Further to its May 2017 preliminary opinion, and following a public consultation, SCHEER has finalised its position on a tolerable daily intake (TDI) for aluminium. The proposed TDI of 0.3 mg/kg bw (including exposure from sources other than toys) was upheld, with neurodevelopmental toxicity in rats deemed the critical effect. From the key study, a no‑observed-adverse-effect level (NOAEL) of 30 mg/kg bw/day was used as the point of departure, with application of a default assessment factor of 100. From its TDI, SCHEER went on to calculate various new migration limits for aluminium under the Toy Safety Directive (2009/48/EC), however as it was noted that exposure to aluminium from other sources, particularly the diet, may already exceed tolerable intakes, SCHEER recommends that any additional exposure from toys should be minimised.

Scientific Committee on Health, Environmental and Emerging Risks (2017). Final opinion on tolerable intake of aluminium with regards to adapting the migration limits for aluminium in toys. https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/scheer_o_009.pdf

The comments from the public consultation and SCHEER’s responses are available at: https://ec.europa.eu/health/sites/health/files/scientific_committees/scheer/docs/followup_cons_alintoys_en.pdf

 

The above items were taken from the December 2017 issue of Toxicology and Regulatory News which is sent automatically to members of bibra.

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