Excerpt
C
onsoli
date
d
S
ub
sta
nces
L
egisl
at
ion
COSMETICS
Regulation
1223/2009
Consolidated version
April 2014
ii
All rights reserved.
© 2014
Attorney-at-Law Stefanie Merenyi, Friedhofstr. 3, 61137
Schoeneck, Germany.
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iii
Preface
Chemicals legislation is quite a vivid regulatory arena. As is the case in the
science of Chemistry itself there is also no standstill in chemicals legislation.
Most of the relevant regulations are subject to chronic revisions.
In order to keep up with the actual legislation beyond the efforts of a loose-
leaf-collection
the series
CSL: Consolidated Substances Legislation
has been created.
It offers a firm outline regarding the different fields of substances legislation
(besides the general substances legislation like REACH also cosmetics
legislation, biocides, etc.) and provides users with the relevant legislative
texts in an actual and consolidated manner. I.e. starting from the original
regulation all modifications can be found at their respective position within
the legal text. Therefore, the need for a detailed compilation of each and any
corrigendum, amendment and adaptation to the technical progress can be
reduced to a minimum.
The area of substances legislation is both a fascinating and demanding legal
field that can hardly be compared to any other, as its regulations create
direct effects on everyone.
The series CSL offers a new access to its origins.
Schoeneck, Germany, May 2014
Attorney-at-Law,
Information Scientist Chemistry
Stefanie Merenyi
iv
v
Consolidated version of
REGULATION (EC) No 1223/2009 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
of 30 November 2009
on cosmetic products
(recast)
last amended by
Commission Regulation (EU) No 1197/2013
of 25 November 2013
vi
Important Notice:
Consolidation implies the integration of Community legislation,
i.e. their basic instruments, amendments and corrections
in one single, non-official document.
Therefore, this document is only be intended as documentation tool.
As outlined by the European Court of Justice several times,
only European Union legislation
printed in the paper edition of the
Official Journal of the European Union
is deemed authentic.
vii
Table of contents of the consolidated version
List of corrigenda and amendments considered in this consolidated
version
1
Recitals
2
Text of regulation
12
CHAPTER I
SCOPE AND DEFINITIONS
12
Article 1
Scope and objective
12
Article 2
Definitions
13
CHAPTER II
SAFETY, RESPONSIBILITY, FREE MOVEMENT
15
Article 3
Safety
15
Article 4
Responsible person
15
Article 5
Obligations of responsible persons
16
Article 6
Obligations of distributors
16
Article 7
Identification within the supply chain
17
Article 8
Good manufacturing practice
18
Article 9
Free movement
18
CHAPTER III
SAFETY ASSESSMENT, PRODUCT INFORMATION FILE,
NOTIFICATION
18
Article 10
Safety assessment
18
Article 11
Product information file
19
Article 12
Sampling and analysis
20
Article 13
Notification
20
CHAPTER IV
RESTRICTIONS FOR CERTAIN SUBSTANCES
22
Article 14
Restrictions for substances listed in the
Annexes
22
Article 15
Substances classified as CMR
substances
23
Article 16
Nanomaterials
24
Article 17
Traces of prohibited substances
26
CHAPTER V
ANIMAL TESTING
26
Article 18
Animal testing
26
viii
CHAPTER VI
CONSUMER INFORMATION
29
Article 19
Labelling
29
Article 20
Product claims
31
Article 21
Access to information for the public
32
CHAPTER VII
MARKET SURVEILLANCE
32
Article 22
In-market control
32
Article 23
Communication of serious undesirable
effects
32
Article 24
Information on substances
33
CHAPTER VIII
NON-COMPLIANCE, SAFEGUARD CLAUSE
33
Article 25
Non-compliance by the responsible
person
33
Article 26
Non-compliance by distributors
35
Article 27
Safeguard clause
35
Article 28
Good administrative practices
36
CHAPTER IX
ADMINISTRATIVE COOPERATION
36
Article 29
Cooperation between competent
authorities
36
Article 30
Cooperation regarding verification of
product information files
36
CHAPTER X
IMPLEMENTING MEASURES, FINAL PROVISIONS
37
Article 31
Amendment of the Annexes
37
Article 32
Committee procedure
37
Article 33
Glossary of common ingredient names
38
Article 34
Competent authorities, poison control
centres or assimilated entities
38
Article 35
Annual report on animal testing
38
Article 36
Formal objection against harmonised
standards
39
Article 37
Penalties
39
Article 38
Repeal
39
Article 39
Transitional provisions
40
ix
Article 40
Entry into force and date of
application
40
Annexes
Annex I
COSMETIC PRODUCT SAFETY REPORT
41
Preamble to Annexes II to VI
44
Annex II
LIST OF SUBSTANCES PROHIBITED IN
COSMETIC PRODUCTS
45
Annex III
LIST OF SUBSTANCES WHICH COSMETIC
PRODUCTS MUST NOT CONTAIN EXCEPT
SUBJECT TO THE RESTRICTIONS LAID
DOWN
119
Annex IV
LIST OF COLORANTS ALLOWED IN
COSMETIC PRODUCTS
254
Annex V
LIST OF PRESERVATIVES ALLOWED IN
COSMETIC PRODUCTS
281
Annex VI
LIST OF UV FILTERS ALLOWED IN
COSMETIC PRODUCTS
294
Annex VII
SYMBOLS USED ON PACKAGING/CONTAINER
298
References on more legal information on cosmetics
Origin of the following reproduced legal text:
© European Union,
http://eur-lex.europa.eu/
.
This document is meant purely as a documentation tool and the institutions do not assume any liability for its contents
yB REGULATION (EC) No 1223/2009 OF THE EUROPEAN PARLIAMENT AND OF THE
COUNCIL
of 30 November 2009
on cosmetic products
(recast)
(Text with EEA relevance)
(OJ L 342, 22.12.2009, p. 59)
Amended by:
Official Journal
No page date
yM1 Commission
Regulation
(EU)
No
344/2013
of
4
April
2013 L
114
1 25.4.2013
yM2 Commission
Regulation
(EU)
No
483/2013
of
24
May
2013 L
139
8 25.5.2013
yM3 Commission
Regulation
(EU)
No
658/2013
of
10
July
2013 L
190 38 11.7.2013
yM4 Commission
Regulation
(EU)
No
1197/2013
of
25
November
2013 L
315 34 26.11.2013
Corrected by:
yC1 Corrigendum,
OJ
L
142,
29.5.2013,
p.
10
(344/2013)
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 1
REGULATION (EC) No 1223/2009 OF THE EUROPEAN
PARLIAMENT AND OF THE COUNCIL
of 30 November 2009
on cosmetic products
(recast)
(Text with EEA relevance)
THE EUROPEAN PARLIAMENT AND THE COUNCIL OF THE
EUROPEAN UNION,
Having regard to the Treaty establishing the European Community, and
in particular Article 95 thereof,
Having regard to the proposal from the Commission,
Having regard to the opinion of the European Economic and Social
Committee (
1
),
Acting in accordance with the procedure laid down in Article 251 of the
Treaty (
2
),
Whereas:
(1)
Council
Directive
76/768/EEC
of
27
July
1976
on
the
approxi·
mation of the laws of the Member States relating to cosmetic
products (
3
) has been significantly amended on several occasions.
Since further amendments are to be made, in this particular case
it should be recast as one single text in the interests of clarity.
(2)
A
Regulation
is
the
appropriate
legal
instrument
as
it
imposes
clear and detailed rules which do not give room for diverging
transposition by Member States. Moreover, a Regulation ensures
that legal requirements are implemented at the same time
throughout the Community.
(3)
This
Regulation
aims
at
simplifying
procedures
and
streamlining
terminology, thereby reducing administrative burden and ambi·
guities. Moreover, it strengthens certain elements of the regu·
latory framework for cosmetics, such as in-market control, with
a view to ensuring a high level of protection of human health.
(4)
This
Regulation
comprehensively
harmonises
the
rules
in
the
Community in order to achieve an internal market for cosmetic
products while ensuring a high level of protection of human
health.
zB
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 2
(
1
) OJ C 27, 3.2.2009, p. 34.
