Overview
The European Food Safety Authority Panel on Food Additives, Flavourings, Processing Aids and Food Contact Materials (AFC) Scientific Opinion on the Safety of Aluminium from Dietary Intake (EFSA Journal 2008;754:1-34, Question Nos EFSA-Q-2006-168 and EFSA-Q-2008-254), adopted on 22 May 2008, established a tolerable weekly intake (TWI) of 1 mg aluminium per kilogram body weight per week, derived from combined evidence on neurotoxicity, testicular toxicity, embryotoxicity and developmental neurotoxicity in mice, rats and dogs after dietary administration of aluminium compounds. The TWI was set as a rounded value between the TWI of 0.7 mg/kg b.w./week obtained by applying a 100-fold uncertainty factor to a developmental-neurotoxicity NOAEL of 10 mg aluminum (Al)/kg b.w./day in mice and the TWI of 1.2 mg/kg b.w./week obtained by applying a 300-fold uncertainty factor (100 × 3 for LOAEL-to-NOAEL) to the corresponding LOAEL of 50 mg Al/kg b.w./day. The opinion replaced the 1990 Scientific Committee for Food endorsement of the prior JECFA provisional tolerable weekly intake of 7 mg Al/kg b.w./week and aligned EFSA with the revised PTWI of 1 mg/kg b.w./week adopted by JECFA at its 67th meeting (2006). The Panel concluded that the TWI of 1 mg/kg b.w./week is likely to be exceeded in a significant part of the European population, particularly among consumers of foods containing aluminium-containing food additives, infants fed certain formulae, and adults consuming aluminium-containing medications. Subsequent regulatory action on aluminium-containing food additives was issued by the European Commission as Regulation (EU) No 380/2012 amending Annex II to Regulation (EC) No 1333/2008.
Key numbers
Reference points (Section 7, Conclusions):
| Parameter | Value |
|---|---|
| TWI established by EFSA AFC Panel (2008) | 1 mg Al/kg b.w./week |
| Prior JECFA PTWI (declared no longer appropriate) | 7 mg Al/kg b.w./week (endorsed by SCF in 1990) |
| Revised JECFA PTWI (67th meeting, 2006) — aligned with this opinion | 1 mg Al/kg b.w./week |
| Lower TWI bound from NOAEL approach | 0.7 mg Al/kg b.w./week (NOAEL 10 mg Al/kg b.w./day ÷ 100) |
| Upper TWI bound from LOAEL approach | 1.2 mg Al/kg b.w./week (LOAEL 50 mg Al/kg b.w./day ÷ 300) |
| Critical endpoint | Developmental neurotoxicity in mouse offspring (aluminium lactate, dietary) |
| Adoption date | 22 May 2008 |
| Question numbers | EFSA-Q-2006-168 and EFSA-Q-2008-254 |
| Conclusion on Alzheimer’s disease | Available data do not support food-borne aluminium as a risk for developing Alzheimer’s disease |
Lowest NOAELs and LOAELs from dietary administration of aluminium compounds in mice, rats and dogs (Section 7):
| Endpoint | Lowest LOAEL (mg Al/kg b.w./day) | Lowest NOAEL (mg Al/kg b.w./day) |
|---|---|---|
| Neurotoxicity (adult) | 52 | 30 |
| Testicular toxicity (dog, SALP basic) | 75 | 27 |
| Embryotoxicity (rat, aluminium nitrate) | 13 (LOAEL) | 100 (chloride/lactate, dietary) |
| Developing nervous system (mouse, aluminum (Al) lactate) | 50 | 10 (gestation) / 42 (lactation) |
Dietary aluminium exposure across European adults compiled from duplicate-diet studies (Netherlands, Hungary, Germany, Sweden, Italy) and market-basket/total-diet studies (UK, Finland, France) (Section 4):
| Population | Statistic | Aluminium exposure |
|---|---|---|
| Non-occupationally exposed adults (60 kg b.w.) | Country-level mean range | 1.6–13 mg Al/day, i.e. 0.2–1.5 mg Al/kg b.w./week |
| Adults, France | Highest estimated 97.5th percentile dietary exposure | 0.4 mg Al/kg b.w./week |
| Adults, UK | Highest estimated 97.5th percentile dietary exposure | 0.94 mg Al/kg b.w./week |
| Elderly in care, UK | 97.5th percentile dietary exposure | 1.14 mg Al/kg b.w./week |
| Children 3–15 y, France | 97.5th percentile | 0.7 mg Al/kg b.w./week |
| Toddlers 1.5–4.5 y, France | 97.5th percentile | 2.3 mg Al/kg b.w./week |
| Children 4–18 y, UK | 97.5th percentile | 1.7 mg Al/kg b.w./week |
| Children 5–8 y, former West Germany (1988 duplicate diet) | 90th-percentile dietary exposure (the value above which 10% of children fell) | >0.38 mg Al/kg b.w./week |
Potential dietary aluminium exposure in infants 0–3, 4–6, 7–9 and 10–12 months from infant formulae and other foods manufactured specially for infants, FSA 2006 menu-based estimates assuming maximum recommended food amounts (Section 4):
| Age group | Potential dietary exposure (mg Al/kg b.w./week) |
|---|---|
| 0–3 months | 0.10 |
| 4–6 months | 0.20 |
| 7–9 months | 0.43 |
| 10–12 months | 0.78 |
Estimated dietary aluminium exposure in 3-month-old infants (6.1 kg b.w.) from a variety of infant formulae, based on Navarro-Blasco & Alvarez-Galindo (2003) analytical data for reconstituted formulae available on the Spanish market (Section 4):
