Nearly half of medium tonnage REACH dossiers possibly 'non-compliant'
Abstract
According to an analysis performed by German Federal Institute for Risk Assessment (BfR) and the German Environment Agency (UBA), nearly half of the medium tonnage (100-1000tpa) REACH dossiers were non-compliant, especially those with regard to the ecotoxicity. The results confirm the level of compliance with REACH is generally low. The analysis selected 8 endpoints and combining the analysis for all three checks for the subset of 500 dossiers.
According to an analysis performed by German Federal Institute for Risk Assessment (BfR) and the German Environment Agency (UBA), nearly half of the medium tonnage (100-1000tpa) REACH dossiers were non-compliant, especially those with regard to the ecotoxicity. The results confirm the level of compliance with REACH is generally low.
The analysis selected 8 endpoints and combining the analysis for all three checks for the subset of 500 dossiers. Results show that the ecotoxicity section was "non-compliant" in 46% of cases. The non-compliant proportion was lower for the other endpoints, such as reproductive toxicity – with just 9% of cases being ‘non-compliant’.
The equivalent proportion for the high tonnage band was 34%. These proportions give an indication of compliance in general but are not meaningful at the dossier level because a single dossier may be non-compliant in relation to multiple endpoints.
The current analysis is part three of the REACH Compliance project, which the UBA and the BfR launched in 2014 to determine the availability and quality of human health and environmental risk data submitted under REACH.
The European Chemical Industry Association (CEFIC) expressed its agreement with the project ’s conclusion: some dossiers need to be updated to ensure that the test strategy in the dossier is consistent with the current ECHA requirements. As part of the plan to optimize the file, the agency signed a cooperation agreement with ECHA to develop more case studies and examples of alternative methods.
The policy manager of the European Environment Agency stated that the results of the project were consistent with the latest ECHA statistics, which emphasized the repeated data quality issues in the dossier. At present, not many countries take active action to solve this problem. ECHA and the Commission launched a joint action plan to solve this problem, but the European Environment Agency believes that the official should first investigate the root cause of this problem and resolve the industry's conflict of interest.
The current analysis report belongs to the third part of the REACH compliance project. The REACH compliance project was initiated by BfR and UBA in 2014 to determine whether the availability and quality of health and environmental risk data under REACH is reliable. The project team published the first part (selection of high-tonnage registration files) and the second part (in-depth analysis of high-tonnage registration files) in 2015 and 2018, respectively. The latter has also caused dissatisfaction among member states and NGOs about widespread non-conformities, which will force ECHA and the European Commission to take action on non-compliance.
Source From Chemical Watch
