[OTDev] ECHA report on evaluation in 2010

Vedrin Jeliazkov vedrin.jeliazkov at gmail.com
Sat Mar 5 00:14:27 CET 2011


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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