Compliance Alert: On April 1, 2026, FDA published a color additive petition (CAP 5C0340, Docket No. FDA-2026-C-3071) filed by the International Association of Color Manufacturers. The petition proposes removing methylene chloride, trichloroethylene, and ethylene dichloride from several color additive listings that cover food-grade colorants used in medical devices. Comments are due June 1, 2026. If your device uses annatto extract, paprika oleoresin, or turmeric oleoresin as a colorant — or inks for device marking — your supplier qualification records may be at risk.
The Real Risk: Supplier Specifications That Reference Regulatory Authority You No Longer Have
Most medical device quality managers do not think of color additive petitions as their problem. That is exactly the gap this article addresses.
Here is the scenario that creates audit exposure: your device uses a natural colorant — say, turmeric oleoresin — for catheter color-coding or component marking. Your supplier's specification sheet lists extraction solvents consistent with the current version of 21 CFR 73.615. That specification becomes part of your approved supplier record under ISO 13485:2016 Section 7.4. If the regulation is amended to remove those solvents, the specification no longer reflects a currently authorized process. Your device is now colored with a substance whose regulatory basis has been modified — and your supplier record has not caught up.
Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), a device is adulterated if it contains a color additive that is not listed for its intended use. That is not a theoretical risk. It is the compliance standard written into the statute.
The IACM petition filed with FDA on March 20, 2026 — published in the Federal Register on April 1, 2026 — proposes exactly this type of change to four regulations. The comment window closes June 1, 2026. That deadline matters because it is your window to inform FDA of the device industry's stake in this rulemaking before the agency acts.
What FDA Filed: Petition CAP 5C0340
The International Association of Color Manufacturers (IACM) submitted a color additive petition to FDA, designated as Petition Number CAP 5C0340, filed by FDA on March 20, 2026, and published in the Federal Register on April 1, 2026 as Document No. 2026-06295 under Docket No. FDA-2026-C-3071.
The petition's legal theory is straightforward: these solvent uses have been permanently abandoned by industry. IACM surveyed its own members as well as members of three other industry associations — the American Spice Trade Association (ASTA), the Flavor and Extract Manufacturers Association (FEMA), and the Natural Food Colors Association (NATCOL) — and found no ongoing commercial use of these solvents in the extraction of the covered colorants. Because no manufacturer currently uses them, continuing to list them serves no practical purpose and potentially creates confusion about what processes are authorized.
This is a different legal basis from the parallel petition filed by the Environmental Defense Fund (EDF) in January 2024 (Federal Register 2024-00410), which sought removal on safety grounds under the Delaney Clause (FD&C Act Section 721(b)(5)(B)). Both petitions are now simultaneously active and both target the same three solvents. The IACM petition does not make safety arguments — it argues the uses are simply gone from commerce.
The practical effect of approval, however, is the same regardless of which legal theory prevails: the solvents would be removed from the applicable listings, and any product manufactured using a process that relies on those listings would face adulteration risk.
The Three Solvents: Why Their Removal Is Significant
Understanding what these solvents are — and why their removal matters beyond color additive chemistry — is important context for quality and regulatory teams.
Methylene Chloride (Dichloromethane / DCM)
Methylene chloride is a chlorinated solvent with a well-documented hazard profile. The EPA classified it as a probable human carcinogen, and FDA banned it from consumer paint strippers in 2019 following documented fatalities. The Occupational Safety and Health Administration (OSHA) maintains a permissible exposure limit of 25 ppm as an 8-hour time-weighted average. Despite these restrictions in consumer contexts, methylene chloride remained listed as a permitted extraction solvent in several food color additive regulations and as a permitted diluent in inks used for marking fresh fruits and vegetables under 21 CFR 73.1.
Its presence in color additive regulations has long been an anomaly given its status under other regulatory frameworks. The IACM petition provides a mechanism to eliminate that anomaly without requiring FDA to make a new safety determination — because the industry survey data shows the use has already ended.
