FDA 21 CFR — Food Contact Pigment Compliance for Packaging
Code of Federal Regulations Title 21 · Colorants in food contact materials, coatings, and polymers
Overview
FDA 21 CFR (Code of Federal Regulations Title 21) governs food contact materials in the United States. Unlike the EU’s blanket approach, the FDA uses a system of positive lists — specific substances that may be used in specific applications under specific conditions. For pigments, this means that suitability for food contact is determined by the exact pigment grade, the polymer matrix, the food type, and the temperature of use. FDA compliance is not generic for a given CI number; it depends on the specific manufacturing process, raw materials, and purity of each grade.
Scope
Relevant FDA sections for pigments in food contact applications:
- 21 CFR §178.3297 — Colorants for polymers (the primary section for pigments in plastic food packaging)
- 21 CFR §175.300 — Resinous and polymeric coatings (pigments in can coatings, film coatings, paper coatings)
- 21 CFR §176.170 — Components of paper and paperboard in contact with aqueous and fatty foods
- 21 CFR §177.1520 — Olefin polymers (specific to polypropylene and polyethylene food packaging)
- 21 CFR §177.2600 — Rubber articles intended for repeated use in contact with food
FDA uses the concept of Conditions of Use A–H, which define the food type (aqueous, acidic, alcoholic, fatty) and temperature range for which a material is suitable. A pigment approved for contact with dry foods at room temperature may not be suitable for fatty foods at high temperature.
FCN vs. Clearance: The Two-Path System
Pigments may enter the US market through either a Food Contact Notification (FCN) — a proprietary submission reviewed by FDA but effective only for the notifier’s specific grade — or through a Food Additive Regulation in 21 CFR, which is an open regulation available to anyone who meets the specification. Most commercially available FDA-compliant pigments rely on clearances under §178.3297, §175.300, or a supplier-held FCN.
FDA-Compliant Pigments
| CI Name | Pigment | FDA Section | Food Type Conditions | SML / Limitation | Status |
|---|---|---|---|---|---|
| PBk7 | Carbon Black (channel/impingement process) | §178.3297, §175.300 | All food types; Conditions A–H | Only channel or impingement process; ≤2.5% in polymer (threshold of regulation) | COMPLIANT (PROCESS-SPECIFIC) |
| PW6 | Titanium Dioxide | §178.3297, §175.300, §176.170 | All food types; Conditions A–H | No specific migration limit; purity spec ≥99% TiO₂ | COMPLIANT |
| PR101 | Iron Oxide Red (synthetic) | §178.3297, §175.300, §176.170 | All food types; Conditions A–H | Must be synthetic; purity requirements for heavy metals | COMPLIANT (SYNTHETIC ONLY) |
| PY42 | Iron Oxide Yellow (synthetic) | §178.3297, §175.300 | All food types; Conditions A–H | Must be synthetic hydrated ferric oxide | COMPLIANT (SYNTHETIC ONLY) |
| PBk11 | Iron Oxide Black (synthetic) | §178.3297, §175.300 | All food types; Conditions A–H | Must be synthetic ferrosoferric oxide | COMPLIANT (SYNTHETIC ONLY) |
| PB29 | Ultramarine Blue | §178.3297, §175.300 | All food types (except strongly acidic) | Acid resistance limited; not for acidic foods (pH <4.5) | COMPLIANT (ACID-RESTRICTED) |
| PB15:3 | Phthalocyanine Blue (copper) | §178.3297, §175.300 (grade-dependent) | Select grades; Conditions limited per FCN | Copper migration limit applies; not all grades compliant | RESTRICTED (GRADE-DEPENDENT) |
| PG7 | Phthalocyanine Green (chlorinated copper) | §178.3297, §175.300 (grade-dependent) | Select grades; Conditions limited per FCN | Copper + chlorine content; not all grades compliant | RESTRICTED (GRADE-DEPENDENT) |
| PR3 (Toluidine Red) | Azo pigment — aryl amine risk | Not listed under §178.3297 | N/A | Prohibited for food contact: aromatic amine release risk | PROHIBITED |
| PY12, PY13, PY14 | Diarylide yellows (azo) | Not listed under §178.3297 | N/A | Prohibited for food contact: DCB-based azo colorants | PROHIBITED |
| PY34, PR104 | Lead chromate pigments | Not listed under §178.3297 | N/A | Prohibited for food contact: lead content | PROHIBITED |
| PO20, PY35, PR108 | Cadmium-based pigments | Not listed under §178.3297 | N/A | Prohibited for food contact: cadmium content | PROHIBITED |
⚠ Not All Grades Are FDA-Compliant
FDA compliance is not inherent to a pigment chemical class. It requires that the specific commercial grade be manufactured from FDA-permitted raw materials under appropriate quality controls and that migration testing confirms compliance under the intended conditions of use. A PB15:3 from one supplier may carry an FCN allowing food contact; a PB15:3 from another supplier — using different process chemicals or with different impurity profiles — may not. Always require an FDA Letter of Guaranty or Food Contact Statement from your pigment supplier for the specific grade you intend to use.
