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.
(Source: Chemical Watch)
CIRS Experts estimates that more
dossiers will undergo compliance checks in the future. Enterprises will possibly
need to repeat/redo the tests due to the non-compliance of REACH dossiers.
Enterprises may also need to repay the data sharing fee for this reason. It is
suggested that enterprises should reassess the European chemical market.