What You'll Learn
- Identify which ingredients are straightforward for approval and which need more documentation
- Recognize the documents certifiers commonly request, and when each is needed
- Use OMRI to identify allowed substances
- Cross-check your documents so they tell one clear story
- Plan a realistic timeline, and know when substances get re-reviewed
Your certifier must confirm that everything in your product is allowed under the USDA organic program, and that task is not always simple. Handlers use a huge range of substances, and new ones appear all the time. Think of this as a primer on the documents your certifier may ask for and how to have them ready before your inspection.1
The Documents You May Need
The table below shows the documents your certifier may request, depending on the category of the substance: certified organic, nonagricultural synthetic or nonsynthetic, and nonorganic agricultural. Details about what types of substances fall in these categories can be explored in the article Allowed Ingredients and Processing Aids in Organic Products. The table below is a guide, not a rulebook. As you build a relationship with your certifier, you will learn exactly what they want. The rest of this article explains each document.
| Document from the Supplier | Certified Organic Substance | Nonagricultural Substance2 | Nonorganic Agricultural Substance3 |
|---|---|---|---|
|
Organic Certificate |
Yes, must be current | N/A | N/A |
|
Certificate Addendum (Product Listing) |
Yes | No | No |
|
Label and/or Spec Sheet |
Maybe, if multi-ingredient |
Yes |
Maybe, if multi-ingredient |
|
OMRI Certificate |
N/A |
If listed, may replace the documents below |
No |
|
List of All Ingredients (if not on the spec sheet) |
Maybe, if multi-ingredient |
Yes |
Maybe, if multi-ingredient |
|
Declarations for Absence of Ionizing Radiation, Sewage Sludge, or Excluded Methods (GMO) |
No | Yes, unless OMRI-listed | Yes |
|
Manufacturing Process Information |
No |
Depends on the listing annotations and known manufacturing details |
No |
|
Commercial Availability Documentation |
No |
For a few §205.605 items (e.g. flavors, yeast, collagen gel, silicon dioxide) |
Yes |
|
Annotation Documentation |
No |
Depends on the §205.605 listing |
Depends on the §205.606 listing |
Organic Certificate
Ingredients that are domestically produced and certified to the USDA organic regulations are the simplest to verify, so some handlers choose to prioritize these suppliers. You can find certificates for certified products in the Organic Integrity Database (OID).4 For more information on how to verify a supplier’s certificate against the OID, see Building and Maintaining a Supplier Approval Program, and for reading a certificate’s parts, see Anatomy of a USDA Organic Certificate. Foreign certificates may need additional documentation, and if you import the substance yourself, include your import records. For more information on imports, see Importing Organic Products Overview.
Certificate Addendum (Product Listing)
An addendum adds detail that a supplier’s organic certificate leaves out.5 The certificate may say apricot puree in general terms, while the addendum names the specific certified apricot puree products and their brand names. Certifiers use different names for this document, including product listing, certified product list, and client profile. The addendum is often not a public document, so you may need to request it directly from your supplier. Raw agricultural commodities typically do not need an addendum.
An addendum is especially important when you are a private-label brand owner working with a co-packer, since you must confirm your branded products appear on the co-packer’s addendum. If a substance you want to source is not on the supplier’s addendum, expect the review to take longer as your supplier will need to reach out to their certifier to get it added.
Spec Sheet
A specification sheet (often shortened to spec sheet) is a technical document describing a product. The product name and brand appearing on the spec sheet should match your other documentation. Not every substance needs one, raw or single-ingredient products like apples or whole grains usually do not, but nonagricultural ingredients and blended or multi-ingredient products often do. Certifiers generally want a spec sheet to list every substance in the ingredient, along with details like CAS numbers,1,6 which you can read more about in Navigating the National List for Allowed Ingredients and Processing Aids. A spec sheet is a good start but does not always contain everything your certifier needs.
Ingredient List
When a spec sheet does not disclose every component, your certifier needs a full ingredient list, because they cannot review a substance without knowing what is in it.1,6 That subingredient information also feeds the review of your finished product label. If the spec sheet falls short, ask the supplier for a formal ingredient statement or a copy of the ingredient’s own label. This can take time when you are not dealing directly with the manufacturer.
