Rapid risk assessment on the possible risk for public health due to the contamination of infant formula and follow‐on formula by mineral oil aromatic hydrocarbons (MOAH)

First published in EFSA Supporting Publications
21 November 2019
Technical Report


Following the detection of mineral oil aromatic hydrocarbons (MOAH) in batches of infant and follow‐on formula in France, Germany and the Netherlands reported by foodwatch, the European Commission (EC) asked Member States (MS) to analyse the concerned batches and to investigate possible contamination sources; and mandated EFSA to perform a rapid assessment on the health risks related to the presence of MOAH in infant and follow‐on formula. MOAH may include the presence of genotoxic and carcinogenic 3‐7 ring polycyclic aromatic compounds (3‐7 PAC). The EFSA opinion of June 2012 on mineral oil hydrocarbons identified a potential health concern related to the presence of these compounds in MOAH. For the current assessment, EFSA received only limited occurrence data from two MS (Austria and Germany), in addition to the data published by foodwatch and data from Specialised Nutrition Europe. Different frequencies of quantifiable MOAH levels were observed, ranging from 50% of detection in the samples tested by foodwatch to lack of detection in the three samples analysed by the German authorities. Quantified MOAH levels were in the range 0.2‐3 mg/kg. Due to the complex analytical methods, there is uncertainty on the reported levels which were used to estimate exposure to MOAH for infants and toddlers. Higher levels were estimated for infants, ranging from 0.8 to 44.6 and from 1.7 to 78.8 μg/kg bw per day for average and 95th percentile of exposure, respectively. No information on the absence of 3‐7 PAC in the samples analysed was made available to EFSA, and therefore the estimated exposure for infants and toddlers is of possible concern for human health. This assessment relies on occurrence data made available up to 14 November 2019. Analysis of further samples by MS is ongoing and an update of the assessment will be considered upon availability of additional data.

Question Number
On request from
European Commission