Details of Presentation – Event, Date, Name ……. Further details

Gerald Renner

Cosmetics Europe

CPNP-Electronic Product

Notification

2 Riga – May 2010

1. LEGAL / REGULATORY ASPECTS

3 Riga – May 2010

Situation under the Cosmetics

Directive 76/768/EEC

Unharmonised & multiple notifications throughout

the EU

� Notification to the Competent Authority

�Notification to Poison Centres

4 Riga – May 2010

Situation under the Cosmetics

Regulation (EC) No 1223/2009

Harmonised EU System

� Central notification at European Commission

level

� Notification required for new products and

existing products still on the market

� Responsible person and distributor

obligations

5 Riga – May 2010

Who needs to notify – and to

whom ?

i. Responsible Person - Prior to placing new product on

the market and for existing products

ii. Distributors –When distributor translates the labelling

on his own initiative for sale in another Member State

iii. Responsible Person -When a distributor re-introduces a

product no longer placed on the market by the

responsible person

In all cases :

Notification to central EU portal CPNP

6 Riga – May 2010

What needs to be notified?Responsible Person (RP)

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

Frame formulation

Original labelling (only once)

Photograph of original packaging - if reasonably

legible (only once)

Exis

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new

pro

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cts

7 Riga – May 2010

What needs to be notified?Distributor (when translating the labelling)

� Only required when:

A Distributor places a product which has already been placed on the market by RP in a Member State (MS) & from its own initiative, place it in another (MS) and translate the labelling

� Distributor is required to notify the following information:

� Category of cosmetic product

� Product name in the Member State of dispatch

� Product name in the Member State in which it is made available -enabling its specific identification

� The Member State in which the cosmetic product is made available

� Distributor name and address

� The name and address of the responsible person where the product information file is made readily accessible

8 Riga – May 2010

• Distributor informs the responsible person in which member

state he will make the product available

• Responsible person has to notify to the EC portal like a new

product only if the product has not previously been notified in

this Member State (under the old Cosmetics Directive)

What needs to be notified ?Distributor (re-introducing a product)

Product placed

on the market by RP

under

the Cosmetics Directive

Product no longer

on the market

Product re-introduced by distributor

after implementation date

9 Riga – May 2010

Who has access to the notified

Information?

� 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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10 Riga – May 2010

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 201311 January 2012

11 January 2010

Cosmetics Regulation

entered into force

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

11 Riga – May 2010

2. PRACTICAL ASPECTS

12 Riga – May 2010

What does CPNP understand

as ‘a product’ ?

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

13 Riga – May 2010

Type of cosmetic products - Examples

of scenarios by increasing complexity

4) Kit products

Hair colour

2) Shaded /fragrance variant

products

Professional Hair colour

Lipstick

3) Composite products

Eye ShadowPalette lips, eyes, cheeks

1) Simple product

Skincare gift sets

ShampooCream

1a)

1b)

14 Riga – May 2010

Some guiding principles

• One notification is linked to one cosmetic product

• One cosmetic product is linked to one PIF

• One product covered in one PIF 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 product can occur in various pack sizes

� One notification maybe comprise

�several components (e.g. oxidative hair dye)

�several variants (e.g: shades, smells, etc.)

�several pack sizes

15 Riga – May 2010

� Sets that group together a number of products, each of

which are also sold separately:

� cannot be notified under one notification.

� each product needs to be notified separately

� However, multi-component products (e.g. permanent

hair dyes) for which the components are not sold

individually:

� have to be notified as under one notification

Sets & Kits

16 Riga – May 2010

What needs to be notified?Responsible Person (RP)

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

Frame formulation

Original labelling (only once)

Photograph of original packaging - if reasonably

legible (only once)

Exis

tin

g &

new

pro

du

cts

17 Riga – May 2010

1. Product Category

Categorisation

• 4 Level 1

• 22 Level 2

• 82 Level 3

18 Riga – May 2010

2. Product Name(s)

• Cosmetic name or names, enabling its specific

identification“ � i.e. enabling the differentiation of products

of the same product line

• If the same product is on the market under different

(translated) names, all names in the different languages

have to be notified

• Industry interpretation:

Information on the side or back of the packaging (e.g.

translated product function) should only be considered as

part of the product name if it is indispensible for the

unique identification of the product.

19 Riga – May 2010

3. & 4. Responsible Person and

Contact Person

• Responsible Person : filled out automatically by

CPNP

• Contact person details to contact in case

necessity• Name

• Address

• contact numbers

• Could be a person or a department

• This is not an emergency contact ! No need to

have a tox expert on standby 24/7 who is able

to speak in all 21 EU languages.

