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Mineral oils and waxes in cosmetics: an overview mainly based on the current
European regulations and the safety profile of these compounds

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DOI: 10.1111/jdv.15946 JEADV

REVIEW ARTICLE

Mineral oils and waxes in cosmetics: an overview mainly

based on the current European regulations and the safety
profile of these compounds
B. Chuberre,1 E. Araviiskaia,2 T. Bieber,3 A. Barbaud4,*
1

al Cosmetique Active International, Levallois-Perret, France
L’Ore
2
Department of Dermatology and Venereal Diseases, First Pavlov State Medical University of St. Petersburg, St. Petersburg, Russia
3
Department of Dermatology and Allergy, University of Bonn, Bonn, Germany
4
AP-HP.Sorbonne Universite
, Tenon Hospital, Department of Dermatology and Allergology, Sorbonne University, Paris, France
*Correspondence: A. Barbaud. E-mail: annick.barbaud@aphp.fr

Abstract
Mineral oils and waxes are mixtures of predominantly saturated hydrocarbons consisting of straight-chain, branched
and ring structures with carbon chain lengths greater than C14. They have been used for many decades in skin and lip
care cosmetic products due to their excellent skin tolerance as well as their high protecting and cleansing performance
and broad viscosity options. In contrast to vegetable oils, mineral oils are non-allergenic since they are highly stable and
not susceptible to oxidation or rancidity. They have a long history of safe use which is confirmed by clinical and epidemi-
ological data. In Europe, mineral oils are only permitted in cosmetics if compliant with purity specifications on polycyclic
aromatic hydrocarbons and safety requirements laid down in the European pharmacopoeia and the EU cosmetics regu-
lation EC/1223/2009. The high quality of these mineral oils is assured by robust quality assurance and a refining/purifica-
tion process designed to exclude substances with carcinogenic potential and to minimize the presence of mineral oil
aromatic hydrocarbons. Given their highly lipophilic properties, mineral oils do not penetrate human skin and, thus, are
not systemically bioavailable in the body. Moreover, no significant changes in the skin and no effects on any internal
organ system have been reported and attributed to the topical application of refined mineral oils. Regarding potential oral
exposure from cosmetic lip care products, Cosmetics Europe, the European trade association for the cosmetics and per-
sonal care industry, has advised cosmetic manufacturers to only use mineral oil fractions for which recognized food
acceptable daily intake (ADI) values apply. The estimated dose of mineral oils ingested via lip care products contributes
to <10% of the ADI value and should therefore be considered of no toxicological concern.
Received: 17 July 2019; Accepted: 3 September 2019

Conflict of interest
BC is employed by Cosmetique Active International. EA and TB are members of the Scientific Advisory Board of
Cosmetique Active International. AB was a member of an international advisory board for La Roche-Posay in
2017. The authors declare they have no conflicts of interest that might be relevant to the contents of this
manuscript.

Funding source
Medical writing was funded by Cosmetique Active International.

Introduction genotoxic substances. To date, there is no alert on the car-

Background
Mineral oils and waxes are chemical substances prepared from
naturally occurring crude petroleum oil. They mainly consist
of mineral oil saturated hydrocarbons (MOSH) and mineral
oil aromatic hydrocarbons (MOAH). The latter could contain
polycyclic aromatic compounds, such as polycyclic aromatic
hydrocarbons (PAH), which are potentially carcinogenic and
cinogenic effect of MOSH. The refining process of crude oil
consists in various steps, such as distillation, extraction, crys-
tallization and purification by acid treatment, hydrotreatment
and/or solvent extraction. The successive purification steps
allow to remove impurities and to reduce PAH levels to trace
amounts to meet specific standards of purity and quality for
pharmaceutical-grade mineral oils as stipulated by interna-
tional and European pharmacopoeia monographs. Moreover,

