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Scientific Opinion on the use of high viscosity white mineral oils as a food additive

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The Panel on Food Additives and Nutrient Sources added to Food (ANS) provides a scientific opinion on the safety of high viscosity white mineral oils (HVMO) (CAS Registry Number 8042-47-5) when used as food additives. HVMO have previously been evaluated by the EC Scientific Committee for Food (SCF) (1995) and the Joint FAO/WHO Expert Committee on Food Additives (JECFA) (1995, 2002). The SCF allocated a Temporary Group ADI of 0-4 mg/kg bw/day for white paraffinic oils which included white mineral oils with a viscosity higher than 8.5 cSt at 100°C. In 2002, JECFA recommended an ADI of 0 – 20 mg/kg bw/day for HVMO. Dietary exposure to HVMO did not produce adverse effects in subchronic toxicity and chronic toxicity/carcinogenicity studies in rats. Infiltration of histiocytes (granulomas) in mesenteric lymph nodes and oil deposition in the liver were considered to be an indication of exposure to white mineral oils rather than an adverse effect. The NOAEL for HVMO was considered to be 1200 mg/kg bw/day, the highest dose tested. Using this NOAEL and applying an uncertainty factor of 100 the Panel established an ADI of 12 mg/kg bw/day for HVMO (kinematic viscosity ≥ 11 mm²/s (cSt) at 100 °C, a carbon number > 28 at 5 % distillation point and an average molecular weight > 500 g/mol). The Panel considered the dietary exposure to HVMO from current uses as well as proposed uses, and estimated that the potential dietary exposures for high level consumers (95th/97.5th) would reach up to approximately 13 mg/kg bw/day for adults and 19 mg/kg bw/day for children. The Panel considers these estimates to be very conservative since high levels of exposure from different sources, in consumers only, have been added up.