Heavy Metal Limits in Pigments — Global Regulatory Limits Comparison
Cross-reference of heavy metal limits across EU REACH, RoHS, EN 71-3, FDA, China GB, Japan, Korea, and US packaging regulations
Overview
Heavy metal limits are the most common reason pigments fail regulatory compliance across global markets. Limits vary dramatically by regulation, application, and jurisdiction — a pigment acceptable for industrial coatings may be prohibited for toys, and what passes FDA food contact may fail China GB 9685. This reference guide provides a comprehensive side-by-side comparison of the major global heavy metal regulations affecting pigment selection. All limits are in ppm (mg/kg) unless otherwise specified.
Scope — Regulations Covered
| Regulation | Jurisdiction | Application Area | Key Reference |
|---|---|---|---|
| REACH Annex XVII | EU / EEA | Chemical substances, articles, consumer products | EC 1907/2006, Annex XVII (restrictions on manufacture, placing on market, and use) |
| RoHS | EU / EEA | Electrical and electronic equipment (EEE) | Directive 2011/65/EU + amendments (RoHS 3) |
| EN 71-3 | EU / EEA | Toys and childcare articles (migration limits) | EN 71-3:2019 + A1:2021 |
| EU 94/62/EC (Packaging) | EU / EEA | Packaging and packaging waste | Directive 94/62/EC, Article 11 — sum of Pb + Cd + Hg + Cr6+ ≤ 100 mg/kg |
| US CONEG / TPCH | United States (19 states) | Packaging and packaging components | Model Toxics in Packaging Legislation — sum of Pb + Cd + Hg + Cr6+ ≤ 100 mg/kg |
| US FDA 21 CFR | United States | Food contact materials (indirect additives) | 21 CFR §178.3297, §175.300, §176.170, §177.1520 |
| China GB 9685 | China | Food contact materials and articles (additives positive list) | GB 9685-2016 |
| Japan Food Sanitation Law | Japan | Food contact utensils, containers, and packaging | MHLW Notification No. 370 (1959), as amended |
| Korea KC Mark / Safety Standards | South Korea | Children’s products (toys, childcare) under Special Act on Safety of Children’s Products | Korean Agency for Technology and Standards (KATS), harmonized with EN 71-3 |
Heavy Metal Limits — Global Comparison (ppm = mg/kg)
| Heavy Metal | REACH Annex XVII | RoHS (homogeneous) | EN 71-3 (Cat III, migration) | EU Packaging 94/62/EC | US FDA (typical) | China GB 9685 | Application Area |
|---|---|---|---|---|---|---|---|
| Lead (Pb) | 0.1% w/w (article SVHC notification) 30 ppm (azo amine release) |
<1,000 ppm | 23 ppm (migration) | 100 ppm (sum Pb+Cd+Hg+Cr6+) | <100 ppm typical CoA spec | <100 ppm (SML 0.01 mg/kg for some items) | Pigments, coatings, plastics, packaging, toys |
| Cadmium (Cd) | 0.01% w/w (articles) Restricted in mixtures & articles |
<100 ppm | 17 ppm (migration) | 100 ppm (sum Pb+Cd+Hg+Cr6+) | <10 ppm typical | <5 ppm (severe restriction) | Cannot use Cd pigments for any regulated application |
| Mercury (Hg) | 0.1% w/w (articles) Annex XVII Entry 18 & 18a |
<1,000 ppm | 94 ppm (migration, Cat III) | 100 ppm (sum Pb+Cd+Hg+Cr6+) | <1 ppm typical | <10 ppm (SML 0.005 mg/kg) | PR106 (HgS) prohibited for all regulated applications |
| Chromium VI (Cr6+) | Annex XVII Entry 47 (leather goods <3 ppm) Auth’d under REACH for limited uses |
<1,000 ppm | 0.053 ppm (migration, Cat III) | 100 ppm (sum Pb+Cd+Hg+Cr6+) | Not specifically regulated; undetectable preferred | <10 ppm | EN 71-3 limit is by far the strictest globally for Cr6+ |
| Antimony (Sb) | Not under Annex XVII restrictions | Not restricted | 560 ppm (migration, Cat III) | Not restricted | N/A | <40 ppm | Flame retardant synergy, Sb trioxide used with halogenated FR |
| Arsenic (As) | SVHC candidate substances; general obligation | Not restricted | 47 ppm (migration, Cat III) | Not restricted | <2 ppm typical | <10 ppm | Impurity concern in some mineral-based pigments |
| Barium (Ba) | Not under Annex XVII; soluble Ba salts are classified | Not restricted | 18,750 ppm (migration, Cat III) | Not restricted | N/A | N/A | Lithopone (PW5), BaSO₄ extenders (PW21) — high Ba content |
| Selenium (Se) | Not under Annex XVII | Not restricted | 460 ppm (migration, Cat III) | Not restricted | N/A | <100 ppm | Cadmium sulfoselenide (PO20) — Se co-released with Cd |
| Cobalt (Co) | SVHC classification for certain Co salts; CLP carcinogen cat 1B | Not restricted | 130 ppm (migration, Cat III) | Not restricted | N/A | N/A | Cobalt blue (PB28), cobalt green (PG26) — restricted in toys |
