Comparing Options for Deriving Chemical Ecotoxicity Hazard Values for the European Union Environmental Footprint, Part II.

Using the European Union's Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) ecotoxicity data, this paper compares 3 different approaches to calculate final substance toxicity hazard values using the USEtox approach (chronic EC50 + acute EC50/2), using only acute EC50 equivalent data (EC50eq ), and using only chronic no observed effect concentration equivalent (NOECeq) data. About 4008, 4853, and 5560 substance hazard values could be calculated for the USEtox model, acute only, and chronic only approaches, respectively. The USEtox model provides hazard values similar to the ones based on acute EC50 data only. Although there is a large amount of variability in the ratios, the data support acute EC50eq to chronic NOECeq ratios (calculated as geometric mean) of 10.64, 10.90, and 4.21 for fish, crustaceans, and algae respectively. Comparison of the calculated hazard values with the criteria used by the EU chemical Classification, Labelling, and Packaging regulation (CLP) shows the USEtox model underestimates the number of compounds categorized as very toxic to aquatic life and/or having long-lasting effects. In contrast, use of the chronic NOEC data shows a good agreement with CLP. It is therefore proposed that chronic NOECeq are used to derive substance hazard values to be used in the EU Environmental Footprint. Due to poor data availability for some chemicals, the uncertainty of the final hazard values is expected to be high. Integr Environ Assess Manag 2019;15:796-807. © 2019 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

Using REACH for the EU Environmental Footprint: Building a Usable Ecotoxicity Database, Part I.

The European Union Environmental Footprint (EU-EF) is a harmonized method to measure and communicate the life cycle environmental performance of products and organizations. Among 16 different impact categories included in the EU-EF, 1 focuses on the impact of substances on freshwater ecosystems and requires the use of toxicity data. This paper evaluates the use of the aquatic toxicity data submitted to the EU Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. It presents an automated computerized approach for selecting substance ecotoxicity values, building on a set of quality and reliability criteria to extract the most relevant data points for calculating the substance specific hazard values. A selected set of criteria led to the exclusion of approximately 82% of the original REACH ecotoxicological data available as of May 2015 due to incomplete initial encoding of the data by the REACH registrant, missing information such as duration of exposure, endpoint measured, species tested, and imprecise toxicity values (i.e., reported with greater than or less than signs). From an initial set of 305 068 ecotoxicity data records available in the REACH database, the final usable database contains 54 353 toxicity records (29 421 characterized as acute and 24 941 as chronic) covering 9 taxonomic groups, with algae, crustaceans, and fish representing 93% of the data. This data set is valuable for assessing the environmental toxicity of the substance contained whether through traditional substance risk assessment, product toxicity labeling, life cycle assessment (LCA) or environmental impact assessment approaches. However, the resulting loss of approximately 82% of the data suggests that changes in procedures used to generate, report, and document the data within REACH are needed to improve data utility for the various assessment approaches. The rules used to select the data to be used are the primary focus of this article. Integr Environ Assess Manag 2019;15:783-795. © 2019 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of Society of Environmental Toxicology & Chemistry (SETAC).