After the long and often arduous process of submitting a REACH registration, registrants might be forgiven for thinking that their work is done following receipt of a REACH registration number, with no necessity for future action.

In reality, ECHA makes a point of assessing certain key aspects of the information submitted by companies, to ensure that registrants are complying with the specific requirements and essence of REACH, and to clarify if a given substance constitutes a risk to human health/the environment. Evaluation under REACH focuses on three main areas: examination of in vivo testing proposals (TPs), compliance check of dossiers, and substance evaluation. Following assessment by ECHA, and response usually by way of a draft decision, the Agency indicates where further work may be required on the part of the dossier submitters.

ECHA guidance indicates that vertebrate animal testing should only be conducted as a ‘last resort’ with regard to satisfying the information requirements of REACH. As such, all submitted TPs (for in vivo studies required at Annex IX or X) are scrutinised by the Agency to ensure the reliability/adequacy of the intended data, and to prevent unnecessary testing. After publication of the TP by ECHA, the floor is open for external comments and submission of relevant data which might then inform the draft decision. Short of outright acceptance of the TP, the Agency might require extra information/clarification (e.g. to show that all the alternatives to testing, including read-across and (Q)SAR, have been suitably considered) or suggest changes to the proposed methods (e.g. exposure route and tissues for examination); in certain cases, a TP might be rejected.

Checks for compliance with the REACH requirements are undertaken so as to verify the adequacy of the submitted information (e.g. substance ID). REACH requires ECHA to check at least 5% of dossiers in each tonnage band, with selection either at random, or based on concern (i.e. targeted – with a focus on specific endpoints, e.g. genotoxicity). If a dossier is considered not to be fully compliant, the need for additional information/testing is communicated to submitters (sometimes informally, but primarily via a draft decision).

Regarding substance evaluation, the community rolling action plan (CoRAP) indicates those substances, as selected by ECHA, which are to be evaluated (over a 3-year period). Evaluation of such chemicals is undertaken by Member States to assess whether their associated use poses a risk to human health or the environment. Evaluators may opt to request further information from the registrants to clarify the concern. Following substance evaluation, future actions to address any issues arising might include changes to harmonised classification and labelling, identification of the chemical as a substance of very high concern (SVHC), substance authorisation and/or restriction on its use.

Clearly, registration is but one part of the overall REACH process. Feedback on the evaluation (typically either informally or as a draft decision) is provided to registrants where a concern has been identified in order to inform any necessary updates to the dossier. There is a relatively short time period to engage in discussions with ECHA Evaluators, and then to submit the updated dossier which meets their expectations (and those of your co-registrants). As such, it is a sensible business decision for registrants to reconsider their dossiers on a regular basis, making sure they contain up-to-date use information and (eco)toxicity data, they are compliant with the most recent IUCLID versions (currently IUCLID 6) and REACH regulatory text/ECHA guidance, and would withstand ECHA scrutiny (notably the read-across approach would hold-up to a RAAF evaluation).

The bibra team have a wealth of experience regarding REACH submissions, including ECHA discussions and feedback, so please get in touch to see how we can help.

 

 

REACH More recent work News Meet our team