(
2
) Opinion of the European Parliament of 24 March 2009 (not yet published in
the Official Journal) and Council Decision of 20 November 2009.
(
3
) OJ L 262, 27.9.1976, p. 169.
(5)
The environmental concerns that substances used in cosmetic
products may raise are considered through the application of
Regulation (EC) No 1907/2006 of the European Parliament and
of the Council of 18 December 2006 concerning the Registration,
Evaluation, Authorisation and Restriction of Chemicals (REACH)
and establishing a European Chemicals Agency (
1
), which enables
the assessment of environmental safety in a cross-sectoral
manner.
(6)
This
Regulation
relates
only
to
cosmetic
products
and
not
to
medicinal products, medical devices or biocidal products. The
delimitation follows in particular from the detailed definition of
cosmetic products, which refers both to their areas of application
and to the purposes of their use.
(7)
The assessment of whether a product is a cosmetic product has to
be made on the basis of a case-by-case assessment, taking into
account all characteristics of the product. Cosmetic products may
include creams, emulsions, lotions, gels and oils for the skin, face
masks, tinted bases (liquids, pastes, powders), make-up powders,
after-bath powders, hygienic powders, toilet soaps, deodorant
soaps, perfumes, toilet waters and eau de Cologne, bath and
shower preparations (salts, foams, oils, gels), depilatories,
deodorants and anti-perspirants, hair colorants, products for
waving, straightening and fixing hair, hair-setting products,
hair-cleansing products (lotions, powders, shampoos), hair-
conditioning products (lotions, creams, oils), hairdressing
products (lotions, lacquers, brilliantines), shaving products
(creams, foams, lotions), make-up and products removing
make-up, products intended for application to the lips, products
for care of the teeth and the mouth, products for nail care and
make-up, products for external intimate hygiene, sunbathing
products, products for tanning without sun, skin-whitening
products and anti-wrinkle products.
(8)
The
Commission
should
define
the
categories
of
cosmetic
products which are relevant for the application of this Regulation.
(9)
Cosmetic
products
should
be
safe
under
normal
or
reasonably
foreseeable conditions of use. In particular, a risk-benefit
reasoning should not justify a risk to human health.
(10)
The
presentation
of
a
cosmetic
product
and
in
particular
its
form,
odour, colour, appearance, packaging, labelling, volume or size
should not endanger health and safety of consumers due to
confusion with foodstuffs, in accordance with Council Directive
87/357/EEC of 25 June 1987 on the approximation of the laws of
the Member States concerning products which, appearing to be
other than they are, endanger the health or safety of
consumers (
2
).
zB
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 3
(
1
) OJ L 396, 30.12.2006, p. 1.
(
2
) OJ L 192, 11.7.1987, p. 49.
(11)
In
order
to
establish
clear
responsibilities,
each
cosmetic
product
should be linked to a responsible person established within the
Community.
(12)
Ensuring
traceability
of
a
cosmetic
product
throughout
the
whole
supply chain helps to make market surveillance simpler and more
efficient. An efficient traceability system facilitates market
surveillance authorities' task of tracing economic operators.
(13)
It
is
necessary
to
determine
under
which
conditions
a
distributor
is to be considered as the responsible person.
(14)
All legal or natural persons in the wholesale trade as well as
retailers selling directly to the consumer are covered by
reference to the distributor. The obligations of the distributor
should therefore be adapted to the respective role and part of
the activity of each of these operators.
(15)
The
European
cosmetics
sector
is
one
of
the
industrial
activities
affected by counterfeiting, which may increase risks to human
health. Member States should pay particular attention to the
implementation of horizontal Community legislation and
measures regarding counterfeit products in the field of cosmetic
products, for example Council Regulation (EC) No 1383/2003 of
22 July 2003 concerning customs action against goods suspected
of infringing certain intellectual property rights and the measures
to be taken against goods found to have infringed such rights (
1
)
and Directive 2004/48/EC of the European parliament and of the
Council of 29 April 2004 on the enforcement of intellectual
property rights
(
2
). In-market controls represent a powerful
means of identifying products that do not comply with the
requirements of this Regulation.
(16)
To
ensure
their
safety,
cosmetic
products
placed
on
the
market
should be produced according to good manufacturing practice.
(17)
For
the
purpose
of
effective
market
surveillance,
a
product
information file should be made readily accessible, at one
single address within the Community, to the competent
authority of the Member State where the file is located.
(18)
In order to be comparable and of high quality, the results of the
non-clinical safety studies carried out for the purposes of
assessing the safety of a cosmetic product should comply with
the relevant Community legislation.
zB
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 4
(
1
) OJ L 196, 2.8.2003, p. 7.
(
2
) OJ L 157, 30.4.2004, p. 45.
(19)
It should be made clear which information is to be made
available to the competent authorities. That information should
include all the necessary particulars relating to identity, quality,
safety for human health and the effects claimed for the cosmetic
product. In particular, this product information should include a
cosmetic product safety report documenting that a safety
assessment has been conducted.
(20)
To
ensure
the
uniform
application
and
control
of
the
restrictions
for substances, sampling and analysis should be carried out in a
reproducible and standardised manner.
(21)
The
term
`mixture'
as
defined
in
this
Regulation
should
have
the
same meaning as the term `preparation' previously used in
Community legislation.
(22)
For
reasons
of
effective
market
surveillance,
the
competent
auth·
orities should be notified of certain information about the
cosmetic product placed on the market.
(23)
In order to allow for rapid and appropriate medical treatment in
the event of difficulties, the necessary information about the
product formulation should be submitted to poison control
centres and assimilated entities, where such centres have been
established by Member States to that end.
(24)
In order to keep administrative burdens to a minimum, the
notified information for competent authorities, poison control
centres and assimilated entities should be submitted centrally
for the Community by way of an electronic interface.
(25)
In order to ensure a smooth transition to the new electronic
interface, economic operators should be allowed to notify the
information required in accordance with this Regulation before
its date of application.
(26)
The general principle of the responsibility of the manufacturer or
importer for the safety of the product should be supported by
restrictions of some substances in Annexes II and III. Moreover,
substances which are intended to be used as colorants, preserv·
atives and UV-filters should be listed in the Annexes IV, V and
VI respectively in order to be allowed for these uses.
(27)
To
avoid
ambiguities,
it
should
be
clarified
that
the
list
of
allowed colorants contained in Annex IV includes only
substances which colour through absorption and reflection and
not substances which colour through photoluminescence, inter·
ference, or chemical reaction.
zB
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 5
(28)
To
address
safety
concerns
raised,
Annex
IV,
which
is
currently
restricted to skin colorants, should also include hair colorants
once the risk assessment of these substances by the Scientific
Committee for Consumer Safety (SCCS) set up by Commission
Decision 2008/721/EC of 5 September 2008 setting up an
advisory structure of Scientific Committees and experts in the
field of consumer safety, public health and the environment (
1
)
has been finalised. To this end, the Commission should have the
possibility to include hair colorants in the scope of that Annex by
the comitology procedure.
(29)
The
use
of
nanomaterials
in
cosmetic
products
may
increase
with
the further development of technology. In order to ensure a high
level of consumer protection, free movement of goods and legal
certainty for manufacturers, it is necessary to develop a uniform
definition for nanomaterials at international level. The
Community should endeavour to reach an agreement on a defi·
nition in appropriate international fora. Should such an agreement
be reached, the definition of nanomaterials in this Regulation
should be adapted accordingly.
(30)
At
present,
there
is
inadequate
information
on
the
risks
associated
with nanomaterials. In order to better assess their safety the
SCCS should provide guidance in cooperation with relevant
bodies on test methodologies which take into account specific
characteristics of nanomaterials.
(31)
The
Commission
should
regularly
review
the
provisions
on
nano·
materials in the light of scientific progress.
