Nanotechnology Lawyer & Attorney : Bergeson & Campbell Law Firm : Nanotechnology Law Blog

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).

 

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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.

 

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On January 23, 2008, the European Food Safety Authority (EFSA) issued a notice entitled “Call for Scientific Data on Applications of Nanotechnology and Nanomaterials used in Food and Feed.” According to the notice, EFSA is seeking data that could be useful as it prepares an initial scientific opinion for the European Commission (EC) regarding the risks arising from nanoscience and nanotechnologies on food and feed safety and the environment. The EC asked EFSA to identify the nature of the possible hazards associated with actual and foreseen applications in the food and feed area, and to provide general guidance on data needed for the risk assessment of such technologies and applications. EFSA intends to release a draft of its opinion in July 2008. Data submissions to EFSA are due March 28, 2008.

EFSA requests data on the following issues:

• Data on the safety of nanomaterials used in food and feed;
• Food and feed applications and products containing or consisting of nanomaterials or produced by nanotechnology;
• Methods, procedures, and performance criteria used to analyze nanomaterials in food and feed;
• Use patterns and exposure to humans and environment;
• Risk assessments performed on nanomaterials used in food and feed;
• Toxicological data on nanomaterials used in food and feed;
• Environmental studies performed on nanotechnologies and nanomaterials used in food and feed; and
• Other data of relevance for risk assessment of nanotechnology and nanomaterials in food and feed.

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The European Food Safety Authority (EFSA) met the week of November 19, 2007, to begin reviewing the regulation and risk assessment of nanotechnology. The European Commission (EC) issued a mandate for a complete evaluation by March 31, 2008, but EFSA responded that, because of the range of differing properties and safety profiles, it will not be able to complete its review by this deadline. EFSA instead proposed to issue an initial scientific opinion by Summer 2008. EFSA intends to create a working group of 10 to 15 scientific experts. The Scientific Committee held its first discussion on the EFSA working strategy on November 19-20, 2007.

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On October 25-26, 2007, the European Commission (EC) held the First Annual Nanotechnology Safety for Success Dialogue. Presentations included:

• Food applications of nanoscience and nanotechnologies -- Ms. Sue O’Hagan, Confederation of the Food and Drink Industries of the European Union (CIAA);
• Consumer products applications of nanoscience and nanotechnologies -- Dr. Michael Holman, Lux Research;
• Health applications of nanoscience and nanotechnologies -- Dr. Carole Moquin-Pattey, European Science Foundation (ESF);
• Nanotechnology risk assessment: Knowns and unknowns -- Mr. Herman B.W.M. Koëter, Deputy Executive Director and Director of Science, European Food Safety Authority (EFSA);
• Nanoparticle toxicology: Scientific state-of-the-art -- Professor Ken Donaldson, University of Edinburgh;
• Nanomaterials. Risk assessment needs -- Professor Jim Bridges, Chair, Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR);
• The EU perspective on policy and regulatory aspects -- Mr. Kees Brekelmans; Enterprise and Industry Directorate General, “Consumer Goods” Directorate;
• Nanotechnology and the Food and Drug Administration:  Science and Policy -- Dr. Richard Canady, U.S. Food and Drug Administration (FDA); and
• The consumer perspective on applications of nanoscience and nanotechnologies -- Dr. Sue Davies, Chief Policy Advisor, Which?.

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