Delivering a toxic-free environment

The EU’S upcoming REACH revision will not be complete without new approach methodologies (NAMs)
Title: “NAMs” | Source: Vincent Lacroix

By Eli Hadzhieva

Eli Hadzhieva is Director of the Dialogue for Europe

09 Nov 2021

If there was a lesson learnt from COP26 in Glasgow, it is that we are running out of time to fight climate change and reduce air pollution. This should reinforce the EU’s zero pollution ambitions in the Green Deal and the implementation of its Chemicals Strategy for Sustainability, which aims to deliver a toxic-free environment. Considering that one in 10 premature deaths is caused by chemical pollution, and that global chemicals production is expected to double by 2030, there is an urgent need to ensure that risk and toxicity assessments of chemicals are being made in a fast, reliable and ethical way.

While the EU Strategy aims to eliminate the most harmful chemicals from consumer products, addressing chemical mixtures and promoting innovative assessment methods and their regulatory uptake, it envisages the extension of REACH (Registration, Evaluation, Authorisation and Restriction of Chemicals) Information Requirements.

Currently, an impact assessment and a survey are being conducted by the European Commission, which will form the basis for the REACH revision next year. According to Elisabet Bergren from the Joint Research Centre, the extended REACH may include a Chemicals Safety Assessment for substances produced in 1-10 tonnes per year, chemicals with critical hazards affecting both human health and environment at all tonnage levels and grouping and read-across based on toxicokinetics and modes of action.

“The use of animal testing is not only an ethical but a legal question, which calls for a greater respect of 3R principles (Replacement, Reduction and Refinement) in the next revision of REACH”

The EU Survey is focusing on solutions based on New Approach Methodologies (NAMs), non-animal testing to predict Derived-No-Effect Level for Human Health, Predicted No-Effect Concentration for Environment, Classification and Labelling, Persistent Bio-Accumulative and Toxic Substances and Very Persistent and Very Bio-Accumulative Substances as well as Critical Hazards.

Last week’s kick-off symposium of the ASPIS Cluster, a joint collaboration of the H2020-funded projects ONTOX, PrecisionTox and RISK-HUNT3R representing the EU’s efforts towards a sustainable, animal-free and reliable chemical risk assessments, came in timely as it can largely contribute to the ongoing debate on the REACH revision. The European Commission substantially increased its funding for NAMs, allocating €60m to the ASPIS Cluster for the next five years in comparison to €20m that were earmarked to the EU-ToxRisk project, which is coming to an end.

The shared goal of the ASPIS Cluster, which consists of 70 institutions across 16 countries, is to rely on technological advances, such as genomics, transcriptomics and metabolomics, robust in vitro (test-tube testing) and in silico (computer-based testing) methodologies and Artificial Intelligence analysis strategies. These revolutionary NAM solutions aim to address the thousands of untested chemicals in market products due to the high cost and slow pace of traditional animal testing.

For example, PrecisionTox focuses on non-sentients (organisms, which do not feel pain), such as zebrafish, fruit flies and worms, as a proxy for human cell lines relying on the evolutionary theory and common disease genes found in the phylogenetic tree. This approach, favouring homology rather than analogy, uncovers similar biomolecular toxicity pathways between humans and invertebrate model species without a neuro-central system, as the latter are not classified as animals by law and are not within the scope of the EU animal welfare legislation.

“If we do not adopt these new methods, we will simply lack the ability to protect human health and the environment from the adverse effects of chemicals”

REACH Regulation aims at promoting alternative methods for assessment of hazards of substances and stipulates that animal testing shall be used as a last resort, while the 2013 EU Cosmetics Regulation also introduces a ban on the animal testing. The EU legislation is well advanced in comparison to the rest of the world, as the US, for example, is planning to introduce a ban on animal testing in 2035. Nonetheless, the EU shall continue to play a pioneer role in promoting NAM solutions.

The use of animal testing is not only an ethical but a legal question, which calls for a greater respect of 3R principles (Replacement, Reduction and Refinement) in the next revision of REACH. Especially now that the ASPIS Cluster demonstrates that scientific progress makes it possible to develop NAMs that are not only based on observation but on mechanistic, precise and fast approaches, such as biopathways and biomarkers.

The extended REACH cannot ignore these new realities and NAMs should be rapidly integrated into the EU regulatory system. If we do not adopt these new methods, we will simply lack the ability to protect human health and the environment from the adverse effects of chemicals while failing to achieve the EU objective of a toxic-free environment.


This article reflects the views of the author and not the views of The Parliament Magazine or of the Dods Group

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