(32)
Given
the
hazardous
properties
of
substances
classified
as
carci·
nogenic, mutagenic or toxic for reproduction (CMR), category
1A, 1B and 2, pursuant to Regulation (EC) No 1272/2008 of
the European Parliament and of the Council of 16 December
2008 on classification, labelling and packaging of substances
and mixtures
(
2
), their use in cosmetic products should be
prohibited. However, as a hazardous property of a substance
does not necessarily always entail a risk, there should be a possi·
bility to allow the use of substances classified as CMR 2
substances where, in view of exposure and concentration, they
have been found safe for use in cosmetic products by the SCCS
and are regulated by the Commission in the Annexes to this
Regulation. With regard to substances which are classified as
CMR 1A or 1B substances, there should be a possibility, in the
exceptional case that these substances comply with food safety
requirements, inter alia as a result of their naturally occurring in
food, and that no suitable alternative substances exist, to use such
substances in cosmetic products on the condition that such use
has been found safe by the SCCS. Where such conditions are
met, the Commission should amend the relevant Annexes to this
Regulation within 15 months of classification of substances as
CMR 1A or 1B substances under Regulation (EC) No 1272/2008.
Such substances should be continuously reviewed by the SCCS.
zB
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 6
(
1
) OJ L 241, 10.9.2008, p. 21.
(
2
) OJ L 353, 31.12.2008, p. 1.
(33)
A
safety
assessment
of
substances,
particularly
those
classified
as
CMR 1A or 1B substances, should consider the overall exposure
to such substances stemming from all sources. At the same time,
for those involved in producing safety assessments, it is essential
that there be a harmonised approach to the development and use
of such overall exposure estimates. In consequence, the
Commission, in close cooperation with the SCCS, the European
Chemicals Agency (ECHA), the European Food Safety Authority
(EFSA) and other relevant stakeholders, should, as a matter of
urgency, carry out a review and develop guidance regarding the
production and use of overall exposure estimates for these
substances.
(34)
The
assessment
by
the
SCCS
of
the
use
of
substances
classified
as CMR 1A and 1B in cosmetic products should also take into
account the exposure to those substances of vulnerable population
groups, such as children under three years of age, elderly people,
pregnant and breast-feeding women and persons with
compromised immune responses.
(35)
The
SCCS
should
give
opinions
where
appropriate
on
the
safety
of use of nanomaterials in cosmetic products. These opinions
should be based on full information being made available by
the responsible person.
(36)
Action
by
the
Commission
and
Member
States
relating
to
the
protection of human health should be based on the precautionary
principle.
(37)
In
order
to
ensure
product
safety,
prohibited
substances
should
be
acceptable at trace levels only if they are technologically
inevitable with correct manufacturing processes and provided
that the product is safe.
(38)
The
Protocol
on
protection
and
welfare
of
animals
annexed
to
the
Treaty provides that the Community and the Member States are
to pay full regard to the welfare requirements of animals in the
implementation of Community policies, in particular with regard
to the internal market.
(39)
Council
Directive
86/609/EEC
of
24
November
1986
on
the
approximation of laws, regulations and administrative provisions
of the Member States regarding the protection of animals used for
experimental and other scientific purposes (
1
) established common
rules for the use of animals for experimental purposes within the
Community and laid down the conditions under which such
experiments must be carried out in the territory of the Member
States. In particular, Article 7 of that Directive requires that
animal experiments be replaced by alternative methods, where
such methods exist and are scientifically satisfactory.
zB
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 7
(
1
) OJ L 358, 18.12.1986, p. 1.
(40)
The safety of cosmetic products and their ingredients may be
ensured through the use of alternative methods which are not
necessarily applicable to all uses of chemical ingredients.
Therefore, the use of such methods by the whole cosmetic
industry should be promoted and their adoption at Community
level ensured, where such methods offer an equivalent level of
protection to consumers.
(41)
The
safety
of
finished
cosmetic
products
can
already
be
ensured
on the basis of knowledge of the safety of the ingredients that
they contain. Provisions prohibiting animal testing of finished
cosmetic products should therefore be laid down. The application,
in particular by small and medium-sized enterprises, of both test
methods and assessment procedures for relevant available data,
including the use of read-across and weight-of-evidence
approaches, which do not involve the use of animals for
assessing the safety of finished cosmetic products could be
facilitated by Commission guidelines.
(42)
It will gradually become possible to ensure the safety of
ingredients used in cosmetic products by using non-animal alter·
native methods validated at Community level, or approved as
being scientifically validated, by the European Centre for the
Validation of Alternative Methods (ECVAM) and with due
regard to the development of validation within the Organisation
for Economic Cooperation and Development (OECD). After
consulting the SCCS as regards the applicability of the
validated alternative methods to the field of cosmetic products,
the Commission should immediately publish the validated or
approved methods recognised as being applicable to such
ingredients. In order to achieve the highest possible degree of
animal protection, a deadline should be set for the introduction
of a definitive prohibition.
(43)
The Commission established timetables of deadlines up to
11 March 2009 for prohibiting the marketing of cosmetic
products, the final formulation, ingredients or combinations of
ingredients which have been tested on animals, and for
prohibiting each test currently carried out using animals. In
view, however, of tests concerning repeated-dose toxicity, repro·
ductive toxicity and toxicokinetics, it is appropriate for the final
deadline for prohibiting the marketing of cosmetic products for
which those tests are used to be 11 March 2013. On the basis of
annual reports, the Commission should be authorised to adapt the
timetables within the abovementioned maximum time limit.
(44)
Better coordination of resources at Community level will
contribute to increasing the scientific knowledge indispensable
for the development of alternative methods. It is essential, for
this purpose, that the Community continue and increase its
efforts and take the measures necessary for the promotion of
research and the development of new non-animal alternative
methods, in particular within its Framework Programmes for
research.
zB
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 8
(45)
The recognition by third countries of alternative methods
developed in the Community should be encouraged. In order to
achieve this objective, the Commission and the Member States
should take all appropriate steps to facilitate acceptance of such
methods by the OECD. The Commission should also endeavour,
within the framework of European Community cooperation
agreements, to obtain recognition of the results of safety tests
carried out in the Community using alternative methods so as
to ensure that the export of cosmetic products for which such
methods have been used is not hindered and to prevent or avoid
third countries requiring the repetition of such tests using
animals.
(46)
Transparency is needed regarding the ingredients used in
cosmetic products. Such transparency should be achieved by indi·
cation of the ingredients used in a cosmetic product on its pack·
aging. Where for practical reasons it is impossible to indicate the
ingredients on the packaging, such information should be
enclosed so that the consumer has access to this information.
(47)
A glossary of common ingredient names should be compiled by
the Commission to ensure uniform labelling and to facilitate
identification of cosmetics ingredients. This glossary should not
be intended to constitute a limitative list of substances used in
cosmetic products.
(48)
In
order
to
inform
consumers,
cosmetic
products
should
bear
precise and easily understandable indications concerning their
durability for use. Given that consumers should be informed of
the date until which the cosmetic product will continue to fulfil
its initial function and remain safe, it is important to know the
date of minimum durability, i.e. the date by which it is best to
use the product. Where the minimum durability is more than 30
months, the consumer should be informed of the period of time
after opening that the cosmetic product may be used without any
harm to the consumer. However, this requirement should not
apply where the concept of the durability after opening is not
relevant, that is to say for single-use products, products not at risk
of deterioration or products which do not open.
(49)
A
number
of
substances
have
been
identified
by
the
SCCS
as
likely to cause allergic reactions and it will be necessary to
restrict their use and/or impose certain conditions concerning
them. In order to ensure that consumers are adequately
informed, the presence of these substances should be mentioned
in the list of ingredients and consumers' attention should be
drawn to the presence of these ingredients. This information
should improve the diagnosis of contact allergies among
consumers and should enable them to avoid the use of
cosmetic products which they do not tolerate. For substances
which are likely to cause allergy to a significant part of the
population, other restrictive measures such as a ban or a
restriction of concentration should be considered.
zB
2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 9
(50)
In the safety assessment of a cosmetic product it should be
possible to take into account results of risk assessments that
have been carried out in other relevant areas. The use of such
data should be duly substantiated and justified.
(51)
The consumer should be protected
from misleading claims
concerning efficacy and other characteristics of cosmetic
products. In particular Directive 2005/29/EC of the European
Parliament and of the Council of 11 May 2005 concerning
unfair business-to-consumer commercial practices in the internal
market (
1
) is applicable. Furthermore, the Commission, in
cooperation with Member States, should define common criteria
in relation to specific claims for cosmetic products.
