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Contact Dermatitis • Original Article COD

Contact Dermatitis

Preservatives and fragrances in selected consumer-available cosmetics


and detergents
Kerem Yazar, Stina Johnsson, Marie-Louise Lind, Anders Boman and Carola Lidén
Institute of Environmental Medicine, Karolinska Institutet, SE-171 77 Stockholm, Sweden

doi:10.1111/j.1600-0536.2010.01828.x

Summary Background. Preservatives and fragrances are important and frequent skin sensitizers,
found in a wide range of products intended for personal and occupational use.
Objectives. To examine the use of preservatives and fragrances in certain cosmetics and
detergents on the market. The product types studied were shampoos, hair conditioners,
liquid soaps, wet tissues, washing-up liquids, and multi-purpose cleaners.
Materials/methods. Ingredient labels of 204 cosmetic products and ingredient data
sheets of 97 detergents, available on company websites, were examined.
Results. The preservatives most frequently identified were phenoxyethanol, methyl-
paraben, sodium benzoate, propylparaben, and methylchloroisothiazolinone/methyl-
isothiazolinone. Parabens were found in 44% of cosmetics and 9% of detergents;
formaldehyde-releasers in 25% of cosmetics and 8% of detergents; and isothiazolinones
in 23% of cosmetics and 28% of detergents. The fragrances most frequently identified
were linalool, limonene, hexyl cinnamal, butylphenyl methylpropional, and citronellol.
Eighty-eight per cent of the products contained fragrances, and any of the 26 fragrances
requiring labelling were found in half of the cosmetics and one-third of the detergents.
Conclusions. Several preservatives and fragrances with well-known skin-sensitizing
potential were common in the examined product types. Such products may be used
several times a day by consumers and workers.

Key words: allergic contact dermatitis; consumer product safety; cosmetics;


detergents; fragrances; preservatives.

Preservatives and fragrances are important and frequent label. In addition, 26 fragrances that have been identified
skin sensitizers, found in a wide range of products intended as skin sensitizers should be listed by name on the label
for personal and occupational use (1, 2). Fragrances are of a cosmetic product if used in concentrations exceeding
the most frequent causes of contact allergy to cosmetics, 10 ppm (0.001%) in leave-on products and 100 ppm
including products for personal hygiene, followed by (0.01%) in rinse-off products (6). Similarly, the regulation
preservatives (3, 4). It has been suggested that fragrances on detergents requires labelling of these 26 fragrance
account for 30–45% of allergic reactions to cosmet- substances if their concentration exceeds 100 ppm (7).
ics (5). According to the Cosmetics Directive, fragrances Several of the 26 fragrances are well-recognized skin
must be identified by the term ‘parfum’ on the ingredient sensitizers, whereas some have been questioned regarding
their importance as allergens (8, 9). The list of the 26 is
currently under review by the European Commission’s
Correspondence: Kerem Yazar, Institute of Environmental Medicine,
Scientific Committee on Consumer Safety. In contrast
Karolinska Institutet, Box 210, SE-171 77 Stockholm, Sweden. Tel: +46
8524 80042; Fax: +46 8 336981. to fragrances, preservatives must always be declared by
E-mail: kerem.yazar@ki.se name on the ingredient labels of cosmetics and detergents.
Conflicts of interest: The authors have no conflicts of interest to declare. In the work environment, sources of preservative
Funding by the Swedish Council for Working Life and Social Research. allergy and dermatitis include, for example, metalworking
Accepted for publication 22 September 2010 fluids, adhesives/glues, water-based paints and lacquers,

© 2010 John Wiley & Sons A/S • Contact Dermatitis, 64, 265–272 265
PRESERVATIVES AND FRAGRANCES IN PRODUCTS • YAZAR ET AL.

