Many NGOs and industries have taken a dim view of the European Commission’s public consultation on the upcoming revision of the Registration, Evaluation, Authorisation and Restriction of Chemicals Regulation (REACH ). Containing several biased questions implying that New Approach Methodologies (NAMs) – a wide range of sophisticated solutions replacing and reducing traditional animal testing, including computer-based modeling technologies, in vitro techniques, or alternative model species - will weaken health and environment protection from chemical hazards, and hamper the competitiveness of the EU industry.
“The language of the survey is misleading because it contradicts the tremendous scientific progress in a wide range of fields developing and using NAMs for precision medicine and safety sciences” as highlighted in an open statement by the coordinators of ASPIS, a cluster of three EU-funded projects - ONTOX, PrecisionTox and RISK-HUNT3R- dedicated to tackle the global challenge of chemicals by developing faster and cost-effective novel methods, in cooperation with the EU Joint Research Center.
The precision, speed and in some instances lower costs of NAMs can also address the issue of non-compliance of REACH dossiers
The survey by the Commission revisits the REACH Regulation’s purpose of “promoting alternatives methods (…) while enhancing competitiveness and innovation” (Article 1). It damages the confidence that the research community needs to ensure the uptake of NAMs and maintain Europe’s position as global leader in the protection of the environment and the promotion of ethical standards.
Such a negative wording on NAMs on the eve of an important EU revision may generate legal uncertainties, additional costs, and further delays in market authorisation by preventing evidence-based decision making. This hampers the very competitiveness of the European chemical industries that the Commission is willing to preserve.
In 2013, the EU set an example worldwide by proving that NAMs could replace animal testing with the adoption of the Cosmetics ban. Recently joined by Mexico, 41 countries are now engaged in this change and the United States are seeking to set meaningful objectives with stakeholders for advancing the goals of eliminating animal testing altogether. In the meantime, tests on animals were requested by the European Chemical Agency (ECHA) on ingredients exclusively used in cosmetics despite the ban, causing disruption among scientists, animal protection NGOs and cosmetics companies.
The complex, diverse and disruptive market of NAMs is however expected to grow annually by 10% from 2022 to 2025 worldwide. Backed by research funding programs and legislative changes in countries such as China, Australia or Switzerland, the leadership on NAMs is at stake in the global race for innovation.
The rapid development of NAMs helps address the challenge of assessing the growing number of substances whose toxicity is still unknown. Novel methods complement data on a wider range of health effects uncaptured by traditional animal testing, such as hormonal disruption and liver toxicity, thus filling the knowledge gaps that regulators are facing.
The precision, speed and in some instances lower costs of NAMs can also address the issue of non-compliance of REACH dossiers and support smarter grouping of chemicals for regulation, accelerating the protective benefits of REACH through the “group first – regulate better” approach, as argued in a video released by the PrecisionTox consortium.
In their statement, the ASPIS coordinators renew their commitment to the EU to push the paradigm shift towards precision toxicology and ensure the best protection for humans and the environment. To achieve this goal, researchers need coherent and continual support of EU institutions to maintain trust in scientific discovery.
This article reflects the views of the author and not the views of The Parliament Magazine or of the Dods Group