The 1st of June 2022, marked the 15th anniversary of introduction of the REACH Regulation on the Registration, Evaluation, Authorisation and Restriction of Chemicals. In a webinar event last week, policy makers and experts came together to discuss its revision, as part of the Commission's European Chemical Strategy for Sustainability, which aims to achieve the zero-pollution by 2050.
Host of the event Swedish S&D deputy Jytte Guteland, and experts in the field of precision toxicology discussed both the regulatory and scientific progress made up to now, to protect human health and the environment from the adverse effects of chemicals.
However more needed to be done. "Despite what is probably the most stringent chemical regulation in the world and the tremendous work of the various EU regulatory agencies, over the last 15 years, only a small fraction of chemicals has adequately been tested for safety in the EU," said Guteland.
The current regulatory system is falling short to adequately protect consumers from the harmful effects of chemicals. We do have an opportunity now to try and get the regulatory system right.
There are over 10,000 data-poor substances that must be evaluated (REACH, Annex VII), and the global production of chemicals is expected to double by 2030. “If we want to protect humans and the environment, we need to understand the way in which chemicals cause harm” explained Leonie Mueller, ecotoxicologist for the Belgium SME Altertox.
Most methods used to detect toxicity to humans rely on tests conducted on mammals. Toxicological trials to be REACH compliant can cost between €2 million and €6 million per substance. They are also time-consuming, condemned by many EU citizens who are concerned about animal welfare, and can sometimes fail to demonstrate toxicity in humans. Animal tests cannot be scaled up to the required degree necessary to address the chemical pollution problem.
“The current regulatory system is falling short to adequately protect consumers from the harmful effects of chemicals. We do have an opportunity now to try and get the regulatory system right. Alternative solutions need to be integrated into the new forthcoming regulatory regime.” said Robert Lee, legal scholar from the University of Birmingham, and member of the EU-funded project PrecisionTox which develops next generation test methods without using animals to accelerate the evaluation of chemicals.
According to a recent report by the Lancet Commission on Health and Pollution, chemical pollution caused 1.8 million deaths worldwide. Despite this alarming figure, experts believed it should not mean that serious health consequences and the burden of diseases also double – as long as we improve our knowledge and regulation of chemical hazards and reduce risks from exposure.
“There has been a biomolecular data revolution that now allows us to move away from observational toxicology testing and adopt modern toxicity testing strategies in regulatory science” said John Colbourne, evolutionary biologist and coordinator of PrecisionTox.
New Approach Methods, Omics data and biomarkers can provide new types of scientific data that industry and their regulators need to better understand human biology and how it is impacted by toxicity, explained Laura Holden, from the University of Birmingham Law School. Many of these innovations are created in Europe, and several of these breakthrough technologies are being applied by dynamic European SMEs, startups and research organisations that are paving the way toward precision toxicology.
The EU is seen as an example worldwide regarding the protection of the environment and animal welfare. Article 25 of REACH contains both of these aims by promoting risk assessment methods to precisely replace, reduce and refine animal testing, according to the 3Rs principles. However, REACH dossiers submitted by industries attempting to avoid animal testing are often rejected.
Dutch GUE deputy Anja Hazekamp deplored the European Chemical Agency, ECHA, for not adopting Non-Animal Methods (NAMs) as much as the European Food and Safety Agency. NAMs can also speed up the evaluation of chemicals and increase safety suggested Luxembourg Greens deputy Tilly Metz
This opportunity for better regulation and a healthier environment cannot be missed. Alternatives to animal testing must receive the attention that they deserve in the implementation of the EU chemicals strategy
As part of the European Chemical Strategy for Sustainability, several actions are planned, including banning the most harmful chemicals from consumer products, accounting for the mixture effects of chemicals, or phasing out Perfluoroalkyl chemicals. However without sufficient data, neither harmful chemicals nor safety exposure thresholds can adequately be identified in a timely manner.
The upcoming revisions of the Classification Labelling and Packaging Regulation and the REACH Regulation will be decisive milestones to ensuring that the ambition of the Commission is met while European citizens are adequately informed to access safer and ethical products. This is an opportunity for EU decision-makers to integrate NAMs and data produced by research in the field of omics into the EU laws and increase the capacity of regulators to identify, monitor and control harmful chemicals.
“This opportunity for better regulation and a healthier environment cannot be missed. Alternatives to animal testing must receive the attention that they deserve in the implementation of the EU chemicals strategy” said Guteland.
This article reflects the views of the author and not the views of The Parliament Magazine or of the Dods Group