Comparative assessment of nanomaterial definitions and safety evaluation considerations.

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.

Nanomaterials are present in almost any industrial sector and addressed in corresponding legislation. The EC has developed a recommendation of the term nanomaterial for regulatory purposes. Due to uncertainties regarding the safety of nanomaterials, it is necessary to develop best practices and facilitate harmonization of assessment practices. However, more research with specific relevance for regulatory questions is still needed, in particular regarding the implementation of the definition of nanomaterials, the enforcement of product labeling, the development of methods for safety testing and risk assessment, and a better availability of quality data on nanomaterials for regulatory purposes.

https://www.onlinelibrary.wiley.com/doi/epdf/10.1002/cite.201600076

Regulatory Aspects of Nanomaterials in the EU

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

Total hip arthroplasty : State of the art, prospects and challenges

Beta+ emitting 44Sc (T1/2 = 3.92 h) and 86Y (T1/2 = 14.87 h) are prospective radionuclides for diagnostic imaging using the PET technique. They can be produced in medical cyclotrons with the (p,n) reaction on enriched 44Ca/86SrCO3 targets and 44Sc additionally from 44Ti/44Sc generators. The main advantages of these radionuclides are the relatively long half-life and the formation of the “matched pair” with therapeutic radioisotopes, 47Sc and 90Y, respectively. A simple and fast procedure is presented for labeling of DOTATATE with 44Sc and 86Y. DOTATATE was used as a model molecule and results can be transferred to labelling of other DOTA-bioconjugates. The proposed method can be applicable for PET imaging, but clinical investigation is necessary. URI: http://link.springer.com/content/pdf/10.1007%2Fs00259-012-2225-6 [1] Authors: KRAJEWSKI Seweryn CYDZIK Izabel ABBAS Kamel BULGHERONI Antonio SIMONELLI Federica HOLZWARTH Uwe MAJKOWSKA-PILIP Agnieszka BILEWICZ Aleksander Publication Year: 2012 Type: Contributions to Conferences

Simple and fast procedure of labelling DOTATATE with 86Y and 44Sc.

Cyclotron Production of High Specific Activity 186gRe for Metabolic Radiotherapy

Excitation functions, thin- and thick-target yields for the 181-186 Re radionuclides were measured by the activation method on natural tungsten foils for proton energies up to 17 MeV. A new data set has been given for the investigated radionuclides. These results are compared both with the experimental literature values and the ones calculated by the EMPIRE II code (version 2.19). In particular, the attention is focused on Re-186g due to its remarkable applications in Nuclear Medicine for metabolic radiotherapy of tumours.

/pdf/excitation-functions-and-yields-for-re-186g-production-by-3jg3o55ewm.pdf

Holzwarth Uwe

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

Total hip arthroplasty : State of the art, prospects and challenges

Simple and fast procedure of labelling DOTATATE with 86Y and 44Sc.

Cyclotron Production of High Specific Activity 186gRe for Metabolic Radiotherapy

EXCITATION FUNCTIONS AND YIELDS FOR Re-186g PRODUCTION BY PROTON CYCLOTRON IRRADIATION