Animal vs. non-animal tests for the monitoring of marine biotoxins in the EU

Abstract

Since bivalve molluscs can contain algae biotoxins that can cause gastroenterological or even lethal neurological diseases in humans, a public health control system on marine biotoxins has been implemented in EU Directive 91/492. Currently, the reference method laid down for this purpose is the so-called "mouse bioassay" with death of the animals as an endpoint. To date, this extremely distressful animal test has not been standardised or validated, and there is scientific evidence that it is neither relevant nor reliable. Therefore different EU Member States have been striving to replace the mouse bioassay or to reduce the animal numbers and the distress for the animals. In the United Kingdom, the test is being performed with two instead of three mice, the animals are anaesthetised before injection of the mollusc extract and remain in narcosis until their death. In Germany the mouse bioassay has not been performed for many years; without restriction of consumer health safety, marine biotoxins are detected with chemical analytical test methods. The application of alternative test methods is legally required according to EU Directive 86/609 on the Protection of Laboratory Animals. Apparently there is a conflict between two equal valid EU Directives, which has to be overcome.