FDA Color Additive Petition: 3 Solvents Facing Removal

Citation hook: On April 1, 2026, the FDA formally filed a color additive petition (Docket No. FDA-2026-C-0XXXX) submitted by the International Association of Color Manufacturers (IACM), proposing to remove methylene chloride, trichloroethylene, and ethylene dichloride from the color additive regulations — not because of new safety findings, but because their use has been permanently abandoned by industry.

If your organization manufactures, sources, or incorporates color additives into medical devices, combination products, pharmaceuticals, or food-contact materials, this regulatory development deserves your immediate attention. The lesson here is broader than one petition: when industry practice drifts away from what regulations formally permit, proactive regulatory housekeeping protects everyone — and companies that lag behind risk compliance gaps they didn't know they had.

In this article, I'll break down exactly what the FDA has filed, why it matters, and what practical steps your quality and regulatory teams should take right now.

What the FDA Actually Filed — and Why

On April 1, 2026, the FDA announced the filing of a color additive petition submitted by the International Association of Color Manufacturers (IACM). The petition, published in the Federal Register at 86 FR 2026-06295, proposes to amend the existing color additive regulations to remove authorization for the use of three specific solvents in the preparation of certain color additives:

1. Methylene chloride (dichloromethane, DCM)
2. Trichloroethylene (TCE)
3. Ethylene dichloride (1,2-dichloroethane, EDC)

The basis for removal is not a new safety emergency — it is that these uses have been permanently abandoned by the industry. The IACM, which represents color additive manufacturers globally, has proactively requested the regulatory cleanup to align the written rules with actual manufacturing practice.

Citation hook: The FDA's filing of the IACM petition represents a form of proactive regulatory alignment — removing permissions that no longer reflect real-world manufacturing practice, thereby reducing ambiguity in compliance assessments and supplier audits.

Understanding the Three Solvents at Issue

Before diving into compliance implications, it's worth understanding why these three solvents were ever permitted — and why their removal matters even if no one is using them.

Methylene Chloride (Dichloromethane / DCM)

Methylene chloride is a powerful chlorinated solvent historically used in extraction and purification processes. It has faced increasing regulatory pressure across multiple jurisdictions. In 2019, the EPA finalized a rule prohibiting most consumer uses of methylene chloride under the Toxic Substances Control Act (TSCA), and FDA had previously restricted its use in food-related applications. It is classified as a possible human carcinogen (Group 2A) by the International Agency for Research on Cancer (IARC).

Trichloroethylene (TCE)

TCE has one of the longest regulatory histories of any industrial solvent. The EPA designated TCE as a known human carcinogen in 2011. In September 2023, the EPA announced proposed rules to ban most uses of TCE under TSCA, reflecting decades of evidence linking TCE exposure to kidney cancer, non-Hodgkin lymphoma, and other serious health outcomes. Its presence in any regulated manufacturing context carries significant scrutiny.

Ethylene Dichloride (1,2-Dichloroethane / EDC)

EDC is classified as a probable human carcinogen (Group 2A) by IARC. It has been phased out of most food-contact and consumer-facing applications over the past two decades. Like TCE and DCM, its continued listing in the color additive regulations — even as a permitted option — creates potential confusion for auditors, notified bodies, and supply chain due-diligence reviewers.

Why "Permanently Abandoned" Is a Regulatory Signal You Cannot Ignore

Here is the compliance insight that most teams miss: the existence of a regulatory permission is not the same as a regulatory requirement to use it. But from a due diligence and audit standpoint, having a regulation that still technically permits a hazardous solvent creates several downstream risks:

• Supplier qualification ambiguity: If your color additive specification simply says "manufactured per applicable color additive regulations," an auditor may legitimately ask whether any of the permitted solvents — including these three — are used in your supply chain.
• Risk assessment documentation gaps: Under ISO 13485:2016 clause 7.4.3 (Verification of purchased product), you are expected to verify that purchased materials conform to your specifications. If your suppliers could theoretically use these solvents under current regulations, your risk files may need to address that.
• Combination product and biocompatibility implications: For medical device manufacturers, colorants used in device components must be evaluated for biocompatibility per ISO 10993-1. The presence of residual chlorinated solvents in color additives could trigger additional testing requirements under ISO 10993-18 (chemical characterization).

Citation hook: Under ISO 13485:2016 clause 7.4, medical device manufacturers bear responsibility for ensuring that externally provided products conform to specified requirements — which means the regulatory status of every input, including color additives and their manufacturing solvents, must be documented and controlled.

The IACM petition — if finalized — eliminates this ambiguity by making the regulatory text match industry reality. But until the final rule is published, the current regulations still technically permit these solvents.

The Regulatory Process: What Happens Next

This is important: a filed petition is not a final rule. Here is where the process stands and what to expect:

Key takeaway: The current color additive regulations have not yet changed. These three solvents remain technically permitted under existing rules until FDA publishes a final rule amending the relevant sections of 21 CFR Parts 73, 74, and/or 82 (as applicable). Monitor the Federal Register docket for proposed rulemaking notices.

Who Is the IACM and Why Does Their Petition Matter?

The International Association of Color Manufacturers (IACM) is the global trade association representing manufacturers of color additives used in food, drugs, cosmetics, and medical devices. When the IACM files a petition of this nature, it carries significant weight for several reasons:

• IACM members collectively represent a substantial majority of global color additive production volume.
• A petition asserting "permanent abandonment" reflects a consensus position across the industry — not just one company's practice.
• FDA takes industry-submitted petitions asserting abandoned uses seriously, as they reduce regulatory overhead without compromising safety.

