Navigating the National List for Allowed Ingredients and Processing Aids

The National List for Ingredients, Processing/Packaging Aids

In organic agriculture, we can say that generally agricultural inputs are allowed and synthetic inputs are prohibited. Similarly, in organic handling and processing, certified organic ingredients are allowed and nonorganic ingredients are generally prohibited. However, there are exceptions: nonorganic materials can be allowed for use in organic products under certain circumstances. It is crucial to know definitively which nonorganic materials are allowed and the situations in which they are allowed.

The definitive source to refer to is the National List of Allowed and Prohibited Substances, often shortened to the National List.¹ It is a section of the USDA organic regulations that lists the nonorganic substances and ingredients that are allowed for use in organic processed products.

Another place you can learn more about many specific materials on the National List is the Organic Materials Review Institute (OMRI). OMRI is an independent nonprofit organization that is ISO 65 accredited by the USDA and is a trusted source of information by the National Organic Program and certifiers.^2,3 OMRI is a great starting point for learning what substances may be allowed in an organic product.

Many ingredients and processing/packaging aids are OMRI-listed. When a material is listed by OMRI, it is a strong indication that it may be allowed by your certifier. There are some exceptions, so always check with your certifier. OMRI has an electronic search feature and downloadable product lists for both brand-name and generic materials.^4,5 The online search and the generic materials list are great places to look up if a generic ingredient is allowed, along with information about any use restrictions.

The sub-sections of the National List most relevant to handling and processing describe specific synthetic, nonsynthetic, and nonorganic materials that may be used if all applicable restrictions are met. These are found in sections 205.605 and 205.606.

Note: This article does not apply to certified organic livestock feed, see Livestock Feed Composition and Product Formulation for guidance on those ingredients and the National List.

Allowed Nonorganic Substances

Nonsynthetic substances are “derived from mineral, plant, or animal matter and do not undergo a synthetic process.”⁶ Examples of allowed nonsynthetic materials include mined substances like calcium carbonate, calcium sulfate, or diatomaceous earth. Also allowed are cultured materials such as enzymes, microorganisms, natural flavors, and yeast. In section 205.605(a) of the National List you’ll find a list of nonsynthetic substances that you can use as material inputs.⁷ Your certifier may require additional verification to show that the specific formulation you are using is nonsynthetic.

Synthetic substances are “formulated or manufactured by a chemical process or by a process that chemically changes a substance.”⁸ Examples of allowed synthetic materials include ammonium bicarbonate, ascorbic acid, carbon dioxide, nutrient vitamins and minerals, and tocopherols. For some synthetic materials, verifying the source or manufacturing method is crucial. For example, citric acid can be used, but only if it is produced by microbial fermentation. Section 205.605(b) lists these allowed synthetic substances.⁷

Nonorganic agricultural products are any raw or processed agricultural commodity or product produced for human or livestock consumption, outside of the organic certification program.⁹ Examples include casings from animal intestines and other materials derived from conventional agricultural ingredients, such as colors, cornstarch, gelatin, and pectin.¹⁰ Section 205.606 lists the allowed nonorganic agricultural products.

“Certified Organic” vs. “Made with Organic” Product Composition Categories

If you plan to use any nonorganic substances in your product, those substances must be included in the National List. The only exception is when you are certifying products as “made with organic” rather than “certified organic”. A product can be made with 99.9% organic ingredients, but it will not qualify as “organic” if it contains a single nonorganic ingredient that is not on the National List. For more detail on this requirement, refer to Product Composition – 100% Organic, Organic, and Made with Organic.

Changes to the National List

From time to time, the National Organic Program (NOP) will update the materials included in the National List. To stay up to date on any changes to the National List and other regulations, sign up for the NOP’s Organic Insider newsletter.¹¹ This newsletter will also tell you about opportunities to give your feedback on proposed rule changes. Your certifier will also inform you of changes when they review your ingredients during your annual certification renewal process.

Commercial Availability Exceptions

Some allowed nonorganic materials in the National List are subject to commercial availability requirements.¹² This requirement means that for certain materials, you must search for organic sources before using a nonsynthetic or nonorganic version, and you must document this search. If you cannot find an organic version of the material in a suitable form, quantity, or quality, then you may be allowed to use a nonorganic material in your organic product. Your certifier will review your commercial availability search documentation and determine whether it is sufficient to justify your use of nonorganic agricultural inputs. The goal is to expand the organic market for these types of ingredients and incentivize more availability.

Some nonsynthetic materials are subject to commercial availability requirements, as outlined in section 205.605. Examples are flavors, yeast, collagen gel, and some uses of silicon dioxide.

All nonorganic agriculture product ingredients listed in section 205.606 are subject to commercial availability requirements.

Your certifier is the one who determines if your justification for using a nonorganic material is reasonable. Certifiers often have their own forms you can use to document exceptions due to a commercial availability issue. Form, quality, and quantity requirements can be very subjective and specific to the type of processing that you do. Document your search and be ready for a conversation with your certifier to explain your justification for why an organic version of a material will not work in your specific product.

