Catherine R. Nielsen

Representative Matters: Assisted multiple plastics manufacturers in conducting risk assessments of non-intentionally added substances/impurities in Europe and in the U.S., respectively; Achieved multiple clearances of additives, polymers, and can coatings through the successful prosecution of numerous Food Contact Notifications (FCNs) in the U.S.; Audited the regulatory compliance of a client's products for sales into food and drug packaging in the U.S. and Canada, based on a review of client's and suppliers' records, formulations, and compliance statements; Guided a major polymer producer in communications with FDA on changes in manufacture to a food contact substance, avoiding the need for a new FCN submission; Counseled a major producer of a food contact polymer on its recall obligations and strategy, in the wake of a significant leak in a processing chemical during production; Achieved FDA regulatory compliance of a color additive for cosmetic applications under Part 74 of FDA's regulations; Oversaw the generation of a No Significant Risk Level (NSRL) under California Proposition 65, in the absence of an Office of Environmental Health Hazard Assessment (OEHHA) level, and evaluated compliance of resin product with Prop. 65 based on that assessment; Conducted training seminars for clients on food contact regulations in the U.S., Europe, China, MERCOSUR, and India