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Matched Legal Cases: ['Art. 1', 'Art 1', 'Art.14', 'art 1', 'art 2', 'art 1', 'Art\n34']

Environmental Sciences Europe | Full text | Dangerous cosmetics - criteria for classification, labelling and packaging (EC 1272/2008) applied to personal care products
enveurope.com/article/10.1186/2190/4715/24/37
Klaschka U
Ursula Klaschka	Correspondence: Ursula Klaschka klaschka@hs-ulm.de Author Affiliations University of Applied Sciences Ulm, Prittwitzstr. 10, D-89075, Ulm, Germany
Environmental Sciences Europe 2012, 24:37 doi:10.1186/2190-4715-24-37
The electronic version of this article is the complete one and can be found online at: http://www.enveurope.com/content/24/1/37
Received:24 July 2012 Accepted:10 October 2012 Published:29 November 2012 © 2012 Klaschka; licensee Springer. This is an Open Access article distributed under the terms of the Creative Commons Attribution License (http://creativecommons.org/licenses/by/2.0), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Cosmetic products need not be classified and labelled according to the Regulation
on Classification, Labelling and Packaging (CLP) in the European Union, even if they
contain dangerous substances. What would happen without this exception? Would cosmetic
products have to be labelled if they were treated like any other consumer product?
The criteria of the CLP Regulation were applied to a selection of cosmetic product
formulas in a conservative approach. All but one product contain hazardous ingredients
in amounts that would lead to classification and labelling of the mixtures. 85% of
the products analyzed would have to be labelled because of potential negative effects
to the eye, and 52% because of potential negative effects to the skin. The signal
word WARNING would have to be on the labels of 64%, DANGER would have to be on 33%
The results here show that it is urgent to inform consumers about the potential dangers
of personal care products, because cosmetics need to be applied even with more care
than any other consumer product. Classification and labelling according to the CLP
Regulation is a very good means to improve the risk communication for consumers. Therefore,
it is strongly recommended that the exception for cosmetic products should be repealed
in the next amendment of the CLP Regulation.
Keywords: Classification and labelling; CLP Regulation; Cosmetic products; Information for the consumer; Risk communicationBackground
The system of classification and labelling of hazardous substances and hazardous consumer
products has proven to be a very efficient tool for risk communication. The purpose
of the European Regulation on Classification, Labelling and Packaging of substances
and mixtures (EC No. 1272/2008) [1] (CLP Regulation) is “providing a primary means by which the general public and persons
at work are given essential information about the hazards of substances and mixtures.
…. This regulation should ensure a high level of protection of human health and the
environment.” (Preamble (1) of the CLP Regulation). Consumer products, such as glue,
varnish, or washing and cleansing products need to be classified and labelled if they
contain dangerous ingredients that render the mixture hazardous.
The CLP Regulation implements the United Nations Globally Harmonized System of Classification
and Labelling of Chemicals (UN GHS) [2] in the EU und replaces the Substance and the Preparations Directives (67/548) [3] and (1999/45) [4]. The CLP Regulation came into force for substances in 2010 and will have to be implemented
for mixtures in 2015.
Cosmetic products were excluded in the Preparations Directive and they are excluded
in the CLP Regulation (Art. 1 (5)) (Table 1(A). Although the CLP Regulation implements the UN GHS, it does not take over everything
as such. For example, the UN GHS does not clearly exclude cosmetic products. It only
quotes the opinion of the Interorganization Programme for the Sound Management of
Chemicals Coordinating Group in Art 1.1.2.4 who says “…, cosmetics, … will not be
covered by UN GHS in terms of labelling at the point of intentional intake. … further
discussion will be required to address specific application issues for some product
use categories which may require the use of specialized expertise.” Apart from this
word-for-word quote, there is no statement in the official UN GHS text about the treatment
of cosmetic products. The following general sentence is not restricted by any exceptions
(in 1.1.3.1.4) “For the consumer sector, it is expected that labels will be the primary
focus of GHS application.”