| Nickel (Ni) | Annex XVII Entry 27 (Ni release from articles with prolonged skin contact <0.5 µg/cm²/week) | Not restricted | 930 ppm (migration, Cat III) | Not restricted | N/A | N/A | Nickel titanate (PY53), nickel azo (PY150 — trace Ni only) |
| Copper (Cu) | Not restricted | Not restricted | 7,700 ppm (migration, Cat III) | Not restricted | N/A | <5 ppm (SML in certain food contact) | Phthalocyanine blue/green (PB15:3, PG7 — Cu in molecule) |
| Zinc (Zn) | Not restricted | Not restricted | 46,000 ppm (migration, Cat III) | Not restricted | N/A | N/A | Zinc white (PW4), zinc ferrite (PY119) — high Zn content but inert |
⚠ Heavy Metal Limits Are the #1 Reason for Pigment Regulatory Failure
Heavy metal limits are the most common reason pigments fail regulatory compliance — always request a Certificate of Analysis (CoA) specifying heavy metal content from your pigment supplier. Note that limits can be cumulative or per-element, apply at the homogeneous material level or the finished product level, and can differ by an order of magnitude between toys (EN 71-3) and electronics (RoHS). The same pigment may be compliant for one application and prohibited for another. Never assume; always test.
Typical Heavy Metal Levels in Pigments
| Heavy Metal | Typical Organic Pigment Level (ppm) | Typical Inorganic Pigment Level (ppm) | Affected Pigment Types | Compliance Risk |
|---|---|---|---|---|
| Lead (Pb) | <5 ppm (most organic pigments) | <50 ppm (iron oxides, TiO₂) 300,000–600,000 ppm (lead chromates) |
PY34, PR104, Lead Molybdate Orange | HIGH: Pb pigments fail all regulations |
| Cadmium (Cd) | <1 ppm (most organic pigments) | <5 ppm (most inorganic) 600,000–770,000 ppm (Cd pigments) |
PO20, PY35, PR108 | HIGH: Cd pigments fail all regulations |
| Mercury (Hg) | <0.1 ppm | <1 ppm (most inorganic) 800,000+ ppm (HgS) |
PR106 (Vermilion) | HIGH: Hg pigments obsolete |
| Chromium VI (Cr6+) | <0.1 ppm | <1 ppm (pure oxides) Variable in chrome yellow/orange |
PY34, PR104 (Cr6+ from CrO₄²⁻ ion) | HIGH: Cr6+ detection is a fail under EN 71-3 |
| Antimony (Sb) | <5 ppm | <20 ppm (most inorganic) | Sb₂O₃ flame retardant synergy | LOW |
| Arsenic (As) | <1 ppm | <5 ppm (synthetic) 10–100 ppm (natural minerals) |
Natural iron oxides, ochres, umbers | MEDIUM: Natural minerals may carry As |
| Barium (Ba) | <5 ppm | <50 ppm (most) 100,000+ (BaSO₄ extenders) |
Lithopone (PW5), Blanc Fixe (PW21) | LOW: BaSO₄ is inert and poorly soluble |
| Cobalt (Co) | <1 ppm | 100,000–400,000 ppm (cobalt pigments) | PB28 (cobalt blue), PG26 (cobalt green), PG19 (cobalt chromite) | MEDIUM: Restricted in toys; OK for industrial use |
| Nickel (Ni) | <5 ppm | 5,000–50,000 ppm (nickel titanate) | PY53 (nickel titanate yellow), PG10 (nickel azo green gold) | MEDIUM: EN 71-3 limits & Ni sensitisation |
| Copper (Cu) | <10 ppm (azo pigments) 50,000–110,000 ppm (phthalocyanine) |
<50 ppm (most oxides) | PB15:3, PG7 (Cu phthalocyanine ring) | LOW: Complexed Cu is not bioavailable |
Testing Methods
| Method | Technique | Purpose | Relevant Standards | Sample Preparation |
|---|---|---|---|---|
| ICP-OES | Inductively Coupled Plasma — Optical Emission Spectrometry | Quantitative multi-element analysis for total metal content | ISO 11885, EN 71-3 Annex C, EPA 6010 | Acid digestion (HNO₃/HCl/H₂O₂ or H₂SO₄); microwave-assisted preferred |
| ICP-MS | Inductively Coupled Plasma — Mass Spectrometry | Ultra-trace metal detection (sub-ppb detection limits) | ISO 17294-2, EPA 6020 | Acid digestion; used for Cd/Hg/Pb at very low levels |
| XRF | X-Ray Fluorescence Spectrometry | Rapid screening (non-destructive) for RoHS, packaging compliance | IEC 62321-3-1, ASTM F2617 | None (direct measurement); limited to surface to ~1mm depth |
| Migration / Extraction Testing | Simulated fluid extraction + ICP analysis | Simulates ingestion/mouthing exposure (EN 71-3), food contact migration | EN 71-3: 0.07M HCl, 37°C, 2h FDA: food simulants per 21 CFR |
Extraction in specified simulant under controlled time/temperature |
| UV-Vis Spectrophotometry | Diphenylcarbazide colorimetric method | Specific detection of Cr6+ (distinguish from Cr3+) | IEC 62321-7-2, ISO 17075 | Aqueous extraction, color development, absorbance at 540 nm |
