gComply Product Safety/Inventories 101 – Tips and Tricks and Advanced Searches
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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.
Contact: keverstine[at]decernis.com
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).
In earlier work, Dr. Fellous was Senior Vice President Global Regulatory Affairs Scent & Care at SYMRISE. His prior activity includes work with IFF and L’Oreal.
Contact: rfellous[at]decernis.com
Rich LeNoir has 37 years of experience in the industry. He currently works as a
Subject Matter Expert for Decernis.
Before forming his own consulting company, The Catcher Consulting LLC in 2013, Mr. LeNoir worked for Hercules, Inc., Himont Inc., Montell Polyolefins, Basell Inc. and LyondellBasell Industries. Over his career, he has held positions of salesman; R&D engineer; plant process
engineer; plant assistant area supervisor; corporate health, safety, environment and regulatory affairs specialist; product safety specialist and product stewardship manager. Of his 37 years in industry and almost 7+ years of consulting, 35 years has been in product stewardship, product safety and regulatory affairs. His expertise includes food contact, chemical registration and other product regulations, on the local and national levels, from all over the world, and developing product stewardship business processes.
In addition to his work experience, Mr. LeNoir has been an active member of Plastic Industries Association (formerly SPI) for more than 30 years. He has been a member of the Food, Drug and Cosmetic Packaging Material Committee (FDCPMC) during this time, serving as its chairman from 2006-2012. Also, Mr. LeNoir has been a member of Plastics EHS+ Committee dealing in issues of worker health and safety, environmental compliance and product regulatory. Other trade association participation has been several committees at the American Chemistry Council (ACC), and the International Material Data System (IMDS) and Global Automotive Declarable Substance List (GADSL) committees organized under the Automotive Industry Action Group (AIAG). Mr. LeNoir has authored chapters on polypropylene regulatory requirements and manufacturing in two Polypropylene Handbooks published by Himont and Montell, respectively. In addition, he has authored a chapter concerning food contact regulation status of various plastics in jurisdictions around the world in “Global Legislation for Food Contact Materials” published by Woodhead
Publishing. A chemical engineer by training, Mr. LeNoir received his B.S. in Chemical Engineering from the University of Delaware in 1975.
Contact: rlenoir[at]decernis.com
In my current role, I serve as an advisor to various clients regarding food labeling as well as supplements labeling. Key activities include:
• Define product strategy and implementation
• Audit data accuracy and currency
• Drive improvements to the gComply Plus database
• Inform clients regarding regulatory compliance issues
I am responsible for gComply Plus which is a regulatory database encompassing the regulations of 224 countries and 28 economic communities. The regulations contained in the database include food additives, contaminants, standards of identity, food contact, cosmetics, supplements, animal feed and much more.
Contact: lgroninger[at]decernis.com
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.
Ms. Milone is admitted to the Louisiana and Florida bars and active in the American Bar Association and the Federal Bar Association. She received her law degree from Indiana University where she served on the Indiana International & Comparative Law Review, serving as editor-in-chief of the Symposium Issue on Contemporary Issues in Chinese Law. She also has carried out graduate studies in East Asian Languages and Cultures at Indiana University. She graduated summa cum laude from Loyola University with a concentration on East Asian history.
Before Decernis, Ms. Milone practiced law at the trial and appellate levels and also taught legal studies, including legal and regulatory research, at the University of Central Florida. She is also a Certified Mediator.
Contact: kmilone[at]decernis.com
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.
Julie has successfully managed 40+ large scale global projects over the past decade and served as a global regulatory lead for an SAP implementation at Degussa Chemical (Fine Chemicals, Additives & Flavors). She has also completed in excess of 30 statements of work related to business level consulting and market strategy. Ms. Holt’s consulting efforts have supported global regulatory needs, R&D projects, sustainability goals, and innovation initiatives.
Ms. Holt has a BS in Biology (emphasis in cellular / molecular biology) and Organic Chemistry and she holds a Master’s Certificate in International Food Law from Michigan State University. She has also completed 30 hours of graduate studies in comparative biology and genetics. Ms. Holt continues graduate studies and is currently enrolled in pharmacology courses.
Contact: jholt[at]decernis.com
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.
Dr. Cheeseman’s career includes a 20-year career at the U.S. Food and Drug Administration culminating in leadership positions in FDA’s Office of Food Additive Safety and Center for Food Safety and Applied Nutrition. Dr. Cheeseman held primary authority for FDA decisions regarding the safety of food additives, color additives, GRAS ingredients and bioengineered plant foods. In addition, Dr. Cheeseman had primary authority for program decisions regarding enforcement decisions in the areas of food additives and ingredients and related issues. During his FDA career, Dr. Cheeseman oversaw the review of over 1100 food contact notifications, 200 GRAS notices and over 100 food and color additive petitions.
Since leaving FDA, Dr. Cheeseman has assisted food industry members developing compliance opinions and recommendations for all of the above compliance areas and has an unmatched record of success with submissions to FDA, USDA and EPA in the above areas. In addition, Dr. Cheeseman has extensive experience assisting clients with compliance issues and submissions for the above product areas in Canada, Europe, Asia (including china and Japan) and South America. As a result of his enforcement experience at FDA, Dr. Cheeseman has advised numerous manufacturers regarding postmarket compliance areas including recalls, responses to inspection reports and other matters of compliance with the Food Safety Modernization Act (FSMA). Dr. Cheeseman has also supported industry members with compliance issues and advocacy with foreign regulators in a wide range of product areas regulated by FDA, USDA and EPA in the US.
Contact: mcheeseman[at]decernis.com
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.
Dr. Jungclas is currently chair of the Food Contact group of the German Paper Converting Association, external expert to the German BfR Commission subgroup Paper & Board and co-author of various books around Food Contact Materials and Hygiene management. He holds a PhD in Analytical Chemistry from the Phillips-University Marburg. His primary interests are global compliance and environmental assessments of Food contact materials.
Contact: hjungclas[at]decernis.com
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.
Kevin is a frequent speaker at international conferences and an active participant in the Regulatory Affairs Committees of food, cosmetic and consumer product associations. Kevin also attends the Codex Alimentarius Committee on Food Additives (CCFA) in China annually as a member of the International Food Additives Council and has done extensive capacity building training seminars for governments in Africa and Asia on Food Additives, Labelling and Food Contact regulation.
Prior to founding Decernis, Kevin worked as a regulatory attorney and later VP, International Operations at Ariel Research, which managed product safety regulations globally for chemical manufacturers. He also taught Public International Law at the Christian-Albrechts-Universität in Kiel, Germany.
Kevin has lived and worked for seven years across five European and Asian countries and is fluent in German, Spanish and French. He possesses an honors Juris Doctor, an LL.M. in International Law and the Hague Diplôm de Droit International. In 1992, he was awarded an Alexander von Humboldt Research Fellowship in Bonn, Germany.
Contact: kkenny[at]decernis.com