Table 1. Synopsis of the various passages of the CLP regulation and the relevance for cosmetic
There are additional provisions in the European CLP Regulation which are important
for a potential classification of personal care products:
(1) Certain hazard and precautionary statements and pictograms need not be listed
on the product label of containers if these are smaller than 125 ml ([1] Annex I 1.5.2.1.1, Table 1B). Shampoos, liquid soap or shower gels are examples of products sold usually in
bigger containers than 125 ml, whereas most personal care products, like tooth paste,
deodorants, aftershave, perfume, lip stick, or nail varnish are usually sold in smaller
containers. (2) Supplemental statements on the product labels inform the consumer
if the criteria for classification are not fulfilled, but information exists about
a potential hazard e.g. sensitization Table 1(C)). (3) However, you will find single cosmetic products with labels: Aerosol dispensers,
such as hairspray, must be labelled for their physical hazard class as highly flammable
according to EC 75/324 [5] and CLP Regulation Art.14(2)c). This labelling requirement could also mislead some
consumers. They might think that cosmetic products must be labelled in general and
there would be no hazard other than the flammability of hair spray. In addition, some
instant nail glue products made in Switzerland are also labelled, although Switzerland
has adopted the CLP Regulation with the exception for cosmetic products.
Table 1 gives an overview about some legal aspects in the CLP Regulation relevant for a potential
classification of cosmetic products and their consequences. The last column summarizes
what would happen if the general exception for cosmetics in the CLP Regulation were
There are several possibilities why an exception of labelling would be justified for
a certain product group. The following potential reasons are briefly discussed for
1. ”Cosmetic products are not dangerous.” No. Many dangerous substances have been
banned for personal care products. More than 13000 substances may not be used in cosmetic
products according to the Cosmetics Regulation 1223/2009 [6] (Annex II, List of Substances prohibited in cosmetic products), and around 250 compounds
may be used only under certain conditions (Annex III, List of substances which cosmetic
products must not contain except subject to restrictions laid down.). However, the
exception for cosmetic products in the CLP Regulation implies that there are mixtures
which would be classified as dangerous for the human health or environment. Otherwise
the exception would be superfluous. In the following, I will focus on this reasoning.
I will describe which cosmetic products would be labelled if the CLP Regulation did
not exclude them.
2. “Everybody knows that cosmetics are dangerous. Therefore, labels are not needed.”
No. Pharmaceuticals for example do not need to be classified and labelled because
everybody should know that they have biological effects and must be used with special
care in minimum doses. This reasoning for pharmaceuticals is not applicable to cosmetics,
as most consumers do not associate health and environmental risks with their daily
used personal care products.
3. “Personal care products are used in such low doses that it is irrelevant whether
the mixtures are dangerous.” No. The classification and labelling scheme is based
on inherent properties of the components. It is not based on a risk assessment where
exposure is compared to effects. Furthermore, personal care products are applied directly
to the surface of the human body frequently and in relatively large amounts [7].
4. “It is sufficient that the ingredients are listed on the containers of cosmetics.”
No. It cannot be assumed that the general public can look up the classifications and
labelling of the ingredients and derive the classification of the mixture themselves
before they buy and use these products. Proper consumer information would include
the labels as for any other consumer product.
5. “Ingredients are not clearly defined, such as essential oils, which would impede
classification and labelling.” No. The quality standard of cosmetic products is usually
very high, and the ingredients are usually clearly identifiable. Components which
are natural mixtures or result from chemical synthesis may be composed of many chemical
substances, but this does not affect potential classification and hazard assessment
6. “Labelling would be a danger for manufacturers` interests and company secrets.”
No. The classification and labelling of their products should not affect producers
of personal care products in a much different way than producers of e.g. washing and
cleansing products or paints and varnishes. Companies’ intellectual property rights
are protected. The list of ingredients on the containers together with the frame formulations
[8] and the Classification and Labelling Inventory [9] (C&L Inventory) might allow to derive rough classifications of the products for someone
who makes the effort already now.
7. “Labelling would lead to a decrease in sales of personal care products.” Probably
not. It is difficult to isolate labelling as one factor that would affect the sales
numbers for a consumer product. E.g. there is no information whether sales of washing
and cleansing products went down because of the labelling. Health warnings on tobacco
products seem to have affected neither consumption nor sales. If cosmetic products
were labelled, this might lead to a shift to products with less hazard pictograms,
and such an effect should be in everybody’s interest.
