title: Toward the definition of specific protection goals for the environmental risk assessment of chemicals: A perspective on environmental regulation in Europe.
abstract: This critical review examines the definition and implementation of environmental protection goals for chemicals in current European Union (EU) legislation, guidelines, and international agreements to which EU countries are party. The European chemical industry is highly regulated, and prospective environmental risk assessments (ERAs) are tailored for different classes of chemical, according to their specific hazards, uses, and environmental exposure profiles. However, environmental protection goals are often highly generic, requiring the prevention of "unacceptable" or "adverse" impacts on "biodiversity" and "ecosystems" or the "environment as a whole." This review aims to highlight working examples, challenges, solutions, and best practices for defining specific protection goals (SPGs), which are seen to be essential for refining and improving ERA. Specific protection goals hinge on discerning acceptable versus unacceptable adverse effects on the key attributes of relevant, sensitive ecological entities (ranging from organisms to ecosystems). Some isolated examples of SPGs for terrestrial and aquatic biota can be found in prospective ERA guidance for plant protection products (PPPs). However, SPGs are generally limited to environmental or nature legislation that requires environmental monitoring and retrospective ERA. This limitation is due mainly to the availability of baselines, which define acceptable versus unacceptable environmental effects on the key attributes of sentinel species, populations and/or communities, such as reproductive status, abundance, or diversity. Nevertheless, very few regulatory case examples exist in which SPGs incorporate effect magnitude, spatial extent, and temporal duration. We conclude that more holistic approaches are needed for defining SPGs, particularly with respect to protecting population sustainability, ecosystem function, and integrity, which are implicit in generic protection goals and explicit in the International Programme for Chemical Safety (IPCS) definition of "adverse effect." A possible solution, which the chemical industry is currently assessing, is wider application of the ecosystem services approach proposed by the European Food Safety Authority (EFSA) for the risk assessment of PPPs. Integr Environ Assess Manag 2017;13:17-37. © 2016 SETAC.
authors.affiliation: Biosciences, College of Life and Environmental Sciences, University of Exeter, Exeter, Devon, United Kingdom.
authors.forename: A Ross
authors.initials: AR
authors.lastname: Brown
authors.affiliation: Shell Health, Manchester, United Kingdom.
authors.forename: Graham
authors.initials: G
authors.lastname: Whale
authors.affiliation: Shell Health, Manchester, United Kingdom.
authors.forename: Mathew
authors.initials: M
authors.lastname: Jackson
authors.affiliation: Unilever, Sharnbrook, Bedford, United Kingdom.
authors.forename: Stuart
authors.initials: S
authors.lastname: Marshall
authors.affiliation: Syngenta, Bracknell, Berkshire, United Kingdom.
authors.forename: Mick
authors.initials: M
authors.lastname: Hamer
authors.affiliation: Bayer CropScience AG, Environmental Safety - Ecotoxicology, Monheim, Germany.
authors.forename: Andreas
authors.initials: A
authors.lastname: Solga
authors.affiliation: BASF, Crop protection, Global Ecotoxicology, Limburgerhof, Germany.
authors.forename: Patrick
authors.initials: P
authors.lastname: Kabouw
authors.affiliation: ECETOC, Brussels, Belgium.
authors.forename: Malyka
authors.initials: M
authors.lastname: Galay-Burgos
authors.affiliation: ExxonMobil Biomedical Sciences, Clinton, New Jersey, USA.
authors.forename: Richard
authors.initials: R
authors.lastname: Woods
authors.affiliation: Albemarle Europe Sprl, Louvain-la-Neuve, Belgium.
authors.forename: Stephanie
authors.initials: S
authors.lastname: Nadzialek
authors.affiliation: Department of Animal and Plant Sciences, The University of Sheffield, Sheffield, United Kingdom.
authors.forename: Lorraine
authors.initials: L
authors.lastname: Maltby
mesh_terms: D044822:Biodiversity; D003247:Conservation of Natural Resources; D017753:Ecosystem; D054750:Ecotoxicology; D004781:Environmental Exposure / Q000706:statistics & numerical data; D004784:Environmental Monitoring / Q000379:methods / Q000592:standards*; D004785:Environmental Pollutants; D005062:European Union; D059022:Food Safety; D018570:Risk Assessment / Q000592:standards
chemical_list: D004785:Environmental Pollutants
keywords: ERA; Ecosystem services; Environmental regulations; European chemical industry; Specific protection goals