The EU Cosmetics
Regulation 1223/2009
1
European Cosmetics
Directive vs Regulation Why?
2
The Single Market in the EU
Different safety
standards in Member
States
are incompatible with
free circulation of goods
3
Is the EU Cosmetics Directive (1976-2013) not
good enough anymore?
a) One single text in the interest of clarity
b) Legal instrument of “Regulation”:
provides clear and detailed rules – no
room for diverging transposition by
Member States (in content or in time)
c) Simplifying procedures and
streamlining terminology
d) Strengthen certain elements, such as inmarket control, to ensure a high level of
protection of human health.
4
Objective of the Cosmetics Regulation
 functioning of the internal market and
 high level of protection of human health
 Objective = safe products meeting the
requirements of the Directive should have
equal and immediate access to the market and
should be able to circulate freely throughout
the European Union.
5
The basic principles
• No pre-market registration/certification
• Responsibility for safety and legal
compliance is with the ‘Responsible
Person ’
• EU wide product notification prior to
placing on the market (CPNP)
• In market control of compliance by
authorities
6
When you place a cosmetic product on the EU
market …
 Your product must be safe (§ 3)
 You must be in a position to demonstrate
this safety (§ 10-11)
 You must give adequate information
 to authorities to facilitate in-market control
(Notification §13)
 to consumers to ensure safe use (§ 19-21)
7
Cosmetics Regulation -Layout of the Regulation
Chapter
Title
Articles
I
Scope, definitions
1-2
II
Safety, responsible person, free movement
3-9
III
Safety Assessment, product information file, notification
10-13
IV
Restrictions for certain substances
14-17
V
Animal testing
18
VI
Consumer information
19-21
VII
Market surveillance
22-24
VIII
Non-compliance, safeguard clause
25-28
IX
Administrative cooperation
29-30
X
Implementing measures, final provisions
31-40
ANNEXES
I-X
8
Chapter I Scope, Definitions
 No change in scope of legislation
 Definition of a Cosmetic Product is not changed
 Codifying the existing understanding through explicit
definitions.




Substance, mixture
Making available, placing on the market
Responsible Person
Serious Undesirable effect
9
Article 2: Definitions
Cosmetic product :
“any substance or mixture intended to be placed in
contact with the external parts of the human body
(epidermis, 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 ....”
10
Cleaning them
11
Perfuming them
12
Changing their Appearance
13
Protecting them
14
Keeping them
in good condition
15
Correcting Body Odours
16
Physical/Chemical Form
• Cosmetics must be substances or
mixtures
• Articles are not cosmetic products even if applied to the skin with a
cosmetic function
• Substances/mixtures released from an
article can be cosmetics (e.g. lotion in a
cosmetic wipe)
17
Intended application site
• Clearly specified and limited.
• In addition : “...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.” (§ 2.2)
• Certain degree of dermal penetration, inhalation
or accidental ingestion is acknowledged and
accepted
18
Primary Function
• Exclusive or main function (primary
function) must be cosmetic
• Secondary, non-cosmetic functions
are acceptable
• To determine the primary function,
consider : Manufacturer’s intention, Presentation /
Labelling / Advertising / Claims, Mode of action,
Composition, Consumer perception
19
Other definitions in the Regulation
Codify the existing understanding :
• Substance, mixture
• Making available, placing on the
market
• Person responsible, Manufacturer,
importer, distributor
• Undesirable effect, serious
undesirable effect
• Technical definitions
20
Cosmetics Regulation
Chapter
Title
Articles
I
Scope, definitions
1-2
II
Safety, responsible person, free movement
3-9
III
Safety Assessment, product information file, notification
10-13
IV
Restrictions for certain substances
14-17
V
Animal testing
18
VI
Consumer information
19-21
VII
Market surveillance
22-24
VIII
Non-compliance, safeguard clause
25-28
IX
Administrative cooperation
29-30
X
Implementing measures, final provisions
31-40
ANNEXES
I-X
21
Chapter II Safety, Responsible Person
Free Movement
• Requirement for a high level of safety with clear provisions
on GMP
• Responsibility remains with the manufacturer / importer;
certain responsibilities are allocated to distributor
• Role of Member States in post-market control is
strengthened
• Safe products meeting the requirements of the regulation
have equal access to the market and are able to circulate
freely throughout the EU
22
Article 3 : Safety
A cosmetic product ...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; instructions for use and disposal;
c) any other indication or information provided
by the Responsible person.....
