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Product Composition & Formulation

Product Composition – 100% Organic, Organic, and Made with Organic

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8.1 Version 1 September 29, 2026

What organic claims you can make on your label, whether you can carry the USDA seal, and which ingredients you can even use all depend on how much of your product is organic and what other ingredients or processing aids are included. This article explains what product composition categories are, and how to choose the claim that fits your product, your company, and your customers.

What You'll Learn

  • What product composition is and why it drives your labeling decision
  • The four composition categories and the rules for each
  • Which nonorganic ingredients and processing aids each category allows
  • Which labeling claim is right for your product

What you can say on your label (and whether you can display the USDA organic seal) comes down to what is included in your product and the share of your product that is organic. Organic product composition regulations place your product into one of four categories, each with its own rules for which ingredients you can use and what claims you can make. Understanding how the categories work is the starting point for every formulation decision you’ll make as an organic handler.

Product Composition Flows from Product Formulation

Product composition is the category that a product falls within based on the formulation including the share of certified organic ingredients it contains, measured by weight or fluid volume and excluding added water and salt.1,2 Your product’s category determines which ingredients you may use, what you may claim on your label, and whether you may display the USDA organic seal.

Determining which composition category your product falls within begins with your product formulation that is reviewed by your certifier. This is the precise list of every ingredient and processing aid that goes into the product and the amount of each.2 The share of the product that is organic and the nonorganic ingredient and processing aids you use determines what you are allowed to claim on the finished label. Selecting the organic claims that you want to make is really a formulation decision. If achieving a certain product composition category matters to you, you may need to adjust your formulation to reach it.

Composition affects much more than your paperwork. The USDA organic seal is trusted by more than seven in ten shoppers,3 and that seal is available only to products in the “100% Organic” and “Organic” categories.4 Your category also determines which nonorganic ingredients and processing aids you may use at all, and how much flexibility you have when a supply chain shifts. And because different categories are recognized differently in different countries, your composition can shape your options for export. In short, what product composition categories you qualify for, shapes your label, your ingredient choices, your customer’s trust, and your markets.

The Composition Categories

The USDA organic regulations sort products for human use into distinct categories by organic content percentage. Each category contains progressively stricter requirements for the ingredients and processing aids used in them and the organic claims used on their labels.

The table below compares the three categories that can make an organic claim on the label. For the full label requirements of each, see Labeling Requirements for Products Intended for Human Use.

“100% Organic”5 “Organic”6 “Made with Organic”7

Organic ingredients

100% of ingredients must be organically produced

At least 95% of ingredients must be organically produced

At least 70% of ingredients must be organically produced

Nonorganic ingredients

None, except water and salt

Up to 5% of ingredients may be nonorganic

All nonorganic ingredients must be items on the National List8,9

A nonorganic agricultural ingredient may be used only if an organic version is not commercially available

No organic and nonorganic forms of the same ingredient may be used

Up to 30% of ingredients may be nonorganic

Nonorganic agricultural ingredients do not need to be on the National List, but cannot be produced with excluded methods (e.g., GMO), ionizing radiation, or from sewage sludge

Nonagricultural ingredients must be on the National List

Organic and nonorganic forms of the same ingredient are allowed, if identified separately on the label

Processing aids

Must be certified organic

May use nonorganic only if on the National List

Nonorganic processing aids are allowed and are not required to be on the National List

“100% Organic” Category5

Every ingredient and every processing aid must be certified organic, and if the product is processed, even its processing aids must be organically produced. The only exceptions are water and salt, which can be used. A processed ingredient may only be used in a “100% organic” processed product if the ingredient itself is certified in the “100% organic” category. This is the strictest category, and products in it may display the USDA organic seal.

“Organic” Category6

At least 95 percent of the ingredients must be certified organic. The remaining five percent or less must be nonorganic or nonagricultural materials specifically allowed on the National List.8,9 A nonorganic agricultural ingredient may be used only when an organic version is not commercially available, and you cannot use both an organic and a nonorganic form of the same ingredient. This is the most common category, and it too may display the USDA organic seal.

Restrictions Common to Both the “100% Organic” and “Organic” Categories

For any product labeled “100% Organic” or “Organic,” and for any ingredient identified as organic on a label, a short list of things is never allowed.10 The material cannot be produced using excluded methods such as genetic modification, processed with ionizing radiation, or produced with sewage sludge. It cannot contain sulfites, nitrates, or nitrites added during production or handling, with a narrow exception for wine labeled made with organic grapes. You cannot use a nonorganic ingredient when an organic version is available, and you cannot include both organic and nonorganic forms of the same ingredient.

“Made with Organic” Category7

At least 70 percent of the ingredients must be organic. This category is more forgiving at formulation. Its nonorganic agricultural ingredients do not have to be on the National List, though they still cannot be produced with excluded methods (e.g., GMO), ionizing radiation, or sewage sludge,10 and its nonagricultural ingredients must be on the National List.8,9 It is also exempt from several rules the top two categories must follow, including the limits on added sulfites, nitrates, and nitrites, the commercial-availability requirement, and the ban on using both organic and nonorganic forms of the same ingredient. The tradeoff is a more restrictive label. It may not display the USDA seal.11

Less than 70% Organic Category12

The organic ingredients that go into products that contain less than 70% organic ingredients still have to be produced to organic standards, but the nonorganic ingredients are free of the other requirements. The labeling requirements of this category are the most restrictive, only allowing ingredients to be identified as organic in the ingredient statement. In fact, an operation that only makes products in this category, with no other organic claims on the label, may be exempt from organic certification.13

Which Claim Is Right for You

Choosing an organic claim reflects your company and your customers. The answer to several questions will help determine which composition category you should aim for:

  • What are you producing, and which ingredients does it require?
  • How much flexibility do you have with the sourcing of those ingredients?
  • What is the highest claim you can reach given those constraints, and what would reformulation open up?
  • Who is your customer? What do they look for on a label?

The seal is a strong pull, given how many shoppers trust it, and it is worth remembering that only the top two categories may use it. Beyond that, each category has its own character.

The “100% Organic” claim is the strictest. Your certifier may ask for extra verification of your suppliers’ certificates, especially for imported ingredients, and the claim can be hard to hold if your product, ingredients, or suppliers change often. It is also not recognized in all countries, which can complicate exporting.

The “Organic” claim is the most common. Because not all ingredients need to be certified to the “100% organic” category it gives you more room to move if your suppliers change.

The “Made with Organic” claim is sometimes the highest a given product can reach. You might have 99.9 percent organic content, but if you use even one nonorganic ingredient that is not on the National List, the “Organic” category is off the table and “Made with Organic” is where you land. It trades the seal and broad wording for real formulation flexibility.

Conclusion

Your composition category sets the rules for everything that goes into your product. It determines which nonorganic ingredients you can use, whether a commercial availability search is required, and how much flexibility you have when your supply chain shifts. Before you finalize any formulation, submit your proposed formulation to your certifier, know which category you’re in, confirm the organic percentage actually gets you there when you run the math, and think through whether adjusting the formula could open up a higher category. One tenth of a percent can be the difference between a product that carries the USDA organic seal and one that doesn’t.

Action Items

  • Determine the organic percentage of each product at formulation.
  • Place each product in its composition category.
  • Confirm the highest claim your formulation can reach.
  • Weigh reformulation where a higher claim is worth it.
  • Get every product formulation and label you might use approved by your certifier in advance.

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