Several scientific areas have benefited significantly from the introduction of nanotechnology and the respective evolution. This is especially noteworthy in the development of new drug substances and products. This review focuses on the introduction of nanomedicines in the pharmaceutical market, and all the controversy associated to basic concepts related to these nanosystems, and the numerous methodologies applied for enhanced knowledge. Due to the properties conferred by the nanoscale, the challenges for nanotechnology implementation, specifically in the pharmaceutical development of new drug products and respective regulatory issues are critically discussed, mainly focused on the European Union context. Finally, issues pertaining to the current applications and future developments are presented.

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Nanomedicine: Principles, properties, and regulatory issues

Single particle inductively coupled plasma mass spectrometry is an emergent ICPMS method for detecting, characterizing, and quantifying nanoparticles. Although the number of applications reported to date is limited, the relatively simple instrumental requirements, the low number concentration detection levels attainable, and the possibility to detect both the presence of dissolved and particulate forms of an element make this methodology very promising in the nanoscience related areas.

Single particle inductively coupled plasma mass spectrometry: a powerful tool for nanoanalysis.

Titanium dioxide (TiO2) is a common food additive used to enhance the white color, brightness, and sometimes flavor of a variety of food products. In this study 7 food grade TiO2 materials (E171), 24 food products, and 3 personal care products were investigated for their TiO 2 content and the number-based size distribution of TiO2 particles present in these products. Three principally different methods have been used to determine the number-based size distribution of TiO2 particles: electron microscopy, asymmetric flow field-flow fractionation combined with inductively coupled mass spectrometry, and single-particle inductively coupled mass spectrometry. The results show that all E171 materials have similar size distributions with primary particle sizes in the range of 60-300 nm. Depending on the analytical method used, 10-15% of the particles in these materials had sizes below 100 nm. In 24 of the 27 foods and personal care products detectable amounts of titanium were found ranging from 0.02 to 9.0 mg TiO2/g product. The number-based size distributions for TiO 2 particles in the food and personal care products showed that 5-10% of the particles in these products had sizes below 100 nm, comparable to that found in the E171 materials. Comparable size distributions were found using the three principally different analytical methods. Although the applied methods are considered state of the art, they showed practical size limits for TiO 2 particles in the range of 20-50 nm, which may introduce a significant bias in the size distribution because particles <20 nm are excluded. This shows the inability of current state of the art methods to support the European Union recommendation for the definition of nanomaterials. © 2014 American Chemical Society.

Characterization of titanium dioxide nanoparticles in food products: analytical methods to define nanoparticles.

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 Commission recently published its recommendation on a common definition of the term “nanomaterial” for regulatory purposes. Proper implementation of this definition requires appropriate tools and methodologies for which measurement aspects are crucial. This report describes the requirements for particle size measurements of nanomaterials based on the definition. It discusses the related generic measurement issues and reviews the capabilities of the measurement methods currently available. Moreover, it illustrates with practical examples the measurement issues that remain to be solved. This report does not cover other related issues, such as the implementation of the definition by means other than through measurements, or methods to detect specific nanomaterials (such as fullerenes and single-wall carbon nanotubes), measurements to assess exposure to or effects of nanomaterials, or the detection and measurement of nanomaterials in consumer products. These will be addressed in a follow-up report.

Requirements on measurements for the implementation of the European Commission definition of the term 'nanomaterial'

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

This report supports the implementation of the European Commission’s Recommendation on a definition of nanomaterial (2011/696/EU). It addresses its key concepts and terms and discusses them in a regulatory context. Corresponding to the broad scope of the definition the considerations in this report can be applied across all relevant legislative areas; they are not specific to any particular piece of legislation. The report provides recommendations for a harmonised and coherent implementation of the nanomaterial definition in any specific regulatory context at European Union and national level. GETTING IN TOUCH WITH THE EU

An overview of concepts and terms used in the European Commission's definition of nanomaterial

............................................................................................................................... 1 Table of contents................................................................................................................. 3 Glossary............................................................................................................................... 5

http://publications.jrc.ec.europa.eu/repository/bitstream/111111111/16161/1/reqno_jrc61819_119-2010.pdf%5b1%5d.pdf

Roebben Gert

Papers

Requirements on measurements for the implementation of the European Commission definition of the term 'nanomaterial'

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

An overview of concepts and terms used in the European Commission's definition of nanomaterial

Certification of Equivalent Spherical Diameters of Silica Nanoparticles in Water - Certified Reference Material ERM®-FD100