JEADV 2019, 33 (Suppl. 7), 5–14 © 2019 European Academy of Dermatology and Venereology
6 B. Chuberre et al.
the production processes of mineral oils follow good manufac-
turing practices and quality assurance controls (EU-GMP,
Directive 2003/94/EC and ISO 9001 or ISO 14001). The final
refined mineral oils also named ‘white oils’ are complex and
strongly lipophilic mixtures of hydrocarbons of different struc-
tures and sizes (from 14 to more than 90 carbon molecules)
that condition their viscosity and melting point. Higher
molecular mass hydrocarbons increase the melting point of
the oil until it becomes waxy at room temperature. In general,
highly refined mineral oils and waxes are colourless, odourless
and tasteless liquids or opaque waxes. Due to their various
physicochemical properties, they are used in many industrial
applications, including food, pharmaceutical and cosmetic
products. They also have medicinal usage, such as in oily
tulles, patch tests and as laxatives (paraffin oil).
Classification of mineral oils The Joint FAO/WHO Expert
Committee on Food Additives (JECFA) have classified highly
refined mineral oils and waxes based on criteria related to their
viscosity, average molecular mass and carbon number at 5%
boiling point (Table 1). Moreover, the JECFA1 and the Euro-
pean Food Safety Authority (EFSA)2,3 have evaluated their safety
profile and allocated them a specific acceptable daily intake
(ADI) value (Table 1). Thus, mineral oil classes with an ADI
(i.e. microcrystalline waxes and high and medium viscosity Class
I mineral oils), referred to as food-grade mineral oils, are autho-
rized as food additives in compliance with this limit. For med-
ium and low viscosity Class II and Class III mineral oils, an ADI
has not yet been established due to the lack of safety data about
them (the temporary ADI estimated in 2002 for these classes was
withdrawn by the JECFA in 20121). These estimated ADI limits
are currently under debate.4,5
Mineral oils in cosmetics In the cosmetic field, mineral oils and
waxes are used in various products as they offer broad viscosity
options enabling viscosity regulation of a formulation, they have
protective and lubricating properties avoiding dehydration of
the skin, and they are stable and dermatologically well tolerated.
Those excellent moisturizers and non-allergenic ingredients are
thus incorporated in many cosmetic products, from skin creams,
Table 1 Classes of mineral waxes and oils†
Classes of mineral waxes and oils Kinematic viscosity
at 100°C (mm²/s)
Microcrystalline waxes ≥11
High viscosity mineral oils ≥11
Medium viscosity Class I 8.5–11
Medium-low viscosity Class II 7.0–8.5
Medium-low viscosity Class III 3.0–7.0
†Adapted from WHO Expert Committee on Food Additives report in 2012 and the latest European recommendations on ‘Mineral hydrocarbons in cos-
metic lip care products’ in 2018.7 ‡This specification means there is no more than 5% of hydrocarbons with a carbon chain length less than the indicated
number.
JEADV 2019, 33 (Suppl. 7), 5–14
ointments and lotions to sunscreens, lip care products and hair
gels. Concentrations of mineral oils in cosmetics range from 1%
to 99% depending on the product.
In Europe, where the regulation on cosmetics is stringent,
only highly refined mineral oils and microcrystalline waxes of
pharmaceutical grade, that is complying with the specifications
of the European Union cosmetics regulation EC/1223/20096 and
the European Pharmacopoeia, are used in cosmetic products for
skin application. Accordingly, the full refining history has to be
known and the starting material should not be carcinogenic
(IP346 method) to prevent exposure to mineral oils with a
potential concern to health. Residual levels of aromatic com-
pounds (MOAH and PAH) have to be minimized through the
corresponding technical refinement, and levels of PAH, such as
benzo[a]pyrene to most common PAH, should not exceed
0.005% w/w.6 More specifically, for lip care products which have
a high oral exposure, Cosmetics Europe, the European trade
association for the cosmetics and personal care industry, has
advised manufacturers to only use food-grade mineral oils and
waxes with an ADI value that meets the associated specifications
for physicochemical properties and the most stringent purity
requirements on PAH (i.e. trace levels in the range of
0.0000001% w/w or 10 ppb) to ensure a safe use for the con-
sumer.7 Of note, some manufacturers also use food-grade min-
eral oils for topical products. However, this recommendation
does not support the use of medium and low viscosity Class II
and III mineral oils in lip care products, as they can be easily
absorbed orally, and an ADI has not yet been established for
those classes.7,8
On cosmetic labels, mineral oil-based ingredients are
described by International Nomenclature of Cosmetic Ingredi-
ents names presented in the following non-exhaustive list: Paraf-
finum liquidum; Paraffin; Isoparaffin; Synthetic wax;
Microcrystalline wax and hydrogenated microcrystalline wax;
Cera microcrystalline; Petrolatum; Ceresin; and Ozokerite. In
addition to MOSH, cosmetics may also contain synthetic hydro-
carbons, such as polybutene or polyethylene waxes with poly-
olefin oligomeric saturated hydrocarbons (POSH), which are
structurally similar to MOSH without having any impurities
such as PAH. Such mixtures of MOSH and POSH used as raw
Average molecular Carbon number at Acceptable daily
mass (g/mol) 5% boiling point‡ intake (ADI, mg/kg)
≥500 ≥C25 0–20
≥500 ≥C28 0–12
480–500 ≥C25 0–12
400–480 ≥C22 None
300–400 ≥C17 None
1
© 2019 European Academy of Dermatology and Venereology
Safety of mineral oils used in cosmetics
material for lip care products should also comply with the Euro-
pean specifications for either microcrystalline waxes, medium
viscosity Class I or high viscosity mineral oils.7
