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TRANSCRIPT
Lima June 2011
Brian Lightfoot,
Colipa
European Legal Framework &
Cosmetics Legislation
Lima June 2011
Content of Presentation
Who is Colipa ?
1) The European Union: legislation making process
2) Introduction to the EU Cosmetic Directive 76/768
3) The Recast : EU Cosmetics Directive vs. EU
Cosmetics Regulation
4) Key points for the implementation of the EU
Cosmetics Regulation
Lima June 2011
Content of Presentation
1) Who is Colipa ?
2) The European Union: legislation making process
3) Introduction to the EU Cosmetic Directive 76/768
4) The Recast : EU Cosmetics Directive vs. EU
Cosmetics Regulation
5) Key points for the implementation of the EU
Cosmetics Regulation
Colipa has been the voice of Europe’s cosmetics industry
since 1962.
As the industry’s European trade association, Colipa’s
membership consists of:
• Major international companies
• EU national cosmetic associations
• Supporting association members
• Corresponding members
Who is Colipa ?
Active Corporate Members
KPC Slovenia
KTF Sweden
KOZMOS Hungary
LIKOCHEMA Lithuania
NCV The Netherlands
PSVAK Greece
RUCODEM Romania
SKW Switzerland
SPT Denmark
STANPA Spain
Slovak Association for
Branded Products Slovakia
TY Finland
UNIPRO Italy
AIC Portugal
Association of Latvian Chemical
& Pharmaceutical Industry Latvia
BNAEOPC Bulgaria
CSZV Czech Republic
CTPA UK
DETIC Belgium
FCIO Austria
FEBEA France
Federation of Estonian
Chemical Industries Estonian
ICDA Ireland
IKW Germany
KLF Norway
Active Association Members
Main roles
• The Voice of the cosmetic industry in Europe.
• The Center of scientific and legal expertise of the European
cosmetic industry.
• The Coordinatoor of activities of national associations
across Europe.
• The Interlocutor with the EU institutions (Commission,
Council, Parliament).
• The Interlocutor with other industry and authorities from
other parts of the world.
• The Developer of joint strategies and actions on behalf of
the European cosmetic industry.
BRAZIL
ABIHPEC– Associaçao Brasileira da Industria
de Higiene Pessoal, Perfumariae Cosméticos
AUSTRALIA
ACCORD – Australasia
SOUTH AFRICA
CTFA S/A - Cosmetic, Toiletry &
Fragrance Association of
South Africa
RUSSIA
- APCoHM-Association of Perfumery,
Cosmetics & Household Chemistry
Manufacturers
- PCAR - Perfumery and Cosmetics
Association of Russia
TURKEY
C.T.I.A. - Cosmetics and Toiletries
Industry Association
SERBIA
ADCPI - Association of
Detergents and Cosmetics
Producers and Importers
Japan
JCIA
China
EUCCC
International Collaboration
Korea
EUCCK
Canada
CCTFA
US
PCPC
CASIC-Consejo de
Asociociones de la Industria
de Cosmeticos
LatinoAmericana
ASEAN
ACA
Colipa Website : www.colipa.eu
Lima June 2011
Content of Presentation
1) Who is Colipa ?
2) The European Union: legislation making process
3) Introduction to the EU Cosmetic Directive 76/768
4) The Recast : EU Cosmetics Directive vs. EU
Cosmetics Regulation
5) Key points for the implementation of the EU
Cosmetics Regulation
The European Union
• Economic and political union of 27 Member States
• Over 500 million citizens, 21 % of Global GDP
• Single market through a standardised system of laws
which apply in all member states
• Free movement of people, goods, services, and
capital
• Legal personality, able to conclude treaties
The EU Institutions
European Council (EU Summit)
European Council (Ministers from Member
States+ European Commissioner
European Parliament European Commission
Roles and actions of EU Institutions
How is the EU cosmetics legislation passed?