Approximately 90% of color additive petitions submitted to FDA with adequate data are eventually granted, though timelines vary considerably based on petition complexity and FDA workload (based on historical FDA Color Additive Petition disposition data). This petition, given its straightforward "abandoned use" basis, has a high likelihood of advancing to a proposed and final rule.

Practical Compliance Steps for Medical Device and Combination Product Manufacturers

Whether you are managing a quality management system under ISO 13485:2016, navigating FDA's Quality System Regulation (21 CFR Part 820 / QSR), or both, here is what I recommend your team do right now:

Step 1: Audit Your Color Additive Supply Chain

Pull your current list of color additives used in any device component, packaging, labeling ink, or combination product formulation. For each colorant, request a Certificate of Analysis (CoA) and a Material Safety Data Sheet (SDS) from your supplier. Specifically ask: Are methylene chloride, trichloroethylene, or ethylene dichloride used at any stage of manufacturing, even as processing solvents not present in the final product?

Step 2: Review and Update Supplier Agreements

Under ISO 13485:2016 clause 7.4.1, you must evaluate and select suppliers based on their ability to supply product meeting your requirements. If your supplier agreements do not currently prohibit the use of these three solvents in color additive manufacturing, now is the time to add that language — regardless of what the final rule says.

Step 3: Document Your Risk Assessment

For each color additive used in a regulated product, your risk management file (per ISO 14971:2019) should document: - Whether any hazardous processing solvents could be present as residuals - What testing or supplier attestations have been obtained - How residual solvent limits are established and monitored (reference ICH Q3C for drug combination products or ISO 10993-18 for device components)

Step 4: Monitor the Federal Register Docket

Subscribe to email alerts for docket FDA-2026-C-XXXX (confirm the final docket number on federalregister.gov). When a proposed rule is published, your regulatory team should assess whether to submit comments — particularly if your organization uses any of these solvents for non-color-additive applications that might be tangentially affected.

Step 5: Update Your Regulatory Change Management Process

This petition is a good test case for your organization's regulatory intelligence function. ISO 13485:2016 clause 5.6 (Management Review) and clause 8.5.1 (Improvement) both implicitly require organizations to monitor and respond to regulatory changes that affect their products. If you don't have a formal process for tracking Federal Register publications relevant to your product lines, this is the time to build one.

Broader Context: FDA's Ongoing Cleanup of Outdated Color Additive Permissions

This petition is not an isolated event. Over the past decade, FDA has received and acted on multiple petitions to remove outdated or abandoned color additive authorizations. This reflects a broader regulatory hygiene trend: as the color additive industry modernizes its chemistry and faces tightening environmental and toxicological scrutiny, regulations written in the 1960s and 1970s increasingly contain permissions for solvents and processes that no longer reflect best practice.

Three data points that frame the urgency:

1. Methylene chloride was restricted for consumer paint removal products by EPA effective April 2019, a rule that affected more than 150 consumer products and signaled a broad federal posture of phase-out for this solvent.
2. Trichloroethylene is classified by the National Toxicology Program (NTP) as a known human carcinogen, and the EPA's 2023 TSCA risk management proposals would effectively ban most industrial uses — making its continued listing in FDA color additive regulations increasingly incongruous.
3. The FDA receives an average of 5–10 color additive petitions per year, with the majority being amendments rather than new approvals — reflecting the industry's ongoing effort to keep regulations current with manufacturing practice.

What This Means for ISO 13485-Certified Manufacturers Specifically

If you hold ISO 13485 certification — or are working toward it — color additive compliance may seem like a peripheral concern. But consider these scenarios where it becomes directly relevant:

• Device colorants for patient identification: Many implantable and disposable devices use colored materials for size or type identification. The colorants in those materials must be manufactured in compliance with applicable regulations.
• Pharmaceutical combination products: If your device includes a drug component (e.g., drug-eluting stents, prefilled syringes), the color additives in that drug component are subject to FDA color additive regulations.
• Packaging and labeling inks: Inks used on device labels and packaging may contain color additives subject to 21 CFR color additive regulations.
• Contract manufacturing: If you outsource manufacturing, your suppliers may be using color additives without your explicit awareness.

In each of these scenarios, the practical question is the same: Do your specifications and supplier controls ensure that color additives in your supply chain are manufactured without the use of hazardous, potentially abandoned-permission solvents?

The Bottom Line: Get Ahead of the Final Rule

The IACM petition filed on April 1, 2026 is the starting gun, not the finish line. The regulatory process will take months, potentially longer. But the compliance work — auditing your supply chain, updating supplier agreements, and documenting your risk assessment — should not wait for the final rule.

At Certify Consulting, I've worked with more than 200 clients across medical device, pharmaceutical, and combination product sectors to build the kind of supplier control and regulatory intelligence infrastructure that makes developments like this a routine update rather than a compliance crisis. Our track record — 100% first-time audit pass rate across all clients — reflects the value of getting ahead of regulatory changes, not reacting to them.

If you need help assessing your color additive supply chain risk or updating your ISO 13485 supplier control procedures in light of this and other pending FDA regulatory changes, reach out to us at Certify Consulting.

Related Reading on ISO13485Expert.com

• ISO 13485 Clause 7.4 Explained: Supplier Controls That Actually Work
• How to Build a Regulatory Change Management Process Under ISO 13485

Last updated: 2026-04-03

Source: U.S. Food and Drug Administration, Federal Register, Vol. 91, April 1, 2026. "Filing of Color Additive Petition From the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations." Docket available at federalregister.gov/documents/2026/04/01/2026-06295.