EC 1223/2009 Regulation

Mrs. Sandra Ferretti – Obelis s.a. C.C.O.

Colombia 2013

© Obelis s.a. 2013

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 Presentation Overview

• Definitions

• European legislation on cosmetic products

• European regulation main requirements

• Recap

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 Definitions (1)

• Directive
o Legislative document issued by the European Parliament
o It gives a direction

• Regulation
o Legislative document issued by the European Parliament
o Law, rule

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 Definitions (2)

• Cosmetic products (art. 1a, 1223/2009/EC)

“means 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
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 odors”

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 Definitions (3)

• A cosmetic product is defined by

o Product full commercial name (e.g., Nivea, L’Oreal…)
o Qualitative and quantitative composition (i.e., formulation)
o Claim / intend of use (i.e., what does it do?)

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 Definitions (4)

• Responsible Person (RP)

o EU resident !
o Assigned to be the representative of a manufacturer’s cosmetic products in front of the
EU authorities, users and any other 3rd parties
 Requirement by the law under the directive (art 7a, 76/768/EEC) & the regulation (art. 4, 1223/2009/EC) ! !

• Safety Assessment report (SA report / Toxicological Assessment report)

o Safety evaluation of a cosmetic product, not a test !

o To be completed by a Safety Assessor (specific profile of this entity !, art. 10.2, 1223/2009/EC)

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 Definitions (5)

• Notification
o One way action, from the RP to the Authorities

 i.e., the authorities are not obliged to confirm the notification

o Requirement by the European legislation on cosmetic products (directive & regulation)

• Product Information File (PIF)

o All safety information concerning 1 cosmetic product
o Any cosmetic product commercialized in the EU must have a PIF

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 Definitions (6)

• Producer (OEM = Original Equipment Manufacturer)

o The one who is making the product

• Manufacturer (OBL = Own Brand Labeler)

o The one rebranding the product under his own brand name

o “means any natural or legal person who manufactures a cosmetic product or has such a

product designed or manufacture, and markets that cosmetic product under his name or
trademark” (art. 1d, 1223/2009/EC)

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 Definitions (7)

• Importer
o The one importing products from outside EU into the EU territory

o “means any natural or legal person established within the Community, who places a

cosmetic product from a third country on the Community market” (art. 1i, 1223/2009/EC)

 “placing on the market means the first making available of a cosmetic product on the Community
market” (art. 1h, 1223/2009/EC)

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 Definitions (8)

• Distributor
o The one commercializing the product within a EU member state

o “means any natural or legal person in the supply chain, other than the manufacturer or

the importer, who makes a cosmetic product available on the Community market” (art. 1e,
1223/2009/EC)

 “making available on the market means any supply of a cosmetic product for distribution,
consumption or use on the Community market in the course of a commercial activity, whether in
return for payment or free or charge” (art. 1g, 1223/2009/EC)

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 European legislation on cosmetic products (1)

• Principle

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 European legislation on cosmetic products (2)

• Directive 76/768/EEC
o Cosmetic products directive in the EU
o Published in 1976 !
o Implemented by all 27 EU member states => 27 slightly different versions
 Followed, generally accepted by the 4 EFTA countries (Norway, Switzerland, Liechtenstein, Iceland)

o National notification
 Each member state has its own system / requirements
 E.g., product notified in France
 Can it be commercialized elsewhere in the EU?

o Will be abolished on July 11th, 2013 ! ! !

 E.g., product notified in Germany in 2008
 Can it be commercialized in Germany on July 12th, 2013?

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 European legislation on cosmetic products (3)

• Regulation 1223/2009/EC
o Cosmetic products regulation in the EU
o Published in November 2009 !
o In implementation process by all 27 EU member states => 1 single law in EU on
cosmetics
o Centralized notification
 CPNP = Cosmetic Products Notifications Portal
 Open since January 12th, 2012
 1 notification for the whole EU
o Currently applicable but will come into full force on July 11th, 2013 ! ! !
 E.g., product notified in the CPNP in March 2012
 Can it be commercialized in Italy on July 12th, 2013?
 What about Portugal?