8. “The image of beauty and wellness that many consumers associate with cosmetics
would be endangered when the mixtures are labelled as dangerous.” Probably not. Some
consumers would certainly be surprised to see personal care products labelled as dangerous.
However, consumers know about the deleterious effects of alcoholic beverages or cigarettes
and they still consume these products. The general public has the right to be informed
about the reality by correct hazard pictograms.
9. “The classification of single substances by various producers is not consistent.
Therefore, product classification is not feasible.” No. This argument would be valid
for classification and labelling of all products and would make classification in
general impossible. Instead, this argument would plead for a more consistent classification
There might be further reasons why an exception for cosmetics was taken up in the
CLP Regulation, but the arguments listed here that plead against this exception are
The classifications presented here tend to be under-classifications to outline the
best case, not the worst case. As I did not have the comprehensive data base like
the producers of the respective products, I deliberately made the following assumptions
which may lead to less severe classifications: (1) Where self classifications of various
companies differed in several H-statements, I used the classification which the majority
of companies agreed upon, which was usually not the most severe classification. (2)
In most basic recipes no specific chemical names were given for preservatives, colorants,
pigments or fragrances. In these cases I did not consider them at all, although it
is known that most of them are hazardous substances. (3) I did not consider any potential
contaminations, impurities or stabilizers/preservatives as part of an ingredient as
I assume that they are present below the cut off values ([1] Annex I 1.1.4.1). (4) I pretended that all properties of all ingredients are known
and did not make use of the possibility to subtract substances with unknown properties
([1] Annex I 3.1.3.6.2). However, when no information could be retrieved for more than
20% of the total product, products were not considered further. Most decorative cosmetic
products which contained up to 10% of unnamed pigments reached this limit and could
not be analyzed further. Also natural ingredients pose problems for the correct classification,
as the available information is scanter than for synthetic ingredients. Some ingredients
do not have a CAS or EC number and could not be investigated further. Products which
contained more than 80% water were not considered if half of the remaining ingredients
were unclear. (5) I pretended that the pH values are in a medium range and not extremely
low or high. Therefore, I did not consider pH-effects of mixtures. (6) I pretended
that diluted ingredients are diluted with water and not with any other solvent. (7)
I had no information about the physical properties like thermal stability, heat of
combustion, flash point or boiling point of the mixtures. I assumed that these properties
were not crucial for cosmetic products and considered only the physical hazards of
aerosol dispensers. (8) When the components were heated to allow chemical reactions
before preparation of the final product (e.g. for soap production) I considered neither
the raw material nor the reaction products.
On this background producers might obtain different results using the precise composition
of their own products and the data of their specific ingredients without a deliberate
under-classification as I had to do here.
Criteria for classification and labelling were applied to 41 cosmetic products as
described in the Methods. Eight products could not be dealt with further due to insufficient
data. Classifications and labels of some products are illustrated in Figure 1 and the resulting H-statements of all 33 products are compiled in Table 2(A). One product (3%) would not need to be classified and labelled. None of the products
would need to be labelled with GHS01 (explosive), GHS03 (oxidizing), GHS04 (compressed
gas) or GHS06 (acutely toxic). Five products (15%) would need to be labelled with
GHS05 (corrosive), 25 products (76%) with GHS07 (acute hazard) and 7 products (21%)
with GHS08 (chronic hazard) and one product (3%) with GHS09 (environmental hazard).
The signal word WARNING would have to be on the labels of 21 products (64%), DANGER
would have to be on 11 products (33%).
Figure 1. Classification and labelling of cosmetic products, on the supposition that the exception
in the CLP Regulation would not be valid.
Table 2. Compilation of H-statements and P-statements attributed to the cosmetic product formulas
The list in Figure 1 shows some examples of the 41 products analyzed. The classifications tend to be less
severe as illustrated in the text. According to Article 18 of the CLP Regulation “….
the identity of all substances in the mixture that contribute to the classification
of the mixture as regards acute toxicity, skin corrosion or serious eye damage, germ
cell mutagenicity, carcinogenicity, reproductive toxicity, respiratory or skin sensitization,
specific target organ toxicity (STOT) or aspiration hazard” must be written on the
label (see first column). Substances responsible for other hazard statements need
not be listed by names.
The most frequently allocated H-statement was H319 ‘Causes serious eye irritation.’
