Exposure calculation under REACH (REACH Reality check)
The REACH Regulation (EC1907/2006) requires, that manufacturers register their substances based on a risk assessment for their relevant uses. From an environmental point of view, the total production volumes of all manufacturers are relevant. To assess the impact of the combined volumes of all manufacturers, ERASM has conducted an environmental exposure assessment using the standard European Union System for the Evaluation of Substances (EUSES). The example of Alkyl Sulfates (AS) is illustrated in this project. Taking into account „substance similarity“ within the AS surfactant groups, all REACH registered AS with production volumes > 100 t/a were included in the assessment. To comply with the competition law, data collection was handled by an independent trustee. The result of the EUSES calculation was benchmarked against recent (independent) environmental monitoring data for AS (US data, adapted to EU frame conditions).
The exposure calculation using the EUSES default biodegradation rate for readily degradable substances [24/d] predicts for the total AS volume an EU average Clocal effluent = 413 µg/l, whereas the US monitoring data result in an estimated EU average Clocal effluent = 11.8 µg/l. This indicates that the EUSES default biodegradation rates for readily biodegradable substances are very conservative, resulting in this case in a 35-fold overprediction of the local effluent concentrations.
Taking this into account, the default biodegradation rate of [24/d] was not used for the exposure calculation in the REACH registration dossiers. Instead, and based on monitored high elimination rates of AS in WWTP simulation tests of > 99 %, a more realistic biodegradation rate of [192/d] was applied. This increased biodegradation rate resulted in an EU average Clocal effluent = 51.6 µg/l, which is still by a factor of 4-5 higher (more conservative) than the predicted effluent concentration from monitoring data. The use of realistic removal kinetics based on monitoring data is recommended for use in registration dossiers for AS as well as other surfactant categories. Furthermore, the case study illustrates the conservative nature of exposure assessment with the EUSES model, which is also an important element to consider for mixtures assessments.
For more information about this project, you can read the abstract of the paper “Comparing the European Union System for the Evaluation of substances (EUSES) environmental exposure calculations with monitoring data for alkyl sulphate surfactants” here.