ALUMINIUM

Comments:

New data did not substantially change the LOAEL range of 50–75 mg/kg bw per day, but one of the studies also provided a NOAEL of 30 mg/kg bw per day. This NOAEL was identified from a study in which aluminium citrate was administered in drinking-water. Aluminium citrate is more soluble than many other aluminium compounds and is likely to be more bioavailable from drinking-water than from food. The Committee concluded that the NOAEL of 30 mg/kg bw per day was an appropriate basis for establishing a PTWI for aluminium compounds.

Intake:

For adults, the estimates of mean dietary exposure to aluminium-containing food additives from consumption of cereals and cereal-based products are up to the PTWI of 2 mg/kg bw. Estimates of dietary exposure of children to aluminium-containing food additives, including high-level dietary exposure, can exceed the PTWI by up to 2-fold.

Tolerable Intake:

PTWI of 2 mg/kg bw

Report: 

Addendum: 

Comments:

The previously established ADIs and PTWI for aluminium compounds were withdrawn. The Committee concluded that aluminium compounds have the potential to affect the reproductive system and developing nervous system at doses lower than those used in establishing the previous PTWI and the PTWI was therefore revised. The available studies have many limitations and are not adequate for defining dose?response relationships. The Committee therefore based its evaluation on the combined evidence from several studies. The relevance of studies involving administration of aluminium compounds by gavage was unclear because the toxicokinetics after gavage were expected to differ from toxicokinetics after dietary administration, and these gavage studies generally did not report total aluminium exposure including basal levels in the feed. The studies conducted with dietary administration of aluminium compounds were considered most appropriate for the evaluation. The lowest LOELs for aluminium compounds in a range of different dietary studies in mice, rats and dogs were in the range of 50?75 mg/kg bw per day, expressed as Al. The Committee applied an uncertainty factor of 100 to the lower end of this range of LOELs (50 mg/kg bw per day expressed as Al) to allow for inter- and intraspecies differences. There are deficiencies in the database, notably the absence of NOELs in the majority of the studies evaluated and the absence of long-term studies on the relevant toxicological end-points. These deficiencies are counterbalanced by the probable lower bioavailability of the less soluble aluminium compounds present in food. Overall, it was considered appropriate to apply an additional uncertainty factor of three. The Committee confirmed that the resulting health-based guidance value should be expressed as a PTWI, because of the potential for bioaccumulation. The Committee noted that the PTWI is likely to be exceeded to a large extent by some population groups, particularly children, who regularly consume foods that include aluminium-containing additives. The Committee also noted that dietary exposure to Al is expected to be very high for infants fed on soya-based formula.

Tolerable Intake:

PTWI 1 mg/kg bw (expressed as Al)

Meeting:

67

Report: 

Tox Monograph: 

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