1. 21.2.2013 Mr. Doram Elkayam – Obelis s.a. Chief Operations Officer
Webinar Update on European Union Regulations for Cosmetics and Beauty Products
Mr. Doram Elkayam – Obelis s.a. Chief Operations Officer

2. Regulatory Framework Cosmetics 1223/2009/EC

3. Introduction (1) 1223/2009/EC 30 November 2009 – 11 March 2013
1223 – reference number
2009 – year of publication
EC – European Community
30 November 2009 – 11 March 2013
Transitional period
Both the current directive 76/768/EEC & the new regulations 1223/2009/EC are applicable
13 July 2013
1223/2009/EC will completely replace 76/768/EC

4. Introduction (2) Applicable to all 27 EU Member States !
No Transposition ! => 1 single law
EU member states may not add or remove requirements

5. Introduction (3) Objectives Better defined responsibilities !
Manufacturer, importer, responsible person, distributor
Safety assessment
Regulation of ingredients
Avoid multiple notifications to authorities and anti-toxic centers
Specific provisions for nanomaterials !
Set criteria for claims
Harmonized market surveillance

6. Introduction (4) Unchanged provisions from 76/768/EEC New Provisions
Basic principles
Ban of animal testing
Regulated ingredients
Manufacturing activities
Labelling (except nano & claims)
Definition of cosmetic product
Responsible Person
Distributors
European notification
Nanomaterials
Product information file (PIF)
Cosmetic product safety report
Cosmetovigilance
Claims
CMR substances
Market surveillance

7. Products already on the market
Introduction (5)
Application Dates
Products already on the market
New products
Notification
11 January 2012  11 July 2013
Prior to placing on the market
Notification of products with nano
11 January 2013  11 July 2013
6 months before placing on the market
Product information file & safety report
11 July 2013
When placed on the market
Labelling [nano]

8. Steps to Compliance, Conformity & EU Market

9. Steps to the EU Market (1)
Step 1 – Designating a Responsible Person
“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.)
Written mandate !
(Article 4.4.)

10. Steps to the EU Market (2)
Step 2 – Product(s) classification
Cosmetic product definition
“Cosmetic product means any substance or mixture intended to be placed in contact with external parts of the human body (epidermis, hair system, nails, lips and external genital organs) or with the teeth and the mucos 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 .“ (Article 2, paragraph 1a)
To consider
Product formulation
Product function
Product claim
! Any change in a product’s function, formulation or claim => a new product

11. Steps to the EU Market (3)
Step 3 – Building the Product Information File, per product!
Description of the cosmetic product
Safety Report (CPSR)
Cosmetic product Safety Information File
Cosmetic product Safety Assessment
Method of manufacture
GMP
Proof of effect(s) claimed, where applicable
Data on animal testing
Labels

12. Steps to the EU Market (4)
Step 4 – Notification
Notification to the Competent Authorities and Anti-Toxic Centers – Directive 76/768/EEC
Notification to the Cosmetic Products Notifications Portal (CPNP) – Regulation 1223/2009/EC
! ! Always completed by the Responsible Person

13. Steps to the EU Market (5)
Step 5 – Entering the EU market

14. Steps to the EU Market (6)
Step 6 – Remain Compliant and Keep updating any individual Product Information File (!)

15. Product Information File
(PIF)

16. Product Information File (1)
Definition
Mandatory technical file required for each cosmetic product to be placed on the market
Full overview of a cosmetic product (in terms of formula, safety reports, labels….)
! Each and every cosmetic product must have a Product Information File (PIF)

17. Product Information File (2)
Remarks
Differences between the PIF by the Directive 76/768/EEC & Regulation 1223/2009/EC
Kept by the RP, at the EU address specified on the label
Readily accessible to the Competent Authorities of the RP Member State
In the national language or a language easily understood by the Competent Authority (in electronic or other format)
For a period of 10 years after the last batch was placed on the market
Updated, when necessary

