SCHER 2010 — Evaluation of migration limits for chemical elements in toys (EU Toy Safety Directive 2009/48/EC)
This SCHER opinion (adopted 1 July 2010) evaluates whether the migration limits in the EU Toys Safety Directive 2009/48/EC (TSD) for 19 chemical elements provide a scientifically sound basis for child safety. SCHER supports a health-based risk-assessment framework anchored to the tolerable daily intake (TDI), recommends use of 10% of the TDI for all chemical elements (rather than the TSD’s mixed 5%/10% allocation that gives the 6 particularly toxic elements a tighter allocation), proposes updated TDIs for Cd (0.36 µg/kg bw/d), Pb (BMDL01 0.50 µg/kg bw/d, non-threshold), and As (pragmatic TDI 1 µg/kg bw/d with 0.1 µg/kg bw/d allocated to children’s toy exposure), and recommends physiologically based extraction media (artificial saliva, simulated gastric juice, artificial sweat) rather than water for mouthing/dermal simulation. The opinion also flags reliability concerns about the EN 71-3 migration test method based on a JRC inter-laboratory comparison.
Key numbers
- TDI updates recommended by SCHER:
- Cadmium: new TDI 0.36 µg/kg bw/day, derived from the EFSA 2009a TWI of 2.5 µg/kg bw/week (based on association of urinary cadmium with β-2-microglobulin, a kidney-function biomarker), replacing the prior RIVM 2001 TDI of 0.5 µg/kg bw/day used in the TSD.
- Lead: BMDL01 of 0.50 µg/kg bw/day for neurodevelopmental effects (1% IQ decline; EFSA 2010). TDI cannot be derived because the critical endpoint is non-threshold. The JECFA PTWI of 25 µg/kg bw/week, previously endorsed by the EU Scientific Committee on Food, is no longer considered appropriate. SCHER recommends a risk-based hazard-classification approach per RIVM 2008 / SCHER 2010 CMR-in-toys opinion.
- Arsenic: EFSA 2009b established a BMDL01 range of 0.3-0.8 µg/kg bw/day with lung cancer as the most sensitive endpoint; EFSA did not derive a TDI but used a risk-based value. SCHER (drawing on its 2010c opinion on the Italian derogation for As in drinking water at 10 µg As/L) concludes that daily human exposure of approximately 1 µg/kg bw/day does not increase tumour incidence, and adopts that as a pragmatic TDI. Children’s exposure via toys should not exceed 0.1 µg/kg bw/day (10% of the pragmatic TDI). The TSD’s RIVM-derived TDI of 1.0 µg/kg bw/day is no longer appropriate per EFSA 2009b.
- TSD worst-case oral intake assumptions (per RIVM methodology):
- 8 mg/day of scraped-off toy material
- 100 mg/day of dry, brittle, powder-like or pliable toy material
- 400 mg/day of liquid or sticky toy material
- TDI allocation under the TSD: 10% per exposure source × 3 sources = 30% total of the TDI for the 13 less-toxic elements; 5% × 3 sources = 15% total for the 6 particularly toxic elements (As, Cd, Cr-VI, Pb, Hg, organic Sn) that should not be intentionally added to accessible toy parts. SCHER does not support the 5% differentiation and recommends the 10% allocation per element across all chemicals.
- EN 71-3 (CEN) is the current migration test method, covering 9 of the chemical elements. The Baer et al. 2009 / JRC IMEP-24 inter-laboratory comparison across 8 metals found up to 10-fold inter-laboratory variation in measurements; SCHER raises concern about method reliability and the suitability of currently applied correction factors.
- Recommended extraction media: physiologically based — artificial saliva and simulated gastric juice for oral/mouthing exposure; artificial sweat for dermal exposure. EN 71-3 currently uses 0.07 M HCl (pH ~2) simulating gastric juice; SCHER notes children’s gastric pH is higher than 2, so the EN 71-3 medium represents a worst-case for gastric simulation.
- SCHER recommendation 6: where children-specific exposure data are unavailable from most European countries, use 50% of adult human exposure as the background-exposure estimate for children.
Methods (brief)
SCHER opinion compiled by Working Group (H. Autrup chair/rapporteur; W. Dekant, H. Greim, E. Testai) with external experts S. Rastogi (Scientific Committee on Consumer Safety) and M.R. Milana (Istituto Superiore di Sanità, Rome). Reviews the RIVM report 320003002/2008 “general methodology for assessment of chemical safety of toys with a focus on elements,” prior SCCP/SCHER/CSTEE opinions on toys, EFSA 2009a (cadmium), EFSA 2009b (arsenic), EFSA 2010 (lead), the SCHER 2010a CMR-in-toys opinion, the SCHER 2010c opinion on the Italian derogation for As in drinking water, and the Baer et al. 2009 JRC IMEP-24 inter-laboratory comparison report. No primary measurement; this is a regulatory evaluation document.
