1400 Independence Avenue, S.W.

Room 2646-South, STOP 0268

Washington, DC 20250-0201

November 23, 2011

MEMORANDUM FOR THE NATIONAL ORGANIC STANDARDS BOARD (NOSB) 

FROM: Miles McEvoy

Deputy Administrator

National Organic Program (NOP)

SUBJECT: Request for Clarification of “Other Ingredients” in Processed Organic Products

November 23, 2011 Revision – Supersedes November 15, 2011 Version

The Organic Foods Production Act (OFPA) authorizes USDA to establish the National List of Allowed and 

Prohibited Substances. OFPA also grants the National Organic Standards Board (NOSB) the authority to 

recommend adding materials to or removing materials from the National List. The National List identifies 

substances that may and may not be used in organic crop and livestock production. In general, synthetic 

substances are prohibited for use in organic production unless specifically allowed, and non-synthetic (natural) 

substances are allowed unless specifically prohibited. For handling, the National List includes the non-organic 

substances that may be used in or on processed organic products. OFPA requires that the National List contain 

an itemized list of each permitted synthetic substance, including its specific use and application. The NOP 

recognizes that additional clarity is needed regarding non-agricultural ingredients used in processed organic 

products and listed under § 205.605.

When used as a formulated product, some substances on the National List may contain additional ingredients in 

various categories, including, but not limited to, carriers, stabilizers, and preservatives. Such “other ingredients” 

are sometimes referred to as inert ingredients, excipients, or incidental additives. For organic crop and livestock 

production, these “other ingredients” are specifically outlined in the regulations. For example, each ingredient 

in a livestock input material (e.g. medication, pesticide, feed additive) must meet one of the following criteria:

• Nonsynthetic (natural) substance which is not prohibited on § 205.604.

• Allowed synthetic substances which is allowed on § 205.603.

• Synthetic inert ingredient which is allowed on § 205.603(e), if listed on the Environmental Protection 

Agency (EPA) List 4-Inerts of Minimal Concern, and used in combination with allowed pesticide active 

ingredients.

• Excipient, only for use in the manufacture of drugs used to treat organic livestock if the excipient meets 

one of the following criteria: 

­ Identified by the FDA as Generally Regarded as Safe.

­ Approved by the FDA as a food additive.

­ Included in the FDA review and approval of a new animal drug application or new drug 

application.

Additionally, all agricultural ingredients listed in the ingredients list for feed additives and supplements must be 

organic.
Request for Clarification of “Other Ingredients” in Processed Organic Products

Page 2 of 2

For organic crop production, examples of products with multiple ingredients include blended fertilizers, 

pesticides with inert ingredients, and potting soil with wetting agents. However, each ingredient must meet one 

of the following criteria:

• Nonsynthetic (natural) substance which is not prohibited on § 205.602.

• Synthetic substance which is allowed on § 205.601.

• Synthetic inert ingredient which is allowed on § 205.601(m), if listed on the Environmental Protection 

Agency (EPA) List 4-Inerts of Minimal Concern , and used in combination with allowed pesticide active 

ingredients. For passive pheromone dispensers, substances on EPA List 3-Inerts of Unknown Toxicity 

are also allowed.

Currently, the allowance of “other ingredients” in substances on the National List for use in processed organic 

products is unclear. Several certifying agents and members of the organic trade have asked the NOP to clarify 

which “other ingredients” are allowed. Since OFPA requires that each non-agricultural ingredient be 

specifically allowed, and because the National List doesn’t specifically list “other ingredients” commonly found 

in formulated products, the NOP is requesting that the NOSB specify whether these “other ingredients” are 

allowed.

NOP Request to NOSB

The NOP is requesting that the NOSB develop a policy on “other ingredients” in § 205.605 substances that is 

comparable to the comprehensive policy for crop and livestock materials. From this point forward, the NOP is 

requesting that the NOSB consider the presence of any “other ingredients” as part of their review processes. As 

substances on the National List come up for sunset review, or as new petitions are considered, the NOP requests 

that NOSB clarify whether any restrictions are warranted for “other ingredients” in § 205.605 substances. Any

third-party technical report that the NOP provides will include information on any “other ingredients”

commonly found in the substance under review. 

The NOP is requesting that the NOSB specify any allowed “other ingredients” in the background section of 

their recommendations for substances recommended for listing on § 205.605, so that these allowances are clear 

to the organic trade, certifying agents, and the NOP. Any “other ingredients” that are not listed on § 205.605, or 

that are not referenced in the background section of the recommendation, would not be allowed in formulations

of substances on § 205.605 that are used in or on processed products labeled as “organic” or “made with organic 

(specified ingredients or food group(s))”. 

The NOP recognizes that the NOSB may want to address the subject further in the future with a comprehensive 

policy for “other ingredients” that may be included in permitted handling materials. Some questions that could 

be addressed in a future recommendation could include the following: 

1. Should all agricultural ingredients that are “other ingredients” be organically produced? 

2. Are synthetic preservatives allowed as “other ingredients?”

These steps will allow the NOP to clearly identify which formulated products are allowed under the processing 

section of the National List. Clear regulations will in turn allow certifying agents and the organic trade to 

consistently interpret these requirements. The NOP looks forward to working with the NOSB to continue to 

enhance the integrity of USDA organic products.