Hack to save lives and avoid animal suffering

Explore methods and ideas to accelerate the transition from traditional animal testing to more human-relevant and ethical approaches

EU Citizens’ Initiative “Save cruelty-free cosmetics – commit to a Europe without animal testing”  has put pressure on EU Commission to accelerate the implementation of non-animal and human-relevant testing of chemical substances in the future. 

However, scepticism related to new approach methodologies (NAMs), which include the use of Artificial Intelligence (AI), models with human cell culture (in vitro test methods), and computer-simulated models (in silico test methods), remains, claiming that uncertainties are a specific problem related to the use of NAMs. However, traditional laboratory test using living animals (in vivo test methods) does have similar uncertainties, and there are several examples of diseases caused by chemical exposure which are specific for respective species, e.g., rats versus human being, e.g., Thalidomide caused malformations in babies, neurodegenerative diseases, cancer research, and stroke.

“More than 160 million chemicals are known to humans. About 40 000 to 60 000 of them can be found in commerce; 6000 of these account for more than 99% of the total volume of chemicals in commerce globally. In 2017, the chemical industry was the second largest manufacturing industry in the world, and the trend is going upwards – chemicals sales are projected to almost double from 2017 to 2030”. (Guidance on chemicals and health, WHO)  

Approximately 20 000 chemicals are registered in the EU under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH). However, the number of chemicals constantly increases, and people/the environment are constantly exposed to a mixture of chemicals, leading to health effects (Living healthily in a chemical world, EEA). 

Consequently, the present modus operandi for testing chemicals is not sufficient to secure better protection of European citizens from all existing and new chemicals in the future – the present traditional testing capacity is insufficient and acceptance of using animals for testing decreases. 

However, the industry has experienced in several examples that the present regulations require an increased number of animal studies before chemicals are approved for use in specific applications (pharma, food, cosmetics, biocides, etc.). Alternative test methods, e.g., NAMs, are only fully accepted in relatively few areas, and regulatory authorities have traditionally required validation of NAMs, which includes benchmark with in vivo studies, before acceptance of these news methods. Assumption: Implementation of NAMs by industry is driven by full acceptance by regulatory authorities. 

Discussion

How to drive the transition from animal test of chemicals to full implementation of human-relevant methods, e.g., NAMs addressing:

• Drivers, e.g., align current incentives to apply a probabilistic approach which include to assess exposure, identify the hazard, and perform the risk assessment; 
• Barriers, e.g., are current guidelines and/or political agendas hampering the transition?;
• Do we need risk assessment paradigm shift, and if so – how?;
• Can we enforce equally validation of traditional animal in-vivo tests with NAMs in relation to uncertainties?