(52)
It
should
be
possible
to
claim
on
a
cosmetic
product
that
no
animal testing was carried out in relation to its development.
The Commission, in consultation with the Member States, has
developed guidelines to ensure that common criteria are applied
in the use of claims and that an aligned understanding of the
claims is reached, and in particular that such claims do not
mislead the consumer. In developing such guidelines, the
Commission has also taken into account the views of the many
small and medium-sized enterprises which make up the majority
of the `non-animal testing' producers, relevant non-governmental
organisations, and the need for consumers to be able to make
practical distinctions between products on the basis of animal
testing criteria.
(53)
In
addition
to
the
labelled
information,
consumers
should
be
given the possibility to request certain product-related information
from the responsible person in order to make informed product
choices.
(54)
Effective market surveillance is necessary in order to ensure that
the provisions of this Regulation are respected. To this end,
serious undesirable effects should be notified and competent auth·
orities should have a possibility to request from the responsible
person a list of cosmetic products containing substances which
have raised serious doubts in terms of safety.
(55)
This Regulation is without prejudice to the possibility for
Member States to regulate, in compliance with Community law,
the notification by health professionals or consumers of serious
undesirable effects to the competent authorities of Member States.
(56)
This Regulation is without prejudice to the possibility for
Member States to regulate, in compliance with Community law,
the establishment of economic operators in the area of cosmetic
products.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 10
(
1
) OJ L 149, 11.6.2005, p. 22.
(57)
In
case
of
non-compliance
with
this
Regulation,
a
clear
and
efficient procedure for the withdrawal and recall of products
may be necessary. This procedure should, where possible, build
upon existing Community rules for unsafe goods.
(58)
In
order
to
address
cosmetic
products
which,
despite
complying
with the provisions of this Regulation, might endanger human
health, a safeguard procedure should be introduced.
(59)
The
Commission
should
provide
indications
for
the
uniform
inter·
pretation and application of the concept of serious risks in order
to facilitate the consistent implementation of this Regulation.
(60)
In order to comply with principles of good administrative prac·
tices, any decision by a competent authority in the framework of
market surveillance should be duly substantiated.
(61)
In
order
to
ensure
effective
in-market
control,
a
high
degree
of
administrative cooperation amongst the competent authorities is
necessary. This concerns in particular mutual assistance in the
verification of product information files located in another
Member State.
(62)
The Commission should be assisted by the SCCS, an independent
risk assessment body.
(63)
The
measures
necessary
for
the
implementation
of
this
Regulation
should be adopted in accordance with Council Decision
1999/468/EC of 28 June 1999 laying down the procedures for
the exercise of implementing powers conferred on the Commis·
sion (
1
).
(64)
In
particular,
power
should
be
conferred
on
the
Commission
to
adapt the Annexes to this Regulation to technical progress. Since
those measures are of general scope and are designed to amend
non-essential elements of this Regulation they must be adopted in
accordance with the regulatory procedure with scrutiny provided
for in Article 5a of Decision 1999/468/EC.
(65)
When,
on
imperative
grounds
of
urgency,
the
normal
time-limits
for the regulatory procedure with scrutiny cannot be complied
with, the Commission should be able to apply the urgency
procedure provided for in Article 5a(6) of Decision 1999/468/EC
for the adoption of certain measures relating to CMRs, nano·
materials and potential risks to human health.
(66)
Member States should lay down provisions on penalties
applicable to infringements of the provisions of this Regulation
and ensure that they are implemented. Those penalties should be
effective, proportionate and dissuasive.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 11
(
1
) OJ L 184, 17.7.1999, p. 23.
(67)
Economic operators as well as Member States and the
Commission need sufficient time to adapt to the changes
introduced by this Regulation. Therefore it is appropriate to
provide for a sufficient transitional period for that adaptation.
However, in order to ensure a smooth transition, economic
operators should be allowed to place on the market cosmetic
products which comply with this Regulation before the expiry
of that transitional period.
(68)
In order to enhance the safety of cosmetic products and
strengthen the market surveillance, cosmetic products placed on
the market after the date of application of this Regulation should
comply with its obligations regarding safety assessment, the
product information file and notification, even if similar
obligations have already been fulfilled under Directive
76/768/EEC.
(69)
Directive
76/768/EEC
should
be
repealed.
However,
in
order
to
ensure appropriate medical treatment in the event of difficulties
and to ensure market surveillance, the information received
pursuant to Article 7(3) and Article 7a(4) of Directive
76/768/EEC concerning cosmetic products should be kept by
the competent authorities for a certain period of time and the
information kept by the responsible person should remain
available for the same period of time.
(70)
This
Regulation
should
be
without
prejudice
to
the
obligations
of
the Member States relating to the time-limits for transposition
into national law of the Directives set out in Part B of Annex IX.
(71)
Since the objective of this Regulation, namely the achievement of
the internal market and a high level of protection of human health
through the compliance of cosmetic products with the
requirements laid down in this Regulation, cannot be sufficiently
achieved by the Member States and can therefore, by reason of
the scale of the action, be better achieved at Community level,
the Community may adopt measures, in accordance with the
principle of subsidiarity, as set out in Article 5 of the Treaty.
In accordance with the principle of proportionality, as set out in
that Article, this Regulation does not go beyond what is
necessary in order to achieve that objective,
HAVE ADOPTED THIS REGULATION:
CHAPTER I
SCOPE, DEFINITIONS
Article 1
Scope and objective
This Regulation establishes rules to be complied with by any cosmetic
product made available on the market, in order to ensure the functioning
of the internal market and a high level of protection of human health.
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Article 2
Definitions
1.
For the purposes of this Regulation, the following definitions shall
apply:
(a) `cosmetic product' means any substance or mixture intended to be
placed in contact with the external parts of the human body (epi·
dermis, hair system, nails, lips and external genital organs) or with
the teeth and the mucous membranes of the oral cavity with a view
exclusively or mainly to cleaning them, perfuming them, changing
their appearance, protecting them, keeping them in good condition
or correcting body odours;
(b) `substance' means a chemical element and its compounds in the
natural state or obtained by any manufacturing process, including
any additive necessary to preserve its stability and any impurity
deriving from the process used but excluding any solvent which
may be separated without affecting the stability of the substance or
changing its composition;
(c) `mixture' means a mixture or solution composed of two or more
substances;
(d) `manufacturer' means any natural or legal person who manu·
factures a cosmetic product or has such a product designed or
manufactured, and markets that cosmetic product under his name
or trademark;
(e) `distributor'
means any natural
or
legal
person in the
supply chain,
other than the manufacturer or the importer, who makes a cosmetic
product available on the Community market;
(f) `end user' means either a consumer or professional using the
cosmetic product;
(g) `making available on the market' means any supply of a cosmetic
product for distribution, consumption or use on the Community
market in the course of a commercial activity, whether in return
for payment or free of charge;
(h) `placing on the market' means the first making available of a
cosmetic product on the Community market;
(i) `importer'
means
any
natural
or
legal
person
established
within
the
Community, who places a cosmetic product from a third country
on the Community market;
(j) `harmonised standard' means a standard adopted by one of the
European standardisation bodies listed in Annex I to Directive
98/34/EC of the European Parliament and of the Council of
22 June 1998 laying down a procedure for the provision of
information in the field of technical standards and regulations
and of rules on information society services (
1
) on the basis of a
request made by the Commission in accordance with Article 6 of
that Directive;
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(
1
) OJ L 204, 21.7.1998, p. 37.
