Dr Minetta Wunderskirchner of Knoell Germany discusses proposed changes in data requirements for chemicals registration in the European Economic Area
Chemicals registration in the EEA : New data requirements
Dr Minetta Wunderskirchner of Knoell Germany discusses proposed changes in data requirements for chemicals registration in the European Economic Area
Some major changes are expected in the requirements for chemical registration in the European Economic Area ( EEA , i . e . all EU member states , plus Iceland , Lichtenstein and Norway ). Many of those will be implemented through the planned revision of the REACH Regulation , which is currently under discussion in the European Commission ( EC ).
CSS
The EU ’ s long-term chemicals vision aims to improve human health protection and reduce the use of hazardous chemicals . The Chemicals Strategy for Sustainability ( CSS ) is part of the EU ’ s zero pollution ambition , which is in turn a key commitment of the European Green Deal .
The CSS seeks to better protect citizens and the environment from harmful chemicals while boosting innovation by promoting the use of safer and more sustainable chemicals . Central initiatives include phasing out the most harmful substances from consumer products and minimising the presence of substances of concern in all products .
The European Chemicals Agency ( ECHA ) plays a crucial role in the CSS by refining and implementing the strategy in relevant areas of REACH . Some elements of the CSS initiative will have considerable implications on the data and testing requirements for the REACH registration of substances , such as animal testing , human health , environmental health and carcinogenicity .
NAMs
REACH and Regulation ( EC ) 1272 / 2008 on the classification , labelling and packaging of substances and mixtures ( CLP ) have generated substantial knowledge and data packages on industrial chemicals to identify hazardous properties , and manage risk to human health and the environment resulting from their use .
Additionally , EU legislation promotes the implementation of the replacereduce-refine ( 3Rs ) principle , as part of the drive towards an ‘ animal-free ’ regulatory system for chemicals and developing roadmaps to support the use of new approach methodologies ( NAMs ). Although they lack a unique definition , NAMs broadly encompass any technology , methodology or approach that can provide information on chemical hazard and risk assessment without the use of animal methods .
Such methods include in silico approaches , in chemico and in vitro assays , as well as the inclusion of chemical exposure information for hazard assessment . NAMs also include a variety of new testing tools , such as high-throughput screening for large-scale studies of the entire set of genes ( genomics ), proteins ( proteomics ), metabolites ( metabolomics ) and other biological components of an organism .
Within the regulatory context of REACH and CLP , several NAM-based
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