The European Chemicals Agency (ECHA; Helsinki, Finland; echa.europa.eu) is introducing a new, systematic targeting of compliance checks based on specified concerns. This will increase the chances of dossiers of insufficient compliance to be scrutinized and ensure higher compliance of REACH registrations.
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 (for example, physico-chemical, environmental and human health endpoints), including the corresponding elements and conclusions provided in the chemical safety report (for example, PBT/vPvB assessment, classification and labeling, exposure assessment and risk characterization.)
Where the 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 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 sensitizing (S) properties of a substance.
The 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 a compliance check.