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Final Opinion on tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toys

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 the migration limits for aluminium in toys under Toy Safety Dire...

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Overview

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 the migration limits for aluminium in toys under Toy Safety Directive 2009/48/EC. This opinion synthesises the EFSA 2008 TWI (1 mg Al/kg bw/week), the JECFA 2007 (superseded) and JECFA 2011 PTWI (2 mg Al/kg bw/week), the WHO 2010 drinking-water guideline, the ATSDR 2008 profile, and the SCCS 2014 cosmetics opinion. It 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), a GLP twelve-month neurodevelopmental study of aluminium citrate in Sprague-Dawley rats. The opinion notes that dietary aluminium exposure in children frequently already exceeds both the EFSA and JECFA reference values, particularly for soy-based formula-fed infants, and recommends that aluminium exposure from toys should be minimised.

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  • JECFA (2007) PTWI: 1 mg Al/kg bw/week (superseded in 2011).
  • JECFA (2011) PTWI: 2 mg Al/kg bw/week, based on NOAEL 30 mg Al/kg bw/day from Poirier et al. (2011) — GLP twelve-month neurodevelopmental study of aluminium citrate in Sprague-Dawley rats; LOAEL 100 mg/kg bw/day for neuromuscular endpoints (hind-limb and fore-limb grip strength); assessment factor 100.
  • SCHEER (2017) TDI: 0.3 mg Al/kg bw/day (equivalent to ~2.1 mg/kg bw/week), derived from the same NOAEL and assessment factor as JECFA 2011 and used as the basis for the toy migration limits below.

Dietary exposure in children (the food-relevant inputs to this opinion):

  • 97.5th-percentile dietary Al intake in EU children (EFSA 2008 data, cited in opinion): 0.7–2.3 mg/kg bw/week for children aged 3–15 years in France; 2.3 mg/kg bw/week for 1.5–4.5-year-olds in the UK; 1.7 mg/kg bw/week for 4–18-year-olds in the UK.
  • Breast-fed infants: < 0.07 mg/kg bw/week.
  • Infants on formula, 0–12 months: 0.10–0.78 mg/kg bw/week, highest in soy-based formula.
  • Ready-made (liquid) infant formula: 176–700 µg Al/L.
  • Powdered infant formula: 2.4–4.3 µg Al/g (as powder).
  • According to Burrell & Exley (2010), cited in the opinion: a 6-month-old infant ingests 200–600 µg Al/day from infant formula, in line with EFSA’s range.
  • Norwegian children (Norwegian Scientific Committee for Food Safety 2013 dossier, cited in opinion): 1-year-olds mean 0.89 mg/kg bw/week, 95th-percentile 1.9 mg/kg bw/week; 2-year-olds mean 0.88, 95th 1.7; 4-year-olds 0.53 mean / 0.90 95th; 9-year-olds 0.35 mean / 0.66 95th; 13-year-olds 0.22 mean / 0.49 95th (all mg/kg bw/week).
  • US FDA Total Diet Study (Pennington & Schoen 1995, via ATSDR 2008, cited in opinion): dietary Al intake 0.10–0.18 mg/kg bw/day overall (0.7–1.26 mg/kg bw/week); 0.35 and 0.30 mg/kg bw/day for 2-year-olds and 6-year-olds respectively; up to 0.161 mg Al/day in soy-formula-fed infants.

Aluminium-containing food additives — EFSA 2013 exposure estimates cited in this opinion:

  • Five additives evaluated: aluminium ammonium sulphate (E 523), sodium aluminium phosphates acidic/basic (E 541), sodium aluminosilicate (E 554), calcium aluminosilicate (E 556), aluminium silicate (E 559).
  • Scenario 1 (CCFA-recommended maximum levels): mean intakes 2.3–76.9 mg/kg bw/week across five population groups (toddlers, children, adolescents, adults, elderly); 95th-percentile 7.4–145.9 mg/kg bw/week.
  • Scenario 2 (broader recommendation set): mean 18.6–156.2 mg/kg bw/week; 95th-percentile 35.3–286.8 mg/kg bw/week.
  • For all five population groups in both scenarios, the mean and 95th-percentile intake from these five additives alone largely exceed the EFSA (2008) TWI of 1 mg/kg bw/week.

Foods highest in aluminium (EFSA 2008 data cited in opinion): tea leaves, herbs, cocoa and cocoa products, and spices (highest concentrations); bread, cakes, biscuits, baking mixes, some vegetables (mushrooms, spinach, radish), dairy, sausages, and shellfish in the range 5–10 mg Al/kg; most other foods < 5 mg Al/kg. ATSDR (2008) reports major sources in the North American diet as milk and dairy (36%), fish and crustaceans (29%), cereals (16%), and vegetables (8%).

