The new EU Cosmetics
Regulation (EC) N°1223/2009
Impact and challenges for
the industry
Istanbul Cosmetics Seminar,
25 March 2013
2
Content
• General features
• Scope and definitions
• Consumer safety
• Responsible persons/Distributors
• Product Notification
• Claims
• Serious Undesirable Effects
• Nanotechnology
3
In July 2013, the Directive will become a Regulation, instantly
and directly enforced across all EU Member States.
This means harmonisation across Europe
Will also be an important motivation for international alignment
The Legal Process:
From Directive to Regulation
4
Key features of the Regulation
a) One single text
b) Legal instrument of “Regulation” : clear and
detailed rules that are directly applicable –
no room for diverging transposition by
Member States
c) Simplifying procedures and streamlining
terminology
d) Strengthen certain elements, such as in-
market control, to ensure a high level of
protection of human health.
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Transition Period - Milestones
Cosmetics
Directive
Cosmetics
Regulation
Dec. 2009
Regulation in
force
Products may
already follow
the Regulation
instead of
Directive
Dec. 2010
CMR
Carcinogenic,
mutagenic for
reproduction
provisions
applicable
Jan 2012
Cosmetic
Products
Notification
Portal
Notification
possible
Jan 2013
Nano-
notification
mandatory
Jul 2013
Regulation
exclusively
applicable
2012
Criteria for
claims
published
2016
Report to EP
on compliance
with claims
criteria
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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
Structure of the Regulation text
7
Scope and definitions
• No change in scope of legislation - cosmetics,
toiletries and fragrances remain in the same
legal framework
• No confusion with OTC drugs or
pharmaceutical products – no cosmoceuticals
• Secondary, non-cosmetic function and claims
remain permitted
8
Consumer Safety
• Confirmed requirement for a high level of safety –
• Products must be safe under normal and
reasonable foreseeable use
• Clearer provisions on Good Manufacturing Practice,
defining the ISO Standard as the benchmark for
best practice – without making it the only mandatory
• Way to achieve Good Manufacturing Practice
9
• Only cosmetic products for which a ‘responsible
person’ is designated can be placed on the EU
market.
• He is responsible for safety and compliance with
the relevant obligations
• He needs to be a natural or legal person,
established in the EU
• In most instances, this will be the manufacturer or
importer of the product
Central role of the Responsible
Person
10
• Not fundamentally new obligations
• Existing ‘common sense’ responsibilities are
made explicit
• Examples : – Safe handling and storage
– Verification of presence of certain labelling elements (but not
verification of content
– Compliance with language at the point of sale
– Date of minimum durability has not passed
Distributor Duties
11
Challenge for industry
"New" Product Information File (PIF)
required in July 2013 for all existing and
new products
Typical differences that may require
updating :
• Written down reasoning of safety
assessment
• Accessibility of background documentation
12
Product Notification
Major improvement for industry
One central, electronic notification at EU level
CPNP (Cosmetic Products Notification Portal)
Replaces current 20+ national schemes
Obligations for Responsible Person and (sometimes)
for distributors
13
What will happen in 2013 ?
Cosmetic companies and authorities :
• will have to fulfill their obligations (compliance and control) without routine measurement tools being available
• will have to manage non-harmonised interpretation
Cosmetics Europe issued a technical information package which can help companies to technically justify decisions they have taken in this situation
14
Basic requirements remain unchanged for non-
misleading claims and proof of effect
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
Product Claims
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Common Criteria for Claims
1. Legal compliance
2. Truthfulness
3. Evidence support
4. Honesty
5. Fairness
6. Allow informed decisions
EU Regulation : “Common Criteria for Claims” –
Adopted in February – to be published in June
Undesirable effects from cosmetics are generally :
• local ,
• transient,
• successfully addressed by patient self-
management without medical intervention
Concerns arise if the type, severity or frequency of
reactions create a safety signal
Priority is given in the EU to serious undesirable effects - need to be actively reported to the authorities
Cosmetovigilance
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Commission, Member States and Industry developed
guidance and template report forms :
• Causality Assessment method
• Requirements for notification and transmission
• Principles of interaction between the Responsible
Person, Distributor and National Competent Authority
• Subsequent actions by Responsible Person and
Competent Authority
• Pilot study with industry is ongoing
Reporting of Serious
Undesirable Effects
Nanomaterials and
Nanotechnologies in the
Regulation:
19
Nanomaterials in cosmetics
• Many stakeholders in the discussion around
nanomaterials perceive « nano » as a negative
property.
• Often sweeping statements are made about
nanotechnology.
• However, we are in position to give a much more
differentiated picture.
20
Nanomaterials – the most
common concerns
Are nanomaterials used in cosmetics safe?
• Already in the existing Cosmetics Directive and as for any other
cosmetic ingredient, cosmetic manufacturers have to be able to
demonstrate the safety of nanomaterials used in cosmetic products
• The requirements for product safety reports have been
strengthened in the Regulation.
•But also requirements specific to nanomaterials have been
introduced in the legislation.
21
Nanomaterials in cosmetics –
the most common concerns (1)
Products containing nanomaterials need to be notified to the
European Commission six months before being placed on the
market.
Notification to the Commission of cosmetic products containing
nanomaterials ensures that an independent review of the safety
of these products can be performed before they go onto the
market.
22
Nanomaterials in cosmetics –
the most common concerns (2)
But there are exemptions, right?
Correct, but only for products containing nanomaterials that have
to undergo true pre-market authorisation (e.g. UV filters), or that
are already listed on an annex, i.e. have undergone a Scientific
Committee on Consumer Safety review before.
23
Nanomaterials in cosmetics –
the most common concerns (3)
I don’t know: are there nanomaterials in my product?
And which ones are they?
For this reason the nanolabelling has been introduced:
Identification of nanomaterials in the ingredient list on every product
“The names of such ingredients shall be followed by the word nano
in brackets”
NB: = consumer information
safety information, warning or hazard labelling
24
Nanomaterials in cosmetics –
the most common concerns (4)
How do regulators and the public know? They cannot
look at every product.
Every year starting from January 2014, the Commission is required to
prepare a catalogue of nanomaterials used in cosmetic products. This
catalogue will be made publically available and updated regularly.
Furthermore, an annual status report will have to be submitted by the
Commission to the Parliament and Council as of July 2014 informing in
particular about new developments.
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Nanomaterials in cosmetics –
the most common concerns(5)
Would it not be good to still have a nano-specific
notification scheme?
A general product notification scheme (Article 13), which also includes
information about the use of nanomaterials, and a specific nano-
notification scheme (Article 16) are in place for the cosmetic sector.
Any additional (national or EU) notification scheme would only duplicate
these systems and not provide more information.
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Summary
Responsible use of nanomaterials by manufacturers and a
robust regulatory framework allow consumers to fully benefit
from their advantages, while making sure that products are
safe.
Consumers can continue to trust that the EU cosmetics
legislation provides a good basis for the safety of
personal care products in the EU.
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Conclusions
After 37 years, full EU harmonization is achieved
• Principles of EU approach on cosmetics are
confirmed
• Evolution in details but not a fundamental change
in our license to operate
• Practical implementation is of course challenging,
but companies who already followed best practice
are well prepared
• The consolidation of the text makes it clearer and
more accessible
28
Conclusions
• The EU legislation was – and will remain – a
major inspiration for regulators across the globe.
• New Regulation breaks down into regulatory
‘modules’ that are portable into other regulatory
approaches (e.g. notification, Cosmetovigilance,
Cosmetic Safety Report, …)
• Opportunity for step-wise progress on
international convergence