(k) `nanomaterial' means an insoluble or biopersistant and intentionally
manufactured material with one or more external dimensions, or an
internal structure, on the scale from 1 to 100 nm;
(l) `preservatives'
means
substances
which
are
exclusively
or
mainly
intended to inhibit the development of micro-organisms in the
cosmetic product;
(m) `colorants' means substances which are exclusively or mainly
intended to colour the cosmetic product, the body as a whole or
certain parts thereof, by absorption or reflection of visible light; in
addition, precursors of oxidative hair colorants shall be deemed
colorants;
(n) `UV-filters' means substances which are exclusively or mainly
intended to protect the skin against certain UV radiation by
absorbing, reflecting or scattering UV radiation;
(o) `undesirable effect' means an adverse reaction for human health
attributable to the normal or reasonably foreseeable use of a
cosmetic product;
(p) `serious undesirable effect' means an undesirable effect which
results in temporary or permanent functional incapacity, disability,
hospitalisation, congenital anomalies or an immediate vital risk or
death;
(q) `withdrawal' means any measure aimed at preventing the making
available on the market of a cosmetic product in the supply chain;
(r) `recall' means any measure aimed at achieving the return of a
cosmetic product that has already been made available to the end
user;
(s) `frame
formulation'
means
a
formulation
which
lists
the
category
or
function of ingredients and their maximum concentration in the
cosmetic product or gives relevant quantitative and qualitative
information whenever a cosmetic product is not covered or only
partially covered by such a formulation. The Commission shall
provide indications for the establishment of the frame formulation
and adapt them regularly to technical and scientific progress.
2.
For the purposes of point (a) of paragraph 1, a substance or
mixture intended to be ingested, inhaled, injected or implanted into
the human body shall not be considered to be a cosmetic product.
3.
In view of the various definitions of nanomaterials published by
different bodies and the constant technical and scientific developments
in the field of nanotechnologies, the Commission shall adjust and adapt
point (k) of paragraph 1 to technical and scientific progress and to
definitions subsequently agreed at international level. That measure,
designed to amend non-essential elements of this Regulation, shall be
adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 32(3).
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 14
CHAPTER II
SAFETY, RESPONSIBILITY, FREE MOVEMENT
Article 3
Safety
A cosmetic product made available on the market shall be safe for
human health when used under normal or reasonably foreseeable
conditions of use, taking account, in particular, of the following:
(a) presentation including conformity with Directive 87/357/EEC;
(b) labelling;
(c) instructions for use and disposal;
(d) any other indication or information provided by the responsible
person defined in Article 4.
The provision of warnings shall not exempt persons defined in Articles
2 and 4 from compliance with the other requirements laid down in this
Regulation.
Article 4
Responsible person
1. Only
cosmetic
products
for
which
a
legal
or
natural
person
is
designated within the Community as `responsible person' shall be
placed on the market.
2.
For each cosmetic product placed on the market, the responsible
person shall ensure compliance with the relevant obligations set out in
this Regulation.
3. For
a
cosmetic
product
manufactured
within
the
Community,
and
not subsequently exported and imported back into the Community, the
manufacturer established within the Community shall be the responsible
person.
The manufacturer may designate, by written mandate, a person estab·
lished within the Community as the responsible person who shall accept
in writing.
4. Where,
for
a
cosmetic
product
manufactured
within
the
Community, and not subsequently exported and imported back into
the Community, the manufacturer is established outside the Community,
he shall designate, by written mandate, a person established within the
Community as the responsible person who shall accept in writing.
5.
For an imported cosmetic product, each importer shall be the
responsible person for the specific cosmetic product he places on the
market.
The importer may, by written mandate, designate a person established
within the Community as the responsible person who shall accept in
writing.
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6.
The distributor shall be the responsible person where he places a
cosmetic product on the market under his name or trademark or
modifies a product already placed on the market in such a way that
compliance with the applicable requirements may be affected.
The translation of information relating to a cosmetic product already
placed on the market shall not be considered as a modification of that
product of such a nature that compliance with the applicable
requirements of this Regulation may be affected.
Article 5
Obligations of responsible persons
1. Responsible
persons
shall
ensure
compliance
with
Articles
3,
8,
10, 11, 12, 13, 14, 15, 16, 17, 18, Article 19(1),(2) and (5), as well as
Articles 20, 21, 23 and 24.
2. Responsible
persons
who
consider
or
have
reason
to
believe
that
a
cosmetic product which they have placed on the market is not in
conformity with this Regulation shall immediately take the corrective
measures necessary to bring that product into conformity, withdraw it or
recall it, as appropriate.
Furthermore, where the cosmetic product presents a risk to human
health, responsible persons shall immediately inform the competent
national authorities of the Member States in which they made the
product available and of the Member State in which the product
information file is readily accessible, giving details, in particular, of
the non-compliance and of the corrective measures taken.
3. Responsible
persons
shall
cooperate
with
these
authorities,
at
the
request of the latter, on any action to eliminate the risks posed by
cosmetic products which they have made available on the market. In
particular, responsible persons shall, further to a reasoned request from a
competent national authority, provide it with all the information and
documentation necessary to demonstrate the conformity of specific
aspects of the product, in a language which can be easily understood
by that authority.
Article 6
Obligations of distributors
1. In
the
context
of
their
activities,
when
making
a
cosmetic
product
available on the market, distributors shall act with due care in relation to
applicable requirements.
2. Before
making
a
cosmetic
product
available
on
the
market
distributors shall verify that:
-- the labelling information provided for in Article 19(1)(a), (e) and (g)
and Article 19(3) and (4) is present,
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-- the language requirements provided for in Article 19(5) are fulfilled,
-- the date of minimum durability specified, where applicable under
Article 19(1), has not passed.
3.
Where distributors consider or have reason to believe that:
-- a cosmetic product is not in conformity with the requirements laid
down in this Regulation, they shall not make the product available
on the market until it has been brought into conformity with the
applicable requirements,
-- a cosmetic product which they have made available on the market is
not in conformity with this Regulation, they shall make sure that the
corrective measures necessary to bring that product into conformity,
withdraw it or recall it, as appropriate, are taken.
Furthermore, where the cosmetic product presents a risk to human
health, distributors shall immediately inform the responsible person
and the competent national authorities of the Member States in which
they made the product available, giving details, in particular, of the non-
compliance and of the corrective measures taken.
4. Distributors
shall
ensure
that,
while
a
product
is
under
their
responsibility, storage or transport conditions do not jeopardise its
compliance with the requirements set out in this Regulation.
5. Distributors
shall
cooperate
with
competent
authorities,
at
the
request of the latter, on any action to eliminate the risks posed by
products which they have made available on the market. In particular,
distributors shall, further to a reasoned request from a competent
national authority, provide it with all the information and documentation
necessary to demonstrate the conformity of the product with the
requirements listed under paragraph 2, in a language which can be
easily understood by that authority.
Article 7
Identification within the supply chain
At the request of a competent authority:
-- responsible persons shall identify the distributors to whom they
supply the cosmetic product,
-- the distributor shall identify the distributor or the responsible person
from whom, and the distributors to whom, the cosmetic product was
supplied.
This obligation shall apply for a period of three years following the date
on which the batch of the cosmetic product was made available to the
distributor.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 17
Article 8
Good manufacturing practice
1.
The manufacture of cosmetic products shall comply with good
manufacturing practice with a view to ensuring the objectives of
Article 1.
2. Compliance
with
good
manufacturing
practice
shall
be
presumed
where the manufacture is in accordance with the relevant harmonised
standards, the references of which have been published in the Official
Journal of the European Union.
Article 9
Free movement
Member States shall not, for reasons related to the requirements laid
down in this Regulation, refuse, prohibit or restrict the making available
on the market of cosmetic products which comply with the requirements
of this Regulation.
CHAPTER III
SAFETY ASSESSMENT, PRODUCT INFORMATION FILE,
NOTIFICATION
Article 10
Safety assessment
1.
In order to demonstrate that a cosmetic product complies with
Article 3, the responsible person shall, prior to placing a cosmetic
product on the market, ensure that the cosmetic product has
undergone a safety assessment on the basis of the relevant information
and that a cosmetic product safety report is set up in accordance with
Annex I.
The responsible person shall ensure that:
(a) the intended use of the cosmetic product and the anticipated
systemic exposure to individual ingredients in a final formulation
are taken into account in the safety assessment;
(b) an appropriate weight-of-evidence approach is used in the safety
assessment for reviewing data from all existing sources;
(c) the cosmetic product safety report is kept up to date in view of
additional relevant information generated subsequent to placing the
product on the market.
The first subparagraph shall also apply to cosmetic products that have
been notified under Directive 76/768/EEC.
