For a few years, mineral oils and their potential adverse health effects have been a constant issue of concern in many regulatory areas such as food, cosmetics, other consumer products, and industrial chemicals. Analytically, two fractions can be distinguished: mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH). This paper aims at assessing the bioaccumulative potential and associated histopathological effects of MOSH as well as the carcinogenic potential of MOAH for consumer-relevant mineral oils. It also covers the absorption, distribution, metabolism, and excretion of MOSH and MOAH upon oral and dermal exposures. The use and occurrence of consumerrelevant, highly refined mineral oils in food, cosmetics and medicinal products are summarized, and estimates for the exposure of consumers are provided. Also addressed are the challenges in characterizing the substance identity of mineral oil products under REACH. Evidence from more recent autopsy and biopsy studies, along with information on decreasing food contamination levels, indicates a low risk for adverse hepatic lesions that may arise from the retention of MOSH in the liver. With respect to MOAH, at present there is no indication of any carcinogenic effects in animals dermally or orally exposed to highly refined mineral oils and waxes. Such products are used not only in cosmetics but also in medicinal products and as additives in food contact materials. The safety of these mineral oilcontaining products is thus indirectly documented by their prevalent and long-term use, with a simultaneous lack of clinical and epidemiological evidence for adverse health effects.

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In accordance with Regulation (EU) No. 16/2011, the exceedance of a legal limit, i.e. ‘non‐compliance’ with a regulatory framework (European or National) does not systematically trigger a RASFF notification. An evaluation on the level of risk is necessary to decide if a notification should be issued. EFSA was requested to propose a risk evaluation methodology that would allow a rapid and consistent risk‐based classification of RASFF notifications. The methodology aims to provide a transparent set of criteria that can support the decision whether to notify in RASFF and increase transparency and harmonization. The methodology was developed for evaluation of contaminants (arising from food contact materials, pharmacologically active substances and other food contaminants) in food. The risk evaluation is based on the assessment of toxicological properties and dietary exposure. The result, expressed as the comparison of exposure to a relevant toxicological reference point, can be classified as no risk; low probability of adverse health effects or low concern for public health; potential risk; or risk. To facilitate the evaluation, the “Rapid Assessment of Contaminant Exposure (RACE)” tool was developed. It uses food consumption information from the EFSA Comprehensive European Food Consumption Database to provide estimates of acute and chronic exposure from single foods and compares the result to the relevant toxicological reference points. The implementation of the FoodEx2 (food categories) and PARAM (hazards) controlled terminologies in the RASFF system is recommended to improve harmonization and facilitate the evaluation.

The EFSA Panel on Food Contact Materials, Enzymes and Processing Aids ( CEP ) was requested by the European Commission to re‐evaluate the safety of styrene ( FCM No 193) for use in plastic food contact materials ( FCM ) following the classification by the International Agency for Research on Cancer ( IARC ) as ‘probably carcinogenic to humans’. The IARC Monograph pertains to hazard identification, based on studies on high‐dose occupational exposures by inhalation and animal studies, also mainly by inhalation. The Panel considered that the IARC conclusions cannot be directly applied to the evaluation of risks for consumers from the oral exposure to styrene, but also concluded that, based on the data provided in the IARC Monograph and by the industry, a concern for genotoxicity associated with oral exposure to styrene cannot be excluded. The migration of styrene into foods packed in styrenic plastics is below 10 μg/kg for the majority of the foods, but up to 230 μg/kg was reported. Migration tends to be high for contact with fatty foods, and/or with high surface to volume ratios of the FCM . Dietary exposure of the consumers to styrene migrating from styrenic plastics was estimated in the order of 0.1 μg/kg body weight (bw) per day. It is in the same range as exposure from styrene present in foods as such. The dietary exposure (food component plus migration from styrenic plastics) is similar or lower than that by inhalation in the general population. Taking the human exposure data into account, the Panel concluded that a systematic review of genotoxicity and mechanistic data, comparative toxicokinetics and analysis of species differences is required for assessing the safety of styrene for its use in FCM .

Various phthalates have been detected in a wide range of food products such as milk, dietary products, fat-enriched food, meat, fish, sea food, beverages, grains, and vegetables as well as in breast milk. Here we present an overview on toxicologically considerable phthalate levels in food reported in the literature. The most common phthalates detected are di-(2-ethylhexyl) phthalate (DEHP), di-n-butyl phthalate (DnBP), and di-isobutyl phthalate (DiBP). Milk analyses demonstrate that background levels in unprocessed milk are usually low. However, during processing the phthalate contents may significantly increase due to migration from plastic materials in contact with food. Among dietary products fat-enriched food such as cheese and cream were identified with highest levels of DEHP. Plasticized PVC from tubes, conveyor belts, or disposable gloves used in food processing is an important source for contamination of food, especially of fatty food. Paper and cardboard packaging made from recycled fibers are another important source of contamination. In addition, gaskets used in metal lids for glass jars have been identified as possible source for the contamination of foodstuffs with phthalates. The highest concentrations of DEHP reported (>900 mg kg(-1)) were detected in food of high fat content stored in such glass jars. Beyond classical food, DEHP and DnBP were identified in human breast milk samples as the main phthalate contaminants. Phthalate monoesters and some oxidative metabolites were also quantified in breast milk.