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 Examples of relevant regulations
• REACh 1907/2006/EC Regulation – Registration, Evaluation, Authorization and Restriction
of Chemicals
o Regulation on chemicals and their safe use
o Relevant when
 Formulating – to ensure that the ingredients are safe (CMRs, restrictions…)
 Labeling requirements given the restrictions of substances

• CLP 1272/2008/EC Regulation – Classification, Labeling and Packaging

o Regulation aligning the EU systems of classification, labeling, and packaging of chemical
substances

• Aerosol Dispensers Directive 75/324/EEC

o Aerosol dispensers compliancy requirements including testing and labeling

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 Examples of relevant guidance documents
• SCCS opinions – Scientific Committee on Consumer Safety
o Adopted in the annexes of the directive/regulation
o Notes of guidance on ingredients, tests protocols… e.g.,
 SCCS 8th revision for the testing of cosmetic substances (finished product pathogens to be measured)
 SCCS 1459/11 on fragrances and allergens – new restrictions

• ISO standards
o Guidance documents on testing, products’ safety evaluation, requirements… e.g.,
 ISO 22716:2007 (Good Manufacturing Practices)
 ISO 10130:2009 (Cosmetics -- Analytical methods -- Nitrosamines: Detection and determination of N-
nitrosodiethanolamine (NDELA) in cosmetics by HPLC, post-column photolysis and derivatization)
 ISO 11930:2012 (Cosmetics -- Microbiology -- Evaluation of the antimicrobial protection of a cosmetic product)
 ISO 24444:2012 (Cosmetics -- Sun protection test methods -- In vivo determination of the sun protection
factor (SPF))

 …
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 Today
• Transitional period

o Period between the publication of the new Regulation (November 2009) and the abolition

of the Directive (July 2013)

o Both laws are applicable => products may be compliant with the Directive or with the

Regulation

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 European legislation on cosmetic products
• Why the Regulation?

Directive Regulation
Product Information File
Safety Assessment report
Pre market notification
27 laws 1 law
National notification
Centralized notification (CPNP)
Clearer defined RP concept
Clearer defined responsibilities of the RP
More requirements

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 To remember !

July 11th, 2013

Regulation 1223/2009/EC Directive 76/768/EEC

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European regulation main requirements (1)

Note !!!

o Compliance with the EU requirements prior commercialization (art. 13)

o E.g., if product X is on the market

 Automatically is assumed to be compliant with the EU requirements !
 Responsible Person appointed
 Complete and compliant Product Information File
 Notification in the CPNP

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 European regulation main requirements (2)

A. Appoint European Responsible Person (art. 4)

o “Only cosmetic products for which a legal or natural person is designated within the

Community as ‘responsible person’ shall be placed on the market” (art. 4.1.)

 The RP is appointed per product not manufacturer

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 European regulation main requirements (3)

B. Product Information File (art. 11)

1. Description of the cosmetic products  Producer !!!

2. Cosmetic product safety report (CPSR) = Annex I
 Part A: Safety information
 Part B: Safety Assessment report
 Based on Part A
 Completed by a Safety Assessor !
3. Description of the method of manufacture  Producer !!!
4. Good Manufacturing Practice (GMP) compliance  Producer !!!
 ISO 22716:2007
5. Proof of effect claimed  producer / manufacturer !!!
6. Data on animal testing  up to the manufacturer to check !!!

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 European regulation main requirements (4)

• Main elements of the Safety Information (Annex I, Part A, 1223/2009/EC)

Information Keeper (usually)

1. Formula (exact quantitative & qualitative information !!!) Producer

2. Raw material physico-chemical, toxicological & microbiological

Raw material supplier
information (why not necessarily the MSDS ???)

