A new alarm haunts Europe.
It is spoken in a whisper, using new acronyms unknown to most.
– What are MOSH and MOAH?
– MOSH alarm
– Risk in lip cosmetics
They are the MOSH: saturated hydrocarbons of mineral oils.
We are still talking about the possible danger of paraffins, petrolatum and analogues derived from fossil substances.
Old story. The novelty lies in the fact that under investigation are no longer only the MOAH aromatic compounds whose potential risk has been known for years. The risks related to substances considered safe, such as alkanes and waxes, are also discussed today. Too bad that, but at the moment almost nobody talks about them, these substances are not found only in mineral oils and can be obtained or detected in thousands of products of plant or animal origin. If an alkane with more than 20 carbon atoms is bad for your health, it does so whether it comes from the refining of oil or is found on the skin of an apple.
MOSH-MOAH what are they?
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MOSH and MOAH are acronyms that very loosely define some fractions of petroleum derivatives.
MO stands for Mineral Oil, the final H stands for hydrocarbons (hydrocarbons) S stands for saturated and A for aromatics. They are components of oil derivatives of petroleum.
The definitions MOSH and MOAH do not clearly characterize what they are, in fact they are complex mixtures whose chemical composition is not defined and usually varies from lot to lot. The health risks of some aromatic compounds (MOAH), in particular some polycyclics (PAHs) such as benzo [a] pyrene, are known. There are thousands of different substances and their isomers that can be classified as MOAH. Only some, considered toxic or carcinogenic, are included in the lists of PAHs subject to regulatory restrictions. 16 PAHs are under observation: benz [a] anthracene, benzo [b] fluoranthene, benzo [j] fluoranthene, benzo [k] fluoranthene, benzo [ghi] perylene, benzo [a] pyrene, chrysene, cyclopenta [cd] pyrene, dibenz [a, h] anthracene, dibenzo [a, e] pyrene, dibenzo [a, h] pyrene, dibenzo [a, i] pyrene, dibenzo [a, l] pyrene, indeno [1,2,3-cd] pyrene,
Their presence in children’s toys, tires or materials in contact with food must not exceed concentrations defined by various regulatory authorities, international, European or USA.
The risk deriving from the presence of MOAH in the multitude of petroleum derivatives that could contain them is normally reduced by the refining processes. This is the reason why refined paraffin, compliant with the Pharmacopoeia, is generally considered safe. Unlike MOAHs, and in particular PAHs, which have been under control and subject to restrictions for some time, saturated hydrocarbons are not regulated and in various toxicological opinions and evaluations have always been considered not worrying. This category is also very generic and includes thousands of substances with their isomers. These are linear and branched alkanes or alkyl-substituted cyclo-alkanes. They are the main constituents of paraffins and among the main ones of waxes.
MOSH alarm
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The health impact of mineral oils has been assessed several times in various institutional settings but above all first in JECFA (Joint FAO WHO Committee for the Safety of Food Additives) and then in EFSA (European Food Safety Agency). Many tests on animals and various researches on humans have defined a fairly accurate toxicological profile, especially considering the risk of ingesting a series of products derived from petroleum, bitumen or fossil waxes.
To the voluntary ingestion of liquid paraffin, it is still sold in pharmacies as a laxative and various diets (eg Dukan diet) or slimming practices, “recommend” it as a substitute for vegetable oils, must also be added the involuntary ingestion of paraffins or waxes of fossil origin used in materials in contact with food or sprayed on some foods as food additives.
From various studies at the time an ADI (admissible daily intake) has been obtained which supports the use of these derivatives in materials in contact with food and as food additives.
Classifying these products by viscosity and molecular weight we have:
paraffins, isoparaffins and naphthenes medium low viscosity (3-8.5 centiStokes, molecular weight 300-500) C10-C25,
high viscosity paraffins, isoparaffins and naphthenes (greater than 11 centiStokes, molecular weight greater than 500) C30,
Microcrystalline wax: C20-C60, viscosity 10-30 centiStokes, molecular weight 300-750 +.
For the Joint FAO / WHO Committee of Experts on Food Additives (JECFA 2002) the ADI for a highly viscous mineral oil is 0-20 mg / kg body weight; while that of a medium-low viscosity oil is 0-10 mg / kg if it is class I and 0-0.01 mg / kg if it is class II or III.
For EFSA, the European Food Safety Authority (ANS 2009), the ADI of high viscosity mineral oil is 12 mg / kg / day.
Considering the considerable difficulty in analytically characterizing these products, which may contain thousands of different substances, the restrictions in their use do not clearly specify the degree of purity or refining, or more simply the maximum permissible content of carcinogenic or toxic components.
Even the rules on European cosmetics, which are generally very accurate, tackle the problem with a not very clear and linear approach. In fact, dozens of petroleum derivatives are prohibited in cosmetics, including paraffins and petrolatum, “unless the entire refining process is known and it can be proven that the substance from which it is obtained is not carcinogenic”. This restriction drafted to reduce the risk of carcinogenic PAHs can be interpreted differently and introduces ambiguity in the definition of which petroleum-based cosmetic ingredients actually comply with the regulation.
I talked about it in: Is Paraffin or Cotton Oil more carcinogenic?
The safety in food use of these petroleum derivatives, bitumen and fossil waxes is not clearly defined as a function of the PAH concentration. With the exception of the European Pharmacopoeia which in any case does not use reliable analytical procedures, even paraffin for medicinal use is not checked for the presence of PAH. In no case, at least until now, have the health risks deriving from MOSH, i.e. saturated hydrocarbons, been considered. It should be noted that while MOAHs can be considered contaminants, in small concentrations, of a paraffin or petrolatum conforming to the European Pharmacopoeia, MOSHs are their main constituents. In conclusion:
In the many tests on animals, some perplexities related to liver enlargement, accumulation in the liver and lymph nodes and body fats following the massive administration of mineral oils had emerged. Although it is known the metabolism of alkanes that ingested can transform first into fatty alcohols then into fatty acids, their accumulation, also verified in the human body, although considered not worrying or a simple adaptive response was suspected of potential adverse effects on health.