Rationale of the present article
Despite the fact that mineral oils have been safely used in cos-
metic products for over 100 years, recent discussions on the
safety of mineral hydrocarbons in food and cosmetic lip care
products have been raised by consumer organizations, media
and some national health institutions. Indeed, the EFSA9 and
the French Agency for food, environmental and occupational
health & safety (ANSES, Agence nationale de s
ecurit
e sanitaire
de l’alimentation, de l’environnement et du travail)10 identified
exposure to MOSH and MOAH, via food and contamination of
food by extensive migration from recycled paper and board
packaging, as being of potential concern for human health. In
view of this concern and a possible oral exposure via other
sources than food, several European consumer organizations
called into question the safety profile of mineral oils in lip
balms.11 Following a cooperative testing of a range of lip balms
representing the main national and international brands, the
European Consumer Organisation Bureau Europ
een des Unions
de Consommateurs (BEUC) considered that daily application of
lip care products represents a major contribution to the overall
consumer exposure to MOSH and POSH. Hence, they asked the
European Commission to establish health-based guidance values
(ADI or tolerable dose intake, TDI) for mineral oils in lip care
products, in particular MOSH and MOAH, to reduce the
amount of potentially problematic mineral oil hydrocarbons in
these cosmetics.11 By association and likely because of confusion,
this warning led the lay public and the media to feed the polemic
of using mineral oils in all cosmetics.
Along this line, the safety profile of highly refined mineral oils
in cosmetic products has been recently assessed by the German
Federal Institute for Risk Assessment (BfR)8 that conducted their
own analyses of MOSH and MOAH in various cosmetic prod-
ucts. Similarly to the BEUC,11 they found MOAH levels up to
the single digit percentage range in petrolatum and several cos-
metic products for skin and lip application.8 Moreover, many lip
care products contained >5% or >10% of MOSH with a chain
length <C25,8,11 which is higher than the 5% recommended by
Cosmetics Europe for lip care products,7 thus potentially expos-
ing consumers to these more strongly absorbed MOSH. Another
independent testing also demonstrated that a high number of lip
care products (8/57, 14% of tested products) from the German
retail trade contained high MOAH levels (0.4% to 1.6% w/w),
similar to levels in mineral oils of technical quality.12 Overall,
the German BfR concluded from their global risk assessment
based on a systematic literature review on mineral oils that no
health risk for the consumer can arise from the cutaneous appli-
cation of cosmetic products containing pharmaceutical- and
food-grade mineral oils.8 Moreover, health risks are not to be
JEADV 2019, 33 (Suppl. 7), 5–14
7
expected from oral intake of highly refined mineral oils, if lip
care products comply with the recommendation of Cosmetics
Europe.7,8 However, as shown by random testing, not all prod-
ucts available on the European market strictly comply with this
regulation. Thus, such products, probably imported from coun-
tries out of Europe with less stringent or no regulation on cos-
metics, should be further scrutinized by health authorities.
The objective of the present document is to give an overview
of the current safety data on mineral oils and waxes in cosmetics,
for skin and lip use, based on data available in the recent BfR
opinion, other European and international official authorities’
reports and additional information available in the medical liter-
ature.
Method of data search
The BfR conducted a comprehensive literature search in various
scientific and chemistry databases.8 These data are used in the
current article as well as information from the EFSA, the JECFA
and the Canadian health authority. In addition, an updated
search of safety data on mineral oils and waxes available from
publications in peer-reviewed journals has been performed using
PubMed on 17 January 2019 with the following search terms:
‘Mineral Oil/adverse effects’ OR ‘Mineral Oil/pharmacokinetics’
OR ‘Mineral Oil/pharmacology’ OR ‘Mineral Oil/poisoning’ OR
‘Mineral Oil/toxicity’ OR ‘MOSH’ AND ‘Cosmetics’ OR ‘Sun-
screening Agents’ OR ‘Sunscreen’. The articles were screened by
two reviewers based on titles and abstracts to select relevant arti-
cles. An updated search of data available in grey literature was
also conducted.
Pharmacological data
Dermal penetration
In a recent review summarizing 13 in vitro and in vivo (human
and animal) studies on the dermal penetration of mineral oils
and waxes used in cosmetic applications, all studies demon-
strated that the majority of the investigated substances were
mostly restricted to the stratum corneum of the skin (Table 2).13
In human volunteer studies, petrolatum and paraffin oils were
not detected in the epidermis and the depth of penetration into
the stratum corneum was estimated to be between 6 and 30 lm
(Table 2). Moreover, the swelling potential of mineral oils did
not lead to an increased penetration beyond stratum corneum
layers. So, there was no evidence from these various studies that
mineral oils and waxes are percutaneously absorbed and become
systemically available. Consequently, given the high viscosity
and hydrophobicity of the mineral oil matrix restricting diffu-
sion, negligible uptake of MOSH, MOAH and residual PAH
components is expected after topical application. Current regu-
latory positions generally agree to consider hydrocarbons with
carbon chain lengths >C20 as non-systemically available via the
cutaneous route of exposure.8,14
© 2019 European Academy of Dermatology and Venereology
 8