How to Comply
- Identify the applicable FDA section: Determine whether your application falls under §178.3297 (polymers), §175.300 (coatings), §176.170 (paper), or another relevant section.
- Select only FDA-cleared pigment grades: Source pigments from suppliers who can provide a Letter of Guaranty, Food Contact Statement, or FCN reference number for their specific grade.
- Define conditions of use: Specify the food types (aqueous, acidic, alcoholic, fatty) and temperature range (Conditions A through H) that your final packaging will encounter.
- Conduct migration testing: Where specific migration limits (SML) apply, perform migration testing using FDA-recommended food simulants under worst-case time/temperature conditions.
- Verify purity specifications: Ensure that the pigment meets the purity requirements (heavy metals, extractables, volatiles) specified in the applicable 21 CFR section or FCN.
- Maintain documentation: Keep Letters of Guaranty, analytical certificates, and migration test reports on file. FDA expects food contact compliance documentation to be available for inspection.
Documentation Required
| Document | Purpose | Key Content |
|---|---|---|
| FDA Letter of Guaranty | Formal assurance from pigment supplier that their grade meets applicable FDA regulations | Grade name, FDA section, conditions of use, date, signatory |
| Food Contact Statement | Detailed letter specifying regulatory basis, food types, temperature limits, use levels | Regulatory citation (e.g., §178.3297 or FCN #), use conditions A–H, maximum loading |
| Certificate of Analysis (CoA) | Batch-specific purity and impurity data | Heavy metals (Pb, As, Hg, Cd, Cr6+), PCBs (for carbon black), polycyclic aromatic hydrocarbons |
| Migration Test Report | Demonstrates that substance migration is within applicable limits | Food simulants used, time/temperature, analytical method, results vs. SML |
| FCN (Food Contact Notification) | FDA-reviewed proprietary clearance for a specific grade | FCN number, effective date, notifier, substance identity |
| GMP / Quality System Records | Evidence of manufacturing under good manufacturing practices | Batch records, raw material traceability, QC testing logs |
Pigments NOT Suitable for Food Contact
The following pigment categories are universally unsuitable for food contact applications in the US market:
- Azo pigments that release carcinogenic aromatic amines (PR3, PR48:2, PY12, PY13, PY14, PY17, PY83, PO13) — risk of 3,3′-dichlorobenzidine and other regulated amine release
- Lead-based pigments (PY34, PR104, Lead Molybdate Orange) — lead migration and toxicity
- Cadmium-based pigments (PO20, PY35, PR108) — cadmium toxicity
- Chromium-based pigments (PG17 Chrome Oxide Green, if Cr6+ contamination present) — hexavalent chromium is a known carcinogen
- Mercury-based pigments (PR106, mercury-cadmium red) — mercury toxicity
- Pigments with heavy metal impurities above applicable limits — even if the base pigment is FDA-cleared, impurities can render a batch non-compliant
FDA-Compliant Pigments for Food Packaging
Our food-contact pigment grades come with full Letters of Guaranty and migration test reports. Grade-specific FDA clearances verified.