ECHA strengthens its compliance check strategy

ECHA strengthens its compliance check strategy

ECHA/NA/12/42
News alert
Media enquiries: ECHA Press

ECHA is introducing a new systematic targeting of compliance checks based on specified concerns. This will increase the chances for dossiers of insufficient compliance to be scrutinised and ensure higher compliance of REACH registrations.

Helsinki, 17 September 2012 – To ensure increased compliance of REACH registration dossiers, ECHA carries out both full compliance checks of the dossiers and now more effectively also targets its evaluation to specific parts of them.

In a full compliance check, ECHA addresses the full dossier content in a single evaluation exercise, especially for randomly selected registration dossiers. This means that ECHA performs a systematic evaluation of all information requirements in the technical dossier (e.g. physico-chemical, environmental and human health endpoints), including the corresponding elements and conclusions provided in the chemical safety report (i.e. PBT/vPvB assessment, classification and labelling, exposure assessment and risk characterisation). Where a dossier is non-compliant with an information requirement, ECHA will request the information in a single decision. The decision is taken in cooperation with the Member States.

In a targeted compliance check, ECHA evaluates only a specific part of the registration dossier based on specified concerns. Selected (groups of) endpoints or criteria, called areas of concern, have been identified that are in particular relevant for the safe use of substances.  The ultimate goal is to focus on those endpoints that matter for human health and the environment. Emphasis will be given to Persistent, Bioaccumulative and Toxic (PBT);  Carcinogenic, Mutagenic or Toxic to reproduction (CMR); or sensitising (S) properties of a substance. IT-assisted targeting combined with expert judgement will help to achieve the necessary increased compliance of the registration dossiers. The chances of non-compliant dossiers being picked up for compliance check are now higher. Dossiers submitted individually outside an existing joint submission and dossiers with obviously incomplete essential elements will be automatically selected for compliance check.

Potentially more Draft Decisions on the same registration dossier

The consequence of the targeted compliance check is that if the dossier contains several non-compliances registrants may in the near future receive more than one draft decision per registration dossier at different moments in time. ECHA invites registrants who receive a first draft decision as a result of these targeted compliance checks, to re-assess the overall quality of their registration dossier and prepare updates where necessary.

In this context ECHA reminds the registrants that for the most common non-compliance issues that have been identified in the past, a list of recommendations for improving dossier quality can be found in the Annual evaluation report. Furthermore, ECHA starts a series of webinars in which registrants will be advised on how to bring their registration dossiers in compliance with REACH.