Table 2 Human studies analysing the skin penetration of mineral oils and waxes†
Mineral oil type Subject type Mineral oil application Bioanalytical Detection zone‡ Reference
method
Dose Zone Duration Replicate Stratum corneum Epidermis (living

JEADV 2019, 33 (Suppl. 7), 5–14

(mg/cm2) part)
Petrolatum A (5–15 years)§ 17 Thigh 15 and 4 at least Light microscopy Upper layer (at all Sebaceous gland Strakosch
B (20–50 years) Forearms 30 min (Sudan IV to time points) orifice (2–24 h) et al.30
C (55–70 years) Back 1, 2, 4, 6, 12 follow the oil) Upper hairshaft
Abdomen and 24 h (6 to 24 h)
Sebaceous
gland (24 h)
Petrolatum 9 adults 4.5 Volar forearm 30 min 12 per Confocal Raman Outermost layers¶ Minor Stamatas
Paraffin oil 1M/8F (30–60 years) 90 min time point Microscopy (up to 30 lm et al.31
depth)
Paraffin oil 7 infants 30 min
5M/2F (6–10 months)
Petrolatum 6 adults 2 Volar forearm 30 min 3 Laser scanning Skin surface only ND Patzelt et al.32
Paraffin oil 3M/3F (25–50 years) microscopy Uppermost layers
(curcumin follow
the oils)
Petrolatum 6 adults 2 Inner forearm 1h 10 at least Confocal Raman Upper layers (about ND Choe et al.33
3M/3F (av 44 years) Microscopy 6.3  1.2 lm
depth)
Petrolatum 6 adults 2 Inner forearm 1h 10 at least Confocal Raman Upper layers Minor (did not Choe et al.34
3M/3F (23–62 years, (2 areas) Microscopy 7.0  0.8 and reach stratum
av 37 years) (4 methods ††) 6.3  1.2 lm spinosum)
(methods 2 and 4)
20.7  4.9 lm
(method 3)
Paraffin oil 6.8  0.9 and
6.5  1.6 lm
(methods 2 and 4)
15.3  5.3 lm
(method 3)

†Adapted from the review of Petry et al.13 ‡These studies mentioned that petrolatum and paraffin oil were never detected in the dermis or the systemic circulation. §All 3 groups were constituted of
an equivalent number of male and female subjects (exact number not specified in original article). The author noticed that the penetration was faster in the skin of young than older subjects. ¶The
authors mentioned that adult and infant skin reacted similarly regarding lipid uptake. ††The authors mentioned that method 1 was not applicable to mineral oils because of the absence of Raman
spectra marker peaks.
av, average; F, female subject; h, hour; m, months; M, male subject; min, minute; ND, not detected; y, years.
B. Chuberre et al.

© 2019 European Academy of Dermatology and Venereology

Safety of mineral oils used in cosmetics
Oral absorption
For cosmetic products, oral intake by a direct (lip care products)
or indirect (hand-to-mouth contact, hand-to-food contact)
route is also relevant. Mineral oils ingested orally follow the
route of intestinal resorption of dietary fats. MOSH and PAH
are both resorbed by the small intestine primarily into the lym-
phatic system and to a lower extent into the liver portal vein.8
Experimental studies in animals showed that the absorption of
MOSH varies with the carbon chain length, from 90% for C14–
C18 to 25% for C26–C29, and further decreases with increasing
carbon number, until above C35 for which absorption is negligi-
ble.9 MOSH are then metabolized to fatty alcohols and fatty
acids by both the small intestine and the liver. Due to low bio-
transformation rates, MOSH having carbon number between 16
and 35 may accumulate in different tissues (see below section
Toxicity and cutaneous side-effects). Although there is no exper-
imental data on gastrointestinal resorption for MOAH, it can be
assumed, from their structural and physicochemical properties
similar to MOSH and PAH, that they can be resorbed via the
gastrointestinal tract in a comparable manner. The data also
indicate that MOAH are well absorbed and extensively metabo-
lized before being excreted, thus resulting in the absence of
bioaccumulation.9,15
In nine healthy female subjects aged 20–31 years and receiv-
ing a single oral dose (1 mg/kg) of a low viscosity Class III min-
eral oil, blood concentration of hydrocarbons (C19–C24) was
below the detection limit of 0.16 lg/mL at all time points (1–
168 h).16 This toxicokinetic study thus concluded to a negligible
absorption of a low viscosity white mineral oil at a dietary expo-
sure of 1 mg/kg, which can reflect daily oral exposure to lip care
products (see below section Exposure estimation to MOSH/
MOAH via lipstick use).
In conclusion, mineral oils and waxes are hardly absorbed by
the skin and do not therefore present a systemic health risk to
the consumer even after repeated and long-term cutaneous
exposure.8 Considering oral route, intestinal absorption of
MOSH in rats was found to be inversely proportional to the
number of carbon atoms, and a negligible absorption has been
shown in humans with a 1 mg/kg dose of a low viscosity white
oil.16 MOSH are metabolized to fatty alcohols and fatty acids by
the small intestine and the liver. MOAH are well absorbed and
extensively metabolized by a similar route and do not bioaccu-
mulate.
Toxicity and cutaneous side-effects
Cutaneous exposure
At least seven rodent studies on subchronic toxicity after skin
application of mineral oils consistently showed no adverse
effects.8 Indeed, there were no indications of histopathological
(mice, rats, rabbits), haematological or cutaneous changes
(rabbits) after repeated, long-term, topical application of white
JEADV 2019, 33 (Suppl. 7), 5–14
9
oils in multiple species.17 Cutaneous irritation representing
treatment-related toxicity was only found in mice, which have
a more permeable and susceptible skin than the human skin.17
Overall, in animals, no significant changes in the skin and no
effects on any internal organ system have been reported and
attributed to the subchronic topical application of refined
white mineral oils.
In humans, patch-test studies with medicinal white oils or
waxes showed no skin sensitization (in almost 80 000 patients18)
or only mild erythema in sporadic cases even on damaged
skin.8,18–20 These cases were never related to cosmetic allergy.
White petrolatum and waxes are hence considered non-sensiti-
zers and rarely allergen, the sensitizing components being proba-
bly PAH.18,21 Other human studies pointed out that
moisturizers containing 10% of mineral oil have a slight reduc-
ing effect on the minimal erythemal dose (MED) of skin for
UVB irradiation (decreased by 5–16%), making the skin slightly
more sensitive to UV, but this sensitivity effect to the sun was
similar to that of seasonal changes (average MED increase of
14% between January and April).22 Thus, according to current
data in humans, there is no robust evidence on dermatotoxicity,
detrimental sun sensitivity and toxicological effects of mineral
oils via the cutaneous route.8,22
Oral exposure
Acute oral toxicity is not relevant in the context of exposure
via cosmetic products, and besides, MOSH and MOAH have
low acute oral toxicity.8,9 Regarding subchronic and chronic
toxicity, a number of studies carried out in rodents with dif-
ferent food-grade mineral oils indicated that repeated oral
exposure to most of those grades caused bioaccumulation of
MOSH in rodent tissues, including liver, mesenteric lymph
nodes and fat.9 The tissue concentrations in rats were consid-
erably lower with microcrystalline waxes and high viscosity
mineral oils than with paraffin waxes, medium and low vis-
cosity mineral oils.5,8,9,23 Moreover, the MOSH accumulation
in the rat liver was shown to be reversible.5,8,23 While high
doses of low viscosity mineral oils and paraffin waxes led to
granuloma or microgranuloma formation associated with
inflammatory responses in rat livers, no changes were
observed with the most highly refined mineral oils and waxes.
In the absence of overt clinical toxicity, the JECFA1 and the
EFSA9 considered those granulomas of little concern from a
toxicological point of view. The EFSA also estimated that no-
observed-adverse-effect levels of 1200 mg/kg/day could be
used for establishing a 100-fold lower ADI guidance value of
12 mg/kg/day for high and medium Class I viscosity mineral
oils.3,9 A further toxicological study in rats confirmed liver
weight increase and granuloma induction in a dose- and
time-dependent manner, following feeding with different
MOSH mixtures representative of the whole MOSH range in
human diet.24 Low and medium Class II and III mineral oils
© 2019 European Academy of Dermatology and Venereology
10 B. Chuberre et al.

