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

Following a request from the European Commission, the Scientific Committee on Health, Environmental and Emerging Risks (SCHEER) hereby reviews the currently available data on the toxicity of aluminium, taking into account the different tolerable intake levels for aluminium established by the European Food Safety Authority in 2008 and by the Joint FAO/WHO Expert Committee on Food Additives in 2011, and presents its recommendation for a tolerable intake level for aluminium based on most recent data that could be used to adapt the migration limits for aluminium in the Toy Safety Directive 2009/48/EC, taking into account the exposure to aluminium from sources other than toys. The SCHEER is of the opinion that for the time being the study by Poirier et al. from 2011 is the fundamental study for the derivation of a health-based limit value. Using the NOAEL of 30 mg/kg bw/d from this study (based on neuro-developmental effects seen at 100 mg/kg bw/d) as the Point of Departure and applying the default assessment factor of 100, a tolerable daily intake (TDI) of 0.3 mg/kg bw/d is considered appropriate by the SCHEER for the calculation of migration limits for aluminium from toys. The resulting migration limits for aluminium from toys, calculated according to the current legislation, which allocates 10% of the tolerable daily intake to toys, are 2250 mg aluminium/kg of dry, brittle, powder-like or pliable toy material, 560 mg aluminium/kg of liquid or sticky toy material and 28130 mg aluminium/kg of scraped-off toy material. However, the SCHEER noted that exposure to aluminium from sources others than toys, in particular from diet, which is by far the major source of chronic exposure, may already exceed the reference value for tolerable weekly intake as derived by JECFA. Therefore, the SCHEER recommends that the additional exposure from toys should be minimised.