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Webinar Update on European Union Regulations for Cosmetics and Beauty Products

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

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  1. 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

  2. Regulatory Framework Cosmetics 1223/2009/EC www.obeliscosmetics.net

  3. 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

  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)

  7. Introduction (5)

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

  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) www.obeliscosmetics.net

  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 + 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

  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 www.obeliscosmetics.net

  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 & 1223/2009/EC • To be updated when necessary • Special Safety Assessment for cosmetic products targeting • Children <3 • Intimate hygiene

  26. Safety Assessment (3)

  27. 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

  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 www.obeliscosmetics.net

  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 “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.)

  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.):

  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.) (Article 4.4.) (Article 4.3.) (Article 4.5.) * * * (Article 4.6.) (Article 4.6.) (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 www.obeliscosmetics.net

  38. EU Notification of Cosmetics (1)

  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 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!

  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 www.obeliscosmetics.net

  42. 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

  43. 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

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

  45. Thank You for Your Attention!Questions?

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