(61%), followed by H315 ‘Causes skin irritation.’ (33%). 85% of the products would
have to be labelled because of potential negative effects to the eye (H318, H319 and
H314). 52% of the products would have to be labelled because of potential negative
effects to the skin (H314, H315 and H317).
Labels of classified products should also bear the precautionary statements (P-statements).
I listed the respective P-statements which the H-statements in Figure 1 would entail Table 2(B). Child resistant fastenings and tactile warnings would be required for products
classified as ‘Causes severe skin burns and eye damage.’. Not more than six P-statements
should be applied to the container of a product out of the selection given in Table
All products scrutinized contain hazardous ingredients. In many cases, the concentrations
of a hazardous chemical in the products were many times higher than the thresholds
for classification. The ‘eye zone cream’ is the only product in the selection that
would not need to be classified and labelled. However, it contains 71.9% water as
solvent for the active ingredients. If in the course of application near the eye,
half of the water amount evaporated, the product would have to be classified as ‘Causes
skin irritation. Causes serious eye irritation.’ and labelled with the GHS07 pictogram
(acute hazard). It is interesting to note that even some liquid products which contain
more than 50% water would need to be classified. There are products where less than
10% of the ingredients were considered for classification and labelling, the rest
being water or substances with unclear toxicity, which would have to be classified
as mixture. Two products for the same purpose can be classified very differently,
e.g. one insect repellent would have to be classified as ‘Causes serious eye irritation.’
and ‘May cause an allergic skin reaction.’, the other as ‘Suspected of damaging fertility
of the unborn child.’ One massage oil is classified as ‘May be fatal if swallowed
and enters airways.’, whereas the so-called carbon-free massage oil is classified
as ‘May cause an allergic skin reaction.’.
The following substances were ingredients in the products under scrutiny here, but
their amounts stayed below the thresholds for labelling the mixtures: Several products
contain ingredients which were classified as ‘Toxic if swallowed.‘ (e.g. Thioglycolic
Acid) or ‘Harmful if swallowed.’ (e.g. Sodium Laureth Sulfate, PVP/VA Copolymer or
Calcium Thioglycolate). Substances classified as ‘Harmful if inhaled.’ were e.g. PEG-40
Hydrogenated Castor Oil which was for example part of the baby shampoo. Substances
classified as ‘May cause respiratory irritation.’ were present, but only the sum of
these ingredients would have led to a classification of the mixture, not the single
substances. Substances present in products of the retail shops, where the exact percentage
in the final product is unknown to the author, were for example Coumarin which is
classified among other H-statements with ‘May cause damage to organs.’ or Laureth-4
classified among other H-statements as ‘May cause respiratory irritation.’.
According to the CLP Regulation, mixtures which contain an ingredient without any
usable information must be labelled with the additional statement “x percent of the
mixture consists of ingredient(s) of unknown toxicity” ([1] Annex I Table 2.1.3 Note 2). This would have to be applicable to several cosmetic products.
According to the CLP Regulation, experiences made in epidemiological data and experiences
from occupational data or accident databases should be taken into account. In the
case of cosmetic products the information gathered by poison centers would be very
precious for the classification process. This is one example where a better coordination
between the Cosmetics Regulation and the CLP Regulation would be very helpful [10]. When evidence in humans indicates problems with certain products, but the criteria
for the regular H-statements are not met, supplemental hazard information should then
be written on the container of such products. For cosmetic products this might be,
e.g. EUH066 — ‘Repeated exposure may cause skin dryness or cracking.’, EUH070 — ‘Toxic
by eye contact.’, EUH071 — ‘Corrosive to the respiratory tract.’ ([1] Annex II Part 1). However, due to the general exception of the CLP Regulation this
supplemental hazard information is not implemented for cosmetic products.
The number of products labelled as sensitizing is presumably underestimated in the
product sample here (Figure 1 and Table 2), because quantitative information about the content of specific sensitizing fragrances
were not available and did therefore not influence the classification of the product.