detergents, and pesticides, as well as cosmetics. Frequently Selection of products and examination of labels
used rinse-off products, such as liquid soaps, can Four types of frequently used cosmetic products for per-
contribute significantly to exposure to preservatives in sonal hygiene that come into contact with the skin, includ-
the work environment, and this has been well demon- ing shampoos, hair conditioners, liquid soaps, and wet
strated with regard to methyldibromo glutaronitrile tissues, were selected. Owing to the large number of sham-
(MDBGN) (10–12). Many of the preservatives causing poos and hair conditioners on the market, only such prod-
contact allergy and dermatitis are present both in con- ucts specified to be used for normal hair, coloured hair,
sumer products and in occupationally used products (13), anti-dandruff purposes, men or children were included.
and this contributes to difficulties in allergy prevention A total of 20 shops in Stockholm were visited between
and avoidance of unwanted skin exposure. Sources of May and June 2008. These were mainly large shops
exposure to fragrance allergens in the occupational set- with nationwide coverage, including department stores,
ting include predominantly cosmetics and detergents; supermarkets, beauty shops, pharmacies, hairdresser
moreover, spices and flavours used by chefs and bakers salons, and grocery stores. No data are available to
may contain fragrance allergens (14). the public on sales rates of specific products. Thus, a
Information on the use of various allergens in cosmetics crude selection of products estimated to be sold in large
and other products in Europe is scarce. Gaining more volume was made, on the basis of information from shop
knowledge on the exposure to allergens in products on assistants and the authors’ own perceptions, gained while
the market can be of great importance for prevention visiting the shops. A total of 206 cosmetic products were
and diagnostic purposes, as new allergens emerge and
purchased. One shampoo and one hair conditioner did
exposures to known allergens change.
not have any ingredient declaration and were therefore
The present aim was to examine the presence of
excluded, leaving 204 products for further examination:
preservatives and fragrances in products that come into
shampoos (n = 92), hair conditioners (n = 61), liquid
frequent contact with the skin of large parts of the
soaps (n = 34), and wet tissues (n = 17). The prevalence
population. Preservatives used in large volumes or with
of the included preservatives and fragrances in the
known skin-sensitizing properties, and 26 fragrances that
products was studied on the basis of information provided
currently must be listed on the labels of cosmetics and
by their ingredient labels.
detergents, were investigated. The product types studied
In April 2010, the same shops were visited once again
were shampoos, hair conditioners, liquid soaps, wet
in order to add information on detergents to that on
tissues, washing-up liquids, and multi-purpose cleaners.
the previous sample of cosmetic products. Two types
of product were selected, including washing-up liquids
Materials and Methods (n = 44) and multi-purpose cleaners (n = 53), specified
either for use on nearly all washable surfaces or for
Selection of preservatives and fragrances for assessment general use in the bathroom or kitchen. According to
A list of preservatives of concern for the present the detergent regulations, consumer-available detergent
study was created. The intention was to include large- products must have a website address on the label where
volume preservatives used in chemicals and cosmetics. information on chemical composition can be found.
Preservatives with known skin-sensitizing properties were Website addresses were recorded from the labels of all
also included. The selection of substances was based multi-purpose cleaners and washing-up liquids that were
on the following sources of information. Data were found in the stores. The prevalence of the included
obtained from the Swedish Chemicals Agency’s Products preservatives and fragrances in the products was studied
Register on the 30 most frequently used preservatives on the basis of ingredient data sheets available on the
in registered chemical products. Preservatives known companies’ websites.
as clinically relevant skin sensitizers were identified in The selected preservatives and fragrances that were
published reviews on preservative contact allergy (4, 15). identified were recorded in Microsoft® Excel, and their
All preservatives in the cosmetic series for patch testing of prevalences were calculated. No chemical analyses were
Chemotechnique Diagnostics AB (Vellinge, Sweden) were performed in the present study.
included. Antioxidants were not included, although they
are sometimes considered as preservatives. In total, 57
preservatives were included in the present study. Results
The 26 fragrances that, according to the Cosmetics The results of the study are displayed in Tables 1 and 2
Directive, must be listed on the label by their name were and in Figs. 1 and 2. Altogether, 30 of 57 preserva-
included (14). tives selected for the study and 20 of the 26 fragrances

266 © 2010 John Wiley & Sons A/S • Contact Dermatitis, 64, 265–272
PRESERVATIVES AND FRAGRANCES IN PRODUCTS • YAZAR ET AL.