23
Article 4 Responsible Person
 The Regulation confirms the responsibility for complying
with the requirements of the cosmetic legislation lies with
the Responsible Person (RP) – that is the person whose
name and address appear on the product label.
 RP must be in the EU – manufacturer or importer
 Exception – a distributor who places the cosmetic product
under his name or Trade Mark
 Identification of the RP is the EU address listed on the label.
Multiple EU addresses – address that is underlined where
the RP makes the Product Information File readily available.
24
Article 5 -7 Responsibilities along the Supply
Chain
 Central role of the Responsible Person
(RP)
 Duties of the RP within the supply chain:
 Safety, GMP, Safety Assessment
 Product Information File – complete
 Notification
 Labeling
 Compliance with all provisions
25
Article 8
Good Manufacturing Practice
 Compliance with GMP is mandatory but
certification is not required;
 Choice of GMP is voluntary :
 Compliance is presumed if EN ISO 22716:2007
(harmonized standard) is applied, but may still need
to be demonstrated;
 Compliance can also be demonstrated in other ways,
e.g. via industry-recognised standards and codes,
etc.
 Authorities may ask for full GMP documentation,
in addition to the statement of compliance.
 Product Information File must contain statement
of compliance with Good Manufacturing Practice as of July 11, 2013
26
Cosmetics Regulation
Chapter
Title
Articles
I
Scope, definitions
1-2
II
Safety, responsible person, free movement
3-9
III
Safety Assessment, product information file, notification
10-13
IV
Chapter
Restrictions for certain substances
14-17
V
Animal testing
18
VI
Consumer information
19-21
VII
Market surveillance
22-24
VIII
Non-compliance, safeguard clause
25-28
IX
Administrative cooperation
29-30
X
Implementing measures, final provisions
31-40
ANNEXES
I-X
27
Chapter III Safety Assessment,
Product Information File
 General concept and approach are maintained
 However:



More explicit content and format
All safety-related information combined in the
“Cosmetic Product Safety Report”
Minimum qualifications of safety assessor are clearly
defined
28
Product Information File - Contents
 What remains the same:
 The concept and general content
 Public availability of certain information
 What is different:
 Overall structure and level of detail
 Statement of compliance with GMP
 Cosmetic Safety Report –


Reasoning for the safety assessment
Clearer minimum qualifications for the safety assessor
29
.
Product Information File
A description of the cosmetic product
which enables the product information
file to be clearly attributed to the
cosmetic product
Cosmetic Product
Safety Report
A description of the method of
manufacturing and a statement
on compliance with good
manufacturing practice
Where justified by the nature or
the effect of the cosmetic
product, proof of the effect
claimed for the cosmetic product
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
Part A – Cosmetic Product Safety
Information
• Quantitative and Qualitative composition
of the product
• Physical / chemical characteristics and
stability of the cosmetic product
• Microbiological quality
• Impurities, traces, information about the
packaging material
• Normal and reasonably foreseeable use
• Exposure to the cosmetic product
• Exposure to the substance
• Toxicological profile of the substance
• Undesirable effects and serious
undesirable effects
• Information on the cosmetic product
Part B – Cosmetic Product Safety
Assessment
• Assessment conclusion
• Labelled warnings and instructions of use
• Reasoning
• Assessor’s credential and approval of part B
30
P.I.F.-related responsibilities
The Responsible Person must:
 Establish and maintain a Product
Information File (P.I.F.) - available for
answering enquiries by control
authorities;
 Ensure that a safety assessment has
been performed by a qualified safety
assessor;
 Keep and update it according to
relevant new data (including the data
upon which it is based)
31
P.I.F.-related responsibilities
 For all products (new and existing),
including imported, professional,
promotional gifts
 No need to retain on paper
 For most parts confidential, kept inside the
company and open only to authorities.
