Low Migration Ink Statement of Composition Review
Review an ink Statement of Composition against low-migration and food-packaging requirements before release. Use it to catch undeclared substances, missing test support, and Swiss Ordinance gaps early.
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Built for: Food Packaging · Printing And Converting · Packaging Compliance · Consumer Goods
Overview
This template is a structured inspection and approval record for reviewing a printing ink Statement of Composition before the ink is used on food packaging. It walks the reviewer through supplier identification, document completeness, migration declarations, restricted-substance screening, and the final release decision.
Use it when an ink supplier provides a new or revised SoC, when a packaging line is being qualified for food-contact use, or when you need to document why a low-migration claim is acceptable for a specific substrate and process. It is especially useful where the compliance basis depends on a functional barrier, curing conditions, or a supplier test package rather than a simple yes/no declaration.
Do not use it as a substitute for a full regulatory assessment of the finished package, and do not rely on it if the intended use is unclear, the food-contact route has changed, or the supplier cannot identify intentionally added substances. If the ink is for non-food applications only, this template is too specific and should be replaced with a general material approval or supplier quality review. The goal is to leave a clear record of what was checked, what evidence supported release, and what non-conformances must be closed before use.
Standards & compliance context
- The template supports food-contact packaging review practices commonly expected under FDA food-contact controls, EU-style migration documentation, and supplier qualification programs.
- It helps document screening against Swiss Ordinance substance restrictions where those requirements apply to the packaging material or market destination.
- The structure aligns with ISO 9001 document control expectations by capturing revision status, review evidence, disposition, and approval authority.
- Where a functional barrier is used, the review should reflect the applicable food-packaging compliance rationale and any internal validation requirements before release.
General regulatory context for orientation only — verify current requirements with counsel or the relevant agency before relying on this template for compliance.
What's inside this template
Inspection Details
This section anchors the review by identifying the exact ink, intended use, and responsible reviewer so the approval record is traceable.
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Ink product and supplier identified
Record the ink product name, supplier, and internal material code being reviewed.
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Intended application confirmed as food packaging
Confirm the intended end use and substrate type for the ink.
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Review date recorded
Capture the date and time the Statement of Composition review was completed.
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Reviewer name and function recorded
Enter the reviewer name, role, and department (e.g., QA, regulatory affairs, production).
Statement of Composition Completeness
This section checks whether the supplier’s SoC is current and complete enough to support a real compliance decision.
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Current Statement of Composition provided by supplier
Verify the supplier has provided a current SoC for the exact ink formulation reviewed.
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SoC identifies all intentionally added substances
Confirm the document lists the intentionally added components, including pigments, binders, additives, and solvents where applicable.
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CAS numbers and concentrations are stated where required
Check whether the SoC includes substance identifiers and concentration ranges sufficient for compliance review.
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Revision status and effective date are current
Verify the SoC revision matches the ink version currently proposed for use.
Migration and Restricted Substance Review
This section tests whether the ink’s declared composition and migration claim are compatible with food-packaging use and restricted-substance limits.
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Migration declaration supports intended food-packaging use
Confirm the supplier declaration addresses migration risk for the intended application and curing conditions.
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Restricted substances are screened against Swiss Ordinance requirements
Verify the formulation has been screened for substances restricted or listed under applicable Swiss Ordinance requirements for materials and articles in contact with food.
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No prohibited or undeclared substances identified
Confirm the review found no prohibited, undeclared, or unapproved substances that would prevent food-packaging use.
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Residual solvents or volatile components are controlled
Verify the SoC or supporting documentation addresses residual solvents, drying conditions, and any controls needed to prevent migration.
Food-Packaging Compliance Controls
This section captures the practical controls and evidence that make the compliance claim credible for the actual packaging application.
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Declared for direct or indirect food-contact packaging use
Identify the permitted use category stated by the supplier or internal approval.
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Functional barrier or process controls documented where needed
Confirm any required functional barrier, curing, or process controls are documented and available to production.
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Food-packaging compliance statement present
Verify the supplier or internal technical file includes a clear compliance statement for the intended packaging use.
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Supporting test data or rationale available
Check whether migration testing, worst-case rationale, or equivalent technical justification is available to support the approval decision.
Approval, Documentation, and Release
This section records the final disposition, any corrective action, and the authorization needed before the material can be used.
