Mineral oil in food, cosmetic products, and in products regulated by other legislations

Abstract

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.

Do Claims about the Naturalness and Dose of Cosmetics Ingredients Affect the Public’s Perception of Their Safety?

“…The dietary intake of MOSHs in Europe is estimated to range from 0.03 to 0.3 mg/kg of body weight per day [14], which corresponds to 2.1 to 21 g per day for someone weighing 70 kg. Because of changes in usage and composition over time, this is one or two order of magnitudes smaller than the intake estimated in the United States in the 1960s [17].…”

“…More generally, MOSH is a generic term that encompasses a wide variety of complex compounds with varied molecular masses. The kind of highly refined mineral oils recommended for use in lip care products sold in Europe by Cosmetics Europe [31] did not cause granulomas or inflammatory lesions in rodents [17].…”

“…These results have led safety authorities to conclude that mineral oils are safe as a cosmetic ingredient at the current concentrations of use. This was the conclusion of the US Cosmetic Ingredient Review Expert Panel [32] and of the German Federal Institute of Risk Assessment, which underscored that the safety of these products is indirectly attested by their long availability and use, and by the lack of evidence, clinical or epidemiological, for negative health effects [17,30].…”

Atmospheric Solids Analysis Probe (ASAP) and Atmospheric Pressure Gas Chromatography (APGC) coupled to Quadrupole Time of Flight Mass Spectrometry (QTOF-MS) as alternative techniques to trace aromatic markers of mineral oils in food packaging

“…This is the case of mineral oils. Once their toxicity has been demonstrated [1][2][3][4][5], their presence in the food context should be avoided. Mineral oils were found in food packaging and the first series of data came from the study of recycled paper and board [6,7].…”

Sunflower seed oil containing ginseng stem–leaf saponins (E515-D) is a safe adjuvant for Newcastle disease vaccine

“…And, the safety of mineral oil in vaccines is frequently questioned ( Stone, 1993 ; Petermann et al., 2017 ). For example, polycyclic aromatic hydrocarbons ( PAH ) left in the oil was reported to be carcinogenic ( Bulder et al., 2008 ; Pirow et al., 2019 ; Li et al., 2020 ). The metabolic fate of mineral oil in chickens has been found very slow, and the oil residue has been detected in the muscles, stomach, and other internal organs ( Liu et al., 2010 ; EFSA Panel on Contaminants in the Food Chain (CONTAM), 2012 ; Liu et al., 2012 ).…”