European efforts to determine potential nanotechnology impact on food safety

As a first step in this exercise, the Commission has asked the European Food Safety Authority (EFSA) to prepare a scientific opinion in order to identify the needs for risk assessment, to assess the appropriateness of methods for risk assessment, and to perform an assessment of the potential risks posed by nanoscience and nanotechnologies in the food and feed area, and assess the appropriateness of current risk assessment methods. This comes on top of various European Commission initiatives that establish a framework for the Health & Consumers Protection Directorate-General action on nanotechnologies:

• The European Action Plan on Nanosciences and nanotechnologies: An action plan for Europe 2005-2009, adopted on 7 June 2005, defines a “safe, integrated, and responsible approach” for nanotechnologies. The Commission adopted on 6 September 2007 a report for the European Parliament on the implementation of the Action Plan.
• Moreover, the 7th EC Framework Program for Research, Technological Development and Demonstration Activities allocates 3.5 billion euros for nanotechnologies in support to the Action Plan, part of which will finance research on safety.
• Recently, the European Group on Ethics produced an opinion on ethical issues in nanomedicine (pdf download, 4.1 MB).
• The Commission adopted on 17 June 2008 a Communication on the Regulatory Aspects of Nanomaterials, which is a legislative review on the suitability of the existing regulation for nanotechnologies.
• Finally, the services of the Commission are involved in international activities (OECD, Transatlantic Dialogue, etc.).

The just released "Draft Opinion" (pdf download, 176 KB) addresses engineered nanomaterials. Food and feed are addressed together, since the basic aspects (applications and potential impacts) are expected to be similar.

Following the recent literature ("Applications and implications of nanotechnologies for the food sector" – this review summarizes nanotechnology applications that are expected to bring a range of benefits to the food sector, including new tastes, textures and sensations, less use of fat, enhanced absorption of nutrients, improved packaging, traceability and security of food products), the EFSA document describes five broad categories of nanotechnology applications in the food and feed sector.

1. Where nanotechnology processes and materials have been employed to develop food contact materials. This category includes nanomaterial-reinforced materials (also referred to as nanocomposites), active food contact materials designed to have some sort of interaction with the food or environment surrounding the food, and coatings providing surfaces with nanomaterials or nanostructures.
2. Where food/feed ingredients have been processed or formulated to form nanostructures. This category includes applications that involve processing food ingredients at nanoscale to form nanostructures or nano-textures to enhance taste, texture, and consistency of the foodstuffs.
3. Where nano-sized, nano-encapsulated, or engineered nanomaterials ingredients have been used in food/feed. This category includes nanoscale ingredients, including additives (such as colorants, flavorings, preservatives) and processing aids (including nano-encapsulated enzymes) that can be produced for a variety of uses.
4. Biosensors for monitoring condition of food during storage and transportation. This category includes packaging which include indicators.
5. Other indirect applications of nanotechnologies in the food and feed area, such as the development of nanosized agro-chemicals, pesticides, or veterinary medicines.

EFSA's opinion is generic in nature and is in itself not a risk assessment of nanotechnologies as such or of tentative applications or possible uses thereof or of specific products. The document's authors also point out that there is as yet no overview of possible food or feed nanotechnology products that may be present on the EU market. Key conclusions of the draft opinion include:

• Established international approaches to risk assessment currently used for non nanochemicals can also be applied to engineered nanomaterials
• 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 engineered nanomaterials 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
• Additional limitations and uncertainties exist, particularly in relation to characterizing, detecting and measuring engineered nanomaterials in food, feed or the body. There is also limited information on absorption, distribution, metabolism and excretion, as well as the toxicity of engineered nanomaterials

In line with EFSA’s policy on openness and transparency and in order for EFSA to receive comments from the scientific community and stakeholders on its work, EFSA invites public comments on this draft opinion. Interested parties are invited to submit comments and pertinent scientific information by December 1st, 2008, 17:00 CET.

Source: Nanowerk