Table 1. Selected preservatives identified on the ingredient declarations of cosmetic products [shampoos (n = 92), hair conditioners (n = 61),
liquid soaps (n = 34), and wet tissues n = 17)] in May 2008, and of detergents [multi-purpose cleaners (n = 53) and washing-up liquids
(n = 44)] in April 2010, on the market in Sweden. Hazard classification as skin sensitizer (H317, former R43) is according to the EC regulation
on the classification, labelling and packaging of substances and mixtures (CLP) (16). Limit of content of preservatives in cosmetic products is
according to the Cosmetics Directive (6)

Products containing certain


preservatives (%)

All Classified In European


Preservative (INCI name or used products Cosmetic Detergent Limit of content in skin patch test
abbreviation) CAS no. (n = 301) (n = 204) (n = 97) cosmetics (%) sensitizer baseline series

Phenoxyethanol 122-99-6 33 39 19 1 — —
Methylparaben 99-76-3 29 41 4 0.4a — PM
Sodium benzoate 532-32-1 27 34 11 2.5b , — —
0.5c,d
Propylparaben 94-13-3 19 25 4 0.4a — PM
MCI/MI 55965-84-9 18 22 9 0.0015 x x
Ethylparaben 120-47-8 15 22 1 0.4a — PM
DMDM hydantoin 6440-58-0 13 17 4 0.6e — —
Cetrimonium chloride 112-02-7 13 19 0 0.1 — —
Butylparaben 94-26-8 9 14 0 0.4a — PM
Isobutylparaben 4247-02-3 9 13 0 0.4a — —
Benzoic acid 65-85-0 8 11 2 2.5b — —
0.5c,d
Potassium sorbate 24634-61-5 7 9 4 0.6 — —
Benzyl alcohol 100-51-6 7 9 1 1f — —
2-Bromo-2-nitropropane-1,3-diol 52-51-7 7 6 7 0.1e — —
Sodium methylparaben 5026-62-0 7 7 5 0.4a — —
Methylisothiazolinone 2682-20-4 6 0.5 16 0.01 — —
Imidazolidinyl urea 39236-46-9 4 5 0 0.6e — —
Chlorhexidine dihydrochloride 3697-42-5 3 5 0 0.3g — —
Benzisothiazolinone 2634-33-5 3 0 9 — x —
Formic acid 64-18-6 2 2 0 0.5 — —
Sodium propylparaben 35285-69-9 2 0 5 0.4a — —
Methyldibromo glutaronitrile 35691-65-7 1 1 0 Before 23 June — x
2008:0.1% in rinse-
off products only
From 23 June 2008:
not allowed
Octylisothiazolinone 26530-20-1 1 0 3 — x —
Quaternium-15 4080-31-3 0.7 1 0 0.2e — x
Sodium salicylate 54-21-7 0.7 1 0 0.5 — —
Chlorhexidine digluconate 18472-51-0 0.3 0.5 0 0.3g — —
Chlorphenesin 104-29-0 0.3 0.5 0 0.3 — —
Iodopropynyl butylcarbamate 55406-53-6 0.3 0.5 0 0.02b , — —
0.01d
Triclosan 3380-34-5 0.3 0.5 0 0.3 — —
Glutaral 111-30-8 0.3 0 1 0.1 x —
Any formaldehyde-releaser — 19 25 8 — — —
Any isothiazolinone — 24 23 28 — — —
Any paraben — 33 44 9 — — —

MCI/MI, methylchloroisothiazolinone/methylisothiazolinone; INCI, International Nomenclature of Cosmetic Ingredients; PM, paraben mix.
a Paraben; the accumulated content of mixtures of esters is restricted to 0.8%.
b Rinse-off products.
c The accumulated content of benzoic acid and its sodium salt is restricted to these concentrations.
d Leave-on products.
e Formaldehyde-releasing preservative.
f One per cent if added as preservative. No limit to content if added for other purposes (fragrance, solvent).
g The accumulated content of chlorhexidine is restricted to 0.3%.

© 2010 John Wiley & Sons A/S • Contact Dermatitis, 64, 265–272 267
PRESERVATIVES AND FRAGRANCES IN PRODUCTS • YAZAR ET AL.

Table 2. Fragrances that must be listed on the label of cosmetics and consumer-available detergents by their name and that were identified
on the ingredient declarations of shampoos (n = 92), hair conditioners (n = 61), liquid soaps (n = 34) and wet tissues (n = 17) in May 2008,
and of multi-purpose cleaners (n = 53) and washing-up liquids (n = 44) in April 2010, on the market in Sweden. Hazard classification as
skin sensitizer (H317, former R43) is according to the EC regulation on the classification, labelling and packaging of substances and mixtures
(CLP) (16). Limit of content of preservatives in cosmetic products is according to the Cosmetics Directive (6)

Products containing certain


fragrances (%)

