Verifying Compliant Ingredients and Processing Aids

What You'll Learn

• The NOP’s definitions of ingredients and processing/packaging aids
• Which types of ingredients and processing/packaging aids are easier to certify, and which types require more documentation
• The types of documents certifiers commonly request in their review
• When each document type is commonly needed
• The timeline you should allow to gather needed documentation, and when ingredients need to be re-reviewed

Your certifier must confirm that everything in your product is allowed under the organic program, and this is not always an easy task. Organic processors use many different ingredients and there are always new ones being developed. This is a primer on what types of documentation may be requested at your inspection.

Since we are talking about the language of certification, and definitions can be crucial, let’s look at the phrase “Ingredients and Processing/Packaging Aids” in more detail.

The same input can be either an ingredient or a processing/packaging aid, depending on how it is used. For example, when carbon dioxide is used as a packaging flush it is a processing/packaging aid (it is not incorporated into the final retail product). But if it is used to provide carbonation, then it is an ingredient (it will be in the final retail product).

What is Allowed in “Organic” or “Certified Organic” Products?

Certifiers must review and approve all substances used in the manufacture of your organic product. They will require you to send them documentation to verify that each ingredient and processing aid is allowed under the USDA organic regulations. You will need to obtain this information from your suppliers. For more information on suppliers and documentation, see Working with Suppliers of Organic Ingredients.

For the sake of brevity, in this article we will on occasion shorten “ingredients and processing/production aids” to “materials”.

There are two categories of ingredients and processing/packaging aids used in the production of organic products intended for human consumption:

• Agricultural ingredients (made from agricultural products), which must be certified organic.¹
• Specific synthetic, nonsynthetic, and nonorganic materials, which may be used for specific reasons.² These specific use reasons are referred to as “restrictions” or “annotations”.

Any allowed nonorganic material you use in your organic product must follow all the restrictions that apply to that material. These restrictions are detailed in the National List of Allowed and Prohibited Substances (National List). The National List is a section of the USDA organic regulations that lists the specific synthetic, nonsynthetic, and nonorganic ingredients and processing aids that are allowed for specific reasons, and all restrictions required for their use.^3,4 For more info on the National List, refer to Navigating the National List for Allowed Ingredients and Processing Aids.

Let’s take a look at the reasons a nonorganic or synthetic substance can be included on the National List:⁵

• The input is necessary or essential because of the unavailability of organic alternatives,
• The input is deemed not harmful to human health or the environment,
• The input is suitable with organic farming and handling (as defined by National Organic Standards Board rules).

Once a substance has been added to the National List:

• Synthetic and nonsynthetic nonagricultural materials may be used as ingredients or processing aids if their listed restrictions are met.⁶
• Nonorganic agricultural ingredients may be used as ingredients in or on organic products if an organic version is not commercially available and if any listed restrictions are met.⁷

All nonorganic ingredients must be produced without the use of: ionizing radiation, sewage sludge, or other excluded methods (such as GMO technology). No other types of ingredients are allowed in organic human food or personal care products.

Organic Materials Review Institute (OMRI)

Just because you see a material listed on the National List does not mean every version or source of that material is allowed for use in organic products. The specific source and composition needs to be reviewed by your certifier to make sure that they meet all criteria. For example, some sources may use processing aids that are not allowed in organic, while the main ingredient you are trying to procure would otherwise be eligible. It can be challenging for individual handlers to vet every source, but there are resources where you can look to confirm if a specific material from a specific company has already been reviewed for organic processing.

Some ingredient manufacturers have registered their products with OMRI. OMRI is an independent nonprofit organization that is ISO 65 accredited by the USDA and a trusted source of information by the National Organic Program and certifiers.^8,9

The OMRI website is a wealth of information, including articles about the proper use of many materials. To make it easier for handlers, many products certified by OMRI have the official logo on their packaging/product listing:

The OMRI materials database has an electronic search feature https://www.omri.org/omri-search, and downloadable product lists for both brand-name products and generic materials.^10,11 The online search and the Generic Materials List are easy ways to find out if a generic ingredient is allowed and to see any restrictions that apply.

Processing ingredients and aids are reviewed by OMRI as their own materials category. Try looking up sodium bicarbonate or citric acid in the online search tool and you will see multiple results from different sources. If it is approved by OMRI (and you want it for the use it was reviewed for and you will follow any restrictions), then your certifier will generally accept OMRI’s review of a branded product without conducting a full review of the ingredient themselves.

An ingredient or processing/packaging aid isn’t required to have OMRI review to be allowed, but OMRI-listed materials can be easier to work with because you and your certifier don’t have to gather all of the documentation needed for a review. You can simply submit the OMRI certificate, and product label or spec sheet, and that might be everything your certifier needs to approve the ingredient.

Tips for using the OMRI-listed materials:

• Confirm the exact product name and code.
• Make sure you are looking at an NOP listing with the American flag symbol. OMRI also lists products allowed under other countries’ organic regulations.
• Check the product listing for any restrictions.
• Submit the OMRI-listed certificate for the material to your certifier for approval before using it in production. Your certifier will need to review and approve how you plan to use the ingredient before you get started.