The Commission, in close cooperation with all stakeholders, shall adopt
appropriate guidelines to enable undertakings, in particular small and
medium-sized enterprises, to comply with the requirements laid down in
Annex I. Those guidelines shall be adopted in accordance with the
regulatory procedure referred to in Article 32(2).
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 18
2. The
cosmetic
product
safety
assessment,
as
set
out
in
Part
B
of
Annex I shall be carried out by a person in possession of a diploma or
other evidence of formal qualifications awarded on completion of a
university course of theoretical and practical study in pharmacy, toxi·
cology, medicine or a similar discipline, or a course recognised as
equivalent by a Member State.
3.
Non-clinical safety studies referred to in the safety assessment
according to paragraph 1 and carried out after 30 June 1988 for the
purpose of assessing the safety of a cosmetic product shall comply with
Community legislation on the principles of good laboratory practice, as
applicable at the time of performance of the study, or with other inter·
national standards recognised as being equivalent by the Commission or
the ECHA.
Article 11
Product information file
1.
When a cosmetic product is placed on the market, the responsible
person shall keep a product information file for it. The product
information file shall be kept for a period of ten years following the
date on which the last batch of the cosmetic product was placed on the
market.
2. The
product
information
file
shall
contain
the
following
information and data which shall be updated as necessary:
(a) a description of the cosmetic product which enables the product
information file to be clearly attributed to the cosmetic product;
(b) the cosmetic product safety report referred to in Article 10(1);
(c) a description of the method of manufacturing and a statement on
compliance with good manufacturing practice referred to in
Article 8;
(d) where justified by the nature or the effect of the cosmetic product,
proof of the effect claimed for the cosmetic product;
(e) data on any animal testing performed by the manufacturer, his
agents or suppliers, relating to the development or safety assessment
of the cosmetic product or its ingredients, including any animal
testing performed to meet the legislative or regulatory requirements
of third countries.
3. The
responsible
person
shall
make
the
product
information
file
readily accessible in electronic or other format at his address
indicated on the label to the competent authority of the Member State
in which the file is kept.
The information contained in the product information file shall be
available in a language which can be easily understood by the
competent authorities of the Member State.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 19
4. The
requirements
provided
in
paragraphs
1
to
3
of
this
Article
shall also apply to cosmetic products that have been notified under
Directive 76/768/EEC.
Article 12
Sampling and analysis
1. Sampling
and
analysis
of
cosmetic
products
shall
be
performed
in
a reliable and reproducible manner.
2.
In the absence of any applicable Community legislation, reliability
and reproducibility shall be presumed if the method used is in
accordance with the relevant harmonised standards, the references of
which have been published in the Official Journal of the European
Union.
Article 13
Notification
1. Prior to placing the cosmetic product on the market the
responsible person shall submit, by electronic means, the following
information to the Commission:
(a) the category of cosmetic product and its name or names, enabling
its specific identification;
(b) the name and address of the responsible person where the product
information file is made readily accessible;
(c) the country of origin in the case of import;
(d) the Member State in which the cosmetic product is to be placed on
the market;
(e) the contact details of a physical person to contact in the case of
necessity;
(f) the presence of substances in the form of nanomaterials and:
(i) their identification including the chemical name (IUPAC) and
other descriptors as specified in point 2 of the Preamble to
Annexes II to VI to this Regulation;
(ii) the reasonably foreseeable exposure conditions;
(g) the name and the Chemicals Abstracts Service (CAS) or EC number
of substances classified as carcinogenic, mutagenic or toxic for
reproduction (CMR), of category 1A or 1B, under Part 3 of
Annex VI to Regulation (EC) No 1272/2008;
(h) the frame formulation allowing for prompt and appropriate medical
treatment in the event of difficulties.
The first subparagraph shall also apply to cosmetic products notified
under Directive 76/768/EEC.
2. When the cosmetic product is placed on the market, the
responsible person shall notify to the Commission the original labelling,
and, where reasonably legible, a photograph of the corresponding pack·
aging.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 20
3. As
from
11
July
2013,
a
distributor
who
makes
available
in
a
Member State a cosmetic product already placed on the market in
another Member State and translates, on his own initiative, any
element of the labelling of that product in order to comply with
national law, shall submit, by electronic means, the following
information to the Commission:
(a) the category of cosmetic product, its name in the Member State of
dispatch and its name in the Member State in which it is made
available, enabling its specific identification;
(b) the Member State in which the cosmetic product is made available;
(c) his name and address;
(d) the name and address of the responsible person where the product
information file is made readily accessible.
4. Where
a
cosmetic
product
has
been
placed
on
the
market
before
11 July 2013 but is no longer placed on the market as from that date,
and a distributor introduces that product in a Member State after that
date, that distributor shall communicate the following to the responsible
person:
(a) the category of cosmetic product, its name in the Member State of
dispatch and its name in the Member State in which it is made
available, enabling its specific identification;
(b) the Member State in which the cosmetic product is made available;
(c) his name and address.
On the basis of that communication, the responsible person shall submit
to the Commission, by electronic means, the information referred to in
paragraph 1 of this Article, where notifications according to Article 7(3)
and Article 7a (4) of Directive 76/768/EEC have not been carried out in
the Member State in which the cosmetic product is made available.
5. The
Commission
shall,
without
delay,
make
the
information
referred to in points (a) to (g) of paragraph 1, and in paragraphs 2
and 3 available electronically to all competent authorities.
That information may be used by competent authorities only for the
purposes of market surveillance, market analysis, evaluation and
consumer information in the context of Articles 25, 26 and 27.
6. The
Commission
shall,
without
delay,
make
the
information
referred to in paragraphs 1, 2 and 3 available electronically to poison
centres or similar bodies, where such centres or bodies have been
established by Member States.
That information may be used by those bodies only for the purposes of
medical treatment.
7.
Where any of the information set out in paragraphs 1, 3 and 4
changes, the responsible person or the distributor shall provide an
update without delay.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 21
8. The
Commission
may,
taking
into
account
technical
and
scientific
progress and specific needs related to market surveillance, amend para·
graphs 1 to 7 by adding requirements.
Those measures, designed to amend non-essential elements of this
Regulation, shall be adopted in accordance with the regulatory
procedure with scrutiny referred to in Article 32(3).
CHAPTER IV
RESTRICTIONS FOR CERTAIN SUBSTANCES
Article 14
Restrictions for substances listed in the Annexes
1. Without
prejudice
to
Article
3,
cosmetic
products
shall
not
contain
any of the following:
(a) prohibited substances
-- prohibited substances listed in Annex II;
(b) restricted substances
-- restricted substances which are not used in accordance with the
restrictions laid down in Annex III;
(c) colorants
(i) colorants other than those listed in Annex IV and colorants
which are listed there but not used in accordance with the
conditions laid down in that Annex, except for hair colouring
products referred to in paragraph 2;
(ii) without prejudice to points (b), (d)(i) and (e)(i), substances
which are listed in Annex IV but which are not intended to
be used as colorants, and which are not used in accordance with
the conditions laid down in that Annex;
(d) preservatives
(i) preservatives other than those listed in Annex V and preserv·
atives which are listed there but not used in accordance with the
conditions laid down in that Annex;
(ii) without prejudice to points (b), (c)(i) and (e)(i), substances
listed in Annex V but which are not intended to be used as
preservatives, and which are not used in accordance with the
conditions laid down in that Annex;
(e) UV-filters
(i) UV-filters other than those listed in Annex VI and UV-filters
which are listed there but not used in accordance with the
conditions laid down in that Annex;
(ii) without prejudice to points (b), (c)(i) and (d)(i), substances
listed in Annex VI but which are not intended to be used as
UV-filters and which are not used in accordance with the
conditions laid down in that Annex.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 22
2. Subject
to
a
decision
of
the
Commission
to
extend
the
scope
of
Annex IV to hair colouring products, such products shall not contain
colorants intended to colour the hair, other than those listed in Annex
IV and colorants intended to colour the hair which are listed there but
not used in accordance with the conditions laid down in that Annex.
The decision of the Commission referred to in the first subparagraph,
designed to amend non-essential elements of this Regulation, shall be
adopted in accordance with the regulatory procedure with scrutiny
referred to in Article 32(3).
Article 15
Substances classified as CMR substances
1.