However, some parts to be opened to the
public.
32
P.I.F.- related responsibilities
Distributors must :
 Ensure that storage and transport conditions do
not jeopardise products’ compliance with the
Regulation.
 Collaborate with the responsible person and the
national competent authorities whenever
necessary, to ensure compliance with the
Regulation;
33
P.I.F.- related responsibilities
 The Safety Assessor must:
 Assess the safety of the cosmetic product before it is
placed on the market
 Collaborate with the Responsible Person to ensure that
the safety assessment is readily available to the
competent authority; and is kept up-to-date.
34
P.I.F. - related timelines
 Entry into force : 11 July 2013
 Retention Period:
 10 years after the last batch was placed on the market
 For product no longer placed on the market as of 11 July
2013, the P.I.F. must be retained until 11 July 2020.
35
P.I.F. Contents
 Information to be kept by the company and to be
made readily accessible to control authorities at the
address of the product’s label:
 Product Description
 Cosmetic Product Safety Report ( CPSR)
 Method of Manufacture and statement of compliance
with GMP
 Proof of the effect claimed
 Data on animal testing
36
P.I.F. Information to be made public
 Information to be made publicly available:
 Product identification (product name and company
name)
 Qualitative and quantitative composition of the
product:



Qualitative: INCI
Quantitative: only for substances classified as dangerous
under Regulation 127/2008; may be noted as “<x %” “or “x-y”
Perfume – name & code number & supplier.
 Data on undesirable effects & serious undesirable effects
that are likely to be attributed to the use of the product.
37
.
Product Information File
A description of the cosmetic product
which enables the product information
file to be clearly attributed to the
cosmetic product
Cosmetic Product
Safety Report
A description of the method of
manufacturing and a statement
on compliance with good
manufacturing practice
Where justified by the nature or
the effect of the cosmetic
product, proof of the effect
claimed for the cosmetic product
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
Part A – Cosmetic Product Safety
Information
• Quantitative and Qualitative composition
of the product
• Physical / chemical characteristics and
stability of the cosmetic product
• Microbiological quality
• Impurities, traces, information about the
packaging material
• Normal and reasonably foreseeable use
• Exposure to the cosmetic product
• Exposure to the substance
• Toxicological profile of the substance
• Undesirable effects and serious
undesirable effects
• Information on the cosmetic product
Part B – Cosmetic Product Safety
Assessment
• Assessment conclusion
• Labelled warnings and instructions of use
• Reasoning
• Assessor’s credential and approval of part B
38
.
Part A – Cosmetic Product Safety
Information
Cosmetic Product
Safety Report
Annex I of Cosmetics
Regulation
• Quantitative and Qualitative composition
of the product
• Physical / chemical characteristics and
stability of the cosmetic product
• Microbiological quality
• Impurities, traces, information about the
packaging material
• Normal and reasonably foreseeable use
• Exposure to the cosmetic product
• Exposure to the substance
• Toxicological profile of the substance
• Undesirable effects and serious
undesirable effects
• Information on the cosmetic product
Part B – Cosmetic Product Safety
Assessment
• Assessment conclusion
• Labelled warnings and instructions of use
• Reasoning
• Assessor’s credential and approval of part B
39
Important Considerations
Safety assessment requires competence and experience
of the safety assessor. Annex I is not intended to
“teach” these skills.
The safety assessment of cosmetics is not a standardized
procedure, but performed on a case-by-case basis.
“Checklist” approaches and decisions based on
hazard alone are considered inappropriate.
By utilizing the entire scope of information available
science-based decisions in a weight-of-evidence
approach are made.
40
Important Considerations
1) Annex I/A describes elements, but not a fixed
structure of a CPSR, i.e. the elements need to be
addressed, but not necessarily in the same
order/under the same headings as in annex I. A
modular approach is the approach of choice.
