EFSA Releases Updated Risk Assessment of MOH in Food

The Scientific Panel on Contaminants in the Food Chain (CONTAM Panel) of the European Food Safety Authority (EFSA) recently released an updated risk assessment of mineral oil hydrocarbons (MOH). The European Commission (EC) had requested the re-evaluation in 2020 as it considered whether to establish maximum levels for MOH in certain food items. More specifically, the EC asked EFSA to assess the toxicity studies on MOH that had become available since EFSA’s 2012 opinion, estimate exposure levels of MOH, and update risk characterizations of MOH based on recent data.

MOH fall into two main classifications: mineral oil-saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH). In performing their risk characterization, the Panel utilized separate margin of exposure (MOE) approaches for MOSH and MOAH. EFSA used available data in food samples to calculate ranges of exposure to MOSH and MOAH across the different age classes, taking into account the guidance developed in 2019 by the Joint Research Centre on analysis of MOH in foodstuffs.  

Regarding MOSH, the CONTAM Panel used the MOE approach due to limitations in the dataset that did not allow for setting a health-based guidance value (HBGV). For the risk characterization, an extra factor of 6 was added to the default of 200, indicating an MOE of greater than or equal to 1,200 of low concern for human health. For MOSH, a lack of critical effects was clearly identified, and the reference point (RP) was the highest dose in a F344 rat study on a white mineral oil product virtually free of wax components. Based on the calculated MOEs, the Panel concluded that it is likely to very likely (66-95% certain) that present dietary exposure to MOSH does not raise concerns for human health for all age groups, including toddlers. 

Concerning MOAH with three or more aromatic rings, the Panel conducted the MOE assessment based on the possible presence of genotoxic and carcinogenic components, with an MOE of greater than or equal to 10,000 being considered of low concern for human health. They used a surrogate RP approach derived from the increased incidence of total tumor-bearing animals observed in a carcinogenicity study of non-alkylated polycyclic aromatic hydrocarbons (PAH), using the sum of eight PAH. The CONTAM Panel concluded that it is extremely likely (99-100% certain) that MOEs lower than 10,000, raising concern for human health, are present for mean and high-consuming toddlers. For other age groups, it is likely (above 66%) that MOEs are below 10,000. However, the Panel stated that additional toxicity and exposure data are needed to conduct a final risk assessment of three or more aromatic ring MOAH. Due to the lack of adequate oral toxicity studies on 1-2 ring MOAH, a risk characterization could not be performed. The Panel concluded that without reliable data, dietary exposure to these MOAH might raise a concern.

Several recommendations were made on data needs for MOSH and MOAH. EFSA did recommend that the EC and Member States update the current specifications for mineral (white) oils and waxes used as food additives and in food packaging materials in order to reduce the risks related to the presence of MOAH.