Opinion of the European Economic and Social Committee on the Proposal for a Regulation of the European Parliament and of the Council on cosmetic products (recast) COM(2008) 49 final — 2008/0035 (COD)
Date: 2008-07-09
Institutions: European Economic and Social Committee
Subjects: ESC opinion, EU programme, cosmetic product, health risk, single market, small and medium-sized enterprises

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Opinion of the European Economic and Social Committee on the ‘Proposal for a Regulation of the
European Parliament and of the Council on cosmetic products (recast)’

COM(2008) 49 final — 2008/0035 (COD)

(2009/C 27/07)

On 13 May 2008 the Council decided to consult the European Economic and Social Committee, under
Article 95 of the Treaty establishing the European Community, on the

Proposal for a Regulation of the European Parliament and of the Council on cosmetic products (recast).

The Section for the Single Market, Production and Consumption, which was responsible for preparing the
Committee's work on the subject, adopted its opinion on 11 June 2008. The rapporteur was Mr Krawczyk.

At its 446th plenary session, held on 9 and 10 July 2008 (meeting of 9 July), the European Economic and
Social Committee adopted the following opinion by 126 votes with four abstentions.

1. Conclusions and recommendations

The Committee endorses the aims and objectives of the
1.1
draft regulation as well as the recasting of Directive 76/768/EEC
as a regulation.

The Committee draws attention to the fact that consider-
1.2
able costs are liable to be incurred, particularly by SMEs,
in
meeting the new requirements for manufacturing practices,
safety assessment and product information file preparation, not
to mention all the relevant tests.

1.3
The Committee considers it advisable to minimise this
negative financial impact on SMEs, for instance by specifying
information file and safety assessment be
that
prepared in accordance with the new requirements for products
placed on the market for the very first time.

the product

The Committee endorses the 36-month period for the
1.3.1
entry into force of
the regulation. However, with regard to
updating the product information files and safety assessment of
cosmetic products already on the market, the Committee recom-
mends a further transition period of 24 months after entry into
force.

The Committee welcomes the introduction of a differen-
1.4
tiated regime based on the risk assessment of substances classi-
fied as carcinogenic, mutagenic or reprotoxic (‘CMR’). The ban
on the use of such substances should be maintained.

2. Foreword

trative burden and unnecessary costs for the competent authori-
ties as well as the industry without contributing to the safety of
cosmetic products.

2.2
Simplification of Council Directive 76/768/EEC of 27 July
1976 on the approximation of the laws of the Member States
relating to cosmetic products (the ‘Cosmetics Directive’) was
announced in the Commission Communication ‘Implementing
the Community Lisbon programme: A strategy for the simplifi-
cation of the regulatory environment’ and in the Commission's
Annual Policy Strategy for 2007 and in the Commission's Legis-
lative and Work Program 2007. The Commission proposed to
simplify the Cosmetics Directive in the form of a recast, i.e. a
legislative technique which makes it possible to codify a legisla-
tive text and its amendments and to introduce substantial
improvements.

On the basis of

2.3
feedback from a public consultation
launched in 2006, as well as several Commission studies, the
Commission prepared an extensive impact assessment prior to
drafting the proposal for a regulation (recast) (1).

2.4
The EU cosmetics sector is characterised by SMEs. 97 %
of all EU cosmetic companies are SMEs and 80 % of them have
less than 19 employees. SMEs account for approximately two
thirds of all people directly employed in the cosmetics sector in
the EU.

employment,

In terms of

approximately
2.5
150 000 people employed in the cosmetics industry in Europe.
Since 1999, the European sector has been steadily creating new
jobs (an increase of 1.2 % per year).

there

are

2.1
The main aim of the directive (Directive 76/768/EEC) is
to protect consumer health while harmonising legal provisions
on cosmetic products within the common market. An assess-
ment of the current market situation shows that the amend-
ments to Directive 76/768/EEC and their inconsistent transposi-
tions by Member States have led to numerous legal uncertainties
and discrepancies. For this reason, it has resulted in an adminis-

2.6
Apart from direct employment, the cosmetics sector has
a strong indirect impact on employment such as retail, distribu-
It can be estimated that approximately
tion and transport.
350 000 jobs are created indirectly by the cosmetics industry.