The Commission proposes
The European Parliament and the
Council of Ministers co-decide
The Commission oversees implementation
The European Court of Justice rules
where necessary
European Commission
promoting the common interest
27 independent members,
one from each EU country
Proposes new legislation
Executive organ
Guardian of the treaties
Represents the EU on the international stage
European Parliament voice of the people
• Decides EU laws and budget together with the
Council of Ministers
• Democratic supervision of all the EU’s work
• Members of EP directly elected by the EU population
• Various groupings and alliances based on political
party, nationality, regional interests
Council of Ministers Voice of the Member States
• One minister from each EU Member States
• Presidency: rotates every six months
• Decides EU laws and budget together with the
Parliament
• Manages the common foreign and security policy
Types of EU Legislation: Binding
• Regulation : directly applicable to operators and/or
authorities
• Directive : requires Member States to achieve a
particular result without dictating the means; needs
transposition to national legislation
• Decision : has direct effect, but only relating to a
specific person / entity
Types of EU Legislation: Non-binding
• Recommendation : without legal force but negotiated
and voted by stakeholders, can create presumption
of conformity
e.g. Harmonised Standard (CEN), EC Guidelines
• Communication : reference document
• Resolution : agreement on policy direction – does not
in itself create specific requirements for operators
• Ensure safety and innovation
• Ensure a competitive economy
• Demonstrate a responsive attitude to the citizen
• Work in a transparent fashion
• Address “the right to know”
Key Common Drivers for Regulators
Work in a transparent fashion
an exemple: Ad-Hoc Working Party
• European Commission
• Competent authorities of 27 EU Member States
(representation is decided at national level)
• Competent authorities of European Economic Area
(e.g. Switzerland, Norway)
• Cosmetics Industry, including suppliers
• EU consumer organisation representative (e.g. BEUC)
• Animal welfare organisation representatives (e.g. Eurogroup)
Lima June 2011
Content of Presentation
1) Who is Colipa ?
2) The European Union: Decision making process
3) Introduction to EU Cosmetics Directive 76/768
4) The Recast : EU Cosmetics Directive vs. EU
Cosmetics Regulation 1223/2009
5) Key points for the implementation of the EU
Cosmetics Regulation
The Cosmetics Directive 76/768/EEC
Articles 1 to 15
Definition of cosmetic
Safety and labelling requirements
Product information requirement
Ban on Animal testing
Annexes II to VI
Positive and negative lists of specifically regulated
substances
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Closer l The Cosmetics Directive 76/768/EEC
34 years of European Cosmetics Directive :
1 core text
+ 7 amendments
+ >40 technical adaptations
= a patchwork
although a well established one …
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1976 – 2013 : EU Cosmetics Directive
EU Member States have to implement it in their national
laws:
Slow process, sometimes not perfect
From 2013 : EU Cosmetics Regulation
Single piece of legislation instantly and directly enforced
across the whole territory of the EU.
Better harmonisation across the 27 EU Member States
Directive vs. Regulation
The « Recast »
The Aim
of the Cosmetics Directive and of the Recast
All 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.
The Basic Philosophy
of the Cosmetics Directive and of the Recast
• Product must be safe
• Safety must be demonstrated
• Adequate and non-misleading information must be given to
consumers to ensure a safe use
• No pre-market registration or certification of products:
all products meeting the requirements should have equal and
immediate access to the market
• Simple notification to relevant Member States prior to placing on the
market
• Post-market control of compliance by Member States authorities
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The “Recast”
No changes
to the fundamental approach and principles
of the Cosmetics Directive
Lima June 2011
the “Recast”
• No change in scope or definition of a Cosmetic Product
• Codifies the existing understanding through explicit
definitions :
• Substance, mixture
• Making available, placing on the market
• Responsible person, Manufacturer, importer, distributor
• Undesirable effect, serious undesirable effect
• Technical definitions (e.g. UV filters, preservative, colorant,
nanomaterial, hair products …)
Lima June 2011
Article 2: Definitions
1.(a) ”A cosmetic product shall mean 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 cleaning them, perfuming them, changing their
appearance, protecting them, keeping them in good
condition or correcting body odours”
Lima June 2011
Article 2: Definitions
1.(d) ”Manufacturer means any natural or legal person who
manufactures a cosmetic product or has such a product
designed or manufactured AND markets that cosmetic
product under his name or trademark
1.(e) “Distributor means any natural or legal person in the
supply chain , other than the manufacturer or importer, who
makes a cosmetic product available on the Community
market”
1.(f) “Importer means any natural or legal person established
within the Community, who places a cosmetic product from
a third country on the Community market”
Lima June 2011
Article 3: Responsible Person
Only cosmetic products for which a legal or natural person
is designated within the Community as “responsible
person” shall beplaced on the market.
