First ECHA Report on the use of non-animal test methods under REACH

[Horst Spielmann]

ECHA has today published a unique report on the use of alternatives to testing chemicals on vertebrate animals. This report is a legal requirement of the EU REACH Regulation of Chemicals

The full 69 page report entitled "The use of alternatives to testing on animals for the REACH Regulation 2001" is available at http://echa.europa.eu/doc/117reports/alternatives_test_animals_2011_en.pdf

A 4 page "Report Summary 2011" is available at
http://echa.europa.eu/doc/117reports/summary/alternatives_test_animals_2011_summary_en.pdf

The report is the first provided by ECHA on the use of alternatives to testing on animals since REACH came into effect. Approximately 25 000 registration dossiers submitted from 1 June 2008 until 28 February 2011 were analysed to get an overall picture of the use of animal studies and non-animal methods used. An additional source of information was the ongoing dossier evaluation work, where selected dossiers undergo a compliance check and proposals to conduct tests are examined.

Data sharing is the key mechanism used to avoid unnecessary animal testing and the analysis of the registration data for this report shows that registrants made extensive use of it. Registrants also made full use of the options available in REACH to use alternatives to testing on vertebrate animals. This includes, for example, using existing studies or applying non-test methods to predict properties of substances instead of experimental testing. The report shows that so far very few new animal studies were conducted for the purpose of registering phase-in substances.

However, the more in-depth compliance checks undertaken so far suggest that quite often the justifications provided by registrants for the use of alternative methods fall short of the requirements in REACH. Therefore, ECHA is urging the companies to proactively improve the quality of their dossiers, and especially of the justifications for waiving testing. However, ECHA currently expects that it will have to also request registrants to carry out some new animal tests to ensure the safe use of chemical substances.

Horst Spielmann

[Jessica Sandler]

PETA statement:

This report is the first comprehensive analysis of the effect REACH is having on animals used in laboratory testing and we are gravely concerned.  Many hundreds of thousands of animals’ lives have been spared by the measures that animal groups and others managed to introduce when REACH was going through the legislative process. Data-sharing and the use of techniques such as read-across have prevented a vast amount of duplicative and pointless testing.  But duplicative and pointless testing have still taken place on a shocking scale.  While we welcome the efforts made by companies to reduce animal testing, it is clear that – despite REACH’s fine and welcome words about animal testing being a last resort -- a checkbox mindset is dominating the approach to fulfilling data requirements. Critical mechanisms to avoid animal tests -- in particular weight of evidence arguments -- are available but companies haven't used them sufficiently and the European Chemicals Agency (ECHA) hasn't compelled them to do so.  It is a scandal that an estimated 58,000 animals* have already been killed in tests conducted without the required public consultation on proposals for those tests, and – it would appear – that validated in vitro methods have not been used for skin irritation tests.  To date, an estimated 200,000 animals have been consumed by REACH*.  As the program moves into its next stage, it is imperative that companies use every means available to avoid animal tests and that ECHA step up its game and fulfil this vital responsibility.
 
*European Coalition to End Animal Experiments