21.2.2013 Mr. Doram Elkayam – Obelis s.a. Chief Operations Officer 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 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

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) 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

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

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]

Steps to Compliance, Conformity & EU Market www.obeliscosmetics.net

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) 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) 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) 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) Step 5 – Entering the EU market

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

Product Information File (PIF) www.obeliscosmetics.net

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) 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) 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) 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) 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) 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) 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) !

Safety Assessment www.obeliscosmetics.net

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) 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 (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

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

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 www.obeliscosmetics.net

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) 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.)

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) 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) 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

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.)

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!

EU Notification of Cosmetics www.obeliscosmetics.net

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

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!

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]

TAKE HOME MESSAGES www.obeliscosmetics.net

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

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

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

Thank You for Your Attention! Questions?