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Quantitative definitions of adverse effects

Quantitative definitions of the terms ‘impairment’, ‘unacceptable’, ‘undesirable’, ‘harmful’ or ‘adverse’ are generally lacking in chemical regulations and supporting guidance documents (Table C1.1; Table 3.2). Furthermore, although prospective ERA places emphasis on assessing population-relevant effects in controlled exposure studies (often in the laboratory), their ‘significance’ is ultimately framed in statistical terms, and the ecological significance of effects on wild populations may be exaggerated, or worse still, overlooked (Forbes et al, 2008; 2011; Brown et al, 2014). Alternatively, the ERA of plant protection products also includes the option for appropriate assessments under field conditions of: the population density and viability of non-target species (including keystone and/or indicator species); biodiversity (e.g. overall species richness of ecological communities); and ecosystem services (including the provision of harvestable resources and aesthetic resources including species with ‘popular appeal’) (SANCO, 2002). However, there is still a lack of clarity in the definition and relevance of unacceptable impacts on each of these ecological entities, and hence their recovery, indicating the absence of long-term effects, may be used as an alternative decision criterion under PPPR (Hommen et al, 2010; Moe et al, 2013) and COMAH (CDOIF, 2013). It is important to recognise that “ecosystems change, including species composition and population abundance” and that environmental management should take account of such natural, background changes (Malawi Principle 9: CBD SBSTTA, 2000). Retrospective environmental assessments (Tables C1.2 and C1.3) have the advantage of historical baselines for established ‘reference’ sites, which are capable of quantifying such natural variability, including seasonal cycles and long-term climate change (Moe et al, 2013). Ecological baselines are fundamental to environmental quality assessment under the Water Framework Directive (WFD) (2000/60/EC), Oslo Paris Convention (OSPAR) (Table C1.3) and the Thematic Soil Strategy (TSS) (COM/2006/0231/EU, COM/2006/0232/EU) (Table C1.2) and retrospective evaluation of chemical impacts under the ELD and COMAH (Table C1.2).

Table 3.2: Definitions of adverse (unacceptable, harmful) effects in international guidance and EU legislation concerning prospective ERA of chemicals

t 3.2t 3.2 2

All URLs were accessed in March 2015

# Guidance on the Biocidal Products Regulation Volume IV, Part B guidance for Environmental Health is currently under development.