Heavy Metal Index
Ask the IndexAboutIndex Pro

Lead and cadmium do not belong in toys

Cite this pageVersion history

Overview

This Bundesinstitut für Risikobewertung (BfR, German Federal Institute for Risk Assessment) formal Opinion, issued as BfR Opinion No. 048/2009 on 1 June 2009, is the agency’s health risk assessment of children’s exposure to lead and cadmium in toys in the context of the then-new European Toy Safety Directive (TSD) 2009/48/EC. The Opinion synthesises ATSDR, EFSA, IARC, JECFA, WHO, DFG, and German HBM Commission evaluations and concludes that (i) because no scientific safe-effect threshold can be established for lead’s neurotoxic and endocrine effects in children, the ALARA principle (as low as reasonably achievable) should govern lead in toys and other consumer products and the prior, tighter migration limit values of Directive 88/378/EEC should not be loosened; (ii) the cadmium migration limits in TSD 2009/48/EC, derived from the older JECFA 2003 PTWI of 7 µg cadmium (Cd)/kg bw/week, must be lowered to align with EFSA 2009’s revised TWI of 2.5 µg Cd/kg bw/week; and (iii) because children’s dietary cadmium intake already exceeds the new EFSA TWI by 100% on a regular basis, toys should contribute at most 5% of the EFSA TWI across all three TSD toy-material categories combined (dry/brittle, liquid/sticky, scraped-off). The Opinion does not report any primary contamination measurements; it is a regulatory-opinion derivation of recommended migration-limit positions from upstream toxicological reference values.

Key numbers

Tolerable-intake reference values reviewed

  • JECFA PTWI for lead (Pb) (1986, reaffirmed 2002): 25 µg/kg bw/week (≈3.5 µg/kg bw/day), derived under the assumption of a safe-effect threshold. The Opinion notes that EFSA was at the time re-evaluating lead and that WHO/JECFA would likely also re-evaluate this PTWI because the safe-threshold assumption underlying it no longer holds (p. 2, 3).
  • JECFA PTWI for Cd (2003): 7 µg/kg bw/week (p. 6).
  • EFSA TWI for Cd (2009): 2.5 µg/kg bw/week (≈0.35 µg/kg bw/day). Based on urinary β2-microglobulin (B2M) modelling; critical urinary Cd of 1 µg per g creatinine identified as correlate of tubular kidney damage. EFSA explicitly notes the revised TWI does not protect all population groups equally — children’s cadmium intake through foodstuffs alone regularly exceeds the new TWI by 100% (p. 6).

Lead in children: dietary intake, blood lead, and exposure pathways

  • EU adult alimentary lead intake (SCOOP 2004): median 0.8 µg/kg bw/day (≈25% of the JECFA PTWI) (p. 4).
  • EU children’s alimentary lead intake (SCOOP 2004): 1.3 µg/kg bw/day for 4-6 year-olds; 0.83 µg/kg bw/day for 10-12 year-olds; latter figure constitutes 35% of the PTWI (p. 4).
  • Alternative dietary-intake estimates (JECFA 2006): 1-4 µg/kg bw/week (≈0.1-0.6 µg/kg bw/day) for children between 0.6 and 30 µg/kg bw/day (≈0.1-4.3 µg/kg bw/day) (p. 4).
  • Tap-water lead intake in German children (Schulz et al. 2008, German Environmental Survey for Children): median 0.75 µg/day, maximum up to 1,000 µg/day (p. 4).
  • Tap-water lead concentration (Lommel et al. 2002): mean 26 µg/L in some German surveys (p. 4).
  • Blood lead in German children aged 3-14 years (Becker 2007 / HBM Commission 2009): mean 18.2 µg/L, maximum 100 µg/L, with a 35 µg/L reference value for the 3-14 year cohort; 5% of children exceed 35 µg/L. The Opinion notes these levels are “certainly in concentration ranges which have been known to produce adverse effects” (p. 5).
  • Threshold of biological effect: “Today it is an accepted fact that even low dosages, i.e. of lead concentrations < 100 µg/L in blood, impair the intellectual development of children considerably” (citing ATSDR 2007, Chen 2007, Lanphear et al. 2005, Schnaas 2006). Hyperkinetic-syndrome risk in children 4-15 years is higher for blood Pb >20 µg/L than for blood Pb <10 µg/L (citing Braun et al. 2006, HBM 2009). At blood Pb <100 µg/L, adverse effects on sexual maturity in girls (delayed first menstruation, pubic hair growth, breast development) have been observed (Selevan et al. 2003, Wu et al. 2003) (p. 3).
  • Lead intestinal absorption asymmetry: “For children it is known that the resorption of lead from the intestines is higher than for adults by a factor of 5” (citing ATSDR 2007). Resorption rate ≈50% in children vs ≈10% in adults (p. 2, 5).
  • HBM Commission position (2009): the Commission deferred setting human biomonitoring reference values for lead in blood for children, women, and men because “the definition of an effect threshold concerning blood lead levels is arbitrary and not justifiable” (HBM Commission 2009, p. 3, German original quoted in footnote).