The responsible person shall ensure compliance with
the relevant obligations set out in this Regulation.
The responsible person can be the manufacturer or the
importer, a person designated by the manufacturer or the
importer by written mandate, established within the
Community
Lima June 2011
The “Recast”
• No change in requirement for a high level of safety
• Responsibility for regulatory compliance and safety in
the hand of the “Responsible Person”
• Some responsibility for correctness of labelling is
explicitly allocated to the distributor
• Single centralized notification
• Role of Member States in post-market control is
strengthened
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Notification to Member States Competent Authorities Scope, Format, Content >> different from one Member State to another
Notification to Poison Centres
>> at discretion of Member States
Unharmonised & multiple notifications throughout EU
Product Notification
Current Obligations under the Directive
Lima June 2011
Product Notification
Changes introduced in the “Recast”
New notification requirements to facilitate in-market
control and post marketing surveillance :
• Notification of Serious Undesirable Effects linked to
the use of the product
• Notification of all products at first placing on the
market
- One electronic European notification portal
- includes notification of frame formulations to poison
control centres
Notification is not a product Registration !
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Establishes a harmonised EU System
- Central notification at European Commission level
- Notification required for new products and existing
products still being placed on the market
- Obligations for the Responsible person and
(sometimes) for distributors
Product Notification
New obligations under the « Recast »
4
Lima June 2011
Product Notification
What will be notified – and to whom ?
Product category
Product name(s)
Responsible person - name and address
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
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Lima June 2011
Notification timeline: Transition Period
24 months
Continued national notification
requirements under Cosmetics
Directive
18 months
Possibility to use EU central
notification under the new
Regulation on both, new and
existing products.
Use of EU system exempts
from national requirements
under the Cosmetics Directive
11 July 2013 11 January 2012
11 January 2010
The “Recast” entered
into force
13
New notification
requirement for new
products
Obligation that all existing
products are notified in the
new EU system
Obligation to notify all
new products in the
new EU system
Obligation for distributors
when translating labelling
or reintroducing products
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Stakeholder group with European Commission,
Industry, Authorities and Poison Control Centers Issues being worked on:
Categorisation of cosmetics products
EU wide Frame Formulation system
IT database
Product Notification
Practical Implementation
5
Lima June 2011
A product can be made up from:
• One component (e.g. cream, shampoo …)
• Several components possibly used separately (e.g.
make-up palettes)
• A collection of components intended to be used as a mix
or sequentially (e.g. hair colouring kit, skin peeling kit,
permanent styling product)
• A range of products, as described above, that are only
differentiated by colour shade, smell or strength
(can be notified under one notification)
Building the IT Data Model
for the EU Notification Portal and Database
14
40
Examples of scenarios by increasing complexity
4) Kit products
Hair colour
2) Shaded /fragrance variant products
Professional Hair colour
Lipstick
3) Composite products
Eye Shadow Palette lips, eyes, cheeks
Plus the additional complexity of multilingual names
1) Simple product
Skincare gift sets
Shampoo Cream
1a)
1b)
16
Lima June 2011
Some principles for the datamodel
One notification is linked to one cosmetic product
One cosmetic product is linked to one product
information file
One product covered in one product information file may
be comprised of several components
One product information file may, in some cases, be
linked to several variants (e.g: shades, smells, etc.)
One notification maybe comprise of several
components (e.g. oxidative hair dye) and several
variants (e.g: shades, smells, etc.)
15
The Cosmetics Directive
Article 4 : Prohibited Products
Products containing ingredients not in compliance with
the Annexes of the Cosmetics Directive (positive,
negative lists of substances).
