In today’s complex regulatory landscape, fulfilling all required compliance obligations is often time-consuming and complex. At Decernis, we offer customized and diligent support from our team of experts to facilitate your compliance procedures. Consulting and Advisory Services are available for our clients in our core competency areas in 224 countries and for 28 organizations.
About Us
The Decernis group of FoodChain ID maintains a practice in both global Managed Services and Compliance Advisory Services. Both practices are managed by an expert internal team. We also work with a team of external subject matter and regional experts where we need additional resources. We have a history of working with global manufacturers to solve critical problems and to support speed to market.
Contact us under consulting[at]decernis.com to connect with our team!
Meet our Team:
Services
- Food Additives: colors, flavors, sweeteners, enzymes, and many more
- Food Contaminants: for example, heavy metals, pesticides, and microbial contaminants
- Dietary Supplements: ingredient evaluation for botanicals, herbals, vitamins/ minerals, probiotics, prebiotics, and novel ingredients
- Claims and Labeling: for example, nutrition, descriptive, red/green light, fortification, risk analysis for use of claim in given market
- Food Contact: all aspects of food packaging from substrate evaluation to sustainability
- Consumer Products [CPG]: e.g., consumer paper products, consumer cleaning products, cosmetics, personal care products
- Market Entry Information:assessments of both established countries/ markets as well as emerging markets
- Surrogate Countries Analysis: for markets without regulations or standards of their own
- FDA Practice: FCN Food Contact
- Advocacy
Example Projects:
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- For food company clients, we have evaluated ingredients, additives, contaminants, claims, and labeling (including nutrition, claims, COOL, allergens), and food contact requirements. We also do deep dives into very innovative and confidential ingredients, products and processes.
- For non-alcoholic beverage company clients, we have evaluated ingredients, additives, contaminants, claims, and labeling requirements for over 200 markets and regulatory authorities.
- For alcoholic beverage manufacturers, we have evaluated ingredients, additives, contaminants, claims, and labeling requirements for over 200 markets and regulatory authorities.
- For flavor company manufacturers and end users, we have evaluated global regulatory status for many common and unique flavor chemicals as well as functional ingredients. Extensive in-house expertise to conduct deep dive type reviews.
- For supplement manufacturers and distributors,we have evaluated over 900 specific ingredients, as for use of ingredients, additives or flavors for some of the most important and most dynamically emerging markets as well as benchmarking those ingredients against relevant regulatory authorities.
- For sweetener manufacturer and industry associations, we have evaluated the permissible uses and market position of various sweeteners including stevia as well as current key innovative materials such as monkfruit.
- For clients with end-use food contact issues, we have conducted intensive regulatory, scientific and market research on innovative materials and applications.
In case you missed our webinar on “Labelling Regulation Challenges Made Easy“, click here for the recording and Labelling Webinar Q&A 20Oct2020 for the Q&A.
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.
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