On July 2, the German Federal Institute for Risk Assessment (BfR) published the English version of its Opinion No. 008/2018 of 27 February 2018 on mineral oils used in cosmetic products, supplementing its first Opinion of 2015. Its risk assessment relates to those mineral oil qualities which comply with the purity requirements for pharmaceuticals and for mineral oil authorised as food additives, and with the requirements of Cosmetics Regulation. According to the currently available scientific knowledge, no health risks are to be expected for consumers who apply cosmetic products containing these mineral oils to their skin, in the view of the BfR.
Cosmetic products can contain mineral oils. These are complex mixtures of hydrocarbons of different structures and sizes. A distinction should be made between mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH). The latter could potentially contain carcinogenic substances, such as polycyclic aromatic compounds.
According to the EU cosmetics regulation, mineral oils are only permitted in cosmetics if the full refining history is known and the starting material is not carcinogenic, or if the distillate was tested using specific methods (IP346). The IP346 method is an initial test for those mineral oils which are to undergo further purification steps for subsequent use in cosmetic products. This should prevent the use of mineral oils which are of concern to health.
Risks of dermal absorption
The German Federal Institute for Risk Assessment (BfR) has evaluated the health risks of dermal absorption of MOSH and MOAH from mineral oils via cosmetics. Highly refined mineral oils and microcrystalline waxes, which comply with the purity requirements for pharmaceuticals, are used in cosmetic products for dermal application. The MOAH levels in these mineral oils are reduced through the corresponding technical refinement. As MOSH are hardly absorbed by the skin, the dermal application of cosmetic products containing mineral oils does not result in systemic exposure.
According to the currently available scientific knowledge, no health risks are to be expected for consumers who apply cosmetic products to their skin, in the view of the BfR. Accordingly, there have been no reports up to now of any effects on health through the mineral oil components contained in these cosmetic products, even though they are used over many years and often on a daily basis.
Risks of oral exposure
In addition to possible absorption via the skin, oral exposure has to be considered, especially with lip care products, which can also contain mineral oils. As low-viscosity mineral oils can easily be absorbed orally, medium- and high-viscosity mineral oils and microcrystalline waxes are recommended for use in lip care products. Certain highly purified food grade medium and high-viscosity mineral oils and microcrystalline waxes were subjected to a health risk assessment by the European Food Safety Authority (EFSA) and approved for use in the food sector. Values for acceptable daily intake (ADI) were derived for these mineral oils and waxes by the Joint FAO/WHO Expert Committee on Food Additives (JECFA) and by EFSA.
Cosmetics Europe, the European trade association for the cosmetics and personal care industry, has advised manufacturers of lip care products only to use those mineral oil fractions for which ADI values apply.
The dose of mineral oils ingested orally via lip care products contributes to less than 10% of the ADI value. If the recommendation of Cosmetics Europe is complied with, no health effects are to be expected from oral intake in the opinion of the BfR.
For further information
• See the full text of BfR Opinion: Highly refined mineral oils in cosmetics: Health risks are not to be expected according to current knowledge, Updated BfR Opinion No. 008/2018 of 27 February 2018, replacing Opinion No.014/2015 of 26 May 2015