Documents for Nonorganic Substances
Nonorganic ingredients and processing aids carry a few documents beyond the basics. The table above shows when each applies. Here is what they are and where to go for the details.
- Declarations for the absence of ionizing radiation, sewage sludge, or excluded methods (GMO): The USDA organic regulations prohibit the use of irradiation, sewage sludge, and excluded methods such as genetic modification in any substance.6 A supplier’s own wording may not satisfy your certifier, since definitions of genetic modification vary. Therefore, certifiers often require their own form signed by the manufacturer. More on the affidavit can be found in Documenting Nonorganic Ingredient Use.
- Manufacturing process information: Your certifier may need to know how a substance was made, to determine whether it is synthetic or nonsynthetic, to rule out genetic modification, or to confirm it meets a restriction.1,6 Citric acid, for example, is allowed only when produced by microbial fermentation.7
- Commercial availability documentation: Some substances require you to search for an organic version and document that search before sourcing the nonorganic one.8,9 For how to perform and record that search, see Commercial Availability Requirement for Nonorganic Ingredients and Processing Aids.
- Annotation documentation: When the National List entry carries an annotation, your certifier may ask for details on how you use or make the substance.1 Interpreting annotations is covered in Navigating the National List for Allowed Ingredients and Processing Aids.
OMRI, a Helpful Shortcut
The Organic Materials Review Institute (OMRI) is an independent nonprofit, ISO 65 accredited by the USDA. Both the National Organic Program and certifiers treat OMRI’s reviews as a trusted source.10 It is a strong starting point for learning whether a specific substance may be allowed for use in your product. Some ingredients and processing aids are OMRI-listed, and an OMRI-listing is a good signal that your certifier may allow you to use the substance, though your certifier always has the final word on whether it is allowed for your intended use.
Inclusion on the National List does not guarantee every source of that substance is cleared for your use. The source, composition, and manufacturing process may need to be reviewed prior to approval. Vetting every substance yourself is hard, which is where OMRI helps. It reviews both branded products and generic substances, so you can check whether a particular product from a particular company has already been reviewed for organic use.
OMRI offers an electronic product search and downloadable Brand Name and Generic Materials lists.10 When a substance is OMRI-listed for the use you want and you follow its restrictions, your certifier will generally accept OMRI’s review without doing a full review of their own. That can shrink the amount of documentation that you must collect to the OMRI certificate plus a product label or spec sheet. A substance does not have to be OMRI-listed to be allowed, but OMRI-listed substances can be a helpful shortcut to approval.
Tips for using OMRI-listed substances
- Confirm the exact product name and code.
- Make sure you are on an NOP listing with the American flag symbol. OMRI also lists products allowed under other countries’ rules.
- Check the listing for any restrictions.
- Submit the OMRI certificate to your certifier for approval before you use the substance in production.
The Washington State Department of Agriculture (WSDA) is another resource that may have pre-reviewed nonorganic ingredients or processing aids. Check with your certifier.
Allow Sufficient Time for Review by Your Certifier
Reviewing a substance and gathering documents takes time, and how much time depends on the complexity of the product. A raw organic commodity is quick to verify. Documenting the manufacturing process for a complex multi-ingredient product is not.
The pace of certifier review also depends on how promptly you, your supplier, the manufacturer, and your certifier respond. Expect questions and requests for more information, and plan ahead rather than counting on a fast turnaround. Sometimes a supplier cannot or will not provide what your certifier requires, and you have to find an alternative.
Substances are reviewed before first use and then re-reviewed periodically to catch changes. Organic certificates are reviewed at least annually, while re-review timing for nonorganic substances varies by certifier. New information can require a new review, and a substance can stop being allowed if the National List changes.
Conclusion
Your certifier can only approve what you give them to work with. Ask your certifier what documents or forms they require as your first step. Then, gather the right documents together before you need them, build in enough time for review, and keep a backup supplier on hand for anything that’s complex to verify. Once a substance is approved, stay on top of certificate renewals and watch for National List changes that could affect your substances. The handlers who find this process least stressful are the ones who treat ingredient verification as an ongoing part of operations rather than something they scramble to finish right before they need to take a product to market.