The European Food Safety Authority (EFSA) has begun a public consultation on its draft guidance on the preparation and presentation of an application for authorization of a novel food. As reported in our December 22, 2015, blog item, the European Commission (EC) promulgated a final novel foods regulation in December 2015. Under the regulation, food consisting of engineered nanomaterials should be considered a novel food. EFSA intends the draft document to provide guidance on the data needed to carry out the safety assessments of novel foods. The draft guidance states that, for foods consisting of “engineered nanomaterials,” the parameters for characterization and identification of engineered nanomaterials outlined in the EFSA Scientific Committee Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain should be provided. According to the draft guidance, where the novel food contains or consists of “engineered nanomaterials,” the applicant should consider the Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain from EFSA’s Scientific Committee. Comments are due April 21, 2016.
- Bergeson & Campbell, P.C.
- EFSA Begins Public Consultation on Draft Guidance on the ...
Synopsis Available for 2016 U.S.-EU: Bridging NanoEHS Research Efforts Joint Workshop
The synopsis is available for the June 6-7, 2016, U.S.-European Union (EU) Nano Environmental and Health Safety (NanoEHS) Research Efforts joint workshop. According to the synopsis, the first day of the workshop was devoted to an interactive nanoEHS scrimmage in which the groups collectively responded to a spill of a hypothetical nanotechnology-enabled product. U.S.-EU Communities of Research (COR) representatives planned the scrimmage, and the highlights and findings from the scrimmage are expected to be...
EFSA Publishes Nano Network 2015 Annual Report
The European Food Safety Authority (EFSA) published on January 11, 2016, the Scientific Network for Risk Assessment of Nanotechnologies in Food and Feed (Nano Network) annual report for 2015. The report states that, during 2015, the Nano Network followed-up on its four priority topics: (1) the need for an inventory of nanomaterials in products on the market; (2) the analysis and monitoring of products under development and on the market; (3) the need for suitable measuring methods, e.g., for physico-chemical...
Governance of new technologies: recommendations for responsible innovation in nanotechnology
Effective risk governance is important when developing new technologies. This study assessed the approaches to governance of nanotechnology in Europe, based on a comprehensive review of literature and practices, complemented by discussions with key stakeholders. The study provides a new analytical framework for exploring the strengths and weaknesses of governance strategies and makes recommendations specific to nanotechnology. Innovative technologies are key to tackling Europe’s societal challenges, from...
The Netherlands Publishes Report on Nanotechnologies in Medical Devices
The Netherlands National Institute for Public Health and the Environment (RIVM) posted on December 17, 2015, a report entitled Nanotechnologies in medical devices. RIVM conducted an investigation to provide insights into and an overview of the field of medical devices using nanotechnologies for products already on the market and for those expected within five years. According to the report, knowledge is evolving on the safety evaluation of nanomaterials in general, and thus also when used in medical devices. The...
EC invites scientists to apply for membership in SCCS and SCHEER
The European Commission (EC) invites scientists to apply for membership in its non-food scientific committees, the Scientific Committee on Consumer Safety (SCCS) and Scientific Committee on Health, Environmental and Emerging Risks (SCHEER). SCCS and SCHEER provide the EC with “high quality and independent risk assessment and scientific advice in the areas of public health, consumer safety and environmental risks.” SCCS provides opinions on questions concerning health and safety risks of non-food...