(1) COM(2008) 49 final — 2008/0025 (COD).

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That

2.7
is why the interests and views of SMEs in the
cosmetic sector in the EU should be taken into consideration
when analysing the impact of the present proposal.

The key elements of the draft regulation proposal are as follows:

Intra-community

2.8
increased
cosmetics
year-on-year since 1999 by an average of 5 % a year in terms of
volume, and by 6.5 % a year in terms of value.

exports have

2.9
The cosmetics industry is an international business in
which Europe is a very important player. The global nature of
this sector is particularly relevant to the EU as a net exporter. In
2005, the export of cosmetic products outside the EU stood at
EUR 16 billion, with imports at EUR 4.4 billion.

The situation varies from one Member State to another.
2.10
Poland is an example of one such a situation. A considerable
part of the Polish cosmetics sector is still
independent with
more than 400 enterprises, mostly SMEs, operating. The Polish
cosmetics market, which experienced a growth of 8.2 % in
2006 and 7.2 % in 2007 and which still has strong growth
potential,
is a good example of steady growth, which is no
longer being experienced in the EU's 5 largest developed econo-
mies (UK, Germany, France, Italy and Spain).

3. Introduction

The Cosmetics Directive is a highly detailed and prescriptive
piece of
legislation. Since 1976 the Cosmetics Directive has
been amended 56 times, which has resulted in legal uncertain-
ties and inconsistencies and the complete absence of any set of
definitions.

The proposed recast of Council Directive 76/768/EEC

3.1
has the following key objectives:

— to remove legal uncertainties and inconsistencies resulting

from the numerous amendments;

— to avoid discrepancies in national transposition which do
not contribute to product safety but instead add to the regu-
latory burden and administrative costs;

— to simplify and unify certain administrative procedures, such
‘cosmetovigilance’ and administrative coop-

as notification,
eration during market surveillance;

— to ensure the safety of cosmetic products placed on the
innovation in this

EU market, especially in the light of
sector;

— to maintain the rules relating to animal testing which were
added to the Cosmetics Directive by the ‘seventh amend-
ment’ in 2003;

— to introduce the clear minimum requirements

for

the

cosmetics safety assessment;

— to introduce a possibility in exceptional cases to regulate
CMR 1 and 2 substances on the basis of their actual risk.

The Commission proposal maintains the scope of Direc-
3.2
tive 76/768/EEC, and the definition of
‘cosmetic product’
remains unchanged. During the public consultation carried out
by the European Commission most parties were in favour of
recasting Directive 76/768/EEC in the form of a regulation.

3.3
A set of new definitions has been proposed for terms
importer, making available on the
such as: manufacturer,
market, placing on the market, harmonised standards, traces,
preservatives, colorants, UV-filters, undesirable effects, serious
undesirable effects, withdrawal and recall. However, no defini-
tion has been proposed for the actual term ‘cosmetic product’.

3.4
The concept of a responsible person who is established
within the Community has been introduced. Responsibility in
cases of products supplied to the consumer from outside the
EU, for example via internet was described.

3.5
the
‘New approach’ principles have been introduced:
reference to the harmonised standards in legal acts in the field
of good manufacturing practices, sampling and analysis as well
as claims relating to cosmetic products.

3.6
The minimum requirements for the safety assessment
and the product information file (a product dossier) have been
established. The Cosmetic Product Safety Report has been
proposed as Annex I to the draft regulation. The safety assess-
ment of the cosmetic product is based on the toxicological
profile of its ingredients.

3.7
A differentiated regime based on a risk (but not a
hazard) assessment of substances classified as carcinogenic,
mutagenic or reprotoxic (‘CMR’) has been proposed instead of
the recent regime based on hazard. In general, the ban of CMR
categories 1 and 2 has been maintained. However, the new
approach allows,
the use of
CMR 1 and 2 substances if they have been found to be safe to
use in cosmetics.

to rigid conditions,

subject

3.8
The overall strategy to ban the animal testing of finished
products as well as timetables of deadlines for the prohibition
of the marketing of cosmetic products containing ingredients or
combinations of ingredients which have been tested on animals
has been maintained.

