FDA Files Color Additive Petition to Remove 3 Solvents From Regulations

If your company manufactures, uses, or distributes color additives in FDA-regulated products, a quietly filed petition in April 2026 could have lasting compliance implications — even if it reads like a routine housekeeping update.

On April 1, 2026, the U.S. Food and Drug Administration (FDA) announced the filing of a color additive petition submitted by the International Association of Color Manufacturers (IACM). The petition proposes amending existing color additive regulations to formally remove three solvents — methylene chloride, trichloroethylene, and ethylene dichloride — from the list of permitted processing solvents used in the preparation of certain color additives. The stated basis: these uses have been permanently abandoned by the industry.

Published in the Federal Register on April 1, 2026 (Docket No. FDA-2026-C-0001, Document No. 2026-06295), this filing marks the beginning of a formal rulemaking process that will ultimately amend the regulations codified at 21 CFR Part 73 (for exempt color additives) and/or 21 CFR Part 74 (for certified color additives), depending on the scope of the final rule.

This article breaks down what changed, why it matters, and what practical steps regulated companies should take now.

What the IACM Petition Actually Proposes

The International Association of Color Manufacturers represents manufacturers and suppliers of color additives used in food, drugs, cosmetics, and medical devices. By petitioning FDA under 21 CFR § 71.1, IACM is formally requesting that the agency amend its color additive regulations to eliminate provisions that currently permit the use of three chlorinated solvents in the manufacturing process for certain color additives:

The IACM's petition rests on a straightforward legal and practical argument: if an authorized use has been permanently abandoned, there is no longer a public health or commercial justification for retaining it in the regulatory text. In fact, maintaining abandoned-use authorizations in CFR creates unnecessary ambiguity for manufacturers, importers, and auditors trying to assess current compliance boundaries.

Why "Permanent Abandonment" Is a Valid Basis for Regulatory Amendment

Under the Federal Food, Drug, and Cosmetic Act (FD&C Act), specifically 21 U.S.C. § 379e, color additives may only be used in accordance with a regulation prescribing the conditions of safe use. When an industry voluntarily and permanently stops using a particular substance in a particular way, retaining that authorization in the CFR is not neutral — it can create compliance confusion, regulatory ambiguity, and unnecessary exposure to scrutiny.

Citation hook: Under 21 CFR § 71.1, any person may file a color additive petition with FDA proposing the issuance, amendment, or repeal of a regulation pertaining to a color additive — including proposals to remove authorizations for permanently abandoned uses.

The IACM's petition is a proactive regulatory hygiene measure. By formally requesting removal rather than simply relying on non-use, the industry is reducing the risk that future auditors, regulators, or trading partners misinterpret existing CFR text as a live authorization for processes that no longer occur and should not occur.

This approach is particularly significant given the heightened scrutiny these three chemicals now face across multiple federal programs:

• Methylene chloride was the subject of a 2024 EPA final rule under TSCA Section 6(a) that banned most consumer uses and is now subject to strict occupational exposure limits.
• Trichloroethylene faced EPA's proposed TSCA Section 6 risk management rule, which would prohibit or severely restrict virtually all uses — a significant regulatory development still unfolding at the time of this writing.
• Ethylene dichloride continues to be scrutinized under EPA's ongoing TSCA risk evaluation program.

What This Means for FDA-Regulated Color Additive Users

1. No Immediate Prohibition — But Rulemaking Is Underway

The April 1, 2026 Federal Register notice is a filing announcement, not a final rule. FDA has accepted the petition for review, which triggers a formal regulatory process. The agency will:

1. Review the petition for completeness and scientific basis
2. Publish a proposed rule (with a public comment period)
3. Evaluate comments and publish a final rule
4. Specify an effective date for the amended regulation

This process typically takes 12 to 36 months from the date of petition filing, depending on the complexity of the rulemaking and the volume of public comments received. There is no emergency interim prohibition triggered by this filing alone.

However, companies that are still using any of these three solvents in color additive manufacturing should treat this filing as a strong regulatory signal to accelerate reformulation and substitution planning.

2. Which Products Are Affected?

The petition targets solvents used in preparing certain color additives — a category that spans a wide range of finished product applications, including:

• Foods and beverages (color additives regulated under 21 CFR Parts 73 and 74)
• Drug products (color additives in dosage forms, coatings, and topical preparations)
• Cosmetics (colorants used in personal care and beauty products)
• Medical devices (where applicable color additive regulations apply)

If your supply chain includes color additive manufacturers — even upstream suppliers — you have a direct compliance interest in this rulemaking.

3. Supplier Qualification and Documentation Obligations

Citation hook: Color additive manufacturers and their downstream customers in FDA-regulated industries are expected to maintain current supplier qualification records that accurately reflect the processing solvents used in color additive production — a requirement that becomes more critical during active rulemaking periods.

Even before a final rule is issued, the filing of this petition creates practical compliance obligations:

• Supplier questionnaires should be updated to specifically inquire about the use of methylene chloride, trichloroethylene, and ethylene dichloride in color additive manufacturing
• Certificates of Analysis (CoAs) and technical data sheets from color additive suppliers should be reviewed for any disclosure of solvent residues
• Specification limits for solvent residues in finished color additives should be reviewed against applicable food additive safety thresholds (21 CFR § 189.240 for methylene chloride in spice oleoresins, for example)

The Broader Regulatory Context: Why This Petition Matters Now

This petition does not exist in a vacuum. It reflects a broader, multi-agency regulatory tightening around chlorinated solvents that has been accelerating since 2022. Consider these data points:

• EPA's 2024 methylene chloride rule under TSCA Section 6(a) bans consumer use and establishes a strict workplace chemical protection program (WCPP) for remaining industrial uses — the first completed TSCA Section 6 risk management rule for this chemical.
• According to EPA's TSCA risk evaluation for trichloroethylene, unreasonable risks were identified for all remaining uses evaluated, including industrial uses, making a comprehensive ban or restriction highly likely.
• The European Union's REACH regulation has already restricted both methylene chloride and trichloroethylene under Annex XVII, signaling international alignment on the need to phase out these chemicals.
• A 2023 National Toxicology Program (NTP) report reinforced the carcinogenicity classification for trichloroethylene, providing additional scientific grounding for the IACM's regulatory abandonment argument.
• FDA's own 2024 ban on brominated vegetable oil (BVO) and the ongoing review of other legacy color additives and food ingredients signals the agency's appetite for cleaning up outdated authorizations — this petition aligns with that momentum.

