ECHA receives updates for intermediate dossiers and announces further follow-up actions
Media enquiries: ECHA Press
The letters sent to registrants based on the IT-based screening of REACH intermediate dossiers in autumn 2012 has lead to promising results. The Agency has received almost 1 900 updates of which 39 were updates into full registrations. For the dossiers not updated, ECHA will follow up with regulatory actions.
Helsinki, 14 February 2013 – In autumn 2012, ECHA undertook a systematic IT-screening of approximately 5 500 dossiers for substances registered as intermediates only. The analysis of the reported uses in these dossiers revealed that 2 388 dossiers included uses that do not, or are very unlikely to, fulfil the definition of intermediates and/or strictly controlled conditions. These dossiers with deficiencies and a potential for incompliance represented 760 substances. As a consequence, the Agency sent letters to 574 registrants, indicating the observed issues for their dossiers and asking them to carefully review the reported uses and update their registration dossiers within three months.
The Agency has now analysed the outcome of its actions. 1 844 dossiers were updated, of which 39 were updates into Article 10 registrations, meaning full registration dossiers. For 107 dossiers, registrants have indicated they were preparing an update of which approximately half will become a full registration.
For approximately 437 dossiers that have not yet been updated or indicated as dossiers for which an update is imminent, ECHA is starting follow up actions. First, a final reminder was sent to the registrants of 183 dossiers, who failed to read the communication ECHA sent via REACH-IT.
If no update is received in the coming weeks, ECHA will initiate legally binding actions including a formal request for information leading to compliance check decisions and the submission of complete datasets.
ECHA will also inform national enforcement authorities and start discussions on possible actions that they could take in support of ECHA's measures.
To further support industry in preparing high quality dossiers, the Agency has recently released an IT-tool to enable registrants to check certain areas of the dossiers before submitting them to ECHA. This Dossier Quality Assistant also performs a number of checks on the use descriptor information in intermediate dossiers.
REACH allows intermediates manufactured and used under strictly controlled conditions to be registered with reduced information on their properties and without a chemical safety report. Workers, consumers or the environment may be adversely exposed to substances registered as intermediates that do not fulfil the definition of intermediates and/or strictly controlled conditions and for which information on their hazards and risks is missing in the registration dossier. For this reason ECHA is actively verifying the compliance of these type of dossiers.