A large-scale assessment of more than 3 800 REACH* dossiers (100-1000 and > 1000 tonnes) by the German Environment Agency (UBA) and Federal Institute for Risk Assessment (BfR) concludes that, for each different endpoint, 2 – 61% on average of responses in dossiers are non-compliant, and that overall (total in all dossiers) 32% of endpoint responses in > 1000 t dossiers and 19% in 100 – 1000 t dossiers are non-compliant. Non-compliance was often identified because of use of unsuitable test methods, inappropriate assessment factors for PNEC*, missing environmental exposure assessment, not all hazard information taken into account, inadequately justified QSAR* or QSAR not corresponding to ECHA* Guidance, insufficiently justified data waiving or use of waivers / adaptation for UVCBs. The difficulty of any such assessment is shown by the conclusion for 37% of endpoint responses overall as “complex” (not identified whether compliant or not). It is noted that the assessment does not include scientific evaluation of studies nor of read-across and does not represent the ECHA Compliance Check. UBA and BfR conclude that there is a strong need to improve quality of REACH dossiers. ECHA has itself repeatedly warned of missing data after its own compliance checks and has welcomed the report. ECHA has published a communication emphasising the legal obligation to update REACH dossiers whenever any new information becomes available, concerning the chemical, its production or uses, in particular through new co-registrants. ECHA has also announced a “major enforcement project” for 2019, covering both registration obligations and control of imported substances by customs authorities.
ECHA “Evaluation under REACH: Progress Report 2017” https://echa.europa.eu/documents/10162/13628/evaluation_under_reach_progress_en.pdf/24c24728-2543-640c-204e-c61c36401048
BfR statement “BfR Communication No 030/2018 of 25 September 201” https://www.bfr.bund.de/cm/349/data-quality-of-environmental-endpoints-in-registrations.pdf and presentation of results by Angelika Oertel, BfR, “Data quality of environmental endpoints in registrations” https://www.bfr.bund.de/cm/349/reach-compliance-workshop-at-the-bfr.pdf at workshop “REACH Compliance – A workshop on data quality in registration dossiers”, Berlin, 23-24 August 2018 https://www.bfr.bund.de/en/event/reach_compliance___a_workshop_on_data_quality_in_registration_dossiers-205356.html
ECHA “Keep your registration up to date” ECHA/NR/18/62 https://echa.europa.eu/-/keep-your-registration-up-to-date
Abbreviations: REACH = European chemical regulation (European Regulation on Registration, Evaluation, Authorisation and Restriction of Chemicals EC 1907/2006). PNEC = Predicted No Effect Concentration. QSAR = Quantitative Structure-Activity Relationship modelling of chemical properties. ECHA = European Chemical Agency