[OTDev] ECHA report on evaluation in 2010
Vedrin Jeliazkov vedrin.jeliazkov at gmail.comSat Mar 5 00:14:27 CET 2011
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Hi OTDevs, I thought you might find the following reading interesting and it could even become source for inspiration: http://echa.europa.eu/news/pr/201102/pr_11_05_evaluation_report_20110228_en.asp I can't resist quoting some key figures from the report: -- only 36% (25 out of 70) of the evaluated dossiers were OK; -- 6 dossiers had substance identity-related shortcomings/issues (e.g. missing spectra, insufficient analytical information and inconsistencies between the composition and the analytical data provided); -- 8 dossiers had CSR related issues (e.g. PNEC or DNEL derivation, exposure assessment, missing description of the waste stage); -- 18 dossiers had classification and labelling-related shortcomings; -- 6 dossiers lacked adequate guidance on safe use, e.g. sufficient advice on the prevention of exposure; -- 1 dossier had issues with purity of the test material; -- 5 dossiers had insufficient level of detail/inconsistencies in robust study summaries; -- 11 dossiers had issues with identified uses, strictly controlled conditions, status as intermediate; -- 3 dossiers exhibited data sharing-related problems; -- 2 dossiers had inconsistent information regarding tonnage band; -- ECHA also noted that many registrants of transported intermediates seem not to have met the requirement of Articles 17(2)(d) and 18(2)(d) to provide any available information on physico-chemical, human health or environmental properties. It does not seem plausible that this information does not exist as without basic information on e.g. physicochemical properties such as boiling or melting point it would not be possible to use the chemical in a process; -- It has been observed that the number of dossiers containing a weight-of-evidence approach is higher than expected. A frequent shortcoming is submission of data from several secondary sources (handbooks); however, all sources quoted making reference to the same primary source; IMHO these findings are quite alerting (e.g. on the lamentable state-of-the-art, both of human and software capacity in this domain of science), but also insightful (e.g. what could and should be improved, e.g. by standards and tools such as those developed in OT). Kind regards, Vedrin
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