Trichloroethylene (TCE)
Trichloroethylene carries one of the most severe hazard classifications of any industrial solvent still in common commercial circulation. The National Toxicology Program classifies it as a known human carcinogen. The EPA has progressively restricted its uses over the past decade, and in 2023 proposed to ban most remaining industrial uses under the Toxic Substances Control Act (TSCA). Kidney cancer and non-Hodgkin's lymphoma are among the malignancies associated with TCE exposure in occupational settings.
That TCE ever appeared in food color additive regulations reflects the era in which those regulations were written — before modern carcinogenicity classification standards were developed. Removing it from 21 CFR 73.30, 73.345, and 73.615 is an alignment with where the rest of the regulatory framework has moved.
Ethylene Dichloride (1,2-Dichloroethane)
Ethylene dichloride is a halogenated solvent used historically in fumigation and chemical synthesis. Multiple agencies have identified carcinogenic properties, and its use in food-contact applications has declined sharply as safer alternatives have become available. Like the other two solvents, the IACM's industry survey found no active commercial use in the extraction of the covered colorants.
The Regulations at Stake: Four Amendments Proposed
The petition proposes amendments to four sections of Title 21 of the Code of Federal Regulations. Each amendment would remove one or more of the three solvents from the list of permitted substances.
21 CFR 73.30 — Annatto Extract
Annatto extract is derived from the seeds of Bixa orellana and produces yellow to orange hues. It is used as a colorant in a range of food products and, where color-coding is relevant, in device applications. The current regulation at 21 CFR 73.30 permits extraction using methylene chloride, trichloroethylene, and ethylene dichloride, among other solvents. The petition proposes removing all three from the list of permitted extraction solvents.
21 CFR 73.345 — Paprika Oleoresin
Paprika oleoresin is an oily extract of dried red peppers, producing orange to red tones. 21 CFR 73.345 currently permits its extraction using the same three solvents. The petition proposes removing methylene chloride, trichloroethylene, and ethylene dichloride from the permitted extraction solvent list for paprika oleoresin.
21 CFR 73.615 — Turmeric Oleoresin
Turmeric oleoresin, derived from Curcuma longa, produces yellow hues and is commonly used in device applications requiring a visible, stable colorant. 21 CFR 73.615 currently permits extraction using the same three solvents. The petition proposes removing all three from the permitted list.
21 CFR 73.1 — Color Additive Mixtures in Inks
This section covers color additive mixtures used in inks for marking fresh fruits, vegetables, and similar products. 21 CFR 73.1 currently permits methylene chloride as a permitted diluent. The petition proposes removing methylene chloride from the list of permitted diluents for inks in this application. This is a narrower amendment than the three oleoresin changes, but it is notable because marking inks for device components and packaging may share similar formulation chemistry with food-grade marking inks.
Why Medical Device Manufacturers Must Pay Attention
The connection between food-grade color additive regulations and medical devices is not intuitive — but it is codified in statute and regulation.
Under the FD&C Act and FDA's implementing regulations at 21 CFR Parts 73, 74, 81, and 82, the color additive regulatory framework applies to food, drugs, cosmetics, and medical devices. FDA's Biocompatibility Assessment Resource Center includes a dedicated page on color additives for medical devices, confirming that these regulations are not food-only. A device is considered adulterated under FD&C Act Section 501(a)(4) if it bears or contains a color additive that is unsafe as defined by Section 721 — meaning one that is not listed for its intended use under an applicable regulation.