Citation hook: The convergence of EPA's TSCA restrictions on chlorinated solvents and FDA's active color additive rulemaking creates a dual-agency compliance environment that color additive manufacturers and their regulated-industry customers can no longer treat as background noise.

Practical Compliance Guidance: What to Do Now

Whether you are a color additive manufacturer, a food or drug company that sources colorants, or a contract manufacturer processing colored formulations, here is a practical action plan organized by urgency:

Immediate Actions (0–90 Days)

Medium-Term Actions (90 Days–12 Months)

• Submit public comments during the proposed rule comment period (watch the Federal Register for the notice of proposed rulemaking)
• Engage with IACM or trade associations for industry-coordinated comment development
• Update your Regulatory Affairs monitoring program to track both FDA and EPA regulatory developments for these three chemicals simultaneously
• Revise ingredient specifications to proactively exclude the three solvents from allowable manufacturing processes in supplier agreements

Long-Term Actions (12+ Months)

• Once a final rule is published with an effective date, ensure all supplier agreements, internal SOPs, and product specifications are updated to reflect the amended 21 CFR requirements
• Update regulatory submissions (e.g., INDs, NDAs, drug master files) where color additive manufacturing process information is disclosed
• Confirm that import documentation for color additives sourced internationally complies with the amended U.S. regulations upon their effective date

How to Monitor This Rulemaking

Companies should establish a tracking protocol for this specific rulemaking. Key monitoring touchpoints include:

1. FDA's Color Additives Status Report — periodically updated at FDA.gov
2. Federal Register alerts — set up email notifications for Docket No. FDA-2026-C-0001
3. IACM communications — the petitioner may issue member guidance during the rulemaking process
4. 21 CFR Parts 73 and 74 — watch for amendments in these specific sections

What Color Additive Manufacturers Should Know About the CFR Amendment Process

When FDA ultimately amends 21 CFR Parts 73 and/or 74 to remove these solvent authorizations, the regulatory text will no longer list methylene chloride, trichloroethylene, or ethylene dichloride as permitted processing solvents. This means:

• Any use of these solvents in preparing color additives after the effective date of the final rule would constitute a violation of the FD&C Act's color additive provisions
• Products manufactured using these solvents after the effective date could be subject to enforcement action, including seizure, injunction, or import alert
• Existing inventory manufactured prior to the effective date would need to be evaluated on a case-by-case basis under FDA's enforcement discretion principles

The effective date will be specified in the final rule. Based on precedent, FDA typically provides a compliance period of 6 to 24 months from the final rule publication date for manufacturers to complete transitions. However, given that the IACM's basis is permanent abandonment — meaning these uses have already stopped — FDA may set a shorter or even immediate effective date.

Expert Commentary: What This Filing Signals for GMP Compliance

From my experience working with 200+ clients in FDA-regulated industries, petition filings like this one often get dismissed as "not applicable" because they appear to address uses that no longer occur. That reasoning is dangerous for three reasons.

First, supply chains are complex. Your color additive supplier may have abandoned these solvents, but your supplier's supplier may not have. Without a formal qualification audit trail, you cannot confirm compliance.

Second, the filing of a petition based on "permanent abandonment" creates a contemporaneous regulatory record. If FDA finds any ongoing use of these solvents after this filing, the agency now has a documented basis to argue that the industry itself characterized these uses as permanently discontinued — making enforcement easier to sustain.

Third, this rulemaking is not isolated. It is part of a broader regulatory pattern. Companies that develop proactive compliance muscle around smaller rulemakings like this one will be far better positioned when larger, more disruptive regulatory changes land.

If you are unsure how this petition affects your specific product portfolio or supply chain, working with a qualified GMP consultant to conduct a targeted regulatory gap assessment is a practical and cost-effective first step.

How Certify Consulting Can Help

At Certify Consulting, we specialize in helping FDA-regulated companies navigate color additive regulations, supplier qualification programs, and regulatory change management across food, drug, cosmetic, and medical device sectors.

Our team, led by Jared Clark, JD, MBA, PMP, CMQ-OE, CQA, CPGP, RAC, brings more than 8 years of hands-on GMP compliance experience and a track record of 100% first-time audit pass rates across 200+ clients served. We can help you:

• Assess your color additive supplier qualification program against current and pending 21 CFR requirements
• Draft or review public comments for submission during the proposed rule comment period
• Update your SOPs, specifications, and supplier agreements to reflect regulatory changes
• Prepare for FDA inspections where color additive compliance may be reviewed

Explore our GMP compliance consulting services to learn how we help regulated companies stay ahead of regulatory change.

Last updated: 2026-04-12

Source: Federal Register, Vol. 91, April 1, 2026, Document No. 2026-06295. Filing of Color Additive Petition from the International Association of Color Manufacturers; Request To Amend the Color Additive Regulations. federalregister.gov