Mineral oil saturated hydrocarbon (MOSH) is found to be one of the highest contaminant in the human body according to studies1, 2.  Studies show that concentrations of MOSH range to approximately 1 g per person and even 10 g in extreme cases. Mineral oil enters in to the body via air, food and skin. Mineral oil is often identified as a major ingredient of many personal care and cosmetic product which includes baby products.  Safety Monitor Research Foundation’s (SMRF) online platform (www.safetymonitor.org) rates products based on ingredients safety on a scale of 1 (poor) to 10 (good). In this article, SMRF provides justification for SMRF rating of “1” (Poor) for mineral oil used in cosmetic and personal care products.

 

What is mineral oil?

Mineral oils are petroleum derived substances, produced by refining crude oils. Mineral oil is a generic term used to group several petroleum derived liquids with “oil-like viscosity” manufactured by atmospheric and vacuum distillation (at temperatures between ~300⁰C and ~700⁰C) of crude oil and then further refined.

Mineral oils differ in their physical chemical properties (e.g. viscosity) and chemical composition (e.g. aromatic content) and cannot thus be described with a single chemical formula. Mineral oil are classified in to class I, II and III based on their viscosity. Mineral hydrocarbons consist of two fractions, mineral oil saturated hydrocarbons (MOSH) and mineral oil aromatic hydrocarbons (MOAH).

 

Where do you find?

They are excellent moisturizers and emollients and provide a lipophilic base in which to deliver active ingredients. Formulas for creams and lotions, bath oils, lipsticks and lip glosses, sun creams, and hair products often contain mineral oils. In some cases, for example Vaseline, virtually consist exclusively of MOSH.

 

Is mineral oil safe?

Mineral oils can be potentially safe in cosmetics if the full refining history is known and the starting material is not carcinogenic. In order to ensure safety some countries have defined specific requirement for its use in cosmetic products.

 

What are the potential health concerns?

Studies show a correlation between the uses of cosmetic products, such as creams or lipsticks, and mineral oil saturated hydrocarbons (MOSH) in human fat tissue and in milk samples collected from women1. This shows mineral oil can enter the body and bio-accumulate and potentially contaminate newborn babies. The mineral oil aromatic hydrocarbons (MOAH) fraction is under scrutiny because it may contain genotoxic carcinogens as contaminants, namely some polycyclic aromatic hydrocarbons (PAH)3. MOAH has been considered as an indicator of the presence of crude oil based products that are not intended to be used in food related, pharmaceutical or cosmetics applications.

 

What are the regulatory requirements available currently to ensure safety?

In Europe and the US, mineral oil used in cosmetics or personal care products should be either pharmaceutical or food grade.

In Europe, mineral hydrocarbons used in cosmetic lip care products shall be compliant with purity specifications on polycyclic aromatic hydrocarbons as reflected in various pharmacopeia or FDA Code of Federal Regulations (CFR) for food additives. EFSA and JECFA based on toxicology study reports have identified average daily intake (ADI) based on the viscosity of the chemicals.

In the US similar to Europe, mineral oils used in cosmetics are expected to be USP (pharmaceutical) grade orto meet the highest standards of purity classified under the US FDA food-grade standards of purity, 21 CFR 172.880.

 

Indian context:

Indian standard IS 7299: 1974 (Reaffirmed 2006) describes that the mineral oil used in cosmetics should be highly refined. However, unlike the Europe it does not require manufacturers to maintain the complete refining history. Also, there is no mention on the grade of mineral oil to be used in formulations.

 

How do you make informed choices?

Mineral oil names on labels:

Mineral oil, microcrystalline wax, white oil, Cera microcristallina, Paraffinum liquidum, petrolatum,ceresin,Slack wax

 

SMRF Conclusions:

Mineral oil is a cost effective emollient that can be used in wide range of formulations. However, it may be noted that the refining history play a crucial role failing which it may have a potential risk to cause some of the serious health implications such as cancer. Also, studies show the possible transfer of these compounds to off-springs. Given the background, Indian standard lack clarity in terms of specification compared to EU and US for safety. SMRF also observed some of the baby product formulations containing mineral oil in India, does not contain mineral oil when sold in the US. The International chemical secretariat classifies mineral oil as a ‘substitute it now’ (SIN) chemical.  It was also noted an analysis of lip care products in Switzerland and Germany demonstrated that mineral oils used in a number of products did not comply with EU recommendations4.

In the presence of safe alternative which can replace mineral oil in formulations, SMRF concludes that the rating of “1” (Poor) for mineral oil is justified.

 

Bibliography

  1. Concin, N. Hofstetter, G. Plattner, B. Tomovski, C. Fiselier, K.Gerritzen, K. Semsroth, S. Zeimet, A.G. Marth,C. Siegl, H. Rieger, K. Ulmer, H. Cocin, H. and Grob, K.(2011).Evidence for Cosmetics as a Source of Mineral Oil Contamination in Women.Journal Of Women’s Health, Volume 20, No:11, pg 1714 -1719.
  2. Concin, N. Hofstetter, G. Plattner, B. Tomovski, C. Fiselier, K.Gerritzen, K.Semsroth, S. Zeimet, A.G. Marth,C. Siegl, H. Rieger, K. Ulmer, H. Cocin, H. and Grob, K. (2008). Mineral oil paraffins in human body fat and milk.Food Chem Toxicol. 2008 Feb;46(2):544-552.
  3. Barp L, Kornauth C, Wuerger T, et al.: Mineral oil in human tissues, Part I: concentrations and molecular mass distributions. Food Chem Toxicol. 2014; 72: 312–21.
  4. BFR (2018). Highly refined mineral oils in cosmetics: Health risks are not to be expected according to current knowledge, Updated BfR Opinion No. 008/2018. DOI 10.17590/20180702-124741-0. www.bfr.bund.de