Color additives appear in medical devices in several common applications:
- Catheter color-coding: Different lumen sizes or functional categories are distinguished by color, often using food-grade colorants approved for medical device use
- Suture identification: Absorbable and non-absorbable sutures are color-coded using listed colorants
- Device component marking: Connectors, ports, and tubing use color-coded systems that rely on listed colorants
- Packaging inks: Inks used to print on device packaging or directly on devices may use formulations that incorporate listed colorants
- Diagnostic test components: Lateral flow assay components and reagent cartridges use colorants for visual readout systems
- Implantable device labeling: Where colorants are incorporated into implantable device materials, they must be listed for such use
If your device uses annatto extract, paprika oleoresin, or turmeric oleoresin as a colorant — directly or through a component supplier — and if your supplier's current extraction process uses any of the three solvents being targeted by this petition, the approval of this petition would require you to re-verify supplier conformance, update your material specifications, and potentially re-qualify the supplier under your ISO 13485 purchasing controls.
The risk compounds when you consider multi-tier supply chains. Your direct supplier may not use these solvents, but their raw material supplier might. Your approved supplier specification may not go deep enough to capture that exposure.
The ISO 13485 Angle: Supplier Control and Regulatory Monitoring
ISO 13485:2016 creates specific obligations that are directly implicated by regulatory changes to material specifications.
Section 7.2.1 — Customer-Related Processes and Regulatory Requirements
ISO 13485:2016 Section 7.2.1 requires that the organization identify applicable regulatory requirements related to the product. This is not a static exercise — it is a living obligation. When FDA proposes to amend the regulatory basis for a material used in your product, that amendment is an applicable regulatory requirement you must track. A petition that could remove the authorization for your colorant's extraction process is the type of regulatory activity that should trigger a review under your regulatory change management procedure.
Section 7.4 — Purchasing
ISO 13485:2016 Section 7.4 and its subsections impose requirements on purchasing controls, supplier evaluation, and verification of purchased product. The key compliance point here is this: your approved supplier list is only as good as the regulatory authority underlying it. If your supplier's colorant is extracted using a process that was once listed but is subsequently removed from the applicable regulation, your supplier approval — and the materials you are purchasing — have changed regulatory status. Your supplier qualification record should reflect current regulatory authorization, not historical authorization.
Auditors under both ISO 13485 certification audits and FDA QMSR inspections look at whether purchasing controls extend to verifying that suppliers conform to applicable regulatory requirements. "Applicable regulatory requirements" includes the current state of color additive listings, not just the state at the time of initial qualification.
FDA QMSR Alignment
The FDA Quality Management System Regulation (QMSR), effective February 2026, aligns 21 CFR Part 820 with ISO 13485:2016. This means that the supplier control obligations that ISO 13485-certified manufacturers know from their certification audits are now also the standard for FDA QMSR inspections. A gap in color additive regulatory tracking that generates a nonconformity finding in an ISO 13485 audit may now simultaneously constitute an observation under a QMSR inspection. The stakes of maintaining current supplier qualification records have increased.
Document Control Implications
If this petition succeeds, it will require a round of document control activity across quality systems that use the affected colorants: updating material specifications, revising approved supplier qualification records, and potentially triggering change control procedures if the reformulation results in a material change to the device. The time to map that exposure is now — before FDA acts — not after.
Practical Compliance Action Steps
The following steps give your quality and regulatory teams a concrete response plan, regardless of whether you believe this petition will be approved. Regulatory uncertainty itself requires management.
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Inventory all color additives used in your device portfolio. Pull a complete list of colorants used in device components, materials, inks, and packaging. Flag any use of annatto extract, paprika oleoresin, or turmeric oleoresin. Include indirect uses through component suppliers.
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Review current supplier specifications against the applicable CFR listing. For each flagged colorant, obtain and review your supplier's current technical specification, Safety Data Sheet, and any Certificates of Analysis. Identify whether extraction solvents are documented and whether those solvents align with the current listing requirements at 21 CFR 73.30, 73.345, or 73.615.
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Survey your supply chain beyond your direct suppliers. Issue a questionnaire to direct color additive suppliers asking whether their supply chain — including their raw material suppliers — uses methylene chloride, trichloroethylene, or ethylene dichloride in extraction processes. Document the responses as part of your supplier qualification record.
