ECHA has found 69% of dossiers evaluated as part of its checks of registrations made by the 2010 tonnage deadline to be non-compliant. The REACH Regulation requires ECHA to check at least 5% of registrations per tonnage band for compliance. The 2010 tonnage band applied to all pre-registered phase-in substances:
- manufactured or imported into the EU at or above 1000 tonnes per year;
- classified as carcinogenic, mutagenic or toxic to reproduction and manufactured or imported into the EU at or above 1 tonne per year; and/or
- classified as very toxic to aquatic organisms and manufactured or imported at or above 100 tonnes per year.
ECHA set itself a target of checking, at least partially, 5% of these dossiers by the end of 2013. ECHA selected dossiers for evaluation on the basis of electronic screening to identify those dossiers where there is potential concern as well as random selection. Dossier evaluation is a key part of ECHA’s aim to improve the quality of registration dossiers (as explained in our previous briefing “REACH Dossier Evaluation – would your dossiers stand up to regulatory scrutiny”).
The two key shortcomings identified by ECHA were deficiencies in the information regarding identification and composition of the substance and insufficient justification for not submitting the studies or information required in the chemical safety report.
Registrants who receive decisions from ECHA asking them to improve their dossier(s) have an obligation to provide the requested information by updating their registration dossier within the deadline set. ECHA is cooperating with Member States to ensure its decisions are respected.
All REACH registrants are reminded to check their REACH-IT accounts regularly to ensure that they are aware of any correspondence from ECHA.