Overall EFSA conclusion on ACF - Review of EFSA Opinion

This is a paper for discussion.

This does not represent the views of the Committee and should not be cited.

229.             The Panel considered that there was uncertainty regarding the extent of the internal exposure to E171 TiO2 nanoparticles across the range of tested doses. The Panel considered that the effect of E 171 in producing ACF reported by Bettini et al. (2017) was not replicated in later investigations (EOGRT study and Blevins et al., 2019).

230.             One source of uncertainty was that it was noted that there were methodological limitations in Blevins et al. A further source of uncertainty is being unclear to what extent animals were exposed to TiO2 Nanoparticles in both the EOGRT study and Blevins et al. The Panel concluded that E 171 may induce ACF in male rats at a dose of 10 mg/kg bw per day when the test substance is pre-dispersed and stabilised in a liquid medium preventing agglomeration of nanoparticles prior to administration by gavage.