International Journal of Cosmetic Science, 2008, 30, 471–474
Recalls of microbiologically contaminated cosmetics
in EU from 2005 to May 2008
M. D. Lundov* and C. Zachariae 
*National Allergy Research Centre, Department of Dermatology, Copenhagen University Hospital, Gentofte, Denmark
and  Department of Dermatology, Copenhagen University Hospital, Gentofte, Denmark
Received 6 June 2008, Accepted 27 July 2008
Keywords: cosmetics, EU, microbiological contamination, Pseudomonas aeruginosa, RAPEX
Synopsis
The Rapid Alert System for non-food consumer
products in the EU (RAPEX) notifies each week the
member countries on dangerous products sold in
the EU. Microbiological contaminated cosmetics
pose a potential health risk and are recalled from
the market. This study investigated the number of
recalled microbiological contaminated cosmetics
products in the RAPEX database from 2005 to
until week 17 in 2008. A total of 173 cosmetic
products were recalled in the period, 24 were
contaminated and the most frequently found
micro-organism was the pathogenic Pseudomonas
aeruginosa. It appears that the number of contami-
nated cosmetic products could be two to three
times higher in 2008 compared to 2007. The
recalled products were manufactured in 17 differ-
ent countries and only one company had more
than one product recalled. It is important to keep
monitoring the cosmetic products for contamina-
tion because an increasing number of products are
recalled each year, and the majority is contami-
nated with potential pathogenic micro-organism.
More knowledge on the reasons for the contami-
nation is needed.
Résumé
Le système européen d’alerte rapide des produits
de consommation non alimentaires (RAPEX) aver-
Correspondence: Michael Dyrgaard Lundov, National
Allergy Research Centre, Ledreborg Alle 40 1, 2820
Gentofte, Denmark. Tel.: +45 39 77 73 09; fax: +45 39
77 71 18; e-mail: midylu01@geh.regionh.dk
ª 2008 The Authors. Journal compilation
ª 2008 Society of Cosmetic Scientists and the Société Française de Cosmétologie
tit chaque semaine les membres des différents pays
des produits dangereux vendus en Europe. Les pro-
duits cosmétiques contaminés microbiologique-
ment posent un risque de santé potentiel et sont
rappelés du marché. Cette étude porte sur le nom-
bre de produits cosmétiques contaminés microbio-
logiquement rappelés du marché de 2005 jusqu’à
la semaine 17 de 2008 et figurant dans la base de
données de RAPEX. 173 produits cosmétiques ont
été rappelés durant cette période, 24 étaient con-
taminés et le micro-organisme le plus fréquem-
ment rencontré était le pathogène pseudomonas
aeruginosa. Il apparaı̂t que le nombre de produits
cosmétiques contaminés pourrait être, fin 2008, 2
à 3 fois plus élevé qu’en 2007. Les produits rap-
pelés ont été fabriqués dans 17 pays différents et
une seule compagnie a plus d’un produit rappelé.
Il est important de continuer à contrôler la con-
tamination des produits cosmétiques car un nom-
bre croissant de produits est rappelé chaque année
et la majorité est contaminée avec des micro-
organismes potentiellement pathogènes. Plus de
connaissances sur les raisons de cette contamina-
tion est nécessaire.
Introduction
To ensure consumer safety, the EU introduced in
2003 the Rapid Alerts System for non-food con-
sumer products in the EU (RAPEX), which each
week publishes notifications on products that pose
a health risk for the consumers and can be bought
in EU member states and the EEA countries [1].
Almost every notification published leads to a
withdrawal of the product from the market.
471
Recalls of cosmetic products
Cosmetics are one of the product groups included
in the RAPEX system. Acting through the Cos-
metic Directive, the Scientific Committee on Con-
sumer Products have divided cosmetics into two
different categories. Category 1 includes cosmetic
products intended to use in the eye area on
mucous membrane or by children under 3 years.
In this category, the number of colony forming
units (CFU) of aerobic mesophilic micro-organisms
must not exceed 100 CFU g)1, and furthermore,
the pathogenic strains Staphylococcus aureus, Pseu-
domonas aeruginosa or Candida albicans must not be
detectable in 0.5 g of the product. Category 2
includes other cosmetic products, and here the
