SCHEER 2017 — Tolerable intake of aluminium: review for toy migration limit adaptation
The Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) was commissioned by the European Commission to review available aluminium toxicity data and advise on a tolerable intake level suitable for adapting migration limits for aluminium in toys under the Toy Safety Directive 2009/48/EC. This opinion reviews and synthesizes the EFSA 2008 TWI (1 mg Al/kg bw/week) and JECFA 2011 PTWI (2 mg Al/kg bw/week), and concludes that a TDI of 0.3 mg Al/kg bw/day is appropriate for toy migration limit calculation, derived from the NOAEL of 30 mg/kg bw/day in Poirier et al. (2011). The opinion notes that dietary aluminium exposure in children frequently already exceeds both EFSA and JECFA reference values, particularly for soy-based formula-fed infants.
Key numbers
Health-based guidance values reviewed:
- EFSA (2008) TWI: 1 mg Al/kg bw/week, derived using weight-of-evidence from rodent and dog studies (LOAEL range 50–100 mg/kg bw/day, NOAEL range 10–100 mg/kg bw/day; assessment factor 100 with additional factor 3 for LOAEL).
- JECFA (2007) PTWI: 1 mg Al/kg bw/week (superseded).
- JECFA (2011) PTWI: 2 mg Al/kg bw/week, based on NOAEL 30 mg/kg bw/day (Poirier et al. 2011, aluminium citrate in rat, GLP-compliant, 12-month neurodevelopmental study).
- SCHEER (2017) TDI: 0.3 mg Al/kg bw/day (= 2.1 mg/kg bw/week), equivalent to the JECFA 2011 basis.
Dietary exposure in children:
- EU children aged 3–15 years: 97.5th percentile 0.7–2.3 mg/kg bw/week (France); 2.3 mg/kg bw/week (UK, 1.5–4.5 years).
- Infants (breast-fed): < 0.07 mg/kg bw/week.
- Infants on infant formula: 0.10–0.78 mg/kg bw/week (0–12 months), highest in soy-based formula.
- Ready-made milk formula: 176–700 µg Al/L; powder form: 2.4–4.3 µg Al/g.
- Norwegian children (1-year-olds): mean 0.89 mg/kg bw/week, 95th percentile 1.9 mg/kg bw/week.
Foods highest in aluminium (EFSA 2008 data cited): tea leaves, herbs, cocoa and cocoa products, spices (highest concentrations); bread/cakes/biscuits/baking mixes, some vegetables (mushrooms, spinach, radish), dairy, sausages, shellfish 5–10 mg Al/kg; most other foods < 5 mg Al/kg.
Resulting toy migration limits (SCHEER 2017, allocating 10% of TDI to toys): 2250 mg Al/kg dry/pliable material; 560 mg Al/kg liquid/sticky material; 28130 mg Al/kg scraped-off material.
Methods (brief)
Systematic literature review (2008–2017), PubMed and European Commission Library databases, 47 publications identified, 30 selected. Evaluation of EFSA 2008, JECFA 2007 and 2011, WHO 2010, SCCS 2014 opinions. No new primary animal study data; reference animal study is Poirier et al. (2011) GLP rat neurodevelopmental toxicity study. No LOD/LOQ (opinion-level document, not analytical measurement study).
Implications
Certification: Key reference for the Al TDI landscape. The JECFA 2011 PTWI (2 mg/kg bw/week) and EFSA 2008 TWI (1 mg/kg bw/week) remain the operative reference values for dietary exposure assessment. Dietary exposures in children can approach or exceed the EFSA TWI, especially toddlers and soy-formula-fed infants. Spices, herbs, cocoa, and tea are flagged as high-Al food categories. The gap between EFSA (1 mg/kg bw/week) and JECFA (2 mg/kg bw/week) is a documented regulatory inconsistency.
Courses: Illustrates how multiple regulatory bodies derive different reference values from the same underlying study set, and why EFSA’s more conservative TWI may be routinely exceeded by certain dietary patterns.
App: Confirms that herbs, spices, cocoa, and tea are highest-Al food categories. Soy-based infant formula is flagged as a high-exposure matrix for infants.