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November 18, 2010

HSI Europe: EU Should Protect Consumer Health and Lab Animals with Immediate End to Discredited Animal Tests for Shellfish Poisons

Humane Society International/Europe

Humane Society International/Europe has welcomed news that the EU’s Standing Committee on the Food Chain and Animal Health has voted to largely end lethal animal testing to detect shellfish toxins [1]. However, allowing Member States a three and a half year phase-out period to replace the tests with more reliable non-animal methods is unnecessary and puts consumer health at risk. The delay in introducing the non-animal test is also in breach of EU law [2] , says HSI Europe. Nearly 600,000 mice are used each year in the EU in laboratory tests to detect marine biotoxins. Hundreds of mice per test will have toxins injected into their abdomen resulting in uncontrollable muscle spasm, convulsions, paralysis, coma and death. In the UK the tests are classified as causing the most severe level of animal suffering permissible under the law. The mouse bioassay also has serious scientific limitations. It has never undergone formal scientific validation and its lack of sensitivity means it can’t detect toxins at the levels required by EU regulators to deem shellfish safe for human consumption.

The EU Standing Committee has voted in support of European Commission proposals to end such animal testing for most (but not all) marine biotoxins. A non-animal alternative test exists––the chemico-physical test Liquid Chromatography-Mass Spectrometry (LC-MS)––and has been exclusively used by Germany and New Zealand for many years due to consumer safety and animal welfare concerns [3]. Despite the fact that EU law has long prohibited testing on animals “if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available” [2], once the regulation comes into force in July 2011, Member States are to be given until 31 December 2014 to introduce the non-animal method.

Gemma Buckland, Ph.D., Science Policy Officer for Humane Society International/Europe, says:

"HSI welcomes the EU Standing Committee’s decision to largely end tests that cause thousands of animals such severe suffering. However, allowing member states to continue using the animal test for the next three-and-a-half years despite it being so clearly and consistently scientifically discredited is putting consumer health at unnecessary risk. The European Food Safety Authority, World Health Organisation, Germany’s Federal Institute for Risk Assessment, and even the European Commission have acknowledged the test’s serious limitations. HSI believes swift implementation of ethical and reliable alternative tests is vital to offer consumers protection against food poisoning that can have devastating health impacts. Failure to do so immediately would also breach the European Union’s own law on alternatives to animal testing.”

The Standing Committee has voted in support of a European Commission draft regulation, which calls for an end to the mouse test for lipophilic marine biotoxins. The non-animal LC-MS method will become the reference method for detecting lipophilic toxins. However, the mouse test will continue to be used to detect new and emerging toxins. Member States will also still be allowed to conduct the mouse test to detect PSPs (paralytic shellfish toxins).

The European Food Safety Authority has produced nine reports [4] at the request of the European Commission, all of which highlight the weaknesses of the mouse bioassay. The Commission’s draft regulation clearly acknowledges these scientific weaknesses, stating: “The panel on Contaminants in the Food Chain of EFSA noted that these bioassays have shortcomings and are not considered an appropriate tool for control purposes because of the high variability in results, the insufficient detection capability and the limited specificity.”

If consumed by people, marine biotoxins can cause nausea, vomiting, diarrhoea, neurological problems, and in extreme cases even death. There were 16 deaths from shellfish related food disease (1999-2000) and more than 77,000 cases of reported illness [5].

Nearly 7,000 mice are used annually in the UK for marine biotoxin testing. The Home Office has confirmed to HSI/Europe that it will take every possible step to avoid the transition period and implement the non-animal alternative test as early as January 2011.


Notes to Editors

1. The EU Standing Committee on the Food Chain and Animal Health voted 17 Nov 2010 in support of a draft European Commission Regulation amending Regulation (EC) No 2074/2005 regarding recognised testing methods for detecting marine biotoxins in live bivalve molluscs.

2. Article 7.2 of Directive 86/609/EEC specifies that: “An experiment shall not be performed if another scientifically satisfactory method of obtaining the result sought, not entailing the use of an animal, is reasonably and practicably available.” The Directive is available at http://eur-lex.europa.eu/LexUriServ/LexUriServ.do?uri=CELEX:31986L0609:EN:NOT.

3. The [German] Federal Institute for Risk Assessment (BfR) Expert Opinion No. 032/2005, 26 May 2005 says the LC-MS “offers greater consumer protection and, at the same time, contributes to animal welfare.”

4. EFSA has produced nine reports on request by the European Commission, the first published January 2008 and the last in June 2010. The reports are available at http://www.efsa.europa.eu

5. Disease Risks from Foods, England and Wales, 1996 – 2000, Goutam K. Adak,* Sallyanne M. Meakins,* Hopi Yip,* Benjamin A. Lopman,* and Sarah J. O’Brien; Emerging Infectious Diseases, Vol. 11, No. 3, March 2005.

Humane Society International/Europe and its partner organisations together constitute one of the world's largest animal protection organisations — backed by 11 million people. For nearly 20 years, HSI has been working for the protection of all animals through the use of science, advocacy, education and hands-on programs. Celebrating animals and confronting cruelty worldwide — on the Web at hsieurope.org.

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