(fraction <C25) were more involved in the formation of hep-
atic granuloma, whereas high and medium Class I mineral oils
(fraction >C25) were more critical to liver weight increase.
Following findings in animals,25 MOSH accumulation in tis-
sues has been thoroughly examined in humans (N = 37;
Table 3).8,15,25 Lipogranulomas were detected in samples of
human fat, as well as of liver, spleen and mesenteric lymph nodes,
in correlation with deposits of MOSH15 that were mainly attribu-
ted to exposure to mineral oils via food. Both Class I and Class II
and III mineral oils were detected in human liver autopsy sam-
ples, indicating their accumulation.15 Of note, the level of MOSH
in fatty tissue was found to increase over time.8,26 However, the
incidence of lipogranulomas in human tissues is low and not
associated with inflammatory reactions or other adverse conse-
quences, leading health authorities to consider these lesions as dif-
ferent from inflammatory granulomatous alterations in rat livers,
and thus of no toxicological relevance for humans.1,9 Regarding
the increase in organ weight, it has not yet been investigated in
humans. It should also be noted that in pregnant women
(N = 142), significant (P < 0.05, univariate analysis) but weak
correlations (Spearman 0.17 < r < 0.26) were found between
increased MOSH levels in adipose tissue and the use of sunscreen
during pregnancy, as well as the use of hand cream and lipstick in
daily life before pregnancy.26 More detailed analyses of these data-
set by the BfR indicated that levels of MOSH in fat tissue were on
average 2.2 times higher in women who used these cosmetic
products than in women who did not.8 These correlations could
be explained by direct and indirect oral uptake, but the cause-to-
effect relationship has not yet been demonstrated. The accumula-
tion of foreign substances in the human body is undesired, but it
is not considered per se as an adverse effect.
Overall, there are no toxic concerns for mineral oils and waxes
through the cutaneous route. Moreover, there is no evidence of
a relevant contribution of cosmetic products via skin uptake to
the accumulation of MOSH in the human body. Regarding oral
administration, it is important to note that animal studies did
not show any indication of granuloma formation in the liver for
medium and high viscosity mineral oils and microcrystalline
waxes, which are the qualities recommended by the Cosmetics
Europe for lip care products.7 Additionally, high doses used in
animal studies are not relevant for mineral oils used in cosmetic
ingredients. Health authorities also considered lipogranulomas
observed in human tissues as non-adverse effects.1,9 For all those
reasons, no toxic risk can be expected from the oral uptake of
MOSH through lip care products which comply with the Cos-
metics Europe recommendations.7,8
Carcinogenicity/mutagenicity
Mineral oil saturated hydrocarbons are not carcinogens by
themselves.9 The carcinogenicity of a mineral oil mixture is
related to its content in MOAH, specifically the PAH which are
classified as carcinogenic and mutagenic by the international
and European health agencies (EFSA, JECFA and IARC) and in
accordance with the European Classification, Labelling, Packag-
ing (CLP) regulation (Regulation EC No 1272/2008). For
MOAH mixtures, there are no dose-response data on their car-
cinogenicity. However, in end-product mineral oils of pharma-
ceutical and food grades, PAH are almost completely eliminated
through extensive refining. Health Canada confirmed by their
own analyses that no PAH or only traces (<0.00001%, w/w) were
detected in a set of topical products containing petrolatum.14
Furthermore, for extracts with a PAH content < 0.7%, the
mutagenic index was found to be null.9 Thus, the carcinogenic
potential of the entire mineral oil as a mixture is classified
according to the valid CLP regulation (Regulation EC No 1272/
2008), stating that mineral oils containing <3% w/w of sub-
stances extractable with the solvent DMSO (IP346 method)
should not be classified and labelled as carcinogenic. The weight
percentage of substances extractable with DMSO hereby repre-
sents an indirect measure of the content of PAH in mineral oil.

