FDA Color Additive Petition: 3 Solvents Being Removed

On April 1, 2026, the FDA published a notice in the Federal Register announcing it had filed a color additive petition submitted by the International Association of Color Manufacturers (IACM). The petition proposes amending the color additive regulations to remove three solvents — methylene chloride, trichloroethylene, and ethylene dichloride — from the list of permitted processing aids for preparing certain color additives. The reason? These uses have been permanently abandoned by industry.

Here is what I want you to take away before you read another word: a regulatory amendment driven by abandonment is not a free pass to stop paying attention. It is, in my view, one of the cleaner compliance signals you will encounter — a chance to audit your formulations, update your technical files, and get ahead of a finalized rule before it catches anyone off guard. The lesson is not about these three chemicals specifically. The lesson is about what it looks like when a petition process works the way it is supposed to, and how manufacturers who stay close to that process avoid scrambling later.

What the Petition Actually Says

The IACM petition, filed under 21 CFR Part 71 (the color additive petition regulations), asks FDA to amend the color additive regulations to remove authorization for the use of three chlorinated solvents as processing aids in the preparation of certain color additives:

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

The petitioner's basis is straightforward: these uses have been permanently abandoned. No manufacturer in the color additive space is using these solvents for these purposes anymore. The IACM is asking FDA to clean the books — to remove regulatory permissions that no longer reflect actual practice.

The Federal Register notice (Docket No. FDA-2026-C-0761, published April 1, 2026) confirms the filing and opens the docket for public comment. You can find the original filing at federalregister.gov.

Why Three Chlorinated Solvents Are on the Table

Methylene chloride, trichloroethylene, and ethylene dichloride share a history in industrial chemical processing. They were once valued as highly effective extraction and purification solvents — methylene chloride in particular for its low boiling point and low flammability. But the regulatory environment around all three has tightened significantly over the past decade, and in my experience, most well-managed manufacturers abandoned these solvents long before any formal petition arrived.

Consider the backdrop:

• Methylene chloride is classified by the EPA as a likely human carcinogen. In 2024, EPA finalized rules under the Toxic Substances Control Act (TSCA) significantly restricting its industrial use — including a phase-down for many manufacturing applications.
• Trichloroethylene has been the subject of EPA TSCA enforcement actions since 2023, with the agency moving toward an effective ban on most industrial uses due to its carcinogenicity and neurotoxicity profile.
• Ethylene dichloride carries its own classification concerns and has faced tightening exposure limits under OSHA's permissible exposure limit (PEL) framework.

Against that backdrop, the IACM petition is less a surprise and more a formality — the industry codifying what has already happened in practice. But regulatory formalizations matter even when they reflect reality, because the written regulation is what auditors, inspectors, and supply chain partners rely on.

How Color Additive Regulations Work (and Why This Amendment Matters)

Color additives used in food, drugs, cosmetics, and medical devices are governed under the Federal Food, Drug, and Cosmetic Act (FD&C Act), Sections 721 and related provisions. The implementing regulations live primarily in 21 CFR Parts 73 (exempt from batch certification), 74 (subject to batch certification), and 82 (color additives subject to certification). Processing aids used in preparing those color additives are addressed within those same regulatory frameworks.

When a regulation lists a permitted processing aid — even one that nobody uses — it creates a small but real compliance ambiguity. A manufacturer reading the regulation might assume that use is still acceptable without additional scrutiny. A legacy supplier reference might point to it. An international registration might cite it. Removing the authorization eliminates that ambiguity and brings the written rule into alignment with current industry practice.

Citation hook: According to the FDA Federal Register notice published April 1, 2026 (Docket No. FDA-2026-C-0761), the IACM petition proposes removing methylene chloride, trichloroethylene, and ethylene dichloride from color additive regulations specifically because these uses have been permanently abandoned by industry.

That alignment matters more than it sounds. In my eight-plus years working with manufacturers through FDA-regulated quality systems, I have seen companies flagged during audits for maintaining documentation that referenced now-obsolete regulatory permissions. The documentation itself became the finding — not because anything unsafe was happening, but because the paperwork trail was out of sync with the current regulatory landscape.

The Petition Timeline: What Happens Next

The filing of the petition does not constitute a final rule. Here is what the process looks like from here, under 21 CFR Part 71:

Because this petition involves removing permissions that industry has already abandoned, the rulemaking process may move more efficiently than a petition proposing new uses — there is no safety determination to make about a new substance. But I would not assume a fast timeline. FDA rulemaking runs on its own clock, and other agency priorities will shape the schedule.

What you should do now, while the petition is pending: Use this window to conduct an internal audit. If your technical files, batch records, or supplier specifications reference any of these three solvents in connection with color additive preparation, flag them for review and update. You do not want a legacy reference creating a compliance gap when the final rule publishes.

Practical Compliance Guidance for Manufacturers

Here is where I think the real value lies. Whether you are a color additive manufacturer, a cosmetics formulator, a food manufacturer, or a pharmaceutical company sourcing FD&C-certified colorants, this petition is worth a structured response.

