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Guest column: Are REACH data appropriate for hazard identification and risk assessment?
The REACH Compliance research project, carried out at the German Federal Institute for Risk Assessment (BfR), evaluates the data availability and quality of REACH registration dossiers. In the first three parts of the project, we looked at chemicals placed on the European market in quantities of 1 000 tonnes or more per year.
Our aim was to evaluate the availability of toxicological and ecotoxicological information on eight selected endpoints. These were mutagenicity; developmental, reproductive and repeated dose toxicity; biotic and abiotic degradation; bioaccumulation and ecotoxicity. We also looked at data included in the environmental exposure assessment.
These endpoints are crucial for identifying hazards and assessing the risks of chemicals. We reviewed 1 814 registration dossiers of phase-in substances submitted to ECHA by March 2014.
From left: Angelika Oertel, Katrin Maul, Jakob Menz, Anna Lena Kronsbein and Agnes Schulte.
The scope of the project
In the first part, we analysed whether the REACH standard information requirements were met. These are set out in Annexes VII to X to REACH. We looked at whether this was done by:
- submitting respective standard data;
- data waiving; or
- adapting the standard testing regime.
For the second part, we assessed whether the registrants justified their use of data waiving and the adaptations in accordance with the formal requirements of the REACH Regulation.
The third part looked in more detail at the weight-of-evidence approaches and the justifications for data waiving – particularly at those justifications referring to the outcome of the chemical safety and environmental exposure assessments.
For each endpoint, we drew a final conclusion based on the outcomes of all three parts of the project.
What we found
We observed that the degree of compliance varied depending on the endpoint looked at. Keeping that in mind, our main findings are that:
- A minimum of 19 % (for developmental toxicity) and a maximum of 56 % (for biotic degradation) of the dossiers had standard information or data waiving/adaptations that were compliant with the formal criteria of the REACH annexes.
- A minimum of 12 % (for abiotic degradation) and a maximum of 61 % (for ecotoxicity) of the dossiers were non-compliant either because they had shortcomings in data quality, data gaps or inappropriate data-waiving/adaptation approaches.
- For a minimum of 12 % (for mutagenicity) and a maximum of 61 % (for bioaccumulation), no final conclusion could be made on the dossier quality due to methodological limitations. We classified these as complex.
The full overview of the results are shown in the chart and the final report on the evaluation of 1 000 tonne registrations will be published soon.
Data availability for human health and environmental endpoints in REACH registration dossiers or phase-in substances placed on the European market in quantities above or equal to 1 000 tonnes per year (n=1 814)
The methods we applied differ to those used by ECHA for dossier evaluation according to Article 41 of REACH. This should be taken into account when interpreting the project results.
Our results suggest that for non-compliant endpoint conclusions, a large number of registration dossiers do not sufficiently address the standard requirements either by using experimental data, appropriate surrogate data, or a sound justification for data waiving.
In these cases, the data are inadequate for identifying hazards and assessing risks. They, therefore, do not form a robust basis to show the safe use of these chemicals.
Although our findings are based on registrations submitted up to March 2014, we think that the results are relevant since a lot of registrants have never updated their dossiers.
Registrants should thoroughly review their dossiers
One of the findings from the project was that relevant (eco)toxicological data was largely non-compliant (61 %). This means that registrants need to thoroughly review their dossiers and:
- fulfil the information requirements either using standard testing, providing a sound justification to waive data or using appropriate surrogate data;
- update registration dossiers whenever new information becomes available; and
- verify that all information was migrated properly into IUCLID 6.
Follow-up project on 100-1 000 tonne substances
We are currently following up this project by evaluating substances manufactured or imported in quantities between 100 and 1 000 tonnes per year.
We will use the concepts developed for the project on 1 000 tonne registrations and adapt them to the standard information requirements for the lower tonnage band. The evaluation of 100-1 000 tonne substances is expected to be completed by June 2018.
Workshop in 2018
In summer 2018, we will hold a workshop at BfR on the availability and quality of human health and environmental data for high tonnage chemicals.
During this workshop, we aim to give a platform to promote dialogue among stakeholders to help them improve the quality of their registration dossiers. The workshop will be open to all stakeholders with an interest in the data quality of REACH registrations.
Agnes Schulte is Head of the Safety of Chemicals in the Department Chemicals and Product Safety unit at the German Federal Institute for Risk Assessment (BfR). She is a member of ECHA’s Committee for Risk Assessment (RAC).
Angelika Oertel, Katrin Maul, Jakob Menz and Anna Lena Kronsbein currently form the REACH Compliance project team at the BfR.
The German Federal Institute for Risk Assessment (BfR) was established in November 2002 to strengthen consumer health protection. It is the scientific institution of the Federal Republic of Germany that prepares opinions and has expertise on food and feed safety, as well as the safety of substances and products. The BfR is the national focal point of the European Food Safety Authority (EFSA) and a partner of the European Chemicals Agency (ECHA).
The REACH Compliance project is financed by the German Federal Ministry for the Environment, Nature Conservation, Building and Nuclear Safety (BMUB) and commissioned by the German Environment Agency (UBA).
Published on: 16 November 2017
Top image: © The German Federal Institute for Risk Assessment
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