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Log this petition as an open regulatory change item. Add FDA Docket No. FDA-2026-C-3071 to your regulatory change management log. Assign an owner, set a monitoring cadence, and establish a decision trigger: if the petition is approved, initiate supplier re-qualification review within 30 days.
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Evaluate whether to submit a comment. If your organization uses any of the affected colorants, you have standing to submit a comment to FDA before June 1, 2026. Comments that provide data on device-specific uses of these colorants — extraction methods, supplier practices, quantity of use — are the type of information FDA weighs when evaluating the petition's scope. If you have relevant data, submit it. See the section below for how.
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Brief your design and engineering teams on marking ink implications. The amendment to 21 CFR 73.1 targeting methylene chloride as a diluent in marking inks has implications beyond food products. Review whether any device inks — for direct device marking, component identification, or packaging printing — use formulations that reference methylene chloride as a diluent. Coordinate with your ink suppliers to confirm current formulation status.
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Update your regulatory monitoring procedure to cover color additive petitions. Your regulatory monitoring SOP should explicitly include FDA Federal Register notices for color additive petitions under 21 CFR Parts 73, 74, 81, and 82 as a monitoring category. This petition is a demonstration that color additive rulemaking is not food-only and should be tracked by device quality teams.
The Comment Period: How to Participate
FDA is actively soliciting public comment on Petition CAP 5C0340 before taking action. The comment period is open through June 1, 2026 at 11:59 p.m. Eastern Time.
Comments must be submitted electronically via regulations.gov using Docket No. FDA-2026-C-3071. The docket is publicly accessible and allows both organizations and individuals to submit comments.
The types of comments that carry the most weight in FDA color additive petition proceedings include:
- Data on current or historical use of the affected solvents in the extraction of annatto extract, paprika oleoresin, or turmeric oleoresin — particularly if you have evidence that contradicts the IACM survey findings
- Device-specific use information, including the types of devices that use these colorants, the quantity used, and the regulatory basis relied upon
- Supply chain transparency data, if you have documented evidence about extraction practices at the raw material level that FDA's review of the IACM survey may not capture
- Implementation timeline concerns, particularly if approval of the petition would require regulatory submissions, change control procedures, or supplier re-qualification that needs a defined transition period
- Comments on the parallel EDF petition, if you have views on the Delaney Clause safety analysis that EDF has advanced in FDA-2024-P-0327 (the related docket from January 2024)
If you are a medical device manufacturer that uses these colorants, your participation in this comment period informs FDA of the device sector's stake in the rulemaking. Agencies rely on public comment to understand the full scope of regulated industry when making petition decisions. Device manufacturers who do not participate forfeit their opportunity to shape the implementation.
Key Dates and Deadlines
| Date | Event |
|---|---|
| January 2024 | Environmental Defense Fund files parallel petition (Federal Register 2024-00410) on safety grounds under Delaney Clause |
| March 20, 2026 | FDA files IACM petition, CAP 5C0340, Docket No. FDA-2026-C-3071 |
| April 1, 2026 | Petition published in Federal Register, Document No. 2026-06295 |
| June 1, 2026 | Comment deadline — 11:59 p.m. Eastern Time via regulations.gov, Docket No. FDA-2026-C-3071 |
| TBD | FDA issues decision on petition (no statutory deadline; timing varies) |
| TBD + 30 days | Recommended internal trigger: initiate supplier re-qualification review if petition is approved |
Action required before June 1, 2026: Survey your color additive supply chain, log the petition in your regulatory change management system, and evaluate whether to submit a comment at regulations.gov under Docket No. FDA-2026-C-3071.
Proactive Compliance Is the Standard
Regulatory petitions are not events that happen to other industries. The IACM petition demonstrates that color additive rulemaking — which device quality teams often treat as a food-sector concern — carries direct implications for medical device adulteration status, supplier qualification, and ISO 13485 purchasing control obligations.
