ECHA urges 574 registrants of intermediates to improve the quality of their dossiers

News alert
Media enquiries: ECHA Press

The European Chemicals Agency (ECHA) has conducted a new IT-based screening of all REACH intermediate registration dossiers, which has raised serious quality and potential compliance concerns. The concerned registrants have been directly informed via REACH-IT and are requested to review and update their dossiers with correct information over the next three months. After this period, ECHA plans to screen these dossiers again and identify those that will be subject to further regulatory actions.

Helsinki, 14 September 2012 – 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. ECHA has earlier reported on the outcome of previous screenings of intermediate dossiers undertaken in 2010 and 2011. Those screenings raised serious concerns in terms of compliance. The most problematic dossiers that seemed to be inconsistent with the definition of intermediates and/or respecting strictly controlled conditions have been pursued through clarification requests and where needed compliance checks. Therefore, there are substances currently registered as intermediates for which potentially important information on their hazards and risks has not been gathered.

ECHA has now undertaken a more systematic IT-screening of the approximately 5 500 registrations for intermediates. The analysis of the reported uses in these dossiers revealed that 2388 dossiers included uses that do not, or are very unlikely to, fulfil the definition of intermediates and/or are used under strictly controlled conditions. These dossiers with deficiencies and a potential for incompliance represent 760 substances.

The Agency has sent letters to 574 registrants with potentially non-compliant intermediate registrations, asking them to carefully review the reported uses and update their registration dossiers within three months. ECHA has also added to this letter practical advice for registrants on how to better report intermediates in IUCLID 5.4 or how to update the registration to a full Article 10 Registration.

After the end of the three month period, ECHA will undertake a new screening of dossiers and identify those that require regulatory action.

More information about the IT-screening and examples of the observed deficiencies can be found in a detailed background document.


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