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Mr. Schoneker will discuss the "real" safety profile of TiO2 E171, and provide recent developments that could lead to the suspension of its use in foods and dietary supplements in France after April 15, 2019. The impact of such a suspension could be significant and there is the potential for this suspension to be extended to pharmaceuticals and cosmetics. The technical challenges of utilizing alternative materials will also be discussed. Mr. Schoneker will explain how a suspension such as this in France could have impact on the rest of Europe and other countries around the world.
This webinar will:
- discuss the supporting safety information for TiO2 E171 that is recognized by global regulatory agencies and the problems with the French study which has created controversy
- explain the political and media environment in France related to “nano” materials which has created this situation
- review industry's efforts, through a new E171 Coalition, to attempt to change this decision on food use in France based on the actual science and safety of E171
- explore the impact of the extension of the proposed suspension to pharmaceuticals and cosmetics as well as to other European countries
David R. Schoneker is the Global Regulatory Director for Strategic Relationships at Colorcon. His responsibilities include global coordination of Colorcon’s worldwide regulatory activities and market expansion projects to gain regulatory acceptance of Colorcon’s products and components for various target markets. He received his B.S. degree from Ursinus College and M.S. in Chemistry from Villanova University. His previous position at Colorcon was Director of Quality Assurance and Quality Control. He has been at Colorcon since 1977. Mr. Schoneker has been active in many professional organizations such as AAPS, PQRI, RAPS, ASQ, ACS, AOAC and the Delaware Valley Chromatography Forum. He also is involved with a number of trade organizations such as the International Pharmaceutical Excipients Council (IPEC), the International Association of Color Manufacturers (IACM), the Consumer Health Products Association (CHPA), the International Food Additives Council (IFAC), the Council for Responsible Nutrition (CRN) and the Institute of Food Technologists (IFT).
Mr. Schoneker is currently the President-Elect of IACM and will become President of IACM in January 2019. In this role he will coordinate IACM’s international regulatory activities related to Synthetic and Natural colorants for use in foods and drugs and will participate as one of IACM’s NGO representatives at the Codex Committee on Food Additives (CCFA).
Mr. Schoneker was the Chairman of IPEC-Americas during the period 2007-2009 and is currently a member of the Executive Committee. He is now serving as the Vice Chair for Science and Regulatory Policy where he is actively involved with the development of Regulatory, Safety, Excipient GMP and Supplier Qualification related guidelines to improve Excipient Acceptability, Safety and Global Supply Chain Security. Mr. Schoneker also Co-Chairs IPEC’s QbD/Product Development Committee, Composition Committee and IID Working Group. He also is a member of the Board of Directors of the IPEC Foundation. He is the Global Expansion Coordinator for the IPEC Federation and has been critically involved in the development of many of the IPEC groups and Partnerships around the world.
He has acted as an interface with many international regulatory agencies and pharmacopeias for the organization. He previously was the USP Liaison for IPEC-Americas and represented them as a member of the United States Pharmacopeial Convention for many years. Mr. Schoneker previously coordinated International Harmonization efforts for IPEC-Americas and participated in the development of IPEC’s Good Manufacturing Practices Guide and Auditing Guide for Bulk Pharmaceutical Excipients. He has also led IPEC’s efforts in developing guidelines for excipient qualification, significant change notification and the appropriate use of certificates of analysis. Additionally, Mr. Schoneker chairs a number of harmonization working groups on various excipients and has been chairing the Coalition for Rational Implementation of the Elemental Impurity Requirements since 2010.
Mr. Schoneker has participated in the area of Color Science for many years and is author of the chapter “Coloring Agents for Use in Pharmaceuticals” in the 4th edition of the Enclyclopedia of Pharmaceutical Technology which was published in 2013. He has also authored many other excipient quality and safety related papers in various journals and trade magazines.