All Limit of Classified In European


products Cosmetic Detergent content in skin patch test
Fragrance (INCI name) CAS no. (n = 301) (n = 204) (n = 97) cosmetics (%) sensitizer baseline series

Linalool 78-70-6 29 38 10 — — —
Limonene 138-86-3 27 28 25 — x —
Hexyl cinnamal 101-86-0 26 32 13 — — FM II
Butylphenyl methylpropional 80-54-6 23 29 9 — — —
Citronellol 106-22-9 17 20 9 — — FM II
Benzyl salicylate 118-58-1 11 16 2 — — —
Geraniol 106-24-1 9 11 3 — — FM
α-Isomethyl ionone 127-51-5 8 11 1 — — —
Benzyl alcohol 100-51-6 7 9 1 — — —
Coumarin 91-64-5 5 6 1 — — FM II
Hydroxyisohexyl 3-cyclohexene 31906-04-4 5 7 0 — — FM II and separate
carboxaldehyde
Amyl cinnamal 122-40-7 4 6 1 — — FM
Benzyl benzoate 120-51-4 3 4 1 — — —
Citral 5392-40-5 3 2 5 — x FM II
Hydroxycitronellal 107-75-5 2 2 1 1 — FM
Eugenol 97-53-0 1 2 0 — — FM
Methyl 2-octynoate 111-12-6 0.7 1 0 0.01 — —
Evernia prunastri extract 90028-68-5 0.3 0.5 0 — — FM
Farnesol 4602-84-0 0.3 0.5 0 — — FM II
Isoeugenol 97-54-1 0.3 0.5 0 0.02 — FM
Any fragrance requiring labelling — 45 50 32 — — —
Only the term parfum — 44 37 59 — — —
Perfume-free — 12 13 9 — — —
Any FM ingredient — 11 15 4 — — —
Any FM II ingredient — 30 36 16 — — —

FM, fragrance mix ingredient; FM II, fragrance mix II ingredient; INCI, International Nomenclature of Cosmetic Ingredients.

requiring labelling were identified in the ingredient products contained at least one formaldehyde-releaser or
declarations of the examined products. isothiazolinone, respectively.
Of four formaldehyde-releasers identified, DMDM
hydantoin was the most common (in 17% of the prod-
Cosmetic products
ucts), followed by 2-bromo-2-nitropropane-1,3-diol (6%),
A total of 26 of the 57 selected preservatives were iden- imidazolidinyl urea (5%), and quaternium-15 (1%). Five
tified on the labels of the examined cosmetic prod- hair conditioners and five shampoos contained two differ-
ucts. Ninety-four per cent of the products were de- ent formaldehyde releasers. MDBGN was present in two
clared to contain at least one of the included preser- shampoos and in one liquid soap.
vatives. The most frequently identified preservatives were Twenty of the 26 fragrances were identified on the
methylparaben (in 41% of the products), phenoxyethanol labels of the cosmetic products. Fifty per cent of the
(39%), sodium benzoate (34%), propylparaben (25%), products were declared to contain at least 1 of the 26
and methylchloroisothiazolinone/methylisothiazolinone fragrances. On 87%, the term ‘parfum’ was listed, indi-
(MCI/MI) (22%). cating the presence of fragrances. Thirteen per cent of the
Six different parabens were identified, and 44% of products did not contain any fragrance according to their
the cosmetic products contained one or more paraben. ingredient labels.
Correspondingly, four formaldehyde-releasers and two The most frequently identified fragrances were
isothiazolinones were identified, and 25% and 23% of the linalool (38%), hexyl cinnamal (32%), butylphenyl

268 © 2010 John Wiley & Sons A/S • Contact Dermatitis, 64, 265–272
PRESERVATIVES AND FRAGRANCES IN PRODUCTS • YAZAR ET AL.

methylpropional (29%), limonene (28%) and citronellol


(20%). Ingredients of the main indicators of fragrance
allergy in the European baseline series for patch testing,
fragrance mix and fragrance mix II, were found in 15%
and 36% of the products, respectively.