Documentation Required for Verifying Eligible Ingredients and Processing/Packaging Aids

The table below lists the type of documentation that may be requested by your certifier depending on the type of material. It is not definitive, but these are the most commonly needed documents. As you develop a relationship with your certifier, you will learn exactly what documentation they require.

Type of Documentation from the Supplier

Type of Documentation from the Supplier	Needed for Certified Organic Materials	Needed for Allowed Nonorganic Materials (Nonagricultural6)	Needed for Allowed Nonorganic Materials (Agricultural7)
Organic certificate	Yes (current, and to NOP standards)	N/A	N/A
Certificate addendum (aka Product Listing or Client Profile Addendum)	Yes	No	No
Label and/or spec sheet	Maybe (if multi-ingredient)	Yes	Maybe (if multi-ingredient)
OMRI certificate	N/A	If applicable to your ingredient, then you may not need to submit other documentation below!	No
Information listing all ingredients (if not included in the spec sheet)	Maybe (if multi-ingredient)	Yes	Maybe (if multi-ingredient)
Declarations: non-irradiated, no sewage sludge, non-GMO	No	Yes (unless OMRI-listed)	Yes
Information about the manufacturing process	No	Depends on the ingredient listing in 205.605 and known manufacturing information	No
Commercial availability documentation	No	For a few items specified in 205.605 (such as natural flavors, yeast, collagen gel, silicon dioxide)	Yes
Annotation documentation	No	Depends on the ingredient listing on 205.605	Depends on the ingredient listing on 205.606

Organic Certificates

Ingredients that are domestically produced and certified to the National Organic Program are the simplest to verify. Handlers are recommended to prioritize sourcing materials from these suppliers, since documentation is easier.

• Certificates for NOP-certified products can be found at the Organic Integrity Database Website (OID).¹³
• See Maintaining Organic Certificates from Suppliers, and Anatomy of an Organic Certificate for more details on using OID to verify certificates.
• Foreign organic certificates:
• Note that additional documentation may be required.
• Include import documentation if you are importing yourself.

Addendum/Product Listing

This is a document certifiers may issue that adds more detail than a supplier’s organic certificate. The organic certificate has more generic information, whereas the addendum or product listing will be more specific, especially for manufactured/processed ingredients. For example, the organic certificate may say apricot puree, but the addendum will list all of the specific certified apricot puree products and associated brand names. Your certifier may require this information to verify the specific product you are sourcing is certified organic. An addendum or product listing may not be needed for agricultural commodities or produce in its raw form.

Addendums are especially common if you are a private label brand owner working with a co-packer. You must verify that your branded products are listed on your co-packer’s addendum. If an ingredient you wish to use is not on your supplier’s addendum or product listing, this may extend the timeline needed for review.

Certifiers use different names for this document including: addendum, certified product list, certified organic products and services, client profile, etc. The addendum may not be publicly available on the certifier’s website or on the Organic Integrity Database because of confidentiality and you will need to request it directly from your supplier.

If you are exporting organic products to another country, your certifier may need additional information to determine if your ingredients meet export requirements. Keep in mind that certified organic products may still be subject to additional restrictions when exported.

Spec Sheet

An ingredient specification (spec) sheet is a detailed technical document with information about a product. The product name and brand listed on the spec sheet should match up with other supporting documentation (organic certificate, addendum, etc.). Not all ingredients will need spec sheets. For example, raw produce or other single-ingredient products don’t need a spec sheet (like apples or whole grains). A spec sheet may be requested for non-agricultural ingredients and any blended or multi-ingredient products.⁶

Some spec sheets are more useful and complete than others for the purpose of your organic certification. Generally, certifiers want a spec sheet to list ALL materials in the ingredient, processing/packaging aid, in addition to other information, like CAS numbers.¹⁴ Spec sheets are a good starting point, but sometimes they don’t provide everything your certifier needs.

Ingredient Listing

If a spec sheet doesn’t include an ingredient listing, your certifier will need full details on all components of your proposed material. They can’t review your ingredients or processing/packaging aids if they don’t know what’s in them. The sub-ingredient information will also be needed when your certifier reviews the ingredient listing for your final product label. When not enough ingredient information is listed on the supplier’s spec sheet, you might need to get more information from the supplier by asking them for a formal ingredient statement, or a copy of the label of the ingredient. This process can take time and be challenging if you are not working directly with the manufacturer, which is another good reason to source from domestic suppliers with OMRI-listed products.

Declarations: Non-Irradiated, No Sewage Sludge, Non-GMO

Organic regulations prohibit the use of irradiation, sewage sludge, and GMO inputs in ingredients and processing/packaging aids. Spec sheets sometimes include statements addressing these prohibitions, but your certifier may not accept them depending on how they are worded. This is because, for example, definitions of “genetically modified” can vary. Certifiers are looking to the definitions in the National Organic Standards, under Excluded Methods.¹ Certifiers may require that their own form be signed by the manufacturer. A supplier generally cannot sign this form if they are not the manufacturer, since they really do not know about the manufacturing process.

