MAY/JUNE 2014

FOCUS ON NANOTECHNOLOGY

One ILSI Collaborative Paper on “Measurement of Nanomaterials in Foods: Integrative Consideration of Challenges and Future Prospects”

The ILSI Research Foundation, ILSI North America and ILSI Southeast Asia Region jointly supported the publication of a paper on “Measurement of Nanomaterials in Foods: Integrative Consideration of Challenges and Future Prospects” in the April 2014 edition of the journal ACS NANO. The paper provides an overview of the current status and knowledge gaps for detection and analytical methodologies used to measure nanomaterials in food that can provide relevant information to support safety assessment procedures. The paper is a direct output of the NanoRelease Food Additive project facilitated by the ILSI Research Foundation’s Center for Risk Science Innovation and Application (RSIA). It also follows the previous work undertaken by the ILSI Europe Task Force on Novel Foods and Nanotechnology, which looked at developing approaches to the safety assessment of engineered nanomaterials in food.

NEWS AND RESEARCH

Defining ‘Nano’ – International Regulatory Developments

Anticipating the future use of nanotechnology in food production, a number of governments around the world, including the USA, Australia-New Zealand and European Union, have started to address pertinent regulatory questions that relate to the use of nanomaterials in food. One of these issues relates to the development of a science-based regulatory definition, which has proven to be a highly complex and challenging undertaking. In this regard, both the US Food and Drug Administration (FDA) and Food Standards Australia New Zealand (FSANZ) have not developed regulatory definitions for nanomaterials in food, but instead consider specific aspects including particle size in combination with physico-chemical properties or biological novelty to determine whether a product or substance contains nanomaterials that require further scrutiny. On the other hand, the European Commission has developed a preliminary recommendation for a regulatory definition of nanomaterials in 2011, which is expected to be further reviewed again by December 2014 taking into account new scientific knowledge and experience since its initial proposal. A regulatory definition for ‘engineered nanomaterials’ in food was further proposed in Commission Delegated Regulation No. 1363/2013 amending EU Regulation No.1169/2011, which relates to the requirement to label nanomaterials for food products. However, this proposal was rejected by the European Parliament.

Updates on International Perspectives on Risk Assessment of Nanomaterials in Food

Through an amendment to the Food Standards Handbook in 2008, FSANZ was among the first government agencies worldwide to describe additional data requirements to be submitted to facilitate safety assessment of food substances that may contain nanomaterials, particularly in cases where particle size is important to achieve its technological function or may relate to a difference in toxicity. In 2010, the Food Safety Commission of Japan  published a survey report on the types of safety assessment information that would be relevant for the use of nanotechnology in food, which also identified the existing available data that could be used for this purpose as well as knowledge gaps. The European Food Safety Authority outlined its risk assessment procedures through the publication of its ‘Guidance on the risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain’ in 2011. More recently in 2012, the US FDA also outlined in a Draft Guidance some of the issues that would be considered when the application of nanotechnology for the manufacture of food substances results in significant alterations of its attributes that could warrant additional or different evaluation of its safety.

International Workshops and Reports on Nanomaterials in Food

Over the last several years, a number of international institutes and agencies have organized workshops and published reports on issues concerning the use of nanotechnology in food. In 2008, the Institute of Medicine (IOM) held a workshop on ‘Nanotechnology in Food Products’ to discuss the different applications of nanotechnology in food, the relevant safety and efficacy issues, as well as the need education of consumers on the application of nanotechnology in food. The workshop summary is available here.

In 2009, the Food and Agriculture Organization of the United Nations (FAO) and World Health Organization (WHO) also organized the Joint FAO/WHO Expert Meeting on the Application of Nanotechnologies in the Food and Agriculture Sectors: Potential Food Safety Implications, which covered issues relating to risk assessment issues and global guidances on adequate and accurate methods to assess potential food safety risks that may arise from nanoparticles . FAO and WHO further provided a global update on these issues in 2013, through the publication of a comprehensive report on the ‘State of the art on the initiatives and activities relevant to risk assessment and risk management of nanotechnologies in the food and agriculture sectors’.

Status of Risk Perception Research on Nanotechnology

Recognizing the important role of societal acceptance in determining the successful adoption of emerging technologies such as nanotechnology, a great deal of research is currently ongoing focusing on risk perception for nanotechnology. The journal Nature Nanotechnology has a special focus on Public Perceptions and Nanotechnology, while a Special Series on Nanotechnology Risk Perceptions and Communication was also published in the journal Risk Analysis in 2011. Additionally, the ILSI Europe Task Force on Consumer Science has supported the publication of a review on consumer responses to novel agri-food technologies, which includes nanotechnology. Comparative studies looking at societal responses to nanotechnology across countries have also been conducted, including in Singapore, focusing on both expert views as well as public attitudes.