Toward the definition of specific protection goals for the environmental risk assessment of chemicals: A perspective on environmental regulation in Europe
Authors: Brown A Ross , Whale Graham , Jackson Mathew , Marshall Stuart , Hamer Mick , Solga Andreas , Kabouw Patrick , Galay-Burgos Malyka , Woods Richard , Nadzialek Stephanie , Maltby Lorraine 
Published: May 2016

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.

Key Points
Despite highly developed environmental principles, regulations, and globally standardized test guidelines, environmental protection goals for chemical registration remain highly generic and vague, for example, requiring the prevention of adverse impacts on ecosystems or the environment as a whole. Due to considerable environmental variability and complexity, it is difficult to determine whether these generic protection goals are being met, justifying the need for specific protection goals (SPGs). Taking a holistic view of the environmental regulation and assessment of chemicals, throughout their life cycles, we highlight a limited number of examples of SPGs, which specify ecological entity, attribute, and magnitude; spatial extent; and temporal duration of effect. Major stumbling blocks include defining “Which key ecological entities and attributes require protection?” and “What constitutes acceptable versus unacceptable adverse effects on these entities?” A potential solution is to consider the effects of chemicals on ecosystem service provision.