The use in cosmetic products of substances classified as CMR
substances, of category 2, under Part 3 of Annex VI to Regulation
(EC) No 1272/2008 shall be prohibited. However, a substance classified
in category 2 may be used in cosmetic products where the substance has
been evaluated by the SCCS and found safe for use in cosmetic
products. To these ends the Commission shall adopt the necessary
measures in accordance with the regulatory procedure with scrutiny
referred to in Article 32(3) of this Regulation.
2.
The use in cosmetic products of substances classified as CMR
substances, of category 1A or 1B under Part 3 of Annex VI to Regu·
lation (EC) No 1272/2008 shall be prohibited.
However, such substances may be used in cosmetic products by way of
exception where, subsequent to their classification as CMR substances
of category 1A or 1B under Part 3 of Annex VI to Regulation (EC) No
1272/2008, all of the following conditions are fulfilled:
(a) they comply with the food safety requirements as defined in Regu·
lation (EC) No 178/2002 of the European Parliament and of the
Council of 28 January 2002 laying down the general principles and
requirements of food law, establishing the European Food Safety
Authority and laying down procedures in matters of food safety (
1
);
(b) there are no suitable alternative substances available, as documented
in an analysis of alternatives;
(c) the application is made for a particular use of the product category
with a known exposure; and
(d) they have been evaluated and found safe by the SCCS for use in
cosmetic products, in particular in view of exposure to these
products and taking into consideration the overall exposure from
other sources, taking particular account of vulnerable population
groups.
Specific labelling in order to avoid misuse of the cosmetic product shall
be provided in accordance with Article 3 of this Regulation, taking into
account possible risks linked to the presence of hazardous substances
and the routes of exposure.
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(
1
) OJ L 31, 1.2.2002, p. 1.
In order to implement this paragraph, the Commission shall amend the
Annexes to this Regulation in accordance with the regulatory procedure
with scrutiny referred to in Article 32(3) of this Regulation within 15
months of the inclusion of the substances concerned in Part 3 of Annex
VI to Regulation (EC) No 1272/2008.
On imperative grounds of urgency, the Commission may use the
urgency procedure referred to in Article 32(4) of this Regulation.
The Commission shall mandate the SCCS to re-evaluate those
substances as soon as safety concerns arise, and at the latest five
years after their inclusion in Annexes III to VI to this Regulation,
and at least every subsequent five years.
3. By
11
January
2012,
the
Commission
shall
ensure
that
appropriate
guidance is developed with the aim of enabling a harmonised approach
to the development and use of overall exposure estimates in assessing
the safe use of CMR substances. This guidance shall be developed in
consultation with the SCCS, the ECHA, the EFSA and other relevant
stakeholders, drawing, as appropriate, on relevant best practice.
4. When
Community
or
internationally
agreed
criteria
for
identifying
substances with endocrine-disrupting properties are available, or at the
latest on 11 January 2015, the Commission shall review this Regulation
with regard to substances with endocrine-disrupting properties.
Article 16
Nanomaterials
1. For
every
cosmetic
product
that
contains
nanomaterials,
a
high
level of protection of human health shall be ensured.
2.
The provisions of this Article do not apply to nanomaterials used
as colorants, UV-filters or preservatives regulated under Article 14,
unless expressly specified.
3. In
addition
to
the
notification
under
Article
13,
cosmetic
products
containing nanomaterials shall be notified to the Commission by the
responsible person by electronic means six months prior to being
placed on the market, except where they have already been placed on
the market by the same responsible person before 11 January 2013.
In the latter case, cosmetic products containing nanomaterials placed on
the market shall be notified to the Commission by the responsible
person between 11 January 2013 and 11 July 2013 by electronic
means, in addition to the notification in Article 13.
The first and the second subparagraphs shall not apply to cosmetic
products containing nanomaterials that are in conformity with the
requirements set out in Annex III.
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The information notified to the Commission shall contain at least the
following:
(a) the identification of the nanomaterial including its chemical name
(IUPAC) and other descriptors as specified in point 2 of the
Preamble to Annexes II to VI;
(b) the specification of the nanomaterial including size of particles,
physical and chemical properties;
(c) an estimate of the quantity of nanomaterial contained in cosmetic
products intended to be placed on the market per year;
(d) the toxicological profile of the nanomaterial;
(e) the safety data of the nanomaterial relating to the category of
cosmetic product, as used in such products;
(f) the reasonably foreseeable exposure conditions.
The responsible person may designate another legal or natural person by
written mandate for the notification of nanomaterials and shall inform
the Commission thereof.
The Commission shall provide a reference number for the submission of
the toxicological profile, which may substitute the information to be
notified under point (d).
4.
In the event that the Commission has concerns regarding the
safety of a nanomaterial, the Commission shall, without delay, request
the SCCS to give its opinion on the safety of such nanomaterial for use
in the relevant categories of cosmetic products and on the reasonably
foreseeable exposure conditions. The Commission shall make this
information public. The SCCS shall deliver its opinion within six
months of the Commission's request. Where the SCCS finds that any
necessary data is lacking, the Commission shall request the responsible
person to provide such data within an explicitly stated reasonable time,
which shall not be extended. The SCCS shall deliver its final opinion
within six months of submission of additional data. The opinion of the
SCCS shall be made publicly available.
5. The
Commission
may,
at
any
time,
invoke
the
procedure
in
paragraph 4 where it has any safety concerns, for example due to
new information supplied by a third party.
6. Taking
into
account
the
opinion
of
the
SCCS,
and
where
there
is
a
potential risk to human health, including when there is insufficient data,
the Commission may amend Annexes II and III.
7. The
Commission
may,
taking
into
account
technical
and
scientific
progress, amend paragraph 3 by adding requirements.
8. The
measures,
referred
to
in
paragraphs
6
and
7,
designed
to
amend non-essential elements of this Regulation, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in
Article 32(3).
9. On
imperative
grounds
of
urgency
the
Commission
may
use
the
procedure referred to in Article 32(4).
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 25
10. The
following
information
shall
be
made
available
by
the
Commission:
(a) By 11 January 2014, the Commission shall make available a
catalogue of all nanomaterials used in cosmetic products placed
on the market, including those used as colorants, UV-filters and
preservatives in a separate section, indicating the categories of
cosmetic products and the reasonably foreseeable exposure
conditions. This catalogue shall be regularly updated thereafter
and be made publicly available.
(b) The Commission shall submit to the European Parliament and the
Council an annual status report, which will give information on
developments in the use of nanomaterials in cosmetic products
within the Community, including those used as colorants, UV-
filters and preservatives in a separate section. The first report
shall be presented by 11 July 2014 The report update shall
summarise, in particular, the new nanomaterials in new categories
of cosmetic products, the number of notifications, the progress made
in developing nano-specific assessment methods and safety
assessment guides, and information on international cooperation
programmes.
11. The
Commission
shall
regularly
review
the
provisions
of
this
Regulation concerning nanomaterials in the light of scientific progress
and shall, where necessary, propose suitable amendments to those provi·
sions.
The first review shall be undertaken by 11 July 2018.
Article 17
Traces of prohibited substances
The non-intended presence of a small quantity of a prohibited
substance, stemming from impurities of natural or synthetic ingredients,
the manufacturing process, storage, migration from packaging, which is
technically unavoidable in good manufacturing practice, shall be
permitted provided that such presence is in conformity with Article 3.
CHAPTER V
ANIMAL TESTING
Article 18
Animal testing
1. Without
prejudice
to
the
general
obligations
deriving
from
Article 3, the following shall be prohibited:
(a) the placing on the market of cosmetic products where the final
formulation, in order to meet the requirements of this Regulation,
has been the subject of animal testing using a method other than an
alternative method after such alternative method has been validated
and adopted at Community level with due regard to the devel·
opment of validation within the OECD;
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(b) the placing on the market of cosmetic products containing
ingredients or combinations of ingredients which, in order to meet
the requirements of this Regulation, have been the subject of animal
testing using a method other than an alternative method after such
alternative method has been validated and adopted at Community
level with due regard to the development of validation within the
OECD;
(c) the performance within the Community of animal testing of finished
cosmetic products in order to meet the requirements of this Regu·
lation;
(d) the performance within the Community of animal testing of
ingredients or combinations of ingredients in order to meet the
requirements of this Regulation, after the date on which such tests
are required to be replaced by one or more validated alternative
methods listed in Commission Regulation (EC) No 440/2008 of
30 May 2008 laying down test methods pursuant to Regulation
(EC) No 1907/2006 of the European Parliament and of the
Council on the Registration, Evaluation, Authorisation and
Restriction of Chemicals (REACH) (
1
) or in Annex VIII to this
Regulation.