Detergents
A total of 17 of the 57 selected preservatives were identified
in the ingredient data sheets of the examined washing-up
liquids and multi-purpose cleaners. Seventy-one per cent
of the products were declared to contain at least one of the
included preservatives. The most frequently identified
preservatives were phenoxyethanol (in 19% of the
Fig. 1. The five most frequently identified preservatives in 204 products), methylisothiazolinone (16%), sodium benzoate
cosmetic products in May 2008; and 97 detergents in April 2010, (11%), benzisothiazolinone (9%), and MCI/MI (9%). Four
respectively. The percentages of products containing at least one different isothiazolinones were identified, and 28% of
paraben, isothiazolinone or formaldehyde-releaser are shown. The
the detergents contained one or more isothiazolinones.
product types studied were shampoos ( ) (n = 92), hair
conditioners ( ) (n = 61), liquid soaps ( ) (n = 34), wet tissues Correspondingly, five parabens and two formaldehyde-
( ) (n = 17), washing-up liquids ( ) (n = 44) and multi-purpose releasers were identified, and 9% and 8% of the products
cleaners ( ) (n = 53) on the Swedish market. MCI/MI, contained at least one paraben or formaldehyde-releaser,
methylchloroisothiazolinone/methylisothiazolinone; MI, respectively.
methylisothiazolinone; BIT, benzisothiazolinone.
MI was the most common of four identified isoth-
iazolinones and was, with the exception of one liquid
soap, always used in combination with some other
preservative, predominantly phenoxyethanol (nine prod-
ucts) and benzisothiazolinone (seven products). Two
formaldehyde-releasers were identified, of which 2-
bromo-2-nitropropane-1,3-diol was the most common
(7%), followed by DMDM hydantoin (4%).
Fourteen of the 26 fragrances that require labelling
were identified on the labels of the washing-up liquids
and multi-purpose cleaners. Thirty-two per cent of the
products were declared to contain at least one of the
included fragrances. On 91% of the detergents, the term
‘parfum’ was listed, and 9% of the products did not contain
any fragrance according to their ingredient data sheets.
The most frequently identified fragrances were limonene
(25%), hexyl cinnamal (13%), linalool (10%), citronellol
(9%), and butylphenyl methylpropional (9%). Ingredients
of fragrance mix and fragrance mix II were found in 4%
and 16% of the detergents, respectively.

Fig. 2. The five most frequently identified fragrances in 204 Discussion


cosmetic products in May 2008, and 97 detergents in April 2010,
respectively. The percentages of products containing fragrance In this study, we have examined the presence of selected
(parfum), any of the 26 fragrances requiring labelling and preservatives and fragrances in consumer-available
fragrance mix or fragrance mix II ingredients are shown. The products that are used by a large part of the population
product types studied were shampoos ( ) (n = 92), hair
conditioners ( ) (n = 61), liquid soaps ( ) (n = 34), wet tissues
and that frequently come into contact with the skin.
( ) (n = 17), washing-up liquids ( ) (n = 44) and multi-purpose Undeclared substances or concentrations could not be
cleaners ( ) (n = 53) on the Swedish market. FM, fragrance mix identified in this study, as ingredient labels were examined
ingredient; FM II, fragrance mix II ingredient. and no chemical analyses were performed. However,

© 2010 John Wiley & Sons A/S • Contact Dermatitis, 64, 265–272 269
PRESERVATIVES AND FRAGRANCES IN PRODUCTS • YAZAR ET AL.