2) All relevant endpoints need to be addressed –
but not necessarily with specific study data.
Data waiving is possible – if justified.
41
.
Annex I - Part B – Cosmetic Product
Safety Assessment
• Assessment conclusion
• Labelled warnings and
instructions of use
• Reasoning
• Assessor’s credential and approval
of part B
42
Important Considerations
Cosmetic Safety Assessment Report:The
reasoning contains, but is not limited to, the
following elements:
 Exposure assessment and calculation – target user
 Product stability and microbiological quality
 Ingredient characterization – impurities, structure
 Selection of the appropriate toxicological endpoints
as the driver for the safety assessment and
justification for waiving of endpoints/data
 Weight of evidence approach
43
Important Considerations
Based on all the available data, the
conclusion of the safety assessment
may be:
 The product is safe for the proposed use
without restrictions
or
 The product is safe with restrictions and
may need specific warnings or
precautions (risk reduction measures).
44
Article 13 : Product Notification
 One central EU notification (CPNP)
 Replaces national schemes
 Required for new and existing products
 Obligations for Responsible Person and
(sometimes) for distributors
45
Who needs to notify – and to whom ?
i.
Responsible Person - Article 13(1&2): Prior to placing new
product on the market and for existing products
ii.
Distributors – Article 13(3): When distributor translates
the labelling on his own initiative for sale in another
Member State
iii.
Responsible Person - Article 13(4): When a distributor reintroduces a product no longer placed on the market by
the responsible person
In all cases : Notification to central EU
portal
46
What needs to be notified ?
Who has access ?
 Product category
 Country of origin (import only)
 Member State where product is placed on the market
 Details of physical contact person in case necessity
 Nanomaterials – identification, exposure conditions
 CMRs (1A & 1B) – identification
 Original labelling (only once)
 Photograph of original packaging - if reasonably
legible (only once)
 Frame formulation
Poison Control Centres
 Responsible person - name and address
Competent Authorities
 Product name(s)
47
Type of cosmetic products - Examples of
scenarios by increasing complexity
1) Simple product
2) Shaded /fragrance variant
products
1a)
Shampoo
3) Composite products
Cream
Palette lips, eyes, cheeks
Eye Shadow
Professional Hair colour
1b)
4) Kit products
Lipstick
Skincare gift sets
Hair colour
48
Product Notification
ECAS website – to register individual users
https://webgate.ec.europa.eu/aida/selfr
eg
SAAS website – to set up organization
profiles. To link individual users to
organizations
https://webgate.ec.europa.eu/saas
CPNP website – to notify your products
https://webgate.ec.europa.eu/cpnp
49
CPNP
 One notification is linked to one cosmetic product
 One cosmetic product is linked to one product file
 One product covered in one product file may be
comprised of several components
 One product file may , in some cases, be linked to
several variants ( shades)
 *One notification may comprise of several
components ( e.g. oxidative hair dye) and/or several
variants ( e.g. shades)
50
CPNP Gift Sets & Kits
 Gift sets that group together a number of products,
each of which is sold separately:


Cannot be notified under one notification
Each product needs to be notified separately
 Multi-component products (e.g. permanent hair dyes)
for which the components are not sold separately –

Have to be notified as under one notification
51
CPNP – Information to be provided
 Product Category
 Product names
 Responsible person (RP) & address, contact
information
 Country of Origin
 Member State where the product is placed on the
market
 Nanomaterials
 CMRs ( 1A & 1B only)
 Artwork – or photograph
52
CPNP – Frame Formulas
 Modeled after SYSDECOS, developed with the
European Association of Poison Control Centres
 Frame Formulas consist of:
 List of category/function of certain ingredients and their
maximum concentration in the cosmetic product
 Additional indication of specific substances with exact
concentration (critical from Poison Control POV)
 Trigger rules for select ingredients (e.g. ethanol,
xanthine & its derivatives, vitamin A & its derivatives,
cationic surfactants, hydrogen peroxide, propellants,
etc)
53
CPNP - Timeline
 Electronic CPNP portal is operational now
 All product placed on the market 11 July 2013 must be
notified
 CPNP training website:
 https://webgate.acceptance.ec.europa.eu/cpnp
54
Cosmetics Regulation
Chapter
Title
Articles
I
Scope, definitions
1-2
II
Safety, responsible person, free movement
3-9
III
Safety Assessment, product information file, notification
10-13
IV
Restrictions for certain substances
14-17
V
Animal testing
18
VI
Consumer information
19-21
VII
Market surveillance
22-24
VIII
Non-compliance, safeguard clause
25-28
IX
Administrative cooperation
29-30
X
Implementing measures, final provisions
31-40
ANNEXES
I-X
55
Principle of substance regulation
• Arises from principle of “Responsible
Person” and authorities’ in-market control
• The choice of safe ingredients is in the
responsibility of the responsible person
(and his safety assessor).
