EFSA Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids (CEF); Scientific Opinion on Flavouring Group Evaluation 20, Revision 3 (FGE.20Rev3): Benzyl alcohols, benzaldehydes, a related acetal, benzoic acids, and related esters from chemical groups 23 and 30

<p>The Panel on Food Contact Materials, Enzymes, Flavourings and Processing Aids of the European Food Safety Authority was requested to evaluate five flavouring substances in the Flavouring Group Evaluation 304, using the Procedure in Commission Regulation (EC) No 1565/2000. None of the substances were considered to have genotoxic potential. The substances were evaluated through a stepwise approach (the Procedure) that integrates information on structure-activity relationships, intake from current uses, toxicological threshold of concern, and available data on metabolism and toxicity. The Panel concluded that the three substances [FL-no: 16.117, 16.123 and 16.125] do not give rise to safety concerns at their levels of dietary intake, estimated on the basis of the MSDI approach. For the remaining two candidate substances [FL-no: 16.118 and 16.124], no appropriate NOAEL was available and additional data are required. Besides the safety assessment of these flavouring substances, the specifications for the materials of commerce have also been considered. Specifications including complete purity criteria and identity for the materials of commerce have been provided for all five candidate substances.</p&gt

A study protocol for the evaluation of occupational mutagenic/carcinogenic risks in subjects exposed to antineoplastic drugs: a multicentric project

<p>Abstract</p> <p>Background</p> <p>Some industrial hygiene studies have assessed occupational exposure to antineoplastic drugs; other epidemiological investigations have detected various toxicological effects in exposure groups labeled with the job title. In no research has the same population been studied both environmentally and epidemiologically. The protocol of the epidemiological study presented here uses an integrated environmental and biological monitoring approach. The aim is to assess in hospital nurses preparing and/or administering therapy to cancer patients the current level of occupational exposure to antineoplastic drugs, DNA and chromosome damage as cancer predictive effects, and the association between the two.</p> <p>Methods/Design</p> <p>About 80 healthy non-smoking female nurses, who job it is to prepare or handle antineoplastic drugs, and a reference group of about 80 healthy non-smoking female nurses not occupationally exposed to chemicals will be examined simultaneously in a cross-sectional study. All the workers will be recruited from five hospitals in northern and central Italy after their informed consent has been obtained.</p> <p>Evaluation of surface contamination and dermal exposure to antineoplastic drugs will be assessed by determining cyclophosphamide on selected surfaces (wipes) and on the exposed nurses' clothes (pads). The concentration of unmetabolized cyclophosphamide as a biomarker of internal dose will be measured in end-shift urine samples from exposed nurses.</p> <p>Biomarkers of effect and susceptibility will be assessed in exposed and unexposed nurses: urinary concentration of 8-hydroxy-2-deoxyguanosine; DNA damage detected using the single-cell microgel electrophoresis (comet) assay in peripheral white blood cells; micronuclei and chromosome aberrations in peripheral blood lymphocytes. Genetic polymorphisms for enzymes involved in metabolic detoxification (i.e. glutathione <it>S</it>-transferases) will also be analysed.</p> <p>Using standardized questionnaires, occupational exposure will be determined in exposed nurses only, whereas potential confounders (medicine consumption, lifestyle habits, diet and other non-occupational exposures) will be assessed in both groups of hospital workers.</p> <p>Statistical analysis will be performed to ascertain the association between occupational exposure to antineoplastic drugs and biomarkers of DNA and chromosome damage, after taking into account the effects of individual genetic susceptibility, and the presence of confounding exposures.</p> <p>Discussion</p> <p>The findings of the study will be useful in updating prevention procedures for handling antineoplastic drugs.</p

Antineoplastic Drugs as a Potential Risk Factor in Occupational Settings: Mechanisms of Action at the Cell Level, Genotoxic Effects, and Their Detection Using Different Biomarkers