studies based on ingredient labelling can provide valuable For the vast majority of preservatives in the present
information on exposure to allergens (17). study, maximum use concentrations are specified in the
MCI/MI was widely prevalent, especially in the cos- Cosmetics Directive. There are no such limits for ben-
metic products, indicating that a considerable proportion zisothiazolinone and octylisothiazolinone in cosmetics.
of the population is frequently exposed to this extremely According to the European Commission database with
potent skin sensitizer. MCI/MI was found even in wet information on cosmetic ingredients, ‘CosIng’ (26), these
tissues, which should be regarded as leave-on products. substances are regarded as antimicrobials and not as
Areas wiped by moist toilet paper will be occluded, and preservatives, meaning that their function is to control
allergic contact dermatitis resulting from such exposure the growth of microorganisms on the skin. According
is probably not uncommon (18, 19). In contrast to the to the new regulation on classification, labelling and
maximum authorized concentration of 15 ppm in cos- packaging of chemical substances and mixtures (CLP reg-
metics specified by the Cosmetics Directive, MCI/MI is ulation) (16), only four of 30 preservatives are classified
limited to 7.5 ppm in leave-on products in the USA, as skin sensitizers (H317); benzisothiazolinone, MCI/MI,
and is allowed only in rinse-off products (15 ppm) in glutaral, and octylisothiazolinone. MDBGN has not yet
Japan (15). attained this classification, which is remarkable, consid-
MDBGN, which has been prohibited in rinse-off ering its well-established importance as a skin sensitizer.
products since 23 June 2008, was found in three MDBGN is thus banned for use in cosmetics, whereas it
cosmetic products about 1 month before its prohibition can be included in other products without restriction or
in such products. This indicates that large producers warning labelling.
and retailers had started phasing out this problematic In approximately half of the cosmetics and one-third of
the detergents examined, one or more of the 26 fragrances
cosmetic allergen (20, 21). In Denmark, the prevalence
requiring labelling were identified, indicating that they
of MDBGN allergy has been reported to have decreased,
are still frequently used in the examined product types.
and this was interpreted to be a result of the regulatory
The fragrances most frequently found in the present study
interventions in the Cosmetics Directive (22). Of interest,
are the same as in a recent study from the UK (27). In total,
but less encouraging, is that large batches of shampoo
90% of the products contained fragrances according to
and liquid soap containing MDBGN were discovered in
their ingredient labels. Fragrance mix II ingredients were
2009 by municipality environmental health inspectors
nearly twice as common in the cosmetics and four times as
in common grocery stores with nationwide coverage in
common in the detergents than fragrance mix ingredients.
different parts of Sweden (personal communication from
Wet tissues differed markedly from the other product
Gunnar Guzikowski, Swedish Medical Products Agency,
types, with only seven of 17 products being declared to
2010). As a result, the responsible importers and retailers
contain any fragrance, and only one product listing any
were obliged to withdraw the products from the market. of the 26 fragrances requiring labelling.
This shows that cosmetic products on the EU market still Recent studies have pointed to oxidation products of
may contain MDBGN, although it is prohibited, and that limonene and linalool as important skin sensitizers (28,
monitoring of the market by the competent authorities is 29). Both substances were widespread in the products,
essential for compliance with regulatory interventions. linalool being the most frequently identified fragrance in
Formaldehyde-releasers are important sources of the cosmetics, and limonene in the detergents.
formaldehyde exposure and allergic contact dermatitis. In contrast to the situation with preservatives,
Contact allergy to the formaldehyde-releaser itself, with- maximum use concentrations are specified in the
out allergy to free formaldehyde, is less frequent (23, 24). Cosmetics Directive for only three of 20 identified
Formaldehyde-releasers were found in one-quarter of all fragrances (hydroxycitronellal, isoeugenol, and methyl-
cosmetic products. Our results were very similar to those 2-octynoate). Only citral and limonene are classified as
from the USA Food and Drug Administration (FDA) Vol- skin sensitizers (H317) according to the regulation on the
untary Cosmetic Registration Database, concerning the classification, labelling and packaging of substances and
presence of formaldehyde-releasers in rinse-off cosmet- mixtures (CLP).
ics. Formaldehyde-releasers were found in approximately European legislation for prevention of adverse health
27% of the rinse-off cosmetics, both in the present study effects of chemicals covers a wide range of product types
and in the FDA data (23). Rinse-off products containing and exposure situations with different directives and
formaldehyde-releasers have been reported to be responsi- ordinances, based on different principles, and not always
ble for allergic contact dermatitis, from both occupational well coordinated. Examples concerning contact allergy
and non-occupational exposure (25). are the Cosmetics Directive, including full ingredient

270 © 2010 John Wiley & Sons A/S • Contact Dermatitis, 64, 265–272
PRESERVATIVES AND FRAGRANCES IN PRODUCTS • YAZAR ET AL.