3.9
The uniform approach to the management of undesirable
effects and serious undesirable effects has been established. Data
on undesirable effects and serious undesirable effects shall
become a part of the Cosmetics Product Safety Report and
will be communicated to the public. Additionally, serious unde-
sirable effects shall be actively reported to the competent
authorities.

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3.10
The simplified, centralised, electronic notification in a
‘one-stop-shop’ has been proposed. Until now, prior to placing a
cosmetic product on the market, notification had to be made
information
separately in each Member State. The scope of
differs from one Member State to another. Moreover, the sepa-
rate notification to poison control centres is currently required
in several Member States.

3.11
The administrative collaboration between competent
authorities and the application of good administrative practices
have been strengthened.

4. General comments

4.1
The Committee endorses the aims and objectives of the
draft regulation — the simplification and unification of certain
administrative procedures — while ensuring a high level of
consumer safety. The proposed regulation is undoubtedly trans-
parent. The legal provisions it sets out clarify previous legal
ambiguities
interpretations and
applications.

that had led to divergent

Recasting Directive 76/768/EEC as a regulation will
4.2
ensure the uniform application of
legal provisions enhancing
the free movement of products within the common market and
simplify administrative procedures on EU markets.

4.3 While the simplification of administrative procedures
could reduce certain costs (i.e. notification of products and noti-
fication to the poison control centres), considerable costs are
liable to be incurred by SMEs in meeting the new requirements
on the content of the product information file and compliance
with harmonised standard EN ISO 22716 (GMP). It should be
emphasised that current legal provisions do not require as high
a level of detailed toxicological data as the proposed regulation.

It is to be expected that the additional costs incurred by
4.4
the requirements set out in the regulation will depend heavily
on the size of
the enterprise. The costs pertaining to the
preparation of the product information files and safety assess-
ment will be borne, first and foremost, by small and medium-
sized enterprises, which formerly used to prepare rudimentary
data as specified in existing legal provisions.

In the case of large international corporations, one should not
expect a considerable increase in costs due to their longstanding
experience, expertise, human resources, technical background
and access to third-party know-how. In the case of large enter-
prises manufacturing products on several EU markets,
the
centralised European notification system will definitely simplify
former administrative procedures. This will partly reduce notifi-
cation costs. Moreover,
international enterprises have already
implemented notification systems for their frame formulations
(formulas).

4.5
In the case of SMEs, one can expect a considerable
increase in costs relating to good manufacturing practices, safety

assessment and product information file preparation, not to
mention all relevant tests.

For research and the dossier and safety assessment alone, the
costs of SMEs may increase by as much as 100 % for every new
formula placed on the market. This will considerably increase
production costs for SMEs and affect the retail price of products,
thus impacting on consumer interests.

One should bear in mind that in the case of SMEs, product
series are manufactured in considerably smaller volumes than
those of large international concerns selling large quantities of
products. As a result, the costs of research and the dossier and
safety assessment per product are much higher for SMEs.

According to this impact assessment prepared by the Commis-
sion, this could be inadequate in the case of Member States with
a high number of small and medium-sized enterprises, such as
Spain, Italy, Poland and Bulgaria.

4.6
It seems advisable to minimise the negative financial
impact on SMEs, for instance by specifying that the product
information file and safety assessment are to be prepared in
accordance with the new requirements for products that are
being placed on the market for the very first time. It would
appear necessary to extend the transition period for updating
the product information files and safety assessment for products
already on the market.

The Committee endorses the 36-month period for the
4.6.1
entry into force of
the regulation. However, with regard to
updating the product information files and safety assessment of
cosmetic products already on the market, the Committee recom-
mends a further transition period of 24 months after entry into
force.

