Experiences of the REACH testing proposals system to reduce animal testing

Abstract

In order to reduce animal testing, companies registering chemical substances under the EU REACH legislation must propose rather than conduct certain tests on animals. Third parties can submit 'scientifically valid information' relevant to these proposals to the Agency responsible, the European Chemicals Agency (ECHA), who are obliged to take the information into account. The European Coalition to End Animal Experiments (ECEAE) provided comments on nearly half of the 817 proposals for vertebrate tests on 480 substances published for comment for the first REACH deadline (between 1 August 2009 and 31 July 2012). The paper summarises the response by registrants and the Agency to third party comments and highlights issues with the use of read across, in vitro tests, QSAR and weight of evidence approaches. Use of existing data and evidence that testing is legally or scientifically unjustified remain the most successful comments for third parties to submit. There is a worrying conservatism within the Agency regarding the acceptance of alternative approaches and examples of where registrants have also failed to maximise opportunities to avoid testing.

Rapid hazard characterization of environmental chemicals using a compendium of human cell lines from different organs

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that encourage the use of alternative test methods for hazard and risk assessment applications, such as read-across, prioritization, and screening (ECHA, 2016; US EPA, 2018;Taylor et al, 2014). Novel analytical and in vitro data, now commonly referred to as new approach methodologies (NAMs), are being used in support of regulatory decisions (Kavlock et al, 2018;Paul Friedman et al, 2020); however, concerns about the limitations of NAMs in decision-making also have been voiced (Gocht et al, 2015;Berggren et al, 2015).

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New European Union statistics on laboratory animal use – what really counts!_suppl

“…64 − Laboratory capacity in Europe has been reached, explaining the astonishingly stable numbers, and additional testing has been exported to other countries, especially China and India, and is thus not accounted for in the statistics. − A lot of testing is still to come: This holds true as completeness checks by ECHA, which shall be launched only in April 2020 65 , and the majority of accepted testing proposals (Taylor et al, 2014) have yet to be executed. Our own analysis of the testing proposals for developmental and reproductive toxicology for the first deadline alone (Rovida et al, 2011) suggested up to 1.6 million animals just for these endpoints.…”

How Long Must They Suffer? Success and Failure of our Efforts to End the Animal Tragedy in Laboratories

“…A further specification is given in Article 13, paragraph 1: In particular for human toxicity, information shall be generated whenever possible by means other than vertebrate animal tests, through the use of alternative methods… But, in reality, the application of the REACH Regulation has been disappointing. The European Chemicals Agency (ECHA) is very conservative when it comes to accepting the use of alternative methods by applicants, and it often demands that animal tests are conducted instead (43). To date, about 400 animal tests have been performed, without going through the proper consultation process (44).…”

“…As a result, the 2014 ECHA report shows that, since 2009, more animal Including comprehensive lists of requirements to be fulfilled and functions to be performed tests than in vitro tests were carried out in experimental studies (Figure 6). The almost 5,000 animal tests mentioned had doubled since the last report of 2011, and it represents the use of a total of at least 700,000 animals (43).…”