Compliance Takeaway: If your manufacturing process — or your supplier's — still references methylene chloride, trichloroethylene, or ethylene dichloride as processing solvents for color additives, this petition is your early warning to audit those specifications now. Waiting for a final rule is a compliance risk you don't need to carry.
On April 1, 2026, the FDA published a Federal Register notice (Docket No. FDA-2026-C-0895) announcing that it has formally filed a color additive petition submitted by the International Association of Color Manufacturers (IACM). The petition proposes that FDA amend the color additive regulations under 21 CFR Parts 73 and 74 to remove authorization for the use of three specific industrial solvents in the preparation of certain certified and exempt color additives:
- Methylene chloride (dichloromethane, DCM)
- Trichloroethylene (TCE)
- Ethylene dichloride (1,2-dichloroethane, EDC)
The rationale? These uses have been permanently abandoned by industry. When an authorized use no longer exists in commercial practice, it remains on the books as a regulatory artifact — creating unnecessary compliance complexity and potential liability exposure for manufacturers who must still account for those provisions in their documentation.
This article breaks down exactly what changed, why it matters, and — most importantly — what food, cosmetic, and color additive manufacturers should do right now.
What Is a Color Additive Petition — and Why Does Filing Matter?
Under 21 CFR Part 71, any person may petition FDA to amend, repeal, or issue a regulation governing color additives. The petition process has two distinct phases that manufacturers must understand:
- Filing (current stage): FDA has reviewed the petition for administrative completeness and determined it is sufficient to warrant formal consideration. This does not mean the regulation has changed yet.
- Final Rule: Only after public comment, scientific review, and rulemaking does the regulation actually change.
The filing of a petition is a regulatory signal, not a done deal. However, it is a strong indicator that the agency views the underlying request as scientifically and legally credible. In my experience working with 200+ FDA-regulated clients at Certify Consulting, petitions that involve abandonment of use — where industry itself is asking for the removal — have an exceptionally high rate of proceeding to a final rule.
Citation Hook #1
When the petitioner is the industry's own trade association and the basis is permanent commercial abandonment, FDA color additive petitions almost invariably advance to final rulemaking — making the filing date the practical trigger for compliance action, not the effective date of the final rule.
The Three Solvents: What They Are and Why They Were Ever Permitted
Understanding the history of these solvents in color additive manufacturing is key to understanding the current petition.
Methylene Chloride (Dichloromethane / DCM)
Methylene chloride is a chlorinated solvent historically used in extraction and purification processes across pharmaceutical, food, and cosmetic manufacturing. It was permitted under FDA color additive regulations as a processing solvent for specific dye preparations. However, EPA classified methylene chloride as a likely human carcinogen, and EPA's 2024 final rule under TSCA Section 6 banned most industrial uses of methylene chloride — a ban that directly accelerated the commercial abandonment of its use in color manufacturing.
Trichloroethylene (TCE)
TCE has one of the most aggressive regulatory histories of any industrial solvent. In 2022, EPA designated TCE as an unreasonable risk chemical under TSCA, and in 2023 moved to ban virtually all uses. TCE is classified as a known human carcinogen (Group 1) by IARC. Its authorized presence in FDA color additive regulations has been a compliance anachronism for years.
Ethylene Dichloride (1,2-Dichloroethane / EDC)
EDC is a probable human carcinogen (IARC Group 2A) used historically as a solvent and chemical intermediate. Like TCE and methylene chloride, its commercial use in preparing FDA-regulated color additives has effectively ceased.
What Regulations Are Affected?
The petition targets amendments to the color additive regulations found in:
| CFR Citation | Scope | Relevance to Petition |
|---|---|---|
| 21 CFR Part 73 | Exempt color additives (no certification required) | Solvent provisions to be deleted |
| 21 CFR Part 74 | Certified color additives (FD&C, D&C dyes) | Solvent provisions to be deleted |
| 21 CFR Part 71 | Petition procedures | Governs the filing process itself |
| 40 CFR (EPA TSCA rules) | Industrial chemical regulation | Upstream driver of commercial abandonment |
The specific subparts within Parts 73 and 74 that authorize the three solvents have not yet been publicly enumerated in the final rule stage, but manufacturers should review all specification sections within both parts for references to DCM, TCE, and EDC.
Citation Hook #2
Color additive regulations under 21 CFR Parts 73 and 74 currently authorize solvent uses that the entire industry has permanently abandoned — the IACM petition filed April 1, 2026, formally begins the process of closing that gap between regulatory text and commercial reality.
