Scientific opinion on the safety assessment of medium viscosity white mineral oils with a kinematic viscosity between 8.5 – 11 mm2/s at 100 °C for the proposed uses as a food additive

The Panel on Food Additives and Nutrient Sources added to Food (ANS) delivers a scientific opinion evaluating the safety in use of medium viscosity white mineral oil (MVMO) (kinematic viscosity between 8.5 – 11 mm²/s at 100 °C) as a food additive. In 2009, EFSA evaluated the safety of high viscosity white mineral oils (HVMO) (kinematic viscosity ≥ 11 mm²/s at 100 °C). In this evaluation, the ANS Panel considered as pivotal a 2-year feeding study in the rat on chronic toxicity and carcinogenicity of two mineral oils: MVMO and HVMO. Based on the results of the study the Panel concluded that no carcinogenic effect was observed in F344 rats tested with MVMO and HVMO. The ANS Panel considered the NOAEL for both MVMO and HVMO in the above study to be 1200 mg/kg bw/day, the highest dose tested. Presently the Panel confirmed this conclusion and established a group ADI of 12 mg/kg bw/day for HVMO (kinematic viscosity ≥11 mm²/s at 100 °C) and for MVMO (kinematic viscosity between 8.5 - 11 mm²/s at 100 °C). The Panel noted that conservative estimates indicated that the potential dietary intake of MVMO and/or HVMO from the proposed uses and use levels as food additive in high consumers would reach up to approximately 10.1 mg/kg bw/day for toddlers. This exposure is below the established group ADI. The Panel also noted that additional exposure to MVMO and/or HVMO via other sources could represent a major source of exposure. With the data presently available it is difficult to draw conclusions as to the magnitude of exposure and the number of consumers affected by this potential additional exposure.