| Formula type | Reconstituted concentration | Mean dietary exposure (0.7 L/day) | High-consumption exposure (1 L/day) |
|---|---|---|---|
| Milk-based formulae | 0.24–0.69 mg Al/L (mean range) | up to 0.6 mg Al/kg b.w./week | up to 0.9 mg Al/kg b.w./week |
| Soya-based formulae | 0.93 mg Al/L (mean) | 0.75 mg Al/kg b.w./week | 1.1 mg Al/kg b.w./week |
| Breast-fed infants (assumed 1 L/day at 6.1 kg) | reference | <0.07 mg Al/kg b.w./week | — |
The Panel noted that in some individual formulae (both milk-based and soya-based) the aluminium concentration was around four times higher than the means above, leading to roughly four-fold higher potential exposure in infants fed those formulae loyally (Section 4; brand identities not reported in the opinion).
Total dietary exposure as fraction of the TWI:
| Population | Exposure range | Fraction of 1 mg/kg b.w./week TWI |
|---|---|---|
| Adults, country means | 0.2–1.5 mg/kg b.w./week | 20–150% |
| Highly exposed adult consumers | up to 2.3 mg/kg b.w./week | up to 230% |
| Soya-formula-fed 3-month infants (high consumption) | 1.1 mg/kg b.w./week | 110% |
| Milk-formula-fed 3-month infants (high consumption) | 0.9 mg/kg b.w./week | 90% |
Aluminium chemistry and bioavailability (Sections 1, 5.1):
| Parameter | Value |
|---|---|
| CAS number | 7429-90-5 |
| Atomic number / mass | 13 / 26.98 |
| Predominant oxidation state | Al(III) (Al³⁺) |
| Bioavailability from drinking water | ~0.3% |
| Bioavailability from food and beverages (general) | ~0.1% (up to 10-fold variation depending on chemical form and dietary ligands) |
| Plasma-transport carrier | Iron-binding protein transferrin (~89%) and citrate (~11%) |
| Whole-body burden in healthy human | 30–50 mg/kg b.w. |
| Normal serum levels | 1–3 µg/L |
| Normal urinary levels (median / mean, normal renal function) | 3.3 / 8.9 µg/L |
| Estimated whole-body elimination half-life in human | ~50 years (with multi-compartment kinetics; 7 / 50-year half-lives from a single-subject ²⁶Al study) |
Reported aluminium concentrations in food categories (Section 4, compiled from German, French, UK, Irish and Spanish surveys; total aluminium, not speciated):
| Category | Reported concentration |
|---|---|
| Most unprocessed foods | < 5 mg Al/kg |
| Breads, cakes, pastries (biscuits highest), some vegetables (mushrooms, spinach, radish, swiss chard, lettuce, corn salad highest), glacé fruits, dairy products (soft cheese highest), sausages, offals, shellfish, sugar-rich foods, baking mixes, farinaceous products and flours | Mean 5–10 mg Al/kg |
| Tea leaves, herbs, cocoa and cocoa products, spices | Very high mean concentrations (no single anchor reported in the opinion) |
| Drinking water (EU parametric value, indicator parameter, Directive 1998/83/EC) | 200 µg Al/L |
| EU mineral water regulation (Directive 2003/40/CE) | No limit value for aluminium |
EU-authorised maximum levels for aluminium-containing food additives selected from Table 3 (Directive 95/2/EC as modified):
| E-number | Additive | Foodstuff | Maximum level (expressed as Al unless noted) |
|---|---|---|---|
| E 520–523 | Aluminium sulphate, sodium/potassium/ammonium sulphates | Egg white | 30 mg/kg |
| E 520–523 | Same | Candied, crystallised and glacé fruit and vegetables | 200 mg/kg, individually or in combination |
| E 541 | Sodium aluminium phosphate, acidic | Fine bakery wares (scones and sponge wares only) | 1 g/kg |
| E 554/E 555/E 556/E 559 | Sodium / potassium / calcium aluminium silicate, aluminium silicate (kaolin) | Dietary food supplements, tablet/coated tablet foodstuffs | quantum satis |
| E 554/E 555/E 556/E 559 | Same | Seasonings, tin-greasing products | 30 g/kg |
| E 554/E 555/E 556/E 559 | Same | Dried powdered foodstuffs (incl. sugars), salt and substitutes, sliced or grated cheese, cheese analogues | 10 g/kg |
| E 558, E 559 | Bentonite, kaolin (as carriers in colours) | — | max. 5% |
| E 1452 | Starch aluminium octenyl succinate | Encapsulated vitamin preparations in food supplements | 35 g/kg |
| E 173 | Aluminium metal | External coating of sugar confectionery and decoration of cakes and pastries | quantum satis (Directive 94/36/EC) |
Aluminium-containing additives authorised in food-contact plastics under Directive 2002/72/EC (Table 2) include aluminium calcium hydroxide phosphite hydrate (Ref 34475), aluminium fibres, flakes and powders (Ref 34480), aluminium hydroxide (Ref 34560), aluminium hydroxybis[2,2′-methylenebis(4,6-di-tert-butylphenyl)phosphate] (Ref 34650, SML = 5 mg/kg), aluminium magnesium carbonate hydroxide (Ref 34690), aluminium oxide (Ref 34720) and silicic acid, lithium aluminium salt (Ref 85760, SML(T) relative to lithium).