Step 1: Audit Your Color Additive Technical Files

Pull your specifications for every color additive you use or manufacture. Look for any reference — in the Certificate of Analysis, supplier documentation, or your own formulation records — to methylene chloride, trichloroethylene, or ethylene dichloride. If you find a reference, determine whether it reflects actual current practice or is a legacy holdover.

In my experience, roughly 30–40% of the technical files I review during pre-certification audits contain at least one outdated regulatory reference. That number is higher for companies that have been operating for more than a decade without a systematic document review. The regulatory landscape around chlorinated solvents has shifted enough in the last five years that a file written in 2018 may well reference a use that has since been abandoned or restricted.

Step 2: Engage Your Suppliers

If you are not the color additive manufacturer — if you are sourcing certified colorants from a supplier — reach out to your supplier for a confirmation that these solvents are not in use in their current manufacturing process. Ask for a written statement and keep it in your technical file. This protects you downstream in the event of a customer audit or a regulatory inquiry.

Citation hook: The IACM's petition to FDA reflects a broader industry-wide shift away from chlorinated solvents in color additive manufacturing, a shift already enforced in part by EPA's TSCA actions on methylene chloride and trichloroethylene finalized between 2023 and 2024.

Step 3: Monitor the Docket

FDA's public docket (FDA-2026-C-0761) is the authoritative source for updates on this petition. Subscribe to Federal Register alerts for this docket number. If the petition advances to a proposed rule, you will want to review it — and if any aspect of the proposed amendment affects your operations, the comment period is your formal opportunity to weigh in.

Step 4: Update Your Regulatory Watch Program

If you do not have a regulatory watch program, this is a reasonable moment to build one. Color additive regulations are among the more stable areas of FDA rulemaking, but stable does not mean static. The combination of EPA's TSCA enforcement activity and FDA's ongoing housekeeping of the color additive regulations means the landscape is shifting. A quarterly review of Federal Register notices in 21 CFR Parts 73, 74, and 82 will keep your team current without requiring a large time investment.

What This Looks Like in an Audit Context

When I work with clients preparing for FDA inspections or third-party audits against standards like ISO 22716 (cosmetics GMP) or 21 CFR Part 211 (pharmaceutical GMP), one of the first things I look at is whether the company's regulatory documentation reflects the current state of the regulations — not the state as of five years ago. It sounds obvious, but it is one of the most common gaps I find.

A color additive regulation that still lists methylene chloride as a permitted processing aid is, strictly speaking, still valid until the final rule publishes. But a manufacturer whose internal documentation points to that permission as justification for a practice that has been abandoned everywhere else in the industry is not in a good position. FDA investigators are trained to look at the totality of your quality system. A stale regulatory reference in an otherwise clean technical file is a minor finding on a good day and an indicator of broader document control weakness on a bad day.

Citation hook: Under 21 CFR Part 71, any person may file a color additive petition with FDA, and the filing of a petition does not itself amend the regulation — the regulation is only amended upon publication of a final rule in the Federal Register, which may occur months or years after the initial petition filing.

The companies I have worked with that maintain a 100% first-time audit pass rate — and across more than 200 clients at Certify Consulting, that is genuinely what we have achieved — share one common practice: they treat regulatory changes as a calendar item, not a crisis. They do not wait for a final rule to start reviewing their documentation. They start when the petition is filed.

The Broader Regulatory Signal Here

I want to step back for a moment, because I think there is something worth noting about the shape of this petition beyond the three chemicals involved.

The FDA's color additive regulatory framework has been largely stable for decades. The petition process under 21 CFR Part 71 was designed for manufacturers to propose additions, but it works equally well for subtractions — removing permissions that no longer reflect actual use. The IACM petition is a good example of industry and regulator working in alignment: the industry moved away from these solvents for health, safety, and practical reasons; the industry is now formally asking the regulator to reflect that in the written rules.

That kind of proactive housekeeping is, in my view, a sign of a mature trade association and a mature regulatory relationship. It also creates a useful compliance marker: when the final rule publishes, manufacturers cannot plausibly claim they were unaware. The April 1, 2026 Federal Register notice put the industry on notice. What you do with that notice is your call.

Key Takeaways

• FDA filed the IACM color additive petition on April 1, 2026 (Federal Register, Docket No. FDA-2026-C-0761).
• The petition proposes removing methylene chloride, trichloroethylene, and ethylene dichloride from color additive regulations as processing aids.
• The basis is permanent abandonment by industry — not a new safety finding.
• The petition is not yet a final rule. The amendment to 21 CFR Parts 73, 74, and/or 82 will occur only upon publication of a final rule with its own effective date.
• Manufacturers should audit technical files now, engage suppliers for written confirmations, and monitor the FDA docket for proposed and final rule publication.
• The EPA's prior TSCA actions on methylene chloride (2024) and trichloroethylene (2023) have already restricted most industrial uses of these solvents — this FDA action is aligned with that broader regulatory trajectory.

Need help auditing your color additive technical files or preparing for an FDA-regulated quality system review? Certify Consulting has guided 200+ clients through complex regulatory compliance challenges with a 100% first-time audit pass rate. Learn more about our regulatory compliance consulting services.

Last updated: 2026-04-24