Non-dietary aluminium sources (briefly summarised in opinion):

  • Drinking water: typical post-treatment concentration < 0.2 mg Al/L, equivalent to up to 0.2 mg/d (≈0.02 mg/kg bw/day for a 10 kg child) (JECFA 2007).
  • Food contact materials: Council of Europe specific release limit (SRL) of 5 mg Al/kg food (CM/Res(2013)9); migration from aluminium cookware increases with food acidity (pH 2.2–7), temperature, contact time, and salt content (Fekete et al. 2012).
  • Dust/soil: in 2- to 7-year-old US children, mean Al in food 30.2 µg/g (range 3.2–91.6), Al from soil and dust accounted for mean 6.6% of intake (range 5.1–7.6); household dust contained mean 1.9% Al by weight (Davis et al. 1990).
  • Inhalation generally minor for the general population; cosmetic/antiperspirant dermal exposure considered uncertain by SCCS (2014).

Resulting toy migration limits (SCHEER 2017, allocating 10% of TDI to toys; body weight 7.5 kg; daily ingested toy-material amounts 100 mg dry/pliable, 400 mg liquid/sticky, 8 mg scraped-off):

  • 2250 mg Al/kg dry, brittle, powder-like, or pliable toy material.
  • 560 mg Al/kg liquid or sticky toy material.
  • 28130 mg Al/kg scraped-off toy material.

(Current Toy Safety Directive 2009/48/EC limits, based on the 2008 RIVM TDI of 0.75 mg Al/kg bw/day: 5625 mg/kg dry, 1406 mg/kg liquid, 70000 mg/kg scraped-off — i.e., 2.5× looser than the SCHEER 2017 proposal across all three material categories.)

Methods (brief)

Literature review covering 01/01/2008–31/01/2017 against the European Commission Library and PubMed, using thirteen “aluminium OR aluminum AND ” search strings. Forty-seven publications identified; thirty selected for inclusion (bioavailability, immune-system effects, neurotoxicity, exposure). No additional chronic-toxicity study yielding a new NOAEL was identified post-2011. SCHEER evaluated EFSA 2008, JECFA 2007 and 2011, ATSDR 2008, WHO 2010, SCCS 2014, CSTEE 2004, RIVM 2008, SCHER 2010, COT 2013, and the Norwegian VKM 2013 dossier. The Poirier et al. (2011) GLP twelve-month rat neurodevelopmental study (aluminium citrate in drinking water, doses 30/100/300 mg Al/kg bw/day, gestational day 6 through postnatal day 364, 20 litters per dose, neuro-histopathology + functional observational battery + Morris water maze) is the reference study supporting the NOAEL of 30 mg/kg bw/day. No primary analytical measurements were performed; LOD/LOQ not applicable (opinion-level document). Public consultation 7 July – 10 September 2017 received ten comments from nine contributors; SCHEER concluded none warranted changes to the final opinion.

Implications

Certification: Key reference for the Al TDI landscape. The JECFA (2011) PTWI of 2 mg Al/kg bw/week and the EFSA (2008) TWI of 1 mg Al/kg bw/week remain the operative reference values cited by SCHEER for dietary exposure assessment. Dietary exposures in EU children — and especially in soy-formula-fed infants — can approach or exceed the EFSA TWI on their own, before contributions from drinking water, cookware migration, or non-dietary sources are added. The two-fold gap between the EFSA TWI (1 mg/kg bw/week) and the JECFA PTWI (2 mg/kg bw/week) is a documented regulatory inconsistency that SCHEER does not resolve. Herbs, spices, cocoa products, and tea are flagged as the highest-Al food categories per the EFSA 2008 data the opinion cites. EFSA’s 2013 exposure assessment of five permitted aluminium-containing food additives indicates that mean and 95th-percentile intakes from those additives alone exceed the EFSA TWI across all five population groups.

Courses: Illustrates how multiple regulatory bodies derive different tolerable-intake reference values from largely overlapping study sets (EFSA 1 mg/kg bw/w vs JECFA 2 mg/kg bw/w vs SCHEER 0.3 mg/kg bw/d for toys), and why the more conservative EFSA TWI may be routinely exceeded by certain dietary patterns even before non-food exposures are considered. Also a worked example of how a 10% allocation factor from a tolerable intake to a specific exposure source (here, toys; analogously, food contact materials or cosmetics) is operationalised into migration or release limits.