• For some classes of substances, however, the
legislator has identified the need to
introduce EU-harmonised restrictions 
Annexes of Cos. Reg.
56
Ingredients with specific attention
Colorants, Preservatives, UV-filters  positive list
(Annex IV-VI)
Specific substances of concern : banned /
restricted  negative lists (Annex II - III)
CMR Substances : ban with exceptional
derogations
Hair Colorants : mechanism for future positive
lists
Nanomaterials : special pre-notification regime
57
Regulation of CMR substances
• All CMR (carcinogenic, mutagenic or toxic for
reproduction) are banned when their chemical
hazard classification becomes applicable.
• Exemptions can be granted for all CMRs – based
on certain conditions
• Bans are automatic - exemptions need
implementing act under the Cosmetics Regulation
 Exemption must be completed before the
automatic ban enters into force !
58
Nanomaterials
• Products containing nanomaterials to be notified
– with certain safety information - six months
prior to placing on the market, unless
• they are subject to positive listing (UV filter,
colorant, preservative)
• they already listed in Annex III
• In case of safety concerns  SCCS review &
regulation of the nanomaterial
• Nanomaterials to be labelled in ingredient list
59
Nanomaterials
 Official clarification of nanomaterials definition is
still awaited – may have sectorial definitions
 Cosmetics Regulation definition (Article 2 (k)) –
 Means an insoluble or biopersistant and intentially
manufactured material with one or more external
dimensions, or an internal structure, on the scale from 1
to 100 nm
60
Colipa interpretation - Decision Tree
This is a guide
based on Colipa’s
interpretation of the
Cosmetics
Regulation
“nanomaterial”
definition. It will be
shared with the
Commission as a
starting point for
discussions.
Note: The DG ENVI
Recommendation
specifies “number
%> 50%”.
It has yet to be
determined how
this will impact the
Colipa
interpretation
61
Cosmetics Regulation
Chapter
Title
Articles
I
Scope, definitions
1-2
II
Safety, responsible person, free movement
3-9
III
Safety Assessment, product information file, notification
10-13
IV
Restrictions for certain substances
14-17
V
Animal testing
18
VI
Consumer information
19-21
VII
Market surveillance
22-24
IX
Administrative cooperation
29-30
X
Implementing measures, final provisions
31-40
ANNEXES
I-X
Requirements are basically unchanged compared the 7th Amendment to the Cosmetics
VIII
Non-compliance, safeguard clause
25-28
Directive ...
62
Animal Testing Ban
 Prohibits the performance of animal tests in the EU
to meet the requirements of the Cosmetics
Directive
 Finished products: September 2004
 Ingredients/combinations : March 2009
63
Marketing Ban
 Prohibits the sale cosmetics products, when the
final formulation or ingredients have been
tested on animals - in the EU or outside the EUto meet the requirements of the Directive
 Tests regarding
- acute effects : March 2009
- systemic/repeat dose effects : March 2013
64
Will the 2013 deadline enter into force ?
 European Commission is obliged to carry out an
assessment of scientific difficultiers in 2011
 EC may consequently issue a proposal to change
the legislation
 Scientific assesment and legislative options are
currently under evaluation
 ??????