4.7
The Committee welcomes the introduction of a set of
definitions. This will facilitate the interpretation of the provi-
sions of the regulation and help to remove legal uncertainties
and inconsistencies. However, a new definition for cosmetic
products has not been proposed. The cosmetics industry is
highly innovative and new efficacies and product categories are
introduced to the market each year. This may generate problems
concerning product qualification (cosmetics, pharmaceutical
products etc.) and ‘borderline products’. It is therefore necessary
to undertake educational and information campaigns as well as
strengthen market surveillance in this field.

introduction of

The Committee welcomes

the
the
4.8
concept of
‘a responsible person’. Establishing a responsible
person — who may be an entrepreneur other than the manufac-
turer — is useful and consistent with existing market practices
such as outsourcing and private labelling. Provisions concerning
the responsible person establish responsibility in cases where
products are made available on the market from outside the EU,
for example via internet.

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Furthermore,

the Committee

4.9
that other
concepts should also be defined, so as to ensure legal certainty,
especially since the instrument is in the form of a regulation.
‘fragrance’ and
This applies in particular to the concepts of
‘active ingredient’.

considers

4.10
The Committee welcomes the introduction of the elec-
tronic notification of cosmetics and frame formulas to poison
control centres. It will certainly unify administrative procedures
on the EU market.

The Committee endorses

4.11
the introduction of new
approach principles to legislation on cosmetic products. The
application of harmonised standards, which can be voluntarily
applied by the manufacturers and competent authorities, enables
the unification of applied methodologies. Harmonised standards
are a good example of self-regulation tools that are both useful
and willingly used by the cosmetics industry. However,
the
Committee has reservations about the uncritical application of
new approach principles. Consumer health and safety issues
must be regulated by the relevant regulations.

products being placed on the market, or also to products
already on the market. Specifying the same transitional period
(36 months) for all products — including those already on the
market — may lead to a situation where products already
legally on the market will have to be withdrawn because their
labelling or
information files has not been
updated. The Committee endorses the 36 month-period for the
entry into force of
the regulation. However, with regard to
updating the product information files and safety assessment of
cosmetic products already on the market, the Committee recom-
mends a further transition period of 24 months after entry into
force.

their product

In document SEC(2008) 117, the impact assessment report, the
European Commission states: ‘All available statistics suggest that
the number of adverse reactions to cosmetic products is very
low. (…) Moreover, since the Cosmetics Directive entered into
force the cosmetics industry has had no major safety crisis,
unlike, for example, the feed sector’.

5. Specific comments

4.12
The Committee welcomes the reference to harmonised
standards for product claims. However, harmonised standards
should address methods of efficacy assessment applied to prove
the claims, not to the claims themselves. Claimed effects can be
measured by reliable and reproducible methods. Moreover,
harmonised standards should take into consideration scientific
and technological progress and the vastness of the subject.

5.1
The Committee is aware of certain provisions included in
the proposal of the Commission which could be difficult to
fulfil. The most crucial ones include the scope of data required
for the product information files and safety assessment (Article 7
and Annex I).

intrinsic properties of

The Committee welcomes the introduction of a differ-
4.13
entiated regime based on the risk assessment of substances clas-
sified as carcinogenic, mutagenic or reprotoxic (‘CMR’) referred
to in Directive 67/548/EEC (Article 12(2)). The ban on the use
of such substances should be maintained. However, the current
the
system is based on hazard (i.e.
substance) and does not take into consideration the dose and
route of exposure. It could lead to the automatic ban of ethanol
(i.e. alcohol) in case of its re-classification in CMR categories 1 or
2, despite the fact that the use of the substance in cosmetics is
safe. The draft regulation provides that substances in CMR cate-
gories 1 and 2 may be used as compounds in cosmetics only
subject
three conditions
(Article 12(2)). However, one of these conditions assumes that
the substance has to be legally used in food and nutritional
products. But there may very well be cases where CMR 1 or 2
substances are considered safe for use in cosmetics but are not
allowed for food (i.e. formaldehyde, boric acid etc.). The drafted
provisions exclude any application of such substances in the
cosmetics industry.

to the simultaneous fulfilment of

The Committee is aware of the transition periods for
4.14
adapting the products dossier and safety assessment
for
products already on the market (Article 34). The draft does not
specify whether the transitional period is only applicable to

The safety assessment under Article 7 must be carried
from outside the

third party,

i.e.

