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EFSA publishes scientific opinion on the ‘Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety’
Published: Thursday 5 March 2009
The European Food Safety Authority (EFSA) has published a final opinion on nanotechnologies in food and feed; entitled ‘The Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety’ (Scientific Opinion of the Scientific Committee on a request from the European Commission on the Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety. The EFSA Journal (2009) 958, 1-39), the Opinion is based on a draft opinion, which underwent to a public consultation in October/November 2008 (the NIA submitted detailed comments on the draft opinion, developed in collaboration with the of the Food and Drink Industries in the EU (CIAA), follow this link to download EFSA's Technical Report on the Outcome of Public Consultation on the EFSA Draft Nanotechnology
Opinion, or to download a Table of Public Comments on the EFSA Draft Nanotechnology Opinion).
- It is claimed that nanotechnologies offer a variety of possibilities for application in the food and feed area [...]
- Formulation at the nanosize may change the physico-chemical characteristics of materials as compared to the dissolved and micro/macroscale forms of the same substance. [...]
- The risk assessment paradigm (hazard identification, hazard characterization, exposure assessment and risk characterization) is considered applicable for ENMs. However, risk assessment of ENMs in the food and feed area should consider the specific properties of the ENMs in addition to those common to the equivalent non-nanoforms. [...]
- The risk assessment of ENMs has to be performed on a case-by-case basis.
- Current toxicity-testing approaches used for conventional materials are a suitable starting point for risk assessment of ENMs. However, the adequacy of currently existing toxicological tests to detect all aspects of potential toxicity of ENMs has yet to be established. Toxicity-testing methods may need methodological modifications. [...]
- For hazard characterization, the relationship of any toxicity to the various dose metrics that may be used is currently discussed and several dose metrics may need to be explored in addition to mass.
- Appropriate data for risk assessment of an ENM in the food and feed area should include comprehensive identification and characterization of the ENM, information on whether it is likely to be ingested in nanoform, and, if absorbed, whether it remains in nanoform at absorption. [...]
- Although, case-by-case evaluation of specific ENMs may be currently possible, the Scientific Committee wishes to emphasise that the risk assessment processes are still under development with respect to characterisation and analysis of ENMs in food and feed, optimisation of toxicity testing methods for ENMs and interpretation of the resulting data. [...] The limited database on assessments of ENMs should be considered in the choice of appropriate uncertainty factors.
This first opinion will allow the Commission to explore appropriate measures, assess existing legislation and determine the scope of possible further requests for scientific opinions.
The EFSA SC made a number of recommendations, including the following:
In relation to applications of nanotechnologies in the food/feed area it is recommended to:
- Monitor current and future commercial applications of ENMs in the food and feed sectors and developments of nanotechnologies, especially since more complex ENMs may be foreseen.
Follow these links to find out more about EFSA’s brief on nanotechnology, to read the launch press release on the EFSA website, to download the Opinion (both Summary and full Opinion available in PDF format), to download the Technical Report on the Consultation Outcome, or the Table of Public Comments.