Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop

Westmoreland, Carl; Bender, Hans; Doe, John; Jacobs, Miriam N.; Kass, George E.N.; Madia, Federica; Mahony, Catherine; Manou, Irene; Maxwell, Gavin; Prieto, Pilar; Roggeband, R.; Sobański, Tomasz; Schütte, Katrin; Worth, Andrew; Zvonar, Zvonimir; Cronin, Mark T.D.

doi:10.1016/j.yrtph.2022.105261

Cited by 51 publications

(17 citation statements)

References 20 publications

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“…Unilever has focused its input around accelerating the regulatory use of NAMs, and in ensuring that the need for any animal testing can be clearly and transparently justified, both by registrants and the ECHA, as complying with the Article 25 “as a last resort” principle. The scientific proposals, 34,35 advocacy and stakeholder discussions, involving many organisations, are now having a positive impact on the intent and direction of the REACH and CLP changes. In December 2022, the European Commission published its proposal for a revision of the CLP regulation; the technical annexes include the ability to use non-animal data as evidence.…”

Section: Chemicals Regulations: Ensuring Animal Testing Is Only Ever ...mentioning

confidence: 99%

The 19th FRAME Annual Lecture, November 2022: Safer Chemicals and Sustainable Innovation Will Be Achieved by Regulatory Use of Modern Safety Science, Not by More Animal Testing

Fentem

2023

Altern Lab Anim

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The decisions we make on chemical safety, for consumers, workers and the environment, must be based on the best scientific data and knowledge available. Rapid advances in biology, in cell-based technologies and assays, and in analytical and computational approaches, have led to new types of highly relevant scientific data being generated. Such data enable us to improve the safety decisions we make, whilst also enabling us to avoid animal testing. Stimulated by the UK and EU bans on animal testing for cosmetics, Next Generation Risk Assessment (NGRA) approaches, which integrate various types of non-animal scientific data, have been established for assessing the safety of chemical ingredients used in cosmetics and other consumer products. In stark contrast, the chemicals regulations in Europe and other parts of the world have not kept pace with modern safety science and regulators are now mandating even more animal testing. Urgently closing this science–regulation gap is essential to upholding the EU’s legislative requirement that any animal testing is a last resort. The ongoing revisions of UK and EU chemicals strategy and regulations provide an opportunity to fundamentally change the design and assessment paradigm needed to underpin safe and more sustainable innovation, through applying the best science and tools available rather than continuing to be anchored in animal tests dating back many decades. A range of initiatives have recently been launched in response to this urgent need, in the UK as well as in the EU.

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Section: Chemicals Regulations: Ensuring Animal Testing Is Only Ever ...mentioning

confidence: 99%

The 19th FRAME Annual Lecture, November 2022: Safer Chemicals and Sustainable Innovation Will Be Achieved by Regulatory Use of Modern Safety Science, Not by More Animal Testing

Fentem

2023

Altern Lab Anim

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“…Although NAMs have been increasingly used in chemical risk assessments, gaps still hinder the use of data derived from NAMs in regulatory decision‐making, including a lack of confidence among stakeholders when using safety data derived from NAMs for chemical registrations (Gellatly & Sewell, 2019). Collaborative efforts of stakeholders from the public and private sectors are needed to gain more confidence in utilizing information derived from innovative methods, such as NAMs, in chemical registrations (Westmoreland et al., 2022).…”

Section: Risk Assessment and Management Of Biocidal Active Substances...mentioning

confidence: 99%

Biocidal products: Opportunities in risk assessment, management, and communication

et al. 2023

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In the coronavirus disease 2019 era, biocidal products are increasingly used for controlling harmful organisms, including microorganisms. However, assuring safety against adverse health effects is a critical issue from a public health standpoint. This study aimed to provide an overview of key aspects of risk assessment, management, and communication that ensure the safety of biocidal active ingredients and products. The inherent characteristics of biocidal products make them effective against pests and pathogens; however, they also possess potential toxicities. Therefore, public awareness regarding both the beneficial and potential adverse effects of biocidal products needs to be increased. Biocidal active ingredients and products are regulated under specific laws: the Federal Insecticide, Fungicide, and Rodenticide Act for the United States; the European Union (EU) Biocidal Products Regulation for the EU; and the Consumer Chemical Products and Biocide Safety Management Act for the Republic of Korea. Risk management also needs to consider the evidence of enhanced sensitivity to toxicities in individuals with chronic diseases, given the increased prevalence of these conditions in the population. This is particularly important for post‐marketing safety assessments of biocidal products. Risk communication conveys information, including potential risks and risk‐reduction measures, aimed at managing or controlling health or environmental risks. Taken together, the collaborative effort of stakeholders in risk assessment, management, and communication strategies is critical to ensuring the safety of biocidal products sold in the market as these strategies are constantly evolving.

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“…The adoption of NAMs has certainly increased and is currently employed to inform decision making at EU and industry levels. Moreover, the movement towards non-animal testing approaches has increased the application of NAMs [ 8 ]. Among these approaches are omics technologies, for example metabolomics, proteomics and transcriptomics.…”

Section: Introductionmentioning

confidence: 99%

Molecular Responses of Daphnids to Chronic Exposures to Pharmaceuticals

O’Rourke

Engelmann

Altenburger

et al. 2023

IJMS

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Pharmaceutical compounds are among several classes of contaminants of emerging concern, such as pesticides, heavy metals and personal care products, all of which are a major concern for aquatic ecosystems. The hazards posed by the presence of pharmaceutical is one which affects both freshwater organisms and human health—via non-target effects and by the contamination of drinking water sources. The molecular and phenotypic alterations of five pharmaceuticals which are commonly present in the aquatic environment were explored in daphnids under chronic exposures. Markers of physiology such as enzyme activities were combined with metabolic perturbations to assess the impact of metformin, diclofenac, gabapentin, carbamazepine and gemfibrozil on daphnids. Enzyme activity of markers of physiology included phosphatases, lipase, peptidase, β-galactosidase, lactate dehydrogenase, glutathione-S-transferase and glutathione reductase activities. Furthermore, targeted LC-MS/MS analysis focusing on glycolysis, the pentose phosphate pathway and the TCA cycle intermediates was performed to assess metabolic alterations. Exposure to pharmaceuticals resulted in the changes in activity for several enzymes of metabolism and the detoxification enzyme glutathione-S-transferase. Metabolic perturbations on key pathways revealed distinct groups and metabolic fingerprints for the different exposures and their mixtures. Chronic exposure to pharmaceuticals at low concentrations revealed significant alterations of metabolic and physiological endpoints.

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Use of New Approach Methodologies (NAMs) in regulatory decisions for chemical safety: Report from an EPAA Deep Dive Workshop

Cited by 51 publications

References 20 publications

The 19th FRAME Annual Lecture, November 2022: Safer Chemicals and Sustainable Innovation Will Be Achieved by Regulatory Use of Modern Safety Science, Not by More Animal Testing

The 19th FRAME Annual Lecture, November 2022: Safer Chemicals and Sustainable Innovation Will Be Achieved by Regulatory Use of Modern Safety Science, Not by More Animal Testing

Biocidal products: Opportunities in risk assessment, management, and communication

Molecular Responses of Daphnids to Chronic Exposures to Pharmaceuticals

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