Craig B SimpsonLima, OH

Keller and Heckman LLP

(320) 264-5503 (Phone)

Advertising and Promotion, Animal and Veterinary Food and Drug, Biotechnology, Chemical Control, Dietary Supplements, Environmental, Food and Drug, Food and Drug Packaging, Food and Food Ingredients, International Regulatory Affairs, Medical Devices, Product Safety, Chemicals and Plastics, Consumer Products and Retail, Food & Life Sciences, Packaging, Trade Associations

<p><strong>Memberships</strong></p><p>•European Food Safety Authority, Former Member of the Management Board</p>

917601376

1998

College of Europe, Bruges, Belgium, M.A., European Political Studies, Mention Bien, 2001; The College of Law, London, Legal Practice Diploma, 1998

University College London, LL.B, Upper Second Class Honors, 1994

Representative Matters: Advised online food supplements and sports food distributor on EU food information, pre-market authorisation, and ingredient restriction requirements, and obtained national borderline product clearances; Determined whether plant extract claimed to improve memory and mental function constitutes a novel food ingredient or medicinal product requiring pre-market authorisation; Represented animal feed multinational before national enforcement authorities concerning its unauthorised placing on the market of a feed additive; Successfully defended U.S. food distributor against allegation by Dutch Food Safety Authority of breach of EU food hygiene requirements at storage warehouse; Counselled third country EU Mission on legal arguments to challenge threatened EU safeguard measures restricting EU imports of its fish containing a prohibited additive; Advised producer of coccidiostat poultry feed additive on implications of preventive antibiotic use restrictions under the EU Medicated Feed Regulation 2019/4; Pursued infringement proceedings against EEA State 'Buy national' fish campaign constituting a measure having an equivalent effect to an import restriction; Reviewed terms of EU sales agreement concerning U.S. retailer's sports nutrition products to ensure EU food, competition, and commercial law compliance; Appealed Decisions of the European Chemicals Agency concerning REACH before its Board of Appeal (see, for example, Decisions A-011-2014, A-008-2015, A-026-2015); Challenged UK MHRA position on medical device classification of self-disinfecting examination glove on basis that active substance is not liable to act on human body; Guided offshore refining equipment producer in obtaining continued market access for in situ generated biocidal product preventing biofouling of offshore water systems; Advised hard drive manufacturer concerning improper affixture of CE mark, eco-design, and product information requirements under CE marking Directives; Compliance counsel to European life sciences trade associations, including advice on regulatory compliance, competition law compliance, and training and contract reviews

903694375

1981

Brigham Young University, B.A.

University of Idaho, J.D.