Lead in toys: TSD 2009/48/EC migration limits and per-day exposure

  • Directive 88/378/EEC (the TSD predecessor): bioavailability of lead ingested through toys limited to 0.7 µg/day (p. 4).
  • Directive 2009/48/EC (new TSD): migration limits for Pb in three toy-material categories (dry/brittle/powder-like/pliable, liquid/sticky, scraped-off). Maximum permitted daily lead intake of 1.3 µg/day per material category; for a child playing with all three material types on the same day the maximum total permitted oral Pb intake from toys is 3.9 µg/day (p. 4).
  • Per-kg-bw scaling under TSD assumptions (child body weight 7.5 kg): 3.9 µg/day = ≈0.5 µg/kg bw/day permitted oral Pb intake from toys, equivalent to about 50% of the estimated alimentary lead intake of children (p. 2, 4).
  • The migration-limit derivation: values were back-calculated from the WHO/JECFA PTWI of 25 µg/kg bw/week (assumed safe-threshold). BfR position: because the safe-threshold assumption no longer holds, the PTWI cannot serve as a reliable basis for risk assessment of lead exposure today; ALARA must therefore apply to toys (p. 4-5).

Cadmium in children: dietary intake, exposure pathways, classification

  • Cd intestinal resorption: documented at an average of 5% of oral intake, varying 1-20% with food composition and nutritional status (WHO 1992). Accumulation potential high; biological half-life in kidneys 10-30 years (p. 6).
  • EFSA 2009 cadmium intake estimates:
  • Adults: 1.9-3.9 µg/kg bw/week (median 2.3 µg/kg bw/week) (p. 7).
  • Children 1-12 years: 0.49-7.9 µg/kg bw/week (median 2.71 µg/kg bw/week); “intake is higher for younger children” (p. 7).
  • Young children (1.5-4.5 years): cadmium intake exceeds adult intake by 165% (EFSA 2009) (p. 7).
  • WHO/JECFA estimate for foodstuffs (cited 2.8-4.2 µg/kg bw/week or 24-36 µg/day): broadly consistent with the EFSA range above (p. 7).
  • U.S. Total Diet Study (ATSDR 1999) average dietary Cd: 30 µg/day (p. 7).
  • IARC classification: Group 1 human carcinogen (IARC 1993) (p. 6).
  • DFG (German Research Foundation) Senate Commission classification: Category 2 carcinogen (substances to be considered carcinogenic for humans), DFG 2003 (p. 6).
  • In vitro endocrine activity: cadmium acts as an oestrogen-response inducer in vitro and is classified as an endocrine-modulating substance (Hofer et al. 2009). Cadmium and lead may also act via epigenetic mechanisms (Baccarelli & Bollati 2009) (p. 6).

Cadmium in toys: TSD 2009/48/EC migration limits and BfR’s per-material-category position

  • Directive 2009/48/EC (new TSD) Cd migration limits: derived from the old JECFA 2003 PTWI of 7 µg Cd/kg bw/week. Maximum permitted daily oral Cd intake 0.2 µg/day per toy-material category (dry, liquid, scraped-off). For a child playing with all three material types on the same day, total permitted oral Cd intake from toys = 0.6 µg/day (p. 7).
  • Per-kg-bw scaling (child body weight 7.5 kg, TSD assumption): 0.6 µg/day = 0.56 µg/kg bw/week (p. 7).
  • Percentage of EFSA 2009 TWI permitted via toys under TSD: 0.56 / 2.5 = ≈20% of the EFSA TWI of 2.5 µg/kg bw/week (p. 2, 7).
  • BfR position on cadmium in toys: because children’s dietary Cd intake alone already exceeds the EFSA TWI by 100% on a regular basis, toys should contribute at most 5% of the EFSA TWI across all three TSD material categories combined. The migration limits for cadmium in toys should be promptly adjusted to the EFSA TWI value of 2.5 µg/kg bw/week (p. 2, 7-8, 9).

