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

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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

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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

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• 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

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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.

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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.

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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.

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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

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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

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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