Products tested on animals / containing ingredients
tested on animals (linked to certain deadlines)
Requirement for Commission to ban substances
classified as CMR under the EU Chemical Legislation
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Substances under the “Recast”
• The current “spirit” works well, no changes to the
principle of positive/negative lists
• Specific regulatory attention to:
- Ban of CMR Substances : exceptional derogations
- Hair Colorants : mechanism for future positive lists
- Nanomaterials : special pre-notification regime
« 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. »
Some important elements:
- soluble vs. insoluble
- intentionally manufactured
- Internal, external structure
Scientific definition vs. Regulatory definition
Nanomaterials: definition
Products containing nanomaterials need to be notified 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
Notification has to include specifications & safety information
on the nanomaterial
In case of safety concerns SCCS review & regulation of
the nanomaterial
Nanomaterials: Pre-notification
Nanomaterials: Pre-notification
The Commission is unlikely to take a favourable decision
on a pre-notification without consulting the scientific
committee (SCCS).
The Colipa believes that submission of an abbreviated
safety dossier will be of no benefit.
Discussions with the Commission are ongoing on practical
aspects, especially on the efficient “re-use” of already
submitted nanomaterial information for similar products
The Cosmetics Directive
Article 6 : Information to consumers
- Company name and address
- Nominal Content
- Date of minimum durability (where relevant)
- Precautions of use (where relevant)
- Batch number
- Product function (unless it is clear from the presentation of the
product)
- List of Ingredients (INCI)
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Labelling under the “Recast”
INCI remains the basis for ingredient labelling
The EU Inventory of INCI names is replaced by a
simpler “Glossary”.
Glossary will be updated more frequently than the
existing Inventory
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Labelling:
Changes introduced in the “Recast”
“Best used before” date
Possibility to use a symbol (hourglass)
Nanolabelling
Identification of nanomaterials in the ingredient list
The names of such ingredients shall be followed by the
word “nano” in brackets
= consumer information
safety information or warning
The Cosmetic Directive
Claims
“Member States shall take all measures necessary to
ensure that, in labelling, putting up for sale and
advertising of cosmetic products, text, names, trade
marks, pictures and figurative or other signs are not
used used to imply that these products have
characteristics which they do not have."
Lima June 2011
Claims:
Changes introduced in the “Recast”
The European Commission obliged to establish an action
plan on claims:
• fix priorities for common criteria justifying the use of a
claim.
• adopt a list of common criteria for claims
• submit to EP and Council a report (2016) regarding
the use of claims
• take appropriate measures to ensure compliance in
cooperation with the Member States, if necessary
The Cosmetic Directive
Article 7a : Product Information
The manufacturer or his agent or the person to whose
order a cosmetic product is manufactured or the person
responsible for placing an imported cosmetic product on
the Community market shall for control purposes keep
the following information readily accessible to the
competent authorities of the Member State concerned at
the address specified on the label in accordance with
Article 6.1.a : …
a) Qualitative & Quantitative Composition
b) Physico-Chemical & Microbiological Specifications
c) Method of manufacturing (complying with GMP)
d) Safety Assessment
e) Name & Address of the Safety Assessor
f) Dara on undesirable effects
g) Proof of the effect claimed, where justified
h) Data on animal testing
The Cosmetics Directive
Article 7a : Product Information
Lima June 2011
Product Information
Changes introduced in the “Recast”
• The concept and general content of the product
information are maintained
• Public availability of certain information is confirmed
However:
• More explicit requirements with regard to content & format
• All safety-related product information (including safety
assessment) combined in a « Cosmetic Safety Report »
• Minimum qualifications of safety assessor are clearerly
defined
Cosmetic Product Safety Report
Part A - Cosmetic Product Safety Information
Part B - Cosmetic Product Safety Assessment
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 forseeable use
Exposure to the cosmetic product
Undesirable effects and serious undesirable effects
Exposure to the substance
Toxicological profile of the
substances
Information on the cosmetic product
Assessment conclusion
Reasoning
Labelled warnings and instructions of use
Assessor’s credentials and approval of part B
Description of the
cosmetic product
Manufacturing method
Statement on GMP
If necessary proof of efficacy
List of animal tests
Product Information File
The Cosmetics Directive 76/768/EEC
Positive & negative lists of specifically regulated ingredients
Annex II : Forbidden substances
Annex III : Restricted substances
Annex IV : Colouring agents
Annex VI : Preservatives
Annex VII : UV filters
The Cosmetics Directive
Annex II: Forbidden Substances
List of substances which must not form part of the
composition of cosmetic products
The presence of traces is allowed provided that it is
technically unavoidable under GMP and the product
conforms with the safety requirements.