Most cosmetic products contain fragrances, many of which are sensitizers [11-14]. It seems to be rather difficult to produce scented personal care products with fragrances
that are not labelled. I found that out of 111 fragrances frequently applied in cosmetics
and washing and cleansing products 106 were classified in the C&L Inventory. Most
of them are skin sensitizers or eye irritants. Also natural substances can be sensitizers
and irritants, e.g. essential oils. Some products consist of a large fraction of fragrances,
for example aftershave lotion contains 10% fragrances. Normally, mixtures which are
not classified as sensitizing but contain at least one sensitizing substance in a
concentration equal or greater than 0.1% must bear the supplemental label EUH208 ‘Contains
(name of sensitizing substance) … May produce an allergic reaction.’ ([1] Annex II Part 2 2.8) Table 1(C). This supplemental label element would be relevant for most cosmetic products,
but it is again not applied to them because they are excluded from the CLP Regulation
Preamble (32) of the new Cosmetics Regulation 1223/2009 says that CMR substances should
be prohibited, but there are exceptions for these substances where their “use has
been found safe by the SCCS” (Scientific Committee for Consumer Safety). The number
of cosmetic products analyzed here which contained substances classified as carcinogenic,
mutagenic or toxic for reproduction (CMR) is small. Mutagens (such as m-Phenylenediamine),
carcinogens (such as Carbomer) or substances toxic for reproduction (such as Cyclomethicone)
were part of the formulas scrutinized, but they usually stayed below the concentration
thresholds for labelling and classification of the mixture. Many substances used in
these formulas were classified as CMR substance in the C&L Inventory by a minority
of notifiers, but these classifications were not considered here. Butylphenyl methylpropional
classified as ‘Suspected of damaging fertility or the unborn child.’ is a frequently
used masking agent present in products sold in retail shops, where the exact percentage
in the final product is not known to the author.
Cosmetic products are still underestimated by aquatic ecotoxicologists even as their
predominant discharge is via waste water [15]. Some ingredients in the products discussed here were classified due to their aquatic
toxicity, e.g. Cocamidopropyl Betaine or Lauryl Alcohol, but the amounts of these
substances in the mixtures stayed usually below the thresholds for classification
as dangerous to the environment. The only product classified as dangerous for the
environment was perfume.
The P-statements Table 2(B) should help to reduce the risks for the consumers. It becomes evident that some
P-statements would ask for different user behaviour or rather for a different formula
of the respective personal care product to avoid the need for these P-statements.
These P-statements are for example: P260: ‘Do not breathe dust/fume/gas/mist/vapours/spray.’
P271: ‘Use only outdoors or in a well-ventilated area.’ P272: ‘Contaminated work clothes
should not be allowed out of the workplace.’ P280: ‘Wear protective gloves/protective
clothing/eye protection/face protection.’ P303+P361+P353: ‘IF ON SKIN (or hair): Remove/Take
off immediately all contaminated clothing. Rinse skin with water/shower.’ P304+P340:
‘IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable
for breathing.’ P405: ‘Store locked up.’
Cosmetic products can be considered as safer compared to other consumer products due
to the following aspects: (1) Many hazardous substances are prohibited or restricted
according to the Cosmetics Regulation (see above). (2) Most personal care products
are diluted in water. (3) The number of people suffering from direct negative effects
due to cosmetic products is relatively low. In Germany, around 2-4% of the German
population suffer from contact allergy to the fragrance mix 1 [16]. However, it must be assumed that the number would be higher, if also other fragrance
compounds were tested. In addition, skin sensitization is an effect where the cause-effect
can be detected relatively easily compared to other effects, like reproduction toxicity.
This could indicate that the number of unrecorded cases of persons suffering from
effects of cosmetic ingredients might be larger.
On the other hand, the risks posed by cosmetic products can also be larger compared
with other consumer products due to the following reasons: (1) Repeated exposure increases
the hazard ([1] Annex VI Part 1 1.2.1.), which is clearly the case for cosmetic products since many
of them are used daily, such as tooth paste, soap or shower gel. (2) Cosmetic products
are applied intentionally directly on the body surface and lead therefore to a higher
exposure compared with most other consumer products. Leave-on products such as lotions
or decorative cosmetics should be differentiated from rinse-off products such as shower
gels or shampoos. (3) Most consumers use several cosmetic products, not only one single
product everyday, which increases the exposure. (4) Solvents in cosmetic products
increase fat solubility and therefore skin penetration. (5) Combined exposure of an
allergen with a detergent e.g. in washing liquids can increase the allergic reaction
[19]. (5) There are further interactions of substances, e.g. musk compounds are known
to inhibit cellular xenobiotic export systems [17]. (6) Cross-reaction is known e.g. for some fragrances which are contact allergens
[18,19]. (7) Many ingredients are not stable, especially in light and at warm temperatures.