3. Finished product physico-chemical & microbiological specifications Producer

4. Finished product tests

• Stability test (usually 3 months) Producer /
• Compatibility test (usually 3 months) Manufacturer
• Challenge test (usually 1 month)
• Patch test !

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 European regulation main requirements (5)

• Main elements of the Safety Information

Information Keeper (usually)

5. Packaging specifications Packaging supplier

6. Instructions for use and warnings Producer / SA

7. Exposure to the cosmetic product Producer / SA

Producer /
8. Undesirable effects and serious undesirable effects
manufacturer

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 European regulation main requirements (6)

• Claims
o A cosmetic product

 “means 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 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 odors” (art. 1a, 1223/2009/EC)

o Claims must be supported by proof

 “shall not be used to imply that these products [which were established to be cosmetics] have
characteristics or functions which they do not have” (art. 20.1)

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European regulation main requirements (7)

Free of preservatives perfume Whitening tooth paste !

Killing bacteria soap Helping circulation foot care cream

Anti-wrinkle cream Prevents formation of cellulite

24 hours sun protection lotion ! Use with injuries

Anti-dandruff shampoo Combats excessive body odor

Cream helping problematic skin !

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 European regulation main requirements (8)

• Claims
o Natural / Bio / Organic = implies that the raw materials were produced following specific

rules & regulations

o When to claim natural / bio / organic

 Different organizations across Europe  Different interpretations

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 European regulation main requirements (9)

• Claims

ECOCERT Natural & Organic Natural

• minimum of 95% of all • minimum of 50% of all

plant-based ingredients in
the formula &
• minimum of 10% of all
ingredients by weight must
come from organic farming.
plant-based ingredients in the
formula &
• minimum of 5% of all
ingredients by weight must
come from organic farming.

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 European regulation main requirements (10)

• Claims

NaTrue Natural Natural with organic Organic

portion
• ingredients must • at least 70% of natural
be natural but they ingredients must stem from
do not have to be controlled
organic organic production and/or
controlled wild collection.
• at least 95 % of natural
ingredients must come
from controlled organic
cultivation and/or
controlled wild collection

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 European regulation main requirements (11)

C. Notification (art. 13)

o To be completed

 To the CPNP

 By the RP

 When the product is compliant

o 1 notification for the whole EU

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 European regulation main requirements (12)

C. Notification (art. 13)

o Who has access to the CPNP

 Responsible Person – to notify

 Only to the files he notified

 Distributor – to notify labels if brought changes (after July 11th 2013)

 Only to the names of the products based on search

 Competent Authorities & Anti-toxic centers

 All information except drafts!

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 Recap (1)

Any substance 1 Cosmetic product

2 Placed in contact with the

or mixture external parts of the human

exclusively
3 & body + teeth + mucous
mainly
membranes of the oral
cavity
1. Cleaning,
2. Perfuming,
3. Changing appearance,
4. Protecting,
5. Keeping in good condition,
6. Correcting body odors

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 Recap (2)

• European laws on cosmetics

o Directive 76/768/EEC = will be abolished on July 11th, 2013

o Regulation 1223/2009/EC = will fully replace the directive on July 11th, 2013

• Principle  Safety

• Compliance with the European requirements prior commercialization

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 Recap (3)

I. Only cosmetic products for which a legal or natural person is designated within the Community as ‘responsible person’
shall be placed on the market (Article 4.1.).
II. For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant
obligations set out in this Regulation (Article 4.2.).

Regulatory
Hand Cream EU RP obligations Hand Cream
appointment (PIF, notification)
EU RP: Name &
1 2 Address

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 Note
• Speed of the notification process depends on:

o RP knowledge, professionalism, capabilities

o the speed of collecting the correct information

o raw material suppliers / packaging suppliers / producers choice

• Producer GMP compliancy (ISO 22716:2007) is a EU requirement

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Thank you for your attention !

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