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2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
2. sandra ferretti   regulación ue
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2. sandra ferretti regulación ue

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  • 1. © Obelis s.a. 2013Version 2, Revised on 04.12.2012EC 1223/2009 RegulationMrs. Sandra Ferretti – Obelis s.a. C.C.O.Colombia 2013
  • 2. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Presentation Overview• Definitions• European legislation on cosmetic products• European regulation main requirements• Recap2
  • 3. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Definitions (1)• Directiveo Legislative document issued by the European Parliamento It gives a direction• Regulationo Legislative document issued by the European Parliamento Law, rule3
  • 4. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Definitions (2)• Cosmetic products (art. 1a, 1223/2009/EC)“means any substance or mixture intended to be placed in contact with the external parts ofthe human body (epidermis, hair system, nails, lips and external genital organs) or withteeth 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”4
  • 5. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Definitions (3)• A cosmetic product is defined byo 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?)5
  • 6. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• Responsible Person (RP)o EU resident !o Assigned to be the representative of a manufacturer’s cosmetic products in front of theEU 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)6Definitions (4)
  • 7. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• Notificationo One way action, from the RP to the Authorities i.e., the authorities are not obliged to confirm the notificationo Requirement by the European legislation on cosmetic products (directive & regulation)• Product Information File (PIF)o All safety information concerning 1 cosmetic producto Any cosmetic product commercialized in the EU must have a PIF7Definitions (5)
  • 8. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• 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 nameo “means any natural or legal person who manufactures a cosmetic product or has such aproduct designed or manufacture, and markets that cosmetic product under his name ortrademark” (art. 1d, 1223/2009/EC)8Definitions (6)
  • 9. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• Importero The one importing products from outside EU into the EU territoryo “means any natural or legal person established within the Community, who places acosmetic 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 Communitymarket” (art. 1h, 1223/2009/EC)9Definitions (7)
  • 10. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• Distributoro The one commercializing the product within a EU member stateo “means any natural or legal person in the supply chain, other than the manufacturer orthe 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 inreturn for payment or free or charge” (art. 1g, 1223/2009/EC)10Definitions (8)
  • 11. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European legislation on cosmetic products (1)• Principle11
  • 12. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European legislation on cosmetic products (2)• Directive 76/768/EECo Cosmetic products directive in the EUo 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?12
  • 13. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European legislation on cosmetic products (3)• Regulation 1223/2009/ECo Cosmetic products regulation in the EUo Published in November 2009 !o In implementation process by all 27 EU member states => 1 single law in EU oncosmeticso Centralized notification CPNP = Cosmetic Products Notifications Portal Open since January 12th, 2012 1 notification for the whole EUo 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?13
  • 14. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• REACh 1907/2006/EC Regulation – Registration, Evaluation, Authorization and Restrictionof Chemicalso Regulation on chemicals and their safe useo 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 Packagingo Regulation aligning the EU systems of classification, labeling, and packaging of chemicalsubstances• Aerosol Dispensers Directive 75/324/EECo Aerosol dispensers compliancy requirements including testing and labeling14Examples of relevant regulations
  • 15. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• SCCS opinions – Scientific Committee on Consumer Safetyo Adopted in the annexes of the directive/regulationo 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 standardso 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 protectionfactor (SPF)) …15Examples of relevant guidance documents
  • 16. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Today• Transitional periodo Period between the publication of the new Regulation (November 2009) and the abolitionof the Directive (July 2013)o Both laws are applicable => products may be compliant with the Directive or with theRegulation16
  • 17. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• Why the Regulation?17European legislation on cosmetic productsDirective RegulationProduct Information FileSafety Assessment reportPre market notification27 lawsNational notification1 lawCentralized notification (CPNP)Clearer defined RP conceptClearer defined responsibilities of the RPMore requirements
  • 18. © Obelis s.a. 2013Version 2, Revised on 04.12.2012To remember !July 11th, 201318Regulation 1223/2009/EC Directive 76/768/EEC
  • 19. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European 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 CPNP19
  • 20. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European 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 theCommunity as ‘responsible person’ shall be placed on the market” (art. 4.1.) The RP is appointed per product not manufacturer20
  • 21. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European regulation main requirements (3)B. Product Information File (art. 11)1. Description of the cosmetic products2. 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 manufacture4. Good Manufacturing Practice (GMP) compliance ISO 22716:20075. Proof of effect claimed6. Data on animal testing21 Producer !!! Producer !!! Producer !!! producer / manufacturer !!! up to the manufacturer to check !!!