Table 3 Overall levels of MOSH in various human tissues obtained from autopsies†
Tissue type Measured MOSH concentrations (mg/kg) Tissue mass (mg) Calculated MOSH levels (mg)

Min-max Average Median Min-max Average Median

Fat tissue‡ 17–493 130 87 12 000–66 000 325–12 400 3390 2200
Liver‡ 14–901 131 71 1560 23–1400 205 110
Spleen‡ 6–1400 93 28 140 1–194 13 4
Lung‡ <2–91 12 7 840 0–77 8 4
MLN‡ 21–1390 223 166 nd nd nd nd
Heart§ <2–41 9 6 280 0–12 2 1
Kidney§ <2–12 6 6 300 0–4 1 1
Brain§ <2 nd nd nd nd nd nd

†Adapted from Barp et al.15 ‡Tissue samples of about 7 g were collected from 37 subjects (26M/11F) aged 25–91 years. §Tissue samples of about 7 g
were collected from 14 subjects (9M/5F).
Max, maximal; Min, minimal; MLN, mesenteric lymph nodes; MOSH, mineral oil hydrocarbons; nd, not determined.

JEADV 2019, 33 (Suppl. 7), 5–14 © 2019 European Academy of Dermatology and Venereology
Safety of mineral oils used in cosmetics 11

The threshold of 3% is considered highly conservative and ade-
quately protective for human health regarding carcinogenicity.
As an example, a low viscosity white oil used in cosmetic prod-
ucts exhibits values <0.2% w/w for DMSO extracts and a muta-
genic index of 0.02, supporting no indication of carcinogenicity
or mutagenicity.8 These assessments are underpinned by the
findings of animal studies summarized below.
Cutaneous exposure
In at least five separate carcinogenicity studies, lifetime topical
exposure of mice to white mineral oils (average dose of
296 mg/kg/day) for up to 2 years revealed no evidence of
tumorigenicity, either at the site of application or in any of
the internal organs examined (Table 4).14,17 Moreover, a
recent comprehensive review conducted by the Concawe con-
firmed that highly refined mineral oils were non-carcinogenic
(three white oils samples tested in CF1 mice) and that the
IP346 method is suitable for the prediction of dermal carcino-
genic potential of mineral oils.27 Additional animal studies
have suggested that emollients including mineral oil may con-
tribute to UV-induced photocarcinogenesis.22 However, these
studies were of a very limited size and conducted in a mutant
mouse that is highly sensitive to UV, which is considered
insufficient for a risk assessment. The relevance of these stud-
ies to human use of mineral oils is thus limited as there is no
evidence for skin tumour development in humans despite dec-
ades of long-term usage of moisturizers.22
Oral exposure
The EFSA evaluated the carcinogenicity of the approved white
oils with oral consumption based on one feeding study in rats.2
Medium and high viscosity white oils of food grade were admin-
istered to rats up to a dose of 1200 mg/kg/day for 2 years, and
none of them were found to be carcinogenic.23 For microcrys-
talline waxes, there are no oral carcinogenicity studies. Neverthe-
less, according to the JECFA, no carcinogenic effects could be
detected in a 2-year feeding study in rats with paraffin waxes of
similar viscosity.1 Taking into account results for paraffin waxes
and for medium and high viscosity white oils, the EFSA con-
cluded that there is no indication of carcinogenic potential for
food-grade microcrystalline waxes.3
In conclusion, carcinogenicity and mutagenicity of mineral
oils are caused mainly by some MOAH, including PAH. Cumu-
lative evidence demonstrated that highly refined white mineral
oils with a very low or undetectable content of PAH are neither
carcinogenic nor mutagenic in vivo. These findings, together
with the restricted penetration of mineral oils to the outermost
layers of the skin, support the non-carcinogenic potential of
food-grade mineral oils and waxes used in lip care products,
both by cutaneous and oral routes.