Implications
- Certification (HMTc): Provides regulatory-baseline reference values for any HMTc threshold work on children’s products where dermal, mouthing, or oral migration is the exposure model. SCHER’s recommended TDIs in the TSD context (Cd 0.36 µg/kg bw/d; Pb BMDL01 0.50 µg/kg bw/d, non-threshold; As pragmatic TDI 1 µg/kg bw/d with 0.1 µg/kg bw/d allocated to children’s toy exposure) supersede the older RIVM/JECFA values that underpinned the original TSD migration limits.
- Courses: Foundational regulatory-affairs reference for EU children’s product safety; demonstrates the migration-limit framework versus concentration-limit framework and the TDI-allocation logic that translates a health-based intake value into a material-concentration limit.
- App: Not relevant to ingredient contamination_profile values. Useful for product-page regulatory crosswalk between EU toy directive limits and HMTc thresholds.
Wiki pages this source may touch
- arsenic
- cadmium
- chromium-hexavalent
- lead
- mercury-total
- tin
- efsa-arsenic-contam-2009
- efsa-cadmium-twi
- efsa-lead-contam-2010
Verification notes
- This is an EU regulatory opinion document. No primary occurrence data. Listed as gov-report A-tier per Part 13.
- The EU Toy Safety Directive 2009/48/EC migration limits themselves (in mg/kg of toy material for each of three material categories) are not reproduced in the SCHER opinion body but are referenced. A dedicated regulation page for EU TSD 2009/48/EC migration limits does not yet exist; the migration limit values would be on that page when it is created (regulation slug proposal noted here for Karen, not auto-created per Part 10).
- Physiologically-based extraction media recommendation aligns with Stefaniak 2014 and Anselm 2022 findings on the importance of bioaccessibility-test formulation.
- Audit subagent 2026-05-17 flagged Implications “should be used as the regulatory baseline” phrasing as a borderline Part 2 wiki/HMTc-firewall concern (reads as an HMTc directive); verified against CLAUDE.md Part 2 — softened to “Provides regulatory-baseline reference values … SCHER’s recommended TDIs in the TSD context” to keep the wiki reporting what SCHER recommended for the TSD without implying HMTc must use these specific values.
- Audit subagent 2026-05-17 also flagged the 30%/15% per-source decomposition arithmetic as wiki-side expansion of source totals; verified against PDF p.5 — finding rejected as false positive. The source explicitly states “10% allocations per source × 3 sources” for the 13 less-toxic elements and “These elements are to be used at levels that are half of those considered safe” (= 5% per source × 3) for the 6 particularly toxic elements, and gives the 30%/15% totals; the wiki’s arithmetic decomposition is faithful and explicit decomposition aids reader comprehension.
- 2026-05-17 enhancement (merge-enhance pass): corrected metals frontmatter
As→tAsper Part 14 speciation discipline (the toy directive migration limits are not speciated; SCHER’s discussion of EFSA 2009b iAs-based BMDL01 is captured in Key numbers narrative). Removed the products-frontmatter pointer to the children’s-makeup product slug — the prior ingest mis-attributed the source to children’s cosmetics because the PDF lives in theChildren Personal Care Papers/babycare_01_Exposure_Pathways/folder, but the SCHER opinion is about the EU TOYS Safety Directive 2009/48/EC, not cosmetics. Notoysumbrella product slug exists in the current taxonomy; the opinion is a category-spanning regulatory anchor for all toy product rows in HMTc Category 21. Removed the matrices entries for the three physiologically-based extraction fluids (saliva, gastric, sweat) — those are extraction MEDIA used in migration testing, not product matrices; the matrix vocabulary is for what was measured (e.g., infant-formula, rice), not how it was extracted. Extraction-media information moved into Key numbers and Methods narrative. Clarified Cd TWI units (per week) and expanded Key-numbers narrative on Pb (JECFA PTWI withdrawal rationale) and As (SCHER’s pragmatic-TDI derivation from the Italian drinking-water derogation opinion). Added the metals/tin wiki page to the touched list (organic Sn is one of the 6 particularly toxic elements in TSD scope).
Page history
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