U članku je prikazana osnovna podjela antineoplastičnih lijekova prema mehanizmima djelovanja na razini stanice. Objašnjeni su mehanizmi genotoksičnosti najvažnijih vrsta lijekova koji se primjenjuju u okviru uobičajenih protokola za liječenje zloćudnih novotvorina. Navedena je važeća klasifi kacija antineoplastika prema kancerogenom potencijalu, podaci o mutagenom potencijalu te je prikazana njihova podjela u skladu s anatomsko-terapijsko-kemijskim sustavom klasifi kacije. Sustavno su prikazani najvažniji rezultati svjetskih i hrvatskih istraživanja na populacijama radnika izloženih antineoplasticima, provedenih u razdoblju 1980.-2009. s pomoću četiri najčešće primjenjivane metode: analize izmjena sestrinskih kromatida, analize kromosomskih aberacija, mikronukleus-testa i komet-testa. Objašnjena su osnovna načela navedenih metoda te raspravljene njihove prednosti i nedostaci. Biološki pokazatelji daju važne podatke o individualnoj osjetljivosti profesionalno izloženih ispitanika koji mogu poslužiti unaprjeđenju postojećih uvjeta rada i upravljanju rizicima pri izloženosti genotoksičnim agensima. Na osnovi prednosti i nedostataka citogenetičkih metoda zaključeno je da je mikronukleus-test, koji podjednako uspješno dokazuje klastogene i aneugene učinke, jedna od najboljih metoda dostupnih za otkrivanje štetnih djelovanja antineoplastičnih lijekova koji su u aktivnoj primjeni.This article brings an overview of the mechanisms of action of antineoplastic drugs used in the clinical setting. It also describes the genotoxic potentials of the most important classes of antineoplastic drugs involved in standard chemotherapy protocols. Classifi cation of antineoplastic drugs according to the IARC monographs on the evaluation of carcinogenic risks to humans is accompanied by data on their mutagenicity and the most recent updates in the Anatomical Therapeutic Chemical (ATC) Classifi cation System. We report the main fi ndings of biomonitoring studies that were conducted in exposed healthcare workers all over the world between 1980 and 2009 using four biomarkers: sister chromatid exchanges, chromosome aberrations, micronuclei. and the comet assay. The methods are briefl y explained and their advantages and disadvantages discussed. Biomarkers provide important information on individual genome sensitivity, which eventually might help to improve current working practices and to manage the risks related with exposure to genotoxic agents. Taking into consideration all known advantages and drawbacks of the existing cytogenetic methods, the micronucleus assay, which is able to detect both clastogenic and aneugenic action, is the most suitable biomarker for assessing harmful effects of antineoplastic drugs currently used in health care

Daten als Gegenstand absoluter Zuordnung | Ein besitzrechtlicher Ansatz

Die Arbeit beschäftigt sich mit der Frage, ob und inwieweit besitzartige Regelungen für Daten bestehen oder durch den Gesetzgeber geschaffen werden sollten. Nach einer Erläuterung grundlegender Begriffe und der Ausgangssituation für Daten werden absolute Rechte an Daten geprüft und es wird anhand ökonomischer Analysemethoden insbesondere ein Eigentum an Daten abgelehnt. Anschließend wird die Idee eines Besitzes an Daten erörtert. Dazu wird zunächst das sachenrechtliche Besitzregime analysiert und dabei besonderes Augenmerk auf den Besitzschutz gelegt. Auf Basis der aus dem Sachbesitz gesammelten Erkenntnisse wird ein Datenbesitz erarbeitet, der es jedoch nicht vermag, die entscheidende non-rivale Nutzung des Datenkopierens zuzuweisen. Daher werden anschließend besitzrechtliche Strukturen im Immaterialgüterrecht untersucht und deren Zwecke mit der Situation für Daten abgeglichen. Als Konsequenz daraus wird ein geheimnisschutzähnlicher Datenzugangsschutz entwickelt, der neben den Datenbesitz tritt.»Assignment of Absolute Rights to Data. Data Possession as an Alternate Approach«: The work deals with the question if and how possession-like rights exist for data or should be created by legislation. Based on the analysis of possession for things, a data possession is derived, which is, however, still leaving open the attribution of non-rivalrous data usage. Therefore, building on the analysis of possession-like structures in intellectual property law, a new data access protection regime is developed, similar to trade secret protection and complementing data possession

An evaluation of the role of macroalgae in mangrove dieback at Whyte Island, Moreton Bay, subtropical eastern Australia

Volume: 54Start Page: 405End Page: 41

Ecophysiological status of nine species of macroalgae and seagrasses in Moreton Bay, Queensland, Australia

Volume: 54Start Page: 391End Page: 40

Legal perspective on possible fairness measures – A legal discussion using the example of hiring decisions

With the increasing use of AI in algorithmic decision making (e.g. based on neural networks), the question arises how bias can be excluded or mitigated. There are some promising approaches, but many of them are based on a ”fair” ground truth, others are based on a subjective goal to be reached, which leads to the usual problem of how to define and compute ”fairness”. The different functioning of algorithmic decision making in contrast to human decision making leads to a shift from a process-oriented to a result-oriented discrimination assessment. We argue that with such a shift society needs to determine which kind of fairness is the right one to choose for which certain scenario. To understand the implications of such a determination we explain the different kinds of fairness concepts that might be applicable for the specific application of hiring decisions, analyze their pros and cons with regard to the respective fairness interpretation and evaluate them from a legal perspective (based on EU law)