Table 4 Animal studies analysing carcinogenicity following topical exposure to highly refined white oils†
Species Number sex Mineral oil application Summary of results ‡ Reference

Duration Volume (lL) Dose §

(mg/kg/day)
C3H/HeJ mice¶ 50 M 39/week 25 296 There was no evidence of any related McKee et al.36
lifetime histopathological changes in any of
the organs examined
There was no evidence of tumour
formation at either the site or
application or in any of the internal
organs
C3H/HeJ mice 50 M 39/week 25 296 There were no apparent abnormalities McKee and Lewis37
lifetime in visceral organs evaluated during
autopsy and gross examination
C3H/HeJ mice 140 M 39/week 25 296 There were no apparent abnormalities Biles et al.35
lifetime in visceral organs evaluated during
autopsy and gross examination
C3H/HeJ mice 40 M 29/week 37.5 296 There were no apparent abnormalities McKee et al.38
24 months in visceral organs evaluated during
autopsy and gross examination.
C3H/HeJ mice 30 M 39/week 20 238 There were no apparent abnormalities McKee et al.39
50 M lifetime 25 296 in visceral organs evaluated during
autopsy and gross examination

†Adapted from the review of Nash et al.17 The mineral oil in these studies was described as ‘highly refined white oil’ (e.g. Mineral Oil, USP) and used at
the maximum tolerable dose. ‡A complete autopsy was performed. Tissues prepared for microscopic examination included the following: brain, heart,
lung, spleen, kidney, liver and lymph nodes (cervical and mesenteric). §The dose was calculated assuming that density of mineral oil was 0.83 g/mL and
the average weight of a mouse 0.03 kg. ¶This mouse strain is particularly sensitive to tumour formation mediated by polycyclic aromatics.
M, male; ND, not detected; min, minute; w, week.

