Table A.1.
Framework for metals risk assessment under different regulations in different countries. Please refer to the glossary for abbreviations
| EFSA (1107/2009) Cu RAR Copper Compounds, 2017 | OECD (No 259, OECD, 2016) | US EPA (Fairbrother et al., 2007; EPA 120/R‐07/001, March, 2007) | ECHA (REACH, App R.7.13‐2; ECHA, 2008, 2017a,b,c, 2018b) | WFD (2000/60/EC; 2008/105/EC) European Commission (2019) | |
|---|---|---|---|---|---|
| Scope | Active substance approval, national authorisation and management of PPP | Incorporation of bioavailability concepts for risk assessment and threshold values | Site‐specific assessment, national level assessment, national ranking | Registration of substances | Water management of river basins |
| Protection goal | No unacceptable effects | Protecting and maintaining the physical, chemical and biological integrity of US waters | Safe handling, manufacture, place on the market or use should not adversely affect human health or the environment | Protection of most sensitive waters; No effects on reproduction, growth or health | |
| Exposure | |||||
| Background | Considered for sediment and soil | Considered as metallo‐regions (several databases for sediment, water, biota) | Considered for water, soil, sediment to differentiate between added and total risk (measured, FOREGS database, geochemical modelling) | Considered for water (NBCa close to undisturbed conditions) | |
| Spatial‐scale | Realistic worst‐case (covers 90% of all cases), edge‐of‐field, in‐field | Local differences | No exposure target defined | Local, site specific, river basin | |
| Timescale | Acute (hours) and long‐term (weeks/year) | Rapid changes | Long‐term (20–100 years) | Short‐term (days) and long‐term (annual) | |
| Models | No specific model to address metals | No specific model to address metals | Monitoring data, ecoregion approach | Monitoring data | |
| Toxicity | |||||
| Bioavailability |
Water: dissolved concentration Sediment: total concentration for 2.5% OC Soil: total concentration No concept for tiered approach regarding bioavailability |
Water: BLM, simplified models (water hardness), dissolved fraction. Sediment: Fe/Mn, org C or SEM‐AVS normalisation Soil: Pore water, lab‐to‐field factor, normalisation models |
Water: water hardness adjustment, speciation models, BLM. Sediment: SEM‐AVS, normalisation Soil: Pore water, bulk soil, ageing |
Water: dissolved concentration, speciation models, BLM. Sediment: Fe/Mn, OC or SEM‐AVS normalisation Soil: worst‐case scenario for soil testing, leaching‐ageing factor, normalisation |
Water: Dissolved concentration, simplified tools, BLM |
| Essentiality | Considered in assessment factor (AF) | Considered in ecotox tests, consider hormesis | Consider in AF, site‐specific bioassays | Consider hormesis | Not explicitly considered |
| Bioaccumulation | Not considered relevant for secondary poisoning | Not addressed | Site specific: regression model for BCF/BAF, kinetic models | Site specific: regression model for BCF/BAF | Not addressed |
| Uptake route causing toxicity | Not specified |
Water: Mainly waterborne ingestion Soil: dermal |
Inhalation, ingestion, absorption, contact |
Water: waterborne ingestion Soil: contact |
Not specified |
Natural Background Concentration.