18. Product Information File (3)
Elements of the PIF - Art. 11, 1223/2009/EC:
Product description which enables the product information to be clearly attributed to the respective cosmetic product
Cosmetic Product Safety Report (Safety Information + Safety Assessment) and data on SUE & UE
Method of manufacturing
GMP
Proof of effect claimed when justified by the nature or the effect of the cosmetic product
Data on animal testing
Labeling

19. Product Information File (4)
Cosmetic Product Safety Report (Annex I, 1223/2009/EC)
Part A – Safety Information File
Qualitative & quantitative composition
Physico-chemical, microbiological & toxicological specifications of the raw materials
Physico-chemical, microbiological & toxicological specifications of the finished product
Stability Test of the finished product
Compatibility Test between the formulation and its packaging
Challenge Test of the finished product
Impurity, traces, information about the packaging material
Data on undesirable/ serious undesirable effects

20. Product Information File (5)
Safety Report
Part B – Safety Assessment report
Safety Assessor – a qualified person, possessing a EU degree in a relevant discipline years of professional experience
Toxicological Assessment of the finished product**
Safety Assessors’ credentials
Any particular label warnings and precautions for use
** The assessment as per the new regulation 1223/2009/EC is more detailed than as per the current directive 76/768/EEC

21. Product Information File (6)
Good Manufacturing Practices = GMP
Were created to ensure that the method of manufacturing is in alignment with the requirements of protection of health
Certificate / declaration
76/768/EEC – no specific requirements according to which the standard must be like
1223/2009/EC – specific standards required ISO 22716
Method of manufacture complying with the GMP

22. Product Information File (7)
Data on undesirable effects
Proof of effect(s) claimed, where applicable
Clinical tests, scientific research…
“Claims manual” to be issued by the European Commission in 2012
Data on animal testing
Performed by the manufacturer, his agents or suppliers
Including any animal testing performed in non-EU countries
Labels
4 possible elements  container, outer-packaging, sticker, leaflet
Specific elements must appear on each (existing) component of the label
National official language(s) !

23. Safety Assessment

24. Safety Assessment (1) Definition
Toxicological Assessment of a finished cosmetic product  no test
Part of the Safety Report in the PIF
Completed by a Safety Assessor

25. Safety Assessment (2) Remark
Differences between the Safety Assessment as per 76/768/EEC & /2009/EC
To be updated when necessary
Special Safety Assessment for cosmetic products targeting
Children <3
Intimate hygiene

26. Safety Assessment (3) 76/768/EEC 1223/2009/EC
Based on the toxicological profile of the ingredients
Based on all the elements of Safety Information File
Qualitative & quantitative specifications
Physico-chemical, microbiological & toxicological specifications of the raw materials
Physico-chemical, microbiological & toxicological specifications of the finished product
Stability Test of the finished product
Compatibility Test between the formulation its packaging
Challenge test of the finished product

27. Safety Assessment (4) Along with the Safety Assessment
Elements Required:
Assessment conclusion
Scientific reasoning leading to the conclusion
Labeling warnings & instructions for use
Safety Assessor signature
Along with the Safety Assessment
Safety Assessor’s credentials
Name
Address
Proof of qualification
Date
Signature

28. Safety Assessment (5) Safety Assessor Qualifications
Diploma in the field of pharmacy, toxicology, dermatology, medicine or similar discipline
Diploma from a EU Member State University!
Minimum of 3 years experience in the field

29. European Responsible Person

30. EU Responsible Person (1)
Definition (Article 2. – 76/768/EEC)
“[…] manufacturer or his authorized agent or any other person responsible for placing the product on the Community market.”
no formal definition

31. EU Responsible Person (2)
Responsibilities under the 76/768/EEC:
Name & address of the “manufacturer or the person responsible for marketing the cosmetic product who is established within the Community” (Article 6.1.a.)
Keep the Product Information File (PIF) readily accessible to the CA (Article 7a.1. a, b, c, d, e, f, g, h.)
Notification to CA & Anti-Toxic Centers – “the manufacturer or his agent, or the person to whose order a cosmetic product is manufactured, or the person responsible for placing imported cosmetic products on the Community market, shall notify the competent authorities of the Member State […].” (Article 7a.4.)