Information about the Manufacturing Process

There are a few reasons that a certifier may need more information about the manufacturing process, such as:

• Determining if the material is synthetic or nonsynthetic
• Requiring more information about the possibility of genetic modification
• Verifying if it meets a specific restriction

For example, citric acid can be used, but only if it is produced by microbial fermentation. Another example are enzymes that are listed as an allowable nonsynthetic, but they must be derived from edible, non-toxic plants, non-pathogenic fungi, or non-pathogenic bacteria. Your certifier will need to verify the way these materials were produced through documentation from the manufacturer.⁶

Commercial Availability Documentation

Some materials require that you first look for an organic option before sourcing a nonorganic option. The goal is to expand the organic market for these types of ingredients and incentivize greater availability. Perhaps in the future organic options will be readily available and they will no longer need to be exceptions on the National List.

“Commercially available” is defined as the ability to obtain a production input in an appropriate form, quality, or quantity to fulfill an essential function in a system of organic production or handling, as determined by the certifier in the course of reviewing the organic system.¹ Note that your certifier determines if your justification is reasonable. Form, quality, and quantity can be very subjective and specific to the type of processing that you do. Be prepared to have a conversation with your certifier to explain your justification for why an organic version will not work in your specific product if form or quality are the concern.

Certifiers generally have their own commercial availability forms for documenting this. Documenting commercial availability can sometimes feel like jumping through a hoop when you already know an organic material is not available. For example, with the low volume of organic meat processing in the United States currently, some common ingredients are rarely available as organic (such as collagen gel casings and casings from intestines). However, certifiers still need to verify that the processor performed a search, because the act of inquiring can create incentive for a business to offer those ingredients in organic form or at a higher organic volume. See Commercial Availability Requirement for Nonorganic Ingredients and Processing/Packaging Aids for more information.

Annotation Documentation

Sometimes there are annotations (also called restrictions) in the organic standards that give specific requirements for how you can use a material or how it is made. For example, ammonium bicarbonate is an allowed synthetic, but only as a leavening agent. Similarly, activated charcoal is only allowed from specific vegetative sources and only for use as a filtering aid, and the listing specifies the exact CAS numbers that are permitted. For materials with their own annotations in the organic standards, your certifier may ask you for additional information on how you are using that ingredient or how it was manufactured. If you want to use activated charcoal, but a different CAS number or not as a filtering aid, then it would not be allowed.

Other Documentation

The organic standards require that you keep records of all activities and transactions.¹⁵ These general documents, like product invoices and inventory logs, should identify the products as “100% organic”, “organic”, or “made with organic” as applicable. For more information on labeling categories see Product Composition – 100% Organic, Organic, and Made with Organic, for more information on general recordkeeping refer to Designing a Recordkeeping System for Your Operation.

Cross-Checking Documents

The documents you submit for a material should all reference the same product identifiers. If the documents you provide have differences in product names, manufacturer, or supplier, your certifier is going to have questions. If documents don’t match up, you will need to provide information to bridge the gap, connect the dots, and adequately explain the reasons the identifiers might differ. You would need to work with your supplier to do that. Generally, the goal of organic documentation is to tell a complete story to your certifier, which allows traceability forward and backward.

Timeline for Reviewing Your Ingredients and Processing/Packaging Aids

As you have read through this article, you may be thinking that reviewing certain types of ingredients and getting needed documents from suppliers might take some time, and you’re right! The timeline depends on the complexity of the review. A domestically produced raw organic ingredient is simple to verify, whereas documenting the manufacturing process for a complex material or determining the non-GMO status can take time. How long it will take depends on the timeliness of your submissions, and on the responsiveness of the supplier, manufacturer, and certifier.

Be prepared for your certifier to have questions or request additional information, and plan ahead. If you anticipate a quick review, you may be disappointed. Sometimes your supplier or manufacturer cannot or will not provide the documents that your certifier requires, and you may need to seek alternatives. Keep this in mind as you begin the process. Ingredients are reviewed initially before use and then re-reviewed periodically to ensure there have been no changes. For organic ingredients, updated certificates are reviewed at least annually. For nonorganic ingredients, re-review timeframes differ by certifier. Sometimes the documentation changes, or more information is available that calls into question some aspect of the review. It is possible that a material will no longer be allowed because new information is discovered. It is also possible that the National List is updated and an ingredient that was once allowed is no longer. Refer to Navigating the National List for Allowed Ingredients and Processing Aids for more information.

Your Next Steps

• Identify your ingredients and your processing/packaging aids – everything going into your product.
• Identify which of your ingredients and processing/packaging aids are likely to be easily approved, and which will require more documentation on your part.
• Familiarize yourself with the types of documents your certifier might require.
• Determine which specific documents will likely be required for each of your ingredients and processing/packaging aids.
• Make a draft timeline for gathering each of the required documents.

Dig Deeper Resources

1. U.S. Department of Agriculture, Agricultural Marketing Service. NOP Petitioned Substances Index