The metabolites can be more toxic than the original compounds. An example for this
case is D-Limonene with a low allergenic potency that can be oxidized by air to strong
allergens [20-22]. Further examples are carcinogenic nitrosamines which can be contaminants or reaction
products of triethanolamin and Cocamide DEA, frequently used components in decorative
eye cosmetics [23]. Cosmetics have been demonstrated to be the cause of contact allergies and many of
them contain acids, bases, inorganic salts, aldehydes, and surfactants, substances
which can be corrosive or irritant at concentrations < 1% and would need to be considered
with special care according to the CLP Regulation ([1] 3.2.3.3.4.1). (9) Cosmetic products are mainly discharged via waste water. Therefore,
their toxicity to aquatic organisms is of greater relevance than for many other consumer
products. (10) The products under scrutiny here correspond to the Cosmetic Regulation
[6]. However, not all products in the retail shops comply with the requirements laid
down there. Many products have to be withdrawn from the market because the levels
of hydroquinone, methyl metacrylate, carbamide peroxide, hydrogen peroxide, formaldehyde,
di-n-butyl-phthalate, di(2-ethylhexyl)phthalate or heavy metals were too high [24]. It is interesting to note that microbiological contamination is another frequent
reason why cosmetic products need to be withdrawn [24].
The comparison of personal care products with other consumer products shows that special
properties of cosmetics ask for even more caution.
Action was taken recently to reduce the hazardous potential for a different product
group: In the new toys directive [25] the thresholds for labelling sensitizing fragrances have been lowered (0.01% compared
to 0.1%), for carcinogenic substances the threshold is now 0.0005% compared to 0.1%.
This shows that there was concern about negative effects at these low concentrations
[26]. More progress for a better consumer protection is also needed for personal care
Cosmetic industry is very successful in creating attractive containers. Many decorations
on containers of personal care products imply beauty, health and well-being. Considering
their hazardous potential it might be questioned whether this goes along with Art
34 a (2) in the CLP Regulation which says: “Packaging containing a hazardous substance
or a mixture supplied to the general public shall not have either a shape or design
likely to attract or arouse the active curiosity of children or to mislead consumers,
Cosmetics are beneficial: They play an important role for the personal hygiene (e.g.
shampoo, soap or toothpaste), for skin care and protection (e.g. sun protection products),
they are important for the well-being (e.g. shaving products, body lotion) or attractiveness
(e.g. deodorants). These benefits go along with unpleasant properties such as the
hazards described here or the risk of microbiological contamination. Labelling might
lead to a shift to less hazardous specimens and would therefore help to reduce the
negative aspects and maintain the benefit of cosmetic products. The labelling should
be transparent and honest. It would not make sense if producers diluted products with
water to avoid labelling.
As long as a decent risk communication for cosmetic products is not guaranteed by
the Cosmetics Regulation [6], the exception in the CLP Regulation should be abolished. This amendment of the CLP
Regulation would best be made before mixtures will have to be classified and labelled
according to the CLP Regulation in 2015.
An abolishment of the labelling exception for cosmetic products would lead to a regular
labelling requirement for containers bigger than 125 ml, e.g. most shampoos, shower
gels or body lotions. Many cosmetic products which are sold in containers smaller
than 125 ml would still not have to be labelled regularly because of the small quantity
exception, which reads that only certain H-statements need to be written on the labels
(see Table 1). This implies that for example skin irritation (category 2) and eye irritation (category
2) would not have to be written on the label of small containers. For better consumer
information, the small quantity exception should be amended so that cosmetic products
should be labelled and classified regularly, also when they are sold in smaller packages.
Many consumers trust that personal care products are perfectly safe and do not pose
any hazard. They should be informed and they should learn that cosmetic products might
be hazardous. This would be one element of a successful risk reduction strategy.