labelling, and restrictions on content based on risk wet tissues, washing-up liquids, and multi-purpose clean-
assessment; and the regulation on detergents, requir- ers. Such products may be used several times a day by
ing labelling of preservatives and selected fragrances. The consumers and workers, leading to repeated exposure to
new regulation on classification, labelling and packaging some of the most important causes of contact allergy,
of chemical substances and mixtures (CLP regulation) often in combination with other allergens and skin irri-
is based on hazard identification. It came into force 20 tants. In addition, we have elucidated some shortcomings
January 2009, and will stepwise replace the directives on in the present legislation for the prevention of adverse
dangerous substances and preparations. One noticeable health effects from chemicals. No maximum use concen-
change is the introduction of so-called hazard statements tration limits are specified in the Cosmetics Directive for
instead of risk phrases, with skin sensitizers being clas- some well-known and much used skin-sensitizing preser-
sified as H317 as a substitute for the preceding R43. vatives and fragrances. Several of the preservatives and
Furthermore, the limitations on nickel in certain articles fragrances are not yet classified as skin sensitizers in the
and chromate in cement have been successful legislative CLP regulation. We suggest that this should be done
measures (30). The directive on general product safety in order to better protect consumers and workers from
has appeared to be useful for the protection of consumer harmful skin exposure.
health, as shown by the recent EU ban of the allergenic
anti-mould agent dimethyl fumarate in articles, based on
a Commission decision in 2009. Acknowledgements
It is concluded that several preservatives and fra- Gunnel Hagelthorn documented all product labels by
grances with well-known skin-sensitizing potential are photo. The Swedish Council for Working Life and Social
common in shampoos, hair conditioners, liquid soaps, Research gave financial support.

References
1 Zug K A, Warshaw E M, Fowler J F Jr et al. (76/768/EEC). Available at: http://eur- Avnstorp C. Contact allergy to
Patch-test results of the North American lex.europa.eu/LexUriServ/LexUriServ.do? methyldibromo glutaronitrile – data from
Contact Dermatitis Group 2005–2006. uri=CONSLEG:1976L0768:20090507: a ‘front line’ network. Contact Dermatitis
Dermatitis 2009: 20: 149–160. EN:PDF. (consolidated version). Off J Eur 2005: 52: 138–141.
2 Uter W, Ramsch C, Aberer W et al. The Union 1976: L262: 169–200. (last 12 Jensen C D, Johansen J D, Menné T,
European baseline series in 10 European accessed 18 Febrary 2010). Andersen K E. Methyldibromo
Countries, 2005/2006 – results of the 7 European Parliament, Council of the glutaronitrile contact allergy: effect of
European Surveillance System on Contact European Union. Regulation (EC) No. single versus repeated daily exposure.
Allergies (ESSCA). Contact Dermatitis 648/2004 of the European Parliament Contact Dermatitis 2005: 52: 88–92.
2009: 61: 31–38. and of the Council of 31 March 2004 on 13 Flyvholm M A. Preservatives in registered
detergents. Available at: http://eur-lex. chemical products. Contact Dermatitis
3 Goossens A, Beck M H, Haneke E,
europa.eu/LexUriServ/LexUriServ.do? 2005: 53: 27–32.
McFadden J P, Nolting S, Durupt G,
uri=OJ:L:2004:104:0001:0035:EN:PDF. 14 Johansen J D, Lepoittevin J-P, Basketter D,
Ries G. Adverse cutaneous reactions to
Off J Eur Union 2004: L104: 1–35. (last McFadden J, Søsted H. Allergens of special
cosmetic allergens. Contact Dermatitis
accessed 18 February 2010). interest. In: Contact Dermatitis, 4th
1999: 40: 112–113.
8 Schnuch A, Uter W, Geier J, Lessmann H, edition. Frosch P J, Menné T, Lepoittevin
4 White I R, de Groot A C. Cosmetics and
Frosch P J. Sensitization to 26 fragrances J-P (eds): Berlin, Springer-Verlag, 2006:
skin care products. In: Contact Dermatitis,
to be labelled according to current pp. 507–535.
4th edition, Frosch P J, Menné T,
European regulation. Results of the IVDK 15 Marks J G, Elsner P, DeLeo V.
Lepoittevin J-P (eds): Berlin, and review of the literature. Contact Preservatives and vehicles. In: Contact and
Springer-Verlag, 2006: pp. 493–503. Dermatitis 2007: 57: 1–10. Occupational Dermatology, 3rd edition,
5 European Commission, Scientific 9 van Oosten E J, Schuttelaar M L, Fathman L (ed.): St Louis, Mosby, 2002:
Committe on Cosmetic Products and Coenraads P J. Clinical relevance of pp. 140–171.
Non-Food Products Intended for positive patch test reactions to the 26 16 European Parliament, Council of the
Consumers. Opinion concerning EU-labelled fragrances. Contact Dermatitis European Union. Regulation (EC) No.
fragrance allergy in consumers, 1999. 2009: 61: 217–223. 1272/2008 of the European Parliament
Available at: http://ec.europa.eu/health/ 10 Diba V C, Chowdhury M M, Adisesh A, and of the Council of 16 December 2008
ph_risk/committees/sccp/documents/ Statham B N. Occupational allergic on classification, labelling and packaging
out98_en.pdf (last accessed 18 February contact dermatitis in hospital workers of substances and mixtures, amending
2010). caused by methyldibromo glutaronitrile in and repealing Directives 67/548/EEC and
6 Council of the European Union. Council a work soap. Contact Dermatitis 2003: 48: 1999/45/EC, and amending Regulation
Directive of 27 July 1976: on the 118–119. (EC) No. 1907/2006. Available at:
approximation of the laws of the member 11 Johansen J D, Veien N K, Laurberg G, http://eur-lex.europa.eu/LexUriServ/
states relating to cosmetic products Kaaber K, Thormann J, Lauritzen M, LexUriServ.do?uri=OJ:L:2008:353:0001:

