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Demonstration European Union

Recently, similar legislation has been introduced in the European Union under regulations EC/1901/2006 and EC1902/2006. This requires that marketing authorisation applications for new drugs submitted after the 28 July 2008 must be accompanied by either the results of specific studies demonstrating safety and... [Pg.152]

Local certification has a number of advantages, not least that it is one way to reduce costs to producers in developing countries via locally determined fees reflecting local incomes (Barrett et al., 2001). To be accepted by the European Union (EU), local certification bodies are required to demonstrate that their standards of organic production and inspection are equivalent to EU regulations. The standards need not necessarily be identical, however, and as such this means more locally appropriate standards can be set in place. For example, local certification bodies may well allow the use of such natural pesticides that would not normally be allowed under EU Standards (Myers, 2000). [Pg.455]

National programs are underway to develop and deploy the reactor and applications in China, France, South Korea, and United States [35-38]. Many more countries are participating in R D through the High Temperature Reactor Technology Network of the European Union [39] and the GIF including the 10 member countries [40]. Builds of full-scale commercial demonstration reactors are actively planned in several countries such as South Africa [41] and the United States [38]. [Pg.147]

While participating in the European Union programme on risk assessment of existing chemicals, Euro Chlor (representing all major European chlorine producers), recognised the need to carry out a detailed risk evaluation on chemicals linked to the production of chlorine. In view of concerns about specific risks of organohalogen compounds to the marine environment as a sink for all watercourses, Euro Chlor focused on this environmental compartment, with emphasis on the North Sea. This sea area has been extensively studied and is controlled by the Oslo and Paris Convention for the Prevention of Marine Pollution (OSPARCOM). For a series of chemicals on lists of concern adopted by the North Sea Conference (1990), risk assessments are being carried out to demonstrate their variable environmental profiles. [Pg.58]

There are several initiatives for the development and demonstration of CCS worldwide. For instance, the European Union has an ambition to deploy 10-12 full-scale CCS demonstration projects within Europe by 2015, testing various ways of integrating CCS in coal and gas-fired power generation it also aims for CCS to be commercially viable for all new fossil fuel power plants by 2020, with existing plants progressively retrofitted (EC, 2007). Other pilot and demonstration plants are planned in the United States, Australia and China.5... [Pg.182]

Union, a 6 months extension of exclusivity may be granted if studies are performed demonstrating safety and efficacy in a paediatric population. In the European Union the problem of off-label use in paediatrics has been recognised by the Commission and a proposal is now in draft form to introduce new legislation in 2006. [Pg.349]

The types of harm that chemicals have the capacity to cause (in other words their hazards) are qualitatively different and not commensurate with each other. At one extreme are effects that require reasonably high concentrations of the substance, are immediate and localized (for example flammability, explosivity, corrosiveness and acute toxicity). The causal relationship between a particular chemical exposure and such effects is usually obvious, or at least easy to demonstrate. Those affected generally include those who deal directly with the chemical and it is often possible to handle and store the chemical in such a way that harm is avoided. The existing European Union (EU) regulatory system, dating from the 1967 dangerous substances directive (Council Directive 67/548/EEC) was clearly set up with... [Pg.164]

Both the European Union and the FDA have pubhshed lists that are subject to regular review. The greatest concern has been expressed over the use of azodye colours as certain individuals can demonstrate an allergic reaction to some of these. Allergic reactions have been reported most frequently for sunset yellow (E110, FD C yellow no. 6) and tartrazine (E102, FD C yellow no. 5). [Pg.114]

In this context, dense C02 represents a sustainable alternative to such volatile organic compounds (VOCs), as demonstrated implicitly by the huge investments made over the past few years, both in the USA (i.e., the cooperation of DuPont with University of North Carolina) and in the European Union (European Research Grants Superpol and Ecopol), in investigating the use of scC02 for the production of fluorinated polymers. [Pg.23]

Moreover, the results obtained demonstrated that the proposed method can be used as a screening test for determination of methyl mercury in real matrix knowing that the legal limit given by the European Union of this pollutant in fish is in 0.5-1 ppm range [9]. [Pg.1102]

The principle of combination of electrochemical glucose oxidase biosensor with the clean-up method for direct extraction and determination of methyl mercury has been successfully demonstrated. The extraction of methyl mercury from the organic solvent has been based on invertase enzyme inhibition. The combination of very low concentration of invertase enzyme and 10 min of incubation time allows the detection of methyl mercury at 5 ppb level. Our method permits the detection of this inhibitor below the legal limit given by the European Union with good recoveries when fish samples were measured. [Pg.1102]

Early work on phthalate esters (section 1.2) and several monomers such as styrene, which are used to make plastics, demonstrated that chemical migration can occur from packaging into food. There has been a huge amount of practical work on this over the last thirty years (Gilbert, 1997), much of it on plastics. Thus there are now in place detailed controls on this aspect of plastics in the European Union (EU) and the USA. The controls in the EU have been fully implemented in Great Britain (FCM Unit, 2000). [Pg.8]

Harmonization of regulatory requirements was pioneered by the European Community (now the European Union) in the 1980s, as it moved towards the development of a single market for pharmaceuticals. The success achieved in Europe demonstrated that harmonization was feasible. The harmonization process was then extended to include Japan and the United States. The ICH was formed from a government body and an industry association from each of these regions. These bodies and associations as listed by Molzon (2006) are ... [Pg.17]

Plug Power, working with its European partners PEMEAS (now BASF Fuel Cell GmbH) and Vaillant, is actively pursuing a PBI-based HT PEM fuel cell system as a CHP system with high system efficiency and great CO tolerance. This system demonstration project is jointly sponsored by the U.S. Department of Energy and the European Union, one of the first collaborations of this kind between the U.S. and the EU. [Pg.280]


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See also in sourсe #XX -- [ Pg.1133 , Pg.1134 , Pg.1135 , Pg.1143 ]




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