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European Union data assessment

Available data can be complementary to a defined base set (e.g., representing a large number of species), but sometimes individual data points are in apparent conflict with other data (e.g., for the same species tested using 2 different methods or for different soils). Outliers may also be present in a data set. In both North America and the European Union, an assessment of the relevance and reliability of the available data is made prior to setting any standard. [Pg.114]

In what is being called the most far-reaching overhaul of European Union environmental policy ever, the European Commission released a draft policy proposal on May 7 that, if enacted, would require virtually all manufacturers of chemicals to provide risk assessments and other information regarding products they sell or ship into the EU. Chemicals would also have to be registered with the EC and many downstream users of products that contain chemical entities would have to file paperwork as well. The Registration, Evaluation and Authorisation of Chemicals, or REACH, proposal would apply to approximately 30,000 new and existing chemicals, and test data would have to be developed on some 5000 specific chemical entities, many of which have been commonly used for decades. EUROPEAN COMMISSION... [Pg.40]

There are no occupational exposure limits for many hazardous substances which may require control of inhalation exposures. The necessary data and other resources required for setting such limits is restricted and unlikely to match the potential demand. A hazard categorisation scheme was, therefore, developed for application within the chemical industry. The scheme used readily-available information on toxicological endpoints to place hazardous substances into a limited range of hazard categories, expressed as Occupational Exposure Bands. These Bands could be used as a basis for risk assessment and the selection of appropriate control regimes. 10 refs. EUROPEAN COMMUNITY EUROPEAN UNION UK WESTERN EUROPE... [Pg.101]

The 22 papers of the symposium [1] were presented under the headings Theory, Laboratory Studies, Calorimetry (2 sessions), Applications. Several papers are devoted to individual instrumental methods of measuring and assessing potential for exothermic runaway reactions to develop. An issue of the Journal of Loss Prevention in the Process Industries is devoted to a variety of, mostly calorimetric, studies of runaway reactions [2], The proceedings of a European Union Seminar in 1994 appear as a book, including hard data as well as debate about such matters as operator training [3],... [Pg.376]

The European Union (EU) and its Member States promote responsible research in order to help society draw the maximum benefit from scientific inquiry and in order to protect the rights of citizens, researchers, and other members of society (EU 2007). All EU-funded research activities must comply with an ethical code according to Article 3 of the Sixth Framework Programme (FP6, 2002-2006) that states All the research activities carried out under FP6 must be carried out in compliance with fundamental ethical principles. No further guidance specifically directed toward the use of human data in the risk assessment of chemical substances is provided. [Pg.52]

The effectiveness of various measures to contain expenditure on medicines in the United Kingdom can only be assessed in the context of the situation in other European Union coimtries. Table 26.1 gives data for the total expenditure on health care as a percentage of gross domestic product (GDP),... [Pg.717]

Suter et al. 1993 Society of Environmental Toxicology and Chemistry [SETAC] 1994 European Union 1997 Ecological Committee on FIFRA Risk Assessment Methods [ECOFRAM] 1999 Campbell et al. 1999). The initial use of conservative assessment criteria (i.e., err on the side of caution) allows substances that do not present a risk to be eliminated from the risk assessment process early, thus allowing the focus of resources and expertise to be shifted to potentially more problematic substances or situations. As one ascends through the tiers, the estimates of exposure and effects become more realistic with the acquisition of more accurate and/or representative data, and uncertainty in the extrapolation of effects is thus reduced or at least better characterized. Likewise, the methods of extrapolation may become more sophisticated as one ascends through the tiers (Figure 1.2). [Pg.4]

If data have already been generated for risk assessments, it may be possible to use these without further quality assessment (as is done in the European Union), but any new and relevant information should be considered scientifically. Usually, the lowest acute and long-term toxicity data for a species should be used (if the endpoint is relevant at the population level and is derived from a validated study). If valid data for the same endpoints and the same species exist, the geometric mean should be taken. This value is then used together with other species values to calculate the EQSs. Use of a mean value in this situation minimizes cumulative conservatism that is, always using the most conservative data point, especially when additional valid data are available, will lead to too much conservatism, giving rise to an EQS that may be unrealistically low. [Pg.55]

Similar approaches were adopted by major regulatory authorities in other countries, including the United Kingdom, France, Germany, Italy, and Scandinavia and subsequently the European Union. The official agencies and the pharmaceutical industries own experts have published recommendations for a wide range of types of toxicity tests to provide comprehensive data in stardardized form for assessment. [Pg.47]


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See also in sourсe #XX -- [ Pg.114 , Pg.115 ]




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