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Alternatives to the detection of algae toxins in mussels

09/2005, 08.04.2005

BfR recommends modern detection methods in order to reduce the number of animal experiments

For the purposes of food surveillance, living mussels are examined for algae toxins, so-called marine biotoxins, during production and marketing. The use of a test in mice as a routine reference method for the detection of these algae toxins has been criticised by the Federal Institute for Risk Assessment (BfR). In order to reliably detect the toxins, the Institute believes chemico-physical measurement methods are the more suitable methods. These are scientific methods which have been validated using international criteria which make it possible to largely do without animal experiments in mice. "The methods have been routinely used in Germany since the end of the 1980s without compromising consumer protection", says BfR President Professor Dr. Dr. Andreas Hensel. Now, it was important to take the necessary steps to have the methods recognised by the European authorities, too, to allow the test to replace the test in mice as the routine method in future. Furthermore, every effort should be made on the European level in order to ensure that as quickly as possible it will be possible, in principle, to do without animal experiments for the detection of algae toxins in mussels.

Marine biotoxins are poisonous substances produced by algae which can be taken up by the mussels and then accumulate in their tissue. If human beings ingest these toxins whilst eating mussels, this can lead to diseases like diarrhoea or paralysis and, in more serious cases, even to death. In order to protect consumers from these toxins, living mussels are examined for marine biotoxins within the framework of food surveillance. Special provisions apply in the European Union to these examinations which routinely stipulate a test in mice. It involves injecting a prepared extract from the mussel tissue into the abdominal cavity of mice. The death of the mice is taken as positive evidence of the presence of marine biotoxins.

In Germany chemico-physical methods are used and animal experiments are only undertaken in borderline cases. This is explained by the claim to use scientifically validatable methods and to apply German animal protection law according to which animal experiments may not be conducted when there are scientifically satisfactory, defensible and practical alternatives. This corresponds to the provisions of the European Directive regarding the protection of animals used for experimental purposes. The most progress has been made in the development of chemico-physical methods based on high pressure liquid chromatography (HPLC) in which the highly sensitive measurement instruments indicate the presence of toxins.

BfR is of the opinion that the chemico-physical measurement methods are superior to the test in mice and more suited to ensuring reliable consumer protection. In contrast to these alternative methods, the mice test is a method which has not been checked or standardised in line with scientific criteria.

BfR suggests first examining mussel samples with the existing chemico-physical methods for the incidence of marine biotoxins. Only if the result is unclear and further clarification is needed in the interests of consumer protection, should the test in mice be used as the reference method.

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Miscellaneous

 (1)
Date Title Size
07.04.2005
Position Paper Nr. 013/2005 of the BfR
Analysis of Marine Biotoxins - Approaches to Validation and Regulatory Acceptance of Alternative Methods to the Mouse Bioassay as method of Reference 194.0 KB
PDF-File

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