Methods (brief)

This is a regulatory-opinion document. No primary analytical work was carried out and no LOD/LOQ is applicable. BfR’s risk-assessment workflow: (i) compile authoritative tolerable-intake reference values for Pb and Cd from ATSDR (1999, 2007), EFSA (2004, 2009), IARC (1993, 2004, 2006), JECFA (1986, 2002, 2003, 2006), and WHO (1992, 1995, 2000, 2007); (ii) compile children’s-specific exposure data — dietary, drinking-water, dust/soil, mouthing of consumer products — from SCOOP (2004), the German Environmental Survey for Children KUS 2003/06 (Schulz et al. 2008; Becker 2007), the HBM Commission (2009), and UBA (2007); (iii) derive the per-pathway and per-material-category exposure burden that would result under the new TSD 2009/48/EC migration limits, expressed both as µg/day and as a percentage of the operative tolerable-intake reference; (iv) compare to the share already consumed by dietary intake; (v) issue an Opinion. The document is structured in three sections: (1) Subject of the Assessment, (2) Results (the agency’s findings statement), and (3) Reasons (the underlying toxicology, exposure, and risk-characterisation evidence for lead and cadmium separately). A “Scope for action / measures” closing section (3.3) records BfR’s specific policy recommendations to the European Commission.

Implications

  • Regulatory baseline (Pb in toys, EU). This Opinion is one of the formal national-agency contributions that shaped the EU’s downstream review of TSD 2009/48/EC migration limits for lead and cadmium. BfR’s position — that the prior 88/378/EEC bioavailability limit (0.7 µg Pb/day) should not be loosened, and that the ALARA principle should apply to lead in toys — is the operative German-agency framing on this question as expressed in this Opinion.

  • Regulatory baseline (Cd in toys, EU). BfR’s recommended cap — toys to contribute at most 5% of the EFSA 2009 TWI of 2.5 µg Cd/kg bw/week (≈0.0019 µg/kg bw/day, or ≈14 ng/day for a 7.5 kg child summed across all three TSD material categories) — is substantially tighter than the TSD 2009/48/EC values in force at the time of this Opinion (≈20% of the older JECFA PTWI). This is the agency position the EU’s subsequent TSD migration-limit amendment process for Cd had to address.

  • HMTc audit implications. For HMTc certification work on children’s-product categories that include toys (and on mouthed sub-categories such as pacifiers and teething aids), this Opinion is the German federal-agency anchor demonstrating two things relevant to threshold-setting governance: (i) the agency-level position that no safe-effect threshold for lead in children can be defended scientifically and that the ALARA principle is the operative regulatory principle (consistent with the wiki’s Part 2 ratcheting frame); (ii) the agency-level position that dietary cadmium intake in young children already exceeds the EFSA TWI on a regular basis, meaning the entire non-food exposure budget (including toys, packaging, drinking water, dust) must be tightened relative to the toy-isolated TSD migration limits to avoid systemic over-exposure. HMTc threshold-setting for pacifiers/teething-aids/toys-painted/toys-substrate-materials categories can cite this Opinion as the regulatory-alignment anchor for either of these positions.

  • App. Not directly relevant to ingredient contamination_profile data because no food-matrix occurrence values are reported. Relevant to a future toys/children’s-product screening surface that explains the regulatory logic behind Pb/Cd migration-limit values to consumers and brand-QA users.

  • Courses. Worked example for the regulatory-history module of (i) how a national regulatory agency derives its position on a forthcoming EU directive from upstream tolerable-intake reference values and downstream exposure-pathway data; (ii) how the ALARA principle is invoked in the absence of a defensible safe-effect threshold; (iii) how a regulator quantifies the cumulative-exposure consequence of a permissive per-pathway limit (here, the demonstration that the TSD-permissive 3.9 µg Pb/day from toys is ≈50% of the typical alimentary Pb intake of children, an immediately interpretable framing for non-toxicologist audiences). Also a primary-source illustration of the regulatory tension between feasibility-driven migration limits and the agency’s preferred ALARA position — directly relevant to the wiki’s Part 19 rationale-tag vocabulary (feasibility-driven vs regulatory-alignment vs precautionary).

Update history

No substantive edit history is available in this build. The full commit record is available in git.

Referenced by