ECHA guidance on rectifying information gaps in dossiers
According to the European Chemicals Agency’s (ECHA) annual evaluation statistics, in 2021, 93% of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Regulation dossiers that were cross checked for full compliance required further data outlining the long-term effects of certain chemicals on human health or the environment.
The long-term impact of chemicals on the environment and human health is an issue that is increasingly gaining traction in the product safety sphere.
Companies should be mindful of this updated guidance from the ECHA and review all dossiers with a view to implement the recommendations, where necessary, in order to fulfil future compliance checks.
Dossiers should be carefully analysed, in particular those dossiers for which information gaps have been previously identified or those that relate to substances for which animal testing has been or will need to relied to make up some of the data.
ECHA compliance checks – key points
Of particular note are the following clarifications in respect of this compliance check:
- The ECHA’s evaluation covered 300 full compliance checks across 288 unique substances. This is in addition to 71 targeted compliance checks covering a total of more than 2,100 registration dossiers in respect of 341 unique substances.
- This is an increase on the evaluation statistics previously published by ECHA - the number of dossiers which required further information was 88% and 81% in 2020 and 2019, respectively.
- It must be acknowledged that, generally, the ECHA opens compliance checks on those dossiers flagged as having information gaps and therefore the statistics will always focus on those dossiers with at least some missing data. However, this should not detract from the significant numbers of dossiers for which key information on long-term data is incomplete.
In an effort to address this information gap, the ECHA has further developed its recommendations to help companies improve their registration dossiers to comply with the necessary information requirements under REACH. These recommendations include:
- Guidance as how to apply read-across and weight of evidence, or combine the two approaches. These approaches use relevant information from analogous substances and independent sources to predict the properties of ‘target' substances and seek to fulfil legal requirements without further testing on animals where this can be appropriately justified.
- Suggestions on how to address a read-across between substances of unknown or variable composition, complex reaction products or of biological materials (UVCBs).
- Additional advice on dose setting for toxicity testing.