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The ECEAE has this week welcomed the European Union Council of Ministers’ agreement to include five new or revised methods for testing chemicals in its third round of updates to the Test Methods Regulation, the TMR (440/2008). The TMR is the ‘recipe book’ of test methods that can be used for REACH (EU chemical testing programme) and other safety regulations such as cosmetics and pesticides.
Two of the agreed guidelines are in vitro methods which can replace the use of animals in tests for skin irritation and gene mutations that may cause cancer. The remaining three tests are adaptations to a mouse test called the Local Lymph Node Assay that either uses fewer mice or does not involve the injection of a harmful drug.
Test guidelines currently enter the TMR after they have been approved internationally at the OECD. All five methods were adopted and published by the OECD on 23 July 2010. The EU was part of the OECD process and yet it has taken nearly two years to be formally adopted for use in Europe. This is a process that is heavily criticised by the ECEAE as it slows down the implementation of methods that may have actually been developed and validated in Europe. For example, the skin irritation method, updated in this round of approvals to reflect the final OECD version, was originally adopted into the TMR in 2009. It had been validated by the European Centre for Alternative Methods in 2007. Had the Commission not taken the step, following political pressure, to include it earlier, it would have actually taken five years following scientific validation to appear in the TMR.
Dr Katy Taylor of the ECEAE says; “Whilst the ECEAE is pleased to see these methods finally recognised formally in EU legislation, we are dismayed by the time it has taken the Commission and the EU member countries to adopt these new or revised methods. It is inexplicable why something that is a largely bureaucratic process should take nearly two years and unacceptable that during this time animals should continue to suffer and die. In 2009, the Commission promised that it had ‘streamlined’ the introduction of alternative methods into the regulation. But instead, it has actually slowed down! We urge the Commission to speed up the process.”
The tests are:
• An update to the existing local lymph node assay for skin sensitisation resulting in fewer mice to be used, the so called rLLNA (TM B.42)
• An update to the in vitro reconstituted human epidermis (RhE) method which adds two further trademarked methods - Epiderm and Skinethic - and with clearer wording on the use for classification of skin irritation (TM B.46)
• A new in vitro micronucleus test used for genotoxicity, the MNvit (TM B.49)
• A further adaptation to the local lymph node assay using non-radioactive materials, which does not involve mice being injected with a harmful immune system boosting chemical first, the LLNA-DA (TM B.50)
• A further adaptation to the LLNA using a different method of analysis, which does not involve mice being injected with a harmful immune system boosting chemical first, the BrdU-ELISA (TM B.51)