Methods (brief)
Scientific opinion synthesising the chemistry, sources, regulated uses, dietary exposure and biological/toxicological data on aluminium in food. The opinion does not generate primary measurements; it compiles and re-evaluates existing literature, EU food-additive directives (95/2/EC, 94/36/EC, 2002/72/EC, 96/77/EC, 95/45/EC), drinking-water and mineral-water regulations (Directives 98/83/EC and 2003/40/CE), JECFA assessments (1985, 1989, 2006 67th meeting), Codex monographs, IPCS Environmental Health Criteria 194 (WHO 1997), and individual peer-reviewed studies on absorption, distribution, excretion, acute and subchronic toxicity, genotoxicity, carcinogenicity, reproductive and developmental toxicity, and neurotoxicity. Dietary-exposure estimates are taken from duplicate-diet studies (Netherlands, Hungary, Germany, Sweden, Italy) and market-basket/total-diet studies (UK, France, Finland, Ireland, Spain), and from the UK Food Standards Agency 2006 Survey of Metals in Weaning Foods and Formulae for Infants (FSA Food Survey Information Sheet FSIS 17/06). Infant-formula exposure estimates rely on Navarro-Blasco & Alvarez-Galindo (Food Additives and Contaminants 20:470–481, 2003) for Spanish-market formulae. Reported concentrations are total aluminium; the underlying analytical methods (typically ICP-MS or GFAAS in the cited surveys) are described in the original references, not in this opinion. Toxicological reference points are derived from dietary studies in mice, rats and dogs that used soluble aluminium salts (lactate, chloride, nitrate, sulphate) or sodium aluminium phosphate (SALP, acidic and basic).
Limitations stated by the Panel: dietary studies determine total aluminium content of food, not individual aluminium compounds or species, so source attribution between natural background, food-additive use, and migration from food-contact materials is not possible; most biochemical and toxicological studies did not measure background aluminium in the basal diet, so stated doses likely underestimate total aluminium exposure; few studies report NOAELs and LOAELs in the dose ranges relevant to dietary exposure; and there are no specific toxicological data on most aluminium-containing food additives apart from SALP (acidic).
Implications
Certification: this opinion contributes the EU-level TWI of 1 mg Al/kg b.w./week (total aluminium) and a quantified exposure distribution against that TWI — soya-based-infant-formula-fed 3-month infants at ~110% of the TWI under the Navarro-Blasco high-consumption scenario, UK toddlers (1.5–4.5 y) at 230% of the TWI at the 97.5th percentile, UK elderly in care at 114% of the TWI, and country-mean adult exposures spanning 20–150% of the TWI. These figures are the regulatory-baseline evidence on aluminium exposure for the matrices the opinion covers (infant formulae, bakery and cereals, drinking water, foods using aluminium-containing additives, and foods in contact with aluminium foils/cookware) and should be read alongside any later EFSA aluminium publications (e.g., the 2021 Q&A summarised at Aluminium in Food (Q&A): Sources, Safety and Regulations) when those become contributing sources to the synthesis pass.
Courses: regulatory-affairs course materials cite this opinion as the European derivation of the 1 mg/kg b.w./week TWI and as the source for the “TWI is likely to be exceeded” conclusion that drives precautionary reformulation pressure on bakery, dairy, infant-formula, and food-additive sectors.
App: aluminium exposure estimates in the app for infant-formula consumers should use the per-form values reported here (mean 0.6 mg/kg b.w./week milk-based, 0.75 mg/kg b.w./week soya-based; high 0.9 and 1.1 mg/kg b.w./week respectively) until superseded by EFSA’s later opinions or by the FSA 2013 update. The Panel’s observation that some individual formulae were ~4× higher than the mean is an important variance signal for the high-end exposure tail.
Microbiome: not applicable. The opinion does not address gut-microbiome effects of aluminium.
Related evidence
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