JEADV 2019, 33 (Suppl. 7), 5–14 © 2019 European Academy of Dermatology and Venereology
12
Reproductive toxicity
There are currently limited reproductive toxicology data in
experimental animals on mineral oil MOSH and MOAH frac-
tions by cutaneous and oral routes.
Cutaneous exposure
The developmental toxicity of a non-food grade MOAH mixture
(a heavy paraffinic distillate aromatic extract) was tested in one
study by skin exposure in pregnant rats (125–1000 mg/kg/day),
and results indicated signs of maternal and reproductive toxicity,
with red vaginal discharge, haematological changes, decreased
bodyweight gain and lower litter size with a higher number of
non-viable offsprings.9 Foetal toxicity including a significant
decrease in foetal bodyweight and incompletely ossified skull
bones was also observed. There are no reports of reproductive
toxicity potential for food-grade mineral oils in animals by this
route.
Oral exposure
In two developmental toxicity studies conducted in female rats,
oral exposure to white mineral oils (mostly MOSH) at 1000–
5000 mg/kg/day before or during gestation until lactation did
not induce maternal or fetal toxicity.9 There were no other treat-
ment-related effects. Moreover, no effects were detected with
regard to reproductive ability in rats (100–1000 mg/kg/day).
Similarly, oral administration of MOAH to gestating female rats
(15–135 mg/kg/day from day 6 to day 19 post-coitum) induced
no treatment-related death in any of the dams and no clinical
signs. Only a decreased terminal bodyweight was observed in
females for the high-dose group.9
Overall, there was no reproductive toxicity by oral route in
experimental animals. A moderate developmental toxicity was
observed only after skin application of a non-food grade mineral
oil containing MOAH to gestating female rats. The EFSA thus
concluded that an effect on reproduction cannot be fully
excluded for MOAH when using non-food grade mineral oil,
i.e., non-highly refined mineral oils which are not used in cos-
metics.9
Autoimmunity
Hydrocarbons are known to induce inflammation and act as
adjuvants by enhancing the immune responsiveness, so that oil-
based materials, such as Freund’s adjuvants, can be used in vac-
cines. In arthritis-prone rodent models, intradermal and
intraperitoneal injections of high doses of certain MOSH can
induce autoimmune responses with autoantibodies and associ-
ated clinical signs.9,28 Weaker effects were observed following
short-term percutaneous exposure on abraded skin, yet there
was no information about a dose-response relationship. Further-
more, a few short-term studies found no clear immune modula-
tion or no arthritic reaction in rats after oral exposure to MOSH
(5–120 days),9,24 but whether long-term oral exposure to low
JEADV 2019, 33 (Suppl. 7), 5–14
B. Chuberre et al.
levels would have similar consequences is unknown. Thus,
results of these studies do not allow to draw any conclusion on
the relevance of such effects after chronic exposure to mineral
oils via the oral route.28 Of note, the lack of immune effects in
rats presenting strong inflammatory granuloma in the liver indi-
cates that the two reactions may have independent mecha-
nisms.24
In humans, a few epidemiological studies and case reports
(N = 49) have suggested an association between exposure to
high doses of different types of mineral oils (i.e. cutting fluid,
motor oil, hydraulic oil, form oil, asphalt, any mineral oils,
mainly via skin and unintended inhalation by aerosols) and
increased risk to develop autoimmune diseases, such as rheuma-
toid arthritis.9,28 Moreover, subcutaneous exposure to high
levels of mineral oils in aesthetic surgery may be associated with
local and systemic autoimmunity reactions.28,29 In particular,
autoimmune/inflammatory syndrome induced by adjuvant min-
eral oils, defined as the infiltration of oily type modelling sub-
stances for cosmetic purposes (illegal practice), is characterized
by chronic granulomatous inflammation with increase of proin-
flammatory cytokines.29 The systemic manifestations of this syn-
drome can be non-specific and specific, meeting criteria for any
autoimmune disease in 40% of patients (systemic lupus erythe-
matosus, scleroderma and systemic sclerosis, rheumatoid arthri-
tis, dermatomyositis and overlap syndrome). Despite being
prohibited in the world, this cosmetic practice remains common
in many countries thus representing a serious health problem.29
However, in those instances, actual levels of exposure to mineral
oils (not all of food grade and by routes other than cutaneous)
in affected individuals have not usually been measured and other
genetic and environmental factors might also be involved in
those autoimmune reactions (including infection, vaccination
and tobacco smoke).28
So far, there are no indications of altered immune function or
autoimmunity after per oral or epidermal exposure to mineral
oils in animal models and in humans. Where presumptive asso-
ciations have been found, high levels of exposure to mineral oils
(of all types) mainly occurred via inhalation or intradermal
route.
Exposure estimation to MOSH/MOAH via lipstick
use
In 2012, the dietary exposure of the European population to
MOSH was estimated to range from 0.03 to 0.3 mg/kg/day, that
is a 60 kg person may consume 1.8–18 mg/day of MOSH via
food.9 Moreover, lip care products may participate in the total
oral exposure and accumulation of MOSH, as they were detected
in some of these products8,11 at levels significantly higher than
the 5% recommended by Cosmetics Europe.7
Nevertheless, these findings have to be considered in view of
the real oral exposure to lip care products and their non-carci-
nogenic potential. Indeed, the amount of lip balm ingested by
© 2019 European Academy of Dermatology and Venereology
Safety of mineral oils used in cosmetics
consumers was estimated reaching up to 20 g per year through
daily use – that is the equivalent of 4 typical lip balms.11 Based
on MOSH contents up to 74% in lip balms, their contribution
to MOSH exposure can be estimated up to 0.7 mg/kg/day for a
60 kg person, thus representing <10% of the ADI value of
12 mg/kg/day set for the highly refined mineral oils used in these
products.8 As a reminder, a similar oral dose (1 mg/kg) of white
mineral oils administered to volunteers led to undetectable
hydrocarbons (C19–C24) in blood.16 Moreover, the presence of
MOSH and MOAH in itself is not indicative of any carcinogenic
potential and highly refined mineral oils are almost devoid of
potentially harmful PAH. Thus, this moderate oral intake of
hydrocarbons through lip care products is not expected to repre-
sent a significant safety risk for the consumer.8 However, con-
sumers should be aware that not all lip care products available
on the European market or websites are fully compliant with the
European regulations and some may contain higher levels of
MOSH and MOAH than recommended. As shown in this arti-
cle, following the European regulations6,7 on cosmetics is a safety
guarantee for consumers, who are encouraged to purchase lip
care products from reliable vendors or official websites and to
control the country of origin mentioned on their labelling.
Conclusion
On the basis of the information presented in this overview,
highly refined mineral oils and waxes used in cosmetic products
can be considered as safe in human for:
• Skin application: no health risk was identified in humans
with respect to systemic toxicity, dermatotoxicity, repro-
ductive toxicity and the development of autoimmune
response and disease. Moreover, there is no evidence of
tumorigenicity or genotoxicity via the skin.
• Oral exposure: although repeated oral exposure to mineral
oils may cause bioaccumulation of MOSH in human tis-
sues, it was considered of little concern from a toxicological
point of view. There is also no indication of carcinogenicity,
mutagenicity, reproductive toxicity or autoimmunity with
mineral oils of pharmaceutical and food grades.
• Lip care products: although they may participate in the total
oral exposure and accumulation of MOSH in humans, no
significant health risk can be expected from lip care prod-
ucts that comply with the recommendation of Cosmetics
Europe, that is highly refined mineral oils with undetectable
or trace levels of PAH (<3% w/w of substances extractable
with the solvent DMSO), <5% of low molecular hydrocar-
bons (<C25)7 and a daily ingestion below the ADI value of
12 mg/kg/day (set for highly refined mineral oils).8
Acknowledgements
The authors thank C
ecile Desjobert, C
eline Zimmer and Marielle
Romet (Sant
e Active Edition) for medical writing assistance. We
also gratefully acknowledge Dagmar Bury, Maya Krasteva and
JEADV 2019, 33 (Suppl. 7), 5–14
13
Delphine Blanchet (L’Oreal Research and Development) for
contributing to critically review the manuscript.
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