Led by France, the European Chemicals Agency (ECHA) and other European Union (EU) member states are working on new guidance to assess antimicrobial resistance (AMR) patterns in biocidal active substances and products.
Wim De Coen, head of unit, hazard assessment and scientific coordination at ECHA, predicted the guidelines will be ready for publication by the end of this year during a recent webinar.
De Coen is also chief editor of ECHA’s Key Areas of Regulatory Challenge (KARCs) document, the updated version of which came out on 12 June 2024. De Coen was joined on the webinar by other ECHA officials, as well as by representatives from the European Food Safety Authority (EFSA) and the European Environment Agency (EEA).
“The possible development of [antimicrobial resistance (AMR)] is actually not a standard assessment criterion for biocidal products, but if information is available, it is taken into consideration,” he told the audience.
De Coen said ECHA was also working on azole-resistant patterns toward Aspergillus fumigatus, which is known to cause an infection called aspergillosis among humans. Triazole antifungal drugs, or azoles, are used to treat this infection. But if the strain of A. fumigatus is resistant to the medication, treatment can be difficult, according to the European Centre for Disease Prevention and Control (ECDC). A. fumigatus also affects plants, for which fungicides are used. Azole compounds used in both antifungal medication in humans and fungicides in plants are chemically similar, according to the U.S. Centers for Disease Control and Prevention (CDC).
AMR Tops Research Priorities
In terms of its environmental monitoring, the effect and spread of AMR tops the research priorities at the EEA. Nadia Cerioli, chemical expert at the environmental agency’s Biodiversity, Health, and Research Program, emphasized the need to investigate the link between environmental quality standards (EQS) and the minimum inhibitory concentration (MIC) of an agent (antibiotic) that inhibits growth of the targeted microbe (bacteria).
Cerioli said that even though AMR research has advanced in human health and food sectors, the environmental aspect is lagging. “A key and unknown risk is that antimicrobial resistance or antibiotic resistance genes can be transmitted through the environment and back to the people,” she said.
She pointed to a revision of the EU Wastewater Treatment Directive that would add AMR to the watch list for emerging pollutants, while pointing out its unclear timeline.
Cerioli also specified the EEA’s need to investigate the link between climate change and chemical-induced effects on surface water and groundwater. She said that there is a “poor understanding” of the impact that extreme weather and climate events like droughts and flooding, along with excessive extraction of groundwater, have on water quality, except in catastrophic events.
She also spoke about her agency’s efforts to monitor persistent organic pollutants (POPs) in European soils, saying that EEA is working to publish a working paper outlining current knowledge about the exposure and biodiversity and ecosystem effects of POPs in soils across the EU. The report will be based on a review of large-scale studies and case studies from academia and the agency. The EEA’s goal is to map POPs’ contamination in soils and maybe other metrics, such as suspended particles in surface water.
‘A REACH For Polymers?’
One other hot topic that was raised during the discussion was polymers, recapping some of the points made in the KARCs document. The outgoing European Commission (2019–2024) pushed ECHA to work on a legal framework to assess the hazards of polymers, which are the building blocks of plastics.
“There’s a lot of discussion ongoing whether [polymers should become part of Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization, and Restriction of Chemicals (REACH)] or we should work toward a REACH for Polymers, but that is currently not decided yet,” De Coen said. He noted that polymers are currently exempt in terms of registration under REACH.
As with the last two iterations of the KARCs document, De Coen said that ECHA urgently needs methods to assess polymers’ bioavailability, their stability (breakdown products), and their hazard properties both for humans and the environment.
Polymers often comprise different molecular weight (MW) fractions due to their varying molecular masses and desired properties. This complicates the interpretation of bioavailability and hazard assessment for regulatory purposes, according to the November 2023 edition of the KARCs document.
Last year, ECHA put together the restriction on the use of intentionally added microplastics in products, including turf, cosmetics (like microbeads used in exfoliation), detergents, glitter, fertilizers, plant protection products, toys, medicines, and medical devices. It came into force in October 2023.
Polymeric PFAS Degradation in Environment?
EEA chemical expert Cerioli said that per- and polyfluoroalkyl substance (PFAS) polymers are exempt from REACH registration, so there is limited information on PFAS in use and their presence in the environment, which can be degraded into smaller PFAS compounds that can be taken up by living organisms. “It is therefore necessary to develop and use analytical methods that are able to detect other PFAS compounds than those typically included in the environmental monitoring program,” she said on the webinar hosted by ECHA.
As PFAS polymers may act as continuous source of release of PFAS degradation products, potentially polluting soil, surface water, drinking water sources, and food sources, the topic is closely linked to key EU chemical legislations, according to Cerioli.
“More research is needed to understand the potential long-term impact on the environment exposure of PFAS polymers,” she said.
New Approach Methods (NAMs)
De Coen, the chief editor of ECHA’s KARCs document, suggested using NAMs for assessing hazards and risks of polymers as much as possible.
“Let’s start to use NAMs to prioritize and screen the most hazardous or at least the polymers of concern, and where possible, also allow NAMs for risk assessment,” said De Coen. “There is nothing that says that it cannot be done.”
Not for classification, though. He said that using NAMs for classification would be a “long jump” for the moment, citing the current system’s use of adversity as its basis.
Also, he emphasized the urgent need to develop new or improve existing NAM-based assays, both EATS and non-EATS, in the realm of endocrine disruption, for invertebrates. EATS stands for estrogen, androgen, thyroid, and steroidogenesis.
“We have a very, very underdeveloped set of assays” in this area, he added, looking at invertebrates as an important class of organisms in terms of biodiversity and ecosystem in light of the EU’s One Heath perspective.
‘Early Warning System’ To Catch Chemicals
Magnus Løfstedt, EEA’s expert on chemicals, environment, and health, said that there are chemicals that can slip through the safety net of REACH registrations and EFSA assessments, posing a risk. He mentioned a legislative proposal in progress at the EU level that would establish an early warning system to catch chemicals before they escape into the ecosystems and human bodies.
This early warning system was developed under PARC, a project Løfstedt is also involved in, he said during the webinar.
PARC is a seven-year EU-wide research and innovation program under Horizon Europe, which aims to advance research, share knowledge, and improve skills in chemical regulatory risk assessment. ECHA is also part of the program.
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