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

Abstract

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 (95 th /97.5 th ) 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. KEY WORDSHigh viscosity white mineral oils; CAS Number 8042-47-5; Liquid paraffin; Paraffinum Liquidum. SUMMARYFollowing a request from the European Commission to the European Food Safety Authority, the Scientific Panel on Food Additives and Nutrient Sources added to Food (ANS) was asked to evaluate the safety-in-use of high viscosity white mineral oils as food additives.In 1995, the EC Scientific Committee for Food (SCF) (1995) evaluated the safety of mineral and synthetic hydrocarbon oils and waxes for use as food additives, in food processing and for use in food packaging materials. The SCF did not allocate an Acceptable Daily Intake (ADI) for those products which, in F344 rats, showed accumulation of hydrocarbons in the liver and lymph nodes associated with a granulomatous response, since it was felt that from the 90-day studies available at that time it was not possible to set a safe level for intake from food. These products included white mineral oils with a viscosity equal to or less than 8.5 cSt at 100°C. For the mineral hydrocarbon products which showed no or minimal accumulation and no toxicity within the duration of a 90-day study in rats the SCF allocated a Temporary Group ADI of 0-4 mg/kg bw for white paraffinic oils. These products included white mineral oils with a viscosity higher than 8.5 ...

Risk assessment of beeswax adulterated with paraffin and/or stearin/stearic acid when used in apiculture and as food (honeycomb)

“…The highest exposure estimate was for high consumers among children aged 3 to 10 years (P95 ranging from 0.14 to 0.32 mg/kg bw/day) (EFSA CONTAM Panel, 2012). Based on data collected in the period 1999-2009, the ANS Panel estimated the dietary exposure to high viscosity and medium viscosity mineral oils intended for use as food additives (EFSA ANS Panel, 2009, 2013b. For adults, the mean exposure to these saturated hydrocarbons was between 0.9 and 1.8 mg/kg bw/day and the highest exposure estimate was for toddlers (P95 ranging from 6 to 10.1 mg/kg bw/day).…”