in 

contact with them. This changed in early 2007, when certifiers were advised during ACA 

trainings that the use of these substances voided 100% organic label claims on processed 

products, but this was later retracted (though not formally) by NOP staff at that time, but in any 

event formal written guidance affirming the loss of 100% organic claim eligibility emerged from 

the NOP and continues in force presently. It is worth noting that several companies were 

forced to change packaging claims as a result to reflect the downgraded organic status. 

In 2010 the NOSB deliberated on the use of inert gases in the packaging of organic products 

and how such use should or should not affect the eligibility for 100% Organic claims. 

The 100% category has been marked by confusion since its inception by certifiers, consumers, 

producers, manufacturers, and by NOP staff at times. This category is not allowed by U.S.

major trading partners the E.U. and Canada and the U.S. is the only jurisdiction to define it

Relevant areas in the Rule

There are no references to processing aids in OFPA. Potentially relevant statutory citations 

pertain to use of synthetic ingredients are found in Sec 2111 - HANDLING 

(a) IN GENERAL – For a handling operation to be certified under this title, each person on 

such handling operation shall not, with respect to any agricultural product covered by this 

title— 

CACC 1 Sanitizers
(1) Add any synthetic ingredient during the processing or any postharvest handling of the 

product:... 

(4) Add any ingredients that are not organically produced in accordance with this title and the 

applicable organic certification program, unless such ingredients are included on the National 

List and represent not more than 5 percent of the weight of the total finished product. 

In NOP 205.2 Terms Defined, the following distinct definitions can be found for “ingredient” and 

“processing aid:” 

“Ingredient. Any substance used in the preparation of an agricultural product that is still present 

in the final commercial product that is consumed. 

“Processing aid. 

(1) A substance that is added to a food during the processing of such food but is removed in 

some manner from the food before it is packaged in its finished form; 

(2) A substance that is added to a food during processing, is converted into constituents 

normally present in the food, and does not significantly increase the amount of the constituents 

naturally found in the food; and 

(3) A substance that is added to a food for its technical or functional effect in the processing 

but is present in the finished food at insignificant levels and does not have any technical or 

functional effect in that food.” 

7 CFR 205.301 (f) (4) states: 

“All products labeled as “100 percent organic” or “organic” ......must not: (4) Be processed 

using processing aids not approved on the National List of Allowed and Prohibited Substances 

in subpart G of this part: Except, That, products labeled as 100% organic,” if processed, must 

be processed using organically produced processing aids; 

The definition of “processing aid” in the Rule is taken verbatim from the FDA definition found in 

21 CFR Subpart F, below: 

21 CFR Subpart F- Exemptions from Food Labeling Requirements comprehensively describes 

those things which do not need not appear on a product ingredient statement. Section 100.101 

(a) (3) (i) and (ii). 

§ 101.100 – Food; exemptions from labeling. 

(a) the following foods are exempt from compliance with the requirements of section 403(i) (2) 

of the act (requiring a declaration on the label of the common or usual name of each ingredient 

when food is fabricated from two or more ingredients).......(3) incidental additives that are 

present in a food at insignificant levels and do not have any technical or functional effect in that 

food. For the purpose of this paragraph (a) (3), incidental additives are:..... 

(ii) Processing aids, which are as follows: 

(a) Substances that are added to a food during the processing of such food but are removed in 

some manner from the food before it is packaged in its finished form. 

CACC 2 Sanitizers
(b) Substances that are added to food during processing, are converted into constituents 

normally present in the food, and do not significantly increase the amount of those 

constituents naturally found in the food. 

 

(c) Substances that are added to a food for their functional effect in the processing 

But are present in the finished food at insignificant levels and do not have any technical 

or functional effect in that food. 

 

(iii) Substances migrating to food from equipment or packaging or otherwise affecting food 

that are not food additives as defined in section 201 (s) of the act; or if they are food 

additives as so defined, they are used in conformity with regulations pursuant to section 

409 of the act. (“Food and Drugs Sub Chapter B-Food for Human Consumption”) 

The definition of “processing aid” found in 7 CFR Part 205 is taken directly from the FDA 

definition of “processing aid,” which, in turn, makes a clear distinction between “processing 

aids” and substances such as some specific atmospheric gases which have no functional 

effect in the food or the processing of that food, but merely modify the environment in which 

the food is packaged. The Organic Rule – 7 CFR Part 205, by including separate definitions for 

“processing aid” and “ingredient” allows that not everything in a package labeled and sold as 

“organic” is an ingredient.

Sanitizers are defined and regulated by FDA (21 CFR Part 178) as “substances used to control 

the growth of microorganisms.” According to the FDA, these substances are classified as Food 

Contact Substances, not processing aids. 

Discussion

CACC members discussed the background and prior activity around this subject, referencing 

especially the 2009-2010 NOSB discussions around inert gas packaging aid use and the 100% 

Organic claim. 

