Craig Simpson counsels multinational corporations and trade associations in the life sciences sector on regulatory compliance of products marketed or produced in Europe (in the European Economic Area (EEA) and the United Kingdom) and on related commercial, contract, and competition matters. His practice focuses primarily on food and feed, chemicals, and product safety issues. 

Craig has particular experience in food and feed regulation, having advised in that area for over twenty years in both private practice and the public sector. He assists clients in identifying the regulatory status of food and feed products and their ingredients (including applicable pre-market authorisation requirements and restrictions), product positioning, compliance of product promotional materials with food information requirements (including claims), and in determining applicable hygiene and traceability obligations. He defends clients under enforcement investigation, including representing clients before national enforcement authorities in negotiating solutions to non-compliance situations in order to minimise sanctions, reputational damage, and business interruption. He also challenges unjustified national trade barriers hindering marketing of client food or feed products and represents clients before European institutions and in proceedings before European Courts and Boards of Appeal. 

Craig also has significant experience advising clients on market access and regulatory compliance matters concerning chemicals (REACH, Restriction of Hazardous Substances (RoHS), Persistent Organic Pollutants (POPs), Classification, Labelling and Packaging (CLP)), medical devices, biocidal products and CE marking, and on specific consumer protection and product safety requirements. This includes advising and providing training to a number of European life sciences trade associations on competition law compliance issues. 

Prior to joining Keller and Heckman, Craig worked for six years as a Senior Legal Officer in the Food and Veterinary Unit of the European Free Trade Association (EFTA) Surveillance Authority (ESA) pursuing infringement proceedings against EEA EFTA State laws or administrative practices constituting illegal trade barriers and advising on regulatory compliance issues under the EEA Agreement. Before joining ESA, Craig practised as Of Counsel in the life sciences group of an international law firm for thirteen years advising and representing multinational companies and European trade associations on EU regulatory compliance issues in the food and feed, chemicals, medical devices, biocidal products, and product safety areas.

Craig regularly lectures at industry conferences and trade association events and authors articles on legal developments affecting the life sciences industry. Click here for a list of recent speaking engagements and publications.

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

Memberships

• European Food Safety Authority, Former Member of the Management Board

Awards

• Previously recognized in the Legal 500 EMEA for EU Regulatory: Food 
• IRCA Certified Lead Auditor for ISO 22000: 2018 Food Safety Management Systems