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EFSA Consults on Draft Guidance on Technical Requirements for Regulated Food and Feed Product Applications to Establish the Presence of Small Particles, Including Nanoparticles

The European Food Safety Authority (EFSA) has begun a public consultation on a draft document entitled “EFSA Guidance on Technical Requirements for Regulated Food and Feed Product Applications to Establish the Presence of Small Particles Including Nanoparticles.”  The draft Guidance sets out information requirements for applications in the regulated food and feed product areas and establishes criteria for assessing the presence of a fraction of small particles.  EFSA states that these requirements apply to particles requiring specific assessment at the nanoscale in conventional materials that do not meet the definition of engineered nanomaterial as set out in the Novel Food Regulation (EU) 2015/2283.  The draft Guidance outlines appraisal criteria, grouped in three sections, to confirm whether the conventional risk assessment should be complemented with nanospecific considerations.  The first group addresses solubility and dissolution rate as key physicochemical properties to assess whether consumers will be exposed to particles.  The second group establishes the information requirements for assessing whether the conventional material contains a fraction or consists of small particles, and its characterization.  The third group describes the information to be presented for existing safety studies to demonstrate that the fraction of small particles, including particles at the nanoscale, has been properly evaluated.  In addition, to guide the appraisal of existing safety studies, the draft Guidance provides recommendations for fulfilling the data gaps while minimizing the need for conducting new animal studies.  EFSA states that the draft Guidance complements the “Guidance on Nanoscience and Nanotechnology” adopted by the EFSA Scientific Committee in 2018.  It advises applicants to consult both guidance documents before conducting new studies.  Comments are due September 9, 2020.

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 195

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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

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 process allows her to develop client-focused strategies whether...

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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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