32. EU Responsible Person (3)
Definition (Article 4.1. – EC 1223/2009)
“Only cosmetic products for which legal or natural person is designated within the Community as responsible person shall be placed on the market” (Article 4.1.)
“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.)
Meaning
Obligation to have an EU RP linked to the product
RP established within the European community
RP to fulfill the obligations under the regulation

33. EU Responsible Person (4)
Responsibilities (Article 4.2.)
“For each cosmetic product placed on the market, the responsible person shall ensure compliance with the relevant obligations set out in this Regulation.”

34. EU Responsible Person (5)
Compliance
“ensure compliance” refers to (Article 5.1.):
Article 3: Safety
Article 8: GMP
Article 10: Safety Assessment
Article 11: Product Information File (PIF)
Article 12: Sampling and Analysis
Article 13: Notification
Article 14: Restrictions for Substances Listed in Annexes
Article 15: CMR
Article 16: Nanomaterials
Article 17: Traces
Article 18: Animal Testing
Article 19(1),(2) and (5): Labelling
Article 20: Claims
Article 21: Information to the Public
Article 23: Communication of SUE
Article 24: Information on substances

35. EU Responsible Person (7)
“Only cosmetic products for which legal or natural person is designated within the Community as responsible person shall be placed on the market” (Article 4.1.)
EU Manufacturer
Non-EU Manufacturer
EU Importer
EU Distributor
Cosmetic product manufactured in the EU & commercialized in the EU
Cosmetic product manufactured outside the EU & imported in the EU
(Article 4.6.) *
(Article 4.3.)
(Article 4.4.) *
(Article 4.6.) *
(Article 4.5.)
(Article 4.5.)

36. EU Responsible Person (6)
Tasks on a Practical View:
Provides name & address in the EU – mandatory on the label
Compiles & ensures PIF compliance prior to notification (including Safety Assessment report, product tests, labeling, GMP…) (Article 11)
Notifies to the European Cosmetic Products Notification Portal – CPNP (Article 13)
Keeps the PIF for authorities’ inspections, for a period of 10 years after the last batch was manufactured (Article 11.1.)
Manages cosmeto-vigilance (Article 5)
Represents the manufacturer towards the Competent Authorities, Anti-Toxic Centers, European Commission, end users…
Updates & consults on EU Regulation!

37. EU Notification of Cosmetics

38. EU Notification of Cosmetics (1)
Registration
One way action
Responsible Person Competent Authorities
Anti-toxic Centers
Two ways action
Responsible Person Competent Authorities

39. EU Notification of Cosmetics (2)
In accordance to the EC 1223/2009 Regulation:
To be completed only after the PIF was completed !
Cosmetic products must be in compliance prior to Notification !
Commercialization on EU market only AFTER notification !
Towards the Cosmetic Products Notification Portal (C.P.N.P.) !
A single notification covering the entire European Union!
Products notified under 76/768/EEC will need to be re-notified under 1223/2009/EC no later than July 11th 2013!

40. EU Notification of Cosmetics (5)
Distributors‘ notification – additional to the RP notification
Trabslated Label
Nanomaterials! = insoluble or biopersistent, intentionally manufactured,
1 or > dimention, 1  100nm
Additional notification
Not for nanomaterials in Annexes III, IV, VI
By the responsible person (or mandate) !
6 months before the placing on the market !
Electronic notification to European Commission !
Labeling: titanium dioxide [nano]

41. TAKE HOME MESSAGES

42. Take Home Message (1)
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.).
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.).
Hand Cream
Hand Cream
EU RP: Name & Address
Regulatory obligations
(PIF, notification) 2
EU RP appointment 1 3

43. Take Home Message (2) Time line to market
When to appoint the EU Responsible Person?
PIF 1. 1. 2. 3. 2.
EU RP
appointment
PIF
Notification / Market
Identification
Verification
Confirmation 3. 4.
Time line to market X1 X2 X3 X4 X5 X6 X7 X8 X9
X10

44. Take Home Message (3) RP & Notification EU market
Hand Cream
Manufactured in or outside EU RP
&
Notification

45. Thank You for Your Attention! Questions?