Derived No-effect Level
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Derived No-effect Level
The derived no-effect level (DNEL) is the level of exposure to a substance above which humans should not be exposed. The REACH regulation defines them as exposure levels beneath which a substance does not harm human health. According to the EU REACH legislation, manufacturers and importers of chemical substances are required to calculate DNELs as part of their chemical safety assessment (CSA) for any chemicals used in quantities of 10 tonnes or more per year. The DNEL is to be published in the manufacturer's chemical safety report (CSR) and, for hazard communication, in an extended safety data sheet. Correspondent to REACH legislation, the registrant (manufacturer or importer) of a substance has to indicate the DNELs for the most probable way of exposition (oral, dermal, inhalative) and the expected frequency and duration of exposure. Depending on the way of exposure it can be necessary to specify different DNELs for affected persons (employees, consumer, children, pregnant women ...
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Registration, Evaluation, Authorisation And Restriction Of Chemicals
Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) is a European Union regulation dating from 18 December 2006. REACH addresses the production and use of chemical substances, and their potential impacts on both human health and the environment. Its 849 pages took seven years to pass, and it has been described as the most complex legislation in the Union's history and the most important in 20 years. It is the strictest law to date regulating chemical substances and will affect industries throughout the world. REACH entered into force on 1 June 2007, with a phased implementation over the next decade. The regulation also established the European Chemicals Agency, which manages the technical, scientific and administrative aspects of REACH. Overview When REACH is fully in force, it will require all companies manufacturing or importing chemical substances into the European Union in quantities of one tonne or more per year to register these substances with a n ...
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Chemical Safety Report
A chemical substance is a form of matter having constant chemical composition and characteristic properties. Some references add that chemical substance cannot be separated into its constituent elements by physical separation methods, i.e., without breaking chemical bonds. Chemical substances can be simple substances (substances consisting of a single chemical element), chemical compounds, or alloys. Chemical substances are often called 'pure' to set them apart from mixtures. A common example of a chemical substance is pure water; it has the same properties and the same ratio of hydrogen to oxygen whether it is isolated from a river or made in a laboratory. Other chemical substances commonly encountered in pure form are diamond (carbon), gold, table salt (sodium chloride) and refined sugar (sucrose). However, in practice, no substance is entirely pure, and chemical purity is specified according to the intended use of the chemical. Chemical substances exist as solids, liquids, g ...
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European Chemicals Agency
The European Chemicals Agency (ECHA; ) is an agency of the European Union which manages the technical and administrative aspects of the implementation of the European Union regulation called Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). ECHA is the driving force among regulatory authorities in implementing the EU's chemicals legislation. ECHA has to ascertain that companies comply with the legislation, advances the safe use of chemicals, provides information on chemicals and addresses chemicals of concern. It is located in Helsinki, Finland. ECHA is an independent and mature regulatory agency established by REACH. It is not a subsidiary entity of the European Commission. The agency, currently headed by Acting Executive Director Shay O’Malley, started working on 1 June 2007. Establishment The ECHA was created by European Union regulation dating from 18 December 2006 to manage the then-new legislation to regulate the manufacture and use of chemic ...
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