65
Cosmetics Regulation
Chapter
Title
Articles
I
Scope, definitions
1-2
II
Safety, responsible person, free movement
3-9
III
Safety Assessment, product information file, notification
10-13
IV
Restrictions for certain substances
14-17
V
Animal testing
18
VI
Consumer information
19-21
VII
Market surveillance
22-24
VIII
Non-compliance, safeguard clause
25-28
IX
Administrative cooperation
29-30
X
Implementing measures, final provisions
31-40
ANNEXES
I-X
66
Labelling
 Name & address of responsible person
 Nominal content
 Product durability
 Precautions for use
 Batch number
 Product function
 List of ingredients
67
Ingredient Labeling
 After the word « Ingredients :» using INCI
nomenclature
 Descending order of weight at the time they are
added (below 1% no particular order)
 If product too small, ingredient list on leaflet, or
enclosed label, tape or card.
 Symbol :
68
Not considered as Ingredients
 Impurities in raw materials.
 Subsidiary technical materials used in
the preparation but not in the
finished product.
69
”
Nanomaterial Labelling
Identification of nanomaterials in the
ingredient list
“The names of such ingredients shall
be followed by the word nano in
brackets”
•consumer information
• not a safety information or warning
70
Product durability
 PRODUCTS WITH MIN. DURABILITY ≤
30 Months:
« best used before the end of…. » or
hourglass symbol
 PRODUCTS WITH MIN. DURABILITY >
30 Months:
Period after opening for which the product
can be used without any harm to the
consumer
12 M
71
Art. 20 : Claims
Misleading Advertisement :
... text, names, trade marks, pictures and
figurative or other signs shall not be
used to imply that these products have
characteristics or functions which they
do not have.
72
Art. 20 : Claims
Basic requirements for non-misleading claims
and proof of effect in PIF
European Commission obliged to establish an
action plan :
• priorities for common criteria justifying use of
a claim
• adopt a list of common criteria for claims
• submit to EP and Council a report in 2016
• take appropriate measures to ensure
compliance, if necessary
73
The six Common Criteria
Legal compliance
Truthfulness
Evidence support
Honesty
Fairness
Allow informed decisions
Annex : Best practice for claim substantiation
1.
2.
3.
4.
5.
6.
Second stage: additional criteria for certain
categories/types of claims where common
criteria prove to be insufficient – but no
positive/negative list !
74
Cosmetics Regulation
Chapter
Title
Articles
I
Scope, definitions
1-2
II
Safety, responsible person, free movement
3-9
III
Safety Assessment, product information file, notification
10-13
IV
Restrictions for certain substances
14-17
V
Animal testing
18
VI
Consumer information
19-21
VII
Market surveillance
22-24
VIII
Non-compliance, safeguard clause
25-28
IX
Administrative cooperation
29-30
X
Implementing measures, final provisions
31-40
ANNEXES
I-X
75
Art. 22 : In-market control
Member States to monitor compliance via inmarket controls of the cosmetic products made
available on the market.
 checks of cosmetic products and on the
economic operators
 through P.I.F. and through physical and
laboratory checks
 also monitor compliance with GMP.
76
Art. 23 : Communication of serious
undesirable effects (SUE)
Definition of (serious) undesirable effects (Art. 2)
Obligation for RP and distributors to report to
authorities :
(a) all serious undesirable effects which are
known to him or which may reasonably be
expected to be known to him;
(b) the name of the cosmetic product
concerned, enabling its specific
identification;
(c) the corrective measures taken by him, if
any.
77
Definitions of terms
Undesirable effect
‘undesirable effect’ means an adverse reaction for human
health attributable to the normal or reasonably
foreseeable use of a cosmetic product;
Serious Undesirable Effect
‘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;
78
SUE Notification Requirement
Who
Responsible person and distributor
Where ?
Country where serious undesirable effect occurred
When ?
Without delay (understood as 20 days)
How ?