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Non-conformances documented with corrective action
List any deficiencies, non-conformances, or open questions identified during the review.
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Material approved for use
Final disposition of the ink for the intended food-packaging application.
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Reviewer signature
Signature confirming the review and approval decision.
How to use this template
- 1. Record the ink product name, supplier, intended food-packaging application, review date, and reviewer identity before you start the document check.
- 2. Verify that the current Statement of Composition is attached, current, and complete, including intentionally added substances, CAS numbers, concentrations where required, and revision status.
- 3. Compare the migration declaration and restricted-substance screening against the intended packaging use, including any functional barrier or process control the supplier relies on.
- 4. Confirm that food-packaging compliance statements are supported by test data, a technical rationale, or other documented evidence that matches the actual print process and substrate.
- 5. Log every non-conformance, assign corrective action, and hold the material from release until the reviewer can approve the file with a signature or equivalent authorization.
Best practices
- Check the SoC against the exact ink grade and revision, not a family name or legacy document.
- Treat missing CAS numbers, missing concentrations, or an outdated effective date as a document deficiency until corrected.
- Verify that the migration claim matches the real use case, including substrate, curing method, food type, and whether the print is direct or indirect contact.
- Flag any reliance on a functional barrier unless the barrier performance and process controls are documented in the file.
- Review residual solvents and volatile components separately from intentionally added substances, since they often drive hidden risk.
- Photograph or attach supplier evidence when a non-conformance is identified so the approval trail is auditable later.
- Do not release the material on the basis of a generic compliance statement if the supporting test data or rationale is absent.
What this template typically catches
Issues teams running this template most often surface in practice:
Common use cases
Frequently asked questions
What is this template used for?
This template is used to review a printing ink Statement of Composition before the ink is approved for food-packaging applications. It helps confirm the supplier’s declaration is complete, the migration claim matches the intended use, and restricted substances have been screened. The output is a documented approval or a recorded non-conformance with corrective action.
Does this apply to direct food contact and indirect food contact packaging?
Yes, the template is structured to cover both direct and indirect food-contact packaging use when the ink could affect the packaged food. It prompts you to confirm whether a functional barrier or process control is relied on, since that changes the compliance rationale. If the ink is only used on outer packaging with no food-contact risk, you can still use the review but narrow the compliance statement accordingly.
How often should this review be performed?
Use it before first approval of a new ink, and again whenever the supplier issues a revised Statement of Composition, changes raw materials, or updates the migration declaration. It should also be repeated if the intended packaging structure, curing process, or food-contact claim changes. Many teams treat it as a gate before material release rather than a one-time file review.
Who should complete the review?
A quality, regulatory, packaging, or compliance reviewer should complete it, ideally someone who understands food-contact risk and supplier documentation. In some organizations, the reviewer may be a competent person from QA or technical services with sign-off from regulatory affairs. The key is that the reviewer can judge whether the SoC, migration support, and restricted-substance screening are sufficient for the intended use.
What standards or regulations does it align with?
The template is designed around food-packaging compliance expectations and supplier documentation control, including Swiss Ordinance substance restrictions where applicable. It also supports broader food-contact and quality-system review practices used under FDA food-contact expectations, EU-style migration controls, and ISO 9001 document control. You should adapt the acceptance criteria to the regulations that govern your market and packaging route.
What are the most common mistakes this review catches?
Common issues include an outdated SoC, missing CAS numbers for intentionally added substances, vague migration language that does not match the actual packaging use, and no support for a functional barrier claim. Reviewers also catch undeclared residual solvents, restricted substances that were not screened against the applicable list, and approvals granted without test data or a documented technical rationale. These are the kinds of gaps that can turn into a non-conformance later.
Can I customize this template for different inks or packaging lines?
Yes, and you should. Add fields for ink type, substrate, curing method, print process, food type, and whether the packaging is primary, secondary, or tertiary. You can also tailor the restricted-substance checklist to your market, supplier approval workflow, and any internal limits for residual solvents or volatile components.
How does this compare with an ad-hoc email approval process?
An ad-hoc email approval often leaves out the exact basis for release, which makes it hard to defend later if a question arises about migration or restricted substances. This template forces a consistent walk-through of the supplier declaration, compliance claim, supporting evidence, and final disposition. That makes the approval easier to audit, easier to repeat, and less likely to miss a critical item.
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