FDA Directive 2/2022: General Classification Of Ingredients – Labeling Order Appendix 2 [English Translation]
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Karen Everstine is Senior Manager, Scientific Affairs with Decernis, which delivers technology-enabled global risk management solutions for product development, compliance, safety, regulatory, and market access. She has fifteen years of food protection experience, most recently focused on supporting the food industry in their efforts to ensure food authenticity and compliance with GFSI food fraud requirements and the EMA-provisions of the Food Safety Modernization Act. She leads food fraud support at Decernis with the Food Fraud Database, a resource that collects and standardizes relevant food fraud data to support vulnerability assessments. She has previously held both research-based and applied roles in academia, government, and non-profit organizations, and has collaborated with members of the food industry and regulatory agencies on many projects, working with expert committees on this issue. She received her PhD and MPH from the School of Public Health at the University of Minnesota and began her food safety career on “Team D” at the Minnesota Department of Health. Her areas of expertise include a strong knowledge of the food regulatory landscape, food safety and authenticity. She has authored many peer-reviewed journal articles, trade journal pieces, and regularly responds to media requests.
Robert Fellous is Senior Director, Scientific Affairs with Decernis. Robert Fellous has more than twenty years of experience in Analytical, Clinical testing and Toxicology and Regulation, particularly with the cosmetics and personal care industry. Previously, in his work at Intertek, Dr. Fellous managed: Clinical Research Services with 35 professionals; Analytical Services Lab with 35 employee providing R&D and routine tests: contaminants & controlled ingredients, characterization & identification of nanoparticles, stability tests, packaging issues (migration of species, interaction between packaging and product), in vitro test (safety and efficacy) and microbiology tests; and Consulting Services Regulatory and Toxicology for Cosmetic and Pharmaceutical products with 25 professionals: e.g. preparation of PIF (Product information file), labelling review, electronic notification to European portal, safety assessment of cosmetic raw materials and API including complex raw materials such as botanicals, literature search, in silico study (SAR Modelling (Structure Activity Relation), design and optimization of toxicological protocols to meet global regulations, placement and monitoring of studies and submission of safety dossier to SCCS, INCI Dossier submission to PCPC).
Rich LeNoir has 37 years of experience in the industry. He currently works as a
In my current role, I serve as an advisor to various clients regarding food labeling as well as supplements labeling. Key activities include:
Kim Milone is an attorney and Senior Director of Regulatory Affairs for the Company, managing all research activities and the work of Decernis’ global research team. She also coordinates the work of the Global Advisory Services practice with that of the global research team. She has served as project lead and expert in Decernis projects with major food, beverage and supplement companies.
Julie Holt is a subject matter expert in the area of food, food ingredients, additives and supplements. She has more than twenty-three years of regulatory experience in the food and food ingredients industries and managed her own advisory firm, Scientific & Regulatory Solutions LLC, for a decade. During this time, her primary client was PepsiCo. Her food ingredient competencies include: flavors, sweeteners, colors, enzymes, probiotic blends, beverages, snack foods, juice, dairy products, supplements and fine chemicals. She has provided global regulatory coverage for more than 200 countries for various employers and clients including Givaudan Flavors Corp. and Degussa AG.
Mitchell Cheeseman has 29 years of experience advising manufacturers on compliance issues for a variety of FDA regulated products including food, food additives, GRAS ingredients, processing aids, color additives, dietary supplements and dietary ingredients, animal feed and animal feed additives, cosmetics, over the counter drugs and medical devices.
Henrik Jungclas is a Project Manager at Decernis, mainly focusing on Food Contact Projects, Supply Chain Management and Auditing. Prior to his recent position, he has worked as a Regulatory Affairs Manager and auditor for quality and hygiene standards at Tetra Pak, Weidenhammer and Sonoco Consumer Products Europe since 2006. He is a trained quality manager and Six Sigma Green Belt.
Kevin is co-founder of Decernis and is an experienced regulatory attorney who has worked and consulted for 24 years in the food and consumer products space. He advises some of the world’s largest manufacturers on Food compliance and Supply Chain challenges globally. Kevin is responsible for both the regulatory content of its products and its Subject Matter Expertise across the 219 countries Decernis covers.