© 2010 John Wiley & Sons A/S • Contact Dermatitis, 64, 265–272 271
PRESERVATIVES AND FRAGRANCES IN PRODUCTS • YAZAR ET AL.

1355:EN:PDF. Off J Eur Union 2008: dermatitis: an experimental study. Br 25 Aalto-Korte K, Kuuliala O, Suuronen K,
L353: 1–1355. (last accessed 24 March J Dermatol 2004: 150: 90–95. Alanko K. Occupational contact allergy to
2010). 22 Johansen J D, Veien N, Laurberg G et al. formaldehyde and formaldehyde releasers.
17 Yazar K, Boman A, Lidén C. Potent skin Decreasing trends in methyldibromo Contact Dermatitis 2008: 59: 280–289.
sensitizers in oxidative hair dye products glutaronitrile contact allergy – following 26 European Commission. Database with
on the Swedish market. Contact Dermatitis regulatory intervention. Contact information on cosmetic ingredients
2009: 61: 269–275. Dermatitis 2008: 59: 48–51. (CosIng). Available at: http://ec.europa.
18 Timmermans A, De Hertog S, Gladys K, 23 de Groot A C, White I R, Flyvholm M A, eu/enterprise/cosmetics/cosing/index.cfm?
Vanacker H, Goossens A. Lensen G, Coenraads P J. fuseaction=search.simple (last accessed
‘Dermatologically tested’ baby toilet Formaldehyde-releasers in cosmetics: 11 May 2010).
tissues: a cause of allergic contact 27 Buckley D A. Fragrance ingredient
relationship to formaldehyde contact
dermatitis in adults. Contact Dermatitis labelling in products on sale in the U.K. Br
allergy. Part 1. Characterization,
2007: 57: 97–99. J Dermatol 2007: 157: 295–300.
frequency and relevance of sensitization,
19 Zoli V, Tosti A, Silvani S, Vincenzi C. Moist 28 Matura M, Sköld M, Börje A et al. Not only
and frequency of use in cosmetics. Contact
toilet papers as possible sensitizers: review oxidized R-(+)- but also S-(–)-limonene is
Dermatitis 2010: 62: 2–17.
of the literature and evaluation of a common cause of contact allergy in
24 de Groot A, White I R, Flyvholm M A,
commercial products in Italy. Contact dermatitis patients in Europe. Contact
Dermatitis 2006: 55: 252–254. Lensen G, Coenraads P J. Dermatitis 2006: 55: 274–279.
20 Wilkinson J D, Shaw S, Andersen K E et al. Formaldehyde-releasers in cosmetics: 29 Christensson J B, Matura M,
Monitoring levels of preservative relationship to formaldehyde contact Gruvberger B, Bruze M, Karlberg A T.
sensitivity in Europe. A 10-year overview allergy. Part 2. Patch test relationship to Linalool – a significant contact sensitizer
(1991–2000). Contact Dermatitis 2002: formaldehyde contact allergy, after air exposure. Contact Dermatitis
46: 207–210. experimental provocation tests, amount of 2010: 62: 32–41.
21 Jensen C D, Johansen J D, Menné T, formaldehyde released, and assessment of 30 Biesterbos J, Yazar K, Lidén C. Nickel on
Andersen K E. risk to consumers allergic to the Swedish market: follow-up ten years
Methyldibromoglutaronitrile in rinse-off formaldehyde. Contact Dermatitis 2010: after entry into force of the Nickel
products causes allergic contact 62: 18–31. Directive. Contact Dermatitis (in press).

272 © 2010 John Wiley & Sons A/S • Contact Dermatitis, 64, 265–272

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