The current guidance from the NOP disallows using the 100% Organic label claim when 

organic goods come into contact with food contact or food contact surface sanitizers, even 

when the sanitizer is no longer present in the finished product prior to sale. This is consistent 

with the loss of 100% Organic eligibility when non-organic (but organic -compliant) processing 

aids are used in otherwise organic products. Of course, any such sanitizers or processing aids 

used must be included on the appropriate section of the National List, included as part of each 

operator’s Organic System Plan, and approved by the operator’s Accredited Certifying Agent 

(ACA).

This guidance leads to some interesting outcomes. For example, organic oranges are 

harvested into bins in the field and may be labeled with a 100% Organic claim. If and when 

those oranges are deposited into a wash tank at the pack shed and that tank has added 

chlorine in it, the oranges lose their 100% organic status. The chlorine is there to keep the 

water from becoming contaminated with pathogens or spoilage organisms. To think of an 

unprocessed orange as anything other than 100% is confusing for some consumers. 

CACC 3 Sanitizers
Beyond that, if and when that orange is sold, for juicing for example, the juice that comes from 

that orange cannot make a 100% Organic claim since the oranges it came from can’t either. 

For the sake of example, assume that no filtering agents are used in the juicing process. If a 

beverage maker wants to use that organic juice in a 100% juice beverage, that operator would 

have to default to allowing only 95% of the orange juice to contribute to the organic percentage 

of the beverage as a whole. This can occur unless the organic certifier of the juice is willing 

and able to issue a letter of some sort to clarify the amount of the juice that may be used in 

excess of 95% toward finished goods percentage calculations. 

Another example of confusion occurs when produce is field packed, such as celery hearts, 

which are typically cut, trimmed and placed on a mobile harvest machine in the field. The belt 

which conveys the produce to those who pack it into cartons is typically sprayed with 

chlorinated water to reduce the likelihood of contamination by pathogens or spoilage 

organisms. Once again, those celery hearts, 100% Organic after being cut from the stem and 

trimmed, are relegated to Organic status (with a presumptive 95% organic percentage) once 

hey touch that belt. 

Other options the Committee discussed were the concept of recommending the removal of the 

100% Organic claim altogether and the concept of recommending the removal of the 

requirement that processing aids used in products making a 100% Organic claim be 

themselves organic. These concepts are more complicated and have intricate ramifications for 

the regulation and industry as a whole, and the Committee is not prepared to focus on those 

options at this time.

It is worth noting, as did the NOSB in 2008, that “sanitizers are defined and regulated by FDA 

(21 CFR Part 178) as “substances used to control the growth of microorganisms.” As such 

these substances are classified as Food Contact Substances, are not processing aids, and do 

not have to be reviewed and approved by NOSB to be placed on the National List to for use in 

organic products.” 

The CACC believes that this issue deserves additional attention and community deliberation. 

The Committee does not feel that adequate information or dialogue has been had on the 

subject to propose a recommendation about guidance on the matter at this time, and we would 

like to promote community discussion. Accordingly, we ask for public comments in response to 

the questions posed below. 

Requested Input from NOSB, NOP and Public Comment

The CACC proposes to put forward the following questions to the NOSB and the organic 

community regarding the use of food contact or food contact surface sanitizers and the 

resultant ability to use labeling claims of “100% Organic”:

1. Does the 100% Organic label claim hold value for you?

2. Do you feel that contact with a non-organic processing aid should prevent an item from 

being 100% organic and why? 

3. Do you feel that contact with a non-organic food contact sanitizer should prevent an 

item from being 100% organic and why?

4. How do you distinguish a processing aid from a food contact sanitizer? 

CACC 4 Sanitizers
5. Does your organic certifier provide guidance on what is a processing aid versus a food 

contact sanitizer? If so, what is that guidance?

6. If your certifier allows you to use a processing aid, how do you show that the processing 

aid “is present in the finished food at insignificant levels and does not have any 

technical or functional effect in that food?” 

7. Should there be a category/list of NOP allowed food contact sanitizers and non-organic 

processing aids that are approved to be used in the 100% organic category? (e.g. 

Chlorine, peracetic acid, diatomaceous earth, etc.) 

8. At what concentration, if any, do you consider a sanitizer/disinfectant to have 

disqualified an item from the 100% organic category? 

9. Should food contact sanitizers be allowed in the 100% organic category if it is proven 

that no residue from the treatment remains in the finished good? 

10.Do you certify items to the 100% organic category? If so, how many? 

11.Do you feel that food contact sanitizers are necessary for food safety concerns? 

12.If food contact sanitizers could be used while still allowing for a 100% organic claim 

would you certify more products with the organic claim? If not, why not? 

13.Do you have customer requests/demand for products in the 100% organic category?

 

The CACC also welcomes comments and input in addition to answers to the questions above.

Committee Vote

Motion: The CACC moves to accept this document and present it for full board discussion at 

the Spring 2012 NOSB meeting

Motion by: John Foster Second: Calvin Walker

Yes: 7 No: 0 Absent: 1 Abstain: 0 Recuse: 0 

CACC 5 Sanitizers