Consumer and environmental protection depend on the careful regulation of all classes of chemicals. Toxicology is the key science used to evaluate safety and so underpins regulatory decisions on chemicals. With the growing body of EU legislation involved in chemical regulation, there is a concomitant need to understand the toxicological principles underlying safety assessments Regulatory Toxicology in the European Union is the first book to cover regulatory toxicology specifically in Europe. It addresses the need for a wider understanding of the principles of regulatory toxicology and their application and presents the relationship between toxicology and legislative processes in regulating chemical commodities across Europe. This title has a broad scope, covering historical and current chemical regulation in Europe, the role of European agencies and institutions, and also the use of toxicology data for important classes of chemicals, including human and veterinary medicines, animal feed and food additives, biocides, pesticides and nanomaterials. This book is therefore extremely pertinent and timely in the toxicology field at present. This book is an essential reference for regulatory authorities, industrialists, academics, undergraduates and postgraduates working within safety and hazards, toxicology, the biological sciences, and the medicinal and pharmaceutical sciences across the European Union.

Consumer and environmental protection depend on the careful regulation of all classes of chemicals. Toxicology is the key science used to evaluate safety and so underpins regulatory decisions on chemicals. With the growing body of EU legislation involved in chemical regulation, there is a concomitant need to understand the toxicological principles underlying safety assessments. Regulatory Toxicology in the European Union is the first book to cover regulatory toxicology specifically in Europe. It addresses the need for a wider understanding of the principles of regulatory toxicology and their application and presents the relationship between toxicology and legislative processes in regulating chemical commodities across Europe. This title has a broad scope, covering historical and current chemical regulation in Europe, the role of European agencies and institutions, and also the use of toxicology data for important classes of chemicals, including human and veterinary medicines, animal feed and food additives, biocides, pesticides and nanomaterials. This book is therefore extremely pertinent and timely in the toxicology field at present. This book is an essential reference for regulatory authorities, industrialists, academics, undergraduates and postgraduates working within safety and hazards, toxicology, the biological sciences, and the medicinal and pharmaceutical sciences across the European Union.

This book will be written by experts for professionals, scientists and all those involved in toxicological data generation and decision-making. It is the updated and expanded version of a monograph published in German in 2004. Chemical safety is regulated on various levels including production, storage, transport, handling, disposal or labelling. This book deals comprehensively with the safety-ensuring methods and concepts employed by regulatory agencies, industry and academics. Toxicologists use experimental and scientific approaches for data collection, e.g. about chemical hazards, physicochemical features or toxicokinetics. The respective experimental methods are described in the book. Toxicologists also deal with much insecurity in the exposure and effect scenarios during risk assessment. To overcome these, they have different extrapolation methods and estimation procedures at their disposal. The book describes these methods in an accessible manner. Differing concepts from one regulation area to another are also covered. Reasons and consequences become evident when reading the book. Altogether, the book Regulatory Toxicology will serve as an excellent reference.

Dieser Band gehört zur bekannten Wiley-Reihe 'Current Toxicology Series' und befasst sich ausführlich mit der Pestizidtoxikologie. Untersucht werden Pestizide nach Gruppen (z. B. Insektizide und Fungizide), ihre Rückstände in Lebensmitteln sowie die Metabolisierung von Pestiziden. Darüber hinaus werden berufsbezogene Aspekte und die Behandlung von Vergiftungserscheinungen umfassend diskutiert. "Pesticide Toxicology" ist das erste einbändige Werk zum Thema Pestizide, das spezialisierte und dennoch umfassende Informationen sowohl für Experten als auch für Doktoranden bereit hält. Herausgeber Timothy Marrs ist ein international anerkannter Experte in der Pestizidforschung und genießt großes Ansehen auf dem Gebiet der Toxikologie. Geschrieben wurde der Band von einem Team international renommierterToxikologen.

This Brief describes in three concise chapters one of the newest ‘hot topics’ under EU Food Law and Policy: the new Regulation (EU) No 2015/2283 from the European Parliament and by the Council, November 25, 2015, on novel foods, applicable from January 2018. In this work, the Authors discuss the long-time criticized EU Regulation on novel foods ((EC) No 258/1997) and how it has been significantly altered by the adoption of the new regulation. In the first chapter, the Authors provide a comprehensive analysis of the genesis of the new Regulation, its rationale and the policy’s goals. In particular, they describe what food business operators shall do in order to get a new product allowed on the EU market, providing updated information on the regulatory developments from the European Food Safety Authority in nanofoods, cloned animals and insect foods. The role of the European Food Safety Authority is also discussed. The second Chapter summarizes the current toxicological studies used to evaluate novel foods safety, which are an extremely important pillar when speaking of food safety and commercial introduction of new products. Finally, the third Chapter discusses the ‘history of safe use’ approach to the problem of novel foods, and factors such as consumption period analysis, preparation advices and processes, intake levels, nutritional composition, and results of animal studies. Food lawyers, professionals and auditors working in the area of official inspections, quality assurance, food traceability, and international regulation, both in academia and industry, will find this Brief an important account.

This book provides information on best practices and new thinking regarding the validation of alternative methods for toxicity testing. It covers the validation of experimental and computational methods and integrated approaches to testing and assessment. Validation strategies are discussed for methods employing the latest technologies such as tissue-on-a-chip systems, stem cells and transcriptomics, and for methods derived from pathway-based concepts in toxicology. Validation of Alternative Methods for Toxicity Testing is divided into two sections, in the first, practical insights are given on the state-of-the-art and on approaches that have resulted in successfully validated and accepted alternative methods. The second section focuses on the evolution of validation principles and practice that are necessary to ensure fit-for-purpose validation that has the greatest impact on international regulatory acceptance of alternative methods. In this context validation needs to keep pace with the considerable scientific advancements being made in toxicology, the availability of sophisticated tools and techniques that can be applied in a variety of ways, and the increasing societal and regulatory demands for better safety assessment. This book will be a useful resource for scientists in the field of toxicology, both from industry and academia, developing new test methods, strategies or techniques, as well as Governmental and regulatory authorities interested in understanding the principles and practicalities of validation of alternative methods for toxicity testing.

In the last decade and a half, great progress has been made in the development of concepts and models for mixture toxicity, both in human and environmental toxicology. However, due to their different protection goals, developments have often progressed in parallel but with little integration. Arguably the first book to clearly link ecotoxicology an