Harmonised report forms
79
Commission Guidelines on SUE Reporting main elements
 Causality Assessment method
 Scope of notification of SUEs
 Requirements for notification and transmission of
SUEs
 Principles of interaction between the Responsible
Person, Distributor and National Competent Authority
 Transmission of information on SUEs between
Authorities
 Subsequent actions
 by a Responsible Person
 by a Competent Authority
80
Important Consideration
Notification of a SUE does not necessarily
indicate a serious risk or non-compliance of
the product.
RP should be given the opportunity to put
forward his viewpoint before any decision is
taken)
81
Cosmetics Regulation
Chapter
Title
Articles
I
Scope, definitions
1-2
II
Safety, responsible person, free movement
3-9
III
Safety Assessment, product information file, notification
10-13
IV
Restrictions for certain substances
14-17
V
Animal testing
18
VI
Consumer information
19-21
VII
Market surveillance
22-24
VIII
Non-compliance, safeguard clause
25-28
IX
Administrative cooperation
29-30
X
Implementing measures, final provisions
31-40
ANNEXES
I-X
82
Housekeeping and good administrative
practice
• Member States must require corrective measures or
market withdrawal in case of non-compliance .
• Measure must be proportionate to the risk.
• In case of serious risk, the RAPEX information
network is used
• In case of serious risk, member states are allowed to
take unilateral action– subject to subsequent review at
EU level.
• Member States must allow the responsible person to
offer his viewpoint
83
Annex II: Forbidden Substances
List of substances which must not form part of
the composition of cosmetic products
Presence of traces is allowed (§ 17) provided that
it is technially unavoidable under GMP and the
product conforms with the safety requirements
(§3)
84
Annex III: Restricted Substances
List of substances which cosmetic products must not
contain, except subject to restrictions and conditions
laid down
85
Annex IV: Positive List for Colorants
List of the colorants permitted for use in
cosmetics. (Does not yet cover hair coloring
agents).
86
Annex V: Positive List for
Preservatives
List of the preservatives permitted for use
in cosmetics.
Listed with maximum use concentrations
Non-preservative use at higher
concentrations is specified in Annex III
87
Annex VI: Positive List for UV Filters
List of the UV filters permitted for
skin-protection against UV light.
Listed with maximum use
concentrations
88
Annex VII: Symbols for Labelling
89
When will the Regulation become
applicable ?
Regulation 1223/2009, adopted on 30 November 2009, and
published on 22.12.2009, entered into force on the [twentieth day
after its publication in the Official Journal of the European
Union. It shall apply from 11 July 2013, with the exception of
Article 15(1) and (2) which shall apply from 1 December 2010, as
well as Articles 14, 31 and 32 to the extent that they are necessary
to apply Article 15(1) and (2); and Article 16(3) second
subparagraph, which shall apply from11 January 2013.
90
Gradual Handover
 Until January 2010 only the Cosmetics Directive was
applicable.
 As from July 2013 only the Cosmetics Regulation will
be applicable – Cosmetics Directive is repealed
 During the transition, products may be placed on the
market
 complying fully with the cosmetics Directive (only at
the beginning of the transition)
 complying fully with the Regulation
 complying for some provisions with the Regulation and
for others with the Directive
91
Transition Period - Milestones
Cosmetics
Regulation
Cosmetics
Directive
Dec. 2009
Regulation
in force
Products
may follow
Regulation
instead of
Directive
Dec. 2010
CMR
provisions
applicable
Jan 2012
CPNP
Notification
possible
2012
Criteria for
claims
published
Jan 2013
Nanonotification
mandatory
Jul 2013
Regulation
exclusively
applicable
2016
Report to EP
on compliance
with claims
criteria
92
Changes to the Cosmetics
Regulation

MODIFICATIONS OF THE ARTICLES
 changes to the basis philosophy
 far-reaching and long-term implications
AMENDMENT

MODIFICATION OF THE TECHNICAL ANNEXES
 regular process to take into account recent scientific
findings
ADAPTATION TO TECHNICAL
PROGRESS (ATP)
93
Thank you for your attention !
94