| GC-MS / HPLC-MS | Chromatography with mass detection | Organic impurity analysis (azo amines, PAHs, phthalates) | EN 14362-1 (azo amines), EN 71-13 (PAHs), IEC 62321-8 (phthalates) | Solvent extraction or thermal desorption |
EU 94/62/EC & CONEG/TPCH — Packaging Limits
Both EU Packaging Directive 94/62/EC (Article 11) and the US CONEG/TPCH model legislation set a combined limit of 100 mg/kg (100 ppm) for the sum of lead, cadmium, mercury, and hexavalent chromium in packaging and packaging components. This applies to:
- Plastic packaging pigmented with colorants
- Inks and coatings on packaging (including flexible packaging)
- Labels and adhesives on packaging
- All components that become part of the packaging waste stream
The 100 ppm sum limit is stricter than RoHS for lead and mercury (RoHS: 1,000 ppm each) but uses a cumulative (sum) approach rather than per-element. A packaging material with 90 ppm Pb and 15 ppm Cd would have a sum of 105 ppm and would fail both EU and US packaging regulations, even though each element independently is below RoHS limits.
Key Takeaway: Organic Pigments Are the Safest Default
Modern high-performance organic pigments — DPP (PR254), quinacridones (PV19, PR122), phthalocyanines (PB15:3, PG7), perylenes (PR179), isoindolinones (PY110), and benzimidazolones (PY151) — inherently contain no regulated heavy metals. Typical heavy metal impurity levels are <5–10 ppm for Pb, Cd, Hg, and As, making them the safest default choice for any regulated application. Inorganic pigments (iron oxides, TiO₂, carbon black, ultramarine) are the next safest tier but require batch-level CoA verification. Lead chromates, cadmium pigments, and chromium VI-containing pigments are unsuitable for any regulated consumer application and should be avoided.
How to Comply Across Multiple Regulations
- Map your target markets and applications: Determine which regulations apply based on the product type (toys, electronics, food contact, packaging), the intended market (EU, US, China, Japan, Korea), and the material type (polymer, coating, ink, textile).
- Establish a “worst-case” specification: Where possible, design pigment specifications to meet the strictest applicable regulation simultaneously (e.g., EN 71-3 for toys + RoHS for electronics + FDA for food contact) to simplify your supply chain.
- Source certified pigment grades: Work with pigment suppliers who can provide CoAs covering the full range of regulated metals (Pb, Cd, Hg, Cr6+, As, Sb, Ba, Se, Co, Ni, Cu) using ISO 17025 accredited methods.
- Implement incoming QC testing: Do not rely solely on supplier CoAs. Perform periodic verification testing (XRF screening + ICP-OES confirmation) on incoming pigment batches, especially for inorganic pigments and pigments sourced from new suppliers.
- Consider total formulation: Heavy metal limits apply to the finished material (plastic compound, coating film, ink layer), not just the pigment. Account for contributions from all raw materials: polymer resin, fillers, additives, processing aids.
- Monitor regulatory changes: Regulations evolve — new SVHCs are added to the REACH Candidate List every 6 months; EN 71-3 element lists and limits are amended periodically; China GB standards are revised. Subscribe to regulatory monitoring services or industry association alerts.
Documentation Required
| Document | Coverage | Standard / Method |
|---|---|---|
| Certificate of Analysis (CoA) | Full metals panel: Pb, Cd, Hg, Cr6+, As, Sb, Ba, Se, Co, Ni, Cu, Zn | ICP-OES per ISO 11885 |
| XRF Screening Report | Rapid screening of Pb, Cd, Hg, Cr, Br (RoHS/EN 71-3 pre-screen) | IEC 62321-3-1 |
| EN 71-3 Migration Test Report | 19-element migration after 0.07M HCl extraction | EN 71-3:2019+A1:2021 |
| Packaging Compliance Declaration | Sum of Pb+Cd+Hg+Cr6+ ≤ 100 mg/kg | EU 94/62/EC or CONEG/TPCH |
| FDA Food Contact Statement | FDA clearance for specific pigment grade under applicable 21 CFR section | 21 CFR §178.3297, §175.300, or FCN |
| REACH SVHC Declaration | Statement that pigment contains no SVHC >0.1% w/w | REACH Article 33, latest Candidate List |
Get a Full Heavy Metal Analysis for Your Pigment
Every Honor Pigment shipment includes an ISO 17025 Certificate of Analysis covering all regulated heavy metals. One CoA, full global compliance.