number of CFU per g must not exceed 1000, and
the pathogenic strains mentioned above must not
be detectable in 0.1 g of the product [2]. Cosmetic
products with CFUs or pathogens above these lim-
its are potentially hazardous for human health
and the products are recalled from the market. In
general, the contamination of cosmetic products
can happen in two ways. (i) The raw material
used in the production is contaminated or (ii) a
part of the manufacturing line is contaminated. To
avoid intrinsic contamination, the manufacturers
are obliged to follow Good Manufacturing Prac-
tices and document that each batch released to
the market fulfils the demands mentioned above
[2]. However intrinsic contaminated products are
marketed, but so far only two studies have investi-
gated the number of recalled cosmetics because of
intrinsic microbial contamination and none of
them are from Europe [3, 4].
Methods
All notifications from 2005 onwards can be found
on the RAPEX website (http://ec.europa.eu/rapex).
Besides the reason for the notification, information
about the product, such as name, brand, notifying
country and the country of origin is also included
on the data given on the website. Furthermore, the
website has a search function where it is possible to
search for words included in all the notifications.
A general search for ‘cosmetic’ was conducted and
all notifications because of microbial contamination
were further investigated. To ensure that no notifi-
cations on the microbial contamination of cosmetics
were left out, a search on ‘micro,’ ‘bacterial’ and
‘contamination’ were conducted as well. More infor-
mation about recalled products and the company
was searched for on the Internet.
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472
M. D. Lundov and C. Zachariae
Results
The search on the RAPEX website showed that
173 cosmetic products were recalled from 2005 to
until week 17 in 2008. This represents an
increase over the years: 14 recalls in 2005, 38
recalls in 2006, 89 recalls in 2007 and so far
32 recalls in 2008. Table I shows the 24 different
recalls that were because of contamination, the
product type, number of CFU g)1 found, isolated
micro-organisms, company name, notifying coun-
try and manufacturing country. Tattoo ink is reg-
istered either as a chemical product or cosmetic in
different notifications. In this study, it is considered
to be a chemical product and hence not included.
In the first 17 weeks of 2008, the number of
recalls due to contamination is almost the same as
in all of 2007 (Table I). The majority of the con-
taminated cosmetics are products with high water
content, such as creams, gels and shampoos, and
furthermore, many of the products are category 1
products (Table I). High levels of contamination
(>105 CFU g)1) were found in more than 60% of
the available bacterial counts, which ranged from
600 to 8 · 106 CFU g)1. The most predominant
micro-organism was the pathogenic Pseudomonas
aeruginosa which was found in more than 40% of
all the recalled products. Pathogenic micro-organ-
isms such as Staphylococcus aureus, Burkholderia
cepacia and Candida albicans were all found in one
case each (Table I). Two products came from the
same manufacturer, EUMADIS in France and both
were contaminated with P. aeruginosa. No other
relationships were found between the 24 different
products which were manufactured in 17 different
countries (Table I). Germany is the country with
most notifications (6), followed by Spain (5) and
France (4) (Table I).
Discussion
A total of 24 different cosmetic products have been
recalled from the EU market as a result of microbi-
ological contamination. The rise in the numbers of
contaminated cosmetics from one in 2005 to nine
in 2007 is in good accordance with the increase
in numbers of cosmetic notifications. In general,
the total number of notifications has doubled from
847 in 2005 to 1605 in 2007 [1]. Based on the
number of contaminated cosmetic recalls so far in
2008, it seems that the final result for 2008 could
be at least two to three times higher than in
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International Journal of Cosmetic Science, 30, 471–474
Recalls of cosmetic products M. D. Lundov and C. Zachariae

