The Revision of EU Chemicals Legislation as a step towards human-relevant, new approach methods

24 Oct 2022
Experts on New (non-animal) approach methodologies (NAMs) informed the Intergroup on Animal Welfare that it is high time we moved away from using animals in laboratory testing.

Chaired by MEP Tilly Metz (the Greens/EFA, LU), the Intergroup heard from a variety of speakers, bringing innovative solutions for alternatives to animal testing. Elisabeth Berggren  from the European Commission’s Joint Research Centre provided a vision for what“Chemicals 2.0” could look like; with the proposal of a pragmatic, long term and robust chemical safety strategy,  by categorising and testing substancesaccording to concern, with  a “phase-out” period,  to immediately reduce and ultimately  replace animal testing, while maintaining full protection for human health and the environment. 

Ms Berggren also proposed a ‘less is more’ approach by focusing on an optimal combination of highly standardised and widely available  NAMs for classification and labelling, allowing for consistency in the assessment and regulatory certainty in the decision. With regard to NAMs for risk assessment , Ms Berggren explained how a  more flexible system could be established, allowing companies to develop their own bespoke solutions and combinations of methods , with requirements in place for harmonised guidance on performance characteristics.

A presentation by Dr Julia Fentem of Unilever aligned very well with  the strategy proposed by t Ms Berggren, by highlighting five different solutions to move away from animal testing.

According to Dr Fentem, the most relevant safety science  data must be used for decision-making to better protect citizens and the environment.. There is a need to transform the way the safety of chemicals is assessed for regulatory decision-making to “close the gap” between companies using NAMs and those in government responsible for public health,who still largely insist on data from animal tests and maintain a ‘tickbox’ approach. Furthermore we must be critical and objective in choosing the best models for assessing chemical safety, also being consistent and progressive in approaches across cosmetics ingredients and other chemicals.. Importantly, Dr. Fentem also explained how next generation risk assessment (NGRA) does not seek to mimic the flawed results of animal tests. Instead new approach methods in NGRA provide better quality, mechanistic and human-relevant data, which can be used to full effect by defining and executing a Roadmap to phase out animal testing for chemical regulatory purposes.

Giving an academic perspective on the situation, Professor Tarazona, from the Instituto de Salud Carlos III, Ministry of Science and Innovation, Spain, opts for both an ‘evolution and revolution’ approach to moving away from animal testing. He suggests, on the one hand, maintaining the current paradigm for selecting a dose/exposure level considered safe. And on the other hand to “think outside the box” based on a new brainstorming exercise, considering the methods and scientific knowledge available today, to develop new paradigms for safety assessment. For example, assessment of genotoxicity, focusing on mechanisms and starting with in vitro methods.  Prof. Tarazona also explained how the vast majority of toxicology-  though performed in vitro (approx 80%), does not get used in chemical safety assessments (with the exception of genotoxicity)

Dr Sylvia Escher, Fraunhofer ITEM also spoke of the need for the  ‘evolution and revolution’ approach. Dr Escher gave a joint presentation with Konstantinos Paraskevopoulos from EFSA. They discussed the revolution of NAMS via the implementation of the EFSA roadmap, which they predict to be achieved by 2027 - transitioning from animal tests to new approach methods, driven by robust evidence and case studies

MEPs present and online were highly engaged in all presentations and discussion, raising questions concerning how long the process continues to take in achieving the paradigm shift towards NAMs .Other points raised included current activity  in countries such as the US in relation to integrating NAMS from MEP Petras Austrevicius (Renew, LT), highlighting how  in fact NAMs activity in North Carolina is leading the way, as well as Canada. MEPs agreed that there is a need for the EU to learn from our partners across the pond to drive harmonised approaches to chemical safety testing.

Michal Weizik, MEP (Renew, SK) questioned whether there was resistance from within the system to change. Dr Fentem reacted, saying that we are indeed facing a cultural mindset challenge and must continue to actively address this, while also being encouraged that that the new generation of young scientists are  different, as they continue to more readily embrace NAMs.

The Intergroup Working Group on Animals in Science will be working hard on this topic until the end of this legislative term, and all Members of the Intergroup are invited to join this working group and contribute to the transition to non-animal testing. 


Bridging science with policy and legislation: What does Chemicals 2.0 look like? 

Safer Chemicals: regulatory use of modern animal-free safety science, not more animal testing, will better protect citizens and the environment

Alternative Methods for Next Generation Chemical Risk Assessments; an Academic View

Paradigm change in risk assessment – alternative methods to replace animal studies