The classification and labelling of personal care products was derived by application
of the criteria given in the CLP Regulation. Bridging principles were not relevant
as no information about comparable cosmetic products tested and classified as mixtures
was available. 41 cosmetic products were selected from a wide range of product groups
(e.g. [27,28]): baby skin product (2), after shave (2), shaving cream, deodorant (4), toothpaste
(2), shampoo (2), hand and body lotion, shower gel, liquid soap and syndet, eye zone
cream, massage oil, carotene skincare gel, all purpose cream, basic cream, hand cream,
emulsion with panthenol, massage oil, hair spray (2), oxidative hair dye formula,
bleaching lotion, depilatory cream, cold wave solution, mascara (2), lipstick (2),
face make up remover, nail glue, perfume, alcohol free cologne, insect repellent (2).
The number of ingredients ranged from 41 (perfume) to a single one (nail glue). The
formulas are basic recipes for standard products and correspond to lists of ingredients
of products in German retail shops and cosmetic frame formulations [8]. The present selection of products is meant to illustrate the situation with some
examples and it is not meant to be complete nor representative. The information on
properties necessary for classification and labelling of all ingredients were compiled
from data accessible to the general public. Preferentially harmonized classifications
were used in the current C&L Inventory [9]. The classifications of substances registered according to REACH were compared with
the classifications in the C&L Inventory. Most substances which are used more or less
exclusively in cosmetics have not been registered according to REACH, whereas cosmetic
ingredients used also in other applications like e.g. glycerol, hydrogen peroxide,
isododecane, isopropanol, or phosphoric acid are registered. The recently installed
cosmetic products notification portal according to the Cosmetics Regulation 1223/2009
[6] is not open for the general public and could not be used. The names used here are
the INCI names [29].
For many chemicals, especially those with low production volumes, not all toxicological
and ecotoxicological standard tests were performed, so that the published information
might not cover all relevant risks. Several compounds are not classified in the C&L
Inventory, either because no hazardous properties were detected for the substance
or because the substance was not scrutinized for its hazardous properties yet. Many
cosmetic ingredients are produced in small production volumes (e.g. 1-10t/y). Data
requirements for these substances according to REACH are rather small, so that the
data might not be sufficient to decide about a classification.
Regulation No 1272/2008 of the European Parliament and of the Council of 16 December
and repealing Directive 67/548/EEC and 1999/45/EC and amending Regulation (EC) No
1907/2006. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:32008R1272:en:NOT webcite
(UN GHS) http://www.unece.org webcite
and administrative provisions relating to the classification, packaging and labelling
of dangerous substances. Off J P 196, 16/8/1967, as amended by Commission Directive
2001/59/EC of 6 August 2001 adapting to technical progress for the 28th time Council
Directive 67/548/EEC on the approximation of the laws, regulations and administrative
provisions relating to the classification, packaging and labelling of dangerous substances.
Off J L 225, 12/8/2001 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31967L0548:en:NOT webcite
Council Directive 1999/45/EC concerning the approximation of the laws, regulations
packaging and labelling of dangerous preparations. Off J L 200 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31999L0045:en:NOT webcite
Council Directive 75/324/EEC of 9.6.1975 on the approximation of the laws of the Member
States relating to aerosol dispensers, OJ L 147 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31975L0324:en:NOT webcite
Regulation 1223/2009 of the European Parliament and of the Council on Cosmetic Products http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:342:0059:0209:en:PDF webcite
Lorenz C, von Goetz N, Scheringer M, Wormuth M, Hungerbühler K: Potential exposure of German consumers to engineered nanoparticles in cosmetics and
personal care products. Nanotoxicology 2011, 5:12-29. PubMed Abstract | Publisher Full Text Cosmetic Frame Formulations. European Association of Poison Centres and Clinical Toxicologists
/ European Cosmetic Toiletry and Perfumery Association 2000.