20 Riga – May 2010

5. Country of Origin

• For imported products only

• If the same product is being “made in”

in two or more countries ---> the

system currently requires separate

notifications

21 Riga – May 2010

6. Member State where product

is placed on the market

• One-off action

• Only one country needs to be identified, i.e. the

country of first making available

• If a product is placed simultaneously in several

countries (or is already on the market in July 2013)

� company choice of one Member State

• CPNP is not meant to be a product distribution

database !

22 Riga – May 2010

7. Nanomaterial

• Identification

� Name - INCI

� CAS number

� EC Number (EINECS or ELINCS)

� IUPAC Name

� INN

� XAN

• Exposure type : Rinse off/ Leave on

• Exposure route

� Oral

� Dermal

� Inhalation

23 Riga – May 2010

8. CMR (1A or 1B)

� Definition: Substances classified under chemical legislation as:

�Carcinogenic

�Mutagenic

�Reprotoxic

� Identification only

�Name, CAS #

�Only the CMR from “harmonised” classification

(Annex VI of Regulation on Classification and

labelling CLP)

24 Riga – May 2010

9. Frame Formulations

• Cosmetics Europe collaborated closely with

European Association of Poison Control Centres

• Starting Point : SYSDECOS, version 2000

• Frame formulations consist of

– lists of category / function of certain ingredients and

their maximum concentration in the cosmetic product

– Additional indication of specific substances with exact

concentration (high concern for poison centres)

• Alternatively : notification of Exact Formula or

Concentration Ranges

25 Riga – May 2010

10. Original Labelling

A one-off operation

Label:

• refers to a copy of the artwork of the outer packaging of the

product if there is a primary container and an outer

packaging….

• otherwise it is the artwork of the primary container”

Original:

• “refers to the first language / country version of the product

that was placed on the market …

• If the product was simultaneously launched in several

countries, you can chose which version you notify”

26 Riga – May 2010

11. Photograph of Packaging

A one-off operation

Photograph of packaging - if reasonably legible

� “Refers to a photograph of the outer packaging of the

product if there is a primary container and an outer

packaging

� Otherwise it is the photograph of the primary container”

Industry Interpretation:

“The photograph is in principle only necessary if it is legible

and provides more relevant information than the artwork”

27 Riga – May 2010

The logic behind the CPNP PortalPart I General Information

28 Riga – May 2010

The logic behind the CPNP PortalPart II Product Details – CMR & Nanomaterial

29 Riga – May 2010

Level 1 Level 2 Level 3

CPNP Relevant pre-selection OR "Other".

In this case the user specifies the formula/function

in a relevant manner

and CPNP triggers full formula notification

List of physical form of product

a it leaves the container :

* solid / pressed powder

* loose powder

* cream/paste/gel

* Liquid/

*Foam

* Spray

* Other

Physical Form

‘Frame’ Formulation

Name

List of all possible

FF Names

The logic behind the CPNP Portal

Part II Product Details

Category & Frame Formulation (1)

Product Categorisation

30 Riga – May 2010

The logic behind the CPNP Portal

Part II Product Details – Category & Frame

Formulation (2)

Is the product presented

in a special applicator/packaging?

YES / NO

IF “YES”

Chose the specific

applicators/packaging

List of specific

applicators/packaging

Wipe / Sponge / Patch / Pad

Capsule

Pressurised Spray Container

Other

31 Riga – May 2010

The logic behind the CPNP Portal

Part II Product Details – Category & Frame

Formulation (3)

Notification by:

1)Predefined FF

2)Concentration range

3)Exact Concentration

If “1”

FF Number

CPNP: automatically selects the

correct FF number

( From the product category)

List of FF Numbers

If “3”

Full Formula

Depending on the Product

Category, the system asks you

the exact concentration

of specific ingredients of

concern to Poison Centers

CPNP

Filter

Input or attach

Formula with

concentration

ranges

If “2”

Concentration

range

Depending on the Product

Category, the system asks you

the exact concentration

of specific ingredients of

concern to Poison Centers

CPNP

Filter

Input or attach

foormula with

exact

concentration

32 Riga – May 2010

The logic behind the CPNP PortalPart II Product Details – Original Packaging &

Labelling

33 Riga – May 2010

3. LET’S TRY IT OUT IN PRACTICE

https://webgate.acceptance.ec.europa.e

u/cpnp

34 Riga – May 2010

4. SOME OPEN QUESTIONS

35 Riga – May 2010

Open questions

• Availability of CPNP manual in all EU languages

� promised for Q2 2012, including manual for account

management (initial login, creation of suborganisations)

• Possibility for electronic ‘machine-to-machine’

upload

� testing phase foreseen for October 2012

�Needs a lot of IT work on the side of the notifyier to ensure

the data are generated in 100% accurate format for CPNP

� Investment probably only worth in case of very large

• Data security and liability for data leakage at the

level of CPNP (EU) and/or Member States (local)

and/or Poison Centers (local)

36 Riga – May 2010

THANK YOU VERY MUCH FOR YOUR

ATTENTION !

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