Towards the Definition of Specific Protection Goals for the Environmental Risk Assessment of Chemicals: A Perspective on Environmental Regulation in Europe

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, use patterns 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. SPGs hinge on discerning acceptable versus unacceptable ‘adverse’ effects on the key attributes of relevant, sensitive ecological entities (ranging from organisms to ecosystems). There are some isolated examples of SPGs for terrestrial and aquatic biota in prospective ERA guidance for Plant Protection Products (PPPs). However, SPGs are generally limited to environmental/nature legislation requiring environmental monitoring and retrospective ERA. This is due mainly to the availability of baseline defining acceptable versus unacceptable environmental effects on the key attributes of sentinel species, populations and/or communities, such as reproductive status, abundance or diversity. Nevertheless, there are very few regulatory case examples 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.