AP(89)-1 Compliance — Pigment Regulatory

Toy Safety Standard

AP(89)-1 — Toy Safety & Pigment Migration Testing

EN 71-3:2019 + A1:2021 · Migration of certain elements from toy materials — simulated gastric juice testing

Overview

AP(89)-1, the former designation for EN 71-3, is the European toy safety standard for the migration of certain elements from toy materials and components. The current version is EN 71-3:2019 + A1:2021. It applies to pigments used in toys, childcare articles, and any material a child may put in their mouth during normal or reasonably foreseeable use. The test simulates stomach conditions by extracting the material in 0.07M hydrochloric acid at 37°C for 2 hours, mimicking gastric juice ingestion by a child. This makes it one of the strictest pigment migration standards globally — especially for cadmium, lead, and chromium VI.

Scope

AP(89)-1 / EN 71-3 applies to:

  • Toy materials — all accessible components of toys intended for children under 14 years
  • Childcare articles — products intended to facilitate sleep, relaxation, hygiene, feeding, or sucking
  • Three material categories:
    • Category I: Dry, brittle, powder-like, or pliable materials (e.g., chalk, crayons, play dough, finger paints)
    • Category II: Liquid or sticky materials (e.g., liquid paints, bubble solutions, slime, glue)
    • Category III: Scraped-off materials (e.g., surface coatings, printed inks, polymer films that can be scraped off)

Migration Limits for 19 Elements (EN 71-3:2019 + A1:2021)

Element Category I Limit (mg/kg) Category II Limit (mg/kg) Category III Limit (mg/kg) Key Impact on Pigments
Aluminum (Al) 5,625 1,406 70,000 Lakes, alumina-treated pigments
Antimony (Sb) 45 11.3 560 Antimony trioxide (flame retardant synergy), some oxide pigments
Arsenic (As) 3.8 0.9 47 Impurity in some inorganic pigments, natural mineral pigments
Barium (Ba) 1,500 375 18,750 Barium sulfate extenders (PW21), lithopone (PW5)
Boron (B) 1,200 300 15,000 Minimal relevance to pigments
Cadmium (Cd) 1.3 0.3 17 Cadmium pigments impossible to pass (PO20, PY35, PR108)
Chromium (Cr) total 37.5 9.4 460 Chrome oxide (PG17), zinc chromate pigments
Chromium VI (Cr6+) 0.02 0.005 0.053 Extremely low — any Cr6+ contamination is a fail
Cobalt (Co) 10.5 2.6 130 Cobalt blue (PB28), cobalt green (PG26), Co-doped pigments
Copper (Cu) 622.5 156 7,700 Phthalocyanine blue/green (PB15:3, PG7 — Cu-based)
Lead (Pb) 2.0 0.5 23 Lead chromates impossible to pass (PY34, PR104)
Manganese (Mn) 300 75 3,750 Manganese violet (PV16), Mn-based pigments
Mercury (Hg) 7.5 1.9 94 Vermilion (PR106), Hg-Cd red
Nickel (Ni) 75 18.8 930 Nickel azo yellow (PY150 — typically low Ni; green gold PG10), nickel titanate
Selenium (Se) 37.5 9.4 460 Cadmium sulfoselenide (PO20)
Strontium (Sr) 4,500 1,125 56,000 Strontium chromate pigments
Tin (Sn) 15,000 3,750 180,000 Minimal relevance to pigments
Organic tin 0.9 0.2 12 Organotin stabilizers (PVC), not pigment-related
Zinc (Zn) 3,750 938 46,000 Zinc white (PW4), zinc chromate, Zn-containing mixed oxides

⚠ Cadmium (17 ppm) and Chromium VI (0.053 ppm) — Virtually Impossible for Cadmium/Chromate Pigments

The Category III limit for cadmium is just 17 mg/kg and for hexavalent chromium is 0.053 mg/kg. These limits make it effectively impossible for cadmium pigments (PO20, PY35, PR108) or lead chromate pigments (PY34, PR104) to pass AP(89)-1 migration testing under any realistic formulation. The infinitesimal chromium VI limit of 0.053 ppm means that even trace Cr6+ contamination in chrome oxide green (PG17) — well below RoHS thresholds — will fail toy safety testing. Any pigment containing cadmium, lead, or chromium VI is fundamentally unsuitable for toy applications.