The Cosmetics Directive
Annex III: Restricted Substances
List of substances which cosmetic products must not
contain, except subject to restrictions and conditions laid
down.
Part 1 : definitive list
Part 2 : provisional list
The Cosmetics Directive
Annex IV: Positive list of colouring agents
List of colorants allowed for use in cosmetic products.
Does not cover hair coloring agents
Classified in 4 categories subject to different use restrictions.
Part 1 : definitive list
Part 2 : provisional list
The Cosmetics Directive
Annex VI: Positive list of preservatives
List of preservatives which cosmetic products may contain.
Listed with maximum use concentrations
Non-preservative use of the substance above the preservative
concentration need to be specified in Annex III
Part 1 : definitive list
Part 2 : provisional list
The Cosmetics Directive
Annex VI: Positive list of UV filters
List of the UV filters which cosmetic products may contains,
for skin-protection against UV light.
Listed with maximum use concentrations
Other UV filters used in cosmetic products solely for the
purpose of protecting the product against UV rays are not
included in this list.
Part 1 : definitive list
Part 2 : provisional list
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Substances under the “Recast”
No fundamental changes
Some editorial changes have been introduced (but also
some mistakes which will be soon corrected...)
Until 2013 the Annexes of the Cosmetics Directive and
of the Cosmetics Regulation will exist in parallel
Lima June 2011
Content of Presentation
Who is Colipa ?
1) The European Union: Legislation making process
2) Introduction to the EU Cosmetic Directive 76/768
3) The Recast : EU Cosmetics Directive vs. EU
Cosmetics Regulation
4) Key points for the implementation of the EU
Cosmetics Regulation
Regulation Implementation
Timeline
Dec 2009 Publication
Jan 2010 Entry into Force
Dec 2010 Exemptions from CMR ban possible
Jan 2012 EU wide product notification possible
Jan 2013 Nanomaterial notification mandatory
Jul 2013 EU wide product notification mandatory
All other requirements fully applicable
Jul 2016 EC report on compliance with criteria for
claims
Lima June 2011
The European Commission has established 4 stakeholder groups
to work on implementation :
1) Notification: frame formulations, cosmetic product categories, IT related
issues (operating since June 2009)
2) Guidelines on Safety Assessment / Cosmetic Safety Report
(operating since March March 2010)
3) Reporting of Serious Undesirable Effects/definition of Serious Risk
(operating since April 2010)
4) Claims: Priorities and Action Plan (operating since May 5th, 2010)
Member States, Colipa and supplier industry associations,
EU-Consumer Groups have nominated participants
Regulation Implementation
“Preventive Dialogue”
Colipa Deliverable
• Colipa package of technical
explanatory and guidance
documents
Indicative timing
By Q1 2011
• Scope, objectives, philosophy
• Roles & responsibilities
• Product composition
• Notification
• Labelling
Indicative timing (2)
By end 2011
• Product Information File
• Claims
• In-market control
Indicative timing (3)
By end 2012
• Manufacturing
• Information to the public
Lima June 2011
Conclusion
The Cosmetic legislation in Europe is a “mature” system
that has developed over 30 years
The change to an EU Cosmetics Regulation is a logical
evolution towards full harmonisation across the EU
Specific requirements have been clarified & codified and
– in some areas – deepened in order to take into
consideration progress in science, technology and EU
regulatory policy
However, the fundamental principles of the EU Cosmetic
legislation remain unchanged
Thank you for your attention !