European Union definitions

Water for injection (WFI) is the most widely used solvent for parenteral preparations. The USP requirements for WFI and purified water have been recently updated to replace the traditional wet and colorimetric analytical methods with the more modern and cost-effective methods of conductivity and total organic carbon. Water for injection must be prepared and stored in a manner to ensure purity and freedom from pyrogens. The most common means of obtaining WFI is by the distillation of deionized water. This is the only method of preparation permitted by the European Pharmacopoeia (EP). In contrast, the USP and the Japanese Pharmacopeias also permit reverse osmosis to be used. The USP has also recently broadened its definition of source water to include not only the U.S. Environmental Protection Agency National Primary Drinking Water Standards, but also comparable regulations of the European Union or Japan. 

Although a united compost quality system of the European Union does not exist, the European Compost Network (ECN), as an initiative of the ORBIT Association developed a Quality Assurance System providing the necessary background information and documentation to build up a European Quality Assurance System (ECN-QAS). Product definitions and characterizations of this system are shown in Table 12.7. 

The definitions below are derived from official public sources, including the National Institutes of Health [nih] and the European Union [EU],... 

The definition of what constitutes a rare disease varies in different regions of the world. The prevalence figure accepted in the European Union is no more than five individuals per 10 000 of the EU population. In the United States, it is defined as a disease that affects less than 200 000 of the population. This size of population is approximately equal to a prevalence of 7.5 individuals per 10 000 of the United States population. Similarly, the prevalence figures accepted in Japan and Australia are no more than 4.2 and 1.1 individuals respectively per 10 000 of their corresponding populations. 

The PED has definitely the merit that it supersedes, from a legal perspective, the very many old local codes in all European member states, codes such as BS (UK), ISPESL (Italy), TUV (Germany), Stoomwezen (the Netherlands), and UDT (Poland). Compliance with PED allows the manufacturer to CE mark their product as required by the European Union (EU) and is an assurance for the end-users that the selected material to protect their systems is in accordance to the law. Manufacturers approvals, however, are limited in time and need to be renewed regularly, which is an additional guarantee. Therefore, even with the most reputable manufacturers, it is always wise to check the status of the approvals to make sure they have not expired. 

Foodomics, Functional Foods, and Nutraceuticals There is a clear trend in medicine and biosciences toward prevention of future diseases through adequate food intakes and the development of new functional foods and nutraceuticals. Although there is no officially accepted definition of functional foods, the definition proposed by Diplock et al. (73) is commonly used in the European Union and considers that a food is functional when it beneficially affects one or more target functions in the body beyond adequate nutrition in a way that is relevant to an improved state of health and well-being and/or reduction of risk of disease. Functional foods may include both natural (unmodified) foods and foods in which a component has been added, removed, or modified (including the bioavailability) by... 

Today, European Union legislation (Reg. EU N° 401/2010) defines and recognizes "Vin Santo" by the following synthetic definition ... 

Australia Canada sediment-resident invertebrate species, including at least 1 benthic amphipod At least 2 of these studies must be partial or full life-cycle tests with ecologically relevant endpoints. For derivation of a definitive EQS, must have at least 20 entries in the BEDS database European Union United States... 

Medicinal products derived from human blood or human plasma means those based on blood constituents that are prepared industrially by public or private establishments, such as albumin, coagulation factors, and immunoglobulins of human origin. This definition reflects the way plasma derived medicinal products are manufactured in the European Union. This class of products may be produced by privately owned industry or by public organizations that are owned by the member state. 

Clinical trials and clinical trial authorizations in the European Union are controlled under the Clinical Trial Directive, 2001/20/EC [9], and all member states are bound by its requirements. Under the provisions of the Directive, a clinical trial is an investigation in human subjects that is intended to discover or verify the clinical, pharmacological, and/or other pharmacodynamic effects of one or more medicinal products, identify any adverse reactions or study the absorption, distribution, metabolism, and excretion, with the object of ascertaining the safety and/or efficacy of those products. This definition includes pharmacokinetic studies. 

There is no single definition of the chemical industry or a universal categorization of the industry s subsectors. There are, in fact, numerous ways of identifying subsectors of the chemical industry, including, according to the Standard Industrial Classification (SIC) codes (US OMB, 1987), the North American Industry Classification System (NAICS) (US OMB, 2000), the European Union NACE Codes for the nomenclature of economic activities,1 the Japanese standard industrial classification,2 and according to S P definitions (S P, 2004), to name a few. 

This article deals with legal requirements in the European Union on basic principles of laboratory quality assurance for official notification to the EC Commission and on method validation concerning official laboratories. Widespread discussions and activities on measurement uncertainty are in progress, and the European validation standards for official purposes may serve as a basis for world-wide efforts on quality harmonization of analytical results. Although much time has already been spent, definitions and require-... 

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