Inert Ingredients Overview and Guidance
This Web page provides information on inert ingredients approved for use in pesticide products and the guidance documents that are available to assist in obtaining approval for a new inert ingredient.
On this page:
- Inert ingredient listings in InertFinder
- Other inert ingredient lists
- Guidance documents for inert ingredients
- For more information
InertFinder allows users to search for inert ingredients by chemical name and CAS Reg. No. to find inert ingredients permitted for use in the following three categories:
Food and Nonfood Use - The only inert ingredients approved for use in pesticide products applied to food are those that have either tolerances or tolerance exemptions in the Code of Federal Regulations (CFR), 40 CFR part 180 (the majority are found in sections 180.910 – 960), or where no residues are found in food. The most up-to-date tolerances and tolerance exemptions are found in the electronic CFR (e-CFR), and InertFinder includes links to the appropriate e-CFR sections.
Many food use inert ingredients have use limitations and restrictions. All food use inert ingredients are also permitted for nonfood use. Inert Finder categorizes these inert ingredients as “Food and Nonfood Use” to keep them distinct from “Nonfood Use Only” inert ingredients, and to avoid listing them twice.
Fragrance Ingredient List (FIL) - Ingredients on the FIL are nonfood use only, but are subject to additional limitations and requirements, as described in EPA’s guidance on the Pesticides Fragrance Notification Pilot Program:
- Guidance for the Office of Pesticide Program’s Pilot Fragrance Notification Program.
- InertFinder includes the latest FIL.
- This spreadsheet can be used in submitting the fragrance formula information for a product.(1 pg, 19 K)
Minimal Risk FIFRA Section 25(b) Inert Ingredients - Are approved for use in minimal risk pesticide products under 40 CFR 152.25, implementing FIFRA Section 25(b); for more information on §152.25(f) products please contact Biopesticides and Pollution Prevention Division (BPPD). Read more about inert ingredients approved for use in minimal risk products.
USDA’s National Organic Program (NOP) Ingredients List - Ingredients, including inerts, that are eligible for use in USDA’s NOP program. More information:
- A brief overview of EPA’s role in USDA’s National Organic Program.
- USDA National Organic Program Ingredients List
Trade Name Inert Ingredients – Formulators sometimes have difficulty determining whether a trade name product is permitted for use as an inert ingredient. To clarify the approved use of inert ingredients/mixtures, manufactures of trade name inert ingredients volunteered to participate in the development of a publicly-available list of trade name inert ingredients, along with the uses for which they are approved, and the manufacturer’s name.
The public listing does not include the composition of trade name inert ingredients, nor products in which they are used. In addition, the posting of the trade name inert ingredient list does not imply any endorsement by EPA of one trade name inert ingredient over another.
- List of trade name inert ingredients
- Directions for adding product trade names and approved uses to the list.
Categorized lists of inert ingredients (old lists) – In 1987, EPA published a policy statement on inert ingredients in 1987: 52 FR 13305, Inert Ingredients in Pesticide Products Policy Statement (04/22/87). The policy established four categories of toxicological concern for the inert ingredients in existence at that time. In 1989, List 4 "Inerts of Minimal Concern" was subdivided into List A and List 4B (see 54 FR 48314, Inert Ingredients in Pesticide Products; Policy Statement; Revision and Modification List (11/22/89)).
The List Category policy, created in 1987, has now served its purpose as a tool for prioritizing the evaluation of chemicals. Now that reassessment of food tolerances/tolerance exemptions under the Food Quality Protection Act (FQPA) is complete, inerts are no longer classified as List 1, 2, or 3. The List 4 and 4A are still referred to by the National Organic Program and minimum risk pesticide regulations.
We have a variety of guidance documents related to the approval and use of inert ingredients.
These guidance documents will assist you with inert ingredient regulatory issues.
- Petition new or amended food use tolerance
- Low risk polymer submission
- New nonfood use
- Open literature database search
- Adding trade product names and approved uses
FQPA required the reassessment of inert ingredient tolerances and tolerance exemptions that were in place before August 3, 1996. In 2006, EPA completed the reassessment of inert ingredients. Completed inert ingredient tolerance reassessment decision documents are now available on the Tolerance Reassessment Decision Document page.
The Federal Food, Drug and Cosmetic Act (FFDCA) provides both exclusive use and data compensation protections for data that inert ingredient manufacturers submit to EPA to establish or maintain tolerances or tolerance exemptions for these ingredients. More information about exclusive use and data compensation for inert ingredients.
Questions or comments related to the inert ingredient guidance documents and the inert ingredients listings can be directed to the Inert Ingredient Assessment Branch (IIAB) (email@example.com).
PV Shah, Branch Chief
Inert Ingredient Assessment Branch