Day 1, 5.05. Athens, May 2014 8:30 8:45 Opening Words 1. 8:45 09:30 2. 09:30 10:15 1223/2009/EC Regulation Principles & Structure; Definitions; Compliance Operators; Implementation; CPNP notification ; Decision taking at the EC level Responsible Person vs. Safety Assessor Definitions; Role and responsibilities; Collaboration principles 10:15 10:30 Coffee Break 3. 10:30 11:15 4. 11:15 12:00 Cosmetics Claims Definition; Criteria 655/2013 GMP ISO 22716:2007 Definition; Role; Structure & Principles; Implementation 12:00 13:00 Lunch Break 5. 13:00 13:45 The 3 pillars of market surveillance of Cosmetics in Germany Analysis of products/check of PIF including safety assessment/check of GMP Crisis management (I) 6. 13:45 14:30 What is a crisis? How a crisis unfolds? Different types of crisis. SUE/UE. Communication between authorities. What request to expect from authorities. RAPEX. Dealing with crisis. 14:30 14:45 Coffee Break Crisis management (II) 7. 14:45 15:30 What is a crisis? How a crisis unfolds? Different types of crisis. SUE/UE. Communication between authorities. What request to expect from authorities. RAPEX. Dealing with crisis. Other European Regulatory Framework Applicable to Cosmetics & 8. 15:30 16:15 Borderline Products REACh; CLP; Biocides 16:15 16:30 Coffee Break 9. 16:30 17:30 Implementation of the European Regulation Authorities View and Feedback Dr. Karin Gromann Ernährung, besondere Waren und internationale Lebensmittelangelegenheiten II/B/14 Bundesministerium für Gesundheit (Austria) Sylvie Gallage-Alwis Hogan & Lovells (France) Dr. Karin Gromann Dr. A. Kriebardis Reckit Benkizer Hellas Dr. Gerd Mildau Expert Cosmetic Products CVUA Karlsruhe Mrs. Sandra Ferretti Obelis C.C.O. Mrs. Sandra Ferretti Obelis C.C.O. Peter Kugel VVGB Greek Authorities (E.O.F.) 1
Day 2, 6.05. 8:30 9:00 Participants Registration and Coffee 10. 9:00 9:45 11. 09:45 10:30 Skin Structure and Penetration Experiments to Test/Predict Skin Penetration Nanomaterials and Their Skin Penetration Nanomaterials Catalogue of the European Commission 10:30 10:45 Coffee Break 12. 10:45 11:30 Dermal Irritation. In-vitro Evaluation of Skin Irritation 13. 11:30 12:15 Skin Sensitization and Testing SCCS 1501/12 12:15 13:00 Lunch Break 14. 13:00 13:45 Eye Irritation. In Vitro Screening Techniques of Eye Irritation 15. 13:45 14:30 Photoallergy and Testing SCCS 1501/12 14:30 14:45 Coffee Break 16. 14:45 15:30 17. 15:30 16:15 Stability Test Report Review Compatibility Test Report Review Challenge Test Report Review Patch Test / HRIPT Test Report Review Other Tests Packaging Impurities & Compatibility Between Packaging and the Formulation Types of packaging, elements to be considered for each type of packaging, packaging and formulations compatibilities 18. 16:15 16:30 Coffee Break 19. 16:30 17:15 Annex I of 1223/2009/EC Annex I Guidelines 2013/674 ; Elements overview 20. 17:15 18:00 Annex II, III, IV, V, VI of 1223/2009/EC List of substances prohibited in cosmetic products; List of substances which cosmetic products must not contain except subject to the restrictions and conditions laid down; List of colorants allowed in cosmetic products; List of preservatives allowed in cosmetic products; List of UV filters allowed in cosmetic products Dr. Mariella Bleve University of Pavia Steffi Friedrichs Nanotechnology Industries Association Dr. Helena Kandarova Executive Director MatTek In Vitro Life Science Laboratories (Slovakia) Dr. Christos Prevezas Dermatologist-Venereologist, MD QACS Ltd Associate Dr. Helena Kandarova Executive Director MatTek In Vitro Life Science Laboratories (Slovakia) Dr. Christos Prevezas Dermatologist-Venereologist, MD QACS Ltd Associate Charilaos Tsitouris QACS Dr. Paola Perugini University of Pavia Dr. Peter Bursch CoSiChem CEO Dr. Peter Bursch CoSiChem CEO 2
Day 3, 7.05. 21. 08:30 09:15 Formulation Principles and R&D Exercises Inovapotek (Portugal) 22. 09:15 10:00 Formulation Principles and R&D Exercises 10:00 10:15 Coffee Break 23. 10:15 11:00 24. 11:00 11:45 Systemic Exposure of the Human Body to Cosmetic Ingredients and the Influence on Product Safety Part I Principles of safety, definitions & theory (MoS, SED, LD50, NOAEL..) Systemic Exposure of the Human Body to Cosmetic Ingredients and the Influence on Product Safety Part II Principles of safety, definitions & theory (MoS, SED, LD50, Dam NOAEL..) 11:45 12:45 Lunch Break 25. 12:45 13:30 Vegetal / Plant Based Ingredients Giada Maramaldi Indena SpA 26. 13:30 14:15 Heavy Metals and Mineral Products Sun Protection Guided tour to Cape Sounion and Temple of Poseidon 14:15 Evening Dinner by the sea Intertek (UK) 3
Day 4, 8.05. 27. 8:30 09:15 Perfumes / Allergens IFRA (TBC) 28. 09:15 10:00 Preservatives & Parabens 29. 10:00 10:15 Coffee Break 30. 10:15 11:00 Regulated Substances 31. 11:00 11:45 Safety Assessment (Opinion 1501/12) MoS Calculation Practical Aspects on How to Make the MoS Calculations 32. 11:45 12:00 Coffee Break 33. 12:00 12:45 Safety Assessment (Opinion 1501/12) MoS Calculation Practical Aspects on How to Make the MoS Calculations Intertek / Schulke & Mayr (TBC) Yiannis Kapetanstratakis QACS Ltd Forensic Chemist M.Sc. Inovapotek (Portugal) 34. 12:45 13:30 Safety Assessment for Different Types of Products & Examples 13:30 14:30 Lunch Break 35. 14:30 15:15 Safety Assessment for Different Types of Products & Examples 36. 15:15 16:00 SCCS Guidelines & Ingredients Databases Definitions; Roles; Examples 37. 16:00 16:15 Coffee Break 38. 16:15 17:45 Cosmetics Europe Science Program developments of alternative testing methods and their regulatory acceptance Patric Amcoff Interim Director Science & Research Cosmetics Europe - The Personal Care Association 4
Day 5, 9.05. 09:00 09:15 Participants Registration and Coffee 39. 09:15 11:15 Group exercises. Preparation of a Safety Assessment 11:15 11:30 Coffee Break 40. 11:30 13:00 Presentation of Safety Assessments. Discussion 13:00 14:00 Lunch Break Dimitris Melissos QACS C.E.O. and QACS Ltd team Dimitris Melissos and QACS Ltd team 41. 14:00 15:00 Overview-Discusion with Greek Authorities Greek Authorities (E.O.F.) 15:00-16:00 WRITTEN EXAM 16:00 16:15 Coffee Break 42. 16:15 17:00 Participation certificate and closing of the workshop 5