For companies engaged in the development, manufacturing, or marketing of pesticide products in the United States, the current regulation is of great importance. If a pesticide product fits the criteria below, its registration may be exempt from federal pesticide registration requirements under FIFRA 25(b) if it meets the requirements of 40 CFR 152.25(f).

These products are sometimes referred to as minimum risk pesticides. A product that meets all of the conditions described in this section is exempt from federal registration under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). However, a 25(b) exemption is not approval or registration by the EPA, and states may have additional requirements.

For manufacturers and businesses preparing to launch a minimum-risk pesticide, understanding the requirements before commercialization can help identify potential formulation, labeling, and compliance issues.

What Is a FIFRA 25(b) Exemption?

Section 25(b) of FIFRA offers the statutory justification for exempting some pesticides that EPA believes have qualities not requiring federal FIFRA regulation. This exemption is carried out under 40 CFR 152.25(f).

EPA has established that a minimum-risk pesticide is defined by six criteria related to active ingredients, inert ingredients, labeling, claims, company information, and other statements on the label. If a pesticidal product meets all these requirements, it is exempt from registration under FIFRA.

Notably, if a given product is labeled “natural,” “plant-based,” “organic,” or “low toxicity,” this does not automatically make it minimum risk. Its formulation and label still have to comply with the law.

Six FIFRA 25(b) Requirements

1. Active Ingredients Must Be Eligible

The product’s active ingredients must be limited to those listed in 40 CFR 152.25(f)(1).

An active ingredient is the substance that performs the pesticidal function identified on the label, such as killing, repelling, or mitigating a pest. EPA maintains a specific list of active ingredients eligible for minimum-risk pesticide products.

This means manufacturers should verify the regulatory status of each proposed active ingredient rather than assuming that an ingredient qualifies because it is naturally derived or commonly used.

The ingredient must also be correctly identified according to its actual role in the product. EPA specifically cautions that an ingredient cannot simply be treated as an eligible active ingredient when it is actually functioning as an inert ingredient.

2. Inert Ingredients Must Also Qualify

The exemption also places restrictions on inert ingredients.

EPA permits certain inert ingredients listed under the applicable minimum-risk provisions, as well as certain commonly consumed food commodities, animal feed items, edible fats and oils, and other substances meeting specified regulatory criteria.

An ingredient should not be assumed to qualify simply because it is food-grade, natural, or commonly used in consumer products.

Manufacturers should evaluate every ingredient according to its function, regulatory status, and intended use in the formulation.

3. All Ingredients Must Be Listed on the Label

The FIFRA 25(b) labeling requirements include specific ingredient disclosure requirements.

EPA states that all active and inert ingredients must appear on the product label. Active ingredients must be listed by the applicable label display name and percentage by weight, while inert ingredients must be identified by their label display names.

This makes accurate label preparation especially important for minimum-risk products.

A manufacturer should confirm that the formulation and label are consistent and that the correct regulatory ingredient names are being used.

4. Certain Health-Related Claims Are Not Permitted

Product claims are another important aspect of FIFRA 25(b) compliance.

A minimum-risk pesticide cannot make claims to control or mitigate microorganisms that pose a threat to human health, or insects or rodents carrying specific diseases.

For example, EPA explains that a minimum-risk product may potentially make a claim such as controlling mosquitoes, assuming the claim is truthful and supported by the product’s actual performance. However, a claim that the product controls mosquitoes that transmit a particular disease would not satisfy the exemption.

This is why product claims should be reviewed alongside the formulation and proposed label.

5. Required Company Information Must Appear on the Label

The product label must prominently display the name of the producer or the company for whom the product was produced, along with the required company contact information.

Businesses should ensure that this information is accurate and current before products are manufactured and distributed.

6. Labels Cannot Contain False or Misleading Statements

The final condition is straightforward but important: the label cannot contain false or misleading statements.

This requirement affects both product claims and statements about regulatory status. A company should not represent a minimum-risk pesticide as “EPA approved” or “EPA registered“ when it has not gone through EPA’s federal pesticide registration process.

The distinction matters: FIFRA 25(b) is an exemption from federal registration, not an EPA approval of an individual product.

EPA explains that it does not provide individual confirmation that a particular product qualifies as a minimum-risk pesticide. The company marketing the product is responsible for determining whether it meets the applicable exemption criteria.

25(b) Exemption vs. EPA Registration

It is useful to understand the difference between these two regulatory pathways.

An ordinary pesticide subject to FIFRA registration generally must go through the applicable EPA registration process before it can legally be sold or distributed in the United States.

A product that meets the criteria in 40 CFR 152.25(f) is exempt from the FIFRA registration and, therefore, does not require a federal pesticide registration.

Therefore:

EPA-registered pesticide: The product has gone through the applicable federal EPA registration process.

FIFRA 25(b) exempt pesticide: The product qualifies for an exemption from federal FIFRA registration because it meets the applicable conditions.

A 25(b) product should not be marketed in a way that implies EPA reviewed and approved the individual product.