2. The
Commission,
after
consulting
the
SCCS
and
the
European
Centre for the Validation of Alternative Methods (ECVAM) and with
due regard to the development of validation within the OECD, has
established timetables for the implementation of the provisions under
points (a), (b) and (d) of paragraph 1, including deadlines for the
phasing-out of the various tests. The timetables were made available
to the public on 1 October 2004 and sent to the European Parliament
and the Council. The period for implementation was limited to
11 March 2009 in relation to points (a), (b) and (d) of paragraph 1.
In relation to the tests concerning repeated-dose toxicity, reproductive
toxicity and toxicokinetics, for which there are no alternatives yet under
consideration, the period for implementation of paragraph 1(a) and (b)
shall be limited to 11 March 2013.
The Commission shall study possible technical difficulties in complying
with the ban in relation to tests, in particular those concerning repeated-
dose toxicity, reproductive toxicity and toxicokinetics, for which there
are no alternatives yet under consideration. Information about the
provisional and final results of these studies forms part of the yearly
reports presented pursuant to Article 35.
On the basis of these annual reports, the timetables established as
referred to in the first subparagraph, could be adapted up to
11 March 2009 in relation to the first subparagraph and may be
adapted up to 11 March 2013 in relation to the second subparagraph
and after consultation of the entities referred to in the first subparagraph.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 27
(
1
) OJ L 142, 31.5.2008, p. 1.
The Commission shall study progress and compliance with the
deadlines as well as possible technical difficulties in complying with
the ban. Information about the provisional and final results of the
Commission studies forms part of the yearly reports presented
pursuant to Article 35. If these studies conclude, at the latest two
years prior to the end of the maximum period referred to in the
second subparagraph, that for technical reasons one or more tests
referred to in that subparagraph will not be developed and validated
before the expiry of the period referred to therein it shall inform the
European Parliament and the Council and shall put forward a legislative
proposal in accordance with Article 251 of the Treaty.
In exceptional circumstances, where serious concerns arise as regards
the safety of an existing cosmetic ingredient, a Member State may
request the Commission to grant a derogation from paragraph 1. The
request shall contain an evaluation of the situation and indicate the
measures necessary. On this basis, the Commission may, after
consulting the SCCS and by means of a reasoned decision, authorise
the derogation. That authorisation shall lay down the conditions
associated with this derogation in terms of specific objectives,
duration and reporting of the results.
A derogation shall be granted only where:
(a) the ingredient is in wide use and cannot be replaced by another
ingredient capable of performing a similar function;
(b) the specific human health problem is substantiated and the need to
conduct animal tests is justified and is supported by a detailed
research protocol proposed as the basis for the evaluation.
The decision on the authorisation, the conditions associated with it and
the final result achieved shall be part of the annual report presented by
the Commission in accordance with Article 35.
The measures referred to in the sixth subparagraph, designed to amend
non-essential elements of this Regulation, shall be adopted in
accordance with the regulatory procedure with scrutiny referred to in
Article 32(3).
3. For
the
purposes
of
this
Article
and
Article
20:
(a) `finished cosmetic product' means the cosmetic product in its final
formulation, as placed on the market and made available to the end
user, or its prototype;
(b) `prototype' means a first model or design that has not been
produced in batches, and from which the finished cosmetic
product is copied or finally developed.
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2009R1223 -- EN -- 01.04.2014 -- 003.001 -- 28
CHAPTER VI
CONSUMER INFORMATION
Article 19
Labelling
1.
Without prejudice to other provisions in this Article, cosmetic
products shall be made available on the market only where the
container and packaging of cosmetic products bear the following
information in indelible, easily legible and visible lettering:
(a) the name or registered name and the address of the responsible
person. Such information may be abbreviated in so far as the
abbreviation makes it possible to identify that person and his
address. If several addresses are indicated, the one where the
responsible person makes readily available the product information
file shall be highlighted. The country of origin shall be specified for
imported cosmetic products;
(b) the nominal content at the time of packaging, given by weight or by
volume, except in the case of packaging containing less than five
grams or five millilitres, free samples and single-application packs;
for pre-packages normally sold as a number of items, for which
details of weight or volume are not significant, the content need
not be given provided the number of items appears on the pack·
aging. This information need not be given if the number of items is
easy to see from the outside or if the product is normally only sold
individually;
(c) the date until which the cosmetic product, stored under appropriate
conditions, will continue to fulfil its initial function and, in
particular, will remain in conformity with Article 3 (`date of
minimum durability').
The date itself or details of where it appears on the packaging shall
be preceded by the symbol shown in point 3 of Annex VII or the
words: `best used before the end of'.
The date of minimum durability shall be clearly expressed and shall
consist of either the month and year or the day, month and year, in
that order. If necessary, this information shall be supplemented by
an indication of the conditions which must be satisfied to guarantee
the stated durability.
Indication of the date of minimum durability shall not be mandatory
for cosmetic products with a minimum durability of more than 30
months. For such products, there shall be an indication of the period
of time after opening for which the product is safe and can be used
without any harm to the consumer. This information shall be indi·
cated, except where the concept of durability after opening is not
relevant, by the symbol shown in point 2 of Annex VII followed by
the period (in months and/or years);
(d) particular precautions to be observed in use, and at least those listed
in Annexes III to VI and any special precautionary information on
cosmetic products for professional use;
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(e) the batch number of manufacture or the reference for identifying the
cosmetic product. Where this is impossible for practical reasons
because the cosmetic products are too small, such information
need appear only on the packaging;
(f) the function of the cosmetic product, unless it is clear from its
presentation;
(g) a list of ingredients. This information may be indicated on the
packaging alone. The list shall be preceded by the term `ingredi·
ents'.
For the purpose of this Article, an ingredient means any substance
or mixture intentionally used in the cosmetic product during the
process of manufacturing. The following shall not, however, be
regarded as ingredients:
(i) impurities in the raw materials used;
(ii) subsidiary technical materials used in the mixture but not
present in the final product.
Perfume and aromatic compositions and their raw materials shall be
referred to by the terms `parfum' or `aroma'. Moreover, the
presence of substances, the mention of which is required under
the column `Other' in Annex III, shall be indicated in the list of
ingredients in addition to the terms parfum or aroma.
The list of ingredients shall be established in descending order of
weight of the ingredients at the time they are added to the cosmetic
product. Ingredients in concentrations of less than 1 % may be listed
in any order after those in concentrations of more than 1 %.
All ingredients present in the form of nanomaterials shall be clearly
indicated in the list of ingredients. The names of such ingredients
shall be followed by the word `nano' in brackets.
Colorants other than colorants intended to colour the hair may be
listed in any order after the other cosmetic ingredients. For
decorative cosmetic products marketed in several colour shades,
all colorants other than colorants intended to colour the hair used
in the range may be listed, provided that the words `may contain' or
the symbol `+/-' are added. The CI (Colour Index) nomenclature
shall be used, where applicable.
2. Where
it
is
impossible
for
practical
reasons
to
label
the
information mentioned in points (d) and (g) of paragraph 1 as
provided, the following applies:
-- the information shall be mentioned on an enclosed or attached
leaflet, label, tape, tag or card;
-- unless impracticable, this information shall be referred to by
abbreviated information or the symbol given in point 1 of Annex
VII, which must appear on the container or packaging for the
information referred in point (d) of paragraph 1 and on packaging
for the information referred in point (g) of paragraph 1.
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Excerpt out of 372 pages
- Quote paper
- Stefanie Merenyi (Author), 2018, COSMETICS: Regulation (EC) No 1223/2009, Munich, GRIN Verlag, https://www.grin.com/document/274383
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