October 27, 2020

Volume X, Number 301

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October 27, 2020

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October 26, 2020

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EFSA Calls for Grant Proposals on the Use of NAMs for the Hazard Assessment of Cellulose Nanofibers

On September 15, 2020, the European Food Safety Authority (EFSA) called for grant proposals on the use of new approach methodologies (NAM) for the hazard assessment of cellulose nanofibers.  EFSA states that the use of cellulose at the nanoscale is increasing and requires an assessment.  According to EFSA, the main concern is that the nanoscale characteristics (e.g., length/shape of the fibers) may influence the toxicokinetic and hazardous properties of cellulose nanofibers.  The main objective of the call is to design and conduct a set of NAM-based studies for addressing the current data gaps and to offer a proposal for including the results in the regulatory hazard assessment of nanocellulose for consumers exposed via food.  The studies should cover the three main areas identified by EFSA:

  • Digestion or degradation, including surface modifications, of nanocellulose by the human microbiome;

  • Assessment of nanocellulose uptake in human intestinal epithelia; and

  • Assessment of local effects, including inflammation, of nanocellulose on the gastrointestinal epithelia.

All studies should be designed using NAMs, avoiding in vivo animal studies, and should specifically address the nanoscale properties.  EFSA states that the studies should also be designed for maximizing the use of the results in the regulatory context, including internal validation protocols and a detailed level of reporting, including access to the raw data for the verification of the results during the regulatory assessment.  The call includes two lots, and applicants may apply to one or both lots:

  • Lot 1 covers the adaptation and use of human cellular models and in vitro microbial gastrointestinal tract (GIT) digestion systems; and

  • Lot 2 focuses on the use of gut-on-a-chip models replicating GIT motility.

The call is restricted to the list of competent organizations established by EFSA’s Management Board.  Proposals are due November 3, 2020.  ECHA expects to notify applicants of the outcome of the call in December 2020.

 

©2020 Bergeson & Campbell, P.C.National Law Review, Volume X, Number 263
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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.

202-557-3809
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