5.2
out by an independent
company in question.

In Article 7(3), the term ‘non-clinical safety studies’

5.3
is
unclear. Available information reveals that this term is inter-
preted differently by various EU Member States. According to
the interpretation of the competent authorities in Poland, clin-
ical tests are tests for medicinal products. Research studies on
volunteers used in the assessment of cosmetics (dermatological
tests, compatibility tests, instrumental tests) cannot therefore be
understood as clinical tests. However, they could not be regarded
as non-clinical studies within the meaning of Article 7(3) of the
drafted Regulation, either. According to Directive 2004/10/EC,
the provisions on good laboratory practices are not applicable
to the tests involving the participation of humans.

5.4 Moreover, a requirement that all toxicological tests and
analysis necessary for safety assessment be performed in accord-
ance with the principles of good laboratory practice prevents
the use of most data included in toxicological databases and
scientific publications, which are a valuable source of informa-
tion. Even in recent scientific publications, one can very rarely
find a declaration of compliance (or non-compliance) with good
laboratory practice by the laboratories carrying out the relevant
tests.

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5.5
The provisions of paragraphs 2 and 4 of Annex I
concerning the assessment of the purity and stability of packa-
ging material,
interactions between the
the evaluation of
the influence of product
compounds and the evaluation of
stability on its safety, and the specification of the ‘period-after-
opening’ may be difficult to fulfil because there is no commonly
available and recognised methodology, for instance in the form
of international or European standards, or scientific publica-
tions. Hence, this data is not readily available.

5.5.1
The Committee welcomes the content of Annex I
(Cosmetic Product Safety Report) with regards to minimum
requirements for data and tests to be performed when preparing
a product dossier. It will improve the quality of the dossier, facil-
itate market surveillance and therefore contribute to consumer
safety.

5.6
The NOAEL value (No Observed Adverse Effect Level)
which is necessary for calculating the MoS (Margin of Safety) is
not available for many substances. The obligation to determine
the NOAEL value will result in animal tests that violate the
EU policy to promote alternative methods. It also contravenes
the provisions of Article 14 (Animal testing).

5.6.1
New legislation should therefore clearly specify which
tests manufacturers are to carry out on substances used in
cosmetics in order to identify potential hazards for consumers.

The Committee does not accept that the list of ingredi-
5.7
ents may be indicated on the packaging alone (Article 15(g));
rather,
it should be indicated on the product
(container).

if possible,

Brussels, 9 July 2008.

5.8
The Committee considers that cosmetic products must
carry special warnings regarding their use by children, clearly
and very visibly stating a minimum age and that they must be
kept out of the reach of children.

5.9
The Committee is also of the view that the regulation
should clearly stipulate that, in the case of distance-selling of
cosmetic products, exactly the same type of information that
must be displayed on labels and packaging when sold in shops
must be clearly set out in distance sales offers.

5.10
The Committee endorses the increased pressure for
administrative collaboration between the competent authorities
and the application of the good administrative practices.

5.11
The Committee endorses rectifying the former Annexes
containing lists of prohibited and allowed substances with
restrictions to be used in cosmetic products, by adding the
CAS and EINECS numbers and INCI names as well as estab-
lishing an electronic inventory of cosmetic ingredients.

5.12 Withdrawing former Annex I of Directive 76/768/EEC
seems appropriate. The division of categories in the former list
was rather arbitrary, and there were numerous repetitions of
category groups, for example: ‘make-up powders’ and ‘products
for making up and removing make-up’. Moreover, the former
list is already out of date — there are new product categories
available on the market, such as anti-cellulite adhesives, and
make-up remover cleanser tissues with active substances.

The President

of the European Economic and Social Committee

Dimitris DIMITRIADIS