One Europe
Environmental Risk Assessment (ERA) in Europe is based primarily on the three basic environments which exist:
-Aquatic (Freshwater)
-Sediment (Freshwater)
-Terrestrial
Because the ERA framework was primarily developed for use in the evaluation of plant protection products, these three environments were chosen to assess impact on the environment in a generic approach. Now that Regulatory Science has moved on, and we have begun to assess pharmaceuticals, industrial chemicals and cosmetics against this same framework, how well does it simulate reality?
Furthermore, how well do these environments reflect European exposure in places where large water bodies, green fields and permanent sediment systems just do not exist? And how about those places where Marine environments have the same exposure as the traditionally used freshwater systems?
In a Regulatory Framework where one approach applies to the whole of Europe, should individual member states have the opportunity to demand more relevant environmental testing which better reflects their own, equally important environments?
Individual Ecosystems
Each individual ecosystem is unique, and of course it is not viable or even desirable to test each individual species and ecosystem but there is a great difference between the water courses of the green North (The Netherlands and Germany, for example) when compared with the arid Southern Isles in which there is little and perhaps only seasonal freshwater and a much greater coastal footprint per square kilometre than land-locked Mainland Europe.
When Regulatory Frameworks focus on large freshwater systems and species of larger freshwater fish, such as Trout, this has little relevance to Garrigue systems where plant and terrestrial life dominates.
The Financial burden versus Market Access
Of course, if we advocate each member state demanding their own suite of testing, the financial burden of registration would increase for industry and there would be the potential for an increase in the numbers of animals used. There may also be restricted market access for smaller, niche areas of Europe as industry elects to avoid testing by retracting from those markets. This is precisely why a consolidated registration system was adopted in the EU.
Equally, the risk to a specific environment such as a marine reef, cannot simply remain unevaluated because the regulatory framework was never established to address such a risk.
One Europe
The solution only exists at the European level. The current REACH Framework holds no place for Marine assessments in the standard submission and rarely is there a need to test on terrestrial organisms because predicted exposure is low (based on the Northern-biased framework). This poorly reflects the landscapes of Southern Europe and in particular the Mediterranean islands.
The interests of Europe are upheld by Europe and as such, the next stage of Environmental Assessment for regulations such as REACH, Pharmaceuticals and Biocides should perhaps look to broaden the scope of assessment in such aspects of ecosystems as non-target plants (selected from wild-type indicator species rather than commercial crop species), terrestrial invertebrates (of arrid as well as moist environments) and Marine ecosystems such as sea-grass planes and places of coral habitation.
As we move towards a more protective future, Europe should not forget the fringes of its environment. In the race to become more protective through higher tier testing, thought should be given to the breadth of data available to date and the applicability of that data to the whole of the European Environment.
Life exists beyond the reaches of the great European watercourses and each ecosystem should hold the same level of protection as the next.