In 2008, some large batches of sunflower oil contaminated (up to 2g / kg) with mineral oil were intercepted in the EU. The affair triggered off various investigations into the safety and risk associated with the dietary intake of mineral oils. Only in 2012 did EFSA, but also WHO / WHO, pronounce on the risks related to the ingestion of mineral oils, noting that the admissible doses (ADI) determined up to then, especially considering the possible presence of PAH, did not can be used to characterize the risk of microgranuloma occurrence in the liver of Fischer 344 mice fed high doses of mineral oils for 90 days.
The conclusions of the regulatory authorities can be summarized as:
– investigations on the toxicology of mineral oils do not adequately characterize the substances, as their chemical composition is missing.
– Fischer 344 rats are particularly sensitive and have a much greater predisposition to the formation of microgranulomas than that found with other species of rats or in humans. Furthermore, the mechanism of formation of microgranulomas is not yet clearly understood.
– there is however a potential concern for the formation of microgranulomas in the liver associated with the widespread and continuous ingestion of saturated hydrocarbons.
Many new researches have been started after 2012, to better characterize the risk deriving from the ingestion of MOSH, following the indications of the EFSA.
To date, however, the use of tests on a species that does not seem to metabolise alkanes due to a probable genetic defect, such as Fischer 344 rats, to calculate a NOAEL is still controversial. The NOAEL is the concentration at which no adverse reactions are observed, which is essential to derive the concentrations at which it is possible to use a substance safely in humans.
Olive oil contains relatively high concentrations of non-contaminated n-alkanes, predominantly with an odd number of carbon atoms.
The chemical characterization of these saturated hydrocarbon mixtures is extremely complex and, if this cannot be done, it is not possible to distinguish the adverse effects due to a mineral oil from those due for example to the alkanes naturally present in various plants and especially in their oils. It is also highly unlikely that a longer or shorter linear alkane will be metabolized as a cyclic or branched one
MOSH risk assessment in lip cosmetics
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In the various surveys to estimate how many saturated hydrocarbons a European citizen could ingest, in addition to food and drugs, cosmetics for lips must be considered.
In fact, applying a lip balm, a lip gloss, a sunscreen or a lipstick on the lips it is reasonable to assume that a certain amount is then ingested.
In light of the new concerns that emerged after 2012, the Association of European Cosmetic Industries (Cosmetic Europe) took care to recommend that only hydrocarbons of which the ADI is known, i.e. the admissible dose, be used in lip cosmetics. This is an answer-not-answer to the safety question of lip cosmetics. In fact, the subject of the dispute today is precisely the fact that the previous DGA defined for petroleum waxes and paraffins are not considered applicable to contain the risk of granulomas in the liver derived from the assumption of MOSH. It is not the first time that the Association of European Cosmetic Industries has made somewhat specious recommendations to overcome some controversies about the safety of petroleum derivatives.
Assuming the worst case, i.e. that all the lip cosmetic is ingested, applying a product composed of 100% MOSH to the lips, we speak of an exposure equal to 0.32 mg / kg body weight / day using the RIFM or 0 model, 9 mg / kg body weight / day using the SCCS model. In the worst case, it is therefore 0.057 grams applied 2 times a day in a subject of average weight. Values much lower than the ADI defined for high viscosity paraffins and not even comparable with the nearly 100 grams / day estimated by the EMA (European Medicines Agency) for paraffin used as a laxative. Therefore, considering the small quantities of product applied to the lips, the surface of the lips is approximately 4.8 cm2 and the actual quantity of product applied is of the order of 1 mg / cm2,
The Fischer 344 strain is more susceptible to the formation of granulomas in the liver following the ingestion of mineral oil.
However, adopting the worst case, i.e. the NOAEL obtained from the 90-day experiments on Fischer 344 rats equal to 19 mg / kg / day and a systemic exposure dose (SED) of 0.9 mg / kg / day, we would obtain a safety margin. (MOS) of 21. It would be a MOS much lower than 100, the minimum value indicated in the guidelines for the safety of European cosmetics, when the NOAEL is derived from animal models. So if Fischer 344 rat experiments were usable and meaningful to calculate the risk of microgranuloma formation in the human liver, a lip cosmetic made from 100% MOSH would not be safe.
Research for a better chemical characterization of what is meant by MOSH is progressing. The concept of MOSH is too vague and if there is indeed a risk of microgranuloma formation which has a significant impact on human health, it is necessary to understand exactly which saturated hydrocarbons are responsible for it. The same saturated hydrocarbons could be found in high concentrations in some cosmetic ingredients of plant or animal origin. Before testing on a few thousand Fischer 344 rats by gorging them for 90 days with alkanes of vegetable origin, squalane, beeswax, candelilla wax etc. it must be understood whether this animal model is actually valid. Recalling then that, in the EU for many years now, it is not really allowed to conduct experiments on animals to define the safety of a cosmetic.
The scientific controversy on the adoptability of experiments on Fischer 344 rats to derive a NOAEL that can also be used in the estimation of safety on humans has just started. The doubt is legitimate, many animal models are not adequate to derive safety in humans. To make me understand, simplifying a lot, if to define the safety of chocolate we adopted data obtained from experiments on dogs or cats, today chocolate would be a prohibited substance.
Rodolfo Baraldini
References:
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WAXES
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Cir: safety ozokerite, fossil syntetic waxes