EFSA publishes opinion on the potential risks arising from nanotechnologies on food and feed safety
EFSA is today publishing its scientific opinion Opinions include risk assessments on general scientific issues, evaluations of an application for the authorisation of a product, substance or claim, or an evaluation of a risk assessment on nanoscience The study of nanomaterials and nanotechnologies in relation to food and feed safety. EFSA’s Scientific Committee (SC) has concluded that established international approaches to risk assessment A specialised field of applied science that involves reviewing scientific data and studies in order to evaluate risks associated with certain hazards. It involves four steps: hazard identification, hazard characterisation, exposure assessment and risk characterisation[1] can also be applied to engineered nano materials (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 Scientific concept used in risk assessment to describe all types of limitations in available knowledge at the time an assessment is conducted, with the agreed resources, that affect the probability of possible outcomes to the assessment.
This 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 European Commission (EC) asked for this opinion because consideration needs to be given as to whether existing risk assessment approaches can be appropriately applied to this new technology.
The EFSA SC recommends that additional research and investigation is needed to address the many current uncertainties and data limitations. Specific recommendations include the following:
- 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, characterise and quantify ENMs in food contact materials, food and feed
- Developing, improving and validating test methodologies to assess toxicity The potential of a substance to cause harm to a living organism of ENMs (including reliability and relevance of test methods)
Prof Vittorio Silano, chair of EFSA’s Scientific Committee, said:
“The Scientific Committee has concluded that in principle it is possible to undertake risk assessments in this emerging scientific area by making use of available international approaches. However, given current data gaps and limitations in a number of cases, it may be very difficult to provide fully satisfactory conclusions.
“This issue will remain a priority for EFSA’s Scientific Committee. We are establishing a working group of experts to be kept informed of any emerging scientific and other data that will help us deliver the best possible scientific opinions based on the most up-to-date evidence available. EFSA will take a cautious case-by-case approach and looks forward to further data and research becoming available to help inform future scientific opinions.”
EFSA’s SC, which includes the chairs of all of EFSA’s Panels, has undertaken this work as it has a multi-disciplinary character and is relevant to a number of the EFSA Panels’ respective areas of expertise. The SC has been assisted by a working group of scientists with relevant expertise. Feedback from a public consultation held during 2008 was taken into account before the final opinion was adopted by the SC.
EFSA’s opinion will 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. EFSA has already received a small number of such requests and is adopting the case-by-case approach.
The EC’s non-food, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) is also undertaking complementary work on approaches to risk assessment of nanotechnologies in the non food area. Their most recent opinion was adopted on19 January 2009, Risk assessment of products of nanotechnologies. Terms and definitions used in this opinion are based on those previously suggested by the SCENIHR (2007), as they are considered relevant for risk assessment.
For further information view the topic section on Nanotechnology
[1] Hazard identification The first step in risk assessment, this involves the identification of biological, chemical, and physical agents capable of causing adverse health effects, hazard characterisation The second step in risk assessment, this involves defining the nature of the adverse health effects associated with biological, chemical and physical agents which may be present in food. The process should, if possible, involve an understanding of the doses involved and related responses, exposure assessment One of the key steps in risk assessment, this relates to a thorough evaluation of who, or what, has been exposed to a hazard and a quantification of the amounts involved and risk characterisation The final stage of risk assessment, in which the likelihood that a particular substance will cause harm is calculated in the light of the nature of the hazard and the extent to which people, animals, plants and/or the environment are exposed to it, (Codex Alimentarius, 1999: Principles and Guidelines for the Conduct of Microbiological Risk Assessment. CAC/GL-3-,7 and European Commission, 2003:. Second report on harmonisation of risk assessment procedures by the Scientific Steering Committee (SSC). Appendix 3: Report on risk assessment of food borne bacterial pathogens: a quantitative methodology relevant for human exposure Concentration or amount of a particular substance that is taken in by an individual, population or ecosystem in a specific frequency over a certain amount of time assessment).
Links to science
How to contact us
EFSA Media Relations Office
Tel. +39 0521 036 149
E-mail: press [at] efsa.europa.eu (Press[at]efsa[dot]europa[dot]eu)
(Only if you are a member of the press)
Ask a Question Service
You have a question about EFSA’s work? Contact our Ask a Question service!