EFSA Publishes Opinion on the Potential Risks from Nanotechnologies Used on Food and Feed

On March 5, 2009, the European Food Safety Authority (EFSA) published a document entitled The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety, which provides its scientific opinion on the potential risks arising from nanoscience and nanotechnologies on food and feed safety. EFSA’s Scientific Committee (SC) concluded that established international approaches to risk assessment can also be applied to engineered nanomaterials (ENM).  The SC also concluded that a case-by-case approach would be necessary and that, in practice, current data limitations and a lack of validated test methodologies could make risk assessment of specific nano products very difficult and subject to a high degree of uncertainty. The opinion focuses on the use of nanotechnologies, particularly ENMs, in the food and feed chain.  It elaborates on approaches and methodologies available for risk assessment of these very small particles but does not address any specific applications of particular ENMs.

The EFSA SC recommends that additional research and investigation is needed to address the many current uncertainties and data limitations.  Specific recommendations include:

  • Investigating the interaction and stability of ENMs in food and feed, in the gastro-intestinal tract, and in biological tissues;
  • Developing and validating routine methods to detect, characterize, and quantify ENMs in food contact materials, food, and feed; and
  • Developing, improving and validating test methodologies to assess the toxicity of ENMs (including reliability and relevance of test methods).

 

EFSA Consults on Draft Opinion on Nanotechnologies and Food and Feed Safety

On October 17, 2008, the European Food Safety Authority (EFSA) began a public consultation on its draft scientific opinion in relation to nanoscience and nanotechnologies and food and feed safety.  EFSA’s draft opinion focuses on engineered nano materials (ENM) that could be deliberately introduced into the food chain and elaborates on approaches to risk assessment. EFSA states that it “is not an assessment of any specific application of ENM.” According to EFSA, the European Commission (EC) requested the opinion “as a first step because consideration needs to be given as to whether existing risk assessment approaches can be appropriately applied to this new technology.”  EFSA states that its final opinion “will then help the EC to explore appropriate measures, assess existing legislation and determine the scope of possible further requests for scientific opinions from EFSA in this field.” Comments are due December 1, 2008.

Key conclusions of the draft opinion include:

  • Established international approaches to risk assessment currently used for non nano chemicals can also be applied to ENM;
  • It is currently not possible to satisfactorily extrapolate scientific data on non nano chemicals and apply it to their nano-sized versions.  Consequently specific case-by-case risk assessments should be performed when assessing their safety, based on specific data from relevant safety tests applicable to the particular application;
  • Possible risks arise because ENM have particular characteristics, due in part to their small size and high surface area.  Small size increases their ability to move around in the body in ways that other substances do not, while their high surface area increases their reactivity; and
  • Additional limitations and uncertainties exist, particularly in relation to characterizing, detecting and measuring ENM in food, feed, or the body.  There is also limited information on absorption, distribution, metabolism, and excretion, as well as the toxicity of ENM.