Affected Pigments & Safe Choices

Pigment at Risk CI Name Failing Element Limiting Category III Limit (mg/kg) Status Compliant Alternative
Lead Chromate Yellow PY34 Pb (23), Cr6+ (0.053) Both fail catastrophically PROHIBITED PY151, PY184 (Bismuth Vanadate)
Lead Molybdate Red PR104 Pb (23), Cr6+ (0.053) Both fail catastrophically PROHIBITED PR254 (DPP Red)
Cadmium Yellow PY35 Cd (17) Cd content >> limit PROHIBITED PY184, PY110
Cadmium Orange / Red PO20 Cd (17), Se (460) Cd content >> limit PROHIBITED PO73, PR254
Cobalt Blue PB28 Co (130) Risk if high loading RESTRICTED (USE-DEPENDENT) PB29 (Ultramarine Blue)
Phthalocyanine Blue PB15:3 Cu (7,700) Low risk, Cu well below limit at typical loading COMPLIANT
Phthalocyanine Green PG7 Cu (7,700) Low risk, Cu well below limit at typical loading COMPLIANT
DPP Red PR254 None Organic, no regulated metals COMPLIANT
Quinacridone Violet PV19 None Organic, no regulated metals COMPLIANT
Iron Oxide Red PR101 Trace impurities Verify Pb, As, Cd per batch COMPLIANT (IF VERIFIED)
TiO₂ PW6 Trace impurities Verify As, Sb, Pb per batch COMPLIANT (IF VERIFIED)
Carbon Black PBk7 PAH content Not covered by EN 71-3, but PAHs regulated separately COMPLIANT

Category Matters: Why Category III Limits Are Higher

Category III (scraped-off materials) has higher migration limits than Categories I and II because the ingestion scenario assumes less material is ingested via scraping versus direct mouthing or swallowing. However, for surface coatings and printed inks on toys, the scraped-off material scenario still applies, and Category III limits are the relevant benchmark. Always classify your material correctly before interpreting test results.

How to Comply

  1. Classify your material: Determine whether the pigmented material is Category I (dry/brittle), Category II (liquid/sticky), or Category III (scraped-off coating). This determines which limit set applies.
  2. Avoid prohibited pigments: Eliminate all lead chromates (PY34, PR104), cadmium pigments (PO20, PY35, PR108), mercury-based pigments (PR106), and chromium VI-containing pigments from any material intended for toys or childcare articles.
  3. Verify organic pigment purity: While organic pigments do not contain regulated metals by design, check for heavy metal impurities (Pb, Cd, As, Hg, Cr6+) introduced during manufacture. Require CoA for every batch.
  4. Test inorganic pigment migration: For inorganic pigments (iron oxides, TiO₂, ultramarine, cobalt blue, mixed metal oxides), conduct EN 71-3 extraction and ICP-OES analysis to verify migration limits.
  5. Conduct extraction testing: Submit a representative sample to an accredited ISO 17025 laboratory for EN 71-3 migration testing (0.07M HCl, 37°C, 2 hours). Test all 19 elements.
  6. Monitor for updates: EN 71-3 is periodically revised. The 2021 amendment (A1:2021) lowered aluminum limits and added chromium VI limits. Stay current with European Committee for Standardization (CEN) publications.

Documentation Required

Document Purpose Standard / Method
EN 71-3 Migration Test Report Quantification of 19 elements after 0.07M HCl extraction EN 71-3:2019+A1:2021 (ISO 17025 lab)
Certificate of Analysis (CoA) Heavy metal content per batch ICP-OES per ISO 11885
Material Classification Declaration Statement identifying Category I / II / III Per EN 71-3 definitions
Supplier Regulatory Declaration Written statement that pigment meets EN 71-3 limits Supplier-specific; should reference test data
PAH Test Report (if applicable) Polycyclic aromatic hydrocarbon content EN 71-13 or AfPS GS 2019:01 PAK (Germany)
EN 71-9 / EN 71-11 (if applicable) Organic chemical migration tests for specific toy categories EN 71-9:2005+A1:2007 (preservatives, solvents, monomers)

Toy-Safe Pigments, Batch-Tested

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