European Chemicals Agency hosts workshop on New Approach methodologies
European Chemicals Agency (ECHA) hosts multi- stakeholder workshop on ‘New Approach Methodologies: towards an animal free regulatory system for industrial chemicals’
On 31st May and 1st June, the European Chemicals Agency (ECHA – see footnote) hosted a two day workshop to discuss with cross sector stakeholders how to accelerate the transition to a chemicals regulatory system without animal testing. Rebecca Ram represented Lush Prize at the event. Videos and slides of presentations are also available on the ECHA website (see below).
The workshop’s main objectives were to explore opportunities to increase the use of existing NAMs (New Approach Methodologies) in the short term and, in the longer term, how research and regulation can support the transition towards non-animal testing.
The workshop was divided into four sessions over two days. The first session on ‘Hazard assessment for industrial chemicals: regulatory landscape and identifying critical needs’ included speakers from ECHA, the European Commission (DG-ENV, the environmental directorate) and Tilly Metz MEP, followed by perspectives from animal welfare (PETA), as well as the environmental group HEAL (Health and Environmental Alliance) and representing industry, CEFIC (European Chemical Council).
The second session, ‘Opportunities for increasing the use of new approach methodologies under the current chemical regulatory systems‘ heard from expert representatives of the Joint Research Centre (JRC) including on how NAMs can be implemented from the perspective of the ECVAM (European Centre for the Validation of Alternative Methods) as well as better use of validation for regulatory purposes. Further talks were also provided by ECHA and the Commission.
Day two saw sessions on ‘Looking beyond current regulatory settings for a completely animal-free system’ and ‘Challenges and opportunities for implementing new approach methodologies in a regulatory context’, including talks from the DG-GROW directorate of the Commission and the European Partnership on Alternative Approaches (EPAA). Throughout the workshop there were several interesting ‘speaker Q&A’ panels and attendees asked interactive questions, also voting on favoured topics of discussion.
A ‘first of its kind’ event at ECHA, the workshop included 500 attendees (both face-to-face and online) from industry, academia, environmental lobby groups and animal protection NGOs, demonstrating the ever increasing interest in the scientific and ethical need to transition to NAMs.
The workshop follows recent major developments during which the voices of both the EU public and policymakers have been heard on ending animal testing. These include the very successful European Citizens Initiative ‘Save Cruelty-Free Cosmetics —Commit to a Europe without Animal Testing‘, which received more than 1.2 million signatures and which followed the 2021 European Parliament resolution calling on the Commission to coordinate a plan to accelerate the transition to innovation without the use of animals in research, regulatory testing, and education. In a follow up, the European Commission recently announced (at the EPAA conference in Nov 2022) a roadmap for chemicals regulation to fully replace animal testing.
However, despite these positive developments, the workshop also highlighted the widespread concerns from animal protection NGOs and other stakeholders over forthcoming revisions to the REACH and CLP regulations, which will greatly increase information requirements and lead to dramatic rises in animal testing. These include controversial animal tests for endocrine disruption which have long been considered a ‘black box’ in toxicology. These include the Uterotrophic Bioassay in Rodents (OECD TG 440) and Hershberger Bioassay in Rats (OECD TG 441) which, aside from major animal welfare issues, provide poor reproducibility. Revisions to increase the information required for low tonnage substances under REACH are at great risk of triggering new in-vivo tests in animals too.
These major revisions, including additional information requirements for registration (under REACH) and hazard classification (under CLP) are a result of the objectives under the new Chemical Strategy for Sustainability (CSS). The CSS describes the EU’s ‘zero pollution’ ambition – a key commitment of the European Green Deal – and “aims to better protect citizens and the environment from harmful chemicals, and boost innovation by promoting the use of safer and more sustainable chemicals.”
With the right investment and stakeholder alignment, NAMs offer the potential for more robust and comprehensive safety data packages. At the workshop there was therefore strong argument from cross sector and industry stakeholders who are already invested in NAMs that the way to meet the CSS objectives is to; i) use existing NAMs and; ii) drive the development of new ones to identify chemicals that are more safe and sustainable by design, while also ‘future proofing’ the language of chemicals regulations to make them dynamic and open to NAMs as science advances and more become available. Furthermore, the business opportunities offered by a transition to NAMs innovation have yet to be fully recognised.
However, as also highlighted at the workshop, there is still firm resistance by some stakeholders to the use of NAMs, with the misconception that they would weaken protection levels for human health and the environment, resulting in a preference to continue reliance on (and increase use of) animal tests, despite their well known limitations.
There is also a general ‘comfort zone’ reluctance to move away from animal tests due to convention and tradition and so an urgent need to change mindsets persists. The fact that the infrastructure of many labs and research establishments are set up for the repeated purchase, housing and use of animals, as well as many other commercial and business factors are something that must also be addressed.
ECHA closed the workshop by remarking on the commitment to move towards animal-free chemical safety, whilst noting the different perspectives and understanding of ‘NAMs’.
A challenge remains in that there are differing definitions of ‘New Approach Methodologies’ which even include animal in-vivo tests in some cases. This has led to use of the term ‘NAMs’ by some NGOs to clearly indicate exclusively ‘Non-Animal Methods’.
Positively, a closing poll at the event showed that 75% of attendees felt ‘more confident’ that animal testing can be replaced with non-animal methods and that increasing confidence in these methods is critical to achieve the scientific transition that is urgently needed, for people and animals.
To see the ECHA workshop in full or easily select sections of choice, the interactive agenda , slides and video presentations see here.
Footnote: ECHA is the competent authority responsible for the EU chemical strategy and for major chemicals legislation including the REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) and CLP (Classification, Labelling and Packaging) regulations.