The European Food Safety Authority (EFSA) has launched a open consultation on the Draft EFSA Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain. This document proposes a tiered approach to exposure assessment and hazard assessment for on human and animal health.
The draft guidance covers a range of possible nanomaterial distinctions as used e.g. in regulations (e.g. Novel foods) but also other descriptions of nanomaterials that can be used in food/feed. The guidance includes a flow chart developed in the EU NanoDefine project to facilitate the assessment of a nanomaterial.
The draft document has been prepared by an EFSA working group under the EFSA Scientific Committee.
A second part of the Guidance will address aspects relating to environmental risk assessment of nanosciences and nanotechnologies.
The EFSA public consultation is open until 4 March, 2018. In its usual fashion, NIA will launch a dedicated NIA Member Consultation to the draft EFSA Guidance.
Further information
http://www.efsa.europa.eu/en/consultations/call/180112
The World Health Organization (WHO) has published guidelines on protecting workers from potential risks of manufactured nanomaterialsof substances. The EC has posted the comments online. Further information at http://apps.who.int/iris/bitstream/10665/259671/1/9789241550048-eng.pdf?ua=1
The United States Federal Drug Administration has published a draft Guidance on Drug Products, Including Biological Products, that Contain Nanomaterials. This Guidance for Industry outlines potential risk factors for drugs containing nanomaterials. It also provides recommendations on quality aspects, environmental impact as well as guidance for both non-clinical and clinical testing. Read more at https://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM588857.pdf
The German Umweltbundesamt (Environment Protection Agency), has publisheda document “Clarification of methodical questions regarding the investigation of nanomaterials in the environment.” This results were included in the OECD Test Guideline on Dispersion stability of Nanomaterials in Simulated Environmental Media, which was approved in April 2017 and published in October 2017. Read more at https://www.umweltbundesamt.de/sites/default/files/medien/1410/publikationen/2017-12-04_texte_108-2017_environmental-behavior-nanomaterials.pdf
The Swedish Chemical Agency (KEMI) has published rules requiring companies to register information about nanomaterials to the Swedish Products Register. Read more at https://www.kemi.se/global/lagar-och-regler/kifs/kifs-20177/kifs-2017-7.pdf
The Organization for Economic Cooperation and Development (OECD) has published a summary dossier of the Testing Programme of Manufactured Nanomaterials on Silver Nanoparticles.
http://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=env/jm/mono(2017)31&doclanguage=en
