European Food Agency

European Food Agency and Consumer Risk Assessment in the U... 

Two forms of pegylated IFN-a have been approved by the Food and Drug Administration (FDA) and by the European Medicines Agency (EMEA) for the... 

The use of food additives is restricted in all European countries by national order concerning food additives, only those antioxidants specially mentioned are allowed to be used. The antioxidants may only be used with the foods mentioned and in the amounts specified. The veterinary service and national food agencies or other national authorities have supervisory powers. 

The provisional tolerable daily intake (TDI) values proposed by the European Food Safety Authority (EFSA 2008) and Health Protection Agency (HPA 2009) amount to 150 ng/kg body weight (bwt)/d and 300 ng/kg bwt/d, for PFOS and PFOA, respectively. 

EC. 2007c. European Commission. Eood and feed - Chemical contaminants website. http /ec.europa.eu/ food/food/chemicalsafety/contaminants/legisl en.htm EES A. 2007. European Eood Safety Authority website. http /www.efsa.europa.eu/en.html EMEA. 2007. The European Medicines Agency website. http /www.emea.europa.eu/... 

European Food Safety Agency. Guidance Document of the Scientific Panel on Genetically Modified Organisms for the Risk Assessment of Genetically Modified Plants and Derived Food and Feed EFSA Communications Department Parma, Italy, 2006. 

Data from European Medicines Agency (2006) Food and Drug Administration (2006) Castilho Medronho (2002). 

FC EMEA FDA GCP GMO HAP HEPA HIV HTLV ICH European Commission European Medicines Agency Food and Drug Administration good clinical practices genetically modified organisms hamster antibody production high efficiency particulate air human immunodeficiency virus human T-Cell leukemia virus International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use... 

This chapter provides a survey of US marketed biopharmaceuticals approved over the past 20 years. It is a simply a profile of the species and types of toxicology studies done for each drug for marketing approval. For a complete list of all preclinical studies for a biopharmaceutical, the reader is directed to the Web sites of the Food and Drug Administration (FDA) and the European Medicines Agency (EMEA). 

Source The main source of the information in this table is either the Food and Drug Administration (FDA) Web site or European Medicines Agency (EMEA) Web site. For biopharmaceuticals approved before 1995 limited information is available so the author used the most recent label (package insert) to derive the reproductive, carcinogeneticity, and genetic toxicology studies completed for marketing approval. 

Like Indiana Jones, virtually every manufacturer of a superfruit product is hot on the trail of the Holy Grail—a health claim approved by a national regulatory agency such as the U.S. Food and Drug Administration (FDA) or European Food Safety Authority (EFSA). In simple terms, a health claim would verify that the product or compound has been scientifically proved to have a direct effect on health or the specific ability to alter the course of a disease. 

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