Handbook Of International Food Regulatory Toxicology Evaluations

Summaries and references decisions and recommendations of the Joint FAO/WHO Expert Committee on Food Additives, the Joint FAO/WHO Meeting on Pesticide Residues, the International Agency for Research on Cancer (IARC), and the Scientific Committee for Food of the Commission of the European Communities.

One of the striking features of our times is the increasing utilization of chemical products in different fields of human activities, as a result of the spectacular progress of chemical research. Our food supply has not been spared from this general trend, however, and chemical sub stances are being continuously incorporated in foodstuffs. Some of these substances are added to food for technological purposes such as pre serving food from bacterial deterioration (antimicrobials), protecting it from oxidative changes (antioxidants), and improving its organoleptic characteristics (sweeteners, flavors, and flavor enhancers), or texture (stabilizers, emulsifiers, colorants). These substances are generally referred to as intentional food additives. Chemical substances may also be found in food as a result of environ mental or accidental contamination. Between these two categories of chemicals, a third class occupies an intermediate position, represented by chemical products utilized to control insect or fungus pests in agri culture and ectoparasites in animal husbandry. These products are cur rently referred to as pesticides and, due to some of their properties, such as chemical stability associated with scarce hydrosolubility, they may be found as residues in or on food from plant and animal origin. In addition, certain drugs that stimulate growth for accelarating productivity in animals may also be found as residues in edible animal tissues. These substances are referred to as unintentional food additives.

Covers all aspects of food safety--science, regulation, and labeling requirements--integrating major developments in the fields of toxicology, analytical chemistry, microbiology, hygiene, and nutrition. Designed to be a reference that bridges the gaps between science, regulation and control of food safety. While this might have been a rather ambitious aim, in putting together this book, the editors have certainly succeeded in gathering a group of experts from industry, government agencies, academia, consumer groups and the media whose knowledge and expertise reflect the complex and multisectoral/multidisciplinary nature of food safety." ---Food Science and Technology

Nonclinical Safety Assessment Nonclinical Safety Assessment A Guide to International Pharmaceutical Regulations Bringing a new drug to market is a costly time-consuming process. Increased regional and international regulation over the last twenty years, while necessary, has only served to amplify these costs. In response to this escalation, developmental strategies have shifted towards a more global approach. In order to create the most cost-effective and safe processes, it is critical for those bringing drugs to market to understand both the globally accepted regulations and the local variations. Nonclinical Safety Assessment: A Guide to International Pharmaceutical Regulations provides a practical description of nonclinical drug development regulations and requirements in the major market regions. It includes: ICH – the International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use National regulations, including US FDA, Canada, Mercosur and Brazil, South Africa, China, Japan, India and Australia Repeated dose toxicity studies Carcinogenicity; Genotoxicity; Developmental and reproductive toxicology; Immunotoxicology Biotechnology-derived pharmaceuticals Vaccine development Phototoxicity and photocarcinogenicity Degradants, impurities, excipients and metabolites Primarily intended for those professionals actively involved in the nonclinical and clinical development of a pharmaceutical product, including toxicologists, pharmacologists, clinicians and project managers, this book provides a roadmap for successful new drug approval and marketing.

From health and economic consequences to exposure assessment and detoxification, this reference comprehensively covers the formation, characteristics, and control of various toxins that occur in the production, storage, handling, and preparation of food. The author discusses toxin sources, mechanisms, routes of exposure and absorption, and their chemical and biochemical components to prevent contamination of food products and reduce epidemics of foodborne disease. The book contains more than 3000 references to facilitate further research, as well as recent guidelines from the FDA and World Health Organization regarding food hygiene and safety.

The ~uestion of whether an infant's diet represents a health hazard is not new. A health risk to infants from the intake of heavy metals via bottled food cannot be excluded at the present time. It is the purpose of this symposium to increase our knowledge of these disquie ting facts. If 70% of all environmental chemicals, including the ubi quituous heavy metals, enter the human body through food, to what extent are infants affected? Generally speaking, the effect on children has thus far been ex cluded from all the discussions concerning safety margins or limits on heavy-metal intake. Furthermore, this age group has also been largely excluded from studies determining the acceptable daily intake values for other substances. Paradoxically enough, such studies often contain a comment to the effect that children are particularly sensitive to these substances. The lack of consideration is certainly also due to the fact that little attention has been paid to this age group in toxicological research. The ZEBS study Heavy Metals in the Infant Diet by Kaferstein and MUller points to a mechanism which may increase the contamination of infant diet, namely the water used to prepare infant formula. Such facts as well as models for risk characterization have been presented by MUller and Schmidt in these proceedings. Yet many questions remain.