App: Confirms that herbs, spices, cocoa, and tea are highest-Al food categories per EFSA 2008. Soy-based infant formula is flagged as a high-exposure matrix for infants. Aluminium cookware contact with acidic or salty foods (vinegar, tomato, apple puree, salted herring, pickles) is named explicitly as elevating Al transfer.

Verification notes

  • 2026-05-28 (v2.0 manual-fetch merge-enhance of the 2026-05-14 batch-ingest page).
  • Legacy raw_handle manual-fetch-source-retrieval replaced with per-PDF MFK_ form (MFK_efsa-opinion-on-tolerable-intake-of-aluminium-with) per current convention.
  • Truncated raw_path (…foo.pdf) restored to full filename (…food additives.pdf).
  • Added raw_sha256, access_url (EU Publications Office), and tier_rationale.
  • products: ["infant-formula"] converted to wikilink form ["[[products/infant-formula]]"]. Scope kept at the umbrella per the broad-not-narrow rule — the opinion cites combined infant-formula data (both ready-made liquid and powder, both soy and non-soy) rather than splitting subtypes.
  • matrices expanded to include drinking-water and food-contact-materials, which the opinion treats as explicit non-food contributors to total Al exposure.
  • Key numbers expanded to capture: (i) Poirier et al. 2011 study design detail; (ii) EFSA 2013 food-additives exposure estimates (E 523, E 541, E 541, E 554, E 556, E 559) under both scenarios; (iii) US FDA Total Diet Study figures; (iv) ATSDR 2008 dietary-source breakdown; (v) drinking-water, food-contact-material, and soil/dust contributions; (vi) Norwegian VKM 2013 children’s intake by age band; (vii) parenthetical comparison to current TSD 2009/48/EC limits showing the SCHEER proposal is 2.5× tighter.
  • Methods section expanded to record literature-search dates and string count, opinions reviewed, and public-consultation outcome.
  • No primary brand-attributed contamination data in the source; no Part 12 brand-firewall edits required.
  • No synthesis claims; no HMTc threshold proposals (Part 2 firewall intact).
  • This is fundamentally a toys-and-dietary-exposure regulatory opinion, not a primary food-contamination measurement study. It enters the HMI corpus because (a) it is the operative EU summary of Al dietary-exposure data through 2017, including infant formula and the high-Al condiments (herbs/spices/cocoa/tea) that the containing folder targets, and (b) it documents the EU regulatory inconsistency between the EFSA TWI and the JECFA PTWI relevant to any Al threshold-setting work.

editorial review audit findings (2026-05-28) verified against source

  • Audit Check 1 ⚠️ “France 1.5–4.5 years” age-band attribution: verified against PDF p.19 — corrected. The 0.7–2.3 mg/kg bw/w range belongs to France 3–15 years; the 1.5–4.5 y attribution belongs only to the UK 2.3 value.
  • Audit Check 3 ⚠️ “fourteen” search strings: verified against PDF p.10 — corrected to thirteen. PDF lists exactly thirteen bulleted “aluminium OR aluminum AND ” strings.
  • Audit Check 2 ⚠️ [[metals/aluminium]] → corrected to [[metals/aluminum]] (canonical page slug uses US spelling).
  • Audit Check 2 ⚠️ [[regulations/efsa-aluminium-twi-2008]] → corrected to [[regulations/efsa-aluminium-twi]] (the actual page slug carries no year suffix).
  • Audit Check 2 ⚠️ [[regulations/jecfa-aluminium-ptwi-2011]] → flagged as missing-slug proposal; no regulation page yet covers the JECFA 2011 PTWI revision. Per Part 10, regulations get pages on first encounter; this proposal is surfaced for next regulation-page-creation pass rather than silently invented here.
  • Audit Check 2 ❌ products: ["[[products/infant-formula]]"] flagged as missing-slug: verified false positive. the linked reference record exists in the current taxonomy and the routing audit fans this source to that page as locked_hmtc_row direct_evidence plus four broad-formula-context siblings. The editorial review’s taxonomy snapshot appears to omit the umbrella infant-formula slug; not changed.
  • Audit Check 2 ⚠️ matrix vocabulary novelty: noted; matrices field uses descriptive functional categories (dietary-intake, infant-formula, drinking-water, food-contact-materials) that match patterns used by other Al-context sources in the corpus and pass the routing audit cleanly; not changed.

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