Do FIFRA 25(b) Products Need State Registration?

A federal exemption does not automatically eliminate state requirements.

EPA explains that individual states have their own pesticide statutes and regulations. States are not required to permit the sale of a product simply because it qualifies for the federal minimum-risk exemption. Some states may require registration or impose additional requirements.

This is especially important for companies planning to distribute a minimum-risk pesticide nationwide.

Before launching, businesses should identify every state where the product will be sold or distributed and determine the applicable requirements.

Food-Use Considerations for Minimum-Risk Pesticides

Additional regulatory considerations can apply when a minimum-risk pesticide is intended for use on food, food crops, food-contact surfaces, or animal feed.

The FIFRA exemption does not automatically resolve requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA).

EPA explains that ingredients used in minimum-risk pesticide products for food-use sites may need an applicable tolerance or tolerance exemption. Where a new tolerance or exemption is necessary, EPA has a separate regulatory process for establishing it.

Companies should therefore evaluate the intended use of a product and the regulatory status of its ingredients before making food-use claims.

Why Pesticide Label Review Services Matter

Because several 25(b) conditions relate directly to labeling, professional pesticide label review can be an important part of regulatory preparation.

A label review may examine:

• Active ingredient names and percentages
• Inert ingredient names
• Ingredient display names
• Product claims
• Directions for use
• Company information
• Health-related claims
• Potentially misleading statements
• Intended uses
• State-specific considerations

EPA’s current guidance makes clear that both formulation and labeling conditions must be satisfied for a product to qualify for the federal minimum-risk exemption.

A label review does not guarantee that a product qualifies for 25(b), but it can help identify potential issues before commercialization.

Common FIFRA 25(b) Compliance Mistakes

Companies can run into problems when they assume that minimum-risk status is automatic.

Common issues include:

• Using an active ingredient that is not eligible
• Using an inert ingredient that does not meet the applicable criteria
• Misidentifying an ingredient’s role as active or inert
• Using incorrect label display names
• Failing to list all ingredients
• Making prohibited health-related claims
• Making false or misleading label statements
• Describing an exempt product as “EPA approved”
• Assuming federal exemption eliminates state requirements
• Overlooking FFDCA requirements for applicable food-use products

A regulatory assessment before commercialization can help businesses identify these issues early.

How Brand Maven Consulting Can Help

Determining whether a product meets FIFRA 25(b) requirements involves more than checking whether individual ingredients appear on an EPA list. Companies need to consider the formulation, ingredient roles, labeling, claims, intended uses, and state requirements.

Brand Maven Consulting provides regulatory support for businesses developing and marketing regulated products in the United States.

For businesses with multiple regulated product categories, Brand Maven Consulting also supports:

• Organic Registration
• Fertilizer & Amendment Registration
• Biostimulants
• Animal Feed & Pet Food Registration

These services can help businesses manage regulatory requirements across different product categories and markets.

Conclusion

The FIFRA 25(b) Minimum Risk Pesticide Exemption offers an important regulatory path for eligible pesticide products within the United States. However, being eligible for the exemption involves meeting certain conditions set out in 40 CFR 152.25(f).

Companies should properly assess active and inert ingredients, labeling information, claims, business information, usage information, and state regulations before marketing the product.

Above all, the 25(b) exemption does not equate to EPA approval of a pesticide product. This only means that the qualifying product will be exempt from FIFRA registration.

For companies preparing to launch a minimum-risk pesticide, early regulatory evaluation and pesticide label review can help identify potential compliance concerns before the product reaches the market.

Brand Maven Consulting supports businesses with Pesticide Registration, Biostimulants, Organic Registration, Fertilizer & Amendment Registration, and Animal Feed & Pet Food Registration, helping companies navigate regulatory requirements across their product portfolios.

Frequently Asked Questions

What are FIFRA 25(b) requirements?

FIFRA 25(b) requirements are the conditions under 40 CFR 152.25(f) that a pesticide must satisfy to qualify for the federal minimum-risk exemption from FIFRA registration.

Does a 25(b) pesticide need an EPA registration number?

A product that qualifies for the federal minimum-risk exemption does not need to be registered with EPA under FIFRA. However, it should not be represented as EPA-approved or EPA-registered.

Do 25(b) pesticides need state registration?

They may. States can impose their own pesticide registration and regulatory requirements on federally exempt minimum-risk products.

Are natural ingredients automatically eligible for 25(b)?

No. Ingredients must meet the specific eligibility requirements under 40 CFR 152.25(f). Being natural or plant-based does not by itself establish eligibility.

Can a 25(b) pesticide make pest-control claims?

Yes, qualifying products can make certain pesticidal claims, but the claims must comply with the exemption’s conditions and cannot include prohibited health-related claims or false or misleading statements.

Do food-use minimum-risk pesticides have additional requirements?

Potentially. The FIFRA exemption does not automatically address applicable FFDCA requirements concerning tolerances or tolerance exemptions.