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Webinar Update on European Union Regulations for Cosmetics and Beauty Products. 21.2.2013 Mr. Doram Elkayam – Obelis s.a. Chief Operations Officer. www.obeliscosmetics.net. Regulatory Framework Cosmetics 1223/2009/EC. www.obeliscosmetics.net. Introduction (1). 1223/2009/EC

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webinar update on european union regulations for cosmetics and beauty products

WebinarUpdate on European Union Regulations for Cosmetics and Beauty Products

21.2.2013

Mr. Doram Elkayam – Obelis s.a. Chief Operations Officer

www.obeliscosmetics.net

slide2

Regulatory Framework

Cosmetics 1223/2009/EC

www.obeliscosmetics.net

introduction 1
Introduction (1)
  • 1223/2009/EC
    • 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
introduction 2
Introduction (2)
  • Applicable to all 27 EU Member States !
  • No Transposition !=>1 single law
    • EU member states may not add or remove requirements
introduction 3
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
slide8

Steps to Compliance,

Conformity & EU Market

www.obeliscosmetics.net

steps to the eu market 1
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.)

steps to the eu market 2
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

steps to the eu market 3
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
steps to the eu market 4
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

steps to the eu market 5
Steps to the EU Market (5)
  • Step 5 –Entering the EU market
steps to the eu market 6
Steps to the EU Market (6)
  • Step 6 – Remain Compliant and Keep updating any individual Product Information File (!)
slide15

Product Information File

(PIF)

www.obeliscosmetics.net

product information file 1
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)

product information file 2
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
product information file 3
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
product information file 4
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
product information file 5
Product Information File (5)
  • Safety Report
    • Part B – Safety Assessment report
        • Safety Assessor – a qualified person, possessing a EU degree in a relevant discipline + 3 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

product information file 6
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
product information file 7
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) !
slide23

Safety Assessment

www.obeliscosmetics.net

safety assessment 1
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
safety assessment 2
Safety Assessment (2)
  • Remark
    • Differences between the Safety Assessment as per 76/768/EEC & 1223/2009/EC
    • To be updated when necessary
    • Special Safety Assessment for cosmetic products targeting
      • Children <3
      • Intimate hygiene
safety assessment 4
Safety Assessment (4)

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
safety assessment 5
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
european responsible person

European Responsible Person

www.obeliscosmetics.net

eu responsible person 1
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
eu responsible person 2
EU Responsible Person (2)

Responsibilities under the 76/768/EEC:

  • Name & address of the “manufactureror 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 orhis agent, or the person to whose order a cosmetic product is manufactured, orthe person responsible for placing imported cosmetic products on the Community market, shall notify the competent authorities of the Member State […].” (Article 7a.4.)
eu responsible person 3
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
eu responsible person 4
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.”
eu responsible person 5
EU Responsible Person (5)

Compliance

  • “ensure compliance” refers to (Article 5.1.):
eu responsible person 7
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.)

(Article 4.4.)

(Article 4.3.)

(Article 4.5.)

*

*

*

(Article 4.6.)

(Article 4.6.)

(Article 4.5.)

eu responsible person 6
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!
slide37

EU Notification of Cosmetics

www.obeliscosmetics.net

eu notification of cosmetics 2
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 AFTERnotification !
  • 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 bere-notifiedunder 1223/2009/EC no later than July 11th 2013!
eu notification of cosmetics 5
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]
slide41

TAKE HOME MESSAGES

www.obeliscosmetics.net

take home message 1
Take Home Message (1)
  • Onlycosmetic productsfor 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

Regulatory obligations

(PIF, notification)

EU RP: Name & Address

EU RP appointment

Hand Cream

1

2

3

take home message 2
Take Home Message (2)
  • When to appoint the EU Responsible Person?

1.

1.

2.

2.

3.

3.

4.

EU RP

appointment

PIF

Notification / Market

PIF

Identification

Verification

Confirmation

0

Time line to market

X1

X2

X5

X6

X7

X8

X9

X10

X3

X4

take home message 3
Take Home Message (3)

EU market

Manufactured in or outside EU

Hand Cream

RP

&

Notification