Nanotechnology has the potential to innovate the agricultural, feed and food sectors (hereinafter referred to as agri/feed/food). Applications that are marketed already include nano-encapsulated agrochemicals or nutrients, antimicrobial nanoparticles and active and intelligent food packaging. Many nano-enabled products are currently under research and development, and may enter the market in the near future. As for any other regulated product, applicants applying for market approval have to demonstrate the safe use of such new products without posing undue safety risks to the consumer and the environment. Several countries all over the world have been active in examining the appropriateness of their regulatory frameworks for dealing with nanotechnologies. As a consequence of this, different approaches have been taken in regulating nano-based products in agri/feed/food. The EU, along with Switzerland, were identified to be the only world region where nano-specific provisions have been incorporated in existing legislation, while in other regions nanomaterials are regulated more implicitly by mainly building on guidance for industry. This paper presents an overview and discusses the state of the art of different regulatory measures for nanomaterials in agri/feed/food, including legislation and guidance for safety assessment in EU and non-EU countries.

Currently established and projected regulatory frameworks require the classification of materials (whether nano or non-nano) as specified by respective def

Determining composition, shape, and size of nanoparticles dispersed in a complex matrix is necessary in the assessment of toxicity, for regulatory actions, and environmental monitoring. Many types of nanoparticles that are currently used in consumer products contain more than one metal which are often not uniformly distributed (e.g., core–shell nanoparticles). This compositional and structural complexity makes their characterization difficult. In this study, we investigate the capability of single particle inductively coupled plasma mass spectrometry (spICP-MS) using time-of-flight (TOF) and quadrupole (Q) mass analyzers to determine the composition, size distribution, and concentration of a series of nanoparticles that are used in a variety of industrial applications: BiVO₄, (Bi_0.5Na_0.5)TiO₃ and steel (which contains Fe, Cr, Ni, Mo) nanoparticles. In addition, we tested both types of mass analyzers with Au-core/Ag-shell nanoparticles, which are well-characterized and have already been used for assessment of multi-element capabilities of spICP-MS. The results confirm that both types of mass analyzers produce accurate estimations of the size of Au-core/Ag-shell particles. For other multi-element nanoparticles, spICP-MS provided the size of aggregates and/or agglomerates in the prepared suspensions. In general, particle size detection limits (d_LOD) of spICP-TOFMS instruments with values of 29 nm for Ti, 14 nm for Mo, and 7 nm for Au, are smaller than those obtained for the quadrupole instruments. This study finds that only spICP-TOFMS can accurately assess the elemental composition of nano-steel particles. By contrast, spICP-QMS is limited to the detection of 2 elements in an individual particle and the elemental composition of nano-steel particles is less accurate. In general, spICP-TOFMS was able to quantify multiple elements with high precision and that currently makes it the first choice for multi-element detection of unknown nanoparticles.

Identifying nanomaterials (NMs) according to European Union legislation is challenging, as there is an enormous variety of materials, with different physico‐chemical properties. The NanoDefiner Framework and its Decision Support Flow Scheme (DSFS) allow choosing the optimal method to measure the particle size distribution by matching the material properties and the performance of the particular measurement techniques. The DSFS leads to a reliable and economic decision whether a material is an NM or not based on scientific criteria and respecting regulatory requirements. The DSFS starts beyond regulatory requirements by identifying non‐NMs by a proxy approach based on their volume‐specific surface area. In a second step, it identifies NMs. The DSFS is tested on real‐world materials and is implemented in an e‐tool. The DSFS is compared with a decision flowchart of the European Commission’s (EC) Joint Research Centre (JRC), which rigorously follows the explicit criteria of the EC NM definition with the focus on identifying NMs, and non‐NMs are identified by exclusion. The two approaches build on the same scientific basis and measurement methods, but start from opposite ends: the JRC Flowchart starts by identifying NMs, whereas the NanoDefiner Framework first identifies non‐NMs.