Using the National List

While the wording of the National List can be dense or confusing at times, being able to navigate and understand it is crucial for organic handlers. Doing so allows you to choose and source material inputs that will maintain your product’s organic certification. The sections that pertain to handling and processing are 205.605 and 205.606.

Let’s say you are considering using activated charcoal as an ingredient or processing/packaging aid, and you need to figure out if there are options that can be used in organic products. Start your investigation by searching the National List to see if activated charcoal is included as an allowed substance.

Navigate to the National List webpage, use the search function, and type “activated charcoal”. You will find:

“7 CFR 205.603(a)(6) Activated charcoal (CAS # 7440-44-0)—must be from vegetative sources. “

There are three pieces of information that may be provided in the National List for each substance: the listing name, CAS number, and annotations.

Listing Name

This is the generic name of the substance, in this case activated charcoal. You will often find this name included in ingredients lists in supplier catalogs, in addition to the branded name a company has for it.

CAS Number

A CAS Registry Number is a unique and unambiguous identifier for each specific chemical substance that allows clear communication and ensures that the correct substance is being referenced. The CAS number links together all available data and research about that substance.¹³ Different forms of a chemical may have different CAS numbers. A CAS number is not included for all listed items, only when it is necessary for clarity.

In the example of activated charcoal, there are two CAS numbers given: 7440-44-0 and 64365-11-3. You can type that number into the CAS Registry, and find the entry below. Under “Other Names and Identifiers” you can find a thorough listing of all the trade names. This can help you locate this material in a supplier catalog.

Annotations

Annotations are the specific, detailed requirements or restrictions placed on some, but not all, substances. They can dictate how the material is produced or how it is used. If your certifier is asking questions about exactly how an ingredient or processing aid is used, it is because they will need this information to verify if your intended use meets the requirements of an annotation.

In the example of activated charcoal, the annotations are:

“only from vegetative sources; for use only as a filtering aid.”

In this example, there are two annotations. One specifies the source of the material, and the second specifies the use of the material.

Examples of Different Kinds of Annotations

Annotations can say many things affecting how you must use the material. Here are examples of the different types of annotations you may see, using some common ingredients or processing/packaging aids¹:

• L-malic acid must be a specific CAS number: CAS # 97-67-6.
• Pullulan may be used only in tablets and capsules for dietary supplements labeled “made with organic.”
• Tartaric acid may only be “made from grape wine.”
• Phosphoric acid may be used for the “cleaning of food-contact surfaces and equipment only.”
• Taurine is “for use only in pet food.”
• Collagen gel can only be used as a casing, and nonorganic versions can only be used when organic is not commercially available.

Commonly Used Substances and Their Annotations

Below are some commonly used nonorganic ingredients or processing/packaging aids, and the annotations that must be met and documented in order to use them in an organic product. To see the exact annotation language, refer to the National List.¹

• Animal Enzymes, 205.605(a)(3): Animal enzymes are commonly used in dairy processing. To meet this annotation, the documentation you submit must verify that your source is one of the 6 types of animal enzymes listed in the annotation, and that if it is rennet or catalase, it comes from an approved source.
• Enzymes, 205.605(a)(11): To meet this annotation, you must document that your source is from plants, fungi, or bacteria, and not animals.
• Flavors, 205.605(a)(12): Nonsynthetic flavors may be used when organic flavors are not commercially available. All flavors must be derived from organic or nonsynthetic sources only and must not be produced using synthetic solvents and carrier systems or any artificial preservative.
• Yeast, 205.605(a)(3): If you are using it as a fermentation agent, you must use organic yeast, unless it is not commercially available. The yeast cannot have been produced on petrochemical or sulfite waste substrates. If the yeast is smoked, you must document a nonsynthetic flavoring process.
• Colors Derived from Agricultural Products, 205.606(d)(1–10): Natural colors must not be produced using synthetic solvents and carrier systems or any artificial preservative. Many colors often have their own specific requirements listed in the regulation. For example, beet juice extract color must not be produced from sugarbeets, which are often genetically modified.

How is the National List Updated?

The National Organic Standards Board (NOSB) is a 15-member volunteer board that represents the organic community. Among their duties is to review materials and recommend changes to the National List.¹⁴ Public input, oral and written, is solicited, and NOSB meetings are free and open to the public.¹⁵ The NOSB makes decisions democratically, by voting within the board, based on research, debate, and consideration of public comments. Any individual or organization, like you, your certifier, or a trade group you belong to, may submit a petition to add, remove, or amend the listing of a substance. The NOSB reviews petitions based on the criteria outlined in the Organic Foods Production Act.¹⁶ Additionally, the NOSB reviews every entry on the National List every five years to ensure that the listing is still appropriate based on the latest data and research.

To learn more about the NOSB review process and how changes are made to the National List, see the National List Criteria: Inside the Review Process.