61% of Reach dossiers checked in 2013 non compliant: ECHA

26 February 2014 11:17  [Source: ICIS news]

COLOGNE (ICIS)--Sixty-one per cent of Reach registrations dossiers scrutinised by regulator the European Chemicals Agency (ECHA) in 2013 were non compliant with information requirements on at least one count, the agency said on Wednesday.

Nearly two thirds of the 928 checks carried out on registration dossiers last year had compliance issues, most commonly related to substance identitity, physiochemical properties, sub-chronic toxicity studies, pre-natal developmental toxicity studies and exposure assessment, the ECHA said.

However, dossiers were selected for investigation based on clear indications of potential non-compliance, meaning the high proportion of non-compliance discovered among submissions does not necessarily indicate the average level of data quality in all dossiers, the agency added.

The ECHA also conducted 222 follow-up evaluations in 2013, examining whether registrants had provided the information requested in the ECHA decision by the set deadline. In 147 of those cases, the registrant had already complied with the decision. In 43 cases, requests had been complied with, but additional requests for data proved necessary.

For 22 compliance checks and 10 testing proposal decisions, the agency concluded that proper implementation had not been carried out, leading the cases to be forwarded to national enforcement authorities of relevant member states for action.

The ECHA’s evaluation report, published on Wednesday, sets out recommendations for dossier improvement, including keeping dossiers up to date, knowing how to react to draft decisions, and improving chemical safety reports to reflect actual uses and risks.

The ECHA has checked a total of 1,130 dossiers so far, above the target of 5% of the total number of dossiers submitted for the 2010 registration deadline.


By: Tom Brown
+44 208 652 3214



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