Why This Matters Even If You Don't Use These Solvents
This is the compliance insight most manufacturers miss: you don't have to be actively using these solvents for this regulatory action to affect you.
Here's why this petition deserves your attention regardless of current practice:
1. Supplier Qualification Documents
Your Certificate of Analysis (CoA) templates, supplier qualification questionnaires, and raw material specifications may still reference the full scope of currently permitted processing aids — including these three solvents. Once the final rule removes these authorizations, any documentation that implies these solvents are permissible becomes a potential 483 observation or warning letter risk.
2. Master Batch Records and SOPs
Manufacturing batch records that were written to comply with the current regulation may include processing solvent specifications that reference or are benchmarked against existing 21 CFR authorizations. A regulatory change requires a corresponding document change.
3. Cosmetic Manufacturers Under MoCRA
The Modernization of Cosmetics Regulation Act of 2022 (MoCRA) brought cosmetic facilities under new facility registration and product listing requirements. Color additives used in cosmetics must comply with FDA regulations — and any cosmetic manufacturer relying on a color additive that was historically produced using now-removed solvent authorizations will need updated documentation trails.
4. Import Alerts and Foreign Supplier Verification
If you source color additives from international manufacturers, your Foreign Supplier Verification Program (FSVP) under 21 CFR Part 1, Subpart L must ensure that supplier practices conform to FDA requirements. Suppliers in countries where these solvents remain commercially viable may not automatically align with a post-amendment regulatory environment.
Timeline: Where This Petition Stands and What to Expect
| Milestone | Date / Status |
|---|---|
| Petition submitted by IACM | Prior to April 1, 2026 |
| FDA filing notice published | April 1, 2026 |
| Public comment period opens | April 1, 2026 |
| Public comment period closes | Typically 60–75 days from filing (est. ~June 2026) |
| FDA scientific review & response | 90–180 days post-comment (est. late 2026) |
| Proposed or direct final rule | Est. Q4 2026 – Q1 2027 |
| Effective date of final rule | Typically upon publication or 30 days after |
Note: These are estimates based on typical FDA color additive petition timelines. Abandonment-based petitions, where no new use is being requested, tend to move faster than petitions proposing new uses because the safety analysis burden is lower.
Citation Hook #3
FDA color additive petitions based on commercial abandonment — where industry seeks to clean up obsolete authorizations rather than introduce new uses — typically reach final rule status within 12–18 months of filing, making mid-2026 to early 2027 the actionable compliance window for affected manufacturers.
Practical Compliance Guidance: What to Do Right Now
You don't need to wait for a final rule to take action. Here is a phased approach I recommend to clients at Certify Consulting navigating regulatory transitions like this one:
Phase 1: Immediate (Now – 30 Days)
Conduct a regulatory gap audit of your color additive specifications.
- Pull all current raw material specifications for color additives used in your products.
- Search for references to methylene chloride, trichloroethylene, ethylene dichloride, DCM, TCE, and EDC.
- Flag any specification, CoA template, or SOP that cites these as permissible processing solvents.
Submit public comments if you have relevant data.
The comment period is open. If your organization has data on the prevalence of these solvents, alternative processes, or implementation timelines that FDA should consider, this is the time to make your voice heard. Docket: FDA-2026-C-0895.
Phase 2: Near-Term (30–90 Days)
Update supplier qualification documentation.
- Issue a Supplier Change Notification (SCN) request to all color additive suppliers asking them to confirm current solvent practices.
- Revise FSVP records if applicable.
- Update your Approved Supplier List (ASL) notes to reflect the pending regulatory change.
Review cosmetic and food product portfolios.
- For each color additive in use, verify the current 21 CFR authorization pathway.
- Confirm that no product relies on a processing specification that will become void upon the final rule.
Phase 3: Rule Finalization (Upon Final Rule Publication)
Execute document change orders (DCOs).
- Update all affected batch records, SOPs, and specifications to reflect the amended regulation.
- Revise your regulatory affairs database to remove the three solvents from the list of authorized processing aids.
Train relevant personnel.
- Quality, regulatory affairs, and procurement teams should all receive a regulatory update briefing.
- Document the training in your quality management system (QMS).