Table I Information on recalled cosmetic product from 2005 to week 17 in 2008

CFU g)1 bacteria/

mould and Country of Notifying
Year Product yeast Species Company origin country

2005 Baby shampoo Pseudomonas aeruginosa Hobby Collection Turkey Germany

2006 Children mouth Burkholderia cepacia Diario Spain Spain
wash
2006 Make-up set 130 000 / 7900 China Spain
2006 Washing gel 100 000 Klebsialle oxytoca Balea Switzerland Germany
2006 Skin gel 320 0000 P. aeruginosa Alosan Denmark Norway
2006 Eye mask 5 000 000 Russia Estonia
2006 Baby cream 6500 P. aeruginosa Fresh Line Greece Greece
2006 Skin cream gel Candida albicans Effect Ukraine Estonia
2007 Shower gel P. aeruginosa Soft & Gentle Germany Germany
2007 Mascara 3500 Rival de loop Netherlands Netherlands
2007 Make-up remover 500 000 P. aeruginosa Eumadis France France
2007 Night cream 17 000 Recepto Babuski Russia Estonia
Agafii
2007 Make-up remover 300 000 P. aeruginosa Eumadis France France
2007 Eye balm Staphylococcus aureus I&M Naturkosmetik Germany Germany
2007 Toothpaste 420 0000 P. aeruginosa and UFSBD, MSA China France
Klebsiella oxytoca and Lang
2007 Body cream 1 000 000 Aromababy Australia Finland
2007 Body lotion P. aeruginosa Hanfwelt Austria Austria
2008 Toothpaste 10 000 Enterobacteriacea Colgate Ireland Spain
2008 Baby balm P. aeruginosa Uriage France France
2008 Eye contour cream Rhizobium radiobacter Euphia Belgium Belgium
2008 Toothpaste 1 100 000 Colgate* South Africa Spain
2008 Facial milk 600 P. aeruginosa Martina Gebhardt Germany Germany
Naturkosmetik
2008 Children 1300 Goliath Hong Kong Spain
make-up set
2008 Sun lotion 8 000 000 Enterobacter cloacea, Schônegger Austria Germany
Enterococcus
faecium and
Enterococcus sp.

*Counterfeit.

2007, and so far it appears that the total number
of notifications is at the same level as in 2007;
this increase is most probably because of an
enhanced control in the different countries. Cos-
metics with high water content are especially
exposed to contamination and the manufacturers
use preservatives to eradicate intrinsic contamina-
tion and reduce the possibility of in-use contami-
nation. Many of the contaminated cosmetics are
from category 1 where the demands to the micro-
biological quality are more restricted than cate-
gory 2. However, there are no products based on
the data available, which could have passed the
demands to category 2 but not category 1. Pseudo-
monas aeruginosa was the most frequently identified
micro-organism in this study as well as in earlier
studies [3, 4]. Pseudomonas aeruginosa is often the
reason for contamination from the manufacturing
line and resistance of the micro-organism to some
of the preservatives used in cosmetics has been
reported [5]. Pseudomonas aeruginosa infections
caused by contaminated cosmetics in hospitalized
persons have been previously published [6, 7]. The
finding of Burkholderia cepacia in a children mouth
wash is a cause of concern because previous cases
of infections caused by mouth wash contaminated
with this pathogen have been reported [8, 9].
The majority of the contaminations are pro-
duced in different countries, and only one com-
pany had more than one product recalled so there
are no indications of problems with specific com-
panies or countries. It is of course important to be

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ª 2008 Society of Cosmetic Scientists and the Société Française de Cosmétologie
International Journal of Cosmetic Science, 30, 471–474 473
Recalls of cosmetic products
aware that the RAPREX only conducts random
sampling of a few of the many thousand different
cosmetic products available in all 30 different EU
and EAA countries. An Internet-based search for
information about the companies behind the
recalled products reveals that both small national
and big international companies have contamina-
tion problems. An interesting note is that the
many of the products are composed of natural
ingredients, including some organic compounds.
Raw materials based on natural ingredients are
one of the main reasons for microbial contamina-
tion, and it is important for the manufacturers to
be aware of the contamination occurring through
raw materials of natural origin. In general, more
information about the cause of the contamination,
if the isolated micro-organisms are resistant to the
preservatives used in the products or the products
are insufficiently preserved, is needed. This infor-
mation could increase the knowledge on some of
the interactions between micro-organisms, cosmet-
ics and cosmetic preservatives, a subject that has
not been given much attention in many years.
Acknowledgement
No funding supplied.
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