Comparative assessment of nanomaterial definitions and safety evaluation considerations.

Background Nanotechnology applications can be found in agricultural production, animal feed, food processing, food additives and food contact materials (hereinafter referred to as agri/feed/food). A great diversity of nanomaterials is reported to be currently used in various applications, while new nanomaterials and applications are reported to be in development. Scope and approach It is expected that applications of nanomaterials in agri/feed/food will increase in the future and thereby increase the human and environmental exposure to such materials. To gain up-to-date knowledge we explored and reviewed the already marketed and in-development applications of nanomaterials in the agri/feed/food sectors upon the request of the European Food Safety Authority (EFSA). In this paper the results of the project are highlighted and discussed in more detail. Key findings and conclusions The majority of the applications of nanomaterials that we identified concerned application in food as food additives and food contact materials, while much fewer applications seem to be developed for agriculture and feed. Nano-encapsulates, silver, titanium dioxide and silica are the most often mentioned nanomaterials in the literature. About half of the identified applications are claimed to be already in use. In-development applications are found for nano-encapsulates and nano-composites in novel foods, food and feed additives, biocides, pesticides and food contact materials.

Nanomaterials for products and application in agriculture, feed and food

Regulatory aspects of nanotechnology in the agri/feed/food sector in EU and non-EU countries.

The European Food Safety Authority has produced this Guidance on human and animal health aspects (Part 1) of the risk assessment of nanoscience and nanotechnology applications in the food and feed chain. It covers the application areas within EFSA's remit, e.g. novel foods, food contact materials, food/feed additives and pesticides. The Guidance takes account of the new developments that have taken place since publication of the previous Guidance in 2011. Potential future developments are suggested in the scientific literature for nanoencapsulated delivery systems and nanocomposites in applications such as novel foods, food/feed additives, biocides, pesticides and food contact materials. Therefore, the Guidance has taken account of relevant new scientific studies that provide more insights to physicochemical properties, exposure assessment and hazard characterisation of nanomaterials. It specifically elaborates on physicochemical characterisation of nanomaterials in terms of how to establish whether a material is a nanomaterial, the key parameters that should be measured, the methods and techniques that can be used for characterisation of nanomaterials and their determination in complex matrices. It also details the aspects relating to exposure assessment and hazard identification and characterisation. In particular, nanospecific considerations relating to in vivo/in vitro toxicological studies are discussed and a tiered framework for toxicological testing is outlined. It describes in vitro degradation, toxicokinetics, genotoxicity as well as general issues relating to testing of nanomaterials. Depending on the initial tier results, studies may be needed to investigate reproductive and developmental toxicity, immunotoxicity, allergenicity, neurotoxicity, effects on gut microbiome and endocrine activity. The possible use of read-across to fill data gaps as well as the potential use of integrated testing strategies and the knowledge of modes/mechanisms of action are also discussed. The Guidance proposes approaches to risk characterisation and uncertainty analysis, and provides recommendations for further research in this area.

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Guidance on risk assessment of the application of nanoscience and nanotechnologies in the food and feed chain: Part 1, human and animal health.

Many products used in everyday life are made with the assistance of nanotechnologies. Cosmetic, pharmaceuticals, sunscreen, powdered food are only few examples of end products containing nano-sized particles (NPs), generally added to improve the product quality. To evaluate correctly benefits versus risks of engineered nanomaterials and consequently to legislate in favor of consumer’s protection, it is necessary to know the hazards connected with the exposure levels. This information implies transversal studies and a number of different competences. On analytical point of view the identification, quantification and characterization of NPs in food matrices and in cosmetic or personal care products pose significant challenges, because NPs are usually present at low concentration levels and the matrices, in which they are dispersed, are complexes and often incompatible with analytical instruments that would be required for their detection and characterization. This paper focused on some analytical techniques suitable for the detection, characterization and quantification of NPs in food and cosmetics products, reports their recent application in characterizing specific metal and metal-oxide NPs in these two important industrial and market sectors. The need of a characterization of the NPs as much as possible complete, matching complementary information about different metrics, possible achieved through validate procedures, is what clearly emerges from this research. More work should be done to produce standardized materials and to set-up methodologies to determine number-based size distributions and to get quantitative date about the NPs in such a complex matrices.

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Nanomaterials in consumer products: a challenging analytical problem.

This report provides the JRC assessment of feedback on the experiences of stakeholders with the EC nanomaterial definition, published in 2011 (EC Recommendation 2011/696/EU). The report is a follow-up report of the previous JRC report (EUR 26567 EN, 2014), which compiled feedback collected by JRC in 2013 and early 2014, partly through a dedicated survey. Based on the current report, JRC will prepare a set of recommendations for the revision of the EC nanomaterial definition, as part of the review process foreseen in the 2011 EC Recommendation. JRC Scientific and Policy Report Towards a review of the EC Recommendation for a definition of the term "nanomaterial" Part 2: Assessment of collected information concerning the experience with the definition

Towards a review of the EC Recommendation for a definition of the term "nanomaterial"Part 2: Assessment of collected information concerning the experience with the defintion

Towards a review of the EC Recommendation for a definition of the term "nanomaterial"; Part 1: Compilation of information concerning the experience with the definition

This report provides the JRC's scientific-technical evaluation of options to clarify the EC Recommendation on a definition of nanomaterial, published in 2011 (EC Recommendation 2011/696/EU). It is a follow-up report of two previous JRC publications, which compiled feedback on the experiences of stakeholders with the EC nanomaterial definition collected by JRC in 2013 and early 2014 (EUR 26567 EN, 2014), and provided an assessment of the collected information (EUR 26744 EN, 2014). The three JRC reports are part of the review process foreseen in the 2011 EC Recommendation. The evaluation shows that the scope of the definition regarding the origin of nanomaterials should remain unchanged, addressing natural, incidental as well as manufactured nanomaterials. Moreover, because of the regulatory purpose of the definition, there is little evidence to support deviating from size as the sole defining property of a nanoparticle or from the range of 1 nm to 100 nm as definition of the nanoscale. Besides the need for clarification of some terms used in the definition additional implementation guidance would be useful. The role of the volume specific surface area deserves clarification and a method to prove that a material is not a nanomaterial would be helpful. A strategy how to avoid unintended inclusion of materials and the list of explicitly included materials deserve also attention. Towards a review of the EC Recommendation for a definition of the term "nanomaterial" Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation Edited by Hubert Rauscher and Gert Roebben Authors Hubert Rauscher,* Gert Roebben,* Ana Boix Sanfeliu, Hendrik Emons, Neil Gibson, Robert Koeber, Thomas Linsinger, Kirsten Rasmussen, Juan Riego Sintes, Birgit Sokull-Klüttgen, Hermann Stamm

Towards a review of the EC Recommendation for a definition of the term "nanomaterial": Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation

Boix Sanfeliu Ana

Papers

Towards a review of the EC Recommendation for a definition of the term "nanomaterial"Part 2: Assessment of collected information concerning the experience with the defintion

Towards a review of the EC Recommendation for a definition of the term "nanomaterial"; Part 1: Compilation of information concerning the experience with the definition

Towards a review of the EC Recommendation for a definition of the term "nanomaterial": Part 3: Scientific-technical evaluation of options to clarify the definition and to facilitate its implementation