The compliance lesson from CAP 5C0340 is not that methylene chloride, TCE, and ethylene dichloride will definitely be removed from your colorant supplier's process — the petition may take months or years to resolve, and FDA may not approve it. The lesson is that your quality system should detect this type of regulatory change before it creates audit exposure, not after. A robust regulatory monitoring program catches color additive petitions the same way it catches device classification rule changes: early, assigned to an owner, with a response plan in place.
ISO 13485 Section 7.2.1 is not satisfied by knowing the regulations as they stood when you first qualified your supplier. It requires ongoing identification of applicable regulatory requirements — including the ones currently being reconsidered through the petition process at regulations.gov.
If your quality system does not currently include color additive regulatory monitoring as a tracked category, this petition is the signal to add it. If you are unsure whether your device portfolio has exposure to the affected regulations, the seven-step action plan above gives you the starting point for that assessment.
The comment window closes June 1, 2026. That is also a deadline for internal action — not just participation in the rulemaking, but completion of your exposure assessment and documentation of your monitoring protocol before the agency moves.
Frequently Asked Questions
Does the IACM petition (CAP 5C0340) apply to medical devices?
Yes. FDA color additive regulations under 21 CFR Parts 73, 74, 81, and 82 apply to food, drugs, cosmetics, and medical devices. A device containing a color additive is considered adulterated unless a regulation is in effect listing the color additive for the intended use. If the petition succeeds, any color additive extracted with methylene chloride, TCE, or ethylene dichloride would lose its listing authorization, creating adulteration risk for devices that use them.
What is the comment deadline for FDA Docket No. FDA-2026-C-3071?
The comment deadline is June 1, 2026 at 11:59 p.m. Eastern Time. Comments must be submitted electronically via regulations.gov using Docket No. FDA-2026-C-3071.
What regulations would change if the IACM petition is approved?
The petition proposes amending four regulations: 21 CFR 73.30 (Annatto extract), 21 CFR 73.345 (Paprika oleoresin), and 21 CFR 73.615 (Turmeric oleoresin) — each to remove methylene chloride, trichloroethylene, and ethylene dichloride as permitted extraction solvents — and 21 CFR 73.1 to remove methylene chloride as a permitted diluent in inks for marking fruits and vegetables.
What ISO 13485 sections are implicated by changes to color additive regulations?
ISO 13485:2016 Section 7.2.1 requires manufacturers to identify applicable regulatory requirements. Section 7.4 requires purchasing controls that verify supplier conformance with current regulatory requirements. The FDA QMSR (effective February 2026) aligns these obligations with ISO 13485. A device manufacturer whose color additive supplier loses regulatory authorization faces potential nonconformity findings under both frameworks.
What is the difference between the IACM petition and the earlier EDF petition?
The Environmental Defense Fund filed a parallel petition in January 2024 (Federal Register 2024-00410) seeking removal of these same solvents on safety grounds under the Delaney Clause (FD&C Act Section 721(b)(5)(B)). The IACM petition (CAP 5C0340) takes a different legal basis: permanently abandoned use. Industry surveys from IACM members plus the American Spice Trade Association, Flavor and Extract Manufacturers Association, and Natural Food Colors Association support the claim that these solvents are no longer used in practice. Both petitions are now simultaneously active.
Last updated: 2026-04-03
Jared Clark, JD, MBA, PMP, CMQ-OE, CPGP, CFSQA, RAC is Principal Consultant at Certify Consulting. With 8+ years of regulatory and quality management experience and a 100% first-time audit pass rate across 200+ clients, Jared provides practical compliance guidance for medical device and pharmaceutical manufacturers. For support with color additive supplier qualification, regulatory monitoring programs, or ISO 13485 implementation, contact Certify Consulting.
Jared Clark
Principal Consultant, Certify Consulting
Jared Clark is the founder of Certify Consulting, helping organizations achieve and maintain compliance with international standards and regulatory requirements.