EFSA Intends to Prepare Inventory of Food Additives in the Area of Nanotechnologies

The European Food Safety Authority (EFSA) published in the October 10, 2012, Official Journal of the European Union a call for tender to prepare a background document on the current knowledge in the field of nanotechnology and prepare an inventory of food additives/food contact materials/feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used. According to the tender specifications, the tasks will include:

  • Performing an extensive literature search to summarize the knowledge in the field of nanotechnology applied to food and feed;
  • Producing inventory lists for each type of application (e.g., food additives, enzymes, flavorings, food contact material, novel foods, feed additives, and pesticides), including at least one inventory list for food additives, one for food contact materials, and one for feed additives applications of nanotechnologies currently used and/or reasonably foreseen to be used;
  • Reviewing the existing non-European Union (EU) legislation on the authorization of food additives/food contact materials/feed additives application in the area of nanotechnology; and
  • Preparing a final report.

The length of the contract will be one year and is not renewable. Responses were due November 23, 2012. EFSA estimates that the contract will be completed in January 2014.

EFSA Publishes Guidance for Assessing Engineered Nanomaterial Applications in Food and Feed

On May 10, 2011, the European Food Safety Authority (EFSA) published a guidance document for the risk assessment of engineered nanomaterial (ENM) applications in food and feed. According to EFSA, the guidance “is the first of its kind to give practical guidance for addressing potential risks arising from applications of nanoscience and nanotechnologies in the food and feed chain.” The guidance covers risk assessments for food and feed applications, including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides. EFSA’s Scientific Committee prepared the guidance in response to a request from the European Commission (EC). EFSA states that the guidance complements existing guidance documents for substances and products submitted for risk assessment in view of their possible authorization in food and feed. The guidance stipulates the additional data needed for the physical and chemical characterization of ENMs in comparison with conventional applications, and outlines different toxicity testing approaches to be followed by applicants. The guidance presents six scenarios outlining different toxicity testing approaches. For each scenario, the guidance indicates the type of testing required. EFSA states: “Risk assessment of engineered nanomaterials is under fast development and consequently, in keeping with EFSA’s commitment to review its guidance for risk assessment on an ongoing basis, this work will be revised as appropriate.”

EFSA Begins Public Consultation on Draft Guidance on Risk Assessment for Nanoscience and Nanotechnologies

On January 14, 2011, the European Food Safety Authority (EFSA) began a public consultation on a draft document entitled “Guidance on Risk Assessment Concerning Potential Risks Arising from Applications of Nanoscience and Nanotechnologies to Food and Feed.” According to EFSA, the draft guidance offers practical guidance for the risk assessment of applications involving the use of nanoscience and nanotechnology in the area of food and feed (including food additives, enzymes, flavorings, food contact materials, novel foods, feed additives, and pesticides). The draft guidance states that the general risk assessment paradigm is applicable for these applications, and consequently appropriate data and information for the various steps should be made available to the risk assessor to carry out a risk assessment. Adequate characterization of engineered nanomaterials (ENM) is essential for establishing its identity and physico-chemical forms in food/feed products. In cases in which transformation of the ENM into a non-nanoform in the food/feed matrix or in gastrointestinal fluids is judged to be complete, then EFSA guidance for non-nanoforms for the specific intended use should apply. The ENM covered by the draft guidance fall into two categories: (1) when a nanoform of an already approved non-nanoform with the same intended use in food/feed is produced; and (2) when a new ENM without a corresponding approved non-nanoform is produced. In the situation where there is an approved non-nanoform of a substance with the same intended use in food/feed, the aim of the draft guidance is to indicate the supplementary and specific data required on the potential additional hazards and risks that may arise from the nanoform. In the situation where the ENM persists in the food/feed matrix and in gastrointestinal fluids and has no approved non-nanoform application, toxicity tests on the ENM should follow the relevant EFSA guidance for its intended use, with some modifications in the testing due to the nanoproperties. Comments are due February 25, 2011.

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.

 

EFSA Calls for Data on Applications of Nanotechnology and Nanomaterials Used in Food and Feed

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.

EFSA Begins Review of Nanotechnology

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.

First Annual Nanotechnology Safety for Success Dialogue Held in October

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