The value of and risk from chemical use

Chemicals are used and released by industry, medicine, energy generation, agriculture and other processes essential for maintaining health, nutrition and well-being. Chemical development, manufacture and use are also important wealth generators, with global chemical sales projected to reach c. $8500 billion by 2030 (OECD 2012). Europe’s chemical industry is the third largest production sector in Europe and total EU28 chemicals sales (excluding pharmaceuticals) reached €615 billion in 2015 (CEFIC 2017).

The manufacture and use of chemicals comes with a potential cost however as it leads to environmental emissions. A significant proportion of chemicals produced in the EU28 are classed as ‘harmful to the environment’ and/or ‘toxic’ as defined by EU regulation. According to Eurostat (2014 data), EU28 production of ‘environmentally harmful chemicals’ (defined as chemicals harmful to the aquatic environment) has been around 135–150 million tons/annum for the period 2004–13, representing around 41-45% of all chemicals produced, and EU28 production of ‘toxic chemicals’ was 200 million tons (62.7% of all chemicals produced) in 2013. Production of the most toxic carcinogenic, mutagenic and reprotoxic (CMR) chemicals was 30.7 million tons (9.5% of all chemicals produced) in 2013.

The conundrum is how to benefit from chemicals without contaminating the environment and causing a risk to the health of wildlife and people. Environmental protection is primarily driven through premarket measures to assess hazard, exposure and risk prior to authorising sale, and post-market measures to further assess, monitor and manage risk once chemicals are in use. Such measures are governed by various European legislative instruments, including REACH and the Biocidal Products Regulation. There is a particular focus on chemicals that are persistent/very persistent (P/vP) bioaccumulative/very bioaccumulative (B/vB) and toxic (T), because such PBT chemicals are not readily degraded and have the potential to accumulate along the food chain, leading to exposure of wildlife and humans.

Why use apex predators?

Apex predators are particularly well suited to contaminant monitoring for risk assessment (RA) and management because:
(1) being at the top of the food chain and relatively long-lived, they strongly bioaccumulate PBT chemicals;
(2) they integrate contaminant exposure over time and over relatively large areas;
(3) most species are relatively easily collected and sampled sampled;
(4) populations can be easily monitored and quantified.

LIFE APEX is a demonstration project that demonstrates an approach to the use of chemical monitoring data that is new Union wide. The Union-wide novelty of LIFE APEX’s approach centres around the use of chemical monitoring data from apex predators and their prey (AP&P) for the purposes of REACH and BPR. The novelty of our approach has several dimensions.

First, LIFE APEX exploits recent technological advances in analytical methodologies in relation to wide-scope targeted analyses and non-target screening as well as the statistical analysis of resulting large data files, which allow the comprehensive screening of all compounds present in a biotic sample. These methods have not before now been applied Union-wide on biotic samples. For example, the use at European scale of non-target screening (NTS) data from AP&P for early warning on presence of chemicals and for mixtures identification, in relation to chemicals addressed by REACH/Biocides, is wholly novel. Existing NTS databanks are largely devoid of data from biota.

Second, our approach in novel Union-wide in the way it seeks, through four ‘Demonstrators’ to focus the use of AP&P chemical monitoring data of four specific regulatory applications for which such data have not before been brought to bear Union-wide, and which together offer considerable potential to enhance protection of human health and the environment. 

These applications relate to:
(1) better identification of chemicals accumulating in the environment through terrestrial, freshwater and marine food webs;
(2) better prioritisation of chemicals for hazard assessment and more informed hazard assessment;
(3) better effectiveness evaluation of risk mitigation and/or restriction measures under REACH and BPR;
(d) and better determination of predominant chemical mixtures in the environment.
Together, these applications will facilitate the assessment of risk at the ‘front end’ of the regulatory process, and also facilitate better understanding as to whether risk management, at the ‘back end’ of the regulatory process, really works in terms of reducing environmental concentrations of and exposures to hazardous chemicals.

Third, LIFE APEX involves a novel, complementary suite of three ‘Key Elements’, which support and sustain the take-up of these novel applications. These ‘key elements; are also new Unionwide.
They are:
(1) the creation of a Europe-wide community bringing together ESBs and NHMs and analytical labs for the provision and analysis of AP&P samples for chemical monitoring regulatory applications;
(2) the promotion of harmonised QA for AP&P sampling, sample treatment and archiving across Europe;
(3) the construction of an APEX KnowledgeBase to provide access to comparable and interoperable data on AP&P samples and related contaminant data from both targeted and NTS analyses.

LIFE APEX will sensitise regulators to the advantages of making more and better use of monitoring data from biota, and in particular from apex predators, for risk assessments and effectiveness evaluation. It will also sensitize regulators to the value of ESB collections and to the complementary value of NHM collections in this regard.