I. Introduction
Nanotechnologies have been valorized as one of the platform technologies of the twentieth century, where their resulting applications and products span converging scientific disciplines, industries, and markets.
The growth of nanotechnology as a niche market segment is dynamically receptive of more innovation into the base industries, mainly electronic and electric products, energy and environment, automotive, and food and agriculture. The segment of food nanotechnology in the global market is forecast to grow more than 24% between 2020 and 2023.1 Over 180 applications in diverse products have already entered the market, with more than 200 products coming from the food and agriculture sector.2 In the food market, the scale of nano-based products is likely to witness an exponential climb and reach more than 50% of the current world population.Concerns over the safety of nanomaterials have progressively grown with the volume of commercialized nanofood products in the market. This has called food safety authorities around the world to review the adequacy of existing regulatory frameworks to manage the risk and safety concerns posed by food cultivated, produced, processed, and packaged using nanotechnology and nanomaterials. Food safety authorities in the the Association of Southeast Asian Nations (ASEAN) region maintain the regulatory status quo that the current food laws are elastic enough to accommodate nanotechnology applications and products in food. This position is consistent with the findings of various scientific and regulatory reports that nanotechnology itself is not being viewed as “new” from a policy and regulatory perspective unless there is safety assessment
1 “Global Food Nanotechnology Market 2019—2023”, Business Wire, available at www.businesswire. com/news/home/20190610005263/en/Global-Food-Nanotechnology-Market-2019-2023- Growing-Applications (last accessed Aug.
15, 2020).2 See, for instance, Nanodatabase, available at https://nanodb.dk (last accessed Oct. 30, 2020); Nanotechnology Consumer Product Inventory, available at https://nanotechproject.org (last accessed Oct. 30, 2020).
DOI: 10.4324/9781003271918-14 data showing a new risk to human health.[606] Despite the insufficiency of safety data, food safety authorities are conscious of the gaps they might encounter in utilizing legal authority under the food law and the limitations of the current risk assessment methodologies on nanofood products.
This chapter will discuss the role of law in controlling and creating (new) regulatory space for the use of nanomaterials under the food law. The discussion is divided into three sections. Section II begins by providing context around the applications of nanotechnologies and potential safety issues associated with them. Section III elaborates on the regulatory practices of food safety law in the European Union (EU) and the United States (US) context relating to products and specified conditions of use in food incorporating nanomaterials such as additives, flavorings, and enzymes. Regulatory responses among ASEAN member countries on the safe use of nanoscale substances in food are deliberated on in Section IV The deliberation looks at how food regulations have evolved in making substantive changes and responses on the market authorization procedures involving nanofood, particularly the intended condition of use of pre-market requirements and the appropriateness of conventional safety assessments to nanofood. It concludes that the principles and practices of food safety law in the ASEAN region are robust enough to cover nanofood in wide product classes and for any newly developed novel food materials, including nanofood. While there are some differences in national food legislation regarding product classification and the need for pre-market authorization, it would not be likely to cause any discriminatory barrier to the free movement of products within the region or the importation of nanofood products from a third country.
II.
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