  • 22. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European regulation main requirements (4)• Main elements of the Safety Information (Annex I, Part A, 1223/2009/EC)22Information Keeper (usually)1. Formula (exact quantitative & qualitative information !!!) Producer2. Raw material physico-chemical, toxicological & microbiologicalinformation (why not necessarily the MSDS ???)Raw material supplier3. Finished product physico-chemical & microbiological specifications Producer4. Finished product tests• Stability test (usually 3 months)• Compatibility test (usually 3 months)• Challenge test (usually 1 month)• Patch test !Producer /Manufacturer
  • 23. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European regulation main requirements (5)• Main elements of the Safety Information23Information Keeper (usually)5. Packaging specifications Packaging supplier6. Instructions for use and warnings Producer / SA7. Exposure to the cosmetic product Producer / SA8. Undesirable effects and serious undesirable effectsProducer /manufacturer
  • 24. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European regulation main requirements (6)• Claimso A cosmetic product “means any substance or mixture intended to be placed in contact with the external parts of thehuman body (epidermis, hair system, nails, lips and external genital organs) or with teeth and themucous membranes of the oral cavity with a view exclusively or mainly to cleaning them,perfuming them, changing their appearance, protecting them, keeping them in goodcondition 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] havecharacteristics or functions which they do not have” (art. 20.1)24
  • 25. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Free of preservatives perfume Whitening tooth pasteKilling bacteria soap Helping circulation foot care creamAnti-wrinkle cream Prevents formation of cellulite24 hours sun protection lotion Use with injuriesAnti-dandruff shampoo Combats excessive body odorCream helping problematic skin!!!European regulation main requirements (7)25
  • 26. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• Claimso Natural / Bio / Organic = implies that the raw materials were produced following specificrules & regulationso When to claim natural / bio / organic Different organizations across Europe  Different interpretations26European regulation main requirements (8)
  • 27. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• Claims27European regulation main requirements (9)ECOCERT Natural & Organic Natural• minimum of 95% of allplant-based ingredients inthe formula &• minimum of 10% of allingredients by weight mustcome from organic farming.• minimum of 50% of allplant-based ingredients in theformula &• minimum of 5% of allingredients by weight mustcome from organic farming.
  • 28. © Obelis s.a. 2013Version 2, Revised on 04.12.2012• Claims28European regulation main requirements (10)NaTrue Natural Natural with organicportionOrganic• ingredients mustbe natural but theydo not have to beorganic• at least 70% of naturalingredients must stem fromcontrolledorganic production and/orcontrolled wild collection.• at least 95 % of naturalingredients must comefrom controlled organiccultivation and/orcontrolled wild collection
  • 29. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European regulation main requirements (11)C. Notification (art. 13)o To be completed To the CPNP By the RP When the product is complianto 1 notification for the whole EU29
  • 30. © Obelis s.a. 2013Version 2, Revised on 04.12.2012European 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!30
  • 31. © Obelis s.a. 2013Version 2, Revised on 04.12.2012exclusively&mainlyAny substanceor mixturePlaced in contact with theexternal parts of the humanbody + teeth + mucousmembranes of the oralcavityCosmetic product1. Cleaning,2. Perfuming,3. Changing appearance,4. Protecting,5. Keeping in good condition,6. Correcting body odors1 2331Recap (1)
  • 32. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Recap (2)• European laws on cosmeticso Directive 76/768/EEC = will be abolished on July 11th, 2013o Regulation 1223/2009/EC = will fully replace the directive on July 11th, 2013• Principle  Safety• Compliance with the European requirements prior commercialization32
  • 33. © Obelis s.a. 2013Version 2, Revised on 04.12.2012I. 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 relevantobligations set out in this Regulation (Article 4.2.).Hand CreamEU RP: Name &AddressHand Cream EU RPappointment1Regulatoryobligations(PIF, notification)23Recap (3)
  • 34. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Note• Speed of the notification process depends on:o RP knowledge, professionalism, capabilitieso the speed of collecting the correct informationo raw material suppliers / packaging suppliers / producers choice• Producer GMP compliancy (ISO 22716:2007) is a EU requirement34
  • 35. © Obelis s.a. 2013Version 2, Revised on 04.12.2012Thank you for your attention !35

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