http://www.poisoncentre.be/IMG/pdf/CosmeticFrameFormulations2000_FullVersion_1_.pdf webcite
CL Inventory http://echa.europa.eu/web/guest/information-on-chemicals/cl-inventory-database webcite
De Groot R, Brekelmans P, Herremans J, Meulenbelt J: The changes in hazard classification and product notification procedures of the new
European CLP and Cosmetics Regulations. Clin Toxicol 2010, 48(1):28-33. Publisher Full Text Klaschka U: Risk management by labelling 26 fragrances? - Evaluation of Article 10 (1) of the
seventh amendment (Guideline 2003/15/EC) of the cosmetic directive. J Hyg Environ Health 2010, 213:308-320. Publisher Full Text Yazar K, Boman A, Lidén C: Potent skin sensitizers in oxidative hair dye products on the Swedish market. Contact Dermatitis 2009, 61:269-275. PubMed Abstract | Publisher Full Text Yazar K, Johnsson S, Lind M-L, Boman A, Lidén C: Preservatives and fragrances in selected consumer-available cosmetics and detergents. Contact Dermatitis 2010, 64:265-272. PubMed Abstract | Publisher Full Text Yazar K, Boman A, Lidén C: p-Phenylenediamine and other hair dye sensitizers in Spain. Contact Dermatitis 2011, 66:27-32. PubMed Abstract | Publisher Full Text Ternes AT, Knacker T, Oehlmann J: Körperpflegemittel in der aquatischen Umwelt. Eine bisher vernachlässigte Stoffgruppe. UWSZ-Z Umweltchem Ökotox 2003, 15(3):169-180. Publisher Full Text Schnuch A, Uter W, Geier J, Gefeller O: Epidemiology of contact allergy: an estimation of morbidity employing the clinical
epidemiology and drug utilisation research (CE-DUR) approach. Contact Dermatitis 2002, 47:32-39. PubMed Abstract | Publisher Full Text Luckenbach T, Epel D: Nitromusk and polycyclic musk compounds as long-term inhibitors of cellular xenobiotic
defense systems mediated by multidrug transporters. Environ Health Perspect 2005, 113:17-24. PubMed Abstract | PubMed Central Full Text Schnuch A, Uter W, Geier J, Lessmann H, Frosch P: Sensitization to 26 allergens to be labelled according to current European regulation.
Results of the IVDK and review of the literature. Contact Dermatitis 2007, 57:1-10. PubMed Abstract | Publisher Full Text Heydorn S, Andersen KE, Johansen JD, Menne T: A stronger patch test elicitation reaction to the allergen hydroxycitronellal plus
the irritant sodium laurylsulfate. Contact Dermatitis 2003, 49:133-139. PubMed Abstract | Publisher Full Text Karlberg AT, Shao LP, Nilsson U, Gafvert E, Nilsson JL: Hydroperoxides in oxidized d-limonene identified as potent contact allergens. Arch Dermatol Res 1994, 286:97-103. PubMed Abstract | Publisher Full Text Matura M, Skold M, Borje A, Andersen KE, Bruze M, Frosch P, Goossens A, Johansen JD, Svedman C, White IR, Karlberg AT: Selected oxidized fragrance terpenes are common contact allergens. Contact Dermatitis 2005, 52:320-328. PubMed Abstract | Publisher Full Text Skold M, Hagvall L, Karlberg AT: Autoxidation of linalyl acetate, the main component of lavender oil, creates potent
contact allergens. Contact Dermatitis 2008, 58:9-14. PubMed Abstract | Publisher Full Text Kantonales Laboratorium Basel Stadt. Analytik, Non food http://www.kantonslabor-bs.ch webcite
EU Consumer Affairs, Rapex http://www.rapex.eu webcite
Directive 2009/48/EC of the European Parliament and of the Council on the safety of
toys. http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=OJ:L:2009:170:0001:0037:en:PDF webcite
Kalberlah F, Schwarz M, Bunke D, Wurbs J: Schadstoffbelastete Erzeugnisse im Verbraucherbereich: Wird REACH zu Verbesserungen
führen? UWSF 2010, 22:188-204. Schrader K, Domsch A: Cosmetology. In Theory and Practice. Edited by Ziolkowsky GmbH H. Augsburg: Verlag für chemische Industrie; 2005.
Volume I to III Fischer R: Körperpflegejahrbuch. The Green Book of Cosmetics. Augsburg: Verlag für chemische Industrie; 2010. PubMed Abstract Commission Decision 96/335/EC of 8 May 1996 establishing an inventory and a common
nomenclature of ingredients employed in cosmetic products. Off J L 132, 01/06/1996,
1-684 http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31996D0335:EN:HTML webcite