December 13, 2018

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December 11, 2018

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EFSA Publishes New Guidance on Nanotechnologies in Food and Feed

The European Food Safety Authority (EFSA) issued a July 4, 2018, press release announcing the availability of new guidance on how to assess the safety of nanoscience and nanotechnology applications.  The guidance covers novel foods, food contact materials, food and feed additives, and pesticides, taking into account new developments that have taken place since publication of the previous guidance in 2011.  Potential future developments suggested in the scientific literature include nanoencapsulated delivery systems and nanocomposites in applications such as novel foods, food/feed additives, biocides, pesticides, and food contact materials.  Therefore, EFSA states, the guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment, and hazard characterization of nanomaterials.  It specifically elaborates on the physicochemical characterization of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterization of nanomaterials, and their determination in complex matrices.  The guidance also details the aspects relating to exposure assessment and hazard identification and characterization.  In particular, the guidance discusses nanospecific considerations relating to in vivo/in vitro toxicological studies, and outlines a tiered framework for toxicological testing.  It describes in vitro degradation, toxicokinetics, and genotoxicity, as well as general issues relating to testing of nanomaterials.  Depending on the initial tier results, EFSA states that studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, allergenicity, neurotoxicity, effects on gut microbiome, and endocrine activity.  The guidance also discusses the possible use of read-across to fill data gaps, as well as the potential use of integrated testing strategies and the knowledge of modes/mechanisms.  The guidance proposes approaches to risk characterization and uncertainty analysis, and provides recommendations for further research in this area.  EFSA notes that the guidance is intended for all interested parties — in particular risk assessors, risk managers, and applicants.  According to EFSA, the guidance will now enter a pilot phase, with a final guidance envisioned by the end of 2019.  EFSA will develop a second guidance in 2019 focusing on the environmental risk assessment of nanoscience and nanotechnology applications in the food and feed chain.

©2018 Bergeson & Campbell, P.C.

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About this Author

Lynn Bergeson, Campbell PC, Toxic Substances Control Act Attorney, federal insecticide lawyer, industrial biotechnology legal counsel, Food Drug Administration law
Managing Partner

Owner of Bergeson & Campbell, P.C. (B&C®), Lynn L. Bergeson has earned an international reputation for her deep and expansive understanding of the Toxic Substances Control Act (TSCA), the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), European Union Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), and especially how these regulatory programs pertain to nanotechnology, industrial biotechnology, synthetic biology, and other emerging transformative technologies. Her knowledge of and involvement in the policy...

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Carla Hutton, Bergeson Campbell PC, global regulatory attorney, public health activists lawyer, metals industry legal counsel, Toxic Substances Control Act law
Regulatory Analyst

Since 1996, Carla Hutton has monitored, researched, and written about regulatory and legislative issues that may potentially affect Bergeson & Campbell, P.C. (B&C®) clients. She is responsible for creating a number of monthly and quarterly regulatory updates for B&C's clients, as well as other documents, such as chemical-specific global assessments of regulatory developments and trends. She authors memoranda for B&C clients on regulatory and legislative developments, providing information that is focused, timely and applicable to client initiatives. These tasks have proven invaluable to many clients, keeping them aware and abreast of developing issues so that they can respond in kind and prepare for the future of their business.

Ms. Hutton brings a wealth of experience and judgment to her work in federal, state, and international chemical regulatory and legislative issues, including green chemistry, nanotechnology, the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), the Toxic Substances Control Act (TSCA), Proposition 65, and the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) program.

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