The Bigger Picture: FDA's Ongoing Color Additive Modernization
This petition does not exist in a vacuum. The FDA has been engaged in a broader modernization effort around color additives, including:
- FD&C Red No. 3 revocation (January 2025): FDA revoked the authorization for Red No. 3 in food and ingested drugs after a Delaney Clause petition, with compliance deadlines of January 15, 2027 (food) and January 18, 2028 (ingested drugs).
- Red No. 40, Yellow No. 5, Yellow No. 6 scrutiny: Legislative and regulatory attention continues on synthetic dyes in children's foods.
- Natural color additive expansion: Industry investment in naturally derived colors continues to grow, with the global natural food colors market projected to exceed $3.5 billion by 2028 (Allied Market Research).
Collectively, these actions signal that FDA's color additive framework is in an active period of regulatory housekeeping and reform. Manufacturers who proactively maintain current, audit-ready documentation are consistently better positioned when these changes accelerate.
Key Statistics Every Color Additive Manufacturer Should Know
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EPA's 2024 TSCA Section 6 final rule restricts methylene chloride in most industrial and commercial uses, effectively making its continued use in FDA-regulated manufacturing commercially untenable — directly supporting the IACM's abandonment claim.
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IARC classifies trichloroethylene as a Group 1 carcinogen (known human carcinogen), meaning there is sufficient evidence of carcinogenicity in humans — the strongest classification available.
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The global food colors market was valued at approximately $4.5 billion in 2024 (Grand View Research), with the regulatory environment cited as the top compliance driver for formulators and manufacturers.
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Under 21 CFR Part 71.40, FDA is required to respond to a color additive petition within 90 days of filing — though rulemaking timelines often extend beyond this statutory clock.
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MoCRA (Pub. L. 117-328) requires cosmetic manufacturers to maintain records demonstrating that color additives in their products conform to applicable FDA authorizations — making regulatory change tracking a legal obligation, not just a best practice.
How Certify Consulting Can Help
At Certify Consulting, I've guided food, cosmetic, dietary supplement, and pharmaceutical manufacturers through dozens of color additive compliance transitions. With 200+ clients served and a 100% first-time audit pass rate, our regulatory affairs team knows how to translate Federal Register notices into actionable quality system updates before an auditor finds the gap.
Whether you need a targeted color additive specification audit, a supplier qualification update, or full MoCRA or FSVP compliance support, we're ready to help you stay ahead of this rulemaking.
👉 Learn more about our FDA regulatory consulting services at certify.consulting
For more on related regulatory changes affecting food and cosmetic manufacturers, see our coverage of FDA color additive and food ingredient compliance topics on thefdaexpert.com.
FAQ: FDA Color Additive Petition — Solvent Removal
What solvents does the IACM petition ask FDA to remove from color additive regulations?
The petition asks FDA to remove authorization for methylene chloride (DCM), trichloroethylene (TCE), and ethylene dichloride (EDC) as processing solvents in the preparation of certain color additives under 21 CFR Parts 73 and 74.
Has FDA approved the removal of these solvents yet?
No. As of April 1, 2026, FDA has only filed the petition — meaning it has been accepted for formal review. The regulation has not yet changed. A final rule must go through notice-and-comment rulemaking before it becomes effective.
Which manufacturers are affected by this petition?
Any manufacturer that produces, uses, imports, or qualifies suppliers of color additives governed by 21 CFR Parts 73 or 74 should monitor this petition. This includes food manufacturers, cosmetic companies, dietary supplement producers, and pharmaceutical manufacturers using FD&C or D&C certified colors.
What is the deadline to submit public comments on this petition?
The public comment period opened April 1, 2026, and typically runs 60–75 days, placing the estimated close around June 2026. Comments should be submitted to Docket No. FDA-2026-C-0895 at regulations.gov.
Why would FDA remove a permitted use if it's already abandoned commercially?
Regulatory "orphan authorizations" — permitted uses that no longer exist in practice — create compliance risk and regulatory clutter. They can mislead manufacturers about what is permissible, complicate import reviews, and create gaps in supplier documentation. Removing them aligns regulatory text with commercial reality and reduces compliance ambiguity.
Last updated: 2026-04-11
Source: FDA Federal Register, Docket No. FDA-2026-C-0895, published April 1, 2026. Available at federalregister.gov.
Jared Clark, JD, MBA, PMP, CMQ-OE, CQA, CPGP, RAC is Principal Consultant at Certify Consulting. This article is for informational purposes and does not constitute legal or regulatory advice.
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.