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Hazard and Risk Assessment of Teratogenic Chemicals Under REACH.
MedLine Citation:
PMID:  23138924     Owner:  NLM     Status:  In-Data-Review    
Abstract/OtherAbstract:
In 2007, a new European chemicals legislation was implemented: Regulation (EC) No. 1907/2006, also known as "REACH." It obliges companies to take the main responsibility for the valid information on the safe use of the chemicals they manufacture and/or place on the European market. So they must, for example, register their chemicals at the European Chemicals Agency (ECHA) and submit extensive substance-related registration dossiers containing information on the substances' intrinsic hazardous properties and documentation of their risk assessment. REACH regulates the registration and evaluation process as well as the authorization and restriction procedure. In addition, classification, labeling, and packaging of chemicals apply in accordance with Regulation (EC) No. 1272/2008 ("CLP Regulation"). It implements almost completely the provisions of the United Nations Globally Harmonised System of Classification and Labelling of Chemicals (UN GHS) into European legislation and will fully replace the Dangerous Substances Directive (67/548/EEC) and the Dangerous Preparations Directive (1999/45/EC) by 2015. According to both the old and the new classification system, teratogenic chemicals are classified as developmental toxicants, with developmental toxicity falling within the hazard class of reproductive toxicity. REACH as well as the CLP Regulation provide several procedures in which reproductive toxicants take a special position because their harmful effects are considered particularly serious. Teratogenic substances are not explicitly named by these legal texts but, as they constitute as developmental toxicants a hazard differentiation of reproductive toxicity, they are implicitly always included by the provisions.
Authors:
Wiebke Prutner
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Publication Detail:
Type:  Journal Article    
Journal Detail:
Title:  Methods in molecular biology (Clifton, N.J.)     Volume:  947     ISSN:  1940-6029     ISO Abbreviation:  Methods Mol. Biol.     Publication Date:  2013  
Date Detail:
Created Date:  2012-11-09     Completed Date:  -     Revised Date:  -    
Medline Journal Info:
Nlm Unique ID:  9214969     Medline TA:  Methods Mol Biol     Country:  United States    
Other Details:
Languages:  eng     Pagination:  517-43     Citation Subset:  IM    
Affiliation:
Federal Institute for Occupational Safety and Health (BAuA), Dortmund, Germany, prutner.wiebke@baua.bund.de.
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