What You'll Learn
- The approval workflow for any nonorganic ingredient or processing aid, from documentation to certifier final approval
- What the “big three” affidavits cover and why they need to come from the manufacturer, not the distributor
- When a natural flavor declaration is required and what it needs to disclose
- How subingredients inside a nonorganic substance can trigger their own documentation requirements
Getting a nonorganic ingredient or processing aid approved for use in an organic product doesn’t have to be complicated, but it does require some effort and time. You need to confirm the substance is on the National List, gather the right documentation from your supplier, update your Organic System Plan, and wait for your certifier’s written approval all before anything can go into certified organic production. This article walks through that workflow so you know exactly what to collect, when to collect it, and what happens if something in the package is missing.
Before You Begin
Nonorganic ingredients and processing aids are allowed for use only in products in the “organic” or “made with organic” product composition categories, never in a product labeled “100 percent organic.”1 Every nonorganic substance, agricultural or not, must appear on the National List and meet the restrictions in its listing, in §205.606 for agricultural products and §205.605 for nonagricultural ones.2,3 Many of these inputs also carry a commercially available condition, meaning an organic form must be used when one is available in the form, quality, and quantity you need.4,5
Approval Workflow
Not every product or brand of an allowed substance will meet all of the requirements to be used in your organic product. It is your responsibility as outlined in your OSP to document that a specific substance meets organic requirements and to submit that proof to your certifier.6 You will assemble a documentation package, update your Organic System Plan, and submit both for review. Your certifier then reviews your submission and decides whether the input is approved for your operation. You must wait for that approval. Even with a complete package, the substance cannot be used until your certifier formally approves it.
Nonorganic Ingredient Approval Workflow
Build a Documentation Package
Collect documentation for any nonorganic ingredient or processing aid you want your certifier to review. For the full table of which documents apply to which kind of substance, see Verifying Compliant Ingredients and Processing Aids. Most certifiers require specific documentation and forms for ingredients and processing aids, so ask for these before you contact your supplier.
Step 1. Gather supplier documentation
Start with the core information from your supplier, the specification sheet, a full ingredient disclosure, and the identity of the manufacturer, not just the supplier or distributor. You need to know exactly who made the input and what is in it before going further. For working with suppliers, see Building and Maintaining a Supplier Approval Program. The documentation must be sufficient to demonstrate to your certifier that the substance meets any of the annotations or restrictions on manufacture process or source on the National List.
Step 2. Identify any additional ingredients or processing aids
Read the full ingredient list for anything else contained in the product, such as anti-caking agents, carriers like maltodextrin, or other processing aids. These ancillary ingredients and processing aids, as well as any substances that come in contact with the product, have to be disclosed and evaluated just like the main one, so consult with your certifier about what documents may be needed.
Step 3. Verify exclusion of the big three
Next, confirm the input was not produced using the three prohibited methods: ionizing radiation, sewage sludge, excluded methods (e.g. genetic modification).7 Ask your certifier whether they have a specific affidavit form, since most do. If so, that legally binding affidavit must be completed and signed by the manufacturer, not the distributor. If your certifier has no form, request a letter signed by the manufacturer stating that none of the three methods were used.
Step 4. Complete a commercial availability search, if required
For every nonorganic agricultural input and some nonagricultural ones, you must determine whether an organic version is commercially available.2,3,4 When this restriction is required, conduct and document the search and keep the record, updating it at least once a year. For more details on conducting a search, see Commercial Availability Requirement for Nonorganic Ingredients and Processing Aids.
Step 5. Complete a Natural Flavor Declaration, if needed
For nonorganic natural flavors, many certifiers provide a form for the manufacturer to complete called a Natural Flavor Declaration. It confirms: no synthetic solvents or artificial preservatives were used, compliance with the FDA natural flavor definition,8 whether an organic version is available, and the flavor’s nonsynthetic source. Your certifier will evaluate the carriers, solvents, and preservatives, since these must meet organic requirements and be fully disclosed.
The OMRI Shortcut
An Organic Materials Review Institute (OMRI) listing can simplify this, though it never replaces certifier approval. If a nonorganic substance is OMRI-listed, your certifier may accept the OMRI certificate in place of some or all of the documents above. Not every certifier or product works this way, so confirm what your certifier accepts before you rely on it.
Update your Organic System Plan
Once your documentation package is complete, update the relevant parts of your Organic System Plan (OSP).6 If there is a section within your OSP describing nonorganic ingredient usage, review it and update as needed. Accurate OSP records are essential to show compliance at inspection.9
Update your Product Formulation Sheets (ingredient declaration or recipe) as well, and make sure nonorganic ingredients are not counted as organic on the label or in the organic percentage of the finished product. Since nonorganic substances do not add to organic content, they count as zero percent organic in the composition calculation,10 which you can work through in Product Formulation and Calculating Organic Content.
Submit to Your Certifier for Review
With records updated, submit the documentation package and OSP forms to your certifier.6,7 Your certifier may have follow-up questions or request additional information from the manufacturer. Do your best to be responsive to continue moving things along. Wait for written approval before using the ingredient or processing aid in any organic product. Even if you believe you submitted everything that’s needed, don’t use a new substance (or risk approving packaging reflecting such) until your certifier officially approves it.
If a handler wants to change an ingredient or product formulation, it is best to contact your certifier ahead of time and see what type of documentation you might need. … These changes would need to be reviewed and approved by your certifier before you began to sell or represent any new products as organic. So the most important thing is to realize that this takes time.
Keep Your Documentation Current
Current records keep you compliant and head off delays, noncompliances, and forced reformulations. For any nonorganic input that requires proof of commercial availability, perform and document a fresh search at least once a year. Your certifier will periodically re-review your nonorganic ingredients and processing aids, and if you learn a substance’s composition has changed, contact them to confirm it is still approved. Do not wait for annual renewal to seek approval for a new nonorganic substance. Every one must be reviewed and approved before use.
Conclusion
Some nonorganic substances are allowed in organic products, but only when they meet the regulatory requirements and are properly documented. Collecting the verification documents, getting approval before use, and keeping that documentation current is what keeps your operation compliant. Clear records and steady communication with your certifier are what protect your organic integrity.