Published in Regulatory Toxicology and Pharmacology, the white paper outlined Humane Society International’s proposal on how the EU’s chemicals regulation REACH could be modernised to accelerate wider use of new approach methodologies (NAMs) and push ahead with a truly animal-free cosmetics testing future.
Animal testing on cosmetic products and ingredients had been banned in the EU since 2013 under the EU Cosmetics Regulation 1223/2009, following initial bans on testing for finished products in 2004 and ingredients in 2009. However, the European Chemicals Agency’s (ECHA) REACH Regulation 1907/2006 still sometimes required animal data – particularly in instances like environmental impact and worker safety.
Since the EU ban, new approach methodologies (NAMs) had fast advanced in the field of cosmetics safety assessment and industry was now determined to push for wider acceptance of these methods under REACH, across all end points tested for safety or risk.
Writing in its white paper, Humane Society International said the adoption of the Chemicals Strategy for Sustainability (CSS) in 2020 that aimed to improve the quality, efficiency and speed of chemical hazard and risk assessments – part of the wider European Green Deal – offered the EU a “golden opportunity to accelerate a transition to animal-free safety”.
Moving beyond a ‘tick-box’ approach
The authors said that whilst REACH had been created to protect human health and the environment with a central aim of doing so via alternatives to animal testing, it had “instead become a long ‘tick-box’ list of in vivo experiments” with questionable relevance to human health outcomes. And this was despite a clear global trend towards new approach methodologies (NAMs) in chemical safety assessment, they said.
As the EU looked to revise its chemicals regulation in light of the Chemicals Strategy for Sustainability (CSS), the authors said proposals presented so far had “significant negative animal welfare consequences”, hence the move by the Humane Society International to issue its own proposal.
“There is still time to correct the course of the ongoing REACH revision,” the animal welfare charity said.
Humane Society International’s proposal was split into three action areas: procedural, technical and structural.
Procedural, technical and structural REACH revisions
On the procedural side, the charity said the European Chemicals Agency ECHA could implement an improved approach to grouping and read-across; create a scientific committee on application of NAMs for chemical safety assessment; and improve reporting obligations and establish reviews.
On the technical side, Humane Society International proposed that ECHA considered redundancy of existing information requirements; increased the use and regulatory acceptance of NAMs; and ensured there were no new or expanded animal testing standard information requirements.
On the structural side, it said ECHA ought to reinforce language around animal testing as a ‘last resort’; optimise the Dossier Review and Substance Evaluation process for existing chemicals under REACH; and implement NAM-based prioritisation and assessment for chemicals by applying a tiered, optimised testing strategy.
Exactly how all of this could be done was outlined in depth throughout the white paper.
Globally speaking and considering all three action areas, though, the authors said the biggest and most impactful change to REACH would be “a complete paradigm shift from the current hazard-driven approach towards a risk-based management of chemicals”.
EU investments and intention
Addressing attendees during a dedicated webinar to present the proposal, Catherine Willett, senior director of Humane Society International, said that despite the European Union investing more than €1 billion in research for non-animal testing over the years, and the initial intention of REACH being very “forward-leaning”, the adoption of NAMs was still “lagging and nearly negligible” under the regulation.
“Now is the time to reassess and re-envision REACH with REACH revision planned under the CSS (…) While we really feel that new thinking is urgently needed, really it’s only through the accelerated science, support and adoption of NAMs that the goals of REACH and aspirations of the CSS can be achieved in our lifetime,” Willett said.
“…The Chemicals Strategy on Sustainability offers a once-in-a-lifetime opportunity to fine tune chemical risk testing in Europe. It’s also an opportunity to capitalise on the investments the EU has made in safety science, specifically its non-animal approaches,” she said.
Willett said industry and the European Chemicals Agency ECHA should also take the REACH revision as an opportunity to “learn from experience” – looking to what has worked elsewhere, notably the US and Canada were guidance language around safety testing was agnostic and there were early-screening NAM-based processes in place.
“While one could argue that the EU has invested more and is potentially the global leader in the science of NAMs testing, it’s far behind the US and Canada on implementing that science,” she said.
Source: Regulatory Toxicology and Pharmacology
Published online ahead of print, doi: 10.1016/j.yrtph.2022.105278
Title: “REACHing for solutions: Essential revisions to the EU chemicals regulation to modernise safety assessment”
Authors: M. Pereira, DS. Macmillan, C. Willett and T. Seidle