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EFSA Publishes Part 1 of Draft Guidance on Risk Assessment of Nanoscience and Nanotechnology Applications in the Food and Feed Chain

The European Food Safety Authority (EFSA) has published Part 1 of a draft Guidance on risk assessment of nanoscience and nanotechnology applications in the food and feed chain that proposes to update a 2011 guidance document on this topic. Part 1 of the draft Guidance focuses on. Part 2 will address environmental risk assessment.

Noting that nano-specific data is not always provided for food contact materials (FCMs) and food/feed additives that include nanomaterials assessed by its Panels, EFSA explains that “[t]he use of a nanomaterial in food/feed and related applications will need to be assessed for safety to fulfil requirements of the relevant EU food laws, and in accordance with the provisions of this Guidance.”

The draft Guidance considers scientific developments that have taken place since publication of the 2011 guidance. In particular, it details nano-specific considerations related to in vivo and in vitro toxicological studies and outlines a tiered framework for toxicological testing. The draft Guidance also discusses how to establish whether a material is a nanomaterial, how to conduct an exposure assessment, and hazard identification and characterization.

The draft Guidance provides the following guidance summary for FCMs:

  • Detailed physicochemical characterization of the nanomaterial used as additive or applied as a surface coating on a food contact material must be provided;
  • Exposure to a nanomaterial must be assessed based on the experimental data on migration or transfer from a FCM to food. Potential release of the nanomaterial from the FCM due to mechanical stress or physical disintegration of a FCM polymer matrix should also be considered;
  • Appropriate techniques should be used to both quantitatively and qualitatively determine the migrating species, and to establish whether they are in nanoparticulate or solubilized/degraded form; and
  • A case may be made for exemption from carrying out toxicological investigations where it can be shown that either the migrating species are not in nanomaterial form (in that case standard risk assessment should apply), or migration of the nanomaterial is only in trace amounts.

The conclusions in the draft Guidance also highlight, inter alia, the following points that may be of particular relevance for FCMs:

  • Irrespective of the presence of a nanomaterial, the existing requirements for safety assessment per EFSA Guidances for conventional non-nanomaterials under relevant regulations must be followed (for example, in the case of FCMs, this would include EFSA’s Note for Guidance for the preparation of an application for the safety assessment of a substance to be used in plastic food contact materials, as last updated on May 8, 2017);
  • The existing risk assessment paradigm for chemicals is also applicable to nanomaterials. However, testing of nanomaterials needs consideration of certain nanospecific aspects that have been highlighted in this draft Guidance;
  • The draft Guidance proposes a structured pathway for carrying out safety assessments of nanomaterials in food/feed and related applications, and provides practical suggestions for the types of testing needed and the methods that can be used for this purpose; and
  • The draft Guidance also highlights certain gaps where further research is needed to facilitate adequate safety assessment of materials that consist of small-sized particles.

Written comments on the draft Guidance are due by March 4, 2018. Details on how to submit comments can be found on EFSA’s website.

© 2018 Keller and Heckman LLP

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Keller and Heckman offers global food and drug services to its clients. Our comprehensive and extensive food and drug practice is one of the largest in the world. We promote, protect, and defend products made by the spectrum of industries regulated by the U.S. Food and Drug Administration (FDA), the European Commission and Member States authorities in the European Union (EU) and similar authorities throughout the world. The products we help get to market include foods, pharmaceuticals, medical devices, veterinary products, dietary supplements, and cosmetics. In addition...

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